chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product confusion, Wrong product administered
Clinical narrative: wrong vaccine administered; product confusion; No additional AE reported; This spontaneous report was received from a registered nurse and refers to a 2-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On an unknown date in 2022, the patient was accidentally vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, lot #, expiration date and route of administration were not provided) instead of receiving planned vaccination with either pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (strength, dose, formulation, lot #, expiration date and route of administration were not provided) or pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) pre-filled syringe (strength, dose, lot #, expiration date and route of administration were not provided) (Wrong product administered, Product confusion). No adverse events were reported (No adverse event).
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Caller stated the patient is now 24 years old and had bloodwork drawn for his new job which showed "no antibodies to varicella".; This spontaneous report has been received from a pharmacist referring to a 24-year-old male patient. The patient's previous drug reactions or allergies were not reported. His concurrent conditions included gastrooesophageal reflux disease, autism spectrum disorder, and hypothyroidism. The patient's medical history included drug hypersensitivity to azithromycin (ZITHROMAX). As concomitant therapies included levothyroxine and dicycloverine hydrochloride.  On 27-MAY-1999, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) at a dose of 0.5 milliliters for prophylaxis (vaccination scheme, frequency, route of administration, anatomical site of injection, lot number, and expiration date were not reported).  On 27-MAR-2007 the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) at a dose of 0.5 milliliters for prophylaxis (vaccination scheme, frequency, route of administration, anatomical site of injection, lot number, and expiration date were not reported).  On an unknown date, the patient had a bloodwork drawn for his new job which showed no antibodies to varicella (antibody test negative). The outcome of antibody test negative was not provided.  The causality assessment between both doses of varicella virus vaccine live (oka/merck)(VARIVAX) and the event of antibody test negative was not provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product leakage
Clinical narrative: Leaking Prior To Opening; no adverse event; This spontaneous report was received from Other Health Professional.   Healthcare professional (healthcare worker) states when the cap was taken off one of the GARDASIL 9, the product began dripping out. Caller states GARDASIL 9 was discarded and not administered to a patient. Caller was unable to confirm if the product is supplied in a vial or prefilled syringe, but believes it may have been a syringe. Caller did not have any other information related to the PQC, therefore questions were not answered in the notes. Caller was provided with case number for call back to provide information related to the PQC. AE filed out of precaution due to caller not able to confirm if contents were exposed to healthcare worker. Pictures unable to be provided and product not available for retrieval due to product being discarded. Caller was unable to confirm the NOC, LOT and Expiration. No additional AE or PQC reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Healthcare provider states improperly stored vaccine involved in a temperature excursion was administered to a patient.; No additional AE reported.; This spontaneous report has been received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On an unknown date, the patient was vaccinated with one improperly stored dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) injection, lot # W006595 confirmed to be valid with expiration date 10-OCT-2024 (exact dose, route of administration, and anatomical location were not reported), for prophylaxis.  On an unspecified date, before administration, the vaccine underwent a temperature excursion of 57.49 degrees Fahrenheit for 1 hour and 45 minutes (product storage error). There was no previous temperature excursion. No additional adverse event was reported.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; HCP reported a patient was inadvertently administered an expired dose of RECOMBIVAX HB.; This spontaneous report was received from a medical assitant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 13-DEC-2022, the patient was inadvertently administered an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 0.5 milliliter (valid lot #U001837, expiration date: 21-NOV-2022) administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). The reporter was provided the "supported" disclaimer per the post expiry memo. No additional information provided. No additional adverse event (AE) was reported (no adverse event).
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Alopecia, Cataract, Depression, Fatigue
Clinical narrative: had lots of flare ups/legs get tired easily and standing for a long time is hard/feeling fatigued; needing cataract surgery; upset stomach; hair is falling out; mildly depressed; feeling fatigued; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): US-AMGEN-USASP2022214483 (Agency).  This serious spontaneous report (USASP2022214483) was reported to Agency on 08/DEC/2022 by a consumer and involves a female patient who experienced had lots of flare ups/legs get tired easily and standing for a long time is hard/feeling fatigued [PT: rheumatoid arthritis], needing cataract surgery [PT: cataract], upset stomach [PT: abdominal discomfort], hair was falling out [PT: alopecia], mildly depressed [PT: depression] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement. The patient's concomitant medications included folic acid, losartan potassium, methotrexate, prednisone, Levothyroxin (levothyroxine sodium). The patient's co-suspect medication included Covid-19 Vaccine. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. On an unknown date, the patient after she got her COVID-19 shot and booster she had lot of flare ups and upset stomach. The patient reported that her hair was falling out and that her legs get tired easily and standing for a long time was hard. The patient was feeling fatigued and scored mildly depressed on survey and needing cataract surgery. No treatment information was received. The outcome of the events rheumatoid arthritis, cataract, abdominal discomfort, alopecia, depression were reported as unknown. Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as unknown for the events rheumatoid arthritis, abdominal discomfort, alopecia, cataract and depression. The causal relationship between the events rheumatoid arthritis, cataract, abdominal discomfort, alopecia, depression and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. No follow up attempts are possible. No further information is expected.  Agency comment: This safety report does not necessarily reflect a conclusion by Agency that etanercept, device caused or contributed to the adverse events reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual report does not change the safety profile of the product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Enbrel is under agreement with Agency.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Rheumatoid factor
Clinical narrative: had lots of flare ups/legs get tired easily and standing for a long time is hard/feeling fatigued; needing cataract surgery; upset stomach; hair is falling out; mildly depressed; feeling fatigued; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): US-AMGEN-USASP2022214483 (Agency).  This serious spontaneous report (USASP2022214483) was reported to Agency on 08/DEC/2022 by a consumer and involves a female patient who experienced had lots of flare ups/legs get tired easily and standing for a long time is hard/feeling fatigued [PT: rheumatoid arthritis], needing cataract surgery [PT: cataract], upset stomach [PT: abdominal discomfort], hair was falling out [PT: alopecia], mildly depressed [PT: depression] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement. The patient's concomitant medications included folic acid, losartan potassium, methotrexate, prednisone, Levothyroxin (levothyroxine sodium). The patient's co-suspect medication included Covid-19 Vaccine. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. On an unknown date, the patient after she got her COVID-19 shot and booster she had lot of flare ups and upset stomach. The patient reported that her hair was falling out and that her legs get tired easily and standing for a long time was hard. The patient was feeling fatigued and scored mildly depressed on survey and needing cataract surgery. No treatment information was received. The outcome of the events rheumatoid arthritis, cataract, abdominal discomfort, alopecia, depression were reported as unknown. Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as unknown for the events rheumatoid arthritis, abdominal discomfort, alopecia, cataract and depression. The causal relationship between the events rheumatoid arthritis, cataract, abdominal discomfort, alopecia, depression and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. No follow up attempts are possible. No further information is expected.  Agency comment: This safety report does not necessarily reflect a conclusion by Agency that etanercept, device caused or contributed to the adverse events reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual report does not change the safety profile of the product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Enbrel is under agreement with Agency.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular, Vaccination failure
Clinical narrative: Had the shot, now have shingles/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 12th December 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had the shingles shot and now he/she had shingles. The reporter had friend who suffered from shingles.  The pain they described sounded unbearable.  They had to put their lives on hold because of this painful, blistering rash caused by shingles, and she wanted to make sure that, never happened to her.  The patient educated herself about the risks and what she could do for prevention. The people 50 years or older are at risk for shingles. The reporter thought that, the event might had been related to the drug. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. This case has been linked to the case US2022AMR155249, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR155249: Additional safety information
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: feeling crappy; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-DEC-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient said post-herpetic neuralgia was a pain syndrome that could last for the rest of your life even after the shingles rash was cleared.  The 8 to 10 hours of feeling crappy after his/her Shingrix shot was worth it.  It was one of the most effective vaccines out there.  The patient mentioned as his/her cousin died from shingles in his eye that spread to his brain after 3 weeks in a coma. Additional Supportive Information: The follow-up would not possible, as no contact, details were available.
Age: 51.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 02Jun2022, 2nd 03Dec2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 51-year-old female patient who received HAB (Twinrix) (batch number J477Y, expiry date 20th May 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 2nd June 2022).   On 3rd December 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 3rd December 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-DEC-2022 Reporter's comment: The pharmacist reported that the patient received second dose of Twinrix late. The health care professional did not have information of expiration date and batch number from first dose because it was not given at her facility. Consent to follow up was asked and agreed but HCP said did not have a reachable email. The reporter consented to follow up. Additional supportive information: The patient received the second dose of Twinrix later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 83.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Alcohol use, Hyporesponsive to stimuli, Injection site pain, Injection site swelling, Loss of consciousness
Clinical narrative: Passed out (taken to ER); Swelling at the injection site (while in ER); Pain at the injection site (while in ER); Fever (while in ER); Tightness in his jaw (while in ER); This case was reported by a consumer via call center representative and described the occurrence of passed out in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ethanol (Ethyl Alcohol) for product used for unknown indication.   On 23rd November 2022, the patient received the 1st dose of Shingrix. On 24th November 2022, the patient started Ethyl Alcohol at an unknown dose and frequency. On 24th November 2022, 1 days after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), injection site swelling, injection site pain, fever and tightness of jaw muscles. The action taken with Ethyl Alcohol was unknown. On an unknown date, the outcome of the passed out, injection site swelling, fever and tightness of jaw muscles were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the passed out, injection site swelling, injection site pain, fever and tightness of jaw muscles to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's comment: The case was self reported by the patient. The patient received first dose of Shingrix and reported that on 24th November 2022 he had been consuming some ETOH (ethanol) for most of the day and then that evening he passed out at the dinner table. The patient reported that an ambulance was called the paramedics were able to get him to begin responding to stimulation and was taken to the emergency room. The reporter reported that while in the ER experienced swelling and pain at the injections site, fever and tightness in jaw. These symptoms had resolved.  The reporter consented to follow up. The patient received ETOH (ethyl alcohol) and less than a day experienced passed out, injection site swelling, injection site pain, fever and tightness of jaw muscles. It was unknown if the reporter considered the passed out, injection site swelling, injection site pain, fever and tightness of jaw muscles to be related to Ethyl alcohol.  Additional supportive information: Vaccination date captured as 23rd November 2022 as per narrative and same had been asked in query.
Age: 83.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Muscle tightness, Pyrexia
Clinical narrative: Passed out (taken to ER); Swelling at the injection site (while in ER); Pain at the injection site (while in ER); Fever (while in ER); Tightness in his jaw (while in ER); This case was reported by a consumer via call center representative and described the occurrence of passed out in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ethanol (Ethyl Alcohol) for product used for unknown indication.   On 23rd November 2022, the patient received the 1st dose of Shingrix. On 24th November 2022, the patient started Ethyl Alcohol at an unknown dose and frequency. On 24th November 2022, 1 days after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), injection site swelling, injection site pain, fever and tightness of jaw muscles. The action taken with Ethyl Alcohol was unknown. On an unknown date, the outcome of the passed out, injection site swelling, fever and tightness of jaw muscles were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the passed out, injection site swelling, injection site pain, fever and tightness of jaw muscles to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's comment: The case was self reported by the patient. The patient received first dose of Shingrix and reported that on 24th November 2022 he had been consuming some ETOH (ethanol) for most of the day and then that evening he passed out at the dinner table. The patient reported that an ambulance was called the paramedics were able to get him to begin responding to stimulation and was taken to the emergency room. The reporter reported that while in the ER experienced swelling and pain at the injections site, fever and tightness in jaw. These symptoms had resolved.  The reporter consented to follow up. The patient received ETOH (ethyl alcohol) and less than a day experienced passed out, injection site swelling, injection site pain, fever and tightness of jaw muscles. It was unknown if the reporter considered the passed out, injection site swelling, injection site pain, fever and tightness of jaw muscles to be related to Ethyl alcohol.  Additional supportive information: Vaccination date captured as 23rd November 2022 as per narrative and same had been asked in query.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Vaccination failure
Clinical narrative: Pain on forhead, pain hairline; Received 2 doses of Shingrix, got shingles; Shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (ZOSTAVAX) for prophylaxis.   In 2021, the patient received the 2nd dose of Shingrix (intramuscular) and the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received ZOSTAVAX. In July 2022, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced forehead headache. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and forehead headache were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and forehead headache to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 08-DEC-2022 Reporter's Comments: The patient self-reported this case. The patient stated that she received Zostavax and 2 doses of Shingrix (2021- did not remember exact dates).  The patient stated that she was diagnosed with shingles 5 months ago from reporting and still had pain on forehead and hairline.  She stated her health care professional prescribed Valtrex for a week and then discontinued it. The reporter was consented to follow up. It was unknown if the reporter considered the Shingles, headache to be related to Zostavax.   Additional supportive information: This case was considered as vaccination failure as details regarding laboratory test confirming shingles was unknown at the time of reporting.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This vaccine dose was given too early  on 12/13/2022.  This was the second dose the patient received.  HIs first dose was on 10/19/2022.  According to vaccine guidelines there should be a 6 month interval between the first and the second dose.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test abnormal, Pain in extremity, Rheumatoid arthritis
Clinical narrative: Pain in joints, toes, fingers, wrist, knee.  Symptoms began about 5 weeks after second dose on Feb. 5, 2021.  April 15, 2021 bloodwork confirmed Rheumatoid Arthritis
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Feeling abnormal, Nasal congestion
Clinical narrative: November 13th 2022, I had a runny nose. 11/14/2022 I developed a cough and extreme fatigue. 11/15/2022 Same symptoms as well and asked for PAXLOVID, I was given the prescription the next day. I had extreme congestion in my nose as well and utilized AFRIN to help with that symptom. Mental fogginess came with my symptoms as well. After taking PAXLOVID for a few days my symptoms started to improve and by November 17th, 2022 I was feeling much better but still fatigued. As of now I am doing much better and feeling perfectly normal.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: November 13th 2022, I had a runny nose. 11/14/2022 I developed a cough and extreme fatigue. 11/15/2022 Same symptoms as well and asked for PAXLOVID, I was given the prescription the next day. I had extreme congestion in my nose as well and utilized AFRIN to help with that symptom. Mental fogginess came with my symptoms as well. After taking PAXLOVID for a few days my symptoms started to improve and by November 17th, 2022 I was feeling much better but still fatigued. As of now I am doing much better and feeling perfectly normal.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Corrective lens user, Impaired work ability, Photopsia, Pupil dilation procedure, Vitreous detachment
Clinical narrative: bright white flashes of light in my left peripheral vision . I initially thought this was the reflection of light in my glasses. When these flashes of light appeared in my L peripheral vision on 10/19 when I did not have my glasses on I scheduled an appointment with my eye Dr. on 10/20/2022. At that time I was diagnosed with a "posterior vitreal detachment " in my L eye.  There is no history of this nor did I have any trauma to my head or eye. There is no history of diabetes or hypertension. I was given a 25# weight lifting restriction as I was at risk for a retinal injury or detachment.  I work in the Emergency room as a nurse and my employer was unable to accomadate this restriction and was told by my manager I needed to "file a leave with PRIVATE "(our short term disability company with Hospital) "and contact employee health.  You can't return to work until cleared with no restrictions. We have no light duty in the ER"
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Headache, Hyperhidrosis, Malaise, Myalgia
Clinical narrative: Day after: Fatigue, headache, malaise/muscle pain.  Day 2: Night sweats & excessive sweating
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Night sweats
Clinical narrative: Day after: Fatigue, headache, malaise/muscle pain.  Day 2: Night sweats & excessive sweating
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Mobility decreased, Muscular weakness
Clinical narrative: Pt started having weakness after vaccine  it was very difficult to use right arm
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthma, COVID-19, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: I thought I was experiencing allergies induced asthma. By Saturday morning I was still having breathing problems. I went to the urgent care, and they tested me for COVID-19 and, I was positive. They prescribed me prednisone for my asthma symptoms and for the COVID-19 remdesivir infusion for 3 days. My symptoms got better after infusion.
Age: 42.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Dry skin, Electric shock sensation, Full blood count, Glycosylated haemoglobin, Heart rate increased
Clinical narrative: Approximately three days after receiving the vaccine I started experiencing issues with my nervous system. At first, I was experiencing internal tremors. These mostly felt like strong vibrations (as if standing next to a washing machine in the spin cycle). Occasionally, it would feel more like waves (almost like lying on a water bed). Sometimes, the tremors were external as well, and others could see my hands trembling. The "spells" would last anywhere from several minutes to 8-10 hours and occurred almost daily for 5-6 weeks post-injection. My heart rate increased to 100 bpm for about 5 weeks. I would often wake up in the middle of the night with a racing heart (pumping hard, and I could hear my heartbeat in my ears). Some days the symptoms were so intense that it made it difficult to work. Besides the termors, I also felt twitching. Sometimes this was in the form of a muscle twitch (seeing my muscles moving involuntarily), but it also sometimes felt like "electric zaps" both in my chest and in my groin area. Two weeks after the injection, I also developed a large rash that spread over the entire left side of my torso. It was blotchy and felt "dry" but it did not hurt or itch. I noticed that I developed spider veins in this area as well. The rash cleared up after about 4-5 days.
Age: 42.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Impaired work ability, Laboratory test, Metabolic function test, Middle insomnia, Muscle twitching
Clinical narrative: Approximately three days after receiving the vaccine I started experiencing issues with my nervous system. At first, I was experiencing internal tremors. These mostly felt like strong vibrations (as if standing next to a washing machine in the spin cycle). Occasionally, it would feel more like waves (almost like lying on a water bed). Sometimes, the tremors were external as well, and others could see my hands trembling. The "spells" would last anywhere from several minutes to 8-10 hours and occurred almost daily for 5-6 weeks post-injection. My heart rate increased to 100 bpm for about 5 weeks. I would often wake up in the middle of the night with a racing heart (pumping hard, and I could hear my heartbeat in my ears). Some days the symptoms were so intense that it made it difficult to work. Besides the termors, I also felt twitching. Sometimes this was in the form of a muscle twitch (seeing my muscles moving involuntarily), but it also sometimes felt like "electric zaps" both in my chest and in my groin area. Two weeks after the injection, I also developed a large rash that spread over the entire left side of my torso. It was blotchy and felt "dry" but it did not hurt or itch. I noticed that I developed spider veins in this area as well. The rash cleared up after about 4-5 days.
Age: 42.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Nervous system disorder, Palpitations, Rash, Rash macular, Sensory disturbance
Clinical narrative: Approximately three days after receiving the vaccine I started experiencing issues with my nervous system. At first, I was experiencing internal tremors. These mostly felt like strong vibrations (as if standing next to a washing machine in the spin cycle). Occasionally, it would feel more like waves (almost like lying on a water bed). Sometimes, the tremors were external as well, and others could see my hands trembling. The "spells" would last anywhere from several minutes to 8-10 hours and occurred almost daily for 5-6 weeks post-injection. My heart rate increased to 100 bpm for about 5 weeks. I would often wake up in the middle of the night with a racing heart (pumping hard, and I could hear my heartbeat in my ears). Some days the symptoms were so intense that it made it difficult to work. Besides the termors, I also felt twitching. Sometimes this was in the form of a muscle twitch (seeing my muscles moving involuntarily), but it also sometimes felt like "electric zaps" both in my chest and in my groin area. Two weeks after the injection, I also developed a large rash that spread over the entire left side of my torso. It was blotchy and felt "dry" but it did not hurt or itch. I noticed that I developed spider veins in this area as well. The rash cleared up after about 4-5 days.
Age: 42.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Spider vein, Thyroid function test, Tremor, Vitamin B12, Vitamin D
Clinical narrative: Approximately three days after receiving the vaccine I started experiencing issues with my nervous system. At first, I was experiencing internal tremors. These mostly felt like strong vibrations (as if standing next to a washing machine in the spin cycle). Occasionally, it would feel more like waves (almost like lying on a water bed). Sometimes, the tremors were external as well, and others could see my hands trembling. The "spells" would last anywhere from several minutes to 8-10 hours and occurred almost daily for 5-6 weeks post-injection. My heart rate increased to 100 bpm for about 5 weeks. I would often wake up in the middle of the night with a racing heart (pumping hard, and I could hear my heartbeat in my ears). Some days the symptoms were so intense that it made it difficult to work. Besides the termors, I also felt twitching. Sometimes this was in the form of a muscle twitch (seeing my muscles moving involuntarily), but it also sometimes felt like "electric zaps" both in my chest and in my groin area. Two weeks after the injection, I also developed a large rash that spread over the entire left side of my torso. It was blotchy and felt "dry" but it did not hurt or itch. I noticed that I developed spider veins in this area as well. The rash cleared up after about 4-5 days.
Age: 42.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Electric shock sensation, Heart rate, Heart rate increased, Loss of personal independence in daily activities, Muscle spasms
Clinical narrative: Approximately three days after receiving the vaccine I started experiencing issues with my nervous system. At first, I was experiencing internal tremors. These mostly felt like strong vibrations (as if standing next to a washing machine in the spin cycle). Occasionally, it would feel more like waves (almost like lying on a water bed). Sometimes, the tremors were external as well, and others could see my hands trembling. The "spells" would last anywhere from several minutes to 8-10 hours and occurred almost daily for 5-6 weeks post-injection. My heart rate increased to 100 bpm for about 5 weeks. I would often wake up in the middle of the night with a racing heart (pumping hard, and I could hear my heartbeat in my ears). Some days the symptoms were so intense that it made it difficult to work. Besides the termors, I also felt twitching. Sometimes this was in the form of a muscle twitch (seeing my muscles moving involuntarily), but it also sometimes felt like "electric zaps" both in my chest and in my groin area. Two weeks after the injection, I also developed a large rash that spread over the entire left side of my torso. It was blotchy and felt "dry" but it did not hurt or itch. I noticed that I developed spider veins in this area as well. The rash cleared up after about 4-5 days.
Age: 42.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Nervous system disorder, Palpitations, Rash, Tremor, Vibration syndrome
Clinical narrative: Approximately three days after receiving the vaccine I started experiencing issues with my nervous system. At first, I was experiencing internal tremors. These mostly felt like strong vibrations (as if standing next to a washing machine in the spin cycle). Occasionally, it would feel more like waves (almost like lying on a water bed). Sometimes, the tremors were external as well, and others could see my hands trembling. The "spells" would last anywhere from several minutes to 8-10 hours and occurred almost daily for 5-6 weeks post-injection. My heart rate increased to 100 bpm for about 5 weeks. I would often wake up in the middle of the night with a racing heart (pumping hard, and I could hear my heartbeat in my ears). Some days the symptoms were so intense that it made it difficult to work. Besides the termors, I also felt twitching. Sometimes this was in the form of a muscle twitch (seeing my muscles moving involuntarily), but it also sometimes felt like "electric zaps" both in my chest and in my groin area. Two weeks after the injection, I also developed a large rash that spread over the entire left side of my torso. It was blotchy and felt "dry" but it did not hurt or itch. I noticed that I developed spider veins in this area as well. The rash cleared up after about 4-5 days.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pt stated that she had the pain on her arm right after the 2nd Pfizer dose which was given on 08/04/2021.  And the pain has not been improved since then and sometimes the pain was excruciating.  pt did received another Pfizer shot on 01/09/2022 then Pfizer bivalent on 10/21/2022
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Contiuous upper left arm and shoulder stiffness and soreness.
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The patient was given Pfizer Bivalent Booster vaccine 1 day past beyond use date on 12/02/2022.  The patient was not able to be reachable and we are not able to gather any information on any symptoms, sings, time course, etc.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient inadvertently received the COVID-19 bi-valent (12/8) vaccine, when was due for the 2nd vaccine of his primary series.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Confusional state, Diarrhoea, Heart rate increased, Muscle contractions involuntary, Nausea
Clinical narrative: Severe vomiting & diarrhea. Nausea. Unusually high heart rate of 176. Slight confusion. Erratic speech. Involuntary muscle contractions. All symptoms lasting around 3.5 hours. Body temp lower than usual for a few hours.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Speech disorder, Vomiting
Clinical narrative: Severe vomiting & diarrhea. Nausea. Unusually high heart rate of 176. Slight confusion. Erratic speech. Involuntary muscle contractions. All symptoms lasting around 3.5 hours. Body temp lower than usual for a few hours.
Age: 61.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Blood test abnormal, Contusion, Full blood count, Platelet count decreased, Thrombocytopenia
Clinical narrative: I went to the emergency room for unexplained bruising. They found my platelet count was low. They spoke to a Hematologist. She confirmed my platelets were low and performed a complete CBC panel. She diagnosed me with Thrombocytopenia. I had a follow-up with the Hematologist the following Monday. She performed more blood work. My platelets were a little higher. She sent me home with a prescription for iron. I have to her again in a month.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Bacterial infection, Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: bacterial cellulitis post right thigh vaccine she received 12/12/22.  Symptoms are swelling, warm to touch, redness.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Injected limb mobility decreased, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Fever 100.3 w use of ibuprofen, hard chills, very swollen arm at injection site preventing movement, pain in arm. All symptoms abated in 48 hours.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysstasia, Gait disturbance, Groin pain, Insomnia
Clinical narrative: After receiving the Omicron variant booster on December 5, 2002 which was a Monday, on Thursday, December 8, I woke up with pan and aching in my left groin and upper thigh.  Previously, I had no problems with this.  Upon tracing back to when I had a previous booster (Pfizer), I also had the same pain and strong aching in my right leg and went through 6 months of physical therapy and had a shot for pain in the right groin.  The shot nor the PT helped the issue at all.  Now I have both groin areas affected and am having trouble walking, getting up from chairs and bending from the waist.  Have had a few sleepless nights with pain but mostly the symptoms are felt during the day.  Quite debilitating for me as I have always exercised and walked every day.  Now I cannot.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: After receiving the Omicron variant booster on December 5, 2002 which was a Monday, on Thursday, December 8, I woke up with pan and aching in my left groin and upper thigh.  Previously, I had no problems with this.  Upon tracing back to when I had a previous booster (Pfizer), I also had the same pain and strong aching in my right leg and went through 6 months of physical therapy and had a shot for pain in the right groin.  The shot nor the PT helped the issue at all.  Now I have both groin areas affected and am having trouble walking, getting up from chairs and bending from the waist.  Have had a few sleepless nights with pain but mostly the symptoms are felt during the day.  Quite debilitating for me as I have always exercised and walked every day.  Now I cannot.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Gastritis, Pyrexia, Respiratory tract congestion
Clinical narrative: Started out with gastritis issues developed vomiting diarreaha runny nose and extreme fatigue. Congestion, mucus and fever. Prescribed Paxlovid subsided within a week then rebounded symptoms subsided after 3 weeks.  Still experiencing fatigue.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Secretion discharge, Vomiting
Clinical narrative: Started out with gastritis issues developed vomiting diarreaha runny nose and extreme fatigue. Congestion, mucus and fever. Prescribed Paxlovid subsided within a week then rebounded symptoms subsided after 3 weeks.  Still experiencing fatigue.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Loss of personal independence in daily activities, Tinnitus
Clinical narrative: About two weeks after my first booster, I started to get ringing in my ears, massive exhaustion from just doing everyday things, and uncontrollable sweating when before I hardly sweat at all. The exhaustion and sweating has subsided, but my ears have been ringing ever since May and have not subsided. It may be getting louder.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID infection. Tested positive on 11/23/22 via a home test. Returned from a 10 day trip on 11/19/22.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The patient was given Pfizer Bivalent Booster vaccine one day past beyond use date on 12/02/2022.  The patient was not able to be reachable and we are not able to gather any information on any symptoms, sings, time course, etc.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring normal, Dyspnoea, Echocardiogram normal, Heart rate increased, Laboratory test normal
Clinical narrative: Date of booster 11/28/21 not 9/11/21 (correction)  Increased heart rate and sob within hours of booster, still present but less frequently over a yr later-getting less and less frequent and shorter duration than previously-occurs randomly Resting heart rate 104-112 (normal 74-85) Occurs sporadically now and last few hours rather than days like before Increased heart rate not present after first and second vaccine but was present for 6 months after having covid 3/2020 and echo was normal
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Date of booster 11/28/21 not 9/11/21 (correction)  Increased heart rate and sob within hours of booster, still present but less frequently over a yr later-getting less and less frequent and shorter duration than previously-occurs randomly Resting heart rate 104-112 (normal 74-85) Occurs sporadically now and last few hours rather than days like before Increased heart rate not present after first and second vaccine but was present for 6 months after having covid 3/2020 and echo was normal
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bronchitis, COVID-19, Cough, Feeling abnormal, Malaise
Clinical narrative: The day after the vaccine I woke up not feeling great (sours throat, congestion, general malaise). I assumed it was just a small reaction to the vaccine, so I went about my day. I started feeling worse and developed a cough.  On 9/19/22  a doctor prescribed me antibiotics for bronchitis. The cough didn?t go away. On 10/31/22 another doctor gave me antibiotics for a sinus infection. The cough still didn?t go away, so on 11/14/22 a doctor gave me prednisone and an inhaler. The cough was improving some, but then I got sick again with a cold and the cough started worsening. A doctor told me I had bronchitis on 11/28/22 and gave me prednisone and cough syrup. The cough was still present but slightly improving, but worsened on 12/13/22. Tested positive for COVID on 12/14/22.
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nasopharyngitis, Oropharyngeal pain, Respiratory tract congestion, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: The day after the vaccine I woke up not feeling great (sours throat, congestion, general malaise). I assumed it was just a small reaction to the vaccine, so I went about my day. I started feeling worse and developed a cough.  On 9/19/22  a doctor prescribed me antibiotics for bronchitis. The cough didn?t go away. On 10/31/22 another doctor gave me antibiotics for a sinus infection. The cough still didn?t go away, so on 11/14/22 a doctor gave me prednisone and an inhaler. The cough was improving some, but then I got sick again with a cold and the cough started worsening. A doctor told me I had bronchitis on 11/28/22 and gave me prednisone and cough syrup. The cough was still present but slightly improving, but worsened on 12/13/22. Tested positive for COVID on 12/14/22.
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sinusitis
Clinical narrative: The day after the vaccine I woke up not feeling great (sours throat, congestion, general malaise). I assumed it was just a small reaction to the vaccine, so I went about my day. I started feeling worse and developed a cough.  On 9/19/22  a doctor prescribed me antibiotics for bronchitis. The cough didn?t go away. On 10/31/22 another doctor gave me antibiotics for a sinus infection. The cough still didn?t go away, so on 11/14/22 a doctor gave me prednisone and an inhaler. The cough was improving some, but then I got sick again with a cold and the cough started worsening. A doctor told me I had bronchitis on 11/28/22 and gave me prednisone and cough syrup. The cough was still present but slightly improving, but worsened on 12/13/22. Tested positive for COVID on 12/14/22.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthma, COVID-19, Cough, Oropharyngeal discomfort, Pain
Clinical narrative: On November 29, 2022 I felt like I was having an asthma attack and I used my inhaler. The next day I felt like my throat was congested and I had a cough. I felt feverish and achy. Thursday, December 1, 2022, in the morning I tested positive for COVID-19. On the same day I saw the physician's assistant and received PAXLOVID. Within about 3 days I felt better.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: On November 29, 2022 I felt like I was having an asthma attack and I used my inhaler. The next day I felt like my throat was congested and I had a cough. I felt feverish and achy. Thursday, December 1, 2022, in the morning I tested positive for COVID-19. On the same day I saw the physician's assistant and received PAXLOVID. Within about 3 days I felt better.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Severe chills for hours, fever 102.6, headache, body aches, injection site red swollen hot and huge. It burned  very badly when injected.  Felt deathly ill, similar to flu. 3 days later injection site redness has spread and is hot and huge.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Injection site warmth, Malaise, Pain, Pyrexia
Clinical narrative: Severe chills for hours, fever 102.6, headache, body aches, injection site red swollen hot and huge. It burned  very badly when injected.  Felt deathly ill, similar to flu. 3 days later injection site redness has spread and is hot and huge.