chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that symptoms were kept mild and tolerable. No concomitant medications were provided. No treatment information was provided. As patient took second dose of Moderna vaccine and experienced COVID-19 event so action taken with the drug will be Not applicable  This case concerns a male patient of an unknown age with no relevant medical history who experienced non-serious unexpected event of COVID-19. The precise temporal relationship cannot be determined, having in mind that the exact vaccination date was not provided. The rechallenge was not applicable as the event occurred following the second dose of the vaccine. It was reported that the patient's symptoms were mild and tolerable, however, detailed information regarding the clinical course of the event was not provided.  Based on biological implausibility, causal relationship between the reported event COVID-19 is not applicable. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age with no relevant medical history who experienced non-serious unexpected event of COVID-19. The precise temporal relationship cannot be determined, having in mind that the exact vaccination date was not provided. The rechallenge was not applicable as the event occurred following the second dose of the vaccine. It was reported that the patient's symptoms were mild and tolerable, however, detailed information regarding the clinical course of the event was not provided.  Based on biological implausibility, causal relationship between the reported event COVID-19 is not applicable. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Achiness; Headache; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achiness), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Achiness), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, MYALGIA (Achiness), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.            No concomitants were mentioned. No treatments were mentioned.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Limited information adverse event report.; This spontaneous case was reported by an other health care professional and describes the occurrence of ADVERSE EVENT (Limited information adverse event report.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Limited information adverse event report.). At the time of the report, ADVERSE EVENT (Limited information adverse event report.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. treatment medications were not reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia, Pain, Pyrexia
Clinical narrative: Difficulty sleeping; Aches; Chills; Fe ver; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Difficulty sleeping), PAIN (Aches), CHILLS (Chills) and PYREXIA (Fe ver) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy. Concurrent medical conditions included Cyst.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Difficulty sleeping), PAIN (Aches), CHILLS (Chills) and PYREXIA (Fe ver). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Difficulty sleeping), PAIN (Aches) and CHILLS (Chills) outcome was unknown and PYREXIA (Fe ver) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.   This case was linked to MOD-2021-355812 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vaccination site pain, Vaccination site swelling
Clinical narrative: I wasn't feeling right; After second dose, whole arm swollen and painful, lasted 3 weeks; After second dose, whole arm swollen and painful, lasted 3 weeks; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Oct-2021 and was forwarded to Moderna on 18-Oct-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (I wasn't feeling right), VACCINATION SITE PAIN (After second dose, whole arm swollen and painful, lasted 3 weeks) and VACCINATION SITE SWELLING (After second dose, whole arm swollen and painful, lasted 3 weeks) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included PRAVASTATIN and LAMOTRIGINE (LAMICTAL) for an unknown indication.    On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (After second dose, whole arm swollen and painful, lasted 3 weeks) and VACCINATION SITE SWELLING (After second dose, whole arm swollen and painful, lasted 3 weeks). On an unknown date, the patient experienced MALAISE (I wasn't feeling right). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. In 2021, VACCINATION SITE PAIN (After second dose, whole arm swollen and painful, lasted 3 weeks) and VACCINATION SITE SWELLING (After second dose, whole arm swollen and painful, lasted 3 weeks) had resolved. At the time of the report, MALAISE (I wasn't feeling right) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Joint range of motion decreased, Neck pain, Pain
Clinical narrative: 10/06/21 Received Pfizer booster injection in my left arm around 0715. Went to bed 1000 and was awaken with severe pain at 1300. The pain was severe for the first 5 days like the previous Pfizer injections.  No relief with Motrin or Excedrine.  At this time I still have pain and it never has gone away. It's like a tooth ache and is much worse with movement.  Around 10/13/21 I noticed loss of range of motion and strength. That also has gotten worse. Examples of pain on movement: pulling up a blanket, moving out to the side, laying on left side and reaching back. I can only move it back half-way ROM . Sleep about 2-3 hours at a time. If I roll on that side, I wake up. The pain is at the top of shoulder, outer left & right side, and between the shoulder and neck area.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Toothache
Clinical narrative: 10/06/21 Received Pfizer booster injection in my left arm around 0715. Went to bed 1000 and was awaken with severe pain at 1300. The pain was severe for the first 5 days like the previous Pfizer injections.  No relief with Motrin or Excedrine.  At this time I still have pain and it never has gone away. It's like a tooth ache and is much worse with movement.  Around 10/13/21 I noticed loss of range of motion and strength. That also has gotten worse. Examples of pain on movement: pulling up a blanket, moving out to the side, laying on left side and reaching back. I can only move it back half-way ROM . Sleep about 2-3 hours at a time. If I roll on that side, I wake up. The pain is at the top of shoulder, outer left & right side, and between the shoulder and neck area.
Age: 60.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Feeling cold, Headache, Influenza like illness, Nausea
Clinical narrative: Slight nausea/headache starting 3 hours after shot.  After 10 hours: moderate fatigue. After 12 hours: severe flu-like body aches (8/10 scale) then severe chills (9/10 scale) lasting about 4 hours.  Moderate body aces (3/10 scale) and headache 20 hours after shots. Had Moderna vaccinations in April/ May 2021
Age: 60.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Pain
Clinical narrative: Slight nausea/headache starting 3 hours after shot.  After 10 hours: moderate fatigue. After 12 hours: severe flu-like body aches (8/10 scale) then severe chills (9/10 scale) lasting about 4 hours.  Moderate body aces (3/10 scale) and headache 20 hours after shots. Had Moderna vaccinations in April/ May 2021
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Nodule, Pain, Pruritus, Rash
Clinical narrative: High anxiety.   Covid arm at day seven still continues.  Rash, itching, knot in arm, swelling and ache.  Ice, Tylenol and hydrocortisone cream.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site reaction
Clinical narrative: High anxiety.   Covid arm at day seven still continues.  Rash, itching, knot in arm, swelling and ache.  Ice, Tylenol and hydrocortisone cream.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Lip swelling, Pruritus, Pyrexia, Rash
Clinical narrative: Severe rash and itching from neck down to thighs, swollen lip. The first trash occurred after my second injection at the injection site which was a rash where the band aid was placed. One week after on June 4th, I woke up with a fever and vomiting diarrhea. Weekly after that, swollen lips, to the severe rash outbreaks weekly. My doctor prescribed 10mg of cetrizine two times per day for one month... that did not help. The dosage was increased to 20mg twice per day, for one month, did not help. Then added additional allergy medication Cingular once per day with cetrizine 20mg twice per day. Still not helping.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Severe rash and itching from neck down to thighs, swollen lip. The first trash occurred after my second injection at the injection site which was a rash where the band aid was placed. One week after on June 4th, I woke up with a fever and vomiting diarrhea. Weekly after that, swollen lips, to the severe rash outbreaks weekly. My doctor prescribed 10mg of cetrizine two times per day for one month... that did not help. The dosage was increased to 20mg twice per day, for one month, did not help. Then added additional allergy medication Cingular once per day with cetrizine 20mg twice per day. Still not helping.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability, Gene mutation identification test negative, Headache, Hypoaesthesia
Clinical narrative: Day of vaccination arm tingling and both hands went numb for 2 days, 4 days later woke up with a headache that lasted for 3 weeks. By Apr 5th all joints started to stiffen and swell up. Got so bad knee on left side was 4 times its regular size but all joints were swollen and stiff in the whole body. Started taking benadryl nightly. Saw PCP on May 17th and started pregnisone, lost 6lbs of water off my joints after 6 days of pregnisone. Saw Dr. (rheumatologist) May 25th. Still stiff and swollen joints but 50% better after benadryl and steroids. Took benadryl for 3 months daily. All the blood test came back negative for rheumatoid, lupus, gout, genetic disorder. But liver, kidney and white blood cells counts are off since the vaccination. Couldn't walk for two months from all the pain in the joints. Still stiff and swollen and headaches 5 days out of 7 in a week.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Joint swelling, Laboratory test, Liver function test abnormal, Paraesthesia
Clinical narrative: Day of vaccination arm tingling and both hands went numb for 2 days, 4 days later woke up with a headache that lasted for 3 weeks. By Apr 5th all joints started to stiffen and swell up. Got so bad knee on left side was 4 times its regular size but all joints were swollen and stiff in the whole body. Started taking benadryl nightly. Saw PCP on May 17th and started pregnisone, lost 6lbs of water off my joints after 6 days of pregnisone. Saw Dr. (rheumatologist) May 25th. Still stiff and swollen joints but 50% better after benadryl and steroids. Took benadryl for 3 months daily. All the blood test came back negative for rheumatoid, lupus, gout, genetic disorder. But liver, kidney and white blood cells counts are off since the vaccination. Couldn't walk for two months from all the pain in the joints. Still stiff and swollen and headaches 5 days out of 7 in a week.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Renal impairment, White blood cell count abnormal
Clinical narrative: Day of vaccination arm tingling and both hands went numb for 2 days, 4 days later woke up with a headache that lasted for 3 weeks. By Apr 5th all joints started to stiffen and swell up. Got so bad knee on left side was 4 times its regular size but all joints were swollen and stiff in the whole body. Started taking benadryl nightly. Saw PCP on May 17th and started pregnisone, lost 6lbs of water off my joints after 6 days of pregnisone. Saw Dr. (rheumatologist) May 25th. Still stiff and swollen joints but 50% better after benadryl and steroids. Took benadryl for 3 months daily. All the blood test came back negative for rheumatoid, lupus, gout, genetic disorder. But liver, kidney and white blood cells counts are off since the vaccination. Couldn't walk for two months from all the pain in the joints. Still stiff and swollen and headaches 5 days out of 7 in a week.
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia
Clinical narrative: Forgot to mention in previous report on Shingrix reaction...Numbness in index finger/thumb area (3/10 scale) in arm shot administered, lasting 3 days. Still have very slight numbness in same area (barely 1/10 scale) 3 weeks later
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/got both doses, had shingles; shingles; This case was reported by a consumer via sales rep and described the occurrence of suspected vaccination failure in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles 4 times prior to vaccination).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, more 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 outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received both the doses of Shingrix vaccine 4 years ago and received them when it first came out and recently experienced shingles. The patient asked if another dose of Shingrix should be recommended. When the patient got the vaccine (both doses), he/she was told it was for life. But he/she read now that it was good for 4 years or more. The patient was waiting for a call from the doctor but would respond after the reporting day. The reporter consented to follow-up. This case was considered as suspected vaccination failure since the detail regarding laboratory test confirming shingles was unknown at the time of reporting.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: Fever of 101; Achy body; Nauseated; Sore at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Moderna (she had side effects with Moderna -Covid vaccine before ever getting her first dose of Shingrix.) and Shingrix vaccine (1st dose on an unknown date).   On 14th October 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 14th October 2021, less than a day after receiving Shingrix, the patient experienced injection site pain. On 15th October 2021, the patient experienced fever, general body pain and nausea. The patient was treated with excedrin (nos) (Excedrin). On an unknown date, the outcome of the injection site pain, fever, general body pain and nausea were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, general body pain and nausea to be related to Shingrix.   Additional details were reported as follows: This case was reported by the patient for herself. The patient received shingrix vaccine and last night her left arm was sore at injection site. The patient also stated that this morning she woke up achy, nauseated and had a fever of 101degree fahrenheit, she added. The patient also mentioned taken Excedrin for her symptoms. The patient asked how long do side effects last. The patient also mentioned that had side effects with Moderna -Covid vaccine before ever getting her first dose of Shingrix. Encouraged the patient to report Adverse event to Moderna, even though it was given months ago. The reporter consented for follow-up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Mass, Nodule, Swelling, Tenderness
Clinical narrative: swollen lump; tender lump; lump; This case was reported by a consumer via call center representative and described the occurrence of swelling in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number J7J4x, expiry date 31st January 2023) for prophylaxis.   On 16th October 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 18th October 2021, 2 days after receiving Shingrix, the patient experienced swelling, tenderness and nodule. On an unknown date, the outcome of the swelling, tenderness and nodule were unknown.   It was unknown if the reporter considered the swelling, tenderness and nodule to be related to Shingrix.   Additional details were reported as follows: This case was reported by the patient for herself. The patient received shingrix vaccine on 16th October 2021 and today she noticed a tender, swollen lump near her left collarbone. The reporter consented to follow-up. The patient given consent for safety to contact her but did not want to provide physician demographics or give consent to contact her doctor at this time.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Cardiac arrest, Chest X-ray, Electrocardiogram, Hypertension, Hypoaesthesia
Clinical narrative: Palpitations; losing feeling on the left side of her face, neck, shoulder, chest, arm and hand; Tingling; the patient ALMOST went into cardiac arrest; blood pressure was 168/102; Itching in arm; Swelling in arm; This case was reported by a consumer via call center representative and described the occurrence of cardiac arrest in a 54-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concurrent medical conditions included latex allergy (she was allergic to latex) and allergy (was allergic to several ingredients and would like to know what ingredients were in the vaccine).   On 17th September 2021, the patient received Boostrix. On 17th September 2021 14:00, less than a day after receiving Boostrix, the patient experienced itchy upper limbs and swelling arm. On 18th September 2021, the patient experienced cardiac arrest (serious criteria GSK medically significant) and blood pressure high. On 18th September 2021 10:00, the patient experienced loss of sensation and tingling. On an unknown date, the patient experienced palpitation. On an unknown date, the outcome of the cardiac arrest, loss of sensation, tingling and itchy upper limbs were unknown and the outcome of the blood pressure high and swelling arm were recovered/resolved and the outcome of the palpitation was not recovered/not resolved.   It was unknown if the reporter considered the cardiac arrest, blood pressure high, loss of sensation, tingling, itchy upper limbs, swelling arm and palpitation to be related to Boostrix.   Additional details were reported as follows: This case was reported by the patient for herself. The patient was unsure whether the Boostrix vaccine administered in left arm to her was from a vial or if it was a pre-filled syringe. The patient was rushed to urgent care after receiving the Boostrix vaccine. The patient reported that she had swelling and itching in her arm at 2 pm on the same day of vaccination.  The patient reported that at 10 am on 18th September 2021, 1 day after receiving vaccination, she experienced tingling and was losing feeling on the left side of her face, neck, shoulder, chest, arm and hand. 1 day after receiving vaccination, the patient reported that she went into cardiac arrest, and her blood pressure was 168/102 mmHg. The patient confirmed that she went to urgent care and was not admitted to the hospital on 18th September 2021. The patient reported that tests were done including EKG (electrocardiogram) and chest x-ray. Less than 2 months after vaccination, the patient reported that she still had palpitations. The patient reported that she had an appointment in November 2021 for a stress test and would have a heart monitor for two weeks. The patient did not have Lot number or expiry date of vaccine. The patient went again to urgent care on 18th October 2021 with same symptoms. The reporter consented to follow-up.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Palpitations, Paraesthesia, Peripheral swelling, Pruritus, Sensory loss
Clinical narrative: Palpitations; losing feeling on the left side of her face, neck, shoulder, chest, arm and hand; Tingling; the patient ALMOST went into cardiac arrest; blood pressure was 168/102; Itching in arm; Swelling in arm; This case was reported by a consumer via call center representative and described the occurrence of cardiac arrest in a 54-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concurrent medical conditions included latex allergy (she was allergic to latex) and allergy (was allergic to several ingredients and would like to know what ingredients were in the vaccine).   On 17th September 2021, the patient received Boostrix. On 17th September 2021 14:00, less than a day after receiving Boostrix, the patient experienced itchy upper limbs and swelling arm. On 18th September 2021, the patient experienced cardiac arrest (serious criteria GSK medically significant) and blood pressure high. On 18th September 2021 10:00, the patient experienced loss of sensation and tingling. On an unknown date, the patient experienced palpitation. On an unknown date, the outcome of the cardiac arrest, loss of sensation, tingling and itchy upper limbs were unknown and the outcome of the blood pressure high and swelling arm were recovered/resolved and the outcome of the palpitation was not recovered/not resolved.   It was unknown if the reporter considered the cardiac arrest, blood pressure high, loss of sensation, tingling, itchy upper limbs, swelling arm and palpitation to be related to Boostrix.   Additional details were reported as follows: This case was reported by the patient for herself. The patient was unsure whether the Boostrix vaccine administered in left arm to her was from a vial or if it was a pre-filled syringe. The patient was rushed to urgent care after receiving the Boostrix vaccine. The patient reported that she had swelling and itching in her arm at 2 pm on the same day of vaccination.  The patient reported that at 10 am on 18th September 2021, 1 day after receiving vaccination, she experienced tingling and was losing feeling on the left side of her face, neck, shoulder, chest, arm and hand. 1 day after receiving vaccination, the patient reported that she went into cardiac arrest, and her blood pressure was 168/102 mmHg. The patient confirmed that she went to urgent care and was not admitted to the hospital on 18th September 2021. The patient reported that tests were done including EKG (electrocardiogram) and chest x-ray. Less than 2 months after vaccination, the patient reported that she still had palpitations. The patient reported that she had an appointment in November 2021 for a stress test and would have a heart monitor for two weeks. The patient did not have Lot number or expiry date of vaccine. The patient went again to urgent care on 18th October 2021 with same symptoms. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose in 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with case US2021218228, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021218228:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: shot 1 in Nov 2020, not yet received shot 2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: second dose wasn't administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 91-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 23rd September 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the second dose, which led to incomplete course of vaccination. The reporter consented to follow up
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose: 2019, second: did not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26th November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: SKIN REACTION ON BOTH ARMS THAT LOOKS GHASTLY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 16-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-JUL-2021, the patient experienced skin reaction on both arms that looks ghastly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from skin reaction on both arms that looks ghastly. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Heavy menstrual bleeding
Clinical narrative: SUFFER THE CONSEQUENCES WITH A TERRIBLE PERIOD FOR 15 DAYS; DISCOMFORT; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced suffer the consequences with a terrible period for 15 days, and discomfort. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suffer the consequences with a terrible period, and discomfort. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased, Hypoaesthesia
Clinical narrative: HEART RATE WAS WAY HIGH; ARM NUMB FROM ELBOW TO FINGERTIPS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced heart rate was way high, and arm numb from elbow to fingertips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm numb from elbow to fingertips, and the outcome of heart rate was way high was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: SIGNIFICANT HAIR LOSS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On OCT-2021, the patient experienced significant hair loss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of significant hair loss was not reported. This report was non-serious. This case, from the same reporter is linked to 20211046209.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Fatigue, Fine motor skill dysfunction, Gait inability
Clinical narrative: Couldn't walk; Trouble with fine motor skills; Trouble with balance; chills; Increased Fatigue; Injection pain; fever; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Couldn't walk), FINE MOTOR SKILL DYSFUNCTION (Trouble with fine motor skills), BALANCE DISORDER (Trouble with balance), CHILLS (chills) and FATIGUE (Increased Fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis, Fatigue, Headache, Spasticity, Depression, Heartburn and Sleep disorder NOS.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (Couldn't walk), FINE MOTOR SKILL DYSFUNCTION (Trouble with fine motor skills), BALANCE DISORDER (Trouble with balance), CHILLS (chills), FATIGUE (Increased Fatigue), VACCINATION SITE PAIN (Injection pain) and PYREXIA (fever). At the time of the report, GAIT INABILITY (Couldn't walk), FINE MOTOR SKILL DYSFUNCTION (Trouble with fine motor skills), BALANCE DISORDER (Trouble with balance), CHILLS (chills), FATIGUE (Increased Fatigue), VACCINATION SITE PAIN (Injection pain) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had medical history of excess fluid. No relevant concomitant medications were reported. No treatment medication was reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Couldn't walk; Trouble with fine motor skills; Trouble with balance; chills; Increased Fatigue; Injection pain; fever; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Couldn't walk), FINE MOTOR SKILL DYSFUNCTION (Trouble with fine motor skills), BALANCE DISORDER (Trouble with balance), CHILLS (chills) and FATIGUE (Increased Fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis, Fatigue, Headache, Spasticity, Depression, Heartburn and Sleep disorder NOS.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (Couldn't walk), FINE MOTOR SKILL DYSFUNCTION (Trouble with fine motor skills), BALANCE DISORDER (Trouble with balance), CHILLS (chills), FATIGUE (Increased Fatigue), VACCINATION SITE PAIN (Injection pain) and PYREXIA (fever). At the time of the report, GAIT INABILITY (Couldn't walk), FINE MOTOR SKILL DYSFUNCTION (Trouble with fine motor skills), BALANCE DISORDER (Trouble with balance), CHILLS (chills), FATIGUE (Increased Fatigue), VACCINATION SITE PAIN (Injection pain) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had medical history of excess fluid. No relevant concomitant medications were reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid 19 infection/SARS-CoV-2 infection; Lack of effect; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Covid 19 infection/SARS-CoV-2 infection) and DRUG INEFFECTIVE (Lack of effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021, the patient experienced COVID-19 (Covid 19 infection/SARS-CoV-2 infection) and DRUG INEFFECTIVE (Lack of effect). The patient was treated with IBUPROFEN for Adverse event, at a dose of 600 milligram. At the time of the report, COVID-19 (Covid 19 infection/SARS-CoV-2 infection) had not resolved and DRUG INEFFECTIVE (Lack of effect) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Oct-2021, SARS-CoV-2 test: negative (Negative) negative. On 15-Oct-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medication was reported. Patient decided to take the Binax Now rapid test. It was negative and to herknowledge administered correctly. On Oct 15, Patient  repeated the Binax Now rapid test because her symptoms  were not better. This time there was a very faint pink line indicative of a positive test so she went in for a PCR test on the same day.   This report concerns a female patient of unknown age, with no relevant medical history, who experienced the non serious unexpected AESI of COVID 19. Additionally, Drug ineffective was considered as an event. The events occurred approximately 8 months after receiving the second dose of Spikevax. Rechallenge is not applicable since it is a COVID 19 case. The benefit-risk relation of Spikevax is not affected by this report.; Sender's Comments: This report concerns a female patient of unknown age, with no relevant medical history, who experienced the non serious unexpected AESI of COVID 19. Additionally, Drug ineffective was considered as an event. The events occurred approximately 8 months after receiving the second dose of Spikevax. Rechallenge is not applicable since it is a COVID 19 case. The benefit-risk relation of Spikevax is not affected by this report.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Nausea; Don't feel good; I feel very weak; Arm hurts; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Don't feel good), PAIN IN EXTREMITY (Arm hurts), ASTHENIA (I feel very weak), NAUSEA (Nausea) and CHILLS (Chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced PAIN IN EXTREMITY (Arm hurts), CHILLS (Chills) and PYREXIA (Fever). On 18-Oct-2021, the patient experienced VACCINATION COMPLICATION (Don't feel good), ASTHENIA (I feel very weak) and NAUSEA (Nausea). At the time of the report, VACCINATION COMPLICATION (Don't feel good), PAIN IN EXTREMITY (Arm hurts), ASTHENIA (I feel very weak), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported  Patient stated that on 18-Oct-2021 he was on bed.  No treatment medications were reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Nausea; Don't feel good; I feel very weak; Arm hurts; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Don't feel good), PAIN IN EXTREMITY (Arm hurts), ASTHENIA (I feel very weak), NAUSEA (Nausea) and CHILLS (Chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced PAIN IN EXTREMITY (Arm hurts), CHILLS (Chills) and PYREXIA (Fever). On 18-Oct-2021, the patient experienced VACCINATION COMPLICATION (Don't feel good), ASTHENIA (I feel very weak) and NAUSEA (Nausea). At the time of the report, VACCINATION COMPLICATION (Don't feel good), PAIN IN EXTREMITY (Arm hurts), ASTHENIA (I feel very weak), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported  Patient stated that on 18-Oct-2021 he was on bed.  No treatment medications were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pyrexia, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Lymph nodes on both sides swollen and hurting; Lymph nodes on both sides swollen and hurting; After third dose had swelling 3-4 hours later; Low grade fever, arm was itching like crazy, glands swollen; Low grade fever, arm was itching like crazy, glands swollen; This spontaneous case was reported by a pharmacist and describes the occurrence of LYMPHADENOPATHY (Lymph nodes on both sides swollen and hurting), LYMPH NODE PAIN (Lymph nodes on both sides swollen and hurting), VACCINATION SITE SWELLING (After third dose had swelling 3-4 hours later), PYREXIA (Low grade fever, arm was itching like crazy, glands swollen) and VACCINATION SITE PRURITUS (Low grade fever, arm was itching like crazy, glands swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A, 030L20A and 023M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRAVASTATIN and LAMOTRIGINE (LAMICTAL) for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Lymph nodes on both sides swollen and hurting), LYMPH NODE PAIN (Lymph nodes on both sides swollen and hurting), VACCINATION SITE SWELLING (After third dose had swelling 3-4 hours later), PYREXIA (Low grade fever, arm was itching like crazy, glands swollen) and VACCINATION SITE PRURITUS (Low grade fever, arm was itching like crazy, glands swollen). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, LYMPHADENOPATHY (Lymph nodes on both sides swollen and hurting), LYMPH NODE PAIN (Lymph nodes on both sides swollen and hurting), VACCINATION SITE SWELLING (After third dose had swelling 3-4 hours later), PYREXIA (Low grade fever, arm was itching like crazy, glands swollen) and VACCINATION SITE PRURITUS (Low grade fever, arm was itching like crazy, glands swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-356141, MOD-2021-356142 (Patient Link).
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Got sick for 4 days; Initial information received on 16-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional via.   This case involves a (unknown age and gender) patient who got sick for 4 days (illness) after receiving INFLUENZA VACCINE.  The patient's medical treatment(s), vaccination(s), Concomitant medication(s) and family history were not provided.  The patient had no medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient got sick for 4 days (illness, non-serious) (unknown latency) following the administration of vaccine.  It was unknown if the patient experienced any additional symptoms/events.  No laboratory data reported.  It was reported "Got mine! sick for 4 days! First time ever! "  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Peripheral swelling
Clinical narrative: Injection site red and armpit still swollen on day 3.  Tried Advil, Tylenol and heat
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Extra dose administered, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: unclear if allergic reaction, as this was 3rd covid dose & pt has had flu vaccine in past.  Pt reported flushed face.  Upon observation cheeks turned bright red, skin mottled & face and neck pink.  No s/sx of breathing trouble, no local reaction at injection sites. Patient sat in observation for 1 hour total, drank cool water & redness/pink/mottled skin slowly diminished over the hour, remaining slight pink at 1:15hr after dose w/o any s/sx of anaphylaxis