chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU3
Symptoms: Allergy test, Lymphadenopathy, Ocular hyperaemia, Periorbital swelling, Swelling face
Clinical narrative: Whites of eyes was completely red; swollen under eyes; face swelling; swollen glands in neck; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via agecy (Reference number- 00448535) and transmitted to Sanofi on 27-Jan-2021.  This case involves a male patient (age unspecified) whose whites of eyes were completely red (ocular hyperaemia), swollen under eyes (periorbital swelling), face swelling (swelling face) and swollen glands in neck (lymphadenopathy)while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 08-Oct-2017 (on Sunday), the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UI840AA, expiry: 06-Apr-2018) via unknown route in unknown administration site for prophylactic vaccination.  On 09-Oct-2017 (on Monday), she had fish  On 10-Oct-2017 (Tuesday afternoon), the patient's whites of eyes were completely red (ocular hyperaemia), swollen under eyes (periorbital swelling), face swelling (swelling face) and swollen glands in neck (lymphadenopathy) 2 days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. These non-serious reactions were severe.  The consumer was trying to get ingredients from the FLUZONE High Dose vaccine she got on 08-Oct-2017, so that she could determine if she is able to get the coronavirus disease (COVID-19) vaccine and why she had the reaction to the high dose (HD) flu vaccine. She had a severe reaction to Sanofi's High dose Flu vaccine. In Oct-2017 she had Sanofi (HD) flu shot for the 1st time and she had a severe reaction. The patient stated that she never had a reaction to the regular dose of Flu vaccine before and is not sure why she reacted to the high dose flu vaccine. Patient had a picture of how her face looked with the reaction. She did not recall having a fever. She went to Urgent Care.   Relevant laboratory test results included: Allergy test showed that nothing else was involved  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Pain level 8/10 arm throbbing pain woke me up. Felt like my upper arm was throbbing like a heart and was going to burst open. My fingers were swollen and I couldn?t get my ring off. I was unable to extend my arm fully. This lasted 40 hours . Then it subsided to a 2/10 ache in my arm that felt like I had been punched hard and felt like I had a salad plate size bruise on my arm. This lasted 2 more days.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Ear pain, Ear swelling, Erythema, Headache
Clinical narrative: 6 days of severe headaches, body aches, cold sweats, swollen lymph nodes; 2 days of on and off fevers (started on 3rd day), over 100 Fahrenheit; 2 days of ears swollen up, red, ringing, and pain.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pyrexia, Tinnitus
Clinical narrative: 6 days of severe headaches, body aches, cold sweats, swollen lymph nodes; 2 days of on and off fevers (started on 3rd day), over 100 Fahrenheit; 2 days of ears swollen up, red, ringing, and pain.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: Pain at injection site, full body aches and headache, fatigue
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling for 2 days at the place of injection.  Fatigue and dizzyness
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiopulmonary exercise test normal, Chest pain, Echocardiogram, Electrocardiogram abnormal, Electrocardiogram normal
Clinical narrative: Pt is a 37y F with previous history of pericarditis diagnosed after an initial COVID infection SEP20 with a second occurrence NOV20. Pt subsequently received her first COVID Vaccine shot on 22JAN21 and reported to medical on 3FEB21 with mild chest pain and an EKG with changes demonstrating pericarditis and a US demonstrating trace effusion. Pt was minimally symptomatic but given her previous episodes was sent to the Role 3 for further evaluation. Her work up on 10FEB21 demonstrated resolution of EKG changes and effusion with normal cardiopulmonary work up. Given her history it has been recommended that she does not receive the second dose of the vaccination.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pericardial effusion, Pericarditis
Clinical narrative: Pt is a 37y F with previous history of pericarditis diagnosed after an initial COVID infection SEP20 with a second occurrence NOV20. Pt subsequently received her first COVID Vaccine shot on 22JAN21 and reported to medical on 3FEB21 with mild chest pain and an EKG with changes demonstrating pericarditis and a US demonstrating trace effusion. Pt was minimally symptomatic but given her previous episodes was sent to the Role 3 for further evaluation. Her work up on 10FEB21 demonstrated resolution of EKG changes and effusion with normal cardiopulmonary work up. Given her history it has been recommended that she does not receive the second dose of the vaccination.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Diarrhoea, Injection site pain, Injection site warmth
Clinical narrative: -Soreness around injection site  ( Started right after and the severity is the same as the flu shot) - Warm feeling around injection site for the first 15-30 minutes after receiving the injection - 6 hours later around 8:00/30 I began having bloating, stomach cramps and diarrhea
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: I felt stupid
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Energy increased
Clinical narrative: Very very hight energy. Can't sleep much as I have an overload of energy. Don't feel tired or exhausted. Everyone seems to have different symptoms after vaccine I seem to be doing the opposite. Is this normal?
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: One week after receiving the vaccine I started experiencing a mild allergic reaction on the skin surrounding the injection site, about 3 inches by 3 inches. The area was red, itchy, hard, and felt warm.  It was uncomfortable, but not painful and it went away on its own after 2 days.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Vomiting
Clinical narrative: Injection site pain within 24 hours, lasting 48 additional hours.  Nausea onset 30 hours after first dose injection.  SEVERE vomiting 33 hours after first dose injection which came in frequent waves over the following 3 hours, but then subsided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: Shortly after - brain fog  Two days of headache,  extreem fatigue,  chills  Symptoms ended - Feb. 12th around 3am  I was too weak to report this earlier.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Nausea
Clinical narrative: I was fine except for soreness in the arm and a mild headache  from the time I got the vaccine (Wednesday 1:20 p.m.) through the evening, but woke up (Thursday morning about 6:00) very sick .  I had a worse headache, extreme tiredness, nausea , vomiting (dry heaves as I  couldn?t eat or drink the whole time), fever and chills.  The bouts of vomiting fever and chills came in three through the day.  I felt extremely unwell the whole time and just kept reminding myself that it would be over soon, but it lasted throughout Thursday.  I fell asleep around 5:00 p..m. Thursday afternoon and woke up around midnight feeling that the symptoms had passed.  Now it?s Friday morning (5:30 a.m.) and I feel completely well again.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Retching, Vomiting
Clinical narrative: I was fine except for soreness in the arm and a mild headache  from the time I got the vaccine (Wednesday 1:20 p.m.) through the evening, but woke up (Thursday morning about 6:00) very sick .  I had a worse headache, extreme tiredness, nausea , vomiting (dry heaves as I  couldn?t eat or drink the whole time), fever and chills.  The bouts of vomiting fever and chills came in three through the day.  I felt extremely unwell the whole time and just kept reminding myself that it would be over soon, but it lasted throughout Thursday.  I fell asleep around 5:00 p..m. Thursday afternoon and woke up around midnight feeling that the symptoms had passed.  Now it?s Friday morning (5:30 a.m.) and I feel completely well again.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site nodule, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: "Patient reports that just after she was administered the Pfizer COVID-19 vaccine (first dose) on 1/16/21, she developed redness around the area that resolved in "two to three days". However, she then developed a wheal-like lesion around the injection site in the last day after the initial redness resolved. She noted diffuse warmth around the proximal left upper arm/left deltoid region. She denies tenderness on palpation. She reported feeling a "knot" underneath skin where lesion occurs. She did not complain of SOB/wheezing, swelling."
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; dose of V AQT A that was inadvertently administered after its labeled expiry date; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 25-JAN-2021, the patient was inadvertently vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) 1 dose, lot # S032359, expiration date 11-JAN-2021 (route of administration and anatomical location were not provided). There was no additional adverse event reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032359; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness, Pain, Pyrexia
Clinical narrative: pretty much like having the flu; fever; aches; weakness; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms, fever, pain and weakness. On an unknown date, the outcome of the influenza-like symptoms, fever, pain and weakness were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever, pain and weakness to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient had a pronounced reaction which included fever, aches, weakness pretty much like having the flu.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes simplex
Clinical narrative: flare ups of herpes simplex; This case was reported by a nurse and described the occurrence of herpes simplex aggravated in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes simplex.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced herpes simplex aggravated. On an unknown date, the outcome of the herpes simplex aggravated was unknown.   It was unknown if the reporter considered the herpes simplex aggravated to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. The patient asked if the Shingrix could ever cause flare ups of herpes simplex. Was this a possible side effect.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Pruritus, Rash
Clinical narrative: Had itching; perspiration; rash on her back / also at the base of her neck to her waist; This case was reported by a pharmacist and described the occurrence of rash in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number XG52X, expiry date 28th November 2021) for prophylaxis.   On 23rd October 2020, the patient received the 1st dose of Shingrix. In October 2020, 24 hrs after receiving Shingrix, the patient experienced rash and sweating. On 26th October 2020, the patient experienced pruritus. On 26th October 2020, the outcome of the rash and sweating were recovered/resolved. On 28th October 2020, the outcome of the pruritus was recovered/resolved.   It was unknown if the reporter considered the rash and pruritus to be related to Shingrix. The reporter considered the sweating to be unrelated to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix and 24 hours later developed a rash on her back after perspiring from physical activity. The pharmacist stated that the perspiration was not from Shingrix but from physical activity of the patient working in her home. The patient was wearing a sports bra and the rash was near the bra band and was also at the base of her neck to her waist, the rash was 2 inches wide on each side of her spine, the rash stayed there for 2 days then resolved. The pharmacist stated that after the rash resolved, 3 days after receiving Shingrix, she had itching that lasted for 2 days then it was gone. All events resolved, no further symptoms reported. The reporter consented to follow-up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Joint range of motion decreased, Myalgia, Sleep disorder
Clinical narrative: Shoulder muscle is sore; Soreness is restricting his movement; Soreness keeps him up at night; it hurts / soreness has worsened; This case was reported by a consumer and described the occurrence of muscle pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included PNEUMONIA VACCINE.   On 1st December 2020, the patient received the 1st dose of Shingrix (intramuscular). In December 2020, several days after receiving Shingrix, the patient experienced muscle pain, mobility decreased, nocturnal awakening and pain. On an unknown date, the outcome of the muscle pain, mobility decreased, nocturnal awakening and pain were not recovered/not resolved.   The reporter considered the muscle pain, mobility decreased, nocturnal awakening and pain to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient received 1st dose of Shingrix in his right arm and a Pneumonia shot and within a couple of days he had a problem with his shoulder, he claimed that his shoulder muscle was sore, and the soreness was restricting his movement.  The patient reported that the soreness keeps him up at night and it hurts, and he felt that the soreness had worsened. The patient stated that the pharmacist was careful while injecting the pneumonia shot in his left arm, but he was not careful when injecting the Shingrix in his right arm. The patient related his symptoms to the Shingrix vaccine. The reporter consented to follow-up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: the patient having a shingles outbreak.; incomplete course of vaccination; This case was reported by a pharmacist and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   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 not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patiernt received 1st dose in 2018 and experienced shingles outbreak. The reporter stated that, the patient was came back for the second dose but the second dose was denied due to the patient having a shingles outbreak. Till the time of reportingf, the patient did not receive dose 2 of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: Did not receive the full dose of the vaccine; The needle was not completely locked in; A spontaneous report  was received from a consumer concerning a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced did not receive the full dose of the vaccine and the needle was not completely locked in.   The patient's, medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patients received the first dose of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient did not receive full dose of vaccine and some came out from injection site. The needle was not completely locked in.   Action taken with the second dose of Moderna vaccine in response to the events for these 2 patients was not reported.  The outcome of the events, did not receive the full dose of the vaccine and the needle was not completely locked in, was resolved on an unknown date.; Reporter's Comments: This report refers to a case of Incorrect dose administered and needle issue for mRNA-1273, lot # unknown with no associated AEs.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received the second dose 18 days later; A spontaneous report was received from a pharmacist concerning a 35-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and received the second dose 18 days later (inappropriate schedule of vaccine administration).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an undisclosed date, the patient received his first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an undisclosed date 18 days later, the patient received his second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection 18 days after his first dose.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, received the second dose 18 days later, was resolved on unknown date.; Reporter's Comments: This report refers to a case of received the second dose 18 days later (inappropriate schedule of vaccine administration) for (mRNA-1273, lot # unknown ) with no associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Incorrect dose administered, Injection site haemorrhage
Clinical narrative: I am concerned that I didn't get a full dose; injection pushed hard drawing blood; liquid trickled all the way down arm; A spontaneous report was received from a female patient (age unknown), who received Moderna's COVID-19 vaccine and experienced incorrect dose administered, injection site bleeding, and exposure via skin contact.  The patient's medical history was not provided.  Concomitant product use was not provided.  On 16 Jan 2021, prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.  The patient received the vaccine on 16 Jan 2021 and stated that the person who gave the injection pushed hard drawing blood. She also noted liquid trickled all the way down her arm causing concern that a full dose was not administered. Treatment information was not provided.  Action taken with second dose of mRNA-1273 in response to the event was not provided.  The event, incorrect dose administered and exposure via skin contact was considered resolved and the outcome of the event injection site bleeding was unknown.; Reporter's Comments: This case concerns a female patient of unknow age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered, Exposure via skin contact and associated non-serious adverse event of Injection site haemorrhage.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Incorrect route of product administration
Clinical narrative: Injection went into subcutaneous tissue; Redness; Headache; Fatigue; A spontaneous report was received from a consumer, concerning herself, a 65-year-old, female patient, who received Moderna's COVID-19 vaccine and injection went into subcutaneous tissue, experienced redness, headache and fatigue.  The patient's medical history reported included hypertension and sleep apnea (CPAP machine). Concomitant medications reported included metformin, pravastatin and fluticasone propionate, salmeterol xinafoate.  On 28-Jan-2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number 004M20A) subcutaneously in her right arm for COVID-19 infection prophylaxis.  On 28-Jan-2021, the patient reported that the injection went into her subcutaneous tissue and developed redness, headache and fatigue. Treatment information was not provided  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the event, injection went into subcutaneous tissue was considered to be resolved on 28-Jan-2021. The outcome of the event, headache was considered to be resolved on 29-Jan-2021. The outcome of the event, redness and fatigue was considered unknown.; Reporter's Comments: This case concerns a 65-year-old, female subject with medical history of Hypertension and Sleep apnea, who experienced nonserious expected events of Erythema, Headache, and Fatigue. The events occurred after the first dose of the mRNA-1273 administration on the same day.   Based on the current available information and temporal association between the use of the product and the start date of the events of Erythema, Headache, and Fatigue a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Temperature excursion; A spontaneous report was received from a nurse concerning 100 patients who received Moderna's COVID-19 Vaccine (mRNA-1273) that was affected by a temperature excursion.    The patients' medical history was not provided. No relevant concomitant medications were reported.  On 06 Jan 2021, the patients received their first of two planned doses of mRNA-1273 (Lot number: 639K20A) intramuscularly for prophylaxis of COVID-19 infection.    On 29 Dec 2020, the refrigerator temperature reached 35.6 Fahrenheit for 4 minutes. 100 doses were administered after the temperature excursion. No adverse events were reported following the vaccinations. A visual inspection was completed at the time of excursion and there was no product complaint reported. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, temperature excursion, was considered resolved on 29 Dec 2020.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273, lot # 639K20A with no associated AEs.
Sex: U
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: Liquid seemed to leak out most of vaccine from the syringe, and didn't appear to be injected into the patient; Liquid seemed to leak out most of vaccine from the syringe, and didn't appear to be injected into the patient; A spontaneous report was received from a pharmacist concerning a consumer (age, gender and ethnic origin were not reported) who was scheduled to receive Moderna's COVID-19 vaccine but liquid seemed to leak out most of vaccine from the syringe and stated "it doesn't appear any was injected into the patient" (syringe leak and underdose).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 01 Feb 2021, the patient presented to the pharmacy for their first of two planned doses of mRNA-1273 (Lot number: 012M2OA) intramuscularly for prophylaxis of COVID-19 infection.  On 01 Feb 2021, during attempted administration, liquid seemed to leak out most of vaccine from the syringe and didn't appear to be injected into the patient. No treatment information was provided.   Action taken with mRNA-1273 in response to the event(s) was not reported.  The events, liquid seemed to leak out most of vaccine from the syringe and didn't appear to be injected into the patient, were considered resolved on 01 Feb 2021.; Reporter's Comments: This case concerns a patient of unknown age and gender who received their first of two planned doses of mRNA-1273 (Lot number: 012M2OA) intramuscularly for prophylaxis of COVID-19 infection and reported by pharmacist that liquid seemed to leak out most of vaccine from the syringe and didn't appear to be injected into the patient. There were no reported adverse events in this case of underdose and syringe issue.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given Moderna 1st shot accidentally; A spontaneous report was received from a consumer's mother concerning female patient who received Moderna's COVID-19 vaccine (mRNA-1273) accidentally.   The patient's medical history was not provided.  Concomitant product use was not provided.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    On the unknown date the patient was accidentally administered the vaccine.  The mother was concerned whether she should be administered the Moderna vaccine for the second dose or try the Pfizer vaccine at this point.  She is also asking to see if her daughter can be enrolled in Moderna's teen clinical trial.  Action taken with second dose of mRNA-1273 in response to the events was not reported.   The event, was accidentally given Moderna first shot was considered resolved.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. There were no reported adverse events after the vaccine was administered in this case of product administered to patient of inappropriate age
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product substitution issue
Clinical narrative: was given Pfizer's vaccine 21 days ago and yesterday i was given Moderna's; was given Pfizer's vaccine 21 days ago and yesterday i was given Moderna's; A spontaneous report was received from a consumer concerning a 93-year-old female, patient, who was administered Pfizer vaccine as 1st dose and Moderna covid-19 vaccine as second dose in 21 days apart.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03 Feb 2021, patient received 2nd of the two planned doses of Moderna covid-19 vaccine. Her first dose  is Pfizer vaccine which was given  21  days ago.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events "Pfizer's vaccine 21 days ago and yesterday i was given Moderna's" was considered as resolved on 03 Feb 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration and product substitution issue for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Needle separated from hub; Partial dose; A spontaneous report was received from a pharmacist, concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine and where in needle separated from hub and received partial dose.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On 26-Jan-2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for COVID-19 infection prophylaxis.  On 26-Jan-2021, while patient was receiving vaccine, in the middle of administration the needle got separated from the hub and patient received partial dose. The exact volume was unknown. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the events, needle separated from hub and partial dose was considered resolved on 26-Jan-2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Device connection issue and Underdose without any associated adverse events.
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Received Pfizer brand on first dose and second dose was Moderna; A spontaneous report was received from a nurse concerning a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and received Pfizer brand on first dose and second dose was Moderna (wrong vaccine administered).   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On an unknown date, the patient received a dose of the Pfizer COVID vaccine.  On 07 Jan 2021, the patient received a dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.    On 07 Jan 2021, the patient was administered mRNA-1273 vaccine for second dose instead of Pfizer COVID vaccine.   Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, received Pfizer brand on first dose and second dose was Moderna (wrong product administered), was resolved on 07 Jan 2021.; Reporter's Comments: This case concerns a male patient of unknown age who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting Wrong product administered without any associated adverse events.
Age: 0.92
Sex: M
Vaccine: FLUX, HEPA, HIBV, MMR
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received the 4th dose of ActHIB at 11 months old (instead of the recommended 12 months), no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Agency (Reference number- 00457196) and transmitted to Sanofi on 02-Feb-2021. This case involves an 11 months old male patient who received the 0.5 ml 4th dose of HIB (PRP/T) VACCINE [ACT-HIB] VACCINE (lot UJ327AA, expiry: 30-Jun-2021) via intramuscular route in the left thigh at 11 months old (instead of the recommended 12 months), for prophylactic vaccination on 29-Jan-2021 (Inappropriate schedule of product administration)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A), INFLUENZA VACCINE (FLU) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination.  It was a case of an actual medication error due to drug dose administration interval too short (latency same day)  The caller stated that a patient has received the 4th dose of ActHIB early and would like to know how to proceed in caring for the patient. The actual day of the month was not available. The patient was supposed to receive the 4th dose of Acthib. The patient's birthday was XX-jan-2021 in the computer and his actual birthday is XX-feb-2020. He received his dose weeks early.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 33.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Dyspnoea, Swollen tongue
Clinical narrative: shortness of breath; tongue swelling; Initial information regarding an unsolicited valid non-serious case was received from a physician via agency (Reference number- 00457437) and transmitted to Sanofi on 02-Feb-2021.  This case involves a 33 year old male patient who experienced shortness of breath (dyspnoea) and tongue swelling (swollen tongue), while he received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 13-Jan-2015, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UI232AA, expiry: 30-Jun-2015) via intramuscular route in the right arm for prophylactic vaccination.  On 13-Jan-2015, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via intramuscular route in unknown administration site for prophylactic vaccination.  On 13-Jan-2015, the patient developed a non-serious shortness of breath (dyspnoea) and tongue swelling (swollen tongue) 2 hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Physician stated the patient is scheduled to have the Coronavirus disease (COVID-19) vaccine tomorrow and she was hoping to get an answer to her question before then. The caller was asking for ingredients of Fluzone Quadrivalent (she is not sure which one) and Adacel from 2015  No laboratory data was provided  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of events was unknown.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pyrexia
Clinical narrative: 102 fever for 2 hours. Body aches for 24 hours
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chest discomfort, Chest pain, Chills
Clinical narrative: Fast heart beat, chest tightness and pain, dizziness and weakness 2hours after got shot  Chills, muscle and join pain, headache the second day
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Electrocardiogram, Full blood count, Headache, Heart rate increased
Clinical narrative: Fast heart beat, chest tightness and pain, dizziness and weakness 2hours after got shot  Chills, muscle and join pain, headache the second day
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Myalgia
Clinical narrative: Fast heart beat, chest tightness and pain, dizziness and weakness 2hours after got shot  Chills, muscle and join pain, headache the second day
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Heart rate increased
Clinical narrative: Fast heart beat, chest tightness and pain, dizziness and weakness 2hours after got shot  Chills, muscle and join pain, headache the second day
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chest discomfort, Chest pain, Chills
Clinical narrative: CHEST TIGHTNESS, INCREASE HEART RATE, DIZZINESS
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Electrocardiogram, Full blood count, Headache, Heart rate increased
Clinical narrative: CHEST TIGHTNESS, INCREASE HEART RATE, DIZZINESS
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Myalgia
Clinical narrative: CHEST TIGHTNESS, INCREASE HEART RATE, DIZZINESS
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Heart rate increased
Clinical narrative: CHEST TIGHTNESS, INCREASE HEART RATE, DIZZINESS
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Monoplegia, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Excruciating pain in left arm starting at shoulder - no movement or feeling - weakness - numbness - tingling
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Pain
Clinical narrative: Severe fatigue, severe body aches, fever up to 103, chills, headache, brain fog
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Severe fatigue, severe body aches, fever up to 103, chills, headache, brain fog
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: After 8 days of my shot (today), I noticed I was pretty itchy on my arm at the injection site. When I finally got a good look at it, it was red and had, what seems to be, little hives around it. It?s also a little tiny bit swollen at that area. Very warm to the touch and I can now feel this continuous, residual heat around it now that it?s later on in the day.   Since it?s only the first day I noticed it, the size of the area is still rather small. I don?t know if it will progress to be any bigger than it is now or if its appearance will change in the future.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: The first dose vaccination on Jan 8, 2021 very mild symptoms of arm soreness about 12hrs after injection. Lasted only a few hrs. Second dose vaccination on Jan 29, 2021 had more symptoms. Arm pain again about 10hrs after, lasted longer, about a day. About 18 hrs after injection was very fatigued and had a headache. This lasted about 24 hrs. Also had episodes of chills and slight fever. All symptoms were better a day later, though have noticed more headaches the following week.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: "39yo Patient c/o left upper arm rash x 1d a/w redness, warm to touch had COVID vaccine 2 wks ago (1/24/21) in left arm no swelling, itchiness, pain, sob/wheeze, throat swelling, drooling; no new foods, products, lotions, pets, hiking, biking, camping; no known exposure, gardening, new medications;"
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Insomnia, Pain
Clinical narrative: 99.8 F fever, body aches, headache, chills, fatigue, trouble sleeping
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 99.8 F fever, body aches, headache, chills, fatigue, trouble sleeping
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash papular
Clinical narrative: Torso, arms and upper legs covered in red, raised rash
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lichen striatus
Clinical narrative: Lichen striatum on right buttocks
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site swelling, Nausea, Pruritus
Clinical narrative: -Large swollen hot area the size of a small grapefruit at site of injection.  -Itching feet, arms, chest - headache  - nausea  - fatigue
Age: 73.0
Sex: M
Vaccine: UNK
Symptoms: Rash
Clinical narrative: rash on my left shoulder where the shot was given
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Feeling hot, Headache, Vomiting
Clinical narrative: I woke up a little afraid 2:00 AM with a headache, body chills and vomiting.  It is now 6:57 AM, I still have the headache, chills and get hot.  I have no fever.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: FEVER, CHILLS, MYALGIAS, HA, INJECTION SITE TTP
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Pfizer BioNTech COVID 19 Vaccine EUA 20 hours later Headache. Tired. Body aches. redness and swelling at the site.  1 pm.  At 630 pm low grade fever 100, took Tylenol.  Took a second round at 1 am.   Illness ended.  Swelling and redness grew around site and left armpit.  Continues to grow 2-12-2021
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Injection site: pain and tenderness, swelling, lymph node swelling, redness  General:  Fatigue, headaches, muscle/joint pain, feverish and chills without an actual fever  All side effects have been very manageable.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Injection site: pain and tenderness, swelling, lymph node swelling, redness  General:  Fatigue, headaches, muscle/joint pain, feverish and chills without an actual fever  All side effects have been very manageable.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Paraesthesia
Clinical narrative: Prior hx. of anapylaxis from ferrlicit, hives from gallalinium, sulfa drugs and clindamycin. Received Trastuzubam yesterday. Individual from pharmacy called and approved vaccine administration. At 11:37 am patient noted tingling in both arms and legs and slight light-headedness. Denied any trouble swallowing, facial or   tongue swelling. states a little chest tightness but not enough to take her inhaler. Vital signs at 12:09pm   BP 149/75, pulse 90, Pulse ox. 100%.At 12:20pm patient still admits to bilateral leg and   arm tingling, no facial/tongue swelling or difficulty swallowing. No change in chest tightness.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Patient reported burning sensation at injection site after vaccine
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warmth, redness and swelling at the injection site developed the next day. I was prescribed Keflex to treat cellulitis.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature decreased, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Low grade temperature, shaking chills, muscle aches, headache, fatigue, nausea
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Nervousness
Clinical narrative: Low grade temperature, shaking chills, muscle aches, headache, fatigue, nausea
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Mobility decreased, Musculoskeletal stiffness, Neuralgia, Pain in extremity
Clinical narrative: Left arm immobilized due to painfully soreness and stiffness with nerve in left arm involuntarily jerking.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Chills, fever (102), nausea,  headache, 24 hours
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count normal, Nausea, Vomiting
Clinical narrative: Aside from the more common side effects, I experienced severe nausea and vomiting.  I vomited every 30 minutes for approximately 8 hours.   I went to the ER and requested IV fluids and meds to stop the vomiting.   This worked wonders.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Covid arm.  Red, itchy circle at injection sight.  https://www.health.com/condition/infectious-diseases/coronavirus/covid-arm-rash-moderna
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: redness in arm, extending from deltoid to elbow, raised, hive. Fever 100.3, lightheadedness, headache, brain fog (hard to think),fatigue, chills achiness, loss of appetite and energy
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: redness in arm, extending from deltoid to elbow, raised, hive. Fever 100.3, lightheadedness, headache, brain fog (hard to think),fatigue, chills achiness, loss of appetite and energy
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: redness in arm, extending from deltoid to elbow, raised, hive. Fever 100.3, lightheadedness, headache, brain fog (hard to think),fatigue, chills achiness, loss of appetite and energy
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient found by  family in his home  deceased  on the morning of 02/10/2021.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Skin warm, Swelling
Clinical narrative: Swollen, hot, sore  for more than 3 weeks
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arteriosclerosis, Autopsy, Condition aggravated, Death
Clinical narrative: No reported adverse reactions from 1st or 2nd vaccine doses Patient died on 2/6/2021 at Correctional facility- autopsy was performed at medical examiner's office. The COD was artherosclerotic cardiovascular disease
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: nausea, light headed  queasy
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Piercing headache 5 hrs after injection. Used heated rice pack and took 2 ibuprofen. Subsided after 4-5 hrs. Following morning woke and severely nauseous and dizzy. Layed down and up a 1/2 hr later and gone. Very tired all day. Next day feeling fine. Sore arm for several days.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Skin mass
Clinical narrative: about 4-5 days after the vaccination I developed a painful lump in my right armpit (same side of the vaccine)that is about the size of a marble .  I has been there for 2 days and is becoming less painful and slightly smaller, but is still there currently.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying, Erythema, Injection site reaction, Peripheral swelling, Tenderness
Clinical narrative: Injection site reaction- circumferential thigh swelling, redness, tenderness. Inconsolable crying for 2 hours.  Given Tylenol and cool compress.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Insomnia, Nausea
Clinical narrative: Initially within a hour slight headache, slight nausea. Lasted 2 days after injection.  Two days after injection, only at night when laying down, severe localized pain near shoulder blade and spine.  Deep throbbing and sharp pain.  Very difficult to sleep.   Lasted 3.5 days, started at night. During day, moving around, working with horses was not noticed.  Still have that localized pain going on 7 days.  As of 2/12/21. But not to the extent stated earlier.   When pain first started, took 800 milligrams ibuprofen each night and 400 milligrams for two nights.  Medicine took about 2.5 hours to actually work enough to be able to sleep.  Have not taken any meds for 2 nights now.  Occasional throbbing but staying away from meds.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Loss of personal independence in daily activities
Clinical narrative: Firmness and itching at injection sight. Itching strong enough to distract from everyday activities. Injection site is still sore to the touch 7 days after the shot.