chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adverse event; received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose).    Concomitant medication was not reported.  Nurse reported that 19 patients received the half doses on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022, and 06-Oct-2022.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-662961, US-MODERNATX, INC.-MOD-2022-662973 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662973:Same reporter US-MODERNATX, INC.-MOD-2022-662961:Same reporter
Right Neck Pain.; Could not move the neck up and down or side to side for a day without pain; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 15Apr2021 at 11:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer. The patient previously took tetracycline (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included exemestane (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. On 16Apr2021 at 10:00, the patient experienced right neck pain and could not move her neck up and down or side to side for a day without pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events right neck pain and could not move her neck up and down or side to side for a day without pain was resolved on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Red area, 2 inch circumference on lateral aspect and 4 inches down from shoulder.
Severe headache, chills, pain and redness of the arm, diarrhea.
Fever, Chills, Body aches, vomiting, lethargic, headache.
Right eye twitching, right side of lip twitching. Lasting 30 seconds.
pt states that she ocular headache immediately after taking the vaccine and then after she could see she had a migraine.  Next day she developed vomiting, diarrhea, and left arm pain that lasted 2 days.  She has fatigue and body aches on the second day that lasted 5 days.   Pt contacted her PCP to let them  know her symptoms.
Fatigue; Headache; Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Sep2021 15:45 (Lot number: 301358A) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lymphoma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 27Sep2021 23:45, outcome "recovered" (28Sep2021), described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 27Sep2021 23:45, outcome "recovered" (28Sep2021), described as "Sore arm"; FATIGUE (non-serious) with onset 28Sep2021 23:45, outcome "recovered" (2021), described as "Fatigue". Therapeutic measures were not taken as a result of headache, pain in extremity, fatigue.  No follow-up attempts are possible. No further information is expected.
This case was reported by a nurse via call center representative and described the occurrence of nausea in a female patient who received FLUARIX QUADRIVALENT (batch number 79PE5, expiry date 15th June 2017). On 18th October 2016, the patient received FLUARIX QUADRIVALENT (intramuscular). On 18th October 2016, less than a day after receiving FLUARIX QUADRILALENT, the patient experienced nausea, diarrhea and vomiting. On an unknown date, the outcome of the nausea, diarrhea and vomiting were recovered/resolved. The reporter considered the nausea, diarrhea and vomiting to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was previously not reported to anyone. The age at vaccination was not reported. The reporter had an employee that received the FLUARIX QUADRIVALENT and experienced nausea, vomiting, and diarrhoea within a couple of hours after receiving the vaccination. The employee believed that the FLUARIX QUADRIVALENT contains monosodium glutamate and because of which she had these adverse events. The call was transferred to medical information. The reporter was unable to provide any further details at the time of the call.
This spontaneous report ws received from a nurse regarding unknown number of patients of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. Since 02-JUN-2014, unknown number of patients were vaccinated with (Oka/Merck) VARIVAX (dose, product lot, expiry date not reported) subcutaneously, which was improperly stored. This was supported. No adverse effects reported. There was no product quality complaint involved. The outcome of the event was unknown. Additional information has been requested.
seronegative rheumatoid arthritis seemed to flare after her vaccines; This is a spontaneous report from a contactable physician. A 77-year-old female patient received bnt162b2 (Pfizer), dose 1 via an unspecified route of administration on 01Mar2021 (Lot Number: EN6205), dose 2 via an unspecified route of administration on 22Mar2021 (Lot Number: EN6205) as single doses for COVID-19 immunisation. Medical history included ongoing seronegative rheumatoid arthritis. The patient's concomitant medications were not reported. The patient experienced seronegative rheumatoid arthritis seemed to flare after her vaccines on an unspecified date with outcome of not recovered. The event was reported as non-serious. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information currently available,The casual association between the reported event and suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
No symptoms until Day 8, at vaccine site a large, welted, itchy oval approximately 2 inches in diameter appeared.  Day 9 continues to itch and is still welted.
Child was given a booster dose of Pfizer despite not meeting age requirement of 16 years.
Received flu vaccine on 10/2/13 in LFA and noted tightness in left neck and shoulder. Similar to last year in which I was in bed for a day and 1/2 for painful muscle spasms and unable to move left arm and head.
After my first shot, my throat constricted an hour after the vaccine.  After the second shot, my throat constricted less than 5 minutes after the shot
Per mom, pt developed a reddish reaction at the injection site & a small bump with a head, almost like a big bite. The next day there were a cluster of red dots on the nape of his neck & then the following day red dots all over his body.
PATIENT'S MOTHER REPORTED ADVERSE EVENT ON 10/15/14.  MOTHER STATED THAT PATIENT DEVELOPED HIVES AROUND 8 PM ON 10/13/14.  HER HIVES STARTED ON HER EYELIDS AND EVENTUALLY SPREAD TO RIGHT SIDE OF FACE, THORAX, BILATERAL EXTREMITIES, AND BACK.  PATIENT TOOK A DOSE OF BENADRYL AND USED HYDROCORTISONE 1% CREAM FOR HER SYMPTOMS ON 10/13/14 AND HAD SOME RELIEF.  PATIENT HAD NEW SITES OF HIVES ON THE MORNING OF 10/14/14 AND TOOK ANOTHER DOSE OF BENADRYL.  HIVES RESOLVED THE EVENING OF 10/14/14 AND PATIENT IS SYMPTOM FREE ON 10/15/14.
Headache Fever 100.1 F Chills Sore throat   Sore throat began first, then chills, then fever, finally headache. All started approx 22.5 hours after vaccination.
Skin felt prickly approx 5 hours after vaccine, woke up at 2 am and had a rash around her mouth, nausea, fever, abdominal pain, and a headache, in the morning she noticed the injection site was red and swollen approx 3in in diameter.
Varicella vaccination given 1-8-08 - 2hr next day child had erythema with noted at site of injection of about 2 1/2 x 2 1/2 reports by mother. Examination of site on 11/10/08 erythema of 4 1/8 x 3 3/4, hot and tender to touch - Tx of Benadryl, Motrin, ice and heat packs to area; 01/16/08 Follow-up call to mother to check on child. Mother reports that they had taken child to "hospital" on Friday the 11th because the swelling and redness had spread almost up to the shoulder and down to the elbow and almost circled the upper arm. She also stated that the fingers on that side were a different color. That doctor at "hospital" diagnosed her with cellulitis and placed the child on clindamycin because the medication that the primary physician had placed her on was not for skin infections. Mother reports that the arm was much improved by the next day and looks good now. Child had twisted her ankle just prior to receiving the vaccination. Apparently the physicians had wondered if maybe the child had a minor abrasion or had possibly scratched the injection site. Mom did not know.
Itchy red, swollen rash around injection site appeared 12 days after shot.  However, patient tested positive for covid on January 20.
Severe Vertigo with vomiting, fever, chills, sweating, nausea, muscle pain headache, and ringing ears.
First symptom began on 2/14/2021 with severe nerve pain in my might jaw bone.  On 2/16/2021 I had a burning, painful red rash on the right side of my face side,  redness, swelling , pain to the touch,  Redness and pain first diagnosed by NP - Urgent Care 2/16/2021 as Shingles - prescribed prednizone and Valtrex.  By 2/18/2021 redness, pain and swelling had progressed to the right eye as well and continued to have all aforementioned symptoms.  I was seen by an ophthalmologist on 2/18/2021.  He said it was not typical of Shingles and had no idea what it was told me to see my primary.  I saw my primary that afternoon.  He agree that it was not shingles but also had no idea what was causing it.  While in his office, my ahnds turned bright red and painful and within 30 that resolved. Prescribed a higher dose of Prednizone, Keflex and Valtrex.  Symptoms  are still unresolved.  No fever involved.
Patient was administered an extra booster dose of 0.25 ml.  Patient had received a 0.25 ml dose in Nov 2021
Lost vision (one eye); This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Lost vision (one eye)) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLINDNESS (Lost vision (one eye)) (seriousness criteria hospitalization and medically significant). At the time of the report, BLINDNESS (Lost vision (one eye)) outcome was unknown.            Concomitant medication were not reported. Hospitalized for two weeks and had administered with steroids.  Company Comment: This case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious event of Blindness. The event occurred on an unknown date after the second dose of mRNA-1273 Vaccine which resulted in hospitalization. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-419388, MOD-2021-423152, MOD-2021-423102 (Patient Link).; Sender's Comments: This case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious event of Blindness. The event occurred on an unknown date after the second dose of mRNA-1273 Vaccine which resulted in hospitalization. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
SUDDEN SENSORY NEURAL HEARING LOSS LEFT EAR; This spontaneous report received from a consumer concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non smoker, and he had no known allergies and he was not a drug abuse or illicit drug user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 18-MAR-2021 to right deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-JUL-2021, the patient experienced sudden sensory neural hearing loss left ear (ringing in left ear) and which was still ongoing and she visited physician's office. On an unspecified date, the patient experienced ringing in left ear. The patient was treated with prednisone 50 mg first 2 days and taper over 10 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sudden sensory neural hearing loss left ear.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210738424 - Covid-19 vaccine ad26.cov2.s-sudden sensory neural hearing loss left ear. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Error storage for Engerix-B given to a patient; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received HBV (Engerix B) (batch number N4GA4, expiry date 2nd January 2023) for prophylaxis.   On 27th October 2021, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The practice manager called to report that Engerix-B was administered to patient after a temperature excursion, which led to incorrect storage of drug. This lot number was exposed to a lowest temperature of 18 degree Fahrenheit for more than 30 days, vaccines are not longer viable. The reporter consented to follow up. This case was linked with case US2021237516, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021237516:Same reporter. Pt 1/2
intermittent sensation radiating from left armpit to left chest area. it will come and go every few minutes and lasts a couple days. This occurred 4-5 days after first dose. Today I took my 2nd dose and I felt the symptom immediately.
itchy whelps across stomach breasts & legs; painful & red seen by MD 15JUL92; rx for Seldane, then Cortisone;
Patient broke out in hives within 24 hours after receiving immunization. Patient took Benadryl and is consulting her physician.
I had a breakthrough case of Covid, scratchy throat then sore throat I had: fever, cough, body aches restlessness, extreme fatigue and lost sense of smell, congestion.
cold few days later more so flu like symptom; 1st dose may not be effective as vial used was opened a day before and refrigerated probably; arm pain; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (cold few days later more so flu like symptom), PRODUCT STORAGE ERROR (1st dose may not be effective as vial used was opened a day before and refrigerated probably) and PAIN IN EXTREMITY (arm pain) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (cold few days later more so flu like symptom), PRODUCT STORAGE ERROR (1st dose may not be effective as vial used was opened a day before and refrigerated probably) and PAIN IN EXTREMITY (arm pain). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at a dose of 1 dosage form; DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at a dose of 1 dosage form and GUAIFENESIN (MUCINEX) at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (cold few days later more so flu like symptom), PRODUCT STORAGE ERROR (1st dose may not be effective as vial used was opened a day before and refrigerated probably) and PAIN IN EXTREMITY (arm pain) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter.
erythematous indurated skin rxn covering entire deltoid area eval pt 2 day p/vax;skin rxn approx 6cm;it was not documented which arm each vax was given in;
I am still having numbness in the right heal and pain in the right thigh and buttocks region. It is not as bad as it was before after the 2nd shot but its still persisting. I am able to walk now but its still painful. The pain level was a 12 back in 02/2021 but it is now a 2.
Mother reports symptoms started Approx 3 weeks ago. Suffering 4 episodes of seizure-like activities per day. Patient knows that episode is going to come on. Patient has body shaking and eyes focus on one object. This patient was seen at Hospital and referred to pediatric neurology.  Patient had bloodwork and EEG/MRI. Patient places on Keppra.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Spironolactone).    On 17-Nov-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 COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 17-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) was resolving.            No concomitant medications were reported  On 22-MAY-2022 patient experienced rebound of symptoms.  Company comment-This spontaneous case concerns a patient of unknown age and gender, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 on an unknown date after third dose of mRNA-1273 vaccine. Patient was being treated with Paxlovid (NIRMATRELVIR, RITONAVIR) for Covid from 13th to 17th May2022, patient also had rebound of symptoms after completion of treatment with Paxlovid .Outcome of the event was resolving at the time of report. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.  Patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment. Device Date was reported as 23-May-2022.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 on an unknown date after third dose of mRNA-1273 vaccine. Patient was being treated with Paxlovid (NIRMATRELVIR, RITONAVIR) for Covid from 13th to 17th May2022, patient also had rebound of symptoms after completion of treatment with Paxlovid .Outcome of the event was resolving at the time of report. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Patient said she was fine 9-12 but woke up 9-13 with severe pain in the back of both of her lower legs.  No other pain or discomfort except for slight discomfort when she raises her arm in the arm injected.
17 year old female received an adult 20 mcg dose; 17 year old female received an adult 20 mcg dose; This case was reported by a physician via call center representative and described the occurrence of overdose in a 17-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   On 10th August 2022, the patient received the 1st dose of Engerix B adult 20 mcg/mg. On 10th August 2022, unknown after receiving Engerix B adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 18-AUG-2022 Reporter's Comments: The physician reported that an adult 20 mcg dose of Engerix B was given to the 17 years old patient. No symptoms were reported. The health care professional did not have the lot/expiry date of the vaccine. The reporter consented to follow up. Additional supportive information: The use of an adult dose of Engerix B to 17 years old patient, which led to overdose and adult product administered to child.
Pt began mild swelling at Pneumonia injection site in the late evening. Fever 101.80 began on Friday and lasted until Sunday evening. Severe body aches with swelling/redness from injection site to elbow. Resolved by Sunday 10/20
sore upper arm w/pain in shoulder & upper arm;unable to sleep well @ noc;small nodule w/induration around upper arm;no inc in heat, purulence;tx w/lodine & heat;
Severe chest, nasal and sinus congestion, wheezing, extreme coughing fits, headaches, sore muscles, mild fever, ear plugging, fatigue, coughing up phlegm. Symptoms persisted for 6 days before seeking medical treatment.
FLUZONE given 11 am, pt called 3pm. Tongue swelling advised take BENADRYL if symptoms get worse seek medical attention.