chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via sales rep and described the occurrence of injection site pain in a patient who received BEXSERO. In December 2015, the patient received BEXSERO .5 ml. On an unknown date, less than a month after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details provided were as follows: The physician's office had called the sales representative to report this case. The patient had been vaccinated with BEXSERO within the last month or so who had about 5 days of pain at the injection site after vaccination with BEXSERO. The patient's gender, lot number and expiration date of the vaccine were unknown.
Increased HR, headache, dizziness, SOB, sore arm, and body aches
Patient presented with redness about the size of a grapefruit on her arm under the administration site. Red spot was round in shape and itchy. Redness had decreased some by the time the patient reported to the pharmacy
arm was very red, red area was large, covering a big portion of shoulder and upper arm; Initial information received on 05-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a male patient (age not reported) who experienced redness on arm and the red area was large and was covering a big portion of shoulder and upper arm (erythema), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], lot number and expiration date not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced a non-serious redness on arm and the red area was large and was covering a big portion of shoulder and upper arm (erythema) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE for few days.  (Other relevant tests included no lab data.)  Final diagnosis was erythema.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event.   Information on batch number was requested.
Severe full body hives from face down to feet starting at approximately 8:00 a.m. on Sunday, becoming more severe on Monday (8/13/12). Another doctor administered a steroid shot at approximately 9:00 a.m. on 8/13/12. Symptoms worsened by 11:30 a.m. and patient was taken to the ER. Patient was given and prescribed 1) Predisolone, 2) Famotadine, 3) Lortamide.  Currently on day 3 of hive breakouts, although not as severe as it was on 8/12 and 8/13.
Breakthrough case admission after 2 vaccines Pfizer 3/17/21 Lot# EN6207;  Pfizer 4/8/21 Lot# Ew0150
I had my 1st shot on 4/1/2021 & I missed my period by about 3 days, but I didn?t think anything of it. I had my 2nd shot on 4/22/2021, and I was tired, had a sore arm and mild temp just like with my 2nd shot, and I just figured it was normal. On 9/1/2021, I had my 3rd booster shot. I have PCOS, but my periods are normal. I am overweight. I also have high blood pressure. I did feel tired after the 3rd COVID shot, no temperature that time, but the 5th came, and I didn?t have my period. I?m not pregnant. I have not had sex for over a year now. I didn?t think about my period til I checked my calendar, and noticed that my period is now 12 days late!
[Johnson and Johnson vaccine] use for COVID-19 under Emergency Use Authorization (EUA):  Pt received vaccine ~April 1, 2021. Now admitted with ITP (thrombocytopenia). Platelets prior to August 2021 unavailable but platelets dropped to 4 prior to increasing to 75 today. Physicians unsure of cause of thrombocytopenia and considered vaccine included may be a differential although the time frame is much longer out than other reported cases.
Pt recvd 1st hep B vax 23JAN91 & exp conjunctivitis of right eye.Tx w/ eye drops.
Vaccine was administered approx. 9am 12/15/2017 my child had not been sick at all when brought to the doctors for the 18 month old well visit. By 2pm that day my child had over 102 f temperature and was sick. Not eating well, cranky, coughing and just overall sick. 12/16/2017 saturday child is still sick and running fever of approx. 100-101, she is coughing, congested, and overall sick. Child is still drinking and eating small amounts and is talking and responsive. Saturday night into sunday early morning child woke up twice that night crying and took an hour each time to console and put back to sleep. Approx 7am 12/17/2017 sunday am child wakes up and grandmother gets child from crib, grandmother states child is still sleepy/lethargic and falls asleep in grandmothers arms alomost immediatly. After 30 minutes of sleep child wakes up but is very lethargic temperature is over 102 degrees f . Mother now wakes up and goes to her child, grandmother states child does not look well.  Child does not respond to her mother, mother is calling her name with no response, child is not blinking, no eye contact, no talking, child becomes limp with no muscle tone, eyes roll back in head, unable to keep child awake. 911 called chuild taken to emergency room in hospital.
9 patients received Moderna booster (vial had black particle floating in it); 9 patients received Moderna booster (vial had black particle floating in it); This spontaneous case was reported by a health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (9 patients received Moderna booster (vial had black particle floating in it)) and PRODUCT QUALITY ISSUE (9 patients received Moderna booster (vial had black particle floating in it)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (9 patients received Moderna booster (vial had black particle floating in it)) and PRODUCT QUALITY ISSUE (9 patients received Moderna booster (vial had black particle floating in it)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (9 patients received Moderna booster (vial had black particle floating in it)) and PRODUCT QUALITY ISSUE (9 patients received Moderna booster (vial had black particle floating in it)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 11-NOV-2014, the patient was vaccinated with an improperly stored dose of (23-valent) PNEUMOVAX 0.5 ml (VIs 10 SDV) (Lot number K007822, expiration date 15-AUG-2015), single dose, route and anatomical location were not provided. There was no concomitant medication provided. On an unknown date, the (23-valent) PNEUMOVAX had a temperature excursion for 1632 hours, with the highest recorded temperature of 59.9 F (15.5 Celsius). The vaccine status was reported as "in excursion", and was storage in a Refrigerator (R). There was no product quality complaint involved and no adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
My symptoms started with a tickle in my throat and my voice became super hoarse. I tested myself regularly every 2 weeks and I tested negative. I went to get tested on Sunday and it was positive. I had general fatigue and I got a little wheezy with a cough. I was given an albuterol inhaler RX, benzonatate, and dexamethasone. My symptoms took a full 14 days to completely resolve.
I felt tired and had a very runny nose the day after the shot.  The 2 following days I felt lethargic and very tired but was able to go about my daily routine as expected.
Onset of productive cough with green sputum, green rhinorrhea subjective fevers, chills.
Within 10 min of injection of the egg free flu vaccine. I experienced swelling, pain and redness below the injection site that has continued into the second day.
This study case was received from the investigator in a trial on 30 November 2012. A 31-year-old male subject had received the following vaccinations on 15 November 2012: ACAM2000 (lot number and route not reported) in the left arm, anthrax vaccine (manufacturer, lot number, route and site not reported) and FLUMIST (lot number, route and site not reported). Eight days post-vaccination on 23 November 2012, the subject experienced onset of chest pain, chest pressure and shortness of breath that was exacerbated by wearing combat gear. All symptoms are in the middle of chest and are a constant sharp pain. The subject also reported headaches since one day post-vaccination on 16 November 2012. The subject started taking ADVIL for the symptoms on 16 November 2012. The subject was evaluated by the provider before visit two. No ECG or labs were performed and the subject returned to full duty. On 28 November 2012, an ECG was done that was abnormal. Troponin I was increased at 0.13 ng/ml. The subject had an allergy to penicillin and had frequent headaches since 1984. No further information was available at the time of the report. The subject's outcome was not recovered. According to the investigator, the event of elevated Troponin was considered another important event and possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: None.
SEVERE HEADACHE; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, and seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested No concomitant medications were reported. On 26-MAR-2021, the subject experienced severe headache. On 26-MAR-2021, the subject experienced fever. On 26-MAR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 27-MAR-2021, and had not recovered from severe headache, and fatigue. This report was non-serious.
diarrhea; bowel issues; fever runs low; headache; chills; muscles are sore; cough; congestion; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 75-year-old female patient received bnt162b2 (BNT162B2), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 75 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing). Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis. Vaccination history included: Covid-19 vaccine (dose 1 , Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (dose 2 , Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset 18Nov2021, outcome "not recovered", described as "fever runs low"; HEADACHE (non-serious) with onset 18Nov2021, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 18Nov2021, outcome "not recovered", described as "chills"; MYALGIA (non-serious) with onset 18Nov2021, outcome "unknown", described as "muscles are sore"; COUGH (non-serious) with onset 18Nov2021, outcome "unknown", described as "cough"; RESPIRATORY TRACT CONGESTION (non-serious) with onset 18Nov2021, outcome "unknown", described as "congestion"; DIARRHOEA (non-serious) with onset 21Nov2021, outcome "unknown", described as "diarrhea"; GASTROINTESTINAL DISORDER (non-serious) with onset 21Nov2021, outcome "unknown", described as "bowel issues". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, headache.  Additional information: The patient took Tylenol (paracetamol) for her headache and fever which helps it subside for a while but then it comes back. The patient reported that she took her Enbrel weekly on Wednesdays. The patient had bowel issues but this came out of the blue. The fever runs low grade in the 90s but also get up into the 100s. Patient reported that having the diarrhea today made her pretty nervous and concerned. She may try to get into a walk in clinic to see a doctor. Her Rheumatologist told her that she had a lesser chance of getting COVID since she was on Enbrel. The causal relationship between the events gastrointestinal disorder, chills, respiratory tract congestion, cough, diarrhoea, headache, pyrexia, myalgia and Enbrel, Single Dose Prefilled Syringe was not provided by the consumer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Very painful during injection and after, felt lightheaded, hot, nauseous (nausea lasted only 15 min) woozy feeling lasted 24 hrs. Breast pain first two nights after vaccine. Apr 6 arm pain worsened along with increased swelling and redness. Noticed left clavicle lymph node was enlarged. Today arm has slight red rash and itching.
Warm red rash around injection site, approximately 2 inch wide by 3 inch long. Appeared on the 17th and was gone approximately one day later. Returned on 4/21/21. Benadryl given by spouse.
once it kicked in it was hard to stay out of the bed; exhaustion, sweating, body aches, and brain fogged; exhaustion, sweating, body aches, and brain fogged; exhaustion, sweating, body aches, and brain fogged; went to urgent care where had a COVID run and an influenza run both negative; constipated for all the Tylenol; cough.; a fever of 99-101 every day; exhaustion, sweating, body aches, and brain fogged; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (once it kicked in it was hard to stay out of the bed), HYPERHIDROSIS (exhaustion, sweating, body aches, and brain fogged), PAIN (exhaustion, sweating, body aches, and brain fogged), FEELING ABNORMAL (exhaustion, sweating, body aches, and brain fogged) and SARS-COV-2 TEST NEGATIVE (went to urgent care where had a COVID run and an influenza run both negative) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (once it kicked in it was hard to stay out of the bed), HYPERHIDROSIS (exhaustion, sweating, body aches, and brain fogged), PAIN (exhaustion, sweating, body aches, and brain fogged), FEELING ABNORMAL (exhaustion, sweating, body aches, and brain fogged), SARS-COV-2 TEST NEGATIVE (went to urgent care where had a COVID run and an influenza run both negative), CONSTIPATION (constipated for all the Tylenol), COUGH (cough.), PYREXIA (a fever of 99-101 every day) and FATIGUE (exhaustion, sweating, body aches, and brain fogged). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (once it kicked in it was hard to stay out of the bed), HYPERHIDROSIS (exhaustion, sweating, body aches, and brain fogged), PAIN (exhaustion, sweating, body aches, and brain fogged), FEELING ABNORMAL (exhaustion, sweating, body aches, and brain fogged), SARS-COV-2 TEST NEGATIVE (went to urgent care where had a COVID run and an influenza run both negative), CONSTIPATION (constipated for all the Tylenol), COUGH (cough.), PYREXIA (a fever of 99-101 every day) and FATIGUE (exhaustion, sweating, body aches, and brain fogged) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Influenza virus test: other (Negative) other. On an unknown date, SARS-CoV-2 test: other (Negative) OTHER.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information also includes: IV Fluids on Urgent Care Concomitant medications were not reported   This case was linked to MOD21-039023.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Non-significant follow up appended
This spontaneous report received from a nurse refers to a 13 month old patient. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 14-SEP-2016, the patient was vaccinated with improperly stored M-M-R II lot #M004305 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/insurance. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1609USA014830: US-009507513-1610USA004339.
patient blacked out and passed out after receiving her first dose within the 15 min wait time. 911 was called and vitals were normal. patient refused admission to hospital
cough; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) and FATIGUE (tiredness) 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 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (cough) and FATIGUE (tiredness). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CORICIDIN [OXYMETAZOLINE HYDROCHLORIDE]) at a dose of 1 dosage form and AZITHROMYCIN (Z-PAK) at a dose of 1 dosage form. At the time of the report, COUGH (cough) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
An MD's office called on 2/4/03 at 10:30 stated child had large palm sized rash on left thigh, no fever, no swelling. Also had quarter sized rash on right thigh, no swelling or fever.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 05-Jul-2022; No adverse event; Patient administered the vaccine after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 05-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 05-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 05-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 05-Jul-2022).    Concomitant product was not provided. Treatment information was not provided.  Patient received half dose.  On 04-Jun-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.
expired dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received DTPa (Infanrix) (batch number 23t73, expiry date 30-APR-2023) for prophylaxis.   On 03-MAY-2023, the patient received Infanrix. On 03-MAY-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: expired dose administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 03-MAY-2023 The reporter consented to follow up. The patient received an expired dose of Infanrix vaccine, which led to expired vaccine used.
Day after 2nd dose COVID19 vaccine, patient reports feelings cramps/pain in both legs/calves.  Still persisting daily 1 month after 2nd dose vaccine.  Did not have reaction after 1st dose COVID19 vaccine.
Pt stated that a few hours after her injection she started to experience shaking in her hands as she picked up objects and described it as seizure like shaking. Later on in the night she became cold and had a fever of 101-102 and tried using Tylenol initially for the fever when she first checked her temperature. she said that the fever resolved after 12 hours and there was no more shaking.
itchiness of the left shoulder; redness of left shoulder; swollenness of left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itchiness of the left shoulder), INJECTION SITE ERYTHEMA (redness of left shoulder) and INJECTION SITE SWELLING (swollenness of left shoulder) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C4A) for COVID-19 vaccination.     Concomitant products included ADALIMUMAB (HUMIRA) for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced INJECTION SITE PRURITUS (itchiness of the left shoulder), INJECTION SITE ERYTHEMA (redness of left shoulder) and INJECTION SITE SWELLING (swollenness of left shoulder). At the time of the report, INJECTION SITE PRURITUS (itchiness of the left shoulder), INJECTION SITE ERYTHEMA (redness of left shoulder) and INJECTION SITE SWELLING (swollenness of left shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.