chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 5 minutes after patient received  1st dose Pfizer COVID-19 vaccine in center of left deltoid, the patient noted a tingling sensation in her entire left arm and reported to store staff monitoring observation area.  met with patient. Patient remained in observation for 30 minutes and departed. Patient reported no difficulty with movement and no other adverse effects were noted by patient.
Vesicular, clustered pastales to (R) frontal scalp - Herpes Zoster.  Follow-up information received states - #1 Influenza - unavailable - #2. MMR Merck # 0764Y exp 5-30-11- #3 Hep A - GlaxoS.Kline # 0913Y exp 5/26/12 - #4 Varicella - Merck #066Y exp 5-8-11. These vaccines were given at the clinic.
Soon after injection on 3/27/21 at 1:47pm, felt weak throughout body, arm very sore and felt heavy, slight headache. Rested the evening, restless during night with body just hurting.  Around 7am began vomiting and diarrhea and body hurting for about 1 hour.  Stayed in bed all of 3/28/21.  Feeling of weakness still lingering  now on 3/30/21 with headache but trying to be at my job and function.
Fluzone High-Dose Quadrivalent was given to a 61-year-old patient with no adverse event; Initial information was regarding an unsolicited valid non serious case was received from an other health professional via Medical Information  (Reference number- 00816733) and transmitted to Sanofi on 18-Oct-2021 in a specific country.  This case involves a 61-year-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 14-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to product administered to patient of inappropriate age (latency: same day).  At time of reporting, no adverse event 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 the 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.  There will be no information available on the batch number for this case.
Received Flu-pneumonia shots on 10/2/10 Tuesday at store. Next day (L) arm weakness noted. He felt fluish and arm hurt. Pr. to Sat it was red and hot and this increased to all around the arm - went to Urgent Care on Sunday and was started on antibiotics. Now is less swollen but still hurts.
This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 07-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received.     Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012724 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent.  This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments:  US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Pt called pharmacy this morning 5/6/21.  Stated she developed a rash on her wrist the next day after vaccination.  Now, starting 5/4 the rash flared up and continued to both arms and legs.  Pt took Benadryl and was advised to call her MD /derm.
pt had flu like sx stiff neck & back fever, vomiting;1-2 days p/vax;pt came down w/a cold & is better now;
Presented on 2 OCT 08 after receiving ACAM 2000 smallpox inoculation. Hx of 3 days of chest pain, fever and SOB. Did well after rest and INDOCIN. Symptoms: Chest Pain, Fever, Dyspnea (Pt is deployed. Awaiting additional history and records. Plan to file Update VAERS when additional information obtained.)
Started feeling nauseous,  some fatigue. Followed by fever that has increased to 102.7 over 2 hours.
Patient received her first dose of COVID vaccine on 5/1/21. On 5/3/21, patient presented to the ED after experiencing cough and fever for about 1 week. Since patient was not hypoxic at the time, she was discharged home from the ED. However, pt's symptoms worsened and she came back to the ED on 5/6/21. This time, she was found to be hypoxic, and she was admitted for COVID treatment (remdesivir, dexamethasone, and tocilizumab were all given during patient's hospitalization) and required heated high flow oxygen.
I may have had an unusual abdominal reaction; This is a spontaneous report received from Pfizer . A contactable consumer of unspecified age and gender reported to have received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient may have had an unusual abdominal reaction to the second Pfizer Covid vaccine shot. Outcome of event was unknown. The patient was directed to the appropriate site to share this information. Forwarded as an Adverse Event by the  team on 29Mar2021. Reporter provided verification of contact address on 27Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a nurse practitioner refers to a 14 year old female patient with no medical history and with no drug reactions/allergies. On 07-MAY-2013 the patient was vaccinated with an adult dose of VAQTA (INJ 50/1.0 U/ML, lot # H010269, exp date 03-NOV-2014, dose/frequency, route and duration were unspecified) for prophylaxis. This was her 1st dose of VAQTA. There was no concomitant medications. The day after vaccination (08-MAY-2013), patient developed a headache and later began to vomit. Patient had sought medical attention via calling the office. Treatment of ibuprofen was given for the event. The outcome were unknown. Additional information has been requested.
Within 1 to 2 minutes of administering the Janssen Covid Vaccine to the patient, the patient fainted while waiting in the observation area at the front of the pharmacy. His wife yelled to staff that he had fainted and wasn't sure if he may be having a seizure. The pharmacist immediately approached the patient, who did not appear to be having a seizure, although she did observe that his face was drained of color (white/gray), and the patient was unresponsive, his eyes were shut. The patient did have a pulse and was breathing normally. At this time, a pharmacy technician was contacting 911 emergency medical services, who were on their way to the pharmacy. A second pharmacist approached to help the patient immediately, and the patient started to wake, and become responsive to verbal cues from his spouse and pharmacy staff. The second pharmacist conducted neurological tests (checked patient's eyes, ability to speak, maneuver arms), and the patient was given orange juice to drink. The patient blood pressure and heart rate were checked (119/95, 41 bpm). The patient became very apologetic and embarrassed (he stated this), and it was explained that he had a history of fainting in response to seeing needles previously (i.e., during blood draw). The patient was able to drink a few gulps of orange juice. Within the first few minutes of waking, the patient then fainted again. He was not responsive for about a minute, and then became responsive again, as EMS arrived. EMS than evaluated the patient, and offered to take him to the ER, which the patient declined. The patient signed a release to not go to the ER, and returned home for the evening, but was instructed to seek medical attention if further warranted at any time.
seen in ER 30CT98;jerking, vomiting, fever 103, LOC fading in & out (lethargy);31OCT98 broke out in rash on thigh;
Allergic rxn (thiomersal). Rash, burning around mouth and face. Txt: BENADRYL q6 hour.
No adverse event; Patient received Moderna booster as first dose But never received any Covid-19 vaccines before.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Moderna booster as first dose But never received any Covid-19 vaccines before) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     The relevant medical history/conditions, allergy, concomitant diseases and risk factor was unknown.   On 27-Mar-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Mar-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Moderna booster as first dose But never received any Covid-19 vaccines before). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Moderna booster as first dose But never received any Covid-19 vaccines before) 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 WRONG PRODUCT ADMINISTERED (Patient received Moderna booster as first dose But never received any Covid-19 vaccines before.).    No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unspecified dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection, lot # L014428, expiration date: 12-MAR-2018, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. The certified medical assistant was unable to provide exact temperatures at the time of reporting, but stated they "went to 32 degrees Fahrenheit or lower" and they were out of range for "15 minute increments, 40 times". No specific cumulative time was reported. The temperatures were reported by a data logger and according to the reporter they were back in range at the time of report. There were no prior excursions reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
positive blood test for celiac disease; Reporter added they basically said to redo all the shots.; sore arm; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 26Mar2021 (Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm on 26Mar2021. She had a positive blood test for celiac disease 4 days after first dose on 30Mar2021. The reporter was seeing a GI specialist for issues she was having, and the doctor thought it was unrelated. Patient received the first dose of the Pfizer Covid-19 vaccine on 26Mar2021 in a clinic that was shut down due to poor safety and storage issues, after investigation the health Department sent her an e-mail (13Apr2021) stating that she should revaccinate regardless of receiving one or both doses of the vaccine. It was based on an investigation the department of health did. The reporter added they basically said to redo all the shots. She was notified of this on 13Apr2021 and is technically scheduled for her third dose tomorrow. The outcome of event celiac disease was unknown, sore arm was recovered on 28Mar2021.; Sender's Comments: -Based on the limited information in the case report , A possible causal relationship between event Celiac disease and suspect drug BNT162B2 cannot be 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
At 12:30 that night I woke and I felt like to throw up and diarrhea at the same time. I had a terrible headache, dizziness, nausea. I had chills. The next day I was still very, very sick and had a fever of a hundred degrees. And I was sick all day Saturday. Unable to hold down any water. Sunday morning it broke and I was starting to come out of it. Today I'm not feeling 100% but much, much better.
DELAYED SKIN HYPERSENSITIVITY REACTION AT THE INJECTION SITE, + ERYTHEMIA, - SWELLING, - PAIN, - PRURITIS . SHE IS ON ABOUT DAY 10, WHEN MOST CLEAR BY DAY 7. I TOLD HER THIS DOES NOT MEAN SHE CAN'T GET HER SECOND DOSE, AND SHE COULD USE ICE +/- CLARITIN TO TRY TO MAKE IT GO AWAY FASTER BUT IT WILL EVENTUALLY CLEAR.
Vaccine caused old dance injury to become inflamed; was in able to walk for two weeks; Pain still resides; causes inability to reform task; This is a spontaneous report from a contactable healthcare professional, the patient. This 22-year-old non-pregnant female patient reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COBVID-19 mRNA vaccine, lot number: EL9267) via unspecified route in the left arm on 18Feb2021 at 07:30 as a single dose for COVID-19 immunization. Medical history included old dance injury. There were no concomitant medications. Past drug history included allergy to cephalexin (CEPHEX). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have COVID-19 prior to vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COBVID-19 mRNA vaccine, lot number: EL9264) via unspecified route on 30Jan2021 at 11:00 (at the age of 22-years-old) as a single dose in the left arm for COVID-19 immunization. On 20Feb2021, vaccine caused old dance injury to become inflamed and patient was unable to walk for two weeks. Pain still resides and causes inability to perform task. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received included Cortisone shot. The clinical outcome of the events 'old dance injury to become inflamed and patient was unable to walk for two weeks' was recovered with sequel (reported as recovered with lasting effects), while for 'Pain still resides and causes inability to perform task' was not recovered. The patient was not tested for COVID-19 post vaccination.; Sender's Comments: based on the temporal relationship the causality between the events inflammation , pain ,unable to walk and the suspect vaccine comirnaty cannot be completely ruled out  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous report as received from a medical assistant refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 that had been left out in the open for 30 to 40 minutes. It was not specified which outside clinic the patient went to receive the vaccine. No adverse effect was reported. The outcome of the event was unknown. Additional information is not expected.
Pts injection site had a large bump size of golf ball. Area red, hot, and bruised. Pt's last flu shot 2003.
had 2 episodes of jerking of head lasting approx 30 sec each followed by blank stare; t101 R; seen by MD next AM & ER that noc; adm for observation; LP nl;
Day 8 injection site reaction--itchy rash over upper arm, burning, splotchy red skin like a sunburn, injection site hard and swollen, deltoid muscle pain from top of shoulder down to elbow. Used over the counter antihistamine (dipenhydramine 25 mg) once, anti-itch cream twice. Symptoms better in 2 days but still present
no additional AE; proquad and varivax injection on the same day; This spontaneous report was received from a nurse and refers to a 1-year-old male patient. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 12-NOV-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T016991 was verified to be valid, expiration date: 11-NOV-2021, albumin status: rHa) and on the same day he received varicella virus vaccine live (oka/merck) (VARIVAX) (lot#T003707 was verified to be valid, expiration date: 30-JAN-2022) both for prophylaxis (exact doses, dose number, routes of administration and anatomical location of aforementioned vaccines were not reported). Inappropriate dose of vaccine was administered. No additional adverse events were reported. The outcome of the events was unknown.
MODERNA COVID VACCINE #3 GIVEN 12/2/21, LOT #030H21B; pt tested positive for COVID in assisted living facility; developed bilateral pneumonia; brought to ED via EMS for poor oral intake and dehydration; DNR; comfort measures; pt passed away in the hospital
increased heart rate up to 136bpm at 10:45pm while laying in bed.  Had increased heart rate over 100 BPM while sleeping for 10  hours and did not come down to under 70 until 2 days later.
Shingles/rash on the left outside of foot, with painful red blisters and burning sensation in toes; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning to a patient of unknown age and gender.  Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 09-MAR-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, subsequently after receiving zoster vaccine live (ZOSTAVAX), the patient suffered rash on the left outside of foot, with painful red blisters and burning sensation in toes and was diagnosed with Herpes Zoster. As a result of these symptoms, the patient was seen and treated by medical providers. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations were not present prior to using zoster vaccine live (ZOSTAVAX) vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX) vaccine, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered serious, progressive, permanent, and incurable injuries. The outcome of the event of shingles was considered as not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of shingles was considered to be disabling event.
Cephalgia; fever; vomiting.  Care giver called CDC # on VIS and was told to seek medical care, so she took patient to ER.  Patient recalls getting an IV.  Care giver recalls being told patient's reaction was due to shots to protect from viral illness.
The patient experienced a itchy rash on both arms and slightly on her legs. It becomes more red throughout the day and is extremely uncomfortable. The rash does appear to be slightly raised.
Red swollen, hot, raised area around injection site. Approximately 2 inches in diameter.
Redness and swelling - cyst like at site of filler injection on face. Chills, fatigue, nausea, headache, pain in left arm
I got swollen, red,  burning, painful toes, but only the big  toes.  Numbness in my toes and ankles.  Is this known as Corona  Toe?
Fever, nasal congestion, sore throat, headaches.  Headaches started 3 days after Flu Mist.
At the time of administration pt was given two doses of bivalent covid by accident.  had pt stay in store for 30 minutes for observation.  no reaction.   5 hours post administration pt feeling ok with some arm soreness.  72 hours post administration pt reports sore arm gone and only feeling extra tired with no other adverse effects.
RASH ON CHEST NECK AND FACE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and  expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On MAR-2021, the subject experienced rash on chest neck and face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash on chest neck and face was not reported. This report was non-serious.
Dizziness, headache, abdominal pain within 10 minutes of vaccine.  Similar to prior symptoms which occurred 4 hours after first vaccine..  Tylenol given. Symptoms improved within 45 minutes. but not back to normal.  Patient went home.
Patient admitted on 7/10/22, tested positive for COVID-19 The primary encounter diagnosis was COVID-19. Diagnoses of Pneumonia of left lower lobe due to infectious organism, Urinary retention, Fecal impaction in rectum (*), and Weakness generalized were also pertinent to this visit.
Suddenly allergic to soy. If soy is eaten, will get bloody poo or red prickly rash all over body. There was previously no allergy to soy at all, and patient never had an allergic reaction to anything prior to receiving vaccine.
Patient got the flu shot in her right arm. About an hour later, she felt "warm, flush" all over her body. Her face was very red. She took TYLENOL, she eventually felt better.
Patient was given Pfizer Bivalent booster 5-11yrs instead of Pfizer Peds primary series. Patient was due for their 2nd pfizer primary series. Patient had no reaction while being monitored in clinic.