chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Appendicitis attack; Appendix ruptured; This is a spontaneous report from a contactable consumer. This report was received via a sales representative. A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 25Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 25Feb2021 as dose 1, single for covid-19 immunisation. The patient reported the appendicitis attack on 09May2021 where her appendix ruptured. This was being reported as she noticed that there were SAEs in similar nature with the vaccine on the CDC website and she did not attribute it to the vaccine but wanted to report, event took place after use of product. The clinical outcome of the events were unknown.  Follow-up activities closed. Batch/lot number not available for [vaccine/BNT162B2].; Sender's Comments: Based on the available information the reported events appendicitis and appendicitis perforated may not be related to suspect product BNT162B2.
Warm rush, BP 180/80, felt like passing out, lightheaded. Continued feeling of being in a "tunnel" disassociated from surroundings. 1200PM 138/80.  Difficulty concentrating. Pulse 70s respirations normal, tearful, fearful, 1222pm bp down to 112/60.
SHORTNESS OF BREATH, WITH THROAT ITCHING, AND DIFFICULTY SWALLOWING
Stomach cramps; not strong contraction type pains, but dull, persistent pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date Mar2021 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FISH OIL; GLUCOSAMINE. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 19Mar2021 22:00, outcome "recovered" (26Mar2021 22:00), described as "Stomach cramps"; PAIN (non-serious) with onset 19Mar2021 22:00, outcome "recovered" (26Mar2021 22:00), described as "not strong contraction type pains, but dull, persistent pains". The events "stomach cramps" and "not strong contraction type pains, but dull, persistent pains" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of abdominal pain upper, pain.  Additional information: The patient had no known allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccine, the patient was not tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. The patient's concomitant medication also included DIGETIZYME. The vaccine was administered at 15:00. Clinical course: On 19Mar2021 at 22:00, the patient experienced stomach cramps, up to one week after the shot not strong contraction type pains, but dull, persistent pains, cannot do ab workouts and bowel movements were not affected.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I started with a headache, it's been constant, it comes and goes but it's not completely gone.; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 32-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported; Expiry date: unknown), via an unspecified route of administration on Jun2021 (at the age of 32-years-old) as a single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. In Jun2021, the patient started with a headache, it's been constant, it comes and goes but it was not completely gone. The patient received the first dose of the Pfizer COVID 19 vaccine a week ago and then two days later she started having a headache that comes and goes but she still has that headache. The patient wanted to know what she could take and how long it would last. The facility agent stated she did answer her question already. She will need an interpreter. The clinical outcome of the event was not recovered.  Information about lot/batch number has been requested.
Flu like symptoms started with sore throat, nasal congestion and progressed to cough and fatigue.
On Thursday I noticed that where I received my vaccine I could feel a 'hardness'.  by Saturday morning I have a red patch, about 5 inches in diameter that is swollen and warm to the touch.  It also itches.  It doesn't hurt when I touch it and it does not affect the use of my arm.  I have not seen a doctor, but will if it starts to affect the use of my arm.
popped and a lot of liquid went out of the syringe. More of the vaccine got on her arm and her face / no AE; popped and a lot of liquid went out of the syringe. More of the vaccine got on her arm and her face; cracked syringe; Initial information received on 22-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves unknown demography patient who had an incomplete vaccination of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] lot UJ273AB (Expiry date unknown) via intramuscular route in unknown administration site.  It was an actual medication error case due to vaccine underdose.  It was also a case of syringe leak and Exposure via skin contact.  At the time of reporting no adverse reaction 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.
After the second vaccination the left arm started aching. It progressively got worse and started traveling up and around to his other shoulder and arm also into his lower back and back calf muscles. He has received multi x-rays  and tests for auto immune diseases. A rheumatologist has told him he has osteoarthritis. His CRP level is elavated to a level of 3.3 even with treatments of steroids the pain.  Meloxicam has been prescribed to help with the pain . Nothing has helped and pain is still getting progressively worse and now affecting his daily life including job/household duties. He can not put his own socks and shoes on in the morning because of the loss of flexibility in his muscles and believes it all started after the second dose of the vaccine.
Mild wooziness the night of the 2nd vaccine; Headache and lethargy the next day or two; Headache and lethargy the next day or two; Just felt a bit strange; Lower energy than usual for a few days; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8727) via an unspecified route of administration in the left arm on 12Apr2021 at 15:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to medications, food, or other products. Concomitant medication received within two weeks of vaccination was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8727) via an unspecified route of administration in the left arm on 22Mar2021 at 14:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation and experienced no reaction whatsoever to first dose. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced mild wooziness on 12Apr2021 at 18:00, the night of the second vaccine. Headache and lethargy the next day or two on an unknown date in Apr2021. Aspirin helped the headache. The patient just felt a bit strange on an unknown date in Apr2021. Lower energy than usual for a few days from an unknown date in Apr2021. Therapeutic measures were taken as a result of headache and included treatment with Aspirin. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events mild wooziness the night of the second vaccine; headache and lethargy the next day or two; just felt a bit strange; lower energy than usual for a few days was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 22-JAN-2016, the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which were improperly stored (incorrect product storage)(Temperature: 9.5 F, Time frame: 2 hours). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Resident stated she felt ill, she was sweating, fatigue, decreased appetite, complaints of nausea.
Wife woke up and found husband around 4am covulsing, with a fever, muscle aches and pressure on chest, which patient said was around the heart.  After eight to nine day, and still having problems with pressure/tightness on chest patient went to a heart institution.  Patient states, this was the first vaccine he has ever received. Patient did cancel the second dose of Pfizer vaccine.
This spontaneous report as received from a registered pharmacist refers to an unknown number of patients. The reporter stated that improperly stored RECOMBIVAX HB (lot number, dose and route not reported) may have been administered to patients. The reporter had no information how many doses were administered that were improperly stored. The improperly stored  RECOMBIVAX HB may have been administered from 24-AUG-2012 to 01-OCT-2012. No adverse event reported. This case is linked to case reports 1210USA001745 and 1210USA010100 (same reporter link; same event also reported for other vaccines). Additional information has been requested.
10min p/vax had hot feeling across chest, nausea, SOB, numbness & weakness, numbness in hands & feet;1hr p/vax went to ER recv Atarax & pred;returned home p/3hr in ER;MD stated was a rxn to vaccine;
Bruising in my left leg, throbbing in left leg, blood test revealed a low hits blood cell count which was not a previous problem.
fever 103 21MAR95 prob had fever yesterday; sores & blisters on lips & tongue; told pt to take to clinic today to have pt checked for infect; MD stated pt had strep & thrush
This spontaneous report as received from a company representative refers to a 3 month old male patient. The patient's concurrent condition included mild diarrhea. The patient's medical history included crying from the previous vaccinations. Historical drug included multiple unspecified injectable vaccinations (unknown brand and manufacturers). The patient's concomitant medications, drug reactions and allergies were not reported. On 01-FEB-2018, the patient was vaccinated with ROTATEQ (dose, units and frequency) (lot # and expiration date not reported) orally as normal vaccination. On an unknown date, after receiving ROTATEQ, patient experienced congestion, and having a hard time breathing. The patient was then orally suctioned and after being suctioned the patient became unconsciousness and limp. Vital signs and oxygens were checked for the patient and revealed normal. The reporter called the paramedics and were able to wake the patient up. The patient then went home, and was very sleepy after the incident. On 01-FEB-2018, reporter contacted patient's mother and informed patient very sleepy (hypersomnia) for a while but patient was completely recovered. The patient did not seek any medical attention. The outcome of the events pulmonary congestion, dyspnea, loss of consciousness, gait disturbance and hypersomnia was reported as recovered/ resolved. The reporter did not provide causal relationship for the events pulmonary congestion, dyspnea, loss of consciousness, gait disturbance and hypersomnia with the suspect therapy. No product quality compliant was involved. Upon internal review, the events pulmonary congestion and loss of consciousness were determined as serious due to medically significant.
Pt was inadvertently vaccinated with one dose of haemophilus b conjugate vaccine + hepatitis b vaccine recombinant (yeast) instead of the second dose of hepatitis b vaccine (manufacturer unknown). The pt subsequently experienced a mild headache and some soreness at the injection site. Pt sought unspecified medical attention. No further information is expected. The follow-up states that this is an amended report. Hep b vaccine was deleted as a concomitant vaccine. This is a corrected report, as amended.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and  expiry: unknown) dose was not reported, 1 total administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-JUL-2021, the patient had confirmed covid-19 infection. On an unspecified date, the patient had confirmed clinical vaccination failure. Laboratory data (dates unspecified) included: PCR (Polymerase Chain Reaction) (Result: Covid 19 positive). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210718595-covid-19 vaccine ad26.cov2.s-Confirmed Clinical Vaccination Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
vacccine exposed to temperatures 31 degrees Fahrenheit for a couple of days with no A/E; Initial information was received on 18-Nov-2021 regarding an unsolicited valid non-serious case from a pharmacist via Agency (under reference- 00864179) and transmitted to Sanofi on 18-Nov-2021.  This case is linked to cases 2021SA389706, 2021SA392836 and 2021SA392842 (CLUSTER).  This case involves a 65 year old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] that was exposed to 31 degrees Fahrenheit for a couple of days with no adverse event (product storage error).  The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided.  On 13-Nov-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ764AC and expiry date: 30-Jun-2022) (frequency : once) via intramuscular route in the left arm in prophylactic vaccination.  It was reported "Caller stated that co-worker called in to report the excursion on Monday. Caller wanted to know what would happen if patient took product after being exposed to temperatures 31Fahrenheit degrees. What to the product when exposed to low temperatures?"  It was case of an actual medication error due to product storage error temperature too low (latency was on same day).  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 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.
Initial report received from healthcare professional on 12 November 2013. A 53-years-old male patient had received first dose of FLUZONE ID (lot number UT4721BA, intradermal in the left deltoid) on 04 October 2013. The patient had no illness at the time of vaccination and does not have any pre-existing allergies, birth defects. On 04 October 2013, after vaccination the patient had experienced numbness at the injection site and pulling of skin. The corrective treatment and laboratory details were not reported. At the time of this report the patient was not recovered. Documents held by sender: none.
Consumer reported not being able to move lips the way they want to after first CoVax dose; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer-sponsored program.  A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/lot number and expiry date: not reported) dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient reported not being able to move lips the way he wanted to after first  dose. The outcome of the event was unknown.   Information on the lot/batch number has been requested
I got the shot on the 9th and attempted to go to work the next day and was feeling tired and fatigue. The next day I had  fever and chills with body aches. I called my doctor and he prescribed OTC and treat it like the Flu.  I also had stomach cramps. I had the symptoms for 3 days. I'm not sure how long it lasted.  The next issue was due to my history with breast cancer so I had surgery for that.  And most recently I had GI upset with body aches and low-grade fever that lasted for about a week.
6/23/23 - severe Charlie horse in left inner thigh muscle (may be unrelated!) 6/24/23 - increased redness at injection site, warm to touch, mildly itchy - cellulitis confirmed 6/26/23, treated with 7 day course of Keflex.  Infection now resolved.
Patient was supposed to get PENTACEL, hepatitis B, PREVNAR 13 and ROTATEQ. Patient was given Hib instead of the hepatitis B.
Patient complained of cramps, cough, mucous, and hot painful arm, shakes, chills, nausea as well as swelling of the eyes and oozing from the eyes in the couple of days following flu shot. (Also fever up to 102.6).
Pt arrived for vaccine.  He received a vaccine that had expired 3 days prior.  No adverse reactions.
No additional AE reported; VARIVAX was administered after a temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown gender and age. The patient's medical histories, concomitant medications, concurrent conditions and drug reaction/allergies were not reported.  On 26-SEP-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U015847, expiration date: 19-MAY-2023 administrated for prophylaxis (dose frequency reported as once, strength, route of administration and anatomical site of administration were not provided) after a temperature excursion. The temperature was reported as 8.42 degrees Fahrenheit (F) for 1 hour 2 minutes (product storage error). There was no previous temperature excursion. No additional adverse event  information was provided (no adverse event).
Dry cough, chills, fever, then developed lesions (blister like) in mouth and then on head, then lymph node enlargement in armpit. Has spoken via telephone to MD and he prescribed medications but client did not take. Awaiting appointment with primary physician
10/25/13 about 0800 received 2014 flu vaccination in left deltoid IM. During night while asleep 10/25/13 awoke with "inability to lift arm (Left) without excruciating muscle pain." Unable to rotate arm in and out without pain normal ADLs affected. Completed incident report at work 10/28/13 at 0900. Sent to hospital for evaluation/treatment. Seen at hospital 10/29/13 for left shoulder contusion since influenza injection. Returned to regular duty on 10/29/13. Follow-up visits on 10/31/13 and 11/5/13 no abnormal findings on left shoulder exam. Returned to regular duty and released 11/5/13. Patient still has tenderness.
Reported on 10/10/06 that she had seizure (absence of reality) approximately one hour after having had vaccines of MMR and Fluzone. States she has had "controlled seizure disorder" on Depakote and has only had one other "seizure" episode.  She has had MMR and Td previously on the same day without problems. She stated she took Benadryl and then slept. She stated the following morning she awoke feeling much better. Has scheduled appt. with neurologist on 10/12/06 for regular annual visit.