chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Localized injection site pain.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8733) via an unspecified route of administration in the left arm on 31Mar2021 at 08:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and environmental allergies. Concomitant medications included testosterone (ANDROGEL), salbutamol (ALBUTEROL), montelukast (MANUFACTURER UNKNOWN) and fluticasone (MANUFACTURER UNKNOWN), all from unknown dates and for unknown indications received within 2 weeks of vaccination. The patient had no known allergies to Allergies to medications, food, or other products. The patient did not receive any other vaccine in four weeks prior to COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 16:00, the patient experienced localized vaccination site pain which peaked about 12 hours after vaccination and almost completely subsided by 24 hours. The patient did not receive any treatment for the reported event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event localized vaccination site pain was recovered on 01Apr2021.   No follow-up attempts are needed. No further information is expected
Dizziness, vertigo, light-headed, brain fog, equilibrium (falling), increased tinnitus
Rash on right arm, and trunk. Benadryl, anti-itch oint. Still red today.
Chest pains, sweating, headache, body weakness, dizziness, high blood pressure, rapid heart rate,
No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 11-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.   This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002744: US-009507513-1905USA002745: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002749: US-009507513-1905USA002750: US-009507513-1905USA002751: US-009507513-1905USA002752: US-009507513-1905USA002753: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769: US-009507513-1905USA002770:
A lump appeared under the armpit (golf-ball sized). It is painful. Also appearing on upper arm on the same side (on inside of arm). No color.
Information has been received from the mother patient concerning a 16 year old female with a knee operation who in "Fall 2007" approximately in September 2007, was vaccinated with her first dose of GARDASIL 0.5mL in her hip, closer to the waist than the thigh. Concomitant therapy included hormonal contraceptives (unspecified). About two weeks after the first shot, at the injection site she developed a scar that is indented and bruised, and the physician said it was dead tissue. She had her second and third dose of HPV vaccine(yeast) in the same spot so that it would not scar her arm too. She had also experienced joint pain. The patient's adverse experience persisted. The patient sought medical attention. Additional information has been requested.
dizzy with the shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizzy with the shot".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Starting around Jan. 15, 2022, started experiencing itching all over my body especially at night and from unknown cause. I also was feeling poorly with feeling extra tired.  Four nights of poor sleep contributed to this. Seen in clinic on 1/20/22 and prescribed Hydroxyzine HCL 25mg tabs: take 1-2 every 6 hours as needed for itching. The itching resolved within about 4-5 days.
Pt recvd 1st dose of vax on 11AUG92 & w/in 20 mins the pt exp a drop in BP, inc pulse rate & a loss of consciousness; exp necessitated a visit to ER;
I experienced a retinal detachment on August 11, 2021. I had emergency scleral buckle surgery the next morning. I am not sure if this is related to the vaccine but I wanted to report that I had this health event in case it is.
Received Varicella vaccine 3/11/03. 20 days after receiving vaccine, broke out with clear vesicle on face, spots multiplied. Low grade fever. On exam by MD on 4/1/03, she had 2 scabbed papule lesions on L post scalp, 1 behind R ear, 1 R jaw, 1 L popliteal, 1 deltoid R.  Tx isolate till scabbed over. Benadryl for itch.
Flu like symptoms about 13  hours after shot. Fever, fatigue, chills, headache.  Took over the counter pain reliever. Symptoms gone after 24 hours. Second day after shot arm got a knot at the Injection site  and started to turn red, get hot, and swollen.  Red spot grew in size for 5 days. Took benadryl and the heat and inflammation went away in 2 days. Lump/knot is still the same size as day 2 on day 9. Ice packs didn't help. Dr is having me rub the knot and apply heat as much as possible along with taking over the counter anti-inflammatory. Lymph nodes behind ears have now swollen.
Initial and follow up information has been received from a physician concerning a female pt (age not reported) who on an unspecified date, in the morning, was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast (date unknown). It was reported that the pt felt dizzy and was administered oxygen. The pt was observed for 30 minutes (previously reported that the pt had not eaten anything. At the time of this report, the pt had recovered from the events (date unk). The physician assessed the events as non serious and reported that she was unsure of the causality of the events. No further information is available.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 21Jan2021 as dose 2, single (Lot number: EL3247), in left arm, on 26Sep2021 as dose 3 (booster), single (Lot number: 30135BA), in left arm and on 13Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: yes" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL], start date: 05Jun2017; HYDROCODONE, start date: 03Aug2011; OMEPRAZOLE, start date: 05Apr2013. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course:The patient received treatment for paxlovid. Treatment start date- 09Jul2022 till 13Jul2022. The patient had received other medication in 2 weeks.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information available, a possible causal relationship between reported events Vaccination failure and COVID 19 and suspect drug BNT162B2 cannot be excluded.
Swollen glands, incapacitating fatigue with neurological problems and severe muscle pain. Extremely poor stamina and malaise, pain and difficulty concentrating. Consulted 4 doctors, none except 1, knowing origin. Treatment ongoing with IVIG, detoxification and supplements. (1st Engerix-B/3023A2/RA on 12/3/99 and 2nd Engerix-B/3023A2/RA on 1/3/00).
burning on bottom of feet, bottom of hands; pins and needles; numbness on tongue; electric impulses on the top of her toes; tongue she has had burning; This is a spontaneous report from a contactable consumer (the patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number- EWO176, expiration date was unknown) via an unspecified route of administration, in left arm upper shoulder, on 06May2021, (at the age of 61-year-old), dose 1, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had her first shot on 06May2021 and ended up not getting the second because she had weird reactions that have not went away. On 08May2021, patient had burning on bottom of feet, bottom of hands; hands have gotten better and her feet no, pins and needles; it's still there every day, it's persisting; numbness on tongue, also got electric impulses on the top of her toes. Patient clarified that, she has had numbness, pins, and needles, burning on both her hands and feet. On her tongue she has had burning, pins and needles. Her tongue was consistent. Patient called to her internist and he said maybe she shouldn't get the second dose because it sounded like an allergic reaction. No additional vaccines administered on same date of the Pfizer suspect. No other vaccine prior vaccinations within 4 weeks. Patient did not require a visit to emergency room and physician office. Patient did not receive any treatment to the events. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Did not know that I was pregnant at the time. On November 30th I found out I was pregnant and on December 8th I found out that the pregnancy was ectopic and stuck in the fallopian tube. Ended up having to have surgery to remove the embryo and the fallopian tube
no adverse event; incorrect product storage; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that on 07-MAY-2019, the patient was administered an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (Lot: R002517; expiry date: 19-SEP-2019) (dose and route of administration were not reported). The vaccine was exposed to 11.3 C for 1 hour and 40 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported.  This is one of the two cases received from the same reporter.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced red spots under the arms and on the legs. The pt was warm for three days and experienced redness at the injection site.
This spontaneous report as received from nurse practitioner refer to a patient of unknown age and gender. No medical history and concurrent conditions reported. On 02-JUL-2015 the patient was inadvertently administered with improperly stored, MMR II, lot # K007107 (dose, route, therapy type not reported). No adverse effects reported. No product quality compliant reported. This is one of several reports received from the same source. Additional information has been requested.
Friday night around 2:30 a.m. I woke up with a migraine headache.  Saturday my migraine headache continued and over the counter meds (Advil) had little effect.  As the day progressed, I lost my appetite, I felt achy, exhausted, and felt light-headed.  Sometime during Saturday night my headache became worse and my muscles ached.  By Sunday morning I could not open my eyes because the light hurt my migraine headache, my muscles felt like they were on fire, I felt nauseated and lightheaded.  By Sunday evening, the pain was almost unbearable both in my head and my muscles.  I could not turn my head or move without the pain being unbearable.  I was extremely nauseated and over the counter meds were not working on any of the symptoms.  By Monday morning I called the doctor and was told to alternate taking Advil and Tylenol every 3 hours.  This seemed to help the headache but not the muscle aches.  I also continued to not have an appetite, no energy, felt achy and hot but did not have fever. By Tuesday I could not stand without pain shooting down my legs.  I went to the doctor's office and was told that I had too much lactic acid built up in my muscles and to drink lots of water and light exercise.  Throughout the week I had the sweats, body aches and exhaustion, along with no appetite and muscle aches and pains.  It is now over two weeks later and I still suffer from exhaustion, painful headaches, body aches, and if I move around too much I get nauseated and  sometimes lightheaded.
Dizziness; CHILLS; FATIGUE; MUSCLE ACHES; HEADACHE; This spontaneous report received from a patient concerned a male 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: Unknown) dose was not reported, 1 total, administered on 10-MAR-2021 15:00 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On 11-MAR-2021 06:00, the subject experienced dizziness. On 11-MAR-2021 06:00, the subject experienced chills. On 11-MAR-2021 06:00, the subject experienced fatigue. On 11-MAR-2021 06:00, the subject experienced muscle aches. On 11-MAR-2021 06:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, muscle aches, chills, headache, and dizziness. This report was non-serious.
Left arm pain, headache, lower back pain, nausea, burning both legs and arms, muscle weakness both legs and arms.
wife of the patient called came in for her COVID-19 vaccine appointment on 4/8/2021 and explained that her husband passed away in his sleep suddenly after a wonderful evening on 3/25/2021.  She expressed that physician said it was not COVID related.  Wife did not want to discuss  the death of her husband at this time so the information is limited for this report.
This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 20-MAR-2017, the patient was vaccinated with an improperly stored doses of M-M-R II recombinant human albumin (rHA), lot # M015931, expiration date 30-MAR-2018 (site, dose and route of administration were not reported).  The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
Hot flashes. Body is hot. Itchy skin. Scratchy throat. Fuzzy tongue.
On 1/14/2021 patient developed pain, redness, and rash at injection site.
Breakthrough COVID-19 case with unknown symptom status. Hospitalized unknown date for unknown duration.
4 mo male with no sig PMH brought into ER for episode of eyes rolling back, limpness and lethargy after receiving vaccines today. Episode lasted about 5-15 min. VSS, PRF upon arrival.
Red, hot, swollen knot at injection site that has started itching 6 days after vaccination
She got the vaccine, got a headache to the left temple area, then she ended up with a stiff neck on the right side. Then she started getting very gassy and the turning of the stomach feeling, then diarrhea. Sometimes she could get out of the bed fast enough to get to the bathroom, and others not. She did take Imodium that did not help the symptoms. She has gone through a lot of Imodium which has slowed it done some. She has not had much of an appetite. She got the vaccine, got a headache to the left temple area, then she ended up with a stiff neck on the right side. Then she started getting very gassy and the turning of the stomach feeling, then diarrhea. Sometimes she could get out of the bed fast enough to get to the bathroom, and others not.  She did take Imodium that did not help the symptoms. She has gone through a lot of Imodium which has slowed it done some.  She has not had much of an appetite. She is still having the diarrhea and has not had much solid food.
Information has been received from a nurse for the Pregnancy Registry for GARDASIL and pediatric medical records concerning a female infant whose mother in approximately November or December 2007, was vaccinated with her first dose of GARDASIL (lot# not reported). In February 2008, her mother was vaccinated with her second dose of GARDASIL (lot# not reported). On 28-APR-2008 her mother was vaccinated with her third dose of GARDASIL (lot# not reported) and found out that she was pregnant. The mother's LMP was 28-MAR-2008. The pregnancy was confirmed on an unspecified date by a positive pregnancy test and complete bloodwork. Concomitant therapy included allergenic extract (allergy shot once a month). On, the female infant was delivered via cesarean section with Apgars of 9 & 9 at 1 and 5 minutes respectively. On 29-JAN-2009, at 4 weeks well check, it was noted the infant was tongue tied. The infant was vaccinated with a second dose of hepatitis B vaccine (manufacturer unknown). The mother returned in February 2009 for her postpartum visit and she was breastfeeding the baby and there were "no problems" for her or the baby. She added the notes from the hospital and the office after the birth had no indication there were any problems. On 04-MAR-2009, at 4 month well check, the infant was vaccinated with a first dose of DT, ACTHIB, IPOL, PREVNAR (MSD). On 06-MAY-2009, at 2 month well check, the infant was vaccinated with the second dose of DT, ACTHIB, IPOL, PREVNAR and ROTATEQ (MSD) and tongue clip was performed. The infant's ankyloglossia was considered a congenital anomaly. The mother's experience has been captured in WAES # 0805USA00511. No further information is available. All medical records will be provided upon request.
I woke up on March 5, 2021 before daylight back of my throat sore, chest congestion, felt like a minor case of COVID. The symptoms was very similar to COVID expect I had a bad headache. I went to my doctor seen another doctor in the practice. She diagnosed me with Bronchitis prescribed me a antibiotic. When I seen my regular doctor informed him of what happened.
first month after receive vaccine,  arm and should pain persist. family doctor offer the priscription of Prednisone 5 days, but pain still persist, and got more worse on third month, now the arm had limited range of motion, very painful to make simple tasks ? such as lifting your arm to change a light bulb or reaching behind you to put your arm through the sleeve of a jacket, even impossible.
Menactra was accidentally given to a 12 month old instead of MMR/no AE; Initial information received on 24-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a twelve months old male patient who was mistakenly vaccinated with  MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (batch number U6486AD, dosing details 0.5 ml and expiry date 16-JAN-2021) instead MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE [MMR] via intramuscularly at the left leg on 23-JUN-2020 for prophylactic vaccination (Wrong product administered).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX II) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It was a case of an actual medication error due to wrong vaccine administered.  At the time of reporting, 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 holders 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.
Received the shingles vaccine Shingrix on 12/1/2020 Woke up morning of 12/15 with a whooshing sound in his ears and a significant decrease in hearing bilaterally . The "whooshing" has stopped, but the hearing loss has remained .
This spontaneous report was received from a nurse, regarding to a 59 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. It was reported that on 13-APR-2017, an adult patient received a pediatric dose of VAQTA which had a lot # M039055 with expiration date on 22-JUL-2018 (dose, concentration and anatomical location were not mentioned). At the reporting time, No adverse effects  were reported.
01/08 sent email to cancel the second dose. I called her and  she states after the first dose after about 1.5 hours started getting tachy and palpations for about 6 hours following her shot. She  states her resting HR was HR 130 for about an hour but she just sat and waited it out.  She denies going to ER or calling she stated she had this happen about 6 years ago and just waitied it out. She stayed and worked stating she just did inservices and after about 6 hours felt better before she states she  felt fine the next day except for sore arm.
Fever, chills, body aches, headache, could not get warm, weak; next day upper back aches, tight chest, left arm pain, sore injection site/very slight bruising