chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A 69-year-old male patient received the 1st dose of  BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history included leg pain (unspecified if ongoing). Concomitant medication included Mobic. The patient experienced fatigue (little tired the first day only), with outcome of recovered. Additional information: Patient stated he has a chronic problem for 20 years: his leg hurting. Reportedly, patient has taken Mobic for years, but discontinued it two days before receiving the first vaccine dose. Patient asked when he can resume his medication. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Severe case of hives, about 90% overall, low grade temperature. Had to get cortisone treatment, shot and oral medications for 5 days.
2043-patient received 2nd dose; 2055- c/o dizziness, lightheadedness, nauseated. Patient has not eaten since 0800  in the morning.  2100 Patient-given granola bar and water and reports feeling much better.  Patient declined ED or Urgent care at this time.  Patient to call if symptoms return.
Dizziness; This is a spontaneous report from a Pfizer Sponsored Program . A non-contactable consumer (patient) reported a female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced dizziness when she received BNT162B2. The outcome of dizziness was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
On August 30,2021, patient received her 1st Covid vaccine. 6 days later she began cramping. It continued til the 18th of September when she began bleeding. On the 19th she passed the baby at home (at 16 weeks) and went to  ER where she passed the placenta. She was treated and sent home. Her due date was March 20th and a C-section was scheduled for the 13th.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 08-OCT-2012 12:42, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
I got my vaccine on the 15 on the 16th when i woke up I felt really hot and had weakness, and the next day I already had nasal congestion on the day of the vaccine but it wasn't bad then two days later I wasn't able to smell or taste it was very faint and thought it was a cold . So I went and got covid tested Thursday the  17 and the 18th I got my covid results and tested positive.
Steady loss of contact, withdrawn, into himself. The 60 day follow up received on 10/1/03 states he is still listed as autistic, has therapy every week in addition to school, has social interaction problems and typical behaviours associated with autistic children. Confirmed link between autism and mercury (thimerosal).
DKA  (Diabetic ketoacidosis) 4 days after flu shot received. Patient was in ICU and recovered.
Hardness and pain at injection site until present (5 days+), fever for 2 days starting day after administration
Janssen COVID-19 Vaccine EUA. Ongoing headache, random sharp pains in my head, fatigue, blurry vision, dizziness, tingling on left side of face.
This spontaneous report as received from a physician refers to unspecified patient. Physician reported that VARIVAX (Merck) was exposed to 19F for an unknown amount of time and did not know if any improperly stored VARIVAX may have been administered to unspecified patients. Physician could not provide lot numbers, expiration dates of VARIVAX or names of healthcare providers that may have administered improperly stored vaccines. No adverse events were reported. Additional information is not expected.
12 hours after my shot: fever, body aches/pain, chills, pain. Lasted for 12 hours (24 total hours after my shot)
Swelling of glands under left armpit (same side as injection). Symptoms are raised red bumps that are sore and tender to the touch. Next day a glad in the right armpit also swelled. Glad under left jaw bone has also been tender.
Sore right arm at injection site approximately 6 hours after injection and lasted for a couple days, and a mild headache for a day.
Noticed I had been itching arm at what felt like a bug bite. Looked in mirror and there was a large red, raised, itchy area at site of yellow fever injection.
Nausea, body aches, headache, fatigue, chills, increased anxiety, sore throat, swollen lymph nodes, wheezing, severe injection site pain.
A few minutes after being given vaccine, patient's face turned blotchy and she stated that she couldn't breathe, her lips turned blue. An Epipen was administered. Her color then returned to normal as well as her breathing.
I contracted COVID-19 in 2021 October 16th. I had an infusion on October the 18th of 2022. After dose 4 of my vaccine, I was having issues with my knees. My right was swollen and hurting. I called my local clinic here and made appointment with the doctor. I had x-rays done on both knees finding arthritis in both and fluid on the right knee. They gave me cortisone shots in both knees. I got scheduled for some gel injections. I don't know the name of them in January. I go back soon for a second dose. I was in shock I have not had issues with my knees.
Presented to our office on 7/21/14 with a 3 day history of nausea and vomiting with abdominal pain. Labs were drawn and all were normal except for an elevated amylase (222) and lipase (354)
3 minutes after vaccines were given patient became flushed. Complained of seeing spots and extreme back pain and shortness of breath. Cool compress applied to face and oxygen was administered. continued to become worse, grunting shallow respirations. Epipen administered in left leg. Benadryl 50mg IM in R deltoid. Ambulance was called by support staff when reaction began. Ambulance arrived 10 minutes after symptoms started. Pt was breathing easier and able to walk to stretcher to be transported to local hospital.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 17-SEP-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Explosive diarrhea, repeated vomiting,  chills to the point of shaking uncontrollably,  throbbing headache.   Took Tylenol
Patient returned for second vaccine in series on July 6, 2021 and stated that on the evening of June 15 she had broken out into a rash on the palms of her hands. Patient took Benadryl for the symptoms and they resolved in 1-2 days.
This case was reported by a healthcare professional and described the occurrence of arching back in a 6-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) PREVENAR. Concurrent medications included Ranitidine and ZANTAC. On 11 June 2014, the subject received unspecified dose of PEDIARIX (unknown route and injection site), unspecified dose of PREVENAR (unknown route and injection site). In June 2014, less than one week after vaccination with PEDIARIX and PREVENAR, the subject experienced arching back, irritability and fever (40 Deg. C). On 12 June 2014 in the morning, the subject was brought back into the doctor's office and from there was taken by ambulance to the emergency room. The reporter thought the subject was not admitted to the hospital but she did not see any further information in the chart to indicate that. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were resolved. After these events, pertussis vaccination was added as a possible allergy to subject's chart.
Within 5mins of vaccine patient said she noticed a pain in her right shoulder area,  she starting feeling clammy/hot, and very nauseous.  Her tongue felt fat or swollen, and her face along her jaw line started getting puffy.  Patient was given benadryl, and we had her stay extra time and monitored her. Patient stayed at  the pharmacy for roughly 30 to 40 mins. Patient was advised to contact her primary care physician and report her reaction and also given information to self report on v-safe.  Patient  left still feeling like her tongue was fat.
Interval between first and second doses was more than 35 days; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Interval between first and second doses was more than 35 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Interval between first and second doses was more than 35 days). On 09-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Interval between first and second doses was more than 35 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-418074 (Patient Link).
no adverse event; improperly stored vaccines administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions and allergies were not provided.  On 28-JAN-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe (lot number S010727 has been verified to be a valid, expiration date reported and validated as 26-JUL-2020); haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot number S006471 has been verified to be a valid, expiration date reported and validated as 22-JAN-2022) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe (lot number 1621926 has been verified to be a valid, expiration date reported and validated as 28-NOV-2021), as prophylaxis (for all vaccines concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported) (product storage error). No adverse effects were reported for the patient. The medical assistant could not confirm which vaccine was administered to the patient.  According to the reporter, the temperature excursion was 34.9 degrees Fahrenheit for a time frame of 7 minutes and 48.2 degrees Fahrenheit for a time frame of 5 hours, on an unspecified date, as recorded by data logger.  The vaccines had no previous temperature excursion; there was no PQC reported.
Pt. states immediately after receiving seasonal flu vaccine in L upper arm-"the arm felt heavy", by end of day, painful. After cont. pain 1 week, made appt with her primary Dr. 11/9/09 who gave her 5 days MEDROL dose pack. Pain still present so took 10 days RELAFEN. Arm still hurts particularly when raises L arm. Has taken 2 courses of steroids and anti-inflammatory meds. Dr. requested dx MRI in January.
Pt came in w/a ho of syncopal episode from the 2nd pfizer dose. Assessed v/s. First B/P after pfizer booster was 140/80, hr 70, o2 sat 99. 4 min after p booster pt c/o feeling ehausted then pt experienced syncopal episode for <10 sec. BP 79/41 hr 74 o2 99. Once pt awoke from episode she was AOx4. Feet were propped up. Rechecked BP 141/82 hr 74. Symptoms resolved 2 min after episode. Pt remained w/ me for 50 min, v/s aftter episode wnl. Pt never c/p SOB or chest tightness.  Pt instructed to check to check blood sugar at home, drink fluids, consume calories and follow up with PCP. And if she continues to feel faint instructed to go to the ER/Urgent care
Right arm - red, hard, hot, swollen from shoulder to approx. 1.5" from elbow. Low grade fever - 103 degrees F, pain.
Heard of people that gets sick from their second shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Heard of people that gets sick from their second shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Heard of people that gets sick from their second shot). At the time of the report, ILLNESS (Heard of people that gets sick from their second shot) outcome was unknown.            No concomitant medications reported by reporter. Treatment medication not reported. Action taken with mRNA-1273 was not applicable.
On 7-3-2021 the client was at a gathering. Friends noted that her left face was drooping and her words slurred. She has a history of stroke in the family. She went immediately to ER . Her CT of the head was normal. Consultation with OSU neurologist on 7-3-21 by teleconference dx Bell's palsy. the client has had no improvement of sx.  Today she is reporting continued pain in the left side of her face that feels like" a bad sinus infection and toothache at the same time". Her words remain slurred and left side of face paralyzed, Left eye unable to close on own, difficulty swallowing.
2 papules < 2 cm on back and 2 on chest; rash over body - father 2-3 wks s/p smallpox vax. (Reporting person has 2ndary reaction)
I have pain and paralysis at injection site; I have pain and paralysis at injection site; This is a spontaneous report from a contactable Nurse. A 39-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: EL3246, Expiration date: Not reported), via intramuscular route of administration, administered in arm Left on 20Jan2021 14:15 (at the age of 39-Year-old) as dose 1, single for an unspecified indication. Facility where vaccine was administered was reported as hospital. Medical history included known allergies: pineapple. There were no concomitant medications. No other vaccine was received in four weeks and no other medications within two weeks of COVID vaccine. No COVID prior vaccination and not tested for COVID post vaccination. The patient experienced pain and paralysis at injection site on 22Jan2021 07:00. No treatment was received for the reported event. The outcome of the events were not recovered.  Follow-up attempts completed. No further information expected.
It's been four days now since I got the vaccine and I still have a throbbing headache and feel a bit weak. I feel malaise and have brain fog that makes it hard to focus and concentrate. My neck feels stiff and I'm having upper back pain. I have an uncomfortable feeling in my chest like a fluttering feeling.
Stroke like symptoms 5 months after shot; This is a spontaneous report from a contactable nurse (consumer). A non-pregnant 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Feb2021 01:00 PM (at 56-year-old) (Lot Number: EN5318) at 2nd dose, single in arm right for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received via an unspecified route of administration on 27Jan2021 08:15 AM (at 56-year-old) (lot number: EN5318) at 1st dose, single in arm right for COVID-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. The patient experienced stroke like symptoms 5 months after shot on 22May2021 08:00. The patient was hospitalized for stroke like symptoms 5 months after shot (cerebrovascular accident) for 3 days. Event resulted in emergency room/department or urgent care, and treatment was received. The patient underwent lab tests and procedures which included SARS-COV-2 test (Nasal Swab): negative on 22May2021. The outcome of the event was not resolved.
OS 42 Y.o. Female AAox4, anaphylactic reaction. translator was used. Pt complained of extreme difficulty breathing, swollen tongue, difficulty swallowing. Pt was out side of vehicle pacing back and forth in distress. Prior to epi admin pt. Was having near syncope also.   Pt. Appeared pale in color and distressed, pacing back and forth with anxious look on her face. Pt pulse rate also was approx 110 prior to administration, and strong. RR was approximately 20. Bp 186/92 post administration.   Tx. Pt was examined and verbal interview conducted through interpreter. EMS summonsed. Pt advised tongue was starting to swell significantly, and increase in SOB, nausea and. Near syncope. Pt administered 0.3 mg epinephrine through autoinjector to r thigh @ 1128. Pt advised after approx 6 min post injection that tongue swelling was decreasing and she was able to breath again and was not having near syncopal episodes. Pt care transfers to hospital with a non-emergent transfer to hospital.
Vomiting; This is a spontaneous report from a contactable consumer received via a Pfizer sales representative. A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported) via an unspecified route of administration on an unspecified date at a single dose as COVID-19 vaccine. Medical history included other health issues mainly being extremely underweight for a 21-year-old female. Concomitant medications were not reported. The patient experienced vomiting on an unspecified date. The event took place after use of product. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Since receiving the vaccine in February of 2021, my menstrual periods have been SEVERE due to an extraordinary amount of blood and cramping.   My periods still occur regularly on a predictable schedule, but they are EXTREME. For example, before the vaccine I would go through 3-4 super tampons on the first couple days of my period each month. Since getting the vaccine, I go through 5-6 super plus tampons (many times changing them overnight which also never happened before).  Also before the vaccine, I would have cramps the first day, take 3 Ibuprofen, and be done with cramps for the rest of my cycle.  Since taking the vaccine, I have had to take Ibuprofen every day of my period, many days, 2-3 times a day.
Diagnosed with Covid-19 on 7-3-2022.  SARS coronavirus 2 RNA (POC). Prescribed Azithromycin 5 days, Molnupiravir 5 days and Promethazine-dextromethrophan (did not take). mild symptoms (stuffy nose, runny nose, cough after sneezing), and the symptoms improved after two days.  Took home Antigen Rapid Test 7-8-2022 and result is negative.
With the second dose of the Moderna covid vaccine the caller had flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (With the second dose of the Moderna covid vaccine the caller had flu like symptoms) in a 58-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (With the second dose of the Moderna covid vaccine the caller had flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (With the second dose of the Moderna covid vaccine the caller had flu like symptoms) outcome was unknown.            No concomitant medications were reported.  The caller was calling about the booster shot and he developed a lump under his armpit (From 31-Jan-2022 To Ongoing). The lump had neem there for about a week already and had not gone away. The caller confirmed that he was calling about the third dose of the Pfizer covid vaccine. Saturday the caller took the shot and the lump started on Monday morning. The caller thought the lump was getting a little bit bigger. The caller got the third dose on 29-Jan-2022. The caller received the vaccine in his right arm which was the same arm that he had the lump in his armpit. The caller had the Moderna covid vaccines for his first and second dose. Batch number of Pfizer vaccine was FL3209.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Witnessed grand-mal seizure at home, followed by another witnessed seizure at hospital several hours later.
Hair loss; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (004756; 159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "Hair loss". Therapeutic measures were taken as a result of alopecia.  Additional information Patient taking treatment with Xeljanz for hair loss.  Follow-up attempts are completed. No further information is expected.
pt recv vax 16MAY95 & immed following vax pt exp a tingling in lt arm, down to fingers; pt was observed in the ofc for approx 10-15mins during which time the sensation persisted; sx persisted for 3 hrs then subsided
Developed erythematous swelling with small surface bullae ~2-3cm irregular borders, mildly tender - this developed prior to child being seen for h/o fever and had defervesced at time of clinic appt. Also 4 episodes watery diarrhea 7 days post vaccination, sneezing without other URI symptoms. fever to 103 on 8/29, fever trend down when he was seen on 9/1. Exposed to +Ill sibling with URI symptoms.
After I received the second dose of Shingrex within 3 -4 days I got a itchy burning sensation in my groin.  I saw Dr. and he visually diagnosed HSV2.  The following week I got a blood test for HSV and was positive for both HSV1 and HSV2.  The sores in my genital area have not gone away since the initial reaction.  They appear as individual sores, not in clusters as expected for HSV2.  I have been taking valacyclovir daily since the initial outbreak.