chrisvoncsefalvay/vaers-outcomes huggingface dataset:
unusually high number of covid infections in fully vaccinated employees; unusually high number of covid infections in fully vaccinated employees; This is a spontaneous report from a contactable physician. This physician reported similar events for 11 patients. This is the 4th of 11 reports.  A patient of unspecified age and gender received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 18Dec2020 (lot number EH9899) and in Jan2021 (lot number unknown), respectively, both via an unspecified route of administration (age at vaccination unknown), as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The physician stated they were seeing an unusually high number of COVID infections in fully vaccinated employees, with second dose plus two weeks, plus well over two weeks. All of whom received Pfizer and all of whom received their first dose from the same lot. The physician stated they may need some kind of investigation here, because they are seeing high viral loads in these individuals and symptoms. It is not right. All eleven individuals received their first dose from the same lot: EH9899. They did the standard dosage with the standard vanishing needle. The report was not related to a study or programme. The outcome of the event was unknown.  Information on the lot/batch number has been requested; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. The case will be reevaluated should additional information become available.,Linked Report(s) : US-PFIZER INC-2021392224 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021445810 same reporter/ vaccine/ event, different patients
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was community acquired pneumonia.
HPV APTIMA positive test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 2, single (Lot number: EN6208) at the age of 62 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZITHROMAX. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, lot number EN6203), administration date: 22Feb2021, for COVID-19 immunisation. The following information was reported: HUMAN PAPILLOMA VIRUS TEST POSITIVE (non-serious) with onset 06Oct2021, outcome "recovered" (2022), described as "HPV APTIMA positive test". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Something significant Pfizer should know was she tested positive for HPV and that was why she will no longer take the booster. It was either after first or second dose of Covid vaccination. It had been way many too years of fidelity in marriage to be testing positive for HPV. Likely it was in her system and something stimulated it. Her HPV APTIMA positive test was on 29Sep from Labcorp. She got her two boosters and went in September for annual GYN. That was when she tested positive. Had never tested positive before. She had two test. One was positive and then a year later with no mRNA in her system a negative test. She was looking up her Labcorp test. Caller clarified the one on 29Sep2021 had report date of 06Oct2021 and she tested positive. She had two doses of Covid vaccine by then. She got that information in Oct2021. Took third dose because of where they were in pandemic. Her doctor died during Covid. 04Dec2020 was plain bloodwork. Trying to figure out when she got the negative test. She had been tested every year before and never had HPV. The body just does not start testing positive for HPV. After so many years in a monogamous marriage something stimulated the HPV virus in her body. After the Sep2021 positive she has had a negative HPV test the following year. Why would she stimulate that in her body again, she would not. Patient reported the weight: was 121 pounds before this started a week ago.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300265759 same reporter/patient, different product/AE;US-PFIZER INC-202300076238 same reporter, different patient/product/AE;US-PFIZER INC-202300265890 same reporter/patient/product, different AE/dose (LOE);
headache; migraine; A spontaneous report was received from a consumer who was a 61-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1272) and who experienced headache and migraine.     The patient's medical history was not provided. No relevant concomitant medications were reported.    On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (039K20-2A) intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient began to experience a headache then a migraine. No treatment information was reported.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, headache and migraine, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt recvd vax 2FEB94 & started w/swelling of arm; later went to ER due to loss of equilibrium & heart fluttering; Epi shot given; allergic react  to Pneumococcal inject-welts all over body; unable to urinate; acute URI;
HIVES  constant itching  with spots and swelling of spots.  I take OTC zyrtec  in that I am normally sensitive to allergies. The HIVING began with first dose of February 12, 2021 and seemed to take on a much aggravated stage after the second dose.  It is now all over my body.  The OTC allergy medicine is a very temporary solution.  More HIVES daily.
Chills and fever (~94 degrees F) for one day them fever (~ increased 1 degrees F) for 2 days.
Overwhelming lethargy; Swollen lymph nodes; Diarrhea; General unwellness; This is a spontaneous report from a contactable consumer. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EN6203) via an unspecified route of administration on 25Feb2021 as 2nd dose, single dose for Covid-19 immunization. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL3247) via unspecified route of administration on 02Feb2021 as 1st dose single for Covid-19 immunization. Medical history and concomitant medications were not reported. It was unknown, if COVID prior vaccination. It was reported that patient experienced overwhelming lethargy, swollen lymph nodes, diarrhea and general unwellness that lasted for around 4 days after second dose. After first dose mention of nausea for one week afterwards. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown, patient received treatment or not. It was unknown, if COVID tested post vaccination. Patient was not pregnant. It was queried, the Pfizer US Drug safety unit recently received the attached report submitted by you via pfizersafetyreporting.com. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. In Response, I overhead her casually telling another friend about having a bad reaction to the vaccine at dinner on 07Mar. As this was a group setting I waited until the following day, Monday 08Mar - at which point I had a solo phone conversation with her. At this point she provided the details I put in the event description and I communicated that it would be reported at work the following day, Tuesday 09Mar. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Offered flu shots 10/8/08.  11 am shot was administered.  1 pm my upper arm started hurting.  (At no time did I have problems breathing).  3 pm it hurt to swallow and I felt a "lump" in my throat.  4 pm - lump felt bigger so I took cold medication (for antihistamine).  5:30 pm - at home I took 2 Benadryl and over the evening the lump decreased.  10/9/08 - Lump in throat gone but upper arm sore and I have no energy.
My first dose of Moderna was on 4/5/21. Nausea started on 4/13 around 11am, concluded in vomiting, and ended after 3 hours. On 4/14 I did not feel sick but my brain was in a fog and I couldn't think. Around 8pm that night I developed a headache. That night, around 1am on 4/15, I woke up drenched in a cold sweat with a splitting headache. The pain was so bad it caused me to vomit. I would describe the level of pain in my head as unbearable. For a while I honestly thought I might be having an aneurysm, but figured a call to 911 would not save my life it were actually an aneurysm (also when in that much pain, making a call is impossible anyway). I slept until 2pm 4/15 when the pain became bearable. I suffer tension headaches almost monthly, but this was very different and intense. It was the first migraine and only I've experienced. Early on 4/16 my period started about 1.5 weeks earlier than it should have.   Though I at first doubted this was a reaction to the vaccine, given it happened a week later, I have since realized it likely was. Sometime after my second dose, I spoke to friends, also women in their 30s, and four of them had had a similar series of events - migraine and early period - a number of days after their first dose. Medical studies really need to take women?s health into account. Knowing I might have this reaction would NOT have stopped me from getting the vaccine, but it would have made me feel a lot better during the episode to know what was happening and why, as opposed to thinking I might be dying of an aneurysm. To realize I was not alone in the experience was an immense relief.  I have not had a migraine since. I had no discernible reaction to the second dose. I have yet to notice any reaction to the booster, which I got five days ago. I wrote down symptoms back in April, and wanted to wait til after the second dose to report; I forgot to until now.
A few minutes after the injection the patient states she felt nausea, dizziness, lightheaded, pale and started sweating. The patient could not sit up. If she tried to sit up she felt like she was going to faint. EMT was called in and assessed the patient. The patient started to feel better while in the store but was taken to the hospital for further test.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient's pertinent medical history was not reported. On 22-NOV-2013 the patient was vaccinated with first dose of GARDASIL. On 22-JAN-2014 the patient was vaccinated with second dose of GARDASIL. The patient was then administered CERVARIX inadvertently on 05-JUN-2014. No adverse effects reported. The outcome of the patient was then administered CERVARIX inadvertently was unknown. Additional information has been requested.
Evening after injection, 6:00 pm on 10/14/2021, body aches and headache, 10/15/2021 7:00 a.m. very fatigued, nausea and vomiting and then terrible diarrhea, the nausea, headaches and diarrhea and fatigue  continued on 10/16/2021 and 10/17/2021.  Have taken zofran and over the counter anti-diarrhea meds on each of the days that symptoms were present.  10/18/2021 still fatigued, nauseated and some diarrhea as well as headaches continue but a little less severe at 1:15 p.m.
Fever/chills, body aches, joint pain, headache lasting approximately 12 hours after onset of symptoms, treated with tylenol and symptoms subsided.
This spontaneous report as received from a registered nurse refers to an unspecified patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot# were not reported) which this single dose was exposed to -1C for 22 days. The nurse stated that she was not sure if dose may had been administered to the patient. No adverse effects reported. Follow-up information has been received from the registered nurse and refers to a 64 years old male patient. On 16-MAY-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route were not reported, lot #K003074, expiration date 13-MAR-2015) that was stored improperly. The diluent was exposed to lower than 2C for more than 15 days, the lowest temperature was -1C for 5 days. No symptoms were reported. No PQC (product quality complained) involved. The reporter asked if the patient had to be revaccinated. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report was received from a pharmacist referring to an unspecified number of patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot# M035147 with expiration date: 25-OCT-2017 (dose, route of administration and anatomical location were not reported) for prophylaxis that was reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccine doses were stored at 5.9 degrees Fahrenheit (F) for 45 minutes and at 8.3F for 1 hour and 30 minutes; a digital data logger was involved. No adverse effects were reported. There was no product quality complaint (PQC) involved.
After first shot no significant adverse effects until Day 8 my right upper arm started to exhibit severe pain and decreased mobility.  Did NOT have redness, only minor swelling at injection area. Initially treated with Tylenol and ice with no relief.  Day 9 increased pain, difficult to lift or move arm.  Seen in clinic- Rx Motrin 600mg 3x daily, ice/heat. Day 10- returned to urgent care with severe right arm pain- could hardly move arm, unrelieved with Motrin.  unable to sleep last 2 nights.  RX with Medrol pack (6 days). Now day 3 have most arm function back and only mild pain in right arm.
c/o epigastric pain and nervousness.  Denies chest pain, SOB. Denies history of heartburn BP: 135/50 HR: 98 Sp02: 99% RA
After the first dose I developed a severe itchy maculopapular and vesicular rash on my back.  It resolved in two weeks.  After second dose the  rash broke out on my trunk and extremities.  Different from first in that the papular. lesions developed into open and scabbed lesions.  And persist almost three weeks later.  No recent breakout but, very slowly resolving.
Nearly passed out, dizziness, light headed, sweating, chills, nausea, diarrhea.
Event happened outside of the ER at a clinic and not witnessed by any hospital staff.  Patient reported dizziness, shortness of breath, headache, chest pain, sore throat, hoarse voice and tightening in the throat and chest minutes after vaccine administration.  Treated with IM epi on scene by EMS. In the ED abtou 30-45 minutes after event, given IV normal saline, solumedrol, benadryl, and famotidine. Given PO potassium after labs for mild hypokalemia. She was monitored for about 4-5 hours total in the ED with complete resolve of symptoms.
Patient received first dose of vaccine on Sunday 9/12/21, and states that his face felt "hot, warm, and red." On Monday 9/13/21 he said his face was still "warm and hot" and his shoulder, and "middle back to upper shoulder" was aching. Patient thought he developed a rash on his left wrist that "looked like poison ivy, but went away after a while." Patient also said he was feeling weak, but felt fine when he reported these events to the pharmacy.
progressive lower leg  weakness, numbness is lower chest, abdomen, pelvis, lower extremities, started on day after vaccination received assessment by neurologist consistent with clinical diagnosis of Guillain-Barre Syndrome
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Nov2021 at 09:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 24Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment".  Additional information: Rebound infection after taking Paxlovid. No Other medication was received within 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a medical assistant concerning an 18 year old female patient who on 13-AUG-2008 was vaccinated with a dose of GARDASIL. On 13-AUG-2008 the patient experienced significant headaches after receiving of GARDASIL. Therapy with GARDASIL was discontinued. At the time of the report, the patient had not yet recovered. Follow-up information has been received from the medical assistant concerning a 17 year old (also reported as 18 year old) student whose headaches at menstrual time was more severe. It was also stated that the patient had experienced headaches after receiving a dose of GARDASIL when she was 16 years old, in approximately 2007. The patient's sibling also experienced headache following vaccination with GARDASIL (MSD WAES# 1004USA00899). Additional information has been requested,
Callers son received 1st dose on Thursday 4/1 tested positive on Tuesday 4/6; This is a spontaneous report from a Pfizer sponsored program. A contactable non-healthcare professional reporter for a male of patient reported that the patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for Injection) as a single dose for COVID-19 immunization on 01Apr2021. The patient tested positive on Tuesday 06Apr2021 and would like to know more information about further process. The outcome of the event was Unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
PERIODIC RINGING IN HIS EARS, EPISODES LASTING ABOUT 30 SECONDS AT A TIME; 4-5 TIMES/WEEK; This spontaneous report received from a patient concerned a 30 year old male. The patient's weight was 166 pounds, and height was 65 inches. The patient's concurrent conditions included penicillin allergy, alcohol use, non smoker, and rash. The patient had no relevant medical history. The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced periodic ringing in his ears, episodes lasting about 30 seconds at a time; 4-5 times/week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from periodic ringing in his ears, episodes lasting about 30 seconds at a time; 4-5 times/week. This report was non-serious.
Severe bloody noses every day since getting the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734) via an unspecified route of administration on 12Apr2021 at 12:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Apr2021 the patient experienced severe bloody noses every day since getting the vaccine. No therapeutic measures were taken as a result of the event. The clinical outcome of the event severe bloody noses every day since getting the vaccine was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
First symptom was stomach discomfort and constipation then flare ups of pain began soon after followed by the following symptoms?   Throat hurt and had sores on back of tongue and red throat Tongue had little red spots  Said bottom front teeth have felt dirty  Hurt to swallow  Said her saliva tasted bad  Roof of mouth hurt complained of an itchy tongue  Skin got red and irritated easily  When she wore a mask, her cheeks got red and she looked flushed  Stomach pains and felt nauseous - stomach pains were sometimes in the lower tummy below her belly button.  Other times the pain was around the entire belly.   Bowel movements were loose and normal at times (no signs of constipation after the first week symptoms began) Had an appetite,  but wasn?t eating as much as normal  Flare-ups of pain in joints and random parts of her body (bottom of feet, head, chin, front and back bottom, chest, finger tips, toes, legs, arms, neck) Her pain in her feet was so uncomfortable at times, she wanted to wear tennis shoes in the house  Holding on to her tennis racket made her fingers hurt  A little redness in eyes that I noticed one day that came and went  Eyes hurt sometimes and felt dry or itchy  Based on chest x-Ray, she was misdiagnosed with bronchiolitis She was then diagnosed with possible walking pneumonia - the only symptom I observed was chest pain, but it was more like the flare ups of pain that occurred in different parts of her body (arthralgia) Hives all over legs and feet, especially after warm bath Hives also have appeared on elbows, abdomen, behind her ears, neck, arms, tummy  Discomfort on her private areas - redness/irritation around the vagina, small rash similar to red pimples on her buttocks, pain/discomfort when wiping after a bowel movement  It did not hurt when she urinated or had a bowel movement.  It was the outside skin that was sensitive and irritated She was bruising more easily - we thought it was her new bike riding skills but it seemed more than just her legs  Her temperature hovered around 99, which is above normal for her  She didn?t want to play as much because of all the discomfort  Her knees have turned red and itchy and felt warm to the touch   Medicines prescribed -  Miralax  Azithromycin  Prednisolone  Cefdinir  Hydroxyzine  Pepcid