chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have been getting my period for long periods of time, heavier flows, all of which I have NEVER experienced prior to vaccine.; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 20-year-old female patient received bnt162b2 (BNT162B2), administered in the left arm, administration date 14Aug2021 at 09:15, (Lot number: EW0173) at the age of 20 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medications included: TRI FEMYNOR and unspecified birth control medications. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 05Sep2021, outcome "not recovered", described as "I have been getting my period for long periods of time, heavier flows, all of which I have NEVER experienced prior to vaccine". The event "I have been getting my period for long periods of time, heavier flows, all of which I have NEVER experienced prior to vaccine" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heavy menstrual bleeding.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. The patient also received bnt162b2 (BNT162B2), administered in left arm, administration date 09Sep2021 at 18:30, (Lot number: EW0173) at the age of 20 years as dose 2, single for COVID-19 immunisation.
Pt vaccinated at 10:18 am Moderna, 2nd dose.  At 10:40 pt reported her tongue tingling. No distress noted. VS BP 134/76 P 73 O2 sat 99%. Upon interview, pt reported same symptoms later in the afternoon after receiving her 1ST dose of Moderna vaccine on 03/11/21 and that her tongue felt burnt when drinking water? Pt given benadryl 25 mg chewable tab at 10:42 am. Pt remained on site another 30 minutes. No worsening of symptoms and reported improvement.  Pt instructed to continue benadryl 25 mg po bid or seek emergency care if worsening. Pt was discharged to home via her own car at 11:15 am. Called the next day to check on pt, no answer. F/U 04/19/21 pt reported tingling went away, only had body aches.
Patient had had abdominal pain for ~1 week but 1 day after vaccination (5/22) developed new pain in left testicle. Was seen in early hours of 5/23 where U/S showed likely torsion.  Patient underwent scrotal exploration and right orchidopexy and left simple orchiectomy.
Unknown exact date of vaccine and reaction, but in Oct pt had 2nd Shingrix, then days later had very pruritic eczematous eruption on most of her trunk. Seen 6/5/19 and has few spots of lichen simplex chronicus that remain, but rest has started to resolve without treatment.
PATIENT'S MOTHER CALLED ON 1/22/21 AND SPOKE WITH ANOTHER STAFF RPH AND SAID THAT HER DAUGHTER WAS EXPERIENCING PARALYSIS IN LEGS AND ARMS AND HAS GUILLIAIN-BARRE SYNDROME (PATIENT MARKED NO ON CONSENT FORM).
Pt recv vax on 11/18/98; on 11/19/98 pt exp vomiting 3x & fever
Test positive for COVID after the first vaccine dose; Test positive for COVID after the first vaccine dose; This is a spontaneous report from a contactable Physician. This Physician reported similar events for 2 patients. This is the 2nd of 2 reports. A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 vaccination. The patient's relevant medical history and concomitant medications was not reported. The patient was tested positive after the first dose of the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and LOE due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.   This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020520651 same reporter/product/event, different patient
Moderna #1:  007M20A  2/14/2021   Moderna #2:  002B21A  3/16/2021 Beginning 7/13/2021, low grade temp (high 99s to mid 100s), loss of appetite.  No cough
Headaches all week and on 8 day, covid arm...swelling, redness, toughness, itchy at injection site
This spontaneous report was received from a medical assistant concerning to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date the patients were vaccinated with unspecified doses of improperly stored VAQTA lot # L015460, expiration date 20-JUL-2017, (dose, dose number, route and anatomical location were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever of 104.5; felt extremely cold; Severe pain in joints and muscles; Severe pain in joints and muscles; Strong metallic taste in mouth; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 26Mar2021 at 18:00, dose number unknown, single for COVID-19 immunization. Medical history included obesity, asthma and penicillin allergy from an unknown date and unknown if ongoing. Concomitant medication included semaglutide (OZEMPIC) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took neomycin and experienced allergy. On 27Mar2021 at 08:00 the patient experienced fever of 104.5, felt extremely cold, no amount of covers kept the patient warm, severe pain in joints and muscles and strong metallic taste in mouth. The patient did not receive treatment for the events. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
had the shingle shot, still had shingles/Suspected vaccination failure; Still had 2 more cases, not as bad; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the shingle shot, still had shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Still had 2 more cases, not as bad). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient via  interactive digital media. The patient had the shingles 4 times over the years, 4 different places on his/her body.  The patient had the shingle shot after the second case.  The patient still had 2 more cases of shingles that were not as bad but definitely got the shingles shot as soon as possible. The reporter stated that way back in first case was told that you only got them once, not so. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Right Sided Bell's Palsy Developed 2 days following the Immunization. No other signs of infection. Not recovered currently.
1 week after GARDASIL vaccine 8/31/09, pt started feeling migratory pain in her legs and weakness. Her running stamina has decreased, and she ever feels weak when she climbs stairs. Exam nl. Temp 97.6. NL DTRs, sensation, strength in legs.10/9/2009 MR from PCP received  office visit 10/2/2009. Presenting c/o's of pain and weakness in legs, sx x 4 weeks. PE was normal. DX: compartment syndrome, myositis, herniated disc syndrome. Referred to Orthopedic MD.    10/12/09 Per parent pt has not been to see any consult. Still having some weakness.
Minutes after vaccine, while walking to car, "syncope" with "shaking & eyes rolling all over" lasting 1-2 minutes. Arms still shaking 3 hrs later (+) wrist injury required splinting (+) chin lac required sutures contusion & other facial contusion.
Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patient's medical histories and concurrent conditions were not provide. On unknown dates, the patient were vaccinated with VARIVAX (dose and routed were unknown, lot # L001330, expiration date 13-JAN-2017; lot # L028278, expiration date 28-JUL-2017; lot # L043624, expiration date 03-NOV-2017 and lot # was reported as L048466, expiration date 02-DEC-207). The nurse provided the details of excursion: temperature max of -7.2 degree centigrade for a cumulative time frame of 9 hours and 17 minutes and a max of -12.6 degree centigrade for cumulative time frame of 6 hours an 10  minutes. The current temperature was -14.1 degree centigrade, which was still out of range at the time of the report. The vaccines were also exposed to a previous excursion of -4 degree centigrade for 3 hours. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # M013377, expiration date 25-MAY-2017, dose and route unknown) that was improperly stored. No adverse effects were reported. Additional information has been requested.
I have had symptoms of a low grade fever on and off and a cough  has developed that sounds like "whooping cough" .  This is the 4th day. Is this normal or does it get better .  do you need to see a dr??
Numerous red bumps on back, abdomen, arms and legs. Some papular, some scabbed over. Itchy.
pt recv vax & approx 10 days post vax pt w/inj site rxn consisting of satellite rash around the inj site & inj site pustule;Md reported that even has resolved & that no tx was required;
Information has been received from a medical assistant referring to an unspecified number of unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On 29-OCT-2016, ROTATEQ (lot# L008054, expiration date 30-NOV-2016; lot# M019691, expiration date 02-NOV-2017) (dose and frequency were unknown) were exposed to temperatures outside of the recommended range. The vaccines were exposure to 52.9 Fahrenheit for 15 hours. There was no previous temperature excursion reported. The incorrect storage of vaccines was not found by a digital data logger. Doses of the vaccine had been administered to unspecified patients on unspecified dates since 29-OCT-2016. The doses were not administered after the expiration date. No adverse experiences had been reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA005060.
Information has been received from a pharmacist who was told by a physician via a company representative referring to three patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were unknown. On an unknown date, the patients were vaccinated with ZOSTAVAX (dose, route, lot # and expiration date were unknown). After vaccination with ZOSTAVAX, all three patients had an outbreak of shingles. The outcome of the event was unknown. The causality was not provided. Additional information has been requested.
Left cheek was extremely red and  crusted the following morning. Infant has had dermatitis on legs, arms, back, stomach, head, and face since vaccine.
About 12 hours after inoculation, I developed flu-like symptoms. They were gone about 24 hours of onset. About 2 weeks later, I started noticing hair loss. I contacted my physician about it; usually when I have hair loss, he has all of my blood levels tested for my thyroid condition to make sure all is regulated. I went to the doctor's office on 11/18/2022 for blood work, and the test came back with everything within normal range. They performed lipid, TSH, T3 and T4 tests which all came back normal so it was assumed the vaccine triggered the hair loss. The inoculation site remained warm to the touch for several days after receiving the vaccine. As of now, everything is fine, and I'm no longer suffering from hair loss.
started getting severe abdominal cramping; This lead to diarrhea, nausea with vomiting; This lead to diarrhea, nausea with vomiting; This lead to diarrhea, nausea with vomiting; Afterwards, was feeling tired, but ok.; This is a spontaneous report from a contactable Pharmacist reported for herself. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular on 21Dec2020 15:45 at single dose for covid-19 immunization. Vaccine location was Arm Right and it was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included Hypertension, asthma, obesity and Seasonal allergies - mold/dust etc.. Concomitant medications included losartan, indapamide, omeprazole, montelukast. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  About 9pm on 21Dec2020, the patient started getting severe abdominal cramping. This lead to diarrhea, nausea with vomiting. This lasted about 60-90 minutes of not being able to leave the restroom. Afterwards, she was feeling tired, but ok. No lingering effects this morning (22Dec2020). No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on 22Dec2020.
This spontaneous report was received from a male pharmacy student of unknown age refers to him self. It was reported, that on 18-OCT-2012 while attempting to withdrawn a dose of reconstituted ZOSTAVAX (lot # not reported) from the vial, the vaccine leaked all over his hands from the needle insertion site. No adverse effect reported. PQC has been already involved. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3, single (Batch/Lot number: unknown) and as dose 4, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NYQUIL; DAYQUIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took Paxlovid from 23Sep2023 to 27Sep023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This case was reported by a healthcare professional and described the occurrence of pain in shoulder joint in a 51-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included hypertension, hypothyroidism and rosacea. Concurrent medications included ALDACTONE, Atenolol, Calcium salt, Multivitamins, LEVOXYL, Piroxicam, Vitamin D and Clindamycin lotion. On 28 September 2010 the subject received a dose of FLULAVAL (.5 ml, unknown left arm). On 29 September 2010, 1 day after vaccination with FLULAVAL, the subject experienced pain in shoulder joint. At the time of reporting the pain in shoulder joint was unresolved. Follow-up was received from the reporting healthcare professional on 19 October 2010. The subject had no medical history of arthritis or shoulder pain. On 29 September 2010, one day after vaccination with FLULAVAL, the subject experienced vaccine complication shoulder pain. At the time of reporting, the events were improved. It was reported that the events were not serious, however, the healthcare professional indicated that they jeopardized the patient or required intervention. The subject required observation after the events. The reporter stated the injection site in biceps was visible, clearly too distant from the shoulder joint to account for pain.
Chills, Fever over 101 degrees, Body Aches, Fatigue, Lasted 2 days
This spontaneous report as received from a nurse refers to a 74 year old patient. Medical history and concurrent conditions were not reported. On 12-MAR-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
pt recv vax 12MAR96 & on 17OCT96 pt exp fever of 102 & was lethargic & devel a rash on trunk & lower extremities;pt devel chickenpox w/approx 25 lesions;pt went to MD;
Patient received vaccination from pharmacy on 9/14/17. Patient returned to pharmacy on 9/16/17 with  a large red rash around injection site, and was warm to touch, stating it had appeared the morning of 9/15/17. Pharmacist recommended to outline rash in marker and take benadryl and if rash continued to spread, go to emergency room or urgent care. Patient was evaluated at local emergency department evening of 9/16 due to spreading rash and was diagnosed with unspecified skin infection. Patient was prescribed Cephalexin 500 mg four times daily for 7 days.
Given vaccine mid afternoon, 2 hours later - hives at site of injection, 4 hours later dizzy. Next day - very pale, nausea, dizziness, headache lasted 48 hours.
Patient reported facial swelling on the right side of her face and lip swelling on the left side of her lip and chin. Also reported itching systemically. Patient stated that she saw her physician and was told to take Benadryl. Symptoms resolved in two days.
15 days after my booster shot, I started getting hives on my wrist. Spread throughout my whole body, It will come and go every 30 minutes. I first started using steroid cream for treatment. I went to see an primary care physician and it was assumed that it was correlated to my anxiety and was prescribed with anti anxiety medication on top what I was taking. It did not work so after that I was prescribed with steroid pack (Prednisone). After that I went to see a dermatologist to have an assessment with my overall skin condition but he/she cannot assess what was going on with me. I was in severe pain and discomfort and decided to see an allergist and was scheduled with a skin test but came back to see my primary care doctor again and was prescribed again with Prednisone. The symptoms did improve but I am still experiencing it as of the moment.
About 15 minutes after vaccination patient stated her throat felt tight and irritated almost like something was stuck in her throat. Patient stated she could still breath normally, no facial, tongue, or throat swelling. I monitored patient for an additional 20 minutes, symptoms did not worsen and patient could still breath properly.  Patient mother stated she does have a history of anxiety and could be related to anxiety. Patient was offered dose of benadryl incase of possible allergy, patient denied dose during visit and patient and her mother were counseled to monitor for any facial/tongue/throat swelling and any difficulty breathing while at home. They were advised to call emergency number/go to ER if anything were to worsen. Patient's mom lives with her and will be monitoring throughout the night.