chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Symptoms verified with grandmother, fatigue, malaise, unable to walk, headache, decreased appetite, slurred speech, flimsy legs, slept for four hours after vaccine at one to two hours after vaccine administration.
positive C19 test; positive C19 test; booster; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Nov2021 (Lot number: FD0809) at the age of 22 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 10Apr2021 (Lot number: EP6955) as dose 2, single and intramuscular, administered in arm left, administration date 20Mar2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022 11:30, outcome "recovering" and all described as "positive C19 test". Since the vaccination, the patient had been tested for COVID-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported  events vaccination failure , Immunisation,  Covid 19 and the suspect drug BNT162B2 cannot be excluded.
Patient should've started menstrual cycle on 7/15/21. However didn't receive her menstrual cycle until  8/2/21, which was 2 1/2 weeks late. This patient has had very regular and predictable menstrual cycles for 20 months prior to the late cycle post vaccination.
Unknown adverse event; This case was reported by a other health professional via call center representative and described the occurrence of injection site reaction in a patient who received DTPa-IPV (Kinrix) (batch number PP9L5, expiry date 16th October 2021) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, less than 2 months after receiving Kinrix, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Kinrix.  Additional details were provided as follows: The age at vaccination was not reported. The purchaser on the line stating there are physicians from the pediatric Unit reporting adverse reactions to specific lot numbers for the product.  The patient had injection site reactions to Kinrix.  The reporter consented to follow up. The reporter did not have any further details for the patient.  The PQC Form was considered an adverse event only.  No product complaint was reported. This case linked with US2019AMR146592, reported by same reporter.
patient who is currently detained and broke out in a rash all over; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (patient who is currently detained and broke out in a rash all over) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (patient who is currently detained and broke out in a rash all over). At the time of the report, RASH (patient who is currently detained and broke out in a rash all over) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were received. No treatment medications were received.
Brain "fog"; Nausea; Headache; Invalid dose of 1ml of Moderna Vaccination; This spontaneous case was reported by a nurse and describes the occurrence of OVERDOSE (Invalid dose of 1ml of Moderna Vaccination), FEELING ABNORMAL (Brain "fog"), NAUSEA (Nausea) and HEADACHE (Headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 06-Apr-2021, the patient experienced OVERDOSE (Invalid dose of 1ml of Moderna Vaccination). On 07-Apr-2021, the patient experienced FEELING ABNORMAL (Brain "fog"), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, OVERDOSE (Invalid dose of 1ml of Moderna Vaccination) had resolved and FEELING ABNORMAL (Brain "fog"), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
rash/rash on her arm; three little spots that are still there from her shots; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the parent.  A 42-year-old 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: RASH (non-serious), outcome "unknown", described as "rash/rash on her arm"; RASH MACULAR (non-serious), outcome "unknown", described as "three little spots that are still there from her shots".  Additional information: the patient received COVID-19 Vaccine and had a rash on her arm with two/three little spots from her shots. She had an allergic reaction which was rash and three little spots that were still there from her shots.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) :PFIZER INC-202201135433 Same reporter/product, different patient/event;
LOW ANTIBODIES AGAINST COVID VIRUS; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: 23-AUG-2021) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-SEP-2021, the patient experienced low antibodies against covid virus. Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) 1.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of low antibodies against covid virus was not reported. This report was non-serious.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
sore arm; tired; This is spontaneous report from a contactable consumer (patient). A 66-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EL9267, expiration date unknown) via unspecified route of administration at left upper arm  on 10Feb2021 at age of 66-year-old at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient had some symptoms and he was fine. He had really no symptoms after the first vaccine just there was sore arm for couple of days and for a few days a little bit tired more than he normally would be. Outcome of the events was unknown.  No follow up attempts are needed. No further information expected.
The patient states she ended up in the hospital 2 weeks after her 2nd covid shot.  She states she had fluid in her lungs and inflammation surrounding her heart.  She now has to see a cardiologist for follow up but the Dr. at the hospital said it could have been caused by the vaccine.
CONFIRMED COVID-19 INFECTION; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced confirmed covid-19 infection. Laboratory data (dates unspecified) included: COVID-19 virus test positive (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection was not reported. This report was non-serious. This case was associated with product quality complaint 20210340676.; Sender's Comments: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Drug ineffective; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) 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 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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: COVID-19 (medically significant) with onset 2023, outcome "recovered" (2023), described as "COVID 19"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "recovered" (2023). Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 08Aug2023 to 12Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300283782 same patient, different drug/event;
Pt recv vax on 10/9/97; on same day pt exp vax site pain, body aches, fever x1wk, joint pain, vomiting, eye pain, &fatigue.
headache 24 hours following vaccine increased heart rate and anxiety following vaccine (normal RHR is ~70 and it increased to 87-90) and lasted one week 4 days post-vaccine a rash appeared on the trunk of the patient - both L and R side and onto the back of the trunk (rash still remains but the pain of it subsided around day 8) left armpit lymph node was slightly swollen (began day 4 and lasted to day 8) left ear was painful and throbbing (began day 4 and lasted to day 6) left pinky toe painful to the touch and throbbing (began day 4 and lasted to day 8) right big toe painful to touch and throbbing(began day 4 and lasted to day 8)
No adverse symptoms reported; the patient was vaccinated with improperly stored Varivax; This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitants was reported.  On 24-OCT-2019, the patient was vaccinated with incorrectly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot# S002395 has been verified to be a valid lot number, expiration date: 23-JAN-2021), (exact dose and route of administration were not provided) for prophylaxis.  The vaccine was stored in temperatures: 15 degrees Fahrenheit (-9 degrees Celsius) to 46 degrees Fahrenheit (8 degrees Celsius) for 1 hour and 44 minutes and 6 degrees Fahrenheit (-14 degrees Celsius) to 14 degrees Fahrenheit (-10 degrees Celsius) for 2 hours and 11 minutes. There was no previous temperature excursion. The digital data logger was involved. There was no adverse effects.
Pt states that itching, swelling, and redness began on 02/26/2013.
Recipient Lost conscious and control of Legs after vaccination. Stated he hasn't received a shot in 20 years. Did not eat lunch. Refused EMS services left on own accord.
I was tested positive after receiving the vaccine even though I work from home and had no been around anyone.
7 year old received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th November 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 10th November 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that the patient 7 years old received Kinrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Suspected  vaccination failure; Shingles; This case was reported by a pharmacist via sales rep and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Rerun- Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication.  The sales representative reported that, the pharmacist told her today approximately 20 minutes prior to reporting that he has having issues with completion rates of Shingrix due to his customers hearing of shingles outbreaks from the Shingrix vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for infection were not provided. The sales representative reported that, the pharmacist told him these comments were coming from multiple patients who were hearing these Rumors or claims from other people. This was 1 of the 2 cases reported by same reporter.
Patient blacked out while sitting during the observation time. He hit his head in the fall and was observed having some convulsions.
Pt recvd flu vax & exp sore throat, runny nose, chills, aching of the limbs for 3-5 days;
W/in 24 hrs swelling, redness of arm; 2nd day swelling & redness, shoulder to elbow; @ ER ATBs given, worsened; day 3 PT returned to ER & given IM ATBs; redness into chest area to wrist lt arm; MDs could not determine infection or allergy
Shortly after receiving the vaccine, the patient passed out. I ran out to him and shook him after having someone call 911. He regained consciousness after about 45-60 seconds. EMT checked his pulse and blood pressure and released him.
VARIVAX was given in left thigh and MMR given in right thigh. Rash appeared immediately following injection at the site. Patient waited with nurse for 10 minutes. Left thigh cleared 100% and right thigh cleared 80%.
Pt. received vaccine on 11/22/13. Noticed a warm red rash at site. She went to an urgent care facility and MD gave her an antibiotic for cellulitis on 11/25/13.
Information has been received from a registered nurse concerning an 80 year old female patient with hypertension, high cholesterol and allergy to narcotics who on 04-APR-2011, was vaccinated with a dose of ZOSTAVAX (Merck) (dose and route not reported) (lot number: 670383/0170AA, exp.: 07-MAY-2012). It was reported that on 25-MAR-2012 the patient developed shingles-scalp pain with a slight rash on the right side of her head and forehead. On 27-MAR-2012, the patient was seen in the office because the rash was worse and painful. FAMVIR, MEDROL DOSEPAK and ULTRACET were prescribed. The patient developed dizziness, nausea and vomiting and the FAMVIR and ULTRACET were discontinued. The patient began to experience right eye pain and saw ophthalmologist but the patient had no sign of herpes in her eye. On 29-MAR-2012, the patient had nausea, vomiting and was unable to eat and drink. The patient went to the Emergency Room and was admitted to the hospital. She was administered IV acyclovir and was seen by an infectious disease specialist. The nurse does not know if the patient was still hospitalized. Labs diagnostic studies performed: "viral culture"- results not available yet. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Booster dose given instead of dosage for second dose in the series, an additional 0.25ml was administered to complete the correct dose.
Tinnitus developed after receiving 2nd COVID vaccination.  It is not known specifically when it was first experienced.  Also, the 2nd shingles vaccination was received on 3/12/2021.  It is possible that the tinnitus is connected to the shingles vaccine.
Headache; Nausea; Multiple bowel movements not diarrhea type form; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 (Batch/Lot number: unknown) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VIRUS VACCINE), administered in arm right, administration date 11Oct2021 (Batch/Lot number: unknown) as unk unk, single. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Single, Lot number: EN6198), administration date: 02Mar2021, for COVID-19 Immunization; Bnt162b2 (Dose: 2, Single, Batch/lot number: ER2613, Dosage text: Unknown dosage injection left arm), administration date: 23Mar2021, when the patient was 67 years old, for COVID-19 Immunization, reaction(s): "Headache", "Nausea", "Diarrhea", "Vomiting", "Backache". The following information was reported: HEADACHE (non-serious) with onset 11Oct2021, outcome "recovered" (12Oct2021), described as "Headache"; NAUSEA (non-serious) with onset 11Oct2021, outcome "recovered" (14Oct2021), described as "Nausea"; FREQUENT BOWEL MOVEMENTS (non-serious) with onset 11Oct2021, outcome "recovered" (12Oct2021), described as "Multiple bowel movements not diarrhea type form". Therapeutic measures were taken as a result of headache.  Additional Information- Reporter Stated that she had the first Pfizer vaccine with no side effects. Stated that with the second one and the booster that she had many side effects. Stated that the second one side effects lasted one day and third one three days. Stated that she was better now. Stated that a local newspaper article stated that Pfizer is looking to give the vaccine to ages 5-11. Stated that after reading it she thought her dad who is 91 years old and had no side effects. Stated that he was a lot heavier than her. Stated that she is 67 years old and only 5 foot and does not even weigh 100 pounds. Stated that if they did not think of fact that different there are weights of people that she would not have reacted if given a lesser dose like children. Stated that getting sick for one day versus Covid was okay. Clarified that this was for the Pfizer Covid vaccine. Stated that she got the flu shot on the same day as her booster. Stated that she has gotten the flu shot for many years so she knows that her symptoms were not from the flu shot. Later clarified that it all of this was for the Pfizer BioNTech. Reporter Stated that she took Tylenol for the headache with the third dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Myalgia, Arthralgia, NauseaVomiting, "severe back and body aches with nausea and migraine Narrative: OTC Tylenol and Motrin: Zofran
Headache DAY 2 AND 3 AFTER INJECTION, PT EXPERIENCE  SOR ARM, HEADACHE, AND LETHARGY Narrative:
Arm felt like styrofoam a few hours after injection for a day Severe sore throat started about 5 days after Seen in urgent care 4/23. Hard to talk and swallow
This case was reported by a nurse and described the occurrence of incorrect storage of drug in a infant patient who received ENGERIX B pediatric. On an unknown date, the patient ENGERIX B pediatric at an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B pediatric, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Nurse reported that approximately 38 infants were vaccinated at birth with ENGERIX  that was stored out of recommended temperatures for approximately 1 month. Nurse did not have any further information at this time.
Woke up feeling like everything around me was "floating." Felt numbness go from my fingers inward towards center of body. Told roomate I was feeling strange. Roomate asked if I was ok. Cold not repond or move for 20min. Roomate tried to dress me- after 20min could dress myself but felt like my surroundings were moving fast; including my roomate talking to me and her movements. Roomate called my parents. Parents came over. Parents had to help me into car since I was not walking that good and very light sensitive. Went to ER first-Parents decided to take me to Urgent Care since I was still able to walk. Got to urgent Care and confusion increased. Was not able to speak to RN or Dr. Urgent Care sent me to ER. Got to ER-Could not move-only could blink my eyes- ER Nurse dug into chest and collar bone for a pain response-Nothing- Had I.V.-CT, and MRI Scans. Drs/nuerologist came in and tested on me. Still could not move. Was sent to neurocritical care for observation-Spend two days at hospital- Did not find anything-was able to move off and on through out the two days. Spent two weeks with parents for observations-During that time went in and out of episodes. On 12/30/2009- went in for sleep study-had several small episodes their-Dr. could not find anything. Presently investigating-Planning to go for more tests.
Narrative:  Patient developed dizziness and headache following administration of first dose of vaccine and transported to emergency department for further evaluation. Patient was sent home with no additional workup needed.