chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient fainted a couple of minutes after receiving vaccine.  Patient fainted while sitting up, was move to the floor and laid flat on back with feet elevated.  He regained consciousness quickly, within several seconds.   Gave cold compress and applied to neck. Paramedics called and arrived and took over.
been taking antidepressants and antipsychotics, but after receiving the vaccine, her medications had stopped working.; gained 10 pounds; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications.  The following information was reported: DRUG INTERACTION (non-serious), outcome "unknown", described as "been taking antidepressants and antipsychotics, but after receiving the vaccine, her medications had stopped working."; WEIGHT INCREASED (non-serious), outcome "unknown", described as "gained 10 pounds". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated that when she received the 2nd dose of the Pfizer-BioNTech Covid 19 Vaccine, her left shoulder got frozen and had a muscle spasm, so she went to the doctor to receive a steroid injection to relief her pain. She wanted to know if this should be reported as an adverse event.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This was my first dose of the vaccine.  12 hours after injection I had chills so bad my teeth chattered, head ache, body aches, temperature of 101.7, weak and very fatigued for 24 hours.  Temp came down to 99 with Tylenol.  36 hours after injection I sweat so badly that my clothes and bed sheets were wet.  Temp continued to be 99 until about 45 hours after injection.   Injection site was sore even without pressure for 5 days.   Red rash around injection site for 7 DAYS.    I went through 6 treatments of chemotherapy for ovarian cancer last year and this vaccine response was every bit as bad as chemo!
Sleeplessness; tinnitus; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Sleeplessness), TINNITUS (tinnitus), FATIGUE (Fatigue) and HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A. and 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN for Cholesterol, VITAMIN D NOS and PROBIOTICS NOS for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced FATIGUE (Fatigue) and HEADACHE (Headache). On 02-Mar-2021, the patient experienced INSOMNIA (Sleeplessness) and TINNITUS (tinnitus). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at a dose of 200 milligram. On 02-Mar-2021, FATIGUE (Fatigue) and HEADACHE (Headache) had resolved. At the time of the report, INSOMNIA (Sleeplessness) outcome was unknown and TINNITUS (tinnitus) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Upon follow up, the patient claimed the event of tinnitus was not resolved.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Non significant information. On 02-Aug-2021: Event Tinnitus outcome was updated to not recovered.
Increased swelling and erythema initially now 24 hr post 48 hr includes deltoid upper shoulder distal to elbow. (L) arm
Two weeks ago she tested positive for COVID; Two weeks ago she tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID. The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Two weeks ago she tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Two weeks ago she tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The caller was a retired Physician Assistant and was calling because she had the Pfizer BioNTech COVID-19 vaccine for all four of her doses, two primary doses and two boosters. Two weeks ago she tested positive for COVID and would like the Pfizer bivalent booster vaccine and would like to know how long it is recommended to wait to get that after an active COVID-19 infection. She stated all of her shots were Pfizer, she and her husband had the same scenario. They were sick but not as sick as she thinks they would have been so they are thankful for Pfizer. She was not sure if she should wait 3 months after their natural immunity because they were both pretty sick, but were not hospitalized. She had monoclonal antibody treatment and her husband had treatment with Paxlovid. Caller on the line who mentioned that her and her husband had two primary doses and two booster COVID-19 shots and tested positive for COVID. Mentioned they were going to get the new bivalent vaccine on 23Sep2022. Asking if they can get the bivalent vaccine on 23Sep2022. Provided the number to company already. product complaint to report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202201161119 same reporter/drug/event, different patients;
pt recv vax 20DEC95 & 1 to 2 hr p/vax pt became very tired,throat swelled shut & broke out in hives;pt noted that had Famotidine & Zantac on a non-regular basis & indicated that pt was not taking these therapies @ time of vax
Shoulder hurting at injection site, headache, chills, bad dreams. Next day, felt shaky and disoriented. 3 days later called doctor who provided no recommendations. Continue to feel shaky, chills, nightmares. Nightmares worsen over time, woke up screaming. It affected neurological system/feels poisoned. Temper changed, affected memory. Shocked that vax is given to children, read on the internet that it is forbidden in another country. Doctor did not given vax info before immunization.
Severe muscle ache in arm that shot was given in,inability to lift same arm for 24 hours  Called doctor & he prescribed motrin 800 which helped a little,but now there is redness & swelling in the affected area!
Pain and swelling at injection site. Treatment advised to use ibuprofen and ice for pain. Also advised to follow up if swelling hasn't resolved in one week from today.
Pt noticed tenderness in (R) deltoid 3/19/15 in the AM. He has approx 4x8 in area which is red, warm to touch, swollen and very tender.
Fever of 101 and higher for over 24 hours. Swelling and itching of injection sight. Sever shaking and body aches. Low grade fever lasting a week. Fatigue lasting for a week. Arm weakness lasting a week.
Arm started itching Saturday night, by Monday morning arm was extremely red and hot to touch. Pharmacy advised patient to check with Dr. Dr. prescribed Cephalexin 500mg BID for 7 days on 7/18/22.
covid_test_result=Positive; covid_test_result=Positive; not sleeping well; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 62 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 17Apr2021 (Lot number: EP6955) at the age of 61 years as dose 2, single and administration date 29Mar2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Jan2022, outcome "recovering" and all described as "covid_test_result=Positive"; INSOMNIA (non-serious) with onset 25Jan2022, outcome "recovering", described as "not sleeping well". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Jan2022) positive, notes: +AG. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, insomnia.  Clinical information: Unknown if other vaccine in four weeks, covid prior vaccination. adverse event: not aware of exposure risk- but sx of covid runny nowse, cough and fevers body aches not sleeping well 1/25 and test 1/25 + AG. Updated information included: Suspect drug coding, Product Details: Batch and lot tested and found within specifications  Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EP6955 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP6955, fill lot EP6954, and the formulated drug product lot EP6953. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out.
mom indicated patient needed MMRV vaccine -signed off on it - after documenting -realized it was too soon for the vaccine.  The patient did not have any reaction to the extra dosage .  Patient was seen a few days later and he was ok.
sweats at night; shakes; had the "shakes; fever on and off (101F); This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats at night), TREMOR (shakes), CHILLS (had the "shakes) and PYREXIA (fever on and off (101F)) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced TREMOR (shakes), CHILLS (had the "shakes) and PYREXIA (fever on and off (101F)). On 25-Feb-2021, the patient experienced HYPERHIDROSIS (sweats at night). At the time of the report, HYPERHIDROSIS (sweats at night), TREMOR (shakes), CHILLS (had the "shakes) and PYREXIA (fever on and off (101F)) outcome was unknown.            No treatment information was provided. Patient had Prednisone regimen between the 1st dose and 2nd dose for a previous undiagnosed cough. Action taken with mRNA-123 is not applicable.   Reporter did not allow further contact
Skin rash around neck, hives Shortness of breath Swelling Nausea
Pt experienced fever of 102-103 and vomiting about 4 hrs after receiving vaccines. Mom gave TYLENOL/MOTRIN and PEDIALYTE.
Swollen lymph nodes of armpit of I njectiin site, severe insomnia since day of vaccination (booster), swollen lymph nodes resolved in around 10 days. Insomnia still persists. No anxiety issues.
Red, raised bump at site of injection (right deltoid) about 1 inch in diameter.
Moderna COVID-19 Vaccine EUA About 7 days after receiving the first dose of the Moderna covid19 vaccine, I started experiencing fatigue, irritability, upset stomach, diarrhea, headache, body aches.  I had these symptoms for 5 days, with the worst day being day 3 and 4.
Patient notified clinic 10 days after vaccination that 2 days after she received vaccine she had bilateral underarm lymph node swelling and numbness to right index finger and bilateral deltoid upper arm soreness. Advised to be seen at Primary Care Provider or to return to medical clinic, returned on 9/16/23 date of reported effects to medical clinic and was examined by FNP, and upon exam findings were no lymph node enlargement palpated on any area, no swelling of bilateral deltoid upper arms, full range of motion of upper extremities, full sensation to touch of upper extremities and fingers, mild discomfort expressed by patient with bilateral deltoid palpation.
Patient received her influenza vaccine at approximately 5 pm on 9/21.  Mom noticed redness at the site of the injection around 11 am on 9/22.  It did not seem to bother her, but looked red and a little swollen.  It got a little worse-spreading and a little more swollen throughout the day on 9/21.  This am it looked like it had spread a lot more and was much more swollen.  She does not seem to be in a lot of pain. She does itch at it.  She is walking but there may be a little bit of a limp.  She has 1 pinpoint spot that developed near the injection site. Mom saw a little drainage come from it this morning. On further clarification, the drainage was a clear yellow. She has not had any fever, URI sx, cough, vomiting. She slept fine last night.  She is eating per normal. No evidence of pain anywhere.  Energy per normal.
It was reported that a pt (2 of 4) complained of redness and rash 3-4 inches in diameter after receiving the 98-99 Fluzone.
Myalgia, Fever & Diarrhea Narrative:  dose 1 - SORE ARM DAY 2 AND 3; DIZZY / FATIGUE- DAY 5-7 UPTO DAY 14 dose 2- day 2-3 sore arm; day 2-3 fever fatigue diarrhea
This spontaneous case was reported by a consumer and describes the occurrence of RASH (experienced a rash on his leg which has gone away.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced RASH (experienced a rash on his leg which has gone away.). At the time of the report, RASH (experienced a rash on his leg which has gone away.) had resolved.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant drug reported. No Treatment drug reported. Reporter reported- Not sure if it the event was after his 1st or2nd dose. Caller declined to provide further information. Also the patient in his 50s received  Moderna Covid-19 Vaccine earlier this year. Reporter did not allow further contact.
sore arm; a little fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm) and PYREXIA (a little fever) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 41L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE PAIN (sore arm) and PYREXIA (a little fever). At the time of the report, INJECTION SITE PAIN (sore arm) and PYREXIA (a little fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   No treatment information was provided.; Sender'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.
doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.    No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Removed from freezer 8 am, 25-OCT-2021
Pt. was given HPV and MCV injections. Pt. then needed to lay back and when she laid back pt passed out. After a few seconds pt. came back and had water and juice. Pt. observed for 15 min. Pt was rechecked and then pt. was released to go home with parent. Pts mother instructed to with further concerns or questions.
Patient reported normal arm soreness the immediate days following vaccination. However the soreness developed into sharp pains when moving her arm. She gets a nauseating feeling during the pain. The pain is so bad that she has a hard time sleep on that arm during the night for it wakes her up. This developed within a week of getting the shot and has not abated. The patient does state it is starting to interfere with daily life. Patient does plan on following up this week with her primary care doctor.
Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist via phone. This case involves 93 year old patient who received two 0.5 ml dose of FLUZONE HIGH DOSE (batch number UI999AA, expiry date 06 April 2019 intramuscularly in right deltoid on 03 Oct 2018 at 11:30 am. It was reported that, patient also received INFLUENZA VACCINE few days ago. It was a case of actual medication error as Extra dose administered as patient had the FLUZONE HIGH DOSE vaccine given to him today, 10/03/2018 at 11:30 am. His family found him there and explained he just had a flu shot at the hospital a few days ago and this was his second flu shot. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Case number PHEH2014US025147, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 48 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 27 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
sore arm; This is a spontaneous report from a contactable consumer (Patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced sore arm from the vaccine. The outcome of the event sore arm was unknown. Information regarding lot/batch number has been requested.
Fever>103; post vax swelling @ inject site, redness, vomited x 1;
This spontaneous report as received from a physician via a field representative refers to a female patient of unknown age. Relevant medical history and concomitant medication were not provided. On 09-APR-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous in the left arm. Lot number was not provided. On 10-APR-2013, the patient experienced redness at site of injection diagnosed as cellulitis. The outcome of redness at site of injection diagnosed as cellulitis was unknown. The action taken regarding ZOSTAVAX was unknown. The reporter causality was unknown. Additional information has been requested.
This is a spontaneous report from a contactable pharmacist and a contactable consumer reporting for herself. An 82-year-old female patient received PREVNAR 13 (Lot# R28320, Exp date Feb2018, NDC 00005197102), via an unspecified route of administration in deltoid right, on 24Aug2017 at around 02:00 PM, at 0.5 ml single, for immunisation and FLUZONE (Lot# U1808AB, Exp date Feb2018), intramuscular in deltoid left, on 24Aug2017, at unspecified dose, for immunisation. Patient was vaccinated in a pharmacy. Relevant medical history included ongoing hypertension (diagnosed a long time ago). Concomitant medications included diltiazem (unspecified trade name) from an unspecified date and ongoing for blood pressure and ADVAIR from an unspecified date and ongoing for an unspecified indication. The patient previously received PNEUMOVAX, years before, for immunisation; FLUZONE (high dose), in 2016, for immunisation and unspecified doses of FLUZONE the years before for immunisation. The patient experienced a good size red warm spot on her arm on an unspecified date with outcome of unknown, considered as medically significant by the reporter; itching on 30Aug2017 with outcome of unknown, considered as medically significant by the reporter; her other arm was sore after the FLUZONE on an unspecified date with outcome of unknown. No therapeutic measures were taken as a result of the events. The reporter considered the event good size red warm spot on her arm as related to pneumococcal 13-val conj vac (dipht crm197 protein). Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of "red warm spot on her arm and itching" cannot be fully excluded. Local reactions including redness/ warmth and pruritus post vaccination are the known risk for PREVNAR 13. Arm sore occurred opposite to the arm vaccinated with PREVNAR 13 is not due to the use of PREVNAR 13. 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.