chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202101863336 (Pfizer).  A 6 year-old female patient received bnt162b2 (BNT162B2), administration date 04Dec2021 08:30 (Batch/Lot number: unknown) at the age of 6 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, single), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 04Dec2021, outcome "not recovered", described as "headaches". The event "headaches" was evaluated at the physician office visit.  Additional Information: The patient started developing headaches in in afternoon of vaccination. Based on the information it is a common side effect that should have been gone in 2-3 days. However she was still had frequent episodes of the headache. She had visited her primary doctor and seems okay.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax & w/in 8hrs post vax exp throat swelling which still persists;18JUN95 exp chills,fever,nausea,upper body aches & h/a;seen by MD 20JUN95 & was treated w/DPH
Sick; random pains all over; lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), PAIN (random pains all over) and DIZZINESS (lightheaded) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included HYDROCHLOROTHIAZIDE for Blood pressure high, VITAMINS NOS (DAILY MULTIVITAMIN) for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced ILLNESS (Sick), PAIN (random pains all over) and DIZZINESS (lightheaded). At the time of the report, ILLNESS (Sick), PAIN (random pains all over) and DIZZINESS (lightheaded) had resolved.       mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  The patient received his first dose April 2021 sometime around the 18th to 20th of the month.   The patient's dose of hydrochlorothiazide had been changed at some point because his blood pressure numbers were getting low, stating he was usually around 132-140 for the top number.  Company Comment: 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.; 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.
Patient stated that they felt fine after receiving vaccine. Started to itch at injection site after a couple of days. Over the course of the past 2 months patient started to develop shingles like symptoms. Patient has not been to doctor about issue. I advised patient to go to doctor.
PATIENT REPORTED FLU LIKE SYMPTOMS, PAIN AT INJECTION SITE, BODY ACHES, HEADACHES, AND UPSET STOMACH.
No adverse effects; patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX); This spontaneous report was received from a registered nurse referring to a patient of an unknown age and gender.   The patient's medical history, concurrent conditions, concomitant medications, past drugs and allergies were unknown.  On 20-NOV-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency and route were unknown) (lot # S019581 and expiration date: 25-JUN-2021) for prophylaxis. No adverse effects were reported. The temperature was minus 0.2 Celsius for 2 hours and 40 minutes. The previous temperature excursion was at 4.25 Celsius for 2 hours 40 minutes. This call was because of digital data logger.
31MAY95 mom states pt had fever 101 that noc on 1JUN95 fever to 102 that day was lethargic & dec not responding to mom for over 12 hrs; mom took pt to ER & was told had rxn to vax;
Patient reported headache, fever, and chills starting the day of the vaccine (10/11/23). She did not feel better until 10/16/23. She asks that I report her adverse reaction in case other patients experience the same side effects.
pt recv vax & w/in 18hr devel a blotchy rash on chest & neck;pt stated that rash resembled a sunburn;pt self treated w/oral DPH & DPH cream;3 days post vax a small area of rash persisted on neck;
Swelling and numbness/tingling in lips, tongue, face, throat. Dizziness/disorientation
A 62 year old patient was mistakenly given the pediatric dose (0.5 ml) of Havrix yesterday; A 62 year old patient was mistakenly given the pediatric dose (0.5 ml) of Havrix yesterday; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 62-year-old male patient who received HAV (Havrix pediatric) for prophylaxis.   On 27-JUN-2023, the patient received Havrix pediatric (intramuscular) .5 ml. On 27-JUN-2023, an unknown time after receiving Havrix pediatric, the patient experienced accidental underdose (Verbatim: A 62 year old patient was mistakenly given the pediatric dose (0.5 ml) of Havrix yesterday) and adult use of a child product (Verbatim: A 62 year old patient was mistakenly given the pediatric dose (0.5 ml) of Havrix yesterday). The outcome of the accidental underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-JUN-2023 A 62 year old patient was mistakenly given the pediatric dose (0.5 ml) of Havrix. Nothing else was reported.  The Vaccine Administration Facility was the same as Primary reporter. Consented to follow up with HCP/reporter.
12/03/08, Hep A, HPV, IVP administered. 12/05/08, red, non-raised rash bilateral antecubitals. 12/07/08, fever, high 102+/-. 12/08/08, dizziness. 12/09/08, temp 103.9 (T). Denies nausea/vomiting, rash remains. Alert and oriented c/o dizziness, advised TYLENOL prn and referred to PCP to seek medical care immediately if symptoms worsen.
Subsequent to receiving the third dose of Lymerix, the pt experienced injection site soreness.  As of 09/27/2000, the outcome is unknown.
Temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 47K47, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd August 2021, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The multiple patients received FluLaval Quadrivalent after the was stored at 17.6F by 40 minutes, which led to incorrect storage of drug. The reporter consented to follow up.
Patient received 1 dose of Moderna vaccine after already completing a 2 dose-series of Pfizer vaccine; Patient received 1 dose of Moderna vaccine after already completing a 2 dose-series of Pfizer vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (Patient received 1 dose of Moderna vaccine after already completing a 2 dose-series of Pfizer vaccine) and EXTRA DOSE ADMINISTERED (Patient received 1 dose of Moderna vaccine after already completing a 2 dose-series of Pfizer vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced OFF LABEL USE (Patient received 1 dose of Moderna vaccine after already completing a 2 dose-series of Pfizer vaccine) and EXTRA DOSE ADMINISTERED (Patient received 1 dose of Moderna vaccine after already completing a 2 dose-series of Pfizer vaccine). At the time of the report, OFF LABEL USE (Patient received 1 dose of Moderna vaccine after already completing a 2 dose-series of Pfizer vaccine) and EXTRA DOSE ADMINISTERED (Patient received 1 dose of Moderna vaccine after already completing a 2 dose-series of Pfizer vaccine) 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.   No relevant concomitant medications were reported. Treatment information was unknown.
90 minutes after receiving flu shot returned to clinic c/o swollen right eye, hoarse voice and slight itching right leg. Rx with 50mg Benadryl IM, evaluated by 911 but refused transport to ER. Better by next AM.
Rash at injection site starting 12-19-11 and lasting about 1 week. Starting 12-27-11 a shingles-type rash on buttocks.
feeling very tired; nauseated on the stomach; sleepy; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number/Expiry date: unknown) via an unspecified route of administration as a single dose for COVID-19 immunization on 11Feb2021. The NDC number of Pfizer BioNTech vaccine was not provided. The past medical history and concomitant medication was not provided. On 13Feb2021, the patient experienced feeling very tired, nauseated on the stomach, and sleepy for 3 days now and it was worst today. The patient reported that tiredness prompted her to go back to bed. The clinical outcome for the events was unknown. Caller is trying to see if this last Pfizer BioNTech vaccine is causing her to feel so tired and nauseous on the stomach.  Information on the lot/ batch number has been requested.
Patient came into the clinic about a month after recieving the Pfizer covid vaccine. She was complaining of extreme vertigo, blurred vision, dizziness and nausea.
Report of HA began 3 hours post vaccination, she has history of Migraines, intermittent chest pain.  Treatment: Alternate with Tylenol and Motrin with some improvement. Outcome: Continues to work, does interfere with ADLs.  Recommend employee follow-up with primary care doctor or go the nearest ER for chest pain.
severe constipation problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), on 28May2021 as dose 1, single (Lot number: Ew0180) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONSTIPATION (hospitalization) with onset 2021, outcome "unknown", described as "severe constipation problems". The patient was administered with 2 doses of the Pfizer COVID-19 Vaccine: Dose 1 on 28May2021 (Pfizer Ew0180) and Dose 2 on 21Jun2021 (Pfizer Ew0181) at pharmacy. Since immediately after he was administered the first dose of Pfizer vaccine, he was hospitalized in view of severe constipation problems.
No AEs; RN called to report temperature excursion that occurred on 7/12/2022. Caller states that 100 doses of PROQUAD and 94 doses of VARIVAX were administered since 7/12/2022 from mobile unit to children in community. No further information provided. No add; This spontaneous report was received from a nurse and refers a child of unknown gender. The patients' concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 12-JUL-2022, 40 doses of the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621with expiration date 20-SEP-2023) underwent a temperature excursion during storage.   On an unknown date, the patient was one of 40 patients vaccinated with vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621, expiration date 20-SEP-2023) 0.5 ml once administered as prophylaxis (dose regimen details were not provided).   No adverse event was reported. No further information was reported.  This is one of several reports received from the same reporter.
Patient received second covid shot from technician certified to vaccinate. Tech knocked on door, because when patient went to stand she felt like putting her head between her legs and fainting. I went in there and it looked like previous episodes of fainting I have seen so I tried to calm her and have her breath while patient was getting the blood pressure machine. Patient then fainted again a little more intensely, but still not alarming me that much. She came to and again I was talking with her to try to keep her alert. I asked her how she was feeling. She said she was extremely hot (she kept repeating this), that she had a headache, and asked for water. I told her we couldn't give her food or water until she felt better. We now had blood pressure monitor on her and it wouldn't read her pressure or pulse it kept saying error. I just used it on another patient with high blood pressure and it had been functional. I had been manually holding her pulse and it was strong and normal. Then she fainted again and started shaking. the shaking quickly stopped. She woke up and said that she couldn't see.  I asked tech to call 911, while I stayed with her and kept assessing her. Tech got the headset got 911 on the phone and turned the phone over to me. I asked her to grab another blood pressure monitor. We tried again and at 3:55pm it was 88/50 and pulse of 66. I was talking 911 and responding to all questions over the phone. I had to ask the patient for the responses (many COVID related questions). I told the lady her blood pressure and the lady said I don't need to know any of that. She wanted me to keep asking the patient questions. The blood pressure was 87/49 and pulse of 65 at 3:58. Now the EMT had arrived and assessed her. They said she fainted and she said she did not want to go with them. So they left. The patient remained at pharmacy for 45 to 90 min more until she was sure she felt okay enough to catch an uber home. I called her at 8:43pm and she said she feels much better, has eaten, and is with her boyfriend in case she experiences anymore ADRS. Upon asking who her primary physician is she said she last saw a doctor in another country.  She said her md only speaks another language. I asked her to call her MD and report to her in a different language what happened since I am unable to speak with her.
swollen face, swollen throat, wheezing. Was treated at ER with epipen and oral steroids.
Day 1- extreme tiredness and complaints of being very sore - we thought was normal Day 2- excessive tiredness  continued Day 3- excessive tiredness  continued Day 4-  excessive tiredness continued and decreased appetite with some weakness  Day 5- all of the above plus less urination and strange breath smell (light scent) Day 6- all of the above plus becoming more severe  Day 7- all of the above and urine output decreased to half of normal - 3x daily and she struggled to urinate  Day 8- all of the above plus inability to urinate back pain excessive sweating  Day 9- ER & admitted to hospital- was told any vaccine not just this vaccine can cause reactions  Day 10- hospital tests continued
Symptoms return and tested positive again 7 days; Symptoms return and tested positive again 7 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Symptoms return and tested positive again 7 days". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative for COVID 2 days after finishing treatment; Positive, notes: Symptoms return and tested positive again 7 days after finishing treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Adverse event: Tested negative for COVID 2 days after finishing treatment. Symptoms return and tested positive again 7 days after finishing treatment. There was other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a pharmacist concerning a 66 year old patient. On 15-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J004270; expiration date 12-JUL-2014) (dose not reported), subcutaneous in the left arm. The pharmacist reported that while administering ZOSTAVAX vaccine on 15-NOV-2013 to a patient, the needle came apart, was not attached securely, and the patient received only a partial dose. No adverse effects reported. At the time of the report, patient's outcome was unknown. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a 20 month old male with no known drug allergies who on 02/12/2002 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 03/04/2002 the pt presented to the doctor's office with varicella. The pt sought unspecified medical attention. Additional info has been requested.
patients administered Moderna vaccine while temperature excursion assessment was ongoing; patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and EXPIRED PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and EXPIRED PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and EXPIRED PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided. on 8 Mar 2022 case was identified valid as patient was identified.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow up received Patient demographics added, Dose details updated.
pt. c/o of feeling anxious after taking the first dose of Covid vaccine.  Denies other adverse effect of the vaccine noted.   Vital signs BP 124/74, HR 117, R 20, O2 Sat 98%.  Advised pt. to follow up with PCP if symptoms reoccured.  Left the parking lot feeling better.
This spontaneous report received from a medical assistant referred to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date, the patients received PEDVAXHIB (Lot number: M010440, Expiry date: 09-DEC-2018) (dose, frequency were not reported) which was improperly stored. No adverse effects reported. Causality assessment was not reported for the events. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 20-OCT-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date- 10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. It was reported that vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
New, left-side chest pain beginning approx. 39 hours after receiving first dose of Pfizer vaccine for COVID-19. Occurred in the night and was painful enough to keep me awake. Pain in sternum, chest, shoulder blade, and neck on left side only, slowly subsiding over four days. Pain was exacerbated with exercise but less noticeable when sitting at desk at work. Did not feel bad in any other way. Nevertheless, a physician advised me to go to the Emergency Dept. to be checked out.
Pt was admitted to the hospital on 11/16/2021. Pt presented with Dyspnea. Pt tested positive for c-19 on 11/16/2021. Pt Treated with 2l o2 via Nasal cannula And  Remdesivir.