chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT  FAINTED AFTER RECEIVING  VACCINATIONS NOTED ABOVE.  PATIENT TURNED PALE.  ASSISTED TO FLOOR AND ELEVATED HIS LEGS ON A CHAIR.  BLOOD PRESSURE  60/44.  PATIENT'S COLOR RETURNED AFTER ABOUT 40 MINUTES.  LIPS PINK.  SPEAKING COHERENTLY.  ORIENTED. ATE A POPSICLE AND DRANK WATER.  BLOOD PRESSURE 102/58.  HR 70 REGULAR ON DISCHARGE FROM  HEALTH DEPARTMENT. LATER, FAMILY STATED THAT THE PATIENT HAD FAINTED WITH 5 Y/O VACCINES.
Headache & NauseaVomiting Narrative: Very shortly after injection developed Bad headache with nausea, no vomiting. Was monitored at site with no intervention.
Fatigue, headache, nausea, throbbing pain in arm (worse than a sore arm)
I had a Shingles shot (the first one) and I got the Shingles / was vaccinated / got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received 1st dose of Shingles vaccines and experienced shingles. The follow-up would not possible as no contact details were available
This spontaneous report as received from a female healthcare worker of unknown age refers to herself. In 1991, as an infant, the patient was vaccinated with a dose of RECOMBIVAX HB 2.5/0.5 (unit not reported) (dose, route and lot # not reported). On an unknown date the patient had negative titers for Hepatitis B, after receiving RECOMBIVAX HB. The outcome of negative titers for Hepatitis B was unknown. This is one of the two reports from the same reporter. Additional information has been requested.
RED KNOT MOM IST NOTICE 10/15/2009 AT 12 PM
Patient came for a COVID-19 bivalent booster but was inadvertently given  a flu vaccine. This is the second dose of flu vaccine this season. The previous dose was received one month prior per patient. Patient opted to receive the COVID-19 booster after the error was discovered and communicated with the patient. No adverse reaction reported by patient or observed by clinic staff.
Presented w/ acute hypoxic respiratory failure and COVID-19 pneumonia; tx w/ remdesivir, steroids, O2; weaned to RA for dc home.
Patient got 3rd dose booster 8 days before 6 months.  No side effects reported.
On 02/22/2023, in the morning, I had a slight runny nose and I felt tired. I had common cold symptoms. My wife was getting over COVID-19, so I did an antigen home test and it was positive. I texted the physician the next day. The next day, they called in Paxlovid, which I began on the afternoon of 02/24/2023.  I took Paxlovid through 03/01/2023. I tested negative 02/28/2023.
back was hurting/back pain; This is a spontaneous report from a contactable consumer (patient's mother). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. On an unspecified date, the patient's back was hurting and missed 2 days of work due to back pain. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Weakness started in left arm 1.5 days after the shot. Since then,  left arm is more weak and painful. Constant numbness of arms and hands.
tinnitus; vertigo; dizziness; This is a spontaneous report from a contactable pharmacist. A 61-years-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On 15Mar2021, the patient experienced tinnitus, vertigo, dizziness. Clinical Trial. A search of adverse events reported at 1 month after Dose 2 in the Pfizer-BioNTech COVID-19 Vaccine Phase 3 trial, which included 21,926 individuals who received vaccine and 21,921 individuals who received placebo, did not identify a safety signal. There were similar rates of tinnitus in those individuals who received the vaccine as those who received placebo injection.2. The outcome of the events was not recovered.  Information about Lot/Batch number has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event of tinnitus, vertigo, dizziness. 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.
Patient developed body aches, dizziness, decreased appetite with nausea and dry heaves, chills, diaphoresis on Saturday Oct 6th. Still going on 10/10/18. Prescribed ZOFRAN ODT 8 mg by mouth ever 6-8 hours as needed for nausea.
It was reported in a newspaper article that a 3 year old received one dose of PEDVAXHIB (manufacturer unknown), and had onset of clinical syndrome of meningitis in February 2008, and died. No further information was available.
ARM HAS NOT STOPPED BEING SORE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced arm has not stopped being sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm has not stopped being sore. This report was non-serious.
Wrong strength administered (dose too high). Patient received 1 dose of Pfizer 5 to 11-year-old (orange cap) COVID-19 vaccine (10mcg/0.2mL), but she was suppose to receive Pfizer 6 month to 4-year-old (maroon cap) COVID-19 vaccine (3mcg/0.2mL).
Itching of palms; 24 hours post injection-hives, on legs. Benadryl 50mg po q 6 hours prn.
received his first dose of the vaccine on 01/13/21 and his second one on 02/10/21. Headaches started 24 hous after his second vaccine but stopped after 02/23/21. Aside from the headaches, nosebleeds also started and ended the same days. Patient went to the hospital for SOB on 02/21/2021 after awakening from a deep sleep to both a headache and nosebleed. The hospital kept him there overnight. NO further symptoms after.
Information has been received from a physician concerning a 19 year old female with no drug reactions or allergies and a history of attention deficit/hyperactivity disorder (ADHD) who on 04-NOV-2008 was vaccinated with the first 0.5 ml dose of GARDASIL. Concomitant therapy included Concerta and Buspar. On 05-NOV-2008 the patient experienced vomiting. At the time of this report, the patient's vomiting persisted. No lab test were performed. The patient was seen by the physician and sought unspecified medical attention. Additional information has been requested. Follow up information was received which reported that the physician was no longer in the practice. Additional information is not expected.
A 14 year old female patient (FC) experienced injection site soreness, generalized muscle ache and headache after vaccination with RabAvert for post exposure prophylaxis. The patient received five doses of RabAvert (dose unspecified) with the first dose on 08/06/04 and the last on 09/04/04. Her past medical history was unspecified. She was concomitantly treated with intravenous anti-rabies immunoglobulin. The patient received RabAvert for post exposure due to a petting zoo situation. She experienced injection site soreness, generalized muscle aches and headache for three to four days following each vaccination. She self treated with aspirin. All adverse events had resolved.
Date: 06Jan2022/Nasal Swab: Positive; Date: 06Jan2022/Nasal Swab: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL8982), in left arm, on 21Dec2021 as dose 2, single (Lot number: EL9267), in left arm and on 22Jan2022 as dose 3 (booster), single (Lot number: FJ1611) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OZEMPIC. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "unknown" and all described as "Date: 06Jan2022/Nasal Swab: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jan2022) Positive, notes: Nasal Swab.
Diarrhea; Sore arm; This is a spontaneous report from a A contactable consumer (patient neighbour) reported that a 90-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, NDC, lot, Expiry Date: Not provided), via an unspecified route of administration, on an unknown date (age at vaccination 90-year-old) as unknown, single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced diarrhea and sore arm. Reporter states as, her old neighbour said she got Pfizer and she had diarrhea too. the patient had diarrhea and sore arm. The patient got hers, so patient was the first round of people. she doesn't think she has enough information to complete a report for her. The patient told her that she barely made it home in time before the symptoms started. Outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
24 hours after injection she had hives in head and back of neck. (5-24-18). 5-25-18 - she developed rash on stomach and arms. 5-26-18 - Her tongue swelled and rash on legs. 5-26-18 - She went to Urgent Care and was treated. 5-29-18 - She notified office of reaction.
This case was reported by a other health professional via sales rep and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On 23rd July 2018, the patient received the 1st dose of SHINGRIX. On 23rd July 2018, less than a day after receiving SHINGRIX, the patient experienced headache. The patient was treated with ADVIL and tramadol. On 24th July 2018, the outcome of the headache was recovered/resolved. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the office manager. In evening, the patient woke up with painful headache unlike anything she has had before. The healthcare professional (HCP) told her to take ADVIL and Tramadol. It lasted one day. The patient had not contacted HCP office for anything further that office manager knew about. The reporter agreed to be followed up.
On day 4 began having itching and redness. By day large (5-6 cm) area of redness in a well defined circle with firmness, pain, and itching
Patient came in with dizziness, lightheadedness and shortness of breath and had to be transferred for higher level of care for an angiogram. She reported diarrhea and abdominal pain prior to this as well.
My body began bad aches around this same time; I could not sleep; injection site in my arm started to hurt very badly; I had a fever of 102.5F; fever chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 20May2022 at 11:30 as dose 3 (booster), single (Lot number: FM7553) at the age of 44 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose number: 2, Lot number: EW6189, Administration date, time and location: 05May2022, 01:30 PM at Left arm), administration date: 05May2022, when the patient was 44-year-old, for COVID-19 immunization; BNT162b2 (Dose number: 1, Lot number: EP7533, Administration date, time and location: 07Apr2021, 02:00 PM at Left arm), administration date: 07Apr2021, when the patient was 43-year-old, for COVID-19 immunization. The following information was reported: INSOMNIA (non-serious) with onset 21May2022, outcome "recovering", described as "I could not sleep"; PYREXIA (non-serious) with onset 21May2022, outcome "recovering", described as "I had a fever of 102.5F"; PAIN (non-serious) with onset 21May2022, outcome "recovering", described as "My body began bad aches around this same time"; PYREXIA (non-serious) with onset 21May2022, outcome "recovering", described as "fever chills"; VACCINATION SITE PAIN (non-serious) with onset 21May2022, outcome "recovering", described as "injection site in my arm started to hurt very badly". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, insomnia, vaccination site pain, pyrexia, pyrexia.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks to the vaccination or other medications in two weeks. The patient had no known allergies. The adverse events started on 21May2022 at 12:00 AM.
gave a patient his 3rd Moderna Covid-19 Vaccine dose on 28 Aug2021 from a vial with an expiration date of 26Aug2021/Expired Vaccine dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave a patient his 3rd Moderna Covid-19 Vaccine dose on 28 Aug2021 from a vial with an expiration date of 26Aug2021/Expired Vaccine dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Aug-2021 at 10:15 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave a patient his 3rd Moderna Covid-19 Vaccine dose on 28 Aug2021 from a vial with an expiration date of 26Aug2021/Expired Vaccine dose). On 28-Aug-2021, EXPIRED PRODUCT ADMINISTERED (gave a patient his 3rd Moderna Covid-19 Vaccine dose on 28 Aug2021 from a vial with an expiration date of 26Aug2021/Expired Vaccine dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was provided.  No Treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Patient weight, race and ethnicity was updated. information about rout of administration and anatomical location was updated.
Weak, painful condition entire body. Sore and stiff shoulder. Fever 102.9 on 3/14/00, 101.1 on 3/15/00, 99.7 on 3/16/00 and 98.6 on 3/17/00.
Admit for resp failure due to COVID-19. Fully vaccinated. Given plasma, steroids, singulair, zinc, doxy, O2. 72 year old male with HTN, HLD, COPD, OSA, DM type 2, Dementia, Hypothyroid, CAD, CABG, was admitted to the hospital secondary to cough, chills, fever, weakness. Pt was diagnosed with COVID. Pt was treated with doxycyline for pneumonia. Pt HGA1C of 9.3. Pt was also noted to have chronic abdominal wound, wound care continued. He will be dischargedto rehab.
pt recvd vax & 3 to 4 days following vax pt devel a generalized rash of over 150 to 200 lesions & a fever;No further details were provided;
This spontaneous report has been received from a medical assistant referring to a patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history, or concomitant medications. The reporter stated that on 19-JUL-2017, the patient received a dose of VAQTA 25/0.5 (units not provided) (route of administration, lot# and expiration date were not provided). On 29-AUG-2017, the patient was vaccinated with the second dose of VAQTA,25/0.5 (units not provided) lot # N014945, expiration date 31-AUG-2018, for prophylaxis. No adverse effects were reported.
COVID 19 Treatment; COVID 19 Treatment; Dose Number: 5:Moderna/Dose Number: 4: Moderna/Dose Number: 3: Pfizer /Dose Number: 2: Pfizer/Dose Number: 1: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 29Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 16Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anemia" (unspecified if ongoing); "Hypoferritinemia" (unspecified if ongoing); "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29May2022, outcome "unknown", described as "Dose Number: 5:Moderna/Dose Number: 4: Moderna/Dose Number: 3: Pfizer /Dose Number: 2: Pfizer/Dose Number: 1: Pfizer"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: It was unknown if the patient took any other medications/products within 2 weeks of starting COVID-19 treatment. The reporter considered event to be non-serious.  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 possible temporal association the causal association of suspect drug  BNT162b2 and for reported events -drug ineffective ,COVID-19,Interchange of vaccine products cannot be excluded.
COVID vaccine administered was the Pfizer Pediatric COVID vaccine instead of the Pfizer Bivalent Booster vaccine. Pt has been advised to come back and receive the correct vaccine.
Fever; chills; severe arm pain; nausea; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8736 and expiration date was not reported), via an unspecified route of administration in right arm, on 11May2021 at 19:15 (at the age of 17 years old) as second dose, single for COVID-19 immunization at a pharmacy or drug store. Medical history was reported as none. The patient had no known allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT), loratadine (CLARITIN) and birth control (unspecified). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0170 and expiration date was not reported), via an unspecified route of administration in right arm, on 17Apr2021 at 13:00  (at the age of 17 years old) as first dose, single for COVID-19 immunization. The patient was not pregnant and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was never tested for COVID-19. The patient experienced fever, chills, severe arm pain and nausea on 12May2021 at 05:00. No treatment was given to the patient for these events. The outcome of these events was recovering at the time of report.   No follow up attempts are needed. No further information is expected.
Admitted for COVID. Vaccine completed Feb 2021. Did not require O2. Treated with zinc and oral steroids. Discharged home.
no adverse effects reported; the patient was inadvertently administered a dose of VAQTA which expired on 10/20/2020; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 26-OCT-2020, the patient was inadvertently vaccinated with an expired dose (reported as a dose) of hepatitis A vaccine, inactivated (VAQTA) injection, lot # S023220 and expiration date: 20-OCT-2020 for prophylaxis (route of administration was not reported). No adverse effects were reported.
This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and allergies were not reported. Concomitant therapies were not provided. On 14-JUL-2016, the patient was vaccinated with an unspecified improperly stored dose of RECOMBIVAX HB "10 microgram/1 ml, 10X1 DS/V TF" with lot number L042846 and expiration date 15-SEP-2017, (dosage schedule, route and anatomical location were not reported), which was stored at 12 Celsius Degrees for 144 hours. The type of excursion and the storage criteria were reported as refrigerator (R) and the vaccine status in excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
At 15:05 voiced complaints of feeling tired and dizzy. Crying and scared. Her mother was in attendance. They gave her some orange juice. No tachypnea or dyspnea.  Skin warm and dry. 15:10  Attendee stated that she "felt funny".  Attendee assisted to the cot and given orange juice. 15:13 - HR: 78 BP: 120/80 O2Sat%: 99.  15:16 Water given 15:20 -No voiced complaints- skin warm and dry.  Attempted to sit her up and she reported dizziness, so she laid back down. HR: 75 BP: 110/70 O2Sat%: 100 Temperature 98.7  15:25  Sat up on cot the and dangled her legs without dizziness 15:26  Assisted to a chair and denies feeling funny or dizzy. 15:30 - discharged to home with her parents