chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered approx. 130 pm via IM injection to (L) deltoid. Within 1 hour, patient became dizzy, very weak, and nauseous, and slightly mentally "Foggy".
I have Covid-19/Symptoms are mild. Dry throat runny nose a little cough. A bit lethargic; I have Covid-19/Symptoms are mild. Dry throat runny nose a little cough. A bit lethargic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I have Covid-19/Symptoms are mild. Dry throat runny nose a little cough. A bit lethargic".  Clinical information: The patient reported that she learned yesterday that he has Covid-19. Symptoms are mild. Dry throat runny nose a little cough. A bit lethargic. She received Pfizer Covid vaccine and all boosters shortly after CDC announced use for my age group.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021247783 same patient, different dose/event;US-PFIZER INC-PV202200060088 same patient, different dose/event;
Fever; Fatigue; Back ache; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration on an unknown date (Lot number: EL3247), at the age of 27 years as dose 1 and also the patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration on an unknown date (Lot number: EP6955), at the age of 27 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 15Nov2021, outcome "recovering", described as "Fever"; FATIGUE (non-serious) with onset 15Nov2021, outcome "recovering", described as "Fatigue"; BACK PAIN (non-serious) with onset 15Nov2021, outcome "recovering", described as "Back ache". Therapeutic measures were not taken as a result of pyrexia, fatigue and back pain.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Administered MMR vaccine-pt developed pain, redness and swelling in vaccine site. BENADRYL and ice given, TYLENOL give before vaccine.
I got my period the day after the shot, only 2 weeks after the last one, which is very unusual for me; Bleeding much more heavily than normal; Severe joint pain; achiness; Headache; Sore throat; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 24Feb2021 at 15:30 (reported at 03:30 PM) (at the age of 46 years old) as first dose, single for COVID-19 immunisation in a hospital. Patient has known allergies to Penicillin, sulfa drugs, and mangoes, all from an unknown date.  Patient was not pregnant at the time of vaccination and prior to vaccine the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), naproxen sodium (ALEVE), montelukast sodium (SINGULAIR), loratadine (CLARITIN [LORATADINE]), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines in 4 weeks. On 26Feb2021 at 00:00, patient experienced to have her period the day after the shot, only 2 weeks after the last one, which was very unusual for the patient. The patient also reported that she was bleeding much more heavily than normal. The patient had severe joint pain and achiness, a headache and a sore throat, which she saw on the list of possible side effects. No treatment was received for the adverse event. After vaccination, the patient has not been tested for COVID-19. Outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever of 100° began @ 10 pm  3/23/21and ended @ 8am on 3/24/21. Minor achy shoulders, back and injection site. Due to MS, fever raises inflammation in quadriceps making walking very difficult.  Treated with Tylenol, cool compress and rest.  General feeling of fatigue 3/24/2021. All symptoms completely resolved 3/25/2021
Symptoms: ecchymosis at injection site, rash around injection site. Treatment: none.
Anemia; This is a spontaneous report from a contactable Other-HCP.  This 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, in Jan2021 at single dose for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included ongoing chronic obstructive pulmonary disease (COPD), ongoing diabetes, ongoing high blood pressure and ongoing high cholesterol. The patient received a lot of concomitant medications (no additional details were provided).  On 26Jan2021, the patient developed anemia for which he was admitted to the hospital on the same day. The patient was recovering from the event.  Information on Batch/Lot number has been requested.; Sender's Comments: Based on the limited information provided and temporal association, a causal association between the reported event and the BNT162B2 cannot be excluded.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Erythema 14cm x 8cm, induration, tender and hot to touch. Treated with BENADRYL.
Two weeks after the vaccine I woke up in the morning and the upper part of my arm at the site of the shot was sore up into my neck. During the day it would lessen but get worse late into the night. It progressed to where I had to hold my left arm with my right to be able to reach up to even get a coffee cup out of the cabinet. I went to my see my PCP a couple weeks late who sent me to see a Physical Therapist. I went to Physical Therapy for six weeks and have regained the use of my left arm.
Red rash appearing on upper body and face. Moves around body. Itchy and raised at times. Goes away with Benadryl but returns within 6 hours.   When I scratch my skin it appears.
This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 years old male patient with anaphylactic reaction to hay and no previous illness, was intramuscularly vaccination in right arm with first dose of GARDASIL lot # (671006/1291AA) on 05-MAR-2012. Concomitant vaccine included: the second dose HAVRIX lot# AHAVB541DA, intramuscularly in right arm on 05-MAR-2012. Historical drug included EPIPEN prescribed for anaphylactic reaction to hay, date unknown. On 05-MAR-2012 11:15, the patient presented c/o "itching all over", no rash or hives noted, and denied shortness of air. The patient was administered BENADRYL 25 mg oral and observed for 15 minutes. On 11:35 the patient remembered getting vaccine this a.m., and stated itching was getting worse, throat feels numb. Red raised circular areas, approximately 5 cm ea, hive like rash noted to right upper arm. The patient was administered oxygen at 4L face mask. On 11:40 the patient was administered epinephrine 1:1000 0.5ml intramuscularly. On 11:58 the patient was transported to hospital via EMS. The outcome was unknown. Upon internal review, the adverse events required epinephrine treatment was considered to be an other important medical event. Additional information is not expected.
she tested positive for COVID Dec. 7, 2021 after receiving 2 doses back in June 2021.; she tested positive for COVID Dec. 7, 2021 after receiving 2 doses back in June 2021.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 13 year-old female patient received bnt162b2 (COMIRNATY), administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jun2021 (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Dec2021, outcome "unknown" and all described as "she tested positive for COVID Dec. 7, 2021 after receiving 2 doses back in June 2021.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Dec2021) positive. 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 50 year old male patient who is a police officer regarding himself. No medical history was reported. On an unknown date in late 1900 or early 2000, the patient was vaccinated with a dose of Hepatitis B (Recombinant)(manufacturer unknown) (lot #, expiry, dose, route not reported) and had a low titer of 2 or no titer. No concomitant medications were reported. Police officer believes he received a primary series for Hepatitis B (Recombinant) (manufacturer unknown), boosters doses and another set of the series. Police Office believed he received 3 complete sets of Hepatitis B (Recombinant)(manufacturer unknown). Police officer in order for the police department to pay for the Hepatitis B (Recombinant) (manufacturer unknown), the titers needed to be done to justify getting the vaccines if necessary. The outcome of low titer of 2 or no titer was unknown. This is 1 of 2 reports regarding the same patient. Additional information has been requested.
02/25/2021. After about 30 minutes, post vaccination I remember saying I feel fine at the moment. I had a momentary lapse of memory and woke up the next day with food in my bed. I do not recall anything between the time of 30 minutes post vaccination and to the time of waking up the next day. I had about 2 weeks of lapse of memory where I could not recall what was going on. I have not had any lapses of memory since then. Since having my vaccination, I have had COVID-19, I have begun to have lapses in memory again. I believe that the vaccine did not immunize me at all. After my second dose I lost work, my apartment, ability to feed my family. I can't get my job back, my family to understand, and that I am homeless now. I did seek medical care and went through CT scans, Blood tests, and MRIs.
short of breath; hypotension; This spontaneous case was reported by a physician and describes the occurrence of DYSPNOEA (short of breath) and HYPOTENSION (hypotension) 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 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (short of breath) and HYPOTENSION (hypotension). At the time of the report, DYSPNOEA (short of breath) and HYPOTENSION (hypotension) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug was not reported. Treatment medication included fluids.  It was reported that the reaction was severe and got better with fluids. It was reported after 24 hours of vaccination patient experienced hypotension and shortness of breath.
Felt sick; developed 102 degrees fever; This is a spontaneous report received from based on the information received  from a contactable reporter(s) (Consumer or other non-HCP). Other Case identifier(s): 2021SA337125.  A 58 -old female patient received bnt162b2 (BNT162B2), administration date 05Oct2021 (Batch/Lot number: unknown) 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), administration date: 01Sep2021, for COVID-19 immunization, reaction(s): "felt sick". The following information was reported: MALAISE (non-serious) with onset Oct2021, outcome "unknown", described as "Felt sick"; PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "developed 102 degrees fever". Relevant laboratory tests and procedures are available in the appropriate section.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a physician concerning a 5 year old male who was vaccinated with a dose of Varivax. Subsequently the patient broke out with chickenpox. Additional information has been requested. The patient's three brothers experienced chickenpox following vaccination with Varivax (WAES# 0605USA04858, 0606USA01457, 0606USA01458).
was given HRIG in one gluteal muscle, rabies vaccine is not recommended to be administered in the gluteal muscle; On 22 Jul 2019, the patient was given HRIG and in one gluteal muscle and rabies vaccine; Initial information received on 26-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a female patient of unknown age who was vaccinated with a dose of HUMAN RABIES IMMUNOGLOBULIN [HUMAN ANTIRABIES IMMUNOGLOBULIN] and RABIES VACCINE (lot number and exp. Date not reported) in the gluteal muscle on 22-Jul-2019  for animal bite as patient's rabies exposure consists of saliva exposure to mucus membrane (no wound).  The patient's medical history not reported.  It was an actual medication error case due to vaccine administered at inappropriate site and Extra dose administered.  It was reported that, the hospital then decided that the first dose of HRIG that was administered to the patient was invalid, for a reason that was not clear. It might have been that since rabies vaccine is not recommended to be administered in the gluteal muscle they thought that HRIG should not be administered in the gluteal muscle either, or since HRIG and rabies vaccine should be administered distant to one another that the two gluteal muscles were not distant enough. Hence as corrective on the same evening (22 Jul 2019) they administered a second dose of HRIG in the patient's left and right thighs.  It was unknown whether the patient experienced any adverse event post vaccination.  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.  Information on the batch number was requested.  List of documents held by sender: none.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY
Suspected vaccination failure; Has shingles 3 times since; Has shingles 3 times since; Has shingles 3 times since; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, shingles and shingles. On an unknown date, the outcome of the vaccination failure, shingles, shingles and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, shingles and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The was reported by the patient's friend. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles 3 times. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Male 41 year old complaining of feeling his heart racing. His stated feeling quizzy.
Information has been received from a 24 year old female, for the Pregnancy Registry for GARDASIL who on 16-DEC-2008 was vaccinated with a first dose of GARDASIL. On approximately 2-FEB-2009 was vaccinated with a second dose of GARDASIL intramuscularly o.5 ml and had a pregnancy test and found out that she was "about 2 weeks pregnant" at the time of the vaccination (The patient was 9 weeks and 3 days pregnant at the time of reporting, so the last menstrual date was estimated as on 19-JAN-2009 and the estimated delivery date was 25-OCT-2009). An ultrasound was done and "everything looked normal". On 16-FEB-2009, (also reported "about 2 weeks ago"), the patient was really sick and couldn't eat or keep anything down. She went to emergency room but was not admitted. This was diagnosed as "stomach virus". The patient recovered from stomach virus after 4 days. Additional information has been requested.
Beginning around 2:00 PM, patient complained of pain while walking on his leg. Around 3:00 PM, I checked his leg for swelling and it was significantly swollen from his groin to his knee, including his knee.  Very noticeable to the plain eye, but also the skin was hard when touched.  Patient had difficulty straightening his knee, causing him to walk with a pronounced limp. He also had a mild fever (99-100 F) for about 24 hours. The significant swelling from groin through knee, lasted for approximately 72 hours, as did the difficulty walking and straightening his knee.
Pt leg at site of injection was indurated, swollen, with erythema, no pain on palpation, but mild limping
Pt said a shingles like rash developed on forearm the ZOSTAVAX was given.
Parents described, at a subsequent visit, a prolonged rough quarter-sized round pink patch over the site x several weeks w/out other assoc. symptoms-to-date. Then self0resolved.
Left eye seems like worse as she got more problem with it (macular is worse); Left eye seems like worse as she got more problem with it (macular is worse); This is a spontaneous report from a non-contactable consumer (patient). An 81-year-old female patient received BNT162B2, via an unspecified route of administration on an unspecified date (Lot number was not reported) at unknown dose #, single for COVID-19 immunisation. Medical history included trouble swallowing pills, could not breathe, pain in stomach, nausea, bad sleeper, gas, high blood pressure (BP), irritable bowel syndrome, depression, constipation, sneezing, 2 miscarriages, fibroid tumor, piloidal cyst, and left eye problem (macular); all from an unknown date and unknown if ongoing. Concomitant medication included ranibizumab (LUCENTIS); losartan; amlodipine; citalopram; levothyroxine; dicyclomine; diflunisal (SENTA); ondansetron; trazodone; cyanocobalamin (VITAMIN B 12); ascorbic acid, bioflavonoids nos (VITAMIN C); simeticone (GAS-X); and unspecified vitamins for focus; all taken for an unspecified indication, start and stop date were not reported. The patient reported that left eye seems like worse as she got more problem with it (macular is worse) on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information on the lot number cannot be obtained. No further information is expected.
No adverse event reported; The patient was inadvertently administered a dose of PROQUAD that was expired; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   On 29-APR-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), lot # N029672 with expiration date 21-APR-2019, (dose, frequency and route of administration were not provided), for prophylaxis. No adverse event was reported. No further information was provided.
was preparing the Menveo vaccination and was unsure of how to properly prepare the vaccine and did not reconstitute the powder with the diluent so patient just ended up receiving the diluent AMXA764A no adverse reaction
Patient experienced a shingles outbreak after receiving the first dose of the shingrix vaccine. Patient reports " I have a new patchy erythematous rash on my neck, tender, not pruritic. Worried I have shingles again" and reports "That it?s acute in onset, tender, and not spreading beyond the dermatome."  Patient has no history of psoriasis or eczema.
Breakthrough case admission after 5 vaccines Pfizer 1/19/21 lot# EL1283;  Pfizer 2/9/21 lot# EL9265;  Pfizer 10/28/21 lot# FF2589;  Pfizer 4/1/22 lot# FJ6369;  Pfizer 10/6/22 lot# GJ2524
has a cold; runny nose; sneezing; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (has a cold), RHINORRHOEA (runny nose) and SNEEZING (sneezing) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Narcolepsy. Concomitant products included DOXAZOSIN for Blood pressure high, MODAFINIL for Narcolepsy, APIXABAN (ELIQUIS), ATORVASTATIN, SALBUTAMOL (ALBUTEROL HFA), CLOPIDOGREL BISULFATE (PLAVIX), DILTIAZEM, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL + HIDROCLOROTIAZIDA), ALENDRONATE SODIUM and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced RHINORRHOEA (runny nose) and SNEEZING (sneezing). On an unknown date, the patient experienced NASOPHARYNGITIS (has a cold). The patient was treated with CHLORPHENAMINE MALEATE, PARACETAMOL, PSEUDOEPHEDRINE SULFATE (CORICIDIN D COLD FLU AND SINUS) for Adverse event, at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (has a cold), RHINORRHOEA (runny nose) and SNEEZING (sneezing) outcome was unknown.