chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A 17-year-old female patient had received a right deltoid, intramuscular injection of Menactra, lot number U2367AA; and a left deltoid, intramuscular injection of Gardasil, manufacturer Merck, lot number G525U; on 15 August 2007. At an unspecified time post-vaccination, the patient experienced a localized injection site reaction (size not provided) to the right deltoid with a 1 cm. dimple that was oblong in shape. There was no skin breakdown or discomfort. At the time of this report, the patient had not recovered.
Same day:Tingly arm.  Metal taste in mouth. That night: very sore arm. Nausea started and dizzy spell at night.  Nausea lasted 2 days 3 weeks after shot: spotting about 6 days before period.   Heavy period with clots that came a few days early.
Patient developed fever, cough, nausea and vomiting at 4am the day after receiving her second Moderna injection.
10-16-14 - Baseball size whelp on L arm where shot administered, red, not and raised.
Fluvirin with thimerosal given to OB pt.  LMP: 07/24/2009.  EDC: 04/30/2009.  Pt does not have an OB/GYN.  Pt notified on 11/06/2009.  Denies any adverse effects.  Pt not hospitalized after receiving H1N1 vaccine. 11/19/2009 OB visit 10/26/2009, patient pregnant EDC 4/30/2009, no sx at this time
Pt recvd 1st hep B vax 22JAN91 & exp fever,nausea,chills & oily looking diarrhea w/goldish streaks(Metallic looking)& lethargy.
The pain started after the 2 shots of Covid vaccines were given to the left upper deltoid site. However, I thought it is expected reaction from the vaccine.  Gradually this person notices that the pain has not been removed or alleviated.  Even after 3 months from the 2nd Covid 19 vaccine (Moderna), moderate to intermittent severe muscle pulling pain in the left upper arm and/or shoulder area, unable to lift the left arm in the full range.
Bruises a bit lower on her injection site; The first little bruise, a little bump on most of her arm and hands; Headache; Trouble clearing her throat; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruises a bit lower on her injection site), OROPHARYNGEAL DISCOMFORT (Trouble clearing her throat), URTICARIA (The first little bruise, a little bump on most of her arm and hands) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Drug allergy (Allergic to sulfur.) since an unknown date.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OROPHARYNGEAL DISCOMFORT (Trouble clearing her throat). On 14-Apr-2021, the patient experienced VACCINATION SITE BRUISING (Bruises a bit lower on her injection site), URTICARIA (The first little bruise, a little bump on most of her arm and hands) and HEADACHE (Headache). At the time of the report, VACCINATION SITE BRUISING (Bruises a bit lower on her injection site), OROPHARYNGEAL DISCOMFORT (Trouble clearing her throat), URTICARIA (The first little bruise, a little bump on most of her arm and hands) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
significant decrease in libido, as in nearly nonexistent libido; This is a spontaneous report from a contactable pharmacist (patient) received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 21Feb2021, at 17:00 (Lot Number: EN6198; at the age of 28 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. The patient took Chinese herbs from acupuncturist within two weeks of vaccination. He did not receive any other vaccines within four weeks prior to vaccination. The patient previously received the first dose of BNT162B2, administered in the left arm on 24Jan2021, at 13:15 (Lot Number: EL9262; at the age of 28 years old) for COVID-19 immunisation. On 22Feb2021, the patient experienced noticeably significant decrease in libido, as in nearly nonexistent libido. Began day after dose 2 of vaccine was administered. Noticed 48 hours after receiving vaccine. Has not reversed in 96+ hours. The patient was not diagnosed with COVID-19 prior to vaccination, and he has not been tested for COVID-19 since the vaccination. No therapeutic measures were taken as a result of the event. The patient has not recovered from the event.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021233930 same reporter, same suspect product, similar event
Left shoulder/arm started with pain and progressively got worse to the point of almost no use of arm w/out severe pain. Waited one week and made a Dr. apt. Look more like a nerve may have been hit. No really much progress as of today 6-11-2010 been on MOBIC since 6-3 notified Dr office today - 6-11-2010.
Headache; Bad dreams; Nausea; Lethargy; Feel crappy; Like an endless hangover; Brain still foggy; fever.; Chills; sick; This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular on 05Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history included non-smoker. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unknown date for covid-19 immunisation. The patient received 2nd vaccine last Monday on 05Apr2021. His fever and chills on Wednesday on 07Apr2021 were off the charts. Have not felt that sick in 10-plus years. It is Sunday on 11Apr2021, the patient still feels crappy. Like an endless hangover. Foggy headed. Never clears. Day 7 since 2nd vaccine on 12Apr2021, still foggy. Nausea. Lethargy. Ugh. Subsequently on 13Apr2021, the patient reported, day 8, brain still foggy. Headaches. Bad dreams. Lethargy, nausea, in a fog continues 8 days after vaccination. The patient is a fit male, exercise every day. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
15mins post vaccination pt c/o vomiting and flushing/sweating. Vitals: 112/67, 60, 12. Pt given water and monitored. VSS Pt stable and released from the vaccination site.
Vomiting x 5 days after immunization received. No fever and only occurred after eating. Mother got antrimetic med from pharmacy.
near complete paraplegia; Transverse Myelitis; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 37 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Jan2022 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (unknown dose number; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PARAPLEGIA (hospitalization, medically significant) with onset 20Jan2022, outcome "unknown", described as "near complete paraplegia"; MYELITIS TRANSVERSE (hospitalization, medically significant) with onset 20Jan2022, outcome "unknown", described as "Transverse Myelitis". The patient was hospitalized for paraplegia, myelitis transverse (start date: 20Jan2022). The events "near complete paraplegia" and "transverse myelitis" were evaluated at the emergency room visit. The clinical course was reported as follows: the patient awoke with near complete paraplegia on morning of 20Jan2022. He ended up being seen at a local ER and was admitted to the hospital with diagnosis of Transverse Myelitis during the evening of 20Jan2022 by the reporting physician. Additional information: it was felt that the event may have been related to the Pfizer COMIRNATY booster shot given the previous day. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: A contributory role of suspect drug  in causing the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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 classic varicella rash approximately 24 hours after receiving vaccination. No known history of prior exposures. Seen at Medical Center 48 hours after vaccination for diagnosis. Plan for supportive care and given acyclovir course due to past medical history of eczema.
slight pain (minimal) down in both of her legs; I just got the pain from the vaccine; I had like slight nerve pain that my leg suffered the first time; I could barely walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (Lot number: EN6204) at the age of 61 years 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: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "slight pain (minimal) down in both of her legs"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "I just got the pain from the vaccine"; NEURALGIA (non-serious) with onset 2021, outcome "unknown", described as "I had like slight nerve pain that my leg suffered the first time"; GAIT INABILITY (non-serious) with onset 2021, outcome "unknown", described as "I could barely walk". Therapeutic measures were taken as a result of pain. Additional information: Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 27Mar2021 and she experienced a slight pain (minimal) down in both of her legs. Then she received the second dose on 17Apr20I just got the pain from the vaccine 21 and the next day she started experiencing a severe pain down her both legs and the pain has not gone away, she also had back pain but it's a little bit better, during the call she mentioned that she didn't have muscle or joint pain, that she had nerve pain. She has gone to many doctors, her life is affected negatively, she said that they should care people better. She would like to know why is she experiencing this pain. Patient have been talking Advil and Tylenol almost every single day. Patient think she just skipped 2 days when she do not have to do too much."  No follow-up attempts are possible. No further information is expected.
Initially - sore throat. Varicella blisters developed in throat and on roof of mouth. Throat tissue swollen, airway constricted. Sore neck. Headache - particularly behind eyes. Excess mucous. Patient reports active Chickenpox 1959, with intermittent outbreaks of HSV1 on lips after prolonged stress. ZOSTAVAX approximately 2014. SHINGRIX #1 ~Sep 2018. Reported symptoms continue, 10 days after vaccination. Typical HSV1 symptoms resolve within 2-3 days.
Customer felt dizzy with blurred vision after administration of COVID-19 shot. She was given some water, helped to a sitting position on the floor and Paramedics called. After about one hour she informed Paramedics that she was fine. Customer was advised to call with any other symptoms.
had covid 2nd vaccine on 12/14. mild rxn w/  mild fever 24hrs later approx that self resolved since this morning pt complained of chest pain, feeling cold and hot, feeling tingly all over.  parents and pt reports sinus arrythmia when it happened but pt states her heart beat was the same if she held her breath in sxs since resolved
dizzy, nauseated, pale, then circumoral cyanosis LOC (approx 2 minutes); pupils dilated; emergency squad here med given IV gluids given blood drawn; alert-taken to ER:
Pain all over the body; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain all over the body) and HEADACHE (Headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included Bursitis and Allergic reaction to analgesics since an unknown date. Concurrent medical conditions included Arthritis. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PAIN (Pain all over the body) and HEADACHE (Headache). At the time of the report, PAIN (Pain all over the body) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Body temperature: 99.8 (High) 99.8.         No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Information has been received from a nurse concerning a 4 year old child who, over the past month, in approximately July 2006, was vaccinated with MMRII. Concomitant therapy included Pediarix. Unspecified medical attention was sought. About 2 days after injection, in approximately July 2006, the patient experienced cellulitis at the injection site. About five days after injection, in approximately July 2006, the patient recovered. The reporting nurse also reported the experience of 4 other patients with MMR II (WAES# 0609USA00641, 0609USA00642, 0609USA00643, 0609USA00644). Additional information has been requested.
Patient, 34-year-old female, arrived to the vaccine clinic nervous and was received by registration. Patient then proceeded to the vaccinations area and the team noticed nervous and she mentioned she was scared and nervous when siting down to receive her first Moderna vaccine at 5:24pm. She stood up and walked to the exit table and mentioned she needed to sit down as she felt lightheaded. After 10 seconds she walked out to the observation area, then came back in complaining about dizziness. As we were approaching to sit her down, she had a nursincuple episode, so we assisted her to the ground. It took her a couple of minutes to be able to fully open her eyes, but she was responsive, no acute shortness of breath and she had pulpable pulses in the low 70s, at the time it was a bit clammy to bilateral upper extremities. As symptoms recovered, she continued to have slight headache, complaining of bilateral paresthesia to the hands and we tried to slow down her breathing, but respiratory rate was in the 20s. After a few minutes we attempted to sit her up while she was still on the ground and gave her some water, she became lightheaded again, a little bit nauseated again and felt like she needed to lay down, so she did. We waited another several minutes and she stared to feel improved, still having a little bit of paresthesia bilateral hands and we sat her up a second time and got her into a chair. Her husband arrived, as she had arrived by herself and developed lightheadedness, recurring nausea again and generalized weakness, so we placed her back to the ground and felt like her symptoms were not improving but not necessary getting worse. At that time, we called 911, EMS arrived at 6:10pm and did an evaluation and blood pressure was normal, 140s/x, heart rates were in the 80 but continued to have lightheaded and generalized weakness. EMS did orthostatics on her and assessment on her and did not feel like she was not having a severe allergic reaction to the vaccine. Patient opted to go home versus transported to the hospital. Continued to have some generalized weakness and lightheadedness. Departed at 6:30pm. No medical history and not on medications at all, ate today and drinks lot of fluids.
vaccinated with 5 ml of expired Pentacel in the right thigh; Initial information received on 12-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.   This case involves a 12 months old female patient who received an expired 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot C5463AA (Expiry date 26-Jul-2018) via unknown route in the right thigh on 10-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); HEPATITIS A VACCINE (HEPATITIS A) and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE).  It was a case of actual medication error due to expired vaccine used.  At a time of reporting 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.  List of documents held by sender: none.
This spontaneous report as received from a 50 years old female healthcare worker with no pertinent medical history or drug reactions refers to herself. The patient was vaccinated SC into left arm with 0.65 ml ZOSTAVAX (lot number not reported) on 21-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 22-AUG-2012 the patient developed a red, raised, hot area the size of a half dollar, on her left arm, at the injection site. She also stated that her left arm became swollen from her shoulder to her elbow. The healthcare worker stated that she also experienced a headache, tingling in her mouth, face and tongue, diarrhea, a bladder infection and hives (the caller stated that this was not a rash, per her physician, but hives) after receiving ZOSTAVAX. The patient had taken phone call and office visit to physician and was treated with MEDROL, CIPRO and PYRIDIUM. The outcome of the patient was reported as recovering/resolving. Additional information has been requested.
Vaccine wasn't good on my body, I am not feeling fine at all; My left hand was swollen and was black in color, I have been going through a series of pain; My whole body is being disorganized; It is making me restless; My left hand was swollen and was black in color, I have been going through a series of pain; My left hand was swollen and was black in color, I have been going through a series of pain; This is a spontaneous report from a contactable consumer or other Non-health care professional (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: 704AZ1A), via an unspecified route of administration, administered in left arm on 12May2021 (age at vaccination was 63 years) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date after taking the vaccination the patient experienced that vaccine wasn't good on her body, as she did not feel fine at all and it even' bought her to the hospital, and medication was given to side effect. She was not feeling fine at all. She reported that since I got it, I have not been myself, my skin on the left hand, and her left hand was swollen and was black in color, she did not know, it seemed to black. Had been going through a series of pain, she was not getting any 'relief' at all, went to the hospital and they gave her 'Naproxen'. She inquired about the when the medicine gets off her body her whole system as her body was being disorganized. She did not feel okay with this. So, she was inquired to reduce the effect on my body, it was making her restless. The event wasn't good on her body, as she did not feel fine was serious hospitalization and other events were Unspecified. The patient received treatment for the event pain. It was reported that patient don't want to get another injection, just the medication that will reduce the pain, that remove the one that she already have one in her body already, that's what she am looking for. The outcome of the events was peripheral swelling, skin discoloration was unknown and other events was not recovered.  Follow-up attempts are completed. No further information is expected.
pt recvd vax & 24 hrs p/vax exp itching, fever, lethargy, & rash; tx DPH & resolved in 2 days;
Vaccine administered was diluted w amount of diluent smaller than recommended resulting in a higher concentration of vaccine administered.
Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concomitant products included DILTIAZEM HYDROCHLORIDE (CARTIA [DILTIAZEM HYDROCHLORIDE]), METFORMIN, METOPROLOL, DILTIAZEM and LOVASTATIN for an unknown indication.    On 20-Apr-2022 at 11:25 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022 at 11:25 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not had any allergies to food or medications.  Total number of doses/vials was 36.  Vial did not undergo any temperature excursions. Patient not experienced any side effects yet.   No treatment information was provided.