chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cold; Runny nose; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program .  An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Feb2021 (lot number and expiry date: unknown) at the age of 80-years-old, as dose 1, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 27Feb2021, the patient experienced cold and runny nose. Outcome of the events was unknown. Patient wanted to know if she could take the 2nd dose on 03Mar2021.  No follow-up attempts are possible. Information on lot/batch number could not be requested. No further information is expected.
myocarditis; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) and COVID-19 (COVID-19) outcome was unknown.            Concomitant medication was not provided.  On 31-AUG-2022 patient had COVID-19, it was simple, did not have much symptoms.  Treatment medication was not provided.  Company comment- This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced expected, serious (medically significant) AESI Myocarditis, which occurred at an unknown time with regards to vaccination with a third dose mRNA-1273. No further information was reported. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced expected, serious (medically significant) AESI Myocarditis, which occurred at an unknown time with regards to vaccination with a third dose mRNA-1273. No further information was reported. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Vaccine given as IM in left deltoid on 2/12/18. This is the 3rd in the rabies series. Client reports redness, warmth, and hard area where vaccine was given. No fever, no nausea, no vomiting. No streaking or exudate at injection site.
sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 071F21A and 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Hives from other sources.) and Iodine contrast media allergy (Hives from Iodine contrast dyes.).   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2022-546931, MOD-2022-546786, MOD-2022-546924, MOD-2022-546503 (Patient Link).
I developed fever and chills and headach for 2 nights now  my fever was a 102.3 lasted at least 6-8 hours  had Pfizer-bioNTech COVID-19vaccine
Patient had never received covid-19 vaccines before, and received Pfizer bivalent booster  vaccine.
got Covid once after receiving my [Pfizer] initial shots; got Covid once after receiving my [Pfizer] initial shots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient received 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 "got Covid once after receiving my [Pfizer] initial shots". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result.  Clinical course: She thought it was targeted towards everyone, which was sketchy to her because she thought that only people at risk of serious illness should be getting boosted. She was a healthy person who got Covid once after receiving her [Pfizer] initial shots and once again after receiving a [Pfizer] booster. She would not have got the booster if she had not been required by her university.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201382415 Same patient/event, different vaccine dose;
Soreness/ pain at injection site, redness, hard lump, nausea. reporting this pain 48 hrs after injection. Please call Dr. for exact vaccine info. Tetanus and whooping cough in one shot.
Information has been received from a physician concerning a patient who was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Subsequently, bloodwork results recorded a low white blood cell count. Additional information has been requested.
Congestion and partial hearing loss for 4 days in left ear starting the morning of 3/28/21; increased congestion and hearing loss in left ear evening of 3/30/21; vertigo the morning of 3/31/21 resolving mid afternoon; improvement in congestion and hearing of the left ear the evening of 3/31/21; tinnitus and congestion in right ear 4/3/21; congestion resolved a week later; tinnitus in right ear since 4/3/21. Doctor prescribed short course of methylprednisolone, 4mg pills. No improvement in tinnitus.
pt recvd vax & devel a rash mac pap; lowgrade fever & coryza conjunctivities; cough; ear infect;
pt states that a couple of days after having the vaccine she starting getting a waive of exhaustion that causing her become very weak and she has to rest until it subsides.  The waive of exhaustion comes and goes which makes her feel like she did when she had covid.  She says she has gotten the flu shot for over 20 years and has never had a reaction from a flu vaccine before.  She feels like the waives of exhaustion is getting some better as she is not having it as often but she is not herself.
15 year old female patient inadvertently administered Flublok Quadrivalent rather than Fluzone Quadrivalent, no AE; 15 year old female patient inadvertently administered Flublok Quadrivalent, no AE; Initial information received on 02-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 15 year old female patient who inadvertently administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered and Product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.   No other vaccines were administered concomitantly.  On 01-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ446AA and expiry date: 18-Mar-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong product administered and product administered to patient of inappropriate age (latency on same day).  At the time of report 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.
lt arm swelling, erythema, induration, warm to touch; circ of lt arm 19.4cm, circ of rt arm 17.8cm; treated for infect Duricef
Information has been received from a medical assistant concerning a 12 month old female patient with no known drug allergies or pertinent medical history who on 20-APR-2010, was subcutaneously vaccinated in the left upper arm with a 0.5 mL dose of VARIVAX (Merck) (Lot# 666044/1428Y). Secondary suspect vaccination included VAQTA (MSD). Concomitant vaccination included PREVNAR. Subsequently, on approximately 20-APR-2010, the patient experienced red, raised areas "the size of a silver dollar" at the injection site of the left upper arm. On 30-APR-2010, the patient had an office exam. There were no lab tests performed. It was unknown if the patient required medical treatment. At the time of the report, the patient outcome was unspecified. Additional information has been requested. This is one of several cases reported by the same source.
Arm was so sore; Never reacted so poorly to any shot in my life; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20-JUN-2023, the patient received the 2nd dose of Shingles vaccine. In JUN-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm was so sore) and feels poorly (Verbatim: Never reacted so poorly to any shot in my life). The outcome of the pain in arm and feels poorly were not reported.   It was unknown if the reporter considered the pain in arm and feels poorly to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and feels poorly to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-Jun-23 This case was reported by a patient via interactive digital media. The patient stated she/he just had my second shot Tuesday, and his/her arm was so sore.  Patient reported that she/he never reacted so poorly to any shot in his/her life.
Early cellulitis - Omnicef 125 mg/5ml 6 ml daily for 10 days (Treated on 7-14-07)
2 weeks after second shot I have had the following: hypertension, lower extremity swelling, loss of my mucus plug and increased/possible abnormal discharge. I have been seen in emergency department 3 times. I am just shy of 32 weeks pregnant
Cellulitis at injection site-redness, 3 inch induration, pain, fever.
Experienced an "electrical fire or electric jolt" in the left shoulder to upper left quadrant of his chest; Feeling lasted about 6 hours, which was how long the achiness feeling lasted.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 19-year-old male patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ELECTRIC SHOCK SENSATION (non-serious), outcome "recovered", described as "Experienced an "electrical fire or electric jolt" in the left shoulder to upper left quadrant of his chest"; PAIN (non-serious), outcome "recovered", described as "Feeling lasted about 6 hours, which was how long the achiness feeling lasted.".  Additional information: Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200105161 same reporter/AE/SD, different patient;
reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.   On 19-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis.   The administered vaccine underwent a temperature excursion below 2 degrees Celsius (°C) of -40.0 °C for a time frame of 15 minutes; and an excursion above 8°C of 9.6 °C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported.   This is one of several cases, from the same reporter.  combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026167; expirationdate: 04-DEC-2022; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Itching and hives 3-4 hours post injection.  Pt self tx'd with Benadryl BID. Nasal congestion and Left earache.  Hives resolved after 24hours.  Itching continues intermittently at time of reporting as will as nasal congestion.
Covid test result Positive; Covid test result Positive; Steadily increasing headache; Muscle ache; weakness; feverish; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCCINE; Lot Number: UNKNOWN- reported as misplace/discarded), dose 1 via an unspecified route of administration, administered in left arm (at the age of 40 years) on 21Dec2020 at 12:15 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. There was no patient medical history. The patient had no known allergies to medications, food, or other products. There were no concomitant medications (no medications within 2 weeks prior to vaccination). The patient did not received any other vaccine within 4 weeks prior to the COVID-19 vaccine. On 21Dec2020 at 14:30, 2.5 hours after the vaccine, the patient had steadily increasing headache, muscle ache, weakness and feverish. He took 250mg Tylenol. At 5.5 hours after the vaccine, his headache was so severe that he went to the Emergency Department of the facility he works in. Treatment for the adverse event included 1gram Tylenol, IV with saline and another drug (unspecified). The patient did not have COVID-19 prior to vaccination. On 24Mar2021, post vaccination, he was tested for COVID-19 via nasal swab with a positive result. The outcome of headache, muscle ache, weakness and feverish was recovered. The outcome of COVID-19 was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Soreness on arm; Redness on arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Apr-2021 and was forwarded to Moderna on 25-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness on arm) and ERYTHEMA (Redness on arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced MYALGIA (Soreness on arm) and ERYTHEMA (Redness on arm). At the time of the report, MYALGIA (Soreness on arm) and ERYTHEMA (Redness on arm) outcome was unknown.            No concomitant medications were provided. No treatment drugs were reported.   Reporter did not allow further contact
The vaccine was administered to a patient outside of the age indication.  Patient was 17 yrs old at the time of vaccination.  No adverse events noted.
Low fever, red swollen painful arm at injection site, nausea, unable to lift arm laterally from body without extreme pain. Hives on neck and middle torso started 7/23, and 7/24, knotted lump with extreme itching at injection site.
Redness, swelling, itching at and near the injection site.  Area is approximately 4" x 2".
Injection site pain; headache; muscle pain; Joint pain; chills; fever (100.9-103.6); feeling very unwell.; first dose was given on 04Jan2021 and the second was on 21Jan2021; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: GL3302, expiration date was not reported), via an unspecified route of administration on 21Jan2021 09:00 at a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included vilazodone hydrochloride (VIIBRYD), quetiapine, and mirtazapine (MIRTAZEPINE TEVA). She was not pregnant. She had no known allergies. Historical vaccine included first dose of PFIZER BIONTECH COVID 19 VACCINE (lot number: EJ1685) on 04Jan2021 in the left arm when the patient was 31-years old for COVID-19 immunization. The patient had no any other vaccine in four weeks prior covid vaccine. The patient had no covid prior vaccination. She was not tested for covid post vaccination. The patient experienced injection site pain, headache, muscle pain, joint pain, chills, fever (100.9- 103.6), and feeling very unwell, all on 21Jan2021 10:00 PM with outcome of recovered on an unknown date in 2021. It was reported that the first dose was given on 04Jan2021 and the second was on 21Jan2021. No treatment received for the events.
Abdominal pain and discomfort (pain level 0-10=10) nausea and vomiting. Calling doctor for advice.
Seven and half hours (noon to 7:30pm) after receiving the vaccine shot, I had an overwhelming feeling of needing to vomit. I dry-heaved for about 10 minutes, then immediately got pins and needles throughout my entire body and I almost passed out. I then proceeded to shake uncontrollably, as if I had convulsions, to the point I almost went to the emergency room. While I was shaking, my hands cramped into a weird position to where I couldn't move them at all and my husband tried to massage them but they would not budge. I was stuck like that for almost an entire hour. Around 11:00pm that night, I took my temperature and had a 102 fever. The fever stayed for a day and a half, and my skin felt like it was on fire wherever clothing rubbed it. I had to take two days off of work. Since then, I have felt extremely depressed, like I am in a funk that I can't get out of. The depression is affecting my home life.
At time of the vaccine: I experienced a tingling/numbing sensation down my left arm into my left hand and fingers.  Approximately 18 hours after the vaccine: I experienced chills, elevated temperature (99 to 100 degrees F), headaches, fatigue. Approximately 42 hours after the vaccine: the chills, elevated temp, headaches, and fatigue were gone, but I had a armpit aching on the left side. The armpit ache faded over the next 24 hours.  Today is 7 days post vaccine and I still have periodic tingling/numbing/cool sensation on the pinky and ring fingers on my left hand.
Was diagnosed with Bells Palsy 6 months to the day of the vaccine being given,. Was diagnosed 10 weeks after that with Ramsey Hunt..
Tremors throughout his body; Weak after the fever; sicker than the first; Dizziness; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (Tremors throughout his body) and ASTHENIA (Weak after the fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction. Concomitant products included METOPROLOL and ATENOLOL for an unknown indication.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced TREMOR (Tremors throughout his body) (seriousness criterion medically significant), ASTHENIA (Weak after the fever) (seriousness criterion medically significant), ILLNESS (sicker than the first), DIZZINESS (Dizziness) and PYREXIA (Fever). At the time of the report, TREMOR (Tremors throughout his body), ASTHENIA (Weak after the fever), ILLNESS (sicker than the first), DIZZINESS (Dizziness) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment provided included Tylenol.  This case concerns a 65-year-old male with PMH of COVID-19, had serious unexpected events of asthenia and tremor, and nonserious unexpected dizziness, illness, and expected pyrexia. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded   This case was linked to MOD-2021-059569 (Patient Link).; Sender's Comments: This case concerns a 65-year-old male with PMH of COVID-19, had serious unexpected events of asthenia and tremor, and nonserious unexpected dizziness, illness, and expected pyrexia. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Sudden onset fatigue (total exhaustion) became nauseated & vomited 1 time. Mother states weakness/ exhaust for 4 days. Mother states PO (ASA) take after every shots (no other) treatment noted. Mother fully resolved without distress/ discomfort.
NauseaVomiting injection site pain Narrative: Per nursing report: "received his 2nd dose of the Moderna vaccine on 8/24/21. Employee complains of adverse effects of injection site pain and nausea."
pt had hives one on each arm under both eyes & lt under arm;pt stated that hives itch;pt devel urticaria-30min p/vax which responded to DPH;