chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid arm. Site redness has spread over the ninth day after the shot. Itchiness, redness, swelling, hard.  Also swollen lymph nodes in left armpit
I had an eye event which was later diagnosed as an optical migraine.  One half of my vision was filled with colorful geometric shapes.  I also saw large black "blobs" floating through my vision for a while.   It lasted for about 1 hour and then gradually cleared up with only black specs recurring.
11/14/2015: 106 degrees F fever, red swollen throat, anorexia, constipation - 11/19/15.
shortness of breath, erythema to forearms, itching to palmar surfaces and perioral Tx:  50mg diphenhydramine IM, transfer to ED, predisone, solu-medrol, & Pepcid IV Discharged to home with instructions to return if sxs recur
11-17-07, 7:00 pm became light headed, chills and shortness of breath.  Took some hot tea and spoke with MD on phone.  Then became better in a few hours.
This spontaneous report as received from a pharmacist refers to a 31 year old patient of unknown age and gender. On 23-NOV-2015, 31 year old patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneously (lot# L027321 and expiry date: 21-OCT-2016). No adverse effects were reported. Additional information has been requested.
I feel like sick; I have like cough/ cough and the phlegm; I have like cough/ cough and the phlegm; I have like sore throat; Runny nose; I have this symptoms in my face, I feel that my face is numb; My body is weak; Pain in my back; Body is sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 27Jan2022 (Lot number: FJ5682) 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: ILLNESS (non-serious) with onset Feb2022, outcome "recovered", described as "I feel like sick"; COUGH (non-serious), PRODUCTIVE COUGH (non-serious) all with onset Feb2022, outcome "recovered" and all described as "I have like cough/ cough and the phlegm"; OROPHARYNGEAL PAIN (non-serious) with onset Feb2022, outcome "recovered", described as "I have like sore throat"; RHINORRHOEA (non-serious) with onset Feb2022, outcome "recovered", described as "Runny nose"; HYPOAESTHESIA (non-serious) with onset Feb2022, outcome "recovered", described as "I have this symptoms in my face, I feel that my face is numb"; ASTHENIA (non-serious) with onset Feb2022, outcome "recovered", described as "My body is weak"; BACK PAIN (non-serious) with onset Feb2022, outcome "recovered", described as "Pain in my back"; PAIN (non-serious) with onset Feb2022, outcome "recovered", described as "Body is sore".  No follow-up attempts are possible. No further information is expected.
Off and  on headaches since receiving the 2nd dose. Pt says that he got sick the day after and headaches have been going on since then
1410:Pt c/o nausea and dizzyness 9/10. BP:86/57, P:66, T: 96.5, Spo2:96.5% RA. Hx: Hypothyroid, DM.Pt instructed to hydrate. 1422: Pt reported feeling better, 3/10. 1433: BP: 104/71, P: 87, T: 96.6, Spo2 100% RA. 1437: Pt released and instructed to notify PCP for persistent and/or worsening of symptoms.
Seizures; Swelling in left arm where she got the vaccine; A spontaneous report was received from a pharmacist concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced seizures and swelling in left arm where she got the vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (batch number: 044A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12 Mar 2021, the patient experienced swelling in left arm where she got the vaccine. On 15 Mar 2021, the patient had medically significant event of seizures and was hospitalized for less than 24 hours. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the event swelling in left arm where she got the vaccine was resolved on 12 Mar 2021. The outcome of the event seizure was resolved on 15 Mar 2021.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273 and the start date of the reported events and excluding any other etiology, a causal relationship with the events cannot be excluded. Injection site swelling is consistent with the safety profile of the product
OFF LABEL DOSING FREQUENCY; This spontaneous report received from a consumer concerned a male of race (other), unspecified age, and ethnic origin. The patient's height, and weight were not reported. The patient was a naturopathic doctor. The patient was previously vaccinated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, 01 total administered on 01-MAY-2021 for covid-19 prophylaxis.  It was unknown whether the patient experienced any adverse events following vaccination with covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient received first booster dose of covid-19 vaccine ad26. cov2. s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194 expiry: UNKNOWN) dose was not reported, 01 total administered on 05-NOV-2021 for covid-19 prophylaxis.  It was unknown whether the patient experienced any adverse events following vaccination with covid-19 vaccine ad26. cov2. s (Dose number in series 2). The patient additionally received second booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin not reported, batch number: 213D21A expiry: UNKNOWN) dose was not reported, 01 total administered on 13-MAY-2022 for covid-19 prophylaxis which was an off label dosing frequency (Off label use) (Dose number in series 3). The consumer reported as they believe that the JANSSEN COVID-19 VACCINE is excellent and the patient has been covid free. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious. This case, from the same reporter is linked to 20230138182.
Patient followed up with OB-GYN on 1/18/2018 after delivery. Patient had been administered an MMR vaccination on 1/6/2018. Had bruising and a "nodule" located at injection site that was not resolving. Documented is a 15 cm x 7 cm yellowish bruised area with a quarter sized palpable lump within noted bruising area. Patient reported minimal resolution within the 12 days since discharge.
This event applies to three separate people - same event,  same description.  Two occurred on 5.7.21, one occurred on 5.5.21, different staff members involved.    Other individuals: DOB: 10.16.2002 AND (name) DOB: 11.5.1995 .  Same immunization, same manufacturer, same lot number. "Vaccinator was giving the patient him/her second dose of the vaccine and said the plunger of the syringe malfunctioned and the needle retracted into the syringe before the entire dose was given. this resulted in vaccine spilling out onto the outside of the patient's arm. vaccinator was informed by team lead to give the patient another dose in order to be sure pt receives the entire dose, per CDC guidelines. a full dose was then given without malfunction. VanishPoint syringes was used. "
This spontaneous case, received on 15-Oct-2018 from a pharmacist (initial and follow-up 1 combinedly processed), concerns a 52-year-old, adult male patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56F for 8 hours following a power outage (explicitly coded as incorrect product storage). On 14-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019) which was stored inappropriately (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious. This case 201804550 was cross-linked to source case: 201804533 due to same reporter.
Muscle aches, cramps, paresthesia in extremities  and feeling of joint stiffness starting at 3 days after vaccination and continuing intermittently even after 1 week from vaccination.  Aches/cramps in the muscles of neck, back of thigh, butt, calves, lower back.   Treated with heat pack and hot showers with some temporary relief.  No response to acetaminophen.
Patient received first dose as an eleven year old.  Patient received second dose at 21 days after first dose.  Patient had turned twelve years old.  Received second dose on Dec. 3rd and turned twelve on Dec. 1st. No reaction from underaged dose.
no additional AEs; CMA called to report TE from 2/22/23 and states that 4 doses of PROQUAD were administered prior to stability evaluation on 3/2/23; This non-valid spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown ages and genders. Information about the patients' pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies was not provided.  On 22-FEB-2023, the patients were vaccinated with improperly stored doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (once, 0.5 mL, lot number: W034977 has been verified to be a non-valid lot number, expiration date: 05-MAY-2024, routes of administration and anatomical locations were not provided) for prophylaxis (product storage error).   On 22-FEB-2023, the vaccines experienced a temperature excursion from -14 to -10 (-13.6) degrees Celsius for 21 minutes. It was stated that 4 doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were administered prior to stabilty evaluation. There were no reported previous temperature excursions. No additional adverse events (AEs) or product quality complaints (PQC) were reported (no adverse event). No further information was provided. The outcome of product storage error and no adverse event was unknown.   This case is non-valid due to an unknown number of patients and lack of patients' identifiers.   Follow-up information has been received from a medical assistant on 16-MAR-2023  The patient was a 12-months female, who had a birth weight 6lbs  9.3 oz, without brothers or sisters.  On 27-FEB-2023, the patient was vaccinated with improper storage vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # W028568 has been verified to be valid lot, expiration date 06-MAR-2024), subcutaneously in right  thigh (product storage error). The outcome was informed as recovered.  The reporter considered the event to be attributable to the suspect vaccine, and important medical event (medically significant).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA000873:
Soreness/Pain at insertion site much less after 48 hours ....I felt numbness to face (like when you take pain pills and that aura type feeling to face) ...lasted  about 30minutes
5 days after receiving flu vaccine pt presented to ED with facial droop, not able to wink eye or chew on left side. Lyme test neg. Pt was given MEDROL dospak and VALTREX symptoms resolved.
Rotarix expired dose was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-week-old female patient who received Rota (Rotarix lyophilized formulation) (batch number AB445, expiry date 16th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 18th July 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 18th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:18-JUL-2022 Reporter's Comments: The patient was administered with expired dose Rotarix. The reporter consent to follow up. Additional Supportive Information: The patient received expired dose of Rotarix, which led to expired vaccine used.
About 10-15mins after injection pt c/o 'feeling off', she went on to describe feeling a cold sensation go throughout her body and then felt her heart racing, denied SOB, but did state that her tongue might feel thick but then that it went away quickly, pt was very anxious at the time.  HR briefly went up to 90's but returned to her normal 70's, BP 130/80 and 120/75.  All vitals remained stable.  After about 45 mins pt stated she felt ready to go home, after walking with her and monitoring pulse and O2 sats, which were normal.  As pt was putting her coat on she had another wave of coldness go through her and heart rate went back up.  Pt sat down and pt started clearing throat and slight cough.  Pt was taken to the Emergency Department for treatment at that time.  Pt given Benadryl and some Solumedrol and discharged with Rx for prednisone.  On 1/4/2020 pt completed course of prednisone and on 1/5/2020 pt's symptoms returned and pt saw her PCP for treatment.
Severe migraines behind left eye, radiating throughout skull; Severe migraines behind left eye, radiating throughout skull; Sharp shooting chest pains; Swollen left eyelid, red itchy; Swollen left eyelid, red itchy; Swollen left eyelid, red itchy; skin peeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 08:00 (Lot number: fg3527) at the age of 32 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: fg3527, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 05Nov2021, when the patient was 32 years old, for Covid-19 immunization. The following information was reported: MIGRAINE (non-serious), PAIN (non-serious) all with onset 28Nov2021, outcome "not recovered" and all described as "Severe migraines behind left eye, radiating throughout skull"; CHEST PAIN (non-serious) with onset 28Nov2021, outcome "not recovered", described as "Sharp shooting chest pains"; SWELLING OF EYELID (non-serious), OCULAR HYPERAEMIA (non-serious), PRURITUS (non-serious) all with onset 28Nov2021, outcome "not recovered" and all described as "Swollen left eyelid, red itchy"; SKIN EXFOLIATION (non-serious) with onset 28Nov2021, outcome "not recovered", described as "skin peeling". The events "severe migraines behind left eye, radiating throughout skull", "severe migraines behind left eye, radiating throughout skull", "sharp shooting chest pains", "swollen left eyelid, red itchy", "swollen left eyelid, red itchy", "swollen left eyelid, red itchy" and "skin peeling" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of migraine, pain, chest pain, swelling of eyelid, ocular hyperaemia, pruritus, skin exfoliation. Additional information: Patient had no known allergies and no other medical history. Patient had no other vaccine in four weeks. And had no other medications in two weeks.  Patient had no COVID prior vaccination and was not COVID tested post vaccination.
First got hives (next day) that night leg and arm and hand cramps 3 and 4th days, extremes hand and joint cramps, swelling of extremities. Numbness in fingers and hands tingling in fingers still after 1 week.
pt recv vax 20DEC95 & 4DEC97 pt devel a mild case of chickenpox w/some vesicles on the chest back & arm;pt was afeb & recovered w/in 6 days;
The injection itself was much more painful than the other two doses and my shoulder became very sore within a few hours. By 5:00 pm I was unable to lift my arm at the shoulder. Pain became worse throughout the night and into the next day.
First vaccine was received while menstruating, menstruation lasted for 5 days past normal; This is a spontaneous report from a contactable consumer (patient). A 26-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EP7534), via an unspecified route of administration, administered in Arm Left on 17Mar2021 at 10:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history reported as None. There were no concomitant medications reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. No allergies to medications, food, or other products. On an unspecified date in Mar2021, the patient experienced first vaccine was received while menstruating, menstruation lasted for 5 days past normal. No treatment received for the adverse event. The outcome of event was recovered on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Within 15 minutes arm was sore, headache, within 3 hours extreme fatigue, headache, nausea, chills, left ear pain, left pain in jaw area  near left ear the gland on left side of neck lasted until 4/24/2021; 4/30/2021 Left arm soreness, swelling, muscle cramp in left arm, 5/01/2021 Arm soreness to touch at injection site, painful arm, tingling, numbness in left arm, headache, hands, thighs, back itching, chills, fatigue
BAD HEADACHE; MILD FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, once a total administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 16-MAR-2021, the subject experienced bad headache. On 16-MAR-2021, the subject experienced mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bad headache, and mild fever. This report was non-serious.
diarrhea; pain; headaches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN (pain), HEADACHE (headaches) and NAUSEA (nausea) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 18-Mar-2021, the patient experienced DIARRHOEA (diarrhea), PAIN (pain), HEADACHE (headaches) and NAUSEA (nausea). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. On 20-Mar-2021, PAIN (pain), HEADACHE (headaches) and NAUSEA (nausea) had resolved. At the time of the report, DIARRHOEA (diarrhea) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: No new information added.
Severe shivering / become worse; This case was reported by a pharmacist via and described the occurrence of shivering in a 83-year-old male patient who received Herpes zoster (Shingrix) (batch number 97PL2, expiry date 8th October 2022) for prophylaxis.   On 8th December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 9th December 2020, 1 days after receiving Shingrix, the patient experienced shivering. On an unknown date, the outcome of the shivering was not recovered/not resolved.   It was unknown if the reporter considered the shivering to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix in the right arm and experienced severe shivering and it became worse.  The reporter consented to follow up.
Information has been received from a physician concerning an approximately 8 week old patient with no pertinent medical history who in June 2008, was administered their first oral dose of ROTATEQ.  There was no concomitant medication.  Within 5 days of vaccination, the patient experienced hematochezia.  The patient was seen in an office visit. Upon internal review, hematochezia was considered to be an other important medical event.  No product quality complaint was involved.  Additional information has been requested. 6/26/08-spoke with PCP office-as of 6/17/08 patient recovered. Final DX: haematochezia with suspected cow's milk colitis.
Rash around the injection site was mostly red; Injection site slightly painful; Injection site was slightly itchy; Injection site raised bumps and did not spread; Rash around the injection site; This is a spontaneous report received from a contactable consumer, the patient. A 21-Year-old non-pregnant Female patient received first dose of BNT162B2{PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6202} via an unspecified route of administration in the left arm on 01Mar2021 at 12:00 (at the age of 21 years), as 1st single dose for COVID-19 immunisation. The patient's medical history included exercise-induced asthma. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures, which included COVID-19 Virus test on 08Mar202, the result was negative and COVID-19 Virus test on 16Mar2021, the result was negative. On 03Mar2021 at 21:00, the patient experienced rash around the injection site which lasted about 3 days and was slightly itchy and slightly painful, and the rash was mostly red, raised bumps and did not spread. No therapeutic measures were taken as a result of adverse events. The clinical outcome of the events vaccination site rash, red rash, itchy rash and painful rash was recovered on unknown date. No follow-up attempts are needed. No further information is expected.
more than 36 days since the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 36 days since the first dose) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (more than 36 days since the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 36 days since the first dose) had resolved.            Concomitant product was not provided by the reporter  Treatment information was not provided   Reporter did not allow further contact