chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I experienced extreme arm pain the night of the vaccine. When I woke up the next morning, my arm was extremely painful at the injection site (more than any other vaccine I have had). I had a 2 inch ring of swelling around the injection site and it was very red. My heart felt heavy like it was being crushed or wrapped in a weighted blanket, and I started developing heart palpitations. By about 2pm that day, I was bedridden with fever, chills and my heart felt like it was having a hard time beating. By that evening, I couldn't get out of bed, and I was considering going to the ER. Also, I felt "lightning zaps" throughout my body, especially in my legs, which I had not experienced before. The next day, I felt 50% better but still experienced the electrical zaps (especially in my legs), mild compression of my heart and mild fever. The 3rd day I was able to move around, fever was mostly improved and I just felt general malaise. The lightning strikes lasted for about 2 weeks (more so in the front of my legs). I went to my cardiologist 10-14 days later. They did an EKG  and halter monitor for 24 hours. They did an echocardiogram and saw some mild fluid around the heart. They said pace yourself as you return to normal, and after about 2 weeks I went back to exercise; however, I was still unable to do my normal level of exercise due to fatigue/irritability. About 6-8 weeks after the shot, I felt mostly normal and able to do my normal routines. During this entire episode, I felt a little "blue".
This spontaneous case report was received from a registered nurse regarding unknown number of patients of unknown age and gender. No concurrent conditions and medical histories of the patients were not reported. On an unknown date the patient was vaccinated with VAQTA stored outside of the recommended temperature range (0.3 degree for 45 minutes with a lot number # L045713 (expiry date: 14-JAN-2017), L023936 (expiry date: 15-MAR-2017), (dosing regimen, strength, route and frequency was unknown). Concomitant medications of the patients were not reported. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Cough, fever, chills, muscle aches, headache, slight chest congestion, sneezing, runny nose
Broke out in itchy red rash on arms, neck, chest, face, legs, headache within 30 minutes of vaccination. Drove myself to ER .Was treated for an allergic reaction, hives, given IV saline solution with benadryl and steroid. Treated by Dr.
swollen left armpit (same arm as injection), possibly swollen glands; swollen left armpit (same arm as injection), possibly swollen glands; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received the second dose of BNT162B2 (brand=Pfizer), lot no. EL3247, via an unspecified route of administration (left arm) on 16Feb2021 12:45 PM at a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included ibuprofen, clindamycin, adapalene, and levonorgestrel (MIRENA). Historical vaccine included first dose of BNT162B2 (brand=Pfizer, lot no. EL3247) for COVID-19 immunisation on 26Jan2021 12:45 PM (left arm) at a workplace clinic. No other vaccine in four weeks. No COVID prior to vaccination. The patient experienced swollen left armpit (same arm as injection), possibly swollen glands on 17Feb2021 07:00 AM. No COVID test post vaccination. The outcome of the events was recovering.
wife is breastfeeding; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Apr-2021 and was forwarded to Moderna on 22-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (wife is breastfeeding) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced EXPOSURE VIA BREAST MILK (wife is breastfeeding). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, EXPOSURE VIA BREAST MILK (wife is breastfeeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were reported.
TINGLING IN EXTREMITIES AND TONGUE, TONGUE SWELLING, MILD HTN, TREATED FOR ALLERGIC RXN WITH DIPHENHYDRAMINE 25MG IM INJECTION AND MONITORED FOR SIGNS OF ADDITIONAL ALLERGIC RXN/ANAPHYLAXIS. S/S RESOLVED S/ DIPHENHYDRAMINE AND TIME. PT WAS ALSO MILDLY HYPOCAPNIC ON ETCO2 MONITORING AND STATED THAT S/S COULD BE DUE TO MILD ANXIETY.
Patient received first dose on 17Aug2021, second dose on 12Oct2021; sweats; headache, splitting headache; Fever; felt exhausted, really tired; a lump in her arm, that was red, swollen and itchy. It felt like she had a knot in her arm.; This spontaneous case was reported by a consumer and describes the occurrence of MASS (a lump in her arm, that was red, swollen and itchy. It felt like she had a knot in her arm.), HYPERHIDROSIS (sweats), HEADACHE (headache, splitting headache), PYREXIA (Fever) and FATIGUE (felt exhausted, really tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A and 019F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MASS (a lump in her arm, that was red, swollen and itchy. It felt like she had a knot in her arm.). In October 2021, the patient experienced HYPERHIDROSIS (sweats), HEADACHE (headache, splitting headache), PYREXIA (Fever) and FATIGUE (felt exhausted, really tired). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 17Aug2021, second dose on 12Oct2021). In October 2021, HEADACHE (headache, splitting headache), PYREXIA (Fever) and FATIGUE (felt exhausted, really tired) had resolved. At the time of the report, MASS (a lump in her arm, that was red, swollen and itchy. It felt like she had a knot in her arm.) and HYPERHIDROSIS (sweats) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 17Aug2021, second dose on 12Oct2021) had resolved.            Treatment information was not provided. Patient developed a lump in her arm, that was red, swollen and itchy. It felt like she had a knot in her arm.   This case was linked to MOD-2021-353465 (Patient Link).
Syncopal episode after receiving vaccine, hypotensive, bradycardic, diaphoretic, clammy.
pt recvd vax 18NOV91 & 3 days p/recvd inject began having complications; complications included swelling in arm, pain, low grade temp, hemorrhaging inside arm & infect;
13JUL92 pt recvd 1st dose of Engerix-B & devel severe joint aching which resolved by itself w/no tx; 13AUG92 recvd 2nd dose of Engerix-B & became faint, shakey & had sweaty palms;
pt recv vax 11APR96 & 18APR96 pt exp lethargy, began tripping, could not stand, could not walk & kept falling down;MD indicated that according to pt mom pt was warm, lethargic & would not bear weight on legs 1 day p/wearing new shoes;
Pt received J&J COVID Vaccine on 3/9/21 at CVS. 4/18/21 Patient went to Expo for first dose of Pfizer and returned to Expo for 2nd dose Pfizer on 5/9/21.  The vaccinator administered 2nd dose Pfizer prior to reviewing the patient chart.  The Pt purposely wanted the Pfizer Vaccine stating that he did not "trust the efficacy of J&J".  No adverse reaction noted at the time of vaccination.
herpes outbreak; This case was reported by a consumer via call center representative and described the occurrence of herpes virus infection in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concomitant products included acyclovir.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, immediately after receiving Shingrix, the patient experienced herpes virus infection. On an unknown date, the outcome of the herpes virus infection was unknown.   It was unknown if the reporter considered the herpes virus infection to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix in few months before the date of reporting, and experienced outbreak of herpes shortly thereafter.  The patient was not sure if it was related to the vaccine as she got herpes flare ups anyway.  The reporter did not consent to follow-up.
She was sick; extended length of time between doses; A spontaneous report was received from a consumer concerning herself a 76 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) with extended length of time between doses/inappropriate schedule of vaccine administration, and experienced sick/ malaise.  The patient's medical history was not included. Concomitant medications were not listed.  On 01 Feb 2021 prior to the onset of events the patients received first dose of their two planned doses of mRNA-1273 (Batch N0:unknown)intramuscularly in the left arm for prophylaxis of covid 19 infection. Her second dose was due on 02 MAR 2021 but she was sick and didn't receive her second dose until 18 MAR 2021.  On 18 Mar 2021 patient received second dose of their two planned doses of mRNA-1273(batch no: unknown) intramuscularly in the left arm for prophylaxis of covid-19 infection, with extended length of time between doses.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event, extended length of time between doses/inappropriate schedule of vaccine administration was considered resolved on 18 Mar 2021. The outcome of the event feeling sick was unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administration for mRNA-1273, lot #unknown. Based on the 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
2 days after vaccination developed 3 blisters on forearm by elbow, both arms.  Itchy, about 3 days, scabbed over, (light flaky scab)
Started with severe back pain, swollen feet, numbness on toes for about 2 weeks.
Pt was administered 3rd dose as med error on 9/3/21 @ 10:30 am.  Pt waited 30 min for observation for any s/s of ADR's. Pt was aware of situation. During observation time period there was no noted s/s of ADR's nor concerns at that time. Pt was educated on ADR's and was told to seek medical advice if any ADR's were present.  Incident report was completed and F/U was performed 9/7/21 with pt stated she was fine and had no questions nor concerns.  Department of Health of  advised of situation as well.  Offered pt to call clinic with any questions or concerns. Reporting this incident as protocol as per my facility at
Administration of expired ROTATEQ; This spontaneous report was received from a licensed practical nurse regarding a 4-month-old patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not reported.   On 18-MAR-2022, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot number: 1741377 and expiration date: 07-MAR-2022; both confirmed as valid) as prophylaxis (expired product administered). No additional adverse events reported (no adverse event).
pt received covid vaccine on 1/29/21,  states that she became extremely fatigued shortly after vaccine, developed a fever that night,  presented to the clinic with respirations greater than 60/minute, fever, fatigue, body aches, and was transported to the local emergency room.
high fever; Initial information received on 26-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional from Sales Representative.  This case is linked to case 2023SA302695(CLUSTER).  This case involves Adult patient of unknown gender who experienced high fever after receiving influenza quadrivalent recombinant vaccine [Flublok QIV].  The patient's past medical history included Cardiac operation (recent heart surgery). The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect influenza quadrivalent recombinant vaccine (strength, formulation, route, batch number and expiry date: unknown) in an unknown administration site for Immunization. Information on the batch number was requested  On an unknown date the patient developed high fever (pyrexia) (unknown latency).  It was reported that a staff member in a clinic gave Flublok Quadrivalent to 2 patient who developed fever high fever which last few days, and both of the patient were high risk patients as one of them had a recent heart surgery. They don't have any information about the patients or treatment done.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (high fever).  At time of reporting, the outcome was Unknown for the event high fever.
This spontaneous report was received from a nurse referring a patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-SEP-2017, the patient was administered improperly stored dose of VARIVAX lot # N012619 with expiration date of 21-APR-2019, for prophylaxis (strength, dose, route and frequency were not reported). No adverse effects reported. It was stated that the vaccines underwent a temperature excursion of 6°F (degrees Fahrenheit) to 14°F (12.2F) for 30 minutes. No previous temperature excursion was reported. The call was because of a "data logger". This one of two reports from the same reporter. Sender's Comments: US-009507513-1709USA004002.
Patient reported feeling dizzy. Advised the patient to remain seated. Patient lost consciousness and fell to the ground. Sat patient upright and began screening for medical history. Cognition was low and speech was quiet. Measured blood pressure and pulse (80/46 mmHg pulse of 60bpm).
body ache; chills; little congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (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: PAIN (non-serious) with onset 23Mar2021, outcome "unknown", described as "body ache"; CHILLS (non-serious) with onset 23Mar2021, outcome "unknown", described as "chills"; NASAL CONGESTION (non-serious) with onset 23Mar2021, outcome "unknown", described as "little congestion".  Additional Information: The patient wanted to know if this was normal and how long would it take to subside.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient's arm was very sore for four days after receiving the flu shot. She went to her primary care physician due to the arm pain and fever she was experiencing.
Achy headache, fatigue, tremors, arm swelling, myalgias, weakness.
Pt became irritable, starting 1 1/2 hours post immunizations. Pt had apneic episode, was hospitalized for 3 days.
19yo male received smallpox vaccination 1 week ago. Upper chest and back (no palms, no mucous membrane, no face/neck). Broke out in erythematous raised rash (papules), one pustule, all actiniform in appearance but with dermatomal distribution. No fever but had mild headache 2-3 days ago. Had good 'take' at small pox site, no evidence of surrounding secondary vaccinia lesions. May be dermatitis given new environment, new detergents, new exposures (vests, uniforms, armor), but dermatome distribution (on back) raises possibility of viral exanthum, recent small pox immunization may be possibility but considered very low risk otherwise. He shows no evidence of illness, rash not bothering.
Moderna booster dose 0.5ml was given instead of 0.25ml. No adverse effect noted.
Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Jul-2023, the patient experienced COVID-19 (Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 07-Jul-2023 to 12-Jul-2023 at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-2023, SARS-CoV-2 test: Positive.         It was reported that, Patient took 3 Moderna vaccines and 1 Booster with Moderna. The last dose date was reported as 10/22.  Patient experienced first symptoms on 06-Jul-2023. Concomitant medication was not provided. Drug Lot number and expiration date was reported as NDC 0069-0345-30.
Received flu vaccine 10/07/15 at 11:55 am. States arm was sore at site but on 10/10/15 at 7:30 am when she woke up the (L) arm was more sore and was swollen down past the elbow. Went to the ER and was given NAPROSYN and a shot.
Complete numbness of right arm within 24 hours of vaccine.   4 weeks following vaccine 20% numbness remains in forearm (starting at elbow) and part of right hand (thumb and index finger)
This spontaneous case was received on 02-Oct-2021 from other non-health professional (consumer) via Med Communications (reference number: SEQW21-03185) and concerned a 68-year-old, female patient. The patient's medical history and concomitant medications were not reported. On 30-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; indication, dose, route of administration and anatomical location: not reported). It was reported that when the nurse pulled the syringe out of the patient's arm a good amount of the vaccine squirted out of the syringe onto the patient arm (explicitly coded as 'Accidental exposure to product'). The patient felt she received maybe half a dose (explicitly coded as 'Incomplete dose administered'). The patient was offered another vaccine, but she declined. The patient had no soreness. The batch number was not reported. On 02-Oct-2021, two days after receiving incomplete dose of Fluad Quadrivalent, the patient developed headache. The outcome of the event of headache was not reported. The reporter did not provide a causality assessment. The reporter assessed the case as non-serious. Company Comment: The event of headache is considered as related to Fluad Quadrivalent. Additionally, 'accidental exposure to product' and 'incomplete dose administered' are assessed as unrelated to Fluad Quadrivalent per company's conventions.; Sender's Comments: The event of headache is considered as related to Fluad Quadrivalent. Additionally, 'accidental exposure to product' and 'incomplete dose administered' are assessed as unrelated to Fluad Quadrivalent per company's conventions.
gen tonic-clonic sz 10min p/vax;eye rolled back lasted 10sec;no post ictal;
Severe dizziness with associated nausea for 6 days post injection.  Continued dizziness off and on to date but slowly subsiding.  Unable to see PCP so went to Urgent care and given Meclizine and Zofran.  After 4 days the scripts were making me feel ill.  Stopped those and started taking Benedryl 25 mg x 2 per day.  Still have dizziness in evening and upon waking as of today.
Large bright red raised area the size of an large egg.   Hard Painful Bright Red    No muscle pain in arm as with the 1st injection.
3RD DOSE COVID VACCINE GIVEN 02/03/2022, MODERNA #069H21A; pt had a positive COVID test on 9/7/22 in   Rehab; she was placed in Isolation; she passed away in the SNF under Hospice care
Administered dose more than 12 hours after vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial puncture) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial puncture). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is taking unknown concomitant medication. Treatment medication was not reported. The vial was initially punctured on Friday 17-Sep-2021 at 8:00 AM.  The patient received vaccine 67 hours after the 12 hours expiry. Therefore, the patient received the vaccine 79 hours after the vials was punctured. The vaccine did had any particulates or discoloration. The accumulative time the vaccine was at room temperature was 15 minutes.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: New reporter added. On 24-Sep-2021: Patient demographics added, added information in I narrative.
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 26-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