chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; injection site pain; This is a spontaneous report from a contactable other hcp (patient herself). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and Lot Number: EL3246) via an unspecified route of administration in arm left on 28Jan2021 10:00 as dose 1, single for COVID-19 immunization. Medical history included CLL, MS from 1996, Bladder incontinence and Hip replacement. Concomitant medications included rituximab, fesoterodine fumarate (TOVIAZ), baclofen, bupropion, vitamin c (ascorbic acid), tocopherol (VITAMIN E), silybum marianum (MILK THISTLE), urtica dioica root (STINGING NETTLE ROOT) and probiotics. The patient previously took sulfa and experienced Hives; myrbetriq and experienced allergic. On 28Jan2021, the patient experienced sore arm and injection site pain. Seriousness criteria was reported as non-serious. Treatment information was reported as no. The outcome of the events was recovering.  Follow-up attempts completed. No further information is expected.
Aprox 25 hours after vaccinations began with chills, fever, diarrhea, and headache. Noted Lt triceps area redness at that time size of orange. Extremely tired and slept 21 hours. Fever broke after 18 hours. Area where Zostavax given still red size of fist but now with itching.
Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Severe, Additional Details: had convulsing of lower extremities. had previous symptoms during flu shot last year. Did not seek medical attention
March 16, 2021, I awoke very dizzy. This continues to today (4/3/2021) but is slowly getting better. I tried several Epley maneuvers and saw both my audiologist and ENT physician. If I tip my head down I have a brief dizzy spell. Sometimes even rolling over in bed can cause an episode. I DID get my second vaccine on March 25th again at a mass immunization site.
Pt reports pain as soon as injection happened. Reports Numbness in Right shoulder and area around injection site. Denies any redness or swelling. No other symptoms of covid 19. Discussed cold compress for 20 minutes and reaching out to PCP.  Advised on s&s to monitor for and when to seek further medical treatment or call 911.
raised skin at injection site. swollen, hot, and itchy. 2inches x 2inches
Baby ran high fever for 3 days, Screamed a high pitched scream for hours fussed all the next day and screamed for hours again the next night this has been going on for 2 weeks and it's still happening she developed red dots on her left leg.
When I got up on 8/10/07, my tongue felt swollen; I called my doctor. He said to take a Benadryl and call back in 2 hrs and did both. tongue worse and lips felt tight. He said to go ER. I did. They gave SoluMedrol 125 MG inj. Sed. CU +9% IV, Rt IV KVO resolved. 50mg Benadryl and Prednisone 10mg. Next AM, all Ok except red in center tongue, tongue still swollen; return to my doctor on Mon. for effects of Prednisone. Now Ok.
Pityriasis Rosea; rash  became itchy/rash stopped spreading but it is very itchy especially at night time, which they describe as moderate in severity; rash, which they did not take seriously, that looked like a patch on right hand, chest ,back; little pain; This spontaneous case was reported by a consumer and describes the occurrence of PITYRIASIS ROSEA (Pityriasis Rosea), PAIN (little pain), RASH PRURITIC (rash  became itchy/rash stopped spreading but it is very itchy especially at night time, which they describe as moderate in severity) and RASH (rash, which they did not take seriously, that looked like a patch on right hand, chest ,back) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced PAIN (little pain). On an unknown date, the patient experienced PITYRIASIS ROSEA (Pityriasis Rosea), RASH PRURITIC (rash  became itchy/rash stopped spreading but it is very itchy especially at night time, which they describe as moderate in severity) and RASH (rash, which they did not take seriously, that looked like a patch on right hand, chest ,back). The patient was treated with TRIAMCINOLONE at a dose of 0.1 % and DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PITYRIASIS ROSEA (Pityriasis Rosea), PAIN (little pain), RASH PRURITIC (rash  became itchy/rash stopped spreading but it is very itchy especially at night time, which they describe as moderate in severity) and RASH (rash, which they did not take seriously, that looked like a patch on right hand, chest ,back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator Treatment medications provided by the reporter included Triamcinolone 0.1 % prescribed by dermatologist, started 17MAY2021 in the morning . Prescriber (telemedicine) recommended to use for 2 weeks. Benadryl - 17MAY2021 in the morning.
COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned a 48 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 20-DEC-2021) dose was not reported, 1 total, administered at left arm on 08-APR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1).  The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194, and expiry: 08-JUL-2022) dose was not reported, 1 total, administered at left arm on 04-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient took Binax Now at home test laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) and tested positive (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This case, from the same reporter is linked to 20220329517.
One week after first shot I developed flu-like symptoms : frequent /chronic diahrrea (still present sporadically), nausea, 1+ nights of fever, headaches, fatigue. A few weeks after first shot I started experiencing chronic fatigue & chronic daily chest pains : I am still experiencing both.
3-4 hours after rota virus vaccine, the patient vomited. He vomited 2-3 times next day, and continued to vomit @ 1 vomit per day until Day 11 when he was taken to the ER. The vomiting was projectile.
An unspecified number of patients received unspecified doses of improperly stored vaccines; No adverse events; This non-valid spontaneous report was received from a registered nurse who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reactions or allergies was provided.   On unspecified days, an unspecified number of patients received improperly stored vaccines. The patients were vaccinated with doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot# S001329, expiration date 14-JAN-2021, lot # R028382, expiry date 10-MAR-2020 and lot # N024701, expiry date 08-SEP-2019 (exact dose and route of administration were not reported) for prophylaxis.   On unknown dates, the patients were vaccinated with improperly stored doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot # N034006, expiration date 01-FEB-2020, lot # R013572, expiration date 21-MAR-2021 (exact dose and route of administration were not reported) for prophylaxis.   On unknown dates, the patients were vaccinated with improperly stored doses of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot # R002700, expiration date 24-AUG-2019, lot # R034105, expiration date 24-JUN-2020 (exact dose and route of administration were not reported) for prophylaxis.  On unknown dates, the patients were vaccinated with improperly stored doses of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) lot # R002354, expiration date 17-DEC-2019, lot# R010724, expiration date 13-JUN-2020 (exact dose and route of administration were not reported) for prophylaxis. Doses of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) were reconstituted with properly stored sterile diluent.   The doses of vaccine were stored at 15.9 °C for 3 hours and 30 minutes. Previous temperature excursion: 10.4°C for 1 hours. Digital data logger was involved. No adverse effects were reported.  This case is non-valid due to lack of patient identifiers.
Transient focal swelling of the medial right conjunctiva associated with mild irritation.; Transient focal swelling of the medial right conjunctiva associated with mild irritation.; This is a spontaneous report from a contactable physician (reporting for himself).  A 35-year-old male patient  received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283: expiration date unknown), via an unspecified route of administration in the left arm on 15Jan2021 at 17:00 at a single dose for COVID-19 immunization.  Medical history included seasonal allergies and no allergies to medications, food or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included acetaminophen on unspecified date for unspecified indication. The patient previously received the first dose of BNT162B2 (lot number: EL1284) on 26Dec2020 at 07:00 PM in the right arm for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 17Jan2021 at 18:00, the patient experienced transient focal swelling of the medial right conjunctiva associated with mild irritation. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included diphenhydramine. The events were considered non-serious by the reporter. The outcome of the events was recovered on unspecified date in Jan2021.
Experienced arm swelling which progressed from the elbow all the way up the arm; Itching; This spontaneous report was received via a company representative from a nurse practitioner who is also the mother of the patient and refers to an 11 year old female patient.  The patient's concurrent conditions, medical history, drug allergies or reactions and concomitant therapies were not reported.  On 28-AUG-2019, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) as prophylaxis on an unspecified arm (dose, frequency, anatomical location, route of administration, lot number and expiration date were not reported).  On the same date, the patient experienced arm swelling, which progressed from the elbow all the way up the arm, and itching. The patient went to the emergency  room where she was treated with unspecified intravenous (IV) antibiotics and then was sent home. No further information was provided.  On an unspecified date, the patient recovered from the events.  The causal relationship between the events and therapy with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.
This is a 60 year old female was brought into emergency department as cardiac arrest.  Patient was seen at care now urgent care with the complain of epigastric pain associated with nausea vomiting and intermittent diarrhea.  Patient received her initial COVID vaccine 2 days ago.  History is obtained from urgent care chart.  As per notes patient started nausea vomiting 6 hours post COVID vaccine administration.  Patient was seen in urgent care for epigastric pain and nausea vomiting.  Patient was found unresponsive at 0902 by tech.  No carotid pulses palpated.  CPR was started.  Patient was brought into the emergency department with Lucas on.  Patient was given 5 epinephrine prior to arrival.  CPR was in progress.  Patient was asystole.  Resuscitation was continued in the ED.  Patient was intubated in the ED by physician assistant 5 epinephrine 2 bicarb and 1 calcium chloride was given in the ED.  Cardiac Ultrasound didn't show any cardiac activity.  Asystole on the monitor.  No corneal reflex people are fixed and dilated.  Patient was pronounced at 1007 am
Narrative: 94 yo male presented to ED on 1/02/2022 with concerns for an episode of confusion and hypoxia. Pt placed on 2L nasal cannula. COVID positive. Treated with dexamethasone and supplemental oxygen. No remdesivir d/t ESRD. Metabolic encephalopathy secondary to Covid infection- Resolved. Discharged on 01/11/2022. PMH includes thrombocytopenia, ESRD/HD, recurrent venous thrombi, BPH, PAF and CHF.
gave a 11 year old patient dtap(infanrix); This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 26-APR-2022 Reporter's Comments: The reporter gave a 11 year old patient dtap (Infanrix) instead of tdap (Boostrix). The reporter mentioned  if the patient needed to wait so long before he could give patient the Boostrix as well as reporter want recommend. The reporter give consent to follow up.
Body aches, chills, migraine, 102 fever, nausea, vomiting.
Soreness at injection site, Muscular & joint soreness, extreme fatigue. Tylenol taken for 2 days.  Slept 2 nights  and next morning  slight lingering of affects. All gone after 3rd day.  NOTE: No adverse affects after injection 1.
No signs or symptoms reported. No other AE reported; temperature excursion that occurred on 3/AUG/2021 and 5/AUG/2021; temperature excursion that occurred on 3/AUG/2021 and 5/AUG/2021; This spontaneous report was received from a medical assistant referring to an unreported age and gender patient. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.    The medical assistant reported that a temperature excursion occurred on 03-AUG-2021 and 05-AUG-2021 involving hepatitis A vaccine, inactivated (VAQTA) lot number T037788, verified to be valid for prefilled syringe formulation, with expiration date 30-APR-2022. The vaccine underwent a temperature excursion of 35.4 and 35.8 degrees Fahrenheit (F) for a cumulative timeframe of 15 minutes (product storage error). There was not a previous temperature excursion.   The 1-time dose vaccine was administered to the patient on an unspecified subsequent date in 2021 for prophylaxis (route and anatomical location of vaccination were not reported).  No signs or symptoms nor other adverse events (AE) were reported (no adverse event).  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T037788; expirationdate: 30-APR-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; Sender's Comments:  US-009507513-2109USA003634:
dizziness; headache; 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 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 13:15 (Lot number: ER8727) at the age of 74 years as dose 2, single and administration date 05Mar2021 (Lot number: EN6204) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (ongoing), notes: Taking PROZAC for depression. Concomitant medication(s) included: PROZAC taken for depression (ongoing). The following information was reported: DIZZINESS (non-serious) with onset Apr2021, outcome "not recovered", described as "dizziness"; HEADACHE (non-serious) with onset Apr2021, outcome "not recovered", described as "headache". Therapeutic measures were taken as a result of headache.  Additional Information: It was reported that, the patient did not receive any prior vaccinations within 4 weeks. History of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same date of the Pfizer Suspect were none. No Family History and relevant test. After getting the Pfizer COVID019 vaccine (Apr2021), he had been experiencing headache, dizziness, and steady head pain. The head pain varies thorough out the days it can sometimes be more intense than other days. It helped a bit with TYLENOL and ALEVE. The patient just didn't understand because headaches were not usually normal for him and had been experiencing this for a month. Headache was reported as worsened. He received the second dose of the Pfizer COVID 19 vaccine 30MAR2021 at 13:15 in the left arm (lot ER8727) at Hospital, he had a headache and at times dizziness. Adds he got the first dose 05Mar2021, but he does not remember the time or which part of his body he received the vaccination. He thought he had headache and dizziness for the whole month of Apr2021. Adds, it could be from the first dose, he was unsure. Stated, he had to get a hold on things like when he is taking a shower, he had to hold on due to the dizziness, but it is okay when he was sitting down. Mentions a couple of times he thought about going to the emergency room or calling his doctor, but he didn't. Additionally, he was going to call his doctor at the facility next because this was not normal for him.  No follow-up attempts are possible. No further information is expected.
Rhabdomyolysis, CK levels greater than 40000, lasted three days hospitalized
I had every symptom you could think of. I had a headache, sore throat, nasal congestion, body aches from head to toe, fever , chills, night sweats, lost my taste and smell, I would profusely sweat my hair would be drenched my clothes soaked. I could not sleep at all, had insomnia. I had a cough. I took cough syrup, I could not produce any phlegm, I would get up and try to walk each day, maybe 100 feet and my oxygen levels would drop to 84, when i came in sat down it rebounded. I went to Well Now  to make sure I did not have covid Pneumonia. I still have night sweats. I still have dieahhrea and abdominal pains.
Left upper arm red, warm and slightly swollen. Area approximately 1.5 X 2 inch oval.
Patient had redness and swelling 2 hrs after vaccine then stopped breathing later. Also possible seizure that same day after vaccine.
ACUTE DVT OF RIGHT FEMORAL VEIN ACUTE DVT OF LEFT FEMORAL VEIN
Patient informed nurse of her allergies before vaccination. After about five minutes, patient reported a burning sensation at the injection site. Nurse evaluated the patient and provided her a cold compress for the injection site. After 30 minutes, patient reported that the burning sensation persisted but she was fine to leave.   Left a message for the patient around 2:30PM on 8/31, and the patient returned the call around 6PM to say that the burning sensation lasted for about one hour after vaccination before dissipating. She reported feeling fine since.
Headache; nausea; vomiting; fever; sweats; chills; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm right, administration date 22Oct2021 09:00 (Lot number: 320803D) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergy: food intolerances" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination= Yes; "known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: METHENAMINE; CELECOXIB; VIT C. Vaccination history included: Comirnaty (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 24Mar2021, when the patient was 63 years old, for COVID-19 immunization; Comirnaty (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 07:45 AM), administration date: 04Mar2021, when the patient was 63 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 23Oct2021 03:30, outcome "recovered" (2021), described as "Headache"; NAUSEA (non-serious) with onset 23Oct2021 03:30, outcome "recovered" (2021), described as "nausea"; VOMITING (non-serious) with onset 23Oct2021 03:30, outcome "recovered" (2021), described as "vomiting"; PYREXIA (non-serious) with onset 23Oct2021 03:30, outcome "recovered" (2021), described as "fever"; HYPERHIDROSIS (non-serious) with onset 23Oct2021 03:30, outcome "recovered" (2021), described as "sweats"; CHILLS (non-serious) with onset 23Oct2021 03:30, outcome "recovered" (2021), described as "chills"; PAIN (non-serious) with onset 23Oct2021 03:30, outcome "recovered" (2021), described as "body aches". Therapeutic measures were taken as a result of nausea, vomiting.  Follow-Up (28Oct2021): Follow-up attempts are completed. No further information is expected.
Patient was inadvertently given Pfizer-BioNTech age 12+ bivalent vaccine at age 8. Patient was informed by administering staff of the error and was monitored for more than 30 minutes and had no obvious adverse reaction. Patient was advised of precautions and normal side effects for vaccination with covid vaccine.