chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day 4 after receiving vaccine dose developed nerve pain in the groin and R glute/thigh, as well as fatigue. Sx worsened on day 5, so I had a virtual visit with a medical provider who prescribed me Valtrex x7d to treat suspected Herpes Zoster, which I previously had in my early 20s.
transit blurred vision; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (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: VISION BLURRED (non-serious), outcome "unknown", described as "transit blurred vision".  Additional information:  The patient asked the doctor if it is transit or permanent in nature.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt states on Friday, 1/27 she went to clinic to get her Hep B vaccine for work and has now broken out in a rash on her left side neck. Pt called clinic to let them know about the rash and they told her to come in again so they can check her. Pt states she received the vaccine because she needed one for work in order to be up to date. Pt states the rash started Saturday or Sunday.
Rash - Information has been received concerning a 10 year old caucasian male who on 05 mar 1996 was vaccinated with one dose of varicella virus vaccine live in the right thigh.  On 18 Apr 2000 the patient experienced a rash with approximately 50 lesions.  The rash was not very itchy and scabbed over quickely.  On 21 Apr 2000, the patient recovered from the rash.
Rash on eyes, chin, chest, leg starting 2 days after MMR vaccine. Treated w/ CLARITIN, triamcinolone cream.
Patient received her first dose of Moderna vaccine on 1.8.2021. Patient called infection control nurse on 1.15.21 and reported her tongue turned black yesterday (1/14). Patient denies use of Pepto or any new medication that she doesn?t routinely take. Patient states she did brush her tongue but it continues to be discolored. Patient denies dry mouth, pain, swelling, or ShOB with it. Patient DOES report macroglossia. Patient denies any other symptoms or recent exposures. Patient instructed to follow up with her PCP.
Reddness, swelling (R) deltoid. Some pain. V/S 98.6-68-20-118/72. Area appx 3 1/2" length 1 1/4" width. Some warmth to touch.
Patient c/o of overall warm, tingly rush through her body, feeling shaky. Denies difficulty breathing or any other symptoms. BP 133/98, HR 95, O2 100%; BP rechecked after a few minutes, 116/81. POC 114. Reports feeling better right away and returned to monitoring area to be observed for 30 minutes.
Covid dx 06Jun; Covid dx 06Jun; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Apr2022 at 12:00 as dose 4 (booster), single (Lot number: 071F21A) at the age of 68 years, in left arm for COVID-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jun2022, outcome "unknown" and all described as "Covid dx 06Jun". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) Covid diagnosed; (13Jun2022) Negative, notes: Day 8; (14Jun2022) Negative, notes: Day 9; (14Jun2022) Positive, notes: Day 10. Therapeutic measures were taken as a result of drug ineffective, covid-19; patient had received treatment with start of drug 06Jun2022 and date of last administration was 11Jun2022.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
patient presented to hospital 11/3/2021 for headache and nausea. stroke work up positive and patient admitted for 4 days (11/3-11/7/2021). patient discharged home with diagnosis of Nontraumatic subarachnoid hemorrhage.
Patient described having unusual pain evening after vaccine, and redness. Area of redness had expanded from shoulder to elbow. Pt says her arm feels "hard."
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 19-NOV-2018, the patient was vaccinated with improperly stored M-M-R II (lot # N024698, expiration date 08-SEP-2019) and VAQTA (lot # R013859, expiration date 14-JUN-2019) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). The sterile diluent used to reconstitute M-M-R II was properly stored. No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
Patient is deceased.   Patient's wife called pharmacy on 8/21/2022 to report  adverse events from covid vaccine.   She states that patient got congestion, cough, trouble breathing the night he got the vaccine on 8/27/2021.   A couple of days later patient saw physician and was prescribed medication.   Over the next week patient continued to be sick and disoriented and was eventually taken to a hospital via ambulance on 9/7/2021.   Patient then passed away on 9/25/2021.
This case was reported by a nurse via sales rep and described the occurrence of extensive swelling of vaccinated limb in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 3 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, pain in arm and skin warm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, pain in arm and skin warm were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, pain in arm and skin warm to be related to SHINGRIX. Additional details were provided as follows: The reporter said that, on a Tuesday (unknown date), the patient received SHINGRIX. On Friday, the patient's arm was wet and swollen from arm down to hip, which led to extensive swelling of vaccinated limb. It felt like it was on fire and hurt. The patient felt like the medicine was going in when receiving SHINGRIX. The reported agreed to be followed up.
passed out; Felt like I was about to have a seizure (am epileptic); Woke up at about 3a; vomited 2x; diarrhea; Dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Nov2021 12:30 (Lot number: FJ8762) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Epilepsy" (unspecified if ongoing); "Allergies: Latex" (unspecified if ongoing); "Allergies: Eggs" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; IPRATROPIUM BROMIDE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0179, Location of injection: Arm Left, Vaccine Administration Time: 14:00 PM), administration date: 24May2021, when the patient was 38 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EWO172, Location of injection: Arm Left, Vaccine Administration Time: 14:00 PM), administration date: 03May2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 28Nov2021 12:30, outcome "unknown", described as "Dose number: 3"; LOSS OF CONSCIOUSNESS (medically significant) with onset 29Nov2021 03:00, outcome "recovering", described as "passed out"; SEIZURE (medically significant) with onset 29Nov2021 03:00, outcome "recovering", described as "Felt like I was about to have a seizure (am epileptic)"; TERMINAL INSOMNIA (non-serious) with onset 29Nov2021 03:00, outcome "recovering", described as "Woke up at about 3a"; VOMITING (non-serious) with onset 29Nov2021 03:00, outcome "recovering", described as "vomited 2x"; DIARRHOEA (non-serious) with onset 29Nov2021 03:00, outcome "recovering", described as "diarrhea". Therapeutic measures were not taken as a result of loss of consciousness, seizure, terminal insomnia, vomiting, diarrhoea. Clinical course: On 29Nov2021, Patient was vaccinated with the third dose of Pfizer vaccine against COVID-19. AE were not Required visit to emergency room visit and physician office visit. This report was considered as serious and the events did not result in death, Life threatening, hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
pt felt nauseated, passed out then had slow resp leading to resp & cardiac arrest;CPR initiated, pt intubated, given med transferred to peds ICU;
Patient had a headache, chills, and a fever of 104 around 8pm that night. Fever broke at 4am the next morning, but then was back to 100 at 10:30am.
Day following injection patient developed redness, swelling around site, fever - was seen by MD et started antibiotic for ? cellulitis.
Night of shot- Severe headache & sore arm at injection site. 4/26/21- severe body aches, extreme fatigue, sore arm at injection site 4/27/21- extreme fatigue & nausea/diarrhea, sore arm at injection site 4/28/21- fatigue
arm was sore; This is a spontaneous report based on the information received by Pfizer. (Case Number: 01845505). A  non-contactable consumer (Wife) reported 50-year-old male patient that:  Description: Voicemail left on PIR line on 14Jan2021 at 10:29 PM. She learned of from her husband, on the Pfizer COVID-19 vaccine. He had his first vaccine on 13Jan2021 and on 14Jan2021 reported that his arm was sore, "really really sore like he had been punched in the arm". There is not permission to contact the patient about this report. No PQC reported.   Physical information: Product: Pfizer Covid-19 vaccine Product circular#: N/A Lot number: EL3249 Expiration date: Unknown by reporter Dose/ frequency: single dose   No follow-up attempts are possible. No further information expected.
The vial expired on 05-May-2022, was moved from freezer to fridge on 29-Apr-2022 and was administered on 06-May-2022; patient received an expired dose of the Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired dose of the Moderna vaccine) and PRODUCT STORAGE ERROR (The vial expired on 05-May-2022, was moved from freezer to fridge on 29-Apr-2022 and was administered on 06-May-2022) in a 19-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired dose of the Moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 05-May-2022, was moved from freezer to fridge on 29-Apr-2022 and was administered on 06-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received an expired dose of the Moderna vaccine) and PRODUCT STORAGE ERROR (The vial expired on 05-May-2022, was moved from freezer to fridge on 29-Apr-2022 and was administered on 06-May-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo any temperature excursion. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2022: Follow up received contain significant information. Patient demographics added and narrative updated. On 11-May-2022: Follow-up received contain no significant information. On 11-May-2022: Significant follow-up appended- Date on which vial was removed from refrigeration updated.
Within in 2 hours of my vaccine my chronic eczema started to flair up and itch.  After my next dose of Dupixant  and use of Clobetasol the itching on my back subsided but my face continues to have issues with an eczema outbreak As of 4/16/21).   Also by the evening of 3/8 (about 24 hours after my injection) my asthma symptoms appeared to increase  (asthmatic  cough)  I have had to increase my Symbacort to 2 puffs 2x a day from  2 puffs once a day.
BODY HURTS/PAIN; SWEATING; COUGHING; CANNOT SLEEP; HARD TIME STANDING ON MY FEET; FEELING VERY WEAK; FELT SICK; FEVER; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 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 an unspecified date, the subject experienced body hurts/pain, sweating, coughing, cannot sleep, hard time standing on my feet, feeling very weak, felt sick, fever, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 39.8, 37.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, had not recovered from headache, body hurts/pain, feeling very weak, sweating, coughing, and cannot sleep, and the outcome of hard time standing on my feet and felt sick was not reported. This report was non-serious.
Case number PHEH2014US021315, is an initial spontaneous report from a health care professional received on 20 Oct 2014. This report refers to female patient of unknown age. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 1412501) intramuscularly on 17 Oct 2014. Lab technician reported that she experienced a full body rash and a swollen face after vaccination on the same day. She self-treated with BENADRYL and still had splotchy skin on day 3 after the vaccination. Her face swelling had subsided and rash was slowly resolving. Seriousness and causality assessment was not reported. Seriousness assessment of swelling face was upgraded based on information available in the source documents.
The patient, a nurse practitioner, reports that about 12 hours after receiving the vaccine, she developed significant edema to her left upper arm. States she took 50 mg BENADRYL at HS, followed by BENADRYL 25 mg in AM. Also reports ADVIL x24 hours (600 mg dose) with full resolution of symptoms.
Diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (she started having diarrhea after she eats food/has continued even after she received her 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included NIFEDIPINE (PROCARDIA [NIFEDIPINE]) and ANASTROZOLE for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (she started having diarrhea after she eats food/has continued even after she received her 2nd dose). Not Provided      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.   This case was linked to MOD-2021-090566 (Patient Link).
The first time with COVID-19 it was like a bad head cold. A bed lingering cough. I had an achy feeling. The doctor's office prescribed Paxlovid. The second time I was convinced I had a sinus infection, it was different. It was pretty much all in my head. I had a really bad headache, achiness, and a cough. I went to the urgent care and they prescribed Paxlovid.
Swollen glands behind the ear at the jaw line, severe chest pain and heart palpitations, fluttering accelerated pulse. Further testing required.  X-rays reveal possibility of a swollen heart valve. Patient has no history of heart problems.
After receiving her flu shot, patient walk out to the waiting area with her mom, patient complained of feeling dizzy and grabbed on to her mom, who slowly lowered her to the ground. Pharmacy staff called 911 and EMT arrived a couple of minutes later. While waiting for EMT, patient complained of thirst and was offered water and orange juice. When EMT arrived, they check patient's vitals and everything was normal. Per EMT, patient is fine to go home with parents. Parents are to monitor her the rest of the day.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unspecified dates in October 2015, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # K015816 and expiration date 29-MAY-2016; lot # L008057 and expiration date 01-DEC-2016; lot # K016279 and expiration date 24-APR-2016; exact doses were not reported, route of administration defaulted to oral). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Received vaccine on 3/9/21. Started experiencing facial numbness , difficulty with speech and swallowing on 3/16/21 around 11pm. Had facial drooping of the mouth and eye on my left side of face. Went to Hospital  ER around 5:30 am on 3/17/21 as symptoms did not subside.  I was later placed in stroke observation unit.   I had  2 MRI's, CT scan and Echo tests ran.  i was diagnosed with TIA.  All test were negative for a cause. I sent  a total of about 26 hours hospitalized.
This spontaneous case was reported by a health care professional and describes the occurrence of DIZZINESS POSTURAL (Feeling faint when standing up), PAIN IN EXTREMITY (arm soreness), FATIGUE (feeling tired), NAUSEA (nauseous) and CHILLS (chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Postural orthostatic tachycardia syndrome from 2015 to 2018. Concomitant products included ADRENAL SUPPORT for Adrenal insufficiency, LYSINE for Cold sores, ASCORBIC ACID (VITAMIN C CITRUS) for Combined immunity deficiency, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN D3, ZINC and FISH OIL for Supplementation therapy.    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness) and FATIGUE (feeling tired). On 14-Jan-2021, the patient experienced DIZZINESS POSTURAL (Feeling faint when standing up), NAUSEA (nauseous) and CHILLS (chills). At the time of the report, DIZZINESS POSTURAL (Feeling faint when standing up), PAIN IN EXTREMITY (arm soreness), FATIGUE (feeling tired), NAUSEA (nauseous) and CHILLS (chills) had not resolved.        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.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Non-Significant Follow-up; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The patient's concurrent condition of Postural orthostatic tachycardia syndrome remains a confounder.
Couldn't receive the second one; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Couldn't receive the second one) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery.    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, the patient experienced PRODUCT DOSE OMISSION ISSUE (Couldn't receive the second one). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Couldn't receive the second one) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant information were reported. No treatment medications were reported.
8 yo male came to the clinic for the 1st time on Jan 03, 2018 for school physical. He had normal PE no past med history, no allergies. He was given Tdap and MMR, went home, no problem but that night he developed severe headache, vomited and passed out, brought to ER and had CT with Rt frontal intracranial hemorrhage-he had emergency surgery and was diagnosed to have AV malformation of the brain (arteriovenous malformation). He survived and has (L) sided weakness and will do therapies and rehab and has unsteady gait and decreased tolerance to activities. I know these are not adverse effects of the shots but just to inform you what happened and the sequence of events and for your file.
Swollen, redness, itchy, pain. Started on Doxycycycline Monohydrate 100mg, warm soaks
Patient developed and increase amount of swelling at site of injection was red and hot to touch for 2-3 days after shot was given.  Redness was 2" x 2" in size.  On 4/10 patient still has 1/2" x 1" rash.
3 Days after vaccine I had itchiness at the vaccine site that developed into red raised rash that started at site and spread to my entire body
Large are of erythema, warm, and induration left deltoid measuring up to 10 x 12 cm with associated pain and pruritus
Soreness at the injection site; Dry / scratchy throat; Extreme fatigue; Slight nasal congestion; This is Spontaneous report from a contactable consumer. This 26-year-old consumer (patient) reported that she/he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown) at single dose for Covid-19 immunisation on 14Jan2021. Relevant history and concomitant drugs were unknown. The patient experienced Soreness at the injection site since 3 hours after the injection (vaccination), and Dry / scratchy throat, Extreme fatigue and Slight nasal congestion since 9 hours after the injection on 14Jan2021. The outcome of event Soreness at the injection site was not resolved. The other events was resolved 8 hours after onset.      Information on lot/batch number has been requested.