chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; body aches; tender left deltoid injection site pain.; fatigue; elevated temp/ tympanic temp of 100.8; This is a spontaneous report from a contactable nurse reporting for herself. A 32-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number EJ1685, via an unspecified route of administration on 21Dec2020 12:30 as a single dose (dose 1) in the left arm (age at vaccination: 32 years old) for COVID-19 vaccination. The facility where the most recent COVID-19 vaccine was administered wasa hospital. There were no other vaccines given in the 4 weeks prior to the COVID-19 vaccine. The patient was not pregnant at the time of vaccination. Medical history included diagnosed with COVID-19 on 06Jul2020, irritable bowel syndrome (IBS), depression, attention deficit hyperactivity disorder (ADD), cervical spondylosis, and herpes simplex virus (HSV); no allergies to medications, food, or other products. Concomitant medication included methylphenidate hydrochloride (CONCERTA), sertraline hydrochloride (ZOLOFT), valacyclovir, levonorgestrel (LILETTA), and colecalciferol (VITAMIN D). The patient woke up at 0400 on 22Dec2020 with tympanic temp of 100.8, chills, body aches, and very tender left deltoid injection site pain. The events were reported as non-serious. Treatment with ibuprofen resolved the elevated temperature, however she spent all of 22Dec2020 with fatigue and body aches despite ibuprofen. The tender left deltoid persisted for a total of 3 days and then became more tolerable, less tender. The clinical outcome of elevated temp/ tympanic temp of 100.8 was resolved on 22Dec2020, of fatigue and body aches was recovered on 23Dec2020, and of chills and tender left deltoid was recovered on an unknown date. Since the vaccination, has the patient has not been tested for COVID-19.
NAUSEA; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included Parkinson's disease, and arthritis, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on left arm on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea. This report was non-serious.
Hives like rash at the injection site area appeared relatively suddenly at 9 PM at night. Area was approx. 2-3" high by 2# wide. Applied topical cortizone cream which reduced itching. Arm was clear and no rash visible by morning (7 AM).
Severe swollen lymph node left axilla/ Injection site left arm; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El9262), via an unspecified route of administration on 22Jan2021 13:00 at a single dose on left arm for COVID-19 immunization. Medical history included Hypothyroidism, depression, vit D def., penicillin allergy and COVID-19. Concomitant medication included liothyronine sodium (CYTOMEL), levothyroxine sodium (SYNTHROID), celecoxib (CELEXA [CELECOXIB]), omega-3-acid ethyl ester (LOVAZA), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), and an unspecified vitamin. The patient experienced Severe swollen lymph node left axilla/ Injection site left arm on 22Jan2021 18:00. No treatment received for the event. The outcome of the event was recovering. The patient was not pregnant. No other vaccine in four weeks. Not COVID tested post vaccination.
red; itchy; bumps started appearing on her neck; some kind of a rash on her neck/looked like Blisters and welts appeared on her neck; some kind of a rash on her neck/looked like Blisters and welts appeared on her neck; rash only hurts to touch it; The caller also reported that her arm did get sore for 1.5-2 days; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6205), via intramuscularly in left arm on 11Mar2021 11:00 AM (age at vaccination was 66 years) as dose 1, single for COVID-19 Vaccination. Medical history included allergic to poison ivy and it looked like red and itchy from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 11Mar2021, 5 hours after vaccination developed some kind of a rash on her neck. The patient reported it looked like blisters and welts appeared on her neck, but the patient was not bothersome at all; it was just there. The patient wanted to know whether she should be concerned and should she get the second dose. She said that she knew that people have reported something like this happening on their arm and they call it Covid arm. It was also reported that bumps started appearing on her neck around 17: 00 that afternoon on 11Mar2021 and that was still red, still hurts, and was itchy. On 13Mar2021 it turned red on Saturday 13Mar2021 and still looked about the same as it did then. On an unknown date in Mar2021 the patient arm did get sore for 1.5-2 days and it was better then. Her rash only hurts to touch it. She wanted to follow up on it and see if she should go see her physician. Her husband did not even feel it. Patient had not received any other vaccine within 4 weeks. No investigation assessment reported. Outcome of the event some kind of a rash on her neck/looked like Blisters and welts appeared on her neck unknown. Bumps started appearing on her neck, red, itchy and rash only hurts to touch it was not resolved. Outcome of arm did get sore for 1.5-2 days was resolving.  No follow-up attempts are needed. No further information is expected.
headache; muscle pain; shivering; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, muscle pain and shivering. On an unknown date, the outcome of the headache, muscle pain and shivering were not recovered/not resolved.   It was unknown if the reporter considered the headache, muscle pain and shivering to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced muscle pain, headache and shivering after receiving a dose of Shingrix vaccine. The patient inquired how long does the side effects would last.
PRESSURE IN LEFT REAR SIDE OF HEAD; SEVERE HEADACHE; BAKER CYST; SHOULDER SWOLLEN LIKE A BALL; RIGHT ARM STARTED TO SWELL AND TIGHT; ARM PAIN AND SEVERE LEG PAIN BEHIND LEFT KNEE AND SWOLLEN; NAUSEOUS; SEVERE BACK PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included bladder surgery, and concurrent conditions included hypertension, frozen shoulder, and bladder problem. The patient experienced drug allergy when treated with cefalexin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 15:15 for prophylactic vaccination. Concomitant medications included mirabegron for bladder problem, amitriptyline hydrochloride for frozen shoulder, naproxen for frozen shoulder, and losartan for hypertension. On 28-NOV-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) negative. On 13-MAR-2021, the subject experienced severe back pain. On 13-MAR-2021, the subject experienced nauseous. On 15-MAR-2021, the subject experienced shoulder swollen like a ball. On 15-MAR-2021, the subject experienced right arm started to swell and tight. On 15-MAR-2021, the subject experienced arm pain and severe leg pain behind left knee and swollen. On 26-MAR-2021, the subject experienced baker cyst. Laboratory data included: Doppler scan (NR: not provided) no clots in arm or leg, had a 5 cm Baker cyst behind left leg. On 28-MAR-2021, treatment medications included: sulfamethoxazole/trimethoprim. On 05-APR-2021 15:00, treatment medications included: cortisone. On 06-APR-2021, the subject experienced severe headache. Laboratory data included: Blood pressure (NR: not provided) Normal. On 13-APR-2021, the subject experienced pressure in left rear side of head. Additional treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe back pain on 14-APR-2021, shoulder swollen like a ball, and right arm started to swell and tight on 03-APR-2021, nauseous, and severe headache on 07-APR-2021, was recovering from arm pain and severe leg pain behind left knee and swollen, and pressure in left rear side of head, and had not recovered from baker cyst. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Headache; fatigue; body aches; This is a spontaneous report from a non-contactable healthcare professional (patient herself). A 19-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the left arm on 13Jan2021 15:30 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. On 14Jan2021 06:00, the patient experienced headache, fatigue, and body aches. No therapeutic measure was taken as a result of the events. Clinical outcome of events was recovering.  No follow-up attempts are possible, information about lot/batch cannot be obtained.
Explosive diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Explosive diarrhea) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced DIARRHOEA (Explosive diarrhea). At the time of the report, DIARRHOEA (Explosive diarrhea) had resolved.            No concomitant medication was reported.  The treatment information was unknown.  Patient took second dose but had no adverse event.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Outcome of the event and narrative was updated.
Info. has been received from a registered nurse concerning a 4 mt old male w/a "casien" allergy, eggs allergy and gluten allergy and a history of transient synovitis in March 01, and hospitalization for pneumonia in April 01. On 11/7/97 and on 1/13/98 the PT was vaccinated with the first (lot #623260/0445E) and 2nd (lot # 624924/1112E) dose of HIB conjugate vaccine (MSD) (lot #623260/0445E). Concomitant therapy on 1/13/98 included alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (TRIPEDIA) and poliovirus vaccine inactivated (IPOL). Other concomitant therapy included cetirizine hydrochloride (ZYRTEC) prn. Subsequent to the vaccinations on 1/13/98 the mother reported that the PT developed a rash and fever (101 F). It was also reported that on 10/8/97 and on 3/13/98 the PT received a first (lot #624497/0923E) and 2nd dose (lot #625399/1447E) of Hep B vaccine recombinant (yeast). Concomitant therapy on 3/13/98 included a dose of alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (TRIPEDIA). Subsequent to the vaccinations on 3/13/98 the PT developed a rash, 13 days duration. The registered nurse reported that both fever and rash were thought to be related to a probable reaction to therapy with alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. On 10/8/98 the PT was vaccinated with varicella virus vaccine live (lot #628027/1257H). It was also reported that on 12/18/98 the PT was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (_) rubella virus vaccine live (2nd generation) (MSD) (lot #628905/1362H) (diluent # 629037/1521H). In June 99, the PT was diagnosed with pervasive developmental disorder, autism (WAES #01110497). The PT was being followed by an MD at the time of this report. Add'l info. has been requested.
Rash, itching  and swelling of my arm from my neck to my elbow. Slight tongue swelling and mouth itch.
This spontaneous report was received from a nurse concerning a 45 year old female patient. The patient's medical history, drug reactions or allergies, and concurrent conditions were not reported. On 07-JUN-2017, the patient was inadvertently vaccinated with a single dose of PROQUAD injection, by subcutaneous route, lot number M041082, expiration date: 04-APR-2018  for prophylaxis. This vaccine was reconstitued with diluent MRK (lot # and expiration date were not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. No product quality compalint was involved.
Patient developed symptoms beginning the night of the vaccine.  She became very dizzy and confused.  The following day she had pain and discomfort, remained very dizzy and confused.  The patient has dementia according to her husband/caregiver.
NONE Covid 19 vaccine expired. 02/08/2023  Given:  03/23/2023
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date the patient was vaccinated with RECOMBIVAX HB, intramuscular. Route, dose, dose number, frequency and lot number were not reported. The nurse reported that improperly stored RECOMBIVAX HB may have been administered to unspecified patients. RECOMBIVAX HB was exposed to temperatures of 31.5F for 4 hours and 31.5F for 1.5 hours. No adverse effects were reported. This case is linked to 1308USA014798, 1309USA013284 and 1309USA013285 (same reporter link). Additional information is expected.
On 12/03/05 patient got up as usual, had coffee, then experienced difficulty talking.  Unable to communicate to friends what was wrong.  Went to ER and experienced a seizure.  According to patient he does not remember what happened after that.  Next thing he remembered was waking up in hospital bed. 1/5/06 review of 2-page d/c summary indicates final diagnosis of new onset seizure disorder and mild gait ataxia. Review of medical record confirms new onset seizure diagnosis.
Severe hives, new food intolerances, Celiac Disease, and general autoimmune symptoms
had the Pfizer bivalent omicron5  booster on 09/07/2022 but 2wks later on 09/20/2022 I began feel pain in my feet&legs which worsened throughout the day causing extreme pain in both legs . It felt as if I had sprained both . My feet turned dark pink & I developed pink blotches up my legs. I also developed a fever over night to 102. I went to urgent care the next day. A rapid&pcr test were performed. I tested negative. Blood was drawn due to the dr believing it could be a vascular issue& clots potentially forming. Was told later d-dimer test confirmed & was told go er. I wen to local Hospital & was admitted because my Troponin I levels were escalating as well.  I spent from 9/21-9/24 in the hospital being tested for numerous causes . I was finally told most likely it was a demand ischemia event of my heart & erythema nodosum. I was seen by several drs including a cardiologist ,infectious disease & rheumatologistas well as attending dr&team
Expired 2nd dose given; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose given) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     The patient's past medical history included Lipid metabolism disorder NOS. Concurrent medical conditions included Essential hypertension. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for Hypertension.    On 29-Nov-2021 at 9:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose given). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication use was reported.   This case was linked to MOD-2021-399961, MOD-2021-399945 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Significant information received: Secondary reporter (Physician) added. Patient demographics (height, weight and race) added. Medical history added. Concomitant medication added. Dosing details updated.
1st vaccine 12/16/2020  2nd vaccine 01/06/2021 5/2/2021: Complaining of sore throat, body aches, chills cough and low-grade fever for 3 days.
Patient developed  abnormal/ elevated D-Dimer after booster shot with Pfizer vaccine  . After having overnight ( while sleeping ) nose bleeds, the patient went to the doctor and the D-dimer was 5 times above the normal limit.
Patient came in on 4/7/21 was set to receive the Covid -19 Pfizer vaccine in the clinic. Patient was give the vaccine on this date. On 4/9/21 patients husband came in with her vaccination card stating that the patient had been previously vaccinated. MD has been notified and advised to monitor patient and document. At treatment today 4/9/21 Nurses assessed patient during treatment, patient stated she was fine. Patients husband states she Nephrologist has been notified and advised to monitor patient and document. At treatment today 4/9/21 Nurses assessed patient during treatment, patient stated she was fine. Patients husband stated she did not have much of an appetite on 4/8/21 but as of 4/9/21 is doing well.
Mainly local reaction--swelling, redness, heat around injection site.  Lasted 5 days.  Had malaise, low grade fever for 2 days.
Pfizer COVID-19 vaccine (5-11yrs) manufacturer expiration date is 8/31/2022. However, vaccine expiration date after being transferred from freezer to refrigerator is 5/17/22. Vaccine was administered on 5/25/22.
mom states 2 hrs p/recvd vax pt became stiff & unresponsive; fever 103 ax; seen in ER; pt adm to hosp for observation; MD advised ped DT in future;
The vial was initially stored in the refrigerator on 06-APR-2023 and vaccine was administred to patient on 13-MAY-2023; no adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-APR-2023 and vaccine was administred to patient on 13-MAY-2023) and NO ADVERSE EVENT (no adverse event) in a 61-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-APR-2023 and vaccine was administred to patient on 13-MAY-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-APR-2023 and vaccine was administred to patient on 13-MAY-2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-APR-2023 and vaccine was administred to patient on 13-MAY-2023).    No concomitant medication was reported.  Dosage text reported as unknown. No treatment information was reported.
This spontaneous report as received from a Doctor of pharmacist concerning a male patient of unknown age with no allergies and no pertinent history who was vaccinated with  0.65 ml dose of ZOSTAVAX (Batch # 0364AE, Expiry date 16-MAR-2013) (lot # not reported), SQ on 14-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated that the patient brought a prescription of BACTRIM and prednisone 5mg 6 day dose pack for treatment of an unspecified condition to the pharmacy on 19-JUL-2012. At the time of reporting the patient had not recovered. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
No additional side effects; Inadverently administered Proquad instead of M-M-R-II; This spontaneous report was received from an other health professional (clinical director) referring to a 42 year old patient. The patient's concurrent condition, pertinent medical history, drug reactions, allergies and concomitant medications were not provided.  On 30-NOV-2021, the patient was inadvertently administered with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant Human albumin (rHA) (PROQUAD) for prophylaxis (0.5 mL; strength, vaccination scheme, route of administration and anatomical location were not reported; lot number T032144 has been verified to be a valid lot number, expiration date was 20-MAR-2022) instead of Measles, mumps, and rubella virus vaccine live (M-M-R II) (wrong product administered). No additional side effects or product quality complaints were reported (no adverse event).
I GOT IT ONCE YEARS AGO AND I GOT SO SICK; THEY FOUND IT DIDN'T WORK; A spontaneous report has been received from a consumer. The report concerns a female patient  of Unknown ethnic origin.    No medical history was reported.    No concomitant products were reported.    The patient started treatment with Flumist (influenza virus vaccine live, intranasal), nasal, on an unknown date.     The report described lack of effect for Flumist. The reported term was they found it didn't work (Preferred term: Drug ineffective).     On an unknown date, the patient experienced i got it once years ago and i got so sick (preferred term: Malaise).     The outcome of the event(s) of i got it once years ago and i got so sick and they found it didn't work was unknown.     The events  i got it once years ago and i got so sick and they found it didn't work were considered non-serious.