chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got covid). At the time of the report, COVID-19 (Got covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Got COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company comment: This is a spontaneous case concerning a  male patient  of unknown age  with no reported medical history, who experienced the non-serious unexpected event COVID-19 (AESI), on an unknown date after receiving an unspecified dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report  No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. Patient wanted to know where patient can get the Moderna booster shot.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2022: Follow-up received and contains no new information. Sender's Comments: Company comment: This is a spontaneous case concerning a  male patient  of unknown age  with no reported medical history, who experienced the non-serious unexpected event COVID-19 (AESI), on an unknown date after receiving an unspecified dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report
Patient was supposed to get Varicella vaccine and was accidentally given MMR by healthcare provider in clinic. No adverse reactions noted during time patient was present. Varicella and Hep B vaccine were given at same visit.
Patient administered with expired vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine after the manufacture date of expiration) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Vial did not undergo any temperature excursion.  Date vial was initially stored in the refrigerator was unknown. Total of 102 doses were given from LOT 026C21A with expiration date 24-Oct-2021. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non-significant follow up received. Reporter details added.
Pt stated on 9/30/2019 that she had been experiencing vomiting for 3 days following her Shingrix vaccination. She also stated she was having pain below her right ribs. I suggested she go to the urgent care to seek care as soon as possible, and she said she would do that.
Attendee developed tingling in the left arm and felt slightly dizzy 5 minutes after receiving the vaccination.  Assisted to a cot and her legs were elevated.  HR 69 BP 118/62 RR 18 O2Sat 99%. One minute later reported that her left leg was also tingly.  One minute later she was given some water and she said that she was feeling better.  She was assisted to a chair and her vital signs were Hr 80 BP 120/60 O2Sat 100%. 15 minutes after receiving the vaccine she denied symptoms and was discharged to home with her mother. They were both educated on adverse reactions and she was advised to rest and drink plenty of water.  Attendee walked out of the clinic independently with her mother at 5:15 pm.
This is a spontaneous report from a contactable nurse, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204 ??? ENG204??) via an unspecified route of administration in the left arm on 20Mar2021 at 12:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included depression. The patient previously had shellfish, iodine, sulfa drugs and experienced shellfish allergy, iodine allergy and sulfonamide allergy. The patient was allergic to chemicals (dye). The patient previously took codeine and ibuprofen and experienced drug allergy to codeine and ibuprofen. Concomitant medications taken within two weeks included meloxicam 15mg everyday (MANUFACTURER UNKNOWN) from unknown date for unknown indication and escitalopram oxalate 15mg every night (LEXAPRO) from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021 at 12:05, five minutes after vaccine the patient felt her throat and neck very tight but 8 could breathe and swallow. Also got sensation in her brain like there were ants crawling in her brain on 20Mar2021. On 20Mar2021 at 12:15, 15 minutes after the vaccine the patient felt itching to her chest and back. No rash developed just itching that got intense every jow and then. The itching lasted three days. The patient did not receive any treatment for the adverse events. The clinical outcome of the events itching to chest and back was resolved after three days on 23Mar2021 and of neck very tight, throat tight, ants crawling in brain was resolved on an unknown date in 2021 at the time of this report. No follow-up attempts are needed. No further information is expected.
Dizziness, syncope, BP dropped Narrative: Follow Up with PMD. Out of work for 3-4 days.
2X3 RASH RED RAISED REACTION AROUND SHOT INJECTION SITE ON POSTERIOR ASPECT OF RIGHT UPPER ARM WITH TENDERNESS. TREATMENT: MONITOR SITE, RETURN TO PROVIDER IF WORSENS.
11/16/10 Abdominal pain, vomiting, runny nose, fever sudden onset grunting, coughing, decreased level of consciousness. O2 started. Transferred to ER then PICU - went by ambulance.
This medically confirmed spontaneous report (initial receipt: 19-Oct-2012) concerns a female patient, who had no drug allergy or taking any concomitant medication. On 18-Oct-2012 the patient received AFLURIA (batch number was not provided) injection at a dose of 0.5 mL intramuscularly. On 18-Oct-2012, within 20 minutes of receiving AFLURIA, the patient developed swelling of her eyelids, both upper and lower. After swelling was noticed, the eyelids became very itchy and within 2 hours of vaccination, both eyelids became very red as well. The patient took two PEPCID AC tablets for swelling on 18-Oct-2012. She was followed up the next morning and she still had some residual puffiness and redness around both eyelids. No lab diagnostic study was performed. The patient was observed by the nurse who gave the injection. The event outcome was recovering.
Nausea, vomiting, feverish, sweating cold, aches, burning eyes.
fever; body aches; This is a spontaneous report from a contactable consumer. This female consumer of an unspecified age reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6208; Expiration Date: Jun2021, NDC Number: not provided), via an unspecified route of administration on 15Mar2021 at 11:15 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Investigation assessment was not provided. She received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiration Date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunisation. The patient had a few side effects following the Covid-19 vaccine but that they occurred on 16Mar2021 at 01:15 (14 hours later after receiving the vaccine). Caller did not provide details of the side effects she experienced. The patient and her husband vaccinated the same day, the same schedule - quarantine. She mentioned that the she received the same lot/batch numbers as her husband, but she was otherwise fine. The patient experienced fever and body aches on an unspecified date and resolved within 2 day. It was spoken from information available in fact sheet that the frequencies for fever and muscle pain are from the 7 days following either dose of vaccine. Provided information on duration of injection site reaction the mean duration of pain at the injection site after dose 2 was 2.5 days (range 1 to 36 days) [LAB-1457-6.0; Revised: 25 February 2021]. Directed caller to back to HCP for treatment recommendations.The outcome of events was recovered on 18Mar2021 at 01:15.   No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect, received from a contactable nurse (patient). A 67-year-old female patient received PREVNAR 13, via an unspecified route of administration in the deltoid on an unspecified date in 2016 (reported about 3 years ago) at a single dose for immunization. Medical history included ongoing rheumatoid arthritis where patient reported that she had symptoms years before but diagnosed 15-20 years ago - probably closer to 15 years ago; multiple orthopedic operations where patient received Encef IV, pneumonia, upper respiratory infections and immune compromised. Concomitant medication included prednisone, etanercept (ENBREL) and methotrexate; all at unknown dose from unspecified date and ongoing for rheumatoid arthritis. The patient previously took keflex cefalexin monohydrate (KEFLEX). The patient reported that the next day after receiving the vaccine, the patient developed rash that lasted for more that a few days. The patient added that the rash was mostly the trunk and back, her neck, chest, and abdomen which may have been on the inner aspect of her arms but she isn't sure. The patient also reported that her rheumatologist wants her to get "PREVNAR 23" and at her pharmacy they won't give her the vaccine if they know that the rash was an allergic reaction. The patient would like to know if the her rash was a side effect of the medication or an allergic reaction. The patient assessed the event as non-serious. The outcome of the event was recovered on an unspecified date.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient 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.    On 11-Jan-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 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) 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 (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    This case contains information for the 13th of 100 adult male patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  Nurse reported that an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again. The 100 adult male patients were involved.  Moderna COVID19 vaccine bivalent, dosage given in ml unknown to the HCP.   Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:MASTER CASE
Patient reported that she developed an odd taste in her mouth while she was sitting  for 15 minutes after she received the vaccine.  She said that she knows her body, and that the taste was unusual, but she could not describe it more than that.
CC: started feeling warm 5 minutes after vaccine administration. dizziness, nausea, vomiting. Treatment: no medication was given. patient was under observation for 30 minutes  Water improved symptoms Outcome: symptoms resolved and patient was sent to POV/Home.
Patient was dizzy, nauseous,  and had trouble walking.  This started Sunday night 2/13/2022, and continued into 2/14/2022 .
This spontaneous report was received from a pharmacist refers to a female of unknown age. Patient's pertinent medical history and drug reactions were not reported. In 2012 (reported as on an unspecified date, approximately 2 years ago) the patient was vaccinated with ZOSTAVAX (dose, frequency, therapy route lot #, expiry date unspecified). Concomitant medications were not reported. The patient reported that during vaccination, some of the vaccine dripped down her arm. No adverse experience was reported. Outcome of the event was not reported. No product quality complaint (PQC) was reported. Reporter considered the event to be not related to ZOSTAVAX. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L038917, expiry date 20-FEB-2018, lot # L048459, expiry date 20-FEB-2018, lot # L044475, expiry date 12-MAY-2017 and lot # L043213, expiry date 28-AUG-2017 (dose, route of administration and anatomical location were not specified). On an unknown date the administered doses of GARDASIL 9 underwent temperature excursion of 1 Celsius degrees for 2 hours. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
After  patient got the shingrix vaccine  she was ready to pick up her prescription.  She complained about dizziness and being not feeling good. We let patient  sit and patient started to lose conciouseness.  We called 911. Nurse practional came to help patient to lay down and gave  water and peanut butter bar. Patient got counscius afrer 2 minutes.  NP checked her vital sign, 128/82, pulse 72, oxygen 98. 911 came and double check her condition. Pt got feel better and left the store with her husband.
Patient developed fever T max 106 degrees F 48-52 hours post vaccination. Cold, runny nose. Seen at the ER and diagnosed with ear infection. Treated with antibiotics.
Hot Flash with Sweats, Followed by fainting, Non-responsive, Elevated blood pressure
her antibody level was checked again and this time it had decreased to 236/ another booster shot of Moderna, after which her antibody level was 74; Patient's antibody levels have decreased despite getting multiple booster shots; receive another booster shot of Moderna; This spontaneous case was reported by a physician and describes the occurrence of ANTIBODY TEST ABNORMAL (her antibody level was checked again and this time it had decreased to 236/ another booster shot of Moderna, after which her antibody level was 74), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient's antibody levels have decreased despite getting multiple booster shots) and EXTRA DOSE ADMINISTERED (receive another booster shot of Moderna) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical history reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANTIBODY TEST ABNORMAL (her antibody level was checked again and this time it had decreased to 236/ another booster shot of Moderna, after which her antibody level was 74), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient's antibody levels have decreased despite getting multiple booster shots) and EXTRA DOSE ADMINISTERED (receive another booster shot of Moderna). At the time of the report, ANTIBODY TEST ABNORMAL (her antibody level was checked again and this time it had decreased to 236/ another booster shot of Moderna, after which her antibody level was 74) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient's antibody levels have decreased despite getting multiple booster shots) and EXTRA DOSE ADMINISTERED (receive another booster shot of Moderna) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 236 (Low) decreased to 236, 74 (Low) level was 74, 392 392 and 61 (Low) 61.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The physician reported that the patient has received the primary series of the Moderna COVID-19 vaccine and after 8 months receiving the 2nd dose, her antibody level was measured which came out to 392. The patient received the booster dose after 3 month from 2nd dose. The patient then decided to receive a Pfizer COVID-19 booster after which her antibody level fell down to 61. The physician is shocked and does not understand what is going on with this patient. He is not sure if there is some sort of immune tolerance that this patient has developed and that is causing a steady decline in antibody levels no matter the number of boosters the patient is getting No concomitant medication reported. No treatment medication details reported.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 14-NOV-2013 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-AUG-2016 the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. Because of the severity of his condition, the patient sought subsequent treatment from another physician for ongoing and worsening shingles symptoms. The patient has been prescribed acyclovir for management of his persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
VERTIGO; This spontaneous report received from a consumer concerned a male of unspecified age. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vertigo. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vertigo was not reported. This report was non-serious. This case, from the same reporter is linked to 20210722977.
pt recv vax & w/in 18 hr began to exp severe arm pain (con to date reported); pt reports lt arm lateral tendonitis & a dec arm strength of 17 pounds in lt arm;
ST; fatigue; congestion; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 43-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, manufacturer unknown), for Covid-19 Immunization, reaction(s): "ag test 10Feb2023"; Covid-19 vaccine (Dose: 2, manufacturer unknown), for Covid-19 Immunization, reaction(s): "ag test 10Feb2023"; Covid-19 vaccine (Dose: 3, manufacturer unknown), for Covid-19 Immunization, reaction(s): "ag test 10Feb2023". The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 09Feb2023, outcome "recovering", described as "ST"; NASAL CONGESTION (non-serious) with onset 09Feb2023, outcome "recovering", described as "congestion"; FATIGUE (non-serious) with onset 09Feb2023, outcome "recovering". It was unknown if therapeutic measures were taken as a result of oropharyngeal pain, fatigue, nasal congestion.  Additional information: Facility type vaccine was workplace clinic.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300063647 same patient, different dose/drug/event;
Received Pediarix, Hib and PCV vaccines on 7/18/06. Since 8PM on 7/18 PT with low grade fever whining, spitting up and decreased appetite.