chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu like symptoms; sore arm; bad headache; body aches; chills; Pyrexia 99-100 degree fever; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PAIN (sore arm), HEADACHE (bad headache), MYALGIA (body aches) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PAIN (sore arm), HEADACHE (bad headache), MYALGIA (body aches), CHILLS (chills) and PYREXIA (Pyrexia 99-100 degree fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PAIN (sore arm), HEADACHE (bad headache), MYALGIA (body aches), CHILLS (chills) and PYREXIA (Pyrexia 99-100 degree fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, Body temperature (99-100): (Inconclusive) 99-100 degree fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.   This case was linked to MOD-2021-044969 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow up information received on 12-JUL-2021 contains no new information.
first dose of Shingrix 3 years ago and never got the second dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago).   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first dose of Shingrix 3 years ago and never got the second dose.).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-AUG-2023 The health care professional (HCP) asked if the patient has to restart the series. The reporter did not provide information about the first dose of Shingrix. The pharmacist reported that a patient received the first dose of Shingrix 3 years ago and never got the second dose, which led to incomplete course of vaccination. The reporter consented to follow up.
7 days after vaccination, injection site warm, red approx 2-2.5 in in diameter, hives and itching.  Applied topical benadryl gel and ice.
On 7/6/22, Pfizer 5-11 orange cap was administered to patient without dilution.  On 7/27/22, this was realized when patient came in for 2nd dose. Pfizer was contacted, no recommendation given for 2nd dose. Patient and parent were notified. Patients Medical Provider notified.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-MAR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-MAR-2022) in a 30-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Mar-2022 at 5:46 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 21-Mar-2022 at 5:46 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-MAR-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-MAR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-MAR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-MAR-2022) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported  No treatment medication reported.
Information has been received from a Registered Nurse (R.N) concerning a patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (Lot # 663819/0036Y). It was reported that a patient had injection site reactions from VARIVAX (Merck). The patient sought medical attention with an office visit. It was reported that the patient was still recovering at the time of the report. In follow up the nurse reported that an 8 year old female patient was vaccinated with a dose of VARIVAX (Merck) (Lot # 663819/0336Y on 05-MAY-2009 (purchased through the vaccines for Children program). The patient recovered. This is one of several cases from the same source. No further information is available.
Within 5 minutes of vaccine admin, child had hives on face; swelling around eyelids was given Benadryl po. Noticed to cough and hoarse voice, hence SC Epinephrine, O2 given, transported to ER via ambulance.
This spontaneous report as received from a 64 year old female patient regarding herself. Patient's medical history was breast cancer and current condition included high blood pressure. The patient had no drug reaction/allergies. On 17-FEB-2013, the patient was vaccinated with a first dose of ZOSTAVAX and on 13-MAR-2013, the patient received a second dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported for both). Concomitant therapies included COREG and DIOVAN HCT. On 13-MAR-2013, the patient experienced body aches, dizzy spells and excessive sweating that usually lasted from one hour to two hours and one time the symptoms lasted all day. The patient sought no medical attention and no treatment was given for the events. No lab diagnostics studies were performed. The outcome of body aches and dizzy spells with excessive sweating was reported as not recovered/not resolved. The outcome of received two injections of the ZOSTAVAX vaccine was unknown. Additional information is not expected.
99.6 fever for about 2 weeks. She stopped wanting to eat about 3 days later and got bad reflux with coughing, sneezing, choking, gagging and spitting up. Refusal to eat and long periods of sleep.
7 year mistakenly getting Moderna vax instead of PFE/she was given a moderna covid vaccine instead of Pfizer for 5-11 year old; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (7 year mistakenly getting Moderna vax instead of PFE/she was given a moderna covid vaccine instead of Pfizer for 5-11 year old) in a 7-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (7 year mistakenly getting Moderna vax instead of PFE/she was given a moderna covid vaccine instead of Pfizer for 5-11 year old). At the time of the report, PRODUCT ADMINISTRATION ERROR (7 year mistakenly getting Moderna vax instead of PFE/she was given a moderna covid vaccine instead of Pfizer for 5-11 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The reporter was unsure of dosage as the pharmacy had not yet sent over the records.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Reference number was added.
No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    Concomitant medications were not reported.  27 adult patients received pediatric dose of Bivalent  COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                  No treatment information was provided by the reporter.  This case contains information for the 11 of 27 adult patients described by the reporter.
arm still hurts; feel really crappppy; This case was reported by a consumer media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16th September 2021, the patient received the 1st dose of Shingles vaccine. In September 2021, less than a week after receiving Shingles vaccine, the patient experienced pain in arm and feeling abnormal. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the pain in arm and feeling abnormal to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported The patient had received the first dosage on last Thursday from the day of reporting and my arm still hurts, also felt really crappy. No contact details were reported.
This spontaneous report was received from a currently 76 year old male patient, reporting on himself. The patient's pertinent medical history and drug reactions/allergies were reported as none. Concurrent conditions and concomitant medications were not reported. On 11-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX subcutaneous for prophylaxis (dose, lot # and expiration date were not reported). Other suspect therapies included PNEUMOVAX23 and an unspecified "flu shot" for prophylaxis (dose, route, lot, expiration date an indication were not reported for both therapies). On an unknown date, the patient experienced a "swollen elbow on the right arm, that was also itchy, red and had muscle aches." It was stated that the patient was experiencing muscle pain "from (his) elbow to (his) shoulder and around (his) neck" and that he had weakness in his legs. No treatment was given for the adverse events. It was reported that the patient had monthly follow up appointments with his physician so his arm could constantly be looked at. At the time of reporting the outcome of the events was reported as not recovered. A product quality complaint was not involved. The causality assessment between the events and ZOSTAVAX, PNEUMOVAX23 and the unspecified influenza vaccine was not provided. Additional information has been requested.
IMMUNIZED 8 MAR 05, FOUND TO HAVE AUTOINOCULATION SITE ON LEFT ARM NEAR ORIGINAL SITE (IN BAND AID AREA). NO SYSTEMIC SX OR OTHER PROBLEMS.
Per pt: sore and achy from elbow up, unable to move arm, hot at injection site, has had chills and been dizzy today. Has taken 2 doses of naproxen without relief.
Rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of RASH (Rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown. Not Provided    No concomitant details were provided No treatment details were 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.
high pitched cry for more than 3 hrs; very hot unable to take temp whooping cough for 3-5 days;
administration of expired PNEUMOV AX 23.; No additional edverse events reported; This spontaneous non-valid report was received from a pharmacist who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On an unknown date, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, exact dose, route of administration and anatomical location were not reported; lot number S018405 was confirmed to be valid, expiration date was not reported but upon internal validation process, it was established as 28-MAR-2021 for prophylaxis.  The reporter asked if the patient would need to be revaccinated. No additional adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S018405; expirationdate: 28-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This literature report as received from a physician through a published journal articles. Physician was concerned about safety of GARDASIL (dose, route and lot number were unspecified) after reading two journal articles stated that GARDASIL has been show to cause premature ovarian failure. Physician stated that he had no information and no access to specific patient information. Action taken with the therapy and outcome of event was not reported. The reporter considered premature ovarian failure to be related to GARDASIL. No product quality complaint involved. Additional information has been requested.
pt states that she developed a head ache, chills, fever and sore arm. Pt took Advil to alleviate the pain and her reaction lasted around 24 hours .  The symptoms had subsided by 2 PM the next day.
That evening /p school pt felt hot T 102.2, Red blotches on body, throat sore /w some swelling felt throat closing off /w breathing difficulty. Cool bath given /w Tylenol & steam. Woke up next morn c/o headache & stomach ache. Saw MD 29Jan
5-6 minutes after vaccine mother came from room reporting that patient was feeling nauseated.  Patient then started to have hives on face and neck.  When patient asked if he was having any difficulty breathing he reported yes, a code was called.  Code team responded.  Patient received IM Epi and was taken to ED for observation.  Patient was later discharged home. Spoke with mother next day she reported patient had no further reaction and was same as prior to vaccine.
Medication was administered at about 4.5 weeks of age follow-up instead of at 6 weeks per package insert due to mix-up at pediatrician office; Mild transient fever; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age  received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that medication was administered at about 4.5 weeks of age follow-up instead of at 6 weeks per package insert due to mix-up at pediatrician office ("earlier this week"). It was reported that no adverse event noted except potential mild transient fever (per grandmother) that resolved without medication within an hour or two that occurred approximately one day after administration.   No follow up attempts are possible. No further information is expected.
warm to touch, large lump, sharp pain; 16APR Pred added to treatment; seen by MD;
Information has been received from a physician via a company representative, referring to a teenaged male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (strength, anatomical location, administration route, lot number and expiration date were not reported) for prophylaxis. On an unspecified date, the teenaged patient developed Postural Orthostatic Tachycardia Syndrome (POTS). The outcome of postural orthostatic tachycardia syndrome was unknown.
Information has been received from a registered nurse concerning a 10 year old patient who on 20-NOV-1997 was vaccinated with a dose of Varivax (Oka/Merck). On an unspecified date, the patient developed a generalized rash with 50 to 200 lesions. It was unknown if the patient had a fever or cough or had known contact with another case of varicella. It was unknown if the patient sought medical attention. Follow-up information received on 03-AUG-2006 stated that no additional information is available on this patient.
Partent called. Child vaccinated 10/28/1997 with varivax. Has outbreak of chicken pox today. 5 students at pt school with varicella.
Patient received fourth dose at quicker interval than recommended.  Received at day 72.  Discovered post administration.  Told patient before she left facility.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 03-JUN-2016, the patient was vaccinated with improperly store ROTATEQ (dose and frequency were not reported). The reporter did not know which dose from which lot was administered to the patient and the possible ROTATEQ lot# administered was: lot # L029618 (expiry date: 20-MAY-2017), L038534 (expiry date: 19-AUG-2017) and/or M004508 (expiry date: 29-JUN-2017). No adverse effects were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the two reports from the same reporter. Additional information has been requested.
Patient gave verbal and written consent for 4th Moderna vaccine.  We checked the computer and he only had 3 doses in it.  After we gave him his 4th Moderna we found out that he had already gotten it 1 month ago at pharmacy which had not yet been reconciled into our records
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Negative, notes: after testing negative day 9. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had Paxlovid for indication of COVID-19 treatment start date on 24May2022 and treatment stop date on 28May2022.Other medication Amlodipine 2weeks start date on 02May2019.Adverse event: Rebound Covid day 13 (after testing negative day 9) Symptoms returned day 13 after initial infection - 6 days after completing paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt came to ER c/o pain with deep breaths, dry cough, loss of taste, abdominal pain.
When she woke she felt like she did when she had Covid/felt like she had Covid; Chills; headache; temperature of 99.6-100.1F/Fever; I still felt a little tired; my arm was killing me; felt weird; felt weird like she was unsteady on her feet; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient (Weight: 53.52 kg, Height: 157 cm) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 26Feb2021 08:30 as 1ST DOSE, SINGLE for covid-19 immunisation. She is unable to clearly identify the Lot due to illegible handwriting on the vaccine card. She thinks it is EN6200 or EN06200. Vaccination Facility Type: Clinic sponsored by (Name). Vaccine not administered at Military Facility. Medical history included covid-19 from 2020. She was also told that she might not need to get the second dose because of having antibodies. When she had Covid it was mild. She did not have the traditional symptoms. It affected her gastrointestinal system more. It was weird. Prior Vaccinations (within 4 weeks) was None. There were no concomitant medications. On 26Feb2021, after she got the vaccine, her arm was killing her. It was awful. She took Tylenol for it. Around 3-4pm she was feeling a little bit weird/"felt a little funny" like she was unsteady on her feet. She was not dizzy. She woke up the next day, 27Feb2021, felt "rotten", "almost like I felt when I had covid/ felt like she had Covid. Same symptoms, milder form": slight headache for 3 hours, chills lasted a couple of hours, temperature of 99.6-100.1F for 3 hours. She was awful in the morning and better as the day went on. It remined her of when she had Covid. After symptoms went away, she still felt a little tired. Didn't feel as good as she did before the day she took the vaccine. Caller said the vaccination Nurse told her that she might have more reaction because she may still have antibodies. Caller asking did she need to get 2nd dose? Should she expect reactions from the second dose? She still plans on taking it. The outcome of arm was killing her was recovering. Her arm is better but if she lays on her arm she can still feel it. The outcome of felt a little tired was unknown. The patient was recovered from other events on 27Feb2021.   Information on the lot/batch number has been requested.