chrisvoncsefalvay/vaers-outcomes huggingface dataset:
But got Covid in between those doses; But got Covid in between those doses; This is a spontaneous report from a contactable consumer or other non-HCP (patient).   A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in left arm on 08Apr2021 (Batch/Lot number was 1005639239) as DOSE 1, SINGLE for covid-19 immunisation. The patient age at time of vaccination was 54 years. The patient medical history and concomitant medications were none. The patient received her first dose and was supposed to get the second dose on 29Apr2021 but got Covid in between those doses. The reporter reported that, patient received her first dose of Pfizer Biontech Covid Vaccine on 08Apr2021 and was supposed to get the second dose on 29Apr2021 but got Covid in between those doses. The patient asked if she should get the second dose. Pharmacist does not want her to get the second dose but upon speaking with her HCP, she was told that she could get them. The patient kept going to vaccination sites but not one wanted to give her the second dose. The patients original vaccination site where she got the first dose is now closed. The patient underwent lab tests and procedures which included COVID-19 test of positive around 22Apr2021 or 23Apr2021. Outcome of the events but got Covid in between those doses was unknown.  Information on the lot/batch number has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site reactions in an unspecified number of patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site reaction and pain. On an unknown date, the outcome of the injection site reaction and pain were unknown. It was unknown if the reporter considered the injection site reaction and pain to be related to SHINGRIX. Additional details were provide as follows: The reporter indicated that she had several patients that they experienced injection site reactions or were achy after receiving the vaccination. The reporter provided this information when she was discussing adverse event for other patient. The reporter was unable to provide any additional details.
Fever (about 102*), major chills, major headache, fatigue, pain at injection site, redness at injection site, minor nausea. Most of the symptoms were better by 2/4/2021 but still had a headache,  redness at injection site,  and fever the second day. Took acetaminophen the night of 2/3/2021 for fever and headache which helped a lot
Received Pfizer vaccines on  3/25, 4/19, 10/25/21 COVID-19 positive by PCR on  1/4/22 admitted to hospital on 1/8/22 to ICU d/t COVID pneumonia
Sudden onset bilateral hearing loss. Onset was 5/04/2021. I saw my ENT on 5/10/2021 where I was examined  and had a hearing test. The test results revealed moderate to moderately severe hearing loss in both ears. I was treated with two rounds of  oral steroids, but there has been no change in my hearing to date.
Systemic: Hypertension-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: She stated that she had some mild temporary pain in chest area.  Blood pressure was taken and was 112/82
190 patients (9 different lot numbers) received a vaccine past the beyond; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond).    No concomitant and treatment medication were provided This case belongs to 137 of 190 patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-704335: MASTER CASE
Developed a knot and rash at injection site along with severe headache and joint pain after the injection. Injection was 06/09/02. Symptoms started 8 hrs post injection and gradually got worse. 06/24/02 HA gone, mild joint pain, mild rash and knot still apparent but getting better.
After 6 hours of receiving the vaccine I had a low fever (between 99.8-101), chills, extreme body pain throughout my entire body. Unbearable body pain (head included) The body pain, fever and chills lasted 36 hours. Redness and significant swelling at sight injection which lasted 3 days. Pain and tenderness at sight injection which lasted three days. Body pain was so severe I couldn't sleep and could barely move.
65 year old patient received HEP A & B in left deltoid and Typhim VI fluvirin in right deltoid on 4/16/08.  Flu HEP B 5/15/08.  Patient did not report symptoms until 10/15/08 - presently pain, decreased ROM - chest exam consistent with brachial right tendonitis.  *Note patient has significant history for repetitive movement - Navajo rug weaver and swimming.
Felt like had the flu the next day; Body aches; Slightly nauseated; Severe chills; Felt like burning up; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 14Apr2021 at 09:30 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included cystitis interstitial and nasal infection; both from unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to food, medications, or other products. Concomitant medications included doxycycline (MANUFACTURER UNKNOWN) from unknown date for unknown indication and unknown if ongoing.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 24Mar2021 at 09:30 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 23:00, that night, the patient had severe chills for 3 hours, then felt like he was burning up. On 15Apr2021, the next day, the patient felt like he had the flu, body aches, slightly nauseated (but no fever). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe chills was recovered on 15Apr2021 and of the events felt like he was burning, felt like he had the flu, body aches and slightly nauseated was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Diabetic; Psoriatic arthritis aggravated; Ache; Vaccination site pain; This is a solicited report from a contactable consumer (patient) received by Pfizer from AbbVie Inc. (Mfr.Control No: 21K-163-4044346-00). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular on 01Apr2021 (Batch/Lot number was not reported) (at age 63-years-old) as dose 1, single, then via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for psoriatic arthropathy. The patient medical history was not reported. There were no concomitant medications. On unknown dates, the patient experienced diabetic, psoriatic arthritis flare up/plaques on lower left leg and felt achy. On 22Apr2021, the patient experienced reaction/had covid-19 vaccination and had a sore arm. In April 2021, the reaction/had covid-19 vaccination and had a sore arm resolved on Apr2021. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Outcome of ache was unknown and for the remaining events was not recovered.   The reporter's causality for the event(s) of reaction/had covid-19 vaccination and had a sore arm and diabetic with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of psoriatic arthritis flare up/plaques on lower front left leg with HUMIRA (adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of felt achy was not provided. The reporter's causality for the event(s) of reaction/had covid-19 vaccination and had a sore arm with PFIZER BIONTECH COVID-19 VACCINE was no reasonable possibility while for the remaining events was not provided.   The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based  on the available information the reported event of Diabetes Mellitus, Psoriatic arthritis, pain is considered as unrelated  to  suspected vaccine and more likely to ongoing medical condition of Psoriasis and also elderly age, The reported event of Vaccination site pain is considered as related to suspected vaccine BNT162B2  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
5 year old patient not received standard scheduled vaccines has received 1 QUADRACEL vaccine with no reported adverse event; Initial information received on 16-Feb-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 5 years old female patient who had not received standard scheduled vaccines , She has received 1 QUADRACEL vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine(strength, dose, formulation, route, lot number and expiry date: not reported) in unknown administration site for prophylactic vaccination.  On an unknown date the patient had not received standard scheduled vaccines, She has received 1 diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine (quadracel)  with no reported adverse event (inappropriate schedule of product administration) (latency: unknown).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event inappropriate schedule of product administration.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
muscle pain; headache; Nausea; chills; feverish; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 25th October 2021 11:00, the patient received the 2nd dose of Shingrix. In October 2021, less than a day after receiving Shingrix, the patient experienced chills and fever. On 25th October 2021 23:00, the patient experienced nausea. On 26th October 2021, the patient experienced muscle pain and headache. On an unknown date, the outcome of the muscle pain, headache and chills were not recovered/not resolved and the outcome of the fever and nausea were unknown.   It was unknown if the reporter considered the muscle pain, headache, chills, fever and nausea to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The patient received dose of Shingrix vaccine at his physician's office and felt nauseous before bed at around 11 pm, and was feverish and had chills in the middle of the night. The patient woke up today (on the day of reporting) with a headache, muscle ache and chills. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
After receiving the second dose of Moderna I started having skin issues first is was diagnosed as eczema which continued to get worse over the summer then in November 2021 after I received a booster my skin condition became severe. I finally saw a dermatologist is March 2022 and was diagnosed with severe psoriasis.   I believe the Moderna vaccine triggered or caused this condition.  I will be starting humira soon.
took APAP p/inject; 4 hr later 230PM 26JAN95 devel high pitched cry, became limp & pale; mom gave APAP; pt improved & the sx occurred each time the APAP was wearing off (ea 4 hr); last dose 9PM 26JAN95; pt has been fine since MN 26JAN95;
11/16/09 Itching, burning pain along L side of back to sternum. Rash developed on 11/22 started antiviral medication on 11/23.
showed cold like symptoms after returning from visit to family home, symptoms started 8-16-2021 in the evening Cough, stuffy nose, fatigue
This wasn?t really an adverse event from the vaccine. It was just that I did have Covid even though I had five vaccines.
incorrect product storage; No additional adverse effect reported; This spontaneous report recibed from a nurse practitioner refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with improperly stored doses of hepatitis a vaccine, inactivated(VAQTA) lot # T020109 expiration date 26-JAN-2022 for prophylaxis (strength, dose and route were not provided). No additional adverse effect was reported.  Digital Data Logger registered a temperature excursion between 47 to 77 Fahrennheit degrees (47.7) for 20 minutes.  This is one of several reports received from the same source. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme devicelotnumber: T020109; expirationdate: 26-JAN-2022; 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; Sender's Comments:  US-009507513-2104USA002701:
Patient came up to counter about 5 minutes after receiving his vaccine and stated he was feeling light-headed and that his sight and hearing  was going. We had patient slowly sit down on the floor near the counter, a tech got him a cool rag for his neck while pharmacist stayed with him. he started to feel much better after the rag was on his neck for a few minutes and said his vision and hearing was normal again. Denied history of this happening after vaccination. Patient denied any difficulty breathing or swelling of throat/tongue. RPH check bp and it was 95/55, pulse 80. Patient stated he  was at clinic yesterday and was told his bp was on the lower end of normal. Reported feeling a bit nauseous also. We gave him a bag in case he got sick and a small bottle of water. He was able to stand up and walk to a chair to sit down. We asked if he wanted us to call someone and he declined and said he was feeling better. We asked him to stay for 30 minutes more so we could monitor. After 30 minutes he reported the nausea had passed and he  was feeling normal again. He said he was ok to drive home.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 9:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 9:30 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient was reported as 53.85. No concomitant medications were reported. On 20-Mar-2021, 19 vials were moved to clinic. The vial was initially moved to the fridge on 09-Mar-2021 and proposed beyond use date was 08-Apr-2021.   On the date of administration, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and at 10:00 A.M., the temperature recorded was 37 degree Fahrenheit has been reached by the vial. The vial was moved to clinic on 20-Mar-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.The healthcare professional (HCP) reported that, each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. The vial was stored in cooler storage during high-pace COVID-19 vaccination clinic at the time of excursion. Temperature recordings were taken using a traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
had a mucus with a pale weird green color; eyes felt like they were burning; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (eyes felt like they were burning) and SECRETION DISCHARGE (had a mucus with a pale weird green color) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced EYE IRRITATION (eyes felt like they were burning). On 19-Feb-2021, the patient experienced SECRETION DISCHARGE (had a mucus with a pale weird green color). At the time of the report, EYE IRRITATION (eyes felt like they were burning) and SECRETION DISCHARGE (had a mucus with a pale weird green color) outcome was unknown.        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.
pt recvd vax & felt funny appeared anxious & c/o joints hurt, pulse was 120; pt screamed when teacher touched elbow; taken to ER;
Daughter stated that patient passed on 07/06, a few weeks after getting her 1st vaccine.  Daughter stated that she noticed that her mother had stomach pains the day before and the day of passing. Daughter stated tat Mother had EKG test and heart inflammation was found. Patient passed due to heart inflammation.
Right arm and under site into armpit was very sore and red.  Luke warm compresses 2-3 times a day and Motrin for pain as prescribed.
sore and swollen arm at injection site.  rash on area around the injection side.  Physical body aches . Shot was on a Friday, symptoms lasted through Saturday.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021 at 1:31 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021 at 1:31 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Sep-2021 at 1:31 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported