chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The evening she received the vaccine, she developed about a 4 in red rash that was flower shaped. It was slightly puffy. She also reported that she felt feverish. The next day the redness continued to spread and pt stayed in bed all day. The following day (day 3) it was a little better. She came to pharmacy day 4. Rash was still present but was resolving.
My wife and I both had all the vaccinations Pfizer offered and all the boosters from Pfizer offered./Pfizer however they were positive with Covid19, he and his wife; My wife and I both had all the vaccinations Pfizer offered and all the boosters from Pfizer offered./Pfizer however they were positive with Covid19, he and his wife; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "My wife and I both had all the vaccinations Pfizer offered and all the boosters from Pfizer offered./Pfizer however they were positive with Covid19, he and his wife". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive.  Clinical course: The was fully vaccinated with Pfizer (COVID-19 Vaccine); still got positive with Covid. This report is related to a study or program. The patient was also the reporter. He was a patient and he was calling to ask if there was a correlation between Paxlovid and all of the vaccination they received. He mentioned that he was fully vaccinated with Pfizer however they were positive with Covid19, he and his wife. What was the correlation between Pfizer vaccinations and boosters My wife and I both had all the vaccinations Pfizer offered and all the boosters from Pfizer offered? What is the correlation between Paxlovid and all the vaccinations we had from Pfizer." The Correlation between Paxlovid and all the other vaccination that he received that was his exact question. All the vaccination he has received, he mentioned that he is fully vaccinated with Pfizer (Later clarified as COVID-19 Vaccine hence captured as suspect and manufacturer checked Yes for Pfizer) and they still got positive with Covid.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200836871 Same reporter/drug/AE, different patient;
Received vaccine at 1530 on 08/16/11. Next day at 1600 complained of burning to touch, hard 1-1 1/2" diameter knot at immunization site. Very localized, red and inflamed. Symptoms continued on 08/19/11. Encouraged patient to see physician if condition persists or worsens. Resolved 8/21.
Suspected vaccination failure; I still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I still got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 22-Jul-2023 This case was reported the patient via interactive digital media. The patient had both the shingles shots and still got shingles. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
Swelling redness right arm. Acetaminophen 650 MG QID.
mo put sunscreen on face day of vax;2 days p/ vax little red dots on upper cheeks, not itchy & T99.3-99.5(ear);4th and 5th day p/ vax, afebrile but out of sorts & wanting to be held more; AM-6th day found dead in bed, COD SIDS, autopsy neg.
7 days post 1st COVID vaccine, developed cellulitis at the injection site (left arm).  Symptoms include:  Redness, warm  to touch, swelling and arm pain.  Antibiotic called into my pharmacy by my primary doctor.
Itching of my skin/skin and entire body is so itchy; slight burning sensation across my entire body surfaces; This is a spontaneous report from a contactable other health professional (patient). A 29-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection, Batch/Lot Number: Ens318), via an unspecified route of administration, administered in left arm on 22Feb2021 12:15 (at the age of 29-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had received first dose BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection, Batch/Lot Number: Ej1g86), via an unspecified route of administration, administered in left arm on 11Jan2021 02:45 (at the age of 29-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Feb2021 16:00, it was reported that, on early evening of the day after receiving the second vaccine the patient experienced itching of my skin. It has become worse and the patient missed work because skin and entire body was so itchy. Patient reported no rash, just an itchy, slight burning sensation across entire body surfaces. The patient underwent lab tests and procedures which included nasal swab: unknown results on 23Feb2021. Patient did not received treatment for an events. Seriousness reported as non-serious. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of the events was not recovered.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
pt recvd Recombivax-HB in 1988; In JUN90 tested neg; booster dose or Recombivax-HB given JUL90; titer done AUG90 was neg; 2nd series of Recombivax was not completed; recvd a dose of Engerix-B MAY92 again tested neg;
arm pain; shoulder pain; headache; pre-syncope episode; This case was reported by a physician via sales rep and described the occurrence of pain in arm in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABX795AA, expiry date unknown) for prophylaxis.   On 7th June 2019, the patient received Bexsero .5 ml. On 8th June 2019, 1 days after receiving Bexsero, the patient experienced pain in arm, shoulder pain, headache and presyncope. On an unknown date, the outcome of the pain in arm, shoulder pain, headache and presyncope were unknown.   It was unknown if the reporter considered the pain in arm, shoulder pain, headache and presyncope to be related to Bexsero.  Additional details were provided as follows: The patient reported arm and shoulder pain, headache, and had a pre syncope episode the next day after receiving the vaccine.
ADMINISTRATION OF VACCINE EXPIRED DUE TO TEMPERATURE EXCURSION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 21 year old female. 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: 1808986, and expiry: 02-OCT-2021) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUN-2021, the patient experienced administration of vaccine expired due to temperature excursion. On 21-JUN-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine expired due to temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915731, 20210915852, 20210916228, 20210916312, 20210916300, 20210916455, 20210913164, 20210915646, 20210916553, 20210916401, 20210916658, 20210916910, 20210916415, 20210916697, 20210916965, 20210917160, 20210915623, 20210916808, 20210916465, 20210915661, 20210917074, 20210916129, 20210916520, 20210916715, 20210916811, 20210916849, 20210916959, 20210917163, 20210916907, 20210916768, 20210917515, 20210917226, 20210917500, 20210916584, 20210918425, 20210915719, 20210916498 and 20210917603.
Information has been received from a registered nurse concerning a female with an estimated age of 20 year old with cheese allergy who on 04-MAR-2008 was vaccinated with a dose of 0.5mL GARDASIL (lot# reported as 658219/0755U) intramuscularly in the deltoid.  Concomitant therapy included VALTREX.  After receiving GARDASIL, the patient developed a "fever of 106 F" and was hospitalized for an unspecified period on time.  The fever lasted two weeks and subsequently recovered.  The patient told the physician of the fever at an office visit on 19-Sep-2008.  No other symptoms or information about treatment reported.  Additional information has been requested.
severely immunocompromised; This is a spontaneous report received from a contactable consumer (patient's neighbor). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on unspecified date in Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if patient had COVID-19 before vaccination. The reporter stated that he/she was on her/him neigborhood homeowner association (HOA) and someone applied to install a fence. When we set up the walkthrough, they volunteered that they hoped everyone was vaccinated since they had a major adverse medical event following the first of the Pfizer vaccine last Mar2021. They indicated they could not receive a second dose and he/she was now severely immunocompromised. The event was reported as non-serious, and it was unknown if treatment was received. It was unknown if patient was tested for COVID-19 since vaccination. The outcome of the event was unknown.
Pt had friend come with her as pt stated she was "really afraid" of shots. Had topical anthesia applied to upper arms - secured by transparent covering. Cleaned site with alcohol, gave shot. Pt slumped on self and friend. Pt stated she was not nauseated and then vomited. Applied cold compress to neck and forehead. Led to chairs in hall where pt drank water and held compresses. Stated she felt better and was advised to sit in lobby 10 min.
she experienced horrible symptoms like neuro symptoms; throwing up; dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 02Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (first dose), for COVID-19 immunisation. The following information was reported: NEUROLOGICAL SYMPTOM (non-serious) with onset Mar2021, outcome "unknown", described as "she experienced horrible symptoms like neuro symptoms"; VOMITING (non-serious) with onset Mar2021, outcome "unknown", described as "throwing up"; DIZZINESS (non-serious) with onset Mar2021, outcome "unknown", described as "dizzy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received Expired dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional information includes COVID-19 vaccine were administered to patients after the vaccine's storage viability had been exceeded. The vaccine was received and placed in a refrigerated sate on 22Apr2021. The vaccines stayed in this condition until their usage dates. No relevant concomitant medications reported.  No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Information has been received from a consumer concerning her daughter, a 19 year old female with a history of environmental allergies to mold and mildew who on 04-SEP-2007 was vaccinated with her first dose of GARDASIL (Lot # 058558/1061U). Concomitant therapy included LOESTRIN. One month after vaccination, the patient developed weight loss(17 pounds since start of GI problems), diarrhea, nausea, vomiting (sometimes bloody), dizziness, abdominal pain, and motion sickness. On 31-OCT-2007 (also reported as 30-Oct-2007) the patient received the second dose of GARDASIL (Lot 3 658563/1063U), the symptoms of weight loss, diarrhea, nausea, vomiting, dizziness, abdominal pain and motion sickness worsened and she developed achy legs. The diarrhea is uncontrollable, the patient is throwing up 5 or more times a day, the abdominal pain has increased. The patient has tried lansoprazole, Phenergan, dicyclomine hydrochloride, unspecified antibiotic, and ondansetron hydrochloride, none of which helped. The patient was seen by a Gastroenterologist and no cause for the gastrointestinal problems can be found. The patient had a colonscopy and follow through procedure, magnetic resonance imaging(MRI), blood tests, and tests for Gallbladder functioning. The patient's weight loss, diarrhea, nausea, vomiting, dizziness, abdominal pain, motion sickness, and achy legs persisted. Additional information has been requested. 4/27/09-records received-10/9/07-routine office visit-C/O vomiting for 2 days, and vomiting blood and abdominal cramps. Allergies to beef and quarter pounder with cheese which cause diarrhea. PMH: Six month history of epigastric pain, gastric ulcer, esophagitis, nausea, blocked eustachian tube. 10/30/07-C/O dizziness and nausea. Right TMJ tenderness. VNG 11/13/07-normal. 12/13/07-after 2nd Gardasil injection C/O reflux now with 2 cycles dysmenorrhea. 4/1/08-presented of ED with C/O abdominal pain nausea and diarrhea. Subjective fever. this is a new complaint. DX: abdominal pain. Gastroeneritis.  4/27/09-records received-10/9/07-routine office visit-C/O vomiting for 2 days, and vomiting blood and abdominal cramps. Allergies to beef and quarter pounder with cheese which cause diarrhea. PMH: Six month history of epigastric pain, gastric ulcer, esophagitis, nausea, blocked eustachian tube. 10/30/07-C/O dizziness and nausea. Right TMJ tenderness. VNG 11/13/07-normal. 12/13/07-after 2nd Gardasil injection C/O reflux now with 2 cycles dysmenorrhea. 4/1/08-presented of ED with C/O abdominal pain nausea and diarrhea. Subjective fever. this is a new complaint. DX: abdominal pain. Gastroeneritis. krk  5/15/09 Hospital records received DOS 11/24/07 to 11/25/07. FINAL DIAGNOSIS: Recurrent vomiting Post vaccination abdominal pain, nausea, vomiting and diarrhea. Later reports fatigue, fevers, chills, night sweats, myalgias, hematemesis, blood with diarrhea. Watery bowel movements. Symptoms worsen when she eats.   8/7/09 Medical records received DOS 9/4/07 to 10/30/07. Annual physical. Oral contraceptives.
Tiredness/slight vaccine reaction; Vaccination site injection redness; Swelling/slight reaction to the vaccines; This spontaneous report was received from a health care professional, via Corporation referring to a 40-years-old male patient.  The patient's concurrent conditions and medical history were not reported. Concomitant therapies included paracetamol (TYLENOL), ciprofloxacin (CIPRO), clonazepam, folic acid, cefalexin (KEFLEX), lamotrigine, methylphenidate, ondansetron, pyridostigmine, oseltamivir phosphate (TAMIFLU), valproic acid, lacosamide (VIMPAT), and pyridoxine.  On 24-JAN-2022, the patient started pegcetacoplan (EMPAVELI) solution for injection 1800 mg, twice weekly, subcutaneously (SC), lot #1949770 (expiration date: 30-SEP-2023) (strength and anatomical location were not reported) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). On 14-APR-2023, he was vaccinated with meningococcal vaccine B rfHbp/NadA/NHBA OMV (BEXSERO) (strength, formulation, route of administration, anatomical location, dose, lot #, and expiration date were not reported). On 16-APR-2023, he was vaccinated with pneumococcal vaccine (manufacturer unknown) injection (strength, route of administration, dose, anatomical location, lot #, and expiration date were not reported).  On an unspecified date in 2023, the patient had a slight reaction to the vaccines, consisting of tiredness (Fatigue), site injection redness (Vaccination site erythema), and swelling (Vaccination site swelling). He was feeling better, thus, at the time of this report, the patient recovered from all the events on an unknown date in 2023.  Causality assessment between the events and pneumococcal vaccine (manufacturer unknown) injection was considered to be related; causality assessment between the suspect vaccine pegcetacoplan (EMPAVELI) and the events was not related, and regarding meningococcal vaccine B rfHbp/NadA/NHBA OMV (BEXSERO) and the events was not provided.
Rash/Hives at site of injection.  Raised bumps that look like mosquito bites, different sizes rash about 4in x 2in area around  site of injection
Swelling and bruising at injection site in the form of a red circle on arm that lasted a week
COPD flare up; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD flare up) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included ATENOLOL for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD flare up). The patient was treated with DOXYCYCLINE HYCLATE (oral) on 27-Feb-2021 for COPD exacerbation, at a dose of 100 mg. At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD flare up) outcome was unknown. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Paxlovid: Treatment of COVID-19; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) on 06Apr2021 at 14:00 as dose 2, single (Lot number: ER8729), in left arm and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details: patient received treatment with Paxlovid, from 26Apr2022 to 01May2022. Adverse event: Return of COVID symptoms after completion of 5-day course of Paxlovid. Symptoms returned 9 days after initial onset and lasted another 5 days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
administering Kinrix today instead of Pediarix to a 6 month old patient which would have been patients 3rd dose of Pediarix; 6 month old patient received kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 25zh4, expiry date 27-OCT-2024) for prophylaxis.   On 10-OCT-2023, the patient received Kinrix. On 10-OCT-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: administering Kinrix today instead of Pediarix to a 6 month old patient which would have been patients 3rd dose of Pediarix) and inappropriate age at vaccine administration (Verbatim: 6 month old patient received kinrix).  The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 10-OCT-2023 A licensed practical nurse reported that administering Kinrix on the day of reporting instead of Pediarix which would had been patient's 3rd dose of Pediarix at an inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
The decedent received his first COVID shot 2 weeks prior to death (8/23/2021). A week before death, the decedent had severe cough and vomitting.
This spontaneous report as received from a licensed practical nurse refers to unknown number of patients of unknown age and gender. On 16-JUL-2014, improperly stored PROQUAD (injection, strength, lot #, dose, dose number, route and duration were unspecified) were administered to the unknown number of patients. No adverse symptoms reported. No further information provided. The outcome was unknown. This is one of the two reports that received from the same source. Additional information has been requested.
Pt recvd MMR vax in 1981; Rubella titer was found to be negative; Then vaxed w/booster dose of MMR in JUN90; In SEP90 rubella titer remained neg;