chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 59-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (received 1st dose on 10th September 2018, refer case US2019GSK052144). On 27th February 2019, the patient received the 2nd dose of SHINGRIX. On 27th February 2019, several hours after receiving SHINGRIX, the patient experienced fever, chills, myalgia, feeling bad, feeling hot and pain. The patient was treated with TYLENOL and naproxen. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, chills, myalgia, feeling bad, feeling hot and pain were recovered/resolved. The reporter considered the fever, chills, myalgia, feeling bad, feeling hot and pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by pharmacist for her husband. The patient felt bad after receiving the 1st dose of SHINGRIX, so he did not want to have the second dose. On 27th February 2019, the patient received the dose in the late afternoon. Then by 7 PM that night, he said he was not feeling good and started to get chills, grade 3 fever, hot to touch, myalgia and shivering. On 28th February 2019 (the next morning), patient's fever (body temperature) was 103.8 degree F. The symptoms were not treated the first time. The patient took second injection of extra strength TYLENOL, then he still felt bad so he took 500 mg Naproxen. It took a full 24 hours, the patient started to feel better. The reporter believed that, the symptoms were related to the SHINGRIX. Lab Comments: On 28th February 2019, the patient's body temperature was recorded as 103.8 degree F.
Breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding) in a 19-day-old male neonate exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 028A21A) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 25-Apr-2021, the neonate was diagnosed with EXPOSURE VIA BREAST MILK (Breastfeeding). The Neonate was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The delivery occurred  on 06-Apr-2021. For neonate 1, the birth weight was 3741 grams (8lbs 4oz). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding) outcome was unknown. Not Provided          Concomitant medication was not provided. Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.    This case was linked to MOD-2021-095626 (Parent-Child Link).   See case MOD-2021-095626 for details regarding the Parent case.
sleepy; terrible pelvic pain 24-36 hours; muscle pain in her pelvis area for 36hrs; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), intramuscular, administered in left arm on 15Feb2021 08:30 (unknown age at time of vaccination) as single dose for COVID-19 immunization. The patient medical history included eczema and small fibre neuropathy. Concomitant medications included ongoing dupilumab (DUPIXENT) taken for eczema; ongoing gabapentin (GABAPENTIN) taken for small fibre neuropathy. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 25Jan2021 08:30 for COVID-19 Immunization. The patient was sleepy the day after 2 shots had terrible pelvic pain 24-36 hours, heat aleve (pending clarification). She had muscle pain in her pelvis area for 36hrs. Onset date of the events was 16Feb2021. "Treatment: No" was also reported (pending clarification). The outcome of the events was recovered.   Information on the lot/batch number has been requested.
aches and pain, skin rash, difficulty breathing (felt like respiratory infection)hives, itching, muscle weakness especially hands ,head ache, right ear felt blocked, unusual tired and weakness. patient went to the urgent care and she was prescribed prednisone
Joint muscle pain rate of 8. Persisted from May 28 til June 1st RA doctor (who told me to get it notified) told to take Tylenol 650mg. up to 3000mg. Pain continued RA MD again called June 8 - told to see PCP or ER unable to see PCP. Seen @ hospital 6/12/23. Placed on prednisone 40mg x 4 days, 30mg x 3 days, 20mg x 2 days, 10mg x 1 day. Pain gradually decreased
5 patients who got the Moderna booster after the vial was already punctured 20 times; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (5 patients who got the Moderna booster after the vial was already punctured 20 times) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939930) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Dec-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (5 patients who got the Moderna booster after the vial was already punctured 20 times). On 21-Dec-2021, PRODUCT ADMINISTRATION ERROR (5 patients who got the Moderna booster after the vial was already punctured 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The vial was removed from the refrigerator storage at 10 am and first puncture then, and the last dose was administered at 4 pm. This administration error has been reported to VAERS already (752547).  No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-423214, MOD-2021-423227, MOD-2021-423242, MOD-2021-423248 (Patient Link).
Three dose rotavirus series; This case was reported by a nurse via sales rep and described the occurrence of extra dose administered in an unspecified number of patients who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   Previously administered products included Rotarix (received 1st dose and 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was 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-2022 Reporter's Comment: The nurse reported that the she had been giving Rotarix as a three dose rotavirus series for pediatric patients at two, four, six months.  The reporter came into the nursing role at the pediatric practice in December 2021. The reporter said she was instructed to give Rotarix as a three dose series. They use only state funded vaccines at this clinic and she had inputted all Rotarix as a 3 dose series in the state registry for each child vaccinated. The reporter did not consent to follow up. Additional Supportive Information: The nurse reported that the patients received third dose of Rotarix, which led to extra dose administered.
light headedness/dizziness; This is a non-interventional study report from the marketing program received from a contactable consumer (patient). This consumer reported information received by Pfizer from Abbvie (manufacturer control number: 21K-163-3889347-00).  A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), intramuscular on 17Feb2021 (at the age of 66-years-old) as 1st dose, single dose for COVID-19 immunisation; adalimumab (HUMIRA, Batch/Lot number was not reported), subcutaneous from Jan2019 and ongoing, at 40 mg, weekly for an unspecified indication. Medical history included recurrent difficulty in sleeping from 1971 and unknown if ongoing, joint pain from an unknown date and unknown if ongoing, elevated cholesterol level from 2005 and unknown if ongoing, rheumatoid arthritis from an unknown date and unknown if ongoing, tobacco user (One pack of cigarettes) from 1966 to 2016, alcohol use (one glass of wine a glass of bourbon) from 1972 and unknown if ongoing. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)) and clopidogrel taken for cardiac disorder; metoprolol tartrate and lisinopril taken for hypertension; atorvastatin calcium taken for blood cholesterol; clobetasol taken for an unspecified indication; folic acid taken for supplementation therapy; ascorbic acid;chondroitin sulfate;glucosamine hydrochloride taken for chondropathy; ibuprofen taken for an unspecified indication; levothyroxine sodium taken for thyroid disorder; omeprazole taken for an unspecified indication; naproxen taken for anxiety; vitamin d3 taken for supplementation therapy; all start and stop dates were not reported. The patient experienced light headedness/dizziness on 17Feb2021. The action taken in response to the event for adalimumab was unknown. The outcome of the event was recovered on 19Feb2021.  The reporter's causality for the events of light headedness/dizziness with humira 40mg/0.4ml (Adalimumab) was no reasonable possibility.    No follow-up attempts are needed. No further information is expected.  The reporters assessment of the causal relationship of the event with BNT162B2 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.; Sender's Comments: Based on the temporal association, the event light headedness/dizziness is considered as related to the use of 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.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 74 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 20-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 20-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. Flu vaccine was delivered on 20-Sep-2016 at 13:30 to 14:00 and the refrigerator was reading 10 degrees Celsius that afternoon. On 21-Sep-2016, it was 6 degrees Celsius, on the 22nd it was 10 degrees Celsius and on the 23rd (morning), it was 7 degrees Celsius. One dose was given between 21 and 22-Sep-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
*other* vaccines route Left Deltoid.  Patient developed an itchy, red patch on her left upper arm approximately 15 minutes after today's immunizations.  Patient denied shortness of breath, wheezing, facial swelling, and lip swelling.  Physical exam showed a large, red, flat patch on patient's left upper arm; no facial and lip swelling; and lungs CTAB..
1 week after vaccination, started itching on the site,  next day developed rash around the vaccination site with itching.  Next day developed a very pink place below the site about two inches in diameter and also itched.  This continued for 4 days.  On 1/25/21 the itch is gone and the rash and pink spot are fading.
Patient developed redness and swelling to the site of injection (left arm) 24 hours after accompanied with pain and itching. On the 2nd day post injection developed several blisters to the sites. Three days after bad episode of vomiting.
9/14/18--pt is experiencing hives, got shingles shot on Wednesday and came in today. I observed hives on her vaccinated arm (left) as well as right wrist. Pt was not having difficulty breathing and minor itching. Advised to take BENADRYL and sold her a tube of hydrocortisone. Told to go to ER if anything got worse as I have not seen the generalized hives with SHINGRIX.
Red rash on arms, chest and hands.  Swelling in both hands.  Pronounced itching in hands.  The event lasted about 18 hours.  The swollen hands over 24 hours.
2 hour bout of atrial fibrillation which began at 22:00. At 22:30, I took additional 1/2 tablet of Rythmol (150mg) and at 23:00, took my usual dosage. Symptoms did not subside until 24:00.
I administered the vaccine, however, person who was drawing up the medication drew up the wrong vial and the wrong dose. The client was supposed to get a Pfizer 1st booster. What was administered was a pediatric 0.3ml dose that was undiluted.  RN'S and Dr. were notified. Client will also be notified once providers get back to us. Pending further instructions.
BODYACHES, SWOLLEN THROAT, CHILLS, DIARHEA, FEVER 100, BLOOD PRESSURE HIGH AND LOW.
Patient got shot 11/26/2014, came in on 01/18/2015 stated she had pain in muscle in arm and trouble lifting arm.
Vaccine clinic vaccinator administered Fluarix vaccine to client instead of COVID-19 Moderna vaccine.  Client previously had flu vaccine 1 month ago.  Consulted with Health Officer, and provided reassurance and information to client.
Rash near injection site about 9 days after the first dose (COVID arm); slight discomfort and some itching/burning
The patient was seen for routine office visit. It was identified by the nurse, that the patients Health Maintenance was not up to date, it indicated that the 18 year old patient had not started her HPV vaccine series. It was identified after the patient went home, that her mother called back upset that her daughter was given a vaccine whose series had already been completed. It was identified in looking at database that this patient, in fact, had received all 3 doses of the HPV series with the last and final dose being given 5/19/2014. Hours after the injection the patient was not known to have had any adverse reactions to the vaccine. Called the patient again this morning 4/16/19 at 8am she was noted to have a slight fever, she also received the flu vaccine at her visit yesterday as well. The patient states that she read that it was a common side effect to develop a fever with HPV vaccine. She will call clinic back if she develops any other symptoms.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On 27-AUG-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis, lot # R002056 and expiration date 22-JAN-2020 (dose, strength, and route of administration were unknown). No adverse effects were reported. The reporter stated that the vaccine was stored at a temperature of -14 degree C to -10 degree C for 30 minutes and -9 degree C to 8 degree C for 2 hours. Digital data logger was involved.
Obtained a COVID test on Friday 11/05 which was positive doing self quarantine for 10 days
Patient had shots at 10am, had tylenol throughout the day, at 8pm crawled up in my lap did not feel real warm and started to seize, pt seizure last 8-10 minutes from the time that we called the ems until they carried him to the ambulance.
FEVER OF 101.6; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced fever of 101.6. Laboratory data included: Body temperature (NR: not provided) 101.6 (unit not provided). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever of 101.6 was not reported. This report was non-serious.
no additional adverse effects; a dose of expired but properly stored M-M-R II was administered; This spontaneous report as received from a medical assistant refers to a 6 year old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 13-FEB-2020, the patient was vaccinated with an expired dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), albumin status: recombinant Human albumin "rha", lot # R000555, expiration date: 08-JAN-2020 (strength and route of administration were not provided) for prophylaxis. The vaccine was reconstituted in a properly stored sterile diluent. No adverse event reported.
Fine, pruritic papules started 24h after vaccines nearly resolved 48 hours after vaccine.
began to experience pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (began to experience pain) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History was reported). Concomitant products included AMITRIPTYLINE, GABAPENTIN, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and SILYBUM MARIANUM FRUIT, TAURINE (MILK THISTLE 35000 PLUS TAURINE) for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN (began to experience pain). At the time of the report, PAIN (began to experience pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Mom reports that child show signs of muscle weakness, unable to stand up properly, walking with uneven gait, happened about 4x this morning but has resolved
Swollen lymph nodes under right arm a few days after both the 1st & 2nd shot was administered. I'm scheduled to see a general physician in a few days to assess the issue.
Sore throat; Cold; He was exposed to covid; Headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Cold), COVID-19 (He was exposed to covid) and HEADACHE (Headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Cold), COVID-19 (He was exposed to covid) and HEADACHE (Headache). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Cold), COVID-19 (He was exposed to covid) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment medications were reported.  Patient was exposed to COVID that past weekend, he was exposed over Friday, Saturday and Sunday. Patient was not sure, he thought it might be just a cold.  Company comment:This is a spontaneous case concerning a  65-year-old male patient with no medical history reported, who experienced the non serious unexpected events of Oropharyngeal pain, Nasopharyngitis, and expected event of Headache. These events occurred on an unspecified date in December 2021. In December 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine).The rechallenge was unknown since there's only information about first dose.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a  65-year-old male patient with no medical history reported, who experienced the non serious unexpected events of Oropharyngeal pain, Nasopharyngitis, and expected event of Headache. These events occurred on an unspecified date in December 2021. In December 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine).The rechallenge was unknown since there's only information about first dose.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Feeling ill; tiredness; headache; muscle pain; chills; joint pain; confused; Diarrhea; dizzy; This is a spontaneous report from a contactable consumer (patient). A 84-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration, administered in arm left on 10Feb2021 at 01:30 as 1st dose, single for COVID-19 immunization. The patient medical history included UTI and known allergies: Penicillin. The concomitant medication included fluoxetine, pravastatin and levothyroxine received in two weeks. The patient did not receive any other vaccine in four weeks. On an unspecified date, the patient experienced feeling ill, tiredness, headache, muscle pain, chills, joint pain, confused and diarrhea. Body, headache and tiredness through to Sunday afternoon. On Monday, the patient was still feeling dizzy. The patient did not had COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.