chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TOOK FOUR UNREFRIGERATED DOSE; This spontaneous case (PVX2019-731) was received from a pharmacist on 26-Mar-2019. It describes a female consumer who "took four unrefrigerated doses", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   Case report: The consumer took 4 unrefrigerated doses of Vivotif.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "took four unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took four unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took four unrefrigerated doses" was considered as not applicable.
This spontaneous report as received from a nurse practitioner, concerning to 133 patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the an unknown number of patients (of the 133 patients) were vaccinated with a dose of PNEUMOVAX23 (dose, dose number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The nurse practitioner reported that on an unknown date, patients were inadvertently administered PNEUMOVAX23 that had been improperly stored. No adverse effects reported.  This is one (1) of four (4) reports from the same source. Additional information is not expected. The nurse practitioner did not give the consent to contact her.
Slight Fever; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Slight Fever) in a 98-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Pneumonia, Diabetes, Dysphagia, Cognitive impairment (Mild Cognitive Impairment) and BPH. Concomitant products included RIVASTIGMINE (EXELON PATCH 10) for Dementia, INSULIN GLARGINE (LANTUS) for Diabetes, HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE SAR) for Hypertension, OXYCODONE HYDROCHLORIDE (OXYCODONE ACCORD LP) for Pain, CARBIDOPA, LEVODOPA (SINEMET DEPOT) for Parkinson's disease.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Slight Fever). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (Slight Fever) outcome was unknown. Not 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.   This case was linked to MOD-2021-315627 (Patient Link).
The  day after it started with malaise and fatigue. Then around mid day the body aches increased. I felt as if I had the flu. I had a low grade fever 99.6.  After the fever broke I still feel malaise and fatigued.
The patient had her second Pfizer covid 19 vaccination at 1835.  During sitting in observation area at 1845 the patient felt nauseated and faint. The patient went to ems room with staff to lay down and was given an ice pack and water.  She felt ok at 1902 and left reporting no dizziness.
The arm in which the vaccine was given swelled up, patient stated he could not see his knuckles.  Patient iced and elevated arm and was better that evening.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 3-year-old patient of unknown gender. On 06-MAR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and a dose of VARIVAX lot number N021720 (expiration date: 10-AUG-2019) (doses, routes and anatomical locations of administration were not provided for both vaccines) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Pt reported to fill lethargic with a fever and fell nauseated. Pt also reported to have rash on arms and body. Pt took Tylenol to help with the fever and pain. Pt is instructed to take Benadryl to help with the rash. Pt fell somewhat better the next day but was still tired and "out of it".
Client was initially vaccinated with Pfizer vaccine at 04/29/2021. Patient agreed to mix vaccines and receive a Moderna as 2nd shot. Patient was offered appointment at another facility for the second shot with Pfizer but preferred to take the Moderna 2nd shot at our clinic. Client is over 42 days from first shot.
adult patient received a pediatric dose of Havrix; adult patient received a pediatric dose of Havrix; This case was reported by a physician via call center representative and described the occurrence of adult use of a child product in a adult patient who received HAV (Havrix pediatric) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd June 2021, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 3rd June 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose 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 details were provided as follows: The age at vaccination was not reported. The adult patient received a pediatric dose of Havrix which led to adult use of a child product and underdose. The reporter declined to provide patient information and did not consent to follow-up.
Large area of inanustim 13x 8 cm left thigh.  Pruritic cellulitis vs local reaction day after shots.  Trustel with Benadryl 25 mg per mouth every 8 hours, Motrin every 6 hours, 3 thromal per mouth.
a little soreness on the injection site; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 23Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "a little soreness on the injection site".  Additional Information: The patient wanted to know if it's ok for the second shot to be scheduled for the 05Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Localized 6 cm x 6 cm red blanching area over right deltoid, slightly warm, nontender.
Parents noted swelling on left thigh after vaccines initially only palpable.  On 07/01/2005, presented with complaint of bruise and abrasions, swelling no fever.  On exam 10x20mm ecchymotic abscess on left thigh.  See in ER on 07/01 - normal CBC and negative culture.  Treated with Clindamycin on 07/06/2005, resolving.
Information has been received from an RN concerning a 6 year old female with juvenile rheumatoid arthritis who on 12/14/1998 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy for her arthritis included rofecoxib, methotrexate, Embrel and Prelone syrup. On 06/14/2004 the pt was seen in the office for varicella with 20 lesions. On 06/15/04 her lesions were worse and she retruned to the office. She was admitted to the hospital and treated with IV acyclovir and she had an immunology consult. On 06/21/2004 she was discharged from the hospital and on 06/25/04 she was seen in the office for followup and her varicella was resolved. The reporter indicated that the pt's sister (WAES0407USA00733) experienced chickenpox following exposure to varicella virus vaccine live. No further inoformation is available.
Within 6-8 hours post vax, the pt developed pain and redness at the injection site. On 3/22/00, the pt developed injection site soreness, swelling, and erythema, and his whole arm was warm and red. the pt sought unspecified medical attention.
no reaction immediately after the vaccination several days later a  red  raised spot  about the size of a nickel   by 9 days after the vaccination the redness had spread to a area about 4 x 4 inches    red and itchy I called my physicians office,  on Saturday March 13th. Dr on call returned the call and asked for a virtual  photo via my cell phone.  She told me to take Benadryl and Advil every 6 hours.  By March 24 most of the redness subsided,   as well as the itching
Swollen arm, fever pain in arm, antibiotics. Follow-up: After receiving the Meningococcal vaccine my arm was very sore. The next day my arm was discolored and swollen followed with a fever. I went to the emergency room and received antibiotics. I went back to my college that night. When swelling got worse I went back to the ER and stayed in the hospital from Friday - Sun.
Information has been received from a nurse practitioner concerning an 43 year old female research assistant with no medical history and no allergies. On 24Feb04 the pt was vaccinated IM with a dose of diphtheria toxoid/tetanus toxoid (Td) (lot U1018BA). On 30Mar04 the pt was vaccinated SC on the left with a first dose of varicella virus vaccine live (lot 647268/1100N). There was no illness at the time of vaccination. On the morning of 13Apr04 the pt developed generalized itching, especially on the scalp, neck and ankles leaving flat, elongated reddened areas from the itching. There were some macular papular areas noted on the ankles and neck. The pt was seen and was treated with diphenhydramine (Benadryl) 25mg stat and 1-2 q 6 hrs and cortisone cream. On 14Apr04, 16Apr04 and 20Apr04 the pt was seen and at each visit there was less itching and rash. On 20Apr04 the pt was back to normal and reported as recovered. It was noted that teh pt will not receive the second dose of varicella virus vaccine live. No further information is expected.
pt states she had a positive COVID test on 1/3/21; PCP (name unknown) gave her a shot of an antibiotic; pt has had increasing SOB with fever since then; sx started with sore throat and sinus drainage; O2 supplementation; positive for COVID; given dexamethasone, remdesivir, baricitinib; pneumonia due to COVID; ARF with hypoxia; metabolic encephalopathy; DNR; pt's condition critical; pt died in the hospital
Right thigh very red and warm. Tender to touch. Almost completely circumference. Lasted several days. Treated with Ibuprofen at home.
Headache that has persisted for seven months; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old female patient received the second dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of meningococcal group b rlp2086 (TRUMENBA) on an unknown date for immunization. The patient experienced headache that has persisted for seven months on an unspecified date within a week of the second dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient did not have any reactions to the vaccine due to the inaccurate use of the temperature the vaccine was deemed unviable in the month of October 2018 because not temperature logs were found.
Erythematous, pruritic papules appeared within an hour over the dorsal and ventral right arm, upper back, and left lower leg.
Pregnant woman received her 1st dose of vaccine; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant woman received her 1st dose of vaccine) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Factor V Leiden mutation (Factor 5 Leiden Disorder (genetic Disorder)). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]).    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 15-Jan-2021 and the estimated date of delivery was 22-Oct-2021. On 17-Jun-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant woman received her 1st dose of vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant woman received her 1st dose of vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included Synthroid ,Prenatal Vitamins. No treatment information was reported. The reporter reported that the patient was pregnant and received her 1st dose of vaccine. Pregnancy was of 2nd trimester Last date of Menstruation was around 15-JAN-2021 (patient wasn't sure) Date of Conception reported as 25-JAN-2021.
Fever, chills, aches, headache, achy joints. Lasted about 15 hours.
Information has been received from a medical assistant concerning an 18 year old female who on 12-FEB-2007 was vaccinated with the first dose of Gardasil vaccine (lot #653736/0014U), IM. Concomitant medication was not reported. On 12-Feb-2007, the patient experienced nausea and said she was "feeling out of it." Subsequently, on an unspecified date, the patient recovered from nausea and "feeling out of it." It was reported that the events "cleared on it's own" and that the patient had finished the vaccination series. No product quality complaint was sought. Additional information has been requested.
pt recv vax 11OCT95 & 16FEB98 pt dx w/a large case of chickenpox;pt had approx 200 lesions all over body;
From telephone call received on 7/17/02 it was reported that a 63 year old female pt received a Fluzone vaccine administered on 11/7/01. The pt stated that she had drop foot syndrome, which occurred approximately one week after receipt of vaccine. Her physician feels this might be attributed to Fluzone. The pt told the reporter of this event that her treating physician instructed the pt to obtain as much info as she could about the vaccine. Product insert, lot # and manufacturer. Pt called this pharmacist because this is the facility where she received flu vaccination during one of the public clinics. The reporter is a pharmacist at the facility that holds public flu clinics (grocery store). She did not have any other additional info at this time.
pt recvd vax; fever, irritability x 2 days;assoc RSV bronchiolitis required 3 days in hosp;
Pfizer-BioNTech COVID-19 Vaccine EUA High fever Chills Weakness Very Tired
Well I got a letter from my son school saying he needed 2 shot for school. And so I went in to do so and the Dr  Dr said my son needed a cancer shot? Along with the 2 he needs for school. Well he had the 2 shot in one arm. The other in the other arm after the third shot he was coherent but then fell back and his eyes were badly dilating  and he was also convulsing I put him on his side he woke up 2 minutes once he was out of it  he then said what happened? I as this was going on the nurse that gave him the shots stood there I the mother put him on his side and waited for the out come while I was yelling get the Dr and all the Dr said was he just fainted? I'm sorry no I've talked to a lady that has nurses on call and she called and yes my son definitely had a seizure  so I'm not sure what I gotta do to resolve this
Patient came back to pharmacy at about 5:30 PM on 05/07/2018 with a sore arm with redness and swelling at the injection site. Said she's been putting ice on it but still not better. RPH gave her an icepack to put on it and called the Dr. right away. The covering doctor Dr. called back later and said to have the patient come in the next day to see if she needed an antibiotic. Rph told patient to do so after explaining what the doctor said. Also suggested was to take anti inflammatory in the interim till the next am and ice it also. Patient felt she didn't need to go to the ER and said will contact Dr. the next day. Rph will followup with MD and patient again .
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.            No concomitant medications were provided. No treatment drugs were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-109850 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109850:
2 months old son was given the Fluzone Quadrivalent by accident, no AE; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious case from a non-health care professional (Reference number- 00315804).  This case involves a two-month-old male patient who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number and other dosing details were not reported) on an unknown date for prophylactic vaccination (inappropriate age at vaccine administration).  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.   This was an actual medication error case due to inappropriate age at vaccine administration (latency was same day).  At the time of reporting, no adverse event was reported.  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 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.  There will be no information available on the batch number for this case.
Approx. 12x5 cm, red, raised, slightly warm area (L) anterior thigh at site of KINRIX injection.
4" diameter, redness, swelling, warm to touch Not using arm well. Antibiotic treatment needed-Keflex 5cc tid x 10 days
The patient statement that he went to urgent care after the shot on 7/6 and was diagnosed with Shingles.
Information has been received from a nurse practitioner concerning a 16 year old female who on unspecified date was vaccinated intramuscularly with 0.5ml of GARDASIL vaccine (lot# unspecified). It was reported that on unspecified date the patient developed a persistent round circle on her arm at the injection site. At the time of this report, the patient's round circle at the injection site persisted. Unspecified medical attention was sought. No other information is available. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/15/2008. No further information is available.
Information has been received from a consumer concerning a female patient who in November 2009, was vaccinated with her third dose of GARDASIL. It was reported that in November 2009, the day after vaccination and continuing to 03-MAR-2010, the patient stated that her arm was stiff and that she had intermittent excruciating pain in her left deltoid, up high. At the time of the report the patient had not recovered. The patient did not seek medical attention. Additional information is not expected.
Pt. started feeling dizzy. Feeling nauseous and pale. Brought in to exam room. Asked pt. to lay on exam table and elevated feet by bending knees. Given alcohol and a piece of chocolate. Per pt. was feeling nervous before vacc admin.
40 hours after getting the vaccine, I was very dizzy getting up off the floor. I didn?t notice any dizziness upon waking, during 30 minutes on the stationary bike, but only got dizzy after laying down on my back for stretches. I wasn?t able to stand right away. After a few minutes sitting, I stood and couldn?t walk a straight line. My head was spinning. I had 40-50 oz of water already that morning, Apple Watch said sinus rhythm, heart BPM was up to 111 during exercise and down to 88 2 minutes after exercise. I didn?t push myself during the workout, it was a normal or easier workout than usual. When I called the HCP hotline and they asked for this information and also: head injury, no. Numbness on face, tingling on hands/legs, no. They recommended I go to an ER if I still had symptoms, but by the time I was done with the call, I wasn?t dizzy. I could bend over without symptoms and was walking straight.
Hives over torso/lips swollen in early AM. Hives groin area also.
Information has been received from an RN concerning a 10 year old Caucasian male who on 10/31/00 was vaccinated with varicella virus vaccine live. On 4/16/01, the pt "developed a case of chickenpox". Unspecified medical attention was sought. In F/U, an RN reported that on 4/16/01, the pt developed a rash, itching to back, abdomen, lasting approx. 4 days. The RN reported that the pt recovered from his experience on 4/20/01. No further information is available.
ARM RED, SORE, DIZZY, LIGHTHEADED, TIRED, SLUGGISH.
Pt received pneumonia vaccine in right deltoid and flu vaccine in left deltoid on 11/06/2001. On 11/07/2001, pt experienced red, swollen arm. On 11/08/2001 pt went to MD and was given "5 pills".