chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1 of 3 pts who was vaxed between OCT91 & NOV91 presented w/herpes zoster approx 3 wks p/vax; no hx of herpes zoster;
Patient received MMR II and PROQUAD instead of MMR II and VARIVAX; No adverse event; This spontaneous report was received from a registered nurse regarding a 12-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, concomitant medications, drugs reactions and allergies were provided.  On an unknown date, the patient received measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (albumin status: recombinant human albumin [rHA]) (M-M-R II) 0.5 mL, (lot# U007685, expiration date: 09-MAR-2023) (strength, dose, route, and anatomical location were not provided) and measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (albumin status: rHA) (PROQUAD) 0.5 mL (lot# U028181, expiration date: 08-MAR-2023) (strength, dose, route, and anatomical location were not provided) both of them for prophylaxis, instead of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (Wrong product administered). No additional adverse event (AE) was reported.
Day after the 2nd vaccine (4/8):  8am fatigue was setting in.  Headache, nausea and dizziness started around 10am and continued throughout the day.  By 11am nausea worsened, fever started, quickly went up to 101 and continued all day.   Chills, sweating, fatigue, body aches chimed in as the day progressed.   Took aspirin around 10pm.   Fatigue continued 3 more days.  Vaccination site hard, warm and tender.
About two months following 2nd vaccine. A rectangular pale patch of skin was present on my outer right thigh. MD aware, US completed and negative for blood clot. I have multiple small white patches of skin on my body some remaining in the same location and larger patches change locations (primarily around my hips/thighs)
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Error: Wrong Dose of Vaccine - Too High-, Additional Details: parent gave ibuprofen night of vaccination
Client developed fever of 103 and vomiting on Wenesday 1-28-09 lasting until Thursday 1-29-09. Treated herself symptomatically and did not seek medical attention
Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     Concomitant products included VALSARTAN, METFORMIN, PIOGLITAZONE, FENOFIBRATE, LEVOTHYROXINE, ROSUVASTATIN and SEMAGLUTIDE (OZEMPIC) for an unknown indication.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 27-MAY-2016, the patient was vaccinated with a dose of PNEUMOVAX 23, lot # L002310, expiration date 08-JUl-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to temperatures excursion of 1.1 Celsius degrees for 920 hours and 0 Celsius degrees for 168 hours with lowest temperature recorded to 34 and 32 Fahrenheit degrees respectively. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Developed shingles, given salves,valacyclovir, 1gm for 7 days, pain patches, gabapentin. Had very achy joints and very sore arm that was injection sight, which is still tender and still sore today and still suffering from shingles. Shingles rash appeared 6 days after shot. Sore arm began 11 hours after shot.
body aches; chills; light headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), CHILLS (chills) and HEADACHE (light headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced MYALGIA (body aches), CHILLS (chills) and HEADACHE (light headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MYALGIA (body aches), CHILLS (chills) and HEADACHE (light headache) outcome was unknown.            Reporter did not allow further contact
one minute after 3rd im given, patient reported "not feeling well". she was pale, diaphoretic and dizzy. She lost consciousness for about 15 seconds. Patient was assisted from chair to a mat on the floor and placed on her side. She was able to communicate appropiatley. B/P was 80/40 and had a weak pulse.  Paramedics were called, but did not treat. B/P remained low, 90/50 with weak pulse. Patient refused medical transport and/or fluids. She drank 20 ounces of water and was released to her parent. No further complications noted with follow up phone to mother.
Extreme tiredness, joint pain - especially in both hands, muscle pain, stiff neck and shivering
Starting the day after the injection, the patient noticed an expanding rash around the injection site and streaking towards her axilla. The rash was approximately 2 " in diameter at its max, the streaking was about 2" beyond that. The rash started resolving in about 24 hours.
2 days post vax pt devel 4cm x 5cm red, sl elevated, warm to touch area over rt deltoid;pt given med;warm moist packs, elevate arm no lifting;if itching develops may taken DPH;
tested positive for # COVID19; tested positive for #COVID19 / come down with Covid is that I'm 11 weeks out since my @pfizer vaccine; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number: UNKNOWN) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient tested positive for covid-19. The patient reported that "I, unfortunately, tested positive for COVID19 today. What sets me apart from millions of others who have come down with Covid is that I'm 11 weeks out since my Pfizer vaccine". The patient stated "please do not let your guard down even after the vaccine". My symptoms was or now are pretty mild. I will quarantine in my home until next Wednesday and I encourage you all to take this seriously and continue practicing Covid protocols. Be courteous to your colleagues and loved ones who are more susceptible. The pandemic has not come to an end. Be safe, take care do not let your guard down even after you have been vaccinated." The patient had tests which included sars-cov-2 test: positive on 28Apr2021.  The clinical outcome of the event was unknown.
mild fatigue on 2nd day; pain at injection site 12 hours after shot decreasing through 2nd day; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: ER2613 and Expiration date: not reported) via an unspecified route of administration, administered on the right arm on 02Apr2021 10:15 (at the age of 66 years old) as dose 2, single for COVID-19 immunisation. The vaccine was administered at a Public Health Clinic/Administration facility. Medical history included type 2 diabetes and hypertension. Concomitant medications included empagliflozin, pioglitazone, furosemide, and metformin for unspecified indications. The patient previously took dicloxacillin for an unspecified indication and experienced allergies. The patient previously received dose 1 of BNT162B2 (Lot number: EN6206 and Expiration date: not reported) via an unspecified route of administration, administered on the right arm on 12Mar2021 at 10:15 AM (at the age of 66 years old) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. On 02Apr2021 22:30, the patient reported pain at injection 12 hours after shot decreasing through 2nd day, and mild fatigue on 2nd day. The patient did not receive any treatment for the events. The patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since vaccination. The outcome of the reported events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Pain on axillary region and swelling of ganglia on left supraclavicular region. Pain scale 7/10. Symptoms started 1/19/2021.
Patient got her first Pfizer COVID-19 vaccine around 1:00pm on 3/8/21.  She returned to the pharmacy around 2:00pm and stated that her nose would not stop bleeding. She continued to bleed for 10 minutes.  Patient was pinching her nose for the entire time, and ice was applied.  She did not complain of light-headedness or dizziness.  After her nose continued to bleed, the paramedics were called to evaluate the patient.  The paramedics arrived and took her blood pressure.  Her blood pressure was 201/94.  The patient stated that she did not take her blood pressure medications today because she was getting the COVID vaccine.  She stated that she did take an aspirin today.  The paramedics took the patient to the hospital.
Had a severe joint pain due to the covid vaccine from Pfizer; This is a spontaneous report from a Pfizer sponsored program. A contactable pharmacist reported for a patient. A patient of unspecified age and gender received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Pharmacist mentions that he has a patient that had a bad reaction to the Pfizer-BioNtech covid vaccine and to other vaccine and he was looking to know if it was safe for him to get Prevnar 13. He mentions that the patient a couple of days ago had a severe joint pain due to the covid vaccine from Pfizer and he was trying to look about the information of the cultures from where the Prevnar 13 is prepared. On an unspecified date, The patient experienced had a severe joint pain due to the covid vaccine from Pfizer. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a 68-year-old female patient who received SHINGRIX for prophylaxis. In March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced abdominal pain, bloating, sweating, shivers, fever and cold. On an unknown date, the outcome of the abdominal pain, bloating, sweating, shivers, fever and cold were unknown. It was unknown if the reporter considered the abdominal pain, bloating, sweating, shivers, fever and cold to be related to SHINGRIX. Additional details were provided as follows: The patient experienced abdominal pain, bloating, sweating that did not start till Saturday and got worse on Wednesday with shivers and slight fever, and the patient asked if these symptoms were the result of the shot or if they were the effects too long after the vaccination.
Headache; heart rate increased; walking difficulty; Palpitations; Chills; Nausea; Fatigue; Fever; myalgia; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate increased), GAIT DISTURBANCE (walking difficulty), PALPITATIONS (Palpitations), CHILLS (Chills) and NAUSEA (Nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE for Gastric disorder, LEVOTHYROXINE for Hashimoto's disease.   On 15-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 15-May-2021, the patient experienced HEART RATE INCREASED (heart rate increased), GAIT DISTURBANCE (walking difficulty), PALPITATIONS (Palpitations), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Fatigue), PYREXIA (Fever) and MYALGIA (myalgia). On 16-May-2021, the patient experienced HEADACHE (Headache). On 16-May-2021, HEART RATE INCREASED (heart rate increased), GAIT DISTURBANCE (walking difficulty), PALPITATIONS (Palpitations), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Fatigue), PYREXIA (Fever) and MYALGIA (myalgia) had resolved. At the time of the report, HEADACHE (Headache) had not resolved.            No Conmeds and treatment medications was reported .  The action taken with mRNA-1273 was not applicable .
Headache, Myalgia & Diarrhea Narrative:  Pt reported headache, bodyache & diarrhea post dose #2 of covid vaccine. Treated with tylenol.
Chilling; Overall not feeling very well; Arm was really sore and hurts; A spontaneous report was received from a consumer, who was also a 36-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced chilling, her arm  was really sore and hurts, she was overall not feeling well.  The patient's medical history was not provided by the reporter. Concomitant medications reported included Coreg, Taxol, Buspar, Protonix.  On 07 Jan 2021, prior to the onset of the events, the patient received their first two planned doses of mRNA-1273 (batch number: 026L20A) intramuscularly on her right arm for prophylaxis of COVID-19 infection.  The patient experienced chilling, arm  was really sore and hurts and was overall not feeling well.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events, chilling, arm  was really sore and hurts and was overall not feeling well, were not reported.; Reporter's Comments: This case concerns a 36-year-old, female, patient, who experienced non-serious unexpected event of Malaise and non-serious expected events of Injection site pain, and Chills. The events occurred after first dose of mRNA-1273, lot # 026L20A. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
This case involves Adult and unknown gender patient who experienced got shoulder injury and flu shot put in wrong place while receiving vaccine INFLUENZA VACCINE. 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 INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious event "got shoulder injury" (limb injury) (unknown latency) following the administration of INFLUENZA VACCINE. On an unknown date the patient developed a non-serious flu shot put in wrong place (product administered at inappropriate site) (unknown latency) following the administration of INFLUENZA VACCINE. Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the events (Got Shoulder injury, flu shot put in wrong place). At time of reporting, the outcome was Unknown for the event got shoulder injury and was Unknown for the event flu shot put in wrong place. 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.
low grade fever of 99.2 F for about 12 hours.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever of 99.2 F for about 12 hours.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (low grade fever of 99.2 F for about 12 hours.). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (low grade fever of 99.2 F for about 12 hours.) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Body temperature: 99.2 (High) 99.2 Fever.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided.  Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-068402 (Patient Link).
Day after vaccine symptoms that presented themselves were the following: redness, swelling and warm to the touch at the injection site, migraine, body ache, loss of appetite and very lethargic. Followed up with Primary Care Doctor for exam and confirmed rapid heartbeat of 171/83 (no high blood pressure in medical history), physician confirmed case of Cellulitis of right upper extremity. Physician prescribed 500mg of CephaLEXIN 2x daily until medication is completely gone.
At the vaccination site  a couple days after it began to to itch. After several more days I did scratch  the site, but now it?s red and the size of a half dollar
generalized, significant weakness limiting ambulation, diarrhea for about a week, chills, abdominal tenderness, poor appetite, nausea, decreased p.o. intake, around 10 pound weight loss over past week
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 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:51 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:51 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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.   Age of patient was reported as 48.33 for dose administered on 31-MAR-2021.  No concomitant medications were reported.  Batch number 030B21A underwent temperature excursion 31-MAR-2021 with temperature 32 degrees Fahrenheit from 08:00 AM to 09:00 AM. This vial was moved to fridge on 30-MAR-2021 and beyond use date for the vial was reported 29-APR-2021. Product moved to clinic 31-MAR-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
got the shot/ less than two weeks later he got shingles.; This case was reported by a consumer and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provide are as follows: The case was reported by patient's children. The age at vaccination was not reported. The patient got the shot and less than two weeks later he got shingles. The follow-up would not possible as no contact details were available.
Patient got vaccine at 10 am, by 2pm she started to develop drowsiness, fever and pain (105F). She described she sleep more than 72 hours in 4 days. Pain is severe. Her arm is swollen as big as the size of a softball.  She called the nurse line and they told her to apply heat to arm-not working. Patient call pharmacy on 10/2/21, I recommend cold compression for the swelling, help a little bit. Patient did not have pain at this time. I advice patient to see doctor if symptoms not resolve or get worse.