chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 14NOV96 230PM & approx 12-13 hr p/vax pt devel swelling of the face, neck & hands w/itchy rash;DPH was taken to relieve sx;approx 24hr later sx got worse & a visit to hosp ER was necessary;shot given for itching;
This spontaneous report as received from a other health professional refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with ROTATEQ, oral for prophylaxis. On an unknown date, the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA012320:
Patient c/o dizzy, weakness of lower extremities, fatigue and pain on the left deltoid.
ATRIAL FIBRILLATION; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: stroke. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. The patient received rivaroxaban (Xarelto) (film-coated tablet, route of admin not reported, batch number: Unknown) dose, frequency, and therapy dates were not reported for an unspecified indication.  No concomitant medications were reported. After receiving vaccine, On an unspecified date, the patient experienced atrial fibrillation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with rivaroxaban was not reported. The outcome of atrial fibrillation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210833202- covid-19 vaccine ad26.cov2.s-atrial fibrillation. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210833202-Xarelto -atrial fibrillation. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient felt tired & weak while standing & passed out. She fell to the ground, but did not hit her head. She was able to get into the chair after regaining consciousness. Pt then vomited for a few minutes. Called 911 & she was given care by medics.
she went back to the vaccie clinic the same day and was given an additional dose; felt groggy and foggy; felt groggy and foggy; a sore arm  which lasted about 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (she went back to the vaccie clinic the same day and was given an additional dose), FEELING ABNORMAL (felt groggy and foggy), SOMNOLENCE (felt groggy and foggy) and INJECTION SITE PAIN (a sore arm  which lasted about 24 hours) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-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 07-Apr-2021, the patient experienced EXTRA DOSE ADMINISTERED (she went back to the vaccie clinic the same day and was given an additional dose), FEELING ABNORMAL (felt groggy and foggy), SOMNOLENCE (felt groggy and foggy) and INJECTION SITE PAIN (a sore arm  which lasted about 24 hours). On 07-Apr-2021, EXTRA DOSE ADMINISTERED (she went back to the vaccie clinic the same day and was given an additional dose), FEELING ABNORMAL (felt groggy and foggy) and SOMNOLENCE (felt groggy and foggy) had resolved. On 08-Apr-2021, INJECTION SITE PAIN (a sore arm  which lasted about 24 hours) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-069691 (Patient Link).
Day 2 of hospitalization first dose given 1/8/2021  100 y/o female.  vaccinated for COVID 19 back in January and February however did have a breakthrough with 90 pneumonia with hypoxia and was progressively getting worse after which she was transferred to emergency room for further eval and treatment.
numbness or tingling sensation in front upper thighs. Almost always present but mostly at night. It began 3-4 days after vaccination and I still have it.
Moderna COVID-19 Vaccine EUA: A few minutes after receiving the vaccine, vaccine recipient developed slight shortness of breath and tingling sensation in mouth/tongue. Vaccine recipient was discharged from the vaccine clinic.
flu shot; diarrhea; vomiting; sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), VOMITING (vomiting), DIARRHOEA (diarrhea) and INFLUENZA (flu shot) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced ILLNESS (sick). On 29-Aug-2021, the patient experienced VOMITING (vomiting). On 30-Aug-2021, the patient experienced DIARRHOEA (diarrhea). On an unknown date, the patient experienced INFLUENZA (flu shot). At the time of the report, ILLNESS (sick), VOMITING (vomiting), DIARRHOEA (diarrhea) and INFLUENZA (flu shot) outcome was unknown.            This case was linked to MOD-2021-302245 (Patient Link).
Very dizzy; Heartbeat was beating fast; Muscles were weak; This is a spontaneous report from contactable female consumer (patient) via Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration on 11Feb2021 as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported that she had the Pfizer Covid vaccine shot on Thursday 11Feb late afternoon. On her way to home she felt very dizzy, and her heartbeat was beating fast, and her muscles were weak on unspecified date in Feb2021. How can she reschedule her second shot so her husband can drive her to the facility. The patient underwent lab tests and procedures which included heart rate: heartbeat was beating fast. The outcome of events was unknown.  Information about batch/lot number has been requested.  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
5/12/18 golf ball size rash around injection site; 5/13/18 new onset wide spread rash and injection site; Nothing done in the ER, follow up with PCP told to patient.
Patient reported feeling the same chest tightness that she felt with the first dose of Moderna vaccine. She said it was hard to swallow, but was not experiencing shortness of breath. Monitored patient and symptoms did not worsen, so patient elected to leave after the 15 minute observation period.
Tested positive for Covid -19 on 1/9/2022.  Expired 1/31/2022 with acute hypoxemic respiratory failure requiring NIPPV, Covid-19 infection with associated viral PNA and AMS
Injection site: rash, redness, warm, tender, swollen (2 inches). Pt statees got worse/larger next day.
He received his vaccine, he had a slightly sore arm.  A couple days after the vaccine he was lying in bed and he started out one sentence in jibberish.  He realized that he had done that, paused and apologized to his wife and it happened again in jibberish and he stopped again and he looked at his wife and said "that's not good".  He then found out that the entire time that he was speaking that way, and was aware that he was not making any sense.  The next day he noticed that he was dragging his right foot when he tried to walk.  He made an APT to his doctor and she said that he had a TIA, but the effects had cleared.   The doctor told him to call the cardiologist office and to get an appointment with them, and he saw a cardiologist.  The cardiologist said that he wants him to loose weight and gave him a prescription for Plavix which he is taking.  Ever since he moved to Arizona he has had spontaneous nosebleeds, and have been getting worse every year since being there.  In 2020 they have been the worst that he has had.  He has had nasal cautery twice.  A week after being on the Plavix he had another bleed, and he was advised to stop taking his 81 mg aspirin.  Then a week later still on Plavix he had another nosebleed and this bleed was so bad that he ended up going to UC, and it stopped by the time he got there, and lasted for more than an hour.  He called his cardiologist and his PCP and told them that he was not taking anymore Plavix until the nosebleeds stopped.  He has since then talked to his ENT and told him that the cauterization is not working and is having the nosebleeds of his life.  He suggested that he have surgery for his deviated septum, and has to have clearance from your PCP or cardiologist to have that surgery.   In the past 5 days he has had 3 nosebleeds.  His cardiologist scheduled him a stress test, and also a carotid ultrasound, as well as a CAT scan of his brain and echocardiogram.
hands were shaking; second degree burns; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer or other non Healthcare Professional (caregiver, reported for her Mother who is the patient).  A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiration date: UNKNOWN), via an unspecified route of administration on 19Feb2021 as a single dose for COVID-19 immunisation. Medical history included breast cancer and liver cancer from an unspecified date and unknown if ongoing. The patient's concomitant medications were not reported.   Reporter stated that on an unspecified date, her mom (patient) was making hot chocolate and her hands were shaking and she spilled hot chocolate on herself. Reporter stated her mom was taken to the emergency room and she was diagnosed with second degree burns and received a tetanus shot this past Friday. Reporter stated her mother is scheduled to receive the second dose next week and her doctor told her to wait two weeks before receiving the second dose. Reporter wanted to know if her mother should receive the second dose of the vaccine after having the Tetanus shot. She was told different things by HCPs (Healthcare Professionals) and wanted to know what Pfizer says. Reporter also stated that her mom was a breast and liver cancer survivor.   Reporter clarified if her mom had breast and liver cancer prior to the 1st dose and she said yes, and stated her mom has a history of breast cancer and therefore has a compromised immune system and she was afraid of getting COVID-19. Reporter also mentioned that her mom's 2nd dose was scheduled 4 weeks between. Reporter would like to know if receiving the second dose of the vaccine outside the 3 week interval is just as effective. Reporter would like to know if the second dose can be given greater than 4 weeks after first dose. Reporter would like to know if the vaccination series will have to be repeated if given after 4 weeks. The outcome of the events were unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Patient presented with shingles; This case was reported by a nurse via sales rep and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than 2 weeks after receiving Shingrix, 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 Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix at a local pharmacy 2 weeks earlier than reporting date and experienced shingles. The patient did not think the shingles was related to the vaccine. The reporter did not consent to follow up.
Pt received vaccine on (R) arm on 9/27. Pt returned to pharmacy on 9/28 with aches on (L) side, redness & swelling on (L) elbow, no fever.
Myalgia, SORE ARMS, CHILLS, SWEATING Narrative:
At 1:45 PM pt came in stating that since she got the Tdap vaccine per pt. it was swollen and hurting a lot. After swelling went down in x3 day then site of injection became itching/red burning like chile per pt. Pt was seen by Dr. and she was given antibiotic clindamycin HCl capsule 300 mg. four time a day 28 cap.
Itching, burning sensation bilateral ventral wrists approximately 12 hours after the vaccine was administered. Shortly thereafter, developed urticarial bilat ventral wrists. Within the next several hours, noted swelling at left lower lip then right upper lip. Swelling and itching around lips persisted for three days when patient sought medical care.
Pt was given dose of TDAP, MENACTRA, VARICELLA, double dose. 1st 6/10/08, MENACTRA, 2nd 6/15/09, VARICELLA. 1st 6/13/07, 2nd 6/15/09, TDAP.
Initially/same day patient had no adversities. The next day arm was extremely sore and had a small wheal in the area that she had been vaccinated in. According to the patient 9/29 It was about the size of a quarter. The following day it had increased to size 8cmx5cm the 30th. Patient complained it was inflamed and itchy and  hot to the touch. The patient took ibuprofen and iced the area. Per the patient it eventually resolved and was much less visible by the 10/5. Patient had no other side effects.
patient got the first dose of Shingrix before the Covid Pandemic but never got the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose before the Covid pandemic).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient got the first dose of Shingrix before the Covid Pandemic but never got the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-MAY-2023 The reporter reported that patient never got the 2nd dose of Shingrix.  The reporter wanted to know if she should restart the series. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine had undergone a Temperature excursion the day before; No adverse event; The patient received Moderna Covid-19 vaccine that had undergone a Temperature excursion the day before; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine that had undergone a Temperature excursion the day before), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine had undergone a Temperature excursion the day before) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7172B and AS7165B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (001C21A expiration date December 13, 2021,Left arm) on 15-Apr-2021, MODERNA COVID-19 VACCINE (lot 005C21A expiration date December 22, 2021,left deltoid) on 13-May-2021, Moderna COVID-19 Vaccine (Lot number 051F21A expiration date is March 25, 2022,vaccine in his left deltoid) on 12-Nov-2021 and Moderna COVID-19 Vaccine (Lot number 051B22A Patient received in left deltoid) on 19-Jul-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.   On 27-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Jun-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 27-Jun-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine that had undergone a Temperature excursion the day before). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine had undergone a Temperature excursion the day before) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine that had undergone a Temperature excursion the day before), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine had undergone a Temperature excursion the day before) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine that had undergone a Temperature excursion the day before) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine had undergone a Temperature excursion the day before).    No concomitant medication was reported.  No treatment information was reported.
started with rash around 12/1/20 - ongoing rash - referred to dermatologist. Per dermatology rash was likely a reaction to vaccine given in October
Vasovagal type reaction,  dizzy, improved with lying down and cont observation x 25min,  juice.  ambulated and bp 118/77 on d/c.  99%ra.  p=78
Fatigue on 12.26, fever 101f on the night of 12.26, fevers 101 to 102 from 12.27 to today 12.28. headache beginning 12.28
A report has been received from a pharmacist concerning a 7 year old male patient. No concomitant drugs or relevant history was provided. The patient had been receiving FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient was administered FLUMIST in one nostril on 28-Sep-2014. The outcome of the event of administered FLUMIST in one nostril was unknown. The report was considered to be non-serious by the reporter.
Three days post vax pt developed an unspecified arrhythmia. This unspecified arrhythmia had been diagnosed 3-4 years prior to vaccination. Physician prescribed medication which the pt has been taking ever since. The physician stated that the vaccine had nothing to do with the arrhythmia.
After 1st dose of Pfizer covid vaccine patient reported itching and irritation in throat.  LS clear, VSS.  Patient medicated with 10mg Cetirizine PO to good effect.  Monitored and d/c to home.
Mom complains that injection site is red and swollen size: 3cm x 2.5 cm Dx: Post vaccination cellulitis. Tx: Augmentin Labs: CBC, Blood cultures, CRP
Initial and follow up information has been received from two registered nurses for the Pregnancy Registry for GARDASIL concerning a 22 year old female, with no relevant medical history, no known drug allergies and no previous pregnancies, who on 12-MAR-2007 was vaccinated IM with 0.5 ml of the first dose of GARDASIL (Lot #656049/0187U). There was no concomitant medication. The patient was currently pregnant with a LMP of 15-FEB-2007. All prenatal labs were normal. It was reported that on an unspecified date, the patient began taking prenatal vitamins. Medical attention was sought. On 17-JUL-2007, the patient had a routine ultrasound which was normal (not further specified). On 21-NOV-2007, the patient gave birth to a healthy baby girl (3510 gm; 20 in), with Apgar scores of 9 and 9. There were no congenital anomalies, complications or abnormalities. There were no complications during the pregnancy or during labor and delivery. Follow-up information was received indicated that in approximately December 2007, the patient experienced mastitis and was treated recently (unspecified). The outcome was unknown. Pediatric medical records were received, refer WAES # 0810USA00111. No further information is available.
Lg local reaction, cm nodule with 2.8cm redness and warm to touch. Rx Augmentin XR 1000 mg 1 PO Daily x 5 days.
This spontaneous report was received from a health care worker, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 20-APR-2015, the patient was vaccinated with PREVNAR (lot #, expiration date, strength, dose, route of administration, anatomical location and indication were not reported). It was reported that the health worker reported that the patient was supposed to receive a dose of PNEUMOVAX 23 (lot #, expiration date, strength, dose, route of administration, anatomical location and indication were not reported) on 20-APR-2017; however due to a nursing error, the patient received a second dose of PREVNAR that day. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.