chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving his vaccination, patient laid down on the floor and fainted briefly. He awoke and complained of feeling warm. Patient sat in the chair for approximately 20 minutes after receiving the shot and left the store without complaint. Patient's father informed us the patient has a history of fainting after shots or during doctor's appointments.
Large swollen lump on shoulder on day of vaccine came back yesterday, lump  with itching
4/27/2021 Swelling of lympnodes in left armpit, side of left breast and down left forearm, Causing pain and discomfort.  Still swollen as of this submission on 5/4/2021  5/4/2021- Rash at and around injection site, with large raised welts
Received Pfizer vaccines on 12/22/20, 1/13/21 Tested positive for COVID-19 on 7/22/21.
Warmness around the injection site; Itchiness around the injection site; Hardness around the injection site; Swelling aroun the injection site; Redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmness around the injection site), VACCINATION SITE PRURITUS (Itchiness around the injection site), VACCINATION SITE INDURATION (Hardness around the injection site), VACCINATION SITE SWELLING (Swelling aroun the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warmness around the injection site), VACCINATION SITE PRURITUS (Itchiness around the injection site), VACCINATION SITE INDURATION (Hardness around the injection site), VACCINATION SITE SWELLING (Swelling aroun the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site). At the time of the report, VACCINATION SITE WARMTH (Warmness around the injection site), VACCINATION SITE PRURITUS (Itchiness around the injection site), VACCINATION SITE INDURATION (Hardness around the injection site), VACCINATION SITE SWELLING (Swelling aroun the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included unspecified medication for high blood pressure.  No treatment information was provided.
This initial spontaneous report was received from a physician referring to a 7 week-old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 15-SEP-2015 at 11:27 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
and later I got shingles; Sick; made me physically ill for 3 days; day off work; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of physically unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced physically unwell (Verbatim: made me physically ill for 3 days), shingles (Verbatim: and later I got shingles), activities of daily living impaired (Verbatim: day off work) and sickness (Verbatim: Sick). The outcome of the physically unwell was resolved (duration 3 days) and the outcome of the shingles and sickness were not reported and the outcome of the activities of daily living impaired was resolved (duration 1 day).   It was unknown if the reporter considered the physically unwell, shingles, activities of daily living impaired and sickness to be related to Shingles vaccine.   It was unknown if the company considered the physically unwell, shingles, activities of daily living impaired and sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-JUL-2023 This case was reported by a patient via interactive digital media. The shingles shot made him/her physically ill for 3 days and cost him/her a day off work because he/she was so sick and later he/she got shingles. The reporter stated that second shingles shot was a hard and no for him/her.
pt recvd vax 16APR93 on 17APR93 pt out w/rash coverning entire body;  some blisters on fingers & toes; took to ER: MD said was allergic react to immun; pt also had tonsillitis & was given DPH & ATB; blisters on chest & back;
Information has been received from a Licensed practical nurse regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previous drug reactions, concurrent conditions and concomitant medication were not reported. On 08-JAN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020352 with expiration date in 10-APR-2020 (strength, anatomical location and route of administration were not provided) for prophylaxis. The GARDASIL 9 was stored at a temperature range of 0 Celsius degrees (°C) to 1°C for the time frame of 75 minutes, and another temperature range of 2°C to 8°C (1.9°C) for the time frame of 6 minutes. The call was because of a data logger. No adverse effects reported.
Headache, NauseaVomiting, fatigue; arm and hand swelling immediately after shot Narrative:  arm and hand swelling immediate after vaccine; Headache persisting and will notify primary care provider since ibuprofen not helping
took 1st capsule & about 24 hrs later had diarrhea & was very gassy; had no nausea, no fever, no stomache cramping;
PATIENT RECEIVED THE VACCINE OUTSIDE OF THE RECOMMENDED TEMPERATURE RANGE 46.8 F TO 52.7 F AFTER  PUNCTURE; THE VIAL TEMPERATURE WENT FROM 46.8 F TO 52.7 F AFTER FIRST PUNCTURE BETWEEN 11AM- 2:41PM; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 23-JUN-2021) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAY-2021, the subject experienced subject received the vaccine outside of the recommended temperature range 46.8 f to 52.7 f after puncture. On 19-MAY-2021, the subject experienced the vial temperature went from 46.8 f to 52.7 f after first puncture between 11am- 2:41pm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient received the vaccine outside of the recommended temperature range 46.8 f to 52.7 f after puncture and the vial temperature went from 46.8 f to 52.7 f after first puncture between 11am- 2:41pm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210540217.
The evening that I took the vaccination I was running a fever body aches and chills the day after taking the vaccination I had the same effects fever body aches chills 5 days after taking the vaccination very sick not feeling well not feeling myself passed out twice at home the sixth day after taking the vaccination I proceeded to work was sent home before I could even get in the building went to ER was treated for an allergic reaction after telling them I was 6 days from vaccination then on 4-9-2021 I was taken by my husband to the ER my entire left side was numb tingling sensation couldn't lift my leg couldn't hold my arm up had no peripheral vision severe headache at the ER I was seen my neurologist and I was told that I had 20 minutes to make a decision whether to take the TPA shot which I chose to take I was released from the hospital on 4/11/2021 I am finally going back to work tomorrow ( 4-21-2021) I am now having more anxiety I've had extreme weight loss I've lost 20 lb since this occurred
1) 100.4F body temperature. Body aches and fatigue. Lasted ~12 hours.  2) Injection site soreness. Lasted ~12 hours.
One week after vaccination, pt had redness, itching, and an irregular-shaped scab. On 1/14/16, the scab became more regular in shape (round), but harder and thicker and black. Pt still has this scab. (Day after vaccine, pt has site bruising; day 2 had purple discoloration.)
Pt has rash at the injection site, itching at injection site and site is warm to touch. Pt also states she has developed itching on neck, face and tongue.
Patient developed red area around injection site about 6-7 cm in diameter and minor swelling.  Area is warm to touch and does not itch. Area is sore. Patient was instructed to use cold compresses, NSAIDS, and diphenydramine. If no improvement seen in 24 hours, patient was told to see physician who prescribed the vaccination.
On 10/30/6 pt rcv'd flu vaccine in L arm and Tdap vaccine in Rarm.  R arm near injection site sore the next day and still sore today near injection site and with certain arm movements--ie. adducting arm.
This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 09-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 13-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis. No Medical History information was reported. On 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 09-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 09-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 09-Aug-2022). No concomitant product use was reported. On 08-Jul-2022, the vials were initially stored in the refrigerator. Vial did not undergo any temperature excursions. The healthcare professional was not aware of any symptoms for any patient after the vaccine was given. No treatment information was provided.
welts under arms on her back; severe rash; This case was reported by a pharmacist via call center representative and described the occurrence of welts in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 5J27J, expiry date 6th May 2023) for prophylaxis.   On 11th July 2022, the patient received the 1st dose of Shingrix. On 11th July 2022, less than a day after receiving Shingrix, the patient experienced welts and rash. On an unknown date, the outcome of the welts and rash were unknown.   It was unknown if the reporter considered the welts and rash to be related to Shingrix.     Additional Information: GSK receipt date: 18-Jul-2022 Reporters comment: The pharmacist reported that the patient had a severe rash and welts under arms and on her back.   The patient did not have anaphylaxis reaction.  The reporter consented to follow up.
Shortly after receiving shot (within the 20 minute observation period) patient began to feel very dizzy to the point of not feeling steady enough to stand. He said he felt like his head was being compressed. His lower lip began to feel numb and tingly, eventually this feeling spread into his mouth and throat. He was coherent the entire time. He received oral Benadryl while waiting for his wife to arrive to drive him to the emergency room.
Drug ineffective; Breakthrough COVID case; dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Oct2021 (Lot number: FF258) at the age of 59 years as dose 3 (booster), single, administered in arm left, administration date 24Mar2021 (Lot number: EP6955) as dose 2, single and administered in arm left, administration date 03Mar2021 (Lot number: EL3248) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". The following information was reported: IMMUNISATION (medically significant) with onset 18Oct2021, outcome "unknown", described as "dose received: 3"; DRUG INEFFECTIVE (medically significant) with onset 25Dec2021, outcome "recovering", described as "Drug ineffective"; COVID-19 (medically significant) with onset 25Dec2021, outcome "recovering", described as "Breakthrough COVID case". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (27Dec2021) positive, notes: Nasal Swab Covid test name post vaccination: BinaxNOW antigen self-test. Therapeutic measures were not taken as a result of immunisation, drug ineffective, covid-19. The patient did not take other vaccine in four weeks and other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
12/04/21 presents to ED for "abdominal pain and headache". PMHx of "abdominal pain 2/2 hiatal hernia, GERD, recent admission for acute on chronic abdominal pain, colitis and UTI"
Pimply/puffy red rash began on face and spread over chest, thighs, arms and back. Baby is covered in spots.
pulmonary blood clots; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (pulmonary blood clots) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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, 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 experienced PULMONARY EMBOLISM (pulmonary blood clots) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (pulmonary blood clots) outcome was unknown.            Concomitant product was not provided by the reporter.  Company Comment: This case concerns a  female patient, who experienced the unexpected event of Pulmonary blood clots. The event occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2021-317542 (E2B Linked Report).; Sender's Comments: This case concerns a  female patient, who experienced the unexpected event of Pulmonary blood clots. The event occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2021-317542:
Chills/fever/joint pain/tremors/ncontrollable limb movement/facial paralysis/headaches/back pain/drop foot right leg/leg paralysis/neck pain/fatigue/sever anietxy/ptsd/double vision /ringing ears/hard to swallow/labored breathing/weight loss/no endurance/no energy/rashes bumps/difficulty concentrate/brain fog/suicidal thoughts/ and the list continues !
pt. recd. vax & later developed a fever,diarrhea, pharyngitits,cough,& conjunctivitis w/ morbilliform rash.admitted to hospital w/ dehydration due to vomiting.
We had a 4 year old boy come into the office for Polio and Varicella vaccinations, prior to this appointment,he was in our office to get MMR , Flu and DTP vaccinations. By mistake he was administered another MMR. No adverse reaction at this time.
This is a spontaneous report from a contactable nurse. A patient of unknown age, gender and race received TRUMENBA for immunization on unknown date at single dose via an unspecified route of administration. On unknown date the patient experienced redness at injection site. The outcome of the event was reported as not recovered.
Approx 3:20 PM pt received vaccine, after 5 min pt felt lightheaded and slightly dizzy. Had pt lie down flat, RN on staff checked pulse. Pulse regular, no abnormal signs observed. 3:50 pt's dizziness was completely resolved. No lightheadedness, pulse regular.
Pt reports shoulder joint pain, crepitus, should instability, limited range of motion of shoulder due to pain.
On that morning, May 31st, I woke up with bad nasal congestion, a cough and 101 fever. I felt achy and tired. This lasted about 2 days. The fever lasted only one day. Still felt lethargic. Congestion lasted longer and has still not gone away completely. I tested positive for COVID-19 on the same day.
Arm soreness at the injection site; Fever of 100.5; shivering; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 47XJ3, expiry date 30th April 2020) for prophylaxis.   On 3rd December 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 3rd December 2019, 12 hrs after receiving Shingrix, the patient experienced injection site pain, fever and shivering. Rechallenge with Shingrix was positive. On 4th December 2019, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the injection site pain and fever were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever and shivering to be related to Shingrix.  Additional details were provided as follows: The patient reported that after vaccination had arm soreness at the injection site, fever 100.5 and shivering. The patient stated that, at the time of reporting, the shivering has resolved, but other symptoms were on going. The reporter did not consent to follow up. This case was 1 of 3 linked cases.
This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received KINRIX (batch number 99A7M, expiry date 3rd September 2016). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: This product has been exposed to temperatures outside of the required temperature range and the efficacy of this product outside the temperature range had not been established. This customer purchased one 10 pack of this product therefore it was administered to ten patients. The age and genders of the patients are unknown at this tome. This case is one of the 9 cases reported by the same reporter for the same vaccine.
her heart stopped/passed away; throwup; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (her heart stopped/passed away) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced CARDIAC ARREST (her heart stopped/passed away) (seriousness criterion death) and VOMITING (throwup). The patient died on an unknown date. The reported cause of death was heart stopped. It is unknown if an autopsy was performed. At the time of death, VOMITING (throwup) outcome was unknown.            No concomitant medication were reported. The patient's first two doses were Moderna COVID-19 vaccine, and she was fine with the first two. The first dose was administered on 20-Mar-2021. Since the patient took the booster dose of the Moderna COVID-19 vaccine, she started to throwup. Her heart stopped and she passed away. No treatment information was provided.   Company Comment - This case concerns a female patient of unknown age with no relevant medical history, who experienced the serious (death) unexpected event of cardiac arrest. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine, and the outcome was fatal. The patient died on an unknown date and the cause of death was cardiac arrest. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the serious (death) unexpected event of cardiac arrest. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine, and the outcome was fatal. The patient died on an unknown date and the cause of death was cardiac arrest. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: heart stopped