chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suffered a stroke 4 days later 06Feb2021; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the left arm on 02Feb2021 at 14:45 (at the age of 71-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient suffered a stroke 4 days later 06Feb2021 after vaccination. The event resulted in an emergency room/department visit and hospitalization in Feb2021 for 3 days. Treatment for the event stroke included medication and therapy. The outcome of the event stroke was recovering. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Shot high blood pressure. Rapid heart rate, flushed, thickness in throat.   75 mm of benedryl   Since vaccine-severe abdominal pain,  doubled  over pain.  Painfull diarrhea.  NEVER HAVE ABDOMINAL STOMACH ISSUES BEFORE.  Put on Prilosec 40 mg.  Still had pain not as server.  After getting Covid I am once again having Severe pain.
no additional AE reported; temperature excursion that was intermittent, involving PROQUAD states thatthere have been administered doses; This spontaneous report was received from a registered nurse and refers to patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.    Beginning 28-JUL-2020, the dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced a temperature excursion of -14 degree Celsius (C) to -10 C (average temperature was -9.5 C) degree Celsius (C) for a period of 38 hours and 30 minutes. It was reported that the vaccine did not had any previous temperature excursion. The excursion was called by a digital data logger.  On an unspecified date in 2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 milliliter (dosage regimen and route of administration were not provided), lot number T009929; expiration date 16-SEP-2021, as prophylaxis. The patient did not experience any adverse event. On 13-AUG-2020, the temperature excursion was noticed.
Day 1 through 12-None. Day 12 fatigue and developed skin pain on left side of face and ear. Pain progressed to scalp and left side of face. Day 14 went to urgent care and Dx  shingles. Doctors notes-"Shingles v trigeminal neuralgia?" . Rx VALTREX.   No relief and moderate to severe pain extended to other side of face and scalp. Day 16 went back to urgent care. Rash on forehead and no blisters. Rash is maculopapular. Not shingles and discontinue VALTREX.  Rx Prednisone  and Cetirizine (oral).  Resolved after 5 days.  Following up with allergist on 6/7/21 for advice on second dose.
Encounter Details     Contact w and exposure to oth viral communicable diseases (Primary Dx);  Infection due to 2019-nCoV
I had slow urination. I had a regular physical that showed a high PSA. I was referred to a urologist. I was placed on an antibiotic. Once I was off the antibiotic my PSA was higher. I am scheduled for a biopsy 8/15/2022.
Headache, fatigue, nausea, tachycardia, muscle pains, chills, subjective fever and subjective shortness of breath
Came to us 6-13-08 with rash on body for the last 3 days.  Also cough & runny nose x2 days.  Labs done measles IgM - EBV titer - CBC done that day (6-13-08).  Pt. normal activity, sleeping well.
Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 026B21A) for COVID-19 vaccination.  Concurrent medical conditions included Drug allergy (Allergy to Demirol) and Drug allergy (Allergy to Loritab). Concomitant products included IPRATROPIUM BROMIDE from 26-May-2022 to 26-May-2022 and AZELASTINE HCL from 26-May-2022 to 26-May-2022 for an unknown indication.  On 04-Mar-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021 at 3:15 PM, 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 COVID-19 (Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 26-May-2022 to 28-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (Covid-19) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  It was reported that the patient received unspecified medications/products within 2 weeks of starting COVID-19 treatment. The patient had trouble swallowing, throat tigtness hoarseness (lost voice) night sweats on 27-May-2022 14:00 with outcome as recovering. The device date reported as 29-May-2022.  Company Comment: This is a spontaneous case concerning a 69-year-old female patient with no reported medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 1 month after receiving the second dose of mRNA-1273 Vaccine. No clinical or treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 69-year-old female patient with no reported medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 1 month after receiving the second dose of mRNA-1273 Vaccine. No clinical or treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
PATIENT REPORTED  OF SKIN IRRITATION AT TH INJECTION SITE( REDNESS ,SORENESS AND SWELLING). HE ALSO REPORTED OF NAUSEA ,SPELLS OF DIZZINESS ESPECIALLY AT WORK
Patient reported that after receiving second COVID vaccination, left arm was very painful, hot to touch and swollen. Thought esperiencing normal reaction but pain never went away. Began experiencing an increased amount of pain and difficulty lifting light objects as well as dropping things.  Reports it was very hard to lift or move arm even with nothing in her hand. Also reports shooting pain behind neck down arm to finger tips. Was seen by PCP because it would not stop. Reports that provider told her that she had nerve damage and is prescribed steroids and physicial therapy
Patient reported that he woke up Saturday morning (10-10-2020) with a full body rash that caused him a lot of itching.
I received the Pfizer Bivalent booster and a flu shot on 9/21/2022. On 11/19/2022, I attended an event, after which several other people reported tested positive for COVID-19 shortly thereafter. On 11/22/2022, I started to feel symptoms early in the afternoon: I had coughing, sneezing, fatigue, and a slight headache. By 8 PM that evening, I took a home antigen test, which yielded a faint positive line. When I took another test on 11/23/2022 at 10 AM, there was a solid positive line visible. The headache subsided quickly, but the coughing persisted until 11/27/2022. I continued to test positive until 12/2/2022, which is the day I tested negative for the first time since being infected. I contacted the doctor on 11/23/2022; he said I was eligible to receive PAXLOVID, but I declined at that point, because I was familiar with a case in which someone had taken it and had a rebound. On 11/25/2022, I spoke to another doctor, who prescribed me benzonatate capsules for my cough and ipratropium bromide nasal spray to alleviate the runny nose. I only took them once or twice, though, because my symptoms resolved quickly.
48 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
SOB, severe cough, tachycardia, labile O2 saturation and severe headache.
COVID shot on 4/21/21. With in an hour got hives, headache and eyes were burning and body aches. Within an hour and a half develop pruritic, hive-like lesions that then morphed into more of a pustule appearance. It is on legs, arms, neck, thighs, and trunk. Had severe body aches the night of the shot. Treated with Claritin, Ibuprophen, fluocinonide 0.05% Cream topically 2X daily.
This case was reported by a nurse, and described the occurrence of influenza in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date, the subject received unspecified dose of Flu vaccine (unknown). The reporting nurse did not have the name of the Flu vaccine that was administered. At an unspecified time after vaccination with Flu vaccine, the subject experienced influenza and lack of efficacy. It was reported that the subject "died from the flu, however, it was unknown which strain of flu the subject died from". It was unknown whether an autopsy was performed. No further information was provided at the time of reporting.
Mother states child awoke the morning after receiving shots with bruising, swelling and soreness in upper left arm. The next day, he had tiny pinpoint red bumps on swollen part of left arm, and states swollen area was very red. The next day he developed similar pinpoint itchy red bumps all over his body. Denies illness at time of vaccination, or prior vaccine reactions.
PT requiring hospitalization and intervention, symptoms started shortly/immediately after first COVID-19 vaccination, which occurred at a facility/pharmacy outside of the reporting facility. I am not sure which manufacturer (Pfizer or Moderna).
Rash around injection site that is spreading to elbow. Patient was informed to get it checked by provider's office to make sure it is not a severe allergic reaction.
large amount of swelling at injection site; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient who experienced large amount of swelling at injection site (vaccination site swelling), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  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 QUADRIVAL A-B VACCINE lot number not reported via unknown route and unknown site.  On an unknown date, the patient had large amount of swelling at injection site (vaccination site swelling) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not reported.  Final diagnosis was vaccination site swelling.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for vaccination site swelling.  Recommended ice to site, motrin, and benedryl.  Information on the batch number is requested.  List of document held by sender: none.
Pt had vaso-vagal reaction, after being given 3 vaccines. Tdap L Deltoid, MMR (neg preg test) LUA, Hep B R Deltoid. Became diaphoretic, blacked out for few seconds. When face patted she opened her eyes with startled reflex and followed commands appropriately. Patient had a vaso-vagal reaction to vaccine administration. She was given 3 vaccines on Friday 4/15/2016 at 16:45. Administered Tdap vaccine to left deltoid, then given MMR vaccine in left upper arm after performing pregnancy test, which was negative. During administration of Hepatitis B vaccine in right deltoid patient became diaphoretic and blacked out a second. She would breath deep when advised and would open eyes on command, but would close them again. When nurse patted pts face she opened eyes with startled reflex and became responsive. She was assisted to a exam room and was assisted to lying down position with cool wet cloth to face and neck. Pt was talking coherently during this time. Pt c/o feeling nausea and dizziness. She was assisted to a reclining chair where we could raiser her feet up. She asked to see the VIS papers again. She asked if her face was swelling and then began to complain of feeling as if her throat was closing. At this time her vitals were taken and WNL, P. 68, 02 sat was 100% and patient continued to talk. She was given water and GATORADE and appeared to be swallowing liquids without difficulty. After about 45 minutes, patient was advised she would need to call someone to pick her up as she would not be able to drive or return to work after having this event. She caller her father and he came to driver her home. He was instructed to monitor her and is she was not better within a few hours to take her to the emergency room and explain she was given 3 vaccines and show them the VIS sheets so they would know what she was given. He verbalized understanding a compliance. Pt was escorted to car via wheelchair. VAERS was completed and sent to CDC.
Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: PATIENT RECIEVED VACCINE AT 2P. Sat in waiting area for about 10 minutes. Our observer noticed that the patient was sliding in his seat and looked dizzy. Patient starting to flutter his eyes and lost consciousness for about 5 secs. He complained about blurry vision, feeling hot, sweating, but with chills. Patient was given water. After he drank the bottle of water patient felt fine. The ambulance was called and arrived, patient reported he felt fine. Patient did not eat/nor drink water today.
This spontaneous report was received from the patient's father concerning a 17 year old female patient. The patient's medical history concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 for prophylaxis (strength, dose, frequency, dose number, anatomical location, route of administration, lot number and expiration date were not reported). The reporter informed that since an unspecified date (reported as for 2 years), GARDASIL 9 did nothing, and that it would have been better if the patient did not get vaccinated at all. At the time of reporting, the outcome of GARDASIL 9 doing nothing (vaccination failure) for 2 years was unknown. The causal relationship between the vaccination with GARDASIL 9 and the event was not provided by the reporter. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1810USA014045.
Patient developed chills about 9pm the night of the vaccine.  She ran 101 temperature, and ached all night.  She took some Tylenol when the chills started and again in the morning.  She said she ran fever till about noon, and then later took some Ibuprofen.  She is feeling better, but just fatigued.
persisting left shoulder/left arm pain within 4 -6 hours after receiving COVID vaccine until present
History from Mother Sat Sept 2nd pt c/o partial vision loss in left eye around 7am, to ER 9/2/06 6pm DX allergies instructed to take Claritin. Woke up Sun 9/3 c/o total loss of vision, family vision Dr eye exam done sent for MRI, seen by opth, had blood work drawn to r/o diabetes, MS, Lymes disease and others. and possible post immunization optical neuritis. Had some improvement of vision over next few days. 9/6/06 vision improved, lab results pending, instructed to return 9/11/06 for repeat MRI, no conclusive diagnosis given according to mother.
No Adverse event; Extra dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022 at 6:18 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Dec-2022 at 6:18 PM, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Extra dose administered).    No concomitant medications were reported.  Pharmacist called to report that the patient received a 2nd Bivalent booster on 16-Dec-2022, 2 months after the first Bivalent booster. All vials thawed on 16-Dec-2022.   No treatment drugs were reported.  This case contains the information of 11th out of 13 elderly patient who received the vaccine as described by the reporter.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-688372:master case
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse 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 aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12Feb2022 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 10th of 43 adult patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-689222:Master case
rash on both sides of face, top of ear jaw line; skin peeling/ears are peeling; little itchy; part of his face feels warmer; This is a spontaneous report from a contactable consumer (patient).  A 57-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unknown route of administration at right arm on 11Mar2021 at 10:50 am (lot number: EN6204, expiration date: 30Jun2021) (age at vaccination 57-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history included acid reflux and hand tremors from an unknown date and unknown if ongoing. He was fairly healthy and spent 20 years in the military and was a healthy guy he thought. The patient concomitant medications included lansoprazole for acid reflux and propranolol for hand tremors both were ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had any no problems with previous vaccines, that he has had lots of shots in the military. History of all previous immunization with the Pfizer vaccine considered as suspect and additional Vaccines Administered on Same Date of the Pfizer Suspect, relevant tests was none. After 3-4 days of the shot, the patient had rash on both sides of his face starting at the top of his ears about an inch wide down to his jaw he had a line of rash that developed on both sides. States his ears are peeling and he had never had anything like this before and nothing else is going on, States he has not changed his soap or shampoo, little itchy and part of his face feels warmer in Mar2021. The patient had had put some moisturizing lotion on for the peeling and has not done anything else for ears are peeling. The adverse event does not required the visit to emergency room or physician office. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
prior to vaccine menstrual cycle was regular and on schedule each month. Since the first dose of covid vaccine, she has only had 2 period since Oct 2021. I heard it could cause some irregular periods, however, at this point it should have returned to normal
After vaccine, walked out of building right away, became pale, sweaty and had blurry vision. Given juice and crackers. She ate the crackers and waited about 10 minutes. After that she c/o a slight headache. About 30 minutes later patient recovered and went home with her mother.
14 post vaccination client had nausea and vomiting x 1 episode, was pale, vital signs observed 1345 BP 95/72 pulse 77 O2 sats 96 %, was observed for additional 15 mins, per client, she vomits when receiving a shot, client now stable and was discharged with family. Client sitting at back of vehicle with family member driving the car. signed medical release.