chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reported that 5 days after receiving flu shot she experienced severe vertigo, severe nausea which kept her out of work for 3 days. This was accompanied by severe ringing in her ears.
Within 24 hours of injection, developed rash roughly 2 inches in diameter at location of injection.  Rash was hot to the touch, slightly itchy, with a painful ?knot? in the muscles underneath.
extreme headache, extreme soreness, extreme chills, violent shaking, foggy/hazy, 103 fever lasting  4 days
Vaccine was stored in refrigerator on 30-Jun-2022 and administered vaccine on 05-Aug-2022; No adverse event; Patient administered vaccine beyond its use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 30-Jun-2022 and administered vaccine on 05-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 30-Jun-2022 and administered vaccine on 05-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 30-Jun-2022 and administered vaccine on 05-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 30-Jun-2022 and administered vaccine on 05-Aug-2022).    No concomitant product use was reported.  Patient had received Second booster.  Vial did not undergo any temperature excursions.  No treatment information was provided.
fever of 102 Severe chills Both subsided within 24 hrs with Tylenol and rest
Information has been received from a physician concerning a patient who was vaccinated with a dose of HPV Vaccine and developed rash and pruritus. The patient's outcome was unknown. Additional information had been requested.
Diffuse urticaria, persisting >24 hours- mild improvement with cetirizine and Benadryl.
Patient was feeling with dizziness after the vaccine administration. 911 was called but the father said to cancel the call because patient was feeling fine.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 64 year old male. The patient's weight was 210 pounds, and height was 193.04 centimeters. 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) 1 total, dose was not reported, administered on left deltoid on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-JUN-2021, the patient was getting sicker and sicker, and performed COVID-19 antigen test and was negative. On 12-JUN-2021, the patient experienced breakthrough infection and tested positive for COVID-19 antigen test (nasal swab) (suspected covid-19 infection, suspected clinical vaccination failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with Product quality complaint number: 90000182630 The suspected product quality complaint has been confirmed to be void n (meet product quality complaint criteria) based on the PQC (product quality complaint) evaluation/investigation performed.; Sender's Comments: V0:20210627620-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
HEADACHE; FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 numbers. No concomitant medications were reported. On an unspecified date, the subject experienced headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210355508 and 20210355949.
Breakthrough case admission after 2 vaccines Moderna 3/30/21 Lot# 017B21A;  Moderna 4/27/21 Lot# 006C21A
Mother called. took child to ER Friday 5/7. C/o of right arm being red from shoulder to about 1" above elbow, warm to touch, and firm. She was instructed to use cool compresses and give child Benadryl. She said the arm is better now.
Information has been received from a Registered Nurse (R.N.) for the pregnancy registry for GARDASIL concerning a 23 year old female patient with sulfonamide allergy and allergy to amoxicillin who on 17-MAR-2010 was vaccinated with the first dose of GARDASIL (Lot # 662529/1317Y) (expiration date: 10-MAY-2011) intramuscularly. There was no concomitant medication reported. It was reported that on 01-APR-2010, the patient received a pregnancy test in the office confirming that she was pregnant. The patient sought unspecified medical attention. The last menstrual period was in "February 2010" and the estimated delivery date was on 08-NOV-2010. No known adverse effect so far. Follow up information has been received from a physician concerning the female patient with no previous pregnancies and no concurrent medical conditions. On 13-MAY-2010, a Down's screen was performed for routine the result was normal. On 13-JUL-2010, an ultrasound was performed for routine and the result was normal. It was reported that on 20-NOV-2010 at 39 weeks from LMP, the patient delivered a male baby with 6 lbs 9 oz of weight and 19 inches in length with a head circumference of 13, Apgar score 9/9. The infant was normal. There were no congenital anomalies. During pregnancy the mother experienced kidney stone (date unknown). Additionally, the patient experienced breech in labor. Additional information is not expected.
11 days p/receiving MMR c/o skin hurting & eyes hurting had t101 on 12th day;
ACUTE RESPIRATORY FAILURE 10/24/2022 DYSPNEA  ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/15/2022 DYSPNEA
Psoriatic arthritis aggravated/flare up of psoriatic arthritis; This is a solicited report based on information received by Pfizer.  Solicited report by a consumer of a 68-year-old female with an event of non-serious after second Pfizer vaccine, had a flare up of psoriatic arthritis with adalimumab (HUMIRA). The patient received adalimumab (HUMIRA, Solution for injection in pre-filled pen) via subcutaneous in 2021 for psoriatic arthritis. Pfizer Biontech COVID-19 vaccine (tozinameran) was also considered suspect. In Mar 2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer for COVID-19 vaccination. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In 2021, patient received 1st dose COVID-19 Vaccine via intramuscular manufactured by Pfizer for COVID-19 vaccination.  There was no reported medical history. The patient's concomitant medications were not reported. In 2021, the patient experienced after second Pfizer vaccine, had a flare up of psoriatic arthritis/psoriatic arthritis aggravated. The action taken in response to the event for the suspect drug adalimumab was unknown. In 2021, the after second Pfizer vaccine, had a flare up of psoriatic arthritis resolved.  Primary reporter did not have the lot number information, because the packaging was discarded. The reporter's causality for the event of after second Pfizer vaccine, had a flare up of psoriatic arthritis with adalimumab (HUMIRA) was a reasonable possibility.  The reporter's assessment of the causal relationship of the event with the suspect product Pfizer Biontech COVID-19 vaccine (tozinameran) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and no alternate explanation the causal role of BNT162B2 vaccine cannot be excluded for the reported events  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
A non-serious spontaneous report of administration to child less than two years of age was received from a pharmacist concerning a 21-month-old female. Neither relevant medical history nor concomitant medications were reported for this patient. The patient who was under two years of age received FLUMIST on 27-Sep-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
ADMINISTRATION OF VACCINE STORED UNDER REFRIGERATOR FOR ROUGHLY 20 HOURS; This spontaneous report received from a pharmacist concerned a 53 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total for prophylactic vaccination (manufacturer unspecified - series 1).   The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: 11-APR-2022) dose was not reported, 1 in total, on right arm administered on 24-NOV-2021 for prophylactic vaccination (Booster dose). The vaccine was stored in refrigerator. No concomitant medications were reported.  On 24-NOV-2021, the patient received the vaccine which was stored under refrigerator for roughly 20 hours as a booster dose. The patient was well otherwise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine stored under refrigerator for roughly 20 hours was not reported. This report was non-serious.
Patient reported that upon exiting store post-vaccination experienced pain/swelling in upper left arm with limited mobility.  Patient reported also experiencing chills, headache, and nausea.  Patient called to report these symptoms 10/5/20 at approximately 1530, and was beginning to feel relief from symptoms and some signs of improvement.
2 days after the vaccine, 03/27/2021,I had a rash on my neck, torso and back I had the same type of rash with the 1st dose of Moderna. This time the rash seemed more noticeable. The rash lasted about 5 days. And was kept in control with Benadryl around the clock. This time I did not need to call the doctor because I had consulted a tele-doc with the first rash I had with the 1st dose of Moderna.
10/17/06 given MMR-V, Hep B-Hib, Hep A, and Flu vaccine. 10/31/06 acute onset transverse myelitis.  12/4/06 Received medical records from hospital which reval patient admitted 10/31/06-11/21/06 for generalized weakness & inability to move extremities well x 1 day.  Had viral URI s/s for approx 1 day. Neuro exam revealed global weakness & decreased tone from the neck down.  Had diminished cry.  Developed UGI bleed possibly secondary to high dose steroids.  Developed ileus probably secondary to ADEM.  Treated with decompression & multiple anti virals & antibiotics.  Neuro, GI & PM&R followed patient & was to received services at home upon d/c. Final Dx: probable ADEM.  Pneumatosis intestinalis, resolved.  Anemia requiring multiple transfusions. Per 60 day follow up: Not fully back to his baseline. He still has grars and fine motor delays. Not sitting unassisted. His getting weekly OT and PT. He has lower extermity atrophy. He is making slow progress developementally. He still has global developmental delays.
Pain in arm; slight fever; felt very dehydrated; fatigue; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 21-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0171) via an unspecified route of administration in the left arm on 23Apr2021 at 09:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included anemia and shrimp allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included iron (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 23Apr2021, the patient experienced pain in arm, slight fever, felt very dehydrated and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain in arm, slight fever, felt very dehydrated and fatigue was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Fever, lack of appetite, irritable, cough, runny eyes & nose. Took to urgent care diagnosed with Hib - conjunctivitis & otitis media. Had 105.1 fever and has lowered to 101.1.
Patient received 1st dose of Pfizer at 08:43. At 08:45, patient was sitting in chair and had a syncopal episode. During syncopal episode, he fell backwards and hit his head on the ground. RN witnessed the fall and attended to patient with RN manager. Team alerted. Within seconds, patient woke up diaphoretic and was A/O x3. Patient denied head pain when asked. Vital signs taken. All measured within desired limits. B/P: 118/66, HR: 72, RR: 20, O2 SAT: 100% and temperature 96.9ºF. Patient assisted to wheel chair and taken to gurney. Fluids provided. He is in stable condition.
Nauseous, clammy, felt hot, skin cold, dizzy, lightheaded, very pale, shaky
Diarrhea and vomiting Unable to keep anything, even water, down until 2:00 pm...still on soda crackers and Gatorade at 3:00. Chills around 3:00 pm Fatigue This may have been a food-poisoning incident. If so, I don?t know the source, but it feels like food poisoning.
Anorexia, nausea, vomiting, malaise, headache, SOB, neck stiffness, fever 102, sore throat. Admitted to ICU; given IV antibiotics, isolation. Lumbar puncture to be performed. Follow up 05/25/2004:Patient was treated with Vancomycin and Ceftriaxone empirically until negative test results were obtained. Diagnosis was meningismus. LP, MRI, Blood/urine cultures were negative. Patient was discharged from hospital on 5/19/04.
During administering vaccine syringe plunger did not get pushed to administer vaccine,  I immediately took the needle out and checked the syringe for the amount noted 0.2ml and tried pushing plunger in the trash can which dispensed all the vaccine in trash can.  Another dose drawn by this writer and vaccine was administered safely to the child.
I have been experiencing extreme body aches. The pain in in the mornings in both arms, but not during the day. My legs are also in pain. My doctor says it is not arthritis.
Employee states initially had pain with injection on 10/21/21 and then fine for the rest of the day.  Woke up the next day with severe right shoulder pain 10/10 and could not go to work. Pain improved some over the next week with heat and ice but never fully resolved.  Continues to c/o 6/10 right shoulder pain with certain movements.  0/10 pain when at rest.
Approx. 3 to 3-1/2 hours  after I received the vaccination (Between 1:00 PM &1:30 PM) I felt dizzy and was going to fall. That lasted less than 1 minute.  Approx. 7 to 7-1/2 hours after I received the vaccination (Between 5:00 PM & 5:30 PM) I was sitting at my computer and suddenly felt light headed and was going to pass out. I asked my wife to take my blood pressure. It was 99/68. It is extremely low for me. My BP usually runs around 120-126/68-74. I was scheduled to have cataract surgery on 4/18 and was concerned. I contacted my physicians office on 4/13 and went in the same day for a visit. They took my BP which was till low and they also took an EKG. Everything was fine. I had my surgery and have had no adverse affects since the two on 4/12/2022
This case was reported by a pharmacist via call center representative and described the occurrence of injection site cellulitis in a female patient who received SHINGRIX for prophylaxis. On 18th September 2018, the patient received SHINGRIX. In September 2018, less than a month after receiving SHINGRIX, the patient experienced injection site cellulitis. On an unknown date, the outcome of the injection site cellulitis was unknown. It was unknown if the reporter considered the injection site cellulitis to be related to SHINGRIX. Additional details were provided as follows: This case was reported via chat. The age at vaccination was not reported. The healthcare professional (HCP) stated that the pharmacist reached out because the patient believed she had a reaction to SHINGRIX. The patient's physician looked at the injection site and believed it was cellulitis. The pharmacist was reaching out because the physician wanted to give her an antibiotic and she wanted to make sure that was appropriate. The HCP did not have any further information.
Death Narrative:  Patient was not previously COVID positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 97 and admitted to Hospital on around 2/20/2021 due to a fall at home. He later passed away on 3/5/21.
Pt recv 1 dose vax. Nov95 pt devel chickenpox. Additional info requested
The day after receiving 2nd Covid19 vaccine (sometime in the afternoon), I began having pain in my right underarm, fatigue and fever.  was not able to go to work the following day with fever & pain in right underarm continuing.  Was able to go to work the next day, however the underarm pain was pretty significant over the next several days and I did notice some swelling in the area.   I went online and saw that this is a side affect that is not that unusual, and would have called my primary care physician if it had persisted.  The pain and swelling subsided in just under a week.
The arm that they injected is extremely swollen; Extremely tender arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (The arm that they injected is extremely swollen) and TENDERNESS (Extremely tender arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (The arm that they injected is extremely swollen) and TENDERNESS (Extremely tender arm). At the time of the report, PERIPHERAL SWELLING (The arm that they injected is extremely swollen) and TENDERNESS (Extremely tender arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     No concomitant medications were reported by the reporter.  Treatment information was not provided by the reporter.
his face was red; his temperature was 102/Fever; aches all over; experienced chills; This is a spontaneous report from a contactable consumer. A 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN61a8) via an unspecified route of administration, administered in Arm Left on 08Mar2021 11:00 (at the age of 82 years old) as dose 2, single for COVID-19 immunisation. Medical history reported as None. There were no concomitant medications. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration, administered in Arm Left on 05Feb2021 11:30 (at the age of 82 years old) as single for COVID-19 immunisation. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Patient did not received other vaccine within 4 weeks of COVID vaccine. The patient experienced experienced chills on 08Mar2021, his temperature was 102/fever, aches all over on 09Mar2021, his face was red on an unspecified date. Reported as, patient received his second Pfizer Covid vaccine on 08March2021. Later that evening patient experienced chill's & temperature. This morning patient's wife noticed his face was red and his temperature was 102 Fahrenheit and he was aching all over. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit on 09Mar2021. Outcome of the event his temperature was 102/fever, aches all over was not resolved and unknown for other event.  No follow-up attempts are needed. No further information is expected.
Long term pain in all joints especially hands, jaw and hips. Headaches, periods of extreme fatigue.  The pain started just over a week after the first vaccine and has continued to date.
Red  Circle under shot site, hot to touch , started itching few days before it subsided. Appeared maybe 2 days after shot and lasted a little over a week
Information has been received from a physician concerning an 11 year old patient who was vaccinated with GARDASIL (lot number, route and site not reported). Subsequently the patient died. Additional information has been requested.
Slight soreness around injection site starting a few hours after injection. Some lethargy that night and into the next day.