chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Report about covid treatment: Yes. if vaccine received: Yes. Patient did not received other medication in 2weeks. Patient received treatment with paxlovid start date: 09Jul2022 and stop date: 06Jul2022. Indication.Adverse event : Covid rebound Day 11. Adverse event country :  Adverse event start date: 20Jul2022. Ae resulted in none of the above.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
(The report was received at the Health Dept on 8-26-2008 on an Epi-1 form.) 7.5 X 13.5 cm red reaction on Left upper arm
Approx 1 1/2 hours after TRUMENBA pt developed severe back pain with nausea, vomiting and a headache. Was taken to ER. DX: Back strain.
Pt presented to office on 3/4/06 with a history of vesicles for 3 x 4d duration. No fever. Generalized lesion >100 scattered over body. Aveeno, Benadryl, Calamine. No ASA, Isolation. vaccine administered 01/20/1998, adverse event onset 03/01/2006.
Tingling in hands, itching skin, joint stiffness, tight chest, twitching muscles, insomnia, limp left arm, (paralysis) possibly related to nerve, feeling came back.
adverse affects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse affects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse affects). At the time of the report, VACCINATION COMPLICATION (adverse affects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
patient stated that her hands, ears,  and eyes  became swollen, red and itchy, seeing blurry, throat burning,
Patient reported bruising 2 inches below injection site 1 day after administration followed by extensive bruising down the arm.
When participant arrived for vaccine #2, he informed PI that for 4 hours post vaccine #1 he experienced being spaced out. It appears that he experienced a fugue state. Proceeded to receive vaccine #2 on 01/04/2002 with no reports of similar fugue state on 01/04/2002.
Hot flashes, lightheaded, swollen, red around injection, broke out in a rash, sore, bruised, whole arm swollen, numb x 2 wks, initially, heart beat rapid, dizziness (Pt stated) (no RN assess)
Frequent headache, I took Acetaminophen and Sumigran plus. Leg weakness, chest pain/ no treatment. A little tachycardia.
Tingling down left arm for a few hours Redness, swelling, itching - start appx 45 minutes after injection 4/7/21 - Still slightly swollen, itchy, red but improving
jerks left arm next day, next day small jerks fr head to toe at night. have lessened but still minor jerks especially arms and hands; stiffness in legs and back; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient (not pregnant) received BNT162B2 (lot number: em9809) second dose on 10Feb2021 10:30 at single dose on left arm for COVID-19 immunisation. Medical history included sleep apnea. Concomitant medications included lisinopril, acetylsalicylic acid (BABY ASPIRIN) and paracetamol (TYLENOL). The patient had allergies to Levaquin. The patient previously took BNT162B2 (lot number: el9261) first dose on 20Jan2021 (at the age of 82-year-old) on right arm for COVID-19 immunisation. Facility type vaccine was Hospital. Jerks left arm next day, next day small jerks from head to toe at night. have lessened but still minor jerks especially arms and hands. stiffness in legs and back. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. No treatment. No covid prior vaccination. No covid tested post vaccination.
From pediatrician records, on 8/17, 2 days after vaccinations of 8/15, patient experienced up and down fevers of 103F, loss of appetite, lethargy, sleepiness, and a red rash on her diaper area which persisted for 7 to 8 days.  The rash left a cafe-au-lait spot.  Patient had previous adverse reaction at 2 month vaccinations.  Patient later suffered permanent hearing loss which may or may not be the result of this adverse event.
Information has been received from a certified medical assistant concerning 12 patients who on an unknown date were vaccinated with a dose of PNEUMOVAX 23 (Lot number: 663888/0627Y or 662599/1076X).  The certified medical assistant reported that the 12 patients had "reactions to PNEUMOVAX 23 ranging from fevers to 102F to 103F and cellulitis."  Some patients had "cold like symptoms including muscle aches, fever, cough and congestion, starting the day after the PNEUMOVAX 23 was given".  At the time of the report the patient's outcome were not reported.  The certified medical assistant stated that 4 patients went to the emergency room and were placed on IV antibiotics but were not admitted to the hospital.  The other patients sought medical attention at the physician's office.  Follow up information was received from the medical assistant who stated that would like to return PNEUMOVAX 23 that caused patient reactions in the office.  Nurse stated "she understands that routine reports had been noted with PNEUMOVAX 23 in the past but had never reactions such as this in their office".  Follow up information has been received from a nurse who reported that a patient who on unknown date was vaccinated with a dose of PNEUMOVAX 23 (Lot number not specified).  On an unspecified date, the patient had adverse reactions to PNEUMOVAX 23.  This is one of several reports received from the same source.
Large erythema warm to touch edematous area 14 cm x 3 cm just below and boarding injection site. Pt to take Benadryl PO PRN for itching and Medrol dose pack.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse 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)) 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case was created for 119th of the 190 patients involved. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine. Treatment information was not reported.   This case was linked to MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MODERNATX, INC.-MOD-2023-704335:Master case
Swelling at sight (hard knot 2-3 across), heat, soreness. When I rubbed at it and found the swelling, I took Tylenol & used an ice pack. Then I went to bed for the night. I assume it will be better or gone tomorrow.
From telephone contact received at Aventis Pasteur Inc. on 04/22/02, it was  reported that a 16 month old child received Tripedia,HIB and prevnar on 04/16/02. Patient's right thigh became swollen, red and hot area almost covered the whole thigh. Temperature is 99.5 degree F axillary.
BUD date excursion. BUD date was 4-7-23 and vaccine was administered 4-21-23.
was taken out to give to a patient and it was / was not put inmediately; was taken out to give to a patient and it was / was not put inmediately; This case was reported by a pharmacist via other manufacturer and described the occurrence of intercepted product storage error in a 20-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included Rabies NVS (RabAvert) for prophylaxis.   Concurrent medical conditions included animal bite. Concomitant products included Rabies NVS (RabAvert) and Rabies NVS (RabAvert).   On 27th July 2020, the patient received the 3rd dose of RabAvert. On an unknown date, the patient received RabAvert. On 24th July 2020, unknown after receiving RabAvert and not applicable after receiving RabAvert, the patient experienced intercepted product storage error. On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the intercepted product storage error and drug dose administration interval too long were unknown.  Additional information was provided as follows: The age at vaccination was not reported, however the patient could be of 19 or 20 years old at a time of vaccination. The Rabavert vaccine was taken out to give to a patient and it was not put back immediately. I think it was out for about 24 hours. As per the pharmacist, this was the patient's 3rd dose and they rescheduled for a couple of days later. The patient did not get this dosage that was left out. It was a single use vial and they set it out to get it to room temperature before the patient got to the appointment. The patient did not show up for the appointment, and the medication was left in the return to pharmacy bin for about 24 hours. The missed dosage was on 24th July 2020. The patient came in for his appointment and got his vaccine on 27th July 2020. The reporter consented for follow up.   Follow up information received from pharmacist on 11th August 2020: PharmD stated that the patient did not receive the dose that was left out. The patient did not miss the dose, they had another injection they could use to give the dose. The reporter was not sure that the vaccine was back in the fridge or not. The reporter wanted to know if something in the future happened again like this and a vaccine was out of the fridge can it be use. The reporter also wanted to know If vaccine being left out occurs did it change the expiration of the vaccine. This vaccine was at room temperature for 24 hours so probably maximum of 68 to 72 degrees, but the reporter was not exactly sure what the temperature was.   Following internal review it was determined that initial reciept date was 5th August 2020, which is earlier than initially reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure. The patient took concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chest pain; Dizziness; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), DIZZINESS (Dizziness) and ASTHENIA (Weakness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced CHEST PAIN (Chest pain), DIZZINESS (Dizziness) and ASTHENIA (Weakness). At the time of the report, CHEST PAIN (Chest pain), DIZZINESS (Dizziness) and ASTHENIA (Weakness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications include asthma medications.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown
Patient stated she started feeling extremely tired, run down, and had a fever and chills and had to leave work early on Wednesday 9/18/19 due to how terrible she felt. She presented on Friday 9/20/19 with a welt on her left arm about 4-5 inches below the injection site. The welt was warm to the touch and spanned the entire front of the bicep and was approximately 6 inches wide and 3 inches tall. Patient was instructed to use cold compress and take acetaminophen/ibuprofen for any fever or pain. Patient was also instructed to return to pharmacy if the reaction worsened over the next 2 days.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2023) Negative, notes: Had 2 negative rapid tests; (May2023) Negative, notes: Had 2 negative rapid tests; (May2023) Positive, notes: tested positive again; (May2023) Positive, notes: But, then tested positive again; (26May2023) Positive, notes: started Paxlovid the day after and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No known allergies. Very mild case of COVID. Had 2 negative rapid tests and then tested positive again. Symptoms had continually improved, energy back, felt very good. But then tested positive again. No new symptoms and energy level high, etc. Now, still testing positive and on day 17 since first testing positive for COVID. Patient is fully vaxed with the vaccine including the bivalent around Oct or Nov2022.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP7534), on 15Apr2021 as dose 2, single (Lot number: ER8731) and on 15Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 33 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Dairy" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE, start date: 01Sep2021, stop date: 22May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected covid-19.
p/vax pt devel small bumps @ joints;few hr later had many many bumps over torso & limbs that itched;then bumps spread to face & were bright red & scratchy;same occurred on next day- 8/8/99;
I began having very stiff joints a few weeks after having my baby. It now continues at week 9.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding the medical history, drug reactions/allergies and concurrent conditions was not reported. On 03-NOV-2017, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneously, lot # N013277, expiration date: 28-APR-2019 (dose and site of administration were not reported) for prophylaxis. It was stored in temperature of 6 Fahrenheit degrees (F) to 14 F (7.9 F) for 19 minutes. There was no previous temperature excursion. The call was a result of a reading from a Digital Data Logger. The nurse reported that the diluent (lot number and expiration date were unknown) used to reconstitute the VARIVAX was properly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA003480: US-009507513-1805USA003481: US-009507513-1805USA003482: US-009507513-1805USA003483: US-009507513-1805USA003484.
My son had a severe seizure in the parking lot of the doctors office. He broke out in hives on his body raised all over. He was seen by the doctor and we were told it wasnt an allergic reaction just a normal reaction.
Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer; No adverse event; Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer) and NO ADVERSE EVENT (No adverse event) in a 31-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Oct-2022, 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 17-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer) 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 (Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer) and PRODUCT TEMPERATURE EXCURSION ISSUE (Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer).    Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-676064 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-676064:same reporter
Immediately after patient received the shot, the injection site swelled up and the patient reported dizziness and eye swollen.
Injection site was sore and red upon waking this AM.  Arm aches down to wrist.
Pt stated was going about her normal routine and by the evening on the day following her vaccination, her right arm was very swollen, warm to touch and numb. PT applied ice that evening. Came into clinic afternoon of the next day, and right arm was still swollen, numb, tingling, red and warm to touch. Right arm circumference 1 inch larger than left. Redness extends from elbow midway up arm and circumferentially around arm.
Extremely tired for a day and 1/2. Could only stand and/or walk for about 5 minutes and then had to go and lay down; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration on an unknown date in Aug2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 unspecified over the counter sleeping pills of 50 mg. On 15Aug2021, the patient experienced extremely tired for a day and half. The patient reported that she could only stand and or walk for about 5 minutes and then had to go and lay down. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event extremely tired for a day and 1/2 and could only stand and/or walk for about 5 minutes and then had to go and lay down was recovered on an unknown date in Aug2021.  No follow-up attempts are possible. No further information is expected.