chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt like a fever; super hot; nauseous; GI issues; fatigued; Arm was sore; This is a spontaneous report from a contactable healthcare professional reporting for himself. A 25-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EK9231/expiration date: not provided), via an unspecified route of administration, on 07Jan2021 12:30 PM (at the age of 25 years old) as a single dose in the right arm for COVID-19 vaccination. Relevant medical history included known allergies to sulfa antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications taken in two weeks) included lisdexamfetamine mesilate (VYVANSE) 20 mg once daily, and paroxetine hydrochloride (PAXIL) 20 mg once daily. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EJ1685/expiration date: not provided), via an unspecified route of administration, on 19Dec2020 04:00 PM (at the age of 25 years old) as a single dose in the right arm for COVID-19 vaccination. The patient did not receive any other vaccines within 4 weeks prior to the second dose of COVID vaccine (except for the first dose of BNT162B2). On 07Jan2021, the patient's arm was sore at night. The patient woke up in the morning on 08Jan2021 at 03:00 AM morning and was super hot. He reported that it felt like a fever. The patient also felt super fatigued, nauseous and had gastrointestinal (GI) issues. The patient drank water and took 400 mg of ibuprofen. The patient reported that this did not happen during the first dose. The patient reported that he felt fine at 09:00 AM on 08Jan2021. Treatment for these events included 400 mg of ibuprofen. The outcome of the events arm was sore, was super hot, felt like a fever, fatigued, nauseous, and GI issues was recovered on 08Jan2021 at 09:00 AM. Since the vaccination, the patient had not been tested for COVID-19.
started becoming ill on 1NOV98 w/h/a, achiness & fever 102-102.8;pt still has cough 9NOV98;no temp, c/o sl achiness;seen by MD 2NOV98 strep negative, urine test negative;
This spontaneous report received from a nurse referred to an unspecified patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that an unspecified patient was inadvertently administered PROQUAD (lot# M032497 exp. 20-JAN-2017) on an unspecified date, that had been improperly stored. No adverse effects reported. The vaccine was stored at 9.5F for 20 min. There was no previous excursion and the call was because of a data logger.  Additional information is not possible as permission to contact physician was not available.
Information has been received from a registered nurse concerning a 53 year old male who on 4/11/02 was vaccinated with hep B vaccine recombinant 10mcg, first dose (641448/1497L). On approximately 4/11/02 the pt developed cold symptoms for the duration of 2-3 days and experienced muscle achiness for the duration of 15 days. On 5/16/02 the pt was administered his second dose of hep B vaccine recombinant10mcg, (642483/0008M). In approximately May 2002, the pt experienced right arm myalgia "which went to the neck and legs." The pt also stated that the muscles under the knees were very stiff. The pt visited his primary physician who recommended ibuprofen and acetaminophen. In approximately May 2002 the pt had a fever of 99-100 degrees F for the duration of 'about one month." The pt's temperature would rise in the middle of the day. The reporter stated that the pt would "take medication in the morning but no additional medication during the day." The pt sought medical attention. Additional info has been requested.
No adverse event; 50-year-old patient received 2nd primary dose of Moderna COVID-19 vaccine, But received Bivalent booster instead on Monovalent; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (50-year-old patient received 2nd primary dose of Moderna COVID-19 vaccine, But received Bivalent booster instead on Monovalent) and NO ADVERSE EVENT (No adverse event) in a 50-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jan-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (50-year-old patient received 2nd primary dose of Moderna COVID-19 vaccine, But received Bivalent booster instead on Monovalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (50-year-old patient received 2nd primary dose of Moderna COVID-19 vaccine, But received Bivalent booster instead on Monovalent) 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 WRONG PRODUCT ADMINISTERED (50-year-old patient received 2nd primary dose of Moderna COVID-19 vaccine, But received Bivalent booster instead on Monovalent).    No concomitant medications were reported. On 09Dec2022 at 14:38 Pm, the patient received first dose of monovalent Moderna vaccine 0.5 mL intramuscularly in left deltoid (Lot number: 015B22A). No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2023: Significant follow up received contains Reporter details and narrative updated
Acute liver injury; Elevated liver transaminases; This is a spontaneous report received from a contactable physician.   A 73-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6201), via intramuscular, on 16Feb2021 (at the age of 73-year-old) at a single dose for COVID-19 immunisation. Relevant medical history included autoimmune hepatitis. The patient did not have allergies. Relevant concomitant medications included azathioprine. On 22Feb2021, the patient had acute liver injury and elevated liver transaminases. The events resulted in the Physician Office Visit. The patient was treated with prednisone. It was unknown if the patient had received other vaccine in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was recovering from the events.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, the events acute liver injury and elevated liver transaminases are likely to be intercurrent events unrelated to the use of suspect product BNT162B2. Contributory factors to consider in this 73-year-old male patient is the patients underlying autoimmune hepatitis and use of azathioprine. This case will be reassessed should additional information become available. 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 RAs, Ethics Committees, and Investigators, as appropriate.
I have been swelling, abnormal swelling; Feeling abnormal (Something is blowing, something is wrong); I am having problems with the right side of my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "I have been swelling, abnormal swelling"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feeling abnormal (Something is blowing, something is wrong)"; DISCOMFORT (non-serious), outcome "unknown", described as "I am having problems with the right side of my body".  Additional Information: The patient is not really sure of what all the side effects were from the Pfizer Covid shot (Clarified as Pfizer Covid-19 vaccine) because it is concerning because patient was not overeating, and had swelling, abnormal swelling. The patient do not know what kind of reaction. The patient stated something is wrong and just wanted to know. The patient does not had information about this vaccination. The patient looks like about 4 or 500 pounds. The patient is hurt and victimized and is in harm's way. The patient had problems with the right side of body, the patient tries to think that he/she had shot on which side of shoulder, and the patient is not sure of which side.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
First menstrual cycle after 1st dose of vaccine  lasted 22 days, was extremely heavy flow, and had lots of blood clots. Typically my period lasts 4-5 days, with day 2 being the heaviest, and the remaining days being medium to light flow. Typically I use Super or Super+  tampons, but now  I have to wear both an ultra tampon and an ultra pad at the same time. I have to change every 1-2 hours,  else the blood overflows and runs down my legs. Extreme clotting. Typically my cycle starts every 30 +/- 1days like clockwork. My period has been abnormally heavy and extremely inconsistent ever since receiving the first dose of vaccine in September 2021.
2/9/2021 3:29 pm RESIDENT HAVING CHILLS, NAUSEA, VOMITING POST COVID VACCINE. 2/10/2021 07:45  am- Resident noted sitting up in W/C in room with head down. Required  increased assist with standing. While eating breakfast he took longer than usual to finish due to dozing off multiple times. BP 178/76. Was experiencing N/V and low grade temp on yesterday Order received to send to ER for eval.
Tingling sensation on the lips and tongue with mild light headedness. Experienced tingling sensation on her lips and tongue 15 minutes after receiving the COVID-19 vaccine #2. Also experienced mild lightheadedness. BP 117/61, HR 81, O2 sat 97%.
Donor received tetanus shot at 1639 and reports having lightheadness and nausea starting at 1900 and lasting on 12/04/06. Donor states she was going from a sitting to standing position. After 15 minutes symptoms didn't reoccur.
(EXTREME)  MIGRANE AND DIZZINESS FOR 24 HOURS - THEN SUBSIDING TO DIZZINESS FOR ANOTHER 24 HOURS - TOTAL SIDE EFFECTS 3 DAYS - ALSO HAVE SEASONAL ALLERGIES TO FOLIAGE AND MOLDS
Strep throat; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGITIS STREPTOCOCCAL (Strep throat) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PHARYNGITIS STREPTOCOCCAL (Strep throat). The patient was treated with AMOXICILLIN for Pharyngitis streptococcal, at an unspecified dose and frequency. At the time of the report, PHARYNGITIS STREPTOCOCCAL (Strep throat) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications reported.
memory loss for 4 hours; This is a spontaneous report from a contactable consumer (patient's girlfriend). This is report 2 of 3. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: EWO167) intramuscularly on an unspecified date as dose 2 single, for COVID-19 immunization. Patient's medical history and concomitant conditions were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: EWO153) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On an unspecified date, about five days after second dose of vaccination, the patient experienced memory loss for 4 hours and ended up in the ER (emergency room). It was not reported whether patient was admit-ted to the hospital relative to this event (as the reporter was unwilling to complete the report). It took patient about 4 weeks for adverse event to go away; they treated it and they've moved on but maybe they are a little bit more healthy than the next person would be. Reporter stated all was resolved now. Reporter stated the lot numbers for her and her friends were similar and concerned they had gotten bad batches. Reporter wanted to know how many vaccines are in each batch. Re-porter and her girlfriends compared their cards and their vaccines Lot numbers were all within dig-its of each other and felt it was worthwhile to look into it. They were all fine, but it might be an is-sue of bad batches of Lot numbers of the Pfizer Covid Vaccine. Reporter verified she believes 3rd character in Lot was letter O like Oscar, not numeral zero. NDC/Expiry: Not provided, caller unwilling to complete report and for 2nd dose: Lot: EWO167, reporter verified she believes 3rd character in Lot is letter O like Oscar, not numeral zero. NDC/Expiry: Not provided, caller unwilling to complete report. Reportedly, they all recovered; but if there was a bad batch Pfizer needs to know this. This patient and her girlfriends were in different locations for their Pfizer Covid Vaccine doses; they just all happened to sit down together and compare their cards. Reported stated if all of the sudden it was asked why are these people who weren't in the same locations experiencing these ad-verse events, it might be worthwhile to consider if those Lot numbers were bad batches. Patient received treatment for the event (unspecified). Outcome of the event was resolved.  Information on Lot/Batch number was available. Additional information has been requested
They have had Covid twice, the first time in Jan2021 and the second time on 24Aug2022.; They have had Covid twice, the first time in Jan2021 and the second time on 24Aug2022.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "They have had Covid twice, the first time in Jan2021 and the second time on 24Aug2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2021) Positive, notes: They have had Covid twice; (24Aug2022) Positive, notes: They have had Covid twice. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information included: The caller thanked Pfizer for the vaccinations and said she and her husband have taken them all, up to the first booster. They can't take the second booster until 3 months after the Covid from August. The caller stated she is doing very well for her age. They have had Covid twice, the first time in Jan2021 and the second time on 24Aug2022. She stated for her age, for the most part she does not have to take medications and she is not on any medications for any conditions.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID-19; COVID-19; experienced body aches; sick to stomach; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program. A 50-year-old adult female received a dose (unknown dose number) of BNT162B2 (solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route on an unspecified date for COVID-19 immunisation. Relevant medical history included Vitiligo. Concomitant medications included zinc; lisinopril; ascorbic acid (VITAMIN C); retinol acetate (VITAMIN A); colecalciferol (VITAMIN D3); amlodipine besylate; tocopherol (VITAMIN E); metoprolol succinate. The patient previously received treatment for an unspecified indication with hydrochlorothiazide and experienced allergies. The patient reported that in Oct2021 she experienced body aches and was sick to her stomach from COVID-19. There was no laboratory testing reported. The outcome of the events body aches and was sick to her stomach was recovering. The outcome of the remaining events was not recovered.    The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19, suspected LOE and other events.  There is limited information provided in this report.  This case will be reassessed once additional information is available. 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.
Patient described substantial pain in his shoulder immediately following the administration of his influenza vaccination, and noted that at the time he felt that the location of administration seemed higher than normal.  Patient has seemed medical direction from his primary physician as well as receiving an MRI on the shoulder in question.  As of 1/25/20, the patient noted a reduction in pain, but it is not 100% improved as of yet.
I had severe Colitis. I had pain, lost weight, and diarrhea; I also had a fever.  My whole gastrointestinal system was swollen.  These symptoms lasted for about a month.  I was hospitalized for 4 days.  I had a CT scan, blood work, and stool sample done.  It went away and now it is back.
Child developed papular rash on abdomen, extremities, and head on 5/2/05, 2 weeks post vaccination.
He fell and broke his hip; He fell and broke his hip; This is a spontaneous report from a contactable consumer (patient's wife) via the Pfizer-sponsored Program.  A 69-year-old male patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on Feb2021 (batch/lot number was not reported) at the age of 69 years old, as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer (patient's wife) called on behalf of her husband who got the first dose of the Pfizer COVID-19 vaccine on Feb2021. The patient fell and broke his hip on Mar2021, the day he was due for his second dose. He had been in the hospital and nursing facility since Mar2021 and until 04Aug2021. The long-term care facility wouldn't give him his second Pfizer dose. They only have the Johnson & Johnson and Moderna vaccines in the area and no one will give him Pfizer. The wife stated she's been trying to get her husband a vaccine since he got home in Aug2021. The patient was home and homebound; the county and city will give shots to homebound people and they only have Johnson & Johnson and Moderna as these are the only available vaccines in their area and no one will give him Pfizer. His Home health and Primary care physician doesn't give the vaccine. Because the patient had the Pfizer one already, they want him to get the same vaccine and are at their wits' end to get him the vaccine. The consumer asked for recommendation. She was advised and agreed to email attached document with link to CDC for information on how to get the vaccine. The consumer further reported that the fall had nothing to do with the vaccine and he already got treatment for that. The day he fell he was supposed to get the second shot and fell before he left the house. That was why he never got it. The hospital and long-term care facility didn't give the vaccine and she really wanted to get him vaccinated and he wanted to be vaccinated. The outcome of the events was unknown.  The batch/lot number for BNT162B2 was not provided and will be requested during follow-up.; Sender's Comments: Based on the current available information, the role of the suspect product BNT162B2 to the development of events Hip fracture and fall is assessed to be unrelated. 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.
Information has been received from a hematologist concerning a 14 year old female with no pertinent medical history, nor drug reaction/allergies, who was vaccinated with the first two doses of GARDASIL. No concomitant medication reported. Subsequently, the patient developed thrombocytosis (platelet count 1,500,000) and eosinophilia after receiving the first two doses of GARDASIL. The immunoglobin E level was elevated at 2,600 too. At the time of the report, the patient had not recovered. Medical attention was sought at the physician's office. Additional information has been requested.