chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he tested on Sunday positive for covid 19.; he tested on Sunday positive for covid 19.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), in Mar2021 as dose 1, single (Batch/Lot number: unknown) and in Mar2021 as dose 2, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "he tested on Sunday positive for covid 19.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Calle reports he started with a cough on Friday that continued on to Saturday, he tested on Sunday positive for covid 19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Caller reported that he was fully vaccinated and has had 2 boosters. He got the J&J in Mar2021 (last year) and both boosters of Pfizer covid 19 vaccine; the first booster was November last year (2021) and the second booster was in April of this year (2022). Caller reported he started with a cough on Friday that continued on to Saturday, he tested on Sunday positive for covid 19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a RN through a pregnancy registry concerning a 17 year old female who on 19Apr04 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (lot #647267/1099N). Concomitant vaccination on the same day included a dose of hep B virus vaccine rHBsAg (manufacturer unk). The reporter indicated that the pt knew she was pregnant at the time of vaccination but did not disclose that information at the time because she had an abortion scheduled for 20Apr04. The pt changed her mind and did not have the abortion. She was also treated for chlamydia and received antibiotics that were not safe for her pregnancy. The name of the drug was not available. Unspecified medical attention was sought and no treatment was required. IT was noted that therapy with varicella virus vaccine live was discontinued. A product quality complaint was not involved. Follow up information was received from a RN who indicated that on 17Nov04 at 40 weeks from her LMP, the pt gave birth to a normal female infant weighing 10 pounds and 7 ounces. There were no complications, infections, or illness during pregnancy. Diagnostic tests during pregnancy included an ultrasound (results not provided). Complications during labor included a cesarean section due to failure to progress. There was no feature of congenital varicella zoster syndrome. Upon internal review, failure to progress was determined to be an other important medical event (OMIC). Information received on 29Apr04 contained the following adverse experience: Chlamydia (onset unk). No further information is expected.
Headache, Fever, chills, fatigue Narrative:  fatigue, chills, fever and headache 1 day post vaccine
Given a low dose (0.2 ml) instead of (0.3 ml) PFIZER Covid vaccine 1st dose.
Nausea (no vomiting), High fever, Chills, Shaking, Aching, Fatigue
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: 5 minutes after vaccine pt felt lightheaded and blurred vision. then passed out. patient advised to sit down then passed out again and started to shake head (seizure like symptoms) for a few seconds. patient was pale, confused and started sweating, fingers were cold to touch. Then her fingers started to get numb and tingly. she was having a hard time seeing colors and she started having ringing in ears. Ambulance was called and they took over.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "Melanoma Insitu" (unspecified if ongoing); "Antidepressant" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM taken for antidepressant therapy, start date: 23Nov2022; NP THYROID; ALLERTEC [CETIRIZINE]; BIOTIN taken for supplementation therapy; CITRACAL MAXIMUM PLUS taken for supplementation therapy; TRIPLE ACTION taken for supplementation therapy; MULTIVITAMINS [VITAMINS NOS] taken for supplementation therapy; PROBIOTICS NOS taken for supplementation therapy; FISH OIL NATURE'S BOUNTY taken for supplementation therapy; MONTELUKAST taken for asthma. Past drug history included: Wellbutrin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "recovered" (27Mar2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Mar2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: It was reported that Paxlovid was taken as treatment for COVID-19 from 18Mar2023 to 23Mar2023 at day 1-6 of the event occurrence.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
my arm pits were slightly swollen; similar itching sensation and the itching has returned and is limited to my thighs & knees, and forearms & elbow; This is a spontaneous report from a contactable consumer(patient). This consumer reported similar events for two doses. This is the second of two reports, for second dose. A 37-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number and expiration date were not reported) via an unspecified route of administration at the left arm on 18May2021 12:30 ( at the age of 37-years-old ) at single dose for covid-19 immunisation. The patient medical history was not reported. the patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included lansoprazole taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number and expiration date were not reported) via an unspecified route of administration at the left arm on 27Apr2021 12:30 (at the age of 37-years-old) at single dose for covid-19 immunisation. After the first dose the patient had an itching sensation in the arms and legs that eventually went away; no rash/hives. The patient previously took omeprazole and experienced allergies to omeprazole. After the second dose  on 18May2021 12:45 the patient had a similar itching sensation that also went away, and the arm pits were slightly swollen for a few days afterwards. The itching has returned and is limited to the thighs & knees, and forearms & elbow. No treatment was received for the events. The patient had not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered. The report was reported as non-serious.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021753984 same patient, same reporter, different dose, similar events
Itching on both arms and legs started 3 days after vaccine.  Rashes noted on 4th day that look like small red bumps mostly on wrists and ankles.  Still with itching and rash on day 7.
myocarditis; chest pain; shortness of breath; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is the first of two reports.  A 16-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06May2021 (Batch/Lot number was not reported) (at the age of 16-year-old) as single dose for COVID-19 immunisation.  Medical history was none.  Prior to vaccination the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported.  The patient previously took ceftriaxone and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation.  On 08May2021, the patient experienced myocarditis, chest pain and shortness of breath.  The patient was hospitalized for 4 days due to the events.  The patient underwent lab tests and procedures which included COVID-19 test (nasal swab): negative on 09May2021.  Therapeutic measures were taken as a result of the events and included treatment with ibuprofen. The patient outcome of the events was recovering.  Information on lot/batch number has been requested.; Sender's Comments: Based on temporal association a contributory  role of  BNT162B2 to the reported myocarditis, chest pain and shortness of breath cannot  be totally excluded.  Additional information is needed to  better assess the report.   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.,Linked Report(s) : US-PFIZER INC-2021565275 same reporter/AEs/vaccine, different patient.
was supposed to start an antibiotic yesterday; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (was supposed to start an antibiotic yesterday) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (was supposed to start an antibiotic yesterday). At the time of the report, VACCINATION COMPLICATION (was supposed to start an antibiotic yesterday) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was going to get the 2nd dose of the Moderna vaccine on Friday (12Feb2021) and patient was supposed to start an antibiotic yesterday.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Apparent life-threatening event with cyanosis and respiratory arrest 2 hours after Hep A administered at well child care  9/2/08 Reviewed ER medical records of 7/18/2008. FINAL DX: fever, febrile seizure Records reveal patient experienced rhinorrhea, fever & seizure x 40-60 secs while in car seat & postictal w/cyanosis for 10-15 min afterward.  Temp was 40.2 in ER.  Tx w/antipyretics.  No further seizures.  D/C to home w/instrutions to have UA & urine c/s repeated at PCP office.
Info has been rec'd concerning a pt with diabetes mellitus who was vaccinated with her 2nd hepatitis vaccine. (lot #641071/1069L) IM. The pt complained of weakness and was feeling nauseated, dizzy, and queasy within 10 min of receiving the 2nd dose. The pt's vital signs were BP 120/98, P 64 and R 20. The pt was given a finger stick and her glucose was found to be within normal limits. The pt was advised to sit and rest and take ice chips and later "something bland". She was advised to lie down and rest. It was noted that the pt did not have breakfast and was given tea and toast. The pt felt better and went home at 12 Noon and was told to see her own physician if the symptoms persisted. Later, the pt had vomiting and diarrhea. She then called her doctor, who ordered treatment that was unavailable at the local pharmacy, then kaolin (Kaopectate) was ordered. The pt improved and the symptoms subsided. The doctor recommenced that she not receive the 3rd dose. It was reported that the pt recovered on 2/2/02. No further information is expected.
Neck itching rash hives, burning itching , fever , night sweats, exhausted, bones aching for several days, left elbo locking up, stomach messed up. Trying to get into dr and having trouble finding anyone who will treat me
Client had an episode of syncope after receiving immunizations; Initially (after shots) complained of not feeling " so good", began to slump forward, eyes half closed, unresponsive; duration of less than 1 minute - used ammonia inhalant to get a response/bring to alert status.
I had a runny nose off and on. It was late in the day that I felt awful. The runny nose was constant, and I was so stuffed that my face hurt. The sinuses made my teeth hurt. I was afraid I had an ear infection because my ears were sore. I had some chills, but I did not check my temperature. I had a little shortness of breath. I called the doctor office and she prescribed Paxlovid. I started the treatment that evening. My symptoms improved by Monday evening I was feeling better. I recovered from all the symptoms after a couple of weeks. I still had a little shortness of breath and brain fog. My arthritis also got worse which I took Ibuprofen and Tylenol. I was already taking the prednisone.
Patient was given second vaccination on 12/28/2017. On 12/31/2017 she was at a friend's house and had a pressure headache. According to friend's father she was not acting like her normal self she was very lethargic. She is an athlete and is never tired. She went to the kitchen and was standing in line for a pancake and passed out, hit her head on tile floor. She was unconscious for a little less than 1 min. She was unable talk or form a sentence. After about 30 min she could say her name but took a lot of thought and could not walk. She was taken to the ED and starting throwing up. She had a CT scan, Labs, Urine sample, EKG, given 2 L fluids and monitored for 6 hours. All testing come back normal. Except her EKG was bradycardic at 49 BPM. Her heart rate has been fluctuating for the last month between 40s to 115s, it changes by the minute (even with no activity). She recovered from the concussion 2 weeks later and no other symptoms for 3 days. However, she then came down with strep throat and had headaches and dizziness again. She has never had strep and has never really been sick. This was her first time ever missing school for an illness. She recovered from strep after a round of amoxicillin. Her breakout on her forehead has not healed even after a month and half of topical clindamycin. She can't seem to get her immune system back in check. 1 month to the day later she started having fatigue in her legs and they feel heavy and weak, this comes and goes. She also seems to be more emotional about a month after getting the vaccination. Her appetite seems to be normal thus far. 8/14/2018 - update: 7 months post 2nd vaccination. Has a headache every day for 3 weeks, fatigue, head is still not cleared up after being on antibiotics and RETIN A. She has insomnia and cannot fall asleep. At times she has numbness or tingling in her feet. She seems to be feeling worse not better.
(L) arm- Knot, redness entire arm into neck, pain-started 7/10/07. 7/12/07-Tx with Keflex and Prednisone for cellulitis and allergic reaction
Very sore arm (right side); Swollen axillary lymph node (right side); Intermittent headaches x 1 day; Fatigue; Mild joint and muscular pain; Mild joint and muscular pain; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm right on 16Apr2021 at 13:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa (Sulfonamide allergy). The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER6213) via an unspecified route of administration in the arm right on 27Mar2021 at 14:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021, the patient experienced very sore arm (right side), swollen axillary lymph node (right side), intermittent headaches x 1 day, fatigue, mild joint pain and muscular pain. 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 intermittent headache recovered on 17Apr2021, while that of the events very sore arm (right side), swollen axillary lymph node (right side), fatigue, mild joint pain and muscular pain was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
I have developed tinnitus in both ears which is massively effecting my quality of life. Fatigue Headaches all of the time Periods of confusion/brain fog Dizziness
Redness & swelling near to injection site - (VARIVAX) worsening w/ rapidly expanding erythema & subjective fever - Tx for infection w/ KEFLEX.
Reports symptoms of low grade fever (<100F), chills, achiness, fatigue, pain and tenderness on left arm at site of injection.
Cellulitis; Fatigue; Minor headache; Methicillin resistant Staphylococcus aureus; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4246636-00.  A 49 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 07Apr2021 (Batch/Lot number: unknown) at the age of 48 years as dose 2, single and intramuscular, administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: CELLULITIS (medically significant), outcome "unknown", described as "Cellulitis"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; HEADACHE (non-serious), outcome "unknown", described as "Minor headache"; STAPHYLOCOCCAL INFECTION (non-serious), outcome "unknown", described as "Methicillin resistant Staphylococcus aureus". The patient underwent the following laboratory tests and procedures: staphylococcal infection: unknown, notes: Unknown. The action taken for adalimumab was unknown and for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) Action(s) taken with drug: Drug discontinued.  Additional information: Clinical course was reported as On unknown dates, the patient experienced fatigue after COVID vaccine, cellulitis, minor headache after COVID vaccine and methicillin resistant staphylococcus aureus. pfizer biontech covid-19 vaccine (TOZINAMERAN) was also considered suspect. Event abates after stopping drug was reported as N/A (not specified) for HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB) and PFIZER BIONTECH COVID-19 VACCINE. On 18Oct2021, patient received third booster dose, Intramuscular COVID-19 Vaccine manufactured by Pfizer/BioNTech.  Causality: The reporter's causality for HUMIRA(ADALIMUMAB) and PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was not reported for all the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As per available information and temporal association, the causal association between the event and the suspect drug cannot be excluded.
Extreme exhaustion; serious muscle pain; joint pain; Injection site swelling; Injection site redness; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration on 22Mar2021 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. It was unknown if the patient was allergic to any medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration on 01Mar2021 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. On 22Mar2021, the patient experienced extreme exhaustion, serious muscle and Joint pain, swelling and redness at the site of injection. It was unknown the patient received treatment for the reported events. The patient was tested for pain scale and the result was 6 on a scale of 1-10. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event extreme exhaustion, serious muscle and joint pain, swelling and redness at the site of injection were recovered on an unknown date at the time of this report  No follow-up attempts are possible; information about lot/batch number cannot be obtained.