chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 2, single (Lot number: EL3247) at the age of 38 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Major depressive disorder", start date: Jun2013 (ongoing); "Graves' disease", start date: Mar2022 (ongoing); "Appendectomy", start date: 1987 (unspecified if ongoing); "Depression" (unspecified if ongoing); "gallbladder removal", start date: 1993 (unspecified if ongoing). The patient's family history included: "Type 2 diabetes", start date: Nov2012 (ongoing), notes: Type 2 diabetes, Mother has asthma, diabetes, bipolar disorder (age 76 years old). Concomitant medication(s) included: METFORMIN oral taken for diabetes mellitus (ongoing); GLIMEPIRIDE oral taken for diabetes mellitus (ongoing); LANTUS taken for diabetes mellitus (ongoing); PROZAC taken for depression (ongoing); METHIMAZOLE oral taken for basedow's disease (ongoing); PROPRANOLOL oral taken for basedow's disease (ongoing). Vaccination history included: BNT162b2 (Dose: 1, Time: unknown, Anatomical site of injection: upper right arm, Route of administration: Intramuscular, Batch/Lot number: EL3247), administration date: 29Jan2021, when the patient was 38-year-old, for COVID-19 immunization, reaction(s): "very sore arm", "felt sick". The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "felt sick".  Additional information: 1st dose of vaccine on 29Jan2021, felt sick 2 days+ very sore arm; 2nd dose of vaccine on 18Feb2021, felt sick 2 days; 3rd dose of vaccine 11Oct2021, felt sick 2 days; On 18Jun2022-flu like symptoms( malaise, sore throat, congestion, headache); on 19Jun2022- positive for COVID, started paxlovid, felt horrible (sore throat, cough, aches, fatigue, bitter taste in throat); On 23Jun2022-finshed paxlovid; on 25Jun-01Jul2022 negative for COVID but still felt tired; On 02Jul2022-positive for COVID again( sore throat, tired, cough, congestion, headache, fatigue, no bitter taste); on 06Jul2022-begged my doctor for antibody test denied. On 10Jul2022-finally felt better and tested negative on rapid test. The patient did not take any vaccination prior to 4 weeks.  No follow-up attempts are possible, no information is necessary.
No additional AEs were reported, no further information provided.; improperly stored; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On 29-MAR-2022, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (1 dose, lot # u026664 was evaluated and changed to the valid Lot #U026664, expiration date 24-FEB-2023 or lot# 1741817, expiration date 30-JUL-2022, oral, (exact dose number, route of administration and anatomical location were not provided) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (1 dose, lot # u026217 was evaluated and changed to the valid lot # U026217, expiration date 02-NOV-2023 (exact dose number, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The nurse did not know which specific lot of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered to the patient. There were no additional adverse events reported or product quality complaint reported. Administered doses of vaccines experienced the temperature excursion of 34.3 degrees Fahrenheit for 55 minutes. There were no previous excursions reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2204USA001791: US-009507513-2204USA001816: US-009507513-2204USA001821: US-009507513-2204USA001657:
children received a higher dose for the second vaccine of COVID; The pts were administered with LOT# FK9729.; Fever; pain in the point of injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 10 year-old female patient received BNT162b2 (BNT162B2), administered in arm left, administration date 11Feb2022 (Lot number: FK9729) at the age of 10 years as dose 2 (tris), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: OVERDOSE (non-serious) with onset 11Feb2022, outcome "unknown", described as "pt received a higher dose for the second vaccine of COVID"; PYREXIA (non-serious) with onset Feb2022, outcome "unknown", described as "Fever"; VACCINATION SITE PAIN (non-serious) with onset Feb2022, outcome "unknown", described as "pain in the point of injection"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 11Feb2022, outcome "unknown", described as "The pts were administered with LOT# FK9729.". Therapeutic measures were taken as a result of pyrexia, vaccination site pain.  Additional Information: It was reported as "One of my friends reported to me that his children received a higher dose for the second vaccine of COVID and that they are experiencing fever and pain in the point of injection. The second dose, the dosage that was wrong. Pts, 8 and 10, the dose administered was a higher dose." This is the case for 10 year old child.  They are both taking only children's Tylenol (Clarified taken as Treatment) at this time (Intent: Treatment), Tylenol for children. They are taking it for discomfort. They are not on any kind of therapy or medication (Further not clarified if taking any medications, hence not captured). The patient did not have any prior vaccination within 4 weeks.   No follow-up attempts are possible. No further information is expected.
Patient reported shortness of breath for 1 day after receiving the vaccination. Patient also woke up with a fever and kept sweating in the early morning after receiving the shot.
Pt received varicella vaccine sub-Q in left arm on 8/20/09. Pt presented to office on 8/24/09 with history of redness on 8/21/09 and s/s getting worse to 4 1/2 by 4 1/4 inch area of redness swelling and warmth  to local site.Diagnosis cellulitis vs allergic reaction to varicella.
Patient had typical 24 hours of flu like symptoms. However in addition to this has had arm pain in the deltoid with difficulty in movement of shoulder joint since the vaccination, now lasting several months (4/29- 7/16). Has not improved with rest, stretches or use of pain medications.
COLD; ARM HURT; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. Patient's daughter had respiratory syncytial virus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination (dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  On an unspecified date, the patient experienced cold and arm hurt with Johnson and Johnson COVID shot (made her arm hurt with Humira) (dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the events was not reported.  Non-company suspect vaccine included: MRNA 1273 (Elasomeran) (form of admin unknown, intramuscular, batch number: unknown expiry: unknown), dose, start therapy date were not reported for prophylactic vaccination (dose number in series 2).  On an unspecified date, the patient experienced cold and arm hurt with Moderna booster (made her arm hurt with Humira) (dose number in series 2).  The action taken with MRNA 1273 was not reported.  The outcome of cold and arm hurt with Johnson and Johnson COVID shot and Moderna booster (made her arm hurt with Humira) was not reported.  Non-company suspect drugs included: adalimumab (Humira) (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. The action taken with adalimumab was not reported.  This report was non-serious.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 51-year-old patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: FD7534), in right arm, on 07Apr2021 as dose 2, single (Lot number: CW0151), in right arm and on 05Oct2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: other medical history: high blood pressure. Concomitant medication(s) included: LISINOPRIL HCTZ; METOPROLOL [METOPROLOL SUCCINATE]; ASPIRIN 81. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jun2022) Positive, notes: On day 1 (onset of mild symptoms), I tested positive for the 1st time; (10Jun2022) Positive, notes: tested positive on day 10 (home test). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: On day 1 (onset of mild symptoms),  tested positive for the 1st time and began taking Paxlovid. By day 5, ended treatment and only had a very mild cough once or twice a day. On days 6-8 patient felt almost perfectly (mild nasal congestion during sleep hours). But since day 9 patient had been sick again with new symptoms (sneezing, runny nose), like having a cold. And tested positive on day 10 (home test). Patient treated with Paxlovid, Treatment start date: 02Jun2022 and Treatment stop date: 06Jun2022 for  Indication of COVID-19
Patient had onset of a rash not abated with oral Benadryl.  Sent to ED after 30 minutes of observation.   In ED received IV Benadryl and symptoms resolved after appx 2 hours.(urticarial rash) resolved.
Incorrect dosage fro Age Group 12 y.o. and up - Booster  sx: Flu vaccine L arm sore from injection site
I have premature ovarian failure so in menopause for the last 2.5 years. 3days after the second dose of vaccine I experienced heavy vaginale bleeding like menstruation for at least 7days (still ongoin; This is a spontaneous report from a contactable other hcp (Patient) reporting for herself.  A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8729), dose 2 via an unspecified route of administration, administered in Arm Right on 04Apr2021 at 14:30 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included premature menopause from an unknown date and unknown if ongoing, at 35 years old have premature ovarian failure so in menopause for the last 2.5 years, premature menopause from an unknown date and unknown if ongoing at 35 years old, gluten sensitivity from an unknown date and unknown if ongoing Known allergies: Gluten. Concomitant medication included estradiol (ESTRADIOL TRANSDERMAL) taken for an unspecified indication, start and stop date were not reported. It was reported that, the patient has premature ovarian failure so in menopause for the last 2.5 years. 3days after the second dose of vaccine, on 07Apr2021 at 02:00, patient experienced heavy vaginal bleeding like menstruation for at least 7days. Stated that, it is still ongoing but decreased intensity. Outcome for the events was recovering.  Follow-up attempts are completed. No further information expected.
Patient felt flush, lips and face tingling while waiting her 15 minutes. We brought her back to monitor vitals. At 5 min post vacine BP 166/87 HR 98 O2 99%, 10 min post vaccine 143/80, 88 and 99%, 30 min post 140/76, 86 and 99%. Pt was then discharged to home feeling "much better"
Patient called the day after receiving the vaccine and reported a fever of 101 degrees. Provided OTC recommendations to control fever and encouraged patient to reach out to primary care physician and pharmacy if fever continues. Followed up with patient in the afternoon after the fever was reported, and she reported that the fever had subsided.
Patient felt faint 5 minutes after being vaccinated. patient says is scared of needles and thinks it is due to this. He did not want us to call 911 since he does not have an insurance. I nevertheless monitored his vitals until his dauugter who is a nurse arrived  .His heart rate varied from 45 to 61.
Got a flu shot in early January 2001.  Got the flu about third week in February 2001.  Took two weeks to recover from severe flu.  Mid-March (about a weeks after symptoms were gone) arms and legs started tingling and going numb with increasing severity.  Hospitalized and diagnosed with Guillain-Barre syndrome.  Treated blood with immunoglobins.  Some nerve damage in arms.
Breakthrough case admission after 2 vaccines Moderna 3/4/21 Lot# 030A21A;  Moderna 4/6/21 Lot# 018B21A
Miscarriage at 8 weeks. Blighted ovum measuring 5 weeks, 6 days. Due date was 4/2022.
Fever of 103F starting around midnight; Joints warm to touch w/some swelling, still present today; 4th DTP, no past problems w/DTP; hx of allergies to smoke & dust; Only child, no family hs of sz;
Dizziness, feeling faint, ringing in ears, muscle aches, and  tiredness.
This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 24-SEP-2018, the patient was vaccinated with improperly stored dose of PROQUAD albumin status: recombinant human albumin (rHA), lot# R009616, expiration date 30-SEP-2020 (exact dose, frequency, site and route of administration were not reported), reconstituted with properly stored sterile diluent lot# N035973, expiration date: 07-AUG-2020. Administered dose of vaccine was exposed to a temperature excursion between -14 degrees Celsius to -10 degrees Celsius (also reported as -12.3 degrees Celsius) for 7 hours and 52 minutes. There was a previous temperature excursion on 07-SEP-2018, between -9 degrees Celsius to 8 degrees Celsius (also reported as -1.8 degrees Celsius) for 7 hours. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1809USA011525.
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free pen. In March 2021, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-618958 (Patient Link).
headache off and on, severe coldness and some chills, diahrrea for 48 hours
mom states pt had DTp 9AM & began w/high pitched cry @ 130PM & cried to 530PM; couldn't be comforted; taken to MD;  MD office 2PM on 24MAR93; MD states it was a pertussis reaction; pt fully recovered;
Tinnitus started by the time I arrived at car after leaving pharmacy.  this is first moderna, had two prior pfizer shots with no reaction whatsoever.   this VAERS entry within 45 minutes of the shot.  Can't yet accurately fill out item 21 below (outcome).
I had an upper respiratory illness. I really think its been allergies. It started around 2/14 and lasted about 10 days.  It was just clear nasal drainage, a little bit of a headache and a couple days of fatigue. I was covid negative on 2/22- home test. It was sometime around St. Patrick's days, I noticed I didn't have any ear wax in my ears. I use ear plugs a lot. I have an appointment on 4/7 to get ears unplugged. I also had a telehealth visit with my cardiologist on 1/21 about the CT scan.
The patient 9 month old may have received the Gardasil 9 shot during a well visit to the doctor/ the nurse may have switched the syringes and accidentally administered the gardasil 9 vaccine to the patient; he patient 9 month old may have received the Gardasil 9 shot during a well visit to the doctor/ the nurse may have switched the syringes and accidentally administered the gardasil 9 vaccine to the patient; No adverse effect; This spontaneous report was received from a consumer who was the patient's mother, regarding a 9-moth-old patient, gender was not provided. Information regarding the patient's past drug allergies / reactions, and medical history, concurrent conditions and concomitant medications was not provided.    On an unspecified date (reported as during a well visit), the patient may had received the vaccination with  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  (strength, dose, frequency, anatomical site of application, lot number and expiration date  were not provided) for prophylaxis;  (product administered to patient of inappropriate age). It was reported that the nurse may have switched the syringes and accidentally administered  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) to the patient (wrong product administered), no product confusion or adverse event was reported.
Initial unsolicited report received from a pharmacist on 12 October 2016. This case is linked with cases 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. This case involves a patient (gender and age not reported) who was vaccinated with a dose of FLUZONE via intramuscular route (Batch number: UI669AA, expiry date: 30-Jun-2017, dose, dose in series and site of administration were not reported) on 04-Oct-2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was unknown. Illness at the time of vaccination was also reported as unknown. No further information regarding medical history was available. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unspecified date, 3 hours following the vaccination, the patient experienced balance disorder, nausea and dizziness. It was reported that the patient required emergency room doctor visit. The patient's laboratory data was reported as unknown. The patient had not received any corrective treatment. The patient's outcome was unknown. List of documents held by sender: none.
Intense tooth pain in upper right of my mouth, beginning on the afternoon after I got my shot, and subsiding over the course of the next two days.
Joint pain by 10 PM on day of injection. By 11 PM Monday rejection severe body chills shaking uncontrollable muscle twitches to the point where I could not speak or walk correctly which lasted for approximately one hour. By the by 8am the next day Fever 99.1 but my baseline temp is 96.7 to 97.1. Headache and nausea started around the time of the fever. I was unable to go to work on fri 4/9/21.  Symptoms resolved by about 11 PM Friday 4/9
This is a spontaneous report from a contactable consumer (patient herself). A 84-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on 10Mar2021 (at the age of 84-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller mentioned that she received the 1st dose of the vaccine on 10Mar2021 and had a lot of problems since she got that shot. She mentioned that on the day she received it, she was okay and just had a sore arm. She mentioned that a day after, she had a headache for 6 days, was tired that she was on and off her couch, had chills, and could not eat because her mandibular joint on the right side of her jaw hurt. She could not chew, not even toast, so she resulted to drinking coffee and sipping soup. She had no good sleep because of it. She did not had a temperature or any dental problems. She said that her mouth was still hurting, she still had a sore throat. It was so bad that she would not wish it on her worst enemy. Because of this, she was very worried about the 2nd dose. She was asking what to expect of it and would it be similar. she was due for it on 31Mar2021. The outcome of the events was unknown. Follow-up attempts completed. No further information expected.
This is an instance of breakthrough COVID-19 disease after which death occurred.  The individual was vaccinated with the Moderna product on 02/02/2021 and 03/02/2021. It is not known if they experienced COVID-19 specific symptoms, but tested positive for COVID-19 via PCR on 11/29/2021 at the skilled nursing facility at which they were a resident.  They then presented to emergency department on 12/11/2021 (the day after being released from isolation). They remained hospitalized until their death on 12/12/2021.
Pain at injection site; Chills; Fever; This is a spontaneous report from a contactable nurse (patient).  A 24-year-old female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK5730 via an unspecified route of administration, in the right arm, from 28Dec2020 07:30 at a single dose, for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included estradiol (ESTROGEN) cream. On 28Dec2020 22:45, the patient experienced pain at injection site, chills and fever. The outcome of events was reported as recovering.  No follow up attempts are needed. No further information is expected. Information on the batch/lot number has been obtained.
(L) arm swollen & red, warm to touch: per mom she can feel a knot in arm.
Within 72 hours post vax, pt developed an injection site reaction characterized by a fairly large area of induration, swelling and heat.  The area would spontaneously bleed and ooze pus.  She treated the area by squeezing it and applying warm soaks.  This continued for approximately one month. One day while squeezing the site an "oily substance fell out". The site then stopped bleeding and oozing pus.