chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Funky feeling; headache feeling; My symptoms seems like it could have been just allergies; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 21Mar2021, outcome "unknown", described as "Funky feeling"; HEADACHE (non-serious) with onset 21Mar2021, outcome "unknown", described as "headache feeling"; HYPERSENSITIVITY (non-serious) with onset Mar2021, outcome "unknown", described as "My symptoms seems like it could have been just allergies". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient got the vaccine on 11Mar2021 and nothing bad had happened to her. On Saturday 20Mar2021, she started getting some funky, headache feeling. Her work made her get a COVID test on the 21st of the month. She had been hanging out with about eight people including her partner but no one had shown symptoms. Her symptoms seemed like it could have been just allergies. She got another test on Thursday (2021) and it came back negative. She understood that polymerase chain reaction (PCR) test pick up tiny traces of genetic material and the vaccine, the spike protein is genetic protein. The patient was asking if there was a paperwork saying it may possible cause a false positive.  No follow-up attempts are possible. No further information is expected.
Persistent neck pain (posterior), relieved by hyperextending the neck, occ. GI problems - gastritis type waking up in the middle of night. Flu-like symptoms.
A 17 year old male pt who had no current illness and who has a past medical history of possible meningitis in March 2006 (no lumbar puncture was performed) had received a first IM dose of Menactra, lot number U2135AA, in the left deltoid, and a second IM dose of Havrix lot number AHAVA035, in the right deltoid on 8/21/06. At an unspecified amount of time later, the pt experienced generalized aches, restless legs, dizziness, weakness, flushed skin, pain with the injection site (site not reported), and a temperature of 101 degrees Fahrenhait. A few hours later, around 17:00 pm the symptoms were resolved. The patient required medical evaluation but no treatment was provided. No diagnostic test lab data were performed. The recovery status of the pt was reported as recovered. Menigitis titer A and C. MD speculates that in March of this year he was ill required ED visit with clinical DX of possible menigitis without LP performed. Follow-up information received on 07/OCT/2006 from the patient's parent, who is a registered nurse. It was reported that MENACTRA and HAVRIX were administered at 8:00 am on 12/Aug/2006. At approximately 11:00 am on 12/Aug/2006, 16 hours post-immunization the patient experimented headaches, fever, generalized achiness, extreme weakness, dizziness, restless legs, erythema, a temperature of 101 degress Fahrenheit and extreme pain at the injection site. On 22/Aug/2006 at approximetly 1:00 pm, most of the symptoms had allevaited, but the patient continued with slight generalized weakness and pain at the site of MENACTRA injection. The erythema subsided by 23/Aug/2006. The patient's left deltoid remained very sore for two weeks. On 22/Sep/2006 labs were drawn for anti-meningococcal antibody to serotype A and C. As of 25/Sep/2006, the patient results were not available. As per the patient's parent, the patient had not require an emergency room at doctors visit for his symptoms, but the physician was notified an there were several telephone follow-ups. The final diagnosis was referrerd as "adverse reactions to MENACTRA".
Information has been received from a physician concerning a 17 year old female who on 13-FEB-2009 was vaccinated with a 0.5mL dose of VARIVAX (Oka/Merck) (route and lot number not provided). The physician reported that in approximately February 2009, after receiving VARIVAX (Oka/Merck) the patient experienced a "shingles like reaction at the injection site". Subsequently, the patient recovered from the event on an unspecified date. Additional information has been requested.
shortly after patient received his dose he complained of blurred vision, dizziness, his skin was clammy, we gave him some water , had him lay down on a bench, after a few minutes we checked his blood pressure it was 113/73 , watched him after 10 or so minutes he started to fill better,we gave hime some crackers and we observed him for around 30 minutes at that point he was no longer dizzy , vision was normal and he was no longer clammy, he felt normal again.
Arm hurt, could barely move it. Then he got the chills and a fever, and really tired. Hours later, he said his tongue started to hurt.  I tried to log this on the daily check in but by the time I clicked on the link it said it expired - 12 hours after receiving  - why wouldn't they give you 24 hours?
Patient got dizzy and felt like legs numb.  Eyes closed and patient became syncopal.  Patient vs stable.  Drank juice and felt ok.  Patient ambulated out of office.
Information has been received from a licensed practical nurse concerning a 13 year old female who on 14-DEC-2007 was vaccinated with her second dose of Gardasil (Lot #1062U/658560).  There was no concomitant medication.  On 14-DEC-2007 the patient developed a rash over her entire body.  The rash was described as "red tiny dots".  By the next day the rash was bright red and "looked as if the skin was on fire".  The patient also developed pruritis.  The patient started taking BENADRYL but symptoms had not improved.  The patient was seen in the physician's office and a Strep test was done with negative results.  The first dose of Gardasil (Lot #0929U/658282) was administered on 05-OCT-2007 intramuscularly.  The patient did not experience any adverse events after the first dose of Gardasil.  No further information is available.  In a follow up the physician was contacted and he described a patient with diffuse, pruritic, papular rash characterized by some umbilication 24 hours after receiving the second dose of Gardasil (Lot #1062U/658560) and was still present 4 days later.  A consultation with a dermatologist was suggested as possible being helpful in determining the etiology of the rash.  Additional information has been requested.
Had Influenza vaccine 12/15/15. Developed Left-sided Bell's Palsy 1 wk later.
Reported to pharmacy on Monday 9/26/2016. Has experienced limited range of motion in the left shoulder since receiving vaccine. 1 month of PT, diagnosis of tendonitis.
Approximately 1 hour after injection I began to hive across my chest and arms.  Urticaria is common when I ingest medications or foods I am allergic to, and this occurred with my last flu vaccine.  The urticaria and redness extended to back and full trunk by 05/08/21 despite used of both Zyrtec and Benadryl 25mg.  Tachycardia was present at 105-111 bpm until Sunday afternoon.   More typical side effects such as low-grade temp, fatigue and headache resolve by 05/09/21 am.
First dose given 5/19/21.  Second dose given 6/10/21, 22 days between doses.
Rash that started after received shots on 10/14/2009 - No fever.
Nausea after 4-5 hours; coughing, fever for 8-10 hours
/P vax 6Mar91,developed worsening throat swelling,laryngitis,pruritis,SOB->sought medical care 10Mar91:PE showed extremely hoarse voice &submandibular tender lymphadenopathy,no strider;Benadryl 25 mg IV-> resolution-swelling &pruritis
autoimmune issues; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune issues". The event "autoimmune issues" was evaluated at the physician office visit. Clinical course: The patient got the first vaccine and was suddenly having all these mysterious like autoimmune issues which resulted to a need to go to the doctor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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 died the night after receiving vaccine. Coroner's office refuses autopsy because of COVID so cause is not knowable.
Kept feeling bad; Was sick like a cold; Congestion; Cough; Tiredness; Had a very bad and strange headache; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Kept feeling bad), NASOPHARYNGITIS (Was sick like a cold), NASAL CONGESTION (Congestion), COUGH (Cough) and COVID-19 (COVID-19) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced COVID-19 (COVID-19). On 30-Mar-2021, the patient experienced FEELING ABNORMAL (Kept feeling bad), NASOPHARYNGITIS (Was sick like a cold), NASAL CONGESTION (Congestion), COUGH (Cough), FATIGUE (Tiredness) and HEADACHE (Had a very bad and strange headache). At the time of the report, FEELING ABNORMAL (Kept feeling bad), NASOPHARYNGITIS (Was sick like a cold), NASAL CONGESTION (Congestion), COUGH (Cough), COVID-19 (COVID-19), FATIGUE (Tiredness) and HEADACHE (Had a very bad and strange headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
One day following the first dose of varicella virus vaccine live the pt experienced a fever which subsided. Three days later the pt developed 7 varicella like lesions scattered on her groin, back and head. Some of the lesion were pustules while others had crusted over.
Foster parent states client has a not on her buttock area from previous vaccination. She states not sure when it happened had vaccination previously on 12/05/2018 then later on 12/18/2019.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 33-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 09Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, 1 year 1 month 15 days after the suspect product(s) administration, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Negative, notes: Symptoms improved and rapid COVID test negative on 20May; (24May2022) Positive, notes: Recurrence of COVID symptoms with positive rapid COVID test 24May concerning for COVID rebound after Paxlovid. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
2 days after getting vaccination - had febrile seizure - beg as focal then generalized - apnea - intubated x about 24 hr. Full recovery with signif local reaction (L) arm with swelling, erythema and tenderness.
malaise; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise) and PYREXIA (low grade fever) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included GERD, BPH, GERD and Allergy. Concomitant products included RABEPRAZOLE, FINASTERIDE, FAMOTIDINE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and DOXAZOSIN for an unknown indication.   On 14-Jan-2021 at 3:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (malaise) and PYREXIA (low grade fever). At the time of the report, MALAISE (malaise) and PYREXIA (low grade fever) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Treatment not reported.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Aug 12, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced  dyspnea/issue breathing, onset Aug 2021, with outcome of unknown. Additional information: The reporter said she had an issue breathing after taking the first shot on Aug 12, 2021. She asked for some information and if she would experience the same side effects after taking the second shot. Follow-up attempts completed. No further information expected.
Patient reported numbness at the vaccination site as well as the left cheek within 30 minutes of vaccine administration. Also noted that numbness spread to right cheek. Patient stated her face felt tight all day on 3/7 and when she went to bed and woke the next morning, she noticed that her right cheek was swollen compared to the right.
Patient  came to the pharmacy on 11/6/21 to receive a Moderna first Covid -19 vaccine. The patient was given 0.5 mL of the vaccine and was 17 years old at the time of vaccination. He reported he had arm soreness after given the vaccine but no other adverse effects. The patient was offered to return to the pharmacy to receive the Pfizer vaccine as a second dose which is approved for his age. The patient understands his options and we will continue to follow up with him.
having seizures; received the booster; This is a spontaneous report from a contactable pharmacist (patient's parent) via medical information.  A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration on unspecified date in Sep2021 (Batch/Lot number was not reported) (at the age of 23 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included brain cancer metastatic (brain cancer survivor). Historical vaccine included COVID-19 vaccine dose 1 and dose 2 (both MANUFACTURER UNKNOWN) on unknown dates for COVID-19 immunization. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication from an unspecified start date and ongoing. It was reported that a month later after receiving the Pfizer covid 19 booster vaccine, patient started having seizures on 23Oct2021. Patient was not hospitalized for the event. No treatments relevant to the event. The outcome of event was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on available limited information and a possible contributory role of suspect product BNT162B2 to the development of event seizure cannot be totally excluded. The case will be reassessed when additional information becomes 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.
Complaint of pain and swelling  (describes as a "hard bump:") at injection site to left arm immediately following injection that has remained months after having had the 2nd dose of the vaccine. She also described feeling fatigued, and dizzy, developing N/V within an hour of the injection. She stated that she has had multiple appointments with her medical team including per PCP, endocrinologist, neurologist and ENT doctors. She c/o loosing the ability to lift her left arm above her head without having severe sharp pain and aches. She was also newly diagnosed with vertigo, and has had ongoing complaints of nausea and vomiting's, bouts of elevated B/P as well as an unsteady gait since the vaccine. She was hospitalized at the end of February on a telemetry unit for elevated B/P and hyperemesis. Client has missed much work since the vaccine.  This is per the client's verbal report.
Patient came in to receive his first COVID-19 vaccination at 2:00pm on 1/25/2021. Patient received his vaccine at 2:08pm intramuscularly in his left arm. Patient was asked to remain in the waiting area to be observed. At around 2:34pm, patient started feeling light headed and started yawning. Patient's wife noticed the yawning and said that he does that before experiencing a seizure. After a couple minutes of slow steady breathing, patient started having a seizure and his eyes started rolling back. Patients pulse was steady at the time and soon came out of the seizure. About 45 seconds-1 minute later he started experiencing a second similar seizure that lasted roughly 15 seconds. EMS was called and they came to help him. Patient experienced 1 more quick seizure in the time it took the EMT to get to the store. Patient started having a stronger pulse, breathing better, and looked a lot better. Patient also is a diabetic at the time and his blood sugar was slightly low. EMT assisted patient the rest of the way and they patient and wife left the store to go home.
No issues with vaccine number 1. With receiving second dose he experienced light headedness and chronic low blood sugars for 4 days post vaccine. He was unable to rise his BS above 100 . He had to check his glucose every 2 hours. Since post 4 days he has been able to maintain his BS as normal.
nausea; achy; feeling tired; flushed on face; neck broke out in hives; dull headache; itching; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6205 and expiration date not reported), via an unspecified route of administration, administered in Arm Left, on 07Mar2021 11:45 (at the age of 55-year-old), as dose 1, single, for COVID-19 immunisation in hospital. Patient was not pregnant at the time of vaccination. Medical history included high blood pressure, arthritis. Concomitant medications included amlodipine besylate; levothyroxine; lovastatin. Allergies included Sulfa, Lisinopril, Adhesive, Vancomycin. The patient previously took lisinopril and vancomycin and experienced allergies. Patient did not receive other vaccine in four weeks. Patient was not diagnosed with COVID prior vaccination and was not tested COVID post vaccination. On 07Mar2021 12:15, 30 minutes after vaccination, became flushed on face and neck broke out in hives, later dull headache and itching. On 08Mar2021, next morning, the patient experienced nausea, achy and feeling tired. Took Benadryl for itching. The outcome for the events was recovering.  No follow-up attempts are possible. No further information is expected.
A nurse reported the occurrence of injection site cellulitis in a 15-month-old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The subject's medical history, concurrent conditions, and concurrent medications were unknown.  On 02/11/2003, the subject received an Infanrix injection (lot DTPA578A9).  Subsequently, the subject experienced injection site cellulitis; the diagnosis was made by the vaccine provider.  The reporting nurse did not know if the vaccine provider had examined the subject or prescribed any medication.  The reporting nurse stated that the event was possibly related to Infanrix administration.  As of 02/18/2003, the outcome of the event was unknown.  Comment:  This is one of five subjects, out of 19 children immunized, who developed injection site cellulitis following receipt of Infanrix lot DTPA578A9.  Please see reports A0397194A, A0398143A, A0398145A, and A0398146A.
Information has been received from a nurse practitioner concerning a 17 year old female patient who was vaccinated with Gardasil (lot# 655619/1427F) (0.5 ml), intramuscularly in the deltoid. Concomitant therapy included birth control pills. Subsequently the patient complained of heaviness and pain in left arm. The patient outcome was reported as recovered. No product quality complaint was involved.
This spontaneous report was received from a doctor of pharmacy concerning a 69 year old male patient with no pertinent medical history and no drug reactions or allergies. On 19-NOV-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date were reported as J006830 and 14-SEP-2013 respectively), subcutaneously in the left arm. Other suspect therapy included a dose of Influenza Virus Vaccine (manufacturer unknown) (lot number, expiry date, dose and route unspecified) administered approximately on 24-OCT-2013 (reported as about 4 weeks ago). No concomitant therapy was reported. On an unknown date in November 2013, the patient developed rash, swelling, warmth and redness on his left arm at the injection site after receiving ZOSTAVAX. The affected area was about 2 inches in diameter. The patient sought medical attention (patient came back into the pharmacy). No treatment was provided. The outcome all the events was reported as not resolved. The relatedness for all the events was unknown for ZOSTAVAX and Influenza Virus Vaccine (manufacturer unknown). Additional information has been requested.