chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initially after having the shot I was fine with a very sore arm.  10 days later now I woke up today extremely confused, I am not able to think straight, I feel as if I?m having a brain fog. It is giving a light headed ness feeling, almost sometimes If I can barely stand.  I am not able to complete normal daily functions, it was all I could do to get ready this morning.  It gives off a very strange and disorienting feeling, almost indescribable.   I am very weak all over and the only thing that helps is laying down.
Sick with COVID; Sick with COVID; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4414172-00.  A 29-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 29 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "Sick with COVID". The action taken for adalimumab was unknown. The reporter considered "sick with covid" related to BNT162b2. Additional information: Solicited report by a consumer of an adult male with an event of non-serious sick with COVID with Humira (Adalimumab). On an unknown date, the patient experienced sick with COVID. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (Adalimumab): The reporter's causality for the event of sick with COVID with Humira (Adalimumab)was no reasonable possibility . Causality: 1)COVID-19 (COVID-19): Causality as per reporter (Drug/Vaccine) : possible  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Headache Local Symptoms: Pain-discomfort, General symptoms:  Chills, headaches, joint pains, fatigue. Narrative:
experiences aches and pain "all over".; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 63 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 63 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "was ill for 14 days with high fevers", start date: Nov2020 (unspecified if ongoing); "covid-19 infection" (unspecified if ongoing), notes: admitted to the hospital on 14Nov20 due to covid-19 infection and remained hospitalized for 6 days; "Patient was admitted to the hospital on 14Nov20" (unspecified if ongoing); "received supplemental oxygen while at home" (unspecified if ongoing), notes: experienced complications after hospitalization. The patient's concomitant medications were not reported. Past drug history included: Xeljanz, start date: 26Feb2020, for Rheumatoid arthritis, notes: Dose: 11mg daily, Route of administration: Oral. The following information was reported: PAIN (non-serious), outcome "unknown", described as "experiences aches and pain "all over".".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a nurse referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 26-JUN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N027000, expiration date: 28-SEP-2019 (dose, anatomical location and route of administration were not reported) indicated for prophylaxis which were reconstituted with a properly stored sterile diluent (MERCK) (lot# and expiration date were not reported). No adverse effects. Administered dose of vaccine experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 12 hours and 40 minutes on unspecified dates called by a data logger. There were no previous excursions reported.
Fever same day administration and apneic spells-taken to emergency room rash appeared 24 hrs post appeared on arm, then progressed to trunk and extremities. Admitted to hospital on 5/19/03.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. Information on the medical history, concurrent conditions and drug allergies of the patient was not reported. On 08-AUG-2016 the patient was vaccinated with improperly stored dose of VARIVAX lot # L025208, expiry date 07-JUN-2017, 0.5 ml, subcutaneously. Concomitant medication were not reported. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. Temperature and time frame at which the administered vaccine was stored was -0.15 degree Centigrade for 5 hours. Additional information has been requested.
Taken @ 7.30pm. By noon the next day, strong muscle aches over all body, a temperature of 102.00 (with Tylenol) and body weakness that lasted 24 hours, fatigue. Painful injection site that lasted several days.
Information has been received through the pregnancy registry from a registered nurse concerning a female who on 20-FEB-2007 was vaccinated with a first dose of Gardasil while she was pregnant. Subsequently the patient experienced vomiting. The patient was seen in the emergency room and treated with unspecified fluids. On an unspecified date, the patient's alpha-human chorionic gonadotropin level was 221,000. At the time of the report, the patient was 4 months gestation. Additional information has been requested. 07/08/2008 Follow up information was received. The patient delivered a healthy and normal female by vaginal delivery in August 2007. No further information is expected.
1st "about a year ago", no 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the 1st dose of Shingrix about a year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st "about a year ago", no 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date:17-APR-2023 The patient would like to get the 2nd dose of shingrix. The reporter did not had an exact lot number and expiry date.  The reporter consented to follow up via email. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Resident had no adverse effects.   Pharmacy sent vaccine to facility. Vaccine was taken out of freezer at the pharmacy. The Use By Date was written on the bag as 3-28-2023 and signed by pharmacy.  The beyond use date was not supposed to be after the Manufacturers Expiration date which was said to be 3-12-2023.  Moderna was called and the Lot # of 071B22A was still Viable at time of use.
Patient presented with altered mental status, hemiplegia, headache and vomiting. Initially concerning for viral meningitis. Symptoms improved and then recurred 2 more times prompting further evaluation. Symptoms consistent with atypical hemiplegic migraine or atypical migraine. EEG with hemispheric slowing.
Extreme tenderness in arm a few hours later.  Body aches , headache all the next day. My arm hurt so bad I couldn't even lift it.  Then I had fevers  that lasted in though the next night even after taking advil etc. Nausea the entire  time .. but didn't throw up.  Barley ate.  Next morning (2 days later now) I finally was fever free but  very weak and nauseous.  I started to feel better by that night.   The next day (3rd day).. just felt like I couldn't eat but definitely  much  better than all before.  Finally  could eat some food ( BRAT  diet.)  Felt  almost  normal by 5th day.
Patient received a chickenpox vaccine VARIVAX (Merck) on her right thigh, after having the pt. wait for 15 minutes mom notified us that pt. was developing a reaction.  The area around the injection site was red and felt hot to the touch.  I notified Dr.
Pt devel an abscess @ inject site p/receiving Td; culture of abscess was not performed;
Left Knee Pain; Left calf tightness; This case was reported by a pharmacist via call center representative and described the occurrence of knee pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th June 2020, the patient received Shingrix (intramuscular). On 18th June 2020, 1 days after receiving Shingrix, the patient experienced knee pain and muscle tightness. On an unknown date, the outcome of the knee pain and muscle tightness were unknown.   It was unknown if the reporter considered the knee pain and muscle tightness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had left calf tightness and left knee pain.  The patient stated she had also worked in her yard. All information was not obtained.
Pt experienced immediate redness, warmth to left upper arm with bullae. Ongoing pain and inflammation. Still at the site 5 months later. Still being treated with steroid injections and topical meds. Being followed by MD.
Patient received vaccine and left the clinic. The patient saw the charge nurse approx 45 mins to 1 hour later while the charge was eating lunch on plaza and c/o of face swelling/feeling flushed. RN walked patient to ER. In the ED, pt reports bilateral eye swelling, facial redness, scratchy throat. Pt initially felt SOB but breathing ok now. No tongue swelling.
Medical Assistant administered Bexsero to patient before verifying order with licensed medical provider. Patient should not have received vaccine (not recommended for patient's age).
Over a week later- Round 3x3inch redness, itching, warm to touch at the site of the shot. Little, tiny red spots on arm away from the site, but on the upper arm that received shot.
Flu like without fever. Extreme ache overall; Extreme muscle weakness, joint ache/pain, headache, labored breathing, eyesight slightly blurred, arthritis pain increased.
Pt reported (R) arm jerking within 15 minutes of getting vaccine in (R) upper arm. 8-13-09 F/U at ph # given per dad. Spoke with G.M. "pt went to school today" "ok as far as she is aware".
DTaP, IPV, MMR and Hep A vac, plus PPD implanted at 4:30 pm 7/17/06 at 4:45 mother came back c/o swollen eyelid, itching and rash, urticaria found to have wheezing. 4:50pm given oral Prelone, Benadryl and Albuterol and Epinephrine 0.15cc.
extra dose of hep b; Patient ordered Pentacel and received Vaxelis; extra dose of hep b; No adverse reaction noted; This case was retrieves during monitoring on 12-APR-2023 with the following Primary ID 2593261-1. The original narrative from the sender is as follows:  Patient ordered Pentacel and received Vaxelis. No adverse reaction noted, just extra dose of hep b.  Due to the nature of the events, the causal relationship between Vaxelis and the events "Patient ordered Pentacel and received Vaxelis. No adverse reaction noted, and extra dose of hep b" was not applicable.  No further information is expected.
Information was received on 10-MAY-2017 from a physician via a company representative regarding a unspecified number of female patients. Medical history, concurrent conditions and concomitant medications were not reported. On 08-MAY-2017 and 09-MAY-2017 the patients received their first dose of GARDASIL 9 ( lot numbers and dose not specified) for the indication of age appropriate HPV prophylaxis. Per the physician, the patients "had the same callback complaints today (10-MAY-2017): headache, nausea, vomiting, chills, and complained their skin was hurting." As of the report, the patients status was reported as not recovered. No further information was provided. The physician did not rate the causal relationship. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 65 year old male patient with no drug reactions or allergies. The patient's pertinent medical history included diabetes type 2. On 27-AUG-2016 (also reported as "Saturday"), the patient was vaccinated with a dose of ZOSTAVAX (19400 plaque-forming units, PFU) (lot # L040445, expiration date: 15-JAN-2017) injected subcutaneously in the right arm. The patient was taking VICTOZA and metformin concomitantly. On 28-AUG-2016 (also reported as "Sunday"), the patient noticed that his right arm appeared to be sunburned "from the elbow down to his hand". On 29-AUG-2016 (also reported as "Monday"), the patient began to experience itching on his right arm. He reported that he applied triamcinolone cream on the affected area, but he did not specify whether or not he experienced any relief from the triamcinolone cream. There were no laboratory diagnostic studies performed. The reporting pharmacist stated that there was no rash present. The patient was not experiencing fever and he had not recovered at the time of the report. The reporter did not provide causal relationship between aforementioned events and the vaccination with ZOSTAVAX. Additional information has been requested.
This case was reported by a physician and described the occurrence of hypotonia in a 2 month old male pt who received Engerix-B. On 5/10/93, the pt received the 1st dose of Engerix-B. On 6/22/93, the pt received the 2nd dose of Engerix-B. At an unspecified time following the 2nd administration of Engerix-B, in 1993, "at 2 months of age", the pt was seen at a physician's office and dx'd  with hypotonia. The immunization series with Engerix-B was discontinued. As of 3/24/03, the event was unresolved.
Pt was given PEDIARIX before the recommended age. Spoke with manufacturer and they stated that according to the CDC it counts as a valid dose and should not be repeated. Age of patient at time of event: 3 years 6 months.
20 minutes after vaccination I began to taste a medicine like taste on my tongue; my heart started racing; my blood pressure went up/It went to 168/91.; felt very heavy and shaky/ I have been feeling very shaky; I feel a lot of pressure at the left chest area; This is a spontaneous report from a contactable Other healthcare professional (patient). A 44-year-old female (not pregnant) patient received received BNT162B2 (lot number: EH9899) first dose on 21Dec2020 04:00 PM intramuscularly on Left arm at single dose for COVID-19 immunization. Medical history included allergies: Some aerosol sprays and chili pepper flakes. Concomitant medication included influenza vaccine (FLU VACCINE VII) on 07Dec2020 on Left arm. Facility type vaccine was Hospital. About "20 minutes" after vaccination she began to taste a medicine like taste on her tongue (21Dec2020 4:15 PM). Then her heart started racing and her blood pressure went up. She have never had high blood pressure. It went to 168/91. She left the facility about 45 minutes later and felt very heavy and shaky. She waited another hour and checked her blood pressure which was still high. The next two days she have been feeling very shaky and she feel a lot of pressure at the left chest area. She have been monitoring her blood pressure and it is normal now. No covid prior vaccination and no covid tested post vaccination. No treatment for the events. The outcome of event blood pressure increased was recovered. The outcome of other events was recovering. The seriousness was reported as no.
soreness in his arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "soreness in his arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itchcy throat, chills, weakness.  Took Benadryl at 6 PM and 10 PM on 10/16/11.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Body temperature: 100.3 100.3F.         No concomitant medication were reported. Treatment included Tylenol and the patient laid down to treat symptoms.
Client light headed and sweaty within a couple minutes of receiving vaccination. Symptoms resolved after reclining back in his seat. No LOC. Initial vitals: bp 97/72, hr 58. Observed for additional 15 minutes. No further symptoms and client declined further evaluation. Bp 134/94, hr 66 prior to leaving. Client reported similar reaction in the past to vaccination and giving blood.  Advised client to let medical staff know in the future prior to intervention.
Vaccine stored at temperature outside the recommended range; Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 year old male patient who received vaccines IPV (VERO) [IPOL] lot NIK931M, expiry date: 18-Nov-2019 via subcutaneous route in the left thigh on 09-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage. A temperature excursion IPOl (open), Typhoid. MIA advised not to use the IPOL. Stated that they did administer the IPOL that was out of range yesterday, but they did not know that and now wants to know what do.  It was unknown if any adverse event was occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Excessive urinating to point of dehydration; Excessive urinating to point of dehydration; Facial numbness; Pain in kidneys; Lips numb; Weakness/ general weakness; Insomnia; Fatigue; Feverish at random moments; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC381) via an unspecified route of administration in the left arm on 24Aug2021 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included neuropathy, epilepsy, bad circulation and radiculopathy. The patient had known allergies to penicillin, shellfish and seafood. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN), flurazepam (MANUFACTURER UNKNOWN), levetiracetam (KEPRA), and super complex b; all for an unknown indication from an unknown dates and unknown if ongoing. The patient previously received acetylsalicylic acid (ASPIRIN) and ciprofloxacin (CIPRO) and experienced drug allergy. On 24Aug2021 at 16:00, the patient had excessive urinating to point of dehydration, pain in kidneys, facial numbness, lips were also numb, insomnia, weakness/general weakness, fatigue and feverish at random moments. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events excessive urinating to point of dehydration, pain in kidneys, facial numbness, lips numb, insomnia, weakness/ general weakness, fatigue and feverish at random moments were not resolved at the time of this report.
Patient sat in observation area and this RN noticed patient had head down between her legs. Patient reports feeling lightheaded and mother reports patient has a history of passing out with blood draws. This RN assisted patient in to wheelchair and wheeled her to the private observation area. Assisted patient on to stretcher. Patient removed mask and had patient recline. Patient also reports nausea. Gave patient apple juice and granola bar. VS as follows: 1002-BP 95/63, P 58, RR 20, 99% RA, no pain. 1007-BP 101/68, P 68, RR 20, 100% RA, no pain. 1013- BP 100/66, P 65, RR 16, 100% RA, no pain. After 30 minutes patient reports feeling back to baseline. Patient driven home by mother.
Patient received vaccine at pharmacy, then called pharmacy an hour later saying she had coughed up blood and wondered if it was a side effect of the vaccine.  Gathered information over the phone, not present with patient.  Patient said she was in good health before the vaccine and had just gotten a physical with no concerning findings.  She said she had some phlegm prior to the vaccination, she thinks it may be from allergies.  Then she coughed up some phlegm and said there were red streaks.  She coughed a few more times over the next few minutes, and the redness disappeared.  May have been from a sharp piece of toast she had.  She has no other symptoms, no fever, no other bleeding, no increase in the phlegm already present, no recurrence of side effect, no difficulty breathing or chest pain, and patient feels well.  No personal history or family history of bleeding disorders or blood clots.  Patient was advised to seek urgent medical care if it happens again.  Followed-up with patient later that evening and 2 days later, with no recurrence or concerns from patient.  Called patient a week later and left voicemail, will continue to follow-up with patient.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with a dose of improper stored PNEUMOVAX 23 (dose, frequency and route were unknown; lot number was M036728 with expiration date 20-MAY-2018) for prophylaxis. No adverse effect was reported. The temperature of storage was between 32 F and 36 F with duration 24 hours. There was no previous temperature excursion. Data logger issue was involved. Additional information has been requested.