chrisvoncsefalvay/vaers-outcomes huggingface dataset:
High Fever with Chills; Tiredness; Headache; Patient was not feeling well; This is a spontaneous report from a contactable other healthcare professional. A 37-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3247), intramuscular administered in the left arm on 12Feb2021, 14:45, as a single dose for covid-19 immunization. The patient has no medical history. The patient has no known allergies. There were no concomitant medications. On 13Feb2021 at 04:00, the patient experienced high fever with chills and tiredness and headache. Patient has no treatment for the events. The patient underwent lab tests and procedures which included body temperature: high. The outcome of the events was recovering. The patient has not had Covid prior to vaccination and was not tested positive for Covid-19 post vaccination.  Follow-up (15Feb2021): New information received in response to the query sent regarding to confirm "First Pfizer Awareness Date" for this Adverse event, and provide the true reporter who reported this adverse event to you, includes: confirmation reported my symptoms on 15Feb2021 and they started on 13Feb2021. Patient's symptoms started very late on 13Feb and I was in high fever on the 14Feb. I was not feeling well and also want to wait to see if I will have any other symptoms so that I can report all of them. I reported on 15th early morning with in 24 hours of my symptoms.
Realized when documenting in the state vaccine database that I had given adult dose covid vaccine to pediatric patient.  Spoke with infectious disease doctor about what to look for.  Child is not currently having any side effects but may expect to have more pronounced fever, chills, etc, according to the doctor I spoke with.
developed a pain under my arm near armpit area on the side of the injection; swollen gland; Dose Number 1 31Dec2020/Dose number 2 17Jan2021; Dose Number 1 31Dec2020/Dose number 2 17Jan2021; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL8982; expiration date: unknown) at vaccination age of 63-year-old via an unspecified route of administration in the right arm on 17Jan2021 09:15 as a single dose for covid-19 immunization. Medical history included GERD (gastrooesophageal reflux disease), asthma, IBS (inflammatory bowel disease), diverticulosis, osteoarthritis, lactose intolerant, penicillin allergy and hives. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included famotidine and montelukast. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: E1284) at vaccination age of 63-year-old via an unspecified route of administration in the right arm on 31Dec2020 at 15:15 as a single dose for covid-19 immunization. The patient previously took codeine but had hallucination, pantoprazole sodium but joint pain, and diclofenac sodium but had anemia. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine in a hospital. The patient first dose was on 31Dec2020 while the second dose was on 17Jan2021. It was reported that on 19Jan2021 (About 36 hours after injection), the patient developed a pain under her arm near armpit area on the side of the injection. It appeared to be a swollen gland. It lasted about 2 days and was moderate pain that she treated with 600 mg Ibuprofen. Soreness remained for another day or two after the pain subsided. The events were considered non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events swollen glands and axillary pain were recovered in an unspecified date in 2021 while the outcome of the other events was unknown.
pt recvd vax & lab eval revealed that pt failed to seroconvert; pt was vaxed w/3 doses of Hep B vax;
Shortness of breath, low energy, paleness, weakness, slight trouble swallowing, disorientation, fever.
Moderna COVID -19 Vaccine EUA Approximately 3 hours after vaccine, shoulder pain began to develop. Pain became significant, waking me in the middle of the night. The following day, I was unable to lift the arm I received the injection in no higher than about 80 degrees from my side. Pain increased despite taking OTC NSAIDS. By the second morning after vaccine administration, pain had worsened and right arm cannot be raised more than about 60 degrees without significant pain. Contacted PCP office about 12 hours after injection, they recommended NSAID dosages alternating ibuprofen and tylenol, and icing the shoulder. Pain impacts daily life activities, including caring for small children , lifting items that weigh more than a few pounds by the impacted arm, and significant difficulty reaching any object above the level of the shoulder. I have never previously experienced this kind of reaction to any other upper arm injection or vaccination.
patient experience dizziness after receiving immunization and later fainted . Patient sat on ground before completely fainting to floor with help of mother and regained consciousness about 1 minute later. patient complained of muffled voices and trouble hearing for about 4 minutes, sweating , dizziness and shakiness. patient received water and Gatorade and cool cloth behind neck area. patient able to leave after approximately 20minutes in care of mother feeling better.
Dx'd with varicella disease on 4/6/01 with 50-100 lesions.
Blurry eyes -  1 day follow dose  Chest sorenes/left side/ - 2 days following Indigestion -2nd day post shot Sore neck Tingling in hands
Patient developed redness,  decreased vision and "blister" to left eye the day after receiving 1st Moderna Covid vaccine.  Both eyes were initially irritated but has since localized to the left eye.  The "blister" on the left eye has resolved.  Patient complains that eyelids feel droopy.  Also reports developing sore throat and upper respiratory congestion, which only lasted a few days.
Date of start of drug 06Jan2021/ Date of start of drug 29Jan2021; 2nd dose Roof of mouth felt like it was swelling; My tongue and lips started tingling; Both ears red and felt very warm; Both ears red and felt very warm; Slight headache; This is a spontaneous report from a contactable other hcp (patient). A 48-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: unknown; Expiration Date: unknown) via an unspecified route of administration in left arm on 29Jan2021 at 09:15 as a single dose for covid-19 immunization. Medical history included Allergies to medications, food, or other products: Penicillin, amoxicillin and codeine. Concomitant medications included esomeprazole magnesium (NEXIUM), ibuprofen (IBUPROFEN) and nature's bounty on unspecified date for unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE). The patient experienced second dose roof of mouth felt like it was swelling, y tongue and lips started tingling and both ears red and felt very warm and slight headache for the second dose on 29 Jan2021 at 09:15 AM. The outcome of the events was recovered on an unspecified 2021.  Information on the lot/batch number has been requested.
At 3:30 PM felt "constriction" in throat, by 5:30 PM eyes were swollen shut and felt fatigued. Took BENADRYL and ADVIL and went to sleep. Awoke at 8:30 AM groggy-as BENADRYL wore off-symptoms returned, took more BENADRYL and ADVIL after speaking with physician.
This case was reported by a healthcare professional and described the occurrence of a red circle around the injection site in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 31 October 2007 the subject received a one time dose of Flulaval at 0.5 ml in the left arm.  On 31 October 2007, at an unspecified time after vaccination with Flulaval, the subject experienced an injection site reaction.  The subject developed a 3 inch circular, red, hot injection site reaction.  At the time of reporting the events were unresolved.
Grand mal seizure.  Lasting 4 minutes , unconscious for 10/12 minutes. Transported to hospital via ambulance.   Vomiting and loss of bladder.
Pt developed high fever for 48 hours of 104 degrees F. With high fever, pt had headache that then developed to migraine 3-4 days after HAV and HPV given. Symptoms continued despite high dose Motrin and Fioricet therapy until 7/30/08. Headache resolved but pt developed new onset of Bell's Palsy - sent to ED. 8/18/08-records received for DOS 7/31/08-DX: Bell's palsy. Presented to ED with C/O right sided facial droop.
Severe migraine, pain and swelling of all joints, muscle pain, dizziness, nausea, swelling of hands and feet. Within the first couple hours there were changes in taste and smell, coldness on left side of body. Those resolved within 5 hours.
Left upper arm got red, hot, edematous and firm with moderate pain 15 hours after administration and sx persist till today. Urticaria behind knees with myalgias and arthralgiax.
Patient diagnosed with pneumonia after X-ray diagnosis. Patient had complete physical when administered. Health excellent. Flu vaccine given at same time.
Headache & Myalgia Narrative:  missed work following second dose due to above symptoms
A report has been received from a Health Professional concerning a 9 year old, male subject, who had been receiving FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. The licensed practical nurse reported that on 10-Dec-2013, they inadvertently administered an expired dose of FLUMIST to the patient. The outcome of the event of EXPIRED FLUMIST ADMINISTERED/INADVERTENTLY ADMINISTERED AN EXPIRED DOSE OF FLUMIST is unknown. The report was considered to be non-serious by reporter.
First Day, Joint Pain 2nd Day:  Joint pain subsided 24 hours of diareah. 3rd Day: Broke out in Hives Lasted a week..
Narrative: COVID infection following COVID vaccine series 12/17/2020, Pfizer, dose #1 01/07/2021 Pfizer, dose #2 09/02 COVID swab, result: detected 09/02 pt cc: exposure: unknown 09/23 COVID swab, result: NOT detected 09/12 clinically resolved
Information has been received from a physician, via a company rep, concerning a 72 yr old male, with hypertension and unk drug reactions/allergies, who on an unspecified date was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine (lot unk). On an unspecified date the pt developed swelling and redness from his upper arm to forearm after receiving the vaccination. The pt was treated with cefprozil (Cefzil) and on an unspecified date recovered. No product quality complaint was involved. Additional information has been requested.
Information has been received from a 60 year old female with cancer and cardiac disorder who on 13-AUG-2007 was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included cancer and heart medications.  On approximately 07-SEP-2007 the patient developed a red rash.  The rash was not itchy, painful or did not have any blisters.  No labs were performed.  As of 10-SEP-2007, the patient's red rash persisted.  The patient had not sought medical attention.  No further information is available.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K006124; expiration date 02-FEB-2017) (dose, route of administration, anatomical location and strength were not reported). There was no concomitant medication reported and no adverse effects were reported. Additional information is not expected as the reporter didn't consent new follow-up attempts. This is one of 3 reports received from the same reporter.
FEVER 8 HOURS LATER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced fever 8 hours later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever 8 hours later. This report was non-serious.
no adverse effects; patients were administered improperly stored PROQUAD; This spontaneous report was received from a vaccine coordinator, referring to two unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, or medical history was provided. The concomitant therapy included sterile diluent.  Since 24-APR-2019, the patients were vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin (rha)) (PROQUAD), lot # R030801 and expiration date 22-APR-2020, for prophylaxis (dose and route of administration were not reported) which was reconstituted with properly stored sterile diluent.  The administered doses of the vaccine experienced a temperature excursion of -14 to -10 degrees Celsius (C) for 1 hour and 12 minutes and of -9 degree C to 8 degree C (-0.04 degree C) for 6 hours and 50 minutes, as recorded by a data logger. The vaccine had had previous temperature excursions of -14 degree C to -10 degree C (-11.6 degree C) for 28 minutes and of -14 degree C to -10 degree C (-13.12 degree C) for 25 minutes. There was no adverse effect reported. No product quality complaint was involved.  This case is non-valid due to lack of patient identifiers.  Follow-up information was received from the vaccine coordinator on 20-APR-2020. The reporter was ready to provide the requested information like administration dates and patient identifiers but, would have to search for the information. The reporter would call back to provide the information.  Follow-up information was received from the vaccine coordinator on  30-APR-2020. The individual patient identifiers and details were reported and the case has become valid. This case was regarding a 9 year old female patient who was vaccinated  with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin (rha)) (PROQUAD) on 19-AUG-2019 (previously reported as since 24-APR-2019).  This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-2005USA000215:
Immediately after the vaccine I had extreme sleepiness and some dizziness. After taking a nap I felt better for a few hours. I did notice my Raynaud?s symptoms became way worse.  At about 5:30pm I started to feel extremely cold. By 6pm I was having horrible pains and spasms in my lower back and hips. My muscles and joints became very stiff. This moved to my neck/shoulders, and down my thighs. I lost feeling in my feet and started struggling to be able to take in a full breath. I felt like my whole body was locked up. I started feeling nauseous, but part of that may have been from the nerves. The next morning I felt a bit more mobile but still nauseous and stiff. I have slowly gotten better throughout the day, but am still stiff and exhausted
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of M-M-R II (rHA) (Concentration, dose and route were not reported), lot # L041456, expiration date 22-OCT-2017. Patients' concomitant therapy was not reported. No adverse effect was reported. A product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX with either lot M000996 and expiration date of 07-JAN-2018, lot M004663 and expiration date of 27-JAN-2018, lot M017292 with expiration date of 07-APR-2018 or lot M008173 and expiration date of 16-FEB-2018 (strength, route of administration and dose were unknown), which were stored at -14.2 Celsius degrees for 1 hour and 51 minutes. There was a previous temperature excursion for the lot number M017292 and M008173 of -12.9 Celsius degrees for 90 minutes. However, for the lot numbers M000996 and M004663 there was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. Additional information has been requested.
recurring shingles outbreaks; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 07-OCT-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered recurring shingles outbreaks. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the recurring shingles outbreaks was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the event recurring shingles outbreaks to be disability.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On 01-JUN-2010, the patient was vaccinated with the first dose of M-M-R II, lot#, dose and route unspecified and VARIVAX (Merck) subcutaneously, lot#, dose unspecified. On 16-JUL-2013, the patient was inadvertently administered both a 0.5 ml dose of PROQUAD (Merck), lot # and route unspecified and a 0.5 ml dose of VARIVAX (Merck). No adverse effect reported. The outcome of the patient was unknown. Additional information has been requested.
significant metallic taste in her mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Apr2021 16:00 (Lot number: EW0151) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Insulin Dependent Type 1 Diabetic" (ongoing), notes: when she was 9 years old she was diagnosed. Concomitant medication(s) included: NOVOLOG taken for type 1 diabetes mellitus. Vaccination history included: Bnt162b2 (Dose 1, LOT: EP6955, Dosage text: intramuscular injection, left upper arm at 16:00), administration date: 21Mar2021, for Covid-19 immunization. The following information was reported: DYSGEUSIA (non-serious) with onset Apr2021, outcome "not recovered", described as "significant metallic taste in her mouth".  Additional Information: Caller stated she just had a pretty significant metallic taste in her mouth, its consistent, it does not go away. Caller stated it's been about 8 to 9 days, maybe even longer. Caller states it started around maybe 18APR2021 or 19APR2021. Caller asked was this going to continue, or would it eventually go away are you able to give any sort of insight to this metallic taste, she has it even with drinking and eating. Caller stated no expiry date or NDC was on vaccine card. Caller stated unsure of dosage given.  Concomitant Products: Novolog: She was placed on a pump probably 15 years ago that basically was a drip that was constantly running. Caller stated she took Novolog, the dosage varies, it's based off of a running basal, constant drip. Caller stated she uses about 26 unites on a 24-hour basis.  Caller stated before then it was just daily injections, but all her life she' been an insulin dependent diabetic (she was 9 years old; she was diagnosed). No Vaccine administered at Military Facility. There was history of all previous immunizations with the Pfizer vaccine considered as suspect. There was no additional Vaccines administered on same date of the Pfizer suspect. Patient did not visit to emergency Room or Physician Office with respect to adverse event. No prior Vaccinations within 4 weeks (List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s)). No adverse events following prior vaccinations. No patient Medical History (Including any illness at time of vaccination). No Family Medical History relevant to adverse event. No Relevant Tests.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from an office manager. On an unknown date, PROQUAD was mistaken for M-M-R II. The mistake resulted in the PROQUAD being improperly stored in the refrigerator for 21 days. No patients received the improperly stored PROQUAD. Additional information has been requested.
Red raised bump on arm. itchy and hot.  Developed a day after the injection. About 2 inches in diameter.
CAREGIVER REPORTED FEVER OF 103.5; PATIENT DID NOT HAVE FEVER AT TIME OF VACCINATION (03/12/2021); SUGGESTED PATIENT TAKE TYLENOL AND IF FEVER WASN'T REDUCED TO REPORT TO ER OR URGENT CARE FACILITY
Shot site for first vaccination in series of three of Gardasil was very swollen, red and painful; I am reporting this because less than 4 years after the shots were given the patient has contract HPV strain that can lead to cancer.
Patient reported to me yesterday during a routine annual wellness visit that after the first shot, she had blindness that last for a few minutes, then resolved.
Resolved completely within 24 hours and injection site become swollen to about the size of small egg 6.5 cm from 3 to 9 O'clock x 3.0 cm from 12 to 6Oclock. Pt denies shortness of breath, Pt states I fee fine.