chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have this little rash; fever; This is a spontaneous report from a contactable consumer or other non HCP. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After 10 days of first shot, the patient developed fever (patient did not feel sick, just running a low-grade fever) and a tiny little rash like a heat rash on an unspecified date. The clinical outcome of events were not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
foggy brain; atrial fibrillation; facial paralysis; This is a spontaneous report from a contactable Nurse. This contactable 36-year-old female Nurse (patient) reported for herself that:  A 36-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 (at the age of 36-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included nervous system disorder from an unknown date, hay fever, environmental allergies, known allergies hay fever, environmental allergies. Patient had no concomitant medications. Patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Patient had not received any other vaccines within 2 weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Post vaccination, the patient was tested for COVID-19On Mar2021 at 15:45, the patient experienced facial paralysis, foggy brain, atrial fibrillation. The patient underwent lab tests and procedures which included Nasal Swab: negative on Mar2021. The patient died on Mar2021. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Facial paralysis, Feeling abnormal, Atrial fibrillation cannot be completely excluded. 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.; Reported Cause(s) of Death: side effect of Covid-19 inoculation
you lift up your arm and you go, oh ok.; soreness/ very mild soreness; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (you lift up your arm and you go, oh ok.) and MYALGIA (soreness/ very mild soreness) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Exposure to fungus (had previously been exposed to black mold.). Concurrent medical conditions included Type 2 diabetes mellitus (Type 2 Diabetes on medication.) and Asthma.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (you lift up your arm and you go, oh ok.) and MYALGIA (soreness/ very mild soreness). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (you lift up your arm and you go, oh ok.) and MYALGIA (soreness/ very mild soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.   This case was linked to MOD-2021-302002, MOD-2021-302003 (Patient Link).
Assumed Vaso-Vagal Syncope, patient was nervous about receiving an injection.  Immediately after removal of the syringe, the patient leaned backwards. He stated that he felt dizzy.  He started to jerk his head backwards (911 called) and then his head fell forward, unresponsive.  At his time, we used an ammonia inhalant close to the nose.  He started to move and we brought him to the floor supine with a pillow at his feet and then his head.  Soon, he was able to sit up and we brought him water to drink.  He was subsequently cleared by the EMT to go home.
right eye pain for the last 3 days / viralconjunctivitis symptoms; This is a spontaneous report received from a contactable healthcare professional (pharmacist). A 36-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en9581) via unspecified route of administration in left arm on 06Mar2021 (at the age of 36-years) as a single dose for COVID-19 Immunisation. Past medication included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en5318) via intramuscular route of administration in left arm as a single dose on 18Feb2021 for COVID 19 immunisation. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not have any medical history. The patient was allergic to codeine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other medications within 2 weeks of vaccination. On 13Mar2021, the patient experienced right eye pain which was one of viral conjunctivitis (not diagnosed) symptoms. The patient had right eye pain for the last 3 days. The adverse event resulted in doctor or other healthcare professional office/clinic. The patient did not receive any treatment for the event. At the time of this report, the patient was not recovered from the event right eye pain. No follow-up attempts are needed. No further information is expected.
Tinnitus- still have and has been ongoing since 4/10. Also ongoing low grade fever, large red area around vaccination site, fatigue. Fever and fatigue have steadily improved. Arm redness has worsened. Tinnitus remains unchanged.
Client was in post vaccine waiting area and after 15 minutes post vaccine she reported dizziness and an "uncomfortable feeling" across her chest (does not describe in any more specific terms). VS: HR 73, RR 20, BP 120/80, O2 sat 96%. Client denies any other symptoms and no other changes are noted. Medical information/history was taken, during this time the clients symptoms began to improve. 2:50pm VS: HR 71, RR 20, BP 120/70, O2 sat 97%; client reported symptoms have completely resolved. Assisted client to stand and walk in observation area, gait is steady and client denies any dizziness or return of the "uncomfortable feeling" across her chest. 3:15pm client was assisted to her family vehicle (driven by her daughter) and with the assistance of the translator information was given for the client to seek medical attention if the symptoms return or worsen.
tooth situation; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (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 (First dose), for COVID-19 Immunization. The following information was reported: TOOTH DISORDER (non-serious), outcome "unknown", described as "tooth situation".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On September 21, 1999 she developed an injection site reaction characterized by extreme redness, warmth and swelling which extended to the elbow. The pt was treated with Benadryl and prednisone; she recovered. This is of 2 patients from this facility who developed an injection site reaction following receipt of vax. Additional information states pt was treated with Medrol dose pack.
2 1/2 x 2in red, raised area LA decreased. Warm to touch area noted on evening of 02/25- Observed over the next day.
This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a patient who received DTaP vaccine. On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), Pertussis (serious criteria GSK medically significant) and cough. On an unknown date, the outcome of the vaccination failure, Pertussis and cough were unknown. It was unknown if the reporter considered the vaccination failure, Pertussis and cough to be related to DTaP vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, in 2014, there was an outbreak of Pertussis in a patient. The patient tested positive, but had no symptoms to minimum symptoms with less coughing. When tested the patient's were pertactin lacking. The reporter was not sure which brand of DTaP that was provided. This case was considered as the suspected vaccination failure since the details regarding basic immunization schedule, time to onset for the event were not reported. This case is 1 of the 5 cases, as reported by same reporter.
pain in arm; This is a spontaneous report from a Pfizer Sponsored Program. A contactable female patient reported that, a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient wanted to know if she could take pain medication after receiving the first covid vaccine due to pain in arm and wanting to take pain medicine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
approx 2 1/2 hrs p/vax pt woke up from nap w/twitching & screaming; t100.3 @ time; later that noc was very lethargic, episode of twitching & had a temp of 103.5;
Information was received from a lawyer regarding a case in litigation involving a male patient, age and medical history not provided. On or about 07-AUG-2013 the patient was inoculated with ZOSTAVAX vaccine at a hospital for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 21-OCT-2015 the patient was treated by a physician at a medical clinic for onset of a vesicular rash, which was diagnosed as severe herpes zoster. The patient was prescribed valacyclovir and TYLENOL for management of his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Acute posterior multi-focal placoid pigment epitheliopathy with minor inflammation (aseptic) meningitis; nearly complete recovery of vision.
swelling of the face and itching all over her body; swelling of her face and eyes; itching all over her body; it is worse with swelling of her face and eyes and itching and rashes; This is a spontaneous report from a non-contactable consumer.  A female patient of an unspecified age (reported as "Age:70; Unit: Unknown) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that his wife had no problem after the first dose of the vaccine on an unspecified date. After the second dose, patient had swelling of the face and itching all over her body. Reporter stated the first two days were okay, but the third day patient went to emergency room and got Cortisol. On "Sunday", patient was better and now it was worse with swelling of her face and eyes and itching and rashes. Outcome of the events was not recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Injection given into top of shoulder into joint, instead of below shoulder into muscle.
Flu like symptoms (feel warm and hot, not fever nor; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms (feel warm and hot, not fever nor) and OROPHARYNGEAL PAIN (Sore throat) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A-0ED91421) for COVID-19 immunization.     Concomitant products included LEVETIRACETAM, CITALOPRAM, MULTIVITAMIN [VITAMINS NOS] and VITAMIN D3 for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms (feel warm and hot, not fever nor) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms (feel warm and hot, not fever nor) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
This case was reported by a consumer via call center representative and described the occurrence of pain in a 76-year-old male patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's wife. The patient felt achy for a day. This case has been linked with case US2018201060 (wife's case), reported by the same reporter and for tolerance after 2nd dose refer case US2018GSK225498.
This spontaneous report as received from a nurse via a representative refers to an 8 year old patient. On 27-NOV-2006 the patient was vaccinated with the first dose of VARIVAX (Merck), injection, (lot#, expiration date and dose unspecified). On 06-JAN-2010 the patient was vaccinated with the second dose of VARIVAX (Merck) (lot # was reported as 12314, expiration date and dose unspecified). On 22-FEB-2014 the patient was seen by the physician due to the patient experienced an unspecified rash on back and abdomen on an unknown date. The representative also reported that the nurse was unsure of "how many lesions developed on the patient". The event outcome was unknown. Additional information has been requested.
so sick after taking that shot; Initial information regarding this unsolicited valid non-serious case was received from a consumer (son-in-law of the patient) and transmitted to Sanofi on 27-Oct-2020.  This case was linked to cases 2020SA305170, 2020SA305230, 2020SA305222, 2020SA305270, 2020SA305371, 2020SA305401, 2020SA305420, 2020SA305444, 2020SA305474, 2020SA305488, 2020SA305545, 2020SA305591, 2020SA305629 and 2020SA305629.  This case involved a female patient of unknown age who was so sick (illness) after taking that shot, of vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, it was reported that it just made people sick as hell and the patient was so sick after taking that shot (illness) unknown latency following the administration of INFLUENZA VACCINE. The reporter thought that she was a goner.  Relevant laboratory test was not reported.  Final diagnosis was illness.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Headache, Myalgia, NauseaVomiting, Developed HA,chills,nausea,myalgias, fatigue 12 hrs. after the 2nd COVID vaccination. She had HA,lightheadedness, and arm soreness with the first  vaccine. Narrative:  Developed HA,chills, nausea, myalgias, fatigue 12 hrs. after the  2nd COVID vaccination. She had HA ,lightheadedness, and arm soreness with the first vaccine. She missed 1 day of work.  Other Relevant History:
Pt recvd MMR 13JAN92 2 days later devel symmetric polyarthralgias in shoulders, elbows, hands, hip, knees & ankles; no rash; no effusion; Seen in ER on 25JAN92 tx Voltaren but still sl sore;
Initial misuse report received from a healthcare professional on 20 February 2014. The cases were received on 21 March 2014 at GPV. A patient had received a dose of YF Vax and a dose of ACT-HIB on an unspecified date. It was reported that gave both ACT-HIB and IF Vax with incorrect diluent. No adverse events were reported. List of documents held by sender: none.
Information has been received from a registered nurse referring to unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX (0.65ml, subcutaneously, lot # L046295 with expiration date 17-FEB-2017), which exposed to temperature excursion (temperature: -1.2 degrees Celsius, time frame: 8 hours) because of data logger. There was no previous temperature excursion. No product quality complaint (PQC) was involved. Additional information has been requested.
Vaccination Administration Error: Patient presented with her mother to vaccination clinic requesting and consenting to an influenza vaccination. The staff member mistakenly gave the patient a Moderna COVID-19 vaccination at adult dose, 0.5 ml, 100 micrograms. The health system Pharmacy contacted Moderna to ask for information about the Moderna vaccination trial for children and what side effects to monitor. This information was shared with the clinic Medical Director and the patient's primary care physician. The parents were contacted by telephone to describe the error and provide monitoring information. On 1/22/21 the child was seen for an in-person visit with her primary care physicians.
Localized swelling to site of injection, red area of diameter of half-dollar coin. Pt denies pain associated with it.
Patient's arm really swollen and red plus pain.  Her doctor gave her a prednisone 5mg 6 days pack to help with the reaction.
DEVELOPED RASH TO NECK AND ARM LASTING 30 MINUTES. RECEIVED 25MG DIPHENHYDRAMINE BY MOUTH AT 3:30PM. RASH RESOLVED IN 30 MINUTES
Full body is sore for about a month and for the first one and half weeks, I even couldn't sleep at night due to the extreme sore
fever 100.1-100.5 and chills for 12hrs overnight.  Next day headache, muscle and joint pain, little appetite.   Took Motrin for pain around 1:30pm Sunday.  Now Wednesday and woke up with headache and nausea. (may be unrelated unsure)
Headache, tingling extremities, mild nausea,  flulike symptoms, extreme muscle pain in legs, back, left bicep, and lower abdominal  area, extreme fatigue, shortness of breath, swollen glands under the chin and diarrhea. These symptoms have lasted 2 weeks and are sever enough that I have been unable to work for most of the last 2 weeks. I still have problems with wearing a mask as I have had shortness of breath and feel like I am suffocating while wearing a facemask.
ER 8/5/2022 Covid +, reported not feeling well, 3-4 days bilateral leg weakness. Wife tested Covid+ 4 days prior. SpO2 90% on RA then decreased to 89% on RA then improved to 94% on 1L O2NC. Temp 99.4. Patient admitted and started on Redesemir.
Bells Palsy, onset 5th day after shot. Mild first day, went to ER 2nd day with stroke-like symptoms. Given steroid, anti-viral
No adverse effect; Adult patient received pediaric dose of VAQTA; This spontaneous report as received from a nurse refers to an adult patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 18-OCT-2019, it was reported that, adult patient was vaccinated with pediatric dose of hepatitis a vaccine, inactivated(VAQTA) 25/0.5 vial (0.5 milliliter) (lot # S007265, expiry date: 07-JUL-2020) (frequency and route were not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse effects were reported. No product quality complaint was involved.
Approximately 30 minutes after injection, arm pain and lethargy set in.  I slept well last night but I've taken 3 naps, all more than an hour long.  I ate lunch at my normal time, around 10:30am.  I'm normally a snacky person, but since lunch I've been anti-food.  Vaguely nauseated but mostly just no appetite and it's well after my normal dinner time.  Also a general feeling of "don't feel good"
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On unknown date the patient was vaccinated with a dose of M-M-R-II, injection (lot # J002502, expiration date 28-FEB-2015). There was no concomitant medication reported. The nurse practitioner reported that the vaccine was exposed to a highest temperature of 11.5 degree centigrade for 22.5 hours. No adverse effect reported. This is one of several reports from same source. Additional information has been requested.