chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he has an infection in her eye; has a really bad eye infection, like conjunctivitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021404824.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METFORMIN HYDROCHLORIDE taken for glucose tolerance impaired. The following information was reported: EYE INFECTION (non-serious) with onset 10Apr2021, outcome "not recovered", described as "he has an infection in her eye"; CONJUNCTIVITIS (non-serious) with onset 10Apr2021, outcome "unknown", described as "has a really bad eye infection, like conjunctivitis". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received the vaccine between 17:30 and 17:45. The patient did not received any prior vaccines within 4 weeks. The patient received the first dose of Pfizer COVID19 vaccine on 25Mar2021. She was scheduled to take second dose on 15Apr2021. The eye infection started two weeks and two days after her fist vaccine, 10Apr2021. She woke up with the eye infection. Honestly, when she woke up with it she didn't initially believe it was another case of conjunctivitis. She had a really bad eye infection, like conjunctivitis. She has had it before. She thought she slept with her eye open. Her eye was dry. She tried to ignore it to see if it would get better. It was really bad. She needs to get treated with antibiotic drops. The patient was asking if it was ok to take the second dose while her eye was in such pain and/or she was taking antibiotics. The patient was asking if she can take the second vaccine along with the antibiotics or should she wait before getting the vaccine.  No follow-up attempts are possible. No further information is expected.
Vaccine given on 12/23/14. On 12/24/14 sore, raised, red, hot area of injection site with flu-like sxs of fever, myalgias, chills. 1/2/15 (R) facial Bell's palsy with weakness of (R) face.
Seizures/new onset (tonic-clonic)  10/12/2009 MR and DC records received for  9/18/2009. Patient presenting with sx of new onset of seizure with tonic/clonic activity, foaming of the mouth and biting of the tongue. There was no B/B incontinence and no fam hx of seizure disorder. PE was normal, admitted for observation and studies 9/18/2009, DC'd 9/21/2009, DC DX  Seizures new onset, R/O reaction to menigoccal vaccine.
p/vax both thighs swollen & 2 to 3hr of constant crying;high pitched;48hr p/vax urticaria both extremities;
3/29 Rapid response team called for c/o dizziness, feeling of fainting and palpitations, near syncope, SOB, abdominal pain. 3/30 She reported that she felt like something was blocking her throat and 3/31 c/o headache
p/vax pt exp myalgia & arthralgia;exam remains compatible w/fibromyalgia but these sx occurred about 2 days p/vax;pt exp vomiting, diarrhea & stiffness of whole body;diff working;tx w/ NSAID & pred;did not respond to NSAID  but pred helped;
This case was reported by a healthcare professional and described the occurrence of arm pain at injection site in a 20-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent vaccination included seasonal influenza vaccine (non-gsk); Novartis; unknown right arm given on 10 November 2013. On 10 November 2013 at 16:21 the subject received 3rd dose of TWINRIX (1 ml, unknown route, left arm). In November 2013, within days of vaccination with TWINRIX, the subject experienced arm pain at injection site. The arm pain at injection site was described as "short stabbing pain going down left arm." The subject did consult a healthcare professional regarding the event. At the time of reporting the event was unresolved.
Information was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unspecified date, the patient was administered a dose GARDASIL injection (lot#, expiry, dose and route unknown). On 25-JUL-2016, the patient was administered the 2nd dose of the series with GARDASIL 9 injection (lot#, expiry, dose and route unknown). No adverse effects were reported. Additional information has been requested.
pt recvd vax 4DEC92 & w/in 24 hrs pt devel severe bilateral parotid swelling, low grade fever, myalgia;
The symptom was nausea and with each day it got more severe. I didn't suspect it was COVID-19. I was a little tired as it went on. The only reason I tested on April 29th is because I was going to see a new born baby. I then went to do a PCR. I was treated with monoclonal antibodies. Once I had this the nausea went away. I am still testing positive 3 months later on the home antigen test. I did a total of 3 PCR tests and they were all negative, April 29th, May 2nd, and May 3rd. Despite having negative PCR tests the doctor had me do the infusion due to all the antigen positive tests I had done. I continue to test weekly and continue to come up as positive and the most recent was yesterday. It's getting fainter but still positive. The doctor is having me go to Infectious Disease doctor.
Pain and soreness in left shoulder and arm area. Weakness in area surrounding shot administration. Limited range of motion. All of these lasted through next day and are improving. Noticeable mood problem of anger and irritability, same onset time and duration. This has resolved.
Vomiting, fever 14 1/2 hours after receiving influenza vaccine. Continued with vomiting and admitted to hospital 11/14 PM with dehydration.  12/8/06 Received medical records from hospital which reveal patient admitted 11/14/06 for abdominal pain & refractory vomiting.  Treated w/IVF & antiemetics as well as protonix.  Improved & had no pain or vomiting on d/c to home 11/15/06. Final Dx: gastroenteritis./ss
Chronic persistent toe/knee/hand pain and fatigue aggravated by 3rd dose.
This spontaneous report was received from a male patient of unknown age regarding him. Historical drug, medical history, concurrent conditions, concomitant medication, drug reactions and allergies were not provided. On an unspecified date, the patient received a "brand new" Zoster Vaccine Live (manufacturer unknown) (dose, strength, frequency, lot number and expiration date were not reported) for prophylaxis. A couple of years ago (date unspecified), after receiving the original Zoster Vaccine Live (manufacturer unknown), the patient stated that he found out it was "only 50 percent effective", and that the new one that was "95 percent effective". The patient reported that he had with high fever, chills, and weak legs and weakness after receiving the new Zoster Vaccine Live (manufacturer unknown); due to the events he was bedridden all the weekend. Despite the aforementioned reactions, the patient did not regret for receiving the vaccine. The patient emphasized that vaccine was "very important", and that it was recommended for anyone 50+, and also shingles was a very painful virus. Additionally, he said that his doctor administered the vaccine to about 10 people so far, and that no one had a reaction, but that the literature said it was possible to have a reaction. He also mentioned that his dad got shingles in his face, and that was just "awful". Furthermore he mentioned that most people did not have reaction and that there was no way to abate the reaction; he took aspirin to mitigate the pain. The outcome of drug ineffective, pyrexia, asthenia, pain, muscular weakness and chills was unknown. The patient attributed to the new Zoster Vaccine Live (manufacturer unknown) to be the cause of the high fever, chills and weakness he experienced. The causal relationship between the drug ineffective, pain, and the muscular weakness with the suspect vaccine was not provided.
blood under the bandaid where injection was; arm was swollen; injection site felt like a ball; colorless liquid under the bandaid where injection was/wondering if she received the full dose; This is a spontaneous report from a contactable pharmacist from a sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 27Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. On 27Mar2021, the patient experienced blood under the bandaid where injection was, arm was swollen, injection site felt like a ball, and colorless liquid under the bandaid where injection was/wondering if she received the full dose. The clinical details were reported as: When the patient got home, she noticed blood and a colorless liquid under the band aid where her injection was. The patient stated that she had no fever, fatigue, or chills but her arm was swollen. She was questioning whether she got a valid dose/full dose. The pharmacist stated they use collapsible needles to administer the vaccine and was inquiring about back flow. The clinical outcome of blood under the bandaid where injection was, arm was swollen, injection site felt like a ball, and colorless liquid under the bandaid where injection was/wondering if she received the full dose was unknown.  No follow-up attempts are possible; information about lot number cannot be obtained.
sore injection site arms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore injection site arms). At the time of the report, VACCINATION SITE PAIN (sore injection site arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported Treatment information was not provided
From initial information received from a health care professional on 10/7/04 regarding an adverse event occurring in the USA, it was reported that an 80 year old male patient with a history of cardiac problems and prostate cancer received a FLUZONE vaccination, lot number U1380AA, administered in the right deltoid on 10/7/04. One hour after receiving the vaccine, the patient died in his car in the hospital parking lot. Per the reporter, the coroner's initial impression was that it may have been a coronary heart attack and he stated that he would check for this. No other information was provided at this time. There was no autopsy done.  Nurse follow up on 10/19/04 states: "No new information."  Follow up on 10/28/04 states: "From additional information received on 10/21/04, it was reported that the pt had no illnesses at the time of vaccination. He received the FLUZONE SV '2004-2005 vaccination IM. He had previously received at least 3 or more influenza vaccines in the past without experiencing any adverse events. His previous medicaitons had included amlodipine, atorvastatin, atenolol, digoxin, furosemide, nitrates, lisinopril and metformin. His current medication list was not available at the time of this report, so it is unknown if the pt was taking any of these medications at the time he received the influenza vaccine on 10/07/04."
No other AE reported; we inadvertently gave a PROQUAD to a patient that was expired; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 22-JAN-2021, the patient was inadvertently vaccinated with an expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, 0.5 milliliter (ml) (lot number S022912 which has been verified to be valid, expiration date reported and validated as 19-JAN-2021) (vaccination scheme, route of administration, and anatomical site of injection were not reported) as prophylaxis (expired product administered). No other adverse events were reported in the patient.
arm soreness; some fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 at 10:00 as dose 1, single (Lot number: EL9261) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "borderline high cholesterol" (unspecified if ongoing); "BPH" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN MEDOXOMIL, start date: Oct2017; ROSUVASTATIN, start date: Jun2018; HYDROCHLOROTHIAZIDE, start date: Jun2001. Past drug history included: Amoxicillin, reaction(s): "Allergy".  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "arm soreness"; FATIGUE (non-serious), outcome "recovering", described as "some fatigue". Therapeutic measures were not taken as a result of pain in extremity, fatigue.  Additional Information: Patient administered other medications in 2 weeks.   No follow-up attempts are possible. No further information is expected.
administered an expired TENIVAC to a patient with no reported adverse event; Initial information was received from  on 22-Nov-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was administered an expired vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an expired total dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection standard (lot U6831AA, expiry date- 30-Oct-2022) via unknown route in unknown administration site for Immunisation with no reported adverse event (expired product administered) (unknown latency).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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.
patient received moderna bivalent dose from previous day vial (out of refrigeration >12 hours)
pt recvd vax;had a febrile sz 9 days later;at time of adm no source for the fever was evident;possible that the sz may have occured due to a febrile illnes following MMR vax;
This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 63-year-old female patient who received FLUARIX QUADRIVALENT. Concomitant products included ibuprofen and MICARDIS. On 18th November 2016 11:00, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular) 0.5 ml. On 18th November 2016 11:01, 1 min after receiving FLUARIX QUADRIVALENT, the patient experienced burning sensation. On 18th November 2016 11:05, the patient experienced neck swelling. On an unknown date, the outcome of the burning sensation and neck swelling were not recovered/not resolved. The reporter considered the burning sensation and neck swelling to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient experienced burning in her shoulder and neck. On 18th November 2016, 5 min after receiving FLUARIX QUADRIVALENT, the patient experienced swelling in her neck. The patient reported that she went to the emergency room and was discharged home.
inc fever, dec appetite, cellulitis @ inj site;hosp tx IV ATB;
On 1/29/03 MMR, IPV, Td, HepB given around 3:00 PM. Mother reports redness of skin and itching 1 hour after arriving home. (Itching upper thighs and calves) Seen in clinic at health dept 1/30/2003. Advised to give Benadryl. If symptoms worsen, advised to go to ER.
SWELLING, REDNESS, PAIN IN AREA OF ARM WHERE VACCINE WAS ADMINISTERED.
There were 4-5 individuals at the clinic on 1/19/23 that received the 6 months to 5 years monovalent formulation due to a preparation error. Clinic is unable determine which 4-5 individuals out of 14 actually received the monovalent formulation instead of the intended bivalent product.  Moderna monovalent Lot number was AS1414B with manufacturer expiration date of 2/13/23.
Bullous pemphigoid lession on abdominal area; This case was reported by a physician via call center representative and described the occurrence of bullous pemphigoid in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd October 2019, the patient received the 1st dose of Shingrix. On 3rd October 2019, 1 days after receiving Shingrix, the patient experienced bullous pemphigoid (serious criteria GSK medically significant). On an unknown date, the outcome of the bullous pemphigoid was unknown.   It was unknown if the reporter considered the bullous pemphigoid to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and next morning on Thursday, had bullous pemphigoid lesion on his abdominal area. The patient would like to had fedback if this was a possible adverse effect that you are aware of. The reporter consented for follow up.
dizziness, nausea beginning at bedtime, and worsening through the night, chills and fever of 102 degrees next morning. Joint pain in the left shoulder was severe.
Low grade temp of 99 degrees x 1 day & red rash on trunk of body.  Occurrence developed 12 days after immunizations administered.
dizziness, fatigue, nausea, head cold, sore throat 4-5 days,  headache  ER visit at Hospital
Patient was 11 years old at time of vaccination and received Pfizer for patients 12 years of age and up. Patient showed no signs or symptoms of distress are adverse reaction while in observation post vaccination. Left the facility in good health/stable condition.
Patient presented to clinic 11/25/2019 with a  diffuse macular rash. Treatment was supported care, no medications prescribed at this visit. Patient also was seen at an Urgent Care clinic 11/23/2019 and was given Benadryl with no change in the rash.  Rash looks clinically well and will continue to watch and follow up in necessary.
immed began w/red blotchy spots approx 1inch from inj site;approx 545PM pt had 3" diameter area on leg that was swollen, hot to touch;area soft & non-tender;no fever, no irritability;19MAY pt was whining some & c/o tenderness;
Running a slight fever (around 100°) for two days and has rash under chin and on chest and arms.
tongue numbness/burn feeling similar to my food allergies; tongue numbness/burn feeling similar to my food allergies; tongue numbness/burn feeling similar to my food allergies; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number: EN6205, Pfizer NTEC), via an unspecified route of administration in left arm on 19Apr2021 at 15:00 (at the age of 63-years-old) as 2nd dose, single for covid-19 immunization. Medical history included Hypertension, arthritis, mostly great health and known allergies: Flagyl, pollen, melon, some shellfish, latex. Prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included losartan and amlodipine. The patient did not receive any other vaccines within 4 weeks. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number: EN62041, Pfizer NTEC), for COVID-19 immunization. On 20Apr2021 patient experienced tongue numbness/burn feeling similar to the food allergies, (melons/some shellfish). It lasted 3-4 days, lessened with Benadryl. The patient not hospitalized due to events. The patient received treatment for the events with Benadryl. The clinical outcome for the events was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
MIGRAINE LIKE HEADACHES; HIGH BLOOD PRESSURE; FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a male of unspecified age. 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: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced flu like symptoms. On 03-JUN-2021, the subject experienced migraine like headaches. On 03-JUN-2021, the subject experienced high blood pressure. Laboratory data included: Blood pressure (NR: not provided) high blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 2021, and the outcome of migraine like headaches and high blood pressure was not reported. This report was non-serious.
Initial report was received from a company representative on 11 October 2011. A female patient (age and date of birth not reported) had received an injection of ADACEL (lot number, route and site of administration not reported). On an unspecified date shortly after receiving the injection, the patient had a flare-up of her fibromyalgia. No further information was available at the time of the report. The patient outcome was not reported. Documents held by sender: None.