chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blood pressure high/high blood pressure of 260/190; Sickness; Creatinine increased; Infection; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP) received by Pfizer from a company (manufacturer control number (21K-163-4172986-00). The reporter is the patient.  A 50-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Jun2021 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis, psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERTENSION (hospitalization, medically significant) with onset 01Jun2021, outcome "unknown", described as "Blood pressure high/high blood pressure of 260/190"; ILLNESS (hospitalization) with onset Jun2021, outcome "unknown", described as "Sickness"; BLOOD CREATININE INCREASED (hospitalization, medically significant) with onset 2021, outcome "not recovered", described as "Creatinine increased"; INFECTION (hospitalization) with onset 2021, outcome "recovering", described as "Infection". The patient underwent the following laboratory tests and procedures: blood creatinine increased: (unspecified date) high; blood pressure measurement: (01Jun2021) 260/190; colonoscopy: (unspecified date) unknown. The action taken for adalimumab was dosage not changed. Clinical course: On 20Jun2021, patient received 2nd dose Covid-19 Vaccine manufactured by Pfizer/BioNTech, lot number Unknown, expiration date Unknown.  Causal relationship between the event(s) and the administration of HUMIRA was not reported as per reporter and no reasonable possibility as per manufacturer.  The reporter's assessment of the causal relationship of the events with the suspect product (BNT162B2) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Hypertension , Illness, blood creatinine increased and infection and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
She started with a runny stuffy nose on about December 1st. Then started a cough approximately 5 days later. Tested multiple times for COVID but all negative. Her mucus turned green over the weekend and the doctor treated her with antibiotics for a sinus infection.
RIGHT HAND RASH; FATIGUE; RIGHT LEG INFLAMMATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 on right deltoid for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced right leg inflammation. On MAR-2021, the subject experienced fatigue. On 21-MAR-2021, the subject experienced right hand rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right hand rash, and the outcome of right leg inflammation and fatigue was not reported. This report was non-serious.
After the second Covid shot, I began having severe symptoms during the ovulation part of my menstrual cycle, which I had never had before.  I now get migraines with muscle cramping/tightness in my back and neck, along with nausea.  The severity is worse than really bad period cramps.  I have also started getting insomnia for about 3-4 nights before getting my period.  I have never had a history of insomnia prior.  I have always fallen asleep fairly easily (and I do not drink caffeinated beverages).
Rash and raised hives appeared, took Benadryl which relieved it but once that wore off they came back. Read a forum that a lot of people had this happen after 2nd dose and was told to report here. Hives between legs and back of thighs, groin area, wrists and sometimes on face. Raised and itchy. Going on day 2 and the hives have come back full force after antihistamines.
This case was reported by a physician via sales rep and described the occurrence of swelling in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On 24th October 2017, unknown after receiving BEXSERO, the patient experienced swelling, induration and mass. On an unknown date, the outcome of the swelling, induration and mass were unknown. It was unknown if the reporter considered the swelling, induration and mass to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported on behalf of physician and reported that he went in today and gave her the label update for BEXSERO with post-marketing experience and she said she had two patients with extensive swelling and the persistent hard lump, a boy and a girl. That was all the information she could remember but asked to feel free to reach out to her and contact her if would like. This case is linked with case US2017GSK164006, reported by the same reporter.
The patient reported to me today that she received her pfizer covid-19 booster dose on 10/14/21 and then the night of 10/15/21 she developed a rash on mostly her chest and neck but also some on her back and arm. She said that the rash was very itchy. She also stated that the rash was getting better but still not completely resolved.
Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On unspecified date, the patients were vaccinated with improperly stored GARDASIL (dose and route unknown, lot # K011325, expiration date: 08-APR-2017). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Migraine headache with aura occurring for the first time on indicated date. Woke 2 days later (April 20th) with severe headache and nausea. Taken to ER. Had headache again (moderate) for 2 days following ER visit.
This case was reported by a healthcare professional, who was also the vaccination subject,  that described the occurrence of not responding to therapy in a 48-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified), and hepatitis A vaccine inactivated (Hepatitis A vaccine, manufacturer unspecified).  The subject's  medical history included a non-cancerous abnormal pap smear, measles and mumps.  Previous vaccinations included Typhoid and Salmonella typhi Vi capsular polysaccharide vaccines;  manufacturers unspecified;  given on 28 September 2004; tuberculin ppd; manufacturer unspecified; given on 23 August 2004;  diphtheria and tetanus toxoids adsorbed;  manufacturer unspecified;  given on 26 July 2004;  meningitis vaccine, strain  not specified;  manufacturer unspecified;  given on 26 July 2004.  Concurrent medications included Multivitamins.  On unspecified dates in 1988, the subject received that 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine (unknown, intramuscularly).  On unspecified dates in 1998, the subject repeated the three dose Hepatitis B vaccination series.   The subject could not recall if she received any concomitant vaccinations at that time.  On 26 July 2004 and 31 January 2005, the subject received the 1st dose and 2nd dose of Hepatitis A vaccine (unknown).  On an unspecified date in 2008, the subject had titers drawn for Hepatitis A and Hepatitis B.  Test results showed that the subject was negative for both antibodies.  The subject stated that she was recently prescribed ENGERIX B by her physician, which was to be given intradermally.  ENGERIX B is not recommended for intradermal use.  At the time of reporting, the outcome of the events was unresolved.
Feeling sick; Stiffness; FELT BODY ACHE; Allergies; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), MUSCULOSKELETAL STIFFNESS (Stiffness), PAIN (FELT BODY ACHE), HYPERSENSITIVITY (Allergies) and PAIN IN EXTREMITY (Pain in arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE (Route: Intramuscular Dose 1) on 01-Jan-2021 and Pfizer/BioNTech COVID-19 vaccine (Route: Intramuscular Dose 2) on 05-Feb-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and Pfizer/BioNTech COVID-19 vaccine.   On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MALAISE (Feeling sick), MUSCULOSKELETAL STIFFNESS (Stiffness), PAIN (FELT BODY ACHE), HYPERSENSITIVITY (Allergies) and PAIN IN EXTREMITY (Pain in arm). At the time of the report, MALAISE (Feeling sick), HYPERSENSITIVITY (Allergies) and PAIN IN EXTREMITY (Pain in arm) had resolved and MUSCULOSKELETAL STIFFNESS (Stiffness) and PAIN (FELT BODY ACHE) had not resolved. Not Provided          Concomitant product use was not provided by the reporter.  The patient received third booster dose of Moderna vaccine. On unknown dates, the patient experienced feeling sick, stiffness, allergies, arm pain and felt body ache. No treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Mom described baby waking at 1 AM for feeding, was about to doze off when he had jerking movements of arms and legs lasting about one minute off and on. Child's eyes closed at time. No color change. No vomiting. Did not stop breathing. Appointment with physician on 11/3/09. DX: ? seizure disorder. Child stable at visit on 11/3/09, 2:50 PM.
he was out of it, couldn't remember anything; Had low blood pressure; Lost weight; symptoms became worse; A spontaneous report was received from a Consumer concerning her husband, a 80- year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced being out of it, couldn't remember anything (memory impairment), had low blood pressure (hypotension) and lost weight (weight decreased).  The patient's medical history was not provided. Concomitant medications reported included tacrolimus, mycophenolic acid, carvedilol, clopidogrel, allopurinol, pantoprazole, prednisone, calcitriol, simvastatin and tylenol.  On 09 Feb 2021, approximately 25 days prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot: 025J202A) for prophylaxis of COVID-19 infection.  On 06 Mar 2021, the patient was out of it, couldn't remember anything, had low blood pressure and lost weight. Most of these symptoms started before patient received the Moderna vaccine but the symptoms became worse on 06 Mar 2021. The patient was hospitalized on 06 Mar 2021.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, patient was out of it, couldn't remember anything, had low blood pressure and lost weight were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
could not find her car. She states she had brain fog, thought she walked 5 blocks/ foggy; confused; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "could not find her car. She states she had brain fog, thought she walked 5 blocks/ foggy"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "confused".  Additional information: She went out on Tuesday to do some shopping and could not find her car. She stated she had brain fog, thought she walked 5 blocks. She was confused and foggy for about an hour and then that passed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial unsolicited report received from a pharmacist on 18 November 2014. A 78-year-old female patient, whose medical history and concomitant medications were unknown, received FLUZONE HD (lot number U5042CA) on 03 November 2014. One day post-vaccination, on 04 November 2014, she experienced a headache and her blood pressure "went up and then down". The patient informed the reporter that she had been hospitalized for three days but that no cause had been found for her symptoms. The symptoms recovered on an unspecified date. According to the patient, she "was having follow-up done for possible cardiac issues". Documents held by sender: None.
Patient c/o chest tightness, SOB, swelling of both eyelids., swelling of sinuses; redness at the injection site.  Took prednisone Tues and Wed, has used the Xopenex but hasn't needed the EPI pen. Also states she took a dose of Benadryl 2 hours BEFORE the flu shot.   Patient is doing better now.
Pt received Shingrix Thursday morning. Later that afternoon pt started with severe fatigue, body aches, chills, fever, and headache. Also with arm pain and "circular rash" approximately 6 inches below injection site. All symptoms resolved by Saturday. Husband also received shingrix injection that morning  and only with arm pain and rash. Both symptoms resolved.
vaccines / been exposed to temperatures in the 50s Farenheit degrees / up to 30 patients could have received vaccines exposed to that temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unknown number of patients who received HAV (Havrix) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Havrix, Engerix B and Boostrix. On an unknown date, unknown after receiving Havrix, Engerix B and Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. A nurse practitioner reported that the system that monitored the temperature of the refrigerator that stored Havrix, Engerix-B and Boostrix had a glitch. The provider did not had data for May-June and July 2021 but suspects the vaccines might have exposed to temperatures in the 50s degree F (as reported).  The nurse practitioner mentioned that an average of 08 to 10 patients were vaccinated per month in the facility and thus, her calculation was that up to 30 patients could have received vaccines exposed to that temperature excursion. No more information was available at the time of reporting. The reporter consented to follow up.
Fever, Vomiting, Body Ache vomiting was only initially, then fever and such for about 18 hours.
I tested positive for covid this week; I tested positive for covid this week; bilateral tinnitus/ amplified; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset Apr2021, outcome "not recovered", described as "bilateral tinnitus/ amplified"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "I tested positive for covid this week". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: I tested positive for covid this week. I have confirmed the positive result with 3 tests.  Clinical course: From 13 hours after patient received 1st Pfizer covid vaccine, patient had bilateral tinnitus 24/7 nonstop for the past 14 months. patient tested positive for covid this week. patient ONLY symptom was that patient tinnitus has been amplified so markedly louder than ever, and on a whim, patient tested for covid because patient had no other explanation. patient had confirmed the positive result with 3 tests.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted when received.
Patient did not have vaccine card on person at time of visit. Medical assistant checked chart for vaccine details, chart did not have this information. Database was not allowing MA to log on at time of visit. Patient stated he received and completed the COVID-19 vaccine series in February, 2021 and had received the Janssen vaccine (1 dose). MA administered booster dose of Janssen. This writer was able to log on to Database after vaccine was administrated. Database stated he received the 1st dose of Moderna on 2/20/21. This writer checked our database with name and DOB which brought up 2 charts for the patient. The chart that the MA did not open was the chart that had the 1st  dose of Moderna vaccine documented. This writer immediately reviewed information with patient regarding CDC recommendations and the difference between both brands of COVID-19 vaccines. Patient stated understanding of this information and did not have any questions and/or concerns at time of discharge. This writer kept patient for observation of 30 minutes after administration.
Pt recv vax on 10/26/98; on same day pt exp flu-like sxs x 1wk
LYMPH NODES UNDER RIGHT ARM WORSENING AND GETTING SPREADING; STIFFNESS; Nausea; FELT JUNK; SHOULDER SORE; This spontaneous report received from a patient concerned an 18 year old male. The patient's weight was 170 pounds, and height was 71 inches. The patient's concurrent conditions included non smoker, and abstains from alcohol, and other pre-existing medical conditions included patient has no known allergies and non drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for vaccination prophylactic. The batch number was not provided and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced felt junk. On 07-APR-2021, the subject experienced shoulder sore. On 07-APR-2021 15:30, the subject experienced stiffness. On 07-APR-2021 15:30, the subject experienced nausea. On 08-APR-2021, the subject experienced lymph nodes under right arm worsening and getting spreading. On 10-APR-2021, treatment medications included: diphenhydramine hydrochloride. Additional treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt junk, had not recovered from lymph nodes under right arm worsening and getting spreading, and the outcome of nausea, stiffness and shoulder sore was not reported. This report was non-serious.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 19-OCT-2017, the patient was vaccinated with an expired dose of PROQUAD lot number L050909 and expiration date of 14-JUN-2017 for prophylaxis. No adverse effects were reported.
significant muscle pain; This case was reported by a consumer via interactive digital media and described the occurrence of myalgia in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was unknown.   It was unknown if the reporter considered the myalgia to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient experienced significant muscle pain after 2nd dose of second dose of Shingles vaccine. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Numbness, tingling and weakness of left arm, progressing to left face and leg within 20 minutes of having vaccine. 90 minutes later I went to ER due to symptoms. I was admitted to inpatient care for 2 days to rule out stroke. I have undergone imaging and nerve tests that reveal nerve damage on the left arm and leg. Left leg and arm weakness as well as abnormal sensation are still present and have no progressed to the right leg and arm. I have been diagnosed with Mononeuritis Multiplex at this time but I am still under the care of neurologists for my condition
Patient received Pfizer COVID-19 Vaccine on 5/14/21 and 6/4/21. On 6/6/21, patient presented to Emergency department due to a "bad chest pain" that started 30-40 minutes ago.  Patient found to have troponin level of 4,904.25, EKG showed some abnormalities with ST depressions in the inferior leads, and ultrasound showed grossly normal LVEF without pericardial effusion or septal bowing. CMP and CBC unremarkable.  Ibuprofen 400mg PO given and patient was transferred out for further evaluation.
Thunderclap headaches. Sudden in onset after orgasm.  I needed help into bed. Extremely painful. 9 out of 10.
I had a fever, coughing, headache, achy all over, my sense of taste changed, I used a home COVID-19 test that came back positive. I was going to let the virus run it's course. Then I started to feel extremely horrible, so I went to the emergency room. They tested me for COVID-19, it came back negative, they could hear rattling in my chest, a CT scan was ordered as well as bloodwork. The CT scan found that I had pneumonia, the bloodwork revealed I also had sepsis. I was admitted to the hospital where I spent five days to recover.