chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menopause; Hot flashes; Breast tissue/It has been 7 months tissue is still swollen + tender; Breast tissue/It has been 7 months tissue is still swollen + tender; Night sweats; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Sep2021 (Lot number: F08448) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Allergies" (unspecified if ongoing), notes: Allergies. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for hypertension (ongoing); CLARITIN [CLARITHROMYCIN] taken for hypersensitivity (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: AW0168), administration date: 18Aug2021, when the patient was 47 years old, for COVID-19 Immunization, reaction(s): "Both breast tissue under arms swelled", "Breast tissue/It has been 7 months tissue is still swollen + tender", "Menopause", "Hot flashes", "Night sweats". The following information was reported: MENOPAUSE (non-serious), outcome "unknown", described as "Menopause"; HOT FLUSH (non-serious), outcome "unknown", described as "Hot flashes"; BREAST SWELLING (non-serious), BREAST TENDERNESS (non-serious), outcome "not recovered" and all described as "Breast tissue/It has been 7 months tissue is still swollen + tender"; NIGHT SWEATS (non-serious), outcome "unknown", described as "Night sweats". The event "menopause" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, patient received first dose of Pfizer COVID vaccine within 5 to 7 minutes both breast tissue under arms swelled, also something happened with 2nd dose. It has been 7 months tissue was still swollen + tender, she had an mammogram + Ultrasound which are negative. Seen 2 breast specialist finally 2nd one said the COVID vaccine sent her into menopause, she having hot flashes, night sweats etc. Seen Gyn to C/O hormone testing. Waiting for results. This has been an horrible or deal for her, she never getting the booster shot. No specific relevant test for thromboembolic events with thrombocytopenia. Patient was taking fluticasone hydrochlorothiazide 25mg daily and claritin 10mg for allergies both orally. vaccination facility type: Hospital. No prior Vaccinations.  No follow-up attempts are possible. No further information is expected.
has cold/currently have a cold; 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 41 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "has cold/currently have a cold". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Additional information: Reason for no lot number of COVID 19 Vaccine was Consumer stated, she doesn't have time, to thought but she thought this was going to be little faster, and don't have it handy, so let's just skip all of that and I am going to thank you very much for your time, Expiry Date of COVID 19 Vaccine was Unknown. She had a caller on the other line, she said that she is schedule to get the booster shot tomorrow, however she has cold, and she took a test and the test, and it was negative (further clarification unknown), so she just wanted to know that she should continue with shot tomorrow, she had a cold. Consumer stated, let me re-phrase that, I am schedule to get a booster shot tomorrow and currently have a cold, should I re-schedule my booster shot, or should I do the booster? Consumer was informed about role of Pfizer Drug Safety and informed that Pfizer Medical Information is the concerned department to answer the question that consumer have regarding the vaccine and offered the number. Consumer stated, I thought this was just about my call experience, what are the questions, let go to the question, she don't have too (Incomplete Sentence).Further probing could not be done as the consumer was unwilling to share any further information. Hence limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pain is awful; muscle spasms; now part of my shoulder is numb; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: pain is awful), muscle spasm (Verbatim: muscle spasms) and numbness in shoulder (Verbatim: now part of my shoulder is numb). The outcome of the pain and muscle spasm were not reported and the outcome of the numbness in shoulder was not recovered/not resolved.   It was not reported if the reporter considered the pain, muscle spasm and numbness in shoulder to be related to Shingles vaccine.     It was not reported if the company considered the pain, muscle spasm and numbness in shoulder to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2023 This case was reported by the patient via interactive digital media. The patient took the vaccine and had it the pain was awful and the muscle spasms and now part of shoulder was numb. Follow-up would not possible as no contact details were available.
7 cm circular area medial to the injection site of the right leg with 1 cm circular urticarial lesions going up the thigh. Similar lesions on the palms of hands and forearms. Advised parents to use BENADRYL and cold compresses.
no additioanl AE reported; adverse event involving vaccines MMR II (stored in freezer) and VARIVAX; adverse event involving vaccines MMR II (stored in freezer) and VARIVAX; This spontaneous report was received from a medical assistant and refers to a 1-day-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 10-MAR-2020, the patient was vaccinated with improperly stored vaccines: measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) 0.5 mL, lot # S039319, expiration date 04-DEC-2021 (route of administration and anatomical location were not provided) and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 mL, lot # T022315, expiration date 30-JUN-2022 (route of administration and anatomical location were not provided) for prophylaxis (inappropriate age at vaccine administration). The vaccines were stored in a temperature between - 50 degrees Celsius (C) to 8 C (- 1.6 C) for 1 hour 36 minutes. There was no previous temperature excursion reported. Digital data logger was involved. No additional adverse event (AE) was reported.
Pt vaccinated with Engerix-B vaccinee received a first dose on 10SEP90. Had onset of lymphadenopathy on 28SEP90 dx with thyroid cancer.
woke up with swollen lips; his arm was sore at the injection site; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (woke up with swollen lips), VACCINATION SITE PAIN (his arm was sore at the injection site) and HEADACHE (slight headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (his arm was sore at the injection site) and HEADACHE (slight headache). On 18-Mar-2021, the patient experienced LIP SWELLING (woke up with swollen lips). At the time of the report, LIP SWELLING (woke up with swollen lips), VACCINATION SITE PAIN (his arm was sore at the injection site) and HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.  No medical history was provided by the reporter.
Patient arm increased sore, feels fatigued late PM after received dose.  Right upper arm red and blotchy, swollen shoulder-elbow, unable to raise right arm next day.  Denies respiratory symptoms.  Advised to take Aleve or Ibuprofen and Benadryl as needed.
LEFT ARM NEUROPRAXIA/NEUROPATHY ... PATIENT WITH COMPLETE NUMBNESS TO LEFT ARM, WEAKNESS TO LEFT ARM.
Injection site is warm to touch; Injection site rash; A spontaneous report was received from a consumer concerning a 56 years old, female patient who experienced injection site rash/vaccination site rash and injection site warm to touch/ vaccination site warmth.   The patient's medical history included allergy.  Products known to have been used by the patient, within two weeks prior to the event, included fexofenadine hydrochloride, fluticasone propionate, vitamins c &d, montelukast sodium and omeprazole magnesium.  On 05 Jan 2021, prior to the onset of the symptoms, the patient received their first/second (not specified) of two planned doses of mRNA-1273 (Batch number: 011L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 15 Jan 2021, the patient experienced injection site rash and injection site was warm to touch.  Treatment for the event included paracetamol.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events injection site rash and injection site was warm to touch were unknown.; Sender'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.
Second dose was due on 24Feb2021 but they had an emergency and could not attend; Missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of INCOMPLETE COURSE OF VACCINATION (Second dose was due on 24Feb2021 but they had an emergency and could not attend) and PRODUCT DOSE OMISSION ISSUE (Missed second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INCOMPLETE COURSE OF VACCINATION (Second dose was due on 24Feb2021 but they had an emergency and could not attend) and PRODUCT DOSE OMISSION ISSUE (Missed second dose). On 24-Feb-2021, INCOMPLETE COURSE OF VACCINATION (Second dose was due on 24Feb2021 but they had an emergency and could not attend) and PRODUCT DOSE OMISSION ISSUE (Missed second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Patient was administered an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 037F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant  and treatment medication were reported. The pharmacist reported that he had administered the expired vaccine.
The pt. received PREVNAR (PCV13) on 7/2/14 and Pneumococcal (PPSV23) Vaccine (Merck Lot J010396) on 9/2/14 in the right upper arm at 1400. The pt was in good health at the time of vaccination; the patient is right handed. At 1600 the pt noted that her right shoulder/arm was sore but nothing unusual after receiving a vaccination. At 1800 the pt stated that the right upper arm was very sore (8/10) and she was unable to feed herself without an increase in pain. She applied an ice pack and took two (2) TYLENOL (650-1000mg). After sleeping for about an hour the pt woke at 2100 in severe pain (10/10)--she experienced shoulder pain with movement of her hand. The pt reported to the ER at 0800. According to the pt she was given DILAUDID and her pain on arrival to our clinic at 1300 was 5/10. The pt has her right arm supported in a sling. On physical exam the right shoulder: Significant tenderness noted with palpation; pt was unable to abduct her arm >15 degree without pain; pt was unable to shrug her shoulder without pain. Slight warmth on noted right deltoid. Pain was elicited with movement (independent or with assistance). The injection site was noted to be high on the deltoid at 1cm from right acromion. The pt was treated with TYLENOL 650mg q4-6prn, NORCO 5-325mg q6prn, ice/heat, sling as needed and gentle exercises as tolerated. At her follow-up visit with her PCM on 9/8/14 she was much improved with complete resolution of her symptoms on 9/11/14.
for the second half (10 mcg) dose inadvertently administered an unknown Men B. on 5/15/22 instead of the other half of the Engerix B (10 mcg).; administered half dose of Engerix (10mcg) to adult patient on 4/12/22; administered half dose of Engerix (10mcg) to adult patient on 4/12/22; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 48-year-old female patient who received HBV (Engerix B 10 mcg) for prophylaxis.   Co-suspect products included Men B NVS (Meningococcal B vaccine) (batch number 2573G, expiry date 28th May 2022) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Meningococcal B Vaccine Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th April 2022, the patient received Engerix B 10 mcg. On 15th May 2022, the patient received Meningococcal B vaccine and Meningococcal B Vaccine Pre-Filled Syringe Device. On 12th April 2022, unknown after receiving Engerix B 10 mcg, the patient experienced underdose and adult use of a child product. On 15th May 2022, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the underdose, adult use of a child product and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 8-Jul-2022 Reporter's comment: Medical Assistant called in to inquired that how to proceed. The reporter reported they administered half dose of Engerix (10 mcg) to adult patient on 12th April 2022 and for the second half (10 mcg) dose inadvertently administered an unknown Meningococcal B on 15th May 2022, instead of the other half of the Engerix B (10 mcg).  The reporter stated they intended to split the Engerix (20 mcg) dose due to the patient's past with medication reactions.  The reporter did not consent to follow-up. Additional supportive information: The patient was administered half dose of Engerix 10 mcg to adult patient and for the second half (10 mcg) dose inadvertently administered an unknown Meningococcal B instead of the other half of the Engerix B (10 mcg), which led to underdose, adult use of a child product and wrong vaccine administered. The vaccine start date for unknown Meningococcal B vaccine was captured as per narrative information. As unknown Meningococcal B was reported therefore suspect was coded with generic name and device with the market.
A report has been received from a consumer mother via medical rep concerning her 4 year old, male subject. The concomitant medications of the patient were not provided. Patient had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started during Aug-2012. Patient's mother reported that the patient got flu after receiving FLUMIST QUADRIVALENT which started during Jan-2013. The outcome of the event of children got the flu after receiving FLUMIST was unknown. The report was considered to be non-serious.
Fever and chills x 48 hrs, severe body aches not relieved by TYLENOL x 36 hrs, injection site red, hard and hot - started 10/19 AM and continues, very fatigued, cloudy thinking and difficulty concentrating continues. INJECTION WAS GIVEN SC RATHER THAN IM.
Bruising at injection site (less than 1 inch diameter) - pain. Rash below injection site (round - about 3 inches in diameter) - redness, itching, and pain. Itching in the armpit area.
Pt called pharmacy 2 days after vaccination to report that her arm is red, swollen and warm to the touch starting 1 day after receiving the vaccination. She said the redness extended over most of her upper arm. I advised her to apply ice, take IBU or APAP if in pain and try some Benadryl or another anti-histamine for swelling. She called back again in 2 hours to again report that her arm is warm to the touch and I advised her to go to urgent care for further analysis. Dr. was also notified of the adverse event.
Nurse was giving the vaccine across the room did not hear its 2 weeks early , staff was notified but  consent was also given for  patient and the patient  is over 65
Moderna Booster dose 0.25 ml administered on 11/5/2021 at Dialysis however, it was unknown prior administration that patient has just received a Moderna booster of 0.25 ml on 11/2/2021 from 5 minute Pharmacy as patient did not mention that he recently just received the booster nor had the vaccination card with him.  Error was noted upon caregiver reporting on the same day when patient got home. Patient did not exhibit any clinical symptoms post administration, denies complaint up to this time of reporting.
Supraclavicular lymphnode swollen and moveable the same side as injection arm. Appeared in less than 24 hours. The location of shot administered was a little higher and closer to underarm than first dose. No pain as of yet, no fever accompanied. Just fatigued and injection arm is weak.
PFIZER COVID VACCINE #3 GIVEN 10/27/2021, LOT #FF2590; pt in the hospital after pulling PEG tube out; unable to replace; catheter in place to open up track; family doesn't want PEG tube to be replaced; at risk for aspiration; tested positive for COVID but without respiratory sx; DNR; dc'd to Care Center where he later passed away
peripheral neuropathy; This case was reported by a physician via sales rep and described the occurrence of peripheral neuropathy in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced peripheral neuropathy (serious criteria GSK medically significant). On an unknown date, the outcome of the peripheral neuropathy was unknown.   It was unknown if the reporter considered the peripheral neuropathy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced peripheral neuropathy following administration of shingrix. The reporter agreed to follow up with GlaxoSmithKline.
Had flu shot, 30 seconds after pneumonia shot could feel throat closing, things went hazy. EMTs called, Epi given, transported to hospital. At hospital from 2:00pm to 12:00 midnight.
Headache, body aches, fever, chills,  lightheadedness, extreme fatigue, nausea  One week later swollen lymph nodes. rash and itching at site of injection
Tested positive for Covid after having 4 doses of the Pfizer COVID-19 vaccine; Tested positive for Covid after having 4 doses of the Pfizer COVID-19 vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6199), on 09Apr2021 as dose 2, single (Lot number: EN6204), on 23Nov2021 as dose 3 (booster), single (Lot number: FJ1611) and on 30Jun2022 at 17:30 as dose 4 (booster), single (Lot number: FJ4991) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Acid Reflux" (unspecified if ongoing), notes: Has been taking medication Omeprazole for a couple of years now. Concomitant medication(s) included: OMEPRAZOLE oral taken for gastrooesophageal reflux disease. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Jul2022, outcome "unknown" and all described as "Tested positive for Covid after having 4 doses of the Pfizer COVID-19 vaccine". The event "tested positive for covid after having 4 doses of the pfizer covid-19 vaccine" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jul2022) Negative, notes: tested negative at home, 15Jul2022/ tested negative on Friday; (17Jul2022) Positive, notes: Then tested positive Sunday 17Jul2022. Therapeutic measures were taken as a result of covid-19.  Clinical course: It was reported that patient had not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. It was also reported that patient went to a emergency care facility to get a test. She first tested at home and then wanted to get test from facility to make sure home test was accurate  No follow-up attempts are possible. No further information is expected
Patient was vaccinated for COVID-19 on 1/11/21, 2/1/21, and 10/6/21, so was fully vaccinated when testing positive for COVID-19 on 10/11/21.
Information has been received from Pfizer, Inc. [2016385284] on 17-AUG-2016 via a consumer. A patient's mother reported her daughter was vaccinated with GARDASIL and experienced alopecia (MARRS # 0901USA02690.) The patient's mother reported that according to the internet 2000 girls had the same problem (alopecia) (MARRS # 1608USA010994), 200 died and 65 had neurological problems and they were in wheelchairs (MARRS # 1608USA011013). No further information was reported. Additional information is not expected. Information was received via a business partner.
Erythema and swelling right bicep to top of shoulder minus point tenderness minus fevers. Immunizations received less than 24 hours prior to reaction. Cold compresses.
Patient experienced fever, chills, and leg cramping on the first night after receiving the vaccination. Symptoms subsided by the next day and only soreness in the arm was experienced.