chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 67-year-old female with history of ovarian cancer, COPD, rheumatoid arthritis. Presented to the ED after a syncopal episode. Patient passed out in the morning upon standing up, went to the ground. Hit her head. Nearly passed out shortly after trying to stand. Several episodes of vomiting after the head injury. Currently denies any headache or neck pain. Complains of diffuse fatigue. Patient also diagnosed positive for covid-19 2 days prior to admission. Symptomatic for 2-3 days. Last dose of chemotherapy 3 days prior to admission, her fourth treatment.
Soreness, redness, warmness, itchiness bicep area (away from injection site), of right arm.
At 12:15 a.m. on March 09 chills and fever suddenly started. I was shivering so bad that I was having muscle spasms so bad that I had difficulty walking on my right leg (hip replacement January 2020). After taking tylenol for fever my temp had gone down to 100. Headaches started soon after the fever and muscle spasms and it lasted well into the afternoon on the 9th along with feeling cold and clammy. At about 7:00 p.m. on the 9th, the fever started going back up so I took another dose of tylenol. The fever lasted until about 4:00 a.m. on the tenth. Currently, 10:00 a.m. on the tenth I feel somewhat normal, just really tired and having muscle pain in my upper back. All things considered, the whole ordeal felt like my time when I was getting better after going through covid in December.
has given Boostrix to a 3 year old patient instead of Infanrix; has given Boostrix to a 3 year old patient instead of Infanrix; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 3-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 523X9, expiry date 3rd July 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th July 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 26th July 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the underdose and inappropriate age at vaccine administration 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 details were provided as follows: The reporter stated that, 3 years old patient received Boostrix instead of Infanrix, which led to underdose and inappropriate age at vaccine administration. The reporter consented to follow up.
Sick; Sore; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date and was okay with the 1st dose).   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 sickness and pain. On an unknown date, the outcome of the sickness and pain were unknown.   It was unknown if the reporter considered the sickness and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated he/she was sick and had soreness from the 2nd dose. The follow-up would not be possible as no contact details were available.
Did get booster12/7, tested positive for COVID 12/9, with symptoms starting prior to booster. Generalized weakness, light headedness, fatigue, cough, congestion, SOB, diarrhea, need for supplemental oxygen.
Waited the recommended 15 minutes in the parking lot. Felt fine. Got 5 minutes down the road, and had to stop in the middle of the road as I got extremely dizzy and light headed and felt like my eye balls were going crazy moving. Lasted about 1 minute, and I continue to get that way every now and then just not as bad.
Patient received a vaccine that was expired. Product was put in fridge on 1/3/23 and should have been discarded 3/14/23.
Rash (red/raised) noted below the injection site.  Faded by March 15, 2021 - Returned March 17, 2021 with additional spots below the original rash.
Redness and swelling at the sites of injection (PNEUMOVAX and flu) and pain to the site of injection.
This spontaneous report was received from a physician's office manager via a company representative refers to a female patient of unknown age. Concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, injection (dose, route of administration, lot number and expiration date were not reported). There was not concomitant medication provided. On an unspecified date, the patient experienced swelling from the point of injection to the shoulder, the reporter stated that the swelling was only in the arm where the ZOSTAVAX was given. The outcome of injection site swelling was not reported. No product quality complaint (PQC) was involved. The reporter did not assess the relatedness of injection site swelling with ZOSTAVAX. Additional information has been requested.
I got the first dose of the Pfizer Covid-19 vaccine at the Medical University. Approximately 10 minutes after administration, an allergic reaction began while I was driving alone in my car. Most notably my blood pressure dropped suddenly, causing me to almost pass out. I stopped driving and my symptoms worsened. Symptoms included shaking, sweating, nausea, confusion, rapid heart rate, red blotchy face, slightly labored breathing, itching and slight swelling of my tongue and lips, anxiety. I could still breathe, so I did not seek treatment, but sat in the parking lot of a medical building for at least an hour for symptoms to subside. Symptoms were acute for about 45 minutes and gradually decreased over four hours. The rest of the day and the next day I felt extremely weak. The following six weeks I continued to have swollen, dry, painful lips every single day and a very itchy rash on my hands and wrists. Occasionally I would wake up with swelling around my eyes. I also had an unusual reaction after eating a salad where my lips swelled even more and became numb, along with an itchy mouth. These long lasting symptoms did not go away until I got a steroid cream from a dermatologist, who denied that my reactions were from the vaccine after talking to me for only five minutes. I just believe that there are many more cases of reactions to the vaccines that have not been reported.
flushed; tiredness; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6202 and expiration date: not reported), via an unspecified route of administration, on 06Mar2021 (at the age of 60-year-old) as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history reported as none. The patient's concomitant medications were not reported. On 06Mar2021, 20 minutes after receiving the 1st dose of the Vaccine, patient started to feel flushed. The patient said it felt like she sat out in the sun for too long. And when patient looked in the mirror, she saw that her face was indeed flushed. It eventually went away after 10-15 minutes. The patient also mentioned that she experienced tiredness and headache after the 1st dose. The patient wants to know if this is a normal reaction to the vaccine and if it would still be safe for her to receive the 2nd dose. The outcome of the event Flushed was recovered in 06Mar2021, while other events was unknown at time of report.   No follow-up attempts are possible. No further information is expected.
Received J&J on 6/22/21 and 1/27/22. COVID positive on 2/21/22. Presented to ER on 2/20/22. initially presented at Local hospital with c/o abdominal pain. Imaging suggestive acute appendicitis. Patient was transferred to alternate hospital for surgical evaluation. Also, COVID-19 positive, vaccinated, and clinical asymptomatic. Discharged on 2/24/22.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 09Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "vestibular migraines" (unspecified if ongoing), notes: vestibular migraines; "migraines" (unspecified if ongoing), notes: migraines; "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Apr2022 at 14:00, outcome "unknown", described as "Dose Number: 4 was Pfizer; Dose Number: 1,2,3 was Moderna"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Aug2022, outcome "recovering" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 01Sep2022, outcome "recovering", described as "Rebound infection". Therapeutic measures were taken as a result of covid-19, drug ineffective. Therapeutic measures were not taken as a result of disease recurrence. Clinical information: Patient received treatment with Paxlovid from 22Aug2022 to 26Aug2022. The patient had a rebound infection on 01Sep2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a consumer via call center representative and described the occurrence of shivering in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 1st October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shivering, pain, influenza-like symptoms and rash. The patient was treated with benadryl (nos) (Benadryl) and ambiguous medication nos (Cortisone (Nos)). On an unknown date, the outcome of the shivering, pain and influenza-like symptoms were unknown and the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the shivering, pain, influenza-like symptoms and rash to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX and experienced side effects. The patient experienced shivering and stayed in bed for 24 hours. The patient also had aches, pains and flu-like symptoms. The patient also developed spots on her face that never went away. Please refer case US2019GSK023593, for tolerance of 2nd dose. This case has linked with case US2019017451, reported by same reporter.
Red area to back of left arm the size of mom's fist with a rash going down the arm towards the elbow, warm to the touch.
Unable to smell unless strong odor was right under my nose. Hot and itchy at injection site/
Patient describes having redness at the injection site and surrounding area, not greater than the size of a quarter. She is itchy on the injected arm above the elbow. Her ears are itchy, more on the left than the right ear. No other symptoms were reported.
Pt developed almost immediate urticaria at injection site. She had already been tx'ed for an asthma attack that am, and required only watchful waiting. The urticaria spontaneously resolved with time (rxn within 2 hours). RUE, face, chest.
chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chills.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown.            Reporter did not allow further contact
About 1 week after flu shot, pt noted pruritus in left deltoid area. Pruritus has spread to dorsal trunk. Shortly after the pruritus started, he developed erythematous macular-papular rash which continues to spread. Seen on 12/19/02 at clinic with rash/itching on dorsal trunk and LUE. No SOB or fever.
his arm is sore; his shoulder is a little sore; he woke up with discomfort; fever; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm left (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: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "his arm is sore"; ARTHRALGIA (non-serious), outcome "not recovered", described as "his shoulder is a little sore"; LIMB DISCOMFORT (non-serious), outcome "not recovered", described as "he woke up with discomfort"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills". additional information: States that his shoulder is a little sore and that's one of the side effect on the poster along with fever, chills and soreness.  States it's alright, like if you work out a lot and it feels like you haven't used that muscle. States it is his left shoulder where he took the shot, he woke up with discomfort but nothing alarming.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Headaches/migraines; appendectomy; ovarian cyst; low blood pressure; stomach pain; reflux; interstitial cystitis; cognitive issues; attention deficit; light sensitivity; noise sensitivities; food intolerances; mental/emotional issues; changes in menstrual cycles; sensitivity to odors; intolerance to citric acid; gastrointestinal issues; sleep disruption.
Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form once. On 27-May-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided. Treatment information was not reported.
fever, chills, upper back pain, pain in shoulder and neck, underarm swollen/painful, confusion
This case was reported by a consumer via call center representative and described the occurrence of pain in a elderly male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Previously administered products included ZOSTAVAX (received on an unknown date). In July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 µg. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, influenza-like symptoms, fever, chills, feeling bad and discomfort. On an unknown date, the outcome of the pain, influenza-like symptoms, fever, chills, feeling bad and discomfort were recovered/resolved. It was unknown if the reporter considered the pain, influenza-like symptoms, fever, chills, feeling bad and discomfort to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's wife. The age at vaccination was not reported but it could be 75 or 76 years. The patient experienced aches, flu like symptoms, fever, chills, pain and just felt lousy for about 24 hours. For tolerance to the 2nd dose of SHINGRIX, refer case US2019GSK028966.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (has developed a lump), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE ERYTHEMA (Red arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032l20A) for COVID-19 vaccination. The patient's past medical history was not reported. Concomitant products included SALBUTAMOL (ALBUTEROL HFA), CITALOPRAM, FLECAINIDE, IPRATROPIUM, MELATONIN, METOPROLOL, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), TRAMADOL and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE ERYTHEMA (Red arm). On an unknown date, the patient experienced VACCINATION SITE MASS (has developed a lump). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (has developed a lump), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE ERYTHEMA (Red arm) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: swollen, redness, warm to touch. advised pt to see md
heat at injection site; itching around injection site; redness around injection site; hardness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (heat at injection site), INJECTION SITE PRURITUS (itching around injection site), VACCINATION SITE ERYTHEMA (redness around injection site) and INJECTION SITE INDURATION (hardness around injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itching around injection site), VACCINATION SITE ERYTHEMA (redness around injection site) and INJECTION SITE INDURATION (hardness around injection site). On an unknown date, the patient experienced INJECTION SITE WARMTH (heat at injection site). At the time of the report, INJECTION SITE WARMTH (heat at injection site), INJECTION SITE PRURITUS (itching around injection site), VACCINATION SITE ERYTHEMA (redness around injection site) and INJECTION SITE INDURATION (hardness around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded. Injection site induration, injection site erythema, and injection site itching are consistent with the product known safety profile.
off label use with no adverse event; Initial information received on 17-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (patient).  This case involves a 64 years old male patient who was given INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] for off label use with no 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 a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE , Suspension for injection in pre-filled syringe (dose, strength, lot number: unknown) via unknown route in unknown administration site as prophylacticvaccination.  On an unknown date the patient developed a non-serious off label use with no adverse event (off label use) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. is unknown if the patient experienced any additional symptoms/events.  Action taken with INFLUENZA VACCINE TRIVALENT (FLUZONE HD) was not applicable.  At time of reporting, the outcome was Unknown for the event.
Information has been received from a nurse referring to a patient of unknown age and gender. On 17-JUL-2017, the patient was vaccinated with improperly stored VARIVAX (lot # M033212, expiration date 13-JUL-2018; dose and route were unknown) for prophylaxis. The vaccine reconstituted with properly stored sterile diluent (lot # and expiration date were unknown). No adverse effects were reported. Data logger was involved. The vaccine was stored under -14 Celsius degree to -10 Celsius degree for 4 hours 3 minutes. Previous temperature excursion was -14 Celsius degree to -10 Celsius degree for 5 hours 13 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA009387.
About 5 minutes after receiving the vaccine my arm hurt and I felt foggy. Within an hour my head hurt. Woke up the next morning, my headache was worse, and my joints were achy. Fell back asleep for a few hours. Woke up with a worse headache, fever, and whole-body aches. I was also nauseous and lightheaded. I sat up and all my symptoms became worse. I had tunnel vision, felt like the room was spinning, and I was going to be sick.  I slept off and on for the rest of the day. My joints hurt more as the day went on making it very uncomfortable to anything, including sleep. I couldn't eat anything all day. I took Ibuprofen in the afternoon, after and hour or so I felt a little better and could drink and get a small snack. Went to bed early. Had a hard time sleeping due to joint pain and headache. Next day woke up, more energy, I could walk, still had a headache, still had joint pain but not as bad. Still no appetite.  Had a headache till about mid-day, joint pain became less as the day went on. No appetite, took a nap, didn't go to work. Woke up the following day, joint pain less, mostly in my lower back/hips, shoulders, and neck. I was able to eat a little more, nothing big, no meals. Half day at work.
Patient reported dizziness and blurred vision initially. Vital signs checked, BP 174/73, HR 87, SpO2 97% on intial check. She also reported a right frontal headache 5/10. Moved to cot to lie down, VS re-checked. Dizziness did not resolve with lying down. BP remained elevated as well. Once lying down, patient also reported "heaviness" in chest. A nurse remained with patient throughout entire incident and VS assessed frequently.   After about 45 minutes, patient still reported HA, dizziness. Patient reported chest heaviness had resolved, but BP and dizziness did not resolve. Discussed calling EMS with patient, she agreed to allow us to call EMS. She was transported to local hospital by EMS at approximately 11:30am.