chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Description of adverse event verbiage: Per the clinical lead the influenza vaccine was transported to clinic in the brown portable cooler. A vaccine excursion occurred with the brown portable cooler. Ther temperature on the data logger attached to the brown portable cooler went out of range according to GlaxoSmithKline Biologicals manufacturer recommendations. The portable cooler was reconditioned and the Influenza vaccine was administered to the patient. Manufacturer contacted by health department representative. Per the Health Department they were advised by GlaxoSmithKline that the Influenza was not viable and the patient needed to be revaccinated.
03/15/2021: Presented with angioedema and associated throat swelling with voice changes.  Patient denies taking any medication prior to arrival. Patient denies any fever, chills, difficulty swallowing, skin rash, shortness of breath. Patient denies any new medication use, soaps, detergent, foods, or clothing. Symptoms improved with steroids, antihistamines, and famotidine. Patient believed to have acute attack of idiopathic angioedema and has outpatient follow up with immunology.
Patient was confused and slurring words the morning after vaccine. Was admitted to the hospital and diagnosed with mini stroke and brain bleed.
patient could not remember phone number, did that all the time, mind just slipped and guess getting old; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Feb2021 (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: MEMORY IMPAIRMENT (non-serious) with onset 2021, outcome "unknown", described as "patient could not remember phone number, did that all the time, mind just slipped and guess getting old".  Additional information: The patient stated, took the Pfizer vaccine (further not clarified hence captured as Unspecified vaccine) and took it on 28Feb on Saturday and 27th, patient thought 27th and patient wanted to know where need to go to get second shot. Patient was informed about role of Pfizer Drug Safety department. Patient was provided with the number of Pfizer pharmacy as (Number), timings 8 AM to 6 PM, Monday to Friday, EST.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative: Pt developed injection site reaction following vaccination. Site was warm to touch and very swollen. Patient stated pain is in his right shoulder and neck area. Rates pain-7/10. Instant cold pack applied to site and APAP or Ibuprofen or Tramadol given for pain. Symptoms: . 1. injection site reaction, swelling, painful, red. Treatment Drugs Used: 1 - ACETAMINOPHEN Dose: 650 Units: MG Freq: QID Route: PO.
Sunday 3/14 pt reported diarrhea which resolved the next day.  She reports fever approx 99.9 for the past 4 days (3/13-3/17) which does resolve w tylenol but is not normal for her.
Fourth vax resulted in tremors in left arm for 2 weeks non-stop. Unable to hold down food or water for one weak, sporadic vomiting for one month, fatigue for one month.
No additional symptoms were reported; that a 5 year old patient was inadvertently administered GARDASIL 9; Information has been received from a medical assistant, referring to a 5 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.      On 21-FEB-2020, the patient was inadvertently administered 1 dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency and route were unknown; lot # R025728 and expiration date 18-JUN-2021) (product administered to patient of inappropriate age). No additional symptoms were reported.
He cant keep anything down and he keeps running to the toilet; Throwing up; Deathly ill; Gave him nausea pills but they're not helping; Sore arm; Cant even keep soup down/still cannot eat.; Can't lift arms and legs; Start passing out; Sick; Progressed into flu like symptoms 3-4 days after the shot; This is a spontaneous report from a contactable consumer reported for her son. A 32 year old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05May2021 at age of 32 year old (Batch/Lot Number: EM4965) at 2nd dose, single for COVID-19 immunisation. Medical history included ongoing shellfish allergy started in childhood. None family medical history included. Concomitant medications were none. None vaccines administered on same date with the Pfizer vaccine. None other vaccinations within four weeks prior to the first administration date of the suspect vaccines. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation, after he had the first shot, he was fine other than a sore arm. He had the second dose on 05May2021 and it started with a sore arm and then progressed into flu like symptoms 3-4 days after the shot on May2021. He was actually sick on 05May2021. He says that he cannot keep anything down and he keeps running to the toilet. He has been missing work and he never misses work. He cannot even keep soup down. He checked himself into the hospital and they released him yesterday after IV fluids and they gave him nausea pills but they're not helping. If he cannot keep anything down then he's going to start passing out on 05May2021. He went and had a Covid test a week ago to make sure he didn't have Covid.  States he has been throwing up on 05May2021 and deathly ill on 05May2021.  States that it started the first couple of days like flu like symptoms that have kept getting worse.  States he can't lift arms and legs on 05May2021.  She says at the hospital yesterday they gave him anti-nausea pills and hydration.  States he still cannot eat on 05May2021. His symptoms began the evening of 05May2021. They have continued to worsen. She wanted him to go be seen at Urgent Care about a week ago; but he just went and got a Covid test.  States he has been missing work ever since 05May2021. States that he finally couldn't stand it anymore and checked himself into the hospital yesterday.  She says he was admitted on 16May2021, but they discharged him in the evening on 16May2021. AEs require a visit to emergency room. No physician office. He ran tests in the hospital, like blood tests.  No specifics or results provided. Outcome of the event cant keep anything down and he keeps running to the toilet, throwing up, gave him nausea pills but they're not helping, sore arm was unknown. Outcome of other events was unknown. Information about Lot/ batch number has been requested
Developed red swollen quarter-sized area with mild pruritus or left thigh (where Dtap was given) beginning 1-2 days after vaccination and lasting 9 days.
STEVENS JOHNSON SYNDROME with desquam rash, stomatitis, conjunctivitis on 08/01/10.
Patient received first dose of Pfizer Covid vaccine 2/8 around 0810.  Visitor has known shellfish allergy with anaphylactic response.    2/8 @ 0828 complained of having a tingling sensation in her tongue.   Benadryl 25mg po given and vitals monitored.  0837 tingling sensation decreasing another 25mg po Benadryl given.  0850 symptoms resolved. 0910 reported feeling well, left auditorium  0828 HR 112 SPO2 98/RA 0830 HR 98 BP 156/88 SPO2 98/RA 0837 HR 100 BP 146/95 SPO2 99/RA 0850 HR 98 BP 156/89 SPO2 100/RA
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with PNEUMOVAX (lot # not reported). The patient developed cellulitis 1 day after administration of PNEUMOVAX vaccine. The patient was examined in the emergency room but was not admitted. The patient is recovering. This is one of several reports received from the same source. Additional information is not expected.
She reports that on 01/18/2021 (10 days after the vaccine) she noticed her arm at the injection site was sore, swollen, red, warm to the touch and itchy.  She also felt generally unwell with a perceived fever.  She slept for most of the day and today 01/19/2021 feels better, arm is less swollen and redness has improved.
Upon injection are immediately was tingly down the outer aspect across outer forearm down hand into fingers. Lasted about 30 minutes. About 4pm arm started to be sore. During the night started running a fever, 101.8 body hurt all over. Felt like I weighed 600 pounds and couldn?t move. Started in the top of my head, neck, shoulders, back, hips, thighs, knees, ankles, and feet. Very tired. No appetite. So much pain doctor ordered toroidal.  Pain under left arm. Now about 36 hours later feeling much better. No fever, little more energy, pain is better but still taking toroidal so not sure.
Patient received Pfizer COVID vaccine 4/29/2021. He should have received a second dose of Pfizer, but was administered Moderna.
Began having consistent, moderate chest pain on left-side less that 2 days after booster vaccination. On the 3rd day after vaccination chest pain intensified and began having left-arm tingling/numbness. Presented to ED at local HCF. They gave painkillers (ibuprofen/tylenol) but did not help with symptoms. Was discharged from ED and told to follow-up with primary care. Chest pain persisted for 1.5 weeks following vaccination (worse with exercise). Arm pain limited to one day (day or ED visit). Self-resolved.
sudden onset, day following Hep B inject, of extreme fatigue & pain rt rib cage area w/o n/v or elevated temp; missed 2 days work due to fatigue; did not see MD;
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 3:56 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 3:56 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 72.25 years old. Concomitant products were not provided. On 29-Apr-2021, Excursion time was 10 AM, temperature was 33, total doses given for the day was 201, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 29-Apr-2021. 5 vials were sent to clinic. Vaccine BUD date was 19-May-2021. On 29-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: Unknown, 9 AM: 36, 10 AM: 33, 11 AM: 44, 12 AM: 45, 1PM: 45, 2 PM: 44, 3 PM: 45, 4 PM: 44 and 5 PM: unknown. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Localized reaction with redness, swelling, fever at site and knot under skin arroximately the size of a baseball.
The vaccine came up in our system as failed to transmit to immunization regsistry so I went to go add in agency. In agency it shows the patient received 4 moderna vaccines and 3 pfizer vaccines. I called the patient and he said that his doctor told him that the moderna didnt take and so he needs to get the pfizer vaccine. so he is currently on both vaccines. I told him that he should only get one or the other once he has had the first two in a series but not get both. he said if I have a problem with what his md told him them i could take it up with him. Moderna- 1/21/21,2/19/21,10/26/21,4/18/21. Pfizer 05/12/21,06/2/21,12/05/21.
Pt and mother came to clinic today for Hep-B and pt asked if any concerns. Pt stated she fainted in her car after she left the clinic on 6/7/01. Mom stated she "came to" less than 1 minute and felt nauseous. She vomited 3 times that evening and felt fine the next day. Pt stayed at clinic for 20 minutes, post vax, with no complaints on 6/7/01. Hep-B #2 not given today.
Post vax pt developed an injection site reaction characterized by tenderness and swelling. This is 1 of 10 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune-23. As of 8/15/00, no further info was available. Manufacturer's Comment: The reporter indicated that 10 pts experienced this event; however, they are not presently identifiable. Addtl reports will be generated when identifying info is provided.
Pt felt fine after receiving flu shot; raked leaves and took her usual evening nap but woke up to get ready for work and felt very weak and throat was dry. Upon arriving at work, she felt warm and her heart was racing (BP-117/90; Pulse-135 and irregular)  which is very unusual. Her legs felt rubbery and she was taken to the ER at 23:59, midnight. Her temperature was 101.6F, she was cool to touch and body was aching. She is recovering.
This vaccine was Moderna 0282L2cA. Symptoms were: Headache, body ache, Fever, chills which carried over into Sunday 02/7/2021
Patient felt like heart was racing 15 minutes after injection. Resolved spontaneously after a couple minutes. No interventions performed
extreme exhaustion; really really tired; very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extreme exhaustion), FATIGUE (really really tired) and VACCINATION SITE PAIN (very sore arm) 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (very sore arm). On 02-Feb-2021, the patient experienced FATIGUE (extreme exhaustion) and FATIGUE (really really tired). At the time of the report, FATIGUE (extreme exhaustion), FATIGUE (really really tired) and VACCINATION SITE PAIN (very sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Caller reports no additional AE or PQC; patient was inadvertently administered VARlVAX via intramuscular route as opposed to the recommended subcutaneous route.; This spontaneous report was received from a registered nurse and refers to a patient of unspecified age and gender. Information about the patient's pertinent medical history, concomitant medications, past drug reactions or allergies was not provided.  On 21-SEP-2021, it was reported that the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters (mL) (dose number and vaccination scheme frequency were not reported; lot number U010401 that was verified to be a valid lot number with an expiration date reported and established as 01-APR-2023) for prophylaxis intramuscularly instead of the recommended subcutaneous route (incorrect route of product administration).  No additional adverse event (AE) was reported.
Pt called on 10/20/20 complaining of continued pain after recieving vaccine, has been self treating with otc pain relievers and ice and the pain has not improved. Pt states he recieved a steroid injection about 3 months prior and the underlying condition seems to have been aggravated.
On the 24th of February I had the second injection. About a week later I had muscle pain on top of the joint pain. I did see my PCP on the 3rd of March she prescribed a pack steroid. April 15th, I had a lumbar steroid injection. That injection helped clear up everything.
stomach pains; diarrhea; Sore Arm; This is a spontaneous report from a contactable consumer (patient). An 82-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of the Pfizer Covid Vaccine (BNT162B2) on 16Mar2021 (lot number: EP7534) at 82-years-old for COVID-19 immunization and had sore arm from first vaccine. The patient experienced sore arm from second vaccine on 06Apr2021 and stomach pains and diarrhea on 08Apr2021 at 17:00. The reporter stated she had the second dose of the vaccine on Tuesday (06Apr2021). On Thursday (08Apr2021) she got severe stomach pains and had diarrhea for an hour and half straight.  Later that morning it happened, and at 3:30, 4:30 and between 6:00 and 7:00. It happened 6 times and just poured out of her. She had been ok since that. It was really bad. She asked if this is a side effect of the vaccine. The events didn't require a visit to Emergency Room or Physician Office. The patient called physician this morning. Treatment of the event sore arm included Arm Tylenol. The outcome of the event sore arm was recovered on 08Apr2021. The outcome of the other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient had a stroke after the covid vaccine; it was A-Fib that lead to his stroke; This is a spontaneous report from a contactable consumer. A 91-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization and experienced sludgy thick stool. It was reported that the patient had a stroke on an unspecified date after the second dose of COVID vaccine. Patient was brought to the emergency room and was told that it was an A-fib (atrial fibrillation) that lead to his stroke. The patient was hospitalized and received treatment (unspecified) for the events reported. Outcome of events recovered on an unspecified date.  Information about lot/batch number has been requested.
Severe vomiting 6 days after vaccination. Groin and testicle bruising. More vomiting on May 9th. Patient did receive Hep A booster the day before symptoms.
voices, paranoia, anxious, difficulty thinking and processing thoughts, light sensitivity, very lethargic
patient woke up with aphasia.  per ER note, differential TIA vs focal seizure vs stress.
Report A0371140A describes inject site react in a 36 y.o. female who received Hep B vaccine recombinant (Engerix-B). This report was received from a nurse. Medical history included "skin reaction" to powder in gloves and similar type items such a Banbaids. Concurrent conditions were not specified, Concomitant medications included thyroxine sodium (Synthroid), vitamins (NOS), and calcium. Reportedly, the PT had received a Hep B vaccination series in the past (date unspecified) with a vaccine other than Engerix-B. The nurse also stated that an unspecified "titer test" did not reveal protective antibodies. The interval between completion of the immunization series and titer determination was not known. Therefore, the vaccination series were repeated on 5/3/02 using Engerix-B. 2 to 4 hrs after receiving her first injection in the repeat series, the PT experienced an inject site reaction characterized by redness "the size of a dime" and itching. The PT treated the area by applying ice for relief. The redness and itching were reported to have resolved the following day. The reporting nurse considered the events to be probably related to the immunization.
Pt states had severe headache and stiff neck day after injection. Pt states not sure how long. Took Tylenol and Advil no physician visit or ER.
Hives Tx 50 mg prednisone x 3 days, angiodema with admission to hospital 6/19/2009, benadry,discharged on 6/21/2009 with hydroxizene 25 mg 3/d for 30 days and ranitidine 300 mg. 1/d for 30 days.  9/23/09 Hospital records received DOS 6/19/09 to 6/20/09. Assessment: Urticaria secondary to allergic reaction. Patient presented with difficulty breathing and feeling of swallowing in throat and hives. Cough, nausea, vomiting. Diffuse multiple urticarial lesions all over body with excoriation marks. Tongue, lips, chin swollen. Speech slurred. Angioedema. Allergic to vaccine.
Severe body and joint aches to the point I thought I might need to go to the emergency room. Very cold unable to get warm even with numerous blankets, also vertigo, and vomiting.  No other signs of illness (e.g., sore throat, headache or congestion).  Missed work the following day and slept the entire day.
Same day of vaccine, in the evening and thru the night, felt achy, chills, shaking, and felt feverish.  She did not take her temperature.
could not sleep on left side; COVID arm; Warm; itchy; Swollen; Red circle patch; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (could not sleep on left side), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE SWELLING (Swollen) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was reported.  Concomitant products included SPIRONOLACTONE for Acne.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, the patient experienced SLEEP DISORDER (could not sleep on left side), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red circle patch). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) (oral) ongoing since an unknown date at a dose of 10 mg once a day. At the time of the report, SLEEP DISORDER (could not sleep on left side), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red circle patch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medicines include birth control pill