chrisvoncsefalvay/vaers-outcomes huggingface dataset:
13MAY92 pt started crying & cried all nite; 345PM leg was swollen sl red; pt would not move leg; mom reports fever didn't go over 101 R w/APAP;
My middle finger and thumb of the hand that the shot was given in started tingling the next day it hasn?t gone away and now my index finger and part of my hand tingle also
The pharmacist and pharmacy technician failed to check the vaccine for the expiration date. There were three containers of vaccine in the fridge - one expired MDV, two expired SDV, and one box of in-date SDV. The expired vials were in no way separated from the in-date vials. Upon filling out the form with lot number and expiration date, the pharmacist discovered the error. The expiration date was a little confusing at first, the pharmacist's lack of familiarity with the particular brand of vaccine was a factor.
Light-headedness started about 11:00 AM, the morning after receiving the shot the previous afternoon. I still have some light-headedness even after a two-nap this afternoon.
rash located over area of injection of pneumonia vaccination (23) 3-4 inches in diameter, lump larger than a quarter, temp 100.2 and sore throat ~36 hours after injection.
kidney pains/pain from your right side; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (kidney pains/pain from your right side) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RENAL PAIN (kidney pains/pain from your right side). At the time of the report, RENAL PAIN (kidney pains/pain from your right side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided by the reporter. No treatment was provided by the reporter.  It was reported that patient received a dose of the vaccine yesterday
Patient passed out while checking out at reception area. Checked patient's vitals and placed in room to lie down. Recovered well.
I went into pre-term labor  - I delivered that day - He was born at 34 weeks and one day.  Was in NICU but now is home. I'm stil recovering from the childbirth. First pregnancy; estimated date of birth 5/22/2021
Red swollen arm 6 inches from the injection site, advised to take Benadryl and ice site, as pt cannot take motrin due to kidney function.  She also iced the site.
1520 patient reported numbness of bottom lip.  Had this response in past--2005 or 2006 with preservative in influenza vaccination.  Has not occurred since with use of preservative free influenza vaccination.  1522 numbness to tongue.  No swelling of oral cavity on assessment.  Face symmetric.  1526 feels slightly nauseous.  BP 122/82, HR 72, RR 14.  1530 Patient states still has numb sensation to bottom lip and little on tongue.  Denies SOB, denies difficulty swallowing, denies pain/tightness/tingling.  Speech is clear.  Mentation unchanged.  BP on retake 124/80, HR 70, RR 12.  Patient refusing further eval and treatment at ER.  Patient verbalizes last time she took benadry and zantac and was fine.  1545 Patient left building.  Sister driving patient.  Instructed patient on signs/symptoms to call 911.    1630--Telephone call to patient to check on her.  Patient states she took benadryl and zantac.  States bottom lip and tongue are still numb.  Highly encouraged patient to return to ER and get evaluated by physician.  Patient said she was fine but knew what to do if needed.  1800--Telephone call to patient to check on her.  Patient states she feels much better and is inquiring about second dose.  Informed patient that we would follow up with her next week regarding next steps.
Extreme inflammation, pain and tightness in left shoulder following flu vaccine. Symptoms worsened. Has been in physical therapy since December 2016 - on-going treatment - to stretch and strengthen shoulder muscles.
After receiving the influenza interdermal vaccination in the left deltoid she experienced a raised red rash that was hot to touch. Shortly there after she started feeling itchy on her upper arms and back and neck. The next day, she noticed a rough diffuse pruritic faintly erythematous rash on her neck and back in a yoke like distribution down to her collar bone. On the following day, the rash continued to spread slowly to below her collar bone by about 3 inches. She attemped to treat herself with OTC Benadryl which she stated did not help very much. Today she was prescribed Atarax 25mg 1 PO every night, and a 5 day course of prednisone.  She was also advised to take OTC Zyrtec.
1.  Heart palpatations - didn't last long - seemed to subside after I drank water and did deep breathing  2.  Woke next morning with pain between my shoulder blades - didn't last long either once I was up and moving
Slight headache started about 30 minutes after vaccine given. By 10:30 pm that say day of vaccine headache turned into severe migraine, racing heart rate, chills, hot flashes, body aches, fatigue and very sore arm that received vaccine. All symptoms got worse over night and by 10am the next morning, my heart stopped racing but then I was really nauseous with some mild dry heaving.
Brain bleed; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01), for Covid-19 immunization; Covid-19 vaccine (Dose: 02), for Covid-19 immunization. The following information was reported: CEREBRAL HAEMORRHAGE (death, medically significant), outcome "fatal", described as "Brain bleed". The patient date of death was unknown. The reported cause of death was cerebral haemorrhage. It was not reported if an autopsy was performed. Reporter stated that the event happened before 14 days.  This report was not related to a study or programme. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Brain bleed
severe shaking chills with A. Fib (pt. has history of A fib)
Shingles at vaccination site to Lt. upper arm, also affecting Lt. upper trunk area.
EXTREME PULMONARY PROBLEMS; LOST ENTIRE QUALITY OF LIFE; RESPIRATORY DISTRESS; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. Initial information was processed along with the additional information received on 10-JUL-2023. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was avid hiker and rode horses. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 in total, administered on 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2021, the patient reported she took the Vaccine little over 2 years ago and had severe adverse events. She was still having trouble with it. She was angry and upset that the company pushed the vaccine on her and now cannot help her. She reported she had extreme pulmonary problems. She was upset. She stated she had been to 4 pulmonologist and her primary care doctor was an internist. She stated that she had lost her entire quality of life. She was am avid hiker and rode horses. She could not do anything of those now because 3 days after she took it, she had respiratory distress where she thought she was going to die. She could not get a test tube amount of air. She had to be on a breathing machine, on rescue inhalers, on disks and pills. She wanted her quality of life back.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme pulmonary problems, lost entire quality of life, and respiratory distress. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: The suspected product quality complaint has been confirmed to be voided (this record describes (multiples adverse events), which does not meet the definition of a product quality complaint or explicitly allege a potency issue. This record will be voided as no) based on the evaluation/investigation performed.; Sender's Comments: V0: 20230713906- Respiratory distress. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Cellulitis at site. Tennis ball sized area of redness/swelling/warmth at injection site.
This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (90-year-old woman) is calling on-behalf of her daughter (female patient). A female patient of unspecified age received unknown dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection), via an unspecified route on 04Mar2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 04Mar2021, patient experienced chills after she received her vaccine yesterday (04Mar2021). Then today, her daughter also complained of having a fever and is verbalizing that she is not feeling well. Mother was asking whether there can be an OTC drug that she can give her daughter since she is not feeling well. The clinical outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
METAL AFTER TASTE WITHIN AN HOUR; This spontaneous report received from a patient concerned a male 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: Unknown) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced metal after taste within an hour after it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metal after taste within an hour after it. This report was non-serious.
Patient was waiting in waiting area for 15 minute post immunization period. Mother came to get nurses and noted son was already experiencing a headache in the middle of his forehead. Vital signs were obtained. Pulse 60, respiratory rate 16, blood pressure 106/64. Patient was given water and goldfish. Patient and mother then self administered Tylenol 500mg.  Mother noted patient has not had anything to eat prior to vaccination. After ten minutes, patient noted he felt better and wanted to go home. Released to mothers care and advised to call hematology and neurology if anything worsens.
This spontaneous report as received from a health professional refers to a 9 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 03-MAR-2014, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, 2 ml, which had a lot # of H017721 and an expiration date of 01-APR-2014 (dose number was not reported). The vaccine had two temperature excursions, the first of 336 hours with the lowest recorded temperature reported as 33 Fahrenheit (F) (0.555555556 Celsius (C)) and second of 248 hours with the lowest recorded temperature reported as 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
No additional AE reported/No additional information provided; PROQUAD and VARlVAX were inadvertently administered concomitantly; This spontaneous report has been received from a physician assistant referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 02-MAR-2022, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) (lot# T034610, expiration date 10-ARP-2022; strength, dose, and route were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot# T021826, expiration date 25-JUN-2022; strength, dose, and route were not reported) concomitantly for prophylaxis (accidental overdose). No additional adverse event or information was reported.
No additional adverse events reported; improperly stored vaccines were potentially administered to unknown patients; This spontaneous report has been received from a licensed practical nurse, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 08-FEB-2022, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (lot # T033815 with expiration date: 05-OCT-2022, route, strength and dose were unknown) for prophylaxis (Product storage error). No additional adverse events reported.  Administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) experienced the temperature excursion with 49.6 Fahrenheit degrees (F) for 35 hours 9 minutes. The previous temperature excursions were reported as 32.9F for 53 hours 16 minutes; 49.1F for 5 hours 9 minutes; 56.3F for 14 hours 7 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA003592: US-009507513-2203USA003310: US-009507513-2203USA003311: US-009507513-2203USA003312: US-009507513-2203USA003313: US-009507513-2203USA003314: US-009507513-2203USA003315: US-009507513-2203USA003316: US-009507513-2203USA003317: US-009507513-2203USA003318: US-009507513-2203USA003319: US-009507513-2203USA003320: US-009507513-2203USA003321: US-009507513-2203USA003322: US-009507513-2203USA003323: US-009507513-2203USA003324: US-009507513-2203USA003326: US-009507513-2203USA003327: US-009507513-2203USA003328: US-009507513-2203USA003329: US-009507513-2203USA003330: US-009507513-2203USA003331: US-009507513-2203USA003332: US-009507513-2203USA003333: US-009507513-2203USA003334: US-009507513-2203USA003335:
4/23/19 About 3-4 hrs post vaccine redness, swelling and pain down the upper arm on (L) side came in on 4/24/19 and showed me her arm. Her right arm had limited motion due to injury approximately 7 weeks prior. Pt was given Shingrix and Pneumovax 23 vaccines in the (L) arm. 4-24-19 - Pt presented to pharmacy around 1-130pm to show me her (L) arm, Redness, swelling, warm, pain and rash on the upper arm down to her elbow. I reviewed her meds with her that she provided, listed below. I advised her to take Benadryl 50mg q 6-8 for two doses to see if improvement and to continue with 25mg. Called her primary care MD, spoke with staff and notified them of the incident. Advised her to call Dr. if no improvement. If no improvement to follow-up with her primary care physician. Called her at the end of my shift (approximately 3:00pm) to see if there was improvement, she stated, yes. 4/25 - 5:28pm - spoke with pt, her primary care, prescribed Medrol ds pak - she is to start. 5/9 approximately 3:15pm followed up with pt, no further tx was required.
Information has been received from a licensed practical nurse concerning an adult pt, with unk medical history and unk drug reactions/allergies, who in early Nov 2005, was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649694/0386P). In Nov 2005, the pt developed an injection site reaction to include redness, pain, local heat and swelling. The pt was treated with antibiotics and subsequently, fully recovered. No product quality complaint was involved. No additional information is expected.
To lay on it was uncomfortable; Sore arm; All her joint hurts; Extreme body ache; A really bad headache with light sensitivity; Fever of 104; Fever of 101; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (To lay on it was uncomfortable), VACCINATION SITE PAIN (Sore arm), ARTHRALGIA (All her joint hurts), MYALGIA (Extreme body ache) and HEADACHE (A really bad headache with light sensitivity) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included INSULIN GLARGINE (LANTUS), INSULIN LISPRO (LISPRO INSULIN), DULOXETINE, DOXYCYCLINE, IRBESARTAN, TRAZODONE, LEVOTHYROXINE, ACETYLSALICYLIC ACID (ASPIRIN 81), PRAVASTATIN, BIOFLAVONOIDS NOS, VITAMINS NOS (LIPOFLAVONOID [BIOFLAVONOIDS NOS;VITAMINS NOS]), PREGABALIN, CARVEDILOL and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PYREXIA (Fever of 101). On an unknown date, the patient experienced FEELING ABNORMAL (To lay on it was uncomfortable), VACCINATION SITE PAIN (Sore arm), ARTHRALGIA (All her joint hurts), MYALGIA (Extreme body ache), HEADACHE (A really bad headache with light sensitivity) and PYREXIA (Fever of 104). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (To lay on it was uncomfortable), VACCINATION SITE PAIN (Sore arm), ARTHRALGIA (All her joint hurts), MYALGIA (Extreme body ache), HEADACHE (A really bad headache with light sensitivity), PYREXIA (Fever of 104) and PYREXIA (Fever of 101) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and Treatment medications were reported.   This case was linked.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up received on 01-jun-2021 and No new information is added
TIREDNESS; This spontaneous report received from a consumer concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid disorder. 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included alprazolam for sleep. On 07-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness on APR-2021. This report was non-serious.
About 5 minutes after vaccines were administered child presented with 1 small red raised lesion on her right hand. Treating care provider was notified immediately and administered 2 teaspoons of benadryl.  After 30 minutes no new onset of lesions.  Made follow uo appointment for child the next day, parent no showed for appointment.
Initial information received on 06-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse by phone. This case involves a 12 months old female patient who was inadvertently vaccinated with an 0.5 ml expired fourth dose of ACT-HIB (Batch number: UI894AAA, expiry date: 21-Feb-2019, route and site of administration were not reported) on 06-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
This events started right away the same day I was administered the vaccine. I experienced all as follows: Nausea, Vomiting, Headache, Severe body ache, Fatigue and No appetite
I had normal side effects to both the original shot (administered 1/11/2021) and the 2nd (3/10/2021), namely fever (~100), fatigue, arm soreness, all of which subsided within 24-48 hours.  But this morning a little area of my chest was itching  - after showering, I looked in the mirror and noticed a small area of rash (about the size of a credit card).  I put some hydrocortisone cream on it for the day, and it has not been itching and has subsided a bit so far.