chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No other AE ocurred; VARIVAX was administered to a patient after improper storage; This spontaneous report was received from a medical assistant referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.       On 06-JAN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T017686, expiration date 21-MAY-2022, for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). No other adverse event ocurred.         The vaccine was stored in a temperature of -12.5 degree Celsius (°C) for 11 hours and 10 minutes as recorded by a data logger. There was a previous temperature excursion of 14°C to -10°C (-12C) for 2 hours and 30 minutes.
Pt. received vaccine 7/23/2018. On 7/26/2018 she stopped by clinic (in her place of employment) c/o chills and not feeling well, sore throat. Patient declined evaluation at clinic - "could not stay" Pt went home. 7/30/2018 - patient calls in to clinic not feeling well. Body aches, decreased appetite, diarrhea - anything she takes orally passes right through. Nurse asks patient to come in to clinic to see provider. Seen by provider same day - mobilliform rash, purpura, on abdomen, back, and bilateral lower extremities, edema in bilateral lower extremities. Diarrhea, dry mucous membranes. BP 125/85, T 98.7 F, HR 98.
Platelet decreased from 202,000 on 28Apr2021 to 30,000 on 13May2021.; Liver enzymes elevated to 100-150 on 13May2021 (normal on 28Apr2021).; Fever starting 08May???? 101-103 Fahrenheit(F). Hospitalized 13May2021 to 15May2021.; This is a spontaneous report from a contactable Health Care Professional (nurse, patient). A 69-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 11:15 (Lot Number: ER8731) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included Hypercholesterolemia and Osteoporosis. The patient received first dose of bnt162b2 (lot number ER8727) on19Mar2021 12:00 PM in left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included alendronate sodium (ALENDRONATE); atorvastatin calcium (LIPITOR); calcium; vitamins nos (MVI); ascorbic acid, retinol, tocopherol (OCUVITE); ubidecarenone (COQ10).  The patient experienced Platelet decreased from 202,000 on 28Apr2021 to 30,000 on 13May2021. Liver enzymes elevated to 100-150 on 13May2021 (normal on 28Apr2021). Fever starting 08May2021 101-103 Fahrenheit(F). Hospitalized 13May2021 to 15May2021. The patient had SARS CoV-2 RNA Rapid NAA test (Nasal Swab) with negative result on 13May2021.  The adverse event resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The outcome was recovering.; Sender's Comments: The reported events likely represents intercurrent medical conditions in this 69 year old female and unrelated to BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Pt. states that after receiving the 2nd dose of Moderna 04/06/2021, started experiencing symptoms 05/06/2021 of intense pain throughout the body, fatigue, shortness of breath, swelling throughout the body, and loss of appetite. Primary communications (Unknown) with recommendations for follow-up with no treatment. Self-treating with Anti-Inflammatory medication. Still continuing to experience symptoms.
Drug ineffective (pneumonia); Pneumonia; This is a spontaneous report based on information received by Pfizer from Merck & Co., Inc., (manufacturer report number 01276238).   A contactable female consumer of an unspecified age reported that she was vaccinated with pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, manufacturer by Pfizer) on an unspecified date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. Subsequently on an unspecified date, the patient developed pneumonia. Clinical outcome of the adverse event was unknown at time of this report. No further information provided.  No follow-up attempts are possible, information about lot number cannot be obtained.
Cannot hear; A Spontaneous report  was received from a caregiver concerning a 84-year-old, female patient, who received dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced cannot hear (deafness transitory).  The patient's medical history included melanoma, anxiety, pain, edema and a non-specific heart/cardiac condition. Concomitant medications included medications for anxiety, pain, heart and edema.  No specific drug names/doses were reported.    On 01 MAR 2021 prior to the onset of events the patients received first dose of their two planned doses of mRNA-1273 (Batch N0:022M20A) via unknown route for prophylaxis of Covid-19 infection.  On 01 Mar 2021, the patient cannot hear since she got vaccinated. It was reported that, it seems to come and go, hearing has been failing. The event, Deafness was medically significant.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, cannot hear (deafness transitory), was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Skin Itching on back abdomen arms legs neck and chest. Initially Atarax  one every 6 hours plus anti itch creams (Sarna - Gold Bond) then Zyrtec for three days . I discontinued all anti itch lotion and applying only aloe vera gel. Warm showers help. Itching seems to have decreased only slightly. Strangely it flares up after a meal. I drink a lot of water and feel very thirsty.
Arm pain  and continued muscle and nerve pain.  Waking up at night / taking ibuprofen to get back to sleep.  Still persisting a month later
Pt recvd 4th DTP/OPV on 15SEP91 & approx 1 hr later devel local rxn unable to move arm, not sleeping, irritable; 16SEP not moving arm; entire deltoid area red & tender; 19SEP better & acting nl;
no adverse effects reporting vaccine was administered past the beyond use date. beyond use date 1/3/22 administration date 1/19/22. Pfizer contacted had no recommendations and referred us back to provider and CDC.
Other side effects with the first and second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Other side effects with the first and second dose) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Other side effects with the first and second dose). At the time of the report, VACCINATION COMPLICATION (Other side effects with the first and second dose) outcome was unknown. Concomitant medications were not provided. Treatment information was not provided. This case was linked to MOD-2021-396027, MOD-2021-396011, MOD-2021-396027 (Patient Link).
Pt reported numbness on the left side of face by left eye and mouth. Started morning of 7/11/21, 2 days after vaccination on 7/9/21.
Severe shingles breakout on left side of groin, side and back.  Worse case Dr ever saw!  Started w/discomfort and pain in abdomen area.  Developed and still has rare complications Psuedo Hernia Abdominal Protrusion (PHAP) and Post Herpetic Neuralgia (PHN).   Still on meds and have pain into 5th month!!!!   Have different doctor now, than when this started. Don?t think either doctor reported it, but believe the vaccine triggered this terrible breakout.  Have found several reports on internet of others getting shingles 2 weeks after the1st shot.
Swelling and burning/tingling on tongue (2/2/10) loss of taste (2/3), Bell's Palsy (2/5), ringing and pain in ear, headache, sensitivity to light and can't close eye (left side of face and neck). Urgent Care 2/5 MD follow-up.
Child started screaming and banging her head approx 2 hours after vaccination per mother. Child continues to exihibit this behaviour at least once daily per mother. Had never done this prior.
muscle aches, chills, sweating, extreme fatigue, unable to move arm at all, dizziness, headache, confusion
And is experiencing a fever of 102.5/temp is 102; Doesn't feel good; This is a spontaneous report from a contactable consumer (Caregiver). A 15-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EW0178), dose 2 via an unspecified route of administration, administered in right arm on 17Jun2021 as 2nd dose, single (at the age of 15-years-old); and previously received BNT162B2 (Lot/batch number: ER8733), dose 1 via an unspecified route of administration in right arm on 27May2021(at the age of 15-years-old) for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included MELATONIN 10 mg, gummy, one at night. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no family medical history relevant to adverse event (AE). On 18Jun2021 12:00 (Today, around noon), patient doesn't feel good and experienced fever of 102/102.5. It was reported patient received Tylenol last about 15 minutes after temperature measurement. Patient had laboratory test included Vitamin D and some kind of hormone: Vitamin D is within normal limit on unknown date; and body temperature on 18Jun2021: 102/102.5. Therapeutic measures were taken as a result of events with Tylenol. The outcome of events was recovered on an unspecified date in Jun2021.  Information on the lot/batch was available, Additional information has been requested.
Information has been received from a physician concerning an adult pt (gender and age not provided) who on 11Nov05 was vaccinated ID with 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot not provided). On 11Nov05 the pt developed an inflammatory reaction at the injection site. The pt was reported as recovering. There was no product quality complaint involved. Additional information has been requested.
February 17 started to get a papular rash on both feet hands and arms with itching. Took over the counter Benadryl 1 tablet February 18 2009. The rash supsided with just a little on hands with no itching.
Patient stated that starting the next morning her arm became red and swollen to the size of a baseball and very painful. She alerted us on day 5 when the symptoms have resolved. She took no intervention.
This spontaneous report was received from a 66 year old female patient reporting about herself. The patient's concurrent conditions included unspecified drug reactions or allergies. The patient's medical history included anaphylactic reaction and toothache. Information concerning the patient's concomitant medications was not provided. On 22-DEC-2017, the patient was vaccinated with half a dose of PNEUMOVAX 23 for prophylaxis (lot number, expiration date, anatomical location or route of administration were not reported). The patient informed that her allergist recommended to administer the half dose and to return later for a final dose of PNEUMOVAX 23 because she had a history of anaphylaxis. On an unknown date, after receiving PNEUMOVAX 23 the patient experienced a tooth infection and was being treated with an unspecified antibiotic. At the reporting time, the patient was recovering from tooth infection. The causal assessment between tooth infection and PNEUMOVAX 23 was not reported by the patient.
Big red spot on arm; This is a spontaneous report from a contactable consumer. This consumer (patient's Mother) reported for a 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 08May2021 13:35 (Batch/Lot Number: EW0165; Expiration Date: 31Aug2021) as dose 2, single (at age of 17-years old) for covid-19 immunization. Medical history included ongoing anxiety. She has had anxiety forever since she was little. She has always been an anxious kid since she was 5 or 6. Concomitant medication included sertraline hydrochloride (ZOLOFT) taken for anxiety, start and stop date were not reported and reported as she has been on it for about a year. The patient previously took first dose of bnt162b2, Solution for injection, via an unspecified route of administration, administered in Arm Right on 17Apr2021 at 13:35 (Batch/Lot Number: ER8731; Expiration Date: 31Jul2021) as dose 1, single (at age of 17-years old) for covid-19 immunization. Both appointments were at the same time. There was no additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations (within 4 weeks) and no Adverse events following prior vaccinations. There was no family Medical History Relevant to AE(s). The patient experienced big red spot-on arm on 09May2021 20:00. It was reported that, Caller's daughter was 17, and she got the second shot of the Covid vaccine on Saturday. Last night she developed this big red spot on her arm like a big welt. She asks if that was normal. There was no Emergency Room/Physician Office visit. Relevant Tests was none. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
The day after the first dose I developed a headache that lasted three days. If I took NSAIDS it did not help the headache and it became a migraine for three days. I saw my doctor and she prescribed migraine medication. I have not had any more migraines since the initial two weeks. but I still have constant headaches. The headaches were constant all day for the first two weeks. Currently I have headaches two to three times a week for the whole day. I feel the headache mostly on the front part of my head and on the left side. My scalp also feels tingly. I am unable to take any NSAIDS because of my condition. Before my vaccines I had rarely had headaches.
Client reported sweating and blurry vision 3-4 minutes after vaccination.  Client visibly pale.  BP 92/60.  On site EMS provided care, fluids.  Monitored for 25 minutes.  BP received 108/64.  Client stated "I feel better, it happens every time I get a shot."
High fever 103.4, vomiting, diarrhea; presented to clinic with bulging fontanelle and fever 102 resolved with Tylenol and ice packs. full eval normal including CSF, blood culture and urine culture. pt's bulging fontanelle improved the next day as well as the fever.
Received Varicella vaccine on Tuesday.  Over the weekend developed a blister-like rash that is over body including face and head.  Called office on Monday evening to report reaction.  Using over the counter medication to control itching and discomfort.
Information has been received from a physician concerning a 15 year old female who approximately 18-JAN-2007 was vaccinated by injection with a 0.5 mL dose of HPV vaccine (yeast). Lot # unspecified by reporter). There was no concomitant medication. Subsequently, it was reported that five minutes after the injection the patient fainted. The patient was taken to the emergency room (ER) but no admitted to the hospital.  The physician did not think the HPV vaccine (yeast) caused the patient to faint, as much as severe anxiety from the shot.  At the time of the report, the patient had recovered.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a physician concerning a 15 year old female who on approximately 18-JAN-2007 was vaccinated by injection with a 0.5 mL dose of GARDASIL, (Lot # unspecified by reporter). There was no concomitant medication. Subsequently, it was reported that five minutes after the injection the paitent fainted. The patient was taken to the Emergency Room (ER) but not admitted to the hospital. The physician did not think the GARDASIL caused the patient to faint, as much as severe anxiety from the shot. At the time of the report, the patient had recovered. In follow-up it was reported, that the patient had some anxiety about the vaccine injection. The actual injection went well, and the patient seemed to tolerate "ok". Five minutes later in the waiting room the patient slumped to the floor and was minimally responsive to verbal instructions, we immediately administered BENADRYL and epinephrine and called emergency. The patient's vitals remained within normal ranges during the entire episode, she was transferred to the hospital and did well with no further treatment. It was reported that the patient recovered on the same day. Additional information has been requested.
The same day of the vaccine administration the child presented with fever (unknown temperature)and swollen lips. Next day (06/07/2008) the child presented with blisters in hands and feet and the swollen lip still persisted.
devel red raised dry rash under lt arm on 11DEC97;evolved to other chest area by Saturday;painful not itchy never had fever or anaphylactic swelling;no malaise or sore muscles;had root canal 12DEC97;
Information has been received from a 47 year old female pharmacist reporting on herself with an unknown medical history and unknown drug allergies/reactions who has received 4 doses of MMR II (lot number, dose and site not reported) subcutaneously. The patient's first dose was when she was younger, her second dose was given in college during 1980-1984 time period, her third dose given in 2003-2004 time period, and her fourth dose in 2006. The patient stated after four doses of MMR II, she still shows no immunity to rubella as indicated by 3 titer tests performed on an unspecified dates. She sought unspecified medical attention and has not recovered. There was no product quality complaint. Additional information has been requested.
Patient reported that after his first dose of the Pfizer vaccine on 6/16, he had a pruritic, erythematous rash of the L arm. After his 2nd dose, he then developed a whole-body, pruritic, erythematous, papular rash. He was given a prednisone burst + taper w/improvement, but after the taper, his symptoms recurred. Now admitted to the facility for an un-related reason and rash was noted. Seen by Dermatology who felt his symptoms were most likely c/w vaccine-induced eczematous exanthem. His symptoms improved dramatically w/40mg of prednisone. Plan for prolonged taper of prednisone.
not feeling well; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 23Feb2021 (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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "not feeling well".  Additional information: HCP, (name) (a Pharmacist) is reporting that her patient got 1st dose of the Covid-19 vaccine last 23Feb2021. The patient cannot attend her 2nd dose schedule on time. The patient can take the 2nd dose after 6 weeks for the reason that the patient will be having surgery and not feeling well. Cannot provide the name of the patient.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial unsolicited report received from a nurse on 02-Nov-2017. This case involves a 74-year-old male patient, who was vaccinated with booster dose of 0.5 ml of TYPHIM VI once (batch number: M15722M, expiry date, dose in series and administration site were not reported) via intramuscular route on 31-Oct-2017. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient's developed scratching his hands so badly they are bleeding again. The patient was previously vaccinated with Typhim VI on an unspecified day. Laboratory data was not reported and corrective treatment included CORTISONE, Diphenhydramine hydrochloride (Benadryl). Outcome of the events were reported as not recovered. List of documents held by sender: none.
Started out the day with a fever of around 100.8, had body aches, chills then that night I started having bad stomach cramps and diahreah and I fainted. Had to call 911 and ended up with an overnight stay in the hospital.
ED NOTE: 2 mo (almost 3 mo) former 38 patient here with episode of cyanosis and decreased responsiveness today. Got PREVNAR yesterday, got TYLNEOL preemptively. Was sleepy after, and slept for several hours before mom finally woke him to feed. He has had fussiness with other shots, but has not been this sleepy before. Then today, he had been sleeping in his swing for 5 hours, mom picked him up to feed. Was feeding for about 5 minutes and then he unlatched, was laying horizontal in mom's arms and shortly after, mom looked down and noticed that his hand and face were white, lips were blue, he was limp and mom stimulated him and he came to and cried. He was fussy for a few minutes, mom was holding him upright and this happened again -she stimulated him and he woke up and cried, but while mom was calling 911, this happened several times in quick succession. This happened at least 5 times and he woke up every time with stimulation. There was no spit up. Mom says that he was making a throat sound - kind of grunty. No rashes, no fevers, no vomiting or diarrhea. Of note, he does spit up at baseline - those episodes begin with a short cry and then he looks startled, extends his arms and his head, holds his breath and then mom suctions and he breathes and is better. Mom has strategically placed bulbs around the house to deal with such episodes. She had planned to talk to the PMD about this. They called 911 and the child has been fine since then. Mom and dad and 4 sibs has had cough and congestion. ED Plan: Former FT child here with unexplained episode of color change and limpness today after being immunized with PREVNAR yesterday. Given history of reflux, with worsening symptoms recently, possibly related to that. Ddx BRUE vs SBI vs immunization reaction (or combination). Low concern for SBI given no fever, otherwise well appearing on exam and normal vitals. Did not pursue labs here for that reason. Fed well with small spit up but no color or activity changes here. Per parents he is at baseline here. Mother very uncomfortable and traumatized by having to call 911 and the whole experience and multiple occurrences. Uncomfortable going home. Will admit to hospital medicine for overnight observation. Signed out to hospital medicine team.