chrisvoncsefalvay/vaers-outcomes huggingface dataset:
small rash on back of right thigh. similar to psoriasis; small rash on back of right thigh. similar to psoriasis; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Ew0183), via an unspecified route of administration, administered in right arm on 13Jul2021 16:45 as single dose for COVID-19 immunization. The patient's medical history included hypothyroidism. The patient had no known allergies. The patient's concomitant medications included estrogens conjugated (PREMARIN) and levothyroxine sodium (LEVOTHYROXIN). Facility where the most recent COVID-19 vaccine was administered was other. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced small rash on back of right thigh, similar to psoriasis on 16Jul2021 at 12:00. No treatment was received for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events was reported as non-serious.  Follow-up attempts are completed. No further information is expected.
Information has been received from a nurse concerning a 15 year old female with no medical history and no drug allergies, who on 24-APR-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil.  Concomitant therapy included hepatitis B virus vaccine (unspecified).  On 10-AUG-2007 the patient was vaccinated with a second dose of Gardasil (Lot #657737/0522U).  On 13-AUG-2007 the patient's period started.  The menstrual bleeding lasted for 3 weeks.  The patient's father contacted the office.  No laboratory diagnostics were performed.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
Pt called on call service stating arm was swollen to the size of an apple and warm to touch and very painful to the point he was unable to sleep at all. patient wife also got the same vaccine same lot # M04324. her arm was also swollen and very painful. We have several other people who have reported very painful arms for up to 1 week with this same lot #. Has there been any other reports?
Patient was not vaccinated but exposed to a vaccinated person who had received Smallpox vaccine, She developed a skin ulcer on her left extensor arm within 2 day of exposure. This was cultured for PCR of vcaccinia, was positive
Left tricep area 10cm by 5cm area erythema and localized reaction. Pt to follow-up with me over the weekend. Given Benadryl, 25mg, apply warm compress.
TROUBLE SLEEPING; SORE BACK; CHILLS; SORE ARM; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced trouble sleeping, sore back, chills, and sore arm. The action taken with covid-19 vaccine  was not applicable. The outcome of the sore arm, chills, trouble sleeping and sore back was not reported. This report was non-serious.
The vaccination was not given by our facility. The patient's parent reported that the patient had been given the influenza vaccine by his PCP. The parents brought him to our facility, D/T concern for possible reaction. I do not have access to the documentation for the vaccine that was given, only the verbal report from parent.
This case was reported by a consumer via call center representative and described the occurrence of rash in a 56-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu unspecified for prophylaxis. On 17th October 2018, the patient received the 1st dose of SHINGRIX .5 ml and Influenza vaccine. On 18th October 2018, 1 days after receiving SHINGRIX and Influenza vaccine, the patient experienced rash, fever, injection site swelling, injection site pain, erythematous rash and pain in arm. On 19th October 2018, the patient experienced injection site itching. The patient was treated with naproxen. On 19th October 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the rash, injection site swelling, erythematous rash and injection site itching were unknown and the outcome of the injection site pain and pain in arm were recovering/resolving. It was unknown if the reporter considered the rash, fever, injection site swelling, injection site pain, erythematous rash, injection site itching and pain in arm to be related to SHINGRIX and Influenza vaccine. Additional details were provided as follows: The patient received SHINGRIX and Flu shot right arm. One day after receiving SHINGRIX, the patient developed a rash that was 3 inches below the injection site, which was red and covered 3 inch circle area. The patient has also developed pain and swelling at the injection site, and he had pain while moving his arm. The patient experienced fever and took naproxen. Two days after receiving SHINGRIX, the rash has turned from red to pink. The pain was less while moving his arm around, and he was also experiencing itching at the injection site. At the date of reporting, the fever had subsided. The patient had denied permission to contact their physician. No further details were provided.
Pt recvd vax in 1990 pt devel pos core antibody, pos immunoglobulin G & pos immunoglobulin M;
Rash at injection site - 1.5" x 1.5". Raised welt underneath.
A lump appeared at injection site this morning. Its not red or hot, it just feels like a nodule under the skin. It is somewhat tender to the touch.
This spontaneous report was received from a physician via company representative and refers to a 12 year old male patient. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 first dose (lot #, expiration date, dose, strength and route of administration were not provided) for prophylaxis. In February 2018, the patient was vaccinated with GARDASIL 9 second dose (lot #, expiration date, dose, strength and route of administration were not provided) for prophylaxis. Other suspect therapies administered on the same date as second dose of GARDASIL 9 included (unspecified), TDAP vaccination and an unspecified meningitis vaccination. In February 2018, immediately after receiving the second dose of GARDASIL 9, the patient fainted and went to the hospital. It was unknown if the patient was hospitalized or if the patient went to the emergency department. The patient sought medical attention. The outcome of the event was reported as recovered on an unknown date. The causal relationship between the event and suspected therapy was not provided by the reporter.
It began as hives on his right forearm before bedtime, which later spread to his entire right arm the next morning along with some hives starting on the other arm. He was treated with a dose of benadryl and the symptoms dissipated.
Three hours after receiving vaccines patient complained of itchy , redness at vaccine site.  In the morning complained of red rash on face and whole body itching.  Called us we advised to see doctor or go to urgent care. Patient had no insurance . Advised to see his school nurse on arrival at school.  Seen by school nurse and given Benadryl.  Called patient in afternoon and patient reported feeling better, rash gone and no itching. He just feels drowsy.  Explained continued Benadryl use as needed and to go to urgent care if problem persists.
Pt called on 4/11/2008 @ 0930 pt immunizations site has redness, swelling and itchiness denies any SOB, chest pain, or tightness on the chest. Instruct pt to call Primary care Provider for fu. Pt called Primary Care Provider (see attached note).
The patient was administered a Moderna Bivalent Booster that was past the 12 hour use by time. The vaccine was administered 26 hours after the vial was punctured. Patient has not experienced any ill effects, and we are awaiting guidance from the manufacturer concerning repeating the dose.
Pt received hepatitis A vaccine and went on to daycare. Awoke from nap 1 hour later with hives, reported respiratory distress and shaking. Seen in office. Had few hives, no resp. distress.
No event; temperature excursion - vaccine not viable according to manufacturer; This spontaneous report was received from a physician and refers to an 8-week-old female patient.  The patient's medical history and concurrent conditions were not reported. The patient's historical vaccine included hepatitis B vaccine (basic series). Concomitant medications included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and vitamin D.  On 05-JUN-2023, the patient received the first (also reported as booster series; conflicting information), improperly stored (Product storage error) dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot # reported and upon internal validation confirmed as: 1968386, expiration date was reported and confirmed as: 23-MAY-2024, administered orally (exact dose was not provided) for prophylaxis, at private doctor's office/hospital, by the physician. No prescription drug treatment was required. Alarm believed to be due to sensory issues, monitoring temperatures with back up logger. Temperature in range, new data logger currently in use. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA013096:
I suffered intense general itching of from my knees to my shoulders approximately 36 hours after the vaccination.; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9236), via an unspecified route of administration, administered in arm left on 30Jan2021 at 08:45 (at the age of 72-years-old as dose 1, single for COVID-19 immunisation. Medical history included high cholesterol from an unknown date. Concomitant medication included meloxicam taken for an unspecified indication, start and stop dates were not reported. On 31Jan2021, the patient experienced suffered intense general itching of from his knees to his shoulders approximately 36 hours after the vaccination. It lasted about an hour and has not recurred. There was no treatment received for the event. The outcome of the event was recovered on an unspecified date.     No follow-up attempts are needed. No further information is expected.
Moderna was given to patient 13 years of age,  which is below the approved age of 18, mother was called, was fine with it, no adverse affects that we have been made aware of.
Patient had first Dose of Pfizer Covid 19, She recieved 0.1mL VS 0.3mL IM. No adverse reactioN noted
Vaccine received 5/3/07 at approximately 0900. Discover area of redness and swelling approximately 6" X 4" that night. Patient also complains of tenderness.
Chemical burn on the arm; Burn like mark at the band aid site like a sunburn; Light headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021535873 (Pfizer).  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 13:00 (Lot number: EW0176) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: CHEMICAL BURN OF SKIN (non-serious), outcome "unknown", described as "Chemical burn on the arm"; SUNBURN (non-serious), outcome "not recovered", described as "Burn like mark at the band aid site like a sunburn"; HEADACHE (non-serious) with onset 02May2021, outcome "unknown", described as "Light headache".  Additional Information: The caller denies being sick at the time of vaccination. Patient says there is a band aid mark where she got the shot is still on her arm and it is like a burn, not a rash. The patient described the mark on her arm as a burn like a sunburn. She said it was like when a sunburn leaves a mark and it was in the exact shape of the band aid. She said it looked like a tattoo. When asked for a start date she said she got her shot on 30APR2021 and it was a couple days later when she realized the mark was still on her arm. She said she thought did she not scrub her arm good enough. She said it looks like part of her skin. She said there has been no change since she noticed it and that she noticed it at midday. She said she experienced other things like a light headache and she thought those things were normal based on what she was seeing on the CDC website and pfizer website. She said the burn was the only thing that had no information on it at all. She said she noticed the headache on Sunday then had daily headaches for about 3 days. No Emergency Room visit, Physician Office. Prior Vaccinations within 4 weeks (List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s)): None.  No follow-up attempts are possible. No further information is expected.
Hard itchy dime sized knot appeared at injection site, and an itchy rash  about 3" in diameter below the knot.
Information has been received from a nurse practitioner referring to a female patient (age and race unspecified). The patient was considered as a high risk patient as she had a history of asthma, hepatitis C with liver damage and was a smoker. No concomitant medication was reported. In April 2014 (reported as "In April, the year before last"), the patient was administered the first dose of PNEUMOVAX 23 (strength, dose, route, lot # and expiration date unspecified). In December 2014 (reported as "In December, the year before last"), the patient was then admitted to a hospital for an ear infection where she received a second dose of PNEUMOVAX 23 (the vaccinated date, strength, dose, route, lot # and expiation date were unspecified). On an unknown date, after receiving the second dose, the patient had an injection site reaction described as redness and swelling in an unspecified area of the body. The outcome of the events was not provided. The relationship between the events and PNEUMOVAX 23 was not reported. This is one of several reports received from the same source. Additional information has been requested.
Narrative: 96 yo M with hx of parkinson disease, HTN, HLD, DVT, hyperglycemia, and tremor received 2 moderna vaccinations on 01/19/2021 & 02/17/2021. Patient died on 08/09/2021. Death is not likely due to vaccinations due to comorbidities, age, and time from vaccine administration.
Baby developed rash on cheeks. Notified pediatrician at follow up visit, and she explained that some children develop rash after vaccine. It was the first time she received that vaccine.
Fever flushing chills and dizziness then nausea,vomiting and diarrhea for days after second vaccine
that PM, lt arm started swelling & hot, swelling went to the elbow on Thursday & Friday swelling went just below elbow;
On 2nd day p/receiving vax noticed a lump-numbness & tingling feeling fore arm; to thumb & 2 fingers; 15NOV91 numbness still there area where shot given was jet black lasted for a wk;
Symptoms: Tingling in hands and feet while standing; Dizziness while standing; Fatigue; Frequent headaches; Panic attack feelings without the panic.
she got her second dose of vaccine on 03April2021; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she got her second dose of vaccine on 03April2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 03-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she got her second dose of vaccine on 03April2021). On 03-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she got her second dose of vaccine on 03April2021) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: F/U uploaded - Patient denied for further follow up
Extreme swelling at injection site about 5 in red, inflamed, warm to touch immense pain creating difficulty sleeping. Treated w/20 mg prednisone taper.
low grade fever; Given a dose of Pediarix at the same injection site (limb/muscle) as another vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of low grade fever in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Haemophilus influenzae type b vaccine for prophylaxis and PNEUMOCOCCAL VACCINE (PREVNAR) for prophylaxis.   On 19th April 2021, the patient received the 3rd dose of Pediarix, Pediarix Pre-Filled Syringe Device, Haemophilus influenzae type b vaccine and PREVNAR. On 19th April 2021, less than a day after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Haemophilus influenzae type b vaccine, the patient experienced low grade fever and wrong technique in drug usage process. On an unknown date, the outcome of the low grade fever was not recovered/not resolved and the outcome of the wrong technique in drug usage process was unknown.   It was unknown if the reporter considered the low grade fever to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Haemophilus influenzae type b vaccine. 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 case was reported by the patient's mother and pharmacist separately. The patient's mother took the patient for his 3rd dose in the Pediarix series on the day of reporting. The patient also received Prevnar and Haemophilus influenzae type B vaccine (Hib) on the same day.  The Prevnar and Pediarix injections were given in the same injection site, which led to wrong technique in the drug usage process. The package insert stated that when Pediarix is administered concomitantly with other injectable vaccines, they should be given with separate syringes and at different injection sites.  The patient had a low grade fever.  The pharmacist did not have the lot number or expiry date. It was unknown if the reporter considered the low grade fever to be related to Prevnar. The patient's mother gave a consent to contact via electronic communication . The pharmacist also consented to follow-up but declined to provide her address as the administration was given at the doctor's office.
Pt had rabies shot and immunoglobulin 3/21/11. 3/22/11 lethargic, headache, dizzy, photophobia, dry heaves and emesis, has bruising (L) forearm where dog bit.
Within 2-3 hrs, developed red, itchy, induration 6 cm in diameter @ varicella injection site.  Within 36 hrs swelling, redness & induration increased to include soft tissue from deltoid to elbow.  Complains of itching - intense.  Mild relief achieved by frequent application of topical corticosteroids.  Area affected was sore to touch for 3 days.  Symptoms began to subside day 4.  Area returning to normal with only slight redness & swelling @ site - day 6.
Experienced an increase in heart rate from 10 p.m. on 1/26/2021 for approximately 24 hours. According to the data on my fitness band, my heart rate averaged at 130 bpm during sleep and rest, and was approximately 170 bpm when standing despite taking metoprolol succinate. I usually take 12.5mg of the metoprolol, and took another 12.5 mg the morning of 01/27/2021, which seemed to help with the increase in heart rate. Despite normally experiencing an increase in heart rate due to my diagnosis of Inappropriate Sinus Tachycardia, my heart rate usually drops into the 60's at night and during the day if I am moving, is about 120-130 bpm. Additionally on 01/28/2021, I had difficulty standing due to feeling faint and dizzy upon standing. All symptoms appeared to resolve by 01/29/2021. Besides taking extra medication, I spent the day resting and hydrating with water.
itchy at site of DTaP, arm swollen elbow to shoulder, no painful, bright red. Mom left a message.
There were no adverse events reported, this was considered by the Moderna company as a "vaccine administration error/unauthorized error (off-label) use-invalid dose" The patient is doing well
CHEST PAIN WEAKNESS - GENERALIZED Hyperkalemia Lactic acidosis Hyponatremia SEPSIS EKG abnormalities Acute kidney injury (CMS/HCC) Neutropenia (CMS/HCC) DEATH
Woke around 7am with a severe headache and nausea. Developed vertigo (which I thought was related to my concussion as I had had vertigo with that, but really not any headaches or nausea) about an hour later. Vomited 3 times between 8am and 3pm. Around 10:30am developed chills and shivering. Felt really ill all day until about 5pm when I felt like I could eat and drink; the headache eased up by then as well. For the next 4 days after this I had sweats that would come and go. I would suddenly and unpredictably get very warm, break out into sweats, and after a short time (5-10 minutes) it would pass.
Flushing skin, numbness, itching, urticaria, burning of eyes.  50mg Benadryl given and EMS called, pt transported by EMS to ED.
Expired COVID Vaccine (5 years to 11 years) was given to patient.  The vaccine expired on 09/30/2022.  The beyond use expiration date of the vaccine was 10/31/2022.
Patient tested positive for Covid-19 on 05/25/2022 at Clinic.  Ordering provider.  No other information available.  Patient expired at home on 05/27/2022.
p/vax pt presented w/difficulty breathing & lightheadedness; paramedic called; epinephrine given;pt taken to hosp for further management
My CRN/midwife, and then later on that day, a perinatologist, diagnosed that the baby I was carrying suddenly stopped having a heartbeat and had died. Follow-up ultrasounds 10 days later confirmed that the baby had died. Both the midwife and perinatologist called the event "strange" because all other signs pointed to a healthy fetus and that the heart had suddenly stopped unexpectedly.  This vaccination resulted in my miscarriage. One of the major side effects of mercury poisoning is that it causes the heart to suddenly stop beating. This vaccine has never been tested on pregnant women and the only difference between this failed pregnancy and my previous successful pregnancy was this H1N1 vaccine.