chrisvoncsefalvay/vaers-outcomes huggingface dataset:
increase in tinnitus in both ears within the hour of each dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 12:45 (Lot number: 330308D) as dose 1, single and administered in arm left, administration date 15Dec2021 12:45 (Lot number: 331308A) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 23Nov2021 13:30, outcome "recovered with sequelae", described as "increase in tinnitus in both ears within the hour of each dose". The event "increase in tinnitus in both ears within the hour of each dose" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Severe yeast infection; This is a spontaneous report received from a contactable consumer (mother of the patient).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received COVID-19 vaccine on 17Feb2021 and shortly after was diagnosed with a severe yeast infection and received treatment for this (unspecified). Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received 0.3 ml of the 5-11 years Pfizer vaccine, patient had no side effects.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2012, the patient was inoculated by a physician (facility not specified) with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, and the male patient subsequently contracted a persistent strain of herpes zoster. On or about 21-MAY-2016, the patient was treated (by an unspecified health care professional) at an urgent care facility for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
This spontaneous report was received from a 83 year old male consumer, reporting on himself. The patient's medical history included shingles. On 02-JUN-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose number, strength and route were not reported). Co-suspect and concomitant therapies were not reported. The patient stated about a week, on 16-JUN-2014, after receiving the ZOSTAVAX he started experiencing muscle ache in his shoulders. He also experiences hip joint and muscle pain in his legs. Patient did not distinguish which/shoulder, hip or legs. Patient indicated his primary physician was on vacation and he saw another physician (name and location unspecified) who indicated it may be arthritis. At the time of the report the outcome was reported as not recovered. Patient seek medical attention at the office visit. Additional information has been requested.
About an hour after vaccination, my tongue started to tingle and then became numb as well as the side of my face.   A bit difficult to talk for a bit.  Facial numbness went away but tongue area was numb and tingly for an hour eventually decreasing.  Noticed a metallic taste in mouth as well.
On a boat 08/26/2022 I felt sick and had a sore throat it was sharp. I tested positive on the 08/26/2022. I was isolated on the boat for 5 days. 09/03/2022 we came home. I tested 09/10/2022 negative. On 09/14/2022 I went to see my doctor but since I was COVID negative. I took over the counter medication MUCINEX for 2 weeks for my cough.
I had had a very small sebaceous cyst on my right cheekbone for about 3 years prior to my covid Pfizer vaccination.  After the 1st dose, it seemed to grow slightly, and following the 2nd dose, it hardened and enlarged to the size of a blueberry in about a week or so.  Coincidence?  Maybe.  But I just thought I should report it, since it is now enlarged and red, and will require minor outpatient surgery later this month to remove.
Pt. received IPV, Td, Menomune, Typhim Vi, Yellow fever on 4/8/02. Symptoms of fatigue, chills, low grade fever (99-100 F) and loose BM started 4/16/02 and persisted to this day. Denied SOB, rash, severe HA/abdominal cramps/vomiting. Advised to consult own physician and homecare advice given - rest, drink lots of liquid, ie., H2O, boullion, decaf. tea, juice. To see MD or call us if symptoms worsen.
This spontaneous report was received from a healthcare worker regarding a patient of unknown age. The patient's medical history and concurrent condition was not reported. On 19-JAN-2016 the patient was vaccinated with expired dose of VAQTA lot # K008332 expiry date 15-JAN-2016 intramuscularly. The patient did not experience any adverse event. There was no product quality complaint involved. Additional information has been requested.
Injection site pain; fever; chills; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th September 2018, the patient received the 1st dose of Shingrix .5 ml. On 4th September 2018, less than a day after receiving Shingrix, the patient experienced injection site pain, fever and chills. On 5th September 2018, the outcome of the fever and chills were recovered/resolved. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain, fever and chills to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix on right arm. The patient experienced fever and chills the evening of vaccination that lasted 24 hours.  The patient also had injection site pain that lasted a few days.  The reporter did not give consent to follow up. For tolerance after 2nd dose refer case US2019GSK074800.
Pt started to regress in development. Stopped hitting milestone at 9 mo. of age.  4/8/08 Case closed w/records attached to VAERS report by parents. FINAL DX: autism (high functioning) Psychiatric evaluation of 2003: Parents noted significant developmental issues at 9 mo of age when he was not crawling or sitting up.  Began crawling 17 mo.  Began single words at 3 yrs old.  Very loud speech & using nonsense words.  Delay in toilet training, fine & gross motor skills.  Enrolled in early intervention program at 18 mo for ST/OT/PT & developmental teacher.  Agressive behavior w/others & poor social skills.  Plays alone or parallel play.  Poor eye contact.  Resists change.  Temper tantrums.  Poor attention span unless involved in repetitive/sterotypical behaviors.  Hyperactive.  Separation anxiety & fear of dogs.   1/21/2010 Child has autism, low muscle bone. Follow-up: (He has social problems along with a list of other related problems. I believe because patient has a weak immune system when he was born he received to many vaccines to soon.) Patient is a 9 year old boy who has had speech, occ therapy, physical therapy, and has many developmental problems. He has received these services since he was 18 months old. Because of his vaccines he has been robbed of his childhood and his future is uncertain.
The client came into our clinic for a bivalent booster, we checked his vaccine card and age, based on his age and the amount of time since the last covid vaccine (10/2022) on his card we administered a dose. When staff was later entering this vaccine into the system, it was found that he had received a bivalent vaccine in 01/2023 at another facility which was not noted on his vaccine card.
Employee stated she was not feeling well the next day and had a upset stomach all day. Employee reported illness 24 hours later.
I was talking with my husband and noticed I was getting short of breath and told my husband to notify the nurse who administered the H1N1 vaccine.  I had a hard time breathing and almost passed out and was sent to the ER.
Intense lower back pain the radiates up and down within 5 minutes of receiving vaccine. Patient had flushed features and felt lightheaded
Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.  revaccination offered.
the skin of the arm is red; itchiness at the site injection; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ERYTHEMA (the skin of the arm is red) and VACCINATION SITE PRURITUS (itchiness at the site injection) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history). Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced PAIN IN EXTREMITY (sore arm). On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at the site injection). On 08-Jan-2021, the patient experienced ERYTHEMA (the skin of the arm is red). On 31-Dec-2020, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, ERYTHEMA (the skin of the arm is red) and VACCINATION SITE PRURITUS (itchiness at the site injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported included Medication for thyroids, Medication for Cholesterol. Treatment for the events included Cortisol cream (started on 07-JAN-2021). Symptoms ongoing but skin is less red  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Swollen painful dark reddish lump 3" x 5" around injection site, left arm stiff and unable to raise above shoulder level. Lasted 3 weeks, gradually decreasing in size and pain.  Not completely gone after 3 weeks.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 6th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 6th July 2018, 12 hrs after receiving SHINGRIX, the patient experienced headache, chills and fatigue. In July 2018, the outcome of the headache and chills were recovered/resolved. On an unknown date, the outcome of the fatigue was recovering/resolving. It was unknown if the reporter considered the headache, chills and fatigue to be related to SHINGRIX. Additional information was received as follows: At 11:00, the patient received SHINGRIX on the left arm. The patient experienced headache, fatigue and chills which started approximately 12 hours after the second dose of SHINGRIX. The patient gave permission to contact her physician.
Woozy, disoriented about 15 minutes after receiving flu vaccine Thermisol free 2mg 0.25 LD.  Felt "drunk" for 4 plus hours during ER visit.
fever; chills; body aches; This is a spontaneous report from a contactable other healthcare professional via a sales representative. A female patient of an unspecified age received 2nd dose of BNT162B2 (Pfizer-BionTech COVID-19 Vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 FOR COVID-19 immunisation. Patient explained that after receiving her second dose of the vaccine she experienced 3 days of fever, chills and body aches on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
Received vaccine 2 days ago - 1/3/12 - left arm pain at site. Complaining of right eye twitching & occasional blurring with reading. Also, discomfort on left side of body & weakness. Exam normal in office.
MMR and varicella vaccine given 05/02/01 mom states patient developed spots head to toe apx 05/13/01 with fever. MOM did not take temperature, but patient felt warm, gave, tylenol x1, rash may more generalized with more distinct "dots", fussy, decrease appetite rash also to face and lips. no problems breathing.  Is also cutting teeth.  Advised her to have patient seen by health care provider, follow up on 05/17 - patient seen by physician mom states he felt maybe MMR, wrote medial exemption for patient
dizziness; This is a spontaneous report from a Pfizer-sponsored program from a contactable nurse, the patient. A female patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown), via an unknown  route of administration on 04Jan2021 as a single dose for COVID-19 vaccination. The patient's medical history included ear infection prior to receiving the COVID-19 vaccine. The patient's concomitant medications were not reported. On an unknown date in Jan2021, the patient experienced dizziness. The event dizziness was reported as non-serious. Treatment for dizziness was unknown. The clinical outcome of dizziness was unknown.    Information on the lot/batch number has been requested.
5 1/2 x 7cm induration began 24 hours after administration at site of DTaP #4 mild pruritus. No systemic sx otherwise.
5 days after the injections were given the  patient experience soreness/achiness in the lower forearms bilaterally.  The injections had been given in bilateral deltoids but there was no pain, swelling, ecchymosis, erythema at the injection sites -- only in the lower forearms.  There was no loss of strength, reflexes, nor sensation.  Treatment of heat and ibuprofen was recommended.
A itch in the bust area, it started with 1 small Rash and today 22 it almost reaches my neck and arms.
Sudden dizziness, fever & almost passed out 19 hours after 2nd Moderna Covid vaccination shot but was better by that evening. 2 days after injection the arm rash reoccurred on the injection arm and was much more intense, itchy & red in comparison to the rash after the 1st Moderna Covid vaccination shot.  The rash finally started disappearing 1 week after injection.
Localized allergic reaction: redness, swelling, pain around area of injection that lastest for 7 days. Saw doctor and no medical attention required.
shortness of breath, chills, headache, dizziness occurred with quick onset in the evening on Friday. the symptoms resolved by the morning. patient felt fatigued for the next 24 hours on Saturday. no symptoms remained by Sunday morning. Patient did not check temperature on Fri. On Saturday morning checked temperature and no fever detected. (patient has not had a COVID test)
all of the side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced all the side effects from Shingrix except for fever.  The reporter did not consent to follow-up.
Fever 103 X 5 days, started 1 week, post vax.  Maculopapular rash started 10 days, post vax.
Patient's mother called to see if she should receive her second dose because 48 hours after the first dose, she broke out in hives from head to toe.
I had 100 degree temperature for two days.  But a month later I started to have rashes on my upper armes n my legs. N they went away. N again about month later a few bumps came up n this time I felt dizzy for a few days. N they went away. N this month which about a month later a few bumps appeared and  not feeling well. I dealt with headache with bumps. Bumps are usually itchy n burning feeling, even I don't scratch them. They are red or pink. N scars won't go away.
about 20" p/vax pt noticed swelling of fingers & hands & red rash on neck;given DPH;itchy;sl joint swelling;
Family of five walked-in requesting Pfizer bivalent boosters. Techs confirmed last Pfizer booster doses with patients? digital vaccine cards. Pfizer bivalent vaccines were drawn (by pharmacist) and administered (by intern) to all five family members.   However, when billing vaccines, four out of five family members? insurance gave rejected, duplicate claims. A report was ran for each family member and found the four family members already received the Pfizer bivalent booster in September/ October. Pharmacist contacted father of the family to confirm if they did, in fact, receive the bivalent booster in September/ October. The father was not sure what booster they received in September/ October but came in because he ?was watching the news and the news said if it?s been two months since your last booster, you are due for another booster? so he decided to bring his whole family in to get another booster.
01/25/21 developed "Covid Arm"  rash, heat, itch continued for ~3 days - treated with antihistamine.   02/15/21 experienced a TIA - no know risk factors prior to this event.
Mother states child had severe swelling and redness to left deltoid area on 8/26/04. Pt seen at clinic 8/27/04: site was slightly swollen and redness to area. Mother states no fever occurred.
Pt received the FLUARIX QUADRIVALENT influenza vaccine at a flu clinic held at the same location as his provider on Sat 9/30/2017. (Note: He did receive a FLUARIX QUADRIVALENT influenza vaccine last year, 10/15/2016, with mild arm swellling). On Sunday evening, mother noted pink papular rash on torso, head, neck, face, as well as facial swelling. No shortness of breath or difficulty breathing. Presenting to the clinic 10/3/2017 with symptoms still present.
Some (unspecified) time p/vax pt exp inj site rxn of redness,swelling, area streaked, warm & tender.
Gets a little fever every once in a while; Sicknesses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 9-year-old female patient received BNT162b2 (BNT162B2), on 06Nov2021 as dose 1 (orange cap), single (Batch/Lot number: unknown) at the age of 8 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Gets a little fever every once in a while"; ILLNESS (non-serious), outcome "unknown", described as "Sicknesses".  Additional information: Daughter did not get sick or anything; did not remember her daughter ever really being sick. Took all her vaccines. Just got a little fever every once in a while. Just normal sicknesses, but that was  it. Had not received any other no other vaccines four weeks prior to the COVID-19 vaccines. Daughter had not received any other vaccines since then either.  Planning on getting medical tests done, but none had been done at this point. No other conditions.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Had a Migraine the following day to include sensitivity to light, headache, nausea.
This spontaneous report as received from a registered nurse refers to an unspecified patient of unknown age. On an unknown date the patient was vaccinated with 1.0 ml dose of PNEUMOVAX23 (lot# not reported). No adverse event was reported. Additional information has been requested.
Client has had a very achy arm since his second injection on April 8th. It was bruised but is healing. Client had a flare up yesterday 04/22/21 of not being able to move left arm well. Client states the injection site is 3 to 3.5 inches below shoulder. Client advised to place heat on arm for 20 mins and complete range of motion exercises.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 13-OCT-2012 12:17, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
has  a head ache; body ache; chills; 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.  A 43 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 12May2021 (Lot number: EW0168, Expiration Date: Aug2021) at the age of 43 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: BUSPAR. Vaccination history included: BNT162B2 (Dose: 1), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 13May2021, outcome "unknown", described as "has  a head ache"; PAIN (non-serious) with onset 13May2021, outcome "unknown", described as "body ache"; CHILLS (non-serious) with onset 13May2021, outcome "unknown", described as "chills".  No follow-up attempts are possible. No further information is expected.