chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PAIN; FEELING UNWELL; FATIGUE EXTREME; LACK OF DRUG EFFECT; ASTHAMA AGGRAVATED; This spontaneous report received from a patient via other manufacturer concerned a 31 year old male of unspecified race and ethnicity. The patient was enrolled in a non-Company sponsored solicited program Facilitated Collection. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (benadryl, dye free benadryl, glycopyrrolate), and ankylosing spondylitis. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 01-APR-2021 (Dose 1 of dose number in series 1) (Age at time of vaccination 30 years old) and 16-OCT-2021 (Dose 2 of dose number in series 1) 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. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: unknown expiry: unknown) 40 mg, 1 time every 2 weeks from 17-DEC-2021 to 25-MAR-2022 for ankylosing spondylitis. On 17-DEC-2021, the patient felt that asthma issues got worse/severe side effects regarding asthma/asthma would flare up (asthma aggravated) and lack of effect (dose number in series 1). On an unspecified date, the patient experienced fatigue/tired/extremely drained more than usual/fatigue was extreme, felt poorly and pain (all events with dose number in series 1). The patient received booster non-company pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin not reported, intramuscular, and batch number: unknown, expiry: unknown) dose was not reported, administered on 15-MAR-2022 for covid-19 vaccination. It was unknown if the patient experienced any adverse event after vaccination with pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with adalimumab was withdrawn on 25-MAR-2022. The patient recovered from lack of drug effect, and asthama aggravated on 25-MAR-2022, had not recovered from fatigue extreme, and the outcome of feeling unwell and pain was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20220427755- covid-19 vaccine ad26.cov2.s- lack of drug effect. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Patient fainted & slid to floor following immunizations. After patient laying down and given fluids pt still feeling faint, dizzy.
temperature excursion due to the product not being refrigerated upon receipt. Caller reporting IPOL at a high of 68F for 75 hours with no reported adverse event; Initial information received on 21-Dec-2021 regarding an unsolicited valid non-serious case received from a physician.  This case involves a patient of unknown demographics who had temperature excursion due to the product not being refrigerated upon receipt. caller reporting ipol at a high of 68f for 75 hours with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a Primary dose of suspect IPV (VERO) (of unknown dose, formulation) lot U1C571M in unknown administration site.  On an unknown date the patient developed a non-serious event temperature excursion due to the product not being refrigerated upon receipt. caller reporting ipol at a high of 68f for 75 hours with no reported adverse event (product temperature excursion issue) (unknown latency) following the administration of IPV (VERO).  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (temperature excursion due to the product not being refrigerated upon receipt. Caller reporting IPOL at a high of 68F for 75 hours with no reported adverse event).  At time of reporting, the outcome was Unknown for the event temperature excursion due to the product not being refrigerated upon receipt. caller reporting ipol at a high of 68f for 75 hours with no reported adverse event.
This is a spontaneous report from a contactable consumer or other non-HCP. This consumer reported on behalf of her father. A male patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on Feb 7, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date Feb 2021, patient's arm bruised after the shot and was still bruised from the shot. She added they gave it at the bottom of the deltoid. She believed that might be why he was experiencing bruising, with outcome of not recovered. Follow-up attempts completed. No further information expected.
This case was reported by a pharmacist and described the occurrence of lymphnode swelling in a subject of unspecified age and gender who was vaccinated with influenza vaccine trivalent (Flulaval). On an unspecified date, the subject received a dose of Flulaval (unknown). One day, after vaccination with Flulaval, the subject experienced lymphnode swelling. The pharmacist reported a subject received Flulaval and one day later experienced "lymph node swelling in the subclavicular area". No other information was provided. At the time of reporting the outcome of the event was unspecified.
This spontaneous report as received from a healthcare worker, refers to multiple unspecified patients of unknown demographics. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD which had lot  L045678 and expiration date of 09-MAY-2017 (dose, dosage number and route of administration were not provided). Nonetheless, no adverse effects were reported. The vaccines experienced the following temperature excursion on an unspecified date: 5.4 F for 16 hours. Reportedly, there had been previous temperature excursion and the aforementioned one was identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
12 hours after dose - headache and bodyaches 18 horus after 1st dose - rigors, chills, hot flashes (flushing).  Severe sore arm (could barely move arm that received dose, could not touch it) 24 hours after 1st dose - fatigue, bodyaches, headache, persistent flushing without fever (max temp 99.1 F) 36 hours after 1st dose - headache, flushing. Arm soreness significantly improved 48 hours after 1st dose - mild flushing, rest of symptoms resolved
right arm (shingrix vaccine given) has heat, welt, slight swelling, redness, entire area of redness is size of half dollar coin, no pain or itch. I advised her to apply ice and take ibuprofen or Tylenol and if the area doesn't improve or worsens, then go to doctor for treatment. She said she would visit the pharmacy tomorrow 10/22/20, if it did not improve to show the pharmacist on duty for further consult.
extreme fatigued, too dizzy to stand, no appetite, couldnt take meds, headache
Viral rash began behind ears on 12/31.  Over next 3 days, spread to neck, shoulders, upper chest, and upper arms.  Area behind ears was most affected - very red and swollen with bumps merging together, but not itchy.  Rash began to spread onto earlobes and into the outer ear by 1/4.  Physician prescribed topical fluocinonide cream (0.05%), which reduced the rash over 5 days.  Skin remains sensitive as of 1/19.
pt recv vax & 13 days post vax pt devel erythema, two varicella-like lesions @ inj site, & 15 lesions on upper & lower extremities, chest, & back;
5 cm x 7 cm sl. elevated and red area noted below injection site. Slight warmth to area.
I am breastfeeding since my child's birth in January 2021, and later the same evening after getting my COVID vaccine, I got a clogged milk duct in my left breast that was very severe, causing a lot of engorgement and pain but resolved after about a day and a half
Within a few days of the first Pfizer vaccine, I developed ringing in the ears. It has persisted to this day over two months later with no diminishment in intensity.  The ringing has impacted my quality of life and it makes it very difficult to sleep at night.
Information has been received from a medical assistant concerning an unknown number of patients; demographics were unknown. The patients' medical history, concurrent conditions, drug reactions and allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX for prophylaxis, lot # L023592 and expiration date: 26-JUN-2017 (dose, frequency and route of administration were not reported), reconstituted with a sterile diluent (manufacturer unknown). The sterile diluent was not involved in the temperature excursions. No adverse effects were reported. It was reported that on an unspecified date, the vaccines were exposed to a temperature between 15 Fahrenheit degrees and 46 Fahrenheit degrees for 1 hour and 18 minutes. The vaccines were also exposed to a temperature between 15 Fahrenheit degrees and 46 Fahrenheit degrees for 1 hour, a temperature between 6 Fahrenheit degrees and 14 Fahrenheit degrees for 30 minutes and finally, a temperature between -50° Celsius (C) and -15° C for 54 minutes. The medical assistant reported that there was no previous temperature excursion. The call was placed because of a Digital Data logger report. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1706USA010994.
Patient taken to School Nurse office with c/o's dizziness;  No headache;  No itching.  Bioject (#4 syringe) was used to adminster the H1N1 vaccine. 1:00PM - Father to take patient to pediatrician.  11/02/09  School Nurse reported patient seen by family doctor - Ok with no problems.
None at this time.   11/30/09:  Prenatal records received for dates of service 10/23/09 to present.  Dx: Pregnancy  This Gravida 2 Para 1 with no obstetrical problems noted at this time.
Information has been received regarding a case in litigation concerning a male child who was injected with vaccinations containing the toxic mercury-based preservative thimerosal. The alleged result of these vaccinations is that the patient suffers from and in the future will continue to suffer the toxic neurological effects of mercury poisoning. Immunization records were received and it was reported that the patient was vaccinated with his first two doses of hepatitis B vaccine recombinant (yeast) (lot# and manufacturer not reported for the dose given 16 SEP 1996; lot# 620757/1101D given in the left thigh on 12 DEC 1996, and MMR vaccine (lot #622262/0594E given subcuttaneously in the right arm), a third dose of hepatitis B vaccine, recomb (ENGERIX-B) (lot# 2292A2 given in the right thigh on 16 JUN 1997), the first through third doses of HIB conjugate vaccine (ACTHIB (Haemophilus B conjugate vaccine)) (lot #6C71070 given in the right anterior thigh on 15 NOV 1996; lot# 6A81169 given in the left anterior thigh on 17 JAN 1997; lot #6A8117 given in the left thigh on 14 MAR 1997), the fourth dose of HIB conjugate vaccine (OMNIHIB)(lot# M0293 given in the left deltoid on 12 DEC 1997), oral poliovirus vaccine (ORIMUNE) (lot#0749L6 given 15 NOV 1996; lot #0750A given 17 JAN 1997 and lot # 0772H given 20 MAR 1998), the first through third doses of alum, potassium, diphtheria toxoid, pertussis vaccine, tetanus toxoid (TRIPEDIA) (lot# 6571059 given in the right anterior thigh on 15 NOV 1996; lot # 6A81169 given in the left anterior thigh on 17 JAN 1997; lot # 6L71162 given in the left thigh on 14 MAR 1997), diphtheria toxoid/pertussis vaccine teta (INFANRIX) (lot# 833A2 given IM in the right deltoid and tuberculin purified protein derivative (PPD TINE TEST) (lot # not provided); result negative. Upon internal review, mercury poisoning and neurological disorders were considered to be other important medical events. No further information is available. Follow up info regarding a case in litigation was received included a pt's hair analysis lab results dated 9/12/97 that revealed aluminum 73.6, antimony 0.254, cadmium 0.555, lead 1.62, mercury 6.88, nickel 0.526, tin 0.739, chromium 1.36, cooper 34.2, iodine 2.78, sulfur 56.389 and zinc 217. It was noted that the pt had elevated results through a repeat analysis on 6/14/01. On 3/22/02, the pt's urine toxic metals lab results revealed mercury at 0.9ug/g. No further info is available.  A 15-day follow up report received 05/20/2003 adds: Follow up info was received that reported the pt was allegedly injected with vaccines containing thimerosal on the following date: 09/16/1996, 11/15/1996, 12/12/1996, 01/17/1997, 03/14/1997, 06/16/1997, 09/17/1997, 12/12/1997 and 03/20/1998. Upon internal review, mercury poisoning and neurological disorders were considered to be other important medical events. No further info is available. A copy of the pt's complete medical records is available upon request.
Patient was given dose 1 of the vaccine and instructed to wait at least 15 minutes in the chairs in front of the RPH for observation.  He waived at us and sat down. We asked if he was ok and he waived again stating he didn't feel well. He sat back down and we proceeded to check on him. As we were coming to check on him, he fainted and fell face forward on to the floor. We called 911 and rolled him gently to his back. He had a laceration  above his eye from the fall. EMT came and assessed the patient. After observation, he was allowed to be picked up from his friend and taken to a clinic for stitches.
At about 4 AM (3/1/2003) started coughing non-stop. Albuterol, Saline - nothing could stop it. Called Allergist, received treatments of prednisolone. He had a fever, and non-stop coughing from 3/1/2003 until 3/4/2003. No medicines had any affect. Also tried mist. Dr. was (pediatrician) called. MD (allergist) saw pt. Pt's arm was inflamed and swollen where DTP was administered. Continuation: Pt received 4 shots listed on 2/28/2003. He was in perfect health at the time of the visit. At approximately 4 AM the following morning, pt began to cough and could not stop. He coughed every minute throughout the night. We called a doctor who informed us to give him saline through the nebulizer also. Prior to this the pt had one cold where they had administered Albuterol and Pulmicort to help him open up his breathing. Using these medication through the nebulizer provided the pt with no relief. He did not have a cold. We were directed by the doctor to keep doing what we were doing. His arm where he received the DTaP shot was swollen, red and hot. He started with a fever throughout the night. He was lethargic and less responsive. On 3/1 we did call the pediatric allergist (pager) whom listened to his cough in the evening on the phone and asked us about the shots he received. He instructed us to try cool mist and to continue the medication and he would see us in the morning. The pt coughed consistently throughout the night receiving nebulizer treatments and saline throughout the night without any relief. Irritable and less responsive. The pediatric allergist brought us into the office on 3/2. He did have us contact the pediatrician to ask about the immunizations that the pt received. He examined the site of the shot. His arm was brighter red and swollen. He has a low grade fever and was irritable. He was still coughing. The allergist prescribed oral Prednisone for the week.  He was still receiving breathing treatments with no relief and cold symptoms. Allergist also saw pt on 3/3 and 3/5 for follow up checks. He finally decreased the coughing spasm on 3/5/2003 when the redness began to subside in the arm and he became less irritable. He did visit his pediatrician that week to evaluate. Physically attacks people, Temper tantrums or a hot temper. He is sometimes cruel to animals (he is rough with the dog and pulls on it paws, destroys his own belongings, adaptive skills severely delayes, fine motor skills moderately delayed, motor skills moderately delayed, speech and language moderately delayed, expressive language skills were severly delayed. Autistic symptoms of developmental delays, perseverates, soocial delays, language delays. Following-up: Still has autistic like behaviors such as social and speech and motor delays. Also was just tested for measles titer and the antibiotics are too high.
I now have tiny red dots, like freckles all over my torso and stomach. I noticed this three days after the vaccine but didn't look in the mirror until that time because I was very sick with flu-like symptoms for the two days immediately following (I wasn't concerned about that). I also noticed my heart really racing on the worst night of the flu symptoms. along with chest pain, which went away.
101 Fever with chills and shakes, heart rate around 100bpm, body  and head ache, pain down whole left arm, Bruit in left ear.
My symptoms started o n February 15, 2023 dizzy, light headed, vomiting, my diagnosis was Hypofunction of Vestibular nerve vomiting along with aura.
Knot in muscle below vaccine site. Also redness and warm to touch in left upper arm.  Symptoms disappeared after day 4 but returned day 8-9.  Some itching and splotchy skin.
Covid positive after immunization; Confusion; Pain; Impaired his ability to work; Eyes becoming hard sensation; Headache/Pain in head; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid positive after immunization), CONFUSIONAL STATE (Confusion), PAIN (Pain), IMPAIRED WORK ABILITY (Impaired his ability to work) and ABNORMAL SENSATION IN EYE (Eyes becoming hard sensation) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced COVID-19 (Covid positive after immunization), CONFUSIONAL STATE (Confusion), PAIN (Pain), IMPAIRED WORK ABILITY (Impaired his ability to work), ABNORMAL SENSATION IN EYE (Eyes becoming hard sensation) and HEADACHE (Headache/Pain in head). At the time of the report, COVID-19 (Covid positive after immunization), CONFUSIONAL STATE (Confusion), PAIN (Pain), IMPAIRED WORK ABILITY (Impaired his ability to work) and HEADACHE (Headache/Pain in head) outcome was unknown and ABNORMAL SENSATION IN EYE (Eyes becoming hard sensation) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported.  This case concerns a male patient of unknown age with no details relevant medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). The event occurred approximately more than 15 days after the dose of mRNA- 1273 vaccine, precise number of doses and schedule of vaccination unknown. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report. Sender's Comments: This case concerns a male patient of unknown age with no details relevant medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). The event occurred approximately more than 15 days after the dose of mRNA- 1273 vaccine, precise number of doses and schedule of vaccination unknown. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report.
Metallic Taste; Soreness to arm; This is a spontaneous report from a contactable consumer (patient).   A 50-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in Deltoid Left on 13Jan2021 03:30, at the age of 50-years-old, (Lot Number: EK9231) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included Sjogren's syndrome from 20Oct2014 and ongoing, gallbladder abscess (gallbladder removed) in 1997. Historical vaccine includes dose 1 of BNT162B2 received on 23Dec2020, 03:30, (at the age of 49-years) Intramuscular on Left Deltoid, Lot number: E49899 in which the patient experienced Metallic taste, Sore arm, malaise, chills, and nausea. Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL S) taken for Sjogren's syndrome from Oct2013; colestyramine (QUESTRAN) taken for gallbladder abscess from Nov1997; and paracetamol (TYLENOL 8 HOUR) taken for an unspecified indication from 04Jan2021 14:00.  On 13Jan2021 22:00, the patient experienced metallic taste and soreness to arm. The outcome of the events was recovered on 13Jan2021.  No treatment was received for the events.   No follow-up attempts are needed. No further information is expected.
patient developed a lump under her arm on Sunday. Monday she woke up with a rash all over her chest
Shot was given on 3/25 at 3:15 pm.  Began to itch on 3/26 at night. Entire upper thigh is swollen, red, and itchy.
This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that 90 percent of patients receiving SHINGRIX complained of sore arm. This 1 of the 4 cases reported by the same reporter.