chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 52-year-old female patient who received SHINGRIX (batch number T5242, expiry date April 2019). The patient's past medical history included shingles. On 21st April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved. The reporter considered the rash to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received vaccine in the left deltoid. The reporter stated that, the patient had a rash on her buttocks that looked like a shingles rash. The reporter stated that the patient has had shingles before and she stated that it looks like the rash she had when she had shingles. The reporter stated that the patient had not been diagnosed with shingles by a doctor for this event. The reporter did not have the original box to get the expiration date and provided the expiration date that was entered into the pharmacy's system when the patient received the vaccine. The reporter stated that their system forced them to put a shortened expiration date in the system so exact expiration date was not available, only month and year.
Mother reported left arm red and swollen for 4 days (incident reported on 3/11/08)
I received my Covid -19 vaccine on 09/29/2022. On 12/10/2022 I tested positive for Covid-19. On 12/09/2022 in the afternoon i felt sluggish, sore throat, and congestion. On the 10 symptoms gotten worse and I started to cough.  As the days progressed the symptoms got worse with added trouble breathing. I contacted my doctor and was prescribed medication. After five days I went and had another apt and was still having symptoms and was prescribed steroids for my lungs. After 6 days I did start feeling better.
not have immunity for the Varicella virus, despite receiving her immunization; Kawasaki Disease; This spontaneous report was received from a patient's mother and refers to a 6-year-old non-pregnant female patient. The patient had an allergy to aspirin. No information regarding her medical history or concomitant medications was provided.  On 06-APR-1996, the patient was vaccinated with varicella virus vaccine live (manufacturer unknown) (reported as an unspecified "Varicella vaccine") one dose for prophylaxis (exact dose, lot #, expiration date, route and site of administration were not reported).  On an unspecified date in December 1996, she was diagnosed with Kawasaki's disease and received an unspecified immunoglobin therapy as a treatment.   On an unknown date in October 2021, the patient had bloodwork performed, which showed that she did not have immunity for the "Varicella vaccine", despite receiving immunization (vaccination failure). The reporter additionally mentioned that the patient was "fertility" and at the reporting time was in the process of trying to get pregnant. The outcome of the events was not reported.  The causality assessment was not provided, however the event of vaccination failure was determined to be related to the suspect vaccine.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2111USA005479:
This spontaneous report was received from an other source and refers to a 5 year old male child patient. The patient's pertinent medical history, concurrent conditions, past drugs and drug allergies were not reported. On 02-MAR-2017, the patient was vaccinated with improperly stored live PROQUAD (lot # M001150, expiry date: 05-JUL-2017) for prophylaxis. It was reported that, the PROQUAD underwent temperature excursion in February 2017. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA005931: US-009507513-1704USA005932: US-009507513-1704USA005930:
Cellulitis right arm.  Pt is going to continue supportive care including Tylenol and Motrin to help with fever and discomfort.  May apply ice pack to that right arm.  Encouraged use of Benadryl to help with swelling and erythema in that area.
Fainted approximately 22 hours after vaccination, head knocked a dent into wall, no treatment sought
The area around the injection site began itching not long afterwards. The next day, around the injection site, I developed a raised, bright pink, itchy patch that measured about 3 x 5 inches.  It took about three-four days before it started to improve.  The rash eventually went away on its own, without any treatment.
pt seen in office today for itchy red spotty rash examined by NP dx with varicella
A report was received from a health care professional on 11/08/2002, concerning a male vaccinee who inadvertently received Fluvirin subcutaneously on 11/07/02. No adverse reaction was reported in relation to the incident. There was insufficient information to determine the reporter's causality assessment. Cross reference with: PJP200200731, PJP2002000743 and PJP200200728.
Fever  Chills Nausea Muscle pain Muscle aches  Joint pain  Shaking  Nervousness  Tremors
This spontaneous report as received from a physician refers to a  patient of unknown age and gender. On 24-APR-2015, the patient was vaccinated with improperly stored PNEUMOVAX (lot # K024976 exp date 09-JUN-2016) (dose and route not reported). The temperature and time of excursion was 1.11 degrees C for 64 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Hurt like hell (minimal side effects); This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR193077   Additional Information: GSK Receipt Date: 23-DEC-2022. Reporter's Comment: This case was received from consumer via interactive digital media. The reporter stated that first shot hurt like hell but side effects were minimal. The follow up would not possible, as no contact details were available. Additional supportive information: For tolerance of 2nd dose refer case US2022AMR193077.; Sender's Comments:  US-GSK-US2022AMR193077:Same reporter
serious hives in my upper chest area; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (serious hives in my upper chest area) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 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 URTICARIA (serious hives in my upper chest area). At the time of the report, URTICARIA (serious hives in my upper chest area) had not resolved.            No concomitant and treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
This case was reported by a physician via call center representative and described the occurrence of aseptic meningitis in a 63-year-old female patient who received RABAVERT. Concomitant products included RABAVERT. On 31st July 2016, the patient received the 2nd dose of RABAVERT 1 ml. On an unknown date, less than a week after receiving RABAVERT and an unknown time after receiving RABAVERT, the patient experienced aseptic meningitis (serious criteria hospitalization and GSK medically significant), headache (serious criteria hospitalization), unsteadiness (serious criteria hospitalization) and rash (serious criteria hospitalization). On an unknown date, the outcome of the aseptic meningitis was not recovered/not resolved and the outcome of the headache, unsteadiness and rash were unknown. It was unknown if the reporter considered the aseptic meningitis, headache, unsteadiness and rash to be related to RABAVERT. Additional details were reported as follows: The patient was vaccinated (post exposure) on 28th July 2016 for 1st of RABAVERT. The patient was then hospitalized on 1st August 2016 for, headache, unsteady feet, rash on both arms, and was still hospitalized due to aseptic meningitis. No further information was known to the physician.
As directed by allergist DR at hospital I premedicated myself with 50 mgs of Benadryl, 8 mg zofran and 20 mg of zyrtec an hour before vaccine.   I provided clearance letter to nurse who was doing registration and will administer the  vaccine  , I explained  prior reaction and escalation to ED due to adverse reaction on 4/24/21. Nurse went to medical section and nurse practitioner who treated me after first reaction was there.  We went over plan and in case of any reaction to raise my hand. Pfizer vaccine was administered at 12:13 pm.  I sat down and at 12:14 pm started burping,. Vomiting, itchiness, lightheaded and chest pressure. nurse practitioner took me to medical section and after 4-5 minutes symptoms were worsening he escalated and contacted EMS for transport to ED to be observed and receive medication.  At arrival to ED I provided premedication plan , allergist information and prior adverse reaction to first Pfizer vaccine.  Attending ED connected DR at hospital. I  was tested with IV, zofran, pepsic and Benadryl 25 mgs. Two  EKG were preformed and I was under observation for 5 hours and then discharged home. Instruction from attending physician at ED and DR at hospital after discharge take Benadryl every 6 hours, zofran 4 mgs every 4-6 hours as needed and zyrtec in the morning and at night.
VERY SICK; ACHES; TERRIBLE CHILLS; FATIGUE; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once a total administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced very sick, aches, terrible chills, fatigue, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from terrible chills, fever, aches, fatigue, and very sick. This report was non-serious.
Received Menactra 5/4/07 - per patient and mother. A few days after Menactra administered into the right upper arm, pt began to develop "reddish - purple bumps" that look like mosquito bites or welts; and was associated with pruritus. Itching tx with OTC Benadryl and lesions resolved. These transient itchy lesions only occur on the right upper arm near the site of vaccine administration. No other skin sites involved. These occurred at least 1 time per week since 5/4/07. The last episode approx 1 week prior to office visit on 7/25/07.
100 degree fever, nausea, aches  Still have hardened circle on my left arm from 1st shot
Information has been received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 05-OCT-2017, the patient was inadvertently administered with VARIVAX lot # was L043622, expiration date was 04-NOV-2017, (dose and frequency were not reported) and M-M-R II therapy type recombinant human albumin (rHA), lot #  M039914, expiration date  26-SEP-2018, (dose and frequency were not reported) with sterile diluent (manufacturer unknown) intramuscularly for prophylaxis (incorrect route of drug administration). No adverse event was reported. Follow up information has been received from an other reporter on 17-OCT-2017. The patient was a 8 years old female. She had no illness at time of vaccination and no pre-existing physician diagnosed allergies, birth defects or medical conditions. Both of the vaccines were the second dose. The vaccines were administered at a private doctor's office/hospital. The vaccines were given intramuscularly instead of subcutaneously. The patient's mother stated the patient was fine and tolerated the vaccines well. The outcome of the event was reported as resolved. Prescription drug treatment for the experiences was not required. Temperature excursion didn't occur as a result of a reading from a digital data logger.
Patient Noticed redness, swelling and pain on 1/31/18 at the injection site. She said that all those reactions were worse as of 2/1/18. Patient took a picture of her reaction on Thursday 2/1/18 and said she would watch to see if it went down but if it did not she would see a doctor about it. She was worried about cellulitis.
Resident of facility was in her usual state of health and found to have Covid infection on 01/01/2022.  She was placed on IV antibiotics on 01/14/2022 and had confusion throughout her stay.  Family did not want hospitalization.
Supraclavicular nodal swelling, left side; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 13May2021 at 12:00 (at the age of 14-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medication included ibuprofen (ADVIL) for unspecified indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. On 15May2021 at 12:00, the patient experienced supraclavicular nodal swelling, left side. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event supraclavicular nodal swelling, left side was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
he has received 3 Pfizer Covid19 vaccines in the past and has had mild Covid symptoms; he has received 3 Pfizer Covid19 vaccines in the past and has had mild Covid symptoms; 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 50-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "he has received 3 Pfizer Covid19 vaccines in the past and has had mild Covid symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: The patient started taking Paxlovid on 07May2022 for Covid infection. The patient stated that he has received 3 Pfizer Covid19 vaccines in the past and has had mild Covid symptoms. Caller states that he tried exercising yesterday and had to stop after 10 minutes due to his heart racing. Caller stated that his heart was racing also when sitting still, patient stated that he took his Paxlovid dose last night, but had not taken it yet this morning. Patient was wondering if he should stop taking Paxlovid due to his heart racing. Patient stated that he was not sure if he wanted to get Paxlovid, but read that it can stop long Covid, so he asked his doctor for it. Patient was asking if heart racing is a normal side effect of Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a pharmacy student concerning a 28 year old female patient who on 28-AUG-2009 was vaccinated with a dose of PNEMUOVAX 23 intravenously. There were no immediate adverse effects noted when the vaccine was received. Subsequently, later the patient developed an increased temperature and an increased respiratory rate. Medical attention was sought, the patient had an office visit. At the time of the report, the patient's status was unknown. Additional information has been requested.
Patient completed all 4 capsules. Called pharmacist to report bumps and itching on hands and feet. Skin is peeling.
After her first Moderna COVID vaccine administration she had flushing, gastrointestinal ( ie abdominal cramping, diarrhea) and urinary symptoms. The patient reported this via VAERS in Feb 2021.  After her second Moderna COVID vaccine administration, she developed muscle spasms, joint pain, dizziness and brain fog. Her symptoms have persisted over one month after administration of the vaccine.  She has had multiple ER treatments for evaluation of her symptoms.  She suspects she is having mast cell activation syndrome.
Pneumo injection site right deltoid on 10/15/03. Bruising 4 cm circle next day, then swelling at site, down arm to midforearm erythema extending 15" down arm, hot to touch. Also swelling into right shoulder and neck. Solemedrol 125mg IM on 10/17/03, Sx decreased in about 1 hour and resolved by 10/19/03.
Local reaction at site of injection. Redness, hot to touch x 2-3 inches began 2 d after injection and lasted 3-4 days.
Pharmacy called mom and told her that they gave the patient double of the dosage for her age group. She was suppose to be given 10 and they gave her 20
Chills, back pain, headache, mouth sores  started 2 days later.
Tinnitus starting 4 days after first dose of Pfizer Covid vaccine. Tinnitus is single toned, bilateral. Mild HA. Was Covid positive in December.
Student received H1N1 LAIV at 1:20 at school. Complained of tingling in mouth and tongue at 1:50. No swelling, hives or wheezing. Vital signs stable. Student observed for 1 hour, mother contacted . Student remained stable and went home with mother at 3:30pm.
Information has been received from a registered nurse refers to a patient (age and gender unknown). On 04-DEC-2012, the patient was vaccinated with 0.65 ml ZOSTAVAX (lot #670986/0730AA, exp: 17-AUG-2012) subcutaneously. No other co-suspects were reported. No concomitant medications were reported. On 04-DEC-2012, the patient received expired ZOSTAVAX. No adverse effects reported. Additional information has been requested.
Tested after being in close contact with a COVID + patient. Tested on 7/14/21. Sx onset was 7/15/2021 with cough, fever, chills, headache, sore throat, nausea, vomiting, abdominal pain, loss of smell & loss of taste.
Pityriasis Rosea  started 2 weeks after 1st dose (admin 11/26/21) spread much worse after 2nd dose (admin 12/17/21)-evaluated at PCP on 12/22/21 (diagnosis pityriasis rosea -rash much worse/spreading 12/20, had small patches started on 12/5)
Pt experienced left arm swelling with cellulitis and returned to physician. Pt was treated with Augmentin, Benadryl, and Motrin.
Strep and tonsillitis flare up immediately after the second dose. Symptoms began exactly 12-hours after the dose. No exposure to individuals sick with strep.
large wheal on neck 2nd dose;lasted 1-2 days but was not debilitating & then resolved;3rd dose will not be given;
Information has been received from a physician, via a company representative, concerning a 12 year old female patient, who on 22-MAR-2007 was vaccinated with a dose, 0.5ml, of Gardasil. The physician reported that on 22-MAR-2007, after the vaccination was administered, the patient "experienced dizziness and almost passed out." At the time of the report, it was unknown if the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Patient was hospitalized on 2/16/21 after receiving their first COVID vaccination. They also presented to the ED and subsequently were hospitalized on both 3/12/21 and 3/27/21.
1/22/2021 - One & one-half hour after shot, little finger on left hand was extremely painful and hot; painful to grip hand.  Took Tylenol & resolved in 4-5 hours. Eight-12 hours after shot - extremely sore arm; took Tylenol & resolved. 1/23/2021 - Latent asthma (no episode for over 2 years) started 24 hours after shot, continued for three days. 1/26/2021 - First-ever episode of Raynaud's syndrome - left hand -occurred during 15 minute walk in 40 degree weather while wearing sheepskin-lined suede gloves. 1/28/2021 - Minor arthritis in hip flared up to very painful & lasted about 8 days.
Prolonged weakness through body; Major headache on right side; Chills; Body aches throughout; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 20Feb2021 at 15:30 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetic. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 29Jan2021 at 09:15 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. On 21Feb2021 at 11:00, the patient experienced prolonged weakness through body, major headache on right side, chills and body aches throughout. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events prolonged weakness through body, major headache on right side, chills and body aches throughout was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.