chrisvoncsefalvay/vaers-outcomes huggingface dataset:
food allergies; auto immune disease (Epidermolysis Bullosa Acquista (EBA)); This spontaneous report was received from a consumer (patient's mother) via a company representative and refers to a female patient of unknown age. Her pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, lot number and expiration date were not reported). On an unknown date approximately in 2017 (reported as about 3 years ago), the patient developed a rare autoimmune disease called Epidermolysis Bullosa Acquista (EBA). On an unknown date, she also developed food allergies that she had never had before. The outcome of the events was not reported. The reporter considered EBA to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), as she believed that the trigger of the disease was from receiving the vaccine. The relatedness between the event of food allergies and the suspect therapy was not reported.  Upon internal review, the event of EBA was considered to be medically significant.
The most painful shots ever, but worth it.; This case was reported by a consumer via  interactive digital media and described the occurrence of pain in a adult 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 recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient reported that it was the most painful shots ever, but it was worth it. No other information was reported. For tolerance of 2nd dose, refer case US2021AMR073669.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073669:same reporter, 2nd dose
Patient received 2nd dose of Pfizer COVID-19 vaccine on 1/9/2021.   On 3/18/2021 patient developed cough, headache, nasal congestion.  Tested positive for COVID.
This spontaneous report as received from a pharmacist refers to his son a 20 years old male patient with no pertinent medical history and no drug reactions/allergies. The patient was intramuscularly vaccinated with 0.5 ml GARDASIL (Lot # and duration were unspecified) on 08-AUG-2012. No other co-suspects were reported. No concomitant medications were used. The father of the patient reported that his son was experiencing chest pain and back pain on 09-AUG-2012, "the day after receiving GARDASIL". The patient had sought medical attention via contacting his father who was also a pharmacist. No lab diagnostics studies performed. Treatment of ADVIL was given for the AE. The outcome was reported as not recovered/not resolved. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. In approximately September 2014 (reported as 2 months before the second dose), the patient was vaccinated with the first dose of RECOMBIVAX HB (lot #, expiration date, dose and route not reported). In approximately November 2014 (reported as 2 months ago), the patient was in the office to receive with the second dose of RECOMBIVAX HB injection, 1 ml (lot #, expiration date and route not reported), which was outside of recommended schedule for RECOMBIVAX HB. No adverse effects were reported. Additional information has been requested.
Rash on his arms, arm pits, chest and back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on his arms, arm pits, chest and back) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced RASH (Rash on his arms, arm pits, chest and back). At the time of the report, RASH (Rash on his arms, arm pits, chest and back) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Pt received VARIVAX 9/27/13. Came in 10/9/13 with Varicella disease.
03May21-daughter C/O obstruction in throat. upon view, left tonsil is enlarged, red, 'puffy', striated with white patches. Uncomfortable to swallow. slight runny nose, congested voice, puffy eyelids (slight). Went to urgent care, was tested for Mononucleosis and results positive.
1st Dose 4/15/21  - Given post Covid -  Rash on Forehead 2nd Dose 5/13/21 - Rash on Forehead worsened  3rd Dose 1/21/22 - (Booster) Rash covered entire face.  Prednisone prescribed multiple times.  Still getting rash as of 3/9/22
Vaccine administered to patient right away before defrosting; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION ERROR (Vaccine administered to patient right away before defrosting) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced VACCINATION ERROR (Vaccine administered to patient right away before defrosting). At the time of the report, VACCINATION ERROR (Vaccine administered to patient right away before defrosting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Light headache ( first day); nausea ( 3 days); severe fatigue (2 days); This is a spontaneous report from a contactable healthcare professional (patient). A 53-years-old female patient received first dose on bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number Bj1685, expiration date not reported), intramuscular, on the left arm, on 07Jan2021 at 15:00 at a single dose for Covid-19 immunization. Medical history included scleroderma, interstitial lung disease (ILD), and Raynauds. The patient's concomitant medications were not reported. The patient previously took erythromycin and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient is not pregnant. On 06Jan2021, the patient had a nasal swab with negative result. On 07Jan2021, the patient experienced light headache (first day), nausea (3 days) and severe fatigue (2 days). The patient had a nasal swab with negative result on 06Jan2021. The patient did not receive treatment for the adverse events. The outcome of the events was recovering.
Info has been received from a health professional concerning a 21 month old male with no medical history and no allergies who on 8/17/04, was vaccinated SC with a 1st dose of varicella virus vaccine live. Concomitant vaccine on an unknown date included MMRII. There was no illness at the time of vaccination. On 5/24/2005, the pt presented with 3 vesicular lesions and no other symptoms. Unspecified medical attention was sought. The pt is recovering. No product quality complaint was involved. Follow-up info indicated that on 5/24/05, the pt developed a mild fever with 3 vesicles. The child was "warm" per the mother. No labs or diagnostic tests were done and the pt recovered. Additional info is not expected.
Body aches/muscle cramps - severe chills, high fever (101F), headaches, shakes, stomach cramps. Lasting about 6 hours then just achy, tired for 24 to 48 hours.
Experiencing upset stomach, gas and diarrhea with a foul odor.  Symptoms are ongoing.
Missed second dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 immunisation.     The patient's medical history was not reported.  Concomitant products included METFORMIN for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided by the reporter.
Patient began breaking out in a small rash. Over the next month and a half the rash got worse and patient saw her MD on 3/3/2010. He prescribed a medrol dose pack and triamcinolone 0.1% cream. This was the first report of the reaction.
He became dizzy, diaphoretic, thirsty and very pale. Head fell backward. Immediately applied ammonia whiffs, lifted his legs up, applied ice to neck. Applied O2 at 2 L per N/C. Heart rate dropped to 40's and B/P to 89/43.  Gave water and apple juice and transported to a treatment area for evaluation.
Case number PHHY2011US27181 is an initial spontaneous case received from a medical assistant on 30 Mar 2011 with combine follow-up from a physician on 28 Apr 2011. This report concerns a 13-year-old male patient. He was vaccinated with MENVEO (batch number: 024011 and expiry date: Apr 2012) 0.5 ml intramuscularly on 21 Mar 2011. Later it was found that the Men A powder conjugate was inadvertently reconstituted with sterile diluent instead of Men CWY liquid conjugate. No adverse event was reported following this drug administration error. The patient was contacted for re-vaccination. Follow-up received on 28 Apr 2011: Updates reporter information.
Ache, headache, extreme fatigue, weakness, sore muscles, sinus drainage, dizziness
On 3/23, pt developed nausea (couldn't vomited despite trying), diarrhea, and blood in stool, so husband took her to  ER.  She ended up being admitted to the hospital, where she received abx, IVF, and analgesic med/s.  She was was discharged yesterday afternoon (3/25) with cefuroxime and metronidazole.  [Additional sx while at the hospital included slight headache and fever.  Only other sx noted was mild arm soreness (onset uncertain)]
high fever 101.0 to 103.2 and headache local reaction w swelling minimal redness
This spontaneous report as received from a Licensed Practical  Nurse refers to a patient of 13 months old child patient and unknown gender. On 04-SEP-2014 the patient was vaccinated with a dose of PROQUAD (lot K006771, expiration date 07-NOV-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Patient came to ED with hypoxia (85% on room air) and bradycardic.  Patient was admitted to the hospital with Covid and treated with remdesivir.
Lt delt where vaccine was given swollen and red  treatment: Doxycycline 100mg PO and hydrocortisone cream 1% outcome: effective
ADMINISTRATION OF EXPIRED VACCINE; INCORRECT STORAGE OF DRUG; This spontaneous report received from a health care professional concerned a 68 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 11-JUN-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced administration of expired vaccine. On 11-JUN-2021, the subject experienced incorrect storage of drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine and incorrect storage of drug was not reported. This report was non-serious.
Patient states she has red, splotchy areas on her face and it burns on her forehead and sides of her mouth
Administered 0.03mL instead of 0.3mL IM.  After the dose was  administered the error was noted but there was not enough vaccine left in vial to administer the remaining dose.  No adverse event or reaction. Will plan to administer remaining dose when we receive additional doses.
Tingly lips and around mouth Swollen bottom lip 10 minutes post infusion Right top of mouth tingly
Fever, stopped breathing went limp, believed to be febrile seizure 08/16/2005.
Approx 20 hours after dose (next day at noon) burning feeling left arm - bright pink in color. Red blotch on knuckles both hands by Friday 24th fading. Vision blurry better by Friday (only lasted about 6 hours after injection). No fever friend also had at same time and ok. Went to see doctor Thurs he did not know cause. No treatment given.
Hive like eruptions area of shot (DPT) posterior axillary L arm anterior
Fever 100 , headache, body pain, vomiting. dizziness, lasting 72 hours
Severe throat swelling & tightness, tightness Left chest, cold & shivering.  During the night, I was awoken with abdo pain & vomiting thee times.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or around 01-JUL-2017, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles. On 15-AUG-2017, she presented to her primary care doctor with "rash" and "rash back thoracic region" for which he prescribed VALTREX (one gram) and BACTROBAN cream. Diagnosis was Zoster. On 31-AUG-2017, she presented rash on her back "left thoracic region", with diagnoses supporting zoster and treatment including BACTROBAN cream and VALTREX. On 12-OCT-2017, her disease had progressed to "face rash - behind and inside left ear". On 20-DEC-2018, she was diagnosed and treated for "post-herpetic neuralgia". As a direct and proximate result of ZOSTAVAX, patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the condition. As a result of ZOSTAVAX, she sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Herpes zoster, herpes zoster oticus and postherpetic neuralgia were considered to be disabling. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were unknown. It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that a few patient had fever and chills from SHINGRIX.
Patient under age 16 was vaccinated with Pfizer, which is a vaccine error.  She is age 15 and will be 15 when she gets the second vaccine. Troubleshooting: Scribe and vaccinator did not validate age.  All parties ignored the age restriction/confirmation of birthdate that was put in place to prevent this type of error. Parent signed consent agreeing that she was at least age 16.
Muscle pain - all muscle areas; Chills; Fever; Loss of appetite; Nausea; Pain in the arm; Pain all over body; Tiredness; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in left arm on 13Mar2021 at 09:00 (at the age of 49- year-old) as a single dose for COVID-19 immunisation. Medical history included dysfibrinogenemia. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in left arm on 19Feb2021 at 14:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within two weeks prior to the vaccination. On 13Mar2021 at 13:00, the patient had pain in arm, pain all over body, tiredness, headaches, muscle pain- all muscle areas, chills, fever, loss of appetite and nausea. Therapeutic measures were taken as a result of events pain in arm, pain all over body, tiredness, headaches, muscle pain- all muscle areas, chills, fever, loss of appetite and nausea and included treatment with tylenol on day 2 after the second dose. The clinical outcome of events pain in arm, pain all over body, tiredness, headaches, muscle pain- all muscle areas, chills, fever, loss of appetite and nausea was recovered on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Patient felt light hearted approximately 3 minutes after vaccination, and regained consciousness within 15 seconds. Patient has a history of passing out with all vaccinations. Patient was treated by laying down, providing water and juice, and graham crackers.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  An 85-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 28Apr2021 at 01:00 as dose 1, single (Batch/Lot number: unknown) at the age of 82 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "CLL - Chronic Lymphocytic Leukemia" (unspecified if ongoing), notes: x 8 years. IVIG q 4 weeks.; "Known Allergies: Sulfa" (unspecified if ongoing); "Known allergies: Chocolate" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Meloxicam, reaction(s): "Known allergies: Meloxicam"; Lyrica, reaction(s): "Known allergies: Lyrica". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 31Aug2023 to 05Sep2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Patient's relevant medical history of "CLL - Chronic Lymphocytic Leukemia may be a contributing factor. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202300301862 same patient, different drug, different event;
PATIENT WAS GIVEN THE VACCINE ON 10/25/2017 AND CAME BACK TO THE PHARMACY AROUND 6PM ACCOMPANIED BY HER DAUGHTER.  SHE INFORMED THAT EARLY IN THE MORNING SHE WAS HAVING MUSCLE SORENESS AND SWELLING AT THE SITE IN THE MORNING HOWEVER NOW THE WHOLE FRONT ARM FROM SHOULDER TO ELBOW IS SWOLLEN, RED, WARM TO THE TOUCH. DR INFORMED THAT THE DOCTOR INSTRUCTED THEM TO GET BENADRYL AND INFORM US ABOUT THE ADVERSE EVENT. PT WAS SOLD BENADRYL  ON HOW TO TAKE IT AND TO MONITOR THE AREA.
my right eye - hurting; I developed pink eye in my right eye; my right eye - swollen; my right eye - would not stop watering; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Dec2021 17:15 (Lot number: 330268D) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, start date: 26Nov2021, stop date: 26Nov2021. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EP7533, prev dose lot unknown: False, prev dose administration date: 05Apr2021, prev dose number: 2, prev dose vaccine location: Left arm), administration date: 05Apr2021, when the patient was 26 years old, for Covid-19 Immunization; Bnt162b2 (prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EL9266, prev dose lot unknown: False, prev dose administration date: 15Mar2021, prev dose number: 1, prev dose vaccine location: Left arm), administration date: 15Mar2021, when the patient was 26 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021, outcome "not recovered", described as "booster"; EYE PAIN (non-serious) with onset 11Dec2021 04:00, outcome "not recovered", described as "my right eye - hurting"; OCULAR HYPERAEMIA (non-serious) with onset 11Dec2021 04:00, outcome "not recovered", described as "I developed pink eye in my right eye"; EYE SWELLING (non-serious) with onset 11Dec2021 04:00, outcome "not recovered", described as "my right eye - swollen"; LACRIMATION INCREASED (non-serious) with onset 11Dec2021 04:00, outcome "recovered" (2021), described as "my right eye - would not stop watering". Therapeutic measures were not taken as a result of immunisation, eye pain, ocular hyperaemia, eye swelling, lacrimation increased.  Additional information: The patient got booster on Wednesday. On Friday overnight she developed pink eye in her right eye, it was swollen, hurting, red and would not stop watering. As she was writing this the swelling and redness remains. The watering had stopped. The patient did not have covid prior to vaccination and not tested post vaccination. The patient did not have known allergy. The patient did not receive any other vaccine in four weeks and other medications in two weeks. Facility type vaccine was pharmacy or drug store.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101780454 Same product and event, different patient
Pt was given Pfizer vaccine as a 2nd dose, after receiving Moderna as a 1st dose approx. more than 6 weeks apart.