chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous prospective pregnancy report as received from a health care worker refers to a 17 year old female patient with no medical history and with no drug reactions or allergies. On 18-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot #: J009166, expiration date: 24-JUL-2014; subcutaneous, dose, anatomical location not reported) to prevent chickenpox. There were no concomitant medications. On 19-SEP-2014 the patient went to see the physician with a complaint of cough. While the patient was at the physician office, she mentioned that she was pregnant (first trimester of exposure). The date of last menstrual period (LMP), estimated delivery date (EDD) and the gestation age was not reported. There were no laboratory test performed. The outcome of "while she was at the physician's office she also mentioned that she was pregnant was" unknown. The pregnancy outcome was outcome pending. The outcome of cough was reported as not recovered/not resolved. There was no treatment given for the cough. The relatedness between the event of cough and (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
The first day of the shot went okay until 10PM, It was primarily in my head pressure like I was coming down with a cold, congestion in my ears and my head and then I got real sensitive on my head primarily typing and I feel like my fingers were not in proper, I had a little of dropsy in my right foot and I did not feel well but there was nausea and it was impeding coronation in my vision and coordination my finger when it came to typing so I just ended up going to bed, By the end of the day it was so strong that I stayed in bed. I have a home office and I couldn't even type from home. It had improved after 48 hours. Initially I didn't think it was related and thought it was a stroke but then it became clearly that it was due to the vaccination and my body did not like the booster.
After vaccinated patient to waiting room for 20 min to see if any side effects. Patient was dizzy and light headed. RN at side. Cool cloth and water given; Patient had not eaten all morning. Patient sent home with family when stable AM
Patient was given refrigerated Moderna that was expired beyond it's 'Beyond Use Label' date of 01/27/2022.  Vial was placed into fridge on 12/28/2021.  Vial was not removed from fridge in time for 'Beyond Use' expiry date and inadvertently administered.  Manufacturer's expiry date is March 25, 2022.  Provider informed.  Moderna informed and stated that 'the vaccine administered on January 28 to February 7, 2022 from lot number 033H21A maintained the activity necessary to protect against the SARS-CoV-2 (covid 19) virus at time of administration'.  Patient advised to vaccine administration and stated 'no concerns'.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.   In 2016, the patient was inoculated by a pharmacist with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by a physician for shingles. As a direct and proximate result of use of zoster vaccine live (ZOSTAVAX), patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
No adverse effect; Patient was administered with an improperly stored VARIVAX; This spontaneous case was received from other healthcare professional (nurse) referring to a patient of unknown age and gender. The patient's concomitant medication included sterile diluent. The patient's current condition, pertinent medical history, drug reactions/allergies were not reported. On 21-JUN-2019, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number S002874, expiration date 29-JAN-2021(strength, dose, frequency, route of administration were not reported) for prophylaxis which was improperly stored (product storage error). The sterile diluent used to reconstitute varicella virus vaccine live (Oka/Merck) (VARIVAX) was properly stored. No adverse effects were reported. Varicella virus vaccine live (Oka/Merck) (VARIVAX) underwent temperature excursion of 7.64 Fahrenheit in time frame of 20 minutes. There was no previous temperature excursion. The call was placed because of a data logger. There was no product quality complaint (PQC) present.
A report received from a health professional on 10/24/2002, concerning a 2 year old male vaccinee who inadvertently received Fluvirin vaccine on 10/17/2002.  The vaccinee experienced no adverse reaction. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/11/2002. One dose of Fluvirin was administered a second dose due one month later was withheld.
1.5 X 0.5 BLISTER AT THE INJECTION SITE.  Has kept the area clean and dry.  No signs of infection.  Site itches, but not enough to make her want to scratch it. The site was painful on 12/10/2011 and her neck was a little sore. No longer painful or sore.
multiple violaceous or erythematous papules with Wickham's striae and pigmented papules; macules on the upper extremities, lateral chest, abdomen, flanks, back, buttocks, lower extremities.; with itching; Possible side-effect of Moderna COVID vaccine; This spontaneous case was reported by a physician and describes the occurrence of LICHEN PLANUS (multiple violaceous or erythematous papules with Wickham's striae and pigmented papules), MACULE (macules on the upper extremities, lateral chest, abdomen, flanks, back, buttocks, lower extremities.), PRURITUS (with itching) and VACCINATION SITE REACTION (Possible side-effect of Moderna COVID vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE, LEVOTHYROXINE, LOSARTAN and METRONIDAZOLE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LICHEN PLANUS (multiple violaceous or erythematous papules with Wickham's striae and pigmented papules), MACULE (macules on the upper extremities, lateral chest, abdomen, flanks, back, buttocks, lower extremities.), PRURITUS (with itching) and VACCINATION SITE REACTION (Possible side-effect of Moderna COVID vaccine). The patient was treated with CLOBETASOL at a dose of UNK UNK, bid and PREDNISONE at an unspecified dose and frequency. At the time of the report, LICHEN PLANUS (multiple violaceous or erythematous papules with Wickham's striae and pigmented papules) and MACULE (macules on the upper extremities, lateral chest, abdomen, flanks, back, buttocks, lower extremities.) had not resolved, PRURITUS (with itching) had resolved and VACCINATION SITE REACTION (Possible side-effect of Moderna COVID vaccine) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatitis C antibody: unknown (Negative) unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable Patient's physician prescribed sunscreen with SPF 30 or greater and vitamin D rich healthy diet including supplements. Also NB-UVB phototherapy has been planned.
Headache, Fever, NauseaVomiting, POSITIVE COVID Test 7/22/2021 Narrative: POSITIVE COVID Test 7/22/2021
Blistering; Breathing difficult; Raw skin; Skin disorder; Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blistering), DYSPNOEA (Breathing difficult), SKIN EROSION (Raw skin), SKIN DISORDER (Skin disorder) and PSORIASIS (Psoriasis flare-up) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ) (COVID-19 VACCINE JANSSEN) for COVID-19 vaccination.   On 05-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received dose of RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced BLISTER (Blistering), DYSPNOEA (Breathing difficult), SKIN EROSION (Raw skin), SKIN DISORDER (Skin disorder) and PSORIASIS (Psoriasis flare-up). At the time of the report, BLISTER (Blistering), DYSPNOEA (Breathing difficult) and PSORIASIS (Psoriasis flare-up) had not resolved and SKIN EROSION (Raw skin) and SKIN DISORDER (Skin disorder) outcome was unknown.            It was reported that on an unknown date in 2022, the patient experienced trouble breathing. the patient still had plaque psoriasis flare up. She had spot on hands that were raw, blistering but not itching. she also got spot on bottom of feet. After taken covid booster of moderna in 2022, she was trouble breathing. It was unknown if she was enrolled in a covid-19 vaccine trial. Primary reporter does not had the lot number information, because the packaging was discarded. The reporter's causality for the event of blistering with skyrizi (risankizumab) was a reasonable possibility. the reporter's causality for the event of trouble breathing, spot on hands that were raw or spot on bottom of feet unknown onset, spot on hands that were raw or spot on bottom of feet unknown onset and plaque, psoriasis flare up was not provided.  No treatment information was reported.
cardiac issues; resting heartrate has increased by 10 beats; ability to do normal activities ceased; This is a spontaneous report from a contactable consumer (patient herself). A male patient of an unspecified age received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced cardiac issues. His resting heartrate has increased by 10 beats and he can no longer exercise due to extremely high heart rate. He had 3 years of data of my cardiac output prior to the shot and the day after his ability to do normal activities ceased. On an unspecified date, the patient underwent lab tests and procedures which included heart rate: my resting heartrate has increased by 10 beats. The outcome of the events was unknown.  No follow-up attempts are possible; no further information is expected.
Stevens-Johnson syndrome; Stevens-Johnson syndrome/lesions started to reappear; Information was received from a 34 year old male consumer, referring to himself. The patient's pertinent medical history included post-traumatic stress disorder. The patient's concomitant medications included ibuprofen(MOTRIN), sumatriptan, propranolol hydrochloride, venlafaxine hydrochloride(EFFEXOR) and gabapentin. The patient had no drug reactions or allergies.  On 19-JAN-2003, The patient received the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot#, expiration date, concentration and route unknown; 1 shot) vaccine for prophylaxis, and about 5 days following that (24-JAN-2003), patient developed bumps all over the body, including eyes and tongue, with low grade fever. Additionally, the bumps were really pronounced on inner thigh, legs, feet, arms, and back. The patient reported that she developed the Stevens-Johnson syndrome. On 27-JAN-2003, the patient was admitted to a Medical Center and was hospitalized for 2 days. Subsequently, the patient was prescribed an unspecified intravenous steroid. The patient stated that the steroids calmed it down, and a week later, the skin started to peel. The Stevens-Johnson syndrome was recovered on an unknown date. About 2 year ago (in 2017), the patient reported lesions started to reappear. The outcome of reappeared stevens-johnson syndrome was reported as not recovered/resolved. The reporter did not provide the causality between events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).  Upon internal review, stevens-johnson syndrome was determined to be medically significant.
headache, body aches, and nausea; No fever, no vomiting on night of 10/14.  s/s continued until 10/15, when child developed "twitching" and visual hallucinations of "dancing purple hearts"  Child was taken to hospital ED 10/15, dx: "viral respiratory illness."  Developed cough  on 10/16. No congestion, No fever, No stiff neck, no diarrhea.  Mother treating with tylenol.
Took first pill 11/15/04. On 11/16/2004 started having a headache and nausea. On 11/17/04 took second pill and vomited x 4 during the night. On 11/18/04 continues with a headache. No fever. Able to eat and drink. Tylenol help relieve the headache.
Left shoulder was sore on 10-13-14. The shoulder was more achy the next day. No redness or warmth. On 10-15-14 she began having problems moving her shoulder. On 10-18, 19, 20 and 21 she felt fine. On 10-21-14 the left shoulder woke her from her sleep and she problems moving her shoulder/arm. She is currently under treatment with her personal Physician and will be having an MRI of the shoulder.
Headache, fever of 100 degrees, fatigue, muscle pain, nauseous next day. Lasting muscle pain in hips, upper legs, buttocks that has not gone away.
Bad mouth taste for three days; Terrible heartburn one day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Cephalexin" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: TASTE DISORDER (non-serious) with onset 07Oct2023, outcome "recovered" (Oct2023), described as "Bad mouth taste for three days"; DYSPEPSIA (non-serious) with onset 07Oct2023, outcome "recovered" (Oct2023), described as "Terrible heartburn one day". Therapeutic measures were not taken as a result of taste disorder, dyspepsia.  Additional information: Patient received no other vaccine in four weeks and no COVID prior vaccination and not COVID tested post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
The case was received on 21 March 2014. Initial misuse report received from a healthcare professional on 16 October 2013. A 07-months-old patient had received 0.5 ml dose of FLUZONE on an unspecified date. No adverse event was reported. List of documents held by sender: none.
This case was reported by a physician and described the occurrence of myalgia in a 65-year-old female patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020). Concurrent medical conditions included hypothyroidism, iodine allergy, vitamin D deficiency, hyperlipidemia and pre-diabetes. On 14th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th May 2018, 1 days after receiving SHINGRIX, the patient experienced myalgia, headache, chills, and injection site erythema. On an unknown date, the outcome of the myalgia, headache, chills and injection site erythema were recovering/resolving. The reporter considered the myalgia, headache and chills to be related to SHINGRIX. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional information was reported as follows: The case was not reported for a medical device. No cosmetic product was involved. Follow-up and targeted follow-up was not requested. The case was not associated with any product complaint. The patient received SHINGRIX vaccine on 14th May 2018. On 15th May 2018, late morning the patient experienced diffuse myalgia's and injection site redness associated with headaches. The chills presented, the patient was bedridden all the day afebrile. On 16th May 2018 the events improved mildly.
itchiness; soreness on her arm; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itchiness) and PAIN IN EXTREMITY (soreness on her arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient did not have any allergies and never had COVID disease.  Concomitant products included LISINOPRIL for an unknown indication.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PRURITUS (itchiness) and PAIN IN EXTREMITY (soreness on her arm). At the time of the report, PRURITUS (itchiness) and PAIN IN EXTREMITY (soreness on her arm) had not resolved.            No concomitant medications were reported.  Patient still had soreness on arm and itchiness after vaccination with the second dose of the Moderna COVID19 vaccine one year ago.  No treatment information was reported.
administration of less than the recommended dose / due to a syringe malfunction the vaccine leaked during the administration / did not know how many milliliters the patient received; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 272F3, expiry date 1st October 2022) for prophylaxis.   On 8th July 2021, the patient received Shingrix. On 8th July 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the administration of less than the recommended dose of the Shingrix vaccine.  The HCP claimed that due to a syringe malfunction the vaccine leaked during the administration and the reporter did not know how many milliliters the patient received, which led to accidental underdose. The vaccine was administrated on the same day of the call.  No further events were reported.  The reporter consented to follow up.
Palpitations started with fever on 12/18/20. Palpitations continued for 3 days. Palpitations returned after the second vaccine was given on 1/7/21 and have continued since.  Holter monitor testing concluded the palpitations were PVC's and occur regularly throughout the day.  Started on metoprolol to control the palpitations in April 2021.
feverish the morning after the vaccine, chills, body aches, tiredness the day after the vaccine
raised rash that itched; raised rash that itched; a little feverish; a tiny bit nauseated; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (age: 60; unit: unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced raised rash that itched, a little feverish, a tiny bit nauseated on unspecified date. Rash was approximately 1.5in by 1.5in. Outcome of the events was unknown.   Information about lot/batch has been requested.
This initial spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions, or drug allergies/drug reactions described. On 15-OCT-2015, the patient was vaccinated with improperly stored (Merck) VARIVAX (lot# L006386 with expiration date 25-FEB-2017; dose and route were not reported. No adverse symptoms were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Fever of 103.1, Respiratory difficulty, muscle aches, dizziness, Headache and sore throat.  Took Advil to relieve fever which broke around noon on Tuesday.  Rest and lots of fluids.
2.8 x 1.5 inch erythematous area on Right thigh at inj site. Area warm non tender.
Stiff neck with reduced range of motion to 10 degrees left, 30 degrees right. Fatigue, chills, low fever. Tooth sensitivity.
101F fever; chills; headache; fatigue; swollen lymph nodes in armpit and right clavicle; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in right arm on 01Apr2021, at 15:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. The patient medical history included Obesity, Hypothyroidism and High blood pressure. Allergies to medications, food, or other products was reported as none. 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 concomitant medication included levothyroxine, amlodipine and rosuvastatin. The patient had not received any other vaccine within 4 weeks prior to the vaccine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) in right arm, on 11Mar2021 at 15:00 for COVID-19 immunization. On 01Apr2021, at 21:00 the patient experienced 101F fever, chills, headache, fatigue, swollen lymph nodes in armpit and right clavicle. The therapeutic measures were taken as a result of events include extra sleep, extra fluids and acetaminophen. The patient underwent laboratory tests and procedure included body temperature resulted in 101 Fahrenheit on 01Apr2021. The outcome of the events was recovering.  Information about batch/Lot number has been requested.