chrisvoncsefalvay/vaers-outcomes huggingface dataset:
large blisters erupted in 2 separate locations on arm of injection and several inches from injection site; This is a spontaneous report from a contactable consumer (patient reporting for herself). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1283, expiry date: unknown), via an unspecified route of administration on the right arm, on 10Jan2021 at a single dose for covid-19 immunization. Medical history included hypothyroidism, high blood pressure, high cholesterol and known allergies: wasp venom, jellyfish and hydroids. The patient is not pregnant. The patient was not diagnosed with COVID prior to vaccination and was not tested for COVID post vaccination. Concomitant medications included levothyroxine, valsartan, and simvastatin. On 11Jan20201, the patient experienced large blisters erupted in 2 separate locations on arm of injection and several inches from injection site. "I had used a heating pad on my arm the evening of the vaccination and noticed the blisters, ranging in size from 1/8 inch to 1/2 Inch and 1/8 inch high, after taking a hot bath the next evening. There are 2 groups with 2-4+ blisters and appear to be filled with clear liquid. They are not painful and do not itch." Therapeutic measure was taken as a result of the event. Outcome of the event was recovering.
Red rash at the injection site.  I had the same thing happen after round one (in opposite arm); however, the first time the rash was warm and itchy and showed up a week after vaccination.  This time the rash was just red.  It wasn't itchy, and it showed up 2 days after vaccination.  The first time the rash lasted 3 days.  This time it has resolved after 2 days.  The size of the rash both times is consistent - about 2" in circular diameter.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. It was reported that on 16-SEP-2010 and 24-JUL-2012 the patient was vaccinated intramuscularly with a first and a second 0.5 ml doses of GARDASIL respectively. Lot # for first dose was 660612/0229X, exp date 20-OCT-2010, for a second one lot # and exp date were not reported. No adverse effects reported. Additional information is not expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 22-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (DILUENT MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA001261: US-009507513-1808USA004379: Original Case : 1808USA001261 US-009507513-1808USA004376 :Original Case : 1808USA001261 US-009507513-1808USA004377: Original Case : 1808USA001261 US-009507513-1808USA004378: Original Case : 1808USA001261 US-009507513-1808USA004380: Original Case : 1808USA001261 US-009507513-1808USA004381: Original Case : 1808USA001261 US-009507513-1808USA004382: Original Case : 1808USA001261 US-009507513-1808USA004383: Original Case : 1808USA001261 US-009507513-1808USA004384: Original Case : 1808USA001261 US-009507513-1808USA004385: Original Case : 1808USA001261 US-009507513-1808USA004386: Original Case : 1808USA001261 US-009507513-1808USA004362: Original Case : 1808USA001261 US-009507513-1808USA004387: Original Case : 1808USA001261 US-009507513-1808USA004388: Original Case : 1808USA001261 US-009507513-1808USA004363: Original Case : 1808USA001261 US-009507513-1808USA004364: Original Case : 1808USA001261 US-009507513-1808USA004389: Original Case : 1808USA001261 US-009507513-1808USA004390: Original Case : 1808USA001261 US-009507513-1808USA004391: Original Case : 1808USA001261 US-009507513-1808USA004392: Original Case : 1808USA001261 US-009507513-1808USA001261: Original Case : 1808USA001261 US-009507513-1808USA004393: Original Case : 1808USA001261 US-009507513-1808USA004394: Original Case : 1808USA001261 US-009507513-1808USA004395: Original Case : 1808USA001261 US-009507513-1808USA004396: Original Case : 1808USA001261 US-009507513-1808USA004397: Original Case : 1808USA001261 US-009507513-1808USA004366: Original Case : 1808USA001261 US-009507513-1808USA004367: Original Case : 1808USA001261 US-009507513-1808USA004368: Original Case : 1808USA001261 US-009507513-1808USA004398: Original Case : 1808USA001261  US-009507513-1808USA004399: Original Case : 1808USA001261US-009507513-1808USA004400: Original Case : 1808USA001261 US-009507513-1808USA004369:Original Case : 1808USA001261US-009507513-1808USA004370: Original Case : 1808USA001261.
Information has been received from a physician concerning a 10 year old female with no known allergies who on 05-AUG-2008 was vaccinated with the second dose of VARIVAX (Oka/Merck) (lot no. 660826/0424X). There was no concomitant medication. On an unspecified date the patient developed red, swollen softball size spot at the injection site. The outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Information was received on 14-JUL-2017 from a registered nurse regarding a 38 year old patient of unknown gender. Medical history, concurrent conditions and concomitant medications were not reported. On 12-JUL-2017, the patient was administered a dose of VARIVAX (lot # L025206, exp 07-JUL-2017) (dose, route, and site of administration not reported). No adverse effects were reported.  The outcome of the event was unknown. Additional information has been requested. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1707USA009935: US-009507513-1707USA009936.
Pt called to report localized reaction - swelling "golf ball size", redness, firmness, & tenderness at site. Reaction same as with varicella #1, but states she is also experiencing itching at site - treating with BENADRYL.
Got the 2 Injection vaccine and still got them/suspected vaccination failure; still got them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported he/ she had darn things now. The patient got 2 Injection of Shingles vaccine and still got shingles. The patient did not knowwhat else to do as he/she was frustrated. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Pericarditis; Pericardial Effusion with surgical drainage; Fibromyalgia; Dose 1: 21Dec2020; Dose 2: 07Jan2021; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2021 at 08:00 as dose 2, single (Lot number: EL1284) at the age of 58 years, in right arm for COVID-19 immunization. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: Other medical history: High Blood Pressure; "High cholesterol" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medications included: ATORVASTATIN; LEVOTHYROXINE [LEVOTHYROXINE SODIUM]. Vaccination history included: BNT162b2 (lot number=EH 9899, administration time=09:00 AM, dose number=1, location=Right arm), administration date: 21Dec2020, when the patient was 58-year-old, for Covid-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 07Jan2021, outcome "unknown", described as "Dose 1: 21Dec2020; Dose 2: 07Jan2021"; FIBROMYALGIA (hospitalization, disability, life threatening) with onset 20Jan2021 at 12:00, outcome "recovering"; PERICARDIAL EFFUSION (hospitalization, disability, life threatening) with onset 20Jan2021 at 12:00, outcome "recovering", described as "Pericardial Effusion with surgical drainage"; PERICARDITIS (hospitalization, disability, life threatening) with onset 20Jan2021 at 12:00, outcome "recovering". The patient was hospitalized for pericarditis, pericardial effusion, fibromyalgia (hospitalization duration: 6 day(s)). The events "pericarditis", "pericardial effusion with surgical drainage" and "fibromyalgia" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of pericarditis, pericardial effusion, fibromyalgia. Adverse events were Pericarditis, Pericardial Effusion with surgical drainage, Hospitalization 1 week (as reported), recurrent Pericarditis, post vaccine syndrome (ongoing), Fibromyalgia. AE treatment: Surgical Pericardial drainage. The patient did not have COVID prior vaccination, was not COVID tested post vaccination. The patient had no known allergies.
Hip bursitis; Hip injury;  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): 21K-163-4188084-00 (Company).  A 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 74 years as dose number unknow, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (ongoing) (Batch/Lot number: unknown) at 15 DF 1x/day for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BURSITIS (medically significant), outcome "not recovered", described as "Hip bursitis"; JOINT INJURY (medically significant), outcome "not recovered", described as "Hip injury". The action taken for upadacitinib was dosage not changed. Therapeutic measures were taken as a result of bursitis. The patient had reported that she had new bursitis and something torn in her hip that required a steroid injection. Her orthopedic did not think it had anything to do with Rinvoq. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Causality for RINVOQ(UPADACITINIB): The reporter's causality for the event(s) of HIP BURSITIS and TORN IN HIP with RINVOQ(UPADACITINIB) was no reasonable possibility. Causality for BNT162B2: The reporter's causality for the event(s) of HIP BURSITIS and TORN IN HIP with BNT162B2 was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal relationship the possibility of causal association between the events Bursitis, hip injury and the suspect drug BNT162B2 cannot be excluded.    The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous case was reported by a non-health professional and describes the occurrence of URTICARIA (broke out in hives), FORMICATION ("skin writing"/crawling sensation under her skin), SKIN DISCOLOURATION (pink marks will last 30 minutes to 1 hour/eats a small snack, pink spots appear/presents at night or after eating his daughter will have pinkness that is flat on skin usually 30 minutes to 1 hour this lasts), PRURITUS (itching/scratching) and RASH MACULAR (skin spots were red/skin spots were dark pink) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 043B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced URTICARIA (broke out in hives), FORMICATION ("skin writing"/crawling sensation under her skin), SKIN DISCOLOURATION (pink marks will last 30 minutes to 1 hour/eats a small snack, pink spots appear/presents at night or after eating his daughter will have pinkness that is flat on skin usually 30 minutes to 1 hour this lasts), PRURITUS (itching/scratching), RASH MACULAR (skin spots were red/skin spots were dark pink), PERIPHERAL SWELLING (arm swelling), ERYTHEMA (redness) and INFLAMMATION (inflammatory response/histamine reaction). On an unknown date, the patient experienced VACCINATION COMPLICATION (had reactions). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Itching, at an unspecified dose and frequency. At the time of the report, URTICARIA (broke out in hives), FORMICATION ("skin writing"/crawling sensation under her skin), PRURITUS (itching/scratching), PERIPHERAL SWELLING (arm swelling), ERYTHEMA (redness), INFLAMMATION (inflammatory response/histamine reaction) and VACCINATION COMPLICATION (had reactions) outcome was unknown and SKIN DISCOLOURATION (pink marks will last 30 minutes to 1 hour/eats a small snack, pink spots appear/presents at night or after eating his daughter will have pinkness that is flat on skin usually 30 minutes to 1 hour this lasts) and RASH MACULAR (skin spots were red/skin spots were dark pink) had not resolved.    No concomitant medications were reported by the reporter.Most recent FOLLOW-UP information incorporated above includes:On 22-Nov-2021: follow up received and vaccination details updated , new events added , event outcome updated. On 22-Nov-2021: follow up received and new event added.
per mom, on airplane for vacation and had seizure like activity, was evaluated at the ED and all testing was normal
Symptoms-fever 99-very fatigued, pale skin lasted 24 hours, took him to CNP at clinic. Was not tested but brother tested positive for Influenza A-he received TAMIFLU for 10 days.
The covid bivalent was given to early. No reaction reported by patient. Guidelines changed after he received his first dose.
Systemic: Allergic: Rash Generalized-Mild, Additional Details: Pt also recieved Gardasil 9 and Flulaval on the same day as the moderan bi-valent booster. Unknown whether rash due to moderna, gardasil and flulaval. Pt said he took Benadryl at home and rash disappeared.  Advised pt to follow up with MD if needed.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 02/26/2023. I contacted my doctor to notify them that, I was positive. I took TYLENOL to help with my symptoms. As of today, I still have a cough.
Severe headaches; dizziness; nonstop nose bleed; early start and much longer; much heavier menstrual cycle; This is a spontaneous report from a Contactable Consumer or other non-health care professional (Patient).  A 48-years-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch No: Not reported/Lot Number: ER8734) via an unspecified route of administration, administered in Arm Right on 24Apr2021 12:30 PM (age at vaccination 48 years old) as dose 1, single for covid-19 immunization, at Pharmacy or Drug Store. Medical history included migraine. Concomitant medications included other medications within two weeks of vaccination was fluoxetine hydrochloride (PROZAC); bupropion (BUPROPION); sumatriptan succinate (IMITREX) all were taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. No other vaccine taken in four weeks of vaccination. It was unknown patient had covid-19 prior vaccination and not tested post vaccination. On 24Apr2021 at 22:45, patient experienced with severe headache, dizziness, non-stop nosebleed (Patient do not get nose bleeds) and early start and much longer/much heavier menstrual cycle. Information on whether patient experienced Covid-19 prior vaccination was unknown. No therapeutic measures were taken as a result of events. The outcome for the reported events were not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021555112 similar report from same reporter
On 9/29/2022 I starting experiencing  menorrhagia and painful bleeding from early morning. At about 10am I fainted at a restaurant and Emergency Services was called. EMT stated that my sugar was low ,my BP was 90/50 and my heart rate was low. At the ER they conducted a CBC and noted that my Iron was low however I am anemic. I was DX with Syncope and  was discharged that evening and instructed to take Acetaminophen  and Ibuprofen as needed. I have a follow up appointment with my PCP and Cardiologist.
Initial report was received from a consumer, who was also the patient, on 30 November 2012. A 53-year-old female patient had received a dose of TYPHIM VI (lot number, route and site not reported) and an injection of gammaglobulin on 03 October 1990. The patient wasn't sure but thought she may have received oral typhoid vaccine. The same day, the patient developed severe itching and broke out in a rash. To this day, 22 years later, the patient continues to get episodes of severe itching and "breaks out". From all the scratching, the patient developed sores on her body. The patient had no illness at the time of vaccination. The patient's outcome was not recovered. Documents held by sender: None.
1 week after 2nd Moderna vaccine patient developed arthritis with significant swelling in elbows, knees, back of neck, and hands for 2 weeks to date and still ongoing.  Given methylprednisolone in the emergency room
Rash on stomach; This is a spontaneous report from a contactable consumer or other non-health-care-professional (patient). A 24-year-old non-pregnant female patient received BNT162B2 (Pfizer COVID-19 Vaccine Formulation: Solution for Injection Batch/Lot number: Unknown Expiration Date: Unknown), via an unspecified route of administration, administered in Right Arm on 05Oct2021 (at the age of 24-year-old), as DOSE 1, SINGLE for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient received influenza vaccine via an unspecified route of administration, administered in Arm Left on 05Oct2021, at unspecified dose for an unspecified indication. The patient medical history was not reported. The patient had no covid prior vaccination. Concomitant medication(s) included Paroxetine; Buspirone Multi for her "Aller-flo" and Ethinylestradiol, levonorgestrel (SRONYX), all taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced drug hypersensitivity. Patient did not receive any other vaccine in four weeks. The patient experienced rash on stomach on 06Oct2021. The patient was not tested for covid post vaccination. No treatment was received to treat the event. Outcome of event was resolving at the time of this report.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I woke up on the 26th with cold symptoms. Stuffy nose, fatigue, scratchy throat. I tested negative for COVID on that day, but 2 days later tested positive. I had a virtual visit with my doctor and was given PAXLOVID. I am feeling better and better every day, the medication didn't seem to have much effect on the symptoms.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed a small rash 7 - 10 blisters at the injection site and a couple of other locations.
Shortened menstrual cycle of 21 days, despite taking oral contraception that normally regulates menses. Menstrual cycle has always been a regular cycle of 28-29 days.
Information has been received from an approximately 41 year old female who on 6/10/93, 7/14/93 and 12/14/93 was vaccinated with the 1st, 2nd and 3rd doses of Hep-B vaccine recombinant. In approximately 1993, lab evaluation revealed a "positive test for Hep-B". No further information is available.
Nausea, fatigue, body aches, swollen lymph nodes in right arm pit
Very sore red swollen arm,  down to the bend in elbow.  Sore and sensitive eyes.  all over ache and the flue like feelings. did not feel well.  I slept alot of 3 days two nights with fever and chills.   This is day 5 my arm is still slightly red and itches.
1st dose of Covid series was Pfizer and gave Moderna as the 2nd dose. At final check before giving the patient the vaccine, asked if Moderna was correct and they agreed. After vaccinating patient reported first one was Pfizer. Outcome patient was notified and had no concerns or side effects at this time.
All symptoms after 2nd dose. Aches in joints for one week, muscular neck/shoulder/thigh aches 26 hours after for 4 hours,  sore arm muscle at injection site 4 days, 26 hours after for 3 days swollen/painful lymph nodes under left armpit, hair loss has been occurring since 2nd dose and continues.
patient reported at 24 hours after injection pain at injection site and low-grade fever chills (did not give temperature).  after 72 hours, fever/chills went away, but injection site showed visible swelling and tender to touch.  swelling area was about 4x2 inch area around injection site.
Patient received the 2nd dose in the series on 12/4/19 and on 12/8/19 she had a small patch of blisters appear on the left side of her face.  She described the blisters as the same appearance as her husband's active shingles case a few years ago.  She said that the blisters dried and are improving on 12/11/19, when she brought this to our attention.
2 red flat non tender coal non-indurated areas on right thigh noticed 2/17/04. Symptomatic treatment with Tylenol or Motrin and Benadryl.
VACCINE WAS ADMINISTERED TO ONE PATIENT 15 HOURS AFTER THE VIAL WAS OPENED; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and 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: 1820095, and expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced vaccine was administered to one subject 15 hours after the vial was opened. On 03-JUN-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was administered to one patient 15 hours after the vial was opened and incorrect product storage was not reported. This report was non-serious.