chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This morning, he woke up very fatigued and tired.; This is a spontaneous report from a contactable consumer (Patients mother). A male patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown, Expiry date: Unknown) via unspecified route of administration on 21Apr2021 at SINGLE DOSE for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 for COVID-19 immunization. The reporter stated in morning, he woke up very fatigued and tired. Reporter was wondering if he can take Tylenol. The outcome of the event was unknown.  No Follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Pt developed vesicular papular rash 7/16/03. Seen in office 7/17/03.
pt presented to office 14OCT96 for vax update;grandma concerned & called 15OCT c/o swelling & dec grade temp, redness 16OCT appt made;
Back pain, tingling in fingers, weakness bilateral lower extremities, bilateral upper extremities. Pt treated with IVIG. Pt currently in rehab facility.
Severe soreness/pain in right arm at injection site and surrounding area. Unable to raise arm. This started approx. 6hrs after vaccine was administered. Flu-like symptoms (chills/fever/body aches) started approx. 8hrs after vaccine was administered. Flu shot was also administered the same day as the PPSV23. PPSV23 was given in right arm (same are where soreness was) Flu shot was given in left arm.
Huge over 2in knot is still red on both of our arms; hot on both of our arms; swollen on both of our arms; Huge over 2in knot is still red on both of our arms; This case was reported by a consumer and described the occurrence of induration in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid vaccine with an associated reaction of no adverse event (received COVID vaccine on an unknown date).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than an hour after receiving Shingles vaccine, the patient experienced induration, skin warm, swelling arm, and erythema. On an unknown date, the outcome of the induration, skin warm, swelling arm, and erythema were unknown.   It was unknown if the reporter considered the induration, skin warm, swelling arm, and erythema to be related to Shingles vaccine.  Additional details were provided as the case was reported by patient. The age at vaccination was not reported. The patient received shingles shot and the patient experienced 2 inch knot was still red, hot, and swelling on the arm.  The patient didn't experience the adverse event the COVID shot. The patient would get the follow up shot in a couple months but never again after that.  The patient stated that she saw that it was good for at least 4 years so not sure why some people were getting it yearly. This case has been linked with the case US2021AMR179310, reported by same reporter. Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179310, Same reporter.
428801 - Number given on Vaccination log - that day of the Vaccination dose 2. (Patient stated shortness of breath was another symptom that she had from COVID and is continuing somewhat especially when I was a mask for work -  but had not put it in the first report). Chills on Friday morning in the middle of night; woke up and my temp was 101.3 and I was feeling bad all day; had headache and went back to bed. Still have pain in hip/knee and joints and those pains got really bad after the vaccine - increased. Doctor  vist told me to use Ibuprofen to 3 times a day for that pain.  Shortness of breath continues from Covid symptoms and so does the hip/joint pain - it has decreased.
Diagnosed with C. difficile on 2/27/09 and 4/21/09
Patient experienced muscle pain at the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Patient experienced muscle pain at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (Patient experienced muscle pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Patient experienced muscle pain at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
Fever rose to almost 103 degrees, Rapid heart rate at about 150BPM, Vomiting.
Patient had developed severe rash that went down from chest down and it itched a lot around 9pm. They were about to take him to the ER, but he took 2 benadryl pills and was feeling better and was able to sleep. His wife reports that most of his rash disappeared except for the one on his arm which still itches, and he is still feeling bad.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 10Dec2022 to 16Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pfizer / BioNTech 05Jul2022/ Treatment of COVID-19  08Jul2022; Pfizer / BioNTech 05Jul2022/ Treatment of COVID-19  08Jul2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 05Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 was not reported. There were no concomitant medications. No other medication in 2 weeks.   The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Pfizer / BioNTech 05Jul2022/ Treatment of COVID-19 08Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jul2022) Negative, notes: Prior Negative result; (Jul2022) Positive, notes: Positive test following Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Rebound of COVID symptoms and positive test following Paxlovid treatment and prior negative result. COVID 19 Treatment included Paxlovid, treatment start date=08Jul2022 and treatment stop date=12Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received vaccine on Wednesday 8.14.19 at 0930. No reaction at the time.  Monday 8.19.19 patient arm became  red, swollen and hot at the injection site. Pain radiated down to elbow and up to neck and headache. Patient reports feeling fatigued and generally unwell. This is persisting today still - 8.21.19.  Patient  states injection site reaction was still increasing in size on Tuesday 8.20.19 - with redness extending over upper arm.  Today - 8.21.19 injection site reaction is approx 20mm, and it warm, red and painful to touch.
a patient received a Pentacel vaccine which was exposed at the actual temperature of 22.7 degrees Fahrenheit, which rendered it unsuitable for use with no Adverse event; Initial information regarding an unsolicited valid non-serious case received on 06-Jan-2021 from the other health care professional.  This case involves a 4 months old female patient who received a 0.5 ml second dose of QUADRIVALENT INFLUENZA VACCINE [FLUZONE] which was exposed at the actual temperature of 22.7 degrees Fahrenheit (lot number: UJ559AB, expiry date: 14-May-2021), via an unknown route at left vastus lateral on 29-DEC-2020 (Product storage error).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  List concomitant or no other vaccines not asked.  It was an actual medication error due to product storage error temperature too low (latency: same day).   At the time of reporting, the patient had no adverse event.  Description: Caller advised previously reported temperatures on inquiry: 00408503 were incorrect. The lowest temperature reached was 22.7 degrees F. Also advised PENTACEL was given to patient, wants to know how they should proceed. Should we re-vaccinate the patient who received Pentacel. He provides Adverse Event (AE) information: It is noted that 408503 did not contain AE information, as the reason documented in that case for the temperature excursion was a technical malfunction of the refrigerator.  Additional Description of event: The facility initially reported a temperature excursion of 32.5 degrees Fahrenheit and were cleared to immunize based on that temperature. However, on further review, it was discovered they made a mistake and the actual temperature the vaccines were exposed to was 22.7 degrees Fahrenheit. During that time period, three patients received vaccines that were actually unsuitable for use. The patient received a dose of Pentacel after the vaccine was exposed to a temperature excursion of 22.7 degrees Fahrenheit, which rendered it unsuitable for use.   Emergency Room/Doctor visit and date 29-Dec-2020. Administering physician Vaccine was administered by a nurse. Product used: Used. First time product used: No and Still using product: No.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
INJECTION SITE LOCAL REACTION---SWOLLEN, RED, HOT TO TOUCH---TYLENOL AND MOTRIN AT HOME
Patient described she had soreness/arm ache 15 minutes after the vaccine was given on 10/22/20. On 10/24/20 morning, she started to develop an extensive bruise from the left elbow to about one-third of the forearm. Patient reported no pain when she visited the pharmacy on 10/29/20. I recommended her to go visit the doctor right away. Patient developed no fever.
BURNING SENSATION LIKE SOMEONE SET THE INSIDE BODY ON FIRE; AWAKEN OUT SLEEP BY FUNNY FEELING THAT SOMETHING NOT RIGHT; SEVERE BODY PAIN ON TOUCH/PAIN WORSE THAN CHILD BIRTH; SKIN STILL SENSITIVE TO TOUCH; NUMBNESS IN FEET/LEGS AND HAND; TINGLING IN FEET/LEGS AND HANDS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no history of previous vaccinations and did not believe in vaccination. The patient was very healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 19-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-SEP-2021, the patient experienced burning sensation like someone set the inside body on fire. On 19-SEP-2021, the patient experienced awaken out sleep by funny feeling that something not right. On 19-SEP-2021, the patient experienced severe body pain on touch/pain worse than child birth. On 19-SEP-2021, the patient experienced skin still sensitive to touch. On 19-SEP-2021, the patient experienced numbness in feet/legs and hand. On 19-SEP-2021, the patient experienced tingling in feet/legs and hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation like someone set the inside body on fire, severe body pain on touch/pain worse than child birth, skin still sensitive to touch, numbness in feet/legs and hand, and tingling in feet/legs and hands, and the outcome of awaken out sleep by funny feeling that something not right was not reported. This report was non-serious.
Headache to top of left side of head and to left forehead above brow. Increased numbness and weakness of left lower extremity.
This spontaneous report was received from a medical assistant, referring to a 16 year old male patient. Information about concurrent condition, medical history, drug reactions/allergies and concomitant therapy were unknown. On 01-FEB-2017, the patient was vaccinated with a dose (it was unknown which dose was administered) of GARDASIL, 0.5 ml, intramuscularly (Lot # and expiration date not provided) for prophylaxis. At the next day, on 02-FEB-2017, the patient experienced rash on forearm, belly, chest and back (rash), Joint pain (arthralgia), was lethargic (lethargy) and he felt dehydrated after pushing fluids (dehydration). Subsequently, on 06-FEB-2017, the patient and his mother sought medical attention because the patient was experiencing " shooting pain from the head into the neck, shoulder, hands, arms and back ". There was no product quality complaint involved. At the reporting time, the patient had not recovered from the event. The causal relationship between vaccination with GARDASIL and the events was not provided. Additional information has been requested.
Warm and bulging around injection site within 2 1/2 hours later. No trouble breathing, itching none. Gave EPIPEN shot at 18:50 by 19:30 pain gone.
I received the Moderna COVID-19 booster on 1/2/2022. On 10/21/2022, I had just returned from my honeymoon. I was pretty tired, and I attributed my fatigue to travel. On 10/22/2022, I lost my sense of smell, so I took a home antigen test, which yielded a positive result. I then started taking vitamin C and zinc supplements, and I recovered about 3 days later. During my illness, I had a light headache, plus I had a fever one night. At the time of this writing, I have regained most of my sense of smell, though I can't smell spinach that has gone bad.
30 mins after injection of second dose a metallic/medicinal taste was discovered in my saliva.  Four hours after dose began feeling nausea.  Day 2 nausea and metallic/medicinal taste in saliva continued.  Metallic/medicinal taste in saliva stopped mid morning of day 2.  Day 2 experienced chills, headaches, elevated body temperatures, severe night sweats, and stiff body.  Day 3 headaches and stiff neck. Also injected arm was very sore during the two day experience.
This spontaneous report as received from a physician refers to a female patient of unknown age. On 18-OCT-2013 and 19-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis.       On an unknown date the patient experienced sore arm. The outcome of the event was unknown. The causality assessment was related.  The case was split from a legal case referring the same patient.; Sender's Comments:  US-009507513-2107USA008917: US-009507513-2111USA009925:
Myocardial infarction (open heart surgery required); Shoulder pain; Local injection discomfort, pain for couple of days; This is a spontaneous report from a contactable physician (patient).   A 73-year-old patient of an unspecified gender (weight: 86.18 kg, height: 176.5 cm) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6700) at single dose, on 22Feb2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. The patient previously, on 01Feb2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL9265) at single dose, for COVID-19 immunisation. After first dose, on an unspecified date, in Feb2021, the patient experienced shoulder pain. On an unspecified date, in 2021, the patient experienced myocardial infarction (open heart surgery required) and shoulder pain described as "patient had no fever just local injection discomfort, pain for couple of days, shoulder pain". The patient underwent lab tests and procedures on an unspecified date, which included multiphasic blood chemistry, brain natriuretic peptide (BNP), electrocardiogram (EKG) full blood count (CBC), and pulmonary function test: all with an unknown results. Clinical outcome of the adverse events was unknown at time of this report. Then, the patient received the third dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. 301458A) on 23Sep2021, at single dose, for COVID-19 immunisation.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to reported event of Myocardial infarction 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,Linked Report(s) : US-PFIZER INC-202101274881 Same patient and drug, different event separated in time;US-PFIZER INC-202101275260 Same patient and drug, different event separated in time
Wheals / at the site of injection; Swelling / at the site of injection; Soreness at the site of injection; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included neuralgia. Concomitant products included gabapentin.   On 29th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site wheal, injection site swelling, injection site pain and fatigue. On an unknown date, the outcome of the injection site wheal, injection site swelling, injection site pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site wheal, injection site swelling, injection site pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient had wheals, swelling and soreness at the site of injection and fatigue, which resolved in about 48 hours. The reporter consented to follow up. For tolerance of 2nd dose refer case US2020AMR232727. This case has been linked with US2020231829 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR232727:Same reporter. 2nd dose US-GLAXOSMITHKLINE-US2020231829:Same reporter
Wrong dosage form administered. Bi-valent peds dose given instead of pfizer primary series children. Adverse event reported so far is sore arm.
Pt reports feeling she is having difficulty swallowing.  States she feels like she has something in her throat and like her throat is dry.  Neck, Face Flushed.  Swelling around lips.  States tongue feels a little swollen.  Vocalization changed from initial intake. Requests sip of water.  Water offered.  States throat feels better but still feels "funny".    Observed for additional symptoms.  After 10 minutes patient continues to report feeling of something in the throat.  Cheeks flushed with faint peri-orbital swelling noted.   Following standing orders, 0.5 mg Epinephrine IM to right anteriolateral thigh given.  EMS called. Transported to Medical Center ED at 2:00 pm.
Narrative: Covid (+) 03/29 after receiving 1st dose of COVID vaccine (03/05/21). Scheduled to receive 2nd dose 04/01/21.
Blisters and severe rash on arms and legs,  itchy, red  and white. After second dose, rash spread to chest and under arms.
stumbled all over the place; pain at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of COORDINATION ABNORMAL (stumbled all over the place) and VACCINATION SITE PAIN (pain at the site of injection) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain at the site of injection).   On 05-Feb-2021, the patient experienced COORDINATION ABNORMAL (stumbled all over the place). The patient was treated with DIPHENHYDRAMINE CITRATE, IBUPROFEN (ADVIL PM [DIPHENHYDRAMINE CITRATE;IBUPROFEN]) for Adverse event, at an unspecified dose and frequency.   At the time of the report, COORDINATION ABNORMAL (stumbled all over the place) and VACCINATION SITE PAIN (pain at the site of injection) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Event outcome updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.