chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At end of visit, after Covid vaccine given, chart was reviewed and provider, CPNP realized that while this visit was scheduled as a 5 year PE,  Patient is not yet 5 (will turn 5 in 5 days). Discussed with PCP. Mom made aware of error. While clinically, no adverse outcomes are expected, mom aware that this initial dose likely will not count toward patient being "fully vaccinated." We counseled on returning for Covid #2 in 3 weeks and advised that he will likely need a booster dose later if wants to travel internationally or be considered "fully vaccinated." Mom understanding of error and agreeable to plan/recommendations. Incident report and VAERS report filed.
Patient given pediatric Pfizer Biotech Covid 19 2023-2024 6mos-4year dose.
Chills, fatigue, began during evening time (evening of vaccination day), lasted during the night. Chills went away in the course of the following day, as did fatigue. Unable to work much that day. Anecdotal evidence from others suggests that these are common side effects for second Pfizer Covid19 shot.
Pt. seen at urgent care 8-30-12 with redness, palpitations, lightheaded, fever, cough, SOB, rash, swelling 1 day after vaccines. Racing heart.
None After 1st dose on 2/13/2021; Very sick after 2nd dose on 3/13/2021.
After having no major reactions to two pfitzer shots, I decided to get my booster around 4:30 pm. I felt fine afterwards, went to bed, and woke up a few hours later covered in hives, itchy, and a swollen throat making it hard to breathe.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date the unspecified amount of clients were vaccinated with improperly stored VAQTA (lot# and expiration date not provided) (dose not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Severe diarrhea. High fever (over 102). Lethargy. Still treating at day 2 of symptoms.
fever blister; cold sore; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (fever blister) and ORAL HERPES (cold sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORAL HERPES (fever blister) and ORAL HERPES (cold sore). At the time of the report, ORAL HERPES (fever blister) and ORAL HERPES (cold sore) outcome was unknown.            No treatment medication provided. No concomitant medication provided.   Reporter did not allow further contact
SkinRash Narrative:  Patient presented to office on 1/5/2021 with complaint of an itchy, red rash/hives to her R lower abdomen. States rash began on Sunday, 1/3/2021. Denies SOB, fever, chills, swelling or other systemic symptoms. Denies recent exposure to known allergens or change in household products. States initially thought the rash may be fungal and was treating with topical anti-fungal and emollient, but neither provided any improvement. It is noted that patient received the Covid-19 vaccine 2 days before on 12/31/20. Patient denies any redness to injection site, itching or any other symptoms. Denies history of prior reactions to vaccines. Denies history of recent illness in month preceding vaccine. Patient did test POS for Covid-19 on 10/4/2020.
within 24 hours Hives, and transient Synovitis followed by high fever 103+ , 7 days later Balanitis and new set of hives
Patient received the FLUZONE HIGH-DOSE on the left arm on 9/14/15. On 9/15/15 evening, she came to the pharmacy and reported reswollen left arm with rashes.
Child immunized 8/8/02. Mom called 8/21/02 with complaints of heat, redness, itching, and leathery type area on right arm. Also states low grade fever after immunizations. Referred to PMD.
pt recv vax 8SEP95 on 11SEP95 had onset of febrile illness; 12SEP95 had a gen tonic-clonic sz; taken to hosp ER by rescue squad;
Information has been received from a registered nurse concerning a 17 year old female patient who on 08-APR-2008 was vaccinated intramuscularly with the second 0.5 mL dose of GARDASIL.  Concomitant therapy included an unspecified immunization.  It was reported that she then had blood work drawn and fainted after the blood draw.  The nurse mentioned that the parents believe that the patient had a seizure and that it was caused from the GARDASIL.  The nurse mentioned that the patient did not have a seizure.  The patient recovered in the office and was discharged home.  No diagnostic laboratory testing was performed.  The patient is going to be having an electrocardiogram performed for follow up.  The parents have requested that the patient not receive any additional doses of GARDASIL.  No product quality complaint was involved.  Additional information has been requested.
I received my second dose on Saturday Wednesday I was in the ER with a unexplained Cardiac event they could not determine what the cardiac issue was; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 42-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route , administered in Arm Right in Apr2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization.Medical history included depression, High blood pressure and covid-19. The patient had allergy to darvon [dextropropoxyphene hydrochloride]. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Left arm on 27Mar2021 10:00 AM as dose 1, single for covid-19 immunization and did not had reaction on previous exposure to drug. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19.On 21Apr2021 at 23:45 patient experienced Cardiac disorder. It was reported that she received her second dose on Saturday and on Wednesday (21Apr2021), she was in the ER (emergency room) with a unexplained cardiac event they could not determine what the cardiac issue. The patient was hospitalized for 6 days. The event resulted in emergency room/department or urgent care. The patient underwent lab tests which included sars-cov-2 test: negative on 24May2021 Nasal Swab. Therapeutic measures were taken as a result of event included heart attack measures were given. The patient recovered with sequelae.  Information on lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the cardiac event and the suspected vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  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.
Temporary numbness (around 3 hours) of left side of face (forehead to jaw)
Patient complained of excess runny nose, fever, chest congestion, and a general feeling of malaise and crabbiness for about 10 days after receiving the vaccine.
No additional AE information provided; lhe patient was administered an improperly stored dose of PNEUMOVAX; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions or allergies or medical history provided.   On 26-FEB-2020, the patient was vaccinated with a dose of improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, lot # S028601, expiration date 02-JUN-2021 (strength, dose, frequency, route of administration, were not reported) for prophylaxis. No additional adverse event was reported.  Since unknown date in September 2019, there were the multiple temperature excursion above 9 degrees Celsius, for a time frame of 30 hours. There was no previous temperature excursion. The digital data logger was involved.
itches hot; swollen like the size of a baseball; chills; itches hot; A spontaneous report was received from a consumer, concerning a female patient of 68 years old ,who received Moderna's COVID-19 vaccine and experienced   itches hot, swollen like the size of baseball raised, chills .  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 1-mar-2021  prior to the onset of events, the patient received their second doses of mRNA-1273 (lot number 032LZ0A) via intramuscular  route for COVID-19 infection prophylaxis.   after second dose of vaccine, the patient experienced itches hot, chills, swollen like the size of baseball raised, treatment medication include Benadryl and hydrocortisone cream.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event,  itches hot, chills, swollen like the size of baseball raised, was considered to be unknown at the time of this report.
Erythema and swelling in area to injection site of about 6 cm 1 day after vaccination, associated with itching.
Got shingles from the shingle shot/ Suspect vaccination failure; Got shingles from the shingle shot; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving 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.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient got shingles from the shingle shot and was suffering beyond explanation. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Initial report received from a healthcare professional on 19 September 2013. A 94-year-old female patient who had no illness at the time of vaccination and was allergic to aspirin, chocolate, weeds and tomatoes, had received an intramuscular dose of FLUZONE HD (dose number, lot number and anatomical site of administration were not reported) on 16 September 2013. On 16 September 2013 same day after vaccination, the patient felt ill and developed a severe rash on scalp and eyebrows and eyelids was swelled. The patient was feeling itchy on these areas. No Laboratory investigations were done and corrective medications were not reported. On an unspecified date, the patient had recovered from events. Documents held by sender: None.
reaction; red mark in the shoulder; pain in the arm / arm hurt; pain in the shoulder; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction), ERYTHEMA (red mark in the shoulder), PAIN IN EXTREMITY (pain in the arm / arm hurt) and ARTHRALGIA (pain in the shoulder) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction), ERYTHEMA (red mark in the shoulder), PAIN IN EXTREMITY (pain in the arm / arm hurt) and ARTHRALGIA (pain in the shoulder). At the time of the report, VACCINATION COMPLICATION (reaction), ERYTHEMA (red mark in the shoulder), PAIN IN EXTREMITY (pain in the arm / arm hurt) and ARTHRALGIA (pain in the shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.
Mother reported to our office on 08/12/08 that patient had a headache and nausea since injections on 8/6/08. Her mother felt it was from the HPV vaccine, however patient received 3 other vaccines as well. No fever noted. She stated she would be seeing her doctor that evening for a physical and would call me the next day. 2 messages left for mother but she never returned my call to let me know the outcome of the visit.
crawling up the stairs on my hands and knees and getting out of bed in agony; bulging disk; severe lower back pain; This is a spontaneous report from a contactable physician (patient). A 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician (who is also the patient), was asking about the Pfizer COVID19 vaccine for any reports of back pain or back problems/issues. The patient stated: "I got the Pfizer COVID-19 vaccine and got the second dose on Friday (08Jan2021). Over the weekend in Jan2021, I had pretty severe lower back pain that has continued. I had an MRI yesterday morning (12Jan2021) and it showed a bulging disk. I have had issues on and off over the years but nothing like this, ie: I am crawling up the stairs on my hands and knees and getting out of bed in agony. What's interesting is, I called a friend of mine and she had a similar reaction. She has a horrific neck issue and a history of minor lower back issues. She also got the second dose of the Pfizer COVID19 vaccine on Friday and over the weekend she was crawling on her hands and knees as well. That raises a red flag for me. I am trying to determine best treatment options for my back issue, either an epidural steroid or surgery or continue on this 'conservative stuff' (undefined) that's not working. I am meeting with my neurosurgeon tomorrow. Once I mentioned this connection to another person I know, he said he had someone complain of unbelievably severe back pain that lasted a few days." The physician (who is also the patient), also asked about the Pfizer COVID19 vaccine regarding any data on use with steroids and impact on mounting an immune response? If a systemic or local steroid is given, after the vaccine, will it inhibit the body's ability to mount immune response? The patient also asked about concomitant corticosteroids and if "Inhaled (except in Phase 1), topical, or localized injections of corticosteroids (e.g., intraarticular or intrabursal administration) were permitted. What were the percentage of patients on corticosteroids that were included in trials and any assessment off outcomes specifically for this group?" The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Expired Hepatitis A given. Expired 6/11/17. Given 6/14/17. Left thigh, lot # 4235D. Man. GSK. Mom aware pt need to come back for Hep A as this shot didn't count.
POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a health care professional concerned a 20 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201a21a, expiry: 23-JUN-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of poor quality drug administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210530455.
Right side of face - sensitive to touch - pain on top of scalp - headache - right ear and eye socket pain. Soreness in throat on right side. Starting on 5-22-12. Still has itchy eye, ear pain but better Dr. advised pt. to "wait it out."
Fever, chills, aches, headache, fatigue, muscle spasms that threw back out, now can?t walk easily  or stand straight  lots of muscle pain
Hep A #1 and Varicella given on 6/12/03. By 6/30/03 pt sent home for lethargy and fever. On 7/3/03 pt break out with blisters all over the body. Mom advised to use Calamine lotion over blisters, Tylenol prn, no ASA, Benadryl 25 mg every 12 hours prn for itching. RTN if not better.
Patient presents to clinic on 9/13/18. Patient states, "My left arm has been sore, hot to the touch, and a little swollen since a few hours after I got the shot," Denies any other complaints or prior injury to left arm. Reports she took 400mg MOTRIN on 9/12/18 with some relief. 4 inch area of erythema and warmth noted to area of left deltoid. Advised patient to report to ER if symptoms worsen.
she cannot attend for the second dose (first dose 19FEB2021, second dose 19MAR2021); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (she cannot attend for the second dose (first dose 19FEB2021, second dose 19MAR2021)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 19-Feb-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 (she cannot attend for the second dose (first dose 19FEB2021, second dose 19MAR2021)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (she cannot attend for the second dose (first dose 19FEB2021, second dose 19MAR2021)) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: received 2nd dose
Family called next day stating fever 104.4 & leg sore.  Advised to take to PCP/ER to have baby checked.
Marked swelling & erythema developed over about 12 hrs, which ranged from top of shoulder to about distal forearm. Area was not painful, but was pruritic & warm to touch. Pt developed low grade fever on 3rd post - vac. day. Treated with antihistamines & cool compresses, but started on OMNICEF when fever developed on 3rd post. vaccination day.
arm was hot; arm was red; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Feb-2021 and was forwarded to Moderna on 18-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm was hot) and VACCINATION SITE ERYTHEMA (arm was red) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE WARMTH (arm was hot) and VACCINATION SITE ERYTHEMA (arm was red). On 17-Feb-2021, VACCINATION SITE WARMTH (arm was hot) and VACCINATION SITE ERYTHEMA (arm was red) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: TCR was received on 13-JUL-2021 contains information about  Patient  Had the 2nd dose also without any issues
Severe muscle pain in legs (upper and lower) requiring 2-3x/day ibuprofen to control lasting 7 weeks. Mild muscle pain in upper legs (usually just above the knee, inner thigh) continues to date, but is slowly subsiding Shortness of breath - moderate for 6 weeks; continues to date but has improved.
When I woke up I was congested, fatigued, sore throat, and a headache.  I took a COVID-19 test immediately and it was positive.  I reached out to the Dr. that morning and had a virtual telehealth visit that afternoon, and they prescribed me Paxlovid. Benzonatate 200 mg capsule, and nasal spray and advised over the counter medication Tylenol, Mucinex, and throat lozenges.  The next day my symptoms got worse with fever, chills, fatigue, and a migraine.  I had symptoms for probably 5 or 6 days and on day 4/5 I started to feel better and finished the Paxlovid on day 5 and I probably had a day or two that I had a relapse on day 10 or 11 with runny nose, congested, and fatigued and that is were I am at now, not recovered but still experiencing symptoms and I am functioning.   I took another test and it is still positive.