chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My 8-yo son received a second vaccine for the Pneumovax 23 from his allergist/immunologist on 2/4/2020. He initially had a local site reaction. Beginning the next day he began to have severe body pain and high fever with the site reaction spreading. On Wednesday, I was unable to control his fever, and went to the ER with a temp of 104.9. He had lightheadedness, headache, body pain, and the site reaction along with severe pain in his arm. They diagnosed as Cellulitis; as his flu swab came back negative and prescribed antibiotics as a prescautionary measure. I took him to his PCP who stated they believe it was a severe reaction due to the vaccine. In the research I have been able to find, the only site that listed any severe symptoms and/or reactions were on the website which identifies: Adverse reactions to Pneumovax 23 Pneumovax 23 vaccine is known to be associated with a high rate of local injection site reactions. The majority of these are mild, with redness, swelling, pain and a feeling of heat around the site where the injection was given and recovery within a couple of days. Some reactions can result in extensive swelling and pain that can limit the use of the arm. Cellulitis-like reactions and abscesses can also occur. Injection site reactions are very common but very severe reactions such as cellulitis-like reactions and abscesses are rare. More information about possible adverse reactions is available in the Pneumovax 23 Product Information (PI), which has recently been revised. I believe he had the cellulitis-like reaction as he is beginning to get relief from steroid and anti-inflammatory medications. While the muscle pain in his arm is still there, the site reaction continued to spread until the steroid was prescribed.
I am in the 15th week of pregnancy and suffer from partial seizures as well. I took a flu shot on 1/26/2013. FLUZONE 9 Mcg/Strain. The one without preservatives. After about 3 hr of taking the flu shot, I had a seizure and over the next 18 hr I had 5 more seizures at regular intervals. Please contact me for more details.
Headache inj site pain/swelling/redness Narrative:  day 1 - inj site pain; Day 3 - inj site swelling; Day 7 - headache; Day 8-12 - inj site secondary swelling and redness
tiredness, headache ( as soon as it was injected) joint pain, nausea, feeling unwell, left arm swollen  chest pressure, swelling of my face, eyes - watering - difficult focus, throat -  dizziness and weakness
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), in Sep2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing); "HBP" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Omeprazole; Enalapril. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jun2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. The patient had no known allergies. The patient did not receive any other medication in 2weeks. The patient took Paxlovid for COVID 19 Treatment. The treatment start date was reported as 01Jun2022 and stop date was 05Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt is under 18, given vaccine for >18 yo. no side effects were reported. pt only knew of the wrong vaccine when they went for the 2nd dose 11 months later
Shooting chest pains, delirium, dry mouth/throat with mild difficulty swallowing, severe weakness, severe fatigue, sweating.
3/14 - Cold feet, headache at 3pm; by 6pm severe chills, nausea, throbbing headache, extreme fatigue 3/15 - 2am woke up drenched in sweat; tired all day; headache; pain and itching at injection site 3/16 - fatigue; pain and itching at injection site itching at injection site still has continued through today 3/25; also today a square rash has developed on my forearm of the arm I received the injection
Redness, swelling, pain following day with fatigue. Same symptoms continued with growing redness, pain, warmth, itching, fatigue, mild headache and decreased appetite since 16th. Evaluated by CNP with diagnosis of cellulitis with cephalexin 500 mg TID x 10 days and recommended ice, Tylenol and benadryl.
Evening of 5/01/03 she noticed redness and swelling at site. Next day swelling from shoulder to elbow. Achy and sore inner aspect of entire arm. Took Motrin for symptoms. All symptoms resolved after 5 days.
results came back positive for COVID-19; results came back positive for COVID-19; This is a spontaneous report received from a contactable consumer. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 16Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was mentioned that caller, calling on behalf of her husband states that he received his 1st dose of the vaccine on 16Aug2021. He was scheduled to get his second dose of the vaccine 06Sep2021 but due to the holiday will be going tomorrow she states. In between his 1st dose and now, before receiving the 2nd dose of the vaccine, her husband had to be tested for COVID by his employer and the results came back positive for COVID-19 on an unspecified date in 2021. Caller would like to know if her husband can get his vaccination as scheduled tomorrow due to his recent diagnosis of COVID. Per the husband's place of employment, he was on quarantine until 02Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in 2021. Outcome of events was unknown  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Chills, body aches, & (R) arm tenderness at the injection site to not able to move her arm, & severe arm pain.
No adverse event; First dose on 18-Oct-2022 and second dose on 30-Nov-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18-Oct-2022 and second dose on 30-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Flulaval (Dose 1) on 15-Nov-2022. Past adverse reactions to the above products included No adverse event with Flulaval.    On 30-Nov-2022 at 11:48 AM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 30-Nov-2022 at 11:48 AM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18-Oct-2022 and second dose on 30-Nov-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18-Oct-2022 and second dose on 30-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18-Oct-2022 and second dose on 30-Nov-2022).    No concomitant medication was reported. No treatment medication was reported. On 18-Oct-2022, the patient received first dose of Moderna Bivalent Vaccine.   This case was linked to MOD-2022-672840 (Patient Link).
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age and sex. Initial information was processed along with additional information on 30-DEC-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: depression, and latex allergy. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 12-NOV-2021 in left arm for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included bupropion for depression.  On an unspecified date in 2022, the patient had COVID-19 infection (dose number in series 2) for which patient received non-company suspect Paxlovid (Nirmatrelvir) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 30-NOV-2022 for covid-19 treatment. Date of last dose of administration was 05-DEC-2022. On 12-DEC-2022, the patient experienced rebound of covid-19 symptoms and positive antigen test following Paxlovid treatment (confirmed covid-19 infection) which resulted to confirmed clinical vaccination failure (dose number in series 2). Laboratory data included: COVID-19 antigen test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000265166.; Sender's Comments: V0: 20221260930-confirmed clinical vaccination failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Pt presented to Health Unit with complaints of swelling, redness, and soreness at injection site.  Patient also complained of sore lymph node under armpit.  Patient had a TD and MMR in the left arm on 12/6/07 and states s/s began 12/8/2007 in the p.m.  Lt arm area assessed with redness all along the deltoid area reaching to the area of the  inner elbow, with swelling was also noted. Pt. also stated she had had a fever, but did not take her temp., so actual reading of temp. could not be obtained.
Syringe/Needle failure resulting in leakage of vaccine fluid prior to injections Patient received less than 0.3 ml dose
Feeling Dizziness and Light headed symptoms; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the arm right on 30Apr2021 at 09:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no past drug history. Concomitant medications included metoprolol tartrate (MANUFACTURER UNKNOWN) of 25mg and biotin (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the arm left on 09Apr2021 at 08:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation.  The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01May2021 at 05:00, the patient experienced dizziness and light headed symptoms seemed to go away during except when moved fast tilt head back look up look to the left or right, in the mornings the dizziness came back and lasted for a few hours. The clinical outcome of dizziness and light headed was not recovered.   No follow-up attempts are needed. No further information is expected.
First dose about three weeks ago; A spontaneous report  was received from a consumer, concerning a male patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient stated that he had received his first dose about three weeks ago without any side effects.  The patient's medical history was not provided. No concomitant product use was provided.  The patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) about three weeks ago without any side effects. On 25 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, it was reported that the patient received his first dose about three weeks ago without any side effects.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, Inappropriate schedule of vaccine administered was considered unknown.  Upon internal review on 13 Apr 2021, action taken with mRNA-1273 in response to the event was updated.; Reporter's Comments: This report refers to a case of Inappropriate schedule of vaccine administered for mRNA-1273, lot # unknown  with no associated AEs.; Sender's Comments: Kindly reassess the start date of first dose.
Patient given 0.3mls dose of pediatric Pfizer (orange cap) undiluted bivalent booster and not the adult (grey cap) Pfizer bivalent booster.
This spontaneous report as received from a consumer refers to a 66 year old female patient. Medical history, current conditions and concomitant medications were not reported. On 27-JUL-2017 the patient was vaccinated with ZOSTAVAX,VIAL 19400 PFU, (unknown lot number) 0.65 ml, subcutaneous for prophylaxis. On 29-JUL-2017, the patient experienced vaccination site erythema, headache, nausea, pruritus, vaccination site pain and vaccination site swelling. On an unknown date (i.e 5 days later) the patient experienced injection site erythema. The outcome of vaccination site erythema, headache, nausea, pruritus, vaccination site pain and vaccination site swelling was reported as not resolved. No treatment was given for the treatment. Causality was not reported.
This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 38-year-old male patient who received ENGERIX B (batch number 995J5, expiry date 6th February 2017). On an unknown date, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Office was sent a recall notification from their distributor regarding ENGERIX B and storage temperatures. The office has already administered the vaccine to 5 adults. Reporter is not certain what type of excursion took place (high or low temps). At this time, no reports to the office have been received from the patients following vaccination. Vaccines were given this week. Three female: 37, 62 and 52-year-old. Two male: 38 and 65-year-old. Follow-up received on 8 December 2014: Patient got ENGERIX B which was not stable. No adverse event reported.
vaccine leaked during the administration from the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site leaking in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 3K743, expiry date 7th November 2022) for prophylaxis.   On 27th February 2021, the patient received the 2nd dose of Shingrix. On 27th February 2021, immediately after receiving Shingrix, the patient experienced injection site leaking. On an unknown date, the outcome of the injection site leaking was unknown.   It was unknown if the reporter considered the injection site leaking to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, patient received the 2nd dose of Shingrix, and the vaccine leaked during the administration from the injection site. The reporter consented to follow up.
Narrative: COVID infection requiring hospitalization; although +antibody and neg antigen by the time presentation to hospital, likely 3 weeks out from initial infection by the time of admission on 5/1/21
This spontaneous report was received from a 60 year old female patient regarding herself. The patient refused to answer about her concurrent conditions or pertinent medical history. The patient was receiving unspecified concomitant medications and had no drug reactions or allergies. On an unspecified date in August 2017 (reported as mid-august), the patient was vaccinated with a dose of ZOSTAVAX and PNEUMOVAX 23 at the same time (lot#, dose, frequency and route of administration were unspecified for both vaccines) for prophylaxis. The patient reported that since she was vaccinated, she had been experiencing hair loss, and that after she received the vaccines she had a large bump near the vaccine site and it was warm to the touch. She sought for medical attention; however, no treatment was given for the aforementioned adverse events. No product quality complaint was involved. At the time of the report, the outcome of alopecia, vaccination site warmth and vaccination site mass was unknown. The relatedness assessment between ZOSTAVAX and PNEUMOVAX 23 and alopecia, vaccination site warmth and vaccination site mass was not provided.
Seizure activity, aggressive behavior, change in LOC, sent to hospital via EVAC for evaluation and treatment
I had headaches 3 ours after the vaccine along with body aches. The next day symptoms worsened My face swell up along with my body due to the vaccine. I got treated where I work here at medical group by one of the FNP  she gave me a Depo medrol shot for the allergic reaction I had.
Itching began on palms of hands, & within hours progressed to entire body, from scalp to feet.  No rash was observed however itching was persistent, day & night, to the point where I scratched my skin in several places to the point that I had bleeding.  One Benadryl tablet did not relieve itching,  so was required to take 50mg's several times, round the clock.  Talked with x2 PCP's, Employee Health RN, head RN.  Noticed not listed as usual side effect of vaccine, but was VERY hesitant about getting 2nd injection since reaction lasted approx 3 weeks, until PCP recommended that I take Famotidine 20mg bid, as well as Zyrtec prior & after 2nd vaccine.  This combo provided relief.
arm started itching; red rash around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (arm started itching) and VACCINATION SITE RASH (red rash around injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (arm started itching) and VACCINATION SITE RASH (red rash around injection site). At the time of the report, VACCINATION SITE PRURITUS (arm started itching) and VACCINATION SITE RASH (red rash around injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       relevant concomitant products usage were not reported by the reporter. Treatment details not included.
fever, muscle,  some difficulty breathing related to muscle pain. Fatigue, nausea, headache. Decrease some on day 2
10 year old felt dizzy and lightheaded immediately after getting Hep A and Gardasil for 5-10 minutes. Patient vital signs were stable BP=90/60, P=70, RR=19. Patient drank 1 glass of water and was back to looking normal within 10 minutes. Patient observed in clinic for 1 hour after vaccine given
Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.)  This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (patient) reported that a 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, lot number: EH9899, expiration date: 31Mar2021) on the left deltoid intramuscularly on 22Dec2020 08:24 at a single dose (30mcg/0.3mL) for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient reported she took the first Pfizer Covid-19 shot and is scheduled to take the second one today 12Jan2021. She had nausea and diarrhea and wanted to know if it's okay to go take the second vaccine, Pfizer Covid-19. The nausea and vomiting started on 11Jan2021 and she also had a headache, but the headache has resolved on 12Jan2021. She felt like crap. Nausea and diarrhea were reported as worsened. No other vaccines given at that time with the first dose. No vaccines 4 weeks prior. Received this vaccine at her workplace and they were very efficient and very quick. Did have a flu shot 30Oct2020. Provides flu shot Lot number of 33BN3 and expiry of 30Jun2021, left deltoid. Never had any problems with previous vaccines. No relevant tests done. No known allergies. Outcome of the event headache was resolved on 12Jan2021; nausea aggravated, and diarrhea aggravated were not recovered and unknown for the other events.
A 57 year old female with rheumatoid arthritis treated with Enbrel, methotrexate and ibuprofen reported that she received an injection of TD Toxoids Adsorbed. After immunization, she stated that her rheumatoid arthritis symptoms "felt better then got worse again". The pt reported that she had developed influenza, an eye infection and an ear infection approx. 4 weeks prior to immunization. At that time, her rheumatologist discontinued methotrexate therapy.
dose given 20hrs after vial expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given 20hrs after vial expiration) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002c21 and 002c21) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included LISINOPRIL for Blood pressure management, ATORVASTATIN for Cholesterol, INSULIN GLARGINE (TOUJEO) and GLIPIZIDE for Diabetes.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose given 20hrs after vial expiration). On 18-May-2021, EXPIRED PRODUCT ADMINISTERED (dose given 20hrs after vial expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-162276 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Additional information received on 30-06-2021 contain patient demographic