chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose is Moderna Covid-19 vaccine and Primary dose as a Pfizer vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose is Moderna Covid-19 vaccine and Primary dose as a Pfizer vaccine) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose is Moderna Covid-19 vaccine and Primary dose as a Pfizer vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose is Moderna Covid-19 vaccine and Primary dose as a Pfizer vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. It was reported that the patient received her Primary dose as a Pfizer vaccine in los Angeles. No other information is known about these doses or adverse reactions. No treatment details were provided   This case was linked to MOD-2022-543462 (Patient Link).
pt recv vax  arm/shoulders sharp tightening pain has been non-stop;suspected rxn lt shoulder myalgia r/o muscular hematoma;
The patient received the vaccine at 16 years of age; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (The patient received the vaccine at 16 years of age) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced OFF LABEL USE (The patient received the vaccine at 16 years of age). On 07-Apr-2021, OFF LABEL USE (The patient received the vaccine at 16 years of age) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was reported.   This case was linked to MOD21-071309 (E2B Linked Report).; Sender's Comments:  MOD21-071309:Cross linked case
6/4/99 breakthrough disease-varicella;25-30 lesions noted had been given varivax 2/20/96;
Patient presented to the ED and was subsequently hospitalized for unstable angina within 6 weeks of receiving covid booster vaccination.
Complaining of rubber taste in throat after receiving 1st shot. Pt vitals remained stable throughout RRT. Pt released back to work, advised to come to the ED if symptoms worsened or persisted.
Rash on my abdomen; Scalp and palm were very itchy; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the arm right on 27Jul2021 at 19:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 as prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Jul2021 at 01:30, the patient woke up with a rash on abdomen and her scalp and palms were very itchy. The events resulted in emergency room/department or urgent care.  Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the reported events and included treatment with diphenhydramine hydrochloride (BENADRYL) and famotidine (PEPCID) from an unknown date. The clinical outcome of the events rash on abdomen and scalp and palm were very itchy was not resolved at the time of this report.
Within 4 hours of receiving my second dose of Moderna my period stopped completely. I was on day 2 of my period, which is my heaviest flow day, and I am extremely regular (25 day cycle and 7 day flow for the past 3 years without any birth control). I have never had a 2 day period in my entire life. My next couple of periods took a week longer to arrive.  I am an RN and I do not get my feathers ruffled about many things, but found this to be an abrupt reaction to the vaccine.
Headache, Myalgia, Rash & NauseaVomiting Narrative: used tylenol and benadryl for symptoms did not repot going to pcp
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 02-NOV-2012 at 10:43, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not provided. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0395AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Initial unsolicited misuse report received from a consumer (patient) via other company (Pfizer) (Manufacturer Report Number: 2016549962) on 13-Dec-2016. This case involves as 76-year-old patient (gender not specified) who was vaccinated with a double dose of INFLUENZA VACCINE (Batch number, expiry date dose form frequency route and site of administration not reported) on an unspecified date few weeks ago. Relevant medical history included allergies. Concomitant medications were not reported. On 22-Nov-2016, within four days of vaccination, the patient was down and out, was sick for two weeks had flu with fever, vomiting and coughing, cheeks were bright red. On an unspecified date, following vaccination, the patient had sinus congestion and pain, had allergy, cheecks were bright red. The patient reported of 'sinuses blew up' and being in terrible pain. It was a case 'extra dose of flu vaccine as patient received double dose. It was also a case of extra dose administered. Relevant laboratory investigations were not reported. It was reported that patient had unspecified labortory tests two weeks back. The patient received ibuprofen/pseudoephedrine hydrochloride (Advil Sinus congestion and pain) from 21-Nov-2016 to 22-Nov-2016 and Ibuprofen 200 mg as corrective medication. The patient received three shots of cortisone, pain shot and antibiotic shot. On an unspecified date, the sinuses were so bad and received three shots and one day before received two shots of advil. At the time of the report the patient was recovering ("Improved") from all the events. List of documents held by the sender: None
2 people developed alopecia after getting the vaccination; This is a spontaneous report from a contactable pharmacist.    A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date as dose 2,single  for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. It was reported that on an unspecified date the patient developed alopecia after getting the vaccination. At the time of the report the outcome of the events was unknown.  Information on the lot/batch number has been requested.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2022 at 11:13 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Mar-2022 at 11:13 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date and time of vaccination was provided as 19-Mar-2022 11:13:48 Patient received booster dose. Patient ethnicity reported. The patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022 and they  no longer possess this lot number.  No treatment medications were reported.
Two vaccinators were working together. One a trainee RN and the other a trained RN Vaccinator. The training RN drew up six syringes with COVID 19 vaccine for client use. Since the first client was known to the trainee vaccinator, it was decided that the trained RN would inject. She placed the needle in the clients arm and then noticed there was no vaccine in the syringe. That nurse reported it to the supervising RN immediately. The supervising RN and supervising MD at the clinic, went to the table. They observed five appropriately filled syringes on the table and still one dose left in the vial. The nurse was instructed to draw up the last dose and administer it to the client. A follow up phone call was made to the client on 3/6/21.
At 3:50 pm, patient complained of feeling dizzy, started vomiting of undigested food, as she stated she ate just before coming to COVID 19 event. Vitals B/P  82/58, HR 61, R 20 O2 sat 99%. Evaluated by EMT and this nurse.  Had patient to rest, gave sips of water and gatorade, and liquids tolerated well.  Second set of vitals taken: B/P 92/60, HR 53, R 20.  At 4:30 pm patient stated she felt much better, and released to parents.
This spontaneous report was received from a nurse and refers to a 16 month old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 27-SEP-2017, the patient was vaccinated with improperly stored RECOMBIVAX HB (dosing details not reported) (lot # N006321, expiry date: 08-NOV-2019) for prophylaxis. No adverse effects were reported. The administered vaccine underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011.
Received 2nd covid vaccine on 4/28/2021 Early morning hours on 4/29/2021, she developed nausea and vomiting She went to ER, was given deoperidol,  IV fluids, sent home with zofran ODT Came in to urgent care on 5/1/2021 because she was still having nausea and vomiting She was unable to keep anything down  Attempted to start IV x 3 attempts, but were unsuccessful she refused to go back to ER We administered phenergan 25 mg IM x 1 dose She was able to keep oral fluids down She was sent home with PO phenergan and rectal phenergan in case she couldn't keep PO down  *** she had similar reaction after first vaccine on 3/31/2021 but symptoms were mild*** ***Was + for SARS-CoV-2 in November 2020***
Date of exposure: 01/12/2022, Tested positive 01/15/2022. As far as symptoms, it started with a very dry throat. No matter how much I drank water, I could not alleviate it. That lasted about a week. I had a very slight cough, nothing to deep. No phlegm. Shallow type cough. I was fatigued. I was sneezing a ton, which is how it started. No muscle aches and no losing of taste and smell. Feeling run down, congestion, wasn?t producing a lot of snot or anything. Fatigue and congestion lasted for about 3 weeks total.
Pfizer shot made her tired and she had a sore arm; Pfizer shot made her tired and she had a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 01Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high diagnosed most of her life; "High cholesterol" (unspecified if ongoing), notes: High cholesterol diagnosed most of her life. Her liver produces too much but it is pretty even; "thyroid" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL HCTZ taken for hypertension. Vaccination history included: BNT162b2 (Dose #1: Pfizer-MRN (lmp-s) PF.30mcg/0.3mL dose Date: 08Feb2021 Lot: unknown NDC: unknown Expiry: unknown Dose: 0.3mL), administration date: 08Feb2021, when the patient was 70-year-old, for Covid-19 immunization, reaction(s): "Pfizer shot made her tired and she had a sore arm"; BNT162b2 (Dose #1: Pfizer-MRN (lmp-s) PF.30mcg/0.3mL dose Date: 08Feb2021 Lot: unknown NDC: unknown Expiry: unknown Dose: 0.3mL), administration date: 08Feb2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "Pfizer shot made her tired and she had a sore arm"; BNT162b2 (Dose #2: Pfizer Date: 03Mar2021 Lot: unknown NDC: unknown Expiry: unknown), administration date: 03Mar2021, when the patient was 70-year-old, for Covid-19 Immunization, reaction(s): "Pfizer shot made her tired and she had a sore arm", "Pfizer shot made her tired and she had a sore arm". The following information was reported: FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Pfizer shot made her tired and she had a sore arm".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Hives present on body from head to navel area; swelling around both eyes; mother notified and instructed to take child to emergency room for further evaluation.
Typically aches and pains middle of the night but started having nausea and led to persistent vomiting. Vomiting stopped for an hour and then occurred again accompanied by swollen abdomen. Finally stopped ~5 hours after it started.
Headache, greater than 15 aphthous ulcers cervical LAD (Lymphadenopathy)
Low grade fever (101 degrees F), chills, body aches, headache, fatigue, malaise, soreness at injection site? Took 1g acetaminophen to help with fever.
RASH RIGHT HAND, ARM, SHOULDER THAT HAS STARTED COMING UP ON LEFT ARM NOW.
Patient received Menactra vaccine without incident. Immediately following the Gardasil vaccine, he stated that he didn't feel well and nearly fainted, with his body falling forward. I was able to sit him upright in the chair and continue to keep him talking to me. After about 20 minutes he walked out on his own. He did not drive home, some one came for him.
This spontaneous case was reported by a physical therapist (subsequently medically confirmed) and describes the occurrence of CHILLS and VOMITING in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced CHILLS (Severe chills) and VOMITING (Vomiting). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, CHILLS (Severe chills) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.; 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.
This spontaneous report was received from a pharmacist refers to a 59 years old female patient who on 14-SEP-2012 was vaccinated an expired dose of PNEUMOVAX 23 0.5 ml intramuscular, left deltoid (lot number 0595AA, expiration date: 30-AUG-2012). No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Information has been received from the VAERS database via a journalist. This spontaneous report refers to a patient of unknown age. The patient was vaccinated with lot # (656606/0033U) ZOSTAVAX on 17-APR-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Feels Faint/sweaty. Did NOT lose conscious. Some neuropathy in arms and legs. Pulse 65, BP 102/59 Observed 30 min. Paramedics consulted. All symptoms resolved <30 mins.
Diagnosed with transverse myelitis, loss of sensation below rib cage, muscle weakness, leg spasms, nerve pain, cramps, currently in wheelchair. Progressive decline over course of a year resulting in loss of employment and financial hardship. Conventional treatments have been ineffective.
Pain in shoulder and neck muscles, stiff neck can not move neck right/left/up/down. Rib cage hurts very much can not breathe completely in/out, short breath.
Patient claims injection was given higher above deltoid and is believing to have adverse symptoms of bursitis and/or rotator cuff pain/inflammation.
Client reports that a few hours after vaccination he started experiencing heavy nose bleeds.  Epistaxis will stop for a few hours and then start again.  Epistaxis has been occurring regularly since 4/27 and is still occurring 4/30.  Client's mother called pediatrician's office on 4/29, spoke to NP she advised bleeding may be from weather change and advised saline rinses.  Client reports no history of epistaxis, reports headache, denies all other sx including rash, bruising and hematuria.  Client has appointment at clinic at 3:30pm on 4/30/21.
Information has been received from a registered nurse refers to a 13 year old patient of unknown gender. On 14-NOV-2014 the 13 years old patient (inappropriate age) was vaccinated with PROQQUAD, lot# and expiry date unknown, standard dose, subcutaneous; which was coded as "Inappropriate schedule of vaccine administered". No adverse effects were reported. Additional information has been requested.
Tired Dizziness right after.  8 hours later tired. Next day fever chills sweating migraine headache tired.
Left upper arm 3in x 3in warm, tender area fever 101 deg; BENADRYL/Ice
I was surprised at how sick I woke up with a sore throat on September 01, 2022. I completed a home COVID-19 test on September 3rd. It was positive. My symptoms progressed throughout that day. I was lethargic, fuzzy headed, had no energy and was extremely congested. I had cough and my throat was so sore that I could barely talk. I contacted the doctor on September 5th because the symptoms had gotten worse. I was treating the symptoms with over-the-counter medicine, but it was not helping. The doctor prescribed PAXLOVID which I started that evening. My sore throat was gone by the next day. Each day I felt a little better and I was not feverish again after the 5th day. The scratchy throat persisted for a month and the lethargy continued thru day 5. I have since made a complete recovery.
patient complained of shortness of breath of 3/22/2021 to primary care physician approximately 1 week post covid vaccine. CT Scan was ordered.  Confirmed on 3/26/2021 as Left Lower lobe occlusion and diagnosed with Pulmonary embolism.  On 3/26/2021 at Emergency department, he also showed bilateral PE with large clot burden.   Patient is hospitalized a this point since 3/26/2021 and has been treated for PE since.  He was discharged on 3/28/2021 and continue treatment as appropriate with Rivaroxaban.
some body aches, left deltoid area is slightly pinkish/little reddened and tender.
Headache, Myalgia, Fever, Fatigue Narrative:  Other Relevant History:
complaint of lethargy 10min post vaccination. Denies chest pain, SOB, palpitation, headache, lightheaded, rash.  BP: 154/103 HR: 74 Sp02: 98% RA Seen and cleared by EMS
Janssen COVID-19 Vaccine EUA.  The vaccine was given at 10:45 AM. At 4:00 PM I began feeling nauseous. At 9:00 or 10:00 PM I began feeling both muscle and joint pain on my upper body which made it somewhat difficult to sleep. After one or two hours of sleep at 1:00 AM I woke up with a fever, headache, and worse muscle and joint pain (upper body only). When I woke up I was sweating profusely that the bed was lightly wet and extremely hot from all the heat my body was letting go. An ice pack can relieve the headache and fever. However, I was still not able to sleep. At 4:00 AM I made the decision to consume 800 mg of ibuprofen and it took 20 minutes for my headache and fever to go away. Yet, after being able to sleep for 30 minutes, I woke up again to the same headache and fever. Around 10:00 AM the symptoms were partly gone and was finally able to get sleep after a long night.
I was sick the day after having the shot which saw me confined to my bed with trouble breathing flue like symptoms and a fever when the flu like symptoms subsided however I am left now with a tightness in my chest that hasn't gone away a numbness in my upper lip that I am unsure is related but started at the same time as the tightness did and a shallow/ somewhat labored breathing pattern. i am still able to get around just fine but the pain in my chest persists as does the odd lack of feeling in my upper lip
Resident received three COVID vaccinations.  04/30/21 Moderna- Lot #003C21A 05/28/21 Moderna- Lot #054C21A 07/30/21 Moderna- Lot #046B21A
Reported by the ER physician in generalized urticaria and sore shortness of breath.