chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am experiencing herpes zoster reactivation/ shingles; Right side of my face is inflamed with shingles rash; Right side of my face is inflamed with shingles rash; This is a spontaneous report from a contactable consumer (patient). A 41-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection; Lot Number: EW0171: Expiration date: was not reported), via an unspecified route of administration in left arm on 12May2021 15:00 as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previous vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection; Lot Number: EWO162: Expiration date: was not reported), via an unspecified route of administration in left arm on 21Apr2021 at 17:00 as 1st dose, single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received medication MULTI VITAMIN within two weeks of vaccination. On 06Jun2021 (with in four weeks), I am experiencing herpes zoster reactivation/ shingles, Right side of my face is inflamed with shingles rash, the patient received treatment included valacyclovir (x3 10days) & amoxicillin (x3 7days) for the events. Adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Patient's arm developed dark streaks, swelling, and a blister/boil that later opened. Seen by Dr 8/28/19, treatment and outcomes pending/unknown.
Moderna covid19 vaccine EUA dizziness and fatigue (lasting over 7 days), headache, sore arm, sore muscle that lasted for 2 days
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Fatigue
The pharmacist injected the vaccine too high up on my shoulder and caused inflammation of the bursa. Had pain and limited arm movement and swelling for 2 weeks. Went to doctor and she injected cortisone into shoulder and prescribed prednisone for a week to help with inflammation. Also has me doing arm exercises and ice on shoulder. Will see if this works.
Within 2 weeks of shot, patient developed acute shortness of breath and chest discomfort.  Ultimately diagnosed with PE/DVT
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Lot number: Fh8027) at the age of 41 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Hypertension" (unspecified if ongoing); "Pre-diabetic" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; METOPROLOL. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 29Apr2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Positive, notes: I began treatment same day as positive test result. Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible. No further information is expected.
Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) 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 HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
About 5 to 10 minutes after vaccination  she  started fainting and was unconscious for couple of minutes. We tried to engage the patient and called 911 . EMS came in and took care of the patient and patient left  the pharmacy without any problems . I called yesterday to find out how she is and she is doing fine.
expired vaccine used; This spontaneous report was received from other health professional referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 12-OCT-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant human albumin) (M-M-R II) lot # S032036, at a dose of 0.5 milliliter for prophylaxis (vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). The vaccine had expired on 10-OCT-2021 (expired product administered). Concomitant therapies included sterile diluent. lot #S024969, expiration date 17-MAR-2022.
She had needle prick pain then on 10/19 then it was better the next day until she did an intense yoga class and felt the pain in her arm. She it may be workout related but it not sure.
been 10 weeks since my first vaccine; 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 PRODUCT DOSE OMISSION ISSUE (been 10 weeks since my first vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (been 10 weeks since my first vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (been 10 weeks since my first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Reporter did not allow further contact
General body aches; soreness in the arm she got her vaccine in; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-APR-2023, the patient received the 2nd dose of Shingrix (unknown arm). In APR-2023, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site reaction/ caller is the patient and didn't want to give any demographics or AE specifics. She states that she got her second Shingrix vaccine 4/24/2023 and she is experiencing body aches and soreness in the arm she got her vaccine in). On 24-APR-2023, the patient experienced general body pain (Verbatim: General body aches). The outcome of the injection site pain and general body pain were not resolved.   The reporter considered the injection site pain to be related to Shingrix. It was unknown if the reporter considered the general body pain to be related to Shingrix.     The company considered the injection site pain to be related to Shingrix. It was unknown if the company considered the general body pain to be related to Shingrix.   Additional Information: GSK receipt date: 25-APR-2023 The patient self-reported this case. The patient did not want to give any demographics or adverse event specifics.
Nervous system involvement/Suspected neurological pain; Abdominal pain,she wakes up from this burning pain and the pain goes through the umbilical area; Burning pain located on her left side between her breast and her hip bone; Burning pain located on her left side between her breast and her hip bone; This spontaneous case was reported by a nurse and describes the occurrence of BREAST PAIN (Burning pain located on her left side between her breast and her hip bone), NEURALGIA (Nervous system involvement/Suspected neurological pain), ABDOMINAL PAIN (Abdominal pain,she wakes up from this burning pain and the pain goes through the umbilical area) and ARTHRALGIA (Burning pain located on her left side between her breast and her hip bone) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (1st dose) on 27-Feb-2021 and Pfizer (2nd dose) on 19-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concomitant products included VITAMINS NOS, VITAMIN C [ASCORBIC ACID] and PROBIOTICS NOS for an unknown indication.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced BREAST PAIN (Burning pain located on her left side between her breast and her hip bone), ABDOMINAL PAIN (Abdominal pain,she wakes up from this burning pain and the pain goes through the umbilical area) and ARTHRALGIA (Burning pain located on her left side between her breast and her hip bone). On an unknown date, the patient experienced NEURALGIA (Nervous system involvement/Suspected neurological pain). At the time of the report, BREAST PAIN (Burning pain located on her left side between her breast and her hip bone), NEURALGIA (Nervous system involvement/Suspected neurological pain), ABDOMINAL PAIN (Abdominal pain,she wakes up from this burning pain and the pain goes through the umbilical area) and ARTHRALGIA (Burning pain located on her left side between her breast and her hip bone) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After 12 hours of vaccination the patient started with abdominal pain which she describes as a burning pain located on her left side between her breast and her hip bone. She feels this pain every day. She was very concerned because she does not know when these symptoms will go away and she was in her reproductive stage of life. She was very scared to get pregnant because of these symptoms. The doctor diagnosed her in the latest days with nervous system involved. Suspected neurological pain might be due to Shingles. The nurse states that the pain was not severe but the patient feels it everyday. The nurse states that the patient does nor present any skin lesions. The patient has never tested positive for COVID 19.  No treatment medication was provided.
itchy rash on the neck, upper chest, and back; rash on the neck, upper chest, and back; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash on the neck, upper chest, and back) and RASH (rash on the neck, upper chest, and back) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information provided.  Concomitant products included APIXABAN (ELIQUIS) and FINASTERIDE for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (itchy rash on the neck, upper chest, and back) and RASH (rash on the neck, upper chest, and back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (itchy rash on the neck, upper chest, and back) and RASH (rash on the neck, upper chest, and back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included anti-itch ointment
NERVE DAMAGE (HAND WENT NUMB WITH ALL FINGERS TWITCHING) 48 HOURS AFTER VACCINATION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included carpal tunnel.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry date: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced nerve damage (hand went numb with all fingers twitching) 48 hours after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nerve damage (hand went numb with all fingers twitching) 48 hours after vaccination was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
PE. Pt was placed on therapeutic Lovenox and supplement oxygen which was weaned off and pt discharged home.
pt recvd vax 9MAY90 & ran fever of 102; convulsed; recvd CPR to revive; no almost 3 yrs p/has a severe sz disorder;
09/10/22 presents to ED for "fatigue". PMHx of "type 2 diabetes mellitus, diabetic peripheral neuropathy, diabetic nephropathy status post renal transplant, coronary artery disease"
soreness in my arm; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in my arm) and PYREXIA (low grade fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 031120A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in my arm) and PYREXIA (low grade fever). At the time of the report, PAIN IN EXTREMITY (soreness in my arm) and PYREXIA (low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102.         The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.
Sick; vaccine given by subcutaneous route; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine given by subcutaneous route) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination, COVID-19 VACCINE for COVID-19 vaccination and ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 02-Feb-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Subcutaneous) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 01-Mar-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Subcutaneous) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient received dose of COVID-19 VACCINE (Subcutaneous) 1 dosage form. On 25-Sep-2021, received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML Citrate free, Single Dose Pen. On 15-Jan-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine given by subcutaneous route). On an unknown date, the patient experienced ILLNESS (Sick). At the time of the report, ILLNESS (Sick) was resolving and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine given by subcutaneous route) outcome was unknown.      No concomitant medications were reported.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial. The reporter's causality for the event of sick with Adalimumab Solution for Injection, Pfizer BioNTech COVID-19 vaccine (Tozinameran) and COVID-19 vaccine (COVID-19 vaccine) was reasonable possibility. No treatment details were reported.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 28-OCT-2015, the patient was vaccinated with improperly stored (Oka/Merck) PROQUAD with lot number: L026728, expiry date: 15-JAN-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
It was probably about 30-40 minutes later after the shot, I started experiencing a headache. I went home and laid down. The next day it actually got worse. I took some ibuprofen that day and it helped it a little bit but still lingered on. I made an appointment for the doctor and told them what was going on. One day, I did have a dry throat, but I wasn?t sure if that was allergies. For the headache they gave me a Toradol shot and just in case it was some type of infection that was going on, they also gave me a prednisone med pack. He said if the headaches continue to take Excedrin migraine OTC. If it persisted, I would need to come back in. I called yesterday because I?m still having headaches so I?m waiting for the doctor?s office to respond. They told me I couldn't take ibuprofen after that Toradol shot for 24 hours. I started prednisone the next day after the Toradol shot. I also took Excedrin migraine medication 2 days after Toradol shot. Headaches are not consistent all day. Yesterday I woke up and I was fine until later on in the day. This morning, I woke up with it already starting the headaches. For the other 3 vaccines, I had no reactions at all. This reaction has been weird.
pt recv vax & devel a small area of redness @ one of the inj sites;the next day devel a 15 to 17cm area of warmth, swelling, pain & induration @ one of the sites & a fever of 102.2 w/shaking chills;
p/vax pt appeared to have sz lasting 15sec;body became rigid, color pale, circumoral cyanosis, jerking movements noted to upper extremities;BP 130/70, pulse 96;pt regained immed alertness, color pink;
Per patient, received three doses of Moderna COVID-19 on 2/2/2021, 3/2/2021, 11/22/2021; was subsequently diagnosed with COVID-19 at our hospital on 1/2/2022
This morning, Sunday, 03/28/2021 @ 10:00:00 A.M.. I woke up with a strained muscle  feeling in my left medial upper thigh!!!  Lateral to the pubic area. It feels like a strained muscle, tendon or ligament!!!
I had Pfizer's Covid booster. And, I'm a long term survivor of polio with minimal noticeable impairments. About 12 hours after the booster, I began to experience severe leg and arm muscle pain. The leg pain made it almost impossible to walk. The only relief I got was by stretching out on the bed and the pain subsided a bit but did not disappear. I sweated profusely and slept from 11 p.m. on Friday night until 9 a.m on Sunday 10/17. Today, 10/18/21, I'm still very wobbly.  To me based on the site of the pain, it seemed to mimic the polio. Is there a correlation? I have several friends who got the booster and no one experienced what I did.
Information has been received on 10-MAY-2017 regarding a case in litigation from a lawyer and a consumer concerning a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 27-JUN-2007 as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-JUN-2016, the patient was treated for a painful rash that was diagnosed as severe shingles. The patient was prescribed valacyclovir hydrochloride (reported as "Valaciclovir"), NORCO and ciprofloxacin for management of the excruciating symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
pt recvd vax & legs & arms were tonic; pt responded to PHN almost immed-was out for approx 10 seconds; father stated never happened a/; pt quiet, tired & nauseated during the p/noon; was fine evening 22OCT92;
Woke up out of a sound sleep with severe headache ,nausea and vomiting. Location of headache:Frontal, top of head, behind eyes. Severe pain. Different than her usual migraines. Had a brain bleed in 2013 so is familiar with how that felt and this felt very different per patient. Tylenol was taken and did help but not much .  Constant thing. Had  severe headache for 1 week. Dissipated and continues with it today. When had headache she was in bed . Only up to do her husbands medication. Was told to contact her PCP on 04/13/2021. Never had pain like this prior.  She took BP 04/14/21 and was 119/65. Waiting for MD call back.
Pt cranky 12JUN91 w/t102(R); 13JUN91 t103.4(R) 3AM; diarrhea x 3; 14JUN91 afebrile acting well, feeding well;
PER PATIENT'S HUSBAND, SHE HAD A "RED STAR PATTERN AND A LUMP ABOUT 1 INCH FROM INJECTION SITE, AND IT WAS WARM."
Initial misuse report received from a healthcare professional on 28 October 2013 and on 21 March 2014. A patient of less than 06-months-old of unknown gender had received FLUZONE intradermal. The patient received FLUZONE at an incorrect age. No adverse event was reported. The list of documents held by sender: None.
PATIENT REFERS ITCH (PRURITUS) ALL OVER BODY AND RASH AFTER RECEIVING THE VACCINE AND THE FOLLOWING DAY.