chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First vaccine given on 2/4/2021. Public Health. Spikevax. Lot: 016M20A. Intramuscular. Right Arm
a little pinkish; slightly uncomfortable; warm; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (a little pinkish), VACCINATION SITE DISCOMFORT (slightly uncomfortable), VACCINATION SITE WARMTH (warm) and VACCINATION SITE PRURITUS (itchy) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 041C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included CALCIUM and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (a little pinkish), VACCINATION SITE DISCOMFORT (slightly uncomfortable), VACCINATION SITE WARMTH (warm) and VACCINATION SITE PRURITUS (itchy). At the time of the report, VACCINATION SITE DISCOLOURATION (a little pinkish), VACCINATION SITE DISCOMFORT (slightly uncomfortable), VACCINATION SITE WARMTH (warm) and VACCINATION SITE PRURITUS (itchy) outcome was unknown.            Concomitant medications included everyday multivitamins and blood pressure medication.  Treatment details included Alcohol and itchy cream for itching.
A hour post vaccine: rash and itchy all over my body (10 am) At night: fever, chills and bones pain. Dizzy.  11:00 am next day (actual moment): still with fever, dizziness and fever
Erythematous papular rash felt be 2 hours to varicella vaccine.
got the vaccine and still got them / Suspected vaccination failure; still got them; Painful; 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got the vaccine 2 years before day of reporting and still got shingles. The patient stated it was painful lordy but not as bad as he or she thought. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Scar from ear to mouth, on her face, a wide scar; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 15:00 (Lot number: ER8731) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sporadic scarring" (ongoing), notes: Diagnosed with Sporadic Scarring, about 28 years ago. Concomitant medication(s) included: CORTISONE, start date: 13Apr2021. Vaccination history included: Bnt162b2 (First dose, Lot: EP6955, Location: left arm, Time: 2 pm.), administration date: 28Mar2021, for COVID-19 immunization. The following information was reported: SCAR (non-serious) with onset 22Apr2021, outcome "not recovered", described as "Scar from ear to mouth, on her face, a wide scar".  Additional information:patient states she got her second vaccine on Tuesday. Patient states that she was diagnosed with Sporadic Scarring, about 28 years ago. and it is scarring, that occurs for no reason. Patient states 50 people in the world were diagnosed with this, disorder. Patient reclarified, at the time she was diagnosed, she spoke to a Dermatologist, at (withheld) about her diagnosis. and it has not reoccurred again in 28 years. Patient mentioned that her son, developed a swollen arm after getting the Pfizer Covid vaccine, after his second shot. Patient states she has been taking the same medicine for many years and she hasn't had an incident, of scarring, so she does not think her medications are relevant to the report.   No follow-up attempts are possible. No further information is expected.
Pt recvd vax on 18AUG92 & w/in 10 minutes & devel localized reaction of itching, pain, hematoma & a hard lump @ the inject site;
Client was given Moderna at age 17. No medical reactions noted. Vaccine series was completed April 21, 2021.
Administered both vaccines. Patient was sitting upright during administration. After about 1 minute, pt fainted. I was able to catch patient and lay her down. Patients body twitched a several times before pt gained consciousness. Pt was unconscious for about 15 seconds. Dr. examined pt afterward. Pt rested in supine position for about 15 minutes following event.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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 was not reported. Other medication in 2 weeks/Concomitant medication(s) included: TRAZODONE; VENLAFAXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19, anti-viral details product: COVID 19 Treatment, Brand: Paxlovid treatment started 19Jul2022, indication: Treatment of COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Right arm became very sore the following day and remained extremely sore for about five days after receiving the first and final dose of the J&J vaccine.  On the day following the injection, I began developing a headache.  I didn't think twice about it until the headache didn't go away on the second day, the third, the fourth, but finally the fifth day it seemed to subside.  The intensity was severe and was concerning due to how long it lasted.  I had simply assumed that it was normal side effects.  Yesterday on Monday, 04/12/2021, I developed severe and sharp pains in my stomach/abdomen that actually put me in bed all day.
Lpn, Mix covid vial with 1.3ml of saline instead of 2.2ml, Patient received 2nd covid vaccine & 3rd. As per CDC patient doesn't need a 3rd vaccine since pt received a Higher concentrated dose.  no symptoms as per mom
Patient requested COVID 19 Moderna Updated Booster 12+ and by error the pharmacist administered 0.5mL of the COVID 19 Moderna Age 6-11. No adverse events was reported by the patient.
Initial report received on 20 November 2009 from a health care professional. A 20-month-old male patient received an initial right thigh dose of INFLUENZA A H1N1 2009 Monovalent Vaccine - No Preservative (lot number UT029BA) on 17 November 2009. The patient had concurrent illnesses, pre-existing medical conditions, and concomitant medications. That night after vaccination, the patient had a rash on his body. The patient was evaluated by a physician three days later with persistent rash, and at that time the patient had temperature of 100.0 degrees Fahrenheit. He was prescribed BENADRYL and PREDNISONE that day. There were no relevant diagnostics tests or laboratory data performed. At the time of the report, the patient had not recovered. Document held by sender: None.
test positive; test positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Apr2023, outcome "not recovered" and all described as "test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Apr2023) Positive, notes: When we got home we both tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Reporter stated that her husband and she were fully vaxxed and double booster with Pfizer products. On 20Feb reporter and her husband flew to (PRIVACY) visited (PRIVACY). 30Apr, the day they were flying home, they both woke up sick. When they got home they both tested positive. 01May they started Paxlovid and finished that 5 days later. On 08May, reporter recovered and her husband did not. Despite vaccines, they both were very sick although they did not required hospitalization. She had fever (moderate) for 4 days. Her husband had fever less than 2 days. Her relapse was like having a severe head cold. No fever.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300191485 same reporter/drug /event different patient;
no additional AE reported; expired dose was inadvertently administered; expiration date format confusion; This spontaneous report was received from a pharmacist and refers to a patient of an unspecified age or gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not provided.  On 11-JUN-2021, the patient was inadvertently vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA, lot # S015961 expiration date was provided and also validated as 23-MAY-2021 (dose, strength, route of administration and anatomical location were not provided) for prophylaxis (expired vaccine used). The vaccine was reconstitued in not expired sterile diluent (manufacturer unknown) (concomitant), lot # S032584, expiration date reported and also validated as 23-JUL-2022.  The pharmacist stated, that the vaccine format used for labeling the expiration date was confusing. It was listed as "2021MAY23", which caused him to think that the vaccine would not be expiring until year 2023, and therefore he administered an expired vaccine by accident (expiration date format confusion). No additional adverse event (AE) was reported (no adverse event). No product quality complaint (PQC).
I have had vertigo, throwing up, disequillibrium, need help walking, dizzy,
This spontaneous report as received from a health professional refers to a 15 months old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact does and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were not previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
administered Boostrix and Pentacel instead of Menveo; accidentally grabbed Pentacel and administered; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number B4C44, expiry date 10th November 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis and PENTACEL for prophylaxis.   On 18th October 2022, the patient received Boostrix, Boostrix Pre-Filled Syringe Device and PENTACEL. On 18th October 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced accidental overdose and wrong vaccine administered. On an unknown date, the outcome of the accidental overdose and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-Oct-2022 Reporter's comment:  The nurse reported that the patient was administered with a dose of Boostrix. The patient was also supposed to administer Gardisil and Menveo.  Instead of the Menveo, the nurse accidentally grabbed and administered Pentacel. The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter. Additional supportive information: The nurse administered Boostrix and accidentally grabbed Pentacel and administered, which led to accidental overdose and wrong vaccine administered.
Milder facial numbness and swelling; Milder facial numbness and swelling; extreme fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL0142, expiry date:not reported), dose 2 via an unspecified route of administration on 04Jan2021 as SINGLE DOSE for covid-19 immunisation. The patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EH9899, expiry date: not reported) via an unspecified route of administration on 14DEC2020 as SINGLE DOSE for covid-19 immunisation and experienced flushed swollen face, thick swallowing, mild facial numbness, gastrointestinal pain, nausea, extreme fatigue and mild joint pain. All resolved 2 days post 1st vaccine dose except mild facial numbness. The patient medical history was not reported. Concomitant medications included estrogens conjugated (PREMARIN) .625 mg daily for an unspecified indication for the past 18 years and ongoing, cetirizine hydrochloride (ZYRTEC) 5mg daily for an unspecified indication for more than 10 years and ongoing, levothyroxine sodium (SYNTHROID) 50mcg taken for an unspecified indication from Oct2020 and ongoing, multivitamins and calcium for the past 28 years. On an unspecified date, the patient experienced milder facial numbness and swelling, extreme fatigue. The outcome was events was unknown.  No follow-up attempts are possible. No further information is expected.
1st dose injection site tenderness.   2nd dose: injection site tenderness . Then about 9pm noticed a red raised bump. Next morning red raised bump, with  larger lighter red circle.  Injection site  slight pain with arm movement.
pain at the injection site; sluggishness; sore arm; injection site swelling; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included guillain barre syndrome (had Guillain-Barre syndrome about 15 years ago).   On 22nd April 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 22nd April 2021, immediately after receiving Shingrix, the patient experienced injection site pain, injection site swelling, sluggishness and pain in arm. On an unknown date, the outcome of the injection site pain, injection site swelling, sluggishness and pain in arm were recovered/resolved.   The reporter considered the injection site pain and injection site swelling to be related to Shingrix. It was unknown if the reporter considered the sluggishness and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient stated that she had recovered from a diagnosed of Guillain-Barré Syndrome (GBS). The patient received dose of Shingrix vaccine in left arm and experienced injection site soreness immediately after the vaccination that lasted several days. The patient also experienced injection site swelling that lasted about a week, sluggishness and sore arm. The patient stated that these side effects felt exactly the same as the effects of GBS when she had previously been diagnosed. The patient asked if the Shingrix vaccine could reactive GBS. The reporter consented to follow-up. No further information reported. For 2nd dose tolerance, refer linked case US2021AMR251606, reported by the same reporter.
On 7/17/17, patient was inadvertently given only the liquid portion of the MENVEO by a staff member, and did not receive the Group A portion of the vaccine. Patient returned on 7/20/17 to receive a full vaccine.
Vaccine leaked from the injection site. No adverse event occured. The dose was reattempted subcutaneously and was successful.
This spontaneous report was received from a medical assistant, referring to multiple unspecified number of patients of unknown ages and genders. The patients' concurrent conditions, medical history and concomitant medications were not provided. On an unspecified date in 2015, the patients were vaccinated with improperly stored doses of ROTATEQ administered orally (strength, dose, lot # and expiration date were not provided) for prophylaxis. It was stated that the vaccines were improperly stored at 34 Fahrenheit degrees for 15 hours and no digital data logger was involved. No adverse effects reported.
Headache, Myalgia, Inj site discomfort, hot flashes Narrative:
On 10/21/08 employee reports he had nausea, body aches following administration of tdap, and for the next two weeks had relatively severe sxs of fatigue, body aches, chills, nausea.   Has had to take frequent doses of ibuprofen, occasional 15 minute naps and for the last two weeks has had continued but milder sxs.  Notes he is under a significant amount of stress (changed jobs from clinic adminstrator to development/M and A, 11 month old at home, wife in med school) but that he has never had a similar reaction when stressed in the past.
Woke up the day after I got my first vaccine shot. Was nauseous and dizzy/unbalanced. This lasted for two days. Slight unbalance feeling still persists on day 5 after the vaccine.
Right swollen painful lump in armpit; This is a spontaneous report from a contactable healthcare professional (patient). A 42-year-old adult female patient  received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), via an unspecified route of administration on 26Dec2020 17:00 (reported as 5:00 PM) at single dose on the right arm for COVID-19 immunisation.  Medical history included asthma, thyroid cancer 2 years ago (2019) and shellfish allergies. The patient's concomitant medications were not reported. The patient previously took  gadoxetate disodium (EOVIST) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. COVID-19 vaccine was administered in the hospital. The patient experienced right swollen painful lump in armpit on 30Dec2020. It was unknown if treatment was received.  The event resulted in doctor or other healthcare professional office/clinic visit. The event was assessed non-serious. Outcome of the event was recovered with sequel on an unspecified date (reported as "Recovered with lasting effects"). The patient has not been tested for COVID-19 since the vaccination.  Information about lot/batch number has been requested.
Severe body aches 12 hours after vaccine. 102 fever 24 hours after. Rash on stomach, neck, chest, back and legs 24 hours later. Severe body aches continued after 24 hours. Severe headache 6 hours later and continued 24 hours later. Taking Tylenol OTC
About 7 min after my shot I stood up to walk into the next room and became very light headed and was ready to pass out. They immediately put me into a wheel chair but I wasn?t getting better until they laid me down in the stretcher. My lips turned blue and I think I was having an allergic reaction to the shot. It was hard for me to breathe before laying down on the stretcher my heart rate dropped and my blood pressure. It took me 30-40 min to come back to stand up and slowly walk out. My arm was super sore afterwards and I would have little shocking pain flashes in my chest. I felt tired and run down/ sensitive the rest of the night. The next day my arm was still super sore and I still feel very tired and run down.  The doctor on site took care of me and they put the stickers on me just in case they needed to revive me. I was sinking quickly but luckily when I laid down I got better.
FEVER; This spontaneous report received from a consumer concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 1 diabetes, non-smoker, and non alcohol user, and other pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, expiry: 29-SEP-2021) dose was not reported, administered on 23-AUG-2021 for prophylactic vaccination. Concomitant medications included insulin glargine for type 1 diabetes, and insulin lispro for type 1 diabetes. On 23-AUG-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.8 F, 102.4 F, 101.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Initial report received from a physician on 02 September 2011. A female patient experienced an "enormous site reaction" one day after receiving an injection of MENACTRA (lot not reported) on 30 August 2011. On 31 August 2011, she was hospitalized with an enormous site reaction, fever, chills, headache, nausea, and diarrhea. The patient had not recovered at the time of the report. No additional information was reported. Of note, the patient also had a site reaction after previous vaccination with Td.
Itchy, Hot, Raised, Red patch, Headache, Cough, Fever, Chills
Vomitting, nausea, stomach pain, mild fever, body aches, muscle cramps, muscle fatigue, chills, headache, extreme pain and discomfort at injection site. Vomitting, nausea, stomach pain, and headache subsided after 6 hours. Fever, body aches, muscle cramps and fatigue, and chills treated with ibueprofen, but symptoms still occuring at 11:45PM on 1-19-17.
Per office note of 1/22/14: 3 - 4 hours after shots (hib, PCV-13) on 1/25/14 developed a low grade temp (100), was very uncomfortable, woke with a high pitched scream, started to have a seizure which lasted about 3 - 4 minutes was limp when paramedics arrived. Temp up to 102 in ER, given TYLENOL/MOTRIN. Noticed a rash last night and red rosy cheeks.
Devel fever on 27JAN x 2 days; temp not taken, but felt hot; 29JAN devel rash over entire body; fine pin point rash no other sx;