chrisvoncsefalvay/vaers-outcomes huggingface dataset:
APPETITE ABSENT; WEAKNESS; FEVER 102.3; NAUSEA; LOOSE GREENISH STOOL; HEART RATE INCREASED; BODY ACHES; CHILLS; SLEEPING DIFFICULTY; FEELS AWFUL; HEADACHE; FLATULENCE; TIREDNESS; DIARRHEA; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included anaphylaxis to penicillin, accident, vomiting, hives, low blood pressure, hospitalised, on iv fluids, redness of arm, swelling of arm, fever, anaphylaxis to tetanus vaccine, reaction to pneumovax vaccine, whipple surgery, adenocarcinoma in situ in pancreas, urinary tract infection, and yeast infection. The patient was previously treated with benzylpenicillin for accident, tetanus vaccine for accident, pneumococcal vaccine, pancrelipase for pancreas adenocarcinoma, and for urinary tract infection.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the subject experienced flatulence. On 09-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced sleeping difficulty. On 10-APR-2021, the subject experienced feels awful. On 10-APR-2021, the subject experienced headache. On 10-APR-2021 03:00, the subject experienced body aches. On 10-APR-2021 03:00, the subject experienced chills. On 11-APR-2021, the subject experienced loose greenish stool. On 11-APR-2021, the subject experienced heart rate increased. On 11-APR-2021, the subject experienced fever 102.3. On 11-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 102.3 F. On 12-APR-2021, the subject experienced appetite absent. On 12-APR-2021, the subject experienced weakness. On APR-2021, the subject experienced diarrhea. Treatment medications (dates unspecified) included: acetylsalicylic acid, and oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness, flatulence, chills, body aches, sleeping difficulty, feels awful, headache, fever 102.3, nausea, loose greenish stool, heart rate increased, weakness, appetite absent and diarrhea was not reported. This report was non-serious.
Suspected vaccination failure; Shingles/ came down with shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included adalimumab (Humira) for rheumatoid arthritis.   Concurrent medical conditions included rheumatoid arthritis.   On an unknown date, the patient received Shingrix and Humira (subcutaneous) at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The action taken with Humira was unknown. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received shingrix vaccine and humira and experienced shingles. The reporter did not have the lot number information for humira because the packaging was discarded. The reporter's causality for the event shingle with humira was no reasonable possibility. No concomitant drugs taken by patient. No relevant medical history was reported. No known allergies were reported. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 06 May 2008 from a nurse. A 15-year-old (also reported as 14-year-old) female patient, whose past medical history was not provided, had received on 03 August 2006 a second intramuscular right arm injection of ADACEL (Lot # C2941AA), and a third left arm dose of VAQTA (manufacturer Merck, Lot number and route of administration was not provided). On approximately 18 April 2008, 624 days post-vaccination, the patient experienced persistent coughing with associated vomiting. On 02 May 2008, Approximately 638 days post-vaccination, the patient required evaluation by a physician and tested positive with a rapid pertussis test completed by state agency. Treatments received, and other diagnostic tests performed were not provided. At the time of this report, the patient was still recovering.
Could not breathe; Lightheaded and dizzy; Lightheaded and dizzy; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM9809), intramuscularly on Left arm on 06Feb2021 17:00, at single dose for covid-19 immunisation administered at clinic. Medical history included Hypertension. The patient's concomitant medications included Lisinopril at 40 mg, 1x/day (once a day) for high blood pressure. Family medical history and medical tests were none. No Allergies reported. On 06Feb2021, the patient experienced, She got the first vaccine on Saturday. She felt like she could not breathe and then felt lightheaded, but there was a firefighter that was with her to make sure she was all right. She seem like she was dizzy. Her weight was described as being between 173-175. She felt like she could not breathe, but it was not overbearing. She is supposed to go back for second dose on 27Feb2021, and she is scared and unsure. She takes blood pressure pills. She cannot think of the second medication. This occurred prior to taking the vaccine. She should remember the medications. The only medication she takes is the two high blood pressure pills. Additional vaccines administered on same date were none. Prior vaccinations (within 4 weeks) was none. Adverse events following prior vaccinations was None. The seriousness was reported as non-serious. The outcome of the events was resolving.  Information on the lot/batch number has been requested.
Pt developed peripheral poly-neuropathy approximately 3 weeks post 3rd vax coupled with demyelinating process such as Guillain-Barre syndrome. Was hospitalized (7 + days) and at the time of this report has not been discharged.  On annual follow up report received 05/30/2003, it is added: Pt received this vaccine on his Navy ship. The person I talked to said he must be okay because he is still on active duty on the same ship.
CONGESTION (NASAL); FEELING ACHY; This spontaneous report received from a patient (physician) concerned a patient. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s vaccination from an unspecified manufacturer (suspension for injection, route of admin not reported, batch number: unknown expiry: UNKNOWN) dose was not reported, 1 in total, (dose number in series: 1) for prophylactic vaccination and it was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, expiry: UNKNOWN) dose was not reported,1 in total, (dose number in series: 2), administered on 30-NOV-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient started getting congestion (nasal). On the same day, the patient was also feeling achy, however was totally fine (dose series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling achy on 02-DEC-2021, and had not recovered from congestion (nasal). This report was non-serious.
sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Single), for COVID-19 Immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: All of the patient's shots including the 3 boosters were Pfizer. The patient had absolutely no complicatins and had only sore arm after each shot. That made the patient want to always use the same company going forward.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300015071 same patient/event, different vaccine dose;US-PFIZER INC-202300035214 same patient/event, different vaccine dose;US-PFIZER INC-202300035213 same patient/event, different vaccine dose;US-PFIZER INC-202300035215 same patient/event, different vaccine dose;
Doses administered by pooling vials; got 12 or 13 doses from each vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Doses administered by pooling vials; got 12 or 13 doses from each vial) 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 WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Doses administered by pooling vials; got 12 or 13 doses from each vial). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Doses administered by pooling vials; got 12 or 13 doses from each vial) had resolved.        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. Treatment information was not provided.; Sender's Comments: This report refers to a case of wrong technique in product usage process for mRNA-1273.
Had fever 100-101 on 11/11/2003 following immunizations with Prevnar.  Gave Tylenol with good results.  Wednesday 11/12/2003 continued to have fever 101-102, face red, fussy, no appetite.  21:00 11/12/2003, child was "shaking" and face "turned blue".  Parent called 911 ambulance came and took child to hospital.  MD said child had reaction to "shot" and gave "antibiotic" for swollen thigh where immunization given.
erythema, swelling, tenderness & low grade fever involving entire upper rt arm (inj site) peaking 72hr p/vax;
Experienced pain in left foot (same side as vaccination) night of vaccination. Upon waking the following day, foot was swollen and red on top. Got worse and was very painful to walk on. In about 1 week, the redness and swelling started to go away.
Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced SINUSITIS (Sinus infection). At the time of the report, SINUSITIS (Sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs were not reported.  The reporter's causality for the event of sinus infection with Humira(Adalimumab) was no reasonable possibility.  No treatment information was provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of retrospective clean-up activity received in the Moderna were missed to be booked-in.
tested positive for covid-19after the 1st dose.; tested positive for covid-19after the 1st dose.; This is a spontaneous report from a contactable Pharmacist reported that a female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unspecified route of administration on 02Mar2021 as a single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. It was reported that the pharmacist asked if she can administer the covid-19 vaccine to her patient who tested positive for covid-19 after the 1st dose on an unknown date in Mar2021. The patient got the 1st dose last 02Mar2021 and is scheduled for 2nd dose on 30Mar2021. The outcome of the events were unknown.; Sender's Comments: The contribution of the suspect drug to the onset of event 'drug ineffective' cannot be ruled out since drug efficacy varies from one patient to another and affected by different factors.
The patient found about 3 new bumps this morning; rash from head to foot/ rash started on her neck and back.; Itching; going crazy; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in arm left on 16Feb2021 (at the age of 82-years-old) as dose 1, single for covid-19 immunisation. The patient medical history included allergy to penicillin. There were no concomitant medications. On 26Feb2021, the patient experienced broke out in a rash from head to foot. The patient said that the itching and all has slowed down but she was still breaking out all over her body. The patient found about 3 new bumps this morning (01Mar2021), the rash was quieting down, no itching or nothing. The last few days the rash has quieted down, she was going crazy. The rash started on her neck and back. Right after she received the vaccine she was feeling fine. The patient was reading the paperwork on it she was trying to figure out if she should go get the second shot, but according to the paperwork, if she had a rash she should not get the second dose. The patient mentioned that she called yesterday (28Feb2021) and she got mad and hung up. The outcome of rash and itching was recovering; outcome of going crazy was unknown.    No follow-up attempts are needed: information about lot/batch number cannot be obtained.
This spontaneous report as received from a registered nurse refers to a 13 year old male patient. No concurrent condition or medical history reported. On 21-APR-2015 at 15:00 hours, the patient vaccinated with 1 dose of GARDASIL intramuscularly in LD (Lot# K007828, expiry date: 02-MAR-2017) which was exposed to temperatures outside of the recommended range. On the same day, the refrigeration temperature was out of range for 30 minute (-1.8 degree Celsius). It was advised that the vaccine was unstable to be vaccinated. The patient was vaccinated at private doctor's office and the vaccine was purchased with public funds. Additional information has been requested.
swollen and sore lyphnodes in the armpit of the arm i got the vaccine, left. mild painf closing arm completely pressing armpit against itself, raising my arm above my head. mild discomfort  with arm at rest.
3 x 4 raised erythematous lesion on lt lateral arm;positive for warmth & positive for tenderness.
ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 2/13/2023 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Hoarse throat; can barely speak; Pregnancy, 14 weeks; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 22Jun2021 at 11:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient delivery date is on 22Dec2021. She was 14weeks pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included doxylamine succinate (UNISOM), prenatal vitamins (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) and pyridoxine hydrochloride  (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jun2021 at 17:30, the patient experienced hoarse throat and barely speak. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hoarse throat and can barely speak were not resolved at the time of the report.  No follow-up attempts are possible. No further information is expected
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 44-year-old female patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 43 years, in right arm 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: "Hypertension" (unspecified if ongoing); "hyper cholesterolemia" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Follow-up attempts are completed. No further information is expected.
Due 9/5/2021. From 15 hours of injection (at 5am) and lasting for 11 hours: migraine-like headache, chills, vomiting every 20 minutes. For 8 hours subsequent: headache, severe nausea but no vomiting
Went to bed - no problems. Woke with extreme discomfort around 430PM. My heart was racing, tool BP reading 151/113 pulse 135! Machine beeping irregular heartbeat. This continued over an hour. My normal pulse between 64-67. I take two BP medicines.
pt recvd vax;4 hrs after vax, pt devel fever of 104 R & had grand mal type sz;
Initially received the Janssen Lot #1805025 on 3/22/2021, no side effects. On 11/1/2021 received the Moderna Booster in my left arm. I began to feel muscle pain in my left thigh 2-3 hours later. I continue to feel soreness on my left side/muscles while moving or resting. I can not sleep on my left side. The pain will wake me up at night if I roll on my left side, I can not sit on the ground and cross my left leg and I feel a throbbing pain in my left leg, thigh, hip when sitting.  This is still continuing on 12/20/2021, 7 weeks after receiving Moderna Booster.
Information has been received from a certified physician's assistant, for HPV vaccine, a Pregnancy Registry product concerning a 16 year old female patient with hypothyroidism who on 25-MAY-2012 was vaccinated with her third dose of HPV (lot # 671463/1359AA). Concomitant therapy included SYNTHROID. On an unspecified date, the patient became pregnant. The patient's LMP (last menstrual period was 20-APR-2012 and EDD (estimated date of delivery) was 27-JAN-2013. The patient had never been pregnancy before. Additional information has been requested. Follow up has been received on 26-JAN-2014, a phone was placed to physician Assistant. The phone call was answered by Certified Medical Assistant (CMA). The CMA stated that on 26-OCT-2012, the patient had a Caesarean Section, and twin boys were delivered at 26 weeks gestational age. There were no congenital anomalies listed and the birth weights were 2 pounds 3 ounces and 2 pounds respectively. There were no indications for the early delivery listed in the patients chart; however at 23 weeks pregnant, the patient was seen at hospital for dehydration and hypothyroidism. Fluids and synthroid were given and patient was instructed to follow up at hospital. There was no information on the infants pediatrician, it was noted that in May 2013 the patient was pregnant again and moved out of the state. No further information was available at that time. Additional information has been requested.
This spontaneous report was received from a 62 year old female patient. The patient's pertinent medical history was unknown. The patient had no known drug reactions/allergies. On 06-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiration date were not provided). Other suspect therapies included PCV (manufacturer unknown) (dose, route, lot number and expiration date were not provided) and influenza virus vaccine (manufacturer unknown) (dose, route, lot number and expiration date were not provided). Concomitant therapies included valacyclovir hydrochloride and ointment. It was reported that the next day after vaccination, on 07-SEP-2013, the patient got the tingling red spots Sat night, the next day after another patch. The patient did get the rash as well as the blistering. The pain was at the base of the spine and went around the right side upper leg. The patient after received the three vaccines on the same date, was told by her pharmacist that it would be fine. The patient received treatment for the events (therapy unspecified). No laboratory diagnostic tests were performed. The patient sought unspecified medical attention. At the time of the report, the patient's outcome and relatedness between the events and suspect therapies were not provided. Additional information has been requested.