chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive; tested positive; This is a spontaneous report from a non-contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (age at vaccination 56 years old), via an unspecified route of administration on 28Jan2021 (batch/lot number: EJ1685) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's wife tested positive for COVID-19 on 25Mar2021. The patient's first symptoms were on 27Mar2021 and tested positive on 28Mar2021. Re-tested 2 weeks later (Apr2021) and tested positive again. It was unknown if the patient had Covid prior to vaccination and was Covid tested post vaccination. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Strange feeling in lip immediately after shot.  I was told to go home and take a Benadryl.  I was asked if I had seasonal allergies and told that may be the reason I was having a reaction.  I have some seasonal allergies, but not active enough to take meds on a regular basis.  I did take the Benadryl.  I experienced some fatigue for about 3 days after vaccination.  I also began having buzzing and ringing in ears since then.  This has not gone away, but increases in severity.    I had arm pain and I still experience some arm pain at the injection site at times.
Pt developed fever and headache tiredness. RA was swollen from collar bone to elbow. The skin was red & tender symptoms started at 7pm 6-9-11.
Left thigh swelling (almost doubled in size), high fever Tmax 102.9, tachypnea increased 90/min.  2/20/07 Received medical records from reporter/provider which reveal patient experienced:  Initial vs was 12/20/06 for well child first visit exam.  Next seen on 2/8/07 for well child visit & immunizations.  Next seen 2/9/07 s/p ER visit due to fever, tachypnea & left leg swelling where received PCV & HIB vax.  Temp in office 100.4 & started on Tylenol.  Recommended to give only 1 at a time vax next time.  No final dx given.
tingling sensation on both arms; This case was reported by a consumer via interactive digital media and described the occurrence of tingling sensation in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tingling sensation. On an unknown date, the outcome of the tingling sensation was unknown.   It was unknown if the reporter considered the tingling sensation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had tingling sensation on both arms after the vaccine. The reporter want to know if that a concern to get the second dose.
Swollen lymph nodes in throat; General weakness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes in throat"; ASTHENIA (non-serious), outcome "unknown", described as "General weakness".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
a rash on forearms; itches; This is a spontaneous report from a contactable consumer (patient) reporting for himself.   A 33-year-old male patient received BNT162B2 (BNT162B2, Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 31Mar2021 as DOSE 1, SINGLE (at the age 33) for covid-19 immunisation (Other). The patient's medical history and concomitant medications were not reported. The patient experienced a rash on forearms on 01Apr2021 13:00, patient wanted to know if it would still be safe to receive the 2nd dose, itches on Apr2021. Rash started on 01 Apr which was two days after. Stated that it comes, itches and then goes away. Stated that it comes and goes. The event rash on forearms was not resulted in visiting emergency room or physician office. Patient has not taken any other vaccines within 4 weeks. Therapeutic measures were taken as a result of events included anti-itch cream. The outcome of the event rash on arms was not recovered and it was unknown for another event.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
She had a back ache; Her neck and shoulder ached; Her neck and shoulder ached; This is a spontaneous report received from a contactable consumer (patient). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 17Mar2021 14:30 as single dose for covid-19 immunisation. Medical history included covid from Nov2020, and lost there sense of taste and smell. The patient's concomitant medications were not reported. The patient experienced she had a back ache, and her neck and shoulder ached on 17Mar2021. The outcome of event back ache was unknown, while other events were recovered on 24Mar2021. Information on the lot/batch number has been requested.
Within 12 hours of vaccine, patient developed fever, hypotension (BP 90/50). She was treated with IV fluids and hydrocortisone due to being on chronic prednisone.
Developed DVT.  Complains of calf pain and swelling starting evening of 4/8/2021, worsening over weekend.  To walk in care on 4/13/2021.  Dx DVT in left lower extremity.  Ultrasound shows DVT in the proximal femoral vein through the portal vein.  Physician notes indicate patient seen for "left leg soreness, tender to touch, protruding veins, redness, cramping in calf, radiating up to posterior thigh"
Information has been received from a consumer's mother concerning her 12 month old son with no prior medical history and no known allergies who on 10/29/98 was vaccinated with a dose of MMR. Concomitant vaccination included a dose of varicella virus vaccine live and a dose of poliovirus vaccine. Subsequently, the patient developed nodules in his thigh under the area where the vaccines were administered. The nodules lasted for nine months. In approximately 2000, at 3 years old, the patient was diagnosed with autism. The reporter stated that she believes that he was autistic from birth, but was not diagnosed until he was three years old. Unspecified medical attention was sought. Upon internal review, autism was considered to be an other important medical event (OMIC). Additional information has been requested.  Follow up on 08/09/04 states: "This is an amended report. The reporter's name now reads confidential."
No adverse effects; patient was vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 13-MAR-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Patient said that he sometime faint when receiving a vaccination, but proceed with the Janssen Covid-19 shot at 9:50a. Then, had a syncope episode at 9:52a. EMS at Amazon was called to tend to the patient while 911 was called. Patient left with the ambulance service.
Patient stated she had redness on entire upper (L) arm where shot was administered. Then developed rashes on forehead. Symptoms only subsided 10 days later. Patient has received vaccine before with no reactions.
pt recvd vax & a few short hrs pt began a high pitched screaming cry this went on for 6 hrs; called the MD office 4 times they kept saying if it keeps up call us back; pt would lapse into an exhausted sleep; pt exp gazing off, sz;
This spontaneous report as received from a currently 69 years old female patient. The patient's medical history included shingles. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). The patient reported that she has already had shingles but everyone said that ZOSTAVAX would keep it from recurring. it didn't. On an unknown date, the patient developed shingles. It was also reported that, after the shot the pharmacist told her ZOSTAVAX should only make shingles less severe. The patient was disappointed. The outcome of shingles was unknown. The relatedness between the shingles and the vaccination with ZOSTAVAX was unknown. Additional information has been requested.
Multiple pea-sized lesions with liquid center to torso, buttocks-itcy-spreading. Exposed 10 d ago to varicella-vaccinated 1/20/00.
Mom states developed fever evening 2-1-06 and not wanting to apply weight to legs this afternoon 2-2-05. Tylenol/Motrin
Patient complained of very sore shoulder  and said couldn't move arm very well. Patient said the doctor treated her with oral steroids. Patient said that arm was still sore after a week post immunization.
apr 24, 21 woke up with swollen face on right side and numb face and fingers and toes. went to dentist 4/27 dr said massive infection, got keflex 500 2 stat, then 1bid , took for 10 days. 4/30/21 full facial paralysis, hands numb, feet numb from arches forward and burning pain in hips and legs and lower back and headache.  went to er 5/3/21.  they diagnosed w/ lyme disease. started on doxycycline 100mg twice daily for 10 days and asked him to finish keflex too.  pt reported zero energy.  Went to dr. early 5/7/21 for results from tests run at hospital.  Early didn't have results and extended doxycycline to 21 day treatment. (21 day doxycycline and 10 day keflex treatment were both completed) Pt asked early to refer to Dr.  pt saw dr  6/1/21.  Dr diagnosed w/ guillan barre syndrome.  drew labs and did mri and spinal tap.  started immunoglobulin tx, plasma transfusions on 6/13/21 for 5 days.  had some improvement but currentyl still has partial facial paralysis, hands are tingly but not numb, feet are still numb, pain in hips and legs is gone.  after tx, DR said results are not conclusive but there are certain aspects of lyme but he does have gbs.  not clear if from shot or tick.  tick discovered 4/15.  tick was attached.
Pt diagnosed with shingles on 7-25. Received vaccine on 7-6-11.
Child has end stage renal disease awaiting transplantation. Parents are required to fully immunize patient before he can be listed for transplantation. His creatinine had been increasing and the need for transplantation has intensified. Family agreed to have child vaccinated and received MMR #1 12/8/2018. Monthly labs to follow his renal disease showed an increase in creatinine from 4.39 to 4.90 and a decrease inhemoglobin from 10.5 to 9.4.
Vaccine stored in refrigerator on 29-Oct-2021, product expired on 13-Oct-2021, product administered on 05-Nov-2021.; 601 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 29-Oct-2021, product expired on 13-Oct-2021, product administered on 05-Nov-2021.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 29-Oct-2021, product expired on 13-Oct-2021, product administered on 05-Nov-2021.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 29-Oct-2021, product expired on 13-Oct-2021, product administered on 05-Nov-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 the vial placed in refrigerator was on 29-Oct-2021. There was no temperature excursion. The patient had no adverse event.  No Treatment information was reported.   This case was linked to MOD-2022-491837 (Patient Link).
uncontrolled chills that lasted for an hour; This is a spontaneous report from a contactable healthcare professional. A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number E5168/expiration date unknown), dose number 2 intramuscularly on 07Jan2021 10:30 at a single dose on the left arm for COVID-19 immunization. The vaccine was administered in a Public Health Clinic facility. No other vaccine was received within 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested for COVID-19 since the vaccination. Medical history included diabetic and high blood pressure. Historical vaccine included dose 1 of BNT162B2 (lot number EK5730) on 17Dec2020 for immunisation. Concomitant medications included unspecified routine diabetic care meds. On 08Jan2021 03:50, the patient experienced uncontrolled chills that lasted for an hour. She received 2 Advil liquid gels for the event. The outcome of the event was Recovered/Resolved With Sequel. The event was assessed as non-serious.
Pt felt nausea following receiving Pfizer vaccine. Pt is a diabetic and insulin pump dependent and felt hypoglycemic. Pt provided juice by paramedic and monitored by EMS and medical provider for over 30 minutes. During this time she was also drinking water. Pt felt better and left in good condition with family.
FALL; HEAD INJURY/HIT HEAD; NAUSEA; DIZZINESS; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205a21a, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced dizziness. On 09-MAY-2021, the subject experienced fall. On 09-MAY-2021, the subject experienced head injury/hit head. On 09-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine  was not applicable. The patient recovered from dizziness on 09-MAY-2021, and fall, head injury/hit head, and nausea. This report was non-serious.
Right arm swelling; Right Axillary Lymphadenopathy; This non-serious case was reported by a physician via call center representative and described the occurrence of swelling arm in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included breast cancer (have a history of breast cancer and with only one breast left).   On 30-AUG-2023, the patient received Arexvy (right arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced swelling arm (Verbatim: Right arm swelling) and lymphadenopathy axillary (Verbatim: Right Axillary Lymphadenopathy).  The outcome of the swelling arm and lymphadenopathy axillary were unknown.   The reporter considered the swelling arm and lymphadenopathy axillary to be possibly related to Arexvy.     The company considered the swelling arm and lymphadenopathy axillary to be possibly related to Arexvy.   Additional Information: GSK receipt date: 08-AUG-2023 The physician reported a patient received a Arexvy vaccine and the came in with right axillary lymphadenopathy and though it was cancer.  The patient did have a history of breast cancer and with only one breast left.  The physician thought the vaccine may have caused the swelling so physician wanted to gather more information. . The physician unable to provide vaccine details. The reporter consented to follow up.
We had a patient that accidentally received a 4th dose; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (We had a patient that accidentally received a 4th dose) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A and 032F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 16-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (We had a patient that accidentally received a 4th dose). At the time of the report, EXTRA DOSE ADMINISTERED (We had a patient that accidentally received a 4th dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.  Patient took booster shot on 08 NOV 2021 and accidentally received a 4th dose as a second booster shot on 16 FEB 2022 at the clinic. No side effects were reported.
a child received a dose of MMR II at age 1 on an unknown date from an unknown provider, and again at age 3; No additional adverse effects were reported in the patient.; This spontaneous report was received from a physician, referring to a child patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On an unspecified date, the patient received a dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, Live (M-M-R II) at the age of 1-year-old, however, on an unknown date, a second dose of that vaccine was administered, when the patients was 3-year-old (doses, routes of administration, vaccination schemes and anatomical sites of injection were not reported; lot numbers and expiration dates were unknown by the reporter) (inappropriate schedule of product administration); both vaccines were administered as prophylaxis. The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) 0.5 milliliter (ml). No additional adverse effects were reported in the patient.
Gave MMRV to client instead of MMR and Var. separately. This was out of approved age range. Foster home notified: no adverse effects.
Patient reports continued pain in her left arm, deltoid area, which radiates to her shoulder and lower arm since receiving the influenza vaccine in January.
I had Covid. I only had a fever for a couple of days. I didn't check it with the thermometer, I just felt hot. On 11/30/2022, I had a scratchy throat. On 12/1/2022, I had a cough and felt sick still with a sore throat. on 12/2, I had a headache, a weird feeling in my chest and Phlegm. I was prescribed PAXLOVID on 12/4, I still had a cough, slight fever. By 12/11-12/12, I was sneezing, coughing. 11 days after testing, I had no smell or taste for 4 days. By 12/18, my sense came back. I also experienced diarrhea throughout the 2 weeks of being sick.
Information had been received on 20-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 01-APR-2015 at a medical facility (family medicine), as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused patient to contract a persistent strain of Herpes Zoster. On or about 03-JUL-2015, the patient was treated by (name) unspecified health professional at a medical facility for a painful rash that was diagnosed as shingles.  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, pain and suffering and other damages. Additional information has been requested.
This spontaneous report was received from a registered nurse refers to an unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 26-SEP-2016, unspecified patients were vaccinated with an unspecified number of improperly stored doses of ROTATEQ lot # M004883 (expiry date: 02-OCT-2017), lot# M019691 (expiry date: 02-NOV-2017) and lot # M025568 (expiry date: 07-NOV-2017). No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Headache, fever...likely due to recovering from COVID less than 60 days prior to Vaccine #1
Information has been received from a registered pharmacist concerning a 73 year old female patient with no known drug reactions/allergies and a history of gastrointestinal digestive issues and shingles who on 09-JUN-2010 was vaccinated SC with a dose of ZOSTAVAX (Merck) (lot# 664671/0149Z) into her left arm. Concomitant therapy included mirtazapine, CREON and NEXIUM. On 09-JUN-2010 upon receiving the injection, there was a burning sensation. After this, the patient developed a 3 inch by 1.5 inch hard, red and warm area at the site of injection. She reported this to the pharmacist on 11-JUN-2010. The pharmacist suggested that the patient massage the area and use TYLENOL. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. No laboratory or diagnostic studies were performed. The reporting pharmacist considered burning sensation upon receiving injection of ZOSTAVAX (Merck), 3x1.5 inch hard area at site of injection, 3x1.5 inch red area at site of injection and 3x1.5 inch warm area at site of injection to be other important medical events. Additional information has been requested.
adm to ER p/90 sec febrile sz 2 days p/vax;
i drew up diluent into syringe, got engaged in conversation with patient about covid vaccine; injected the diluent in arm; realized the mistake; prepared a complete imz and administered the correct imz immediately; informed primary physician about the incident.  this is not an adverse event;   this is an error of administration