chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose on SEP, didn´t received 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-NOV-2022 Reporter's Comments: The reporter called to inquire about how to proceed with Series. Pharmacist reported a patient received the first dose of Engerix B on 10th September 2022. Adult patient would like to continue with the series but it had over a month since the first dose.  The reporter confirmed first dose was administered in their facility.  The reporter was unable to provide any patient details.  The reporter did not consent to follow-up. Additional Supportive Information:  Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
On 10/25/2021, I noticed a drop in kidney function and anemia in my lab results. Then on 01/11/2022, I had a more dramatic drop in kidney function, and on 01/14/2022, even more dramatic drop. The on 02/02/2022, I had a kidney biopsy and was diagnosed with Microscopic Polyangiitis. I am still having these issues at this time.
This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN6203), via an unspecified route of administration, administered on arm left on 17Mar2021 (age at vaccination was 46-year-old) as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL3247), via an unspecified route of administration, administered in arm left on 24Feb2021 as dose 1, single for covid-19 immunization at clinic. Medical history was reported as none. The patient concomitant medications were reported as none. Device Date was 05Aug2021.The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not received any other medications the patient received within 2 weeks of vaccination. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient tested for COVID-19. The patient stated tested positive for covid on 28Jul2021 and sick on an unknown date 2021. The patient was tested for COVID on the 27Jul2021 and received result. On an unknown date 2021 (following day) the patient was sick so was not able to log in and report. Since the vaccination, the patient was tested for COVID-19. The patient lab tests included polymerase chain reaction PCR (nasal swab) was positive on 27Jul2021 and negative on 03Aug2021. No treatment medications were received for the event tested positive for covid. The outcome of the event COVID-19 was resolving and the outcome for the event sick was unknown.   No follow-up attempts are needed. No further information is expected
Rash at imm site .2" (R) arm slightly raised and itchy. Minimal discomfort. No fever.
Got shot at 8:15am on 3/8/2021. Felt fine all day other than arm slightly tender & sore at shot site. Went to bed around 11:30pm, woke up at 1am chilling & aching, freezing cold, couldn't get warm, added another blanket & went back to sleep. Woke around 6:30am on 3/9/2021 still achy & chilling & feeling headachy, took a Tylenol & went back to bed for an hour. Got up again around 7:30m, felt better & continued to slowly feel better throughout the day but just a little out of sorts all day.  Felt much better on Wednesday 3/10/2021 but not completely 100% until Thursday 3/11/2021.  I had the virus in January & the effects felt just like when I had the virus.  I also understand the vaccine contains the virus to allow your system to make itself immune to it.  I am a small person = 5' tall, 110 lbs. I wondered if the amount of the dosage I received was too strong for a small person. I understand that the same amount of dosage is given to each patient, but I'm sure it can affect smaller people differently than someone of more body mass.  Anxiously awaiting my 2nd shot scheduled for March 29 and wonder if I will have adverse effects again.  I will certainly watch for any next time.  Hope this info helps.
Pain in shoulder. Told it would be sore a few days, pain in arm still continues 4 months later. Severe pain when using arm.
10/8/02 pt received DTaP #5 in R delt at our office. Called 10/10/02 with report R delt was warm to touch, red and swollen. Pt was eval and treated 10/10/02.
Tickle on my throat, wheezing, coughing in the clinic within a couple of minutes; all which subsided within 30 minutes and without treatment. Upper right abdominal pain, itchiness, head pressure, numbness and itching of my mouth 2.5 hrs after getting the vaccine. Took benadryl for itch and numbness. It subsided between 30 and 40 minutes later. The other symptoms are still ongoing.
Developed itchy red rash after Hepatitis B vaccine and Tdap vaccines on 11/23/16. Also developed a second rash/hives on 11/28/16 that was more severe. Also had facial redness/flushing.
eye is red; eye is burning; visual issues; vaccine squirted in her eye; This spontaneous case was reported by a nurse and describes the occurrence of OCULAR HYPERAEMIA (eye is red), EYE IRRITATION (eye is burning), VISUAL IMPAIRMENT (visual issues) and ACCIDENTAL EXPOSURE TO PRODUCT (vaccine squirted in her eye) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced OCULAR HYPERAEMIA (eye is red), EYE IRRITATION (eye is burning), VISUAL IMPAIRMENT (visual issues) and ACCIDENTAL EXPOSURE TO PRODUCT (vaccine squirted in her eye). On 23-Mar-2021, ACCIDENTAL EXPOSURE TO PRODUCT (vaccine squirted in her eye) had resolved. At the time of the report, OCULAR HYPERAEMIA (eye is red), EYE IRRITATION (eye is burning) and VISUAL IMPAIRMENT (visual issues) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment medications were reported.
Pfizer Monovalent dose was given instead of the recommended Pfizer Bivalent dose.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: PT DEVELOPED LIGHT PINK COLORED RASH ON ARMS, UPPER CHEST, AND FACE APPROX 4 HOURS AFTER RECEIVING VACCINE. NO DIFFICULTY BREATHING OR ANY OTHER SYMPTOMS. PT TOOK BENADRYL & WAS ADVISED TO MONITOR & IF SYMPTOMS GOT WORSE TO SEEK MEDICAL ATTENTION RIGHT AWAY.
Information has been received from a Doctor of pharmacy concerning a 55 year old female patient with "something about her brain" and no drug reactions or allergies, who on 01-APR-2011, was vaccinated with a dose of ZOSTAVAX (Merck), 0.65 ml, subcutaneously in the left arm, (lot # 669259/1360Z, expiration date: 15-JAN-2012). On 02-APR-2011, the patient called the pharmacy to report that she developed a rash on her left arm at the injection site. Also, pharmacist reported that the patient reported that the rash "looks like shingles" and the rash was "pretty big" and red, but the rash was not itchy. The patient took unspecified doses of BENADRYL (manufacturer unknown) to treat the rash. The pharmacist reported that the patient called the pharmacy again on 03-APR-2011, and the patient stated that she would go to the pharmacy to show the rash on 04-APR-2011 but the patient had not gone to the pharmacy yet. No lab diagnostics were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Headache, swollen, red, painful injection, kept me from sleeping, headaches, muscle aches. That is extremely off. On 1/10, developed left swollen painful axillary lymphadenopathy - on 1/11, feels like it is getting worse. Narrative:
phlebitis; This is a spontaneous report from a contactable consumer reported for herself. A 36-year-old female patient (will be 37 next week) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/lot number: EN6207, Expiration date: Unknown), via an unspecified route on 23Mar2021 (age at vaccination: 36-year-old), as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced bursts of blood vessels. One of her veins down my arm inner arm, elbow was all bruised swollen and painful, reaction it was categorized as: phlebitis. Patient asked if they recommend for the 2nd dose. Therapeutic measures taken as a result of the events included Medrol dose. She has not yet, but they have just prescribed her with Medrol dose. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Myalgia, Arthralgia, stiffness in neck and back Narrative:  Other Relevant History:
Cold; Fever; Headache; The green light little little phlegm; Loss of taste and smell; Loss of taste and smell; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 03Apr2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 04Apr2021, the patient experienced cold, fever, headache, "the green light little little phlegm", and loss of taste and smell. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This was NOT an Adverse Event.  The vaccine was in freezer longer than 14 days.   The patient was advised to revaccinate per CDC.   Patient re-took 11/2/2021
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 10-JUN-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J006955, expiration date: 07-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient hospitalized for hyponatremia, hypokalemia, and hypomagnesemia within 6 weeks of receiving COVID vaccination.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 07-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). On 05-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
p/ pt recv vax in 1996 lab evaluation revealed a lack of seroconversion.
Redness, induration 2x1 1/2 cm to left outer aspect of upper left arm and warm to touch. No treatment prescribed other then Benadryl OTC.
After receiving 2nd dose of Pfizer vaccine, within 5 minutes, c/o chest pressure, tachycardia (P=105) and left arm pain. team was called and was taken to the ER.
This spontaneous report as received from a health professional refers to mutiple patients of unknown ages. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # N003702 or lot # N011851 for prophylaxis. No adverse events were reported.; Sender's Comments: US-009507513-1709USA000505: US-009507513-1709USA000507:
This infant had a fever greater than or equal to 102 for 5-6 days with petechial type rash. Phone consult with Peds ID specialist suggested probable viral infection rather than vaccine related.
Pt in office for Varicella vaccine.  Approx. 20 min later pt called c/o "lump" in throat and generally feeling bad.  Instructed pt to take Benadryl and see MD ASAP.  MD office was closed so pt went to the local ambulance service and was transported to the nearest ER facility.  Pt was reportedly given Benedryl in the ambulance and was stable upon arrival.  After being evaluated and observed in ER pt was released to home.
No additional AE reported; Expired Varivax administered; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender.   The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 26-JAN-2022, the patient was vaccinated with an expired varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T000340, expiration date) 0.5 milliliter (route of administration not provided) for prophylaxis (expired product administered). Caller stated the vaccine did not experience any temperature excursions. No additional adverse events reported.
She got her 4th vaccine, had no reaction initially, not tired.  Two days later on the 12th her arm started getting very red, started swelling and then started spreading.  This happened with the 2nd vaccine on 2/20/21.  She put an ink line on it, went to her doctor who took a picture of it, and she gave her Cephalexin 500 mg antibiotic every 12 hours, which helped as it did with the first vaccine.  It would not stop spreading until she took the antibiotic.  By the 2nd pill she had improvement, the redness started going down and the swelling as well.  It is not spreading anymore, the redness is still there, and the area is receding.  She is still on the antibiotics and is no longer warm to touch, it is soft now where before it was hard and "terrible".
Shoulder pain, capsulitis, limited ROM.  Sx currently lasting 8 days.
she was pretty sick with the other two; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she was pretty sick with the other two) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Shortness of breath (shortness of breath due to anxiety and deppresion). Concurrent medical conditions included Thyroid disorder NOS, Cholesterol, Fibromyalgia, Recurrent UTI, Irritable bowel syndrome (stomach ibs) and Arthritis. Concomitant products included CELECOXIB (CELEBREX) for Arthritis, VITAMINS NOS for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (she was pretty sick with the other two). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, ILLNESS (she was pretty sick with the other two) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-406411, MOD-2021-035455 (Patient Link).
left arm became really red and swollen; left arm became really red and swollen; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 63-month-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced erythema of extremities and extensive swelling of vaccinated limb. On an unknown date, the outcome of the erythema of extremities and extensive swelling of vaccinated limb were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities and extensive swelling of vaccinated limb to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and her left arm became red and swollen from her shoulder to her elbow.
COLD; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (COLD) and CHILLS (CHILLS) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0322L20A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced NASOPHARYNGITIS (COLD) and CHILLS (CHILLS). At the time of the report, NASOPHARYNGITIS (COLD) and CHILLS (CHILLS) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Expired Havrix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a male patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 02-FEB-2023, the patient received Havrix. On 02-FEB-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). The outcome of the expired vaccine used was unknown.   Additional Information:  GSK Receipt Date: 17-MAR-2023 The reporter was a supervisor public health. The reporter did consent to follow up. The patient received a Havrix vaccine which was already expired, which led to expired vaccine used.
about 5hr p/vax pt had brief tonic activity, staring & unresponsiveness;no subsequent problems;
Dizziness, hives, swelling at injection sites, body aches, itchy throat 20 minutes after shots. Was taken to ER and given Antihistamine and parent doesnt know what else.
flu like symptoms; fever; aches; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2019, the patient received the 2nd dose of Shingrix. On 23rd July 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, fever and pain. On an unknown date, the outcome of the influenza-like symptoms, fever and pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever and pain to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The caller stated that the day before the reporting date she received Shingrix and on the reporting date experienced flu like symptoms. The patient explained more of a fever of 101 degree F. and aches. The reporter declined completing the adverse event report. The reporter did not consent to follow-up.
3/23/2022- Presents to ER, with vomiting, etoh withdrawal and cough. Covid + ,  O2 sat dropped to 59%  ABG: 7.11 / 17.3/149/5.5-15.0  4 L via NC, EGFR-42 and BUN/creatnine: 20/14 and glucose 346. Admit Covid , DKA and AKI. Start dexamethasone and Sotrivumab.  3/25/2022- AKI resolved- BUN/creatnine: 10/0.6 and EGFR >60. Spo2 97% on RA.  3/27/2022-  Covid symptoms improved, O2 sat wnl on RA. Waiting on hyperglycemia to stabilize to discharge: 510. 3/28/2022- Discharged to home. Glucose 185.
I woke up the night after getting the booster with normal and expected fever and chills. However, as the night went on, I started having sharp chest pains in the center of my chest. The following 3 or 4 days, I kept experiencing the pain in my chest as well as sharp pains in my back that would come and go.
Rash started as small circle around injection site and progressively got bigger and started down the patients leg.
This spontaneous report as received from a licensed practical nurse refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot# M016193, expiry date 24-APR-2018; lot# M011117, expiry date 07-DEC-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
first dose 27FEB2021 ,received the second dose in the Moderna COVID-19 vaccine series on 28Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 27FEB2021 ,received the second dose in the Moderna COVID-19 vaccine series on 28Apr2021) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 27FEB2021 ,received the second dose in the Moderna COVID-19 vaccine series on 28Apr2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 27FEB2021 ,received the second dose in the Moderna COVID-19 vaccine series on 28Apr2021) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment information not provided. Concomitant medications were not provided.   This case was linked to MOD-2021-044506 (Patient Link).
Severe chills and fever. Fainted once about 18 hours after injection. Nausea.
Scattered areas of papular lesions w/ superficial sl excoriations - posterior LUE, (R) flank, periumbilical and suprapubic - was noticed 3 days after vaccine.
Erythema, warm to touch, edema and itchy at injection site. Took 2 Ibuprofen at 08:30. Spoke to Dr., physician at hospital clinic who examined arm and told patient to take BENADRYL. Physician told her that if the symptoms progress to notify her and to go to the Emergency Room.