chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning six patients who were vaccinated with varicella virus vaccine, 0.5 mL, injection (Oka/Merck) (lot # and route not provided). Subsequently, the patients developed chickenpox and had been previously vaccinated. Unspecified medical attention was sought. The patient outcomes were not reported. There was no product quality complaint. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Further information has been received from a school nurse who reported that a female was vaccinated with varicella virus vaccine live, on 21-MAY-1997. The nurse reported that the patient developed chickenpox. All of the parents and pediatrician felt the cases were mild with minimal missed time at school (approx 2-3 days out sick). This is one of several reports from the same source. No further information is available.
sore arm; Initial information received on 30-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.   This case involves an unknown age female patient who had sore arm after receiving Influenza vaccine.   The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   Concomitant medications included Covid-19 vaccine for Prophylactic vaccination.   On an unknown date, the patient received an unknown dose of suspect Influenza vaccine produced by unknown manufacturer (with unknown formulation, strength, route, lot number, expiration and at unknown administration site) for prophylactic vaccination (immunization).   On an unknown date, the patient had sore arm (pain in extremity) (unknown latency) following the administration of Influenza vaccine.   It was also reported that Got me my husband and grandson that lived with us got our flu shot in October me my grandson got two covid one booster and fixtung to get our updated one he got his at Pharmacy the Phyfer I got my two covds at health center and my booster at another Pharmacy.   No lab data were reported.   Action taken: not applicable.   It was not reported if the patient received a corrective treatment for the event.   At time of reporting, the outcome was Unknown for the event.; Sender's Comments:  SanofiPVPortal20230131000336: SanofiPVPortal20230131000326:
Information has been received from a female patient of unknown age via Pfizer, Inc (ref# 2016398589), concerning the patient self. No relevant medical history or concurrent conditions were reported. Approximately in 2016 (reported as "a while back"), the patient was vaccinated with a regular pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as "probably PNEUMOVAX") (dose, route, lot# and expiration date were not reported). On an unknown date in 2016, the patient got pneumonia. At the time of this report, the patient's condition was better (the outcome of the event was recovering). Causality between the event and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not provided. Upon internal review, the event was considered as medically significant. Additional information has been requested.
Child received Tdap and Varicella in (L) arm at approximately 09:30. At about 1140 am pt return to vaccine area LDT area itchy, (+) hives and warm to touch. No resp. symptoms. 25 mg of BENADRYL adm. IM LOQ per standing orders.
got achy and that lasted a few hours and he was past it.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (got achy and that lasted a few hours and he was past it.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (got achy and that lasted a few hours and he was past it.). At the time of the report, PAIN (got achy and that lasted a few hours and he was past it.) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
booster shot; it took a substantial amount of effort to walk from the bedroom to the kitchen; chills; extreme exhaustion/it took a substantial amount of effort to walk from the bedroom to the kitchen; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), administration date: 24Mar2021, when the patient was 58 years old, for COVID-19 Immunization, reaction(s): "chills", "extreme exhaustion", "it took a substantial amount of effort to walk from the bedroom to the kitchen"; Bnt162b2 (Dose 2, single), administration date: 2021, for COVID-19 Immunization, reaction(s): "chills", "extreme exhaustion", "it took a substantial amount of effort to walk from the bedroom to the kitchen". The following information was reported: IMMUNISATION (non-serious) with onset Dec2021, outcome "unknown", described as "booster shot"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "unknown", described as "it took a substantial amount of effort to walk from the bedroom to the kitchen"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "extreme exhaustion/it took a substantial amount of effort to walk from the bedroom to the kitchen".  Additional information: The patient reported that she had experienced "extreme exhaustion" for about a week after each shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About a week after my vaccine and two weeks after my regular menstrual cycle, I began bleeding. I take birth control and don't normally have any spotting or bleeding mid cycle. The bleeding began light and quickly turned heavy. It has remained heavy all week, with constant cramping. This is not in alignment with my regular menstrual cycle, nor was it time for it. I shouldn't start for another 5 days. So far, I haven't seen any decrease in flow or cramping. I am still taking my daily dose of prescribed birth control. If no better tomorrow, I plan to contact my OBGYN.
Generalized hives. No acute shortness of breath or cardiorespiratory symptoms. Treated with Epinephrine 1:1,000, 0.3cc, IM, Benadryl 25mg po.
I have ?covid arm.? While I had swelling, redness, and warmth for a couple of days after the vaccine, it went away. However, exactly one week after the vaccine, I began experiencing intense itching. I now have a large reaction on my arm that keeps growing. It is itchy, red, warm, and slightly swollen.  It also has a slightly bumpy texture.
Patient presented to the ED on 5/4/2021 with chest pain. Patient hospitalized for cholecystitis and s/p cholecystectomy. These visits are within 6 weeks of receiving COVID vaccination.
Itchy arm; Very sore arm; Big red circle on arm; Hard (circle); Hot (circle); Lump on arm by injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Lump on arm by injection site), PRURITUS (Itchy arm), PAIN IN EXTREMITY (Very sore arm), ERYTHEMA (Big red circle on arm) and INDURATION (Hard (circle)) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.  Concomitant products included METOPROLOL TARTRATE, HYDROXYCHLOROQUINE, CLOPIDOGREL BISULFATE (PLAVIX) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE MASS (Lump on arm by injection site). On 04-Mar-2021, the patient experienced PRURITUS (Itchy arm), PAIN IN EXTREMITY (Very sore arm), ERYTHEMA (Big red circle on arm), INDURATION (Hard (circle)) and FEELING HOT (Hot (circle)). At the time of the report, INJECTION SITE MASS (Lump on arm by injection site), PRURITUS (Itchy arm), PAIN IN EXTREMITY (Very sore arm), ERYTHEMA (Big red circle on arm), INDURATION (Hard (circle)) and FEELING HOT (Hot (circle)) had resolved.            No treatment information was reported   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: significant follow up received .Event outcome and second dose information updated
PT LOST CONSCIOUSNESS FOR A FEW MINUTES AFTER VACCINE WAS ADMINISTERED, SLOWLY REGAINED CONSCIOUSNESS BUT NOT FULLY ADHERENT, BP 82/40, WEAK PULSE, NON VERBAL, TRANSFERRED TO LOCAL ED
Case number PHEH2014US020024 is an initial spontaneous report received from a pharmacist on 04 OCT 2014. This report refers to a 59 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX 2014/2015 (batch number: not reported) on 04 OCT 2014. IT was reported that patient received FLUCELVAX intravenously instead of intramuscular injection. No adverse events reported after the maladministration (wrong route of administration).
Gave me flu like symptoms; Achy all over; Fever; Cold chills; Cold chills; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20th April 2022, the patient received the 1st dose of Shingles vaccine. In April 2022, less than a week after receiving Shingles vaccine, the patient experienced influenza-like symptoms, general body pain, fever, chills and cold. On an unknown date, the outcome of the influenza-like symptoms, general body pain, fever, chills and cold were unknown.   It was unknown if the reporter considered the influenza-like symptoms, general body pain, fever, chills and cold to be related to Shingles vaccine.     Additional Information: GSK receipt date: 22-APR-2022 Reporter's comments: This case was reported by a patient via interactive digital media. The patient got the first shingles vaccine 2 days prior to the reporting. The patient experienced flu like symptoms, achy all over, cold chills and fever Additional Supportive Information: Follow-up would not possible as no contact details were available.
Became sick on 12/14 with fever and poor eating, lethargy. Blood culture from that day grew Serratia Marcescens. 1/29/09-records received for DOS 12/16-12/25/08DC DX: R/O sepsis. Serratia bacteremia resolved. Presented with fever 101-102 increased sleeping and decreased appetite began on day of presentation to ER.
Information has been received from a registered pharmacist referring to an elderly patient in long-term care. On an unknown date the patient was vaccinated with ZOSTAVAX (1 DF, intramuscularly in an unspecified thigh, lot# and expired date not reported) (inappropriate schedule of vaccine administered, subcutaneous injection formulation administered by other route). The pharmacist had not been informed that the patient experienced an adverse effect. Additional information has been requested.
Suspected vaccination failure; I've had them twice and have had the shot; Yes they are painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult 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 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 vaccine indication. The patient received shingles vaccine and had shingles twice and they were painful. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination scedule, laboratory test confirmation for shingles infection and time to event onset was unknown.
This spontaneous report was received from a pharmacist via a company representative, and refers to an immunodeficiency elderly patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. On unspecified dates, within a two year period, the patient was vaccinated with two doses of PNEUMOVAX 23, for prophylaxis, (dose, frequency, route, lot number and expiration date were not provided). No adverse effects and no product quality complaint (PQC) was involved.
I have had tinnitus starting the morning after the vaccine. I've never had tinnitus before and it's getting louder and louder to the point that it's waking me up in the middle of the night.
The pt experienced localized redness and swelling at the injection site, fever. Treated with warm wash cloth and Tylenol. By by 6/10 AM.
Patient reported no significant pain during injection, but within a few minutes had pain at injection site, by the next day felt as though he had significant pain at injection site, enough to diminish ROM and strength of his LUE. Care sought in our clinic 10/24. No abnormalities of LUE found on exam.
improperly stored vaccine administered; This spontaneous report as received from a medical assistant refers to a 15-month-old patient of unknown gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 12-NOV-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot number: T012551, expiration date: 10-APR-2022; route of administration was not provided) 0.5 mL. The vaccine was stored in temperatures between -9 and 8 degrees Celsius (1.7 degrees Celsius) for 1 hour and 11 minutes. There was no previous temperature excursion. Digital data lodger was involved.
The patient requested a Pfizer COVID vaccine and the pharmacist administered the Janssen COVID vaccine.
Moderate swelling around the injection site, bright red, hot to the touch, and moderate fever.  Child is always extremely healthy and is not a "complainer," but feels limited due to the amount of pain.
pt recv vax & devel lethargy x 24hr, then fever & irritability on day #1 & 2;
Information has been received from a currently 58 year old female nurse practitioner with unspecified chronic lung condition referring to herself. It was reported that the patient had been vaccinated with a total of 4 doses of PNEUMOVAX 23 (strength, dose, route and lot # not reported) on unspecified date. No adverse effects reported. Additional information is not expected because the reporter was not consented to be contacted.
i would like to report side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (i would like to report side effects) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (i would like to report side effects). At the time of the report, VACCINATION COMPLICATION (i would like to report side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
pt recvd vax & the 2nd dose of vax devel a rather sever dermatological problem;
The patient died from COVID 19 symptoms.  His body was being taken to be autopsied on 08/27/2021.  I was notified after he had passed.
For 5 days after vaccination, mild pericarditis-like chest pain. Day 18 and ongoing: Intermittent fevers up to 102, muscle aches, chills, consistent headache with varying intensity.
This spontaneous report was received from a licensed practical nurse refers to a multiple unknown patients of unknown age and gender. No pertinent medical history, drug reactions/Allergies and concomitant medications were reported. On an multiple unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # M027879 and expiry date 24-JAN-2018) (dosing regimen was unknown by the reporter). The vaccine was exposed to temperature of 0.2 degree Celsius for 4 hours and 51 minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Two days after receiving FLUMIST, patient developed red rash on face and trunk. This rash was painful and itchy which caused concern and child was taken to the ER.
Rubella vac. in May 1970. Most likely first onset was July 1970, by late Oct. I was blind no light perception.
Patient complained of increased shortness of breath, generalized weakness and fatigue with mild cough worsening today and was admitted on 12/25/20. Patient is an employee of the hospital in the ICU and received the covid-19 vaccine on 12/25/20.  Patient believes symptoms started after the vaccination. On admission, patient was in sinus tachycardia with O2 saturation 91% on room air. Tested SARs CoV 2 RNA, RT PCR positive on 12/24/20. Transferred to ICU for closer monitoring after transitioning to high flow nasal cannula on 12/26. Patient recovered and discharged on 12/31/20.
Two + months' history of cough, chest congestion, post-nasal drip, sinus pressure, headaches and throat irritation after vaccination.  Potential hypersensitivity to components of the vaccine with debilitating side effects.
shortness of breath; This is a spontaneous report from a contactable consumer (patient).  as single dose for covid-19 immunization.  Medical history included none. Concomitant medications included vitamins nos (MULTIVITAMIN); colecalciferol (VITAMIN D3); whey protein (WHEY PROTEIN ISOLATE) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. In 2021, the patient suffered from shortness of breath 20 days after first dose and 3 days prior to second dose. Tested for COVID-19 was negative. The patient underwent lab tests and procedures which included COVID-19 PCR Nasal Swab was negative on 17Apr2021 and on 21Apr2021. Treatment received for the event included indomethacin and colchicine. The outcome of the event was not recovered.
This spontaneous report was received from a Medical Assistant refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with VARIVAX (Merck) (dose and frequency were not reported0 that went through a supported temperature excursion. It was reported that the VARIVAX (Merck) which was administered to the patient were exposed to the temperature of 1.5 degrees C for 22 hours and also was exposed to -1.4 degrees C for 1.5 hours. It was reported that according to prescribing information, the VARIVAX (Merck) should be stored frozen between -58 degree F and +4 degree F(-50 degree C and -15 degree C). Use of dry ice may subject the VARIVAX (Merck) to temperatures colder than -58 degree F (-50 degree C). No adverse effects reported. No further information was provided. Additional information has been requested.
So the day before my mom had noticed red rash behind back of legs. I came home and put on cortisone cream to see if improve it did not so contacted telehealth visit. Sent photos via telehealth. Had mild burning according to notes for Doctor spent 35 min on patient care dermatitis. After two weeks healed.
A few hours after the vaccine he experienced acute confusion, a fever of 103.8 degrees F, tachycardia, hypertension, neutropenia, and thrombocytopenia. He was given Tylenol, placed ice packs under arms and neck, normal saline, and ceftriaxone. He has been hospitalized for the past 4 days.
Patient developed pain and swelling at the injection site along with flat, red rash to right arm, back, side, and chest.  PATIENT DID NOT HAVE hives, shortness of breath, throat swelling.
Patient came to the pharmacy, almost a month after the vaccine was administered, stated that it still hurts at the injection site. His provider suggested that it might have been an arm injury due to the vaccine
Patient received both doses of COVID Moderna vaccine (2/13/21 and 3/13/21).   She presented to the ER on 7/7/21 after a fall at home. She was noted to have altered mental status/confusion and claimed she was dizzy. CT brain was negative, as well as chest X-ray and pelvic X-rays (also negative). Pt was tested for COVID  per protocol, and was found to be positive on 7/7/21, despite being fully vaccinated and being asymptomatic.  Patient was admitted for Neuro work-up and was started on ceftriaxone for presumed UTI. COVID treatment has not bee started since pt is asymptomatic and is not hypoxic.
Pt's mom called after hours answering service & was transferred to Dr. on 7/25/19 for possible Reaction to Kinrix Vaccine. Size of Redness was size of mom's hand Approx with a hard knot under it. Was told to use ice pack & told to give ibuprofen for swelling. Update: Mom reports resolution of warmth, redness and swelling by 7-26-19.
No additional AE; Improperly stored administered GARDASIL 9; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender.  Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 31-MAY-2023, the patient was vaccinated with one improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection as prophylaxis (exact dose, route of administration, vaccination scheme frequency, and anatomical location were not reported; lot number w013388 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe, expiration date reported and upon internal validation established as 16-DEC-2024) (product storage error). No adverse events were reported.
Redness and swelling at injection site of right arm. Mother of child called 5/21/03 to report, 5/22/03 resolving
Patient admitted for sepsis/pyelonephritis/pneumonia/hypoxemia. COVID 19 negative.
R arm red, warm and swollen.  Motrin, Benadryl, dexamethasone, warm compresses.