chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to multiple unspecified patients. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX 19400 plaque-forming units (PFU) injection (dose, route of administration, lot# and expiration date were not provided) or VARIVAX injection (dose, route of administration, lot# and expiration date were not provided). The nurse could not provide lot# and expiration date of the properly stored sterile water diluent (manufacturer unknown) used to ZOSTAVAX or VARIVAX. No adverse events was reported. The recent temperature excursions (temperature and time frame) for the vaccines were unknown by the reporter. It was also unknown whether the vaccines had experienced any previous temperature excursion. Digital data logger was involved. Additional information has been requested.
0n 06 Apr 2022 vial was initially stored in the refrigerator and administered on 09 May 2022; they administer a Moderna covid19 vaccine after the 30 day by use date to 4 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they administer a Moderna covid19 vaccine after the 30 day by use date to 4 patients) and PRODUCT STORAGE ERROR (0n 06 Apr 2022 vial was initially stored in the refrigerator and administered on 09 May 2022) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001m21a) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (they administer a Moderna covid19 vaccine after the 30 day by use date to 4 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (0n 06 Apr 2022 vial was initially stored in the refrigerator and administered on 09 May 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they administer a Moderna covid19 vaccine after the 30 day by use date to 4 patients) and PRODUCT STORAGE ERROR (0n 06 Apr 2022 vial was initially stored in the refrigerator and administered on 09 May 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The number of doses/vials was reported as 4 doses at 1 vial.  The vial does not undergone any temperature excursions.  No treatment medications was reported.
No additional AE reported; VARIVAX which was improperly stored; This spontaneous report was received from a nurse refers to a 12 month old female patient. Her pertinent medical history and drug reactions or allergies were unknown. Concomitant therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  On 25-MAR-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # T024286, expiration date 15-JUL-2022, subcutaneously in the left thigh (formulation and dose were not reported) as prophylaxis (product storage error). The temperature excursion was -5.67 degrees Celsius for 30 minutes (also reported as for 46 minutes). There was no previous temperature excursion. A data logger was used to capture the temperature. No additional adverse event was reported. The patient did not require any treatment and recovered from the event. The vaccine was not available for return, it was administered and discarded.  Causality was not provided.
Caller stated that she received her second vaccine on 04/29/2021 and 24hrs later she has developed fever of 100.7.
Fever, chills, achy, joint pain, severe headache, exhaustion, sore muscles,
PATIENT'S  MOM REPORTED PATIENT HAVING SWOLLEN LIPS WITH BUMPS AND  SWOLLEN LEFT EYE WITH BUMPS ON THE SKIN SAC BELOW THE LEFT EYE ON TUESDAY NIGHT (09/10/2019) DAY AFTER THE SHOT (09/09/2019).  PT ALSO COMPLAINED ABOUT "NOT FEELING WELL " ON WEDNESDAY (09/11/2019).
Information has been received from a health professional concerning a 6 year old male who is severely mentally retarded from a beta streptococcus infection at birth. In March, 1999, the patient developed streptococcal pneumonia A meningitis and was successfully treated for this condition. In May, 1999, the patient again presented to the ER and was dx with a strep pneumococcal sepsis. The patient was again successfully treated for this and recovered. The registered nurse reported  that in July, 1999, the patient was vaccinated with pneumococcal vaccine 23 polyvalent, intramuscular injection. On 04/20/01, the patient once again showed a pneumonia A sepsis. The registered nurse  indicated that the patient was dx after having positive blood cultures. The patient was subsequently vaccinated with Streptococcus pneumoniae vaccine. Additional information is not expected.
Delayed severe allergic reaction: hives to R neck, R axillary, needle type rash to torso, severe burning and itching. Both hand swollen and red, angioedema to R face and lips, SOB lasting 7 days.
left arm started to hurt pretty bad; patient felt flushed and hot; skin was red; shivering and shaking on left side of their body; left side numb, kind of Bells Palsy syndrome; feel cold in their shoulder; cold behind left eye then from wrist to behind both eyes; left side of the body was swollen, like swollen pecks, back and chest, like they had been stung; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (left side numb, kind of Bells Palsy syndrome) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical event).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PERIPHERAL COLDNESS (feel cold in their shoulder), ABNORMAL SENSATION IN EYE (cold behind left eye then from wrist to behind both eyes) and SWELLING (left side of the body was swollen, like swollen pecks, back and chest, like they had been stung). On 09-Jan-2021, the patient experienced FACIAL PARALYSIS (left side numb, kind of Bells Palsy syndrome) (seriousness criterion medically significant) and CHILLS (shivering and shaking on left side of their body). On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (left arm started to hurt pretty bad), HOT FLUSH (patient felt flushed and hot) and ERYTHEMA (skin was red). At the time of the report, FACIAL PARALYSIS (left side numb, kind of Bells Palsy syndrome), PERIPHERAL COLDNESS (feel cold in their shoulder), ABNORMAL SENSATION IN EYE (cold behind left eye then from wrist to behind both eyes), PAIN IN EXTREMITY (left arm started to hurt pretty bad), SWELLING (left side of the body was swollen, like swollen pecks, back and chest, like they had been stung), CHILLS (shivering and shaking on left side of their body), HOT FLUSH (patient felt flushed and hot) and ERYTHEMA (skin was red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
fatigue; headache; fever; chills; This is a spontaneous report from a contactable consumer (reported for herself). A 50-years-old female non-pregnant patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6203/Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 17Mar2021 at 10:30 (at the age of 50-years-old) as dose 2, single for covid-19 immunisation at clinic. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient has no reported allergies. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL3247/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 24Feb2021at 10:30 (at the age of 50-years-old) as dose 1, single for covid-19 immunisation at clinic and experienced no adverse effect. On 18Mar2021 at 10:00, the patient experienced fatigue, headache, fever and chills. This case assessed as non-serious. No treatment was given for the events. The outcome of the events was resolved on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Slight headache around 5pm 4/30. Large knot at injection site that was warm to the touch beginning around midnight 5/1. Nausea and vomiting around 3am 5/1. Fatigue and body aches and headache upon waking up morning of 5/1. Symptoms continued to worsen throughout day. Took Tylenol for aches and low grade temp. Took Benadryl out of precaution.
Local injection site pain within 24 hours, but developed into severe stabbing pain in shoulder.  Difficulty raising arm due to extreme pain and weakness.
has previously received 1 dose of AstraZeneca; Administration date of Moderna vaccine past the BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration date of Moderna vaccine past the BUD) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (has previously received 1 dose of AstraZeneca) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE ASTRAZENECA.    On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration date of Moderna vaccine past the BUD). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (has previously received 1 dose of AstraZeneca). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administration date of Moderna vaccine past the BUD) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (has previously received 1 dose of AstraZeneca) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported. It was reported that 13 doses of Moderna vaccine were inadvertently given past the vaccine beyond use-date (i.e. past 30 days at fridge temperature) of 9/5/21.   This case was linked to MOD-2021-320876 (Patient Link).
Patient presented nine days after vaccination with redness, swelling, pain, warmth,  induration, and a spreading rash around the injection site. Patient reported that she first noticed the symptoms about 24 hours prior to reporting to clinic for evaluation. Patient presentation was consistent with injection site cellulitis  with probable cause of vaccine being given via the subcutaneous route.
Joint/muscular body pain nausea, vomiting, diarrhea sore throat, fatigue, nasal congestion.
Immediate pain, redness. In about 1 hour shot raised about 1 inch round lump and pain continued. In a few hours 1/3 upper arm turned black and blue and pain continued. Next day and for two additional days movement in upper right arm caused radiated pain. Lump disappeared in one week. Discoloration faded and disappeared in three weeks.
Narrative:  PT WAS VACCINATED IN TIMELY MANNER WITH PFIZER MRNA VACCINE. PATIENT'S INFECTION HAD ESSENTIALLY NO LUNG INVOLVEMENT, BUT HE EXPERIENCE SIGNIFICANT NAUSEA, VOMITING, DIARRHEA RESULTING IN WEAKNESS AND WEIGHT LOSS. AFTER SHORT HOSPITAL STAY, PT IMPROVED AND WAS DISCHARGED
pt recvd vax 1JUL93 & w/in 36 hrs devel t104 neg exam on 3JUL93; temp down by 72 hrs;
This spontaneous report was received from a certified medial assistant and refers to two patients of unknown age and gender. The patients concurrent conditions, medical history and concomitant therapies were not reported. The reporter stated that a shipment of ZOSTAVAX (lot # reported as L028281, expiration date: 28-OCT-2016) was shipped out on 12-OCT-2015 in a shipper that was only rated to maintain the correct shipping temperatures for 2 days. However, the shipment did not arrive at the physician's office until 15-OCT-2015. It was unspecified what temperatures the ZOSTAVAX could had been exposed to during that third day in transit. As soon as the ZOSTAVAX  shipment was received in the physician's office on 15-OCT-2015, this ZOSTAVAX (doses unspecified; subcutaneous) was administered to each of 2 patients. No known adverse effects were reported. Additional information has been requested.
APPROX 15 MINS AFTER THE VACCINATION WAS ADMINISTERED THE PATIENT NOTED FEELING LIKE HER HEAD WAS "HEAVY" AND HEART WAS RACING, SHE ALSO FELT NAUSEATED,  SHE DID HAVE DRY HEAVES WITH NOT VOMIT.
Symptoms afterwards; low grade queasiness; headache; had aches in the morning,achy; felt very uncomfortable physically; was lying here moaning; writhing,moving around constantly; a little bit of pain in arm; delirious kind of dreams; developed a fever in the night; a little bit tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Symptoms afterwards), VACCINATION SITE PAIN (a little bit of pain in arm), PAIN (had aches in the morning,achy), ABNORMAL DREAMS (delirious kind of dreams) and FEELING ABNORMAL (felt very uncomfortable physically) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included MIRTAZAPINE, ALPRAZOLAM (XANAX), IBUPROFEN, PARACETAMOL (ACETAMINOPHEN), MELATONIN, MULTIVITAMIN [VITAMINS NOS] and UBIQUINOL for an unknown indication.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced VACCINATION SITE PAIN (a little bit of pain in arm), ABNORMAL DREAMS (delirious kind of dreams), PYREXIA (developed a fever in the night) and FATIGUE (a little bit tired). On 11-Nov-2021, the patient experienced PAIN (had aches in the morning,achy), FEELING ABNORMAL (felt very uncomfortable physically), MOANING (was lying here moaning) and PSYCHOMOTOR HYPERACTIVITY (writhing,moving around constantly). On 12-Nov-2021, the patient experienced HEADACHE (headache). On 15-Nov-2021, the patient experienced NAUSEA (low grade queasiness). On an unknown date, the patient experienced VACCINATION COMPLICATION (Symptoms afterwards). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) in November 2021 for Fever, at an unspecified dose and frequency. On 11-Nov-2021, MOANING (was lying here moaning), PSYCHOMOTOR HYPERACTIVITY (writhing,moving around constantly) and PYREXIA (developed a fever in the night) had resolved. On 14-Nov-2021, HEADACHE (headache) had resolved. At the time of the report, VACCINATION COMPLICATION (Symptoms afterwards), VACCINATION SITE PAIN (a little bit of pain in arm), ABNORMAL DREAMS (delirious kind of dreams), FEELING ABNORMAL (felt very uncomfortable physically), NAUSEA (low grade queasiness) and FATIGUE (a little bit tired) outcome was unknown and PAIN (had aches in the morning,achy) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: 99.3 (High) Fever did not get above 99.3 degrees Fahrenheit.         Reporter stated  that she was just lying down, moaning, writhing, and moving around constantly and said that her symptoms lasted a few hours. She said that her fever broke in the afternoon after she took Advil and her aches reduced around the same time as well.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow up received on 16-NOV-2021 Added patient demographics, concomitant and treatment medications, added new events.
This case was reported by a other health professional via call center representative and described the occurrence of tingling sensation in a 23-year-old male patient who received ENGERIX B adult (batch number 92M2J, expiry date 3rd FEBRUARY 2017). On 17th SEPTEMBER 2015 08:45, the patient received the 1st dose of ENGERIX B adult 20 pg. On 18th SEPTEMBER 2015, 1 days after receiving ENGERIX B adult, 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 ENGERIX B adult Additional details were received as follows: The patient experienced a sensation of little needles (tingling sensation) that came and went from his torso to his neck on both the sides.
Swelling, redness, pain and warmth at injection site.  Pt did state he worked out the day after the injection site.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On 06-JUL-2015, the patient received an expired 2 ml dose of ROTATEQ lot # K010219, expiration date 02-JUN-2015, orally. No adverse effects were reported. Additional information has been requested.
Area on left thigh where DTaP given grew swollen hot and red - a hard lump appeared by clinic appointment one week later redness, gone but firm area persists
I am disabled from a car accident and few weeks after the shots  like the pain level, everything in my body went up a little bit.; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: DEP8733), dose 2 intramuscular, administered in Arm Right on 30Mar2021 as single dose for covid-19 immunisation. Medical history included ongoing diabetes, ongoing high blood pressure, disabled from a car accident, bad arteries from an unknown date and unknown if ongoing and had bypass surgery of heart. The patients concomitant medications were not reported. Patient stated, his concern was over, he received his second shot of the vaccine on 30Mar2021, as of couple of days ago he still did not have any antibodies in him. He talked to his doctor about it. The patient had a lot of medical issues. He was disabled from a car accident (moto vehicle accident) and few weeks after the shots like the pain level, everything in his body went up a little bit on an unspecified date. Patient was concerned about how long he was going to have wait, when he started seeing antibodies in his blood. The patient underwent lab tests and procedures which included antibody test which tests negative. The outcome of the event was unknown.
pt recv vax 20OCT98 & 3MAR99 reported: c/o back pain 6NOV--7NOV w/increasing intensity on 8NOV;c/o chest pain;adm to hosp 9NOV98 w/dx of pericarditis;states MD feels there was a direct correlation between the flu vax & pericarditis;Annual follow-up received on 12/21/00 provides no additional data.
The next day I started feeling pain in my left area of my back. Had treatment with the chiropractor. Have still been seeking care and also saw my PCP and he ordered an x-ray and there is no structural damage but looks like my hip was turned on the left side. I was given Naproxen 500 mg and then given a 10mg muscle relaxer and 50mg prednisone. Waiting on MRI for hip. Now my pinky and ring finger have been falling asleep.
Hours after receiving the first dose the left side of my tongue began to swell, along with my gum on the left side of my face, it eventually subsided. However four days after my appendix began to swell and I was rushed into an emergency surgery where it had to be removed. I shared my concern with all the doctors attending to me at Hospital that the vaccine caused the swelling within my body and every one of them dismissed my concern regarding the allergic reaction. I was released after surgery and was scared to take the second dose, none of the doctors documented my concerns so I reluctantly took the second dose 2 weeks later. When I returned more symptoms began to develop. I started to pee way more frequently than normal, my body temperature was always higher than normal and between October 2021 to January 2022  I lost a lot of weight. My doctor ordered me to do a MRI and ultrasound which both returned normal however the symptoms remained until around March of 2022 when I began to feel like myself again.
pt recvd flu vax & exp a h/a 2 1/2 hrs later; pt also was dizzy that evening;
pt recv vax 18NOV97 & pt devel 20 to 30 lesions;@ the time of the report the lesions were still erupting;
Anaphalatic response; Mental confusion; Unsteady gait; This is a spontaneous report received from a contactable reporter(s) (Nurse).  An 84-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 09Oct2023 at 08:00 as dose 1, single (Lot number: HF5020) at the age of 84 years intramuscular, in arm for immunisation; for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 02Oct2023 as dose 1, single; HCTZ; LOSARTAN; MELOXICAM; OMEPRAZOLE; ROSUVASTATIN. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen", notes: Known allergies: Ibuprofen; Lisinopril, reaction(s): "Known allergies: lisinopril", notes: Known allergies: lisinopril. The following information was reported: ANAPHYLACTIC REACTION (hospitalization) with onset 09Oct2023 at 08:15, outcome "recovered" (09Oct2023), described as "Anaphalatic response"; CONFUSIONAL STATE (hospitalization) with onset 09Oct2023 at 08:15, outcome "recovered" (09Oct2023), described as "Mental confusion"; GAIT DISTURBANCE (hospitalization) with onset 09Oct2023 at 08:15, outcome "recovered" (09Oct2023), described as "Unsteady gait". Therapeutic measures were not taken as a result of anaphylactic reaction, confusional state, gait disturbance. Additional information: Abrysvo vaccine location was deltoid. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event based on the temporal association  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.