chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored PROQUAD (dose, route, lot and expiration date unknown) for prophylaxis. The details of the storage were two occurrences when the temperature of the freezer reached 29 Fahrenheit degree for 30 minutes on each of the two occasions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted. Sender's Comments: US-009507513-1701USA001058: US-009507513-1612USA011816.
I went to my new physician and I was sent to get lab work and he said my A1C and blood sugar was through the roof. There were enzymes and antibodies were present and I was diagnosed with Type 1 Diabetes.
Erythema, pain at site of injection. 10 cm area of redness with central 4cm area that was even more raised and painful.
pins and needles of toes and feet bilaterally; This spontaneous report was received from a registered nurse referring to a 37-year-old female patient.  The patient's medical history and concurrent conditions were not reported. There was no known drug allergy. Concomitant therapies were not reported.  On 14-MAR-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 mL, administered intramuscularly for prophylaxis (lot #U019413, expiration date: 01-NOV-2023; strength was not provided).  On an unknown date in 2023, the patient experienced pins and needles of toes and feet bilaterally. It happened more so when she was sitting and standing. She did not have any weakness, dizziness, discoloration, warmth or issues with hands and arms. It had been happening frequently throughout the day since a few days after vaccination. The patient was unable to provide an exact date of onset. The patient had sought medical attention. She called the nurse on 04-APR-2023 (reported as today). No treatment was given for the event. She was not hospitalized. The outcome of the event was not recovered. Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was discontinued, the patient refused additional doses, she would not receive any additional hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccines.   The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
i get sick every year with flu shot; Based on additional information received on 20-Oct-2020, the case was updated from non case to a valid non serious case due to addition of adverse event sickness with the suspect vaccine.  Initial information received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional (patient) via social media.  This case is linked to cases 2020SA297294, 2020SA297267 and 2020SA273251 (cluster).  This case involves a 83 years old patient of unknown gender who reported that i get sick every year with flu shot (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer via unknown route at an unknown administration site (lot number and expiry date not reported) for prophylactic vaccination.  On an unknown date, (unknown latency) the patient stated that he/she got sick every year with flu shot (illness), the doctor knew it and he/she had to go somewhere with others for 24hrs and could not have the above 65 one.   No laboratory data was reported.  Corrective treatment and event outcome were unknown.  There will be no information available on batch number for the case.  Additional information regarding the valid non-serious case was received on 20-Oct-2020: The case was updated to valid non serious due to addition of event sickness. Corresponding fields and narrative were updated accordingly.
I didnt notice but evidently my eyes changed because the CNO looked at me and asked if I was ok.  Im not sure of what they looked like to make her cue in on I wasnt feeling well but she came over and began to monitor me at that time.  I felt light and fluffy and when I got up to get juice I felt  like I was disassociated from my body, my movements were awkward, I was severely weak and was not steady on my feel.  I felt as if my mind was moving but my body couldnt keep up.  I was very laggy and felt as if I was intoxicated.  The head of the ER made me drink alot of cold water about 24oz of water and 4 oz of juice which then caused me to get super cold and shivery.  Vitals were stable the whole time but my BP shot up to 170/90 a few moments after the water.  I was transferred to a monitoring room where I was covered with alot of blankets and allowed to lay down until I warmed up until my BP lowered and I was released.  My arm didnt begin to hurt until about 6-8 hours after and I have a red mark and the top layer of skin just do not want to heal.  I am still today having to put bandages on the spot because its red and the skin on top keeps coming off. I had joint pain and aches into the next day after causing me to take an Aleve gelcap for the pain.  Nausea here and there also.
No additional information available.; vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant concerning a 68-year-old patient of unknown gender. No concurrent condition, medical history, or concomitant therapy was reported.     On 16-AUG-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, and route were unknown; lot # T040202 has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 11-SEP-2022) for prophylaxis following a temperature excursion (product storage error). Temperature were 12.7 degrees celsius (C) and 1.6 C. The time frame was reported as 2 hours and 20 minutes, and 21 hours. There was no previous temperature excursion. No additional information was available. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: T040202; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Post first vaccine L axillary lymphadenopathy.  Post #2-L sub acute thyroiditis with difficulty swallowing, pain and  significant lymph node swelling  that became worse over a week.
Bloody diarrhoea; The patient did not finish the ROTATEQ series; This spontaneous report has been received from a physician, via a company representative, and refers to a 2 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant therapies, drug allergies or reactions were not reported.    On an unknown date (reported as "several months ago"),  the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), oral (lot #, expiration date, dose and frequency were not reported) to prevent rota-virus. On an unspecified date (reported as " the next day"), the patient experienced "bloody diarrhea"  (haematochezia) and went back to the physician office. A stool culture test performed to the patient was positive for blood in stool. On an unspecified date (reported  as "4 - 6 days later"), the diarrhea cleared on his own but the patient did not finish the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) series.  The causality assessment between haematochezia and Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ) was unknown.   Upon internal review the event haematochezia was considered as medically significant.
soreness in the arm; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm) and DIARRHOEA (diarrhea) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm) and DIARRHOEA (diarrhea). At the time of the report, PAIN IN EXTREMITY (soreness in the arm) and DIARRHOEA (diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
reaction to vaccine; swelling in joints; toes, ankles and calves were swollen, knees were also swollen; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of JOINT SWELLING (swelling in joints), PERIPHERAL SWELLING (toes, ankles and calves were swollen, knees were also swollen) and IMMUNISATION REACTION (reaction to vaccine) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced JOINT SWELLING (swelling in joints) and PERIPHERAL SWELLING (toes, ankles and calves were swollen, knees were also swollen). On 26-Apr-2021, the patient experienced IMMUNISATION REACTION (reaction to vaccine). At the time of the report, JOINT SWELLING (swelling in joints), PERIPHERAL SWELLING (toes, ankles and calves were swollen, knees were also swollen) and IMMUNISATION REACTION (reaction to vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported . No treatment medication was reported .
The patient received the third/booster dose of BNT162b2; The patient received the third/booster dose of BNT162b2; Injection site pain; Fever; Fatigue; Muscle aches; Difficulty breathing; This is a spontaneous report from a non-contactable consumer, the patient. A 64-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 06Oct2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6178) via an unspecified route of administration in the left arm on 24Feb2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 17Mar2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 06Oct2021, the patient experienced injection site pain, fever, fatigue, muscle aches and difficulty breathing. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain, fever, fatigue, muscle aches and difficulty breathing was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 5 year old female who on 20-NOV-2001 was vaccinated with a dose of Varivax. On 01-MAY-2006 the patient developed breakthrough, thee was no lesion count. The patient received no treatment and she was not hospitalized. No further information was available. There was no product quality complaint involved. Additional information has been requested.
received expired dose of Pediarix  on 6/15/2021/  expired on 6/14/2021; This case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number unknown, expiry date 14th June 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th June 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 15th June 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was the mother of the patient. On 15th June 2021, patient received Pediarix, which was expired on 14th June 2021. The reporter mentioned that, patient was not experiencing any adverse events. The reporter consented to follow up.
This spontaneous report as received from a medical assistant and refers to an unspecified number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # M007762, expiration date on 07-DEC-2018, lot # M036057, expiration date on 18-MAY-2017, lot # M045207, expiration date on 30-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47-77 degrees Fahrenheit for 70 minutes. Data logger was involved in recording of the temperature excursions. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA005091.
This spontaneous report as received from a register nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD lot # M001152 with expiration date 05-JAN-2017, and lot #M007960 with expiration date 15-AUG-2017 (dosage and route of administration were not reported) for prophylaxis, which were exposed to a prior excursion a total of time in the range -14°C to -10°C (-11°C) for a time frame of 15 minutes because of data logger. Additionally, were also exposed to a current temperature excursion of -14°C to -10°C (-14°C) for 25 minutes because of data logger. No adverse effects were reported. One of this excursion temperature was in November 2016. This is one of the several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA011215:
This spontaneous report was received from a doctor of pharmacy concerning an unspecified number of patients of unknown age and gender. It was reported that on an unknown date, an unspecified number of patients may have vaccinated with a dose of RECOMBIVAX HB (lot number, expiry date, dose and route unspecified) which was exposed to 10 degrees Fahrenheit (F) for 8 hours, which was an excursion that was unsupported by in-house stability data. No concomitant medications were reported. No adverse symptoms were reported. This is one of the two reports from the same source. Additional information has been requested.
at 16:37 making rounds to check on status of vaccination patients . Patient stated "that her mouth lower lip and tongue were tingling and numb".  Notified  EMT   (on site) patient moved to area of closer observation, Complete assessment . Patient A & O x 3. denies any c/o SOB or Dyspnea.  Color wnl,   Notified  (CN) who immediately came to site of need. Noted at 16:47 Patient appears to have pink circumoral  flushed areas around her mouth. Patient also had noted hives on her left upper bicep area.   Discussion with  (CN) and Paramedic , decision to give 50 mgs of Benedryl.  4:55 PM  50 mgs Benedry l given IM into right Deltoid.  Continual monitoring of patient. 5:19 patient stated "I feel much better".  Continual monitoring of patient until 5:25PM.   Patient discharged home (per her and her son's wish) .  Discussion to call 911 or go to ED if condition worsens or returns.  Patient recommend to make primary physician aware of incident as well as to  take benedryl  prior to second dose of vaccine as well as patient to make clinician aware of this occurrence prior to injection..
Swelling, erythema, pain, fever. Right arm 9 inches at swelling area. Left arm 7 inches.
Based on information received on 15 Nov 2017, the product code has been amended from 448 (MONOVALENT INFLUENZA A/H1N1 THIOMERSAL VACCINE) to 449 (MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE). SERIOUSNESS CRITERIA OTHER: IMPORTANT MEDICAL EVENT. Initial unsolicited report received from consumer on 15 Nov 2017. This case involves patient (age and gender were not reported) who was vaccinated with a dose of MONOVALENT INFLUENZA A/H1N1 THIOMERSAL VACCINE (batch number, expiry date, route and site of administration were not reported) on an unspecified date in 2009. The patient's medical history and concomitant medication were not reported. On an unspecified date, post vaccination, patient got developed narcolepsy which ruined patient's life. Laboratory investigation and corrective treatment were not reported. Outcome of event was not reported. Upon internal review the case was considered as serious because of important medical event: Narcolepsy. List of documents held by sender: none. Addendum: 29 Nov 2017. The product code has been amended from 448 (MONOVALENT INFLUENZA A/H1N1 THIOMERSAL VACCINE) to 449 (MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE). Sender's Comments: Patient experienced Narcolepsy after vaccination. Time to onset is not known. However, further information including patient's medical history, time to onset, details of the progression of narcolepsy, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
FIRST DOSE: Patient received a COVID-19 Vaccine dose involved in a temperature excursion; FIRST DOSE: Patient received a COVID-19 Vaccine dose involved in a temperature excursion; This is a spontaneous report from a contactable Consumer or other health care professional. A 13-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0196; Expiration Date: 30Sep2021), via an unspecified route of administration in left arm on 08Jul2021 (at the age of 13-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Investigation assessment was not provided. The reporter was an office manager who reported invalid COVID-19 vaccine doses were administered to 4 patients. "PRIVACY" clarified that the office manager reported their practice had kept the COVID-19 vaccine in the freezer since 08Jun2021, past the allowed extended freezer time, and then the COVID-19 vaccine was then given to 4 patients. "PRIVACY" said the COVID-19 vaccine can only be kept in the freezer for 3 weeks. "PRIVACY" said a temperature excursion had occurred on the practices COVID-19 vaccine, and the practices office manager was being transferred to report on the 4 patients that received the COVID-19 vaccine involved in the temperature excursion. Caller stated that the patients was vaccinated with expired use by date including on 08Jul2021 and later. Caller was looked for guidance on how to proceed. Reported the patient was unaware the COVID-19 vaccine was involved in a temperature excursion, and the patient had not reported any adverse events to their office since the COVID-19 vaccine was administered.  Follow-up attempts are completed. No further information is expected.
right side pain between butt and hip; right side pain between butt and hip; This is a spontaneous report from a contactable consumer (patient, self-reported). A 65-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 07Mar2021 (age at vaccination: 65 years), as dose 2 single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 14Feb2021, as dose 1, single for COVID-19 immunisation and experienced left hip pain. The patient reported that, he got second COVID-19 vaccine and on 08Mar2021, he woke up with sharp pain on right side between his hip and butt. It was pronounced pain. He stated that, he probably felt uncomfortable, but was expecting it. On an unspecified date, the patient underwent lab tests and procedures which included physical examination with unknown results and weight which fluctuates to about 190Ibs. Outcome of the events was resolving.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
On 3-2-21, my mother noted vision in her right eye was unclear and wavy.  On 3-4-21, she woke up in the morning and had lost all sight in the right eye.  The examining eye doctor stated there appeared to be a "blister" behind the eye and she was sent to an retinologist for further evaluation on 3-5-21.  The retinologist instructed her to go to the ER.  My mother was admitted for futher evaluation.  Her protime in the ER was 1.7.  MRI of head was otherwise negative for changes.   Her protime had been stable between 2.0 and 3.0 for years.  At her follow-up  appointment with her doctor, her protime was 1.8.  Her Coumadin dose has been adjusted,
On 12/30/2020 I got a pain in the stomach as if someone kicked me and then a taste of medicine like when you chew a aspirin after taste. But it went away 12/31/2020 I felt dizzy around 3:00pm