chrisvoncsefalvay/vaers-outcomes huggingface dataset:
*** SEVERE NEUROLOGICAL IMPACT***       ***  MASSIVE BRAIN INFLAMMATION***       ***  DEATH ***  3/07/2021: Intractable stabbing pain in head at ears every 3-4 seconds. Pain level 10.  3/10/2021:  Intractable stabbing pain in head at ears every 3-4 seconds. Pain level 10.        ER visit Urgent Care          ER Treatment:  morphine IV         ER Tests: CT brain w/o IV contrast; CTA carotid; Basic Metabolic Panel; CBC w platelet count                       Diagnosis: Neck muscle spasm                       Rx: tramadol (not helpful after morphine wore off)  3/12/2021:  Intractable stabbing pain in head at ears every 3-4 seconds continues. Pain level 10.            ER visit Urgent Care:              ER Treatment:  morphine pills - twice; Tylenol; Colace; Lidocaine     ER Tests: XR 2 views; Basic Metabolic Panel; CBC w platelet count; Lactic acid, venous                          Diagnosis:  Left ear pain; pneumonia due to infectious organism, unspecified laterality,  unspecified part of lung                          Rx: amoxicillin-clavulanate; neomycin-polymyxin-hydrocortisone (did not                              fill these prescriptions)  3/14/2021:  Intractable stabbing pain in head at ears every 3-4 seconds continues.  Pain level 10.           ER visit Hospital:  admitted to hospital; treatment for 14 days;                          Discharge diagnosis:  ACUTE METABOLIC ENCEPHALOPATHY and HEPATITIS   3/28/2021: Transferred to Hospice.  3/31/2021: Transferred to Home Hospice.  4/10/2021: Death occurred         Death Certificate: PRESUMED MENINGITIS
Thought I had a cold and went to the doctor, tested positive for COVID-19. Was prescribed Paxlovid. Felt better after 3 days.
Mother brought patient to the clinic on 12/4/18. Rash seen on 12/3/18. (L) upper thigh with redness, swelling. Spreading. Dxd with cellulitis of (L) leg. Rx - clindamycin 75mg/5mL 8mL po q 8 hrs x 10 days.
Covid Diagnosis after fully vaccinated with Pfizer; Covid Diagnosis after fully vaccinated with Pfizer; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 18Mar2021 at 10:30 (Batch/Lot Number: EN6198) as dose 2, single, and on 26Feb2021 at 09:30 (Batch/Lot Number: EN6207) as dose 1, single, both at the age of 56-years-old, via an unspecified route of administration, administered in arm left for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included telmisartan (MICARDIS) taken for an unspecified indication, start and stop dates were not reported. The patient had a Covid diagnosis after (being) fully vaccinated with Pfizer on 04Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 04Aug2021. The outcome of the events was recovering.
At 2 days following MMR and Hep-B, he had increasing headache, temperature 104F, cough and pneumonia, (Per mother).
Rash started on abdomen 7/18, spread to arms and legs by morning 7/19 (today)
Shingles pain started 30 days after the initial dose of the  vaccine. Full blown shingles with lesions occurred 2 days after the 2nd dose. The second dose was on 2/26/2021. Shingles was diagnosed on 3/3/2021. I started a prescription of acyclovir 800 mg five times a day for 7 days.  I am healthy. I have not been sick in years. I take no medicine. I did not get the shingles vaccine.
The Covid Vaccine (Gray top) Pfizer given to patient was outside of the 12 hour at room temperature recommendation for vaccine. No symptoms, side effects, or other concerns at this time. Spoke with the Pfizer Safety team. Staff states that a punctured vial of the Covid vaccine gray top should not exceed 36 hours at room temp range of 46 - 84 F. Vaccine was given from the vial that was at 26 hours at room temp of 70 F.
8 hours post vaccine - vomiting x 2 (30 minutes apart) - low grade temp of 100.4, severe abdominal pain, extreme headache I have never experience before, both ears felt like I had severe ear infections, and my eye balls felt like there was so much pressure they were going to pop out - this last for 36 hours and then felt just week. At the 48 hour mark low grade temp for 8 hours with a mild headache. Woke up and headache remains and muscle weakness.
Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE. Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE. Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE. Manufacturer: Unknown), for COVID-19 Immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE. Lot: GH9694), for COVID-19 Immunization, reaction(s): "Fever".  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received COVID-19 vaccines and boosters when available (24 hour fever after each).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Vaccines were administered following a temperature excursion; No adverse event; This spontaneous report was received from a vaccine coordinator/administrator and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with improperly stored dose (product storage error) of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T030707, expiration date: 14-APR-2023 (dose number, dose and route of administration were not reported) for prophylaxis.  It was reported that the vaccine was stored in the temperature of 48 Fahrenheit (F) for a time frame of 1 hour and 2 minutes without a previous temperature excursion. There were no adverse reactions (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA003600: US-009507513-2110USA003601: US-009507513-2110USA003603: US-009507513-2110USA003604: US-009507513-2110USA003605: US-009507513-2110USA003599: US-009507513-2109USA001290:
still having problems breathing; anaphylactic reaction; A spontaneous report was received from a consumer concerning a77-year-old, female patient who developed anaphylactic reaction and still having problems breathing (dyspnea).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    The patient received the unknown of two planned doses of mRNA-1273 (Batch number: 030M20A) on  24 Feb 2021 intramuscularly at unknown injection site for prophylaxis of COVID-19 infection.    On 24 Feb 2021 the patient experienced anaphylactic reaction (lips went numb, face went numb, blood pressure went up, heart rate went up, her throat closed, and she couldn't breathe or talk). An ambulance was called and the patient was transferred to the ER (emergency room) where they administered intravenous diphenhydramine.  Five hours later, the patient was okay, but reported that as of 25 Feb 2021, they are still having problems breathing. Treatment of the events included prednisone and diphenhydramine.    Action taken with mRNA-1273 in response to the event was not provided.  The event anaphylactic reaction was considered resolved. The outcome of the event, still having problems breathing, was unknown.; 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.
patient received the shot one week before actual date actual date 10/21/21 pt received the shot 10/14/2021
This 96 year old resident was diagnosed with COVID on 10/28/2020. She has a significant, complicated medical history and  did not return to her pre-infection level of health. She began declining in early  January and was made care and comfort measures only on 1/2/2021.  Most of her medications were d/c'd except for those that provided comfort.  No obvious reaction to the vaccine was seen and we do not suspect that her death was vaccine related, however we were directed by Dept of Epidemiology to report her death as it was within one week of receiving the vaccine.
difficulty walking; sore muscles; burning feeling in spine; headache; extremely thirsty; This case was reported by a pharmacist and described the occurrence of walking difficulty in a female patient who received Herpes zoster (Shingrix) (batch number 477S3, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced walking difficulty, muscle soreness, burning sensation, headache and thirst. On an unknown date, the outcome of the walking difficulty, muscle soreness, burning sensation, headache and thirst were unknown.   It was unknown if the reporter considered the walking difficulty, muscle soreness, burning sensation, headache and thirst to be related to Shingrix.  Additional details were provided as follows: The customer field a claim and its subsidiaries for injuries/ damages sustained resulting from an alleged product hazard arising from a Shingrix product supplied to pharmacy. The age at vaccination was not reported. After the vaccination, the patient had difficulty walking, sore muscles, burning feeling in her spine, headache and was extremely thirsty. The patient received treatment at a hospital twice and was still seeking medical treatment. Based on the above information, this claim was received for further handling and denying liability on behalf of pharmacy and it's subsidiaries. The reporter asked to notify insurer if required.
headaches; A spontaneous report was received from a consumer concerning a 71-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 25 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number:013L20A)via unknown route for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient received their second of two planned doses of mRNA-1273(Batch number:016M20A) for prophylaxis of COVID-19 infection.  After the first dose of vaccination, the patient experienced headache.   Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.  The outcome of event headache was unknown.
Developed generalized urticaria 15-20 minutes following MMR. Got Epi SC, Prelone and Zyrtec. Observed for 45 minutes and sent home with Prelone X 4 days.
Reported by mother to have developed "red blotches on right arm and redness "bullseye" at injection site.  Temp 101.2 and became lethargic evening after receiving shots.  Mother took him to ER where he was given injection of Benedryl.  Mom states that he improved very quickly.  Is sleeping this am and no signs of distress.
tested positive greater than 14 days post 2nd vaccine Narrative: tested positive greater than 14 days post 2nd vaccine
1:28PM PT 'FELT LIGHTHEADED AFTER SHOT'. A/O, PINK, W/D, RESP REG WITH EASE. BP 180/90, HR 99, R 16, 02 SAT 97%. STATES SHE HASN'T HAD MUCH TO EAT TODAY. BS 86MG/DL. JUICE GIVEN.  PT STATES SHE 'FEELS BETTER NOW'. 1:40PM  BP180/90, HR 70, R 16, 02 SAT 99%. ADVISED TO F/U WITH PCP R/T ELEVATED BP. AMBULATORY TO EXIT WITH FIANCEE. 4-8-21 12N TC: FIANCEE STATES PT IS 'DOING FINE NOW'.
The patient was given a dose of the undiluted (Gray cap) Pfizer COVID-19 Bivalent booster that was not stored in an ultra-cold temperature freezer and was instead stored in the regular freezer (between -30 to -20 F). It was moved out of the regular freezer to the refrigerator after more than 3 weeks in the regular freezer. The doses were then used after more than 24 hours in the refrigerator. We have contacted Pfizer about this and according to their off-label studies they provided via file, they are not able to support the temperature excursions that occurred. As per guidance, the recommendation is to re-vaccinate the individual with the full authorized dose of any Bivalent vaccine (either Pfizer or Moderna) and we have communicated with the patient for re-vaccination.
Patient became dizzy as soon as the vaccine was given. She had pulse and was breathing, but did not respond.
Recently had his Cominaty booster; Fatigue; Low-grade fever; Joint aches; This is a spontaneous report received from contactable reporter (Physician) via Pfizer sales representative.  A 55-year-old male patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) 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), for Covid-19 immunisation; Bnt162b2 (Dose 2), for Covid-19 immunisation. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "Recently had his Cominaty booster"; FATIGUE (non-serious), outcome "recovered" (2021), described as "Fatigue"; PYREXIA (non-serious), outcome "recovered" (2021), described as "Low-grade fever"; ARTHRALGIA (non-serious), outcome "recovered" (2021), described as "Joint aches".  Additional information: Twenty-four hours after the booster patient experienced fatigue, low-grade fever and joint aches. These symptoms went away after 12-16 hours.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
mom stated pt had shot 1FEB95 & the next day face was numb; phone call from mom 8FEB95 took pt to MD p/talking w/PHN; dx w/Bell's Palsy 9FEB95; liquid steroids x 10 days;
Almost immediately following vaccine administration I had tingling in my lips, followed by swelling and tingling of my soft palate. It was minimal and became worse at around 20min following the vaccine. I had left the facility and was having some increased mucous production. No difficulty breathing, but I had some slight difficulty swallowing. I took 50mg of Benadryl and after about 1.5 hours the symptoms had resolved. Now over 24 hours out. I have some swelling of my right bicep, as well as some tenderness with right elbow and right wrist pain. Some myalgia worse in my right shoulder and right sciatic area and right thigh. Slight fatigue.
c/o extremely sore left arm from neck to fingers. unable to move arm.  Pain started soon after injection and continued to increase throughout the evening.  Tried to apply heat but was too painful.  Fainted upon arising the next morning.  No redness or swelling noticed.  Advised ibuprofen. Contiued to have pain and extreme fatigue and malaise until 10/24/05
Pt recvd vax & died due to sudden infant death synd; pharmacist reported 2 pts; they were assigned WAES 93040017 & WAES 93040018; addt info has been requested;
Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Other suspect therapy included STERILE DILUENT lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the STERILE DILUENT used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Follow up information was received from the medical assistant on 17-MAY-2017, referring to an 11 months old female patient. The patient administered the vaccine on 25-APR-2017. The medical assistant reported that they did not exactly know what caused the temperature excursion in April 2017, but they were thinking the door to the refrigerator might have been left slightly open. There had been no temperature excursions since that time. All telephone attempts to obtain follow-up information on 17-MAY-2017 had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013406: US-009507513-1705USA014055: US-009507513-1705USA014056: US-009507513-1705USA014057: US-009507513-1705USA014058: US-009507513-1705USA014059: US-009507513-1705USA014060: US-009507513-1705USA014061: US-009507513-1705USA014062: US-009507513-1705USA014063: US-009507513-1705USA014064: US-009507513-1705USA014065: US-009507513-1705USA014066: US-009507513-1705USA014068.
Hi Blood sugar for about 12 hours post vaccine starting about 4 hours after vaccine. Blood sugar over 500 for several hours.
Pt experienced arthralgias, myalgias, headache, started post 4th Anthrax vaccine. Pt also had an 8 1/2 x 12 cm erythematous macula on left upper arm at injection site with a central nodule.
Pt developed a high fever (maximum of 103.4F) and a rash. Pt developed fever 8 days, post MMR. He received Amoxicillin X 48 hours after ER visit.
Patient received Moderna COVID vaccine on 3/18/21 and 4/16/21 at an outside facility. On 7/23/21, patient was admitted to our facility for acute COPD exacerbation and COVID-19 pneumonia (CRP low, not current candidate for COVID directed therapies). As of 7/31/21, patient is still hospitalized.
This spontaneous report was received from a pharmacist referring to his 60 year old female aunt. The reporter stated that he was not familiar with his aunt's medical history but appeared to be diabetic, no known drug allergies. His aunt reported to him that on 08-NOV-2014 she was vaccinated with a dose of ZOSTAVAX (Lot no. K009198, exp. 27-SEP-2015), subcutaneously in the upper arm. On 09-NOV-2014 the patient injection site felt sore and also experienced malaise, body ache and headache. On 10-NOV-2014, Monday, the patient reported that her injection site was swollen to about the size of a tennis ball and the surrounding area was a "light pink". She showed her injection site to the reporter who said the injection area was warm and elongated that "looks like cellulitis". On 11-NOV-2014, patient's injection site was "30% more inflamed". She did not seek for medical attention nor received treatment. No rash was observed. At the time of the report the patient had not recovered from the events. The relationship between the adverse effects and the therapy with ZOSTAVAX was not reported. Additional information has been requested.
Covid arm rash and welt on my arm where the injection site is and is getting bigger.  Itching and burning sensation.
The first day there was site soreness.  Days two and three has substantially worse affects.  I was unable to stand on day one and had a fever of 103.  Day two there was confusion, i wasn't able to read, entire body ached and a fever of 101.  Day 4 my fever finally broke and I was able to function at a depressed level.
Received H1N1 vaccination on 12-16-09. At 1:00am 12-17-09 developed symptoms: dizzy, weak, itching (but no obvious hives), coughing. She contacted her PMD this a.m. Has underlying illness of COPD. Private PMD declined to see at this time. Advised client to seek medical care @ walk in or ER if symptoms worsen.
After giving vaccine went to enter into electronic record and noticed pt had received same shot 4/2015 called pt and she does not remember getting that shot and thinks it was reported in error.
Chest pain, headache, dizziness, shortness of breath starting 24 hours after vaccine and chest pain continues a week later.
Erupted with multiple wheels/hives to deltoid region of Left arm.  Only placed DTaP/IPV on the arm. Redness & mild itching noted along with hives - 5 min after administration.
Developed 99.0 temp, body aches, headache the day after ZOSTAVAX vaccine.  Sx lasted 3 days after vaccine.
Nausea and fever for three days. Redness at the site of the arm. Red streaks down the arm. Golf-ball size swelling at site.
A purchasing agent reported that a 50 year old male received an injection of TD Toxoids Adsorbed, Purogenated on 7/11/00 and 7 days, post vax, the pt developed an injection site reaction. He was seen by a physician and recovered. This is 1 of 2 pts from this facility who developed an injection site reaction following receipt of this vaccine, lot 470531.
has a hard time walking first thing in the morning; achiness in left leg and it's been over a month; pain is so bad; achiness in left hip and it's been over a month; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (has a hard time walking first thing in the morning), PAIN IN EXTREMITY (achiness in left leg and it's been over a month), PAIN (pain is so bad), ARTHRALGIA (achiness in left hip and it's been over a month) and VACCINATION SITE PAIN (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 015M20A) 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 09-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore arm). On an unknown date, the patient experienced GAIT DISTURBANCE (has a hard time walking first thing in the morning), PAIN IN EXTREMITY (achiness in left leg and it's been over a month), PAIN (pain is so bad) and ARTHRALGIA (achiness in left hip and it's been over a month). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) at an unspecified dose and frequency. On 11-Mar-2021, VACCINATION SITE PAIN (sore arm) had resolved. At the time of the report, GAIT DISTURBANCE (has a hard time walking first thing in the morning), PAIN IN EXTREMITY (achiness in left leg and it's been over a month), PAIN (pain is so bad) and ARTHRALGIA (achiness in left hip and it's been over a month) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Action taken with the product mRNA_1273 is not Applicable.
8 HOURS AFTER VACCINE GIVEN, I DEVELOPED BODY ACHES, PRIMARILY IN THE TORSO. 10 HOURS AFTER VACCINATION, I DEVELOPED MILD CHILLS. 12 HOURS AFTER VACCINATION, I HAD FEVER, CHILLS, BODY SHAKES, BODY ACHES, SINUS CONGESTION AND HEAD/SINUS PAIN. FEVER PEAKED AT 102.1 BUT WAS OVER 100 DEGREES F. FOR THE NEXT FOUR HOURS UNTIL I MEDICATED WITH  TWO TYLENOL EXTRA STRENGTH 500 MG. LOW-GRADE FEVER CONTINUED FOR ANOTHER 8 HOURS.  I WAS UNUSUALLY TIRED/SLEEPY FROM 12 HOURS UNTIL 32 HOURS AFTER THE VACCINATION WAS GIVEN. I SLEPT MOST OF THAT TIME. I CONTINUED TO TREAT SYMPTOMS WITH TYLENOL 500 MG OR ADVIL PLUS MUCINEX-D FOR SINUS CONGESTION. SYMPTOMS DISAPPEARED 32 HOURS AFTER VACCINATION.