chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came in today (11/13/22) and wanted to update us that she was diagnosed with bacterial cellulitis following her shingles vaccine. Shingrix was given in the right arm on 10/24/22. She came in on 10/30/22 with a red, hot, itchy arm with a lump and spoke with the pharmacist on duty. She sought medical care after her visit and was diagnosed with bacterial cellulitis.
Severe Tinnitus; Chronic fatigue; This is a spontaneous report from a contactable other health care professional, the patient. A 51-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER1734) via an unspecified route of administration in the left arm on 09Apr2021 at 20:00 (at the age of 51-year-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 4 weeks prior to the COVID vaccine. The patient previously received pethidine hydrochloride (DEMEROL) for unspecified indication from unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER7534) via an unspecified route of administration on the left arm on 19Mar2021 at 20:00 (at the age of 51-year-old), as a single dose for COVID-19 immunisation. On 10Apr2021, the patient experienced severe tinnitus and chronic fatigue. The events did not result in a visit to the doctors or other healthcare professional office/clinic, 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 severe tinnitus and chronic fatigue was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
TINNITUS-Ringing of the ear the day after the shot.  Ringing hasn't stopped since.  Also, a few days after the second shot, Evan started feeling Chest pain, Shortness of breath and  pounding heart.  Chest pain comes and goes
throwing up; slept almost 23 hours per day; headache, really bad headache; chills; Muscle Pain; Joint Pain; feverish; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache, really bad headache), CHILLS (chills), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain) and PYREXIA (feverish) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 20-Mar-2021, the patient experienced HEADACHE (headache, really bad headache), CHILLS (chills), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), PYREXIA (feverish) and HYPERSOMNIA (slept almost 23 hours per day). On 21-Mar-2021, the patient experienced VOMITING (throwing up). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. On 21-Mar-2021, VOMITING (throwing up) had resolved. On 25-Mar-2021, HEADACHE (headache, really bad headache), CHILLS (chills), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), PYREXIA (feverish) and HYPERSOMNIA (slept almost 23 hours per day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sore at sight annoying headaches , body aches and fatigue still going on  Taking Tylenol and   Ibuprofen
This spontaneous report was received from a physician referring a 4 year old male patient. Current conditions included developmentally delayed, the patient's medical history was not reported. On 15-SEP-2016, the patient was vaccinated with PROQUAD (lot number, expiration date, concentration, dose, frequency and via were reported as unknown), other suspect therapies included influenza virus vaccine (unspecified) (lot number, expiration date, concentration, dose, frequency and via were not reported) and DAPTACEL (lot number, expiration date, concentration, dose, frequency and via were not reported) that were administrated simultaneously in the same date and were indicated. No concomitant medications were reported. On 15-SEP-2016, during a visit to the physician's office, the patient experienced brief episode of vomiting. No laboratories or studies were performed. At the time of the report, the outcome of vomiting was unknown. The causality between PROQUAD and the adverse event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Body aches and fatigue followed by numbness in left arm, nausea, elevated blood pressure and pulse leading to ER visit. Labs, Head CT, and EKG all normal. Persisting fatigue, and body aches with left arm numbness coming and going.
blood clots in her legs; blood lot traveled to lungs, had a very severe case of blood clots; severe pain in her legs; could not walk; weak; feeling fatigued; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots in her legs), PULMONARY EMBOLISM (blood lot traveled to lungs, had a very severe case of blood clots) and PAIN IN EXTREMITY (severe pain in her legs) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (severe pain in her legs) (seriousness criterion hospitalization), GAIT INABILITY (could not walk), ASTHENIA (weak) and FATIGUE (feeling fatigued). On 31-Mar-2021, the patient experienced THROMBOSIS (blood clots in her legs) (seriousness criteria hospitalization and medically significant) and PULMONARY EMBOLISM (blood lot traveled to lungs, had a very severe case of blood clots) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 31-Mar-2021 due to PULMONARY EMBOLISM and THROMBOSIS. At the time of the report, THROMBOSIS (blood clots in her legs), PULMONARY EMBOLISM (blood lot traveled to lungs, had a very severe case of blood clots), PAIN IN EXTREMITY (severe pain in her legs), GAIT INABILITY (could not walk), ASTHENIA (weak) and FATIGUE (feeling fatigued) outcome was unknown.            No concomitant and treatment medications were reported.  The patient had no side effects from the first dose of Moderna vaccine.   The patient remained hospitalized at the time of report.  Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Fatigue is consistent with the Known safety profile of the product.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Fatigue is consistent with the Known safety profile of the product.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    No concomitant medications were reported. No treatment medications were reported.  This case contains information for the 78th of 100 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
So far my arm is very swollen like there is a baseball under my arm and is painful to the touch.
2 days after immunization (DtaP ,HIB) given child developed very swollen thigh with erythema. Gredually refused to walk on affected leg and parents brought her in on day 5. Believed to be cellulitis and pt. treated with antibiotics, area marked and f/u done next day. Improved greatly.
the patient received an improperly stored dose of VARIVAX; This spontaneous report was received from a registered medical assistant and refers to patient of an unknown gender and age. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.    On 02-SEP-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen and route of administration were not provided), lot number T002844; expiration date 23-JAN-2022, as prophylaxis. The vaccine was reconstituted using a properly stored sterile diluent (MERCK STERILE DILUENT) Lot # S035537 has been verified to be a valid lot# for sterile diluent, expiration date 25-JUN-2022.    The improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced a temperature excursion of 5.5 Fahrenheit degree (F) for a period of 25 minutes. It was reported that the vaccine did not had a previous temperature excursion. The call was because a digital data logger.
Patient started to cough within a few hours after receiving the vaccines(Monday, July 21).  He had a mild fever throughout the entire week until Friday evening when it got progressively worse 102.  Saturday his fever continued to rise into the high 102s.  On Sunday it was 104.1.  Sunday night we took him to the emergency room.  A chest X-ray revealed a mild case of Pneumonia.  The antibiotic Augmentin was percribed and appears to have cured patient of the Pneumonia, if that is what he had.  The vaccines he received were for Measles, Mumps & Rubella; Chickenpox; Diphtheria, Tetanus & Pertussis.
Pt recvd vax & began to experience flu-like sx (back, legs, body ache, neck weakness); did not have a fever pt took 2 APAP & felt better on 5MAr93 & then on 6MAR93 went to the ER;
Persistent left upper arm pain 8/10. No mass, no warmth, no fever. Pain started day of injection. Not improving with time. Heating pad will help.
PT COM[PLAINING OF VOMITING AFTER VACCINES WERE ADMINISTERED. HE WAS SEEN BY ANOTHER PROVIDER LATER THE SAME EVENING.
Pt recvd vax 5JAN93 devel severe joint pains; lab eval for a rheumatoid factor & ANA were neg; fingers still hurt;
On 8/31/2022 patient received Moderna expired beyond-use-date of 8/26/2022.
03/29/2022- I was sitting at my computer when my watch went off informing me that my heart rate dropped to 33 and stayed there for over 10 minutes.
bruising  and swelling of the arm and then radiates to the neck. patient had to go to the emergency room, she was diagnosed with vaccine administration related cellulitis which required antibiotic and oxygen use since she had been hypoxic from it
Pt. had hives, tremors, swelling of the mouth and tongue. Pt. was transported to the local ER where she was treated with IV steroids and was discharged home.
At 3 hours: arm pain.  At 15 hours: chills, fever, joint and muscle pain, severe headache.  At 39 hours: fever, dizziness, lower back spasms and pain. At 52 hours: back spasms and pain, dizziness.
I am wondering different parts and areas of my body itching/itchiness; This is a spontaneous report from a contactable consumer (Patient). A 65-years-old female patient  received first dose of  (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL1283, NDC number; UPC number; Expiry Date: unknown) via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunisation. Covid-19 vaccine was a Pfizer product. Covid-19 vaccine manufacturer was unspecified. The patient's medical history included high blood pressure. Concomitant medication included valsartan for High blood pressure. The patient stated "I had my first vaccine, Pfizer Covid vaccine on the 19th of Jan (19Jan2021) and on the 12th day (12 days after) on Monday (01Feb2021) she began to feel itchiness, she wondering different parts and areas of her body were itching." She stated, "I have no idea if it's related, I haven't used any other detergents or anything that would have caused and so I thought it may be related to the vaccine." No investigation assessment. The second dose was due on 16Feb2021. No laboratory test was reported, she would go next week. No treatment was received for the events. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
My baby woke up having a seizure at 7:20 AM. She was sweating, she was blue and shaking with her hands by her face. Her eyes were rolling and I had to turn her on her side to calm her down. I then drove her to the ER. Spent two the first two days in the ICU. My baby had two more seizures when we arrived in the ER.
dose that expired was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 73-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st February 2023, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 1st February 2023, unknown after receiving Twinrix and Twinrix 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 Information: GSK Receipt Date: 01-FEB-2023 Reporter's Comment: The health care professional called to inform that a dose of Twinrix that expired and was administered to a patient.  The reporter consented to follow up. Additional Supportive Information: Expired Twinrix vaccine was administered to a patient, which led to expired vaccine used.
Severe bodyaches; Especially back & front thigh to below knee; Especially back & front thigh to below knee; Especially back & front thigh to below knee; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UUNKOWN) via an unspecified route of administration in the right arm on 07Apr2021 at 15:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, diabetes 2 and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included multiple plus insulin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 07Apr2021 at 16:30, the patient experienced severe body aches especially back & front thigh to below knee, fatigue and headache. The events did not result in doctor or other healthcare professional office/clinic visit, 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 severe body aches especially back & front thigh to below knee, fatigue and headache were not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Pain after injection that has worsened and pt now has reduced ROM and weakness 1 week later
Received call 10/15/13 stating red bumpy area L arm where inj given about 2" x 4" in size - not going away - itchy - no temp - no drainage. Checked back 10/16 w/client - no worse not getting bigger - 10/17 going away.
Vaccines receved on 8/20-no reaction that evening. 8/21 in am had a sm bump at site of DTaP. Grew to apple size by that evening and leg extremely sore. Fever of 101.2. This am redness had increased up thigh through groin down in pubic area. No fever today and no soreness. Area is "rash like redness." Seen in ER MD recommended Benadryl and Tylenol.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo any temperature excursions. The date of vial initially stored in the refrigerator was unknown. Number of doses/vials were 168. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non significant live follow-up: Additional reporter added.
I had Covid in dec 2020 and lost my sense of taste and smell completely for a few weeks. It had returned partially, but not fully when I got my vaccine in March. I have had severe parosmia since I got my first shot-- after 4 days, everything I ate and drank began to taste and smell like burned rubber/trash combination - and I started to notice that the air I breathed smelled the same way. Worse, this  seemed to intensify after my second shot and then I started to smell cigarette smoke with every breath, or a chemical odor-- like paint fumes and sharpie fumes mixed together. And I got a headache as if I was smelling fumes. I was not ever smelling fumes or smoke- I live with 3 kids and a husband and they assure me I'm crazy.  I've googled it and learned the word phantosmia. I'm now 7 days after my second shot and panicking that this will never end. More importantly no one told me this could happen, and no one acknowledges that this has happened or could happen. And maybe it's a bizarre coincidence... but I'm reporting it in case others are experiencing it. It would be good to make this known so that people know what is happening and why...
This case was reported by a pharmacist via call center representative and described the occurrence of generalized urticaria in a 56-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2019) for prophylaxis. On 10th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 10 days after receiving SHINGRIX, the patient experienced generalized urticaria. On an unknown date, the outcome of the generalized urticaria was not recovered/not resolved. The reporter considered the generalized urticaria to be possibly related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that, the patient developed hives all over her body, about 10 days after vaccination. At the time of this report, two months later, the patient had the hives.