chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ear felt full with fluid; Slowly became more painful over the couple of a week; Pain/fluid spread to jaw; Could only sleep all day; Lost some hearing in my left ear; Fluid constantly in my ears now and infection; This is a spontaneous report from a contactable consumer (patient). This consumer reported events for two separate vaccine doses. This is the second of two reports. This report is for the events related to the second vaccine dose. This report is serious. The additional report is non-serious.  A 21-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an intramuscular route of administration in the left arm on 15Apr2021 at 15:00 (Batch/Lot Number: ER8731 at the age of 21-years-old patient at vaccination) as a single dose for COVID-19 immunisation at a Pharmacy or drug store (non-military facility). Medical history included vertigo from 08Jan2020 and ongoing and ear pain from 08Jan2020 and ongoing (no surgeries, unexplained occurrence). The patient underwent computerised tomogram and found nothing abnormal in Sep2020. The patient did not have COVID-19 prior to the vaccination. COVID-19 test in Oct2020 was negative. There were no concomitant medications. Historical vaccine information includes the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an intramuscular route of administration in the left arm, on 18Mar2021 at 15:00 (Batch/Lot Number: EP6935) as a single dose for COVID-19 immunization and experienced ear infection, nausea, vomiting, dizziness, intense menstrual cramps/bleeding, swollen lymph nodes, loss of appetite, weight loss and fast heart rate. The patient did not receive any prior vaccinations (within 4 weeks) of the COVID-19 vaccine. On 15Apr2021, the patient received the second dose of the BNT162B2 vaccine. On 17Apr2021, a couple days after the second vaccine, the patient experienced the ear felt full with fluid, slowly became more painful over a week. The pain/fluid spread to the jaw. The patient missed work and could only sleep all day. The patient found relief with antibiotics, but the pain/fluid never fully went away. The patient was still fighting constant fluid in ears. The damage was so bad that the patient lost some hearing in the left ear. It was somewhat better but he/she has fluid constantly in ears now and infection wherever the fluid does not drain. The events required visit to urgent care, physician office. Seriousness criteria was reported as persistent/significant disability. Treatment: included antibiotics. The outcome of the events lost some hearing in my left ear, fluid constantly in my ears now and infection, ear felt full with fluid, slowly became more painful, pain/fluid spread to jaw and could only sleep all day was reported as not recovered.  Follow-up (19Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021899547 same patient, drug/ different dose
Severe headache; runny nose; watery eyes; severe fever; severe chills; nausea; reduced apetite; bloating; sweats; This case was reported by a consumer and described the occurrence of headache in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis and TOZINAMERAN (COVID 19 VACCINE PFIZER) for prophylaxis.   Concurrent medical conditions included heart disease, unspecified and immunodeficiency.   On 25th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season, Fluarix Tetra Pre-Filled Syringe Device and the 3rd dose of COVID 19 VACCINE PFIZER. In October 2021, 4 hrs after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced headache, runny nose, watering eyes, fever, chills, nausea, decreased appetite, bloating and sweating. On an unknown date, the outcome of the headache, runny nose, watering eyes, fever, chills, nausea, decreased appetite, bloating and sweating were recovered/resolved.   It was unknown if the reporter considered the headache, runny nose, watering eyes, fever, chills, nausea, decreased appetite, bloating and sweating to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device.  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 reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received the 3rd Covid vaccine from (Pfizer) along with the Flu vaccine on Monday. Four hours after the injections of Covid vaccine and Flu vaccine, the patient started with a severe headache, runny nose and watery eyes. Then, every two to three hours (less than a day after vaccination), the patient developed severe symptoms of fever and chills, nausea but no vomit, reduced appetite, bloating and sweats. This all ended in a 12 hour period. The patient was extremely cautious there, wearing masks and taking our exposure seriously and had not been exposed to anyone with any Flu like symptoms. The patient had reported this to his/her Immunologist and in the last 24 hours, his/her sense of normal had return. The patient would not get a Covid vaccine and a Flu vaccine at the same time if at all in the future. It was unknown if the reporter considered the headache, runny nose, watering eyes, fever, chills, nausea, decreased appetite, bloating and sweating to be related to Covid vaccine.
One hour after vacc administration experienced mild asthma attack & very dizzy for approx 40 mins. That subsided. Next day Friday-Sat felt really bad/unable to determine cause but lethargic, difficulty at any activity. Sunday (4th day) fever 101/took ibuprofen x4 fever not down until 3:00 AM. No other s/s but fever.
Overnight within 36 hours of receiving the Moderna booster I developed a full body painful and itchy red rash. It was mainly on the trunk of my body, front and back, spreading to my inner thighs, and up the side of my neck on the right side, where the injection was given. The rash is continuing nearly 72 hours after the injection. Treating with Benadryl 25 mg every 4 hours and applying topical Diphenhydramine HCL & Zinc Acetate.  Today the rash is subsiding. I have not needed to use the Epipen.
Surrounding erythema measuring 13 cm in diameter that began approximately 24hrs after vaccination. Started on KEFLEX 500mg TID.
low temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number N3S45, expiry date 27th May 2023) for prophylaxis.   On 1st April 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 2-May-2022 Reporter's comments: The patient received Shingrix that was exposed to a low temperature excursion of 28.8 degree F. The vaccine was no longer viable. The consent to follow up was given. Additional Supportive Information: The patient received Shingrix that was exposed to low temperature, which led to incorrect storage of drug. This case was linked with case US2022072588, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022072588:same reporter
Patient experienced red bruising at the injection site on 03/05/2021. She visited a Medical Center on 03/09/2021 and was told she might have an infection. She was prescribed Mupirocin ointment to be applied twice daily as well as Keflex antibiotics. After applying the ointment for several days patient's bruising darkened and began to peel. The antibiotics caused diarrhea for about ten days.
The patient didn't experience an adverse event but was given a Td on 2/1/21 that had an expiration date of 1/28/21
Information has been received from a registered nurse concerning a 26-month-old female who on 10/26/2005, was vaccinated SC in the right thigh with a 0.5 mL dose of varicella virus vaccine live (oka/Merck) (lot #65117/0428R). Concomitant vaccination on the same day included a dose in the left thigh of influenza virus vaccine (unspecified) (lot #U1743IA) and a first dose in the left thigh of hepatitis A vaccine (inactive) (manufacturer unknown) (Havrix) (lot #AHAVA018BA). There was no illness at the time of vaccination. On 11/09/2005, the patient developed two lesions at the injection site. It was noted that the patient's mother, who had a history of chickenpox, was pregnant and it was unknown if she had chickenpox at that time. Unspecified medical attention was sought. A product quality complaint was not involved. Follow up information was received from the registered nurse who reported that the mother called on 11/09/2005 and stated that her daughter had red spots on the right upper thigh which were hard. The patient did not have a fever. The reporter was not able to provide any further information. No further information is expected.
Had pain, tenderness, swelling, redness, itchy, difficulty moving arm, headache, nausea, fever.
The following day, day 2 of vaccination. I started experiencing sharp stabbing pain in my ovaries.  The pain was like I never felt before, so sharp that it would make me jump and scream due to the fast and sharp pain.  On day 4, the sharp pain continued and menstrual cramps started (both pains are very different).  On this day at night, I started bleeding like a regular menstrual period ( which I have not had in +4yrs due to menopause).  The bleeding, cramps and sharp pain continued for 3 weeks. Then 2nd dose was on 4/20 which caused same cycle but not as sharp the pain and less cramps and bleeding.  AND NOW I constantly (weekly) get cramps and sharp pain with sporadic blood spotting.
After getting the readings back from a blood test, on October 4th,  I was told by my Doctor that my PSA (prostate specific antigen) was elevated past the normal level.  The previous test was 1.5. This test, the PSA level was at 5.2
The day after her vaccination, she had a local reaction around the area. The area of the vaccination was raised, red, and painful. It resolved the day after. The day after (2 days post vaccination), she had a red, raised band below the area of immunization. She stated, "It felt like Shingles."
2/13/04 Watery stools. 2/15/04 Blisters started on face. 2/16/04 Blisters covered entire face ears temp 100.8. 2/17/04 still rash face and head-stopped eating 101.3. 2/18- temp 102. 2/19 101.8. 2/20/04 temp 103. 2/20/04 took to Dr-throat culture for strep-Neg. CBC tested for wheat, rye, rice, soy, milk allergy. Stomach x-ray and stool samples watery stool since 2/13/04.
On 3/22/99, the pt developed varicella and sought unspecified medical attention. No further information is available.
Patient received vaccine and was waiting in front of pharmacy for his allotted time. I noticed his head was down and he was kind of sunk in his chair. Went out to assist him, but he had fainted. I grabbed his shoulder and shook him for about 30 seconds and he came to. He was a little disoriented and pale and pulse was fast. he refused us calling for an  ambulance. I directed him to sit on the floor. We sat and talked for about 30 minutes until he felt well enough to drive home
Pain, swelling and bruising for couple of weeks.  Persistent pain for almost two months.  decreased range of motion 2/2 pain
Fever; chills; achy joints; sore throat; upset stomach; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 13Apr2021 at 13:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included tachycardia. 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. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL), vitamin b12 nos (VITAMIN B12), cetirizine hydrochloride (ZYRTEC) and ethinylestradiol, drospirenone (NIKKI) all from an unknown date and unknown if ongoing for an unknown indication. The patient previously took hydrocodone (MANUFACTURER UNKNOWN) and experienced allergy. On 14Apr2021 at 07:00, the patient experienced fever, chills, achy joints, sore throat, upset stomach. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, achy joints, sore throat, upset stomach was not recovered at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severely hyperactive - got the shot around 1 pm, woke up at 3 am wide awake and was like a 6 year old on 6 red bull and a bag of pixie sticks for the next 20 hours. Then I crashed and slept for maybe 6 hours, and it was slight better the next day. Kept lessening each day, but it took about 5 days to wear off entiey.
patient was to receive the PENTACEL dose today but the patient only received the DTAP-IPV vaccine with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician, other health care professional and consumer/non-health care professional via (Reference number- 00829371) and transmitted to Sanofi on 26-Oct-2021.  This case involves a 6-month-old female patient was to receive the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] dose today but the patient only received the DTAP-IPV vaccine (product preparation issue)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE for prophylactic vaccination.   On 26-Oct-2021, the patient received third 0.5ml (total) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot: UJ466AAA and expiry date: 21-May-2022) (Frequency = once) (Strength = standard) (dosage form: solution) via intramuscular route in the right thigh for prophylactic vaccination but the patient only received the DTAP-IPV vaccine (product preparation issue).  It was reported "Caller is want to know what to do. Caller provided with the PENTACEL reconstitution video".   This case was an actual medication error due to inappropriate reconstitution technique (latency: same day).  At the time of reporting, no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
10/21 at 10am I started feeling hot and dizzy, at 11:00am I started to have a cough, @ 1 had to go on my Inhaler and Syrup Codeine. Then Thursday I woke up with the severe chills. Dizzy, couldn't breathe very good I went to work saw a Dr went home went to bed all day Friday 10/23/09 couldn't walk or eat coughed until Monday Oct 26th. After the shot (20-30 min) I started feeling hot and my chest turned Red. I also started coughing which got worse with time. This didn't go away for 2 - 3 days. The next morning I couldn't walk I had severe chills and severe cough. I had to go to the doctor I had fever and flu symptomes. I was fine before the H1N1 vaccine.
AFTER RECEIVING VACCINES C/O ITCHING AND RASH, UNLABOR BREATHING, LUNGS CTA ALL LOBES.
She had her Day 0 and Day 7 dose in October, but she had to delay her third dose due to cost; Case reference number US-BN-2021-000020 is a spontaneous case report initially received from pharmacist via Agency (reference number USBAV21-0021) on 15-JAN-2021, and concerns a 27-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date in Oct-2020, on day 0, the patient started therapy with RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dose for pre-exposure vaccinations.   On an unspecified date in Oct-2020, on day 7, the patient received second dose of RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dose for pre-exposure vaccinations.   It was stated that the patient had to delay her third dose due to cost (product dose omission issue).  At the time of this report it was not known whether the patient developed any adverse event.  Additional information received from Agency on 18-Jan-2021 included LRD.; Reporter's Comments: Product dose omission is listed by convention. Reportedly, the patient had to delay the third dose due to cost which is considered to be missed dose (product dose omission issue). No adverse events were reported. Product dose omission issue is not related to RabaVert, but to human action.; Sender's Comments: Product dose omission is listed by convention. Reportedly, the patient had to delay the third dose due to cost which is considered to be missed dose (product dose omission issue). No adverse events were reported. Product dose omission issue is not related to RabaVert, but to human action.
fever, aching joints, headache, tired. These occurred on Day 2. Took ibuprofen and went to bed. I am reporting this on Day 2 so I don't know how long these symptoms will last. Same symptoms as Dose #1 which lasted for about a week.
Extraction of Moderna vaccine from the vial was not consistent with a Moderna technique. i.e. more than 20 doses were drawn from the vial.
Mom called and reported both arms swollen and warm to touch, right arm worse than left arm. Told mom to put cool compress on them. She will follow up if not better in a couple of days.
PATIENT STATED THAT ON THE EIGHTH DAY HAD COVID ARM, RED, ITCHY, SWELLING, RASH LASTED A FEW DAYS WENT AWAY. SHE TOOK BENADRYL AND APPLY COMPRESS.
Pt vaccinated with DTP/OPV/MMR at 10AM mom noticed baby shaking while asleep; Seen by MD fever 104, red throat. Given Tylenol at MD office.
Patient came in and stated her arm was red, warm to touch, and achy the next day after the shot, she came into the pharmacy on 12/14/17, by this time the redness in her arm had decreased (it was still slightly red) and it was no longer warm to touch she said and she said she felt fine besides her arm still being slightly red, she felt that her arm was improving. She was going to keep an eye on her arm, and contact us if it got worse.
Narrative:  COVID infection following COVID vaccine series 04/13, MODERNA, dose #1 05/11, MODERNA, dose #2 08/03 COVID swab, result: detected 08/04 pt cc: chills, cough, fatigue, headache, rhinorrhea, dyspnea exposure: +COVID wife 08/13 clinically resolved
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 2/25/2021 and 3/23/2021. Presented to the ED on 8/11/2021 for asymptomatic testing so he may resume dialysis. On 8/14/2021 patient returns to ED with a two day history of fatigue, nausea, vomiting, diarrhea, chills, body aches, and loss of taste and smell. Denies shortness of breath, headache or chest pain, Has O2 sats of 100%. Patient was discharged from ED with instructions to return if dyspnea occurs. On 8/17/2021 patient returns to ED with shortness of breath and sepsis secondary to infected dialysis catheter (MSSA bacteremia). Treated with dexamethasone, heparin prophylaxis dosing, zosyn, and vancomycin. Antibiotics were later changed to cefazolin once culture and sensitivity resulted. Patient also developed bleeding from catheter site. he eventually succumbed to multiple acute illnesses with multiorgan failure.
Initial unsolicited report received from nurse on 17-Aug-2017. This case involves a 17-year-old female (reported as 18 years) patient who was vaccinated with a MENACTRA (batch number: U5712AA, expiry date: 11-Oct-2018) via intramuscular route on 11-Aug-2017. Illness at time of vaccination reported as no. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify): Allergic to sulfa, Allergic rhinitis. Concomitant medications was not reported. On 11-Aug-2017, shortly after the vaccination, the patient began feeling lightheaded, feeling as if she would pass out, having palpitations and nausea. Symptoms have continued to occur for one week now. The patient required ER/doctor visit. The patient's laboratory data was reported as unknown. Corrective treatment was not reported. The patient was not recovered from events. List of documents held by sender: none.
Patient was administered incorrect dose of Pfizer Infant/Toddler COVID-19 vaccine. The Pfizer Infant/Toddler COVID-19 vaccine was incorrectly diluted. The vial received 0.22 mL of diluent. The patient received 0.2 mL  of an intramuscular injection from this vial. Patient was observed for 15 mins after vaccine. Patient did not exhibit any sign/symptoms of reactions after getting the vaccine. MD was notified of incident and informed RN to educate mother on signs and symptoms of adverse reactions and when to seek emergency care. Patient's mother also educated to continue monitoring daughter for adverse reactions.
Swelling in deltoid region on Saturday. Pt said felt kind of tender. Sunday swelling went down but felt kind of warm to the touch. Monday no swelling in deltoid area but there is redness toward outer aspect of biceps and feels warm to the touch no pain.
Fingers have pain like arthritis; Pain in her bones that became worse; This spontaneous case was reported by a patient and describes the occurrence of BONE PAIN (Pain in her bones that became worse) and PAIN IN EXTREMITY (Fingers have pain like arthritis) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067F22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 25-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. In November 2022, the patient experienced BONE PAIN (Pain in her bones that became worse). On 29-Nov-2022, the patient experienced PAIN IN EXTREMITY (Fingers have pain like arthritis). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BONE PAIN (Pain in her bones that became worse) and PAIN IN EXTREMITY (Fingers have pain like arthritis) had not resolved.     No concomitant medications were provided. The patient had her first dose, second dose and third dose of Moderna COVID-19 vaccines by intramuscular injection on 17-Feb-2021 (lot number 0320A), 17-Mar-2021 (lot number 640A21A) and 11-Jul-2022 (lot number 002M21A) respectively. After the most recent dose of the Moderna COVID-19 vaccine she experienced pain in her bones that became worse yesterday. Today her fingers have pain like arthritis. She had taken Tylenol for her symptoms.
Noon on Saturday, January 9th, just felt achy, a slight headache, and chills.