chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hearing loss; tinnitus; severe headaches since my 2nd dose of the Moderna Covid-19 vaccine last April (April 2021)/ It feels like a vice fell on my head /My headaches are sharp; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (hearing loss) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hashimoto's disease (Have been on thyroid medicine since  patient's daughter was born.) and Autoimmune disorder.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced DEAFNESS (hearing loss) (seriousness criterion medically significant), TINNITUS (tinnitus) and HEADACHE (severe headaches since my 2nd dose of the Moderna Covid-19 vaccine last April (April 2021)/ It feels like a vice fell on my head /My headaches are sharp). At the time of the report, DEAFNESS (hearing loss), TINNITUS (tinnitus) and HEADACHE (severe headaches since my 2nd dose of the Moderna Covid-19 vaccine last April (April 2021)/ It feels like a vice fell on my head /My headaches are sharp) outcome was unknown.            No concomitant drug information provided. The patient was recommended to have hearing aid and was provided with IV medicines to treat the headaches.  The Neurologist told the patient to get medical marijuana.  The patient had been to the hospital for headaches. It felt like a vice fall on head.  Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with medical history of Hashimoto's disease and autoimmune disorder, who experienced serious unexpected event of Deafness, as well as non-serious events of Tinnitus and Headache in an unknown timeframe after the second dose of mRNA-1273 vaccine. Rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender with medical history of Hashimoto's disease and autoimmune disorder, who experienced serious unexpected event of Deafness, as well as non-serious events of Tinnitus and Headache in an unknown timeframe after the second dose of mRNA-1273 vaccine. Rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This case was reported by a consumer and described the occurrence of pain in arm in a 52-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm and erythema of extremities. On an unknown date, the outcome of the pain in arm and erythema of extremities were recovered/resolved. The reporter considered the pain in arm and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The age at vaccination was not reported. The reporter received the 1st SHINGRIX vaccine approximately three weeks ago on left arm. The patient arm was very sore and red for the first 4 to 5 after receiving the vaccine. Then the events were slowly resolved. The patient had denied permission to contact their physician. The reporter would not provide her address and did not want her information used to contact her and unable to obtain additional information.
Red rash; red rash; warm to the touch; arm was sore at injection site; was tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Red rash) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination.     The patient's past medical history included Back pain, Pneumonia (Legionnaires disease (double pneumonia)) in June 2007 and Breathing difficult (Legionnaires disease (double pneumonia) in June 2007 which has resulted in some breathing problems). Concurrent medical conditions included Diabetic. Concomitant products included PARACETAMOL (TYLENOL) and NAPROXEN SODIUM (ALEVE) for Back pain.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE RASH (Red rash). At the time of the report, VACCINATION SITE RASH (Red rash) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
Multiple blood clots in lungs 4/14/08-records received-Presented to ED on 11/30/07-with C/O SOB/DOE, pleuritic left chest and shoulder pain times 5 days. Pain began after a 5 hour car ride. 8/25/08-records received for DOS 11/29-12/1/07- DC DX: Pulmonary emboli, low back pain.  Per 60 day follow up: Patient is still on blood thinner as of 2/26/08. Has not been re-screened for clotts yet. There is no warning to patients about potential for blood clots or adverse effect. These situation have been reported on internet why not tell the public. 1/20/2010 She just finished blood thinner meds not too long ago. Unknown if issue wil return.
Pt. received vaccination on 11/25/2009. Woke up out of bed on 11/26/2009 @ 7:39 am, and glucose level was 341, normal it should be between 90-120, pt had severe leg cramps, stuffy nose, horrible cough, upset stomach, still cont a sot 12/9/2009.
Monovalent pfizer was given instead of bivalent. Will contact patient offer bivalent in three months. PCP has been notified and agreed with the plan.
expired vaccine was administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided.
No adverse side effects; accidently reconstituted MMR-11 with preservative free saline instead of Merck sterile diluent; This spontaneous report was received from a pharmacist and refers to a 21-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-SEP-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 1 dose, 0.5mL subcutaneously (lot # S031483, expiration date: 07-OCT-2021) for prophylaxis, which was accidently reconstituted by a nurse, with a preservative free saline instead of Merck sterile diluent. No adverse event was reported.
8 days after shot I noticed a raised red area and itchy where the vaccine was administered.  I immediately put Cortizone 10 over area and it helped with the itching.  Keeping application as directed.  Seems to have helped.  This is only day one, I will see what the outcome is tomorrow
Almost immediately after getting injected with my first shot of the Pfizer vaccine (around 2 mins after if i had to approximate), I felt the ride side of my face tingling and it became partially numb. The feeling didn't go away the rest of the day. When I went to bed that night, I woke up early around 5-6 am and got a strange feeling in my lips. I kept sleeping, but then woke up at 7am. I looked in the mirror and saw my lips were swollen on the left side. It was swollen on the upper left part of my lips. Also, that part of my lip feels numb too. Overall, my face feels somewhat stiff too.
This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. 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 GARDASIL 9 lot # M020103 with expiration date 15-FEB-2018 or lot # M024261 with expiration date 30-JUL-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced a temperature excursion of 34 Fahrenheit degrees for 1 hour. There were no previous temperature excursions. Data logger was not involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA013789.
Began having Swelling, pain w/moving Rt arm after shot on 8/18/20 - Redness around the shot (injection Site) 1.5 inches x 1.75 inches in diameter. Tender. Full ROM in shoulder, but pain w/ movement. Seen on 8/20/20.
Severe muscle aches, shaking chills, hot spells, severe tachycardia, head pain, fever.
runny nose; itchy eyes; tender throat; severe headache; A report was received from a consumer concerning a 53-year old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced severe headache, runny nose, itchy eyes and tender throat.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 24 Dec 2020, approximately 1 day prior to the onset of the event, severe headache, and 2 days prior to the onset of the events, runny nose, itchy eyes and tender throat, the patient received their first of two planned doses of mRNA-1273 (BATCH # 037K20A) intramuscularly in the hip for prophylaxis of COVID-19 infection.  On 25 Dec 2020, the patient had a severe headache and took Tylenol. On 26 Dec 2020, her headache was not resolved and she started to have runny nose, itchy eyes and tender throat. Symptoms were ongoing. Treatment for the event included Tylenol.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events were unknown.   The reporter did not provide an assessment for the events, headache, runny nose, itchy eyes and tender throat.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
death was reported by death certificate.  we do not have date  of covid test.  Admitted 11-19-22 to Med Center and discharged on 11-26-22.  She passed 11-27-22 with Hospice.   She had been seen as outpat 11-18-22 at Dr. office.  Her family had noted not herself since she had covid.    Admitted with community acquired pneumonia  and acute encephalopathy.
Fever, hypertension, altered mental status, seizure. Presented to the hospital requiring intubation for airway protection. Septic shock requiring blood pressure support and broad spectrum antibiotics. Pancytopenia. Hospitalized for 3+ days, clinically improving.  Localized induration of vaccination site
weakness Narrative:  Patient called seeking evaluation of symptoms. He states "I got the covid vaccine last Thursday and on Friday I began to get real dizzy. When I went to bed that night I was still but I felt like the bed was going to flip over on me, the room was spinning". He admits the dizziness has improved since then, so now intermittent, worse when lying down flat or when walking but never while sitting in a chair. Denies headache, fever, chest pain, sob, I sided body weakness, headache, numbness or tingling, slurred speech. He has slept in chair last 2 nights because of difficulty lying flat. He has never had vertigo in the past. He has not used any medications for dizziness. Please advise. Thank you.
Chills, fever, lower back pain, leg cramps, pain in shot area, fatigue, lost of appetite, shortness of breath.
Had non intractable headache for several weeks before and after second vaccine on 1/29/21. Went to ER for chest pain and headache on 2/8/21. Admitted to Hospital.
Numbness and tingling in feet and hands. Burning sensation all over body and muscle twitching  all over body. Roof of mouth burning. Tingling on lips and tongue. Bruising  and gum bleeding.
Fever 102.7 F; Shivering; Tired; Muscle Aches; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm), PYREXIA (Fever 102.7 F), MYALGIA (Muscle Aches), CHILLS (Shivering) and FATIGUE (Tired) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm) and MYALGIA (Muscle Aches). On 27-Feb-2021, the patient experienced PYREXIA (Fever 102.7 F), CHILLS (Shivering) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PAIN (Sore Arm), PYREXIA (Fever 102.7 F), MYALGIA (Muscle Aches), CHILLS (Shivering) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: 102 (High) Fever.         No concomitant medications were reported.  Treatment included Luke warm shower and luke warm water on her forehead
Received Nasal spray at elementary school in AM. Around 7 PM, complained of severe abdominal pain followed by vomiting. Duration lasted from 2 minutes to 7 minutes. Some relief after vomiting. Continued every 45 minutes to 1 hour for 12 hours. Relieved with Phenergan suppository until it wore off and then abdominal pain and vomiting reoccurred. Accompanied with fever, flushed face, headache, and red, glassy eyes. Small amount diarrhea.
Dizzy and severe runny nose first within a few hours after injection.  Next by early evening fatigue and weakness and loss of appetite and muscle aches.  No fever!  Slept many hours that night and the next morning but by evening of the 12th of November started feeling better!  Slowly better each day!  Lasting about 3-4 days total.  Notified Medical Center and nurse contacted me and took details!  Since essentially back to normal the weekend no studies done
Four hours after vaccine, patient developed fever. Next morning, developed seizure lasted 3 minutes;hospitalized.
A few hours after the vaccine, my heart went to racing at 140 beats per minute for over an hour.  I went to the ER, where I was admitted and eventually had to stay for 3 days. During that time, I was given various medications to try to regulate my HR. I continued to have arrhythmia for months following the vaccine, resulting in me having to have a Catheter Ablation surgery on 8/9. I am currently being monitored with new additional meds that have been added and so far, I am doing pretty good.
Fever of 102.7, extreme weakness to the point of barely being able to walk or talk.  Extreme Swelling & pain on a scale 1-10 at 10 on the arm of the injection site. Loss of appetite and when I eat I am feel woozy. Severe headache and body aches.  Very swollen lymph gland under the area of the injection site.  Unable to sleep the night the shot and for 2 subsequent nights after the shot was given due to swelling and pain.  Fever started next evening around 3:00pm and continued to steadily rise after taking Ibuprofen.  Fever rose to 102.1 around 7pm and then went as high as 102.7 around 8:30 when taken to the ER.  Fluids were administered and I could feel the medicine in the arm release and the swelling started going down.  I have continued to struggle even as long as today with weakness and continued loss of appetite. The day after the shot was given I had my son at a baby sitter and went to get him struggling just to drive there and when I got there I could not drive home until after I had laid down for at least an hour because of the severe weakness I was dealing with. Doctor gave me Oxycodone for pain and Naproxen for swelling.
Pt reported intermittent dizziness lasting 30 min - 1 hr reports symptoms reoccur q2-7d. Pt also reporting palpitations.
sharp pain; stabbing pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sharp pain) and VACCINATION SITE PAIN (stabbing pain) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 Dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (sharp pain) and VACCINATION SITE PAIN (stabbing pain). At the time of the report, VACCINATION SITE PAIN (sharp pain) and VACCINATION SITE PAIN (stabbing pain) outcome was unknown.            no concomitant medications reported. no treatment details reported.
pain in rt arm lasted 2-3 days, Nausea (24 hr), weakness (24 hr), headache and body soreness (lasting 24 hrs).
I experienced a cold-sore flare up a few hours after receiving the vaccine. I went to the health clinic and they prescribed me a medication. I had the flare up for about a week or so, then it resolved on its own.
Right arm swollen, red, painful, slightly warm to touch. 7/17/03 Called mother back-arm much better, swelling, redness mostly subsided. Still a little sore when area pressed.
This spontaneous report as received from a pharmacist refers to a currently less than 50 year old female patient (also reported as "she was in her thirties and forties"). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. It was reported that in 1997, the patient might have been vaccinated with ZOSTAVAX injection (exact dose, route of administration, lot #, expiration date and anatomical location were unspecified) (Product use issue). There were no adverse effect reported. Additional information is not expected because there was no consent to contact the pharmacist.
This spontaneous report as received from a medical assistant refers to a 12 year old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 27-SEP-2017, the patient was vaccinated with improperly stored doses of GARDASIL 9 from lot N017697 expiry date 21-JAN-2020 by intramuscular route for prophylaxis. No adverse events reported. The call was made due to a digital data logger. The vaccine was exposed to a temperature of 50.5 degrees Fahrenheit for a time frame of 1.5 hours. There was no previous temperature excursion involved. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1711USA004678: US-009507513-1711USA004679: US-009507513-1711USA004680: US-009507513-1710USA000490: US-009507513-1711USA004677.
sore arm at injection site; sore arm; fatigue; This is a spontaneous report from a non-contactable other HCP (patient). A 22-years-old non-pregnant female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL9267, via an unspecified route of administration on 09Feb2021 12:00 at SINGLE DOSE in the right arm for COVID-19 immunisation.  The patient's medical history was not reported.  Concomitant medication included levothyroxine sodium (SYNTHROID).  Other vaccine was not given in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09Feb2021 15:30, the patient experienced sore arm at injection site and same day fatigue. No treatment received. Outcome of the events was recovered in Feb2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Delayed reaction of a Rash at injection site.  Itchy and hot to touch.  About four inches by four inches circular.
POOR QUALITY VACCINE  ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 180897 expiry: 13-JUN-2021) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of poor quality vaccine administered was not reported. This report was non-serious.
Fever 100 Elevated heart rate 93 bpm (normal 60 bpm) Headache  Buzzing in the head Body aches and chills No treatment. Symptoms subsided at 48 hours
Fever of 102 F, severe body aches, lethargy. Lasted for 24 hours with treatment of rest/sleep.
Late dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late dose). The outcome of the drug dose administration interval too long 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: 06-JUL-2023 The patient received dose two of Twinrix 6 months after dose 1.  The reporter consented to follow up. The reporter did not provide lot number, expiration date, or patient details.  No additional information provided. The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule. This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023092925:Same reporter
Information has been received from a female consumer, via a company representative, who in approximately August 2007 ("six to eight weeks ago"), was vaccinated in the upper quadrant of the arm, with a dose of Gardasil (lot # not provided). On the day of vaccination, she experienced numbness and discomfort on her whole right arm, and was not able to use her arm. After two days, she recovered. Additional information is not expected.
This spontaneous report as received from a registered nurse (also reported as medical assistant) refers to unspecified multiple patients of unknown age. The concurrent condition, medical history and concomitant medication was not reported. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB (lot# L033343 and Expiry: 13-SEP-2017; lot # L027733 and Expiry: 13-SEP-2017; lot# L039660 and Expiry: 04-FEB-2018). The vaccines were stored at a temperature of 9.5 degrees Celsius for an hour. There were no previous temperature excursions. No adverse effects were reported. Additional information has been requested.