chrisvoncsefalvay/vaers-outcomes huggingface dataset:
increase in the noise level of tinnitus and additional hearing loss; increase in the noise level of tinnitus and additional hearing loss; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 64-years, dose 3 via an unspecified route of administration, administered in arm right on an unspecified date (batch/lot number: EJ1685) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation, in hospital. Medical history included asthma. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient is not pregnant at time of vaccination. Concomitant medications included budesonide (PULMICORT); triamcinolone acetonide (NASACORT). The patient historically received BNT162B2 for COVID-19 immunization (at the age of 63-years), first single dose (lot number: FF2587) in right arm on 23Dec2020 and second single dose (lot number: EL1289) in right arm on 13Jan2021. On 04Nov2021, the patient experienced increase in the noise level of tinnitus and additional hearing loss. No treatment received. Outcome of the events was unknown. Since the vaccination, the patient has not been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 16 years old female patient with no medical history and no pre-existing illness. The patient was vaccinated IM with dose 2 GARDASIL (lot # 669795/1317AA) on 30-MAY-2012. No other co-suspects were reported. There was no concomitant medications. On 30-MAY-2012 the patient was a check out and passed out. She fell backward and Hit her head on door frame. Her eye rolled back and she started to shake for 20 seconds. The patient had ordered a CT of head and an EEG. At the time of the report, the outcome was unknown. Upon internal review, passed out was considered to be a medically significant. The original reporting source was not provided. Additional information is not expected.
Shot give in buttocks, Rgt. Inlarge to size of grapefruit fever, red rash, painful to touch. Walk with limp. Very sore and move to lower part of thigh and whole buttocks. Cellulitus put on antibiotic ASAP ER.
Diarrhea, nausea, fever, headache, redness and pain at  the injection site, chills and all my body hurts.
Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DIZZINESS (Dizzy). At the time of the report, DIZZINESS (Dizzy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported by the reporter. Treatment details was not reported by the reporter.
Large raised; Red at the site of the injection; Painful area at the site of the injection; This is a spontaneous report received from a contactable other healthcare professional (patient reported for herself). A 38-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 08Mar2021 10:15 (at the age of 38-years-old) as dose 1, single for COVID-19 immunisation. Medical history included hypothyroidism, attention deficit disorder, known allergies: penicillin, cephalosporins from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. Patient received vaccine facility in hospital. The patient experienced large raised, red at the site of the injection, painful area at the site of the injection on 08Mar2021 18:00. No treatment was received for the events. The outcome of the events was reported as not recovered.  No follow up attempts are possible. No further information is expected.
On 314/19, moother reported tactile warmth & swelling, approximate "thumb-size" noted on 3/12/19.   Mother was advised to apply a cold compress & to notify our office if she notes any worsening.
Patient had her Covid Vaccine.  She reported itching on her arms.  No rash.  She was given Allegra 60 mg per standing order.  Patient monitored for response.  Relief was reported.  Patient was instructed to proceed to the ER for worsening symptoms or call 911 for difficulty breathing.
patient friend called, said there was an adverse effect to flu shot that the pt received, they called their insurance nurse, nurse told them to call pharmacy to report adverse event, said that pt arm was swollen from shoulder to middle arm, was told to put ice and take acetaminophen
Sore throat, muscle body aches, weakness congestion in head. Has had regular flu shot in past without problems.
Rash developed approximately 1 week following the 2nd SHINGRIX vaccination. First appeared on legs and then spread to back. Flat, red, no pain or itching. Large areas. PC physician believes it to be an adverse reaction to the 2nd SHINGRIX innoculation. Treated with steroid ointment for 7 days. Treatment was ineffective.
One the first day I started feeling very tired and sleepy, then I started feeling a little nauseous.  I took a COVID test because my husband got sick with COVID 2 days prior. I tested positive and called my doctor?s office. Since I am 66 years old, have asthma and was recovering from surgery performed on 10/13/22 my doctor prescribed me Paxlovid 150.
Information has been received from a registered nurse concerning a 13 month old white female with no allergies or medical history who on 03 Aug 2006 was vaccinated SC with a first dose of Varivax (lot # 653436/0562F). Concomitant vaccination on the same day included an IM fourth dose in the right thigh of Prevnar (lot # B08640H), an IM first dose in the left thigh of Hep A (lot#651877/0706R), a SC first dose in the right arm of MMR II live (lot#650121/0831R), and an IM third dose in the left thigh of HIB (lot#652705/1160R). There was no other concomitant medication. On 28 Sep 2006, the patient came into the physician's office with four to five lesions at variable stages. One lesion was vesicular and two to four were crusted. Her temperature was 98.1. One week prior, on approximately 21 Sep 2006, the patient has a faint rash on her arms and legs and a fever for two days. The patient also had papules on her forehead. It was noted that the patient had varicella and chickenpox protocol was reviewed. No medications were prescribed and no diagnostic laboratory tests were performed. At the time of the report, the patient was recovering. A product quality complaint was not involved. The patient's vaccination history also revealed the following vaccinations: a first, second, and third dose of Hep B on 31 Jul 2005, 02 Sep 2005, and 06 Feb 2006; a first and second dose of PedVaxHIB on 03 Oct 2005 and 05 dec 2005; a first, second, and third dose of Prevnar on 03 Oct 2005, 05 Dec 2005, and 06 Feb 2006; and a first and second dose of Ipol on 03 Oct 2005 and 05 Dec 2005. Additional information is not expected.
Experiences dull ache at injection site (L) arm says he was given "wrong" injection - first (different needle) has seen MD.
within 2 days she felt really sick; ears hurt; ear feels full; ears ringing, tinnitus; head hurts; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (within 2 days she felt really sick), EAR PAIN (ears hurt), EAR DISCOMFORT (ear feels full), TINNITUS (ears ringing, tinnitus) and HEADACHE (head hurts) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced ILLNESS (within 2 days she felt really sick), EAR PAIN (ears hurt), EAR DISCOMFORT (ear feels full), TINNITUS (ears ringing, tinnitus) and HEADACHE (head hurts). The patient was treated with DEXAMETHASONE at an unspecified dose and frequency. At the time of the report, ILLNESS (within 2 days she felt really sick), EAR PAIN (ears hurt), EAR DISCOMFORT (ear feels full), TINNITUS (ears ringing, tinnitus) and HEADACHE (head hurts) had not resolved.            No concomitant medication were reported.  After receiving the second dose, within 2 days she felt really sick, her ears hurt and started ringing, and her head hurts, her left ear feels full and she is experiencing tinnitus. This has continued up until the day of reporting.  Patient received steroids including Dexamethasone and been to the hospital twice since then. Patient does not know the lot numbers of this vaccine, but has found them on Bad Batch a website dedicated to addressing lot specific side effects   Reporter did not allow further contact
The patient did not have any adverse reactions but received an expired vaccine.  The vaccine was not moved from the refrigerator until 10/09/21 instead of 09/30/21.
It was reported in a published literature article title as stated 12 days after admission.  WBC count 8,900 mm(3) 3,500-11,000, absolute band neutrophil count 2% 0-5, platelet count 780 /mm(3) 140-450, serum aspartate aminotransferase 30 U/L 10-40, serum creatinine 0.7 mgl/dL 0.5-1.0, temperature measurement 38.9 degree C, whole blood bicarbonate test 10 mmol/L 7-17, whole blood bicarbonate test 28 mmol/L 20-30, serum alanine aminotransferase 25 U/L 4-40.  Additional information has been requested.  A copy of the published article is attached as further documentation of the patient's experience.
Pt received smallpox vaccination at 09:00, 04/18/04.  Pt reported to tER at 18:00 on 04/08/04 with chest pain.  Pt was admitted to hospital with possible myocarditis or myopericarditis.  Pt also received Anthrax vaccination.  Nurse follow up on 06/17/04 states: "Per review of hospital d/c summary, please add to Box 7 rhabdomyolysis (RHABDO), mitral regurgitation and tricuspid regurgitation (CARDIOVASC DIS). The impression in ER was myocarditis and chest pain, but final diagnosis was rhabdomyolysis with a secondary diagnosis of chest pain."
Swelling in glands/lymph nodes; earache (right ear); burning and tightness in chest; burning and tightness in chest; Aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 60- years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ep6955) via unspecified route of administration in the left arm on 15Mar2021 at 15:15 (at the age of 60-years old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling in n glands/lymph nodes, earache (right ear), burning and tightness in chest, aches and fatigue on 19Mar2021. The patient underwent lab tests and procedure which included COVID test (Nasal swab) on an unknown date and tested negative. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the reported events. The clinical outcome of events swelling in n glands/lymph nodes, earache (right ear), burning and tightness in chest, aches and fatigue was not resolved. No follow-up attempts are needed. No further information expected.
Early AM on 9/6/00, pt developed a fever, double vision, listlessness and vomiting. He was admitted to the hospital with cranial nerve palsy. Dx'd with meningoencephalitis. Went home after 5 days.
Severely dizzy, left hand totally numb but painful, cold to touch. Felt better before she got to ER.
My 17 year old daughter got the Pfizer vaccine and has been struggling with heaviness in her head, where she feels like she can't hold her head up; severe neck pain; and seasonal allergy-type symptoms. She has had to miss some school because of it.
Strong flu like symptoms starting early in the morning and progressing until mid-afternoon then slowing feeling better.  Just weak two days afterwards and fine the third day.
experienced shingles/Suspected vaccination failure; Shingles; rash on side of the body, face, along nerve path; Blisters; Scabs; Pain; Itching; Tingling; Numbness; Fever; Headache; Not feeling well; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, blister, scab, pain, pruritus, tingling, numbness, fever, headache and feeling unwell. On an unknown date, the outcome of the vaccination failure, pain, pruritus, tingling, numbness, fever, headache and feeling unwell were unknown and the outcome of the shingles, rash, blister and scab were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, blister, scab, pain, pruritus, tingling, numbness, fever, headache and feeling unwell to be related to Shingrix.  Additional details were reported as follows: This case was reported by patients wife. The age at vaccination was not reported. The patient experienced all symptoms listed except gastrointestinal issues. The listed symptoms were as follows: Shingles typically produces a painful rash that blisters and scabs over in 7 to 10 days and clears up within 2 to 4 weeks. The reporter stated that 1 to 5 days before the rash appears, people might experience pain, itching, tingling, or numbness in the area where the rash would develop. Other symptoms at this time could include fever, headache, and a sense of not feeling well. The rash usually erupts in a single stripe on either the left or right side of the body, or sometimes the face, along a nerve path. The reporter stated that it could develop on the arm, thigh, head and even the ear or eye. It was most common on the chest and abdomen. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided. The follow-up would not possible as contact information not available.
Tingling with numbness R hand. Scheduled for EMG 11/11/02 and neuro consult with MRI of brain ordered.
bruising; sore arm; This is a spontaneous report from a contactable consumer (patient) or other non hcp.   A 62-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6203, Expiry date: unknown) via an unspecified route of administration, administered in Arm Right on 04Mar2021, at 11:15 as dose 1, single for (at the age of 62-years-old) for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. Patient had no known allergies. Concomitant medication(s) included zinc; fish oil; vitamin d [vitamin d nos] all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient did not tested for COVID-19. Allergies to medications, food, or other products was not reported. On an unspecified date in March2021, patient experienced bruising, sore arm. The patient did not received any treatment for event. The outcome of events recovered on unspecified date in March2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021392354 Same patient, same product with different dose, partial same event
Rash developed on neck, and the next day has spread all over body in red splotches. Rash is mildly itchy.
shortness of breath; tightness across her chest; soreness around her check and back of neck; sinus issues; sneezing; no appetite; tiredness; left arm began to hurt; chills; headache; felt an elevated body temperature, temperature of 99.8 degrees Fahrenheit; A spontaneous report was received from a pharmacist who was also 67-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a headache, her left arm began to hurt, felt an elevated body temperature, measured temperature of 99.8 degrees Fahrenheit, chills, tiredness, no appetite, shortness of breath, tightness across the chest, soreness around her chest and back of neck, sinus issues and sneezing.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 05 Jan 2021, 8 hours post injection, the patient developed headache, her left arm began to hurt, felt an elevated body temperature, measured temperature of 99.8 degrees Fahrenheit, chills and tiredness. On 06 Jan 2021, the patient stated that she slept all day. On 07 Jan 2021, she experienced shortness of breath, tightness across her chest, soreness around her chest and back of neck, sinus issues, sneezing, productive blowing of her nose. On 08 Jan 2021, the patient stated that when she woke up, she felt completely back to her normal self. Treatment included pseudoephedrine hydrochloride and ibuprofen.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, headache, her left arm began to hurt, felt an elevated body temperature, measured temperature of 99.8 degrees Fahrenheit, chills, tiredness, no appetite, shortness of breath, tightness across the chest, soreness around her chest and back of neck, sinus issues and sneezing, were considered resolved on 08 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 3:37 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 3:37 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 51.57. No concomitant medications were reported. On 03-Apr-2021 at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and vial was initially moved to the fridge on 30-Mar-2021 and beyond use date was 29-Apr-2021. Product moved to clinic on 03-Apr-2021.  Vial was stored on cooler 1, on 03-Apr-2021, Excursion duration At 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM : 41, 3 PM: 40, 4 PM: 40 and 5 PM : 41. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Patient had a negative COVID-10/Influenza A,B Molecular nasal swab  on 05/19. Needed a repeat test for SNF admission: 05.24 COVID-19 Molecular nasal swab positive x 2
It started around 2 AM while I was sleeping. I had a fever of 103 and vomited several times.   I still have a low grade fever at 10:34 AM and have been taking tylonel and advil.   I have a horrible headache as well.
pt recvd 1st dose of Hep B vax on 12FEB91 & following vax devel a red, raised pruritic rash; pt given DPH; 1 wk later pt recovered;
pt recv vax & w/in 5min devel hives over entire body, began wheezing & became swollen, inc HR adrenalin 1:1000 0.1cc was given;pt was transported to ER & later released;
At 9 pm the day of my shot- I got a fever of 101, and was  lethargic. I went to bed. At midnight I woke up with a bad headache, fever, chills, lightheaded and dizzy. For the entire next day, I had all of these symptoms, along with body ache and lethargic.  I went to bed around 9 pm, and when I woke up the next day- I felt much better, other than a slight headache and body ache
pt recvd vax felt tired out next 3 days & by the 4th day devel sore throat, temp & cold sx; arm got a red blotch that stung & then got itchy & a sugary, watery scab formed; also red blotches on 4th day; not feeling well;
1401- cold, clammy, diaphoretic, hypoxic (vital signs: b/p 90/70, 87% on Room Air, 20 respirations, 68 HR)  1404- RRT called   1404- 2-3 seconds of shaking, no medical history, per pt 10 weeks pregnant  1409- 101/69 99% 02 2L n/c, 69 HR,  20 RR   1420- 113/70 99% 02 2l n/c, 68 HR, 20 RR (pt transferred to ER)