chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019 (dose and route were not reported) for prophylaxis. The vaccine was exposed from 47 Fahrenheit degrees (°F) to 77 Fahrenheit degrees (°F) for 12 hours. There was no previous temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
received COVID Moderna vaccine, now with significant tenderness of the left deltoid extending superiorly to the left side of the neck, and inferiorly to the left side of the chest wall/armpit, now difficult to raise left arm above head, minimal amount of erythema at the injection site  no improvement over the past 2 days  advised patient to use tylenol alternating with ibuprofen for pain  also has the V-SAFE app and has reported this adverse effect
Severe pain at injection site for greater than 3 months causing shoulder to feel stiff, painful to move. Feeling of heaviness.
Fever - 101.5 degrees starting at 04:00 pm on 3/23/2021 --  Chills Muscle and joint pain headache severe fatigue Treated with ibuprofen. Fever remains on 3/24/2021. 99.9 degrees. Headache and joint pains continue.
PAIN BEGAN TO MOVE TO BACK; SHOCK LIKE PAIN IN RIGHT PECTORALIS; This spontaneous report received from a patient concerned a 44 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 204A21A expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced pain began to move to back, and shock like pain in right pectoralis. The action taken with covid-19 vaccine  was not applicable. The outcome of the shock like pain in right pectoralis and pain began to move to back was not reported. This report was non-serious.
Initial unsolicited report received from a healthcare professional via other company (Pfizer) on 29 February 2016. Manufacturer Report Number: 2014326408. This case involves a 58-years-old male patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu Vaccine) (batch number, dose, dose in series, route and site of administration was not reported) on an unspecified date. The patient had a medical history of allergy to ACE inhibitors which caused angioedema, swelling and allergy to Enalapril which caused angioedema. Concomitant medications were not reported. On 19 February 2016, following the vaccination, the patient experienced flu like syndrome, nausea, vomiting, myalgia, allergies to flu vaccine. Lab data was not reported. Corrective treatment was not reported. It was reported that patient was treated outpatient. Outcome of patient was not reported. List of documents held by sender: none.
Broke out in Hives even inside mouth, ears & nose. Itch every where from head to toe
Ongoing hospitalization for hypoxic respiratory failure, pneumonia due to COVI-19 virus,  blood sugars controlled in setting of steroids,  VAPOtherm/BiPap, baricitinib, HTN on nitro drip,
Over the course of 3 days: uncontrollable shivering for 3-4 hours, hot and cold flashes, nausea with vomiting, intense headache for 3 days, sharp pain to touch of skin all over body, pain and stiffness in joints, and loss of appetite. ALEVE for headache: two tablets, twice a day for 2 days. Increased hydration with PEDIALYTE.
Muscle stiffness; Extreme headache; Chills; Fatigue; This spontaneous case was reported by a physician and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Muscle stiffness), HEADACHE (Extreme headache), CHILLS (Chills) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Muscle stiffness), HEADACHE (Extreme headache), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, MUSCULOSKELETAL STIFFNESS (Muscle stiffness), HEADACHE (Extreme headache), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and Treatment medications were not provided by reporter.
Rheumatoid Arthritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (I ran a slight temperature after the first shot), for Covid-19 immunization, reaction(s): "slight temperature". The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid Arthritis". The lot number for bnt162b2 was not provided and will be requested during follow up.
Right eye began twitching  / clamping shut within 2 days time. AS of 11/10/21, eyelid appeared to droop; vision is blurred in right eye at times.Right side of face is asymetrical when compared to left. No other facial discrepancies; no other notable neurological symptoms noted by mother, who is LPN
metallic taste in mouth; breathing problems; This is a spontaneous report from contactable consumer as a patient. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown) via an unspecified route of administration on 04Mar2021 at 14:00 pm in the left arm as a first dose for COVID-19 vaccination. Medical history included gastro esophageal reflux disease (GERD) and asthma. Patient was allergic to Penicillin (manufacturer unknown), Doxycycline (manufacturer unknown), trees, nuts, shellfish and environment. Concomitant medications within two weeks of vaccination included Xyzal (manufacturer unknown), Omeprazole (manufacturer unknown), Vitamin D (manufacturer unknown) and Multivitamins (manufacturer unknown). 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. Since the vaccination, the patient had not been tested for COVID-19. The facility where the most recent COVID-19 vaccine was administered was at a public health clinic. On 15Mar2021 at 02:00 am (10 Days after the shot), the patient had breathing problems and metallic taste in mouth. The adverse event resulted into Emergency room/department or urgent care. The patient reported that, he was never admitted before for asthma. Therapeutic measures for the reported events were Albuterol (manufacturer unknown) and Albuterol, Steroids intravenous injections (manufacturer unknown). The clinical outcome of breathing problems and metallic taste in mouth was reported as recovering. Information about lot/batch number cannot be obtained and no further information is expected.
severe arm pain; Fever; moderate joint/muscle pain; moderate joint/muscle pain; chills; headache; fatigue; intermittent burning in arm that vaccine was given; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 15:45 (Lot number: FJ8757) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tramadol, reaction(s): "Known allergies: Tramadol and phenergan"; Phenergan, reaction(s): "Known allergies: Tramadol and phenergan". Vaccination history included: Bnt162b2 (Dose 1, lot number: EN6206, administration time: 09:00 AM, location: Left arm), administration date: 09Mar2021, when the patient was 32 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, lot number: ER8730, administration time: 09:00 AM, location: Left arm), administration date: 30Mar2021, when the patient was 32 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 15:45, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious) with onset 07Dec2021 20:00, outcome "not recovered", described as "severe arm pain"; PYREXIA (non-serious) with onset 07Dec2021 20:00, outcome "not recovered", described as "Fever"; ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 07Dec2021 20:00, outcome "not recovered" and all described as "moderate joint/muscle pain"; CHILLS (non-serious) with onset 07Dec2021 20:00, outcome "not recovered", described as "chills"; HEADACHE (non-serious) with onset 07Dec2021 20:00, outcome "not recovered", described as "headache"; FATIGUE (non-serious) with onset 07Dec2021 20:00, outcome "not recovered", described as "fatigue"; BURNING SENSATION (non-serious) with onset 07Dec2021 20:00, outcome "not recovered", described as "intermittent burning in arm that vaccine was given". Therapeutic measures were not taken as a result of pain in extremity, pyrexia, arthralgia, myalgia, chills, headache, fatigue, burning sensation. No Covid prior vaccination. No Covid tested post vaccination.
headache; anxiety; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and ANXIETY (anxiety) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and ANXIETY (anxiety). At the time of the report, HEADACHE (headache) and ANXIETY (anxiety) outcome was unknown. Not Provided
face was feeling hot and flushed; blood pressure was high 140-150, usually it is no more than 125; face was feeling hot and flushed; fever; felt jittery; This is a spontaneous report from a contactable consumer (patient herself). An 85-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6198, expiry date: unknown) via unspecified route of administration on 02Mar2021 (age at vaccination: 85-years) as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2, via unspecified route of administration, left shoulder as reported on 06Feb2021 (age at vaccination: 85-years) as dose 1, single for covid-19 immunisation and experienced sore arm, face was flushed, Blood pressure high, face was feeling hot and flushed, 98.5F fever and felt jittery. vaccination facility type was building adjacent to the main hospital. Patients medical history included high blood pressure, from an unspecified date and unknown if ongoing (Diagnosed around 2010. Under control with medication). Past drug included sulfameth TMP and Adenosine and experienced allergies. There was no other additional Vaccines administered on same date of the Pfizer suspect. Patient had always been in good health. She did not have any side effects except a sore arm the next day. The next day her face was flushed and then she developed a 98.5F fever, felt jittery then it went away. This was with the first shot. This Saturday the caller began to feel the same thing, her pressure went up pretty high, she took blood pressure medicine every day. On Saturday and Sunday patients blood pres-sure was high 140-150, usually it was no more than 125. She noticed that the same symptoms as the first shot were occurring to her. The patient had a sore arm but went away after 2 days, she put a heating pad on it. Her face was feeling hot and flushed. She did not take her temperature the first day she got the shot. For about a day or 2 days for her blood pressure was high. The second shot she didn't have a sore arm. The patient was concerned that why was it after a couple of weeks or a month she was having the same symptoms. The patient underwent lab test which included, blood pressure measurement, results: 140-150, high, and no more than 125 and fever, result: 98.5 Fahrenheit on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Pt called on 11-16-11 at 830 am stating he felt feverish, sweaty, and had body aches at 7pm on 11-15-11 pt states he took TYLENOL pm with no relief, pt was unable to take his temp (no thermometer) no reaction at site of injection. Pt advised to push fluids, take MOTRIN & call if symptoms persist.
Client is a 12 year old male who came in for his covid-19 vaccination. Client received the Pfizer pediatric (5-11 year old) formulation. Client's mother reports no adverse symptoms at this time.
Vial was kept initially at refrigerator on 11-Jan-2022 but expired on 05-May-2022; Patients administered expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients administered expired moderna vaccine) and PRODUCT STORAGE ERROR (Vial was kept initially at refrigerator on 11-Jan-2022 but expired on 05-May-2022) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Janssen (LOT- 1822809 and Primary 1) on 29-Oct-2021. Past adverse reactions to the above products included No adverse event with Janssen.    On 11-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients administered expired moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was kept initially at refrigerator on 11-Jan-2022 but expired on 05-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients administered expired moderna vaccine) and PRODUCT STORAGE ERROR (Vial was kept initially at refrigerator on 11-Jan-2022 but expired on 05-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was administered with 1st booster of Moderna on 11-May-2022 No concomitant medications were reported.  Date the vial was initially stored in the refrigerator was 11-Jan-2022. The vial did not undergo any temperature excursions. No patients had reported any adverse reactions  No treatment medication were provided.
61Y F w/ PMHx of HTN and prior left sided umbilical hernia repair w/ mesh (2008 at hospital) who presented to ED today for evaluation of b/l "shaking"/paresthesias/numbness for 6 hours. Patient is excellent historian and accompanied by her husband. She reports having shingles vaccine on 10/31/12. On 11/9/12 she started having frequency/urgency and what she describes as bladder spasms without any dysuria, she called her PCP who gave her Rx for MACROBID which she took for 3 days. Urgency/frequency improved. A wk after that she began having sx again, PCP did urinalysis and UCx, which per her report grew 30k of unknown bacteria and was changed to ciprofloxacin. A couple of days later she went to hospital b/c of new onset rectal pressure described as baseball in rectum. There they performed abdominal CT scan which per patient was normal. She was told that could be allergic reaction to ciprofloxacin. She stopped taking medication. Since 11/9/12 she began having these sensation of b/l LE proximal "shaking" intermittently throughout the day. On further description was more of "creepy-crawly" description of b/l thighs w/ no visible shaking. This although intermittent has continued. She denied any weakness, no sensory changes, no bowel/bladder changes (retention or incontinence), no saddle anesthesia, no LBP, no neck pain, no diarrhea/no vomiting, some nausea on/off when had UTI initially. She was improving and went away for Thanksgiving. There she began having worsening of her bladder spasms, urinary freq/urgency again and perineal irritation. She got off plan and went to hospital where she had UTI w/u again as well as pelvic US which she was told were negative. She was given pyridium for 7 days. For the past 2 days she has been feeling b/l LE weakness and paresthesias, some anorexia, has mostly remained in bed. When getting up and walking has no objective weakness per report. Today at around 2 pm developed RUE tingling proximally which went down her arm in course of 30 mins and nor most notably numbness in all fingertips on volar aspect of her RUE. She denies any sx like this in the past, she has never had acute vision loss of eye pain in past, no vision changes, no slurred speech, no dysphagia, no word finding difficulty, no falls, no accidents, no neck pain, no lbp, no fevers, chills, no diarrhea, no sick contacts, no extra stress per her report, no fatigability, no worsening throughout the day or improvement throughout the day. Only medication is COZAAR which was increased from 25mg to 50mg b/c she was found HTN in ED visits. She reports weakness in b/l legs only when having the paresthesias.
Started out with a migraine with aura.  Went to bed early around 6 woke up at 3am on 2/24 and started vomiting. Had a fever with chills and body sweats. Called the advice nurse and was prescribed Zofran. Took Zofran around 9am finally stopped throwing up and took a well needed nap around 10am as I had been awake since 3 am.  Vomited and didn't feel better until about 6pm on 2/24. 2/25 woke up with body aches and a fever but no vomiting since  just before 6pm on 2/24. 2/25 woke up extremely nauseous was prescribed more Zofran which helped. Finally felt better by 2/26
Pt. stated did not feel well a few days after vaccination, no fever, 8 days after vaccination broke out in a rash all over face, chest & arms. She went to the Doctor and he placed her on medication for 7 days and told her she had chickenpox. Name of medication unknown.
Cystitis x 2; minimal relief with antibiotic use. Very irregular periods with increased abdominal pains.
Case number PHEH2012US023350, is an initial spontaneous report received from consumer (patient) on 26 Nov 2012. This report refers to an adult female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 123124, expiry date: Jun 2013) on 09 Oct 2012. On 15 Nov 2012, about 10:00 PM, the patient went to the hospital emergency room where it was found that her blood count was 2000 (units not provided). She was immediately admitted to the hospital. She had numerous tests conducted but the results did not point to any other specific reason for this condition (details for the results were not reported). She was discharged from the hospital on 20 Nov 2012. The outcome, seriousness and causality of the event was not reported.
Pain, tenderness, and swelling at injection site resulting in cellulitis from the injection site down below the elbow.
This case was reported by a pharmacist and described the occurrence of not responding to therapy in a 46 year old female subject who was vaccinated with Twinrix for prophylaxis. Concurrent medical conditions included diabetes. Concurrent medications included Insulin, Atenolol, Spironolactone and "sifaxan". On 22 May 2006, the subject received 3rd dose of Twinrix (unknown). She received 1st and 2nd doses of Twinrix on unspecified dates. On an unspecified date in 2007, after completing the 3 dose Twinrix series, the subject did not respond to Twinrix therapy, as indicated by unspecified "titers that were drawn within the last month". As a result of not responding to therapy with Twinrix, the pharmacist reported that the subject's physician had written the subject a prescription for 40mcg of Engerix B. At the time of reporting the outcome of the event was unspecified.
I had Covid before I got vaccinated. After I got vaccinated with the Pfizer shots I got sick again with Covid. I currently have Covid.; I had Covid before I got vaccinated. After I got vaccinated with the Pfizer shots I got sick again with Covid. I currently have Covid.; This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query.  The patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), first dose on via an unspecified route of administration on unspecified date as Dose 1,Single for COVID-19 immunization. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unspecified date as Dose 2,Single for COVID-19 immunization. Medical history includes COVID-19 infection. No concomitant medications reported. Patient got sick again with Covid-19 after vaccination on unspecified date. The patient underwent SARS-CoV-2 test and found positive. The outcome of Events was unknown.   Information on the lot/batch number has been requested.
Experienced chills, fatigue, malaise, myalgias and sweats that lasted approximately 16 hrs
pt recv vax; diffuse somewhat concentrated erythematous maculo-papular rash involving rt upper arm & both lower extremities, secondary to immun;
This spontaneous report as received from a certified medical assistant refers to a 11 years old female patient. The patient was vaccinated with dose 1 GARDASIL (Lot #, dose ad route not reported) on 12-JUL-2011. The patient received dose 2 GARDASIL (Lot #, dose ad route not reported) on 06-JUN-2012. The patient received dose 3 GARDASIL (Lot #, dose ad route not reported) on 02-MAR-2012, less than 4 weeks after the second dose. No other co-suspects were reported. No concomitant medications were reported. Medical assistant stated that the patient had not experienced any adverse effects. Additional information has been requested.
A serious spontaneous report of bloody nose had been received from a father/consumer concerning his child, a 36-month-old male, subsequent to H1N1 vaccine, intranasal. The patient has no relevant medical history. the patient was neither on any concomitant medications nor vaccinated previously. On 23-Mar-2010, the patient received H1N1 vaccine, Intranasal via nasal route for an unspecified indication. On 24-Mar-2010, in the morning, the patient woke up with bloody nose which occurred less than ten hours after receiving the H1N1 nasal vaccine. The patient experienced two nose bleeds the first one was heavy, the second bleed was not as heavy. Parent did call the patient's PCP, but no treatment was given. The child recovered in 48 hours. The outcome of bloody nose was recovered on 26-Mar-2010.