chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adberse event; Temperature -7.9 for 53 minutes and -10.5 C for 52 minutes; This spontaneous report was received from a vaccine administrator and refers to a 16-year-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 01-FEB-2021, the patient was vaccinated with incorrectly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with lot # 1637651 and expiration date on 09-JUN-2022 (also reported as 09-SEP-2022) or with lot # T026954 with expiration date on 13-APR-2022 (exact dose, route of administration were unknown) for prophylaxis. On 29-JAN-2021, the suspected vaccines underwent the temperature excursions of -7.9 degrees Celsius for 53 minutes and of 10.5 degrees Celsius for 52 minutes. The digital data logger was not involved. There was no previous temperature excursions. No adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Appointment for Hep-B vaccine. Prior to giving shot, assessed allergies to PCN, Sulfa, naproxen, zithromax and pineapple. Denied wheat/yeast allergy. This nurse clarified pt. wished to proceed with vaccine. She stated "yes." Pt. waited 10 min. in nurse's office without reaction and 10 min in outer office then c/o itching. Erythema only where pt scratched. VS BP 120/78, P = 80 and R = 16. Pt behavior escalating so 911 called EMT's assessed and pt. discharged to care of fiance.
Respiratory illness starting June 2022, had Cta of Chest in July that found a 5mm pulmonary nodule that was not present prior to vaccination in the right middle lobe. Repeat CTA of chest in October showed lung scarring to area
doctor prescribe Shingrix to / patient born in 92 that is immunocompromised; This case was reported by a pharmacist and described the occurrence of product prescribing error in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product prescribing error. On an unknown date, the outcome of the product prescribing error was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the doctor prescribed Shingrix to the patient was younger than 50 years of age and was immunocompromised, which led to product prescribing error. The patient's identifiers was not provided. The reporter did not consent to follow up.
Fever for 20 hours, Chills and headache for 36 hours, nausea for 12 hours.
Information has been received from a physician concerning a 27 year old caucasian female patient in human resources with no allergies and oral herpes who on 11/03/2003 abd 12/03/2003 was vaccinated subcutaneously in the arm with a first and second dose of varicella virus vaccine live, respectively.  Concomitant vaccination on 12/03/2003 included an intramuscular dose of influenza virus split virion 3v vaccine inactivated (Fluzone) and an intramuscular dose of hepatitis B virus vaccine rHBsAG.  Previous vaccination on 11/03/2003 included an intramuscular dose of hepatitis B virus vaccine rHBsAG.  There was no illness at the time of vaccination.  On 07/13/2004, an IgG EIA titer was 0.25.  The reporter stated that patient failed to serconvert and indicated non for adverse events.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information is not expected.
I was in mid conversation and my voice just stopped. I saw Dr was given MEDROL PAK and LEVAQUIN and ZYRTEC. Saw Dr again was given doxycycline, ZPAK, MEDROL PAK, saw ENT - given DECADRONE IM and PO for 10 days, doxycycline, follow up given RYNEZC and BACTRIM.
I lost complete use of my legs; Transverse myelitis; diagnosed with transverse myelitis from a direct reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Feb2022 (Batch/Lot number: unknown) at the age of 30 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: MONOPLEGIA (hospitalization, medically significant) with onset Feb2022, outcome "unknown", described as "I lost complete use of my legs"; MYELITIS TRANSVERSE (hospitalization, medically significant) with onset Feb2022, outcome "unknown", described as "Transverse myelitis; diagnosed with transverse myelitis from a direct reaction". The patient was hospitalized for monoplegia, myelitis transverse (start date: 27Feb2022, discharge date: 07Mar2022, hospitalization duration: 8 day(s)). No other medication. No Prior vaccination (within 2 weeks). Consumer stated, I just would like to report a side effect of the Pfizer booster (Clarified as Pfizer COVID-19 Vaccine BNT162b2). Consumer stated, I received my COVID booster, my Pfizer COVID booster last week Monday, no 2 weeks ago 2 Monday's ago, 21Feb and within a week I lost complete use of my legs, I was diagnosed with Transverse myelitis from my Pfizer COVID booster and I am learning how to walk again right now. I was diagnosed with transverse myelitis from a direct reaction from my COVID Pfizer booster. Date of Hospitalization: Consumer stated, Last week Sunday, 27Feb I was admitted to the hospital, I have been in the hospital till today, today is Monday till 07Mar. This case was Serious case with Seriousness criteria-Caused hospitalization.The events "i lost complete use of my legs" and "transverse myelitis; diagnosed with transverse myelitis from a direct reaction" were evaluated at the physician office visit. Therapeutic measures were taken as a result of monoplegia, myelitis transverse.  The lot number for bnt162b2 was not provided and will be requested during follow up.
When we got home from her "well child visit"  she became very lethargic, spiked a fever (103.8), her chest and extremeties turned bright red and she looked very sick.  That night she began screaming - a high pitched, wierd scream that lasted all night.  I called the doctor around midnight and was told to use Tylenol and cold compresses.  Nothing worked.  The next day was the same.  Then patient started to squalk and flutter her hands and feet, like a squalking bird.  Her face would contort and she would scream and squalk wildly while flapping her hands and feet.  The rednesand fever subsided after 4 days, however the flapping and squalking continue to this day (she is now 11).  She was diagnosed with Autism/Tourette's Syndrome 6 months later.  Prior to her MMR vaccine she had NEVER had ANY of these symptoms.  As I look back now it is SO CLEAR that the vaccine did something to her system that it could not handle and she never was able to fully recover from the assault to her system.  8/01/2008 MR received from PCP including neuro consults and previous consult with Lyme specialist prior to vaccines.  Seen by Lyme specialist beginning 4/8/2000 for sx of hand flapping, rashes, excessive sleeping, joint pain, bladder problems, h/a, sweats and fatigue following a tic bit in 1999. (+) 6th cranial nerve palsy, rash and periorbital edema noted on exam. Seen by current PCP for new pt WCC on 2/7&20/2001.  Tics, hand flapping and hair pulling noted by parent and MD.  Sent for Neuro consult on 2/23/01. Neuro exam WNL except tics. DX:  Complex Motor Tics, felt to unrelated to Lymes nor meeting criteria for Tourettes. Seen by PCP for OV 3/2/01. DTaP and IPOL given.  Seen 4/25/01 with increased hand flapping, knee pain, fatigue, sleepiness and low stress tolerance.  2nd Neuro exam  10/23/2001.  Behavioral changes reported in months following tick bite at age 15 mon. PE and neuro exam WNL. ? chronic Lyme CSF infection. Increased sx noted when off abx through 2003.
w/in 1/2hr of vax began high pitch cry & mom has held pt over 24hrs; refuses liquids & food; t103.2R @ present 18MAR95 4PM; 18AUG95 dx w/OM-not present on 17AUG95; URI dx @ time of vax
No adverse events occurred. The patient was administered a Pfizer Pediatric Covid vaccine that was stored in the refrigerator for 14 days beyond what is approved by the manufacturer.
pt recv vax 26MAR98 & devel fever 27MAR98;had brief gen sz w/postictal period;APAP given w/prompt dec in fever;seen in office shortly p/episode;T100.2;exam unremarkable x/mild coryza, single soft palpated ulcer;neuro intact;symptomatic tx c
Fever and malaise same day. vomiting three times the next day. Jaundice noted on 01/27.
red dots all over arms, body that itch, feels crawling, on set 4/6/2021
Administered expired flumist vaccine intranasally. Upon recommendation from representative and guidelines, patient was revaccinated (same day) with parental knowledge of incident. Educated on recommendations.
pt recvd vax 24JUL95 & 18AUG95 had onset of abd pain; pt was seen by 19AUG95 abdo pain become;c/o sore throat;rapid strep test pos @ that time;emesis, joint aches, nausea, bilat elbow swelling,t102.8, ESR elevated to 20;
Intense burning pain during administration, radiated all the way down the arm. Shooting, throbbing pain with movement lasting 3 months. Diagnosed with axillary nerve damage/ palsy
A large welt; Itchy; Red; This spontaneous case was reported by a non-health professional and describes the occurrence of URTICARIA (A large welt), INJECTION SITE PRURITUS (Itchy) and INJECTION SITE ERYTHEMA (Red) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included CITALOPRAM HYDROBROMIDE for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced URTICARIA (A large welt), INJECTION SITE PRURITUS (Itchy) and INJECTION SITE ERYTHEMA (Red). At the time of the report, URTICARIA (A large welt), INJECTION SITE PRURITUS (Itchy) and INJECTION SITE ERYTHEMA (Red) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2021: No specific follow-up information recorded.
Within hrs. of receiving the vaccination, my left arm began to get sore, it got increasingly more sore as the day progressed. By 8:00 p.m. my arm was so sore and stiff, I could hardly move it. by 6:30 p.m. the same day, I had body aches and chills. I also had a slight fever by 8:30 to 9:00p.m. Slight head-ache the same evening. The next morning, I felt slightly better but my arm was still very sore and tender. I noticed the beginning of some redness slightly below the injection area. By 6:30p.m. the reddened area was approx. 4 to 5 inches in diameter and was not an exact circle. The reddened area was from the middle of my arm to almost my elbow. It was also warm to the touch. Today, 1-16-2021 the reddened area is still the same size and is still stiff and sore to the touch. It is still warm to the touch.
Charge nurse administered the COVID-19 Pfizer dose instead of the TB skin test using a tuberculin syringe subcutaneously. No negative effects reported.
The pt developed redness, swelling and a 10cm area of induration at the injection site. She also developed a fever and arthralgia. She was treated with corticosteroids, antihistamines and antibiotics. The redness, swelling and induration resolved, but a 1cm area of necrosis had developed. Some drainage from the site was noted.
pt seen @ hosp 5SEP97 w/hx of post vax fever 103-104 accompanied by sz;sz @ hosp as febrile sz & OM;
it is past the 35 days window; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it is past the 35 days window) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN POTASSIUM for an unknown indication.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it is past the 35 days window). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it is past the 35 days window) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was unknown.
The first episode he turned white and went limp, barely breathing and around his eyes turned blue. It looked klike he was slipping into a coma. I flipped him over and patted him on the back and put him in a steamy bathroom. It took him a good 8 hours to be back to himself. It ocurred about 6hours after the injection. He was very lathargic the whole time. On the second episode there was vomit present and required 911 paramedics and a trip to the ER because we couldn't get him from slipping out of consciousness. That was on his 6 months visit and that's when I made the connection that it was the shots. He was sick with a cough and cold the first time.
No immediate after affects of the vaccine. The health event has been related to circulatory issues (insufficiency)  in my lower legs and feet and pre-dates the vaccination but it got worse much more quickly recently. I got a really nasty skin infection. It took over my lower legs on both my legs. It's responding wound dressings - compression dressings on them. It didn't respond to three different antibiotics. The circulatory symptoms, we are still trying to address the cause. I'm not diabetic and they have tested and I don't have any arterial problems. So that's a mystery.
feels a stuck chest, "like when you eat something and is stuck in the throat, this sensation , but in the chest; rash that doesn't go away on hands , arms , and in the trunk of the body: chest and back; This spontaneous case was reported by a health care professional and describes the occurrence of CHEST DISCOMFORT (feels a stuck chest, "like when you eat something and is stuck in the throat, this sensation , but in the chest) and RASH (rash that doesn't go away on hands , arms , and in the trunk of the body: chest and back) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced CHEST DISCOMFORT (feels a stuck chest, "like when you eat something and is stuck in the throat, this sensation , but in the chest) and RASH (rash that doesn't go away on hands , arms , and in the trunk of the body: chest and back). The patient was treated with PREDNISONE for Chest discomfort, at a dose of 1 dosage form. At the time of the report, CHEST DISCOMFORT (feels a stuck chest, "like when you eat something and is stuck in the throat, this sensation , but in the chest) and RASH (rash that doesn't go away on hands , arms , and in the trunk of the body: chest and back) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included unspecified birth control pills.   Treatment medications also included antihistaminic.
103 degree fever; feet are swollen; can''t move legs; She is feeling really bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Sep2021 13:00 (Lot number: 30155BA) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic asthmatic", start date: 11Sep2021 (ongoing), notes: Additional Information for Other Conditions: Diagnosed after 11Sep2001; "Nerve disease" (ongoing), notes: Additional Information for Other Conditions: Diagnosed 8 years ago; "Neoplasm malignant" (unspecified if ongoing), notes: Additional Information for Other Conditions: Is in remission. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, LOT Number: EW0186, Route, Anatomical Location: right shoulder), administration date: 08Sep2021, when the patient was 57 years old, for Covid-19 Immunization.  The following information was reported: PYREXIA (non-serious) with onset 30Sep2021, outcome "unknown", described as "103 degree fever"; PERIPHERAL SWELLING (non-serious) with onset 30Sep2021, outcome "unknown", described as "feet are swollen"; MOVEMENT DISORDER (non-serious) with onset 30Sep2021, outcome "unknown", described as "can''t move legs"; FEELING ABNORMAL (non-serious) with onset 30Sep2021, outcome "unknown", described as "She is feeling really bad". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not receive Vaccine Administered at (Privacy) Facility. Additional Vaccines Administered on Same Date of the Pfizer Suspect, Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s), AE(s) following prior vaccinations and Patient's Medical History (including any illness at time of vaccination)? were None.  Follow-up attempts are completed. No further information is expected.
red oval shaped area near injection site; Warm oval shaped area near area of injection; puffy/oval shaped area near injection site; This case was reported by a nurse via sales rep and described the occurrence of localized erythema in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced localized erythema, localized feeling of warmth and tissue puffing. On an unknown date, the outcome of the localized erythema, localized feeling of warmth and tissue puffing were unknown.   It was unknown if the reporter considered the localized erythema, localized feeling of warmth and tissue puffing to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 57 or 58 years. The  patient experienced red,warm, puffy, oval shaped area near area of injection. The patient reported this information on the reporting date as they were getting their 2nd dose on the reporting date
unexpected therapeutic benefit; This is a spontaneous report from contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNTI62b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734), via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 11:45 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as allergic asthma, hypothyroidism, post-nasal drip, sneezing, and cough expectorating phlegm. The patient had drug allergies to sulfonamide drugs, fluconazole, montelukast, spriva and allergies to wines, melon and sulfites. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had received medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient experienced unexpected therapeutic benefit on 29Mar2021 at 12:45. It was reported that the event was a happy and unintended one, she believed. she had cough-variant allergic asthma and take inhalers for it daily, including bronco-dilators. The patient coughed a lot even with the inhalers was on a five-month hiatus from her allergy injections and off antihistamines while awaiting a skin test, so the patient coughing had been particularly severe. Within an hour of receiving her first COVID vaccine, her allergy symptoms (post-nasal drip, sneezing, and severe asthma cough expectorating phlegm) were completely gone. It was the weirdest thing but she was thrilled. The clinical outcome of event unexpected therapeutic benefit was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
pain; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), PYREXIA (fever) and HEADACHE (headache) 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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (pain), PYREXIA (fever) and HEADACHE (headache). At the time of the report, PAIN (pain), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Whooshing sound in ear; Body aches; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Whooshing sound in ear), MYALGIA (Body aches) and PYREXIA (Low grade fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A211A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-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) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced TINNITUS (Whooshing sound in ear), MYALGIA (Body aches) and PYREXIA (Low grade fever). At the time of the report, TINNITUS (Whooshing sound in ear), MYALGIA (Body aches) and PYREXIA (Low grade fever) outcome was unknown.            No relevant concomitant medications were provided.  The patient reported that whooshing sound in her ear was being worse when lying down. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
I am not sure of the vaccine brand, etc. It was my tetanus shot. The night AFTER I received the vax, deep armpit pain, applied heat, hydrated and ibuprofen. Today is day 3 of pain.