chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I went to the bathroom and the next thing I know was that I woke up on the bathroom floor, I passed out for couple of minutes; Chills; Weak; Dizzy; Nausea; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, at the age of 79-year-old, on 06Mar2021, as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, on an unspecified date, as SINGLE DOSE for covid-19 immunisation. After taking the second dose on 06Mar2021, the patient waited for half an hour and there was no problem. The patient came home no problem. In the middle of the night, the patient woke up with chills, the patient know that is one of the side effects, she was okay and not worried about it. The patient took her temperature that was normal but then couple of hours later, she went to the bathroom and the next thing she knew was that she woke up on the bathroom floor, the patient passed out for couple of minutes. Then she went to bed and was very weak and dizzy and nausea. The patient didn't want to call right away or did not wanted to go to the emergency room. The patient called her friend because she got very nervous and she said come back to her house. The patient took a Benadryl (treatment) and came back home and slept few hours. The patient woke up this morning, felt pretty good and took Benadryl (treatment) and then came here of her friend house and took Benadryl (treatment) again few minutes ago and four hours later. The patient had several things like these like she was dizzy and had nausea. The patient felt okay now and she doesn't want to go to emergency room and she seems to be fine now. The patient was dizzy, nausea and passed out. The patient had a chills and experience sore arm. Outcome of the events was recovered in Mar2021.  Information on the lot/batch number has been requested.
tinnitus with hearing loss; tinnitus with hearing loss; vertigo and tinnitus with hearing loss; This is a spontaneous report received from a contactable consumer (patient). Follow-up (05Mar2021) information was processed together with initial information. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. On an unknown date, a week later actually, the patient had vertigo and tinnitus with hearing loss. She had received a steroid injection into the ear and her second Covid dose is Friday. She stated do you have an opinion on this matter. Caller was on her way to receive the second dose of the Pfizer Covid 19 vaccine. She wants to know if there could be any interactions from the steroids and the vaccine. Outcome of the events was reported as unknown.
COVID-19; COVID-19; Drug effect decreased; Stress; Colitis ulcerative aggravated; Bleeding; This is a solicited report from a contactable consumer (patient) based on information received by Pfizer from Company (Mfr. Control No.: 21K-163-3988258-00).  A 63-year-old female patient (same age at vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 11Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 intramuscular on 08Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for Covid-19 immunization; and adalimumab (HUMIRA), subcutaneous from Sep2016 (Batch/Lot number was not reported) to Oct2020, at 40 mg, subcutaneous from Jan2021 (Batch/Lot number was not reported) and ongoing, at 40 mg for colitis ulcerative. No relevant medical history. The patient's concomitant medications were not reported. On unknown dates, the patient experienced humira completely stopped working, COVID-19, and stressed. In 2021, the patient experienced bleeding. On 13Mar2021, the patient experienced ulcerative colitis flare ups. In May2021, the ulcerative colitis flare Ups resolved. In 2021, the bleeding resolved. Pfizer BionTech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 11Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On 08Apr2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. The patient was treated with Prednisone. The outcome of event Colitis ulcerative aggravated was recovered in May2021; outcome of bleeding was recovered in 2021; outcome of other events was unknown.  The reporter's assessment of the causal relationship of the events with BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: The reported events are assessed as possibly related to the suspect drug BNT162B2 based on information provided in the case but consider also possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Right after I took the dose I was extremely thirsty. The next day I had a really high fever that would only lower to around 99 degrees even after taking Tylenol. My temperature had gotten up to 105 degrees. So I continued to take Tylenol. After which my temperature went down to 95 degrees. Over the course of the next 2 days my body was having trouble regulating my temperature. My temperature was fluctuating between 95 to 101 degrees. I was able to stabilize my temperature from the fever using Tylenol and I was able to bring my temperature back up using a heated blanket, hot showers and hot teas. After the fact I started having issues with my heart racing. I felt that my liver and heart medication stopped working. It took 2 months for my heart medication to work again and my liver medication completely stopped working so my doctor took me off of it.
Information has been received from a health professional concerning a 9 year old female pt who was vaccinated on 04/10/1997 with a dose of varicella virus vaccine, live. Subsequently, on approximately 03/10/2004, the pt developed breakthrough chickenpox with less than 50 lesions. Follow up information indicated that "there was not a single report of adverse reaction following varicella vaccination". The reporter indicated that 49 other patient's developed breakthrough cases of chicken pox ( WAES # 0405USA2615, 0405USA00572, 0405USA00573, 0405USA00574, 0405USA00575, 0405USA00576, 0405USA00577, 0405USA00578, 0405USA00579, 0405USA00580, 0405USA00581, 0405USA00582, 0405USA00583, 0405USA00584, 0405USA00585, 0405USA00586, 0405USA00587, 0405USA00588, 0405USA00589, 0405USA00590, 0405USA00591, 0405USA00592, 0405USA00593, 0405USA00594, 0405USA00595, 0405USA00596, 0405USA00597, 0405USA00598, 0405USA00599, 0405USA00600, 0405USA00601, 0405USA00602, 0405USA00603, 0405USA00604, 0405USA00605, 0405USA00606, 0405USA00607, 0405USA00608, 0405USA00609, 0405USA00610,  0405USA00610,  0405USA00611,  0405USA00612,  0405USA00613,  0405USA00614,  0405USA00615,  0405USA00616,  0405USA00617,  0405USA00618, and  0405USA00619). No additional information is expected.
feeling tired today; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd February 2020, the patient received the 1st dose of Shingrix. On 4th February 2020, 1 days after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The day before reporting, the patient received the 1st dose and felt tired on the reporting date. The patient asked how long might the side effects last.
7-8cm of erythema w/induration;warm to touch;tx amoxicillin;
Swollen leg: started at 8pm Swollen injection site: started at 8pm Red injection site: started at 8pm Decreased sleep: started at 8pm Irritability: started at 8pm Decreased appetite: started at 8pm Can barely walk on leg: started at 8pm 100 Fever: started at 8pm Knot in muscle where injection is: started at 8pm  All symptoms are ongoing 20 hours later
Pt. reported itchy skin, similar to first injection.  She was given Benadryl and felt better.  She saw her provider and was given a methylprednisolone taper.  She refused an epi-pen.  Patient called by nurse and reported feeling better.
Janssen COVID-19 Vaccine EUA. Directly after the shot I felt arm pain. At 6:30pm I began to have uterine/abdominal cramping, vaginal pain, lower back pain. At 7:30 I began to feel extremely overheated and a little fatigued. At 9:00pm I felt chills, extreme fatigue, all over body ache and joint pain. At about 2:00 am overnight I again felt extremely overheated. The following morning I continued to feel fatigue, abnormal temperature swings, body ache and joint pain. This lasted until night (about 30/36 hours after the injection). About 48 hours after the injection, I felt some dizziness and abdominal upset.
Infant had fever, body stiffening and APNEA (Seizure).  12/14/07 Reviewed hospital medical records which reveal patient experienced staring episode then began shaking all extremities then stopped breathing.  Then started crying inconsolably.  Postictal in ER.  Admitted 11/21-11/22/2007. Sepsis w/u & LP done.  No further seizure activity in hospital but was very sleepy.  Temp on admit 39.8.  Received IM antibiotics.  D/C to home on continued antipyretic to f/u w/pcp. FINAL DX: febrile seizure.
Back surgery; COVID vaccine made sick; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL OPERATION (Back surgery) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SPINAL OPERATION (Back surgery) (seriousness criterion medically significant), ILLNESS (COVID vaccine made sick) and COVID-19 (COVID-19). At the time of the report, SPINAL OPERATION (Back surgery), ILLNESS (COVID vaccine made sick) and COVID-19 (COVID-19) outcome was unknown.            The indication of suspect drug Humira was reported as moderate to severe rheumatoid arthritis.  No concomitant product was reported. COMPANY COMMENT: This is an spontaneous case concerning an elderly female patient with medical history of Co-suspect product ADALIMUMAB for Rheumatoid arthritis who experienced the unexpected  events of SPINAL OPERATION (seriousness criterion medically significant), COVID-19 (AESI) and ILLNESS unknown days after  a dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   The reporter's causality for the events of Back surgery, Covid vaccine made sick and Covid with Humira (Adalimumab) was reported as not provided and the opinion was that there was no reasonable possibility that the events of Back surgery, Covid vaccine made sick and Covid are related to Humira (Adalimumab).  It was unknown if the patient was enrolled in a COVID-19 vaccine trial.  No treatment information was provided.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an elderly female patient with medical history of Co-suspect product ADALIMUMAB for Rheumatoid arthritis who experienced the unexpected  events of SPINAL OPERATION (seriousness criterion medically significant), COVID-19 (AESI) and ILLNESS unknown days after  a dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient felt dizzy.  Became pale and diaphoretic.  1215 - 98/52 HR 54, repeat at 1220 110/64 HR 78, repeat.  12/25 patient feels better, able to ambulate, alert and oriented.  1234  symptoms completely resolved and able to resume normal activity.
mom states pt devel red raised hives on inner arms few hr p/vax by 230AM was covered w/rash over entire body & itching;given DPH & APAP;called ER instructed inc DPH;seen by MD 5AUG97;
Patient has myasthenia gravis and received a pneumonia vaccine and a flu vaccine in the same arm (left arm) and the patient came into the pharmacy on 11/8/18 to tell me she spent the next day in the ER with a paralyzed arm. She said the ER doctor told her it was too much fluid (1 ml) for her muscles to withstand, so they gave her some muscle relaxers and that solved the problem.
Possible Arthus-Type reaction. Patient presented to clinic on 10/28/15 with 10cm circular erythematous, edematous, firm lesion with well defined margins on right thigh. Lesion had central darkening at location of injection. Area of erythema was tender to touch. Patient also reported that region was itchy.
On 06/26/1998 immunization reaction vs. cellulitis on left thigh with large indurated erythematous area injection site. Cold compresses and Duridef given.
fever; chills; headaches; excruciating generalized body aches like he had just be ran over by a truck; nausea; patient has passed away; A spontaneous report from was received from a Consumer concerning a 74 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea, headaches, chills, fever, excruciating generalized body aches like he had just be ran over by a truck, patient has passed away.    The patient's medical history was not provided.  No relevant concomitant medications were reported.    On 23-02-2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, The patient experienced  nausea, headaches, chills, fever, excruciating generalized body aches like he had just be ran over by a truck.  The patient had a cardiac angiography on 24-02-2021. The result was unknown.  The patient was found dead on 06-03-2021.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events nausea, headaches, chills, fever, excruciating generalized body aches like he had just be ran over by a truck was recovering.  The patient died on 06-03-2021.   The information about the autopsy was unknown. The cause of the death was unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. The patient must have been in some form of cardiac issues before death, that's reason why cardiac angiography was done.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 26-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 26-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 26-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 26-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 26-Jul-2022). Concomitant medication information was not provided by the reporter. Patient received half dose. Vial was initially stored in the refrigerator on 04-Jun-2022.  Vaccine administered to 346 patients after the 30 day by used involved 35 vials. Vial did not undergone any temperature excursions. Treatment information was not provided by the reporter.
pt recvd vax 6PM; 930PM mom attempted to waken pt & found pt unresponsive; pt was pale & limp; p/picking up pt responded w/ a distressful cry; for the next 10 minutes had episodes of apnea lasting 10-20sec; pt taken to ER; dx shock collapse
1. Sinusitis, left sinus, congestion, pain, pressure, headache, no fever - began 2 weeks post vaccine on 3/26/21. Aleeve, Afrin (3 days only), Flonase after Afrin.  2. Sinusitis symptoms did not resolve/ear feeling full or clogged. Zpak antibiotic (5 day course), Flonase, Zyrtec - given 4/19/21, 3 weeks after onset of symptoms. 3. Continued sinus pressure/buzzing/hearing loss/tinnitus mostly left ear, minimal in right ear - second round of antibiotics (10 day course doxycycline given 4/27/21).  4. Hearing loss resolved/sinus pressure resolved. 5. Tinnitus has not resolved. Started Lipo Flavonoid tablets, 2 tablets three times a day.
her forehead feels a little warm; soreness on her arm at the injection site; has a little bit of a headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING HOT (non-serious), outcome "unknown", described as "her forehead feels a little warm"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "soreness on her arm at the injection site"; HEADACHE (non-serious), outcome "unknown", described as "has a little bit of a headache". The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Patient was vaccinated at approx. 2:07 PM on 2/17/2021. Patient was told to wait in waiting area for 30 minutes prior to leaving to monitor for adverse events. At approximately 2:17 pm patient started to feel "unwell" and was seated next to nurse for close observation. At 2:18 patient was given 50mg benadryl due to request and felling itchiness in throat. At 2:35 pm Epi-pen was administered due to patient complaint of swelling in the throat and tingling of the tongue. Emergency services called at 3:35. Vitals were as follows BP 181/115 pulse 100 SpO2 97 on RA.
ActHIB was administered but with expired diluent/no AE; Initial information received on 07-May-2020 regarding an unsolicited valid non-serious case from a other health professional (medical assistant).  This case involves a 18 months old male patient who received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (Box: LOT: UI974AAB, expiry date: 01-Apr-2020, Act-HIB: LOT: UI974AA, expiry date: 27-Jul-2020 and Diluent: LOT: U6193AA, expiry date: 01-Apr-2020) via an intramuscular route in the right thigh) for prophylactic vaccination on 22-Apr-2020. The patient ACT-HIB and only diluent portion was expired.   The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) for Immunisation; HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation all on 22-Apr-2020.  It was an actual medication error due to Expired medical agent used (Expired product administered).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Body aches; Fever of 102 degree; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (Fever of 102 degree) and FATIGUE (Fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (the patient was tested positive for covid-19 on 01-12-2020.) on 01-Dec-2020.    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Dec-2020, the patient experienced PAIN (Body aches), PYREXIA (Fever of 102 degree) and FATIGUE (Fatigue). On 28-Dec-2020, PAIN (Body aches), PYREXIA (Fever of 102 degree) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment medications included Paracetamol and Ibuprofen.   Reporter did not allow further contact; Sender'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.
Felt warmth from legs to head, could not breathe, heart beating fast, BP dropped and felt like passing out, body temperature was 96.8F, had tingling in fingers and toes. Lasted about 20 minutes. On 9/29/00, felt really weak. Mentally still recovering. Muscles in neck inflammed.
Localized cellulitis (redness, pain, swelling, warmth) at injection site (Lt gluteal) x2days.  Alternative site was requested by pt due to adverse effects by previous vaccines in deltoids.  Treated successfully with cephalexin by the Clinic.