chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EN5318), in left arm, on 21Feb2021 as dose 2, single (Lot number: EN6201), in right arm, in Aug2021 as dose 3 (booster), single (Lot number: EW0182), in left arm and on 01Jun2022 as dose 4 (booster), single (Lot number: FN2908) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Paxlovid", start date: 01Sep2022, stop date: 06Sep2022, notes: Stopped. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.
Within 2-3 minutes of receiving the second dose, patient started to tremble. Patient complained of myalgia, nausea, dizziness, and light headaches.
2ND DOSE: I'm having constant noise in my right ear; Eyes are sensitive to light; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 19Sep2021 (Batch/Lot number: unknown) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Pemphigus Vulgaris" (unspecified if ongoing), notes: affects mucosa areas; "morphine" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine. The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "2ND DOSE: I'm having constant noise in my right ear"; PHOTOPHOBIA (non-serious) with onset 2021, outcome "not recovered", described as "Eyes are sensitive to light". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus, photophobia.  Additional Information: After 2ND DOSE: Patient was having constant noise in her right ear for 5 days now, sounds like was standing in a field of loud crickets. Eyes were sensitive to light. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Other medications the patient received within 2 weeks of vaccination: MSM with glucosamine, omega 3, vitamins. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot FC3183 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FC3183, fill lot EY0555, and the bulk formulated drug product lot EP8657. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.
Low grade fever 11 and 12 days after administration of MMR, Varicella, and DTap vaccines.  Followed by bright erythematous 2-6 mm itching lesions without vesicles on day 12-13 after immunization.
The patient received her first dose of pediatric pfizer at 02:44 pm. At 02:49 pm mother brought the patient back onto the bus stating she had a rash now. It was noted that she had splotchy unraised red areas on her upper chest and right upper shoulder. She said that it was itchy. Administered one children's Benadryl 12.5 mg to chew with the mothers' verbal consent. Observed the patient for approximately 30 minutes the red areas began to dissipate. Discussed with mother who felt comfortable taking her home advised her if any more problems happened to seek care at the emergency room.
black bump / swollen; redness; "blue and red" way up around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (black bump / swollen), ERYTHEMA (redness) and VACCINATION SITE ERYTHEMA ("blue and red" way up around the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jun-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 SWELLING (black bump / swollen), ERYTHEMA (redness) and VACCINATION SITE ERYTHEMA ("blue and red" way up around the injection site). At the time of the report, SWELLING (black bump / swollen), ERYTHEMA (redness) and VACCINATION SITE ERYTHEMA ("blue and red" way up around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.).    This case is for 34th patient out of 77 patients reported.  No concomitant medication information was provided.  It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:case
Child had seizure like convulsions immediately after the shot. Episodes of eye rolling and arms up increased during the next 2 weeks- ranging from 8x per day to 50 times per day. EEG test was done to rule out seizures- no seizure activity was recorded. All the doctors are uncertain why it appears the child has convulsion like activity. Child was also dizzy and had difficulty with cruising and crawling.
Feeling like my brain was sweilling; long haul adverse reaction; made situation worse/My situation is getting worse; Shortness of breath; neck pain got worse; headache; neck pain; neck swelling; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling like my brain was sweilling), VACCINATION COMPLICATION (long haul adverse reaction), SWELLING (neck swelling), CONDITION AGGRAVATED (made situation worse/My situation is getting worse) and DYSPNOEA (Shortness of breath) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 217B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Parkinson's disease since July 2019. Concomitant products included CARBIDOPA, LEVODOPA (SINAMET) and ALPRAZOLAM (XANAX) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced SWELLING (neck swelling) and NECK PAIN (neck pain). On an unknown date, the patient experienced FEELING ABNORMAL (Feeling like my brain was sweilling), VACCINATION COMPLICATION (long haul adverse reaction), CONDITION AGGRAVATED (made situation worse/My situation is getting worse), DYSPNOEA (Shortness of breath), PAIN (neck pain got worse) and HEADACHE (headache). At the time of the report, FEELING ABNORMAL (Feeling like my brain was sweilling), VACCINATION COMPLICATION (long haul adverse reaction), SWELLING (neck swelling), CONDITION AGGRAVATED (made situation worse/My situation is getting worse), DYSPNOEA (Shortness of breath), NECK PAIN (neck pain), PAIN (neck pain got worse) and HEADACHE (headache) had not resolved.            No treatment information was provided.   This case was linked to MOD-2021-074208 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: AE added. Patient reported that her situation is getting worse. Patient can't access FU form on her Kindle and would like to be contacted personally. On 16-Jul-2021: Follow up received on 16 Jul 2021 contains no significant information.
This employee received a Moderna covid-19 vaccine 9/10/21.  Today    presented with patchy red blotches and warm to the touch site on    right deltoid.  Injection site clear.  Also complains of right    shoulder pain. Also complained of fatigue. Said he woke up with    what he thought might be conjunctivitis 2 days later and eyes    swollen shut.  He has been taking Ibuprofen for the symptoms.  No    complaints of nausea vomiting or diarrhea or respiratory    difficulty.  He had covid-19 11/2020.  Assessment.   Vital signs stable.  We will continue to follow this employee    until his condition is resolved.  A Medical Exception Letter to    be done Per MD and forwarded to  Employee    health Nurse.
Fever with temperature readings of 99.8 F and 101.2 F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever with temperature readings of 99.8 F and 101.2 F) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 05-Apr-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 06-Apr-2021, the patient experienced PYREXIA (Fever with temperature readings of 99.8 F and 101.2 F). At the time of the report, PYREXIA (Fever with temperature readings of 99.8 F and 101.2 F) outcome was unknown. Not Provided          No concomitant medications were reported. Treatment details included Tylenol.
Erythematous papular area approximately 8-9 cm surrounding injection site on left thigh.
Prior to second vaccination last menstrual period was regular and lasted 22jan21-28jan21. Post vaccination I started to have spotting 2feb21 which gradually became full menstrual bleeding through 6feb21. I started menstrual bleeding again on 14Feb21-24Feb21 then had a few days of no blood, started menstrual bleeding again 28feb21-3mar21. I experienced more regular menstrual bleeding in the last month 1apr21-8apr21 and have not gotten my period this month yet.
This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age with no Pertinent Medical History and no Drug Reactions/Allergies. In approximately March 2010 (4 years ago) the patient was vaccinated with the first dose of GARDASIL, injection, (lot # expiration date and dose unspecified) for Immunisation in an unspecified physician's office, and reported "flu like symptoms" after receiving the dose. She reported body aches and malaise and shortness of breath. She reported that these symptoms resolved without treatment. She reports that the patient stated that she experienced the same symptoms after receiving the second dose of GARDASIL. The patient's symptoms resolved on their own after the second dose as well, in an unspecified amount of time. The patient had not yet received the third dose. The event outcome was reported as recovered. The patient sought medical attention. No treatment was given. Additional information has been requested.
Information has been received from a physician concerning a 17 year old female patient, who on 17-JAN-2008 was vaccinated orally with the first dose of Gardasil. On 17-JAN-2008 the patient experienced lymphadenopathy and a fever. Medical attention was sought. The patient's lymphadenopathy and fever persisted. No product quality complaint was involved. Additional information has been requested.
Stomach pain -- was curled up in a ball and crying off and on for 6 days.  No blood in stool.  Not any more spitty than usual (is a spitty baby per mom).
(R) thigh tenderness onset same day as vaccine. Morning after, parent noted significant swelling to right upper thigh. Seen in office and noted to have generalized swelling of right thigh from groin extending to and involving the right knee. No erythema or measured sign of reaction at injection site. Leg is warm to touch with uniform swelling to anterior and posterior thigh. Given Motrin and Benadryl, cold compress PRN.
Patient developed a red, swollen upper arm (entire upper arm) within 36 hrs of vaccination. Lasted about 2 days.
Renal function abnormal; Automobile accident; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4190167-00 (AbbVie).  A 62 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 03Dec2021 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RENAL IMPAIRMENT (medically significant) with onset Dec2021, outcome "not recovered", described as "Renal function abnormal"; ROAD TRAFFIC ACCIDENT (non-serious) with onset Dec2021, outcome "not recovered", described as "Automobile accident". The patient underwent the following laboratory tests and procedures: renal function test: (Dec2021) abnormal. The action taken for adalimumab was unknown.  Clinical course: Solicited report by a consumer of an adult female with an event of non-serious car accident showed abnormal kidney with humira (adalimumab). There was no reported medical history. On an unknown date, the patient experienced car accident showed abnormal kidney. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 03Dec2021, patient received 1st dose covid-19 vaccine manufactured by Pfizer/biontech.  Causality for humira(adalimumab): The reporter's causality for the event(s) of car accident showed abnormal kidney and car accident showed abnormal kidney with humira(adalimumab) was no reasonable possibility.  Causality for Pfizer Biontech Covid-19 Vaccine: The reporter's causality for the event(s) of car accident showed abnormal kidney and car accident showed abnormal kidney with Pfizer Biontech Covid-19 Vaccine was possible.  No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,   possible causal relationship between the event Renal impairment and suspect drug BNT162B2 cannot be excluded.  Based on currently available limited information and nature of event ,Automobile accident is considered Unrelated. Case will be reassessed once more information is available.  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.
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 09-JAN-2020, the patient was vaccinated with an improperly stored (product storage error), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number S006210 and expiration date 22-DEC-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
28 year old male with complaint of intermittent rash and increasing bilateral knee and hand swelling and pain that began, post vax, 3rd dose and progressively worsened after the 4th dose on 11/23/98. Hard to climb stairs. Abnormal weight gain despite strenuous exercise program at physical training. Anthrax provider thought it might be related to vaccine received 8 or 9 months ago. Skin had mild bilateral erythematous region. Temporal region with blanches. Minimal erythema left and right of anterior neck at collar line. Questionable exercise induced urticaria vs less likely reaction to Anthrax vaccine.
The day I received the vaccine, 4 hours later, I had diarrhea and exhaustion. I went home, got in the bed and slept. When I woke up the next day my body was hurting. Everything was hurting. My body was in a lot of pain. My muscles were hurting bad, and I had weakness. I couldn't get out of bed because it was too painful. I missed a day of work. Later on, Sunday I could move my joints without pain. My body also felt heavy, and I didn't have an appetite.
This patient had a sore throat 2 days before he got his vaccine on 01/08/01. On 01/10/01, he had a maculopapular red rash on his body and head, exudate on tonsils, nasal congestion. Took 2 Penicillin (Amoxicillin) on 01/09/01.
Pt received varicella injection on 9/25. Father handed pt on to pt's mother then got him back on 9/28 at which time father noted 3"x2"  size swelling on left thigh where Varivax was given. Father unsure when symptoms started as mother did not communicate any concerns. No fevers noted at time of call on 9/28. Father also notes that lympth node in left groin is inflamed. Appears to be tender to touch.
Redness and swelling (about 4 inches in diameter) at injection site on 11/12/21-11/14/21 Sharp chest pain and shooting pain down left arm beginning on 11/19/21
This spontaneous report was received from a medical assistant and refers to a 65-year-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 08-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # L012521 and expiration date: 01-FEB-2017 )dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
RN administered pediatric dose of Pfizer vaccine intended for 5-11 year olds (0.2 ml/10ug) instead of the Pfizer COVID Vaccine for 12+ (0.3ml/30ug). Dr. informed of medication error. Patient scheduled for his second dose of the correct vaccine in 21 days. Patient's mother made aware.
I had headache, dizziness, body aches, vomiting,  joint pain.  I have to take the day off of work after my first and my second vaccine.  I rotated ibuprofen and Tylenol.  The first vaccine reaction lasted about 36 hours.  The second is going on 48 hours.
Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Additional Details: PAIN IN THE RIGHT THIGH, BURNING, RADIATING, TYPICALLY WORSE AT NIGHT
Spoke with pt and he tells me that "I have a Hx of bronchial problems, but haven't had Sx's in a while." He tells me that he had "tightness in my throat, SOB, wheezing. It knocked me out for a whole day." He was using PRIMATENE mist and his roommate's inhaler which did help.
Pt recvd 1 doses of Hep B vax on 1FEB90 & 2 doses of Engerix-B on 1MAR90 & 2AUG90; NOV90 Hep B surface antibody was neg; pt recvd 2 booster doses of Engerix-B on 28NOV90 & 2JAN91; MAY91 HBSAB was pos;
Pt. states she developed tachycardia, tingling, SOB and the evening following Tdap vaccinnation. Seen in local ED, negative cardiac work-up. She had similar rxn to Influenza vaccine in past and was told she as allergic to that. Diagnosed by Allergist at that time.