chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after her husband got his 1st dose of the COVID-19 Vaccine on 29Mar2021, his sense of smell was fully restored; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Mar2021 08:10 (Batch/Lot number: unknown) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "lost his sense of smell", start date: Feb2020, stop date: 30Mar2021. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 30Mar2021, outcome "not recovered", described as "after her husband got his 1st dose of the COVID-19 Vaccine on 29Mar2021, his sense of smell was fully restored".  Additional information: Caller (Patient's Wife) stated she wanted to give Pfizer some positive feed back on the COVID-19 Vaccine. She said her husband had gotten vaccinated (on 29Mar2021), clarifying it was her husband's first COVID-19 Vaccine dose. She said her husband had lost his sense of smell in Feb2020. She said it wasn't documented that her husband had the COVID-19 Virus in Feb2020, but he thought he probably had the COVID-19 Virus because of losing his sense of smell. She said at that time, in 2020, it was difficult to get COVID-19 Virus testing. She said the day after her husband got his first COVID-19 Vaccine dose (30Mar2021), his sense of smell was fully restored. She said both her and her husband found it to be interesting that he got his full sense of smell restored after getting his first COVID-19 Vaccine dose. Patient woke up in the morning on 30Mar2021, and his full sense of smell was restored and he was so excited.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Refrigeration excursions identified; No Adverse Event; Poor quality product administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No Adverse Event) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Sep-2022 at 3:23 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 17-Sep-2022 at 3:23 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) 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 (Refrigeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered).    No concomitant medication was reported.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department made aware of the situation. The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022.  Date vial moved from freezer to refrigerator was 07-Sep-2022.  No adverse reactions reported for the patient.  No treatment information was provided.
continuous coughing; constantly drinking; constantly clearing throat; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (continuous coughing), POLYDIPSIA (constantly drinking) and THROAT CLEARING (constantly clearing throat) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-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 COUGH (continuous coughing), POLYDIPSIA (constantly drinking) and THROAT CLEARING (constantly clearing throat). At the time of the report, COUGH (continuous coughing), POLYDIPSIA (constantly drinking) and THROAT CLEARING (constantly clearing throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.6 (High) 100.6 temperature and was sent to the Emergency room.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
2-4-06 Red spot on L thigh at site of injection, red spots on chest/back; 2-7-06 increased red spots.
About 20 minutes after vaccination, felt tingling throughout body.  Slight headache, followed by feeling dizzy and wobbly.  Must hold onto something to walk.  Has some trouble focusing, "like a fog".
Received pfizer vaccine on 10/29/21 and 11/19/21. COVID positive on 1/17/22. Presented to ER on 1/17/22 and admitted. presented 01/17/22 with hematemesis . It is noted that she was alert and oriented to person and place , but has short term memory loss. She was a nursing home resident. She also has history of combined CHF . CXR in ED showed congestive heart failure , small right pleural effusion. CT scan of chest showed large right and smaller left pleural effusions , extensive consolidative changes , calcific changes of posterior wall of urinary bladder , 1.5 cm right hepatic lobe posterior medial lesion of uncertain etiology , cholelithiasis , extensive arthrosclerotic changes abdominal aorta with areas of severe stenosis at level of proper haptic artery . She tested positive for COVID 19 01/17/22. She was noted to have hyperkalemia 5.6, INR elevated 1.4 , many bacteria in urine . She was admitted for upper GI bleed , acute cystitis , and COVID 19 infection. Patient became unresponsive , ABG showed PH 7.08 , PCO2 117 , PO2 55 on 6 L NC . She was tried on BIPAP with no improvement. Per chart review, family decided for comfort measures only. Patient passed away 01/18/22
Felt achy; felt blechy; Chills; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt achy), FEELING ABNORMAL (felt blechy), CHILLS (Chills) and FATIGUE (tired) in a 13-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) 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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Felt achy), FEELING ABNORMAL (felt blechy), CHILLS (Chills) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Felt achy), FEELING ABNORMAL (felt blechy), CHILLS (Chills) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter.  It was reported that, the patient took Tylenol. The patient felt a little better next day but felt more achy thru out day. Event took place after use of the vaccine.
Sore arm (Had this same reaction from first shot) Swollen red, itchy, warm arm below injection site next day (Had this same reaction from first shot) Mild headache Tiredness
Ten minutes after I received the vaccine, my left arm and leg felt very heavy, like I was uneven. I started to feel very dizzy and my left eye became very blurry. I started feeling nauseous, as well. On the car ride home I noticed a rash. We thought it was an allergic reaction. After I got out of the car I noticed it went away. It came back later again, around my neck that evening, but it only lasted 5 minutes. It was a rash with white bumps and then it went away. At night I experienced chills. When I woke up I had a blistering headache with neck pain that lasted a couple days. The nausea and balance picked up and got worse. I spent two weeks being unable to see, walk, read or drive safely. I have had to take time off of work. I cannot view a computer screen without feeling nauseous. Most of the first week I spent on the floor because of the nausea and spinning issues. I sought medical treatment. I had a CAT scan and they ruled out a blood clot. I still have low grade nausea. I have regained peripheral vision in my left eye, which was missing for three weeks. I have been off work for more than 2 weeks. I still cannot work at my normal capacity. I still have a very strong chemical taste in my mouth. It is getting less and less, but I can still taste it. I've have a lot of swelling at the base of my skull, that has not resolved.
Pt presents to ER with fever of 103.1n nausea, vomiting, headache, overall body pain. All occurring within 12 hours of getting Pneumovax vaccine. Area of injection 8x7 cm area of erythema, warmth and induration in his left deltoid region. Margins of erythema are sharp. Some axillary tenderness without definite adenopathy. Pt also has had intermittent shaking, chills and weakness.
pt recvd vax; had closed head injury as a result of falling during fainting episode p/ vax; recovered quickly;
immed lt shoulder pain radiating to lt neck;while driving home approx 1/2 hr later had dizzy spell & tachycardia;pain still very noticeable in arms & neck;15mins p/1st episode had another similar;took DPH;fine later in evening;only soreness
redness; small pinprick red spot underneath their right forearm armpit/ pinprick red spot was only on their right arm; bumps; itches; Rest are irritations; rashes were on both forearms (left and right); skin rash/rashes were on their left and right side of stomach; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), RASH MACULAR (small pinprick red spot underneath their right forearm armpit/ pinprick red spot was only on their right arm), MASS (bumps), PRURITUS (itches) and SKIN IRRITATION (Rest are irritations) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032HZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer Biontech Covid-19 vaccine (Second dose) and Pfizer Biontech Covid-19 vaccine (First dose). Past adverse reactions to the above products included No adverse event with Pfizer Biontech Covid-19 vaccine and Pfizer Biontech Covid-19 vaccine.    On 18-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 20-Dec-2021, the patient experienced ERYTHEMA (redness), RASH MACULAR (small pinprick red spot underneath their right forearm armpit/ pinprick red spot was only on their right arm), MASS (bumps), PRURITUS (itches), SKIN IRRITATION (Rest are irritations), RASH (rashes were on both forearms (left and right)) and RASH (skin rash/rashes were on their left and right side of stomach). On 18-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, ERYTHEMA (redness), RASH MACULAR (small pinprick red spot underneath their right forearm armpit/ pinprick red spot was only on their right arm), MASS (bumps), PRURITUS (itches), SKIN IRRITATION (Rest are irritations), RASH (rashes were on both forearms (left and right)) and RASH (skin rash/rashes were on their left and right side of stomach) had not resolved.            No Concomitant product use was reported.  The patient reported that the previous two doses were Pfizer vaccine and after receiving the booster, two days later, there was skin rash, redness, bumps, and itches. There appeared to be small pinprick red spot underneath their right forearm armpit. Locations of the rashes were on both forearms (left and right) and on their left and right side of stomach. The patient specifically said the pinprick red spot was only on their right arm, and the rest were irritations.  No treatment information was provided.
Menactra administered at approximately 2:30 pm on 6/22/07 Facial swelling 1st noted at 7:30 pm on 6/22/07 after patient awoke from nap. mother reported peri-oral swelling/lip swelling/and swelling of bilateral forehead region above both eyes. No respiratory symptoms/ No shortness of breath. Patient was referred to local emergency department for evaluation.
Presented to ER just a/MN on 3NOV90 w/focal status epilepticus required large dose of anticonvulsants intubation & mechanical ventilation a/sz stopped. Pt continues to require anticonvulsants.
blood clots; pulmonary embolism; trouble breathing; The initial case was missing the following minimum criteria: ICH-Unidentifiable reporter. Upon receipt of follow-up information on 06Jun2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for covid-19 immunisation; Bnt162b2 (dose 2), for covid-19 immunisation. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots"; PULMONARY EMBOLISM (medically significant), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "trouble breathing". The patient had blood clotting since the patient got 3 jabs of Pfizer vaccine Covid Vaccine - BNT162b2. After pulmonary embolism the patient have trouble breathing. Therapeutic measures were taken as a result of thrombosis, Pulmonary embolism.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Soft, red 33mm x 55mm tender area noted on 04/05/2002 when the pt came for PPD reading. Mother was told to apply ice and to give Tylenol for the symptoms.
Patient stated she had a vaccine aftertaste "could taste the vaccine" for a few hours after the vaccine. Patient also stated she is having left-sided stomachache under the rib that started the day she got the shot and at the time she called the pharmacy today on 07/26/2021. I followed up with her 2 hours later on 07/26/2021 and stated that she took Tylenol which relieved the pain.
pt began having sz p/DTP shot; pt arms would become still, then would bring them up to body & begin shaking all over; pt also exp drooling, eyes rolling around in pts head; pt continues to have both petit & grand mal sz;
Excessive Sweating on waking up; Tiredness; Nausea; Headache; Chills; Sore arm/Throbbing pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm/Throbbing pain in the arm), HYPERHIDROSIS (Excessive Sweating on waking up), FATIGUE (Tiredness), NAUSEA (Nausea) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PANTOPRAZOLE and ATORVASTATIN for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm/Throbbing pain in the arm). On 20-Mar-2021, the patient experienced FATIGUE (Tiredness). 20-Mar-2021, the patient experienced NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills). On 21-Mar-2021, the patient experienced HYPERHIDROSIS (Excessive Sweating on waking up). On 21-Mar-2021, NAUSEA (Nausea) and HEADACHE (Headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm/Throbbing pain in the arm), HYPERHIDROSIS (Excessive Sweating on waking up), FATIGUE (Tiredness) and CHILLS (Chills) outcome was unknown.            No treatment information provided.    This case was linked to MOD-2021-046115 (Patient Link).
stomach upset; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach upset) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Malignant neoplasm without specification of site (Malignant neoplasm of unspecified site of unspecified female breast.). Concomitant products included TUCATINIB (TUKYSA) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach upset) and FATIGUE (fatigue). At the time of the report, ABDOMINAL DISCOMFORT (stomach upset) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Body aches all over, I hurt; Body is warm; Hands and feet cold; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th October 2022, the patient received Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced general body pain, feeling of warmth and cold extremities. On an unknown date, the outcome of the general body pain, feeling of warmth and cold extremities were not recovered/not resolved.   It was unknown if the reporter considered the general body pain, feeling of warmth and cold extremities to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got Shingrix vaccine the day before reporting.  The patient body aches all over and he/she had hurt.  The patient body was warm but hands and feet cold. The reporter wanted to know if he/she could take something like Tylenol or just ride it out. Additional Supportive Information: The follow up would not possible as no contact details were available.
p/ recv 2nd dose of varivax on7/13/95 subsequently lab evaluations revealed neg varicella titers (did not seroconvert)
Patient now has renal cell carcinoma with Mets to bone.  First vaccinated 12/16/2020 & 1/6/2021
Case number PHEH2012US015690 is an initial spontaneous report received from a healthcare professional on 07 Aug 2012. This case refers to an 11-year-old patient of unspecified gender. This patient was vaccinated only with MenCWY-135 liquid component of MENVEO (batch number: M10133) without being reconstituted with Men A component of MENVEO on 29 Jun 2012. Thus this patient received only partial dose of MENVEO. No adverse event was reported. No other information was available.
Rash appeared on abdomen and back about 10 minutes after administration. Instructed to give BENADRYL.
Well I was experiencing a low grade fever and pressure on my left side. I thought it might me a kidney infection. I went to the Urgent Care on Wednesday the 18th of August 2021. I was at the urgent care maybe thirty minutes. My symptoms are still happening, this began on the 16th of August. The urgent care doctor did not give me any medication or help my situation. I have an appointment with a PCD later in August.
Day after vaccination I woke up having similar symptoms as I did when contracted Covid19 in June 22nd , 2020  Chills, lethargy, tiredness, thirst, diarrhea, slightly elevated fever, dry cough which lasted 2.5 days. Then recovered and it lasted 3 days and woke up feeling dizzy in head.  Sudden raise for blood pressure which kept fluctuating during 2 days, reaching at worst 199/103! Finally came down with doctor's help and adjusting some existing medication and adding Tylenol to the mix.
Tested positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive). At the time of the report, COVID-19 (Tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive.         No concomitant medications were reported. It was reported that the patient was vaccinated with three doses. He came down with light cold and tested positive. No treatment medications were reported.  Company Comment: This is a spontaneous case concerning a male patient of unknown age, with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19 (tested positive), which occurred unknown number of days after receiving the third dose of mRNA-1273 Vaccine. According to the patient, on an unspecified date, he came down with light cold and tested positive. There is no available information regarding clinical course and treatment medication. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age, with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19 (tested positive), which occurred unknown number of days after receiving the third dose of mRNA-1273 Vaccine. According to the patient, on an unspecified date, he came down with light cold and tested positive. There is no available information regarding clinical course and treatment medication. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Pt reports lightheadedness, dizziness, and ?my vision turned black?. Pt denies LOC or nausea