chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 59-year-old non-pregnant female patient. The patient's concurrent conditions included diabetes mellitus and an allergy to codeine. Information regarding concomitant therapies was not provided. On 17-DEC-2016, the patient received a dose of ZOSTAVAX subcutaneously (dose, lot # and expiration date were not reported) as a shingles vaccination at a pharmacy. On an unknown date in December 2016, the patient experienced an injection site redness larger than a silver dollar and darkness to an old scar. On 20-DEC-2016, the patient sought medical attention at the pharmacy. The outcomes of the events were reported as not recovered. No lab diagnostic studies were performed. The relatedness between the events and ZOSTAVAX was not provided.   Additional information has been requested.
A rash at the site of injection, and red spots located all over both arms. patient was advise to take Benadryl and use hydrocortisone cream.
vaccine that was given had expired on 12/13/22. Patient was notified and a replacement dose was recommended.
I became pregnant shortly after receiving the vaccine. I spotted the entire pregnancy and bleeding increased during the week of 6/28. Bleeding became alarming over the holiday weekend. OB ordered an ultrasound and it was scheduled for 7/9. I went to OB triage on 7/8 around 4:30 pm. I delivered (miscarriage) on 7/8/2021 at 11 weeks 6 days gestation.  Bleeding has greatly reduced since 7/8.
Dizziness; vertigo; nausea; headache; This is a spontaneous report from a contactable physician reporting for himself. A 69-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730, expiry date not reported) on an unspecified date in Dec2020 12:45 via an unspecified route of administration in the left arm, and the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3246, expiry date not reported) on 11Jan2021 13:30 via an unspecified route of administration in the left arm, for COVID-19 immunization. Medical history included penicillin allergy, mild hypothyroidism, gastrooesophageal reflux disease (GERD) and benign prostatic hyperplasia (BPH), unspecified if ongoing. Concomitant medication included levothyroxine sodium (LEVOTHYROXINE), famotidine, dutasteride, from an unspecified date to an unspecified date (received in two weeks, as reported); simvastatin, tadalafil, herbal pollen nos/quercetin (PROSTATE PQ), and "Supplements Prostagenix", from an unspecified date and ongoing. The patient had not had COVID piror to the vaccination, and had not tested post the vaccination. The patient experienced dizziness/vertigo with nausea and headache beginning 1-2 weeks (unspecified date in Jan2021) after the initial vaccination and worse after the second dose. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received scopolamine 1mg/3 day patch x 5 for the events. The events were not resolved.
Received Moderna vaccine and developed a rash at injection site on  right arm 7 days after receiving the vaccine. It?s itchy and swollen. A bit bigger than the size of a quarter.
diarrhea; gassy; vomit's; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 26Mar2021 at 14:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication was not reported. Allergies to medications, food or other products were reported as no. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient had experienced diarrhoea, gassy and vomits. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not received any treatment for the events. The clinical outcome of the events diarrhoea, gassy and vomits was recovered at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
LETHARGY; CONGESTION; SLEEPY; FEVER; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 15:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced lethargy. On 01-APR-2021, the subject experienced congestion. On 01-APR-2021, the subject experienced sleepy. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 99.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, lethargy, congestion, fever, and sleepy. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
About 30 mins after the injection I was itchy all over for the last two days. I took Benadryl to help with the itching.  My left shoulder is still a little swollen but the pain is going away. I am not itchy today.  I just wanted to make note of how itchy I was as I could not find any information on this kind of side effect.
red arm at injection site Narrative: Pt reported red arm at injection site with first dose of moderna covid vaccine which occured 2 weeks after injection No treatment required.
IMMEDIATELY FOLLOWING VACCINATION, PATIENT FELL OFF OF CHAIR TO FLOOR AND APPEARED TO LOSE CONSCIOUSNESS - PHARMACIST RESPONDED WITH YOGA MAT AND LAID HIM FACE UP ON FLOOR. TOOK BP AND IT WAS AT 130/90 WITH PULSE 72. PATIENT REGAINED CONSCIOUSNESS ALMOST IMMEDIATELY BUT WAS CLAMMY, SWEATY, AND PALE. CALLED EMS AND WHEN THEY ARRIVED PATIENT WAS CONSCIOUS AND DECLINED TRANSPORT. IMMEDIATELY AFTER EMS LEFT THE FIRST TIME, THE PATIENT PASSED OUT AGAIN, THIS TIME SITTING UP. WE RETREIVED EMS FROM THE PARKING LOT AND THEY CAME BACK. THIS TIME HE LEFT WITH THEM AFTER REGAINING CONSCIOUSNESS.
COVID 19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID 19) in an 83-year-old male patient 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. In 2022, the patient experienced COVID-19 (COVID 19). At the time of the report, COVID-19 (COVID 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that around Oct or Nov-2022 patient had mild case of covid. The reporter did not provide more information on patient  symptoms of covid-19  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-735448 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2023: Live significant Follow-up information received contains patient information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735448:Master Case ( wife case)
11:38am- Facial flushing noted when mask removed. Patient reports tingling and itching in the face, neck, chest, and ears. Monitored patient and talked. Patient speech is clear. She denies shortness of breath.  12:02 pm- Itching and tingling continues, 25 mg  Benadryl given, continued to monitor continuously. 12:10 pm- Patient states tingling and itching is a little better and says no longer itching. 12:22 pm- patient states she is feeling a lot better. Requested to leave. Going to work 3 miles away and has friends at work she said that will keep an eye on her. Patient left at 12:24, drove self.    Follow- up with client on 4/16/21 at 2:58 pm. States tingling and itching is a lot less and less than it had been in the same amount of time after the first Moderna shot.
Beginning the day after she received vaccine, patient complained of her arm being very sore. As of Monday, Nov. 21 ( 1 week later ), she stated her arm was still very sore. She contacted MD but had not heard back yet.
deep, intense pain & ache in shoulder joint w/ache all the way down arm, wrist into thumb;there was no surface pain around shot area;took 6wk to go away;MD said was given too close to shoulder joint, too high up arm;
On 11/10/09 after receiving the flu vaccines she became light headed & fell down 1 step & hit the side of her face. Had a witnessed seizure. No noted trauma to head or face. Positive bldy nose.  Seen on 11/11/09 for recheck. Xray ordered for mandible & mastoid & hearing evaluation, c/o pain of jaw. Also rechecked on 11/18/09 positive nose discomfort & popping sound in ear nasal bone xray done.
COVID-19 symptoms; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine and experienced COVID-19 symptoms.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   On Unknown date, after receiving the vaccine, the patient experienced COVID-19 symptoms. Upon follow up call, the patients symptoms were fever, vomiting, nausea, headache fatigue, body ache, chills, have sneezing, stuffiness, loss of taste and smell.   She also tested positive for COVID-19.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the event was recovered.; Reporter's Comments: Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19 symptoms and mRNA-1273 use is assessed as unlikely.
Jaw Hurt; Sinus hurt; Face numbness that went away within 24 hours, left side of her face and neck numbed up; Facial pain for a few days; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Face numbness that went away within 24 hours, left side of her face and neck numbed up), FACIAL PAIN (Facial pain for a few days), PAIN IN JAW (Jaw Hurt) and SINUS PAIN (Sinus hurt) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced HYPOAESTHESIA (Face numbness that went away within 24 hours, left side of her face and neck numbed up) and FACIAL PAIN (Facial pain for a few days). On 04-Aug-2021, the patient experienced PAIN IN JAW (Jaw Hurt) and SINUS PAIN (Sinus hurt). On 04-Aug-2021, HYPOAESTHESIA (Face numbness that went away within 24 hours, left side of her face and neck numbed up) and FACIAL PAIN (Facial pain for a few days) had resolved. At the time of the report, PAIN IN JAW (Jaw Hurt) and SINUS PAIN (Sinus hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was provided by the reporter.  No Treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Follow-up received contains updated drug start date, anatomical location and events of pain in jaw, sinus pain updated.
high blood pressure; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (high blood pressure) and HEADACHE (headache). The patient was treated with LISINOPRIL at a dose of 40 milligram two  times a day. At the time of the report, HYPERTENSION (high blood pressure) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Dose 1. Severe migraine headache roughly 24 hours out, leading to blindness, loss of feeling in limbs, shallow breathing. Went to ER following day. Released. Dose 2. Flu symptoms about 24 hours out. 102 fever. achy. chills, fatigue. Lasted about 24 hours.
Mild soreness at the injection site; This is a spontaneous report from a non-contactable consumer (patient). A 78-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EM9809), via an unspecified route of administration on left arm on 08Feb2021 at the age of 78 years old at a single dose for COVID-19 immunisation at Doctor's office/urgent care. Medical history included high cholesterol. Allergies to medications, food, or other products was none. Concomitant medications included unspecified medications. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) received at the age of 78 years old on an unknown date for COVID-19 immunization. On 08Feb2021, the patient experienced mild soreness at the injection site. The patient assessed the event as non-serious. It was unknown if the treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was recovering from the event.  No follow-up attempts are possible. No further information is expected.
Date of positive COVID-19 test: April or May 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Date of positive COVID-19 test: April or May 2022) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21a, 040B21A and 047A21A) for COVID-19 vaccination.     Concomitant products included MONTELUKAST SODIUM (SINGULAIR), LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) and ALENDRONATE SODIUM (FOSAMAX) for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced COVID-19 (Date of positive COVID-19 test: April or May 2022). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Date of positive COVID-19 test: April or May 2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient did not had allergies. Patient did not have history related to mentioned AE and both acute and chronic illnesses at the time of vaccination. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. In Apr or May-2022, patient had COVID positive test or diagnosis. Patient did not have hospitalization due to COVID-19   This case was linked to MOD-2022-656961 (Patient Link).
Recurring shingles 6-8 months post dose 2/ Suspected vaccination failure; Recurring shingles; This case was reported by a pharmacist via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 04-AUG-2022 Reporter's Comments: Sales Representative submitted medical information request including information regarding recurring shingles in a patient 6 to 8 months post dose 2.  No additional details provided. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding laboratory test confirming shingles were unknown at the time of reporting.
MMR was administered 5/12/08. Mother called 5/15/08. Gene c/o fever 100.6, vomiting. HA, body aches. Advised to take ALEVE or TYLENOL for fever. Rx'd PHENERGAN 12.5 FOR N/V. Per Dr.
A physician reported that a pt rec'd Prevnar, Tripedia (Aventis Pasteur Inc), ActHIB (Aventis Pasteur SA), and IPV (Aventis Pasteur SA) vaccines on 9/25/01. The following day, the infant developed a fever of 103 to 104F and vomiting. He also developed an injection site reaction characterized by swelling and redness. The infant was better by 9/28/01 and subsequently recovered. This is 1 of 4 pt's from this facility who had an adverse experience following receipt of Prevnar lot 481-817. Information regarding this event has been forwarded to Aventis Pasteur, manufacturer of the concomitant vaccines.
9cm area left upper arm 8.5cm  @ right upper arm of erythema, edema and warmth to injection site. Advised Benadryl Q 4-6 H.
While brushing teeth, his teeth tasted blood; Patient had Comirnaty and Moderna vaccine (second shot); Patient had Comirnaty and Moderna vaccine (second shot); This spontaneous case was reported by a patient family member or friend and describes the occurrence of GINGIVAL BLEEDING (While brushing teeth, his teeth tasted blood), INTERCHANGE OF VACCINE PRODUCTS (Patient had Comirnaty and Moderna vaccine (second shot)) and COVID-19 IMMUNISATION (Patient had Comirnaty and Moderna vaccine (second shot)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, the patient experienced GINGIVAL BLEEDING (While brushing teeth, his teeth tasted blood), INTERCHANGE OF VACCINE PRODUCTS (Patient had Comirnaty and Moderna vaccine (second shot)) and COVID-19 IMMUNISATION (Patient had Comirnaty and Moderna vaccine (second shot)). At the time of the report, GINGIVAL BLEEDING (While brushing teeth, his teeth tasted blood), INTERCHANGE OF VACCINE PRODUCTS (Patient had Comirnaty and Moderna vaccine (second shot)) and COVID-19 IMMUNISATION (Patient had Comirnaty and Moderna vaccine (second shot)) outcome was unknown.            No treatment and concomitant information was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
pt exposed to chickenpox 15FEB98;came to office on 28FEB98 w/ c/o nasal drainage & red, bumpy rash on back, stomach, arms & legs;afeb;dx by MD varicella;
Due to a nodular thyroid diagnosed in 1994, I have been taking synthroid 100mcg 7 days a week for nearly 30 years. In 2022 after taking the first covid vaccine I began having tachycardia. My dose was changed to 100 mcg skip every other Sunday. In April of 2022 I had knee surgery and sometime in June I began to lose my appetite and lost 12 pounds. My dose of Synthroid was then decreased to 100 mcg 5 days per week. I May of this year my TSH was 3.24. I was ok but began to experience frequent dizzy spells. Shortly afterwards, I experienced hair loss, then it progressed to breakage of my fingernails, constipation and gastric burning. This continued and then I began to lose weight, although I was trying to do so, I did not plan to 16 pounds in less than two months. I then began to experience puffiness in both eyes. In August I had blood work done and my TSH was .06. My T3 and T4 were normal. I saw my doctor and he decreased the dose by half and the symptoms continued. On September 4 I began experience dizziness upon movement. My blood pressure was 98/60 at the doctor's appointment I had on September 6. My doctor and I have been adjusting my dose to see what will work. Thus far, I continue to experience dizziness and other side effects. I would probably not reported this issue, but I am concerned that the formula has been changed and once I started talking with family and friends, I have learned of 6 other people who were on some form of levothyroxine, mostly Synthroid who are also experiencing similar if not the same side effects. Please assist me in finding out what is causing this apparent issue with the Synthroid. I am afraid to take it given the safety aspect of always being dizzy. Your assistance and response will be greatly appreciated. Thank you.
Left arm where vaccine was given swelled and turn red around injection site > 4" diameter area per mom report. Also had pain. Mostly resolved by 7/17/12 when mom called to report.
On 14th day after receiving Meningococcal injection, developed rapid heart rate which resolved, but wore Holter Monitor for 24 hours; awaiting results. Woke today with stiff neck. Plans to see physician.
Received a phone call 10/13/17 in regards to this patient with a one day history headache and one episode of syncope that day. She received influenza and meningitis vaccines on 10/12/17 (the day prior). She had headache all day - up to 6/10 on pain scale - on 10/13 and felt lightheaded and dizzy/vertigo on and off during the day. She was eating well and was not dehydrated. She took ADVIL with resolution of her headache. However, a few minutes after standing up and walking, she felt lightheaded and had a syncopal event witnessed by parent. LOC was momentary such that patient didn't feel like she had a complete syncopal event (parent confirms she was unresponsive briefly). No seizure like activities. She returned to her baseline within a few minutes and was not sleepy. No fevers. No myalgias. No other symptoms. They called nurse advice as they were concerned it could be a reaction to vaccination. Nursing advice was recommending UC/ER evaluation for the syncope.