chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (COVID-19) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 202F23A) for COVID-19 prophylaxis.     Concurrent medical conditions included Rheumatoid arthritis, Sjogren's syndrome, Long QT and Drug allergy (Several drugs). Concomitant products included CARVEDILOL, OMEPRAZOLE, ATORVASTATIN, BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), ASCORBIC ACID (VITAMIN C ACID), FERROUS SULFATE and NAPROXEN SODIUM (ALEVE) for an unknown indication.    On 19-Oct-2023 at 11:30 AM, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In 2023, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 01-Nov-2023 to 06-Nov-2023 for COVID-19 treatment, at an unspecified dose and frequency. In November 2023, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2023, SARS-CoV-2 test: (Negative) After complete resolution of symptoms, (Negative) 48 hours apart first test and Positive.         It was reported that the patient had  recurrence of nasal congestion and malaise 12 days after original symptom onset, accompanied by positive home Covid test.
5 to 10 days after vaccine she started noticing her pulse going up. Shortness of breath  and heart flutters
tiny little blisters on the injection site; Covid Arm; red arm; itching; Rash; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 18-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE VESICLES (tiny little blisters on the injection site), VACCINATION SITE REACTION (Covid Arm), ERYTHEMA (red arm), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE RASH (Rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012.M00M) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included VITAMIN D [VITAMIN D NOS] and ZINC for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE VESICLES (tiny little blisters on the injection site), VACCINATION SITE REACTION (Covid Arm), ERYTHEMA (red arm), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE RASH (Rash). The patient was treated with CORTISONE (topical) for Itching, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE VESICLES (tiny little blisters on the injection site), VACCINATION SITE REACTION (Covid Arm), ERYTHEMA (red arm) and VACCINATION SITE RASH (Rash) had resolved and VACCINATION SITE PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was not given.    No laboratory was not given.    No treatment information was not given.
1 week and 1 day after the first dose, the injection site became red, hot, and swollen. The upper left arm had a dull ache as well. That started in the morning. In the afternoon of 3/23, symptoms also included flushed face, neck, and ears.
Information has been received from a Nurse concerning a female who on 18-FEB-2008 or 19-FEB-2008 was vaccinated with her second dose of Gardasil (lot# not provided). The patient passed out and fell in the exam table after vaccine administration. The patient was brought to the hospital but it was not reported whether the patient was admitted to the hospital. Additional information has been requested.
One week after my first Pfizer vaccine on 4/21/21, I got a bump on my genital area for the first time in my life and was diagnosed with hsv1 on 5/6. I had antibodies meaning I likely had a dormant virus for many years as I?ve been married for 7 and he is negative.  I?ve never even had an oral cold sore so the diagnosis was a complete shock.  I got my booster by Moderna on 11/23 and about a week and change after my booster, I got what I thought was a hemorrhoid, only to find out that I had a massive anal herpes outbreak with tons of sores and blisters (again I?ve never had a cold sore anywhere in my life). My dermatologist has sent a biopsy to the lab. The vaccine has both caused a fully dormant virus to come out for me and causes me to have outbreaks each time I take it as shown with the booster. I am devastated and in pain.
Hospitalized for Erythema Multiforme major on 12/13/2021. First signs/symptoms started on 11/12/2021.
Site: Swelling at Injection Site-Severe, Additional Details: According to patinet, she was admitted to the emergency room for injection site/arm swelling after the first and third dose of COVID - moderna.  swelling of the arm didn't happen til  much later after vaccine. middle of the night.
Patient with swelling, red and warm. Pt complained of not being able to move arm. Hurt to move arm.
Inconsolable crying; lasted several hours. No redness at injection sites. Questionable incarcerated hernia versus vaccine reaction. Per ER report, calmed when inguinal bulge down.
Information was received on 13-JUL-2017 from a pharmacist regarding a male patient (age not reported).  Medical history, concurrent conditions and concomitant medications were not reported.  On 20-JAN-2017, the patient received a dose of VAQTA (lot # L017757, exp 08-APR-2018) (dose, route, and site of administration not reported) for the indication of prophylaxis. The patient received a second dose of VAQTA (lot # L017757, exp 08-APR-2018) one month later, on 21-FEB-2017. No adverse effects reported. No additional information was provided. Additional information has been requested.
Patient was put to bed by his parents the previous night. His Mother discovered him deceased in his bed the next morning.
SKIN CONDITION-DR. DIAGNOSED AS ECZEMA AND SENSITIVE SKIN RED PATCHY DRY FLAKY SKIN ENTIRE BODY, WORSE ON TORSO AND FACE AND SCALP. ALSO, BAD CIRCLE OF DIAPER RASH THAT WOULD NOT CLEAR UP-TREATMENT WAS MAALOX MIXED WITH BOUDREAUX'S, IT WORKED, DR. SAID WAS A REACTION FROM SOMETHING COMING FROM HER INTENSTINES INTO URINE.  SHE IS BREAST FED.
Swollen lymph node under his right arm pit, no redness noted. Doctors appt today at 4 PM. He had a temp of 99.7 with Tylenol, flushed cheeks, and swollen tonsils. Throat culture done, no Strept, no redness, or swelling at the injection site.
Patient presented to the ED with mild chest pain and hypertensive urgency and was subsequently hospitalized.
BURNING ALL OVER THE BODY; FEVER; HEADACHE; NOT BEEN ABLE TO SLEEP; BODY ACHE; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, high blood pressure, and sulfonamide allergy, and other pre-existing medical conditions included patient had not pregnant at the time of reporting. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced not been able to sleep. On 09-APR-2021, the subject experienced body ache. Laboratory data included: Body temperature (NR: not provided) just below 100 F. On 09-APR-2021 12:30, the subject experienced burning all over the body. On 09-APR-2021 12:30, the subject experienced fever. On 09-APR-2021 12:30, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from burning all over the body, and the outcome of fever, headache, not been able to sleep and body ache was not reported. This report was non-serious.
Hives; Chills; sweats; This is a spontaneous report from a contactable consumer.   A 85-years-old elderly male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 01Feb2021 at 12:00 as, single for COVID-19 immunization. Patient's medical history included hay fever and penicillin allergy. The patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no: unknown) on 11Jan2021. Concomitant medications included diltiazem, warfarin and simvastatin for an unspecified indication, start and stop date were not reported. Patient had no COVID-19 infection prior to vaccination and patient was not tested for COVID-19 post vaccination. on 03Feb2021 at 16:00, The patient experienced hives, chills and sweats. He was treated with Ointment and compression hose. Patient was not tested positive for covid post vaccination. The outcome events was reported as recovered.  Information about lot/ batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Typhoid vax administered on 04/08 and approximately 4 hours post vax, pt noted onset of itching and hives on back of neck, spreading to arms, trunk, and legs by 03:00 on 04/09. Pt reported symptoms at 07:30, 04/09. Benadryl given.
Patient seen in the ED on 9/27 for evaluation after a fall. On 9/26 she slipped and fell off her couch and was unable to get off the floor. The next day (9/27), her son came and found her on the floor so patient was brought to the ED. While in the ED, the patient also reported a cold that started a few days ago, with significant coughing and low grade fever. She was swabbed for COVID in the ED which came back positive. Patient was admitted on 9/27 - 9/30. She was diagnosed with atrial fibrillation with RVR, thought to be precipitated by COVID-19 infection and UTI. Additionally diagnosed with acute hypoxic respiratory failure due to COVID-19 infection. She was on supplemental oxygen during admission but was able to wean off.
This case was reported by a nurse and described the occurrence of cellulitis of arm in a 12-year-old female patient who received MENVEO (batch number X15147, expiry date unknown). On 9th August 2016, the patient received the 1st dose of MENVEO. In August 2016, less than a month after receiving MENVEO, the patient experienced cellulitis of arm (serious criteria GSK medically significant), injection site induration and injection site redness. The patient was treated with Antibiotic. On an unknown date, the outcome of the cellulitis of arm was unknown and the outcome of the injection site induration and injection site redness were recovered/resolved. It was unknown if the reporter considered the cellulitis of arm, injection site induration and injection site redness to be related to MENVEO. Additional details were provided as follows: In the morning of reporting date, the sales representative called the office nurse and at this visit they discussed that there were a high number of patients with severe local reactions to the MENVEO and BEXSERO vaccines. These patients were returning to reporter's office with very large, reddened, swollen, hardened, warm induration at the injection site and the surrounding area, many times measuring 6 inches or more from the injection site. The physician had prescribed oral antibiotics for most of these patients. The patient concerned in this case had experienced 12 mm induration and redness at injection site (arm) after MENVEO vaccination, which had lasted for 7 days. An antibiotic was prescribed by the physician for cellulitis of arm. The reporter had tried several different methods of mixing the vaccine (letting it sit, administering it immediately, etc) but none had proved effective in reducing reaction rates. The reporter requested for suggestions on how they could possibly reduce the potential for a local reactions. Also, they inquired if there had been any problems with certain lot numbers of the vaccine, so that they could compare those numbers to the vaccines which they administered to their patients. This case has been linked to 4 other cases (MENVEO vaccine), reported by the same reporter.
Diagnosed with Lichen Planus; Skin rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single 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 immunization. The following information was reported: LICHEN PLANUS (non-serious), outcome "unknown", described as "Diagnosed with Lichen Planus"; RASH (non-serious), outcome "unknown", described as "Skin rash".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT CAME TO SHOW US HER ARM WHICH WAS SWOLLEN. HER PRIMARY SENT HER TO ER BECAUSE HE THOUGHT IT WAS INFECTED BAD. ER GAVE PATIENT ANTIBIOTIC FOR THE INFECTION. PT SAID SHE IS FELLING FINE JUST HER ARM HURTS.
Warm to the touch at the site of injection; Itchiness at the site of injection; Redness at the site of injection; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch at the site of injection), VACCINATION SITE PRURITUS (Itchiness at the site of injection), VACCINATION SITE ERYTHEMA (Redness at the site of injection) and PYREXIA (Fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch at the site of injection), VACCINATION SITE PRURITUS (Itchiness at the site of injection), VACCINATION SITE ERYTHEMA (Redness at the site of injection) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warm to the touch at the site of injection), VACCINATION SITE PRURITUS (Itchiness at the site of injection), VACCINATION SITE ERYTHEMA (Redness at the site of injection) and PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: follow up received: contains no new information
concerned administer hit a nerve.; concerned administer hit a nerve.; extremely sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (extremely sore arm), NEURALGIA (concerned administer hit a nerve.) and ANXIETY (concerned administer hit a nerve.) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (extremely sore arm). On an unknown date, the patient experienced NEURALGIA (concerned administer hit a nerve.) and ANXIETY (concerned administer hit a nerve.). At the time of the report, PAIN IN EXTREMITY (extremely sore arm), NEURALGIA (concerned administer hit a nerve.) and ANXIETY (concerned administer hit a nerve.) outcome was unknown.            no concomitant medications are provided.
Client reported short-term memory loss the afternoon of 1/16/23 while conversing with family. She does not remember the incident, states family members told her she was repeating questions over and over after being answered. They checked her blood glucose as a diabetic which was WNL, and they took her to an ED. Diagnosis of TGA and elevated troponin. Amnesia resolved around midnight same day, but was inpatient x2d for troponin levels. Client reports no other symptoms other than redness and soreness at injection site prior to amnesia onset. Client was discharged from hospital after resolution of high troponin, no DC medications or plan for follow-up visits.
Hives on the left side of body, near the stomach and waist/Itchy hives, around 6 in total; Left arm swelled a little bit; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (Hives on the left side of body, near the stomach and waist/Itchy hives, around 6 in total) and VACCINATION SITE SWELLING (Left arm swelled a little bit) 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 Asthma. Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergy NOS.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Left arm swelled a little bit). On 07-Apr-2021, the patient experienced URTICARIA (Hives on the left side of body, near the stomach and waist/Itchy hives, around 6 in total). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives on the left side of body, near the stomach and waist/Itchy hives, around 6 in total) and VACCINATION SITE SWELLING (Left arm swelled a little bit) 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.
It started out with a headache and runny nose and about 4-5 days I had to start using my rescue inhaler every 4-6 hours.  About 10 days in I went to urgent care on Sunday, they tested me with a rapid test it came back negative, They gave me a ZPACK and steroids. I was on steroids for about 2 1/2 weeks. A week after urgent care I went to my primary care doctor did a XRAY and scheduled an MRI after the 4th of July weekend. Even though I tested negative, my allergist feels like I had covid and waited to long to get tested.
About a month after my second Pfizer inoculation I awoke one morning with almost no vision in my right eye.  I was diagnosed April 1 with a blood clot in my retina that has changed my vision from 20/30 in that eye to 20/125.  My left eye remains 20/20.  I'm in excellent health and never had any kind of clot or eye issue.  The traditional causes of Retinal Vein Occulosis don't pertain to me - no heart trouble, high blood pressure or diabetes.  I'm thin and physically active, never smoked, drank or used drugs.
Soon after the injection, the site became sore. The next day, the shoulder (about 3" circle all around the site) got very hard, warm and sore. I felt quite fatigued with the sore arm for about 3-4 days. Fortunately this was on off working days, and I did end up sleeping quite a bit. On day 3 or 4, I noticed an itchy lower back. On day 5 after feeling my lower back burn and itch in the shower, I looked at it in a mirror. I saw a rash on my lower back that looked like pox. This covered an area of about 2.5" X 4" After about a week, I was back to normal.
had covid and also received the Pfizer covid 19 vaccine.; had covid and also received the Pfizer covid 19 vaccine.; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender started received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on an unspecified date for immunization. The patient's medical history and concomitant medications were not reported. They have a patient that meets the criteria to receive product bamlanivimab. The patient had Covid and received the Pfizer covid 19 vaccine. The nurse asked if patient can still get the bamlanivimab after receiving vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: Based on the information currently available, it is unclear if Covid developed after BNT162B2 Pfizer covid 19 vaccine, pending further clarification, at this moment, the Company would handle the reported COVID related to the suspect, BNT162B2, for reporting purpose.
Only liquid of component  was used; Only liquid of component  was administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) (batch number he4p7, expiry date 25th January 2024) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 12-Dec-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient only received liquid component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.