chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer, describes the occurrence of erythematous rash (site of injection developed a red rash), vaccination site warmth (site of injection is warm), vaccination site pruritus (site of injection is itchy), vaccination site pain (site of injection is sore) and fatigue in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 025B21A) for COVID-19 immunization. No medical history reported. On Apr 1, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 6, 2021, patient experienced erythematous rash (site of injection developed a red rash), vaccination site warmth (site of injection is warm), vaccination site pruritus (site of injection is itchy) and vaccination site pain (site of injection is sore). On an unknown date, patient experienced fatigue. At the time of the report,  erythematous rash (site of injection developed a red rash), vaccination site warmth (site of injection is warm), vaccination site pruritus (site of injection is itchy), vaccination site pain (site of injection is sore) and fatigue outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. No concomitant medication or treatment information provided. Reporter did not allow further contact.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored ROTATEQ (strength, dosing regimen and frequency unknown) (lot # N024294 expiry date: 26-FEB-2019) for prophylaxis (product storage error). The vaccine was stored at a temperature of 32 degrees Fahrenheit (F) up to 35 F (32.3 F) for 1 hour 45 minutes and 30.2 F for 37 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No further information was provided. There was no product quality complaint (PQC) reported. This case is linked to case number 1804USA005778 and 1804USA005184 via same reporter link.; Sender's Comments: US-009507513-1804USA005778: US-009507513-1804USA005184:
1 Erythema surrounding the injection site 4 cm dia.  2 Single hive type lesion 1" diameter.
Diarrhea; Severe stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Severe stomach pain) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Severe stomach pain). On 19-Apr-2021, ABDOMINAL PAIN UPPER (Severe stomach pain) had resolved. At the time of the report, DIARRHOEA (Diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported watery stool multiple times a day following severe abdominal pain that patient describes as "worse than cramping". Patient reports Pepto-Bismol relieved the abdominal pains and they have not returned; however, the diarrhea has continued for an entire week. No Concomitant medication were reported. Treatment medication was not provided.
4 days after / vaccine / peripheral neuropathy; Numbness of her left foot that is on and off; Having the sensation that she might fall; Vertigo; This case was reported by a consumer via call center representative and described the occurrence of peripheral neuropathy in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 4 days after receiving Shingrix, the patient experienced peripheral neuropathy (serious criteria GSK medically significant), numbness in feet, feeling abnormal and vertigo. On 18th November 2020, the outcome of the vertigo was recovered/resolved. On an unknown date, the outcome of the peripheral neuropathy, numbness in feet and feeling abnormal were not recovered/not resolved.   It was unknown if the reporter considered the peripheral neuropathy, numbness in feet, feeling abnormal and vertigo to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. Caller reported that she got her 1st dose of Shingrix about 3 weeks ago.  The patient reported that 4 days after receiving the vaccine, she began to experience peripheral neuropathy, numbness of her left foot that was on and off, and feeling a sensation like she may fall. About 2 weeks after the vaccine the patient did experience one episode of vertigo that was now gone.  Outcome date for events peripheral neuropathy, having the sensation that she might fall, vertigo was reported as 18th November 2020. She was still experiencing the other symptoms. The reporter did not consent to follow-up.
[Janssen covid vaccine (J&J] use for COVID-19 under Emergency Use Authorization (EUA): pt vaccinated 4/10/2021 with Janssen - J&J vaccine. tested positive on 8/20/2021. Received Regn-cov2 infusion on 8/25/2021. Currently hospitalized, on oxygen, remdesivir, dexamethasone
Information has been received from a physician concerning a 12 month old patient who was vaccinated with a dose of Proquad. It was reported that the patient developed a severe rash about 14 days after vaccination that was not measles like. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
A male patient (approximatley 57-58 years) received and initial series of Tice BCG to treat bladder cancer.  In mid-September, approximately 4 weeks after treatment ended, he developed a fever of 38.9-39.44 degrees C for 3-4 days and his urine tested positive for Enterococci.  These symptoms were treated successfully, however, reappeared two weeks later when his urine again tested positive for Enterococci.  He was diagnosed with Bacterial Prostatitis.  Cipro for one week after initial symptoms appeared.  Second series of Cipro prescribed to be taken over six weeks.  Symptoms are currently resolving.
Information has been received from a non-Merck clinical site coordinator and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported. On 05-OCT-2018, the patient was vaccinated with improperly stored ROTATEQ, orally (exact dose was not provided), lot # N030364, expiration date: 06-MAR-2019, for prophylaxis. The vaccine was stored at 11 Celsius degrees (C) for 1 hour 20 minutes and 8.7 C for 7 minutes. There were no other previous temperature excursions noted. No adverse effects were reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1810USA012274: US-009507513-1810USA005531.
PATIENT RECEIVED BOOSTER DOSE 2 MONTHS EARLY. PRIMARY SERIES FINISHED DECEMBER, BOOSTER DOSE GIVEN IN MARCH. OBSERVED 15 MINUTES POST VACCINATION. NO SIGNS OF DISTRESS. NO COMPLAINTS. PATIENT INFORMED OF POSSIBLE SIDE EFFECTS AND FOR WORSE SYMPTOMS TO CALL 911 OR GO TO E.R.. PATIENT AGREED TO UNDERSTANDING.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 22-JUN-2016, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # L024993 and expiration date 17-OCT-2017 (strength, dose number, anatomical location and route of administration were not reported). Concomitant therapies were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
First shot--sore arm, no problems. Second shot--pain and swelling in joints, especially my knees that swelled quite large. Pain to move in bed, couldn't walk without assistance of a cane. I saw orthopedic doctor on 3/16 and again on 4/7. On second visit I had cortisone shot in left knee, I noticed no discernible improvement. After 3-4 weeks the pain subsided.  BTW--I had booster on 12/02/2021 with no problems.
This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unknown date, the unspecified number of patients received unspecified doses of GARDASIL, (dose number, lot/batch number, expiration date, route of administration not reported) that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively through 07-MAY-2014. It was reported that also M-M-R II, PNEUMOVAX, ROTATEQ and PEDVAX were improperly stored (event captured in MARRS# 1405USA012894, 1406USA000956, 1406USA000957 and 1406USA000958 respectively). No adverse effects were reported. This is one of several reports from the same reporter. Follow-up information has been received from the Registered Nurse. It was reported that the nurse was inquiring about temperature excursions that occurred from October 2013 to March 2014. The nurse also stated they were replacing the refrigerator, freezer, and the data logger and were sending the old data logger for calibration to the health department. All telephone attempts to obtain follow up information have been unsuccessful. Follow up information has been received from Registered Nurse on 27-JUN-2014. The nurse stated that one dose of GARDASIL (Lot#J010395, expiration date 29-APR-2016, dose not reported) that was exposed to highest temperature of 9.5C for 6 hours from 28-AUG-2013 to June 2014 was administered to unspecified patient (unknown age and gender) on an unknown date. This is one of several reports from the same source. Additional information is not expected.
EE report pain at the injection site , malaise, headache and joint pain. He took Tylenol and symptoms resolved within 6 hours. He is working today 01/07/21 and feels fine with no complaints
Administered varicela vaccine 4-27-07. Reports on 4-29-07 small red spot developed at injection site, left upper arm. Redness spread and hot to touch. Unable to sleep. C/O injection site itching. Here 4-30-07, afebrile 4cm x 2cm oval slightly raised macular rash with pinpoint vesicles, about 8 to upper periphery of macula.
Injection site edema/redness. Pt went to ER was given Abx but got worsening redness & weakness and went to ER a second time. Antibiotics switched.
Could not sleep post first vaccine; Second Dose on day 37; Severe COVID Arm 7 days post first Vaccine; Itchy Injection Site from Shoulder to Elbow; Red Injection Site from Shoulder to Elbow; Swollen Injection Site from Shoulder to Elbow; Swollen Lymph Nodes in groin area post first vaccine; Joint Pains post first vaccine; Chills post first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Dose on day 37), TYPE IV HYPERSENSITIVITY REACTION (Severe COVID Arm 7 days post first Vaccine), INSOMNIA (Could not sleep post first vaccine), INJECTION SITE PRURITUS (Itchy Injection Site from Shoulder to Elbow) and INJECTION SITE ERYTHEMA (Red Injection Site from Shoulder to Elbow) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Severe COVID Arm 7 days post first Vaccine), INJECTION SITE PRURITUS (Itchy Injection Site from Shoulder to Elbow), INJECTION SITE ERYTHEMA (Red Injection Site from Shoulder to Elbow), INJECTION SITE SWELLING (Swollen Injection Site from Shoulder to Elbow), LYMPHADENOPATHY (Swollen Lymph Nodes in groin area post first vaccine), ARTHRALGIA (Joint Pains post first vaccine) and CHILLS (Chills post first vaccine). On 05-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Dose on day 37). On an unknown date, the patient experienced INSOMNIA (Could not sleep post first vaccine). The patient was treated with AMMONIUM CHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ORIGINAL) at an unspecified dose and frequency. On 10-Feb-2021, LYMPHADENOPATHY (Swollen Lymph Nodes in groin area post first vaccine) and CHILLS (Chills post first vaccine) outcome was unknown. On 16-Feb-2021, INJECTION SITE PRURITUS (Itchy Injection Site from Shoulder to Elbow) and INJECTION SITE SWELLING (Swollen Injection Site from Shoulder to Elbow) outcome was unknown. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Dose on day 37), TYPE IV HYPERSENSITIVITY REACTION (Severe COVID Arm 7 days post first Vaccine), INSOMNIA (Could not sleep post first vaccine), INJECTION SITE ERYTHEMA (Red Injection Site from Shoulder to Elbow) and ARTHRALGIA (Joint Pains post first vaccine) outcome was unknown.            Other treatment information include cold compress for an unknown indication. No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-039362 (Patient Link).
Tiredness, Headache, Muscle Pain, Joint Pain, Nausea, Feeling Unwell
patient reported having fever of up to 102.6 for a day and half following vaccinations and developed sores inside her nose and on her ear 3 days after vaccinations
I came home from a series of errands on 02/15/2023. About 4PM, it came on suddenly and I felt awful. I laid down on the couch and just wondered what was happening. Because it was such a strange feeling, I figured I should do an at home COVID-19 test. I did two tests and both came back positive. I was with a friend prior and he also had it as well. We don't know where we got it. I just felt awful and I wanted to call my doctor and ask if I could be put on Paxlovid. I contacted them on Thursday and my doctor wasn't available that day. They did contact another doctor in the office who did prescribe the Paxlovid. I did take my first dose that evening on 02/16/2023. The taste of the Paxlovid the first three days was awful, but I kept taking it. I felt like in the 5 days that were the worst for me, I feel like I had every disease I've ever had in my life. I had GI issues from the Paxlovid, but fortunately it wasn't too bad with COVID-19 itself. The worse symptom I had was a severe headache on the back of my head and a deep sore throat one day, and a sore throat that felt higher in my throat another day. I had a cough that was a bit deep. It has lingered. I had a very bad runny nose day 1 and day 2. The headache was really bad for the first two days and that lingered but got better. I was lethargic, but I didn't stay in bed. My appetite was fair. I feel like it did affect my appetite because I don't eat as much now. I do not feel 100% yet. I feel like I've felt much better since those last 5 days, but I don't feel the same I did a month ago. I do not feel like I have the same amount of energy currently.
NO ADVERS EVENT:  Vaccine expired on 08/24/2021 was given on 08/27/2021
Admitted 12-19JAN10 at hospital for evaluation treatment of Guillain Barre syndrome.
40 minutes after my injection (as I drove home) on Friday, I began to feel tingling and numbness in my left hand and weakness in my left arm. Within an hour after my injection , I began to feel tingling and numbness on the left side of my face beginning with my jaw and chin area. Over the following hour, the tingling and numbness spread to my lips, nose, eyelid, eyebrow, and the entire left side of my face and head. Around this time, my husband and son came downstairs to check on me noticed a change in my face and asked me "What's wrong with your lip? It's like a different color or something different on one (left) side." Approximately 2 hours and 30 minutes after the injection, the left side of my mouth and tongue were tingling and went numb. The left side of my face was noticeably weaker than my right and it became difficult to control my left eyelid and lips. My injection site became extremely tender as the evening wore on and I took two tylenol before going to bed to help with the pain. By the next morning on Saturday, the tingling had stopped, and my mouth/tongue were no longer numb, however weakness and occasional numbness persisted on the left side of my face, most especially my jawline and chin area. I noticed my left eye felt dry, so I began using eye drops occasionally. My injection site remained extremely painful throughout the day and I took tylenol and ibuprofen periodically to help with the discomfort and to allow me to sleep. By Saturday evening, no outward signs remained of my facial weakness on the left side, although I could still "feel" the difference. By Sunday morning, the numbness was only sporadic around my jawline and chin and I realized that when taking tylenol or ibuprofen, it seemed to improve sensation in my face. My injection site discomfort abated as Sunday wore on, but a slight weakness on the left side of my face persisted, noticeable only to myself. The weakness has persisted through today (Tuesday evening), however, it does seem slightly improved each day and it is mild. I am able to work and function normally.  I believe that I experienced a mild episode of Bell's Palsy following my Moderna vaccine, something that I have experienced (much more severely) once before <5 years ago after contracting a strain of antibiotic-resistant strep throat.
Information has been received from a registered nurse concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The nurse stated that the patient received unspecified doses of ROTATEQ (lot # M031802, expiration date 09-NOV-2017) that were improperly stored (dosages and routes of administration not provided). The doses were administered between 06-APR-2017 and 29-JUN-2017. No adverse effects reported. Excursion information: Temperature 35°F for 30 minutes. No prior excursions. Data logger involved. No further information provided. This is one of four cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA004306: US-009507513-1707USA004305: US-009507513-1707USA004307.
On 03/25/2021, I drank an herbal tea, Tension Tamer Tea, Celestial Seasonings brand, about 01:30 AM.  I went to lie down and within 20 minutes, I started feeling heart palpitations.  It lasted a half hour. I woke my husband and told him I needed to go to the hospital.  There, they gave me an IV, and my heart rate was 107 beats per minute. My heartrate finally corrected after medication.  I stayed overnight in the hospital.  The tea has an ingredient that is a form of Ginseng. I now have AFIB.
Extreme migraine; Loss of taste; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04May2021 at 17:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. It was unknown whether the patient was pregnant at the time of this report. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN) and montelukast (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 16:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 05May2021, the patient experienced extreme migraine and loss of taste, it was day 5 after vaccination and still could not taste things (at the time of this report). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme migraine and loss of taste was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a physician via a sales representative and described the occurrence of neutophilic leukopenia in a male subject of unspecified age, who was vaccinated with Hep-A vaccine (Havrix) and diphtheria tetanus and poliomyelitis vaccine (Revaxis) for prophylaxis. On an unspecified date, the subject received unspecified dose of Havrix together with unspecified dose of Revaxis. At an unspecified time after vaccination with Havrix and Revaxis, the subject experienced fever and chills. The neutrophilic leukocyte count was low. This case was assessed as medically serious by mfr. At the time of reporting, the outcome of the events was unspecified. Follow-up info has been requested.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 24-FEB-2016, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # L040459, expiration date 06-APR-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 27.7 degrees Fahrenheit for 10 hours. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.