chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011f21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date).    No concomitant information was reported. BUD reported as 04Nov2021. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Non-significant Live follow-up.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:master case
Swollen lymph node in left armpit area; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 13:45 (Batch/Lot number: unknown) at the age of 56 years as dose 2, single and administered in arm left, administration date 09Mar2021 13:45 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type II Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 01Apr2021 09:00, outcome "recovered" (2021), described as "Swollen lymph node in left armpit area". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information:  No known allergies to medications, food, or other products.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a 60 year old female patient regarding herself who is also a registered nurse. The patient was allergic to erythromycin and tetracycline. Patients medical history was none. On 24-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number expiry date, route and dose were not reported) vial in the left arm. Concomitant therapies included PRILOSEC and PAXIL. On 24-SEP-2013, the patient experienced injection site reaction. On 24-SEP-2013, later in the day noticed the patient noticed that the injection site of her left arm was beginning to show redness and was becoming itchy. The patient noted that on 25-SEP-2013, when she woke up, her injection site had "a great deal of redness, was much more itchy than the previous day and a hard area of approximately 2 and a half inches across had formed. The patient did not seek medical attention right away. But on 30-SEP-2013 she did when she was still nothing the injection site reaction and she returned to the unspecified pharmacy where she had received the ZOSTAVAX to speak with the unspecified pharmacist about her arm. Lab Diagnostics Studies performed was none. No treatment was given. The outcome of all the events was reported as recovering/resolving. Additional information has been requested.
Patient developed hives the day after she received the vaccine. She describes them as all over, and she took benadryl and they were resolved.
Pfizer COVID vaccine was administered at about 12:30 PM. Patient called staff over around 12:35 PM due to facial swelling, flushing and voice change.  Benadryl was administered at 12:40 PM via IM in the Right Deltoid. At 12:45 PM pulse was 78, Respirations were 20, and BP was 118/84. At 12:50 PM pulse was 76, Respirations were 21 and BP was 140/90. At 12:55PM pulse was 72, Respirations were 19 and BP was 132/82.  Patient denied ambulance services. Stated that she felt better at this time. Monitored patient for a total of 30 minutes and stated she felt fine at that point. Patient was followed up with the next day. She stated that no more Benadryl was needed at home. She slept a few hours after and continued to have slight facial swelling that lasted for a couple of days. Patient is unsure if she wanted to get the 2nd dose, but wanted to keep her appointment for it still. Her doctor recommends getting the second vaccine dose and told her to just take Benadryl and Pepcid before the vaccine. We educated her about the possibility of getting that second dose at her doctor's office or at Hospital in order for her to have more immediate access to emergency care.
Malignant pleural effusion - procedure, Thoracoscopic pleurodesis. Recovery in hospital. Hospital admission within 6 weeks of receiving the COVID vaccine.
Fatigue, dizziness, feverish, headache, redness and sore injection site
Patient died on 02/20/2021.  Cause of death was pulmonary embolism.
Patient noted he had no adverse reactions with his first dose of the Covid vaccine or other vaccines he has had in the past.  He was informed that  there are more chances of side effects experienced with the second dose ( such as headaches, flu like symptoms, nausea).  He was directed to stay in the store for at least 15 minutes and to inform the pharmacy immediately if he felt anything  out of the ordinary.  He said he walked down several aisles then started feeling light headed and having tunnel vision.  He was on his way back to the pharmacy when he ended up on the ground.  He does not remember how he ended up laying on the ground.  He said his head did not hurt but does not know if he hit it.  When started regaining conscience, his right arm and leg jerked somewhat then calmed down.  When he came to, he said he didn't feel dizzy when he tried to sit up.  The ambulance was called so he was instructed to remain laying on the floor.  The EMT personnel asked him his name, the date, and where he was while he was laying down and after sitting up on the floor.  He answered correctly both times.  He was then asked to sit down on a chair to take his blood pressure.  The EMT personnel were having trouble   getting a good reading so he was transported to Hospital.
pt recvd vax; throbbing, warm, itchy, blotchy arm & inject site; 20sep93 f/u: as of 7aug93 condition improved;
tired feeling; cold; This is a spontaneous report from a non-contactable reporter other HCP reported for a unknown consumer. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization for which the patient had experienced sore arm on unspecified date. It was reported that Pfizer had 2 shots of vaccines. After the second shot, patient's arm didn't bother too much, but patient had like this kind of cold and tired on an unspecified date. That felt for about twenty four hours and patient was kind of just laid in bed most of the day. It went after twenty four hours. So, patient might know neither one of them was completely without symptoms. The outcome of events was recovered on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No adverse reactions at the time of vaccine.  Was admitted to hospital 5 days later with BLL pneumonia and passed away on 03/10/2021
Night sweats; Pain at injection site; Fever >101F; Rigors; body aches for about 4-5 days; generalized fatigue; This spontaneous case was reported by a physician and describes the occurrence of NIGHT SWEATS (Night sweats), VACCINATION SITE PAIN (Pain at injection site), FATIGUE (generalized fatigue), PYREXIA (Fever >101F) and CHILLS (Rigors) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 23-Jan-2021 to 13-Feb-2021.    On 02-Mar-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced FATIGUE (generalized fatigue). On 03-Mar-2021, the patient experienced NIGHT SWEATS (Night sweats), VACCINATION SITE PAIN (Pain at injection site), PYREXIA (Fever >101F), CHILLS (Rigors) and MYALGIA (body aches for about 4-5 days). On 06-Mar-2021, NIGHT SWEATS (Night sweats), VACCINATION SITE PAIN (Pain at injection site), PYREXIA (Fever >101F), CHILLS (Rigors) and MYALGIA (body aches for about 4-5 days) had resolved. At the time of the report, FATIGUE (generalized fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was treated with over the counter NSAID (Motrin and Tylenol).   This case was linked to MOD-2021-105140 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Reporter details, Patient's demographic information, Past medical history, Product details, Outcome of events with recovered dates, 2nd vaccine information was provided by the reporter.
The immediate area around the patient's right arm injection site was "fine"/ patient experienced redness and swelling of the upper half of the right arm above the elbow; The immediate area around the patient's right arm injection site was "fine"/ patient experienced redness and swelling of the upper half of the right arm above the elbow; This spontaneous report has been received from a pharmacist referring to a 77-year-old female patient. The patient's medical history included breast cancer. The reporter stated that she believed the patient underwent a lumpectomy on the right breast. The patient had allergy to latex, sulfonamide (reported as "sulfa"), sulfamethoxazole (+) trimethoprim (BACTRIM) and penicillin. Her concomitant medications included levothyroxine sodium (SYNTHROID) and anastrozole. Historical vaccines included pneumococcal vaccine conj 7v (crm197) (PREVNAR).   On 24-FEB-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) 0.5 ml one time administration, intramuscularly (IM) in her right arm (lot number U010534 has been verified to be valid, expiration date reported and established as 31-OCT-2022) for pneumonia prevention.   On 24-FEB-2022, the patient experienced redness (erythema) and swelling of the upper half of the right arm above the elbow (peripheral swelling). The reporter stated that the immediate area around the patient's right arm injection site was "fine".   On 26-FEB-2022, the patient told the reporter that the redness and swelling was better. On 28-FEB-2022, the patient told the reporter that the redness and swelling was almost gone. It was reported that the patient did not seek medical attention, and no treatment was given for the events.   Additionally, it was reported that the patient did not have reactions to any other vaccines.   At the time of reporting, the patient was recovering from erythema and peripheral swelling. The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) and the events was not provided.
Low grade fever, tennis ball size soreness at the site of injection, warm to touch. Muscle ache.
Patient reports a sore arm for seven days after injection of vaccine. States that the soreness began after the injection on 7/2/2021 and is still occurring today 7/8/2021. Patient denies any redness or swelling to the injection site. Patient states that when you touch it, it's kind of hard feeling and tender.  The pain comes and goes with activity and degree of arm movement.  When lifting  the affected arm over shoulder level has pain.  When not moving the arm or using it as much, has more pain. Patient recommended to try Ibuprofen for arm soreness.
My arm after the shot about 3 hours got hot red and swollen around the shot site. I am a week out from my first dose and I had the same reaction again below the shot site localized to the skin it seems(hot,red and swollen)
Got exposed to Covid infection after receiving the 1st dose of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Got exposed to Covid infection after receiving the 1st dose of Moderna vaccine) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-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 EXPOSURE TO SARS-COV-2 (Got exposed to Covid infection after receiving the 1st dose of Moderna vaccine). At the time of the report, EXPOSURE TO SARS-COV-2 (Got exposed to Covid infection after receiving the 1st dose of Moderna vaccine) outcome was unknown. Not Provided      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.   This case was linked to MOD-2021-114301 (Patient Link).
Warm to touch, redness and swelling at injection site and just below site.  Size approx 10 cm by 8 cm.
Fever, chills, cold sweats, joint pain all over, muscles are soar, hot to touch. Started at 0200 at 7/24-could not get out of bed until the next day on Wednesday 7/27.
This initial spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 22-DEC-2015, the patient was inadvertently administered an expired dose of PNEUMOVAX 23 intramuscular injection (0.5 ml, once, lot# K004281 with expiration date 22-MAR-2015). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. Additional information has been requested.
Had leg pain several days prior to going to the ER. Went to ER had blood clot in lung and leg and put on Eloquist.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not reported. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. Several unspecified patients had reported a sore arm after a SHINGRIX injection. The patient had denied permission to contact their physician. The reporter said this in passing, but needed to get to MI for a stability question.
10 days after I received the Moderna booster vaccine in November 2021 I began daily hives. I have now had chronic Uticaria every day sense. My allergist believes it is due to the vaccine.
Patient was pale, white, clammy, sweaty after getting vaccinated. We called 911 and after evaluating him they said he had a severe panic attack
01/28/11 - slight erythema, no tenderness 01/31/11 - erythema unchanged, no induration to minimal, c/o sore forearm. Erythema 1cm 02/02/11 - 1/2cm mild induration, 1cm surrounding erythema.
Sept 14, 2021: 32 year old male patient received his first COVID 19 vaccine. Patient stated before the vaccine was administered that he tends to feel lightheaded. After the vaccine was administered the vaccinator asked the patient how he was feeling and the patient stated he was "fine".  Patient was given discharge instructions and told to sit in the observation area. It was there that the patient stated "he was feeling hot and sweaty" approx. 10 minutes after receiving the vaccine. Patient then laid himself on the ground for comfort. Patient stated this was a common reaction for him. Vital signs were Within Normal Limits. Patient taken to the Emergency Room based off hospital protocol.
This spontaneous report as received from a nurse practitioner refers to a 60 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were unknown by the reporter.  On 03-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque-forming units (PFU) refrigerated vial (injection) (route of administration, lot # and expiration date were not reported) for prevention of shingles. On 03-JAN-2017, the patient experienced redness and pain in the arm with an unspecified rash. On 04-JAN-2017, the patient had a headache and left lower quadrant abdominal pain. On 06-JAN-2017 through 09-JAN-2017, the patient had diarrhea, fever and chills. As of the date of this report the diarrhea had gone away, but the patient "still had symptoms coming to the middle through her rectum" and a decreased appetite developed on an unknown date in January 2017. On 10-JAN-2017, the patient sought medical attention and visited nurse practitioner office complaining about her symptoms. The nurse practitioner ordered unspecified blood work and a urinalysis. Both came back normal. The nurse practitioner recommended a bland diet and over the counter PEPCID or omeprazole. As of 18-JAN-2017, the the symptoms were improving but not gone except of diarrhea which was resolved on an unknown date in January 2017. It was reported, if the symptoms remain unresolved, the nurse practitioner would order a computer tomography (CT) scan. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Information has been received from a physician concerning a 67 year old female who was vaccinated with Zostavax (Oka/Merck).  Subsequently the patient experienced shingles.  Additional information has been requested.
Pt. states that after receiving the 3rd dose of Moderna 01/14/2022, starting experience symptoms 01/15/2022 of fever (101.0), injection site swelling, and vomiting. Symptoms lasting 3 days before subsiding. Primary communications 01/15/2022 with recommendations hot/cold pack at the injection site.
My ear neck; Face got swollen; Still have severe pain on my head; Severe pain in shoulder; Still have sever pain in my arm; Still have sever pain on my leg only on right side of body; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 22Apr2021 at 09:45(at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included type I diabetes, high blood pressure, epilepsy, pancreatitis and known allergies to penicillin, sea shellfish. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included insulin (MANUFACTURER UNKNOWN) and buprenorphine (BUTRANS) patches; both for an unknown indication from unknown date and unknown if ongoing. On 23Apr2021 at 08:00 the patient experienced his ear neck and face got swollen. Still have severe pain on his head, shoulder and arm and leg only on right side of body. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of events. Since the vaccination, the patient had been tested for COVID-19. On 05Nov2020, the patient underwent COVID-19 test (Nasal swab) and the result was negative. The clinical outcome of the events ear neck, face got swollen, severe pain on his head, shoulder and arm and leg only on right side of body was not recovered 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.
"some people get Bell's palsy"; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY ("some people get Bell's palsy") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY ("some people get Bell's palsy") (seriousness criterion medically significant). At the time of the report, BELL'S PALSY ("some people get Bell's palsy") outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-034224 (Patient Link).
9/22/10 ZOSTAVAX given. 9/23/10 SYNVISC injection to (R) knee. 10/1/10 Shingles outbreak L2-L4 dermatome (L) sided.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 01-DEC-2017, the patient was administered an improperly stored dose of ROTATEQ, lot # N015129 with expiration date on 11-DEC-2018 (dose was not reported). The administered dose of vaccine underwent a temperature excursion of 47.6 degrees Fahrenheit, which lasted for an unspecified time. There was no previous temperature excursion. A digital data logger was not involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1712USA002258: US-009507513-1712USA008157:US-009507513-1712USA008158: US-009507513-1712USA008159: US-009507513-1712USA008160: US-009507513-1712USA008162:
5MAR93 numbness in back; lt hand arm-leg & foot; edema lt foot; dec edema now, but feel numbness; 10MAR93 cont numbness; 11MAR93 p/talking w/MD ordered no further MMR: