chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer, describes the occurrence of product dose omission issue (hasn't had a second dose) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. May 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced  product dose omission issue (hasn't had a second dose). At the time of the report,  product dose omission issue (hasn't had a second dose) resolved. No concomitant medications or treatment information reported.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2022 at 1:40 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 1:40 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient was 23.41 years.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 6-Apr-2021, vial was moved to clinic on 314Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 9-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 43, 4 PM: 44 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Swelling in both armpits, and tenderness in both the armpits and the groin began the day after the 2nd dose of the Moderna Vaccine, lasted for several days, then subsided. Approx three weeks later, the same symptoms came back, but with less severity.
After receiving the vaccines, Red blotches/rashes showed up on both my hands. They have been on mu hands for a week now and feel hot.. not too itchy. This is the first time ive had rashes/spots like this on my hands.
Patient stated that besides pain and fever he also had a nosebleed the following morning after receiving the vaccination.
No additional AE reported; Caller is a HCP calling to report a TE for PNEUMOVAX 23.; This spontaneous report has been received from a nurse, referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.  On 11-APR-2022, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot number U021995 has been verified to be a valid lot number, expiration date: 13-JAN-2023) (strength, dose, frequency, and vaccination scheme were not provided) (product storage error) administered for prophylaxis.   The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was stored at a temperature of 0.7 Celsius (C) for a time frame of 24 hours. There was a previous temperature excursion.   No additional adverse events were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2206USA007094: US-009507513-2206USA006587: US-009507513-2206USA006674: US-009507513-2206USA006670: US-009507513-2206USA006731: US-009507513-2206USA007090: US-009507513-2206USA006981: US-009507513-2206USA007045: US-009507513-2206USA006852: US-009507513-2206USA007070: US-009507513-2206USA007098: US-009507513-2206USA006952: US-009507513-2206USA007059:
high blood pressure; not feeling well at all; enlarged aorta; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure), MALAISE (not feeling well at all) and AORTIC DISORDER (enlarged aorta) in a 73-year-old male patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced HYPERTENSION (high blood pressure), MALAISE (not feeling well at all) and AORTIC DISORDER (enlarged aorta). At the time of the report, HYPERTENSION (high blood pressure), MALAISE (not feeling well at all) and AORTIC DISORDER (enlarged aorta) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Blood pressure measurement: high (High) High blood pressure. In December 2021, Computerised tomogram: abnormal (abnormal) enlarged aorta. In December 2021, SARS-CoV-2 test: results pending (Inconclusive) Results pending.         Patient had to go to the emergency room last night, on 20-DEC-2021, because of having issues with high blood pressure, and not feeling well at all. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Patient reported to pharmacy 2/17/23 that she had a "shingles" outbreak a few days after her Shingrix vaccination. Her medical chart indicates that she had similar lesions and outbreak shen she had CMV from her lung transplant. Was evaluated in clinic on 10/11/22 and had HSV diagnosis and symptoms started 5 days after the Shingrix vaccine showing lesions on leg and labia. Immuno compromised patient then prescribed Valtrex (PO) and Zovirax (topical) to address symptoms.
Pt is a 22-year-old male who received the smallpox vaccine (smp) on 12 May. Stated he noticed nothing unusual. On Saturday 22 May he began to experience heartburn, described, as a mild burning feeling across his chest and nothing seem to make it better or worse. He denied chest pain, shoulder or neck pain, nausea, vomiting and shortness of breath. Stated this episode only lasted a couple of hours. He felt ok throughout the day on Sunday and woke up 3 am on Mon 24 May with "bad" chest pain but again though it was just heartburn. Pain lasted 4 hours. He denied neck and shoulder discomfort. No nausea, vomiting or shortness of breath. Stated the pain felt worse when he laid down. He stated he noticed slight discomfort throughout the day and reported no relief with Tums. Stated he had slight relief with Pepto-Bismol. At 1600 hrs he decided to go to the hospital. By the time he got there at 5 pm the pain was a # 8-9 on a scale of 1-10 with 10 being worse. He stated the pain was all across his chest and this time was associated with shortness of breath. He also reported that the pain increased with deep breathing but he noticed no change in pain with position change. He said the pain eased with the administration of medication in the hospital. o25 July 04: Cardiology confirmed smallpox associated myopericarditis, resolved Discharge summary states bacterial infection.
The day after receiving the vaccine, she noticed the injection site growing red and painful to the touch. The following day she went to see her doctor because the red area was growing. At that visit they measured the length and width of the area, and she was told to call back if it grew. The next day, 10/16/21 it grew an additional inch. She reported to the doctor, who then prescribed antibiotics and asked her to come to my pharmacy to report the event.
Patient presented to the ER with chest pain and shortness of breath. After workup in the ER he was found to have an elevated troponin and sinus tachycardia noted on his EKG.
It started off with a sore throat. I thought I was getting a cold. The sore throat went away but I felt really tired and real weak. After Christmas, the symptoms got really bad. A cough kicked in. We thought it was just a cold. On January 3rd, 2023, we were feeling really sick by then. We went to the doctor, and she swabbed our throats but did not do a COVID-19 test. She prescribed antibiotics. That night I had fever. I told my husband there was something wrong. So, we took an at home COVID-19 Test and it was positive. We called the doctor, and she called anti-viral tablet. After the 5th day I felt really good, and I tested negative. It only lasted one day. The next day I was even worse. I felt so sick. My body was achy. I slept the entire day. I took another COVID-19 Test by the doctor's recommendation. She gave me more medication but something different, but I don't recall what it was. I started taking this medication and the symptoms lasted 2-3 days. I retested again and it was negative. I still could not taste or smell. It lingered for about 2 weeks.
Extreme joint and muscle pain in shoulders, upper arms, wrists, hands; Extreme joint and muscle pain in shoulders, upper arms, wrists, hands, and occasionally lower spine.; Extreme joint and muscle pain in shoulders, upper arms, wrists, hands; Muscle spasms in upper back and shoulders.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 12:00 (at the age of 56-years-old) as a dose 2, single for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any other medications within 2 weeks of 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 on an unknown date (at the age of 56-years-old) as a dose 1 for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021 at 03:00, the patient experienced extreme joint and muscle pain in shoulders, upper arms, wrists, hands and occasionally lower spine and muscle spasms in upper back and shoulders. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events extreme joint and muscle pain in shoulders, upper arms, wrists, hands and occasionally lower spine and muscle spasms in upper back and shoulders were not resolved.    The batch/lot numbers for BNT162b2 were not provided and will be requested during follow-up.
Flushing in my face, in my cheeks and the redness; Flushing in my face, in my cheeks and the redness; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3249; Expiration Date: May2021) via an unspecified route of administration, administered in right arm on 15Feb2021 09:30 as single dose for COVID-19 immunisation. Medical history included fibromyalgia, migraine and ongoing asthma. Concomitant medications included duloxetine at 50mg, amitriptyline at 50mg, topiramate at 150mg and fluticasone propionate (FLOVENT) for asthma with a dosage regimen of 2 Sprays one in morning and one in the evening. It was reported that Yesterday patient went to get the shot (clarified as Covid-19 Vaccine Pfizer, 1st shot) in about 9:30 in the morning and know that patient listed all the side effects, you can go ahead and get from it and the only thing that patient experienced shortly after it was flushing in face, in cheeks and the redness in Feb2021 and I still do have that today. For treatment patient stated, "No, I took a tiny bit of Benadryl this morning, since the, if it would help like lessen the redness but it seems like it lightly helped it because I woke up this morning and I was like oh my god I am still red, it seems like lightly helped." The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
The day after her flu shot had: Warm, swelling and tenderness at injection site hives on trunk and bilat arms eye swelling lip swelling  scratchy throat  She was treated in the ED with Zantac, Benedryl and epinephrine IV drip  Hospitalized for 26 hours
This is a spontaneous report from a contactable consumer via a Pfizer Colleague. A patient of unspecified age and gender received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient diagnosed with COVID and symptomatic/got COVID-19 after first vaccination but before second one in recent weeks. Event took place after use of product. The outcome of events was unknown.  Information about lot/batch number has been requested.
After initial redness disappeared, 7days later the left arm had redness again, large area and itching. Observed, on this date only slight itching and redness
20 mins p/vax pt exp chest pressure & difficulty breathing, while driving home; @ home felt dizzy, hot, pt laid down & exp muscle weakness & pain (fleeting) all over, exp in abdo, nausea & h/a; abdo pain lasted 2 hrs& had muscle weakness;
About 5 weeks after the vaccination, I developed a very large blister at the injection site on my arm, my chest was covered in cold sore-like blisters and hives, my neck had some blisters, my jawline and face had random blisters. Now, I still have random single blisters appear on my chest, neck and face.  On May 18th, I had developed a severe ulcer in my eye. The optometrist said that there is a very good chance that the ulcer was caused by shingles.  I began taking my Valtrex medication to try and calm and reduce the outbreaks and continue to take this daily. My husband had the same Shingrix vaccination at the same date and time. He developed full blown blisters covering the entirety of his back and across his stomach. He was in so much pain he couldn't sleep. Later he developed blisters on his calves, behind his knees and on the inside of his elbows. His reaction is much more intense.
Acute pain on right side of body radiating from lower back neck up side of head to hairline, jaw area and mouth and ear.
Myalgia day 1-4 sore arm, day 2-fatigue chills; day 3-4-  fatigue; day 5 resolved Narrative: day 1-4 sore arm; day 2- fatigue chills; day 3-4 fatigue; day 5 resolved
pt recv vax 17OCT97 & next morning felt fatigued;about 43hr later awakened by severe chest pain radiating to the shoulder;stated felt like was exp a heart attack;required for pain relief;also devel hoarseness, h/a, n, weakness;
This is a spontaneous report from a contactable consumer reporting for herself. An 89-year-old British and Norwegian female patient received PREVNAR 13 (NDC number: 00005-1971-02; UPC number: 0000028144), via an unspecified route of administration on 26Jul2017 at single dose for immunisation. Medical history included, trouble with her memory related to old age, osteoporosis, neck injury and spinal disorder as in the past she had a broken neck and a broken spine. The patient's concomitant medications were not reported however the patient took other medicines. The patient previously took polio vaccine ctv for immunisation and experienced poliomyelitis. The patient experienced can't lift right arm and can't lift anything, on 26Jul2017 with outcome of recovering. Therapeutic measures were taken as a result of the events and included menthol product, cold compress and lymph massage.
Fever (100 F, even with ibuprofen, 2 days duration). Myalgia, general malaise, arm moderately sore.  Lightheaded and dizzy upon standing.
This spontaneous report received from a health care professional via other manufacturer (Pfizer) concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, hyperlipidemia, hypothyroidism, anxiety, depression, gout, OSA (Obstructive Sleep Apnea), insomnia, and allergy (unspecified). The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 in total, on 09-APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 49 years old. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received non-company suspect vaccine: Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 11-NOV-2021 for covid-19 prophylaxis. On an unspecified date, the patient experienced suspected covid-19 infection (dose number in series 2). The patient was treated with Paxlovid (form of administration not reported, oral, batch number: unknown, expiry: unknown) dose was not reported, administered from 10-AUG-2022 to 14-AUG-2022 for treatment of COVID-19. The patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment. On 14-AUG-2022, the patient experienced hives on bilateral lower extremities (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran (Moderna Covid-19 Vaccine) was not applicable and with Paxlovid was not reported. The patient was recovering from hives on bilateral lower extremities, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
Noted under left arm slight redness with mild warmth to area, no swelling or drainage. Per client has lasted 8 days no acute distress noted.
Client verbalized feeling sudden headache after receiving the vaccine.  Client was evaluated.   Mrs./Ms. was released to go home at 10:51 am after symptoms subsided accompanied by niece.
This case was reported by a nurse via call center representative and described the occurrence of shivering in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 24th July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, 8 hrs after receiving SHINGRIX, the patient experienced shivering, headache, dizziness and general body pain. On an unknown date, the outcome of the shivering, headache, dizziness and general body pain were unknown. It was unknown if the reporter considered the shivering, headache, dizziness and general body pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported via chat. This case was reported by nurse for herself. About 8 hours after receiving the SHINGRIX vaccine, the patient experienced shivering, body aches, severe headache and dizziness. The healthcare professional did not have lot number or expiry date of the SHINGRIX.
pt recv vax 23AUG97 & 9MAY97 pt devel chickenpox;
On Wednesday, 1/25/2023 at 7PM, I began to experience body aches and feel tired. I went to bed early, which was by 8 PM. I couldn't sleep, because I had a headache, so I tossed and turned for most of the night. I woke up at about 6 AM, and I felt that the headache was due to being dehydrated. I got up, went to the restroom, changed clothes, and came back to my bedroom. I began to feel weak in the legs and extremely exhausted. I started to walk out of my bedroom to tell my daughter I wasn't feeling well, and before I made it out of my room, I fainted. I then got up and proceeded to walk down the hall towards where my daughter was. When I got to the doorway of the room where she was, I fainted again. From there, I crawled on my hands and knees to the bathroom, which was adjacent to where I was, and I was able to pull myself up and sit on the toilet. I was sweating profusely and had diarrhea. I had no strength in my legs at all. My daughter called 911. The paramedics helped me walk downstairs and get on the gurney to the ambulance. As I was descending the stairs, my legs felt shaky, and I had an attendant on each side of me holding me up. They transported me to a local hospital. En route, they hooked me up to an IV. They took my temperature, and I had no fever. They monitored my BP and heartbeat. My BP wasn't high, and I had no trouble breathing. My heartrate was also fine. I was taken to the ER, where they continued the IV fluids. They did a lot of blood work, an EKG, and tested me for COVID-19 and the flu. They monitored my breathing, and I had a 97% saturation rate, and my BP was 105/60. Because I had fainted twice that morning, they decided to keep me overnight for observation. They did an echocardiogram to ensure that my heart was not the reason for my fainting. The results of the majority of the blood tests were normal. I was told that because I had had the boosters and was fully vaccinated against COVID-19, that was probably the reason why I wasn't experiencing various other symptoms associated with the virus. They also said that my dehydration was probably caused by my COVID-19, as they had also seen various other patients with the same symptoms. I was discharged on 1/27/2023 at about 7 PM. I came home. I did not retest myself, but I did go to my NP on 2/6/2023, and I asked her if I needed to be retested for COVID-19. She told me that the protocols had changed that the test was no longer needed after 5 days. At the hospital, I was told that I needed to be in isolation for five days when I came home. I still occasionally feel like my legs are sometimes momentarily weak and wobbly, but not enough to cause me to fall. I just sit and rest when that happens. I sometimes get tired. I then rest and take it easy for about 30 minutes. During the time I was in the hospital, I wore a heart monitor from the time I was admitted until the time I was discharged.
Induration, swelling and erythema at right deltoid area, measuring 3" X 3".
Pt recvd vax & approx 2 wks p/inject devel hives on arms & knots in breasts; rash recently subsided but still has knots;
LPN from group home call and stated client developed "Head to Toe" raised red, blotchy, itchy rash approx 3 hours after he recieved HEP B vaccine. No fever, no breathing difficulties.  Rash disappeared approx 30 mins after taking 25mg of Benadryl P.O.