chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reporting itching, redness,  and swelling on left upper arm around injection site extending toward her elbow. She received the booster on 11/4/21. The swelling and redness was localized to the injection site until 11/6/21. On the morning of 11/7/21 she noticed that the redness and swelling had moved down to her elbow. She had the same reaction with her 2nd Moderna vaccine as well. I instructed her to use ice, Benadryl and Tylenol to help her be more comfortable and decrease the irritation and swelling, as well as to watch the area and seek medical attention if it got worse.
Since the covid vaccine especially after the booster shot, I am having allergic reactions to certain foods like peanuts, avocado, maybe wheat foods. My eyelids were swollen and my whole face, scalp, and neck are mod-severely itchy. I have never experienced food allergies prior to the covid vaccine.
In early October, I had gone to see my daughter. I woke up with a scratchy throat that I didn't think much of. However, as the day went on it got worse. I took an at home COVID-19 test which came up positive. I started to get fever, chills, headache, tiredness. I went to a local urgent care. They prescribed prednisone and TUSSIN. They tested me for Flu and COVID-19. The COVID-19 test was positive while the Flu was negative. I then developed sinus drainage that got really bad, a cough, and some diarrhea. I also had night sweats. The doctor told me to isolate for five days and mask for an additional five days. I retested for COVID-19 on 10/11/2022 before my flight. I was still positive, but the doctor said that I was safe to fly as long as I was masked. I flew home on 10/11/2022 and was still having some sinus drainage, coughing, and tiredness. On 10/19/2022, I had some dizziness and shortness of breath which continued into the next morning. I called my doctor who advised that I go to the emergency room. At the emergency room, they put me on and I.V. of TORADOL and some anti-nausea medicine. They hooked me up to an EKG and I was there for most of the day. They also did a chest x-ray to check for pneumonia and a CT scan to check for blood clots. The TORADOL seemed to help my breathing. They put me on a medication for a sinus infection and apparently saw some bacteria in my urine. They also advised that I follow up with a mammogram from something they saw on the CT scan. I did follow up and it was benign. Ever since visiting my daughter, I have had an achiness in my lungs that seems to be worse in the evenings and the cold air. At this point, all of my symptoms have improved or are gone. I still have to clear my throat occasionally and feel a bit of fatigue from the whole experience, but overall, I'm feeling ok.
Beginning about 10 hours after vaccine dose, I started to feel mild muscle ache and headache.  Beginning at about 12 hours after vaccine dose, I experienced significant nausea without vomiting that continued for several hours.  At about 18 hours after vaccine dose, the nausea somewhat subsided, leaving fatigue and headache as main symptoms.  Beginning at about 24 hours after vaccine dose, I experienced an episode of sharp, intense chest pain that lasted for about 1 hour.  The chest pain slowly subsided, but did not entirely disappear.  At about 28 hours after vaccine dose, I experienced another episode of very intense chest pain, which caused me to go to the hospital.  The second episode was more intense than the first, and lasted for about 1.5 hours.  I have not experienced another chest pain episode since the second episode.
On 03/04/2001 the patient developed a severe varicella rash on her scalp, mouth, face, back, legs and arms. Unspecified medical attention was sought. Additional information has been requested.
Severe body aches and pains and headache. Nausea, fever of 102 for 23 hours first day followed by heavy sweats the second.  No appetite and unable to eat.  Could drink water.  Second day developed enlarged supraclavicular lymph nodes in my neck and is still swollen into third day.  The lymph nodes cause a weird "electric" feeling.  Aching in joints and especially in hips.  Itching on extremeties since first day.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 05-MAY-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot #L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 168 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 72 hours with the lowest recorded temperature of 31 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Dizzy; Shakes; Lower back pain; Runny nose; Arm on fire; Sore; Rash on chest; Fever 103; Bad headache; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), TREMOR (Shakes), BACK PAIN (Lower back pain), RHINORRHOEA (Runny nose) and FEELING HOT (Arm on fire) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced DIZZINESS (Dizzy), TREMOR (Shakes), BACK PAIN (Lower back pain), RHINORRHOEA (Runny nose), FEELING HOT (Arm on fire), PAIN (Sore), RASH (Rash on chest), PYREXIA (Fever 103), HEADACHE (Bad headache) and NAUSEA (Nauseous). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy), TREMOR (Shakes), BACK PAIN (Lower back pain), RHINORRHOEA (Runny nose), FEELING HOT (Arm on fire), PAIN (Sore), RASH (Rash on chest), PYREXIA (Fever 103), HEADACHE (Bad headache) and NAUSEA (Nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 103 (High) fever of 103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.
Pt came into the clinic for a covid vaccination. She filled out the necessary covid vaccination paperwork. After the vaccine was given, she mentioned another vaccine she needed. Varicella.  I advised I can not give any other vaccine with a covid vaccine. She then told me she has already had both covid vaccines previously.  Today she was given a third vaccination with pfizer and previously she received Moderna vaccinations x 2. These were given in Dec. 2020 & Jan 2021.  She tolerated vaccine well and had no immediate reaction or side effects.
Hives right armpit that extends above the ribcage/hives in LEFT side from armpit until above of his chest with clumps; itchiness; redness; hives in LEFT side from armpit until above of his chest with clumps; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives right armpit that extends above the ribcage/hives in LEFT side from armpit until above of his chest with clumps), PRURITUS (itchiness), ERYTHEMA (redness), SKIN MASS (hives in LEFT side from armpit until above of his chest with clumps) and INJECTION SITE PAIN (injection site pain) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Environmental allergy (Sneezes when dusty). Concomitant products included MELATONIN for Sleep disorder.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced INJECTION SITE PAIN (injection site pain). On 03-Oct-2021, the patient experienced URTICARIA (Hives right armpit that extends above the ribcage/hives in LEFT side from armpit until above of his chest with clumps), PRURITUS (itchiness), ERYTHEMA (redness) and SKIN MASS (hives in LEFT side from armpit until above of his chest with clumps). On 01-Oct-2021, INJECTION SITE PAIN (injection site pain) had resolved. At the time of the report, URTICARIA (Hives right armpit that extends above the ribcage/hives in LEFT side from armpit until above of his chest with clumps), PRURITUS (itchiness), ERYTHEMA (redness) and SKIN MASS (hives in LEFT side from armpit until above of his chest with clumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided.
Headache; fever; chills; This is a spontaneous report from a contactable consumer. An adult male patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 07Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown if the patient had received any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 15:00, the patient experienced headache, fever and chills. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown if the patient had received any treatment for the reported events. The clinical outcome of the events headache, fever and chills was recovering at the time of this report.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Tinnitus.  Onset on or about 03/04/2021.  Intermittent at first, now constant.
24 hours after Fluzone, developed minimal redness at injection site; 36 hours after Fluzone, site redness increased 8cmx9cm, indurated/warm/itchy.  Given Zyrtec 2.5mg twice daily within 24 hours, redness decreased/swelling.  No further itching.
I experienced muscle aches the spread across my entire back starting at about 8 PM on 2/4/21. At 2:30 AM on 2/5/21, I passed out three times after rising from the toilet, resulting in a split lip.  I was covered with sweat the third time I "came to" and soon got the chills.
I am having a hard time breathing, everything smells and taste funny. And having a hard time catching my breath.  Also I am really weak feeling, I feel very nauseous and cant throw up
Symptoms of fever, nausea, and weakness started 3 days following vaccination. Denies any exposure to COVID positive person.  Presented to local emergency department on 3/27/21 with nausea, fever, chills, dizziness, and confusion. Due to patient's condition, he was transferred to larger facility for further management. Patient was admitted to hospital and subsequently transferred to ICU on 4/17/21. He was intubated at that time. Patient went into multisystem organ failure and died on 4/18/21.
This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced rash and headache. On an unknown date, the outcome of the rash was unknown and the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the rash and headache to be related to SHINGRIX. Additional details were provided as follows: The patient did mention during the call that her pharmacist reported this event to her doctor and CDC (center of disease control and prevention). The age at vaccination was not reported. The patient called to ask about how long did the headache last after receiving SHINGRIX. The patient mentioned that she developed a rash next morning, and she also had a headache. The reporter gave medical disclaimer, provided information from prescribing information. The call had disconnected before asking any questions in the CAMEL template, attempted to call back the patient but got no answer.
COVID-arm; Itchy/ itchy, red area at injection site; Red spot where the vaccine site was/red area at injection site; red rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID-arm), VACCINATION SITE PRURITUS (Itchy/ itchy, red area at injection site), VACCINATION SITE ERYTHEMA (Red spot where the vaccine site was/red area at injection site) and VACCINATION SITE RASH (red rash at injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer and Osteoporosis. Concomitant products included LETROZOLE from 30-Mar-2020 to an unknown date for Breast cancer, DIAPLEX for Digestion impaired, TURMERIC [CURCUMA LONGA RHIZOME] for Disorder joint, ALENDRONATE SODIUM (FOSAMAX) for Osteoporosis, COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    On 20-Jul-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced VACCINATION COMPLICATION (COVID-arm), VACCINATION SITE PRURITUS (Itchy/ itchy, red area at injection site), VACCINATION SITE ERYTHEMA (Red spot where the vaccine site was/red area at injection site) and VACCINATION SITE RASH (red rash at injection site). The patient was treated with LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D) (oral) for Adverse event, at an unspecified dose and frequency and HYDROCORTISONE from 29-Jul-2021 to 31-Jul-2021 for Adverse event, at an unspecified dose and frequency. On 03-Aug-2021, VACCINATION COMPLICATION (COVID-arm), VACCINATION SITE PRURITUS (Itchy/ itchy, red area at injection site), VACCINATION SITE ERYTHEMA (Red spot where the vaccine site was/red area at injection site) and VACCINATION SITE RASH (red rash at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included unspecified supplements, Aromatase inhibitor and Catalyn.  The patient reported the red rash and itchiness appeared on 29-Jul-2021 and grew in size to about 3 by 3 inches over the next two days.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow-up received provided no new information. On 04-Aug-2021: ADR form received provided patient details, concomitant ad treatment medications, additional event and updated outcome.
Dizzy; trying to eat some food but it still not working/ unable to eat; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 03Mar2021 09:15 (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 03Mar2021, outcome "unknown", described as "dizzy"; DECREASED APPETITE (non-serious) with onset 03Mar2021, outcome "unknown", described as "trying to eat some food but it still not working/ unable to eat".  Additional information: It was reported that the shot was making the patient sick. It was also mentioned that the patient "don't do" drugs and all the patient took was "high blood pressure."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient started experiencing swelling, redness, and itching in the upper left arm around the injection site within hours of receiving the immunization.
Patient immediately vomited (small amount) became pale and sweaty. Never lost consciousness. Recovered  fully within 15 minutes. History of anxiety. Did faint when he had his PPD test 2 weeks prior.
Improperly stored vaccines administered; This spontaneous report was received from an administrator, referring to a neonate male patient (reported as baby boy). The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 27-JUL-2021, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot# T022566, expiration date 03-NOV-2022, for prophylaxis (strength, dose, route and frequency were not reported).  The temperature excursion was of -1.4 Centigrade degrees (°C); -26.4°C, for 1 hour; 4 hours. A previous temperature excursion was not reported. A digital data logger was involved.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA001905: US-009507513-2108USA001815: US-009507513-2108USA001990:
Arm soreness starting night of first day (05/08/21), rash begins to appear.  Morning (5/09/21) continued larger area of soreness with swelling at injection site, rash grows in size at injection site to 2 inches diameter.  Rash persists for 5 (five) weeks after injection growing to largest size (4-5 inches) 7 days after administration.  Subcutaneous itching begins at day 2 after vaccine at injection site.  Subcutaneous itching worsens for four weeks after administration.  Arm soreness is replaced by dull persistent ache around injection site with shooting pains, joint and muscle pain sporadically throughout left arm continuing to the present day (11/04/21).  Ache in left shoulder lower deltoid has become ...constant, chronic and more intense which is limiting and restricting my ability to lift, clutch, strain, or push objects. Deep tissue muscle ache, joint discomfort and emanating sharp pains are now constant even when arm is completely at rest.  Emanating sharp pains are often accompanied by a burning sensation that began to appear around (07/01/21) but has become more noticeable and constant, especially in and around the left elbow and sometimes shoulder and wrist.  My left arm seems to have waning strength and what feels similar to soft tissue tears in both the shoulder and now the elbow and forearm.   Acute pain/discomfort persists at bottom of left deltoid in deep muscle tissue/tendon connection.  Within three days following the administration of the Moderna vaccine I experienced a series of persistent and spreading HSV2 outbreaks that were as severe and worse than any I'd experienced prior.  I had not needed to take a daily course of ValAcyclovir prior to getting the Moderna vaccine for many months.   Once the outbreaks began I was forced to take the medication twice daily and continue to take it daily as the prodrome is now a constant feeling indicating an outbreak is imminent.  The Valacylovir severely affects my digestive track causing diarrhea but there is no alternative.
Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th January 2019, the patient received the 1st dose of Shingrix. On 25th January 2019, 9 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received dose 1 of Shingrix and developed shingles 13 days later.  The patient reported that various food items smell differently than before dose 2. This did not occur after dose 1. The reporter did not consent to follow-up. This case has been linked with US2019AMR177867 having same patient (dose 2)
That afternoon, I got a headache and dizziness. I also had ringing in my ear. These lasted for about a day.
Patient had marked change in behavior- and became very irritable, aggressive and did not stop crying for 3 days, she stopped talking normally for two weeks. Patient could not sleep and was very fussy. she had a fever 5 days after the vaccine of 106.7 and had a full body rash. She did not have much appetite. Patient had marked emotional, verbal, and physical regressions.
After administering the above vaccine to patient today, I realized that it expired 3/17/2021. And informed the patient.  She is having no problems currently.
1/30/21 late night started to vomit, 1/31 am temp 102 and non responsive, sent to hospital via EMS
Treatment of COVID-19/ Re-occurance of Covid- Rebound Covid; Treatment of COVID-19/ Re-occurance of Covid- Rebound Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2022 at 17:00 as dose 4 (booster), single (Lot number: FJ9943) at the age of 76 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "lung cancer" (not ongoing), notes: Recovered lung cancer; "emphysema" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE, start date: Jan2020, stop date: 05Jul2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19/ Re-occurance of Covid- Rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results.   Therapeutic measures were taken as a result of drug ineffective, covid-19.