chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Product Temperature frozen 47 minutes -13.79 degree C and refrigerator 59 minutes 12degree C; Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product Temperature frozen 47 minutes -13.79 degree C and refrigerator 59 minutes 12degree C) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product Temperature frozen 47 minutes -13.79 degree C and refrigerator 59 minutes 12degree C) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product Temperature frozen 47 minutes -13.79 degree C and refrigerator 59 minutes 12degree C) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) had resolved.        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.   Concomitant medications details were not reported by the reporter Treatment details was not reported by the reporter.   This case was linked to MOD21-068707, MOD21-068705, MOD21-068620, MOD21-068645, MOD21-068696 (Patient Link).
Swelling/hardness of injection site area.  Area hot to the touch. Throbbing and soreness.   Was experienced the day of injection and for 3 days. Side effects went away then returned one week after injection.
BODY ACHES; SEVERE FATIGUE OR LETHARGY; FELT DEHYDRATED; SEVERE CHILLS OR SHAKING; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not really had a medical history. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the patient experienced body aches. On 12-APR-2021, the patient experienced severe fatigue or lethargy. On 12-APR-2021, the patient experienced felt dehydrated. On 12-APR-2021, the patient experienced severe chills or shaking. On 12-APR-2021, the patient experienced headache. On 12-APR-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) Under 102. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient recovered from body aches, severe chills or shaking, and fever on 13-APR-2021, severe fatigue or lethargy, and headache on 14-APR-2021, and felt dehydrated. This report was non-serious.
Abdominal pain the day after second dose of vaccine, relieved with Ibuprofen. The same pain returned 2 months later on June 15th and was diagnosed as appendicitis.  The patient underwent emergency appendectomy on June 15th.
rt deltoid injection 24 hours later cervical, clavicular and epitrochlear lymphadenopathy
Alopecia Areata, Clobetasol solution topically, substantial hair loss in patches
A rash about 5x2 appeared on arm at site of vaccine along with small bumps.  Two days later a rash appeared on arms, back.  This rash then kept spreading up my back and chest onto my neck.  Besides itching the rash tingles like pins and needles.  When the arm tingles so does the rash on my back, shoulders and neck.  The rash at the site of the vaccine left after about three days, but the site still tingles plus it radiates heart sometimes.  Doctor had me put on over the counter steroid cream once a day plus over the counter itch creams.  In a week since the creams weren't working she put me on a steroid pack, plus more over the counter steroid creams and itch creams.  A week later she put me on a 10mg steroid, seven days full strength, and then half strength for three days.  A month has now passed and the rash is still itching, stinging, and red; however it appears to not be spreading any more.  It is on my back, shoulders, chest around collar bone, and all around my neck.  My allergist on November 9, 2015 put me on Singulair, Allegra, and over the counter moisturizers.  Eight days have passed and the rash is no better, but st least it is no longer spreading.  I just want to know if there have been any other complaints of this happening to other people and are there any known cures.
Patient's daughter, called and states she is her mom's POA and she stated that she was with her mom when she got the vaccine in the parking lot. About 3 weeks ago her mom started dragging her foot and fell twice, she went to a facility and then was sent to hospital and was hospitalized for about 3 weeks, she has had two mini strokes, she is currently at nursing home. She also provided the name of her mom's PCP.
I woke up the morning of the 12th with a knot of soreness in the left upper arm at the site of my tetanus vaccination. Since then I have developed extreme soreness in my arm, shoulder blade, and neck. I have reduced range of motion in my left arm. I have intermittent burning pain radiating up my arm to my neck. NSAIDs, Tylenol, warming pads, and sore muscle creams do not adequately dampen the pain. The pain is so intense and that it often keeps me up at night. I will have to have a follow up appointment as the pain seems to be intensifying.
05/16/2022 In the evening I started breaking out in hives in different parts of my body. This happened every afternoon. A patch would appear in one part of my body for an hour or two hours. Then I would break out in a different area. Over the course of a week, the hives were more painful, itchy and broke out all over my torso. I went to a doctor 2 or 3 weeks after this. I did not make a connection that it had anything to do with the booster. My doctor ran thyroid functioning test that came back normal. Then I was referred to an allergy clinic. I was tested for a panel of allergies. She asked about my booster shot compared to symptoms. She ruled out any allergies that would be causing this and suggested these hives were caused from the vaccine. The allergist prescribed Zyrtec to take daily for two months. Then stop taking to see if the hives were still there. I stopped taking it and the hives reappeared. I am back on Zyrtec and plan to go for a follow up. The Zyrtec helps with the symptoms.
Patient states that he woke up with a rash all over his body and swelling in the legs.  I strongly advised the patient to call his physician.  (Provider's office closed at this time)
Dr said I have polymyalgia.  Never had it before the shots. Pain in all my joints, and weak muscles.
Within a couple of hours of vaccination, she started crying and vomited several times. On evaluation, she was felt to have unusually tender thigh where vaccine had been administered. Following APAP administration, she was consolable, until moved or manipulated, especially by lower extremities.
upper left arm , where received the vaccine , is swollen; Hot upper left arm; Itchy upper left arm; Very painful upper left arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (upper left arm , where received the vaccine , is swollen), FEELING HOT (Hot upper left arm), PRURITUS (Itchy upper left arm) and PAIN IN EXTREMITY (Very painful upper left arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PERIPHERAL SWELLING (upper left arm , where received the vaccine , is swollen), FEELING HOT (Hot upper left arm), PRURITUS (Itchy upper left arm) and PAIN IN EXTREMITY (Very painful upper left arm). At the time of the report, PERIPHERAL SWELLING (upper left arm , where received the vaccine , is swollen), FEELING HOT (Hot upper left arm), PRURITUS (Itchy upper left arm) and PAIN IN EXTREMITY (Very painful upper left arm) outcome was unknown.            No concomitant medications were reported. Treatment details were not provided.
Headache, body aches, abdominal discomfort/mild nausea, fatigue, mild chills/shivering, moderate pain and redness/hard swelling at injection site (@4 inch diameter welt), 100ºF fever.  All side effects resolved within @40 hours of injection except painful welt, which is still slowly shrinking and less painful.  I felt no need to contact doctor over these symptoms as they dissipated within  48 hours.  I had similar but less pronounced side effects after the first injection in the series, so I knew to expect some discomfort.  I am filing this report because the Shingrix site suggested doing so.
1" x 2" area of redness at injection site. Slight induration. Slight itching. Hydrocortisone cream. Warm/cool compress.
10MINUTES  AFTER SHOT-CLENT STARTED  COMPLAINING ABOUT FEELING HOT- BECAME PALE IN HER FACALSO SHE STARTED HAVING SPME NAUSEA- B/P 121/91-103-PULSE O2-99(11:10)- OFFERED WATER AND SNACKS-UNAB;E TO EAT SNACKS- 11:15 B/P-148/106 -PULSE-87 O2-99- DR. ASSESSED CLIENT AMD ASSURED SHE WAS DID NOT NEEDED TP BE TRANSPORTED.= AFTER ADDITIONAL 15 MINUTES C;IENT B/P- 134/88- 82= OFFFERED A RIDE HOME-CLIENT DECIDED TO DRIVE HERSELF
It was on May 20 2021 between four and five AM that my smart watch woke me up with high rate heart notification so I did one lead EKG on watch and indicated I was in atrial filiation I took six readings from my home to the hospital and the heart rate ranged form 116-143 BPMs. At the hospital blood work was done and all results were normal.
3" diameter red circular rash around injection site persisting for 2+ weeks, including itching
Coughing starting Saturday Sun - flu-like sx, joints achy, exhausted, Mon- not aching, increased energy but wobbly & weak, sweats when walks. Pt. to follow up physician. No SOB, no wheezing, remained conscious.
10/5 UC with dizziness, 10/9 symptoms of dizziness decreasing with Meclizine, 10/13 Dizziness increases with photosensitivy, 10/16 Dizziness with vision changes sent to ER
Varivax on 3/6/00. On 3/9/00 had brief episode of leg weakness. On 3/15 seen with leg weakness. Neurologist exam on 3/16/00; dx: periodic paralysis, resolved spontaneously.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in right arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, Covid-19. Treatment product Paxlovid, for indication treatment of COVID-19. Clinical information: The patient was previously received a COVID-19 Vaccine. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment: Yes. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
arrivied via ems from home, fell, per pt missed the chair, no head injury, no LOC, denies any blood thinners, pt did C/O weakness x3 days. Covid exposure 3 days ago
Painful, itchy rash on right deltoid in region mom reports both vaccines were given. Rash covered entire shoulder and half of upper arm. It was treated in our ED on 1/30 and resolved when I saw her 2/1. Successfully treated with BENADRYL.
Patient received a flu shot in her left arm and PREVNAR 13 in her right arm. Patient's husband reported to the pharmacy today to show a picture of red bruising on the patient's right arm and stated that the bruising began originally on 10/30/2018 and is "warm to the touch" as of last night. The patient's husband has also stated that the patient's temperature is normally 97.6 but is now 98.6 degrees as of today. The patient has not reported any adverse effects to her left arm and has not reported any difficulty with breathing.
Breakthrough case:  Patient is fully vaccinated, first dose 12/29/20, second dose 1/19/21.  Patient tested positive for COVID-19 on 11/22/21.
Received dose one of Moderna covid vaccine on 3/12/21 lot number 001B21A. Received dose two of Moderna covid vaccine on 4/11/21 lot number 037A21B. At the time of vaccine, patient was 31 years old and had a regular menstrual cycle of ~32 days for almost 3 years straight. Since getting vaccinated, all menstrual cycle stages ceased. No ovulation, periods, etc. As of 11/3/21, it is now 7 months from date of second vaccine. Had a full gynecologist visit in February prior to vaccination, with many labs done and every deemed adequate. To add, there is no pregnancy with several tests being administered. Turned 32 in June and while yes, stress and factors do exist, starting to consider this a side effect of the vaccine.
Pt was admitted to her local hospital for less than 7 hours for fever, chills, fatigue, intense body aches, nausea and vomiting.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Lot number: EL3247), in Apr2021 as dose 2, single (Lot number: EL3247) and in Dec2021 as dose 3 (booster), single (Lot number: FE3594) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31May2022, outcome "recovering" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical information: Age group Adult: , Facility type vaccine: . No other vaccine in four weeks. No Covid prior to vaccination. The patient was tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Patient had a rash localized to the lower back in 2018. After getting the first dose of the SHINGRIX, that rash was spread from head to toe per patient.
5 days p/vax lt arm became very hot & hard-4" long - 1 1/2" wide;saw MD 15NOV96;told had a infect from vax & was put on ATB;area much smaller 18NOV96;
Positive 5/2 for Covid now with 2 days of increased dyspnea. Hospitalized with pneumonia due to Covid 19. Hypoxia. Receiving Remdesivir and dexamethasone
pt inadvertently given vax & devel an inj site rxn;pt was recovering as of the date of this report;
This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 74-year-old female patient who received SHINGRIX. On 17th May 2018, the patient received the 2nd dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue. On 18th May 2018, the patient experienced injection site pain, myalgia and sleepiness. In May 2018, the outcome of the myalgia and fatigue were recovered/resolved. On 20th May 2018, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the sleepiness was unknown. The reporter considered the injection site pain, myalgia, fatigue and sleepiness to be related to SHINGRIX.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced myalgias and fatigue which were not experienced after the first dose of SHINGRIX. She did Pilates later that day with some fatigue and less performance than usual, but on 18th May 2018, 1 day after receiving SHINGRIX, the patient really noted the fatigue and myalgias which she initially attributed to Pilates but realized was secondary to the vaccine especially as she found herself sleepy and falling asleep several times throughout the day. There was also some moderate injection site pain she described as like a flu shot on the 18th which by 20th May 2018 was resolved completely (see case US2018GSK096241). On the day of reporting all symptoms had completely resolved. She did attribute all the aforementioned symptoms to receiving SHINGRIX. This case has been linked with US2018GSK096241, reported by the same reporter for the same patient.
I?ve had a heavy period with clotting for a month now. I usually don?t have one at all because I have an IUD, but it started on May 3rd, and has lasted throughout the whole month. Also have had mood swings and headaches that are unusual to me.
first one sore; This case was reported by a consumer via media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received 1st dose of Shingles vaccine and experienced sore. The patient also had the second one which was sore but not both and one day it's good to get your single shot it helps keep itching bumps and everything away from you and patient feel fine. The reporter reported that some people can take the shingles shot some people cannot like patient for instance it was all right for patient. For tolerance with 2nd dose of Shingrix, refer case US2021AMR127226.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR127226:Same reporter
Extreme vertigo. Loss of balance. Loss of memory. Had to be taken to be laid down to sleep.  When woke up 4 hours later there were no symptoms. It happened again a few days later.   Then a few days later. It has happened a total of 8 times - the most recent were 7/4/21 and 7/6/21. Extreme vertigo and loss of balance without loss of memory during the last 6 of the 8 episodes. Never had episodes anything like this in the prior 47 years before the vaccine.
Cold sores; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Apr2021 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included oral herpes simplex virus (HSV), always asymptomatic which was diagnosed in 2009 (12 years). The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. On 19Apr2021, the patient's immune system seemed to have triggered the formation of a cold sore after second dose of vaccine. The patient was unsure whether she would now have symptomatic oral HSV moving forward. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event cold sore was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
vaccination site told the consumer that he need to wait for 90 days before getting his second dose; got COVID-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (got COVID-19 positive) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccination site told the consumer that he need to wait for 90 days before getting his second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.No concomitant medication was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (got COVID-19 positive). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccination site told the consumer that he need to wait for 90 days before getting his second dose). At the time of the report, SARS-COV-2 TEST POSITIVE (got COVID-19 positive) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccination site told the consumer that he need to wait for 90 days before getting his second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, SARS-CoV-2 test: Positive.   Treatment medication was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
PATIENT HAS LEFT SUPRACLAVICULAR LYMPH NODE SWELLING. LEFT AXILLARY LYMPH NODE SWELLING. AND TENDER LEFT BREAST.
Symptoms: Child became irritable and bowels were extremely active. Area arround eyes and mouth turned red and eyes appeared red. A rash over the entire body began to occur. No labored breathing and lungs were clear. Treatment: Called on call physician. Instructed to give 1/2 TSP of Benedryl every 6hrs. Infant brought to Physician next day for followw up. .
pt recvd vax 6PAR93 & on 9APR93 pt devel a knot @ the inject site which persisted 4 wks following vax; No further details were provided;
itchy red rash at site of injection about 2-3 inches in diameter; feels firm and warm to touch; occurred for 24 hours after initial injection and went away, but has returned 1 week later
48 hours post injection, the site became hot, itchy, red and bumpy. The symptoms eased after three days. Three days after that (8 days post injection) the site began turning red and the splotch started to spread covering a lager area around the injection site. The last three days, it has slowly looked larger in area, and has remained red, hot and itchy. Today I could see a clear outer ring spreading around the injection site (like a corona) in the morning. This evening there?s now a section spreading asymmetrically outward on one side of the ring. I?m 10 days post injection.