chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives on back, arm, knee, toe and hands; Itching on different parts of body; This is a spontaneous report from a contactable consumer, the patient.  A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3248), via intramuscular route of administration on 13Jan2021 at 13:35 (at the age of 25-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included asthma that is fairly mild (the patient has rescue inhaler that she does not use very often, she uses it once every few months as needed.  Diagnosed in early childhood when she was 4-5 years old). The patient had no relevant family medical history.  Concomitant medications included an unspecified medication, the patient reported she has been taking it for years, but did not provide further information. Historical vaccine included flu shot in Nov2020, which was greater than 4 weeks prior to receiving the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Jan2021 at 15:00-16:00, the patient experienced itching on different parts of body. On 14Jan2021 at 10:00, the patient experienced hives on back, arm, knee, toe and hands. The reported clinical course was as follows: Initially, on the first day, she had itching not at injection site.  It was on different parts of her body.  The following day, she developed hives on her back, arm, knee, toe and hands.  The patient reported it is not very severe, she did not have any fever, swelling, or shortness of breath. The patient reported some of the areas have gone down and some have inflamed more. The patient did not undergo any relevant test and reported just visual examination. The patient went to urgent care (physician office) and they said it was potentially caused by the COVID-19 vaccination.  The patient was prescribed steroids by the urgent care as treatment for the events. The patient received one steroid injection of Methyl Prednisone into her buttocks and then was prescribed prednisone 10 mg tablets. The clinical outcomes of the itching on different parts of body and hives on back, arm, knee, toe and hands were not recovered. The patient was inquiring if she should get the second dose.
vaccine was expired, no temperature excursions occurred and moderna determined the vial "maintained the activity necessary to protect against the SARS Co-V2 virus at the time of administration".  Patient reported on adverse reactions.
Influenza shot virus vaccine. Back pain, upper arm pain for a month, sore throat fever, stuffy nose. Irritability upper arm tenderness and decreased range of movement.
Got high fever, chills, headache that go along with the normal symptoms but had heart palpitations. Thought it was body in shock from everything- COVID symptoms cleared up in a day, but the heart palpitations continued to happen very frequently for weeks
Pt  called the day after receiving her vaccine, stating she was experiencing chills,body aches, nausea, vomiting, could not keep nausea meds or even sips of water down, also reports her blood pressure spiked and she does not take any blood pressure meds. Pt was advised to report to ER.
18 YOF had a brief syncopal episode after receiving the vaccine. She felt lightheaded  associated with nausea prior to the syncopal episode. Pt has a fear of needles and reports that she did not eat much this morning. Denies CP, SOB, palpitations, difficulty breathing or any other complaints. There was no head injury.
Fever, Chills, runny nose, diarrhea, muscle and joint ache, extremely tired
Info has been received from a registered pharmacist concerning a female registered nurse who on 10/11/2002 was vaccinated with pneumococcal vaccine 23 polyvalent (Lot #640981/1050L) intramuscularly in the deltoid. The registered pharmacist reported that he heard from a physician's office that three members of the office staff received pneumococcal vaccine 23 polyvalent and experienced swelling from the site of the injection down to almost the elbows. Follow-up info from the registered nurse indicated that 3 employees, herself included, were vaccinated with pneumococcal vaccine 23 polyvalent on 10/11/2002. (The registered nurse administered 2 vaccinations and she received her vaccination by someone else). All 3 pts experienced soreness in a few hours. The swelling appeared that night. The area was warm and inflamed. Two of the pts were treated with ice. The reactions seemed to resolve in 48 hours. Unspecified medical attention was sought. Related reports: WAES #0210USA02049 and 0210USA02050. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
about a week and a half after taking the booster shot, 3rd covid vaccine, i began to get cold sores none stop. I f/u with my dr on 11/17 about cold sores. On 11/24, I was diagnosed with shingles. The day after to completed treatment for shingles, I was diagnosed with strep on 12/2. On 12/23, i tested positive for covid, whole time, expect when I was on shingle medication, I've been having multiple cold sores on my mouth, nostrils, corners of my mouth/ & face.
Abnormal gait - walks with wide and wobbly gait, swinging hips around.
This spontaneous report as received from a pharmacist refers to a 74 year old female patient with no drug reactions or allergies. On 18-MAR-2015, the patient was vaccinated with ZOSTAVAX 0.65 ml, lot # K026365, expiry date: 15-MAR-2016, subcutaneous in the right arm. Concomitant therapies included hydrochlorothiazide, MAXZIDE, BACTRIM DS and triamcinolone cream. On 24-MAR-2015, the patient woke up with rash/bumps on her left forearm and later in the day, rash became red and started to blister. Patient also reported itching around rash. Patient described rash to pharmacist as "looking like fiery ants bites". The patient sought medical attention - spoke to pharmacist. Pharmacist reported that patient put BENADRYL cream on rash and BENADRYL helped with itching. Pharmacist reported that patient received ZOSTAVAX in her right arm and rash appeared on left forearm. No lab diagnostic studies had been performed. The outcome of the events was reported as not recovered/ not resolved. Relatedness between the events and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
PATIENT COMPLAINED OF A HEADACHE AND A RASH IN HER RIGHT ARM. BY THE TIME OF EVUALTION RASH WENT AWAY AND PATIENT STATED THAT SHE FELT BETTER. VITALS WERE NORMAL.
Extreme shaking chills.  Significant soreness/pain in arm of injection.  Difficulty moving arm.  11/30/09 DOS 11/20/09   Final DX: Rhabdomyolysis and presumed postviral myositis.  On 11/19/09, Pt c/o lower leg pain bilaterally, swelling and macular rash. On examination: bilateral edema with tenderness to deep palpation below the knees bilaterally. Pt developed difficulty urinating, inability to walk due to the LE pain.  12/01/09 Consult notes DOS 11/22/09  11/24/09. DX: rhabdomyolysis, myoglobinuria, possible viral infection or post vaccination associated myositis. Pt continues c/o pain and swelling in LE.
Hepatitis A administered today, mother called in stating pt. had 1 vomit episode after the shot, mother denies any other concern or symptom at this time, advice to keep pt. under observation, if vomit persist or any other symptom, to call back or take pt. to the urgent care for medical evaluation, mother agreed and instructions verbally understood.
This serious initial spontaneous case, was received from Other Non-Health Professional on 27-Nov-2017, concerning a 59-year-old, adult female patient. The patient had received in past flu vaccine and had sharp pain in right shoulder into chest, watery itchy eyes and pleurisy. It was reported that the patient broke her left shoulder in the last July (year unknown). Concomitant medications included: Baby aspirin, Multivitamin and Calcium for unknown indication. On 08-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195781, expiry date: not reported). On 10-Nov-2017, after 2 days of vaccination, the patient woke up in middle of the night with sharp pain in right shoulder into chest and was diagnosed with pleurisy that lasted for 2 weeks. The patient also had watery and itchy eyes. The patient visited urgent care. The chest x-ray and oxygen saturation was found to be normal. It was reported that the patient did not have treatment measures associated with the events. The outcome of the events (watery and itchy eyes) was recovered on 15-Nov-2017 and the event pleurisy was recovered on 27-Nov-2017.
No additional AE details; 1 dose of VAQTA was inadvertently administered to a patient less than the recommended age; This spontaneous report was received from a nurse referring to an infant (could have been 6 weeks old, 7 months old, or 9 months old, but the reporter was not sure exactly which patient received the vaccine) patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On an unspecified date between 26-DEC-2022 and 30-DEC-2022, the patient was inadvertently vaccinated with 1 dose of hepatitis A vaccine, inactivated (VAQTA) injection (0.5 ml, lot#: W036135, expiration date: 13-MAY-2024; strength, route of administration, anatomical location were not reported) for prophylaxis. The patient was less than the recommended age (product administered to patient of inappropriate age). No additional adverse event details were reported (no adverse event).
Started with chills and then severe body aches to were I felt almost stiff. It was painful to move.  Dizziness, slight headache. This last through the night of 10/22 until mid noon of 10/23. By mid day all I was having were sweat break outs and my body was just sore. I called my PPI in the morning and was prescibed Atarax. Missed two days of work.
is there a possibility that I have to many red blood cells because of the vaccine/is the vaccine causing me to have to many red blood cells; I am  having issues with my blood counts since the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of POLYCYTHAEMIA (is there a possibility that I have to many red blood cells because of the vaccine/is the vaccine causing me to have to many red blood cells) and BLOOD COUNT ABNORMAL (I am  having issues with my blood counts since the vaccine) in a  patient of an unknown age and gender 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 POLYCYTHAEMIA (is there a possibility that I have to many red blood cells because of the vaccine/is the vaccine causing me to have to many red blood cells) and BLOOD COUNT ABNORMAL (I am  having issues with my blood counts since the vaccine). At the time of the report, POLYCYTHAEMIA (is there a possibility that I have to many red blood cells because of the vaccine/is the vaccine causing me to have to many red blood cells) and BLOOD COUNT ABNORMAL (I am  having issues with my blood counts since the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: abnormal (abnormal) issues with blood counts. On an unknown date, Red blood cell count: increased (High) many red blood cells.     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.   No concomitant medication was reported.                   No treatment medication was reported.
tic-eyelid;blinking rt eye excessive since hep b vax #2;
Patient complained of light headed and dizzy. She was giving water and laid down after 3 mins of drinking water in a seating position. The ems was called after  15 mins because the patient was still feeling dizzy when she sad down. After being checked by the ems and asked to stand when patient affirmed of feeling better, she refused to go to the hospital. She left the building walking on her own to the car. She affirmed that she felt fine.
This spontaneous report was received from a physician and refers to a 2 year old female patient. The patient's concurrent conditions, medical history and allergies were not reported. On 13-SEP-2017, the patient was vaccinated with an unspecified improperly stored dose of VARIVAX, lot number M033905 with expiration date 28-JUL-2018, for prophylaxis (strength, dosage schedule, route and anatomical location were not reported), which was reconstituted with a properly stored sterile diluent (STERILE DILUENT). Concomitant therapies included M-M-R II, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid, pneumococcal conj vaccine (unspecified), and hepatitis a virus vaccine (unspecified). No adverse event was reported. The administered dose experienced a temperature excursion of 15 to 46 degree Fahrenheit for 1 hour and 20 minutes;it was also reported that due to a natural event the VARIVAX was transported from the physician's facility to another in a refrigerator container instead of a freezer, and the container temperature was 40 degree Fahrenheit for 40 minutes for both outgoing and return trips, data logger was involved. No previous temperature excursion was reported. This is one of two reports from the same reporter.; Sender's Comments: US-009507513-1709USA012166:
it was like having Covid again; anxiety attack; 102.5°F; joint pain and muscle pain; joint pain and muscle pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (it was like having Covid again), ANXIETY (anxiety attack), PYREXIA (102.5°F), ARTHRALGIA (joint pain and muscle pain) and MYALGIA (joint pain and muscle pain) in a male patient of an unknown age 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 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 COVID-19 (it was like having Covid again), ANXIETY (anxiety attack), PYREXIA (102.5°F), ARTHRALGIA (joint pain and muscle pain), MYALGIA (joint pain and muscle pain) and HEADACHE (headache). At the time of the report, COVID-19 (it was like having Covid again), ANXIETY (anxiety attack), PYREXIA (102.5°F), ARTHRALGIA (joint pain and muscle pain), MYALGIA (joint pain and muscle pain) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
C/O Jolt through body, following dizzy, light headed, all extremity weakness (greater in legs-:"heaviness"). Tingling in face/throat(no swelling and no breathing difficulties), decreased sensation in legs to touch, no pain, last 75minutes and taken to ER d/t not resolved
DTaP and IPV given 8/5/03. Large red area around shot developed 8/6 PM. Spreading slightly. Warm, slightly raised, no itch or pain, able to walk on leg. Area documented 8/8 to be 13cm x 9.5cm in diameter.
Warm, red, raised area at injection site, 24cm in diameter, no respiratory distress, note 18.5 hours later.
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 18-SEP-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to two separate temperature excursions (dates unspecified): one with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius) and another with the highest recorded temperature of 47 degrees Fahrenheit (8.333333333 degrees Celsius), each of them lasting for 24 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
varicella vaccine administered in RUE on 9/20/07. Family reports swelling, redness, and warmth at site on 09/21/07. Phone call from parent on 9/24/07 reports decreased redness and increased swelling. Parent reports arm looks "hive like" is larger than silver dollar and beginning to wrap around arm. I instructed parent to call and inform physician of this vaccine response as to keep medical provider aware of child's symptoms.
Hives - rash - running nose - headache. Severe pain in arm at site of injection. Limited arm movement. Visit medical center 10-24-15 treatment - prednisone - DEPO-MEDROL 80mg - Toradol (60).
This spontaneous report as received from a physician refers to a 11 year old male patient with no pertinent medical history. On 27-JUN-2006, the patient was vaccinated with PROQUAD (Merck), subcutaneous. Lot number reported as 0770R, expiration date 04-AUG-2006. On 16-AUG-2014, the patient developed "a staph infection on the buttocks". On an unspecified date after this, the patient was started on prednisone 20mg daily for 3 days, and also BACTRIM. The patient recovered on 20-AUG-2014. A skin culture was performed (unknown date and results). The patient sought medical attention (went to see a physician). Additional information is not expected.
This spontaneous prospective pregnancy report was received from a nurse regarding to a 30-year-old female patient. The patient's concurrent conditions, historical conditions, past drugs were unknown. Drug reactions/allergies were none. Concomitant medications included unspecified prenatal vitamin. On 17-DEC-2018 the patient came to receive her diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (TDAP) vaccine and was instead vaccinated with a dose of GARDASIL 9 (dose, frequency, lot# and expiration date were unknown) intramuscularly for prophylaxis (wrong product administered). The patient sought medical attention (office visit). The patient was currently 31 weeks of pregnant (exposure during pregnancy). The mistake was discovered on 18-DEC-2018, when the patient back to the office and was vaccinated with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (TDAP) vaccine. The nurse explained that she was unsure if the patient had any history of receipt of GARDASIL or GARDASIL 9 prior to the event. There were no specific adverse symptoms (no adverse event) being reported. No treatment was given for events. The LMP and EDD was not known. The outcome of wrong product administered, no adverse event and exposure during pregnancy was unknown.
muscle weakness; confusion; balance/falling related issues; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 70-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 26Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "muscle weakness"; CONFUSIONAL STATE (non-serious), outcome "not recovered", described as "confusion"; BALANCE DISORDER (non-serious), outcome "not recovered", described as "balance/falling related issues".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe swelling, pain, redness of left arm.  Swelling from shoulder to below elbow.  Very hard, red and hot to touch.
Pt recv  vax on 11/2/98; on 11/13/98 pt exp fatigue, cold sx, paralysis of legs, respiratory failure-intubated; tx=oxygen, physical therapy; Annual follow-up dated 12/21/00 states that the pt reports some improvement, hoever legs remain paralyzed, also reports she was diagnosed with Gullain Barre syndrome.
Lump in armpit muscular tissue.  Felt slight pain, discomfort about 5 days, did armpit/breast check and felt lump about the size of a small grape deep in armpit musculature. Mentioned to doctor and she called back advised it could be a lymph node swelling and I have dr. appt next week on 2/10/2021 for my physical so we will see if it is better.  It does seem to be getting less hard...softening and spreading out a little.
worsening diffuse body pain/arthralgia/myalgia about two weeks after vaccine given. had started with this pain post-viral may 2018 did have  worsening of pain had occurred in july 2018 after 1st dose of HPV 9 given on 7/24/2018.
Injection site pain; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and INJECTION SITE PAIN (Injection site pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa (Moderate To Severe Hidradenitis Suppurativa).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK,CF. In 2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced INJECTION SITE PAIN (Injection site pain). At the time of the report, DIARRHOEA (Diarrhea) had not resolved and INJECTION SITE PAIN (Injection site pain) was resolving.            Concomitant medications details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   It was reported that the patient had burning or tender at injection site and diarrhea.  The reporter's causality for the event of Diarrhea was reported as no reasonable possibility and for Injection site pain was reported as reasonable possibility for Humira.  No treatment medication were provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
2:00 pm Vaccine 8:00 pm - 6:00 am Severe Chills and Body Aches, some leg cramps. Body Aches and headache til 6:00 pm  (28 hours). I then took Ibuprofen.   Felt sluggish for 3 days.   No Fever.  No Nausea.