chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 5-6 days after the 2nd vaccine dose I have broken out in an itchy skin rash; The breakouts are located in random places (e.g., small clumps on shoulders, individual lumps on stomach, back, hips, inner thighs, arms), but not at the vaccination site.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Aug2021 at 11:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and stupidity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included thyroid (ARMOUR THYROID), herbs and calcium (MANUFACTURER UNKNOWN) all from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Aug2021, approximately 5-6 days after the second vaccine dose, the patient had broken out in an itchy skin rash that she thought may be due to fleas, mosquitos, or bedbugs, however, there was no evidence of any in her home. The breakouts were located in random places (e.g., small clumps on shoulders, individual bumps on stomach, back, hips, inner thighs, arms), but not at the vaccination site. Rash was still active, not recovered at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events the patient had broken out in an itchy skin rash that she thought may be due to fleas, mosquitos, or bedbugs, however, there was no evidence of any in her home; the breakouts were located in random places (e.g., small clumps on shoulders, individual bumps on stomach, back, hips, inner thighs, arms), but not at the vaccination site was not resolved 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.
Client's intradermal Jynneos-BN 0.1mL injected into Left Forearm at 5 degrees did not produce a wheal or bleb, client informed that this was not expected result and would need another injection, he verbalized understanding and 0.5mL Jynneos-BN given subcutaneously in the back of the left arm.
Patient received their COVID vaccine in the pharmacy waiting area and went to the pharmacy register to pay for an item after receiving the vaccine.  The patient fainted or passed out at the register.   The patient fell backwards and collapsed.  The patient recovered almost immediately after passing out.  We called 911 and had the paramedics come take a look at the patient.  While waiting for the paramedics we had the patient sit in a chair and wait.  We gave the patient orange juice to drink since the patient was a diabetic and he said he felt a lot better after drinking the orange juice.  He was treated by the paramedics onsite but didn't go with them and left the store on his own.
Mother relates child had a quarter size or > red raised area at varicella site 8/26/15 by bedtime. 8/27/15 the area was baseball size and had fever, site warm to touch. Instructed to use cool moist cloths and see M.D. asap. 8/31/15 follow up call-child was referred to a surgeon and the site was opened to drain. No further problems reported. Had f/up appt. 9/1/15 with surgeon was given AUGMENTIN and clindamycin.
This is a spontaneous report from a contactable nurse (patient) via Medical information team. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265, Expiry Date: 31May2021) via an unspecified route of administration in left arm on 18Feb2021 (at the age of 70-year-old) as dose 2, single for COVID- 19 immunisation. Relevant medical history included ongoing secondary hypoadrenalism (diagnosed 8 years ago, she takes steroids for it). It was further clarified that secondary hypoadrenalism came from her having a pituitary brain tumor benign that was diagnosed 8 years ago, and radiation to that in Feb2018; ongoing Hypothyroidism (she has had this for 20 years, she takes a thyroid medication). Concomitant medications were none (the patient had not received any other recent vaccinations or medications). The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) on 26Jan2021 (at the age of 70-year-old) as dose 1, single for Covid-19 immunization. The patient received her second dose of the Pfizer covid vaccine on the 18Feb2021 and clarified that she had muscle achiness, she had joint pain in her knees and shoulder. The patient had facial skin sensitivity. She said for the sensitive skin on face treatment she was going to see her doctor today to see if it could be shingles, thought there was no rash, it was just sensitive around her right eye. At the time of reporting, the patient aching got better. Seriousness was not provided. The outcome of the event of hyperaesthesia was unknown and other events was recovering.  No follow-up attempts are possible. No further information is expected.
BP at 1105 154/105, Pulse 86, O2 Sat 100%. Near syncope, hand numbness and itchiness
1.5" x 3" erythematous, firm and warm to touch, at injection site.
Localized swelling and erythema ~ 10X12 cm over left deltoid (location of vaccination administration yesterday) - was administered at a different clinic and came to WIC to be evaluated.
Left chest pain within a few hours of shot, along with malaise, diaphoresis. Accompanied by fatigue, chills, fever, nausea, headache over next 48 hours. Other symptoms resolved after 48 hours with rest and 500-650 mg Tylenol 2-3x/day, except chest pain, pleuritic at times, associated at times with nausea, retching, cough, fatigue. Chest pain was 3-5/10 and intermittent, until escalated to 10/10 and awoke me from sleep 60 hours after shot, no longer pleuritic but crushing, associated with sense of doom, nausea/vomiting, and radiation to left ear.  This episode lasted about an hour and returned to 1-2/10 pain after 650 mg Tylenol by the time I reached the ED. Found to have elevated troponin, and cardiac MRI identified myoperciarditis. Admitted for 1 night. Being treated with colchicine and ibuprofen (initially aspirin given contra-indication to NSAIDS due to history of idiopathic angioedema).
Shingles rash and symptoms appeared in left arm ~ 5 days after shot but itchiness, nerve pain, fatigue appeared 1-2 days after. Now 11/26/21, still experiencing itchy skin all over, fatigue.
Pain at injection site; muscle pain below injection site; severe bruising below injection site; This is a spontaneous report from a contactable consumer reporting for himself. An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL8982, expiry date unknown) on 16Jan2021 15:30 at a single dose via an unspecified route of administration in his left arm for COVID-19 immunization. Medical history included diabetes, heart disease and arthritis, from unknown date and unspecified if ongoing. The patient had known allergies to penicillin and tramadol hydrochloride (ULTRAM). The patient's concomitant drug included apixaban (ELIQUIS), no other vaccine received in four weeks. The patient had not had COVID prior the vaccination and no COVID tested post the vaccination. On 16Jan2021 (time provided as 22:00), the patient experienced pain at injection site, muscle pain below injection site, severe bruising below injection site. The patient took apixaban and he believed the injection caused severe bruising. The patient received home remedy: elevated arm applied warm compress, as treatment for the events. The patient was recovering from the events.
Patient received Moderna booster on 1/11/2022 after already receiving J&J booster on 11/2/2021.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 24-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L023936, exp. date: 15-MAR-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received form a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2014, GARDASIL underwent a temperature excursion. On 11-AUG-2014, the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
had redness, swelling and itching for approximately three weeks after receiving what she understood was a shingles vaccine; had redness, swelling and itching for approximately three weeks after receiving what she understood was a shingles vaccine; had redness, swelling and itching for approximately three weeks after receiving what she understood was a shingles vaccine; This spontaneous report was received from a lawyer and the patient, and refers to a female adult  patient (57 or 58 years-old). The patient's concurrent history included abstains from alcohol and non-tobacco user. The patient's medical history included road traffic accident, injury, knee Operations (three) and historic vaccinations included flu (unspecified). No information was provided regarding the patient's previous drug reactions, allergies and concomitant medications.  In approximately 2015, the patient was vaccinated with what she understood was a shingles vaccine (manufacturer unknown) from the pharmacist at her workplace (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis.  In approximately 2015, the patient experienced redness (erythema), swelling and itching (pruritus) for approximately three weeks after receiving the vaccine. The outcome of pruritus, swelling and erythema was reported as recovered.        The reporter did not provide the causality assessment between the events and therapy with shingles vaccine (manufacturer unknown).  On 15-FEB-2019, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) and experienced adverse events, under litigation (Captured in: 2202USA003923).; Sender's Comments:  US-009507513-2202USA003923:
Started itching and broke into hives. Rash on injection sight (right thigh). Slight fever. Gave Benadryl. Barely ate that day. Hives cleared some in a few hours and completely cleared the next day.
tinnitus for several years which worsened; little tired; sore arm; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), dose 1 via unspecified route of administration on Feb2021 as single dose for COVID-19 immunisation. Medical history included ongoing tinnitus. Concomitant medications were not reported. Patient asked he would like to know if there is data on anyone who had new or worsened tinnitus after receiving the 1st dose of the Pfizer COVID vaccine. After receiving the vaccine last week, he reported a history of tinnitus for several years which worsened the morning after receiving the vaccine on an unknown date in Feb2021, when he woke up. He was also a little tired on Feb2021 and had a sore arm for the first couple of days on Feb2021. And patient would like to know if he could get the second dose of the Pfizer COVID vaccine after his experience with the 1st dose and what is considered a severe allergic reaction to the COVID vaccine and how quickly it could occur. Patient would like to know what is an example of the contraindication: had a severe allergic reaction to any ingredient of this vaccine and would like to know the efficacy of one dose of the COVID vaccine. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: patient requested call 911, 911 came , check blood presuure , they said everything is fine and advised the patient to follow up with the provider
Patients vaccinated using old vial from 03/10/21; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients vaccinated using old vial from 03/10/21) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients vaccinated using old vial from 03/10/21). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients vaccinated using old vial from 03/10/21) outcome was unknown.        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 medications were reported. No Treatment information was reported.   This case was linked to MOD-2021-208074, MOD-2021-258552, MOD-2021-258572, MOD-2021-258587, MOD-2021-258599, MOD-2021-258615, MOD-2021-258632, MOD-2021-258644, MOD-2021-258660, MOD-2021-258672, MOD-2021-258682, MOD-2021-258689, MOD-2021-258691, MOD-2021-258693, MOD-2021-258697, MOD-2021-258699, MOD-2021-258702, MOD-2021-258703, MOD-2021-258704, MOD-2021-258706, MOD-2021-207548, MOD-2021-258660 (Patient Link).
Pt had progressive shortness of breath/weakness and fatigue. CT scan did not show PE. CK level was 17000, inflammatory labs were mixed. Rheumatology consult concluded it was myositis related to COVID vaccine. admitted to hospital 4/27-4/30.
Cough; Diarrhea; Headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of   in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        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 information was provided.
Slight circular swelling (3/4 inch in diameter) around injection site in left arm beginning today (3/19/2007).  Maybe some minor weakness in that arm with weight lifting.
lethargic, weak, difficulty with movement of extremities. Unable to sit, inflammed joints
Caller Got covid vaccine 12Jan- tested positive on 19Jan; Caller Got covid vaccine 12Jan- tested positive on 19Jan; This is a spontaneous report from a Pfizer sponsored program. A non-contactable male consumer (Patient) reported a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced tested positive on 19Jan2021 and wondering if it's okay to get the second dose.  The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Within 15 minutes after vaccine, patient was light headed and sweating.  Had patient lay down and gave him Sprite to drink at his request.  Sypmtoms resolved within a few minutes. Patient was monitored for an additional 20 minutes and felt fine.
Swelling in the bicep area. The area was hot and swollen. It was swollen to where it was just puffy not tight per patient.
Client came into vaccination clinic. RN BSN administered vaccination and then realized it had only been a little over 4 months and not the 5 months yet. Client was informed she had received the vaccine a little too early. She stated husband was headed to clinic to get his vaccine. She was informed that her husband would need to wait one more month since his last vaccine was the same date as hers.
Patient received menactra vaccine and approx. 3 min later patient had syncopal  episode in clinic room. Dr. responded. Vitals obtained O2  96%, HR 66, B/P 93/53, temp. 98.2. Per Dr. patient had vasovagal syncopal  response to vaccine. Patient noted to have bite mark to lower lip, no other  visible injury. Patient denies hitting head. Patient monitored in clinic for 30 min. after event. Patient mother present and instructed to take patient to ER for worsening symptoms. Mother voiced understanding.
Information has been received from a 43 year old female respiratory therapist with asplenia, spherocytosis and antiphospholid antibody syndrome who on 19-FEB-2007 was vaccinated IM in the left deltoid with a dose of Pneumovax 23. Concomitant therapy included COUMADIN. Thirty minutes after the injection the patient's left arm became swollen. Her arm was extremely painful and she began taking 2 VICODIN tablets ever 2.5 hours to control the pain. The next day, 20-FEB-2007, she called the office and was referred to an orthopedic physician who examined her on 22-FEB-2007. By that date, the patient stated that the pain was so bad that she felt as though her arm was dislocated. The physician diagnosed her with synovitis and withdrew the fluid from her joint. She was prescribed steroids and BACTRIM. On 23-FEB-2007 her arm became swollen from her shoulder to her wrist and felt warm to touch. She was admitted to the hospital later that day. A joint lavage was performed. She was treated with IV LEVAQUIN and unspecified pain medication. On 26-FEB-2007 she was released from the hospital with VALIUM, LEVAQUIN, OXYCONTIN. The following week, the patient began occupational therapy and was still receiving therapy at the time of the report. The swelling in her arm had decreased but it was still very painful to move. She had some improvement and was able to move her wrist and elbow but had problems moving her shoulder. The reporter considered synovitis to be immediately life-threatening, disabling, and an other important medical event. There was no product quality complaint involved. No further information is available.
Injection site pain immediate and severe.  Pain started at the time needle inserted and increased as Vaccine was administered.  Severe Pain diminished somewhat in first 72 hours but moderate to severe pain remains in L arm around and adjacent to injection site.  Pain exacerbates with motion of the arm.  No injection site erythema, edema or rash was ever noted.  At present, I am experiencing constant pain wich exacerbates upon movement of my arm and have difficulty performing activities of daily living.
severe local allergic rxn 10x15cm area of redness, no sign of infect on lt thigh;
0230 - chills, achey all over, 0630 - severe nausea, 0700 - began vomiting and then diarrhea repeatedly until so weak that took ambulance to ER - arrived with temp of 103.1, dehydration, hypokalemia - given 3000 cc of lactated ringers, IV Zophran, IV compazine, IV potassium, Tylenol, extensive labs including full resp panel  which ere neg, CT of and and pelvis, (2) 12 lead EKG?s, abnormal rhythms in strip, elevated Troponin that stayed same 2 hrs later - in ER over 12 hrs
big, itchy patches all over both of my legs; site of the injection was really hot, red, and itchy; site of the injection was really hot, red, and itchy; site of the injection was really hot, red, and itchy; Little lump; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (Little lump), PRURITUS (big, itchy patches all over both of my legs), VACCINATION SITE WARMTH (site of the injection was really hot, red, and itchy), VACCINATION SITE PRURITUS (site of the injection was really hot, red, and itchy) and VACCINATION SITE ERYTHEMA (site of the injection was really hot, red, and itchy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE MASS (Little lump). On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (site of the injection was really hot, red, and itchy), VACCINATION SITE PRURITUS (site of the injection was really hot, red, and itchy) and VACCINATION SITE ERYTHEMA (site of the injection was really hot, red, and itchy). On an unknown date, the patient experienced PRURITUS (big, itchy patches all over both of my legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 22-Feb-2021 at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Little lump), VACCINATION SITE WARMTH (site of the injection was really hot, red, and itchy), VACCINATION SITE PRURITUS (site of the injection was really hot, red, and itchy) and VACCINATION SITE ERYTHEMA (site of the injection was really hot, red, and itchy) outcome was unknown and PRURITUS (big, itchy patches all over both of my legs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-096058 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: The event pruritis outcome was changed from unknown to not recovered.
Mild headache soon after injection (Friday afternoon) which got worse through the night.  Severe headache all day Saturday and moderate headache all day Sunday.  Mild headache still today, Monday morning. Saturday I had major fatigue and couldn't walk up a short hill without being out of breath.   Some chills Saturday afternoon.   And periodic periods of abnormal sweating throughout the weekend and this morning as well.\ My prescription morphine for back pain wasn't working for the headache.  2 ibuprofen tablets were taken at 4 different times this weekend with no real noticeable impact.   Didn't know anything else to try.  Drank a lot of water.
Severe flu like symptoms within 9 hours, fever of 103.5 within 12 hours. Severe headaches pressure, and feeling of burning in the head, eyes, and ears. At 18 hours, fever remains at 101.1, with severe headache pressure.  Treatment included acetaminophen and water.
Redness, swelling at and around injection site starting 24 hours after injection also with fever to 102 degrees.