chrisvoncsefalvay/vaers-outcomes huggingface dataset:
break out with rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 11th January 2022, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had shingle shot in January. The patient broke out with rash on 11th January 2022. The follow-up would not possible as no contact details were available.
headache; fatigue; muscle pain; pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at the injection site".  Additional Information: The patient experienced the events 2-3 hours after receiving her first and second Pfizer Covid vaccines. The reporter (patient's husband) mentioned that the patient had her booster dose on 05Oct2021 and didn't feel anything.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient states that about one week after vaccination she noticed tingling / weakness in her pinky and ring finger which radiates to her arm.  Today is three week out and patient state it still is bothersome.  Recommended patient not take 2nd dose until reviewed with a healthcare provider.
Lump at left neck, diarrhea, pain in Lymph nodes(left and right), arthralgia, fatigue, stomachache and mostly pain in left and right upper body.
Administration of Expired Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided.   This case was linked to MOD-2021-237427 (Patient Link).
Sore shoulder where the injection was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore shoulder where the injection was given) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sinusitis (Sinus allergy.).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore shoulder where the injection was given). At the time of the report, VACCINATION SITE PAIN (Sore shoulder where the injection was given) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD-2021-122922 (Patient Link).
Hallucinations; My left arm felt like it had carpel tunnel and it looked purple/blue in color; My left arm felt like it had carpel tunnel and it looked purple/blue in color; My left arm felt like it had carpel tunnel and it looked purple/blue in color; My arm hurt extremely bad; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0164; Expiration date was not reported) administered on the left arm on 29Jul2021 (15:00) as dose 2 single, with route of administration unspecified, for COVID-19 immunization at the public health department. Medical history included seasonal allergies. The patient's concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot umber: ER8733; Expiration date was not reported) on 01Jul2021 (11:15) (at the age of 39 years old) on the right arm for COVID-19 immunization. On 30Jul2021 (21:30), the patient had hallucinations (to the point where she had almost caused harm to her child); left arm had felt like it had carpel tunnel and it looked purple/blue in color; and arm hurt extremely bad. The patient did not receive any treatment for the reported events. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.  Follow-up attempts are completed. No further information is expected.
On 10/7/17 in the night, patient awoke with left arm/left leg/left hemifacial numbness and weakness. Also palpitations, diaphoresis, shortness of breath and lightheadedness. Went into the bathroom and had an episode of syncope, then generalized weakness, unable to get up. Called to family for help and was taken to the hospital. CVA protocol was followed, patient was admitted to local hospital 10/7 through 10/9. Initial workup including head imaging was all negative. Sought second opinion at hospital 10/10/17. The left-sided limb weakness on exam had prominent giveaway component. They did not find evidence of CVA and ultimately neurologist felt diagnosis was consistent with conversion disorder. Referred for outpatient PT/OT and psychology evaluation due to multiple life stressors and depression.
Mom reports a large swollen armpit  ("hard knot") on the left (vaccine) side, accompanied by fever/aches/headache. Unsure if lymph node/axilla swelling is related to vaccine but the other symptoms were expected while the swelling  not at vaccine site was not
pt developed subdermal rash, consisting of bumps. Pt seen by HCP for symptoms. Pt began displaying  symptoms on the evening that he received the vaccine that have persisted until his appointment this morning .
A day after the vaccine, she developed a low grade fever and fatigue, her fever continue (99.5-101) for approximately 3 weeks. I took her to the emergency room and her lab values were all abnormal. They also found a large ovarian tumor. She subsequently had surgery for removal, was diagnosed with a brain aneurysm, end stage liver disease, severe peripheral neuropath and hepatic encephalopathy. She lost a total of 65 pounds. She is on full disability now. Prior to the vaccine, she had the same job for 36 years.
FEVER; CHILLS; COPIOUS SWEATING; This spontaneous report received from a patient concerned a 34 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022 expiry: 25-MAY-2021) .5 ml, administered on 06-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 103 F. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced copious sweating. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, chills, and copious sweating on 08-MAR-2021. This report was non-serious.
4 hours after injection, the patient was unable to move her arm. It started in her fingertips. Eventually entire arm in pain. No redness or swelling.
After shot, noticeable fatigue and hot / cold sweats sleeping first night. no other symptoms. 24-36 hrs later, dry mouth, weird taste in mouth, and very painful swelling, irritation, redness and "splits" on tongue. White spots near back of tongue and general discomfort. Went to Urgent Care on 4/16/21 (3 days after first vaccine dose) - because my normal Dr office could not see me for 2 weeks. Diagnosed with Oral Thrush and given meds.
purple around injection site; warm at injection site; sore arm; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (purple around injection site), VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE PAIN (sore arm) and FATIGUE (feeling tired) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (purple around injection site), VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE PAIN (sore arm) and FATIGUE (feeling tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DISCOLOURATION (purple around injection site), VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE PAIN (sore arm) and FATIGUE (feeling tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported.
Patient experienced an injection site reaction that included redness, warmth, and pruritus. The reaction became worse not better in the days following the vaccination.
A 6 year old male developed chickenpox that consisted of forty lesions after being exposed to his sister who was vaccinated with one dose of varicella virus vaccine live on 1/15/99. The pt was not immunized against varicella. The vaccinee experienced chickenpox on 9 days post vax. It was noted that the pts older brother who also was not immunized against varicella experienced a similar episode.
after 25 minutes of injection patient experienced numb throat but not airway constriction.  Patient sat for addition 20 minutes before I gave diphenhydramine 25mg.  I told her she can't not drive when she takes diphenhydramine.  15 minutes after she took diphenhydramine her friend came to pick her up.
I previously had COVID in 10/11/2020 and developed a rash.  After Dose 1 Pfizer-BioNTech  03/10/2021 EN6204; 03/12/2021. I developed a rash that was identical to the rash she had when had COVID it was red, itchy and it was inch in half below the injection site and warm to the touch that concerned me about the cellhouse issue. Went doctor and was unsure of medication at this time.
Pain swelling @ injection site , that night, the next AM pain in bicep worse with movement, then that evening  pain, swelling & redness on bicep area. Next AM (today) swelling & redness Spread to inner elbow.
tightness of her chest; sore arm at the site of injection; swollen arm at the site of injection; red rash in the site of injection; headache; Immunocompromised patient received 3rd full dose beyond 25-35 days after second dose.; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (tightness of her chest), VACCINATION SITE PAIN (sore arm at the site of injection), VACCINATION SITE SWELLING (swollen arm at the site of injection), VACCINATION SITE RASH (red rash in the site of injection) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 044A21A and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised and Cancer. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), MECOBALAMIN (ELGIN), CALCIUM and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient experienced CHEST DISCOMFORT (tightness of her chest), VACCINATION SITE PAIN (sore arm at the site of injection), VACCINATION SITE SWELLING (swollen arm at the site of injection), VACCINATION SITE RASH (red rash in the site of injection), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Immunocompromised patient received 3rd full dose beyond 25-35 days after second dose.). On 30-Nov-2021, HEADACHE (headache) had resolved. On 06-Dec-2021, VACCINATION SITE PAIN (sore arm at the site of injection), VACCINATION SITE SWELLING (swollen arm at the site of injection) and VACCINATION SITE RASH (red rash in the site of injection) had resolved. On 13-Dec-2021, CHEST DISCOMFORT (tightness of her chest) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Immunocompromised patient received 3rd full dose beyond 25-35 days after second dose.) outcome was unknown.            It was reported that with 1st and 2nd dose patient did not experienced any symptoms. After 3rd dose patient experienced sore and swollen arm with a red rash in the site of injection for 1 week, headache for a couple of days, and tightness in her chest intermittently 1or 2 weeks. It was unknown if AE cause patient to seek medical care. Treatment information were unknown.
3:30 pm 11/11/11 PC from pt who reports she received vaccines on Mon. 11/7/11 and noticed on Fri. 11/11/11 that the vaccine she received in her upper Lt arm was red, rashy, itchy and she just didn't feel good in general so took Ibuprofen. Pt reports that the red itchy rashy area is bigger now about the size of her hand. Referred pt to urgent care center now. 11/15/11 Pt reports saw MD, given Rx KEFLEX & cream.
About a week after immunization started having severe lower back pain, from central spine radiating out to both sides. Followed by a stiff and sore neck. Could not lay on left side muscles would jump. She is just now starting to feel better.
Local reaction only; no systemic 6-8cm area left upper arm reaction of edema and erythema.
Shortness of breath especially on exertion. Pulse ox readings were 94 at rest and dropped to as low as 87 when doing yard work  .Heart rate would skip a beat while  listening with stethoscope.  Symptoms lasted 3 months
Pt received Moderna vaccines at the Health Department on 4/3/21 and 5/1/21. Pt received booster Moderna vaccine on 11/18/21. On 1/7/22, pt presented to the ED with complaints of generalized myalgias, nausea, and cough. Pt noted that symptoms were worsening since 1/3/22. Pt was test for COVID on 1/7/21 and was found to be COVID positive. Pt did require oxygen while admitted, but was weaned off of oxygen prior to discharge.
Pt received vaccine 2/7/21, awoke 2/8/21 with b/l rash/discoloration of both hands, all fingers, well demaracated just proximal to MCP joints, deepest discoloration left 3rd digit, itching at onset, no blistering, sloughing, pain or swelling. Denies any other complaints. Presented to office (in person)on 2/17/21, rash/discoloration unchanged, itching resolved. neuro exam normal, brisk cap refill, no other rashes, no other systemic complaints. Pt completed blood work and returned to office (via telemed) on 2/22/21 - no change in rash/discoloration appearance.
Patient was sitting in chair waiting for the 15 minute observation time, about 3 minutes after injection patient started convulsing, patients husband lowered patient to floor and myself and another nurse rolled patient to her left side, seizure lasted  approximately 2 minutes , patient awakened and was disoriented  and approximately a minute later had another seizure lasting one minute. EMS was called and arrived but patient and husband refused transport to ER.
Approximately 2-3 minutes after receiving the vaccination, caregiver passed out while still sitting in chair. He was unconscious for approximately 3 minutes and twitched a little. Employee Health Nurse protected his airway by holding his head up right until some color returned to his cheeks and he regained consciousness. A Rapid Response was called and that team arrived within about 2 to 3 minutes. Caregiver was sitting upright, talking, joking, and drinking orange juice when the Nursing Supervisor escorted him to a place where he could lay down and recover for a while. No further adverse response was reported. Of note is the fact that the caregiver had worked all night the night before, he slept for 4 hours prior to coming for the shot. He had not eaten since the middle of the night. He reports having passed out once before while donating plasma (which he does routinely about once per month).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Known allergies: Pcn" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 03Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID vaccine breakthrough case. Pfizer EN6207 on 04/07/2021 and Moderna on 12/21/2021.
Lethargic and sleepy day after and not as much on 2nd day. Had extreme leg cramping on day after.  Center back and down both legs.  Tears because i had no control of pain. 3rd day site sore and warm bruising still there but not painful.
Per patient, she started w/symptoms of pain, swelling, irritability to lift arm after 3 days then presented w/bruising over 2 months later. Pt. claims there was no pain during the administration and had no reactions in past. She stated her family doctor said the pain/swelling may be due to improper administration.
Patient received Pfizer 5-11 orange top and should have received Pfizer 12+ gray top
Left arm with erythema, warmth and pustular vesicles surrounding injection site about 7-10 days later. In recovery process on antibiotic.
dizziness; vomiting; vertigo; did not lodge up quick or bend down and she felt unsteady; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 08Mar2021 (Lot number: EN6202) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (1st Dose, Lot: EL9266, Route of administration: Intramuscular), administration date: 15Feb2021, when the patient was 69 years old, for COVID-19 Immunization; Flu shot (She gets the flu shot every year and she gets nothing except a sore arm and she went for the flu shot a month ago and had a sore arm), reaction(s): "Sore Arm". The following information was reported: VERTIGO (non-serious) with onset May2021, outcome "recovered" (20Oct2021), described as "vertigo"; GAIT DISTURBANCE (non-serious) with onset May2021, outcome "unknown", described as "did not lodge up quick or bend down and she felt unsteady"; DIZZINESS (non-serious) with onset 21Oct2021, outcome "unknown", described as "dizziness"; VOMITING (non-serious) with onset 21Oct2021, outcome "unknown", described as "vomiting". The events "vertigo", "did not lodge up quick or bend down and she felt unsteady", "dizziness" and "vomiting" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vertigo, dizziness.  Additional information: The patient is calling about the Pfizer covid vaccine. She had a question and asks if vertigo is a side effect. Reports she never had vertigo before, and it happened approximately 6 weeks after getting the covid second shot and happened a couple of times since. She heard from people that read on internet that vertigo happens with the covid shot and she looked it up. When querying outcome, reports the vertigo happens out of nowhere, she could get up and it happened, first time she was getting out of a car, did not lodge up quick or bend down and she felt unsteady. The last time vertigo occurred was 20Oct2021. Reports it has happened 4 times since beginning of May2021 and she does not have exact dates to provide. Treatment: went to ENT doctor and the doctor did not find anything. She was sent for a brain MRI and did not find anything. Reports she was sick as a dog and this put her out of commission for 6 or 7 hours and saw her primary doctor. Her doctor did a series of blood tests and said it was fine and cannot come up with anything else. She asked her doctor if it was a possible side effect and her doctor told her that anything is possible and did not really answer her.   No follow-up attempts are possible. No further information is expected.
(R) deltoid area with redness in distribution of band aid; above & underlying induration - minimal.
Started the night of the vaccines received.  "Crying nonstop acts like in pain, not sleeping and not eating.  Pain seems like it may be positional.  Thighs slightly swollen, not reddened, not warm.  1 small reddened 'poke'.  Temperature: 99 F.  Infant Tylenol not relieving discomfort.  Discomfort helped by cold compresses to thigh.  07/04/2003: Developed slight cough and runny nose."
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the incorrectly stored (33.1 F for 90 minutes) doses of ROTATEQ (orally, lot # M012495, expiration date 09-OCT-2017; dose was not reported). No previous excursion was reported. The call was made because of the data logger. No adverse effects were reported. This is one of several reports received form the same reporter. Additional information has been requested.
Pt had vaccines and acted fine, stable, walked out of clinic. Mom denied fever stating, "he ate dinner and slept fine last night." Mom said next day he was crying, held his breath, passed out and then had a seizure for 30 sec. Mother states he vomited on way to clinic. was placed on O2 and monitored. Mom states pt had a cold prior to vaccines w/croupy cough.
chest pain, palpitations, dyspnea s/p covid vaccine (about 40 minutes after) Patient cane to office and then was sent to ER for ongoing chest pain