chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received both vaccines, one in each arm and waited in the exam room for 15 minutes. Patient then went to the lab to have blood drawn. When patient was in the lobby, she stated that she felt hot and didn't feel well and a nurse told her to sit down. The nurse at the front desk and went to check on the patient. The patient then got very pale, eyes rolled back into her head, nostrils sucked in, was gasping, then she got rigid and appeared to stop breathing, legs started to turn in and the nurse called for help. Multiple staff responded. One of the nurses noted that her left leg had a tremor for a few seconds. Patient was given a wet washcloth for her head and started to perk up and she was given some water. BP was taken and was within normal limits. After her color came back, she was placed in a wheelchair and taken back to the exam room for evaluation. She was assessed by her provider twice before it was determined that she had a response to the vaccines and was OK to go home. Patient was walked to her vehicle.
Allergic reaction, including tingling sensation on tongue and cheek that lasted 24 hours, reddening of the face that lasted for three days, and itchy feeling on head for three days.
Patient stated she had numbness in the lips and a metallic taste in her mouth. She then stated that her tongue was stinging about 15 minutes later. She experienced NO swelling, hives, or shortness of breath. Patient was monitored for 45 minutes. Patient was encouraged to take some liquid benadryl which alleviated her symptoms. Patient stated that these symptoms resolved around 15 minutes after taking the liquid benadryl. Patient was encouraged to follow-up with PCP and to go to the ER if any new or worsening symptoms.
second dose was given 2 weeks after first, should have been a 3 week interval.
Severe pain in left arm and severe pain across my entire back, especially in the area of my shoulder blades, as well as  muscle aches and pain throughout my entire body. Fever of 101.2. Severe headache. Slight degree of nausea that I connected to having such a bad headache.
Impingement syndrome of the left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ROTATOR CUFF SYNDROME (Impingement syndrome of the left shoulder) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A2/Z1A and 007M(2/Z)0A) for COVID-19 vaccination.     Concomitant products included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) from 21-Mar-2021 to 21-Mar-2021 for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-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 experienced ROTATOR CUFF SYNDROME (Impingement syndrome of the left shoulder). At the time of the report, ROTATOR CUFF SYNDROME (Impingement syndrome of the left shoulder) outcome was unknown.            Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow up information received updated event information.
wrists started to hurt again; KEPT SLEEPING; could not even walk; whole body ached; CHILLS; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (KEPT SLEEPING), GAIT DISTURBANCE (could not even walk), ARTHRALGIA (wrists started to hurt again), CHILLS (CHILLS) and MYALGIA (whole body ached) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0001335991) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for Dry eyes, DICLOFENAC, HYDROCHLOROTHIAZIDE, FISH OIL, LEVOTHYROXINE, ADALIMUMAB (HUMIRA), ASCORBIC ACID, ACETYLSALICYLIC ACID (BABY ASPIRIN), ATENOLOL, TRAMADOL, OMEPRAZOLE and SIMVASTATIN for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced CHILLS (CHILLS). On 29-Jan-2021, the patient experienced SOMNOLENCE (KEPT SLEEPING), GAIT DISTURBANCE (could not even walk) and MYALGIA (whole body ached). On 14-Feb-2021, the patient experienced ARTHRALGIA (wrists started to hurt again). On 15-Feb-2021, SOMNOLENCE (KEPT SLEEPING), GAIT DISTURBANCE (could not even walk), CHILLS (CHILLS) and MYALGIA (whole body ached) had resolved. At the time of the report, ARTHRALGIA (wrists started to hurt again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not receive any treatment medications.
redness; swelling; hardened; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2019, the patient received Shingrix. On 23rd October 2019, 2 days after receiving Shingrix, the patient experienced erythema of extremities, swelling arm and induration. On an unknown date, the outcome of the erythema of extremities, swelling arm and induration were recovering/resolving.   It was unknown if the reporter considered the erythema of extremities, swelling arm and induration to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient had couple of inches down from the injection site that become red and swollen and  when she touched it, it was hard. The reporter did not consent to follow up.
Red, blister like bumps on (R) lateral upper arm, since noticed 4 days ago has gotten worse.
Vaccine given , symptoms started 1150 am, Itching, rash, lips "like bee stings", chest pressure, throat scratchy.  10 minutes after vaccine administered. Benadryl 50mg and Epineprhine pen 0.3ml. Symptoms continued until EMS picked her up at 1231pm
The patient received the vaccine at about 1500, did wait 15 minutes for observation, and left around 1515 with no reported complaints. At around 1535 while driving home patient started having difficulty swallowing and contacted hospital advice nurse who referred the patient to the emergency department.
8/15/21-8/17/21 petechiae appearing on user body and extremities, followed by deep and extensive bruising from minimal contact. 8/18/21 Appointment with primary care physician, blood was drawn and platelet count was critically low at 3000 platelets per microliter of blood. 8/18/21 Emergency admission another blood test confirmed results above. Decision was made to begin IVIG therapy.  8/19/21 Discharged from Hospital with platelet count of 22,000 platelets per microliter of blood. 8/23/21 Another blood test with results of 20,000 platelets per microliter of blood 8/25/21 IVIG Therapy was given again. 8/27/21 Blood draw 74,000 platelets per microliter 9/15/21 Blood draw 120,000 platelets per microliter
symptoms - fatigue; weakness; body/muscle aches; chills; fever (100 degrees); "Covid arm" (soreness, swelling, hot to the touch, slightly itchy, red circle around injection site roughly the diameter of a baseball)  Symptoms started three hours after shot (Saturday afternoon) and peaked Sunday night; all symptoms except Covid arm abated Monday morning. Arm issues abated by Friday May 7.  Treated majority of symptoms with Ibuprofen, rest, liquids. Treated Covid arm with Benadryl taken orally and topical cream.
no additional AE; HCP reports that VARIVAX was administered to patient  with temperature excursion; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On 10-FEB-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter (lot # W008712, has been verified to be a valid lot number, expiration date reported and upon internal validation established as 14-MAR-2024), administered for prophylaxis (anatomical location, and route of administration were not reported) (Product storage error). Temperature excursion as following: 15.7 Fahrenheit (F) for 0 hours 20 minutes and 0 seconds. No additional adverse event was reported (no adverse event).  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-2304USA001247:
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age or gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 03-SEP-2015, the patient was inadvertently vaccinated with an expired dose of GARDASIL (lot # H020901, expiration ate 05-JUL-2015) (route, strength and route of administration were not reported) (expired product administered). The patient was vaccinated by a nurse practitioner. There was no concomitant medication reported. Additionally, no adverse effects were reported. Additional information has been requested.
Macular erythematous rash that covers both legs, arms, torso, and neck that began after pneumococcal vaccine. Tx: CLARITIN 10mg QD; Ranitidine 150 BID; MEDROL Dose pak.
Information has been received from a nurse practitioner concerning a 15 month old male patient with no pre-existing allergies, birth defects, medical conditions, who 0n 08-FEB-2005 was vaccinated in the right leg at 3:10 with a first dose of varicella virus vaccine live (Oka/Merck) (lot number: 648940/0657P). On 30-OCT-2007 at 9:50 AM the patient experienced chickenpox that including papular lesions, fluid-filled vesical and scabbed over lesions. There were no relevant diagnostic tests and laboratory data. There was no illness at time of vaccination. There were no adverse events following prior vaccinations. No further information was provided. There was no product quality complaint. Follow-up information indicated that the outcome was reported as recovered. No additional information is expected.
Child had varicella vaccine 12/17/03.  On 12/27/05 woke up with 2 typical chicken pox lesions on trunk.  Mom gave Benadryl.  Child recovered from incident.
All for right arm, at injection site: Cannot raise arm, arm pain, arm weakness, limited mobility
>35 days since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (>35 days since first dose) 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 28-Jul-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 PRODUCT DOSE OMISSION ISSUE (>35 days since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (>35 days since first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications was provided.  No Treatment medication was provided.
Reported to Employee Health with swelling of her right lower jaw area which she is attributing to her MMR shot on 3/29/22. Her start date with company is 4/4/22.
fever 104 ax; ankle, knee-joint pain, fussiness x 1 day only;
Bad headache; low grade fever; bed rest for 24 hours; This is a spontaneous report from a contactable consumer reported for herself. A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL9241; Expiration date was not reported), via intramuscular on 11Feb2021 11:30 (at the age of 77-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history, concomitant medications, prior vaccination within 4 weeks included none. Historical vaccines included first dose of BNT162B2 (Lot number: EL0142) via intramuscular rout on 21Jan2021 11:30 as DOSE 1, SINGLE for covid-19 immunisation and had no problem, went well. The patient experienced bad headache, low grade fever, bed rest for 24 hours on 11Feb2021 23:30. Onset time stated as 12 hrs later. After second injection, patient was ok for first 12 hours. Then had bad headache, low grade Fever, bed rest for 24hours. Next day, felt fine. The events did not require the initiation of new medication/other treatment/procedure. Had no problems. Relevant tests included none. The events were not serious. Clinical outcome of events was recovered on 12Feb2021.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a medical student refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On unknown dates (reported as over a year ago), the patient was vaccinated with two doses of GARDASIL for prophylaxis (doses, lot numbers and expiration dates were not reported). On 29-JUN-2018 (reported as "today"), the patient completed the vaccination series with GARDASIL 9 (dose, lot number and expiration date were not reported). No adverse event was reported.
Starting the night of the vaccine, a lot of constant buzzing in ears, periodic feeling of fullness in ears & sensitivity to loud sounds in ears. Went to sleep. Awakened dry heaving & had vomited some bile. Couldn?t stand or walk due to extreme dizziness & moderate nausea continued. Called PCP and was seen at 1pm on march 26th. My son had to help me walk all day so far. The doctor office checked my vitals & my ears. Vitals good. No infection. Diagnosed with vertigo & prescribed Meclizine. 4p was 1st dose. Seems to be helping some. Nausea has subsided. Buzzing is present, but quieter. Still too dizzy to walk without assistance
Very rapid heart beats when working outside on the swimming pole install and I checked my heart beat and it was 150, 170 at the ER it was 165 170. This was 6 months after the vaccine. They gave me medication to bring the rate down. I was placed on metoprolol. Then after that I followed up with my Cardiologist and Physician and I was told it's possible that it could be from having COVID-19. I had COVID-19 on the 14th of June. One night I felt off and then had a sore throat the next day and then nothing else ready.
Felt nauseated late morning and tired, so went to bed for most of the day. No appetite.
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 48-year-old female patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: FH8027), in left arm, on 25Mar2021 as dose 2, single (Lot number: EP6955), in left arm and on 29Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 47 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 that included Paxlovid.
The day after my second dose ( February 18th) I felt sore at injection site and slight headache/neck ache and fatigue. next day (February 20th) I noticed a tightness in chest and started checking pulse and ECG on my smartwatch. Results came back as showing signs of AFib. Never saw this before. I have checked the ECG app on the watch  on and off since getting it in December. Every time  before the second dose of the Moderna vaccine the results came back as normal Sinus rhythm. Since February 18th my ECG on the smartwatch has indicated Afib, going on 11 days now.
After administration, patient experienced difficulty breathing, headache, anxiety, and elevated blood pressure (160/102 - 180/110 for 30 minutes). Patient was transported to Hospital as precaution.
Fever started that night; Went up to 102 & up to 104 the next day; Also arm became red; cellulitis; no other sx;
This spontaneous report as received from a pharmacist refers to a 79 year old male patient. On 28-MAR-2015 the patient was vaccinated with ZOSTAVAX (0.65 ml, lot # K020802, exp. date: 31-JAN-2016, subcutaneous). Concomitant therapies included lisinopril, oxycodone, gabapentin, metformin and ranitidine. On 28-MAR-2015 the patient experienced knot, forming at the injection site, immediately, after receiving ZOSTAVAX. The knot was described further as a harder nodule, than normal, which lasted a day or two, and resolved in two or three days (in March 2015). The subject was treated with massage and TYLENOL. The relatedness between knot and ZOSTAVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 1/8/2023 &  1/9/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
shortness of breath; chest pressure/tightness; chest pressure/tightness; dizziness; I started shivering a lot and felt like I was freezing; I started shivering a lot and felt like I was freezing; my body was covered in goosebumps and couldn't stop shaking; my body was covered in goosebumps and couldn't stop shaking; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 20:00 (Lot number: FC3181) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "pre diabetes" (unspecified if ongoing); "chronic back pain" (unspecified if ongoing); "year'round allergies (sinus allergies)" (unspecified if ongoing); "Known allergies: Cherries" (unspecified if ongoing); "Known allergies: grapefruit (sensitivity)" (unspecified if ongoing); "Known allergies: peanuts (mild allergic reaction)" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: HYDROCODONE. Past drug history included: Lipitor, reaction(s): "Known allergies: Lipitor". The following information was reported: DYSPNOEA (non-serious) with onset 18Aug2021 20:30, outcome "recovered with sequelae", described as "shortness of breath"; CHEST DISCOMFORT (non-serious), CHEST DISCOMFORT (non-serious) all with onset 18Aug2021 20:30, outcome "recovered with sequelae" and all described as "chest pressure/tightness"; DIZZINESS (non-serious) with onset 18Aug2021 20:30, outcome "recovered with sequelae", described as "dizziness"; CHILLS (non-serious), FEELING COLD (non-serious) all with onset 18Aug2021 20:30, outcome "recovered with sequelae" and all described as "I started shivering a lot and felt like I was freezing"; PILOERECTION (non-serious), TREMOR (non-serious) all with onset 18Aug2021 20:30, outcome "recovered with sequelae" and all described as "my body was covered in goosebumps and couldn't stop shaking". Therapeutic measures were not taken as a result of dyspnoea, chest discomfort, chest discomfort, dizziness, chills, feeling cold, piloerection, tremor.  Additional information: Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient received any other medications within 2 weeks of vaccination was Hydrocone 10/325mg, Multivitamin supplement. known allergies are penicillin, lipitor, cherries, grapefruit (sensitivity), peanuts (mild allergic reaction) latex.  Follow-Up (27Aug2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
PATIENT HAS A LARGE AREA OF WHAT APPEARS TO BE PERMANENT TISSUE ATROPHY ON THE RIGHT THIGH. MOM STATES IT STARTED OUT AS A FEW GRAYISH COLORED DOTS ON RIGHT THIGH A FEW DAYS AFTER VACCINATIONS. THE DOTS APPEARED TO BE LITTLE INDENTIONS IN THE SKIN PER MOM .MOM ALSO STATES IT GOT WORSE AND NOW IT IS A LARGE AREA ABOUT THE SIZE OF A HALF DOLLAR. MOM DID NOT NOTIFY PHYSICIAN OF SKIN CHANGES SO NO TREATMENT WAS STARTED.
diagnosed positive for COVID/ tested positive for COVID virus; This is a spontaneous report received from two contactable consumers (patient and patient's husband) via the sponsored program medical Information Team. The consumers reported similar events for 2 patients. This is the 1st of 2 reports.   A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's first dose was a week before his (husband), so a week before 21Jan2021, she received her vaccine at work. She did not know the exact date of her first dose. She was diagnosed positive for COVID/ tested positive for COVID virus 2 days before he was diagnosed. She was diagnosed positive on either 21Jan2021 or 22Jan2021, she also did a test in which it gave her the test results the same day. She probably had the same type of test. Her antibody infusion was a couple days before him. The case was assessed as non-serious. The outcome of event was reported as unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s): 2021144363 same reporter/drug/AE, different patient.
a patient received Fluzone Quadrivalent High Dose that was too-long in transit and was not suitable for use, No AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a nurse practitioner.  This case is linked to case 2020SA268092, 2020SA268091, 2020SA268094, 2020SA268089 and 2020SA268093 (same reporter).  This case involves a 77 years old female patient who was vaccinated with 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (prefilled syringes, lot number UJ498AA and expiration date:30-Jun-2021) via unknown route in the right deltoid for prophylactic vaccination on 28-Sep-2020. The vaccine was too-long in transit and was not suitable for use (PT: product storage error).   Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant was given to the patient on the same day.  It was an actual medication error case due to incorrect product storage.   It was reported that the boxes were cold, but the ice packs were not hard frozen, they gave 6 doses before they got call not to use product because it was too long in transit and asked if they should revaccinate patient.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.