chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs were reported; a patient received improperly stored vaccine; This spontaneous report was received from a medical assistant  and refers to a patient of unknown age and gender.    The subject' s concurrent conditions, medical history, concomitant therapies, drugs reactions or allergies were not provided.  On 22-OCT-2021, the subject was vaccinated with improperly stored  0,5 milliliter of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # U006313 with expiration date 24-AUG-2021). The vaccine was stored in temperature between 6 to 14 Farenheit degrees for 1 hour and 3 minutes and in between 14 to 46 (20.8 F)Farenheit degrees for 20 hours and 32 minutes. There was no previous temperature excursions. There was no additional adverse events reported.
it sounded like she was dying.3 people she knows that have this.; This is a spontaneous report from a Pfizer sponsored program COVAX Support. A contactable consumer reported similar events for 4 patients. This is 1 of 4 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Consumer reported that her friend got vaccinated, and it sounded like the patient was dying. 3 people, the consumer knew that had this (from Withheld), and she thinks that maybe (Withheld) were getting worse effects. The consumer wanted to know anyone have these same symptoms and if we knew anything about that. The reporter was provided information from the attached document and referred to HCP for further guidance, symptom management and treatment recommendations. Also spoke from the no information section of the attached VR regarding knowing if the information on side effects was broken down by race. The reporter replied, stating that 3 of them (her and some friends from Withheld) have this. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) :PFIZER INC-202101007383 same reporter, same drug/event, different patient
pain in chest; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (pain in chest) 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 CHEST PAIN (pain in chest). At the time of the report, CHEST PAIN (pain in chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.
Left arm from injection site became very sore.; lower neck became very sore.; shoulder blade became very sore.; fore arm area became very sore.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158), via an unspecified route of administration in the left arm on 11Apr2021 at 17:00 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and asthma. Concomitant medications included metoprolol succinate (METOPROLOL), atorvastatin (MANUFACTURER UNKNOWN), lamotrigine (MANUFACTURER UNKNOWN) and fluticasone furoate; umeclidinium bromide; vilanterol trifenatate (TRELEGY) for an unknown indication from an unknown date. The patient did not have a history of past drug therapy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Apr2021, the patient had experienced very sore left arm from injection site to lower neck to shoulder blade and down my arm to my fore arm area which started about 7 days after injection and was still feeling the same till the day of report. Therapeutic measures were taken as the result of adverse events, which included treatment with heating pad. The clinical outcome of the events very sore left arm from injection site to lower neck to shoulder blade and down my arm to my fore arm area  was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Neck is swollen like my lymph node; Neck is swollen like my lymph node; Sore throat; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6205, Expiry date was not reported), via an unspecified route of administration on 16Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient experienced sore throat on 18Mar2021 and neck is swollen like my lymph node on an unspecified date. It was reported that, patient just received the vaccine on 16Mar2021 in the late afternoon and on the 18Mar2021 started to get a sore throat and had one since (incomplete sentence). Patient did not see sore throat specifically listed on the list of side effects and neck was swollen like lymph node and just wanted to make sure that might be the sore throat could be a side effect. Patient did not know if needed to call Doctor. The outcome of the events was unknown.  No follow-up attempts are possible, No further information is expected.
Patient reported to pharmacy on 02/11/2020. He stated he developed a rash, swelling and pain in his fingers. His fingers also bleed  occasionally.
Pfizer-BioNTech COVID-19 Vaccine EUA: during clinic visit to establish care patient reports initial flushing, body aches, fever, and headache a few hours after vaccination. A few days later patient reports facial swelling, tinnitus, and hearing loss on the left side. Patient  took diphenhydramine and symptoms mostly resolved within a week. The patient was evaluated by an ENT specialist and the examination was documented as benign. Patient will continue to follow-up with ENT and allergy/immunology.
Pt felt dizzy after vaccination, passed out and fell, hitting tile floor.  LOC x 5 seconds.  Pt dx c left orbital fracture (lateral & inferior wall).  Pt hadn't eaten breakfast prior to vaccination.
This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, 0.65 ml, once, subcutaneous (strength and anatomical location were not reported). There was no concomitant medication reported. On an unknown date, the patient experienced a non blistering rash (rash), erythema (vaccination site erythema) at injection site of ZOSTAVAX vaccination (vaccination site reaction). The reporter stated that the rash was not shingles and no pustules developed. On 07-SEP-2015 (reported as "two weeks ago"), the patient contacted the pharmacy (not specified). Additionally, the reported stated that the only treatment was the pharmacy manager advised patient to "cover up the area". At the reporting time, the outcome of rash, vaccination site reaction and vaccination site erythema was reported as recovering. Additional information has been requested.
82 yo M with history of epilepsy, asthma, BPH, GERD who was brought by family due to not being able to get out of bed for 3 days in setting of malaise, poor appetite, and new cough. Found to be COVID positive here.  He received two doses of COVID vaccine, last in May, but has not gotten boosted.  Patient really only describes "not feeling good" and not wanting to eat.  Has been able to get to the rest room but otherwise has just had progressive generalized weakness and has been in bed.  Denies fever, sputum production, dyspnea, congestion, HA, GI symptoms.  Hasn't had BM in 3 days but is passing gas.  Lives with his wife and they have an in-home caregiver a few days a week.  At baseline he gets around with cane and
very itchy around her eyes; red and rashy; red and rashy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 20-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (very itchy around her eyes), INJECTION SITE RASH (red and rashy) and INJECTION SITE ERYTHEMA (red and rashy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE RASH (red and rashy) and INJECTION SITE ERYTHEMA (red and rashy). On 19-Feb-2021, the patient experienced RASH (very itchy around her eyes). At the time of the report, RASH (very itchy around her eyes), INJECTION SITE RASH (red and rashy) and INJECTION SITE ERYTHEMA (red and rashy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided. Treatment products were not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: not significant
achiness to the injection arm, put ice on it and it was gone within an hour; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 72 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (ongoing), notes: Diagnosed for 20 years; "High cholesterol" (ongoing), notes: for the last 10 years; "Arthritis" (unspecified if ongoing), notes: Diagnosed for last 5 years. Concomitant medication(s) included: LISINOPRIL taken for hypertension; SIMVASTATIN taken for blood cholesterol increased. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, NDC: Unknown, Lot: EM9810, Exp: Unknown, Dose and Route: Unknown dose, injection given in arm), administration date: 04Mar2021, when the patient was 71-year-old, for COVID-19 Immunization, reaction(s): "slight Headache", "Had achiness to the injection arm"; BNT162b2 (DOSE 2, SINGLE, NDC: Unknown, Lot: ER2613, Exp: Unknown, Dose and Route: Unknown dose, injection given in arm), administration date: 25Mar2021, when the patient was 71-year-old, for COVID-19 Immunization, reaction(s): "slight Headache", "Had achiness to the injection arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "achiness to the injection arm, put ice on it and it was gone within an hour". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity.  Additional information: Patient had high cholesterol Sort of has high cholesterol. States it wasn't really high, she had a stressful job. Had high cholesterol for the last 10 years and Arthritis Diagnosed for last 5 years. It's been bothering her. She just has an ache to the arm and maybe a slight fever to other vaccines, but does not provide any product names. She has taken many vaccinations as she travels a lot. Has never gotten really sick.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201240143 Same patient and drug, different event separated in time;
sinus tachycardia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 20 year-old female patient received bnt162b2 (BNT162B2), administration date 14Aug2021 (Lot number: FA7485) as dose 2, single and administration date 17Jul2021 (Lot number: FA6780) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Robust antibodies" (unspecified if ongoing), notes: my daughter who was actually had Robust antibodies on her prior infection. The patient's concomitant medications were not reported. The following information was reported: SINUS TACHYCARDIA (non-serious), outcome "unknown", described as "sinus tachycardia". The event "sinus tachycardia" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of sinus tachycardia.  Additional information: Caller was asking for how long the Pfizer covid-19 vaccine (gray cap) unpunctured, could be stored in the refrigerator after the deep freeze. Caller ended the call before the agent finish the closing spiel. Caller said, 5 days when it first came out. Caller is referring to the Pfizer covid-19 vaccine (gray cap) storage in the refrigerator. Caller asked if the first two doses of the Pfizer covid-19 vaccine make you sick, is it ok for you to take the booster (Not verified if she was referring to her experience). Reporter called on behalf of daughter. Patient was actually had Robust antibodies on her prior infection, (Further clarification unknown) was coerced to take 2 shots of the emergency use authorization vaccine not the one that was approved by the FDA and she ended up in the emergency room not once but twice and she is now on a beta blockers (Treatment) and was diagnosed with sinus tachycardia and her cardiologist said this was as the result of the drug that medication when she took. When paraphrased the above concern, Reporter also wanted to know what happens now like they were telling, she was only 20 years old, they were saying the school that she goes to says now she needs to get the booster and she was afraid. Treatment: Reporter stated, it was called the beta blocker, Caller did not know the actual brand name, Metoprolol Tartrate 25 mg, twice a day, orally. Well this an ongoing thing now.  No follow-up attempts are possible. No further information is expected.
redness at injection site; swelling at injection site; felt feverish; injection site warm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2019, the patient received the 1st dose of Shingrix. On 12th October 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, feeling hot and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling, feeling hot and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, feeling hot and injection site warmth to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced redness and swelling at the injection site. The patient also noted that the injection site felt warm and that she felt feverish. At time of report, the events had not resolved. The reporter consented to follow up.  The pharmacist was busy and did not had time for a full report.
Mentions soreness in her arm after the Moderna Vaccines; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Mentions soreness in her arm after the Moderna Vaccines) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 from March 2020 to April 2020 and Cancer. Family history included Rheumatoid arthritis since an unknown date and Celiac disease (Her daughter has Celiac disease.) since an unknown date. Concurrent medical conditions included Lupus erythematosus and Immunocompromised (immunocompromised due to lupus,immune system goes up and down up and down).    On 20-Jan-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 PAIN IN EXTREMITY (Mentions soreness in her arm after the Moderna Vaccines). At the time of the report, PAIN IN EXTREMITY (Mentions soreness in her arm after the Moderna Vaccines) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Ethnicity reported as private.  No concomitant medications were reported.   Patient mentions soreness in her arm after the Moderna vaccines. states only that it wasn't bad, says it was like normal little soreness after a shot.  No treatment medication was 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.   This case was linked to MOD-2021-626128 (Patient Link).
dose of Daptacel expired on 21-Jun-2023 was administered to a patient with no reported adverse event; Initial information was received on 22-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 18 months old unknown gender patient to whom an dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] expired on 21-jun-2023 was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Jun-2023, the patient received an unknown dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot:C5893AA, expiry date: 21-Jun-2023, unknown strength) via unknown route in unknown administration site for prophylactic vaccination (Immunization).  On 22-Jun-2023 the patient had an expired dose of daptacel with no reported adverse event (expired product administered) (Latency:same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the guidelines. 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.
Mother called clinic, states child has fine rash all over body this am. Denies fever, seizures or respiratory distress.
No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from lead medical assistant refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 12-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R011805 and expiry date 23-APR-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.
Shoulder pain. Unable to lift arm past horizontal to date. Patient is attending physical therapy. Patient received Fluzone PF Lot 43576aa Exp. 06/30/11.
Mom told of fever 104.2 on 8MAY91; Upon being checked in ER fever 101.5; Returned to ER for continuous crying 11MAY91 & dx BOM & throat infect; Records of 8MAY91 shows dx of BOM;
Rash with itching started approximately 48 hours after receiving Moderna vaccine (1st dose) Patient reports taking Benadryl 25 mg tabs (2) as directed per package.
Large swollen round area around injection site, area temp is 101.6, very red and itchy
VOMITING; This spontaneous report received from a parent concerned a 32 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting. This report was non-serious.
Patient administered first dose on 5-Mar-2021 and second dose 6-Dec-2021 then third dose on 19-Apr-2022; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered first dose on 5-Mar-2021 and second dose 6-Dec-2021 then third dose on 19-Apr-2022) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 0121421B and 0101A21A) for COVID-19 prophylaxis.     The patient's past medical history included Viral pneumonia (5 year ago.). Concurrent medical conditions included Rheumatoid arthritis since 02-Mar-2006, Fibromyalgia since 02-Mar-2006, Osteoarthritis since 02-Mar-2006, Immunocompromised and Acute gastritis (sever).   On 05-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Dec-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered first dose on 5-Mar-2021 and second dose 6-Dec-2021 then third dose on 19-Apr-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered first dose on 5-Mar-2021 and second dose 6-Dec-2021 then third dose on 19-Apr-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2022, Blood test: Cholesterol little high, all other was great.         No concomitant medications were provided by the reporter.   Treatment information was not provided.   This case was linked to MOD-2022-628396 (Patient Link).
Body aches and headache beginning at 4 am on 1/9/2021. Fever at 9:30 am 1/9/2021 to 100.5.  Swollen left axillary lymph node noted. Sunday 1/10/2021 symptoms resolved except for lymph node enlargement and soreness at injection site.  Taking tylenol and motrin with relief.
Pt awoke without reaction, however this afternoon c/o redness, warmth, and raised area at injection site. 2.25 in x 1.5 in.