chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feels like throat blocked (not inhibiting airway); coughing; stalling saliva; Mild to moderate headache; Mild nausea; injection site sore; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19; solution for injection, Lot Number: EW0167) via an unspecified route of administration in the left arm on 19May2021 at 20:00 (at the age of 66-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included severely broken nose/ deviated nasal septum (waiting to repair), migraine headache, allergy to Sulfa drugs, and the patient concomitant medication included SUMATRIPTAN SUCCINATE (IMITREX) for unknown indication. The patient previously took Sulfa (unspecified) for an unknown indication, from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19May2021 at 21:00, approximately 1 to 2 hours after vaccination the patient experienced patient feels like throat is blocked, mild nausea, stalling saliva causing intermittent coughing, headache, injection site sore. It was reported that after 24 hours later and same symptoms continued and injection site sore was expected. The adverse events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. No therapeutic measures were taken a result of the adverse event. At the time of this report outcome of all events were not recovered. Information on the lot/batch number has been requested
8 days after shot, circular raised welt on arm, very itchy, warm to touch, at injection site.
Janssen COVID-19 Vaccine EUA                 Days 1 & 2: extreme muscle fatigue and 100% bed rest.   Days 3 & 4; fatigue and 100% bed rest.  Days; 5 through 8; limited morning activity, 1/2 day bed rest.   Days 9-10; very limited activity without exhaustion.   Days 11-15; moderate activity with exhaustion
7 cm left upper arm w/ erythema, edema, and itching. Localized allergic rxn.
Patient's sister, spoke to Public Health staff to say that he passed away suddenly on 4/3/21 from a cardiac arrest, he had no underlying health conditions she states but did take some medications, she believes for blood pressure.
pt recvd vax & woke up w/ SOB & severe chest pain, was shakey in a cold sweat; pt went to MD & revcd albuterol neubulizer due to expiratory wheezing;
The day baby received immunizations, he became very irritable with crying and fever within 2 hours. Baby refused to drink. This improved slowly, but was admitted in hosp. after 48 hours for rule out sepsis as fever continued.
fever 101; Chills; Sweating; Headache; arm has heat in it; arm being sore; tired; This is a spontaneous report from a contactable consumer (patient).  A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EP6955, expiration date was not reported) via an unspecified route of administration, in left arm, on 24Mar2021 15:15 (at the age of 61-years-old), at dose 1, single for covid-19 immunization. Medical history included mechanical aortic valve; pig valve inserted (as reported) in 1981 and two surgeries in 1991. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. No history of previous immunization with the bnt162b2 and no additional vaccines administered on same date of vaccination. The patient experienced arm being sore, tired on 24Mar2021, fever 101, chills, sweating, headache, arm has heat in it on 25Mar2021. The patient underwent lab tests and procedures which included body temperature: 101 on 25Mar2021. Therapeutic measures taken included Tylenol for fever 101. The outcome of the events headache was recovering, sweating, chills were recovered on 25Mar2021 and other events were not recovered.  No follow-up attempts are possible. No further information is expected.
Pt made appointment online and filled out paperwork online for Pfizer CoVid Bivalent shot.   When pt arrived to pharmacy, the tech at data entry asked if she was here for the Covid shot and processed the bivalent like her form said.   The immunization certified tech pulled up vaccine and had pharmacist verify she had done it correctly.   She then proceeded to give the shot.   After immunization was given, pt then asked if she comes back in 3 weeks for her second dose.   That is when it was discovered that pt had never received Covid vaccine before and should have been given the primary series.   The pharmacist then talked to pt and let her know that she may develop a higher immune response and advised her to drink plenty of water and take Tylenol for fever.
Information has been received from a licensed practical nurse concerning a pre-term infant who on an unspecified date received their first dose of ROTATEQ but the child regurgitated most of it. The patient sought medical attention via an office visit. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested.
No adverse event; Monovalent dose administered after the BUD to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient) and NO ADVERSE EVENT (No adverse event) in a 28-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 02-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient).    It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    Concomitant product use was not provided by the reporter.  It was reported that 77 Monovalent doses administered after the BUD to patients 12 and up. Breakdown of doses were as follows- 37 doses from Lot 059H21, 26 doses from  Lot 065K21A, and 12 doses from  Lot 058A22-2A.  Treatment information was not provided.
This spontaneous report was received from a certified medical assistant referring to a three unspecified patients of unknown ages and gender. No medical history or concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L017142 expiration date 13-MAY-2017) (dose and route were not provided). Concomitant medication was not reported. No adverse effects were reported and it was also reported that no product quality complaint was involved, temperature was 20 F, time frame was 108 hours, it was not previous temperature excursion and the call was not because of a "data logger". Additional information has been requested.
For my 1st and 2nd shot I had absolutely No Shire affected it all. Is on Tuesday the 9th my wife and I both got Is our 3rd shot. Both nights I was very dizzy and tell several times something I have never done in my entire life and last night I believe I was sleepwalking is sleepwalking and almost a 100% about the The sleep walking. Is my wife also God is shot at the same time and also I'm still dizzy.  I figured it was important to let you know about thow about this is definitely weird for the both of us do you need any other information or my records give me a call and you can have whatever you need but I just got my physical about a month ago which included an echo cardio Graham and everything so I have a pretty good  Update records that may possibly help you but you can have anything you want or don't care
Rash at injection site, swollen lymph node in neck and behind ear. (One to two vesicles with induration and erythematous area locally at site.)
No additional AE; Involved VAQTA expired on 01/11/2021 and was administered on 01/20/2021.; This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant therapies were not reported.   On 20-JAN-2021, the patient was inadvertently vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) (exact dose, route of administration, anatomical location were not provided), lot number S032359 has been verified to be a valid lot number, expiration date: 11-JAN-2021, for prophylaxis. There was no known temperature excursions. The nurse inquired about need for revaccination. No additional adverse event reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032359; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Information has been received from a health professional concerning a 4 month old male who at "2 months of age" on approximately 28-JUL-2006 was vaccinated with a first oral dose of rotavirus G1 G2 G3 G4 P1 reassorted vaccine live (human bovine). On 08-SEP-2006 the patient developed diarrhea and green stools. The stool was not cultured. It was noted that the patient did not appear ill as he was eating normally and thriving. The patient was treated symptomatically and appeared to be recovering. There were no laboratory or diagnostic tests performed. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Hives, Spreading all over, started in am before shots. Had reaction to Robitussin DM and then continues to spread after immuns given 8/7/06.
12 hours after 2nd  dose 104.8 fever, vomiting,  arm swelling  twice size,  day 4 still fever. Had  reaction after first shot also on Day 8.  High fever covid arm and lymph nodes swollen  on left side.
her throat started to bother her; Anxiety; lips got tingly; hives on her face and arms; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (her throat started to bother her), ANXIETY (Anxiety), PARAESTHESIA ORAL (lips got tingly), URTICARIA (hives on her face and arms) and RASH (rash is just now fading) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included BENZOYL PEROXIDE (ACNE MEDICATION-10) for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced THROAT IRRITATION (her throat started to bother her), ANXIETY (Anxiety), PARAESTHESIA ORAL (lips got tingly) and URTICARIA (hives on her face and arms). On an unknown date, the patient experienced RASH (rash is just now fading). On 09-Apr-2021, RASH (rash is just now fading) was resolving. At the time of the report, THROAT IRRITATION (her throat started to bother her), ANXIETY (Anxiety), PARAESTHESIA ORAL (lips got tingly) and URTICARIA (hives on her face and arms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
complains of redness and burning around eyes and mouth. no swelling or difficulty breathing. pt told to monitor condition and call md immediately if getting worse
Tendonitis of the shoulder.  I took 2 months of oral anti inflammatory meds, and PT.  Next month I was sent to an ortho doctor he gave me a shot and 1 month of pt. The next month same thing.  No MRI was done an xray was done.  Now I am dx with bursitis and they want to do an MRI after 4 months.  I was told by emplyoee nurses that they had 3 other case reported  and that they found it was the vaccine that caused it and not the technique of the RN.  Anyway my shoulder is still not back up to 100% like it was prior to the shot.
pt recv vax; c/o swelling of lymph nodes, sore throat, red raised rash on face & upper lt arm;pre-placement lab showed that pt not immune to Rubella;
Pericardical effusion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 2, single (Lot number: ER8733) at the age of 64 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypertension", start date: 1999 (ongoing); "Depression", start date: 2007 (ongoing); "Prediabetes", start date: 2019 (ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (First dose, Lot. EN6205, administered intramuscularly), administration date: 04Mar2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: PERICARDIAL EFFUSION (hospitalization, medically significant, life threatening) with onset Apr2021, outcome "recovered", described as "Pericardical effusion". It was specified that the adverse event started sometime in Apr2021, days after the second dose. She went to emergency on 24Jan2022 when it got very bad and unbearable. The patient was diagnosed with pericardical effusion and had heart surgery. The patient was hospitalized for pericardial effusion (start date: 24Jan2022, hospitalization duration: 5 day(s)). The event "pericardical effusion" required emergency room visit. The patient underwent the following laboratory tests and procedures: Chest X-ray: (24Jan2022) Pericardical effusion; Echocardiogram: (unspecified date) Unknown results. Therapeutic measures were taken as a result of pericardial effusion. Then, the patient received BNT162b2 (BNT162B2), on 16Oct2021 as dose 3 (booster), single (Lot number: FF8641) at the age of 64 years intramuscular for covid-19 immunisation.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201185032 same patient/drug, different event/dose number;
Patient received vaccine and was waiting for the required 15 minutes in the pharmacy waiting area. Following this waiting period, the patient got up and walked to the in-window of the pharmacy to ask if they could leave. A this time the patient became dizzy and fell down in front of the counter. The patient came to on his own and was sitting up when the pharmacist came around from inside the pharmacy. Pt was responsive and aware of the events that took place as well as his surroundings. Patient contacted father and left on his own after approximately 5 minutes.
Patient left clinic after receiving vaccine but returned after a few minutes stating her "throat feels funny". Stated it felt like a "thickening" of the throat. Also c/o wheezing. Wheezing auscultated bilaterally at end of respiration. Pt given dose of Benadryl and observed for one hour. No signs of rash, hives, itching, or swelling. Vitals stable. Pt condition did not worsen. Pt given instructions on what to do if conditions changes or worsens.
PT WAS 17 YO AT TIME OF VACCINATION AND MODERNA WAS ADMINISTERED INSTEAD OF PFIZER. NO HARM OR ADVERSE SYMPTOMS WAS REPORTED BY MOTHER OR PT HERSELF.
pediatric dose was administered to adult patient; pediatric dose was administered to adult patient; This case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 63-year-old patient who received HAV (Havrix pediatric) (batch number Y67YJ, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th January 2023, the patient received the 1st dose of Havrix pediatric and Havrix Pre-Filled Syringe Device. On 5th January 2023, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 05-JAN-2023 Reporter's comment: A pharmacist had called up to informed that, a pediatric dose of Havrix was administered to an adult patient. The date of administration was not specified by the reporter. When looking for the lot number that the HCP gave, it was not found in the system. The reporter had consent to follow-up. Additional supportive information: The adult patient received the Havrix pediatric dose, which had led to adult use of a child product and underdose.
tested positive for COVID/ no symptoms; lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of ASYMPTOMATIC COVID-19 (tested positive for COVID/ no symptoms) and DRUG INEFFECTIVE (lack of efficacy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 023M20A) for COVID-19 vaccination.   Concurrent medical conditions included Hepatitis B and Fracture. Concomitant products included TENOFOVIR DISOPROXIL FUMARATE (VIREAD), CLONIDINE (CATAPRESS) and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2021, the patient experienced ASYMPTOMATIC COVID-19 (tested positive for COVID/ no symptoms) and DRUG INEFFECTIVE (lack of efficacy). At the time of the report, ASYMPTOMATIC COVID-19 (tested positive for COVID/ no symptoms) and DRUG INEFFECTIVE (lack of efficacy) outcome was unknown.         The patient was very pleased with the vaccine. Treatment information was not provided.
itching so bad; Hives; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), PAIN (Soreness) and PRURITUS (itching so bad) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced URTICARIA (Hives) and PAIN (Soreness). On an unknown date, the patient experienced PRURITUS (itching so bad). At the time of the report, URTICARIA (Hives), PAIN (Soreness) and PRURITUS (itching so bad) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported. No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Event Itching so bad was added
Injection site hot to touch with red circle surrounding, ultimately grew to 2" diameter red and stayed that way for ~48 hours following injection. Nausea & vomiting starting 12/28/16 11pm, ending 12/29/16 10am. Fever of 99.5 degrees taken 12/29/16 9am. Itchy raised red hives in patches that appeared & disappeared in random locations all over entire body, starting 12/29/16 8am, ending by 12/30/16 7am, hives were almost always present somewhere on the body during this period of time.
Pain initially just at administration site. Vaccine inserted into left shoulder. Shoulder still is hurting with severe pain, taking NSAIDs to help, cannot lift anything heavy, and I have short range of motion without serious pain.
Pt received the shot in the morning around 9 am, and called back at around 4 pm, stating he has diarrhea, not feeling good. No other symptoms per pt.
24APR98 appt 1PM for hep b vax pt called hlth dept p/returning home approx 2-3hr pt reports red blotches on chest just popped out;itching @ inj site;denied SOB;saw MD given med;
developed large raised red spots that itched and then became painful on side and small of back, continued itching of face and neck intermittently beginning day of injection
Bells Parsley symptoms; This spontaneous case was reported by a patient and describes the occurrence of BELL'S PALSY (Bells Parsley symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 BELL'S PALSY (Bells Parsley symptoms) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bells Parsley symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Patient was sitting in the ER due to facial dropping headaches along with many other Bells parsley symptoms. Facial dropping (PT: Facial paralysis) and headaches were the reported symptoms to event Bell's palsy.  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.  Company Comment:  This is a spontaneous case, reported by a patient, concerning a female patient of an unknown age with no medical history reported, who experienced the expected serious (medically significant) adverse event of special interest Bell's palsy, reported as symptoms of Bell's palsy, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. It was reported that the patient went to emergency room due to facial drooping, headache, and symptoms of Bell's palsy. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a patient, concerning a female patient of an unknown age with no medical history reported, who experienced the expected serious (medically significant) adverse event of special interest Bell's palsy, reported as symptoms of Bell's palsy, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. It was reported that the patient went to emergency room due to facial drooping, headache, and symptoms of Bell's palsy. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
13 days p/vax pt reported rash, which persisted for 4 wks;  pt dx as measles;
Local redness, Edema, LUE at injection site weakness LUE, Not reported until 10/07/02 by pt, Unknown connection   Per acknowledgement letter- Onset date and time- Unknown.