chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling Sick; lightheaded; tired; leg pain; Cough; Sneezing; Cold; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th August 2019, the patient received the 1st dose of Shingrix. On 18th August 2019, 1 days after receiving Shingrix, the patient experienced feeling unwell, light headedness, tiredness, leg pain, cough, sneezing and cold. On an unknown date, the outcome of the feeling unwell, light headedness and tiredness were not recovered/not resolved and the outcome of the leg pain, cough, sneezing and cold were unknown.   It was unknown if the reporter considered the feeling unwell, light headedness, tiredness, leg pain, cough, sneezing and cold to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. On Sunday, the patient experienced feeling sick with cough, sneezing, and cold, lightheaded, tired and leg pain. The reporter consented to follow up.
Local reaction at site of injection (right thigh). 2cm brownish pigment on skin with underlying 3 cm area of induration.
ON 1/7; CHILLS, LOW GRADE FEVER (100F), BODY ACHES, HEADACHE, AND FATIGUE X 14 HRS. TOOK ADVIL - 2 TABS AND REST.
Severe tinnitus for 5 days. Headaches, neck pain and low level tinnitus still prevalent to this day.
late 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old female patient who received HAB (Twinrix) (batch number J477Y, expiry date 20th May 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX) for prophylaxis.   On 27th September 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 3rd July 2022, the patient received the 1st dose of TWINRIX. On 27th September 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was 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: Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comment: The health care professional reported a patient received a late 2nd dose of twinrix. On 3rd July 2022 the patient received 1st dose of Twinrix. The vaccine administration facility was the same as the primary reporter. The reporter did consent to follow up. Additional supportive information: The patient received 2nd dose of Twinrix late than recommended time frame, which led to lengthening of vaccination schedule.
Felt lightheaded and sweaty, LOC ~ 10 sec , loss of bladder control . all other VS WNL
Large red spot (2 inches in diameter) at the injection site approximately 10 days after vaccination. Spot is slightly itchy and is raised to the touch.
Information has been received from a licensed practical nurse referring to a 1 year old female patient. No concurrent condition, medical history or concomitant therapy was provided. On 12-JAN-2016 at 10:16, the patient was subcutaneously vaccinated in the right thigh with the first dose of VARIVAX (Merck) (lot # L025207, expiration date on 07-JUL-2017, dose unknown). No adverse effects were reported. All telephone attempts to obtain follow up information had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested.
1st- 12/29/2020; 2nd- 2/5/2021. Small, left breast cyst increased in size from less than 1 cm to 5 cm between 2/5/21 and when observed on 4/25/21. It is benign after diagnostic evaluation.
My symptoms started on December 29,2021. I had cough on December 30.2021 tested with a home test followed up with PCR. Later that same day experienced brain fog, no fever and stats was normal. The next day I had diarrhea and on January 1, 2022 symptoms continued. On January 2, 2022 was given monoclonal antibodies. I received the new antibody on January 3, 2022 due to me being high risk and had slight improvements by January 4, 2022. Then on January 7th or 8th, 2022 everything had resolved resides the post viral cough lasted about a month.
Within 30 minutes after shot, tongue went numb. Continued to get worse. Caused a terrible case of thrush on my tongue, in my mouth and down my throat.
Extreme joint/muscle pain. Musculoskeletal flare. Back, bilateral hip, neck and bilateral shoulder pain. Pain in knees, toes, ankles and wrists. Joints felt like they were on fire. Severe myalgia in back, legs and shoulders. Muscles hurt to touch. Neuropathy in hips and legs. Hurt to walk, sit, bend and lay down. Symptoms lasted for 8 days. Physician prescribed Prednisone to treat symptoms. Unable to work for several days.
**9;25 am: 25 minutes after vaccine administered; Moderate Nausea/Lightheadedness; Laid down & still; Duration of 5 hours.   **11:00 am: 2 hours(120 minutes) after vaccine administered; Moderate Tenderness/Inflammation at the injection site; Unable to lift arm or away from the body without feeling soreness; Duration 36 hours & counting.   **10:30 am: 1 Hour & Half (90 minutes) after vaccine administered Mildly feverish, chilled, Temp check 99.1* F; Duration 45 minutes (OTC Naproxen 220 mgs taken by mouth to reduce temperature & ease pain.   **10:30  am: 1 Hour & Half  (90 minutes) after vaccine administered; Extreme tiredness & fatigue; Duration 36 hours & counting.
MOM STATES PATIENT HAD SWELLING AND REDNESS TO INJECTION SITE STARTING ON 3/16/2020. DR. INSTRUCTED FAMILY TO CONTINUE WARM COMPRESS AND TO RTC IF IT DOES NOT IMPROVE OR GETS WORSE.  MOM HAD CALLED BACK LATER 3/16/2020 PATIENT HAD VOMITED X2 AND HAD 1 EPISODE OF DIARRHEA, DR. PRESCRIBED ZOFRAN.  SPOKE WITH MOM 3/17/2020, PER MOM PATIENT IS DOING BETTER, NO REDNESS OR SWELLING, VOMITING/ DIARRHEA HAS RESOLVED.
did not have any antibody titers following completion of GARDASIL 9 dose series; This spontaneous report as received from an office manager refers to a 19-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies, and concomitant therapies was provided.  On unknown separate dates, the patient was vaccinated with 3 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and anatomical location of administration, lot # and expiry date were not reported) for prophylaxis.  On an unknown date, the patient's antibody titers were tested and the result showed that he did not have any antibody titers following completion of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose series (antibody test negative).  The outcome of antibody test negative was unknown. The relatedness between the event of antibody test negative and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
I had a reaction; Lymph nodes underneath my arm began to swell/Underneath my arm it's like a water bed; Fever; Inappropraite schedule of vaccine; Sweats; The whole nine yards and felt like he had the flu; Cough; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had a reaction), HYPERHIDROSIS (Sweats), COUGH (Cough), INFLUENZA LIKE ILLNESS (The whole nine yards and felt like he had the flu) and LYMPHADENOPATHY (Lymph nodes underneath my arm began to swell/Underneath my arm it's like a water bed) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06721A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: pfizer (The first dose was given ,into his left arm (he thinks) . The lot number was ER3729) on 12-Apr-2021, pfizer (The second dose was given  and Also into his left arm (he thinks) Lot number EV0175.Each of these doses were given) on 03-May-2021. Past adverse reactions to the above products included No adverse event with pfizer and pfizer.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced COUGH (Cough). On 23-Nov-2021, the patient experienced HYPERHIDROSIS (Sweats), INFLUENZA LIKE ILLNESS (The whole nine yards and felt like he had the flu), PYREXIA (Fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropraite schedule of vaccine). On 26-Nov-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes underneath my arm began to swell/Underneath my arm it's like a water bed). On an unknown date, the patient experienced VACCINATION COMPLICATION (I had a reaction). In November 2021, COUGH (Cough) and LYMPHADENOPATHY (Lymph nodes underneath my arm began to swell/Underneath my arm it's like a water bed) had resolved. On 23-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropraite schedule of vaccine) had resolved. On 24-Nov-2021, HYPERHIDROSIS (Sweats), INFLUENZA LIKE ILLNESS (The whole nine yards and felt like he had the flu) and PYREXIA (Fever) had resolved. At the time of the report, VACCINATION COMPLICATION (I had a reaction) outcome was unknown.            Patient received the Moderna booster shot on 23NOV2021 into the muscle of his right, upper arm at the,Lot number was difficult to discern, but thinks it was 06721A. No expiration date was provided. Patient received the Pfizer vaccines as the primary series.Also into his left arm (Patient  thinks).  No concomitant medication  were reported. No Treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: Significant Follow-up appended-Includes event updates, historical vaccine updates.
Patient received meningococcal  vaccine on 08/10/2005.  In late September or early October the patient developed weakness in the left hand and had trouble playing the clarinet and piano.  The patient was referred for physical therapy.  Symptoms resolved after approximately 30 days of physical therapy.
4 hours after injection malaise, body aches, injection site pain lasting 1.5 days
Quarter size knot on arm followed by a red rash at injection site. Arm is hot to touch.
couldn't sleep one night; have had a tightening in the chest; This is a spontaneous report received from contactable consumer (patient). This 44-year-old-male patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EN6206) via an unspecified route of administration on 04Mar2021 at 13:30 (at the age of 44-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure and COVID-19 diagnosis on an unspecified date prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included lisinopril and hydrochlorothiazide from unknown dates for unknown indications. On 07Mar2021 at 23:00, the patient could not sleep one night and since had a tightening in the chest. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of couldn't sleep one night and tightening in the chest were not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Information has been received from a registered nurse concerning a female, pediatric patient, who was vaccinated by HPV vaccine, (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the time of injection.  The pain lasted for 2 days and then resolved.  The patient was treated with warm compresses. The patient sough unspecified medical attention.  Additional information has been requested
Moderna: dose 1-2, Pfizer / BioNTech: 3-5; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 13:15 as dose 5 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Nov2021 at 15:30 as dose 3 (booster), single (Lot number: PH8030), in left arm and on 08Apr2022 at 17:00 as dose 4 (booster), single (Lot number: FR9894), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Feb2021 at 18:45 as dose 1, single (Lot number: 013M20A), in left arm and on 04Mar2021 at 16:30 as dose 2, single (Lot number: 040A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Cholesterol" (unspecified if ongoing); "Allergy to pollen" (unspecified if ongoing), notes: Allergies to pollen, fragrances, dust, etc.; "Allergy to fragrances" (unspecified if ongoing), notes: Allergies to pollen, fragrances, dust, etc.; "Allergy to dust" (unspecified if ongoing), notes: Allergies to pollen, fragrances, dust, etc.; "Recently got over ear infection" (unspecified if ongoing), notes: Recently got over ear infection; "Thyroid" (unspecified if ongoing), notes: Thyroid. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna: dose 1-2, Pfizer / BioNTech: 3-5". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received anti-viral treatment: Paxlovid.
pt recvd vax & exp episode of sz like activity this morning;discovvered pt 3hrs ago;hot, sweating & foaming from mouth;holding self stiffly & had tremor movement of extremities lasted 30 min did not respond to mom;T of 101;dx sz, viral synd
Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 3:25 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 3:25 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 50.84  No concomitant medications were reported.  Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature 34 degrees Fahrenheit from 9 AM. This vial was moved to fridge on 06-Apr-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-Apr-2021.  Vial was stored in cooler 1, on 15-Apr-2021, temperature excursion at 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 PM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  The healthcare professional (HCP) reported that, each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. The vial was stored in cooler storage during high-pace COVID-19 vaccination clinic at the time of excursion. Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
11/22/21 vaccine Pfizer lot FJ1620 was administered (adult vaccine) to pediatric patient. 11/23/21 Mother of the child was notified. Mother reports child not presenting any symptoms after vaccination
Sore arm; slight head ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (slight head ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (slight head ache). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (slight head ache) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication reported  No treatment information was provided    This case was linked to MOD-2021-041056 (Patient Link).
injection site pain, headache, tired muscle and joint aches, shivers, slightly sick to stomach.
Already in car leaving clinic when felt dizzy and according to mom blacked out for one minute. Hands were twitching and funny look on face,as if having seizure. Mom called ambulance and BP normal, taken to ER and blood test was normal. Doctor advised to keep an eye on patent for 24 hours.
pt recv vax 9APR97 & 10MAY97 pt exp an absence of menses;
Ws completely norml for 24 hrs.  Not even arm pain.  Then arm started aching.   More  in triceps and down arm.  Then  couldn't even lift my arm.  Then spiked fever which went of up 101.6 with chills and aches.  Took 2 tylenol and  it really helped.  Fine this AM
A spontaneous report was received from a consumer, concerning a 49 years-old, female patient, unknown race and ethnicity, who was administered COVID-19 vaccine, and the patient experienced reaction to the injection nine days out, red, swelling, hot and painful, and vaccine was injected below the deltoid in error. The patient's medical history was not provided. No concomitant medications were reported. On 13 JAN 2021, prior to the onset of events, the patient received their first dose of (Lot number: unknown), intramuscular in the deltoid area for prophylaxis of COVID-19 infection. It was reported that the patient had a reaction to the injection, nine days out from it on an unknown date. The reaction was red, swollen, hot and painful. The patient took ibuprofen and acetaminophen and was rotating every few hours for eight days, along with icing it. She went to the doctor's office yesterday and was prescribed steroids and loratadine. The patient also stated that the vaccine was injected below the deltoid area in error. The patient discussed with her doctor if she should get the second dose and they advised her not to take due to her adverse reactions and would like to know more information about vaccine. Action taken with second dose in response to the events was not reported. The outcome of the events, reaction to the injection nine days out, red, swelling, hot and painful, were not reported and that of event, vaccine was injected below the deltoid in error, was reported as resolved on an unknown date.; Reporter's Comments: This case concerns a 49 year old female with NS unexpected event of Incorrect route of product administration and NS expected injection site erythema, injection site swelling, injection site pain, injection site warmth. Event onset 9 days after first dose. Treatment: ibuprofen, acetaminophen, steroids, loratadine. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Arthritis in both hands where the Proximal Phalanx and Metacarpal of the pointer finger meet.
Vaccination site swelling/ARM REALLY BAD/THREE TIMES THE SIZE; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Vaccination site swelling/ARM REALLY BAD/THREE TIMES THE SIZE) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling/ARM REALLY BAD/THREE TIMES THE SIZE). In 2021, VACCINATION SITE SWELLING (Vaccination site swelling/ARM REALLY BAD/THREE TIMES THE SIZE) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jul-2022, Rectal examination: healing.         No concomitant drug information was provided.  No treatment drug information was provided.  It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial
I smell metallic, acidic, bitic, acerbic tastes and smells and extreme sensitivity to food.