chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Achy; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) and FATIGUE (Tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-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 PAIN (Achy) and FATIGUE (Tired). At the time of the report, PAIN (Achy) and FATIGUE (Tired) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-339288, MOD-2021-339317 (Patient Link).
cramps; Tingling on head, face, arms and legs; Initial information received on 14-Nov-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp (patient).  This case involves a 45 years old female patient who experienced tingling on head, face, arms and legs (Paraesthesia) and cramps (muscle spasms), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The medical history, medical treatments, vaccinations and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date in Sep-2018, the patient developed a serious tingling on head, face, arms and legs (paraesthesia) (Unknown latency) and cramps (muscle spasms) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient was hospitalized for this event 1 week after vaccination.   Other relevant tests included No lab data.  Final diagnosis was tingling on head, face, arms and legs, cramps.   A patient has been treated by a neurologist.  The outcome of the events was Unknown for tingling on head, face, arms and legs, cramps.  Information on the batch number was requested.; Sender's Comments: This case concerns 45 years old female patient who experienced Paraesthesia and Muscle spasms after vaccination with FLUZONE QUADRIVALENT. The time to onset is unknown. Additional information regarding patient's past medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
(L) upper arm - Bruising at site of injection - Pt. on ASA therapy daily. (L) upper arm - sl. swollen and red below injection site.
This is a spontaneous report from a Pfizer sponsored program, IBCC (Inbound Call Center for HCPs). A non-contactable consumer reported that a female patient of an unspecified age received PREVNAR 13 (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient experienced allergy on an unspecified date. The outcome of the event was unknown.
Swelling of the lymph nodes in neck-on the right side; Face started to swell; woke up in the middle of the night; Angioedema/lips started to swell after the injection/face started to swell; Felt pressure on the chest; This spontaneous case was reported by a patient and describes the occurrence of ANGIOEDEMA (Angioedema/lips started to swell after the injection/face started to swell) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D), PANTOPRAZOLE, BACLOFEN, MONTELUKAST SODIUM (SINGULAIR) and LORAZEPAM for an unknown indication.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced ANGIOEDEMA (Angioedema/lips started to swell after the injection/face started to swell) (seriousness criterion medically significant). 16-Jul-2021, the patient experienced CHEST DISCOMFORT (Felt pressure on the chest) and INSOMNIA (woke up in the middle of the night). On an unknown date, the patient experienced LYMPHADENOPATHY (Swelling of the lymph nodes in neck-on the right side) and SWELLING FACE (Face started to swell). The patient was treated with METHYLPREDNISOLONE ACETATE (DEPO-MEDROL) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CIMETIDINE HYDROCHLORIDE (TAGAMET [CIMETIDINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 16-Jul-2021, CHEST DISCOMFORT (Felt pressure on the chest) had resolved. On 17-Jul-2021, INSOMNIA (woke up in the middle of the night) had not resolved. At the time of the report, ANGIOEDEMA (Angioedema/lips started to swell after the injection/face started to swell), LYMPHADENOPATHY (Swelling of the lymph nodes in neck-on the right side) and SWELLING FACE (Face started to swell) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient experienced angioedema her lips started to swell 30 minutes after the injection, and her face started to swell 2 days after vaccination. The patient experienced swelling of the lymph nodes in her neck  on the right side. The patient woke up in the middle of the night and felt pressure on the chest, but it lasted a couple of seconds and then went away.   The patient went to the rheumatologist and was given a Depo-Medrol shot. The patient was also taking Benadryl and Tagamet.  Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.
rash below the injection site; arm sore; This case was reported by a consumer via call center representative and described the occurrence of rash in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 29th July 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 31st July 2020, the patient experienced rash. On an unknown date, the outcome of the rash was unknown and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the rash and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received 1st dose of Shingrix at an unspecified pharmacy.  The patient experienced 2days after vaccination injection site rash sore arm that was still continuing at the time of reporting.  The patient also reports a small rash below the injection site.
Adult Havrix given to 5 patients under age 19; Adult Havrix given to 5 patients under age 19; This case was reported by a other health professional via sales rep and described the occurrence of adult product administered to child in a patient who received HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.  Additional information was provided as follow: The patient was under 19 years of age and received Havrix adult, which led to adult product administered to child and overdose. The reporter denied permission to follow up. This is 1 of the 5 cases reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR137655:Same reporter US-GLAXOSMITHKLINE-US2021AMR137654:Same reporter US-GLAXOSMITHKLINE-US2021AMR137652:Same reporter US-GLAXOSMITHKLINE-US2021AMR137642:Same reporter
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, previous drug reactions or concomitant medications. On unspecified dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot number N020015, with expiration date on 17-JUL-2019 and (Oka-Merck) PROQUAD lot number N014950, with expiration date on 11-NOV-2018 for prophylaxis (strength, doses, routes of administration, anatomical locations, lot numbers and expiration dates were not reported for any of the vaccines). The MERCK STERILE DILUENT used for the reconstitution of the vaccines was properly stored. The administered doses of the vaccines experienced a temperature excursion in the range between -14 to -10 degrees Celsius (°C) for 52 minutes, as recorded by a data logger. The vaccines had a previous temperature excursions in the range between -14°C to -10°C for 67 minutes, There was no adverse events reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Follow up information has been received from a nurse and stated that she did not have further information about patient details or dates of vaccination. Also, she stated that she was unsure where to find the information. Sender's Comments: US-009507513-1805USA009829.
Running a fever over 101; This case was reported by a consumer via call center representative and described the occurrence of fever in a 40-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On 11th October 2022, the patient received the 1st dose of Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The day before reporting patient had Shingrix vaccine. The patient was 40's and immunocompromised and was running a fever over 101 degree Fahrenheit. The reporter asked was this normal. The fever was a lot of different degrees.
Information has been received from a registered nurse concerning a 28 year old white female physical therapist with no pre-existing allergies, birth defects, or medical conditions who on 8/31/04 was vaccinated SC with a second dose of varicella virus vaccine live (lot # 647717/0192P). There was no illness at the time of vaccination. On 9/1/04, the patient developed a localized reaction on her right arm that included itching, redness, and swelling. On 9/7/04, the reaction went systemic and she developed a fever and rash on her body that came and went after a few days. Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that on 9/1/04 at 8:40 AM, the patient had redness on his right arm with some induration, swelling, and pain, and she also had a fever for 2 days, and a rash that came and went on her body. There were no diagnostic tests or laboratory data. The outcome was reported as recovered. No additional information is expected.
Ringing in both ears with intermittent pain in both ears. Treated with Prednisone and Famciclovir.  Course of treatment 14 days.  After treatment, ringing in both ears remain. Occasional pain in right ear.  Decrease hearing in both ears.
No adverse events reported at this time.  Reporting because a 1.0ml dose of Moderna COVID19 vaccine was administered.  Patient received a double dose of vaccine
Pain from injection site (left deltoid) to wrist 6/10 with limited mobility. Numbness/tingling in ulnar nerve distribution in the left hand. Started day after injection. 48 hours of fatigue and hypersomnia. Day 6 post injection, left side supraclavicular and posterior cervical chain lymphadenopathy which has persisted without change. 2nd dose scheduled 2/13/2021.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter consumer or other non HCP. The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Apr2022 at 14:30 as dose 4 (booster), single (Lot number: FJ4991) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Thyroiditis" (unspecified if ongoing); "IBS" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures includes that SARS-CoV-2 test on an unspecified date positive and on 06May2022 positive, about 5 days after ending the paxlovid patient covid symptoms returned and patient began testing positive again. patient have been sicker than she was the first time, and a week later she still testing positive. Paxlovid has resulted in her being sick and in quarantine for 3 full weeks now, with no end in sight. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient had no Known allergies. Patient had no other medication in 2weeks of vaccination. Anti viral details includes tat product of COVID 19 Treatment. Brand was paxlovid. treatment start date was 27Apr2022 and treatment stop date was 01May2022.  No follow-up attempts are possible. No further information is expected.
4/3/2021 3:45 pm vaccine left arm lot 6955 4/4/2021 1:15am. Woke with headache, chills, fever 101.8; severe muscle and joint pain, diarrhea (almost had to crawl to toilet due to pain); coughing.    Took 2 875 mg Tylenol 4/4/2021 4:20am threw up.  4/4/2021 9:15am tried eating a bowl of wheat Ives but fel sick to stomach. Only ate 2 bites. Took my vitamin, Effexor and losartan with oj.  4/4/2021 12:18pm   Fever down to 99.4, dizzy, severe pain in joints and muscles throughout body, severe headache, back pain on right side, pain under lower rib cage both sides, nauseated, runny nose, cough took 2 more Tylenol 875mg.  Now it?s 4/4/2021 at 1:10 pm. Joint pain, terrible, terrible headache   Fever gone. Whole body feels like someone put me in a dryer on tumble. Injection site still really hurts but that minor compared to everything else.  I have had covid twice. Early January 2020 through March 2020. I then  donated plasma  13 times, and then caught it again August 2020. Had antibodies until mid March 2021 then I got my first vaccine. 1st vaccine symptoms were not as severe. Just vomiting and diarrhea 3rd-5th day,  headache for about 7 days but nothing like this.  The 2nd time reminds me of my 1st time I had covid.
Information as received from   a certified medical assistant (CMA) refers to a 12-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-JUN-2015, the patient was vaccinated with a dose of GARDASIL (lot number K014191 and expiration date 10-MAY-2017) (dose and route not reported) which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
When patient filled out the form she stated that she tended to have seizures with immunizations. About 3 minutes after the Covid immunization she did have a light seizure.
This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction), COUGH (Coughing), PYREXIA (Fever), WHEEZING (Wheezing) and CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication.    Concurrent medical conditions included Psoriasis.   In 2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. In 2021, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to 150 milligram. On 24-Sep-2021, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to 150 milligram. On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PRURITUS (Itching). On 09-Nov-2021, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction), COUGH (Coughing), PYREXIA (Fever), WHEEZING (Wheezing), CHILLS (Chills), DECREASED APPETITE (Appetite lost) and FATIGUE (Tiredness). On 10-Nov-2021, IMMUNISATION REACTION (Vaccination adverse reaction), COUGH (Coughing), PYREXIA (Fever), WHEEZING (Wheezing), CHILLS (Chills), DECREASED APPETITE (Appetite lost) and FATIGUE (Tiredness) had resolved. At the time of the report, PRURITUS (Itching) outcome was unknown. Not Provided.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2021, Body temperature: Fever.         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.  No treatment medication information provided No concomitant medication information provided  It was unknown if patient was enrolled in a covid-19 vaccine trial.
Fever, achy for 4-5 days in hips and joints.  8 days later red spot that grew at injection site... COVID RED ARM, raised spot that itched and was HOT, and hurt.
Pt. only requested to get the flu shot. A Pfizer covid shot was given by mistake. Pt. already had received 2 moderna shots in the past. Pt. was aware of the vaccine given and did not have any ADR.
Dreams every time i fall asleep (Day or Night) Reoccurring mild headaches and light headedness which last for a few seconds at a time
Information has been received from a physician concerning a 2 month old pt who was vaccinated PO with a dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). concomitant vaccinations included a dose of Hib conj vaccine (OMPC) and all routine 2 month immunizations. The physician reported that the pt subsequently developed a high fever. The physician also reported that the pt was admitted to the hospital for possible sepsis for an unknown length of time. The physician indicated that the pt did not have sepsis and the child recovered while hospitalized. Additional information has been requested.
had 2nd shot at 9 am woke up 2 am throwing up with chills and fever and stomach discomfort.  took advil; when i woke back up at 6 am underneath my tongue was so swollen I could not talk and difficultly in swallowing.  Took an allegra and swelling went down about 2 hours.  Now I have ulcers/sores under my tongue, slight sore throat and ears.  As of today, June 16th, condition still persists.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 at 09:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25Feb2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Aug2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Mar2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "known allergies Keflex". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid from 09Aug2022 to 14Aug2022, for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Tinnitus - Ringing in ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 2, single (Lot number: EP7534) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Arm Left), administration date: 22Feb2021, when the patient was 35-year-old, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 25Mar2021, outcome "not recovered", described as "Tinnitus - Ringing in ear". The event "tinnitus - ringing in ear" required physician office visit. Therapeutic measures were not taken as a result of tinnitus.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, unknown if patient been tested for COVID-19. Patient had no known allergies and no other medical history.
Swelling at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE SWELLING (Swelling at the injection site) 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 VACCINATION SITE SWELLING (Swelling at the injection site). At the time of the report, VACCINATION SITE SWELLING (Swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported by the reporter.
Pain in legs and joints, severe fatigue, short breath and Chronic Headaches, still experiencing all symptoms.
24 hours after injection - chills and fever up to 101.  Fever lasted for 12 hours and was only minimized with use of acetaminophen  48 hours after injection - injection site became red and hot to touch.   Heat/redness lasted for 96 hours before it subsided
Fever, neck ache into back of head,  dizziness,  "busy brain", achy,  fatigue.  Arm became red, swollen about & itchy about 2" below injection.
pt recv vax & exp a red rash over whole body;rash resolved w/in 1 wk;