chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 at 16:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Feb2021 at 13:00 as dose 1, single (Lot number: EN6200), in left arm, on 13Mar2021 at 13:00 as dose 2, single (Lot number: EM6206), in left arm, on 19Aug2021 at 16:00 as dose 3 (booster), single (Lot number: EW0217), in left arm and on 17Jan2022 at 16:00 as dose 4 (booster), single (Lot number: FJ6369), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Guaifenesin, reaction(s): "Known allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" (10Dec2022) and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid treatment from 19Nov2022 to 23Nov2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
This non-serious spontaneous case, was initially received on 25-Sep-2017, concerning a 42-year-old adult pregnant female patient. On 25-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: intramuscular, batch number: 00544611A, expiry date: 16-Jun-2018, anatomical location: not reported). It was reported that, vaccine was administered to a pregnant woman (explicitly coded as vaccine exposure during pregnancy). The patient said everything was fine and that she was healthy enough. The estimated date of delivery was reported as 11-Apr-2018. The outcome of the event was not reported. The reporter assessed the event as non-serious. Non-significant case correction received with IRD 22-Sep-2017: Batch number was updated on the screen. Narrative was amended accordingly.
Had itching on her hands and feet; The area turns a little pink when she itched it; Cold congestion; Chills; Headache; Has experienced congestion, stated her head felt like a marshmallow; She was hot and cold for 2-3 days; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot number: FC3183), dose 2 via an unspecified route of administration, administered in Arm Left on 28Sep2021 17:50 (at the age of 58 years) as dose 2, single for covid-19 immunization. Medical history included asthma from 1990 and ongoing, chronic obstructive pulmonary disease from 2015 and ongoing, fat tumor from an unknown date and unknown if ongoing, covid-19 from Nov2019 to an unknown date patient stated she believed she had Covid before it came out, like in Nov2019 because she was in the hospital for 5 days and she couldn't breathe. There were no concomitant medications. Patient previously took BNT162B2 on 07Sep2021 as Dose 1, Lot Number: FC3183 in Left Arm. Patient had no prior vaccination within 4 weeks. On 28Sep2021, 3-4 hours after her vaccine, the patient experienced has experienced congestion, stated her head felt like a marshmallow, she was hot and cold for 2-3 days, had itching on her hands and feet, the area turns a little pink when she itched it, cold congestion, chills, headache, has experienced congestion, stated her head felt like a marshmallow. The patient underwent lab tests and procedures which included biopsy: fat tumor. Therapeutic measures were taken as a result of events. She has been doing nebulizers treatments and was really not too concerned about that. Patient had itching on her hands and feet; there are no bumps or rashes associated with it, just that the area turns a little pink when she itched it. It comes and goes sporadically. Patient had cold congestion, chills, and headache started about 3-4 hours after her vaccine on 28Sep2021. She had had a couple of cancer scares, so she got a biopsy and it was not cancer and another was a fat tumor. Treatment was Nebulizer and Inhaler, Advil; Tries to let her body recover on its own. Clinical outcome of the events had itching on her hands and feet, the area turns a little pink when she itched it was reported as not recovered; unknown for Cold congestion and recovered on 02Oct2021 for rest of the events.  Follow-Up (12Oct2021): Follow-up attempts are completed. No further information is expected.
Pain in arm immediately following vaccination. Pain spread to neck and back. Followed by fever, chills, extreme fatigue and body soreness, rapid heart beat and some difficulty breathing. Red, bumps on forearm.
1st dose in 2019, 2nd dose in 2022; 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 79-year-old female patient who received Herpes zoster (Shingrix) (batch number AY7BP, expiry date 28th August 2023) for prophylaxis.   Previously administered products included Shingrix (received first dose in November 2019).   On 11th October 2022, the patient received the 2nd dose of Shingrix. On 11th October 2022, unknown after receiving Shingrix, 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.   Additional Information: GSK receipt date: 11-Oct-2022 Reporter's comment: The pharmacy intern reported that the patient did not back for second dose until the date of reporting. The reporter did not had the exact date of the first dose, nor the lot number/expiration date information. The reporter consented to follow-up. Additional supportive information: The patient received the second dose of Shingrix later than recommended interval, which led to lengthening of vaccine schedule.
Patient developed acute bursitis of the (R) shoulder 24 hrs after administration followed by progressive motor loss with
This case involves a patient of unknown demographics who had flu (Influenza) after receiving INFLUENZA VACCINE. The patient's past vaccination(s) included INFLUENZA VACCINE. The patient had flu every time when the patient received the INFLUENZA VACCINE. It was unknown if the patient had any other medical history, concomitant disease, or risk factor. The patient's past medical treatment(s) and family history were not provided. Details for the concomitant medications was not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "Flu Shot Fridays You missed the point of my comment, every time I get the flu shot I get the flu." It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was unknown for the event. There would be no information available on batch number for this case.
Minor stroke; Weak muscles; Terible pain in neck and lower back; Terible pain in neck and lower back; Nerve pain; Achy; Injection site reaction; A spontaneous report was received from a consumer who was also a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced C, injection site reaction, and achy.  The patient's medical history was not provided. Concomitant medications were not reported.  On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 043L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 21 Jan 2021, after vaccine administration, the patient experienced injection site reaction.  On 22 Jan 2021, she was feeling achy.   On 23 Jan 2021, she had nerve pain that felt like cutting on the back, legs, and arms.  On 24 Jan 2021, the patient's muscles were weak and were not working or responsive on both sides.   On 25 Jan 2021, the patient could not control her left hand and weakness was more predominant on left side. The patient went to the doctor and was hospitalized with minor stroke for 24 hours. The patient stated that she was still experiencing terrible pain in neck and lower back.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, minor stroke, weak muscles, nerve pain, injection site reaction, and achy, was unknown. The outcome of event, terrible pain in neck and lower back, was considered not resolved.; Reporter's Comments: Based on the current available information and evidence of a temporal association between mRNA-1273 use and the onset of injection site reaction and achy, a causal relationship cannot be excluded. There is limited information to asses causality for the events of injection site reaction, and achy.  Additional information has been requested.
1. high pitched, shrill crying x 3-4 hours. 2. inconsolable.
PATIENT EXPERINCED AFTER APROXIMATELY 15 MINUTES AFTER THE SHOT SWALLONESS ON THE LEFT SIDE OF THE FACE AND LOWER LID OF THE LEFT EYE, ALSO OF THE LIPS. ALSO HIVES ON THE LEFT SIDE OF THE NECK. PATIENT WAS GIVEN 25MG BENADRYL PO. AND 40 MINUTES AFTER THE REDNESS AND SWALLONESS IS IMPROVING.
1.5 hours after vaccine -ongoing 1)Sunburn-like skin sensitivity/pain on right thigh and buttock. 2) Tight skin feeling on entire right leg . 3) Joint/ligament pain in right hip and knee.  Noticed 2 days after vaccine -ongoing 1) Raised,  painful rash on buttock. 2) Raised rash on right calf. I did have a massage after the vaccine.
back pain; heart palpitations; flu like symptoms; skin sensation; anxiety; fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of BACK PAIN (back pain), PALPITATIONS (heart palpitations), INFLUENZA LIKE ILLNESS (flu like symptoms), SKIN SENSITISATION (skin sensation) and ANXIETY (anxiety) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hyperparathyroidism, Blood pressure high and High cholesterol.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (back pain), PALPITATIONS (heart palpitations), INFLUENZA LIKE ILLNESS (flu like symptoms), SKIN SENSITISATION (skin sensation), ANXIETY (anxiety) and FATIGUE (fatigue). At the time of the report, BACK PAIN (back pain), PALPITATIONS (heart palpitations), INFLUENZA LIKE ILLNESS (flu like symptoms), SKIN SENSITISATION (skin sensation), ANXIETY (anxiety) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided No treatment details were provided
Redness to upper left arm-some swelling area around injection site, warm to touch. Afebrile. Cool packs to upper arm today. Advised to use Children's Motrin and Benadryl. 08/12/04: Resolution of reaction. Redness and swelling has resolved.
COVID19 BV vaccine administered despite contraindication disclosed by patient to pharmacy that patient had received JYNNEOS MPX vaccine within four weeks prior (8/18/22) and is a young adult male at increased risk of myocarditis.
no adverse effect were reported in the patient; 16 years old patient inadverently administerd adult dose of vaqta; This spontaneous report was received from a pharmacist refers to a 16 year old patient. Information on pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 12-AUG-2019, the patient was inadvertently vaccinated with an adult dose of hepatitis a vaccine, inactivated(VAQTA) 50/1.0 U/ml (lot # S012250, expiry date:07-JUL-2020, anatomical location and route were not reported) for prophylaxis (incorrect dose administered). No adverse effects were reported in the patient (No adverse event). No PQC was involved.
event: patient passed out shortly after vaccine (in store) treatment: patient was instructed to remain seated on the floor. Patient was sweating and pale in the face. She was given water, BP was taken and within range. Patient remained sitting in store for 20 min. Patient left with an alternative driver and stated she was okay and felt much better.
Shingles; Arm pain; Fever; Chills; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) 50 mcg/mg. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced shingles, pain in arm, fever and chills. On an unknown date, the outcome of the shingles, pain in arm, fever and chills were unknown.   It was unknown if the reporter considered the shingles, pain in arm, fever and chills to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's wife. The age at vaccination was not reported. The reporter stated that the patient was a kidney transplant patient. The patient after vaccination experienced arm pain, fever, chills and developed shingles. The patient was on immunosuppression drugs. The reporter asked whether patient should get the second shot.
A physician reported that a female, presently 38 years of age, received an injection approximately 20 years ago. She subsequently developed paralysis of the left side of her body. The paralysis was temporary and the pt fully recovered. This event is considered medically important.
Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning an "18 year old" female who on 19-OCT-2009 was vaccinated with the second dose of GARDASIL (unspecified when the first dose was given) and was approximately 4 weeks pregnant at the time of reporting. The patient was currently had "cramping". The patient's estimated conception date was 07-OCT-2009, and estimated delivery date was 14-JUL-2010. The patient called the physician's office for medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Positive test for SARS-Cov2; Positive test for SARS-Cov2; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 79-year-old patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Drug allergies: Penicillin" (unspecified if ongoing); "AF/ Atrial fibrillation" (unspecified if ongoing); "T2DM/ Type 2 diabetes mellitus" (unspecified if ongoing); "HTN/Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "neuropathy" (unspecified if ongoing); "Heart disease" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "sepsis" (unspecified if ongoing), notes: sepsis requiring ventilation in Sep2022; "ventilation", start date: Sep2022 (unspecified if ongoing), notes: sepsis requiring ventilation in Sep2022; "non-smoker " (unspecified if ongoing); "No alcohol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset Apr2023, outcome "recovered" (2023) and all described as "Positive test for SARS-Cov2". The patient was hospitalized for drug ineffective, covid-19 (start date: 28Apr2023, discharge date: 02May2023, hospitalization duration: 5 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2023) Positive, notes: over the counter Nasal swab; (28Apr2023) Negative, notes: tested negative in hospital; (02May2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-PV202300078346 same reporter/patient,different drug/AE;
mom reported child to ER d/t rash, hives & swelling;MD ER felt it was an allerg rxn d/t vax that was given 19FEB98;dx allerg rxn;dx rxn to vax altered skin integrity;
Fever (over 101 degrees), chills, headache (severe), muscle pain, body aches, fatigue,  nausea and vomiting starting 2 days after vaccination, lasting over 5 days.
POC alleges that she observed that resident began to swell and retain fluids and the nurse noticed that he was not urinating,  felt  a lot of tiredness and had swollen legs. He was evaluated by the doctor and sent for several studies (EKG) and his heart was weakened. He was sent to do another study, because snoring was heard. He was transferred to the hospital to the ER, he had the fluid in his lungs. He  is placed  intensive and dies on 3/23/2021 from heart failure.
Cough then throat pain and trouble breathing,  started about 1.5 hour after vaccine given.  Hx of asthma, but no symptoms prior to vaccine given
Moderna COVID-19 Vaccine EUA  Headache for about 16 hours.
Caller got the 1st COVID shot then devolped a cyst in the back of her mouth; This is a Spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (unspecified trade name), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization.  The patient medical history and concomitant medications were not reported. The patient got the 1st covid shot then developed a cyst in the back of her mouth on an unspecified date with outcome of unknown.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected
Face started swelling at the place she had fillers and hurting; Face started swelling at the place she had fillers and hurting; Dissolved all the fillers in her face; Thought all her teeth were abscessed; Every joint in her body is aching; Persistent cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Persistent cough), SWELLING FACE (Face started swelling at the place she had fillers and hurting), FACIAL PAIN (Face started swelling at the place she had fillers and hurting), DEVICE MALFUNCTION (Dissolved all the fillers in her face) and TOOTH ABSCESS (Thought all her teeth were abscessed) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Skin cosmetic procedure (fillers) in January 2020 and Skin cosmetic procedure (fillers) in November 2019.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COUGH (Persistent cough). On an unknown date, the patient experienced SWELLING FACE (Face started swelling at the place she had fillers and hurting), FACIAL PAIN (Face started swelling at the place she had fillers and hurting), DEVICE MALFUNCTION (Dissolved all the fillers in her face), TOOTH ABSCESS (Thought all her teeth were abscessed) and ARTHRALGIA (Every joint in her body is aching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (Persistent cough), SWELLING FACE (Face started swelling at the place she had fillers and hurting), FACIAL PAIN (Face started swelling at the place she had fillers and hurting), DEVICE MALFUNCTION (Dissolved all the fillers in her face), TOOTH ABSCESS (Thought all her teeth were abscessed) and ARTHRALGIA (Every joint in her body is aching) outcome was unknown.            No relevant concomitant medications were reported. Patient also took steroid medications (unspecified) for treatment.   This case was linked to MOD-2021-100618 (Patient Link).
No further AE detials; HCP called to report an expired dose of VARIVAX was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE d; Date of excursion: 02-MAR-2023; This spontaneous report was received from a pharmacist and refers to a 16-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 02-MAR-2023, it was reported a temperature excursion of varicella virus vaccine live (OKA/MERCK) (VARIVAX). Temperature was 70 Fahrenheit (F) for 9 minutes. On 08-JUN-2023, the patient was vaccinated with an expired dose of varicella virus vaccine live (OKA/MERCK) (VARIVAX) injection, 0.5 milliliter, once administered for prophylaxis (Lot number W0252273 is an invalid lot number for VARIVAX, expiry date: 02-JUN-2023) (strength, lot #, anatomical location and route of administration were not provided). No additional adverse events were reported.