chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shoulders was hurting a little; This is a spontaneous report received from a contactable consumer. This consumer reported similar events for 5 patients. This is 5th of 5 reports. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration, on an unknown date, as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the reported stated that "there was 5 of them had reactions and their shoulders was hurting a little but they did not have fever." The outcome of the event was unknown.  Information on Lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021171049 same drug/AE, different patient.
viral bronchitis; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported, Expiry date: not reported) via an unspecified route of administration on 09Mar2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced viral bronchitis (for over a week now, it started on Saturday) on 20Mar2021 and caller initiated the call to report for her friend . Therapeutic measures were taken as antibiotics, Benezonetate and Salbutamol inhaler for the event. reporter wanted to know if she can cancel her second dose schedule on 30Mar2021. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Felt squeezing in heart; severe headache like a cement block in head; chills and fever 101.4. The next morning, severe fatigue and could hardly get out of bed to use the bathroom. Sensations lasted 36 hours.
Patient describes having a local reaction of itchiness, redness, swelling around site of where she received her ZOSTAVAX injection. She says reaction has decreased noticeably after BENADRYL and ice applied.
tested positive; tested positive; This is a spontaneous report from a contactable consumer reported for a male patient (father) that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration from 08Feb201 to 08Feb2021 at single dose (dose number 1) for covid-19 immunisation. Patient's medical history and concomitant therapy was not reported. As per verbatim and Event Description the caller's father tested positive before getting the 2nd dose. The outcome of event was unknown.   Information on the Lot/Batch number has been requested
Client had 3 doses of Pfizer and should not have received this dose of Moderna Bivalent
past 2 nights, temp elevation, fever breaks in AM w/diaphoresis;dizzy w/h/a & diarrhea x 36hr;inc fluid intake, especially H2), Ibuprofen for fever;
Dtap given RVL- Rash/swelling to leg later that night. Loratadine and Hydrocortisone for treatment.
Localized edema and erythema, approx. 3 inch diameter: reported as warm and tender to touch. Symptoms appeared the morning after the vaccine was given. Pt took BENADRYL which relieved redness and edema w/i 24 hrs. Soreness and tenderness went away 48 hrs after w/o taking pain reliever.
In November 2022, I began to have symptoms of chest pain, back pain and pain in my left arm. I had this pain for about 3 weeks. I called 911 twice. I went to emergency department, and I was diagnosed with a heart condition. I had a mild heart attack and 40% blockage. I was in the hospital for 4 days. I had an angiogram. I did not have surgery.
This literature report (initial receipt: 10-Jul-2012) concerns a 9-year-old female patient, with a history of recurrent otitis media since 15 months of age, chronic sinusitis, and 2 episodes of pneumonia, who presented for the evaluation of a possible immune deficiency. According to the parents, the patient was always 'chronically' ill and has received multiple courses of antibiotics, including a trial of prophylactic antibiotics. The past history included symptoms consistent with asthma, for which she was being treated with a leukotriene modifier, and allergic rhinitis, for which she was being treated with topical nasal steroids and antihistamines. Family history was positive for allergic disease in both parents. Allergy skin test results are negative for inhalant allergens. There was no family history of an immune deficiency disorder. On an unknown date the patient received an influenza vaccine (brand name and manufacturer were not reported). Eight weeks after receiving vaccination, the patient had a blood work. Antibodies to influenza A and B were absent. The event was reported as poor response to influenza vaccine. The significant history of recurrent infections, ongoing chronic sinusitis, multiple antibiotic use, poor response to influenza and also PNEUMOVAX vaccines, and month of presentation (November) led to a consideration of starting replacement intravenous immunoglobulin (IVIG) therapy at 400 mg/kg on a monthly regimen. She did well on the replacement IVIG therapy, with markedly less episodes of otitis media and also improvement in the frequency of sinusitis. Shortly after her parents divorced, the patient moved out of town with her mother. She was lost to follow-up and apparently discontinued her replacement immunoglobulin therapy. At age 16 years, the patient decided to live with her father again and presented with recurrent infections, including draining ears, chronic cough, and recurrent sinusitis. High-resolution chest CT (computed tomography) showed no bronchiectasis, and spirometric results were normal. Repeat immune evaluation at age 16 years and after being off immunoglobulin replacement therapy for 3 years showed a serum IgG level of 376 mg/dL, IgA level of 7 mg/dL, and IgM level of 21 mg/dL. Specific antibody to influenza type A/B was absent. She also responded poorly to influenza vaccine with titers of only 1:4 for influenza A. The patient was restarted on replacement immunoglobulin therapy in hospital infusion center at 600 mg/kg per month, with a subsequent follow-up serum IgG level of 840 mg/dL.
This spontaneous report as received from a licensed nurse practitioner refers to multiple unspecified patients of unknown age and gender. On 01-OCT-2014 the patients were vaccinated with ROTATEQ (dosing details unknown). The reporter stated that she had a supported temperature excursion that affected ROTATEQ. Reporter stated that she presumed she had administered to multiple unspecified patients since the first excursion date, on 01-OCT-2014, but had no patient or product specific information to offer. No adverse effects were noted. Outcome of the temperature excursion of ROTATEQ was unknown. No product quality complaint was involved. This is one of the several cases received from the same reporter. Additional information has been requested.
This case was reported by a nurse via sale rep and described the occurrence of influenza-like symptoms in a 51-year-old male patient who received SHINGRIX. On 7th February 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, erythema of extremities and activities of daily living impaired. On an unknown date, the outcome of the influenza-like symptoms, erythema of extremities and activities of daily living impaired were unknown. It was unknown if the reporter considered the influenza-like symptoms, erythema of extremities and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported, but it could be 50 or 51 years old. The patient received SHINGRIX at his work. The patient experienced Grade 3 flu like symptoms, he could not brush his hair, and his arm was red all the way around (like a band around his arm). He missed work for 3 to 4 days due to these symptoms and they lasted for 1 weeks. He told his wife that he believed he would have rather had shingles then experience these side effects. This case has been linked to the case US2018GSK053449 and US2018GSK053450 reported by the same reporter.
pt recv vax & devel h/a, flushed, red face;lt upper arm was swollen & warm to touch, stomach distress;next morning pt exp sore throat, earaches, chills, sneezing, muscle aches, pain & swelling in upper lt arm & coughing spasms;lack of sleep
body aches started around 5:30 pm.  Body aches all night and headache.   Body aches still today and as of 5 pm a temp of 99.5  Hands and arms hurt the most.   I had covid february 28.  so this first vaccine is acting more like a second vaccine .  My second dose is due 5-17 I will wait later than that to get the second dose.
Fogginess; Trouble breathing; This spontaneous case was reported by a non-health professional and describes the occurrence of BRAIN FOG (Fogginess) and DYSPNOEA (Trouble breathing) in a 36-year-old male patient 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 BRAIN FOG (Fogginess) and DYSPNOEA (Trouble breathing). At the time of the report, BRAIN FOG (Fogginess) and DYSPNOEA (Trouble breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided.  Treatment information was not provided.
Leg and feet swelling 4-5 days after the vaccine injection; After the medical check discovered abnormal heart size and systolic heart failure that never happened before. The patient was sent to the hospital and stay for 5 days for cardio check-ups and monitoring. Now is discharged from the hospital on the pill.
Syncope. Pt fell on ground and thus hit head. Patient was alert but for precaution was taken by ambulance to the ED to get evaluated.
Sleepy; Achy; Felt a little bit sick; Got a  J&J vaccine a couple of months ago and then got the Moderna first dose; Tired; Fever of 103°F/temperature dropped to 100°F; Felt they had a cold; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), PAIN (Achy), ILLNESS (Felt a little bit sick), NASOPHARYNGITIS (Felt they had a cold) and INTERCHANGE OF VACCINE PRODUCTS (Got a  J&J vaccine a couple of months ago and then got the Moderna first dose) in a 23-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: COVID-19 VACCINE NRVV AD26 (J&J vaccine a couple of months ago).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced NASOPHARYNGITIS (Felt they had a cold) and PYREXIA (Fever of 103°F/temperature dropped to 100°F). On an unknown date, the patient experienced SOMNOLENCE (Sleepy), PAIN (Achy), ILLNESS (Felt a little bit sick), INTERCHANGE OF VACCINE PRODUCTS (Got a  J&J vaccine a couple of months ago and then got the Moderna first dose) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) on 30-Sep-2021 at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Sleepy), PAIN (Achy) and FATIGUE (Tired) had not resolved, ILLNESS (Felt a little bit sick), NASOPHARYNGITIS (Felt they had a cold) and PYREXIA (Fever of 103°F/temperature dropped to 100°F) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (Got a  J&J vaccine a couple of months ago and then got the Moderna first dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2021, Body temperature: 103 deg f 103 Degree F. On 30-Sep-2021, SARS-CoV-2 test: negative (Negative) negative. On 01-Oct-2021, Body temperature: 100 degree f 100 Degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned since Patient 1(Reporter) was not aware of any medication Patient 2 may be taking regularly. Patient's historical vaccine included J&J vaccine taken a couple of months ago with No indication mentioned.
SOB for few min. and severe lower left back pain. 911 called, transported to ER.
On 01/15 patient reported an onset of erythema, tenderness, and warmth of her left deltoid. She stated this reaction started at the injection site and spread outward over her left upper arm. She reported some numbness in her arm at this time as well. These symptoms lasted until 01/20, and they resolved on their own by this date. Patient states she was seen by her primary care during this time, who stated she had a cellulitis. She was not given any treatment by her primary care. Patient reports that on 01/28 she had a recurrence of erythema, tenderness, and warmth at her injection site. This reaction was localized to her left deltoid and lasted for 3 days, after which is resolved on its own.
Significant muscle ache/limited ability to move arm at injection site.  Soreness all night.  Weakness and dizziness (keying off p. 2 of PPSV (10/6/09) CDC handout).  I bumped into wall at home twice walking down hall, almost fell once.  Never had a reaction like this.
Received an expired dose of Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-year-old male patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29-APR-2023) for prophylaxis.   On 05-MAY-2023, the patient received Infanrix. On 05-MAY-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Received an expired dose of Infanrix). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2023066934   Additional Information: GSK Receipt Date: 09-MAY-2023 The reporter at a health department reported that patient received an expired dose of Infanrix. The reporter consented to follow up. The patient had received an expired dose of Infanrix vaccine, which had led to expired vaccine used. This case is linked to the case US2023066934, reported by the same reporter.
ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 28 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: 25-MAY-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210554908, 20210554431, 20210551574, 20210554478 and 20210554296.
Severe pain on the left side of my body for three days after I took Pain medication it was not effective.  Numbness and heavy arm for three days, I was not able to sleep on my left side for three day.  Flu-like symptoms and fever.
Patient complained of progressively worsening of redness/pain/swelling at injection site. She saw her primary on 5/8/18, who prescribed her cephalexin. She's been experiencing worsening of symptoms, more specifically, pain/stiffness in her neck, and he's been in and out of the ER. She is currently at hospital where she is waiting to hear back from Infectious disease.
This is a spontaneous report from a Pfizer sponsored program, by a contactable consumer. A 65-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on 30Aug2017 for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced severe pain in her back, very emotional, upset and crying with outcome of unknown.
This spontaneous case initially received on 03-Nov-2016, was reported by a health professional and concerns a(n) unk patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) from 2014 to 2014 Dose regimen: Not reported, Route of administration: Unknown. Batch number: Not reported. Non -company suspect drugs: ZOSTAVAX. Adverse reactions/events and outcomes: On 2014, shortly after receiving the vaccine, the patient experienced Eczema (outcome: Not Reported), Eosinophilia (outcome: Not Reported).
the following morning low grade temp; chills; I also had areas of pain in my spine; I also had areas of pain in my spine, lower back; the pain( a dull ache) radiated over to both sides of my kidneys off and on; I was sweaty and fatigued; I was sweaty and fatigued; joint pains; My right Arm was sore at injection site/real bad arm soreness; This is a spontaneous report from a contactable healthcare professional (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration in right arm on 21Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 21Jan2021, patient received her 1st vaccine dose and her right arm was sore at injection site. Then the following morning (22Jan2021) she had low grade temp and chills and real bad arm soreness. She also had areas of pain in her spine, lower back and the pain (a dull ache) radiated over to both sides of her kidneys off and on, on 22Jan2021. She took Advil and felt better. That night (22Jan2021) she woke up during the night with the chills really bad and had a low grade temp and she was sweaty and fatigued. Felt ok most of the day yesterday (22Jan2021), some joint pains. She went to sleep last night and woke up because of chills, low grade temp and aching in my spine again. Woke up later last night and she was sweaty. Today, she was doing fine and took some Advil this morning. Patient was nervous about taking the second dose because of the symptoms she was having because she experienced these side effects. She wanted to know if it will be worse with the 2nd shot. Outcome of the events was recovered.  Information on the lot/batch number has been requested.
Herpes Zoster; Information has been received from a lawyer regarding a case in litigation concerning a currently 68 years old female patient(pt). The pt's medical history, concurrent conditions and concomitant medications were not provided. The pt was prescribed the zoster vaccine live(ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In May 2015 , the pt was administered zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a pharmacist. On an unknown date, the pt was treated by a physician at medical office for the following injuries resulting from the pt's Zoster Vaccine Live (ZOSTAVAX) use: herpes zoster. The outcome of the event was unknown. Causality assessments were related.  Additional information has been requested.
shortly after receiving vaccination patient became nauseated and hot and sweaty. eventually vomited as well. after about 5 minutes symptoms resolved and patient felt normal
injection site is red, firm, hot and tender to the touch along with the surrounding area 2-3" in diameter of the injection site
Rash lasted 4 days, slight itching in evenings only Not seen by medical folks
Itchy rashes all over the body. The rashes started on the arms, after 2 days it became severe to the point I could not sleep. I went to see dermatologist the next day. I was prescribed Antihistamine and ointment which provided temp. relief for first 2 days. Then itching rashes started to become more severe. So I consulted homeopathic clinic. Its been 2 weeks since the onset of the rashes and I feel exhausted from lack of sleep, fatigue and mental stress.
rash/from neck to knees and it was very itchy; Booster shot on 31Aug2021; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash/from neck to knees and it was very itchy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster shot on 31Aug2021) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A, 002B21A and 022C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug hypersensitivity. Concomitant products included METFORMIN, LISINOPRIL, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), URSODEOXYCHOLIC ACID (URSODIOL), LEVOTHYROXINE SODIUM (SYNTHROID), HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S), CELECOXIB (CELEXA [CELECOXIB]), PRAVASTATIN and CELECOXIB for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster shot on 31Aug2021). In September 2021, the patient experienced RASH PRURITIC (rash/from neck to knees and it was very itchy). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Itchy rash, at an unspecified dose and frequency; HYDROXYZINE for Itchy rash, at an unspecified dose and frequency; PREDNISONE for Itchy rash, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Itchy rash, at an unspecified dose and frequency; AMMONIUM LACTATE for Itchy rash, at an unspecified dose and frequency; SALICYLIC ACID (EUCERIN [SALICYLIC ACID]) for Itchy rash, at an unspecified dose and frequency; DOXEPIN for Itchy rash, at an unspecified dose and frequency and LEVOCETIRIZINE for Itchy rash, at an unspecified dose and frequency. On 31-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster shot on 31Aug2021) had resolved. At the time of the report, RASH PRURITIC (rash/from neck to knees and it was very itchy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: abnormal (abnormal) Abnormal.         Patient went to several doctors (primary, kidney doctor, dermatologist and allergist) and none could solve the problem. She said that the only thing that changed was the vaccination.  Patient reported that Kidney doctor said to stop almost all the regular medications.
Information has been received from an unspecified reporter referring to a 9 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 29-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.