chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling in left leg; burning in her torso and upper arms and upper chest; Caller received her 3rd  Pfizer Covid BT Vaccine, Comirnaty, dose on 03Sep2021; Caller received her 3rd  Pfizer Covid BT Vaccine, Comirnaty, dose on 03Sep2021; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received third dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 03Sep2021 as DOSE 3, SINGLE for covid-19 immunization. Medical history included RA for which Humira injection and Ibuprofen was received. The patient's concomitant medications were not reported. Historical vaccine included first and second dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on unspecified date as DOSE 1, SINGLE and DOSE 2, SINGLE both for covid-19 immunization. On 03Sep2021, the patient experienced caller received her 3rd Pfizer covid BT vaccine, comirnaty, dose on 03sep2021, on 05Sep2021, the patient experienced burning in her torso and upper arms and upper chest, on 12Sep2021, the patient experienced swelling in left leg. Therapeutic measures were taken as a result of burning in her torso and upper arms and upper chest. No Serious events reported. The outcomes of events (swelling in left leg, Caller received her 3rd Pfizer Covid BT Vaccine, Comirnaty, dose on 03Sep2021) were unknown and the outcome of event (burning in her torso and upper arms and upper chest) was recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
sore throat, headache, chills, loss of taste, loss of smell, , post nasal drainage, sinus congestion, nasal congestion, sneezing, ear fullness starting 11/18/21
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-FEB-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-FEB-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-FEB-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-FEB-2022) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2022 at 1:11 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Feb-2022 at 1:11 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-FEB-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-FEB-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-FEB-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-FEB-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received Booster dose on 05 Feb 2022, 01:11:57pm Concomitant medications were not provided by the reporter. Treatment information was not provided.
1/12/10 445 PM - H1N1 administered. Around 7PM - itching all over body. 936 blisters and hives appeared in arms and abdomen. Itching around mouth. Went to ER. also had chills. - Given prednisone, BENADRYL, PEPCID, blood work and EKG done. Released at 1230. Told to see allergist.
Pt called the clinic on 10/15/2020, stating she had a lot of soreness in her left arm with tenderness when raising her arm. Pt states her arm was so sore, that she had decreased ROM. Pt states the next day she developed a headache which improved with Advil. Pt states on 10/11, she had significant dizziness when she went from sitting to standing. Pt notes she then developed diarrhea and nausea. Pt states she did not feel like she was running a fever, but states her "brain felt cold."  According to the pt, her symptoms have now resolved. Pt denies seeking medical treatment when her symptoms were present, but states she wants to f/u with her PCP.
pt recv vax 6SEP96 & 17SEP96 pt devel a fever up to 105 & flu-like sx including nausea, malaise & h/a;17SEP96 pt presented to MD:lab eval that same day revealed AST 495, LDH 2643, serum alk phos 284 & serum bilirubin 0.6;WBC2700;
got Shingrix first shot and second shot / believes he might have developed shingles/suspected vaccination failure; believes he might have developed shingles; bumps on his lower leg, inner thigh and stomach on same side; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and papular rash. On an unknown date, the outcome of the vaccination failure, shingles and papular rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and papular rash to be related to Shingrix and Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. For tolerance of 1st dose of Shingrix, refer case US2021AMR146065. The patient got bumps on his lower leg, inner thigh and stomach on same side. The patient believed he might have developed shingles. This case was considered as suspected vaccination failure as details regarding  time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The patient declined to provide demographics or any additional information. The reporter did not consent to follow up. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR146065:Same reporter
Pt. reported shortness of breath, tightness in chest.  Reported that chest tightness lasted a moment then resolved.
Initial unsolicited report received from a consumer (patient) on 28 September 2016. This case involves an 80 years old male patient who was vaccinated with a second dose of FLUZONE HD (batch number: UI697AA, expiratory date: 06 May 2017, route and site of administration was not reported) in right side on 27 September 2016 around 15:00. Patient's illness at the time of vaccination was denied. Patient pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as Hyperlipidemia and sleep apnea. Patient denied to report about any other vaccinations within 4 weeks of vaccinations. Concomitant medications was not reported. On 28 September 2016 (at 05:00), 14 hours following the vaccination, the patient had experienced pain from knees up to hips and muscles spasms on both sides at every muscle. On 28 September 2016, one day following vaccination, the patient experienced pain which continued all night and pain was excruciating and felt sore in the morning. Relevant laboratory data was not reported. It was reported that the patient had taken treatment with twice of extra strength Tylenol. On an unspecified date, the patient was recovered from event. List of documents held by sender: none.
Pt. was given Flu vaccine in right arm and the pneumonia vaccine in left arm. Pt. stayed in facility 5-10 minutes for no reaction.
Admitted to hospital on 12/19/11 with a report of seizures (5 episodes) in a 2 week period. Dx with seizures & put on phenobarbital. First PREVNAR was administered on 12/6/2011. Within hours of receiving 2nd dose of PREVNAR on 3/22/12 pt had 20 reported seizures and airlifted to hospital. Pt was given ATIVAN to stop seizure activity, and blow by oxygen for transient desaturations. He had consultation with his neurologist who increased his phenobarbital dose and added KEPPRA. Patient has follow-up for further diagnostic testing. Has been stable on current medications with no repeating seizure activity. Specialty doctors are advising to discontinue vaccination with PREVNAR until further studies can be completed.
RIGHT ARM, GENERALIZED BODY ACHES, CHILLS, JOINT ACHES AND FATIGUE.
HOT FLASH LIKE SYMPTOM; BLURRED VISION; IMPAIRED VISION; WEIRD FEELING; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included carpal tunnel surgery, deviated septum surgery, and rectal seal surgery, and concurrent conditions included sleeping trouble, penicillin allergy, alcohol user, and non-smoker. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced hot flash like symptom. On 26-MAY-2021, the subject experienced blurred vision. On 26-MAY-2021, the subject experienced impaired vision. On 26-MAY-2021, the subject experienced weird feeling. The action taken with covid-19 vaccine was not applicable. The patient was recovering from blurred vision, had not recovered from impaired vision, and the outcome of hot flash like symptom and weird feeling was not reported. This report was non-serious.
The patient fainted as soon as she got the immunization/Moderna 1st dose and fall down to the side of the chair she was sitting.  She regained consciousness  after a few seconds and sat down on the floor, she had mild seizure for a few seconds before she regained consciousness. She had no headache and her breathing was normal. She told she has no history of seizures. She told she was feeling fine. But after a few minutes she told she was feeling dizzy again, so we called the paramedics and she was taken to the hospital. I called and left message for patient to follow up with her.
Following 1st dose of vaccine - developed headache and migraine - called PCP and was prescribed sumatriptan which worked. Was also advised to check her BP again, as she previously was on blood pressure meds but stopped due to her BP being controlled without meds. After 1st dose of vaccine, BP started fluctuating and worsened after the 2nd dose to the point where PCP started her back on amlodipine 5mg. Also had headache and severe pain from left side of head down to ear after 2nd dose.
Information has been received from a physician's assistance concerning a female who on 01-MAR-2007 was vaccinated with Gardasil. On 01-MAR-2007, the patient experienced a little blood at injection site when Gardasil was administered. Unspecified medical attention was sought. The patient's outcome was not reported. Additional information has been requested.
nausea, vomiting, diarrhea, confusion, amnesia, low potassium, dehydrated, upper arm pain and hospitalzation
On 3/2 there was the 3rd visit clinic for this facility. They registered this patient to receive their second dose. Only upon returning to the pharmacy to process the paperwork did our records indicate that he in fact has already received 2 previous doses. Facility was contacted, and internal reporting was completed.
Pt reported mild injection site pain and fatigue for a day or so starting the day of immunization. He also reported very sore thighs starting on 2/2/20 (6 days after imz) and very sensitive skin of the thighs.  He reported the skin on his thighs is painful to the touch.
Moderna COVID-19 Vaccine  Headache started at six hour following vaccination and persisted through the night. Pains in lower back, knees, and fingers started in the middle of night and persisted through the night. At about 24 hours following vaccination, I?m experiencing moderate to sever pains in lower back, joints, and fingers.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 8th November 2018, the patient received the 1st dose of SHINGRIX. On 8th November 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, feeling unwell and headache. On 9th November 2018, the patient experienced fever, feeling cold, injection site erythema, sleep disturbance and injection site pain. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the feeling unwell, headache, fever, feeling cold, injection site erythema and injection site pain were recovered/resolved and the outcome of the sleep disturbance was unknown. It was unknown if the reporter considered the pain in arm, feeling unwell, headache, fever, feeling cold, injection site erythema, sleep disturbance and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX last Thursday on left arm and later that evening she had a sore arm, general unwell feeling, and headache. Early in the AM on Friday 1 day after vaccination, the patient kept waking up freezing, stated she had a fever probably and she had a 4 inch long by 2 inch wide red area at the site of the injection and more painful. On Saturday the area was now 2 inches lower on her arm. All issues resolved except the area was still tender to touch. The patient noted she also had allergy shots in her left arm in the same area as the SHINGRIX shot on Thursday as well. The patient noted she gets the shots every 7 weeks and the two she received that day were for mold and dust which were major allergens for her. Consented to follow up. The healthcare professional info not asked. The product received at pharmacy.
Anaphylactic reaction including swelling of the throat, skin irritation, shortness of breath, increased heart rate & blood pressure.
A couple of days after the second vaccine I developed a rash on my face, both sides but the right is worse. I still have the rash after several treatments by dermatologists
40-year-old female with history of occasional headaches and Hashimoto?s thyroiditis (euthyroid not on medication) who presented for evaluation of a new purpuric rash on her gluteal region of unknown duration. Twenty days prior to presentation, she received the second dose of the Pfizer?BioNTech BNT16B2b2 mRNA vaccine, reporting mild fatigue and myalgias lasting 2 days post injection. She developed a purpuric rash on her buttocks that was consistent with Henoch-Schönlein purpura. Rheumatology, hematology, and fertility doctors agreed the rash was consistent with early-stage HSP triggered by Pfizer?BioNTech BNT16B2b2 mRNA vaccination. Given lack of systemic involvement, she was asked to monitor symptoms. Rash resolved within a week.
Within hours high fever and rash. Within 48 hours seizure, lethargic. Within few days stopped talking. Seizures lasted over 1 year after vaccine.
This spontaneous report was received from a pharmacist via a company representative concerning a female patient, age unknown. The patient was vaccinated with a single dose of ZOSTAVAX (dosage information not provided) on 14-SEP-2012. The pharmacist reported that the patient experienced redness and warmth around the injection site after administration of ZOSTAVAX on 14-SEP-2012. No treatment information or further details were reported. The outcome of redness and warmth around the injection site is unknown. Additional information has been requested.
dose number=3 date=24Oct2021; COVID 19 Treatment; dose number=3 date=24Oct2021; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 24Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 49 years 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. Relevant medical history included: "Hypertension" (unspecified if ongoing); "dyslipidemia" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE, start date: 01Jan2018; METOPROLOL TARTRATE, start date: 01Jan2018; ROSUVASTATIN, start date: 01Jan2018, stop date: 27Apr2022; ASPIRIN [ACETYLSALICYLIC ACID], start date: 01Jan2018.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "dose number=3 date=24Oct2021; COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05May2022) fainter; (06May2022) fainter; (08May2022) Positive; (Apr2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 28Apr2022 to 02May2022.  The patient was taking other (unspecified) medications/products within 2 weeks of starting COVID-19 treatment. It was reported that last dose of Paxlovid was taken on the morning of 03May2022, and antigen results were getting fainter on 05May2022 and 06May2022, have had runny nose for a few days and antigen test (same type, taken under same conditions) was now strongly positive today 08May2022, so it seems like the virus has rebounded. The patient had no Known allergies.
Bad metallic taste; Tested positive for covid; This spontaneous case was reported by a patient and describes the occurrence of DYSGEUSIA (Bad metallic taste) and COVID-19 (Tested positive for covid) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Bad metallic taste) and COVID-19 (Tested positive for covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, DYSGEUSIA (Bad metallic taste) and COVID-19 (Tested positive for covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19.         No concomitant drug reported.  Product information was reported with code as, BNT162B2. The patient received booster dose from Pfizer. The patient took Paxlovid and it helped to recover faster.  Company Comment: This is a spontaneous case concerning a female patient of unknown age with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, on unknown date after receiving the second dose of mRNA-1273 and a booster dose of other COVID-19 vaccine (Pfizer). The patient was treated with Nirmatrelvir/Ritonavir and the event had resolved at the time of the report. Interchange of vaccine products was also reported as the patient received primary doses of mRNA-1273 (unknown interval) and a booster dose of other COVID-19 vaccine (Pfizer). The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-580630 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, on unknown date after receiving the second dose of mRNA-1273 and a booster dose of other COVID-19 vaccine (Pfizer). The patient was treated with Nirmatrelvir/Ritonavir and the event had resolved at the time of the report. Interchange of vaccine products was also reported as the patient received primary doses of mRNA-1273 (unknown interval) and a booster dose of other COVID-19 vaccine (Pfizer). The benefit-risk relationship of mRNA-1273 is not affected by this report.
diarrhea; shaking; chills; high temperature; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), TREMOR (shaking), CHILLS (chills) and PYREXIA (high temperature) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DIARRHOEA (diarrhea), TREMOR (shaking), CHILLS (chills) and PYREXIA (high temperature). At the time of the report, DIARRHOEA (diarrhea), TREMOR (shaking), CHILLS (chills) and PYREXIA (high temperature) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Noticed my left arm felt funny and rubbed it a little. When I took off my shirt it was a large, raised lump, red and oval shaped at the site of the injection.  I took 2 Benadryl and slept for a couple hours. It wasn't any better so I went to Dr just so he could see it.  He prescribed a Z pack and Medrol pack. I used an ice pack which seemed to help. I didn't pick up Rx until the next day; by then the swelling had gone down and wasn't as itchy. I didn't use the antibiotic or the steroid. By Friday 4/2 it was no longer swollen at at but still a bit red but didn't bother me. Was gone by Sunday.
Pt administered VARIVAX and DAPTACEL in (R) Thigh on 4/21/09. On 4/22/09 Pt developed quarter size area of redness, swelling, with pruritus. Given ibuprofen and BENADRYL with ice. On 4/23/09 Pt returns from school with 3" area enlarged, red, itching.
This case was reported by a physician via call center representative and described the occurrence of pain in a 70-year-old female patient who received SHINGRIX. On 20th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st April 2018, 1 days after receiving SHINGRIX, the patient experienced pain, coldness, fever, nasal stuffiness, headache, fatigue and feels poorly. On an unknown date, the outcome of the pain, coldness, fever, nasal stuffiness and headache were not recovered/not resolved and the outcome of the fatigue and feels poorly were unknown. It was unknown if the reporter considered the pain, coldness, fever, nasal stuffiness, headache, fatigue and feels poorly to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in the left deltoid. Only partial information was provided by the physician. The reporting physician stated that he had patient with possible side effects from the SHINGRIX vaccine going on for 5 day. The patient had symptoms of headache, achiness, fatigue, temperature to 99.8 and feels poorly. The physician has contacted the 2 different nurse and they did not call him back.
My left arm feels frozen hurts can't use  lift it above my head. I can't stretch out my arm.