chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reported feeling nauseous a few seconds after receiving the vaccine. Patient vomited X3.  (11:10 am, 11:25 am and 12:10 pm). Pt reported that her eyes feel heavy (this feeling went away 8 minutes after receiving the vaccine), reported mild headache and tiredness, reported that she did not eat or drink anything since last night (she last ate at 9pm, 5/24/21).  Pt did not show any signs of respiratory distress, no swelling of the throat, mouth, or face, respiratory rate was within limit X3  Vital signs X3 WNL pt.'s baseline  11:15 - BP 136/85, HR, 88, temp 97.7,RR 15 11:35 - BP 129/89, HR 70, temp 97.8, RR 16, 11:55 - BP 128/86, HR 75, temp 97.8 RR 14
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 29-MAY-2015, the patient was vaccinated with an unknown dose of expired M-M-R II, subcutaneously (lot # J006137, and expiry date 24-MAY-2015). No adverse event occurred. Additional information has been requested.
This case was reported by a consumer and described the occurrence of injection site pain in a elderly female patient who received Shingrix for prophylaxis. On 7th June 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported but it could be 82 or 81 years old. The patient experienced pain at injection site and no other symptoms. For the tolerability of 2nd dose, refer linked case US2018GSK170050 reported by the same reporter for same patient.
The patient received the COVID-19 vaccine at approximately 10:00 and within 10 minutes stated that her throat was tingling and scratchy and she felt like she had something in her throat.  She proceeded to try to clear her throat.  These symptoms worsened and the patient was sent to the ED for observation/treatment. Benadryl 25mg IVP, Pepcid 20mg IVP, Solu-Medrol 125mg IVP and Zofran 4mg IVP  was administered at 10:54.  Then a GI Cocktail was also administered PO (contains Donnatol, Lidocaine and Maalox) immediately following.  Ativan 0.5mg IVP was administered at 11:28.  The patient was discharged home at 12:27 and was stable.  Take home prescription from the ED was for Prednisone 40mg daily for 5 days.
I noticed a little bit of irritation around my left side of my face and throat which suggests eustachian tube and it progressed into my throat and then into my upper respiratory. I had coughing and I had mucus that I coughed up. I felt irritation in my sinuses. I think I had sneezing. I felt like it was a common cold. I haven't had one in a very long time since I have been diagnosed with RA in 2013. The next year, I got flu vaccines every year since 2014, I don't believe I have had any kind of flu or cold since that time. I had called my doctor's office and asked about getting the COVID test, and because I had symptoms they said I needed to see the provider. He concluded that it was the common cold and said it has been going around. He said I shouldn't get a COVID test. Guaifenesin (expectorant to help); Nasal sinus rinse and he said to gargle. I had the symptoms a little bit less than a month, about three weeks.
Severe chest pain, palpitation and shortness of breath. Felt like a heart attack.
Breakthrough COVID-19 case with symptom onset 7/22/2021:  Fever >100.4,  Muscle or body aches,  Cough (new onset or worsening of chronic cough),  Fatigue or tiredness,  Diarrhea (>/=3 loose/looser stools in 24 hr period), a lot of phlegm. Hospitalized for COVID-19 pneumonia and low blood oxygen levels. Hospitalized for at least 4 days starting 7/24/2021
body ache; fever; headache; This is a spontaneous report from a contactable consumer reporting for herself. A 52-year-old female patient received bnt162b2 (BNT162B2, lot number and expiration date were not reported), via an unspecified route of administration on 18Dec2020 at a single dose for immunization. Medical history and concomitant medications were not reported. The patient stated that she took the covid vaccine the day before (18Dec2020) and was experiencing body ache, fever and headache on an unspecified date in Dec2020. The outcome of the events was unknown.   Information on batch number has been requested.
Initial literature report received on 01 Nov 2010: This patient participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with FLUVIRIN 2007/2008 (manufacturer unknown, batch number: unknown) during the fall of 2007. The influenza Surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-illness (ILI) symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction (PCR) assay of the nasal swabs or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza (LCI). This patient tested positive for seroconversion of A/H32 strain (antibody titer values not provided). Therefore this patient was considered as an LCI case of influenza A/H3N2. The outcome was not reported.
expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 24-year-old female patient who received HAB (Twinrix) (batch number 4s3yy, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th January 2023, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 5th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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.   Additional Information: GSK receipt date: 5-Jan-2023 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received a dose of Twinrix, which led to expired vaccine used.
ARM PAIN, CHEST PAIN, BODY ACHES OF LOSS TASTE AND SMELL, FAINTED, FATIGUED, AND CONGESTION
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 30Nov2021 as dose number unknown, single at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood preasure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 01Jul2022, stop date: 21Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details: product: COVID 19 Treatment, brand: PAXLOVID Start date: 13Jul2022, stop date: 17Jul2022. No Known allergies.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if  and when received.
Pt. complained of difficulty in swallowing. A few minutes later stated slightly better/ not worse. A few minutes later stated not feeling good. Gave ZEPIPEN shots (IM) (total dose 0.6 mg). Called 911 paramedic showed within 5 minutes. Pt volunteered to go to ER.
One month later I broke out with a severe case of Shingles. Backbone to Sternum  ,, around waist on left side.
Patient was very nervous when checking in for vaccine. After vaccine administered, patient began sweating and becoming increasingly pale.  He then reported discomfort bilaterally in his hands and forearms.  He described it as weakness, "tingling", and an inability to move his hands. This lasted for 30-45 minutes and then seem to start to ease.  Patient was released to his mother.  At 8:30 PM his mother reported that he was still feeling weak but seemed ok otherwise. Adverse reactions to the vaccine, especially after a recent case of COVID, were discussed in detail with the patient and mother.  Due to this reaction, it was recommended they talk to his doctor before getting 2nd dose.
body aches; chills; fever; sore arm; swollen lymph nodes; fatigue; headache; neck stiffness/pain; neck stiffness/pain; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 14Apr2021 at 11:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 23Mar2021 at 11:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 21:00, the patient experienced body aches, chills, fever, sore arm, swollen lymph nodes, fatigue, headache, neck stiffness/pain. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events body aches, chills, fever, sore arm, swollen lymph nodes, fatigue, headache, neck stiffness/pain was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
2 days after patient recieved his COVID-19 vaccine, he developed  fever, rash, vomiting, and diarrhea in the setting of hypotension and LV dysfunction on ECHO most consistent with fluid refractory septic shock likely 2/2 MIS-C. He required vasoactives in the  ICU and has since improved. Of note, patient was COVID+ 6 weeks prior, which likely is related to his presentation, but given he recently had his vaccine, felt it was appropriate to report.
Extreme Fatigue, Severe Chills, Severe Migraine, Severe Heartburn, Severe Body aches, loss of appetite, shortness of breath, bruise on my right foot a fee hours after the vaccine was given.
Four days after receiving Covid 19 Pfizer vaccine I developed a severe case of shingles on left torso.
Dizziness, Myalgia, SkinRash & NauseaVomiting Narrative: Day after injection, got dizzy and nauseous. Left arm sore with mild rash from wrist to almost elbow. Patient expressed it may be poison ivy. Used Benadryl cream.
slight site pain.  Fever of 100.5 for over 48 hours; respiratory symptoms starting with some sneezing and a cough, which settled into chest after first 24 hours causing wheezing and difficulty breathing.  Took albuterol to relieve pressure.  Continued yet decreased cough and wheezing at 72 hours post-vaccination.  Breathing difficulty has subsided as of 8/26/19.
She had chest tightness and facial tingling 5 to 15 minutes after receiving vaccine. Her blood pressure was elevated to 149/96 and heart rate increased to 100-136. Oxygen saturation remained at 99-100%. She did not have loss of consciousness, complaints of tongue swelling, or difficulty swallowing. EMT was called; they evaluated her and recommended emergency room, but symptoms improved within 60 minutes. She had similar symptoms after a bee sting last year.
My arm hurts like someone punched me. Yesterday, I had a migrane. Today I am washed out and tired. I thought "only" a rash could ensue.  I was thinking that how the provider administered the vaccine might impact; I didn't know it was intramuscular and would have preferred someplace besides my arm, if that was the case.
swelling in my arm; soreness; Patient is calling to report side effects she incurred during Pfizer vaccination went away after receiving Spikevax 2023-2024; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (swelling in my arm), PAIN (soreness) and THERAPEUTIC RESPONSE UNEXPECTED (Patient is calling to report side effects she incurred during Pfizer vaccination went away after receiving Spikevax 2023-2024) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 pneumonia (hospitalized with COVID Pneumonia. And while in the hospital, patient woke up screaming in pain.), Bursitis (Muscle tissues and Bursitis going through my arms and down my Chest and stuff .), Musculoskeletal pain (Patient was inflamed. Skeletomuscular Pain.) and Chills. Previously administered products included for Product used for unknown indication: Pfizer monovalent (First Primary Pfizer monovalent dose) on 21-Feb-2021, Pfizer monovalent (2nd Primary Pfizer monovalent dose) on 11-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 3, First Pfizer t Booster dose) on 23-Aug-2021, Pfizer (Dose 4, 2nd Pfizer Monovalent Booster dose) on 14-Apr-2022 and Pfizer (Dose 5 Pfizer Booster) on 15-Nov-2022; for Shoulder pain: lidocaine (They placed lidocaine patches on shoulders.). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, Pfizer, Pfizer, Pfizer monovalent, Pfizer monovalent and lidocaine. Concurrent medical conditions included Costochondral separation (Patient kept having pain in arms and shoulder and went to see cardiologist. And He said patient had Costochondral-separation.).    On 18-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 18-Oct-2023, the patient experienced PERIPHERAL SWELLING (swelling in my arm), PAIN (soreness) and THERAPEUTIC RESPONSE UNEXPECTED (Patient is calling to report side effects she incurred during Pfizer vaccination went away after receiving Spikevax 2023-2024). At the time of the report, PERIPHERAL SWELLING (swelling in my arm) and PAIN (soreness) had resolved and THERAPEUTIC RESPONSE UNEXPECTED (Patient is calling to report side effects she incurred during Pfizer vaccination went away after receiving Spikevax 2023-2024) outcome was unknown.            Patient past medications included steroids. Patient took oral steroids, then steroid shots. Patient had therapeutic massages. She went through a lot and could not even lift her arms up. It hurt so badly. The evening of 18-OCT-2023, patient had a little swelling in her arm and soreness. Since having the Spikevax vaccine on 18-OCT-2023, those issues have gone away. They all went away. Patient could move her arm now. It was not hurting. No treatment medication reported.
losing hair pretty rapidly/ hair loss/ Telogen Effluvium; This is a spontaneous report from a contactable consumer (patient).  A 48-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), dose 1,on 26Jan2021 14:15 (Batch/Lot number was not reported), dose 2 on 16Feb2021 (Batch/Lot number was not reported); both via an unspecified route of administration, administered in left arm at the age of 48 years old as single dose for covid-19 immunization. The facility type vaccine: Home/Facility. The patient medical history includes borderline HPB and borderline high blood sugar due to PCOS. The patient was not pregnant. No vaccines were given 4 weeks prior. The patient has no COVID-19 prior to vaccination. Concomitant medication included losartan and metformin. On 01Feb2021, the patient noticed that she was losing hair pretty rapidly. She went to her primary care physician and had bloodwork completed which all came back normal. She then went to a dermatologist who felt there may have been a link between the vaccine and her hair loss. The dermatologist diagnosed her with Telogen Effluvium on 25Mar2021. The event resulted to doctor or other healthcare professional office/clinic visit and no treatment was given. The event was reported to have caused disability or permanent damage. The patient had COVID-19 test PCR nasal swab on 23Mar2021 and the result was negative. The outcome of the event was recovering.  Information on about lot/batch number has been requested.
Information has been received from a 56 year old physician reporting herself with a history of asthma who in the AM of 05-DEC-2008 was vaccinated with an expired dose of PNEUMOVAX (lot # 659922/1667U).  By evening of 05-DEC-2008 the patient experienced swollen, red, painful arm from shoulder to elbow.  The next day the pain and redness subside but the swelling persists still.  On 08-DEC-2008 the patient experienced upper respiratory congestion, fever and chills.  Additional information has been requested.
Headache, NauseaVomiting, SOB-RESLOVED, INCREASED FATIGUE Narrative:
Report described weak legs in a 34 year old female who received hep A vaccine. This report was received from the vaccinee and has not been verified by a physician or other healthcare professional. The vaccinee's allergies are not specified. She took no concomitant vaccines. She hs hep B. On 05/25/2001 13:00, the vaccinee received a left arm dose of Havrix, it is unknown whether she received previous doses of Havrix, On 05/25/2001 15:00, the vaccinee started experiencing light-headedness and dizziness. The vaccinee stated that her lefts were very weak. As of 05/25/2001, the outcome of the adverse events was unresolved.
Patient had chest pain, shortness of breath, and a mild increase in her troponin.  She was hospitalized for less than 24 hours and received ibuprofen.  She was discharged 6/14/21
Physician checked the wrong vaccine box to administer on the Encounter/order. She meant to check HPV. Parent was notified. Patient did not experience any side effects.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No current conditions and medical history were provided. On an unspecified date, the patient was vaccinated with the first and second doses of GARDASIL (Lot Number and expiration date were not provided) 0.5ml, intramuscular. On an unspecified date, in May 2015, the patient was vaccinated with the third dose of GARDASIL (Lot Number and expiration date were not provided) 0.5ml, intramuscular. On 25-JUN-2015 the patient was vaccinated with the fourth dose of GARDASIL (Dose, Lot Number and expiration date were not provided), intramuscular. There was no concomitant medication provided. No adverse effect was reported. Additional information has been requested.
Dose was placed into the refrigerator initially on 4-MAY-2023 and administred between 06-JUN-2023 to 09-JUN-2023; no adverse event; 9 patients received vaccine after the 30 day BUD between 06-JUN-2023 to 09-JUN-2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 patients received vaccine after the 30 day BUD between 06-JUN-2023 to 09-JUN-2023.), PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-2023 and administred between 06-JUN-2023 to 09-JUN-2023) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    In June 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In June 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 patients received vaccine after the 30 day BUD between 06-JUN-2023 to 09-JUN-2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-2023 and administred between 06-JUN-2023 to 09-JUN-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (9 patients received vaccine after the 30 day BUD between 06-JUN-2023 to 09-JUN-2023.), PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-2023 and administred between 06-JUN-2023 to 09-JUN-2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (9 patients received vaccine after the 30 day BUD between 06-JUN-2023 to 09-JUN-2023.) and PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-2023 and administred between 06-JUN-2023 to 09-JUN-2023).    No concomitant medication was reported.  Dose was placed into the refrigerator initially on 04-MAY-2023. No treatment information was reported.  The case contains information for patient 1 out of 9.   This case was linked to US-MODERNATX, INC.-MOD-2023-729627, US-MODERNATX, INC.-MOD-2023-729629, US-MODERNATX, INC.-MOD-2023-729628, US-MODERNATX, INC.-MOD-2023-729630, US-MODERNATX, INC.-MOD-2023-729631, US-MODERNATX, INC.-MOD-2023-729632, US-MODERNATX, INC.-MOD-2023-729633, US-MODERNATX, INC.-MOD-2023-729634 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729628:Patient 3 US-MODERNATX, INC.-MOD-2023-729629:Patient 6 US-MODERNATX, INC.-MOD-2023-729627:Patient 2 US-MODERNATX, INC.-MOD-2023-729630:Patient 7 US-MODERNATX, INC.-MOD-2023-729631:Patient 4 US-MODERNATX, INC.-MOD-2023-729632:Patient 8 US-MODERNATX, INC.-MOD-2023-729633:Patient 9 US-MODERNATX, INC.-MOD-2023-729634:Patient 5
This is in follow-up to report(s) previously submitted on 2/13/2009. Information has been received from a Certified Medical Assistant (C.M.A.) concerning a 21 year old female with a history of dysmenorrhea and pelvic pain as well as no known drug allergies who was 08-FEB-2008 vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot# 655327/1287U). There was no concomitant medication or lab diagnostics. On an unspecified date the patient experienced pain in the same arm she received her first dose of GARDASIL. The patient was not able to lift her arm. At the time of reporting the patient was recovered. Follow up information was received from the physician's office asked if they are required to fill out the AE form that was sent to them regarding this AE. No follow up information was provided. The patient sought medical attention by visiting the physician's office. Additional information has been requested.
Nausea and severe chills until next morning after shot. Low grade fever and body aches day after shot.