chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flush; Feels weak/just sitting  there; Not hungry; Not well; Has headache; Has nausea; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flush), ASTHENIA (Feels weak/just sitting  there), DECREASED APPETITE (Not hungry), MALAISE (Not well) and HEADACHE (Has headache) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included NAPROXEN for an unknown indication.   On 01-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced FLUSHING (Flush), ASTHENIA (Feels weak/just sitting  there), DECREASED APPETITE (Not hungry), MALAISE (Not well), HEADACHE (Has headache) and NAUSEA (Has nausea). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, FLUSHING (Flush), ASTHENIA (Feels weak/just sitting  there), DECREASED APPETITE (Not hungry), MALAISE (Not well), HEADACHE (Has headache) and NAUSEA (Has nausea) outcome was unknown.            The patient received the first dose about 3 weeks ago.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up received- Reporter Declined follow-up.
PT RECIEVE IMPROPER VACCINE DUE TO FAILURE OF ADMINISTRATOR. PROPER VERIFICATIONS WERE DONE. PT FELT BURNING SENSATION 11:13. WRONG MED IDENTIFIED. PROVIDER AND PREVENTATIVE MED TECH. INSTRUCTED ADMINISTRATOR ON PROTOCOLS AND PROCEDURES. PT FELT LITTLE TO NO SIDE-EFFECTS AFTER 30:00 MINUTES AND WAS RELEASED UNDER PERSONAL CARE WITH INSTRUCTIONS ON TEDIOUS OBSERVATION FOR NEXT 72HRS. ANY ISSUES PT WAS INSTRUCTED TO NEAREST MEDICAL FACILITY A.S.A.P.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2022 as dose 1, single (Lot number: EL9262), in left arm, on 19Feb2022 as dose 2, single (Lot number: EN6201), on 27Sep2021 as dose 3 (booster), single (Lot number: FD0809), in left arm and on 16May2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "Seizure disorder" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; PHENYTOIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Sep2022) Negative; (06Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Symptoms reappeared 2 days after last dose. Tested negative 05Sep2022. Tested positive 06Sep2022.
high blood sugar levels; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 73 year old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced high blood sugar levels on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included high blood glucose.  Follow-up attempts are completed. No further information is expected.
Had eaten a full meal 40 minutes before and cookies 30 minutes after taking first dose of Vivotif; Spontaneous report received on 14FEB2020.  A healthcare professional reported that a consumer "had eaten a full meal 40 minutes before and cookies 30 minutes after taking first dose of Vivotif" (PT: Product administration error). The consumer was receiving Vivotif for immunisation. On 13FEB2020, the consumer ate a full meal then took the first dose of Vivotif 40 minutes later and then ate a couple of cookies 30 minutes after that same dose. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer had eaten a meal 40 minutes before taking first dose of Vivotif and also ate cookies 30 minutes after taking Vivotif first dose (product administration error). Vivotif should be taken one hour before a meal and consumer should eat or drink for at least an hour both before and after taking Vivotif dose. Considering the nature of the event, the causality of product administration error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer had eaten a meal 40 minutes before taking first dose of Vivotif and also ate cookies 30 minutes after taking Vivotif first dose (product administration error). Vivotif should be taken one hour before a meal and consumer should eat or drink for at least an hour both before and after taking Vivotif dose. Considering the nature of the event, the causality of product administration error is assessed as not applicable to Vivotif.
A week after the vaccine my arms turned red from shoulder to elbow on both arms. It was itchy and warm to the touch. There was a visible line on both arms. It lasted for four days and got progressively better after using warm water compresses. I got the second dose, and I had a rash that was scattered over my arms and my torso. It started a week after the vaccine. This rash was a lot itchier and blotchier rash. It lasted two days.
Nausea; Throwing up; This is a spontaneous report from a contactable healthcare professional, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the arm left on 03Mar2021 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included tri lo sprintec (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 03Mar2021 at 23:30, the patient experienced nausea and throwing up. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea and vomiting was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
A mother reported that her 4 year old daughter received DTP, HIB and oral Poliomyelitis virus vaccines on 3/31/91. She subsequently, developed an URI and was treated by a physician. She "eventually" recovered.
bloating; abdominal pain; Cramping; stomach bloated, like it was filled gas, with severe pain; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FA6780), via an unspecified route of administration in the left arm on 08Jul2021 (at the age of 61-year-old) as dose 2, single for COVID-19 immunisation. Medical history included acid reflux from an unknown date and unknown if ongoing, sjogren's syndrome from an unknown date and unknown if ongoing. Concomitant medications included pantoprazole (started about 4-5 years ago) taken for acid reflux disease from an unspecified start date and ongoing; cevimeline (about 4-5 years) taken for sjogren's syndrome from an unspecified start date and ongoing; cyanocobalamin (B-12) (started this in the last month and for to be healthy) taken for an unspecified indication from an unspecified start date and ongoing. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0171), via an unspecified route of administration in the left arm on an unknown date as dose 1, single for COVID-19 immunisation. It was reported that the she got the second Pfizer COVID vaccine shot yesterday, 08Jul2021, and not sure if this is a side effect or not, states she pretty active yesterday, but after lunch about 3-4 hours after the vaccine her stomach got very bloated, like it was filled with gas, had severe pain and cramping, abdominal pain, stated that subsidized with heating pad that evening but bloating and abdominal pain was coming back "today", bloating and abdominal pain was tender to the touch, has improved some. Caller was wondering if these are side effects that has been reported with the Pfizer COVID-19 vaccine. The patient was received treatment for the events. The outcome of the events was resolving.  Follow-up attempts are needed. Additional information has been requested.
Pt informed us on 11/3/20 that her Left arm has been soRE for over a month. She says there is no redness or swelling at the site of injection. But her arm is still soRE.
Patient Received An Expired Dose of Heplisav-B; Initial Report Received on 06-Oct-2022  This is a spontaneous report, received from a certified medical assistant in the regarding a female patient, aged 56 years, who received HEPLISAV-B for hepatitis B immunisation.   Medical history at the time of vaccination was reported as allergic to fluoxetine, paroxetine, and Wellbutrin (buproprion).  Concomitant medications were not reported.  On 06-Oct-2022, an unspecified dose # of HEPLISAV-B (Lot #934974, expiration date 29-Apr-2022, NDC #43528-003-05), route not specified, was administered in the left deltoid for hepatitis B immunisation. No concomitant vaccinations at the time of vaccination were reported.   The patient has not reported any adverse reactions.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
low grade fever, chills, body aches, headache so bad that meds would not help, dizziness, frequent urination the day after, blurred vision and fatigue.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in right arm 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Anti-viral details includes COVID 19 Treatment. Treatment start date was on 24May2022 and Treatment start date was on 29May2022. Adverse event reported as COVID symptoms returned 5 days after Treatment. Patient had no known allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rash around the injection site. Reporting on the second day after noticing the rash.
Redness and burning sensation between first and second fingers of both hands; Redness and burning sensation between first and second fingers of both hands; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 24Feb2021 09:30 (age at the vaccination 66-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included depression, cholesterol and urine flow. Concomitant medications included duloxetine hydrochloride (CYMBALTA) via unknown route from Nov2020 and ongoing at 30 mg, twice a day for depression, Atorvastatin via unknown route from unspecified date in 2020 and ongoing at 40 mg, daily for cholesterol and Tamsulosin via unspecified route from unspecified date and ongoing at 0.4 mg, twice a day for urine flow. Patient received the Covid-19 vaccine yesterday morning. Today between the first and second fingers of both hands he has redness and a burning sensation on 25Feb2021. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient had received the same vaccine on 08/25/2021.  Discovered date: 10/11/2021.  Called patient a few times to check if he was doing ok; however, patient did not answer his phone.  I left him message and asked him to call us back.
Tested positive for Covid-19 on 6/20/21. Suspect came in contact with the virus at an Arena.; Tested positive for Covid-19 on 6/20/21; This is a spontaneous report from a contactable consumer (reported for himself). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in Arm Right on 09Feb2021 as DOSE 1, SINGLE and received second dose of bnt162b2 (Batch/Lot Number: EN6198), via an unspecified route of administration, administered in Arm Right on 03Mar2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not received any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 20Jun2021, the patient experienced Covid-19, suspect came in contact with the virus. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient underwent lab tests and procedures which included nasal swab: positive on 20Jun2021. Events resulted in Doctor or other healthcare professional office/clinic visit/physician office visit. No treatment received for events. Events were considered as serious (medically significant). The clinical outcome of tested positive for Covid-19 on 6/20/21, suspect came in contact with the virus was recovering.   Information on batch/lot numbers are available. Further information has been requested
Initial report received from healthcare professional on 21 November 2014. This case is linked to case 2014SA163375 (same reporter, same patient). A female patient, whose age at the time of event, medical history and concomitant medications were not reported, had received a dose of FLUZONE (batch number, route and anatomical site of administration were not reported) on an unspecified date of 2013. It was reported that on an unspecified date, after receiving FLUZONE, the patient had a very severe local reaction for which she required hospitalization. The patient's corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none.
Got vaccinated, still got shingles even with two doses/Suspected vaccination failure; Got shingles, less severe; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 08-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingrix, the patient still got shingles. The patient stated that, it was less severe because he/she was vaccinated but know you could still get them even with getting two doses of Shingrix vaccine. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
Patient with no prior otologic history noted sudden onset of bilateral non-pulsatile tinnitus after second dose of vaccine. No associated hearing loss
I started getting symptoms of itchy sore throat. I thought it was allergies at first. Then my symptoms progressed to cough, dizziness, headaches, extreme hunger. I got a positive at home COVID-19 test and also went to my doctor the next day and received a positive rapid COVID-19 test. While at the doctor I received a steroid shot and a Z-Pak antibiotic. I did develop an odd symptom of a lowered heartrate when I usually have a high heartrate. I also got a PCR COVID-19 test that was positive just to have documentation. I went to the ER due to chest pain due to coughing. I had a chest x-ray, EKG, and blood work which everything was normal. The blood work did indicate something but they wanted to do a CT Scan with contract which I refused due to not being able to handle the contrast dye. I still have lingering cough, mucus drainage, dizziness, and headache. I have also had to get back on my blood pressure medication. I was off of the medication and COVID-19 has brought my blood pressure back up.
Beyond Use Date for this vaccine was 11/16/22 Pt received first dose on 11/17/22 Need to inquire if this dose will need to be repeated or not No reaction from patient
p/vax fever, nausea @ home treated w/APAP, slept;n/v of 10-15min w/cramping;felt better sx gone;no localized rxn;
had aches; was vomitting; headache that lasted lasted more than 2 days; fatigue for about a day and a half; first/ on November 3, 2020/ second dose was on July 9, 2021 / more than 6 months after the first due to receiving her COVID vaccine/nine months after the first dose; pain in bones; nauseas the day after vaccine; This case was reported by a consumer via call center representative and described the occurrence of pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (received 1st dose on 3rd November 2020 and also experienced pain, pain in arm and feeling unwell, refer case US2021151044). Concomitant products included COVID-19 VACCINE (COVID 19 VACCINE).   On 9th July 2021, the patient received the 2nd dose of Shingrix. On 9th July 2021, less than a day after receiving Shingrix, the patient experienced pain, vomiting, headache, bone pain, nausea, fatigue and social problem. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain, vomiting, headache, bone pain, nausea and fatigue were recovered/resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the pain, vomiting, headache, bone pain, nausea and fatigue to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient herself. The patient had received 2nd dose of Shingrix and experienced vomiting, had aches, headache that lasted more than 2 days, pain in bones, nauseas the day after vaccine, and fatigue for about a day and a half. The patient reported that she got her 2nd dose not within the 2 to 6 months recommended period, but 9 months after the 1st dose due to receiving her COVID vaccine around the time when she was supposed to get her 2nd dose of Shingrix, which led to social problem. The patient wanted to know whether there was any information about, how that would impact the effectiveness. The reporter consented to follow up via email only.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151044:same patient, same reporter
Injection site pain; swollen axillary lymph nodes; whole body joint pain; whole body muscle pain; whole body skin pain; Fatigue; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 23Apr2021 at 17:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, peppers allergy, bananas allergy, latex allergy, dust allergy and boxelder pollen allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), multi vitamins (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) and oxymetazoline hydrochloride (AFRIN) all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received clobetasol (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration on 01Apr2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 11:00, the patient experienced injection site pain, swollen axillary lymph nodes, whole body joint pain, whole body muscle pain, whole body skin pain, fatigue and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events injection site pain, swollen axillary lymph nodes, whole body joint pain, whole body muscle pain, whole body skin pain, fatigue and nausea were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.