chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dysgeusia - moderate bitter/metallic taste in mouth. Onset within 30 mins of taking first dose. Lasts several hours. Does not change taste of food or liquid. Improved within 8hrs after last dose; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSGEUSIA (Dysgeusia - moderate bitter/metallic taste in mouth. Onset within 30 mins of taking first dose. Lasts several hours. Does not change taste of food or liquid. Improved within 8hrs after last dose) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 024M20A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (No drug was reported). Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE from 13-Apr-2022 to 22-May-2022, FLUTICASONE PROPIONATE from 13-Apr-2022 to 22-May-2022, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) from 30-May-2022 to 01-Jun-2022 and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) from 24-May-2022 to 25-May-2022 for an unknown indication.   On 14-Jan-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021 at 6:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021 at 6:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2022 at 9:00 AM, the patient experienced DYSGEUSIA (Dysgeusia - moderate bitter/metallic taste in mouth. Onset within 30 mins of taking first dose. Lasts several hours. Does not change taste of food or liquid. Improved within 8hrs after last dose). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 26-May-2022 to 30-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 30-May-2022, DYSGEUSIA (Dysgeusia - moderate bitter/metallic taste in mouth. Onset within 30 mins of taking first dose. Lasts several hours. Does not change taste of food or liquid. Improved within 8hrs after last dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 vaccine  Device Date was reported as 03-Jun-2022
Case number PHEH2013US001678, is an initial spontaneous report received from a pharmacist on 16 JAN 2013. This case refers to a 31-year-old female patient. Her medical history and concomitant medication were not reported. During her pregnancy, she was vaccinated with FLUVIRIN 2012/2013 (batch number: 1206101) intramuscularly on 16 JAN 2013. No adverse event was reported after vaccine exposure during pregnancy.  31 MAR 2014: Multiple attempts have been made to obtain follow-up information and outcome of pregnancy event without success. This case is considered lost to follow-up.
This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Elevated temperature), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills) and MYALGIA (body aches) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (Elevated temperature), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills) and MYALGIA (body aches). At the time of the report, BODY TEMPERATURE INCREASED (Elevated temperature), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.            No concomitant medications were provided. No treatment information provided.
I had a sore my tongue, I went to a dentist, and he sent me to an oral surgeon, He said I had cancer, on February 2023 I had part of your tongue was removed.
This initial spontaneous report was received on 04-JAN-2018 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 27-JAN-2013, at the pharmacy, the patient was inoculated (by an unspecified person) with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration, lot # and expiration date were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-MAR-2016, the male was treated (by an unspecified healthcare professional) at an Urgent care clinic, for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster with ophthalmic complications. The male patient suffered interference when his zoster infections spread into his eyes. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Upon internal review, the event of Onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as Severe herpes zoster with ophthalmic complications. Zoster infections spread into his eyes was determined to be medically significant. Additional information has been requested.
Sudden pain, malaise, weakness, fever 101.8 the first night. Fever up to 103 degrees - felt immediately "in blood" shortness of breath
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (Lot #, dose and route not reported). Concomitant therapy was not reported. On an unknown date the patient was evaluated in the office and examination revealed a " inch red, not area" at the injection site. The patient was treated with an unspecified antibiotic. The outcome of a 2 inch red, hot area at the injection site was unknown. Additional information has been requested.
I am the epidemiologist reporting on behalf of 42 year-old male patient.   Patient received three doses of the Pfizer vaccine, according to immunization records. The first dose was on 02/13/21, the second on 03/06/21, and the third was on 10/16/2021.   According to death certificate, patient was found dead on 10/31/21 at home (15 days post dose 3). Immediate cause of death listed is ?complications of pericarditis.? Interval between onset and death is listed as ?unknown.? I do not have any further details on underlying health conditions that may have contributed to this fatality.
100-103 fever for 26 hours, body aches, joint pain, lung pain, chest pain, injection site pain, heartburn, chills, slight sore throat, fatigue, nausea, headache, ringing in ears. Took 2 Tylenol every 6 hours, lots of fluids, took 2 ibuprofen about 30 hours after getting vaccine because fever would not reduce.  Symptoms began to subside 32 hours after vaccine.
Headache, NauseaVomiting, chills, fatigue, upper back soreness Narrative:
My body breaks out into a red hive. It usually starts on my ears or arms, then it spreads like wildfire. It feels like a sunburn and turns red and blotchy all over. When it is at its worst, I feel like ants are stinging me all over.
After I received the flu vaccine in my left arm, my arm became very sore and painful. I also developed swelling in my face, especially around my eyes, which took several days to subside. The pain and soreness in my left arm has not gone away. I have lost range of motion in my left shoulder. I am unable to sleep on my left side because of the pain in my shoulder and the pain wakes me up at night several times. I have decreased strength in my left arm and shoulder as well. I have taken Ibuprofen and Tylenol with no relief.
This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (elevated, pounding heart rate for a day or two) and HEART RATE INCREASED (elevated, pounding heart rate for a day or two) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PALPITATIONS (elevated, pounding heart rate for a day or two) and HEART RATE INCREASED (elevated, pounding heart rate for a day or two). In March 2021, PALPITATIONS (elevated, pounding heart rate for a day or two) and HEART RATE INCREASED (elevated, pounding heart rate for a day or two) had resolved. Concomitant medication use was unknown. Treatment information was unknown.
Patient states that she received her 1st dose of COVID-19 vaccination roughly 1.5 hours ago and roughly 20 minutes later was driving her car home when she began experiencing central chest pressure and tightness which occasionally radiates into her abdomen.  She states that she was shaking all over, experience blurred vision, vertigo, and numbness to the bilateral legs. Symptoms resolved in 2 hours. Patient discharged from the ED. Patient given Tylenol prior to discharge and to follow up with PCP.
On Tuesday, January 12, 2021 the day after I received my first dose of the Moderna vaccine I woke with severa muscle and joint pain, headache, pain at injection site unable to lift arm above head.  As day progress I was extremely fatigued and began to get chills to the point I could not get warm.  I left work and went home and had to put on three layers of clothes and a blanket to try and stay warm.  The pain was extreme, still had a headache and a low grade fever.  I took two ibuprofen and by 9p that evening the headache had subsided as did the fever and chills.  Pain was more aches than pain at this point.  This morning, January 13, 2021 the aches remain with some fatigue but also a red rash up the inside of both arms, wrapping around the outside of the upper arms down my entire back, buttocks and the back of my legs below my calves on the lower legs.
I have developed tinnitus that was never present before second vaccine.  I have had a hearing test, medication change and have now been scheduled for a test to determine no blockage in my neck on 4/23/2021.  My blood pressure is continued to be normal with today?s reading 122/70.
Upper arm swelling; Upper arm heat; Upper arm redness; This spontaneous case was received on 20-Oct-2020 from other non-health professional via Health Authority (reference number: SEQW20-03981) and concerned a 9-year-old, male patient.   The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 283850 and expiration date: 30-Jun-2021.  On an unspecified date, an unknown amount of time after receiving Flucelvax QIV, the patient developed upper arm swelling, heat and redness. It was not known whether the patient received any corrective treatment.  The outcome of events was unknown.  The reporter did not provide causality assessment.  This case was assessed as non-serious.  Company comment:The patient developed peripheral swelling, skin warm and erythema on an unknown date and unknown amount of time after vaccination with the suspect product, Flucelvax QIV. Chronology is unclear. No information regarding concomitant medications and medical history was provided. Based on this information, causal relationship for all events is assessed as unassessable, due to the lack of information regarding events onset date.; Sender's Comments: The patient developed peripheral swelling, skin warm and erythema on an unknown date and unknown amount of time after vaccination with the suspect product, Flucelvax QIV. Chronology is unclear. No information regarding concomitant medications and medical history was provided. Based on this information, causal relationship for all events is assessed as unassessable, due to the lack of information regarding events onset date.
redness and swelling at injection site, severe arm pain, whole body myalgias, fatigue, weakness, headache managed with ibuprofen. symptoms are  improving except for  redness and swelling that is still in the process of  going away
Covid Vaccine given 815am complaining of swollen throat + itchyness. 817 AM Benadryl 25mg po stable vital signs. 817AM feels a rash  No prior HX of reactions ,denies feeling hot. 820AM  NAD Speaking clearly ,throat feeling slightly better., drinking water no dysphagia 828 AM Drinking OJ, throat feels less swollen states feels no better or worse. 831 AM Feeling much better vital signs stable  118/78,73, 98%,speech clear ,D/C with Benadryl 25 mg po, if needed. Recommended to call  PCP re: effects  2nd vaccines
2 days after vaccine - throwing up, very fussy, tired, no appetite. 12/17 - Patient broke out in hives over entire body (this has never happened before and she did not eat new food).
7/2/08, injection site swollen, red, hot.  2 weeks later, 7/16/08, ran a fever of 104 for two days then broke out with bumps/blisters on upper and lower extremities.  7/23/08, client healing.  7/31/08, client doing fine per mother.
Pt was w/o neurologic symptoms until 12/1/01, when she recalls experiencing a funny lightheaded sensation and headache following a drill she was performing for Army Reserve training. She ret'd home and improved w/rest but subsequently noticed that when she was taking a shower and doing other activities, she would become lightheaded and dizzy and feel as though she might faint. Symptoms persissted and limited her ability to do her normal physical exercise regimen. Denies any antecedent illness but did receive flu shot on 11/15/01. She also describes a one-year history of mild headaches. Two weeks ago she began to experience numbness and tingling in her hands and feet. Initially occured only at night and then began to occur during the day. She had episodes where she had unusual paresthesias extending into the face and scalp area. Does not find any connection between her neurologic symptoms and the findings on her MRI scan of the brain. Discussed w/her treatment of her paresthesias with Ultram or Neurontin.  Diagnosed with orthostasis and sensory symptoms.
Narrative: Patient with one dose of COVID VACCINE. Patient with active malignancy proceeding to hospice. Patient died at outside hospital, no further documentation of death. Reported due to network 5 guidance.
I was 6 weeks pregnant at the time and suffered from a miscarriage 2 weeks later after receiving 1st dose in 1st trimester. 2 weeks after shot I should have been 8 weeks and baby was only measuring 6 weeks with no heartbeat. The timing adds up perfectly from 1st dose when baby stopped growing to complete miscarriage. The vaccine killed my baby.  Should not be given in 1st trimester, the most important trimester.
Ringing of the ears; This case was reported by a nurse via call center representative and described the occurrence of ringing in ears in a 42-year-old female patient who received HAV (Havrix) (batch number F4EL2, expiry date 11th September 2021) for prophylaxis.   On 8th February 2019, the patient received the 1st dose of Havrix (intramuscular) 1 ml. In February 2019, 14 days after receiving Havrix, the patient experienced ringing in ears. On an unknown date, the outcome of the ringing in ears was unknown.   It was unknown if the reporter considered the ringing in ears to be related to Havrix.  Additional case details were provided as follows: The patient received the dose of Havrix in the left deltoid and about 2 weeks later, the patient started experiencing ringing in the ears. No further details were provided.
Fever, nausea, headache, abdominal pain, sepsis upon admission with negative blood cultures, UA, fever to 104 F; diagnosed with proximal descending thoracic aorta thrombus
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX, (strength, dose, frequency, rough of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARVAX temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot#J012211, expiration date: 28-SEP-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of plenty reports received from the same source. Additional information has been requested.
Initial report was received 11 March 2013 from a health care professional. A four-month-old male patient had received an injection of ACTHIB lot number UH609AA (corresponding sanofi pasteur SA lot number H1123-1), PEDIARIX (manufacturer GSK, lot number AC21B357 and PREVNAR (manufacturer Pfizer, lot number 918175) on 07 March 2013, and two days later on the evening of 09 March 2013, the patient passed away. He had previously received a first dose of RSV vaccine on an unspecified date. The patient had been chronically ill with a history of T fistula with esophageal atresia which was repaired, traceomalacia, PDA (patent ductus arteriosus), PFO (patent foramen ovale), and cardiac issues. He had no known allergies. The event outcome was fatal. Documents held by sender: None.
Fever 101.2, heart rate 108-117, body shaking chills, body aches, abdominal cramps, fatigue, nausea , chest pains, shortness of breath
Chief Complaint: Covid-19.  SOB on exertion.  was diagnosed with COVID infection on 01/28/ 22.  Started on remdesivir, IV Zithromax and cefepime. Continue IV Solu-Medrol 60 mg q.12 hours. Continue vitamin-D and zinc.
Pt presented at approx. 15:30 for PPD reading. Mother states she noticed a rash on his right arm, mild erythema at injection site; no pain, no shortness of breath and no other symptoms at this time. Reassured and advised if increased redness or pain to return to clinic or go to ER.
Lethargic, body aches, headache, fatigue, pain at injection site.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 19 month old infant patient. On 09-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J015437, expiration date 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
My legs were very achy after covid  after shot pins and needles in upper thighs both legs and now in left arm and terribly in left hand.  It comes and goes but when it strikes I can't stand it  the pa; My legs were very achy after covid  after shot pins and needles in upper thighs both legs and now in left arm and terribly in left hand.  It comes and goes but when it strikes I can't stand it  the pa; I can't stand it  the pain is terrible; My legs were very achy after covid  after shot pins and needles in upper thighs both legs and now in left arm and terribly in left hand.  It comes and goes but when it strikes I can't stand it  the pa; This is spontaneous report from contactable consumer (patient).  A 70-years-old female (pregnant: No) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Lot Number: EK3247) at Left arm as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included covid-19, Penicillin allergies. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 05Jan2021 09:00 AM (at age of 70 years old) (Lot Number: EK4176) as single dose for covid-19 immunisation.  There were no concomitant medications in two weeks.  Clinical course as reported: My legs were very achy after covid after shot pins and needles in upper thighs both legs and now in left arm and terribly in left hand. It comes and goes but when it strikes I can't stand it the pain is terrible and I have a high pain threshold. Adverse event start date was 05Feb2021 08:00 AM. AE resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. No treatment received for events.  Outcome for events was unknown. The patient underwent lab tests and procedures which included sars-cov-2 test(Nasal Swab, Rapid test weekly at work): negative on 01Mar2021 (post vaccination).  Since the vaccination, the patient has not been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-Up (18Aug2021): Follow-up attempts are completed. No further information is expected.