chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness of arm; This is a spontaneous report from a contactable pharmacist (patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported) on an unspecified date for COVID-19 immunization and experienced pain in arm/injection site, headache, weakness and fatigue. The patient called to ask if it was true that most people experience increased side effects from second dose. Patient stated that he had no side effects after second dose, other than soreness of arm on an unspecified date. Patient would also like to know the guidance for timing between vaccine and other immunizations (example: flu shot) and how soon after 2nd dose of vaccine are antibodies present. The outcome of the event was unknown.  Information on Lot/Batch number has been requested.
Patient experienced soreness/aching hand on injection arm that traveled to other arm the next day. Also spread to arm. Soreness traveled back and forth between arms and into neck at night. Doctor visit found no cause.
Muscle aches, low grade fever, fatigue, mild headaches. Note I did not want flu shot. I was reminded how important it was. Dr was very pushy.
One week after 1st inoculation a large red area at inoculation site of right upper arm appeared. It is itchy and warm to touch. Mild pain on touch.
This non-valid, social media, spontaneous report as received from a patient's mother refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the patient was vaccinated with GARDASIL (lot #, expiry date, dose, and route of administration were not reported). The reporter stated that the patient suffered terrible effects from the GARDASIL (date not reported). It was also reported that the patient was not healthier and she was in the hospital again, at the time of the report. Action taken with suspect therapy was not provided. The outcome of the event was not reported. The relatedness between the event and therapy with GARDASIL was not reported. This is one of two reports received from the same reporter. Additional information is not expected, as no contact details were provided. Sender's Comments: US-009507513-1605USA011378.
This spontaneous report was received from a physician concerning about a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 28-SEP-2018, the patient was vaccinated with the first dose of GARDASIL 9. On 26-OCT-2018, the patient was vaccinated with the second dose of GARDASIL 9, indicated as prophylaxis (lot number: R023608, expiration date: 30-APR-2021). On 02-NOV-2018, the patient was vaccinated with the third dose of GARDASIL 9 (lot number: R023608, expiration date: 30-APR-2021), all the doses indicated for prophylaxis (strength, dose, route of administration, and anatomical site were not reported). No adverse effects were reported.
Achey joints & muscles, fatigue, diarrhea, chills, sweats, headaches, sore left arm (injection side more sore than rest of sore body), pain & edema at injection site limiting shoulder range of motion for two days.
Rash, bump, red at injection site -sore blisters, swollen eyes -left shoulder pain.
Patient experiencing hives on arms shortly after first dose of Pfizer covid vaccine.  Patient was given 25mg Benadryl IM and the hives resolved.  Patient was discharged home without incident.
inadvertently administered PEDVAX subcutaneously in patient's thigh as opossed to intramuscularly; No additional ; This spontaneous report as received from a medical assistant, concerning a 15-month-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was inadvertently vaccinated subcutaneously in the patient's thigh with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter, lot number T026959 with expiration date 11-MAR-2023 (frequency was not provided) for prophylaxis. No additional adverse event.
Severe swelling & redness at site and hard lump. Severe central nervous system inflammatory response resulting in inability to stand or sit without pain lasting over 2 weeks. Treated with regimen of steroids (8 days).
stomach cramps; stomach pain; Diarrhea after every meal and snack; lost weight; eight pounds; very fatigued; nausea without throw up; headaches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain), DIARRHOEA (Diarrhea after every meal and snack), ABDOMINAL PAIN UPPER (stomach cramps), WEIGHT DECREASED (lost weight; eight pounds) and FATIGUE (very fatigued) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction. Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), LEVOTHYROXINE, METFORMIN and VITAMINS NOS for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced DIARRHOEA (Diarrhea after every meal and snack), WEIGHT DECREASED (lost weight; eight pounds), FATIGUE (very fatigued), NAUSEA (nausea without throw up) and HEADACHE (headaches). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain) and ABDOMINAL PAIN UPPER (stomach cramps). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain), DIARRHOEA (Diarrhea after every meal and snack), ABDOMINAL PAIN UPPER (stomach cramps), WEIGHT DECREASED (lost weight; eight pounds), FATIGUE (very fatigued), NAUSEA (nausea without throw up) and HEADACHE (headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details include ibuprofen and vitamins.
4 inch wide x 8 inch long redness/itching/induration on right arm starting 3-4 days after injection given. Induration is directly over injection site.
Follow-up report received from a physician on 26 Feb 2010: This patient (2 year old) was inadvertently administered a second dose of FLUVIRIN (batch no. 102147P1) of the recommended 2 dose series on 24 Feb 2010. No adverse reaction had occurred. After an internal review done on 08 May 2010 to the information received on 26 Feb 2010, the following significant correction was made: The suspect product FLUVIRIN was recoded to S-OIV FLUVIRIN. It was identified that the report received on 26 Feb 2010 was an initial report and not a follow-up, as previously reported.
Loss of the ability to walk, could not control bowel or bladder function.  Upper extremities worked and lower extremities did not work for 2 hours the day following vaccination. Took Tylenol for fever also following day.
Nausea, vomiting, diarrhea beginning 3-4 days following the vaccine leading to hospital admission for dehydration.
(vaccine was taken at 12pm of 11/30/2021).  No effects until 3am.  at 3am of 12/1/2021:  tiredness, headache, muscle pain, chills, nausea, vomiting, arm pain, diarrhea.  at 12pm of 12/1/2021: tiredness, muscle pain, arm pain, leg pain, not very hungry.  at 6pm of 12/1/2021:  tiredness, muscle pain, light headache, not very hungry.
At 9pm I started to feel tired and went to bed.  At 3am I woke up with nausea, headache, and arm very sore at site of injection.  I was also a bit dizzy when I got up.  By 10am, I just had a bit of a heachache and fatigue.
pt recv vax 4JAN96&22JAN96 pt devel a rash which was initially described as a few tiny papules;6MAR96&14MAR96 pt was seen by dermatologist because the rash cont&was described as a raised rash w/linear distribution on abd,thigh;pruritis
Severe and chronic inflammation in the spine, joints and muscles.; Severe and chronic inflammation in the spine, joints and muscles.; Tingling and numbing sensation from the neck down.; Tingling and numbing sensation from the neck down.; Swelling in the lower legs, ankles and feet; Swelling in the lower legs, ankles and feet; Sciatica in both legs; Left leg calf pain; Loss of appetite; Depression; anxiety; This is a spontaneous report from a non-contactable consumer.  This 27-year-old (non-pregnant) female consumer (patient) reported that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EWQ17Q) via an unspecified route of administration into the left arm on 21Apr2021 at 11:15 AM (at the age of 27-year-old) as single dose for COVID-19 immunisation. The patient medical history included lupus-like syndrome from an unknown date and unknown if ongoing. The patient previously took plaquenil [hydroxychloroquine sulfate] and experienced drug hypersensitivity, meloxicam and experienced drug hypersensitivity. Known allergies to Plaquenil and Meloxicam. Concomitant medications were not reported. On 23Apr2021 at around 10:00 AM, the patient experienced severe and chronic inflammation in the spine, joints and muscles, tingling and numbing sensation from the neck down, swelling in the lower legs, ankles and feet, sciatica in both legs, left leg calf pain, loss of appetite, depression and anxiety. No other vaccine in four weeks, no other medications in two weeks. AE resulted in doctor or other healthcare professional office/clinic visit. No treatments, no COVID prior vaccination, no COVID tested post vaccination. Outcome was not resolved for all the events.  No follow-up attempts are possible. No further information is expected.
Extreme fatigue beginning 5 hours after vaccination. Uncontrollable shivering 6 hours after, alternating (rapidly) with overheating and uncontrollable sweating. Eventually fell asleep ~11:00 PM. Woke up at 2:20 AM thirsty, shivering. Used restroom and stomach started to feel 'off' or 'upset,' followed by ~45 minutes of dry heaving. After bouts of dry heaving ended, instantly overheated and began sweating profusely (to the point I was as wet as if I had just gotten out of the shower). Eventually fell asleep again. Day after - headache, body aches, sweating alternating with chills. Feels like flu now (6:50 PM 17 April)
Patient has lesions on her legs, hands and arms. Patient was seen today 8/21/17 in the office and her primary care doctor diagnosed her with Varicella without complication.
Vaccine administered 4/11. On 4/11 and 4/12 slept poorly, sleep walking anxious also fever. Also leg pain on 4/13 mother called and said arm swollen, red, left message to follow up in clinic. She said she would send me a picture but didn't. On 4/16 called back and patient symptoms had resolved within the same day (4/13).
This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 76-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On 17th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In December 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On 18th December 2018, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the feeling bad and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The reporter was patient's wife. The next day after vaccination, the patient felt bad and this had resolved. The patient was experience sore arm till the time of reporting. The reporter gave consent to follow up. This case has been linked with case US2018231001, reported by the same reporter.
I have developed a metallic/salty taste in my mouth effecting  the taste pf food and causing nausea at times.
Two days post vax, the pt experienced malaise, sore throat, dizziness, cough, nausea, lymphadenopathy. Four days post vax, the pt developed hives.
Information has been received from a health professional concerning an 85 year old female also reported as male with no relevant medical history or illness at time of vaccination who at 2:00pm on 10/10/2005 was vaccinated in the left deltoid with a second dose of Pneumococcal 23v polysaccharide vaccine (lot 650649/0790P). AT 1:00 am on 10/11/05 the pt experienced dizziness. The dizziness progressed throughout the day on 10/11/05 to the point that the pt felt that she could not ambulate without assistance. The physician advised the pt to come to the office for an exam. The pt was unable to come to th office because of the vertigo. The physician advised the patient to take one teaspoonful of diphenhydramine HCL liquid four times daily. The pt was instructed to contact the office if symptoms worsened. The office did not receive a call from the pt. On 10/12/05, the pt recovered from dizziness. Additional information is not expected.
VACCINE VIAL WAS FROZEN TOO LONG. VACCINE MAY HAVE BEEN COMPROMISED
One day after vaccines given, child developed itching hives on both thighs surrounding injection sites. Also noted temperature elevation for one reading. Given BENADRYL which reduced itching and redness of area. Papular rash around sites persisted. Prescribed ORAPRED and hydrocortisone cream for 5 day course.
Since 4/17 evening, experiencing pain/tingling/itching of upper and lower lips.
Patient developed itching & rash 2 days after 2nd COVID vaccine.  The rash was on neck, trunk, extremities. Biopsy confirmed a drug eruption.  Treated with Fluocinonide cream, alclometasone cream, prednisone.
Admitted with respiratory failure due to COVID-19 pneumonia.  He was started on steroids.  Not on remdesivir due to the late presentation.  Patient was started on supplemental oxygen, had been using incentive spirometry and Acapella. His respiratory status slowly started to improve.  At some point he was using BiPAP at night.  He was doing very well on room air while sitting with oxygen saturation 94%, but he is hypoxic with ambulation.  Patient requires 4 L of oxygen per nasal cannula with ambulation. MD had discussion with the patient about the need of steroids. Gave him prescription for prednisone tapering dose for 10 days.  At some point patient had extremely high blood sugars and the Lantus dose was doubled.  That  resulted in low blood sugars.  MD discussed with Patient that he will continue taking his Lantus at night only - educated that if he sees high blood sugars in the morning then he can increase his Lantus with by 2 units only. Patient was discharged home on 4LO2.
No additional AE information provided; an unspecified number of patients were administered an improperly stored dose of VARIVAX since 2/27/2020.; This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions and allergies were unknown. Concomitant therapies included sterile diluent.   Since 27-FEB-2020, the patients were vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot # S010297, expiration date 03-APR-2021 (dose number, frequency, route of administration, anatomical location were not reported) for prophylaxis (product storage error).   Temperature excursion of this vaccine was minus 14 degrees Celsius to minus 10 degrees Celsius (minus 10.4 degree Celsius) for 6 hours 2 minutes. There was no previous temperature excursion. No additional adverse event was reported. Data logger was involved.  This is a non-valid case due to lack of patient identifiers and unspecified number of patients.  Follow up information has been received on 29-JUL-2020, the medical assistant was not about to talk due to office being busy. Telephone call and fax numbers were provided.  Follow-up information has been received from the medical assistant on 26-AUG-2020.  The case is valid. The identifiers of 8 patients were provided.   The patient was 4 years old. On 19-MAR-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of the eight reports from the same reporter.; Sender's Comments:  US-009507513-2008USA013488: US-009507513-2008USA013489: US-009507513-2008USA013490: US-009507513-2008USA013491: US-009507513-2008USA013492: US-009507513-2008USA013493: US-009507513-2008USA013494:
This spontaneous report as received from a nurse refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, the patient was inadvertently administered a dose of M-M-R II injection (lot # H018948 with expiry date: 18-OCT-2014, albumin status HSA; 0.5 ml injected subcutaneously; strength and indication unspecified). No concomitant medications were reported. No adverse effects were reported. Additional information is not expected as the reporting nurse did not grant permission to contact her or physician.
pt recv vax 12MAR97 & 19MAR devel fever of 101.2 lasted 4 days; to MD found nothing 22MAR broke out in rash-face, stomach, rash gone by 24MAR;no other problem;
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) 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.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 27-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 27-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Suspected vaccination failure; 15 people I have spoken to who said they experienced shingles / all of them say they got it after; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient got shingles after getting vaccinated with the shingles vaccine. The patient declined an offer for the current shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided. This case is 1 of the 16 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088476:
A report has been received from a Health Professional concerning a, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent stared on 03-DEC-2014. The patient experienced received FLUMIST Quadrivalent two doses which started on 04-DEC-2014. The outcome of the event of received FLUMIST Quadrivalent two doses is unknown. The report was considered to be non-serious. Summary of follow-up information received on 11-DEC-2014 from consumer. Reason for suppression was changed from Medication Error with  no AE to Non-valid because reporter called back to state only 1 male patient got 2 doses of FLUMIST Quadrivalent and not the female patient. Narrative updated.
She states that they placed 1 punctured vial of Moderna COVID-19 vaccine, which was first opened yesterday 23AUG2021 around 8-10AM, in the refrigerator for more than 12 hours; Expired vaccine administered to patient; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT STORAGE ERROR (She states that they placed 1 punctured vial of Moderna COVID-19 vaccine, which was first opened yesterday 23AUG2021 around 8-10AM, in the refrigerator for more than 12 hours) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Aug-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 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (She states that they placed 1 punctured vial of Moderna COVID-19 vaccine, which was first opened yesterday 23AUG2021 around 8-10AM, in the refrigerator for more than 12 hours). On 23-Aug-2021, PRODUCT STORAGE ERROR (She states that they placed 1 punctured vial of Moderna COVID-19 vaccine, which was first opened yesterday 23AUG2021 around 8-10AM, in the refrigerator for more than 12 hours) had resolved. On 24-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were provided No  Concomitant medications were provided  On 24AUG2021, They Injected the expired Moderna COVID-19 vaccine to 7 patients between 8AM - 11:30AM. Number of doses/vials : 7 doses/ 1 vial. Date the vial was initially stored in the refrigerator : 23AUG2021.  Total amount of time the vial was exposed to Refrigerator temperature: Greater than 12 hours in the refrigerator. The nurse states that the vial was placed in the sharps container by now.
Got it worse symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Got it worse symptoms) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Got it worse symptoms). At the time of the report, VACCINATION COMPLICATION (Got it worse symptoms) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Patient got it worse symptoms for a few days. No concomitant product reported. No treatment medication reported.