chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEADACHE; This spontaneous report received from a parent concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Within days after the 2nd dose I had an extremely severe gout incident. Pain in my left foot was very intense. I was unable to bend my right elbow until prednisone & allopurinol took effect thanks to my nephrologist and I had to find a rheumatologist.  My right elbow still aches. The prednisone caused my blood sugar to skyrocket and it turns out alloprinol caused a serious rash.
Chills/shivers, injection site pain, back pain/body aches, nausea, syncope, low blood pressure Started getting chills at 0300, back pain started and injection arm became very painful. at 0430, got out of bed, nausea became severe and I passed out for 2 minutes. Subsequently fractured my nose from the fall after passing out and ended up in the ER for 6 hours with low blood pressure.
This spontaneous case was reported by a patient and describes the occurrence of PAIN ("it's like a shooting pain), NECK PAIN (and now it's going to my neck), RASH (rash), MYALGIA (pain on the arm / it's been a month and the arm hurts) and ARTHRALGIA (it's gone to my shoulder, it's like sore) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. Concurrent medical conditions included Asthma and Allergy. On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced PAIN ("it's like a shooting pain), NECK PAIN (and now it's going to my neck), RASH (rash), MYALGIA (pain on the arm / it's been a month and the arm hurts) and ARTHRALGIA (it's gone to my shoulder, it's like sore). At the time of the report, PAIN ("it's like a shooting pain), NECK PAIN (and now it's going to my neck), RASH (rash), MYALGIA (pain on the arm / it's been a month and the arm hurts) and ARTHRALGIA (it's gone to my shoulder, it's like sore) outcome was unknown. Concomitant medication use was unknown. Treatment information was unknown
Sore arm & sore body with extreme exhaustion for about 24 hours.  He?s fine & back to normal today.   Only a sore armpit continued today.
Headache MODERATE STEADY HEADACHE ABOVE LEFT EYE, SOME TINGLING IN LEFT ARM  Narrative:  Patient received first dose of Pfizer covid vaccine and evekoped  moderate steady headache above left eye. Also some tingling in left arm - same  location as shot. Admit to being anxious about receiving vaccine. VS: 137/68, P 86, PO2 98%. No breathing difficulties. Given some water to drink as she admits to being a bit dehydrated. Symptoms subsided and patient released home with advise to hydrate and atke Tylenol for headache and report to ED if symptoms worsen.Patient received first dose of Pfizer covid vaccine and evekoped  moderate steady headache above left eye. Also some tingling in left arm - same  location as shot. Admit to being anxious about receiving vaccine. VS: 137/68, P 86, PO2 98%. No breathing difficulties. Given some water to drink as she admits to being a bit dehydrated. Symptoms subsided and patient released home with advise to hydrate and atke Tylenol for headache and report to ED if symptoms worsen.  Other Relevant History:
rash on chest and upper arm could b a reaction from smallpox vaccination. Seen by provider rash tochest, arm, and back.  Appreared 3/23. PMHx of Hodkins 5 years ago, also hx of ezema.as a child EM to chest, noted erathema to right shoulder.
Pediatric dose probably  given to adult; Pediatric dose probably  given to adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 43-year-old female patient who received HBV (Engerix B) (batch number J014855) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced adult use of a child product (Verbatim: Pediatric dose probably  given to adult) and underdose (Verbatim: Pediatric dose probably  given to adult). The outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt Date: 27-MAR-2023 Nurse called to inform that around 2014, a dose of Engerix-B of unknown dosing (pediatric or adult) was administered to an adult patient.  HCP provided the lot number, but it wasn't found in system. However, HCP stated that it was from GlaxoSmithKline and that it was most likely for adult but was not completely sure. The reporter did not consent to follow up. The adult patient received dose of Engerix B, which led to underdose and adult use of child product. This case is linked with US2023046122 and US2023046123, reported by same reporter.; Sender's Comments:  US-GSK-US2023046122:Same reporter US-GSK-US2023046123:Same reporter
(06/18/2021)Onset of Gout and reoccurring and ongoing issue (08-09-2021) Amoxicillin (7/2021)  Prednisone(ended in 7/2021), Alopurinol, Doxycycline Hyclate, Bactrim-DS
This spontaneous case reported by a consumer, describes the occurrence of myalgia (muscle aches in legs after second vaccine) and chills in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037A211B and 011A21A) for COVID-19 immunization. No medical history reported. On Feb 26, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 26, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 26, 2021, patient experienced myalgia (muscle aches in legs after second vaccine) and chills. At the time of the report, myalgia (muscle aches in legs after second vaccine) and chills outcome: unknown. No concomitant medication or treatment information provided. This case linked to MOD-2021-395800 (patient link).
The patient was given the wrong age group of the COVID vaccine. He was given the 5-11yr monovalent instead of the 12yr+ monovalent covid vaccine (Pfizer).
After administration of vaccine, patient was sitting in chair for 15 minutes. Within 5 minutes of shot patient fell out of chair and hit head. Never seemed to loose consciousness but was disoriented and dizzy . Called EMS and before their arrival sat with the patioent in uprigjht position/applied cool towel to head and neck/ and monitored slow small sips of water. EMS arrived and took over vitals and while patient was alert, transported to hospital due to hitting head
Strong Feet Pain (First week after the vaccine second dose) Fever 100F (Just the next day of the vaccine second dose) Nausea (Just the next day of the vaccine second dose) Lightheadedness (Just the next day of the vaccine second dose) Dizziness (Just the first week of the vaccine second dose) Currently: Light Feet Pain Legs Muscles Pain  Tiredness Weakness
This pt's 2 month vaccinations resulted in about 4 days of unusual twitching and irritability. Her 4 month immunizations given individually. The DTAP caused "batting at air, like on speed". She had less slept for the next 24 hours. Happy throughout the reaction. Afebril. Resolved after about 24 hours.
Chills, fever, aches and pains, nauseous, dizzy, vomiting
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (strength reported as 120 microgram, dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients' identifiers were obtained. This report concerns one of the patients. On 06-MAR-2014 at 16:20, the 22 year old patient (gender not provided) was vaccinated with the first dose of GARDASIL (lot # J005661, exp. 26-SEP-2014) into left deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14, 22/26; Jan 16, 26; Jan 17, 26/20; Jan 20, 28/32; Jan 25, 22; Jan 27, 24/26; Jan 28, 20/20. This is one of several reports received from the same source. Additional information is not expected.
No ADR, timing ERROR, 2nd dose given 45 days after 1st one.   Narrative: No ADR,  timing ERROR,2nd dose given 45 days after 1st one
BLOOD CLOTS; This spontaneous report received from a patient concerned a female of an unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medication included rivaroxaban for drug used for unknown indication.  On an unspecified date, the patient experienced blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210807458-COVID-19 VACCINE AD26.COV2.S-BLOOD CLOTS. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. .
Expired Dose of Heplisav-B was Administered; Initial Report Received on 30-Apr-2021  A pharmacist in the US (KY) reported that a 19 year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 29-Apr-2021, the patient received a dose of HEPLISAV-B (Lot # 933094, expiration date 17-Apr-2021, NDC # 43528-003-05 and serial number 410737010614) in the left deltoid from a pharmacist on staff. The pharmacist had not realized that the vaccine was expired until filling out the card for the patient. She was then notified that this incident occurred.  At the time of the report, no adverse events were reported.  No additional information was reported.    Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
A territory representative reported that a pt inadvertently received a 0.4 ml dose of Prevnar instead of the recommended dose of 0.5 ml. A few days, post vax, the child developed an upper respiratory infection. No further information was available at the date of this report. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Prevnar.
11/30/21 - Received Pfizer booster shot. Sore at injection site 12/01/21 - Low grade fever, body aches, fatigue. These lasted for 2 days. Mild fatigue continued to last 12/06/21 - Sore throat and fatigue and dizziness, heart palpitations, and vasovagal syncope and pre syncope episodes begin. The sore throat lasted for over 2 weeks. Fatigue and dizziness has been continuous. Vasovagal syncope episodes continued to last for 1.5 months. I saw near vasovagal syncope episodes because I took steps to make sure I did not faint. For example, if I saw my vision was dimming/blackening, I would quickly sit or lie down. 12/27/21 - Extreme dizziness started, it is constant. Fatigue is getting worse.  Both symptoms continue until present time 1/10/22 - Tension headaches begin Present time - fatigue, dizziness, autonomic disorder, tension headaches, heart palpitations, exercise and heat intolerance, postural lightheadedness , diagnosed with Postural orthostatic tachycardia syndrome
30 minutes after shot my throat and tongue started to swell. I took benadryl at that time. 8 hours later I became very itchy and my face swelled (including lips)
PAIN AND BURNING ON ADMINISTRATION OF VACCINE.  PAIN LASTED UP TO 4 DAYS POST VACCINE
pt recv vax;was fussy;inconsolable crying began & cont till 3:30pm;denies fever;local erythema inj site w/ small amount of swelling;apap;crying stopped when baby fell asleep;
No additional AEs reported; administered VAQTA that expired; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 03-SEP-2021, the patient was vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) (0.5 ml, lot # T014590, expiration date 15-APR-2021; strength and route were not provided) for prophylaxis (expired product administered).  The hepatitis a vaccine, inactivated (VAQTA) did not have any temperature excursions. No additional adverse event reported.
Severe Diarrhea for 48 hours, Extreme Fatigue, Headache, Elevated Heart Rate
No further AE; improper storage of prduct in use; HCP called to report an expired dose of VARIVAX was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE d; This spontaneous report was received from a pharmacist referring to a 3-year-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 02-MAR-2023 the varicella virus vaccine live (oka/merck)(VARIVAX) underwent a temperature excursion of 70 degrees Fahrenheit for 9 minutes and on 07-JUN-2023, was administered to a patient, 0.5 milliliter, lot number W0252273, expiration date reported as 02-JUN-2023 (route of administration not reported) for prophylaxis (expired product administered and product storage error). No adverse event was reported.  Lot number W0252273 is an invalid lot number for varicella virus vaccine live (oka/merck)(VARIVAX).
Immediately following patient's two-month immunizations, and especially by that evening she was acting very uncomfortable and was not herself. She started having trouble swallowing, and when she nursed she coughed and gagged which was completely abnormal for her. She started running a low fever of about 101 degrees. Thankfully her fever broke by the next morning. However, her personality and alertness changed significantly as she started having severe fatigue and she slept almost constantly. When she was awake, her eyes were not focusing on me as usual, and she was not being responsive and cheerful. Even though at two months old she normally slept a lot, she kept falling asleep for prolonged periods of time without her general awake, happy, alert periods throughout the day. It was very difficult to see the dramatic change to her personality, and not get to interact with her as I normally did for a couple days. On Saturday she was swallowing normally again, and by Sunday, three days after her shots, she had returned to her normal self.
pt c/o lt ear popping, then dizziness & emesis on day of hosp adm; sx persisted despite antiemetics, Valium & IV fluids; devel hearing loss w/in 5 days; tx-prednisone; dx acute labrynthitis w/complete deafness, probably post viral;
Information has been received from an approximately 30-year-old medical assistant who was vaccinated with a three dose series of RECOMBIVAX HB "about eight plus years ago", in approximately 1999, at another facility. An antibody titer was drawn "recently", in approximately 2007, with a result of 3.0; her paperwork showed that anything less than 9.0 is inconclusive for hepatitis immunity. Unspecified medical attention was sought. No additional information is available at this time. No product quality complaint was involved. Additional information is not expected.
Hoarse voice, dizziness, face and upper chest flushed.  Felt like mild flu symptoms.  Lasted for 2 days after injection.  Did not seek treatment for symptoms.
April 30, 2005, Pt noted really achy joints in evening. May 1, 2005 felt very hot feeling, lasted til May 4 evening, sore throat, but not typical sore throat feeling. May 4, 2005 noted rash on face, stomach and chest. Little red dots scattered 1/4"-1/2" apart. Some itching, not severe. May 5, 2005 rash clearing on face, still very noticeable on abdomen area.
(MENACTRA) Erythema 6cm x 5cm R deltoid. No fevers. No treatment done.
(L) leg 10 x 10 cm red/swollen area (R) leg 2 x 2 cm red swollen area - noted 6/11/10 AM of red/swelling to both legs - above measurements were done at 4pm 6/11/10.
Information has been received from a pharmacist referring to a 16 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 25-SEP-2016 and 23-FEB-2017, the patient was vaccinated with the first dose and the second dose of GARDASIL 9 (strength, dose, frequency, route, lot# and expiration date were unknown) respectively for prophylaxis (Inappropriate age at vaccine administration). No adverse effect was reported. Additional information has been requested.
The toenail fungus was beginning to improve, and has continued to improve; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administration date 18Oct2021 (Lot number: EP7533) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "toe fungus" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, lot number EC9231), administration date: 19Jan2021, when the patient was 67 years old, for COVID-19 immunization; Bnt162b2 (second dose, lot number EN9581.), administration date: 02Feb2021, when the patient was 68 years old, for COVID-19 immunization, reaction(s): "After the 2nd vaccine, he had toe nail fungus that started to disappear.", "He got his first COVID vaccine dose on 19Jan2021/his follow up for the second vaccine was 02Feb2021". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "The toenail fungus was beginning to improve, and has continued to improve". The event "the toenail fungus was beginning to improve, and has continued to improve" was evaluated at the physician office visit.  Additional Information: After the 2nd vaccine, patient had toe nail fungus that started to disappear. It started on all of his small digits, and he even started to grow new toenails. Patient big toes started to get better as well, and the toe nail fungus is 1/4 gone. He is getting a new nail on his big toes too. He has done nothing different with his medical care or anything. The only thing that changed was the vaccine. He was 68 years old when he started to see improvement, but he just had a birthday so now he is 69. Patient got his first COVID vaccine dose on 19Jan2021 with lot number EC9231, and his follow up for the second vaccine was 02Feb2021, with lot number EN9581. Patient got the COVID booster 18Oct2021 with lot number EP7533. Patient noticed an improvement in his toenail fungus probably 1.5-2 months after the second COVID vaccine. The toenail fungus was beginning to improve, and has continued to improve. Patient rheumatoid arthritis doctor, said her 15 year old young son had the Pfizer vaccines as well, that his toe nail fungus is starting to improve too. Patient doesn't have further information to do a report on him, but he is going to message his doctor the Pfizer safety department number because she said she would report it. Patient has pictures of his toes as well if he gets contacted by Pfizer. Patient has not received any other vaccines  No follow-up attempts are possible. No further information is expected.
thrush; lesions; sniffles for 2 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (sniffles for 2 days after first dose), CANDIDA INFECTION (thrush) and SKIN LESION (lesions) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (sniffles for 2 days after first dose), CANDIDA INFECTION (thrush) and SKIN LESION (lesions). The patient was treated with EUCALYPTUS GLOBULUS OIL, MENTHOL (ROBITUSSIN COUGH DROPS) for Thrush, at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (sniffles for 2 days after first dose) had resolved and CANDIDA INFECTION (thrush) and SKIN LESION (lesions) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant products were not provided. This case was linked to MOD-2022-506705 (Patient Link).
Breakthrough Covid-19 diagnosis.; Breakthrough Covid-19 diagnosis.; This is a spontaneous report from a contactable consumer or other non hcp. A 40-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration on Mar2021 (at the age of 40-years) as dose number unknown, single for covid-19 immunisation. She was no pregnant. The patient medical history was not reported. The patient's concomitant medications were not reported. No covid prior vaccination, no covid tested post vaccination. On 17Jul2021, the patient experienced breakthrough covid-19 diagnosis. She had taken doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included Covid test: positive on 18Jul2021. Treatment for event was Unknown. The outcome of the event breakthrough covid-19 diagnosis was recovering.
Developed moderate tinnitus about 10 days after my 2nd Pfizer vaccination.  Almost 5 months later,  the tinnitus persists and disrupts my daily life and sleep.    I saw an Ear, Nose, Throat doctor who said they have seen multiple patients who developed tinnitus from the vaccine.