chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable pharmacist.   A 56-year-old female patient received PREVNAR 13 (Lot # N34935, Expiry Date 01Oct2017, NDC number 0005197102), AFLURIA (Lot # WT54106, Expiry Date 26Jun2017, NDC number 3332001601), both via an unspecified route of administration at 0.5 ml, single on 06Oct2016 for immunisation. Medical history included ongoing smoker. Concomitant medications were not reported. The patient experienced her arm is still very sore to move and it is a little red on an unspecified date in Oct2016 with outcome of not recovered.
swelling @ inject site-adv seek eval-eval done 25MAR94 @ clinic-no tx needed;
Patient was to receive JYNNEOS 0.1mL intradermal. However, syringe malfunction caused all of dose to leak out. So, injection was repeated successfully.  A few minutes into observation, patient reported feeling warm, uncomfortable, and "going to pass out". Lead RN and auxiliary RNs immediately began anaphylaxis assessments. Patient was moved from seated position on chair to seated position on floor against wall to mitigate possible physical trauma.  ~11:45 = BP 118/82, HR 88, RR 16, Diaphoretic, Lethargic, Bilateral Lung Sounds Clear ~11:55 = BP 120/78 HR 84, RR 16, Less Diaphoretic, AOX4, Bilateral Lung Sounds Clear  Patient was held in observation station for an additional 30 minutes. Thereafter, patient verbalized feeling OK. RNs noted fully AOX4, normal gait, sans gross neurological deficit, and pleasantly conversational. Patient counselled to watch for further adverse at home and to immediately call 911 if such occurs. Patient discharged.
SORENESS AT INJECTION POINT (SHOULDER); NAUSEA; FATIGUE; This spontaneous report received from a patient via a company representative concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose, 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 number. No concomitant medications were reported. On an unspecified date, the subject experienced soreness at injection point (shoulder), nausea, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness at injection point (shoulder), nausea, and fatigue. This report was non-serious.
sore arm, body aches, chills, low energy - symptoms for 2 days then all ok.  did not seek medical attention
Trimmers on hands , feet and some time face. Burning sensation on arms and lower extremities  Chest pains
Initial report extracted from VAERS via a QSCAN FDA report on 24 February 2009 (VAERS Identification number 334936). A 56-year-old male patient, whose past medical history was not provided, had received on 25 November 2008 a intramuscular injection of Fluzone SV 2008-2009 (lot number U2831AA). The route and site of administration was conjunctivitis, sore throat, non-productive cough, chest tightness, slight wheezes, swelling around the eyes and body aches. He self medicated with oral Benadryl 25 mg and oral Ibuprofen 200 mg twice a day with no effect. The patient recovered; however a recovery date was not provided. Documents held by sender: None
vaccination site rash; ache; vaccination site erythema; ache; This spontaneous case was reported by a physician and describes the occurrence of the second episode of PAIN (ache), the first episode of PAIN (ache), VACCINATION SITE ERYTHEMA (vaccination site erythema) and VACCINATION SITE RASH (vaccination site rash) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 UNK. In April 2021, the patient experienced the first episode of PAIN (ache). On an unknown date, the patient experienced the second episode of PAIN (ache), VACCINATION SITE ERYTHEMA (vaccination site erythema) and VACCINATION SITE RASH (vaccination site rash). At the time of the report, last episode of PAIN (ache), VACCINATION SITE ERYTHEMA (vaccination site erythema) and VACCINATION SITE RASH (vaccination site rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment: The patient was treated with Prednisone.  On 21-APR-2021 received update to patient demographics, event information, reporter opinion of causality, suspected drug information, concomitant drug information and narrative description. The event of "ACHY" and "VACCINE RASH, RED RASH AT THE INJECTION SITE AFTER SECOND DOSE" were added.
Infections; Patient missed her second dose (more than 11 weeks since first dose); This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Infections) and PRODUCT DOSE OMISSION ISSUE (Patient missed her second dose (more than 11 weeks since first dose)) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0112196) for COVID-19 vaccination.     The patient's past medical history included Surgery (opening in stomach).    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed her second dose (more than 11 weeks since first dose)). On an unknown date, the patient experienced INFECTION (Infections). On 19-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Patient missed her second dose (more than 11 weeks since first dose)) had resolved. At the time of the report, INFECTION (Infections) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included antibiotics. No Treatment medication were reported.
herpes zoster; postherpetic neuralgia; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 04-OCT-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On an unknown date, the patient was administered with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered herpes zoster, and postherpetic neuralgia. As a result of these symptoms, the patient was seen and treated by a medical provider and was still under their care. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using Zoster Vaccine Live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution, and or sale of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental, anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of herpes zoster, and postherpetic neurlgia was not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).
Although I do suffer from depression, I have not had a depressive episode in over a year. I received my second dose on 4/2 and woke up on 4/5 feeling very depressed. Nothing else changed other than getting the vaccine. I'm reporting this in the event that potentially a side effect is it could cause depression in those predisposed to it.
Death 2 days post shots. 2/28/05 Autopsy report received which revealed that patient was large for gestational age & was not rolling over yet.  Hx of recent URI.  Found in crib w/heavy pillow over face.  Bystander CPR unsuccessful.  Also found hyperostosis w/expanded bone marrow at right parieto-occipital calvaria.  COD: no anatomic COD.  Manner of death: undetermined.
Diarrhea; Exhaustion; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 84 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 03Mar2021 09:10 (Lot number: EM9809) as dose 2, single for covid-19 immunisation. Relevant medical history included: "remove gall baldder", start date: Dec2018, stop date: Dec2018; "bleeding ulcers", start date: Dec2020, stop date: Dec2020, notes: taken care of; "arthritis", start date: 1970 (ongoing), notes: radio frequency ablation12Mar21. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose,, batch,lot-EM9809, route-intramuscular,, Anatomical location-arm right.), administration date: 10Feb2021, for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 05Mar2021 10:00, outcome "recovered" (06Mar2021), described as "Diarrhea"; FATIGUE (non-serious) with onset 05Mar2021 10:00, outcome "recovered" (06Mar2021), described as "Exhaustion"; HEADACHE (non-serious) with onset 05Mar2021 10:00, outcome "recovered" (06Mar2021), described as "headache". Therapeutic measures were not taken as a result of diarrhoea, fatigue, headache.  No follow-up attempts are possible. No further information is expected.
Bell's palsy; partial facial paralysis on the right side; This case was reported by a consumer and described the occurrence of bell's palsy in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) (batch number 54C23, expiry date unknown) for prophylaxis.   On 15th October 2021, the patient received Influenza vaccine Quadrivalent 2021-2022 season. On 22nd October 2021, 7 days after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced bell's palsy (serious criteria GSK medically significant) and facial paralysis (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy and facial paralysis were unknown.   It was unknown if the reporter considered the bell's palsy and facial paralysis to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient received flu vaccine manufactured by GlaxoSmithKline and one week later was diagnosed with bell's palsy and partial facial paralysis on right side. The patient reported that the physician believed that the adverse event occurred due to flu shot. The patient wanted to report this adverse event properly. The reporter consented to follow up.
This case was reported by a other health professional and described the occurrence of swallowing difficult in a 35-year-old female patient who received FLUARIX QUADRIVALENT (batch number 4ZY53, expiry date unknown) for prophylaxis. On 14th September 2018, the patient received FLUARIX QUADRIVALENT. On 14th September 2018, less than an hour after receiving FLUARIX QUADRIVALENT, the patient experienced swallowing difficult (serious criteria life threatening and other as per reporter), allergic reaction (serious criteria life threatening and other: as per reporter) and hives (serious criteria life threatening and other: as per reporter). FLUARIX QUADRIVALENT was discontinued. On an unknown date, the outcome of the swallowing difficult, allergic reaction and hives were recovering/resolving. The reporter considered the swallowing difficult, allergic reaction and hives to be probably related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received the vaccine and within 15 minutes she had the difficulty swallowing and skin reaction. She was brought to the emergency room. The patient was treated there for an allergic reaction and subsequently discharged. The events were not associated with other seriousness criteria like hospitalization, death, disability and congenital anomaly.
Mom called on 4-6-18 to report that after patient received shots on 4/5/18, around 2:30pm he started shivering, grunting, trembling and crying in his sleep. Had no fever and was better on 4-6-18. No injection site redness or swelling.
Pt vaccinated w/Influenza 1 day after immunization pt c/o throat & aching all over.
This spontaneous report was received from a registered nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date(s), the patient were vaccinated with improperly stored doses (4 doses) of PROQUAD (dosing details not known) (lot # L019998 and expiry date: 02-DEC-2016). The administered doses experienced a temperature excursion of -6.1 degree Celsius for 5 hours. The vaccine underwent previous temperature excursion of -14.8 degree Celsius for 20 minutes and -12.7 degree Celsius for 8 hours 20 minutes. The call was because of a data logger. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
This spontaneous case reported by a consumer (subsequently medically confirmed), describes an episode of dizziness, dizziness/headaches, back and neck pain in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 045A21A) for COVID-19 immunization. No medical history reported. On Apr 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 7, 2021, patient had an episode of dizziness. On Apr 8, 2021, patient experienced back pain and neck pain. On Apr 18, 2021, patient experienced dizziness/headaches. The patient treated with Advil (ibuprofen), at an unspecified dose; and frequency and Tylenol (paracetamol), at an unspecified dose and frequency. On Apr 20, 2021, back pain and neck pain resolved. On Apr 30, 2021, dizziness/headaches resolved. At the time of the report, an episode of dizziness outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications reported. The patient stated Apr 30, 2021 was the first day he did not have any side effects. The patient went to chiropractor. Treated with Advil and Tylenol for 13 to 14 days.
10-20-06 vaccine 11:30, at 5pm malaise and tiredness, 10-21-06 loss function legs-walking abscent admit to medical center 11 days CSF done on 10-28-07 100% lymphs viral encephalitis and treat with Acyclovir, 11-1-06 hosp, 11-9-06 nursing home rehab.
Fever; This is a spontaneous report from a contactable consumer (Patient). A 64-years-old female age patient received bnt162b2 (Pfizer BioNTech COVID-19 vaccine, Solution for injection, Batch/Lot Number: Not reported), dose 2 via an unspecified route of administration, administered on unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccines include bnt162b2 (Pfizer BioNTech COVID-19 vaccine, Solution for injection, Batch/Lot Number: Not reported), dose 1 via an unspecified route of administration, administered on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. No prior vaccination within 4 weeks. On an unspecified date patient experienced fever. Consumer stated, patient had not side effects with the first shot but with second one had fever. The outcome of the event was Unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.  Follow-up (10Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Discomfort to left shoulder/it is bothering them/is affecting their job, that is their livelihood; Pain in their left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Discomfort to left shoulder/it is bothering them/is affecting their job, that is their livelihood) and ARTHRALGIA (Pain in their left shoulder) in a 52-year-old female patient who received mRNA-1273 (batch nos. 021b21a and 007d21a) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE DISCOMFORT (Discomfort to left shoulder/it is bothering them/is affecting their job, that is their livelihood) and ARTHRALGIA (Pain in their left shoulder). At the time of the report, VACCINATION SITE DISCOMFORT (Discomfort to left shoulder/it is bothering them/is affecting their job, that is their livelihood) and ARTHRALGIA (Pain in their left shoulder) had not resolved.            No concomitant medications were provided by the reporter. It was reported that the patient took the ibuprofen for pain in their left shoulder. It was also mentioned that the patient wanted o do a class action lawsuit and wanted to know what to do with these side effects.
Systemic: Delayed/Unusual menstrual cycle-Medium, Additional Details: Patient discribes no mentrual activity except for one large dispersion of blood then nothing after that
Shortness of breath, irrational heartbeat; Shortness of breath, irrational heartbeat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Aug2021 13:00 (Lot number: EW0179) at the age of 31 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEART RATE IRREGULAR (non-serious), DYSPNOEA (non-serious) all with onset 03Aug2021, outcome "not recovered" and all described as "Shortness of breath, irrational heartbeat". Therapeutic measures were not taken as a result of heart rate irregular, dyspnoea.  Addition Information: No other vaccine in four weeks. No other medications in two weeks. She did not have Covid prior vaccination, She did not have Covid tested post vaccination. Patient had not any known allergies.  No follow-up attempts are possible. No further information is expected.
received a total of 4 doses of the Moderna Covid 19 vaccine; Huge Muscle pain; Nausea; lack of sleep; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (received a total of 4 doses of the Moderna Covid 19 vaccine), INSOMNIA (lack of sleep), MYALGIA (Huge Muscle pain) and NAUSEA (Nausea) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jun-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced INSOMNIA (lack of sleep). On 13-Feb-2021, the patient experienced MYALGIA (Huge Muscle pain) and NAUSEA (Nausea). On 01-May-2021, the patient experienced EXTRA DOSE ADMINISTERED (received a total of 4 doses of the Moderna Covid 19 vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (received a total of 4 doses of the Moderna Covid 19 vaccine), INSOMNIA (lack of sleep), MYALGIA (Huge Muscle pain) and NAUSEA (Nausea) outcome was unknown.            No concomitant information was reported. No treatment information was reported.
Began with violent shakes and chills.  Migraine type headache developed, followed by nausea feeling, all over sore muscles.  This lasted about 12 hours, then slowly started to subside.   By second day, nausea gone, headache gone, but very light-headed.  On third day, still very light-headed.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. No information on concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL (unknown strength, route and dose). Concomitant medications were not reported. No adverse effects were reported. The outcome of incorrect product storage was unknown. There was no product quality complaint involved. This is one of the three reports received from the same reporter. Additional information has been requested.
Patient had 3rd dose of vaccine 20Feb18 and presented to clinic 21Feb18. States this morning @0600 the site felt warm to touch, tender to touch, swollen and stiff. Site was marked 5cmx7cm and patient was given MOTRIN, ZYRTEC and 3 day course of Prednisone. Pt was told to f/u tomorrow.
About 2/3 weeks after the vaccine I noticed that onions and garlic had different taste and smell.  But the bad part was that on the side of both my breast are always very tender and it feels like I have swollen nodes.  That has not gone way, but I have not visited a doctor for it. Note I had had COVID back in November 2020.
erythematous wheals & tenderness;lt upper arm 3 wheals;1 wheal 3 1/2x3cm;2 smaller wheals;
pt recv vax inadvertently subcutaneously ;pt devel an allerg rxn characterized by difficulty breathing & redness & swelling @ the inj site;pt was taken to the ER & tx w/unspecified med; 2 days post vax skin @ inj site was peeling from arm;
The patient passed out after shingle shot and woke up after 2-3 minutes. We called EMS and they took him for further check up. When he woke up, he said that he had fainted at home last week but he woke up  after few minutes and he has been seeing his doctor
sick for a few days; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for a few days) and PYREXIA (low grade fever) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick for a few days) and PYREXIA (low grade fever). At the time of the report, ILLNESS (sick for a few days) and PYREXIA (low grade fever) outcome was unknown.            No Concomitant medication information was reported. No Treatment medications were provided.   This case was linked to MOD-2021-283128 (Patient Link).