chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Lot number: EN6201), in right arm, on 28Mar2021 as dose 2, single (Lot number: EN6208), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "Aspergelosis" (unspecified if ongoing); "Bronchiectasis" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT, start date: 01Sep2009. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive; (Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral treatment included nirmatrelvir/ritonavir (PAXLOVID) from 30Jul2022 to 04Aug2022.; Sender's Comments: Based on the information currently available, a causal association between the reported event and BNT162b2 cannot be excluded.
Immediate burning and physical pain entire length of arm into hand and fingers (middle, ring, and pinky) as medication traveled down arm. By 9-28 (approx. 2:00 am) could not lift my right arm (injection was in right arm) to shoulder height, fever (100.6), extreme chills, severe back and body aches (similar to flu). Could not get warm. Sweating and nausea. I took acetaminophen (500mg and buffered aspirin (500mg) at 2:00 am and again at 11:00 am. It is now 4:30 PM and I still have body aches, headache, and low grade fever.
Shortness of breath, sore throat, runny nose, woozy or dizzy, exhausted
Dizziness/Light headedness; Some vertigo; Patient has not gotten 2nd dose after 1st dose more than 42 days later; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness/Light headedness), VERTIGO (Some vertigo) and PRODUCT DOSE OMISSION ISSUE (Patient has not gotten 2nd dose after 1st dose more than 42 days later) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness/Light headedness) and VERTIGO (Some vertigo). an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not gotten 2nd dose after 1st dose more than 42 days later). At the time of the report, DIZZINESS (Dizziness/Light headedness) and VERTIGO (Some vertigo) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient has not gotten 2nd dose after 1st dose more than 42 days later) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  About 3 weeks after her 1st dose she experienced those above mentioned adverse events. The patient further stated that she was doing better and she had also been under doctor's care.  Company comment: Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 39 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular, Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 19-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Covid-19; Covid-19/Trouble breathing, Fever and Lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier(s): 20220124000818.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; dupilumab (DUPIXENT) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 07Jan2022, outcome "unknown", described as "Covid-19"; COVID-19 (medically significant) with onset 07Jan2022, outcome "unknown", described as "Covid-19/Trouble breathing, Fever and Lethargy". The reporter reported lethargy, fever, trouble breathing for 3 days after receiving Dupixent first dose and Pfizer COVID dose 2 on same day. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (07Jan2022) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Swollen, red, hard softball size rash on arm for 60 days.  As soon as rash went away, glands under arm and in breast swelled up and were very sore for 60 or so days.  As soon as glands started feeling better, hip area starting hurting.
COVID Breakthrough  J&J Dose 3/23/21 (1808609) COVID Positive 8/11/21 Presented to and discharged from ED 8/11/21:  8/12/21: The patient presents with SOB/COVID +.  Onset: 08/12/2021 .  Location: Respiratory. Context: A 73 y/o male presents to the ED with SOB. Patient is COVID positive and was diagnosed yesterday. Patient had the Regeneron infusion today. Pt also dialysed. Patient's pulse ox was 88% at home so he came to the Hospital. Patient is feeling sob, he has a cough and feels feverish. Patient is borderline DM, on Dialysis and has HTN. Patient did have the Johnson and Johnson Vaccine. Pt had PO 82% on arrival to ER and Patient denies chest pain, abdominal pain, N/V, diarrhea, constipation, dysuria, joint pain, headache, dizziness or lightheadedness.  8/23/21: 73-year-old male with a history of ESRD on HD MWF schedule, recent diagnosis of COVID-19 infection, T2 dm admitted for worsening SOB with hypoxia. Initially placed on biapa and optiflow in icu, slowly weaned down to 2 liters at rest and 5 liters with ambulation. he has already received the j and j vaccine, but still tested positive. he received regeneron and dexamethasone, as well as iv antibiotics. he continue his 3x a week dialysis. patient seen by PT and cleared for discharge.
A nurse reported the occurrence of injection site cellulitis in a 24-month-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The pt's medical history, concurrent conditions and concurrent medications were not specified. On 09/30/2002 the pt received her 4th injection of Infanrix (lot DTPA571A2) into the left upper leg. One day later, the subject developed redness at the injection site followed by bruising, itching, swelling and firmness 3 days post-immunization. The area of swelling measured 18.5 cm. The pt was seen by a physician, who made a diagnosis of injection site cellulitis. The reporter considered the injection site cellulitis to be related to Infanrix administration. Comment: This report has been linked to reports A0382391A, A0386782A, A0386783A, and A0386785A due to same reporter.
The first Moderna shot was received on 05/01/2021.  The only symptom after the first shot was soreness at the injection site for a few days.  The second shot was received on 06/01/2021.  The symptom of soreness at the injection site started later that same night.  The next morning a feeling of tiredness increased throughout the day with teeth-chattering chills starting in the early afternoon and a fever that spiked up to 103 degrees at one point.  Nausea, loss of appetite, low-grade fever, and extreme lethargy continued.  Tylenol, water, crackers, and Jell-O helped provide relief.  Today (06/03/2021) there is no more fever.  I still feel tired but I no longer feel extremely lethargic.
This is a spontaneous report from a noncontactable consumer or other non-HCP. A female patient, of an unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient had a head cold on an unspecified date. Verbatim and Event Description: No patient identifiers provided but the reporter has firsthand knowledge of the patient and reporting on a specific patient. Mother-in-law got first vaccine. She is scheduled for her second dose. She got a head cold just recently. She is inquiring if mother-in-law can take second vaccine while sick. The event outcome reported unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Headache, Sedation, Myalgia, Arthralgia, Fever,  Chills, pain at the injection site Narrative:  Other Relevant History:
Since patient is 13 years of age, she should have received the Pfizer COVID-19 vaccine.  Patient has reported no side effects from receiving the Moderna vaccine, just wanted to properly document the error.
This spontaneous report as received from a medical assistant, refers to a currently 14 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored GARDASIL 9, which had a lot # of N022728 and an expiration date of 31-MAY-2020; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excusions and the aformentioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006354.
felt ill; This is a spontaneous report from a contactable consumer (parent reported for her daughter). A 17-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0181), via an unspecified route of administration on 23Jun2021 (at the age of 17-year-old) at a dose 1, single for COVID-19 immunization. The patient medical history included COVID-19 (in course of conversation reporter found out that both of them tested COVID positive approximately 90 days prior to receiving the vaccine). The patient concomitant medications were not reported. The patient felt ill on an unspecified date in Jun2021. Approximately one hour after receiving their first dose of Pfizer COVID-19 vaccine patient felt ill. The patient underwent lab tests and procedures which included COVID-19 test was positive on an unspecified date. Outcome of the event was unknown.  Follow up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021791190 Same reporter/ drug, different patients/ events
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date Oct2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HEADACHE (non-serious) with onset Oct2021, outcome "unknown", described as "headache".  The lot number for BNT162b2 was not provided and will be requested during follow up.  Follow-up (21Oct2021): 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.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "poliomyelitis osteopathy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No known allergies. Patient was received COVID 19 antiviral treatment with Paxlovid oral from 19Jul2023 to 24Jul2023. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.
The first issue was diagnosed as COVID arm that started 7-29-2021left arm swollen  with rash and subsided by 08-01-2021 then a day or two later I began getting stabbing pains in my head and left ear that were constant, debilitating and lasted a week.  My regular Dr was on vacation and I went to see another Dr  who indicated I had shingles triggered  by the shot. I stil have pains in my head
Pain at injection site. Difficulty moving or raising the left arm of injection site because of pain. Warmth, red, and swelling in the whole upper left arm. Feeling feverish and generally weak. Occasional headache. These symptoms continued but improved during the next day except the swelling and redness in the upper left arm. These symptoms finally resolved on 05/14/2016.
Systemic: Patient stated that they started to have on and off on-going pain on right side of back 2 days after getting shot.-Mild, Additional Details: Patient stated that she had used Tylenol which did not help. I advised she try oral ibuprofen and voltaren topical alternating to see if they help. I also advised she see a DR if still no relief.
This medically confirmed report (initial receipt: 21-Oct-2013) concerns female patient in her 20s. The patient has no pertinent medical history and no known allergies. On 19-Oct-2013, the patient received AFLURIA (batch number: 08449211A) 0.5ml intramuscularly into the right deltoid. On 21-Oct-2013, the patient experienced a painful rash, that hurt really bad, in her right upper shoulder. The rash was a small area six centimetres by four centimetres, with painful little blisters. The patient sought medical attention and was diagnosed with shingles. The patient was prescribed unspecified medication for treatment. Outcome was reported as not recovered.
Noticed my right arm became hot to the touch. Upon examination I noticed that it was swollen and red. Now it has started itching. Pu ice on it.
Presented to clinic on Sat. Feb 2, 2013 with blood in stools. Guaiac positive proceeded with barium x-ray which was negative. Blood in stools noted only Sat. Feb 2, 2013. None since.
Swelling and soreness on arm. Flu like symptoms. Pt presented in pharmacy on 2/24/2017 with red arm up from the elbow to shoulder. Patient says it is sore to touch and itchy.
TONGUE PROBLEMS-BURNS; LIGHT HEADED NOW AND THEN; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced tongue problems- burns, and light headed now and then. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tongue problems-burns and light headed now and then was not reported. This report was non-serious.
Swollen, painful lymph nodes in neck and arm pit on right side only, still present as of 4/11/21. Swollen right forearm 4/8/21 for 24 hours. Insomnia 4/5-4/9/21  Ibuprofen was the only treatment taken for swelling and pain.
Pt states arm swollen from shoulder to hand, softball size knot at injection site, redness, knot under arm, painful.
Information has been received from a nurse practitioner concerning a female (age unknown), who on three unspecified dates was vaccinated with a dose of Gardasil. Subsequently, after each dose the patient developed deep pigmentation. At the time of the report, the patient's outcome was unknown. This report is 1 of 2 reports received from the same source. Additional information has been requested.
10/25/08- 10pm redness & warm at injection site R arm, pain at site when lying on R side. 10/26/08 redness moved to inside of arm 5x5" area.  10/27/08 seen by MD dermatologist- Rx given for Z Pak (AZITHROMYCIN x 5 days) 10/30/08- area faded & almost gone.
Information has been received from a registered nurse concerning an 1 year old male with no known drug allergies who on 08/21/2001 was vaccinated with a dose of varicella vaccine. There was no concomitant medication. On 09/10/2001, the pt presented with about 12 vesicular lesions. The pt sought unspecified medical attention. Additional info has been requested.
chills, headache & migraine, achy joints, vomit  Note that events were correlated in time, but not established to be caused by vaccine.
Severe vertigo, related violent vomiting, soreness at injection site, flu like symptoms, severe fatigue
product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech; I tested positive on a rapid test.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 33 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech"; COVID-19 (medically significant), outcome "not recovered", described as "I tested positive on a rapid test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: covid-19 treatment; (12May2022) Negative, notes: 4 days after end of treatment I tested negative on a rapid test; (13May2022) Positive, notes: The next day (5days after end of treatment) I tested positive on a rapid test. Therapeutic measures were taken as a result of covid-19.Clinical course: adverse event- Metallic and acidic taste in mouth for entire course of treatment. 4 days after end of treatment patient tested negative on a rapid test. anti viral details: product- COVID 19 Treatment, brand- Paxlovid, treatment start date- 03May2022, treatment stop date- 08May2022, indication-Treatment of COVID-19. known allergies was reported as no.  No follow-up attempts are possible. No further information is expected.
Chest pain onset 3 days post second dose of pfizer vaccine resulting in 2 day hospitalization, cardiac workup and serial lab draws.
Vaccine was given as an expired dose. Greater than 2 hours after first puncture at room temp.
About 2 months after 2nd injections up to swelling of legs and muscle fatigue legs and arms. Up to and including today I have muscle tingling, twitching, spams and what I can only describe as under my skin bubbling sensation. I am in good health and have reported this to my doctor and he doesn't understand it.
Tonic Clonic Seizure 7/28/21 0550 Found by husband in bed seizing
Bell's Palsy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) at a pharmacy for the long-term prevention of shingles and zoster-related conditions (dose, dose number, route of administration, anatomical location, lot # and expiration date not provided). On an unknown date, the patient was treated by a healthcare provider for Bell's palsy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the patient had and would continue to suffer the ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  Upon internal review, Bell's palsy was considered medically significant.