chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant (M.A.) refers to an unspecified number of unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. In approximately 2015 (reported as since an unspecified date in October 2015), the patients were vaccinated with doses of improperly stored PEDVAXHIB injection (lot # L009649 with expiration date 29-NOV-2017 and lot # L012837 with expiration date 11-MAR-2018, dose, and route of administration were not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
COVID Virus. Sore throat, runny nose and having trouble taking deep breaths; COVID Virus. Sore throat, runny nose and having trouble taking deep breaths; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization), COVID-19 (hospitalization) all with onset Mar2022, outcome "unknown" and all described as "Now she has it again on Saturday-COVID Virus. Sore throat, runny nose and having trouble taking deep breaths. She also confirmed that got all the Pfizer COVID vaccine injections. Got all 5 of them from Pfizer.". The patient was hospitalized for drug ineffective and COVID-19 (start date: 2022, discharge date: 2022, hospitalization duration: 5 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2022) positive. Therapeutic measures were taken as a result of drug ineffective and COVID-19 and PAXLOVID. Clinical information: At the end of Mar2022, she got the COVID virus and was in the hospital 5 days (in 2022). She again had sore throat, runny nose and having trouble taking deep breaths. She went in a supermarket instead of medical place (advised not to come if she had symptoms) and did the test there and it was positive. They called the doctor because they gave her medication for a cold and had to change it for the virus instead. She received PAXLOVID as treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Within three days of administration of influenza vaccine, patient developed worsening muscle weakness especially of axial muscles.  This peaked at about two weeks post administration and is improving.  There were no other symptoms or muscle pain or tenderness.  This was significant enough that she could not climb stairs at its peak.  Concern is of possible mild Guillain-Barre (pt declined LP) Per 60 day follow up: Recovery is still unknown, weakness is improved so so but persists, and has been determined to have shot given which may contribute. The medical record states GBS, demyelinating polyneuropathy.
For this patient, the number of days that have passed were 26. Patient received second dose on 29Jul2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (For this patient, the number of days that have passed were 26. Patient received second dose on 29Jul2021) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (For this patient, the number of days that have passed were 26. Patient received second dose on 29Jul2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (For this patient, the number of days that have passed were 26. Patient received second dose on 29Jul2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications and no treatment medications were reported.  CROSSLINK TO ORIGINAL CASE MOD21-126929   This case was linked to MOD-2021-278394 (Patient Link).
Patient was given Pfizer COVID-19 bivalent vaccine as first dose in series. No adverse reaction has been reported by patient.
This spontaneous report was received on a newspaper article and refers to multiple female patient of unknown age. The patients' medical history and concurrent condition were not reported. The patients on an unknown date were vaccinated with Quadrivalent HPV vaccine (manufacturer unknown) (dosing information not provided). Concomitant medication were not reported. On an unknown date it was reported that the patients were very sick, totally debilitated, and their personalities had changed. Action taken with quadrivalent HPV vaccine (manufacturer unknown) was not applicable. The outcome of the events Malaise, Asthenia, and Personality change were unknown. The reporter did not provide the causality assessment between the events and quadrivalent HPV vaccine (manufacturer unknown). This case is linked to the case 1512USA000013 and 1512USA001052. Additional information has been requested.
Swelling; Arm hurted; Itching; Big red spot, firm, baseball size area; Warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurted), PRURITUS (Itching), RASH MACULAR (Big red spot, firm, baseball size area), FEELING HOT (Warm to the touch) and SWELLING (Swelling) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Grass allergy and Allergy to plants. Concomitant products included CELECOXIB, HYDROCHLOROTHIAZIDE, SIMVASTATIN, OMEPRAZOLE, MONTELUKAST and LEVOTHYROXINE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm hurted). 24-Mar-2021, the patient experienced PRURITUS (Itching), RASH MACULAR (Big red spot, firm, baseball size area) and FEELING HOT (Warm to the touch). On 31-Mar-2021, the patient experienced SWELLING (Swelling). At the time of the report, VACCINATION SITE PAIN (Arm hurted), PRURITUS (Itching), RASH MACULAR (Big red spot, firm, baseball size area), FEELING HOT (Warm to the touch) and SWELLING (Swelling) had resolved.            It was reported that the patient arm hurt initially for a couple of days but went away and actively experiencing symptoms that started 31-Mar-2021, of itching, big red spot, firm, baseball size area, and warm to the touch since. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information received on 13-May-2021 contains information regarding onset date and outcome of the events.
wheezing; sob; This case was reported by a pharmacist via other manufacturer and described the occurrence of wheezing in a 39-year-old patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced wheezing and shortness of breath. On an unknown date, the outcome of the wheezing and shortness of breath were unknown.   It was unknown if the reporter considered the wheezing and shortness of breath to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced shortness of breath and wheezing after vaccination with flu. This case has been linked with the case US2021AMR012841 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR012841:same patient
Malaise, body aches, fever to 104F, exacerbation of seizure, although no treatment sought at the time.
Slight erythema, swelling at the injection site, left deltoid with no treatment required other than moist heat.
Abnormal looking lymph nodes with necrosis; Tenderness and itchiness on the lymph nodes that went away but "came back"; Fatigue; Headache; Muscle pain; Joint pain; Chills; Nausea; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NECROSIS (Abnormal looking lymph nodes with necrosis) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced LYMPH NODE PAIN (Tenderness and itchiness on the lymph nodes that went away but "came back"). In March 2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever). On 18-Mar-2021, the patient experienced NECROSIS (Abnormal looking lymph nodes with necrosis) (seriousness criterion medically significant). In March 2021, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever) had resolved. At the time of the report, NECROSIS (Abnormal looking lymph nodes with necrosis) and LYMPH NODE PAIN (Tenderness and itchiness on the lymph nodes that went away but "came back") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Mammogram: negative (Negative) Negative.   Patient had a biopsy and magnetic resonance imaging done on her breast tissue. The biopsy results were inconclusive. No treatment information was provided. No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.  Further information has been requested.   This case was linked to MOD-2021-237379 (Patient Link).
Immediately following my second dose I had a migraine that lasted for weeks.  The migraines continued throughout all of last year and currently remain uncontrollable causing loss of work and loss of quality of life
Information has been received from a registered nurse concerning a 29 year old female health care employee with no past medical history or allergies, who on 03/11/02 was vaccinated with a dose of measles virus vaccine live (Moraten) (lot # reported as 0459C). In December 2003, a titer was drawn and the results were equivocal. Unspecified medical attention was sought. Additional information has been requested.
The following day after receiving the Shingrix vaccine, the patient reports that he fell and scratched his forehead and the top of his head as well and had to get stitches. The patient states that the fall could not be attributed to anything else aside from vaccine as nothing else in his daily routine or diet had changed. Patient does not recall feeling faint or unwell prior to the fall but just remembers falling down.
Red ring around the area and swollen lump, firm to touch.  Soreness to the touch.
This spontaneous report as received from a pharmacist refers to a 78 year old male patient. The patient's medical history included herpes zoster.The patient had a case of shingles, waited six weeks after symptoms stopped. Between 14th and 17th of February (in 2013) the patient was vaccinated with ZOSTAVAX (lot number was not reported) (0.65 ml, subcutaneous on unknown injection site). On 14-MAR-2013 the patient developed shingles again. The outcome was unknown. The action taken and causality were not provided at the time of report. The patient had an office visit for medical attention. Additional information has been requested.
The patient received his first Moderna Covid-19 vaccine about 3:30pm. At about 3:45pm the patient presented with generalized itching. He stated that he had taken one Claritin 10mg tablet earlier in the day. I recommended taking some Benadryl and the patient agreed. I gave him 4 teaspoonsful of Benadryl Elixir (50mg). I ask the patient to remain in the waiting area for  30 minutes or so and afterwards to let me know how he was doing. He didn't return to the pharmacy counter and was gone before a could speak to him. I called his mobile number and left him a detailed message and to call me if he had any further concerns. I didn't hear back from the patient.
pain at injection site; chills; low fever; axillary LN swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site), CHILLS (chills), PYREXIA (low fever) and LYMPHADENOPATHY (axillary LN swelling) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at injection site), CHILLS (chills), PYREXIA (low fever) and LYMPHADENOPATHY (axillary LN swelling). At the time of the report, VACCINATION SITE PAIN (pain at injection site), CHILLS (chills), PYREXIA (low fever) and LYMPHADENOPATHY (axillary LN swelling) had resolved. Not Provided          Pain at injection site started after 6 hours of vaccination and ended 4 days later, Chills and low fever started after 24 hours of vaccination and ended 36 hours later, Axillary LN swelling started after 24 hours of vaccination and ended 3 days later.  No concomitant product reported by reporter. No treatment medication reported by reporter.
SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (pfizer) concerned a 41 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total, administered at left arm on 11-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 40 years old. No concomitant medications were reported.   The patient also received non-company suspect vaccine Spikevax (elasomeran) (Dose number in series 2) (form of admin and route of admin was not reported, batch number: 027HZ1B expiry: unknown) dose was not reported, administered at left arm on 20-NOV-2021 for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (Dose number in series 2). On an unspecified date in 2022, the patient had covid-19 (suspected covid-19 infection) for which she received non company suspect drug as paxlovid (form of admin and route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, administered from 07-DEC-2022 to 11-DEC-2022 for covid-19. On 15-DEC-2022, the patient experienced covid rebound (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and with paxlovid was drug withdrawn. The patient had not recovered from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
This spontaneous report as received from a medical assistant via company representative refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a doses of improperly stored VAQTA (lot# L034381, exp.date: 21-DEC-2016)(strength, route and frequency were not reported). The temperature of the storage was 50 Fahrenheit degree for 24 hours. No adverse symptoms were reported. The outcome of the patient's event was not reported. This is one of several reports from the same source. Additional information has been requested.
Patient started complaining that it was hard to swallow and that her throat was swollen.  She was given an allergy medication and it didn't seem to help. At one point she feared her throat would swell shut. She was taken to Urgent Care and diagnosed with Acute Pharyngitis and prescribed 10 MG Prednisone  1/day for 3 days. After 3 days of Prednisone she was still trying to clear her throat and complaining about her throat still bothering her.
Second dose canceled due to previous reaction; Tachycardia/fast heart beat; disorientation; heart was palpitating; Dizziness; High pressure in head; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEAD DISCOMFORT (High pressure in head), PRODUCT DOSE OMISSION ISSUE (Second dose canceled due to previous reaction), TACHYCARDIA (Tachycardia/fast heart beat) and DISORIENTATION (disorientation) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (allergy to hydrocodone and morphine), Egg allergy (allergy to egg white) and Food allergy (allergy to dairy). Concomitant products included LIOTHYRONINE for an unknown indication.    On 11-Mar-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DIZZINESS (Dizziness), HEAD DISCOMFORT (High pressure in head), TACHYCARDIA (Tachycardia/fast heart beat), DISORIENTATION (disorientation) and PALPITATIONS (heart was palpitating). On 08-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose canceled due to previous reaction). On 11-Mar-2021, DIZZINESS (Dizziness), HEAD DISCOMFORT (High pressure in head) and TACHYCARDIA (Tachycardia/fast heart beat) had resolved. At the time of the report, DISORIENTATION (disorientation) and PALPITATIONS (heart was palpitating) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Heart rate: increased (High) fast heart beat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Concomitant products included compounded hormones estrogen group.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up information was received on 14 May 2021 as additional information which included patient contact details, conditions and events were updated.
June 1, 2021 After a trip  I had a fever of 102 and coughing and sneezing and bodyaches. My doctor and I did a telehealth call and he said I may have Acute Bronchitis and maybe Adverse reaction to a new drug I was on called Latanoprost for Glauoma after I had Laser surgery.   I stopped the drug for a few days and took a Zithromax Z- Pak  and all is well.
Date of first (+)ve test: Monday, 19Jul; Date of first (+)ve test: Monday, 19Jul; Light case so far, similar to mild flu-like symptoms; some head congestion; runny nose; loss of smell but not taste; sweating; body ache; This is a spontaneous report from a contactable consumer or other non hcp. A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6199; Expiration Date: 30Jun2021), via an unspecified route of administration on 25Mar2021 (at the age of 59-year-old) as dose 2, single, dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot Number: EN6199; Expiration Date: 30Jun2021) as dose 1, single for covid-19 immunisation.  The patient had no medical history. There were no concomitant medications. On 18Jul2021, patient experienced body ache and sweating but no temperature or cough. On 19jul2021, patient experienced vaccination failure, covid-19, similar to mild flu-like symptoms, no fever, no body ache, some head congestion and runny nose, loss of smell but not taste. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 17Jul2021, sars-cov-2 test: postive on 19Jul2021. The outcome of the event covid-19 was not recovered and the outcome of events body ache, sweating, flu-like symptoms, some head congestion, runny nose, loss of smell but not taste were unknown. The product Quality Complaint group provided additional investigational results which indicated the following: Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6199 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
On May 24 arm was sore at site and to lift. On May 25 saw that upper arm was slightly swollen, warm and red. The warmness went away by May 27, however whole upper arm was red from shoulder to elbow. Redness wrapped around arm. By May 28 the redness was less and by May 30 was gone.
Pt. stated her right arm was swollen with an area of redness about 3 inches in diameter. Now has some red areas on her back with itching, which she thinks are hives.
Reason for contact: Complains of sore arm where PNEUMOVAX was given yesterday. Lump noted size of a golf ball, no redness. Experiencing chills. Has applied ice and taken TYLENOL. Denies any shortness of breath, wheezing, fast heart rate, dizziness, hives, high fever or behavior changes. Plan of care: Instructed to continue to apply ice and taking TYLENOL. Reviewed VIS sheet/potential side effects and those he should seek emergency evaluation for. Myalgia and sore arm with lump noted size of golf ball, no redness. Having chills as well.
Medical assistant was administering vaccine, most of serum was injected into the arm, the child pulled away and the medical assistant had some of the serum splash in her eye and the child had serum on his arm, requiring re-vaccination (it has not been done yet but the child will be rescheduled.