chrisvoncsefalvay/vaers-outcomes huggingface dataset:
(thinking it's swollen neck lymph nodes); sore neck; Shingles; upper torso skin HURTS; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0164), via an unspecified route of administration, administered in arm left on 27Apr2021 at 09:15 (at the age of 57-years-old) as 2nd dose, single for COVID-19 immunisation. Medical history included psoriasis, migraine and known allergies to some medications from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: EW0150), on 06Apr2021 at 14:00 for COVID-19 immunisation and experienced sore arm. The day the patient received the second dose, she felt fine. Woke up on the 2nd day (28Apr2021 04:30) to sore neck (thinking it was swollen neck lymph nodes) and upper torso skin hurts (she feels like it's the shingles again). Two (2) ibuprofen (MOTRIN) has helped, but the MOTRIN is wearing off. Therapeutic measures were taken as a result of neck pain and skin pain; no treatment received for other events. The outcome of the events was recovering.
Information has been received from a licensed practical nurse concerning a patient who on an unspecified date was vaccinated with a first dose of zoster vaccine live (Oka/Merck). Subsequently, the patient came down with a case of shingles. Unspecified medical attention was sought. The patient's outcome was not provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Headache which does not quit. It is still going on right now; I feel real week; My bones hurt like I am catching cold or something; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 23Feb2021 as UNKNOWN, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. patient has been waiting for over an hour because of your machine and now you are telling me you do not understand me. Is this waste of my time or what. patient got his Covid-19 vaccine yesterday. An hour later, patient has been having a headache which did not quit. It is still going on right now. patient felt real weak and now patient bones hurt like patient was catching cold or something. Patient was wanted to know that it was normal. Outcome for the event headache was not resolved and for remaining events outcome was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
This case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included SHUNGRIX for prophylaxis. The patient's past medical history included shingles (mild breakout of shingles on my forearm). Previously administered products included Radiation therapy. Concurrent medical conditions included lung cancer metastatic and immunocompromised (immune resistance was probably compromised). In April 2018, the patient received the 1st dose of SHINGRIX. In May 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.  It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The patient previously had a mild breakout of shingles on forearm. The patient's immune resistance was probably compromised at the time as the patient was in radiation treatment for cancer; primary lung cancer with metastases. At the time of reporting, the patient was in remission. Since the past two weeks from the date of reporting (in 2018), the patient had a re-occurrence of Shingles on the same forearm. This case was considered as suspected vaccination failure, since the details regarding time to onset for shingles and lab test confirmation of shingles was not provided. The patient was asking if it was possible or advisable to be re-vaccinated with SHINGRIX.
vaccine fluid came out of top of syringe; Repeat of 2nd dose per CDC recommendation; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Apr-2021 and was forwarded to Moderna on 22-Apr-2021.    This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of UNDERDOSE (vaccine fluid came out of top of syringe) and IMMUNISATION (Repeat of 2nd dose per CDC recommendation) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. v012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 22-Apr-2021, the patient experienced UNDERDOSE (vaccine fluid came out of top of syringe) and IMMUNISATION (Repeat of 2nd dose per CDC recommendation). At the time of the report, UNDERDOSE (vaccine fluid came out of top of syringe) and IMMUNISATION (Repeat of 2nd dose per CDC recommendation) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Patient experienced pneumonia-like sypmtoms and swelling on the arm of the injection site. She also had a fever.
pt recv vax 25JUN96 & 27JUN96 pt devel a florid case of chickenpox & a temp of 103;
Patient received expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that  vial did not undergo any temperature excursions.  On 24-Aug-2021, vaccine was stored in refrigerator.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-338604 (Patient Link).
Headache, Myalgia, Arthralgia, Fever, chills, injection site soreness Narrative:  The morning after receiving her second dose of the vaccine, the patient reported experiencing chills and generalized body aches. Later in the day, she measured her temperature to be 100.4 (F). She took one dose of ibuprofen 400mg and one dose of acetaminophen 500mg for her symptoms.
Pt became pale, sweaty and diaphoretic within 2-3 minutes after influenza vaccine was given in left vastus lateralis (IM). Pt was Rx with epinephrine 0.1cc SC injection; Benadryl 25mg IM injection. Patient is presently evaluated by pediatric cardiologist for dilated cardiomyopathy.
Encephalitis; Meningitis; This case was reported by a consumer via call center representative and described the occurrence of encephalitis in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 9th June 2021 and also experienced swelling arm, arthralgia, fatigue, diarrhea, difficulty breathing, headache and stomach pain, refer case US2021135683) and COVID-19 VACCINE MODERNA (dose received on April 2021).   On 9th August 2021, the patient received the 2nd dose of Shingrix. In August 2021, less than 2 weeks after receiving Shingrix, the patient experienced encephalitis (serious criteria GSK medically significant) and meningitis (serious criteria GSK medically significant). On an unknown date, the outcome of the encephalitis and meningitis were unknown.   It was unknown if the reporter considered the encephalitis and meningitis to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient reported that, she received 2nd dose and developed encephalitis and meningitis and was not hospitalized.  The patient said that, she was too confused and could not answer more questions. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021135683:Same reporter.
COVID-19 pneumonia. Tested positive 8/18. Acute hypoxic respiratory failure. Worsening respiratory failure. Steroids, Baricitinib. vitamin-C zinc.  ID and Pulmonary on the case.  Not a candidate for remdesivir with symptoms started more than 10 days ago. Received BiPAP/ high flow oxygen with persisting hypoxia.Poor prognosis was explained to the family. Patient was made DNR and continued comfort measures.Patient expired on 9/2/2021
Pt c/o light headedness & anxious, not feeling right. 4:05 Brought to tent to lie down. BP 192/107 P84 R12.   4:10 BP 186/99 P 78  Pt states she went to Dr 5-6 wks ago for BP issues.  Dr gave her new medication. 4:20 BP182/100 P76 Feeling better & went to Bathroom.  C/o pressure in her head. 4:30 BP187/113  4:58 BP186/105 Paramedics called  5:14 Paramedics BP210/100.  Pt refused to go with paramedics.   5:55PM Her son picked her up to take her to the ER
not feeling 100 percent good; pain; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not feeling 100 percent good), PAIN (pain) and PYREXIA (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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced FEELING ABNORMAL (not feeling 100 percent good), PAIN (pain) and PYREXIA (fever). At the time of the report, FEELING ABNORMAL (not feeling 100 percent good), PAIN (pain) and PYREXIA (fever) outcome was unknown.            Agent was unable to gather more information or consent  Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Sneezing, coughing, wheezing, sore throat, ear ache, sore arm, redness, big welt over the size of a silver dollar, itching on site and hot.
9-11-09 in the afternoon patient presented right elbow rash.  PE right elbow is vesicular lesions with erythematous base.
NEUROTIC (IN TERMS OF HYSTERIA AROUND THE JANSSEN VACCINE); TINY ACHY; LITTLE HEADACHE; TINY FEVER; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient concerned a 60 year old, female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, sulfite allergy, non alcohol user, non smoker, b-thalassemia, osteoporosis, and meningioma, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient had lot of genetic mutations and she gets tested for every medication. The patient previously received experienced pfizer covid-19 vaccine (tozinameran)(dose number in series 1) (form of admin, route of admin not reported, batch number were not reported, expiry: unknwon) dose was not reported, administered on 09-FEB-2021 for covid-19 prophylaxis.  On 09-FEB-2021, immediately after the vaccination, the patient experienced anaphylactic reaction and had to go to the hospital (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 18-FEB-2022) dose was not reported, administered on right arm 08-AUG-2021 for covid-19 prophylaxis. Age at time of vaccination 60 years old. No concomitant medications were reported.  On 08-AUG-2021, the patient experienced revaccination with different covid-19 vaccine (dose number in series 2). On an unspecified date, the patient experienced neurotic (in terms of hysteria around the janssen vaccine), tiny achy, little headache, and tiny fever (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neurotic (in terms of hysteria around the janssen vaccine), tiny achy, little headache, and tiny fever, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious. This case, involving the same patient is linked to 20220925588.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 29-Mar-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 29-Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 29-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 29-Mar-2022) in a 55-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 29-Mar-2022 at 10:39 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Mar-2022 at 10:39 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 29-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 29-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 29-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 29-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's ethnicity was reported.  No Concomitant product use was reported.  The patient received vaccine past its 30 day expiry date The vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021. The vaccine was administered up until it manufactured expiry date of 04-Apr-2022. The patient received booster dose.  No treatment information was provided.
Lightheadedness,  Extreme fatigue,  Hypersensitivity to stimuli,  Shortness of breath,  Violent bouts of coughing,  Nausea,  Irritability,  Numbness of extremities,  Working memory interference
Rash; breakout of eczema on his thighs, and he noticed for about 5 days he broke out with some eczema spots on his legs; atopic dermatitis; This is a solicited report based on information received by Pfizer. (manufacturer control 2021SA092686), from a non-Pfizer sponsored program (marketing program not available). A contactable consumer (patient) reported that a 74-year-old male patient received BNT162B2, via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose 3 (booster), single for COVID-19 immunisation; dupilumab (DUPIXENT, Batch/Lot number was not reported), subcutaneous on 01Jan2018 at 600 mg (Ioading dose), followed by (on an unspecified date) maintenance dose of 300 mg every 2 weeks for intrinsic eczema and attention deficit hyperactivity disorder. The patient's medical history and concomitant medications were not reported. The patient previously received first and second dose of BNT162B2 in 2021. On Mar2021, the patient experienced rash; breakout of eczema on his thighs, and he noticed for about 5 days he broke out with some eczema spots on his legs; and atopic dermatitis. He was only been giving his injection on the right and left side of his abdomen - dupilumab used for attention deficit hyperactivity disorder. The nurse encouraged the injection on his thighs so that maybe better coverage or rotate the sites at least. He was going to his doctor's office on an appointment in 2 weeks. He would speak with them then and possibly switch over to pen that time. His last dose was on 05Mar2021. The patient had rash (medically significant) after COVID booster in Mar2021. He said it lasted for 3 weeks and was different than atopic dermatitis (AD), was transitory. At the time of the report, it was unknown if dupilumab was continued or discontinued. Physical assessment of 'PTC' was done. The action taken in response to the event(s) for dupilumab was unknown. Outcome of rash was recovered, while other events were unknown.   Company causality: not reportable for all events for dupilumab; related for rash for tozinameran [Pfizer biontech covid-19 vaccine]; not reportable for rest of the events for tozinameran [Pfizer biontech covid-19 vaccine].   The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.    The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the Limited information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be established.
This spontaneous report was received from a consumer referring to a female patient of unknown age, who was her mother in law. The patient's pertinent medical history, allergies and concurrent conditions were not reported. Approximately, in September 2014 (also reported as "in fall 2014"), the patient was vaccinated with ZOSTAVAX (anatomical route of vaccination, dose number, lot number and expiration date were not provided). The patient's concomitant medications were not reported. On an unknown date, the patient presented with pain followed by a rash days later. Subsequently, on 11-JUN-2016, the patient was diagnosed with shingles. The patient started treatment with antiviral on an unspecified date. Moreover, she was prescribed with CAPZASIN (also reported as capsasin) cream and lidocaine patches for the pain. The reported stated, that the patient's pain persisted and due to it on 11-JUL-2016, she was placed on therapy with NEURONTIN. At the time of this report, the outcome of herpes zoster was reported as not recovered and the outcome of vaccination failure was unknown. Additionally, the reporter did not provide for a causality between the adverse events and vaccination with ZOSTAVAX. Additional information has been requested.
UTI; Anemia; Colitis; A spontaneous report was received from a healthcare professional concerning a 77 years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed anemia, colitis and Urinary Tract Infection (UTI).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 039k208) on 29 Dec 2020. On 26 Jan 2021, approximately 6 days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 019K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 01 Feb 2021, the patient had a hospital visit for anemia and colitis for which patient was admitted and was discharged on 04 Feb 2021.The patient was again admitted to the hospital on 22 Feb 2021, for UTI and was at the hospital at the time of reporting.   Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events was not reported.; Reporter's Comments: Very limited information has been provided for this cases Although, a temporal association exist between the product use and the reported events of anemia and colitis, critical details such as the patient's medical history concomitant medication list lacking.  Urinary tract infection is of an infective etiology as  such a causal relationship is unlikely.
fever, vomiting, nausea, diarehia, chills, sweats, headeache
5 days after both the first shot and the last shot, I had sever lower leg swelling and pain so much so that I went to Urgent Care to get scanned for blood clots.  I did not have blood clots.  The pain and swelling lasted for almost a week after the first shot.  I am on onset of the swelling for the 2nd shot.
Swollen arm and redness in the area to this day after the application of vaccination and without pain. The pain was only for the first two days.
BOOSTER ADMINISTERED BEFORE APPROVED DATE. LAST DOSE WAS RECEIVED ON 10/18/2021 AND THE BOOSTER WAS RECEIVED ON 01/13/2022.
ROTATEQ administered after temperature excursion; No adittional AE/PQC identified; This spontaneous report as received from a nurse and refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 20-JAN-2021, the patient was vaccinated with a improperly store vaccine of  Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 0.5 milliliter, intramuscularly (IM), lot number reported and validated as 1688504, expiration date reported and validated as 19-NOV-2021 for an unknown indication.  The vaccine underwent a temperature excursion of 9.6 degree Celsius (°C) for a period of 7 hours. The vaccine did not underwent a previous temperature excursion. The excursion was called by a digital data logger. The patient did not experience any adverse event.