chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female who has negative titers for Rubella after she was already given 2 doses of MMR II during childhood. The patient is now looking to become a health care professional and so the office performed titers. No product quality complaint. Additional information has been received from a nurse indicating that after speaking with the physician, it was realized that they had no records concerning this patient or their reaction to MMR II in their office. The physician states that a medical center was involved with this during an emergency room visit. Additional information has been requested.
No adverse event. Patient was VFC eligible and was given private stock. Mother of child stated that he was normal. Patient did not complain of any symptoms.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 22-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
pt recvd vax & exp burning & swelling @ inject site which required tx w/ice; w/in several hrs of vax sx subsided; The nurse then switched to a different lot# of vax & the sx did not recur; No further details were provided;
Initial information received from a Health care professional on 04 September 2012. A 29-year-old male patient whose medical history and concomitant medication were not reported received an intradermal dose of FLUZONE ID vaccine (Batch lot number UT4463BA) (Expiry date 26 March 2013) in right arm on 27 August 2012. The reporter stated that on the 03 September 2012, the patient had bruising down length of upper right arm, beginning into right forearm and slightly swollen right arm. Laboratory details and corrective treatment were not reported. Outcome of the event was unknown. Documents held by sender: none.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 11Jan2021 at 13:00 as dose 1, single (Lot number: EK9231), in left arm, on 01Feb2021 at 13:00 as dose 2, single (Lot number: EN9581), in left arm and on 28Sep2021 at 13:00 as dose 3 (booster), single (Lot number: FF2587) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "previous heart attack" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Known allergies: penecillin" (unspecified if ongoing); "Known allergies: buckwheat" (unspecified if ongoing). Concomitant medication(s) included: CARVEDILOL, start date: 01Feb2019, stop date: 10Jun2022. Past drug history included: Fentanyl, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" 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. Patient received Paxlovid from 26May022 to 31May2022 for treatment of COVID-19 in 2 weeks. Patient had rebound Covid 19 positive test with symptoms 9 days post Paxlovid treatment.  No follow-up attempts are needed. No further information is expected.
sick; Initial information received on 21-Nov-2020 regarding an unsolicited valid serious case from a non-health care professional via social media.  This case involves an adult patient with an unknown demography details who was sick (illness), after being vaccinated with influenza vaccine.  The patient's medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, (unknown latency) after starting the suspect vaccine therapy, the patient was very sick (illness) for about six weeks. It was reported that an inept nurse pulled the wrong vial when she was giving the patient a TB (tuberculin) skin test.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment. At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case. No further relevant information was reported.
Lymph node swelling right side neck presented 9/20/06 size if egg, a febrile, experiencing discomfort.
Feeling like I had UTI.; Frequent urination; amber to brown urine; Everything I put into my mouth tasted bitter for a day; This is a spontaneous report from a non-contactable consumer or other non hcp.     A female Non-Pregnant patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 16Feb2021 12:15 as dose 2, single dose for covid-19 immunisation. The patient medical history and concomitant was not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was Reported that, the patient experienced feeling like had UTI, frequent urination, amber to brown urine, everything put into my mouth tasted bitter for a day on an unspecified date with outcome of unknown.    No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.; Sender's Comments: Linked Report(s) : INC-2021225127 same reporter/drug with different patient, similar AE
Red; Had a big welt on the side of my arm; Size of a coffee cup opening; It's raised; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red), URTICARIA (Had a big welt on the side of my arm), SWELLING (Size of a coffee cup opening) and RASH PAPULAR (It's raised) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced ERYTHEMA (Red), URTICARIA (Had a big welt on the side of my arm), SWELLING (Size of a coffee cup opening) and RASH PAPULAR (It's raised). At the time of the report, ERYTHEMA (Red), URTICARIA (Had a big welt on the side of my arm), SWELLING (Size of a coffee cup opening) and RASH PAPULAR (It's raised) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
After injection, I had some tingling in my arm.  This continued for several days, then began to go from right elbow up to my jaw. Along with the tingling, I felt like there was pressure being put on my right shoulder, when there was nothing touching me. This began on or about March 27,2021. This continued so I saw my primary care, on April 13, 2021 to determine if I should get the second dose, I was advised to get it in the other arm. She also advised me to take Aleve, 4 in the morning and 4 in the evening for one week, but to not take any the day of the second dose, to see if that would help. She believed it may have been inflammation.  This did not help in any way, there was absolutely no change or improvement.
Patient got the vaccine and shortly afterwards started feeling different with sweating and redness/rash developing at injection site.  She sat down and then noticed rash spreading to chest, arms and neck areas.  She took two Benadryl capsules and remained seated.  Then her eyes began watering and turning red followed by subtle eyelids swelling.  She notified her dr and was told if no improvement, go to ER.  She needed to finish her shift and decided to wait it out.  I called to check in at 4pm and she still felt bad with intermittent chest pain.  Her shift ended at 6 and she was going to still wait it out.  She was able to drink water and informed me that her mouth/throat felt a little puffy.  I advised to go to ER and she said she would if it didn't go away.  We ended our phone call at that point.
My second dose of the vaccine was 10Jan2021. I conceived around 24Jan2021. I suffered a missed miscarriage detected 10May2021, then an incomplete miscarriage 14May2021.; This is a spontaneous report from a contactable physician (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 10Jan2021 10:00 (lot number not reported), as 2nd dose, single dose, at age 34 years old, for covid-19 immunisation, at a workplace clinic. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications (other medications received within 2 weeks of vaccination: no). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in the left arm, on 20Dec2021 at 10:00 (lot number not reported), at age 34 years old, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported, "My second dose of the vaccine was 10Jan2021. I conceived around 24Jan2021. I suffered a missed miscarriage detected 10May2021, then an incomplete miscarriage 14May2021." The event resulted to emergency room and physician office visits, and hospitalization (date not reported, duration: 1 day). Treatment was reported as "incomplete miscarriage, hemorrhaged, D&C". The patient tested negative to COVID-19 via nasal swab on 14May2021. The outcome of the event was recovered with sequel in May2021.   Information on batch/lot number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event miscarriage with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Itchy in the area were the vaccine was given, but in that arm I had the tuberculosis vaccine as well. It turned red on that area.
Information has been received from a medical assistant and a nurse practitioner (N.P.) concerning an 81 year old female patient with hyperlipidaemia, osteoporosis, hypertension, osteoarthritis as well as aspirin and CODEINE allergies who on 09-FEB-2009 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included CELEXA, SIMVASTATIN (MSD), DYAZIDE, SULINDAC and alendronate sodium (+) cholecalciferol (MSD).  On 11-FEB-2009 the patient may possibly have developed shingles.  The patient noticed that one arm (unknown which arm) developed erythema and was warm to the touch.  The area was not pruritic.  The patient came to the office and the nurse practitioner initially thought it was cellulitis.  The affected area was 3 inches in diameter and there were a few areas that were of a different texture.  The patient was prescribed KEFLEX but the patient has not had any improvement.  The nurse practitioner suspected that it may be shingles.  At the time of reporting (12-FEB-2009) the patient had not recovered.  The patient sought medical attention by visiting the physician's office.  Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number kn3j4, expiry date 29th June 2023) for prophylaxis. Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis. On 28th December 2021, the patient received Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On 28th December 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The reporter stated that the patient received only the diluent component of Rotarix vaccine, which led to inappropriate preparation of medication and Inappropriate dose of vaccine administered. The reporter denied consent to follow-up.
Fifth day after received the booster shot, small rashes appeared on the both forearms and gradually rashes appeared on the upper torso. No fever or fatigue condition but extremely itch on affected areas
History of Present Illness 55-year-old male patient with no past medical history was brought to ER the patient complaining of cough and shortness of breath for the past few days.  Patient did mention he took J & J vaccine 6-month ago.  Patient had the symptoms about 10 days ago and complaining of body aches and pain all over.  Patient was tested positive for Covid on 9/27/2021.  Patient denies any diarrhea no abdominal pain.  Patient noted to shortness of breath and currently on 2 L of oxygen.  Patient was admitted with a ID consultation.  Patient currently on steroids and REMDISIVIER.  Patient admitted for evaluation..
This case was reported by a physician via other manufacturer and described the occurrence of allergic reaction in a 67-year-old female patient who received Seasonal Influenza vaccine. Concurrent medical conditions included drug allergy (Gabapentin, NEURONTIN, COMPAZINE). On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. It was reported that, the patient was also taking some prescription and over the counter medications like, Acetylsalicylic acid, Valsartan, Metoprolol, Repaglinide, Mepyramine, LYRICA, Tramadol, Stool softener, PRILOSEC, Duloxetine.
continuing tinnitus in left ear; Swelling of the face; swelling of the lymph nodes in the jaw; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 75-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL3247, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 09Feb2021 11:30 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Medical history included penicillin and sulfa drug allergy from an unknown date. Concomitant medications included losartan (LOSARTAN) taken for an unspecified indication, from an unknown start date, levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, from an unknown start date. On 09Feb2021 12:15, the patient experienced continuing tinnitus in left ear with swelling of the face, swelling of the lymph nodes in the jaw. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the events were resolved with sequelae.
Reported being awakened from sleep with severe stomach pain, diarrhea and vomiting. Vomited x 12 (twelve) into the morning, became pale, diaphoresis and felt faint, lasted until 12 noon 11/24/09.
Dizziness, Myalgia,  TINGLING SKN, QUESSY STOMACH Narrative:
Moderna on 1/26 and 2/19. Positive on 9/30
02/28/2023 I started having a fever, cough, headache, and sore throat. After reaching out to my doctor I was diagnosed with Covid-19. I was prescribed PAXLOVID. Symptoms lasted 10 days with ongoing cough and fatigue as results from Covid-19.
Myalgia, Fever, Chills, loss of taste/smell Narrative: tested COVID positive in 1/4/21 from household exposure she learned about after she had the immunization
Itching at injection site; This is a spontaneous report from a contactable consumer. A 69-Year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EM9810 and expiry date was not provided), via an unspecified route of administration, in the left arm, on 08Feb2021 at 12:15 (at the age of 69-years-old) as a single dose for covid-19 immunisation. Patient had allergy to penicillin and various rifampicin (MYCIN) antibiotics that cause itching. Patient's medical history included osteoporosis and osteoarthritis. Patient concomitant medications included injection for allergy and calcium tablet. Patient had received other vaccine in four weeks. Patient received other medications in two weeks as injection for allergy and calcium tablet. Patient has not been Covid prior vaccination. Patient had not tested Covid post vaccination. On 10Feb2021 (after 3 days), patient experienced itching at injection site. The outcome of event was recovered on 13Feb2021 (after 3 days).
Information has been received from a physician concerning a patient who on 18-MAR-2009 was vaccinated with ZOSTAVAX (Merck). The physician reported that on 20-MAR-2009, the patient developed bullous pemphigoid. The patient sought medical attention and was seen by the physician. Additional information has been requested.
Soreness, redness, swelling at injection site, itching at site and face and neck, chills, flushing of face and neck, extreme fatigue, brain fog, feeling of being far away. The pain and redness at injection site continued for 2 days.
Migraine approximately 4 hours after injection along with runny nose and itchy skin on chest; Migraine approximately 4 hours after injection along with runny nose and itchy skin on chest; Migraine approximately 4 hours after injection along with runny nose and itchy skin on chest; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 13:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease and failed back surgery syndrome (reported as failed back syndrome). The patient previously experienced latex allergy. The patient previously took Aspirin and experienced drug allergy. The patient received prescription medications (unspecified) within two weeks of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 17:30 the patient experienced migraine approximately 4 hours after injection along with runny nose and itchy skin on chest. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event Migraine approximately 4 hours after injection along with runny nose and itchy skin on chest was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
redness on injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness on injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness on injection). At the time of the report, INJECTION SITE ERYTHEMA (redness on injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Injection site erythema is consistent with the product safety profile
PATIENT STATED UPSET STOMACH, CHILLS, COLD CLAMY, SWEATING, NAUSEA. WITHIN 10 MINUTES SYMPTOMS RESOLVED.PATIENT LAYED DOWN ON FLOOR  AND SYMPTOMS RESOLVED.  SHE SAT IN OBSERVATION AREA FOR 20 MINUTES LONGER AND WAS FINE AND LEFT. I FOLLOWED UP PHONE CALL TONIGHT AND SHE HAD SLIGHT FEVER AND WAS TIRED .
flu-like symptoms such as cough but no fever; flu-like symptoms such as cough but no fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms such as cough but no fever) and COUGH (flu-like symptoms such as cough but no fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms such as cough but no fever) and COUGH (flu-like symptoms such as cough but no fever). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms such as cough but no fever) and COUGH (flu-like symptoms such as cough but no fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.
Change in mental health, possible seizure (unresponsive, then diaphoretic and disoriented).