chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Acute Pancreatitis Stomach pain began around 16:00 4/8/2021,  Progressively worse,  3 trips to ER.  Last trip on 4/10/2021 noon, diagnosed pancreatitis and admitted.  Saw my PCP on 4/9/2021.
Urticaria  to arms, legs, chest, back, and face with intense itching, beginning 9:30pm day of vaccine.  Resolved with Benadryl 50mg po and Prednisone 20mg po but recurred daily for next 4 days around 3pm, approximating time vaccine was given.  Each day prednisone and Benadryl were repeated, which resolved urticaria for that day.
Local reaction (R) upper arm. Cellulitis. SVT secondary to injection. KEFLEX 500 qid x 10d.
Initial report received from healthcare professional on 20 June 2014. A female patient, whose age, medical history and concomitant medications not reported, had received a subcutaneous dose of YF VAX (batch number, dose, dose number, and site of vaccination not reported), a dose of pneumococcal vaccine (batch number, dose, dose number, route and site of vaccination not reported) and a dose of VIVOTIF (manufacturer: Crucell, batch number, dose, dose number and site of vaccination not reported) on an unspecified day in June 2014. It was reported that one day after vaccination, patient had a black colored discharge from the vaginal area. She stated the amount of discharge is enough to saturate a tampon. She reported that it was not her monthly menses, which already occurred that month. Lab investigations and corrective treatments were not reported. Outcome of the event was reported as unknown. Documents held by sender: None.
Pt presented by EMS for acute epigastric pain radiating to the back. While waiting for lab results, she was found down in her room and in post-ictal state. She was moved from an urgent care room to an ER bed and returned to near baseline when she had witnessed seizure activity and subsequently required multiple medications to break her status that lasted around 30 minutes
This case was reported by a consumer via call center representative and described the occurrence of thrush in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. Co-suspect products included TRELEGY ELLIPTA inhalation powder for flu symptoms. On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season and TRELEGY ELLIPTA (inhaled) 1 puff(s) once daily (1 puff(s) daily). On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2018-2019 season and TRELEGY ELLIPTA, the patient experienced thrush, nasal congestion, difficulty breathing and flu symptoms. The action taken with TRELEGY ELLIPTA was unknown. On an unknown date, the outcome of the thrush and flu symptoms were unknown and the outcome of the nasal congestion and difficulty breathing were not recovered/not resolved. It was unknown if the reporter considered the thrush, nasal congestion, difficulty breathing and flu symptoms to be related to Influenza vaccine Quadrivalent 2018-2019 season and TRELEGY ELLIPTA. Additional details were provided as follows: The patient experienced flu symptoms after receiving a dose of flu vaccine. The patient 2 samples of TRELEGY ELLIPTA, when she started the second sample she was diagnosed with thrush. Reporter had difficulty understanding the questions and her answers were not always clear.
This spontaneous report was received from a Licensed Practical Nurse regarding a multiple unspecified number of patients of unknown age and gender. Information on pertinent medical history, concurrent conditions and drug allergies of the patient were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX lot # L048464, expiry date 02-DEC-2017 (dose number, units, route and anatomical location were not specified) subcutaneous. Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Complaint (PQC) involved. This report is cross linked to MARRS# 1609USA008428 (same reporter link). Additional information has been requested.
I had a sore arm at injection site beginning about 8 hours after injection. There was no visible swelling or redness at injection site. The following day I felt fatigued and arm was still very sore. These symptoms left within 48 hours.  On February 6, 2021 (9 days after the first dose of Moderna vaccine) I noticed a red blotchy area around the injection site and it got bigger through the day, approximately 2 inch by 3 inch area. It was not itchy and it was not painful but it was warm to the touch. The next morning,, February 7, 2021, the area was noticeably light pink, not as red and not as large. It is gradually going away. I took 1 Benadryl on the evening of February 6 before going to bed.
headaches; discoloration on right and left arm/ reddish-purple discoloration at the injection site/ discoloration on the back of her right arm; discoloration on right and left arm/ reddish-purple discoloration at the injection site/ discoloration on the back of her right arm; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 66-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 97NL3, expiry date 5th June 2021) for prophylaxis.   On 15th May 2019, the patient received Boostrix (intramuscular) .5 ml. On 16th May 2019, 1 days after receiving Boostrix, the patient experienced headache, skin discoloration and injection site discoloration. On an unknown date, the outcome of the headache, skin discoloration and injection site discoloration were not recovered/not resolved.   It was unknown if the reporter considered the headache, skin discoloration and injection site discoloration to be related to Boostrix.  Additional details were provided as follows: The patient received Boostrix on left arm. The day after the patient received the Boostrix vaccine, she developed a reddish-purple discoloration at the injection site that has increased in size over the weekend. The patient also developed this same discoloration at another spot on her left arm and on the back of her right arm. Since receiving the Boostrix vaccine, the patient was experiencing headaches at night.
Patient fainted, but came to in less than a minute.  2 BP readings were normal; gave patient water and a cold wet towel was placed on his forehead.
Acute onset of symptoms 8 days after injection: erythema, swelling, itching, pain with 11 cm (not mm- 11 CM) induration at injection site. Waves of nausea and diaphoresis. Duration approximately 4 days, then began to subside.
A whole-body rash was evident 2-3 weeks after the first vaccine dose. Subject was unsure at the time if it was vaccine related. Severe swelling of hands and legs began the same day after the second vaccine dose with general malaise and concerns about fainting. Oral steroids were prescribed for 2 weeks, and progression of the symptoms seem to stabilize during steroid treatment. After steroid treatment, the symptoms resumed at full strength with swelling in the hands and legs causing the superficial skin to peel off and split down into the dermis with bleeding and pain. Joints in the hands and legs were painful. Severe swelling and pain in the hands and legs persisted for at least 6 weeks after the second vaccine dose. A diuretic was prescribed at about 4-5 weeks after the second vaccine dose. The subject is currently reporting improved symptoms.
Impetigo of the pelvic region. Need lengthy treatment of greater than 2 weeks.
Fatigue; Chills; Muscle Pain; Headaches; Dizzy; Itchy; Mentally Disoriented; Big red ball at injection site,swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Big red ball at injection site,swelling at injection site), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Muscle Pain) and HEADACHE (Headaches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Big red ball at injection site,swelling at injection site), CHILLS (Chills), MYALGIA (Muscle Pain), HEADACHE (Headaches), DIZZINESS (Dizzy), PRURITUS (Itchy) and DISORIENTATION (Mentally Disoriented). On an unknown date, the patient experienced FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form once a day. At the time of the report, VACCINATION SITE SWELLING (Big red ball at injection site,swelling at injection site), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Muscle Pain), HEADACHE (Headaches), DIZZINESS (Dizzy), PRURITUS (Itchy) and DISORIENTATION (Mentally Disoriented) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications included for asthma , allergies medications.    This case was linked to MOD-2021-067314 (Patient Link).
Patient called after receiving flu vaccine and called to say shortly after she started feeling light headed and having blurry vision and itching at site and soreness when raising arm. Advised pt to go to the ER and get evaluated. Pt declined and said she only wanted to lay down. I called pt back about an hour later and she said she had went to lay down and felt better but was still having some light headedness and blurred vision. Pt encouraged again to go to ER or at least follow up with PMD that the symptoms may or may not be related to the flu vaccine.
Vaccine exposure via breastmilk; This is a spontaneous report from a contactable consumer. A child patient of an unknown gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number: unknown and expiry date: unknown), transmammary on 27May2021 at 12:00 PM at dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. It was reported that the patient experienced vaccine exposure via breastmilk on an unknown date. The reporter considered the event to be non-serious. The patient did not receive any treatment for the reported event. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Running fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2020, the patient received the 2nd dose of Shingrix. On 17th December 2020, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient had 2nd Shingrix vaccine on the day of reporting and experienced running fever.
Muscles were tired; Hard to walk; Felt feverish; felt hot; Nausea; Arm with redness; Soreness in arm; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscles were tired), GAIT DISTURBANCE (Hard to walk), ERYTHEMA (Arm with redness), PAIN IN EXTREMITY (Soreness in arm) and PERIPHERAL SWELLING (Swollen arm) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced ERYTHEMA (Arm with redness), PAIN IN EXTREMITY (Soreness in arm) and PERIPHERAL SWELLING (Swollen arm). On 24-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Muscles were tired), GAIT DISTURBANCE (Hard to walk), PYREXIA (Felt feverish), FEELING HOT (felt hot) and NAUSEA (Nausea). At the time of the report, MUSCULAR WEAKNESS (Muscles were tired), GAIT DISTURBANCE (Hard to walk), PYREXIA (Felt feverish), FEELING HOT (felt hot) and NAUSEA (Nausea) outcome was unknown and ERYTHEMA (Arm with redness), PAIN IN EXTREMITY (Soreness in arm) and PERIPHERAL SWELLING (Swollen arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported.  No treatment information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up received contains non-significant information of reporter email address.
patient reports left arm swelling, tingling and numbness.  Patient educated that is normal to have some swelling and numbness in the vaccinated arm.  patient instructed if new or worsening symptoms occurred,  after 2 minutes patient stated that she felt less anxtous knowing that symptoms were expected
Congested in chest; Heat sensation in the stomach; like a fire in stomach; Allergy type cough here and there; Heat sensation in knees; Fever, aches and pains all over - muscle, joint, back, knees, arms; Fever, aches and pains all over - muscle, joint, back, knees, arms; Aches and pains all over-muscle, joint, back, knees, arms; Aches and pains all over-muscle, joint, back, knees, arms; Fever; Aches and pains all over-muscle, joint, back, knees, arms; Headache; A spontaneous report  was received from a Consumer concerning a 73 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pyrexia, arthralgia, pain in extremity, myalgia, headache, dyspepsia, pulmonary congestion, cough, feeling hot and back pain .   The patient's medical history was not provided. Relevant concomitant medications included Valsartan and Levothyroxine.   On Date 19-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L20A) for prophylaxis of COVID-19 infection.   On date 20-Jan-2021, The patient experienced the events fever, aches and pains all over - muscle, joint, back, knees, arms, bad headache, heat sensation in the stomach- Like fire in stomach, congested in chest, allergy type cough and heat sensation in knees.   Laboratory details if provided.   Treatment details include Tylenol for the event increased body temperature.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events fever, aches and pains all over - muscle, joint, back, knees, arms, bad headache and heat sensation in the stomach- Like fire in stomach was recovering; outcome of the events congested in chest, allergy type cough and heat sensation in knees was unknown.; Reporter's Comments: This case concerns a 73-year-old female who had a serious unexpected event of pulmonary congestion along with nonserious unexpected dyspepsia, feeling hot, back pain, pain in extremity and expected pyrexia, headache, myalgia, arthralgia. Event onset on day 2 after first dose mRNA-1273. Treated with Tylenol. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
about 2 to 3 weeks after receiving the vaccine,  I started feeling like "Menthol" or the feeling of applying "Bengay" on my legs and arms, less so in my core. The feeling of wet legs and arms especially when I touch something cold. Bed sheets make me feel that my legs are wet until the sheets a warmer. My arms also feel always this menthol or "ben-gay" feeling. My lips and inner mouth also feel the same when I drink or eat something cold. No other symptoms. I taste food ok and smell ok. I am exercising and moving around with no issues.   this feeling started in my legs around my knees and slowly over the last 2-3 weeks progressed to my leg and arms and a bit to my back and chest.  I had more than my usual sun exposure 2 weeks after the injection, from July 8th to July 20th had almost daily tennis practice for about 2 hours. And was very active.
ACUTE RESPIRATORY FAILURE 1/30/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
3-4 minutes p/vax pt devel redness & hives along face, arms, legs, & abdomen;
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. On 27-OCT-2014, the patient was vaccinated with M-M-R II (route, dose, frequency and lot # were not reported) which underwent a temperature excursion (on an unspecified date). This is one of several reports received from the same reporter. Additional information has been requested.
headache; cold feeling; muscle pain; flu like symptoms; tired; bilateral jaw pain; Cold feet and hands; This case was reported by a consumer via call center representative and described the occurrence of headache in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included paracetamol (Tylenol) for headache.   On 30th July 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, the patient started Tylenol at an unknown dose and frequency. On 31st July 2019, 1 days after receiving Shingrix, the patient experienced headache, feeling cold, muscle pain, influenza-like symptoms, tiredness, jaw pain and cold feet. On an unknown date, the outcome of the headache was recovering/resolving and the outcome of the feeling cold, muscle pain, influenza-like symptoms, tiredness, jaw pain and cold feet were unknown.   It was unknown if the reporter considered the headache, feeling cold, muscle pain, influenza-like symptoms, tiredness, jaw pain and cold feet to be related to Shingrix.  Additional details were provided as follows: The patient received first dose of Shingrix in right arm. The patient experienced headache, cold feeling her hands and feet were cold, she had muscle pain all over like she had the flu. The patient was tired, and bilateral jaw pain.  The patient called her physician who didn't believe she would see these symptoms this quick from the product and she said he told her she might had the flu. She was advised to take Tylenol, which she did, and her headache has gotten better.  She was concerned about getting the 2nd dose since she had these events. So the prescribing information was reviewed and she was encouraged to speak with her physician about the 2nd dose.  The reporter did not consent to follow up. There was discrepancy between the outcome of the event Headache, reported in the structured field (recovering) and the outcome reported in the source document (Fatal).
VAXELIS was administered to 6 patients after product experienced an excursion was was not suitable to use.; This non-serious spontaneous safety report, was received on 23-FEB-2023, from a HCP. This case is linked to case MCM-004541 (reference number 2023SA055890 and Inquiry number 01495388).  Due to the nature of the event, the causality between the reported event "VAXELIS was administered to 6 patients after product experienced an excursion was not suitable to use" and Vaxelis was not applicable.  No further information is expected given that there were no adverse events following Vaxelis administration post-excursion.  For reference purposes this case is linked to MCM-004541 (source case), MCM-004562, MCM-004563, MCM-004565, and MCM-004566, due to same reporter.
A healthcare professional reported that a 4 month old male received his second dose of Prevnar and a dose of Comvax (Merck) vaccines on 05/24/02. Two to three days post-immunization, he developed  hoarseness, At the date of this report, the "hoarseness persists, but is improving.' Information regarding this event has been forwarded to Merck, manufacturer of Comvax.
Patient experienced lip swelling, facial redness & swelling with tingling.  Patient transported to ER for further treatment.
Chest pains that led to a Minor heart attack; Chest pains that led to a Minor heart attack; shortness of breaths; myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Aug2021 12:00 (Lot number: FC3180) at the age of 25 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination, no known allergies.  Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FA6780, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 21Jul2021, when the patient was 25 years old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (hospitalization, life threatening), MYOCARDIAL INFARCTION (hospitalization, life threatening) all with onset 24Oct2021 03:00, outcome "recovered with sequelae" and all described as "Chest pains that led to a Minor heart attack"; DYSPNOEA (hospitalization, life threatening) with onset 24Oct2021 03:00, outcome "recovered with sequelae", described as "shortness of breaths"; MYOCARDITIS (hospitalization, life threatening) with onset 24Oct2021 03:00, outcome "recovered with sequelae", described as "myocarditis". The patient was hospitalized for chest pain, myocardial infarction, dyspnoea, myocarditis (hospitalization duration: 3 day(s)). The events "chest pains that led to a minor heart attack", "chest pains that led to a minor heart attack", "shortness of breaths" and "myocarditis" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Oct2021) negative. Therapeutic measures were taken as a result of chest pain, myocardial infarction, dyspnoea, myocarditis included Heparin drip, blood pressure medication, aspirin.  No follow-up attempts are possible. No further information is expected.
about 3 hours post shot, mild headache,. about 7 hours after severe chills, lasted 4 hours, switched to overheated, low grade fever 101.  resolved with acetametaphine.  All symptoms resolved with 24 hours.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 02-MAY-2016, the patient was vaccinated with an improperly stored dose of VAQTA (lot # L045713, expiry date 14-JAN-2017, dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed of temperature excursion (date unspecified) lasting for 176 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (-1.11 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.