chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash; looked like a shingles rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash and vesicular rash. On an unknown date, the outcome of the rash and vesicular rash were unknown.   It was unknown if the reporter considered the rash and vesicular rash 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 selected as an adult per the vaccine indication. HCP could not provide and patient demographics, lot number, or expiration date. The patient experienced rash following 1st dose  of Shingrix.  The rash looked like a shingles rash. HCP noted the patient received the dose from their Doctors office and not from the pharmacy.
lightheadedness; headache; flushed; left deltoid where vaccination given hot to touch; nausea; Blood pressure elevated; This is spontaneous report from a non-contactable Other HCP. A 73-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM9809) via an unspecified route of administration in left deltoid as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that during her 15-minute waiting period after the injection, the patient began to experience lightheadedness and headache, flushed, left deltoid where vaccination given hot to touch, nausea. She denied rash, difficulty breathing, lip swelling and tongue swelling. Patient with flushing, headache, left arm warm to touch, and nausea after first vaccine administration of Pfizer in the 15-minute waiting period. Blood pressure elevated, SpO2 was 98-99% on room air, pulse 68. Patient notes that she has reactions with medications and vaccines. Water provided. After sitting for a few minutes, patient reports that she was no longer lightheaded, headache was almost gone, nausea has resolved. Patient feeling back to normal. BP 152/76 at 12:03. All symptoms have resolved. Left deltoid without swelling, redness, rash. Patient ambulating without difficulty. She was cleared to drive home. The patient underwent lab tests and procedures which included blood pressure elevated, and 152/76, SpO2 was 98-99% on room air, pulse 68. The outcome of the events was recovered on unspecified date.  No follow up attempts are possible. No further information is expected.
I usually have a very regular menstrual cycle and my period was late by a full week. Also had unusual period side effects.
Patient's skin has red raised itchy irregularly shaped patches (hives) on left arm around injection sites and all across her back from shoulders to hips. No discharge, bleeding or other c/o. BENADRYL tablets by mouth as directed with significant improvement noted by client. Denies any other side effects.
red; hard; itchy; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE ERYTHEMA (red), INJECTION SITE PRURITUS (itchy) and INJECTION SITE MASS (hard) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE and LOSARTAN POTASSIUM (LOSARTAN CANON) for an unknown indication, HYDROCHLOROTHIAZIDE.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced INJECTION SITE PRURITUS (itchy). On 02-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (red) and INJECTION SITE MASS (hard). At the time of the report, INJECTION SITE ERYTHEMA (red), INJECTION SITE PRURITUS (itchy) and INJECTION SITE MASS (hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Onset of shingles symptoms at about 6-7 days, developed shingles rash at 8 days
Redness, swelling and warm to touch on left thigh where HIB and Prevnar 2 - 3 inches in diameter.
The 1st 24 hours I was chilled and achy and tired the next day I woke to only finding a rash on my body (trunk only)
Fever (102F), chills, muscle aches, fatigue, join aches, loss of appetite
Received 1st dose on 3-1-21.  Developed rash on entire neck (welped, red, itchy, feverish) on 3-18-21.    Received 2nd dose on 3-29-21.  Developed swollen right eyelid on 4-23-21.  Developed rash on both hands and arms (same characteristics as first rash) on 4-24-21.  Developed rash on inner thigh (same) on 4-25-21.  Developed swollen and numb lip (upper right side) on 4-30-21.  Developed rash on abdomen (same) on 5-2-21.  Developed swollen and numb lip (upper left side) on 5-4-21.  All symptoms resolved with antihistamines.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: EL9263), in right arm, on 13Feb2021 as dose 2, single (Lot number: EL9266), in left arm, on 25Sep2021 as dose 3 (booster), single (Lot number: Ff2588), in left arm and on 12May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 71 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2022) Negative; (08Jun2022) Negative, notes: After the 2nd dose symptoms began to rapidly improve and by day 6 all that remained was fatigue. Antigen test was negative; (Jun2022) Positive, notes: 5 days later I woke up in the middle of the night with a fever, cold symptoms and headache. Antigen test was positive in 15 seconds; (02Jun2022) Positive, notes: started on 02Jun and were confirmed with a PCR test on 02Jun. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 03Jun2022 to 08Jun2022. Paxlovid Rebound patient's Covid symptoms (scratchy throat, cough, headache, muscle aches, fatigue) started on 02Jun and were confirmed with a PCR test on 02Jun. Antigen tests were negative, physician prescribed Paxlovid on 03Jun and she took the first dose that day. After the 2nd dose symptoms began to rapidly improve and by day 6 all that remained was fatigue. Antigen test was negative. 5 days later she woke up in the middle of the night with a fever, cold symptoms and headache. Antigen test was positive in 15 seconds. The patients was now on day 3 and symptoms were the same.  No follow-up attempts are possible. No further information is expected.
Fever; Body aches; Body aches especially in the lower back region; Muscle soreness; Nausea; Nausea which led to vomiting; Headache; All over ill feeling; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 07May2021 at 13:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disorder, osteoarthritis, joint replacement, cataracts, glaucoma and known allergies to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) and paracetamol (TYLENOL EXTRA-STRENGTH); both were taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration on 16Apr2021 at 16:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 22:00, the patient experienced fever, body aches especially in the lower back region, muscle soreness, nausea which led to vomiting, headache and all-over ill feeling. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events fever, body aches, body aches especially in the lower back region, muscle soreness, nausea, nausea which led to vomiting, headache and all-over ill feeling was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Beginning about Monday, March 20, 2023, I was feeling fatigued. Friday afternoon I had a sore throat. I tested positive for COVID-19. My symptoms got worse over the weekend with fever, chills, sore throat, runny nose and cough. My fatigue continued. I had heart palpitations. I took over the counter pain medication. Sunday I was having trouble breathing and went to urgent care. I was prescribed a steroid and inhaler. As of today, I am still fatigued with cough. I tested negative on day 5.
Patient was accidentally given a Moderna dose of 0.25 mL instead of the intended Pfizer pediatric 0.2 mL dose.  No harm occurred, reporting to document vaccination error.
Cold like symptoms, dry cough, sleepiness, sore arm, chills- woke up the next day all of this. Felt a lot better 2 days out.
Really bad arm soreness the first and second day  the third day I had Muscle aches tiredness and fatigue.
had an awful reaction, was sick for a month; Initial information regarding this unsolicited valid non-serious case Health Authorities without narrative (level 2A), was received on 25-Jan-2021 from consumer/non-HCP (healthcare professional) via the health authority (under reference: US-SA-SAC20210130000197). The following narrative was based on the information retrieved from all other accessible data.  This case involves an adult patient of unknown gender who had an awful reaction, was sick for a month (Malaise), after received INFLUENZA VACCINE.  Medical history, past medical treatment, medical treatment(s), family history and concomitant medications were not provided.   On an unknown date, the patient received a dosage form of each suspect INFLUENZA VACCINE via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious had an awful reaction, was sick for a month (Malaise), and same day following administration of INFLUENZA VACCINE.  Relevant lab data were not reported.   It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  Batch lot number was not provided.
Injection site at Right arm became swollen, inflamed, red, and tender, spreading to about 4" and raised about a 1/2". Maintained inflammation, hardness and swelling for about 10 days. From the 29th until 7/12 the area was hard but not tender, with massaging it the hardness dissipated on the 12th. The area is still discolored to purplish tint on skin. A friend that is a nurse at clinic kept an eye on it for us.
Left arm injection site is warm to the touch; Left arm injection site is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Left arm injection site is warm to the touch) and VACCINATION SITE ERYTHEMA (Left arm injection site is red) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced VACCINATION SITE WARMTH (Left arm injection site is warm to the touch) and VACCINATION SITE ERYTHEMA (Left arm injection site is red). At the time of the report, VACCINATION SITE WARMTH (Left arm injection site is warm to the touch) and VACCINATION SITE ERYTHEMA (Left arm injection site is red) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-368929, MOD-2021-368836 (Patient Link).
Initial unsolicited case received from a physician on 22-Oct-2015 and additional information received on 23-Oct-2015 and 24-Oct-2015. This case involves a female patient (age not reported) had vaccinated with a dose of FLUZONE QUADRIVALENT (batch number, dose number, route of administration were not reported) in right deltoid on unspecified date. Medical history and concomitant medications were not reported. Illness at time of vaccination was not reported. On unspecified date the patient experienced swelling, redness and hardness of right arm. On unspecified date patient has been hospitalized for observation, as the reaction continued to spread. Laboratory examinations were not reported. Corrective treatments included antibiotics. At the time of this report, the outcome of the event was reported as not recovered and patient was discharged from the hospital on 22-Oct-15. Documents held by sender: none.
My COVID-19 infection symptoms started on 02/03/2023 in the evening about 7:00PM. I started shaking, rapid heart beat and chills. I took TYLENOL all day I didn't know I had COVID-19. I wear a heart monitor and I went online but I didn't see any AFIB event. On Sunday 02/05/2023, I came home and tested I also send a text to my doctor telling him that I was positive. He send over a prescription of PAXLOVID for 5 days. He advised me to take cough medication if I have cough. On 02/10/2023 I tested negative for Covid.
03/16/2021: Presented to the emergency department with chest pain. The patient was admitted for chest pain observation. There are no acute ischemic ECG changes and her first 2 troponins are normal.
Diarrhea began the next morning and lasted 3 days.; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EV6205), via an unspecified route of administration, administered in Arm Left on 10Mar2021 at 12:00 (at the age of 77-years-old) as single dose for covid-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension and hypercholesterolaemia. Patient had no known allergies. The patient's concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid prior vaccination. Patient was not tested covid post vaccination. The patient experienced diarrhea began the next morning on 11Mar2021 at 08:45 and lasted 3 days. Therapeutic measures were taken as a result of diarrhea began the next morning and lasted 3 days and patient was treated with probiotic gummies of bacillus coagulum. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Slight HA, exhausted, leg heaviness, nausea, resolved by the end of the day
Initial case was received on 14 October 2010 from a healthcare professional. The reporter provided individual patient identifiers for a cluster of three patients (previously reported in case 2010-04957 as a cluster of six patients). This case contains information for the second of the three patients who had received on 09 September 2010 an injection of FLUZONE (lot number UH214AB). The patient was a 32 year old female patient, with no known pre-existing medical conditions and no concomitant medications. On 09 September 2010, she experienced a cough, lump feeling in throat and exhaustion. She had no illness at the time of the vaccination, no other vaccinations within 4 weeks and no adverse event following prior vaccinations. The outcome was recovered. Follow-up information was received 28 December 2010 from a health care professional who reported that the patient had not been seen by a doctor and had not received any corrective treatments. The reporter had no additional information to provide at the time of the report. The reporter for this case (2010-05957) is the same as case number 2010-04957 and 2010-05958. Documents held by sender: None.
Erythema, swelling, pain at injection site. Tightness in Right upper extremity. Given Medrol dose pack and Augmentin given.
WIFE CALLED AND SAID HUSBAND HAD NAUSEA, VOMITING, COLD, SHAKING DURING THE NIGHT , NEXT DAY STILL NAUSEA AND HAD RASH ON FACE,  AND BACK .   INJECTION SITE WAS RED BUT NO RASH.  SHE IS PLANNING TO TAKE HUSBAND TO ER
One week after the injection, irritation near the injection site began to appear, consisting of warmth, redness, swelling, itchiness, and a 1 inch lump in the muscle, deep to the skin.  The inflammation area is approximately 3-4 inches in diameter. This has persisted for over 24 hrs and has not gone away at the time of reporting.
Information has been received on 09-MAR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-JUL-2016, the patient was treated for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested
Patient presented 12/19/16 after receiving vaccine Friday before with generalized hives and a 5 x 5 cm red, hot indurated circular area around the injection site. Patient complained of generalized itching. Pt W HX of allergy to carme and did have a muffin 2 days prior to but no meds after that.
Headache, mild fever, fatigue, cold sweats. They lasted 2.5 days. I took over the counter NYQUIL and DAYQUIL.
Awoke with sore throat, runny nose, and general ill feeling. Noted muscle aches, face flushed with sensation of warmth. Treated self with Zyrtec and Ibuprofen and OTC decongestant.
Swelling at injection site (L) upper arm, extending to (L) neck and axillary area. Possible lymph node involvement. Treated with BENADRYL/ice 2 days after injection.
Churning of stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 46 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Apr2021 (Batch/Lot number: unknown) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 19Apr2021, outcome "recovered" (2021), described as "Churning of stomach". Therapeutic measures were not taken as a result of nausea.  Additional information: It was unknown if the patient did receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The reporter classified the events as non-serious. Since the vaccination, it was unknown if the patient has been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Myalgia, Arthralgia, Phlebitis & Fever Narrative:  Other Relevant History:
Red knots under the skin on both hands, knees, elbow and foot.; itchy knots under the skin on both hands, knees elbow and foot.; Swollen knot under the skin on both hands, knees, elbow and foot; This spontaneous case was reported by an other health care professional and describes the occurrence of   in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Reporter's Comments: This case concerns a 34-year-old male who experienced nonserious unexpected events of urticaria, erythema, and pruritus.  Event onset occurred 10 days after the first dose of mRNA-1273. Treatment with Diphenhydramine. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Arm hurt; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received the first dose of Shingrix about 2 months before and his arm hurt for 2-3 days after the injection. The reporter consented to follow up.
Funny cough that was dry and persistent; Lungs felt kind of heavy; Feels extremely cold; Funning feeling around eyes; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Funny cough that was dry and persistent), DYSPNOEA (Lungs felt kind of heavy), FEELING COLD (Feels extremely cold) and OCULAR DISCOMFORT (Funning feeling around eyes) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced COUGH (Funny cough that was dry and persistent), DYSPNOEA (Lungs felt kind of heavy), FEELING COLD (Feels extremely cold) and OCULAR DISCOMFORT (Funning feeling around eyes). At the time of the report, COUGH (Funny cough that was dry and persistent), DYSPNOEA (Lungs felt kind of heavy), FEELING COLD (Feels extremely cold) and OCULAR DISCOMFORT (Funning feeling around eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant products included herbal products and supplements. Treatment information was not provided.
Normal sore arm, but the next day woke up with extremely heavy and irregular menstrual bleeding.
Chills, fever, body aches, joint pain, head ache, fatigue, swollen lymph nodes in right arm/arm pit/breast/neck for 6 weeks