chrisvoncsefalvay/vaers-outcomes huggingface dataset:
indentation at the injection site 3 inches long to a quarter inch deep; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDENTATION (indentation at the injection site 3 inches long to a quarter inch deep) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 017B21A) for COVID-19 vaccination.     The patient's past medical history included Melanoma in 2016 and Skin neoplasm excision (melanoma removal) in 2016. Concurrent medical conditions included Penicillin allergy, Sumac rash, Drug allergy and Allergy to antibiotic.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced INJECTION SITE INDENTATION (indentation at the injection site 3 inches long to a quarter inch deep). At the time of the report, INJECTION SITE INDENTATION (indentation at the injection site 3 inches long to a quarter inch deep) had not resolved.            No concomitant medications were reported. Treatment information was not reported   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up received on 17-MAY-2021 and Patient Race ,ethnic group ,Allergies were updated and  second dose was updated On 25-Jul-2021: Follow-up  received on 25-Jul-2021 and does not contain any new information. Patient reported no change.
Patient received varicella vaccine (1st dose ever) 10-22-07. Had 1st outbreak of rash with blisters 0024, crusted over on 10-29-07. No fever, No pain. lasted 1 wk. Had 2nd out break 12-25-07; rash more extensive (over trunk, arms, legs); raised vesicles no fever, more itching, bigger blisters. Diagnosed by own MD
This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 20-MAR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9, (lot # N022728 with an expiration date in31-MAY-2020), for prophylaxis, (dose, frequency and route were not provided), that underwent multiples temperature excursions with a temperature below of 32 degrees Fahrenheit, during an unknown time frame. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1804USA003815; US-009507513-1804USA003816; US-009507513-1804USA003817; US-009507513-1804USA003819; US-009507513-1804USA003820; US-009507513-1804USA003821; US-009507513-1804USA003822; US-009507513-1804USA003823; US-009507513-1804USA003824; US-009507513-1804USA003769.
Muscle ache; Headache; Fever; Cough; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain, headache, fever and cough. On an unknown date, the outcome of the muscle pain, headache, fever and cough were recovered/resolved.   It was unknown if the reporter considered the muscle pain, headache, fever and cough to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The age at vaccination was not reported. The patient have had muscle aches and headache, fever and cough for 6 days since taking the Shingrix vaccine was this normal.
Got shot 8:15 on 10/20/10. That afternoon arm got hot and started to swell, later it started to get red and hurt. Was worse Thurs 10/21/10. Went to Dr. Dr said good thing he saw him, could have gone to hospital a day or so.
Received MENACTRA #2 and HPV #3 (GARDASIL) on 10/2/2013 1630 pm was fine after vaccination. Started with rash 10/3/2013 AM and rash progressed. Seen today 10/4/2013 in office with generalized urticaria. No joint swelling, no trouble breathing. No wheeze.
Adult patient came in to clinic for a vaccine appointment. Intended to receive the COViD-19 Pfizer bivalent booster. Has already received the monovalent booster >2 months ago. Patient was accidentally administered the monovalent adult booster dose instead of the bivalent dose. Patient was contacted after the fact regarding the incident, and encouraged to report an adverse symptoms.
Employee had a reaction approximately 30 minutes post vaccination.  Employee had itching and reported having hives.  Took 50mg of Benadryl PO.  Employee reports having chills and low grade fever the following day.
Episodes of staring into space, lasting 2-15 minutes at a time, he would look up and to the side, and sometimes have repetitive head movements back and forth. Would not respond to name, noise, visual stimulus, or physical stimulus. Would spontaneously come out of it and act as if nothing happened. This has been occurring daily, sometimes multiple times a day. Patient also having episodes where he repetitively move hands and head, and lips, lasting about 30 seconds to 2 minutes. No loss of bowel or bladder control. Patient has also been more fatigued, going to bed earlier, falling asleep at dinner table, sleeping longer. Also more irritable and throwing more temper tantrums, with resolution only when being put to bed.
Generalized urticarial rash, treating with oral steroids and anti histamines due to itching.
Patient felt a little out of it; Patient head was hurting; Patient felt really tired; Patient reported an allergic reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (Patient felt a little out of it), HYPERSENSITIVITY (Patient reported an allergic reaction), HEADACHE (Patient head was hurting) and FATIGUE (Patient felt really tired) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. No Medical History information was reported. On 19-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In September 2022, the patient experienced HYPERSENSITIVITY (Patient reported an allergic reaction). On 19-Sep-2022, the patient experienced FEELING ABNORMAL (Patient felt a little out of it), HEADACHE (Patient head was hurting) and FATIGUE (Patient felt really tired). At the time of the report, FEELING ABNORMAL (Patient felt a little out of it), HYPERSENSITIVITY (Patient reported an allergic reaction), HEADACHE (Patient head was hurting) and FATIGUE (Patient felt really tired) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. Reporters degree was reported as PA (Physician assistant). No concomitant medication information was provided.  No treatment medication was provided.   This case was linked to MOD-2021-297516, MOD-2021-297590, MOD-2021-297591 (Patient Link).
I began to notice pain in my left ear which then escalated to become Herpes Zoster Oticus in my left ear , on my face and in my throat. The pain was unbearable, I lost unnecessary weight because it was so painful to swallow. I lost hearing in my left ear and have not yet regained it fully back yet.  While trying to figure out what was wrong with me before I was diagnosed I went to urgent care twice, then later to the ER. I have since seen an Ear nose and throat doctor along with an ophthalmologist and my primary.  Lots of doctor visits, and many medications like prednisone, oxycontin, valaciclovir, gabapentin, montelukast, anti nausea, and physical shots of steroids in my left ear.  This all happened over a coarse of  about  9 weeks of treatment.  To this day I have some lingering side effects and I have to keep taking the montelukast medication as a result of the shingles in my throat.
Experienced no adverse reactions on the say of the injection. Woke the following morning after with extremely sore muscles and joints, especially in both shoulders, chest, upper back, and neck, plus headache. Pain was not alleviated by Advil. Also experienced extreme fatigue and significant mental lethargy which lasted about 18 hours. The soreness had diminished somewhat by the following day but did not go away completely until the morning of the third day.   I had no adverse to reactions at all to the previous three doses, so this was a surprise.
Headache; Runny nose; Sore throat; mild fever; fatigue; This is a spontaneous report from a contactable other hcp (patient) from a Pfizer Sponsored Program. A female patient of an unspecified age received bnt162b2 (lot/batch number and expiration date not provided) via an unspecified route of administration, first dose on 16Dec2020 (reported as last wednesday of 23Dec2020), at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Stated that she got her first dose COVID vaccine last wednesday and experienced mild fever and fatigue on 16Dec2020. Stated that this morning (23Dec2020) she woke with a headache, runny nose and sore throat. Stated that she had wanted to know if the side effects are normal for the time frame and if she would have to be tested. The patient underwent lab tests and procedures which included body temperature: mild fever on 16Dec2020. The outcome of the events mild fever, fatigue was unknown, of the other events are not recovered.  Information on the lot/batch number has been requested.
BODY ACHE; MIGRAINE HEADACHE; FEVER; EXTREME FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-MAY-2021, the subject experienced body ache. On 07-MAY-2021, the subject experienced migraine headache. On 07-MAY-2021, the subject experienced fever. On 07-MAY-2021, the subject experienced extreme fatigue. On 07-MAY-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on MAY-2021, had not recovered from fever, extreme fatigue, and body ache, and the outcome of migraine headache was not reported. This report was non-serious.
Headache; Back Pain; muscular weariness; Tired eyes; feel strange as sick; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient (Pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 10Apr2021 at 08:45 AM (lot number: EW0150) at single dose for COVID-19 immunization. The relevant medical history was reported as none. Concomitant medications were not reported. On 17Apr2021 at 17:00, the patient had headache, back pain, muscular weariness, tired eyes. She felt strange as sick. It's been almost two weeks since she got the vaccine but only on Saturday she started with a headache. When she empused herself she was in pain head for two days but they became all the symptoms together a week after. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events were reported as non-serious. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Clinic medical record system had correct lot number attached to incorrect vaccine. As a result, MCIR rejected the vaccine. Error wasn't discovered until the initiation of the second dose. One vaccine was given on 9/17/2021 and another was given on 9/21/2021. Incident form completed and sent to VFC.  Clinic medical record system has been updated. Spoke about incident on 9/28/21. Patient has reported no symptoms.
Client developed sweat, chills, fever, and muscle spasms in arms and legs. Client states his arms and legs were shaking uncontrollably and it was difficult to stand. A rash developed on his arms and legs with sunburn appearance. Side effects developed on 5/7/2021 around 9:00 AM and lasted 48 hours. Client states he is feeling good today but still has a rash on his neck that has not yet faded. Client states the spasms in his arms and legs lasted for about 6 hours.
Patient awoke at 11:30 PM after going to sleep at around 9:30. She was gravely chilled, shaking uncontrollably and nearly unintelligible. She was achy but no serious fever to the touch of my cheek. She wanted ibuprofen which I got for her and she took two pills. She went back to sleep after covering completely with a heavy comforter for warmth. The following day she was lethargic and physically unable to perform anything other than basic non-physical actions. She took a long, hot bath for an hour. She slept normally that night and the following day was feeling mostly normal.
Vertigo; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History Provided).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced VERTIGO (Vertigo). 08-Jan-2021, the patient experienced NAUSEA (Nausea). On 09-Jan-2021, VERTIGO (Vertigo) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Developed shingles first notice painful rash to my right side of trunk and back on 07/18/21. Went to urgent care for same on 07/23/21.  Started on valacyclovir 1 GM tid  Prednisone 20 mg , 2 tabs po daily  Tylenol
Injection site reaction - large dark bruise at injection site, size of a silver dollar. Injection site 1/2 inch lower than normal.
Patient was administered with vaccine that was beyond use date after the thaw proces; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw proces) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw proces). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw proces) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Age of patient was 47  years 5 months. It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19, nor if patient had chronic or long lasting health conditions. Patient had reported no adverse reactions after the administration of vaccine. Treatment details was not reported by the reporter.
pt had c/itchiness at the injection site quick onset of HA Diaphoretic numbness upper and lower lips  dry throat Monitored vitals vitals stable fluid provided Sx continued advised  assessment at the ER  pt agreed pt escorted to the ER denied SOB or chest pain
Staring, rolled eyes back of head ? seizure.  Seen in office 2/25/2009 for this.
Lymph nodes in armpit swollen and sore after a Pfizer  COVID booster vaccine
Pt. states that after receiving the 2nd dose of Phizer 04/02/2021, started experiencing symptoms of suffering a (A-Stroke) 04/25/2021.
The rash begin Monday night Wednesday I called my doctor she wasn't in so I called my dermatologist July 7th she saw me. The dermatologist looked at it and said it was shingles. I was prescribed an antiviral drug and my primary called in Gabapentin for the nerve pain. I was taking the nerve pain pills as needed and then I was able to just take them at night as the pain started to go away. In about three weeks, time the pain was going away. I am currently at week 5 and its still present but not nearly as bad.
This spontaneous report as received from a physician refers to a 19 month-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 03-JUL-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (exact dose, dose number, route of administration were not reported; lot# reported as N00236 with the expiration date of 24-OCT-2019) for prophylaxis. The administered dose of PEDVAXHIB underwent multiple temperature excursion between 49 and 54 Fahrenheit degrees, which lasted for 16 hours, since 19-MAY-2017. Digital data logger was not involved to capture the temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Sxs 90 minutes post vax. SOB, palpatations, nausea, tachycardia.  Presented to ED. CXR/EKG normal, labs normal, given Zofran inj.
Rash on arms, and legs. Pink Papular rash. It did blanche.
NECK PAIN, GRADUALLY WORSENING OVER 2-3 WEEKS, FEELS LYMPH NODES ARE SWOLLEN IN HIS SUBMANDIBULAR REIGON, ANTERIOR CERVICAL CHAINS, SUPRACLAVICULAR REGIONS.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "MI" (unspecified if ongoing); "stroke" (unspecified if ongoing); "afib" (unspecified if ongoing); "cardiomyopathy" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Known allergies: iodine based contrast, reaction(s): "Known allergies: Iodine based contrast", notes: Known allergies: Iodine based contrast; Known allergies: keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex; Known allergies: opioids, reaction(s): "Known allergies: opioids", notes: Known allergies: opioids. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment; Negative, notes: Paxlovid rebound 5 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Patient had received vaccine. Had other medications in two weeks which were too many to list. Patient had COVID-19 treatment from 26May2022, to 01Jun2022. Vaccine lot unknown reason: Misplaced/discarded. Patient had Paxlovid rebound 5 days after testing negative on 07Jun2022 04:30 AM. Outcome was not recovered and did not receive treatment.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
expired drug used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26-MAY-2023) for prophylaxis.   On 23-JUN-2023, the patient received Kinrix. On 23-JUN-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: expired drug used). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-Jun-2023 The vaccine administration facility was the same as primary reporter. The reporter mailing address in health care professional details. The reporter consented to follow up. The patient received an expired dose of Kinrix, which led to expired vaccine used.
Patient experienced severe abdominal pain and nausea. Pt went to emergency department Thursday and Saturday. Two CT scans of abdomen showed severe inflammation of stomach and intestines.
Moderna COVID-19 Vaccine EUA.  Night sweats. Arm soreness. Fatigue. Lasted 4/2-4/4/21.
Blurred vision 1/2 hr. dizziness 1/2 hr., headache 1/2 hr., shortness of breath,  no treatment it just went away on it's own. following month patient had a stroke.
I started to have numbing on my right side especially on the back of my head. After that I had dizziness and confused. I felt like I could not breath. I was finally able to catch my breath. I am still not able to catch my breath. I went to the ER. They checked my pulse and took notes. They were just trying to rule out everything. They monitored me for a while. The did do an MRI. After that I followed up with my PCP, she ran labs, and they came back normal. They did a COVID test which cam back negative. I still experience irregular heartbeat. I am going to follow-up with my cardiologist at the end of month.
Patient had first dose on 3/19/2021, second dose due 04-16-2021. Patient was given dose too early on 04-09-2021 only 21 days after first dose. Patient had no adverse reactions due to receiving dose too soon based on manufacturer recommended interval.
Info. has been received from a registered nurse concerning an approx 11 y.o. male w/no medical history and NKDA, who on 8/20/02 was vax'd w/a 1st dose of Hep B vax recombinant. There was no concomitant medication. Subsequently, the PT developed a severe headache for 3 days and a rash on his back, chest, and arms. Unspecified medical attention was sought. No further info. is available.