chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 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 reported as follows: The patient received the first dose of Shingrix vaccine on November 6 or 7 of 2019.  The patient states she experienced arm pain after getting the first dose of Shingrix vaccine that lasted for 2 to 3 days.  Did not consent to follow-up. No further details were provided.
They both had COVID Disease and a positive home COVID Test on 01FEB2023/On 01FEB2023 patient got COVID-19 with mild to moderate symptoms; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (They both had COVID Disease and a positive home COVID Test on 01FEB2023/On 01FEB2023 patient got COVID-19 with mild to moderate symptoms) in a 40-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Anxiety and Migraine. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Anxiety, FREMANEZUMAB (AJOVY [FREMANEZUMAB]) for Migraine.    On 07-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (They both had COVID Disease and a positive home COVID Test on 01FEB2023/On 01FEB2023 patient got COVID-19 with mild to moderate symptoms). At the time of the report, COVID-19 (They both had COVID Disease and a positive home COVID Test on 01FEB2023/On 01FEB2023 patient got COVID-19 with mild to moderate symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2023, SARS-CoV-2 test: Positive.     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.   Patient had not received any vaccine 4 weeks prior to COVID-19 vaccination.  Patient had received Monovalent Dose 1 on 09Mar2021 and dose 2 and dose 3 on an unknown date.  It was reported that the patient got COVID-19 with mild to moderate symptoms and this diseased was prolonged. With bivalent booster patient experienced no other symptoms.  Patient had not received any treatment.   This case was linked to US-MODERNATX, INC.-MOD-2023-714734 (E2B Linked Report). This case was linked to MOD-2023-714954 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2023: Follow-up received, added additional reporter, updated patient initials, suspect drug details and I narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714734:Husband's case
5 days p/vax pt awakened to find an area on lt arm from shoulder to 3" above the elbow reddened, swollen, hot & itchy; prior to this, pt had pain in the area but it was resolved;
Just about 2 weeks after the 2nd vaccine I developed an immune response, mast cell response, dermatographic response
Resting heart rate of 147 at time of reaction (2/11/2022 11:30PM) lasting for 10 hours Supraventricular Tachycardia on EKG Rash on arms & shoulder Chest pain with arrhythmia Shortness of breath Dizziness Palpitations Alleviated with rest and vagal maneuvers
Patient was sitting after the keeping his eyes closed.  His limbs were too tensed to measure his blood pressure.  When the pharmacist on duty told the patient that we were calling 911, he started to move and talk saying not to call 911 and saying he was fine.  The pharmacist called 911 anyways and had the patient wait until 911 came.  The paramedics assessed his condition and sent him home.
On Oct 25th I went to emergency room because my legs were really sore and swollen and they admitted me to the hospital. They put me in ICU overnight IV drip clot buster medicine.  Then after they were able to break up clots, they removed them and put in at least 2 stents.  On Monday November 1st I had pseudoaneurysm in femoral artery that was leaking into the tissue of the leg and on Tuesday They did interventional radiology on the aneurysm
Back spasms on the lower back muscle , cough, chills and no fever Bad cough Stay home and rest and prescription Flexeril 5mg and noise spray Dymista spray
Severe, persistent, inconsolable crying for 4 hours. Called clinic which stated it was only due to pain in injection site and to put a cool cloth on it. Later read side effects of vaccine and realized the reaction was not normal.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 26-NOV-2015 at time- 00:19, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.9 and 2.4 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
7 days after the booster my husband had dizziness, vertigo, pressure on his ears and muffled hearing.  Three days later, 10 days after our booster shot, I lost hearing in my right ear, same pressure  but I appear to have worse hearing loss and he seems to have worse tinnitus.   We both have taken a course of prednisone.   I had an MRI on January 23, 2022 which came back normal.  The ENT can find no reason for the hearing loss, tinnitus.  My husband's family doctor can find mo reason for his hearing loss, tinnitus.  We both got our booster shots the same day and we both had severe unexplainable hearing loss within 7-10 days.
Patient developed bruising a day after flu shot administered the size of 2 inch - diameter. He has never bruised from flu shots in previous years. He takes aspirin 81 mg. He denies pain/itching or swelling.
symptomatic COVID +, CT + ground glass opacities c/w COVID PNA on 4/18/2021, completed vaccine series 2/5/2021
On 9/04 began experiencing symptoms of an allergy event that I experience often, tested on this day but it was negative. Woke up 9/05 feeling much worse, had horrible headache. Headache was so severe that my teeth hurt. Took another at home COVID-19 test that returned positive. Ran fever off and on, fatigue, chills, hot flashes, lost sense of smell and taste. Loss of appetite. Reached out to walk in clinic on 9/06 and was prescribed PAXLOVID and NSAID for pain. Missed work the entire week. After I began medicine symptoms began to improve after 12 hours. Fatigue continued off and on for another week, By end of September I felt pretty much back to normal.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and Treatment medications were not provided by reporter.
08/04/2014 Severe. Other. Severe urticaria/hives. 08/05/2014, Moderate. Other Fever to 102 degrees.
Initial report was received from a consumer, who was also the patient, on 11 October 2012. A 55-year-old female patient had received a dose one intramuscular injection in the left deltoid of ADACEL, lot number not reported, and a dose eight intramuscular injection in the right deltoid of Influenza Vaccine, manufacturer and lot number not reported, on 04 October 2012. Twelve hours later on 05 October 2012, the patient had hives with intense itching on lower back and left arm. There were three inches of hives over the injection site. By the next day, it was up to the shoulders and both arms then spread to the hips, thighs, face, feet and palms of hands. The patient saw an allergist and was treated with BENADRYL and a prednisone schedule. The patient was on BACTRIM for a sinus infection, had no known med allergies and seasonal allergies. The patient's outcome was recovered. Documents held by sender: None.
Swollen with a diameter of about 2", raised about 1/4". Right below the injected site. Swollen area appears like a bruise. No itching, no pressure, not hot to the touch. Subside with ice application.
Patient started experiencing pain and soreness in arm and under the arm after the immunization. She said it got really bad under the arm the night after the immunization so that she couldn't sleep and that TYLENOL did not help much. Pt will contact her doctor if it's not better tomorrow.
Developed hives over trunk, extremities and severe itching within hours of immunization. Also developed abdominal pain, nausea and vomiting which has just today, 5 days later
My ears are ringing. Like a high frequency test tone. It?s constant in both ears. I have never experienced tinnitus before nor diagnosed with it.  What I?m experiencing is not of an orthostatic nature. It?s constant laying down or standing/walking.
Developed hair loss on beard area on chin approximately 3-4 weeks after Pfizer booster, then noticed patch of hair loss (about the size of a half dollar coin) on the back of my head about 6 weeks after I received the Pfizer booster.   Currently applying Clobetasol Sol 0.05% to the affected areas since 9/14/22.
Information has been received from a pharmacist concerning an approximately 25 year old female patient, who on 07/23/2000 was vaccinated with a third dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Subsequently the patient recently tested negative.  It was reported the patient had received two previous doses of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation), the dates are unknown.  Additional information has been requested.
Soon after receiving flu shot Left arm began burning. I figured it was just part of getting an IM. It burned like fire going down my arm for several months every day. The pain also went into my back. The pain slowly subsided over the past 9 months but it still hurts in the exact spot of the injection and I have to rub topical pain medication over the area every night.
expired dose of Infanrix was administered to a patient; 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 15-month-old female patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 17-JUL-2023, the patient received Infanrix. On 17-JUL-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: expired dose of Infanrix was administered to a patient). 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: 19-JUL-2023 Clinical Manager states an expired dose of Infanrix was administered to a patient, which was already expired on 10 June 2023, which led to expired vaccine used. The reporter consented to follow up via postal. The vaccine administration facility is the same as primary reporter.
Only adjuvant suspension component administered without lyophilized component of vaccine (SHINGRIX). Pt will be revaccinated per GSK and CDC recommendation.
Case number PHEH2014US025012 is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 32 years old male patient. Past medical history and concomitant medications were not reported. The temperature excursion of FLUVIRIN (batch number: 145701) began around 16 Oct 2014 and the patient received the vaccine intramuscularly at a dose of 0.5 ml on 04 Nov 2014. It was reported that the vaccine administered was at 49 F 12 times over a period of 34 days. There were 12 separate temperature excursions lasting 30 minutes each in which the temperature was 46 to 49 F during each of those excursions. No adverse events were reported following the maladministration.
Didn't menstruate for 3 months after Gardasil vaccine. Had to get medicine to restart menstrual cycle.
LEFT EAR ACHING; LEFT EAR THROBBING; LEFT SIDE NECK SORE; LEFT SIDE THROAT SORENESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and expiry: UNKNOWN) .5 ml, administered on 12-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol.  On 12-MAR-2021, the patient experienced left ear aching, left ear throbbing, left side neck sore, and left side throat soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left ear aching, left ear throbbing, left side neck sore, and left side throat soreness. This report was non-serious.
101.7F most of the day, all day; A spontaneous report was received from a Consumer concerning a 79 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pyrexia.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 20-jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 21-jan-2021, The patient experienced fever, she had a temperature of101.7F most of the day. Upon calling back Patient states that she is ok. She said the highest temperature she had  on 21Jan2021 was 102F. The patient had taken Tylenol.   Action taken with mRNA-1273 in response to the events was not reported.   On 21-jan-2021, the outcome of the event fever was unknown. At the time of this report, the outcome of the event fever was unknown.; Sender's Comments: Based on the 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.
Injection site soreness, low grade fever, extreme fatigue and body aches, headache, mild congestion
pt vax 5/27/99 & on 7/12/99 pt tested & found to be preg; LMP 5/29; 2nd dose of vax not administered; f/u info indicated 8/5 pt electively terminated preg;
Within 6 hours of second vaccination: Severe headache almost like the inside of my head was on fire. Vomiting, nausea, fever, severe fatigue that lasted for over two months, still have lingering affects. Loss of muscle in left hand making it hard to grip items, also when walking left food will slightly drag at times causing me to trip. Sometime slurred speech or hard to get out words.
Shingles; Sore arm; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tiredness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for Pain relief, PREDNISONE, IBUPROFEN, ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL) and ERYTHROMYCIN for an unknown indication.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tiredness). On 07-Mar-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Herpes zoster: (Inconclusive) shingles diagnosis.         Action taken with mRNA-1273 in response to the events was not applicable.  Treatment medications include acyclovir, pain relief (tylenol & ibuprofen), prednisone, erythromycin ointment.
I work as a nurse. I took the annual flu shot offered by our hospital for employees. Several hours after the injection I developed some soreness to injection site and upper arm-which I expected. Later in evening as I was working in the hospital I felt my left arm going numb and some tingling. I mentioned this to other workers at the time. During the night I awakened many times due to numbness in my arm and the inability to lie on my left side due to arm pain, severe swelling of deltoid area. I went to a mirror to check on the site and the area was swollen greatly and a large-size of a Progresso soup can-reddened circular area at injection site was highly visible. My fingers went from tingling during the day t complete numbness by day's end on the 12th of October. The numbness resolved on Tuesday the 15th. I was very nervous about this, called my personal physician on Saturday morning, the MD on call returned my phone call and told me it would just resolve itself-and offered me pain killers. I told him the discomfort was NOT the problem, I just needed reassurance that my arm would be okay. He told me to keep an eye on it. I have received the flu shot other years since the age of 25 or so. I have never had any reaction before to a flu shot other than minor discomfort at injection site for a few hours Never had a bullseye mark either.
Moderna COVID-19 Vaccine EUA Dizziness fell to floor after standing and passed out (stayed in bed remainder of day), normal other symptons: sore throat, headache, fever, chills, fatigue, joint pain, 93 rapid heart beat, ringing in ears
Patient developed lightheadedness and extreme shaking in the extremities such as the hands.  It slowly progressed worse over a period of 20 minutes.  Patient had no nausea or vomiting.
AFTER RECEIVING THE IMMUNIZATION, THE PATIENT WAS SHOPPING IN THE STORE AND FAINTED (VASOVAGAL SYNCOPE).  SHE REAGINED CONCIOUSNESS IMMEDIATELY.  SHE CONTINUED TO FEEL LIGHTHEADED AND DIZZY.  SHE ALSO EXPERIENCED SOME SHAKINESS AND COLD SWEATS.  I ADMINISTERED DIPHENHYDRAMINE 50mg JUST IN CASE THERE WAS A MORE SERIOUS REACTION OCCURRING.
Patient eligible for Pfizer vaccine and the pediatric pfizer vaccine was administered by the pharmacist. Patient had no reaction to vaccine in 15 minute waiting period and parent was called and a voicemail was left.
I have had (2) cases of urticaria in a short period of time since my vaccination and have not eaten any foods that can trigger my food allergy. Any epinephrine injection was required to combat anaphylaxis. Stomach issues still persist.
Headache, Myalgia, Arthralgia, Fever, cervical adenopathy Narrative:
arm soreness/Arm being sore to the touch; fatigue; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), PAIN IN EXTREMITY (arm soreness/Arm being sore to the touch) and FATIGUE (fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M204) for COVID-19 vaccination.     The patient's past medical history included Arthritis.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and FATIGUE (fatigue). On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness/Arm being sore to the touch). The patient was treated with NAPROXEN (NAPROXIN [NAPROXEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm soreness) and FATIGUE (fatigue) had resolved and PAIN IN EXTREMITY (arm soreness/Arm being sore to the touch) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. treatment information also include ice pack.   Reporter did not allow further contact
Starting at approx 15 hour post, severe chills and fatigue, over the following several hours my temp was 102 degrees. I took ibuprofen and TYLENOL but it did nothing to reduce the fever. I had severe body pain, on a 1-10 scale it was 9 for almost 12 hours. Headache that lasted 3 days even with ibuprofen. I could not get up from my bed. I started to feel better at approx 48 hours post. It was five full days before the symptoms subsided, I still feel fatigued and am having trouble concentrating as if my brain is foggy.
Shortness of breath, elevated heart rate, heart pounding  upon moderate exertion.  Lasts 15-20 minutes after exertion and then very tired for hours.
my joints hurt; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (my joints hurt) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (my joints hurt). At the time of the report, ARTHRALGIA (my joints hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment medications were reported   Reporter did not allow further contact
No further adverse effect reported; on 20-FEB-2020 patient received a dose of improperly stored VAQTA; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.       On 20-FEB-2020, the patient was vaccinated with a dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) (dosage regimen, route of administration and anatomical location were not reported; lot number S025993 has been verified to be valid, expiration date reported and validated as 17-OCT-2020)  as prophylaxis (product storage error). No further adverse effect reported.  The temperature excursion was reported as: below 36 degrees Fahrenheit for 27 minutes. No previous temperature excursions reported.  A data logger was used. ; Sender's Comments:  US-009507513-2002USA010005: US-009507513-2002USA010017: US-009507513-2002USA010018: US-009507513-2002USA010021: US-009507513-2002USA010023: US-009507513-2002USA010046: US-009507513-2002USA010054: US-009507513-2002USA010078: US-009507513-2002USA010083: US-009507513-2002USA010140: US-009507513-2002USA010152: US-009507513-2002USA010216: