chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hidradenitis suppurativa flare up in groin area; after receiving the Moderna vaccines had arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (hidradenitis suppurativa flare up in groin area) and VACCINATION SITE PAIN (after receiving the Moderna vaccines had arm hurt) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF pen. In 2021, the patient experienced VACCINATION SITE PAIN (after receiving the Moderna vaccines had arm hurt). On an unknown date, the patient experienced HIDRADENITIS (hidradenitis suppurativa flare up in groin area). At the time of the report, HIDRADENITIS (hidradenitis suppurativa flare up in groin area) had not resolved and VACCINATION SITE PAIN (after receiving the Moderna vaccines had arm hurt) outcome was unknown.            No concomitant medications were reported.   The reporter's causality for the event(s) of after receiving the Moderna vaccines had arm hurt with Humira (adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of hidradenitis suppurativa flare up in groin area with Humira(adalimumab) was a reasonable possibility. The reporter assessed event after receiving the Moderna vaccines had arm hurt as not related with Moderna Covid-19 vaccine.  No treatment details were reported.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report was received from a physician via company representative regarding multiple unspecified female patients. Information on the patients past medical history, other concurrent conditions, drug reactions or allergies and concomitant medications were not provided. On an unknown date, the patients were vaccinated with GARDASIL 9 (strength, dose, frequency, route of administration, batch/lot # and expiration date were not provided) for prophylaxis. On an unknown date, the patients return to physician office to report being HPV positive (human papilloma virus test positive). Outcome of human papilloma virus test positive was unknown. Causality assessment was not provided by the reporter.
07/12/22 presents to ED for "dizziness and weakness". PMHx of "CHF, COPD, CKD, HTN, sleep apnea (non compliant with CPAP, Afib, pacemaker/defibrillator"
No adverse effects. Staff at our clinic continued to give 0.25 mL for booster dose to Adults when we switched to giving booster doses from Moderna to Moderna Bivalent. This affected 52 patients. All have been informed and many have come back to receive their full doses. All staff are now educated on the correct dose of Moderna Bivalent to give to an Adult being 0.5 mL not 0.25 mL.
R arm developed a large area of non-tender blotchy erythema > 16cm across that resolved slowly over approximately 3 weeks.
Woke up at 2am to 6am with extreme heart palpitations / spasms - just as body aches /chills were coming on from the second dose, which is normal.  The spasms were not necessarily painful, but certainly new and unusual and aggressive. FYI
This 12 week 4 day old infant was seen 02/12/08 for her first set of immunizations.  Her age was calculated to be 11 weeks 5 days and oral Rotateq was administered.  The error was noted 02/13/08 at 1030 a.m.  Mother of the infant was contacted and she reported no adverse effects.
Case number PHEH2015US017654, is an initial spontaneous report from a nurse received on 09 Sep 2015. This report refers to a 64-year-old male patient. Medical history was not reported. Concomitant medication was not reported. Vaccination history included administration of FLUVIRIN (batch number: not reported) two times and the patient tolerated the vaccinations. Concomitant medication was not reported. The patient was vaccinated with 0.5 ml of FLUVIRIN (batch number: 157103) intramuscularly at left deltoid on 08 Sep 2015 (at 12:45). It was reported that patient received an out of temperature range FLUVIRIN pre filled syringe which was stored at a temperature range of 33.2F. The case was reported as non-serious. No adverse reaction was experienced by the patient following this medication error.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 24-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the vaccines was stored in freezer, they took out one to two vials and place in fridge each day as needed.  No treatment medications were reported
Information has been received from a registered nurse (RN) concerning her 3-year-old daughter who was "not immunocompromised", who in approximately 2004, 2006 and 2007, at 1, 3 and 4 years of age, was vaccinated with a first, second and third dose of varicella virus vaccine live (Oka/Merck) in Germany. Concomitant therapy for the second and third doses of varicella virus vaccine live (Oka/Merck) included a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). After the second and third doses, in approximately 2006 and 2007 the patient developed a generalized varicella rash which lasted over 1 month. Subsequently, the patient recovered from both occurrances of generalized varicella rash. Additional information has been requested.
Patient started having an earache on 06/25/2021 and by the morning of 06/28/2021 patient stated she had drooping on one side of her face. She went to the ER 06/28/21 and was diagnosed with Bell's Palsy.
Left side facial numbness and tingling.  tongue numbness.  left eye blurred vision.  Symptoms stayed active for 24-48 hours
7/20--7/20 87y.o. female with a PMH of persistent Afib (on eliquis), CAD s/p stents, HFpEF (EF 45%), DM type 2, HLD, and ischemic cardiomyopathy s/p ICD who presents s/p syncopal episode this morning. LOC lasted "a few seconds" per her daughter. + head trauma on eliquis. Patient was at a HCF for TEE. Prior to the TEE, she got up to the bathroom and synopsized. She has been experiencing lightheadedness upon standing and with ambulation since Sunday. Also admits to SOB on exertion which has been ongoing since May. Denies current lightheadedness, palpitations, chest pain, dyspnea, orthopnea, weight gain, or diaphoresis. Pt had COVID in May 2022. Subsequently, she was diagnosed with persistent Afib. Had a negative COVID test at an urgent care on Monday. Incidentally found to be COVID positive while in the ED. Vaccinated with Pfizer x2. Denies fevers, chills, headache, cough, abdominal pain, nausea, vomiting, diarrhea, hematuria, dysuria, or hematochezia. Received message that pt wants to leave AMA because she refuses to be admitted to COVID floor. Spoke again with pt and her daughter at bedside regarding possible consequences of leaving AMA. Pt verbalized her understanding. Pt cleared by cardiology for discharge. Pt to decrease lasix to the following dose: Lasix 40mg q AM and 20mg qhs. D/c hydralazine.
This spontaneous report was received from a pharmacist via a company representative on 07OCT2015 which refers to an unspecified number of patients (gender and age not reported), who on unknown dates, were vaccinated with ZOSTAVAX (route, dosage, dose number and lot number unknown). The pharmacist mentioned that, in general, occasionally some "clear fluid" comes out of the injection site when he administers ZOSTAVAX to the unspecified patients. The pharmacist did not provide any additional information about these unspecified patients. The outcome of the event was unknown. Additional information has been requested. This is one of several reports from the same source.
HCP called regarding VARIVAX. Product had undergone TE and it was administered after the TE. No reported adverse reactions. Permission to contact HCP was given. No additional AE/no PQC.; No reported adverse reactions.; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #w039294, expiration date: 11-DEC-2024, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, HCP called regarding VARIVAX. Product had undergone TE and it was administered after the TE. No reported adverse reactions. Permission to contact HCP was given. No additional AE/no PQC.; Sender's Comments:  US-009507513-2310USA000671:
6AUG92 4 hrs p/shots devel t130-104, shakes & groaning; 7AUG92 t105 R to ER; 8AUG92 t103 R AM;
Dizziness, fatigue, light headed, shortness of breath, heart palpitations, sweating
some pain at injection sight,   day and 1/2 back ache,   slight headache,  felt hot then cold,  Very sleepy for day and 1/2.
Developed Pancreatitis, Pneumonia , and blood clots in both lungs. cant lift arms.
Could not move right arm, or lift it after administration of ZOSTAVAX. Went to physical therapy, received cortisone injections, still has problems.
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with first dose of GARDASIL (dose and lot # not reported) on 15-AUG-2011 and the second dose of GARDASIL on 16-AUG-2012. No adverse effect has been reported or observed. It was unknown if the patient sought medical attention. Additional information is not expected.
Patient's symptom log:  1/21/2021: 1st dose of COVID-19 vaccine (Pfizer); just sore arm 1/27/2021: Numbness felt in front left thigh 1/27/2021 - present: - continued numbness in legs that comes and goes - numbness in arms; both but more in left - pins and needles in both hands, feet - hands fall asleep during night - back spasm overnight; left side of back - numbness in back; both left and right sides - middle and upper back - in back, stiffness/achiness, not quite pain - back sensations feel like a radiating spasm that comes and goes - new this week - pins and needles (slight) in trunk - at work, have felt slight difficulty typing with left hand  Areas Affected: - neck (slight soreness) - shoulders (stiffness and achiness/numbing) - back (achiness, stiffness, spasms, numbness) - arms (stiffness, achiness, pins and needles, numb) - hands (pins and needles, possible muscle loss) - buttocks (numbness) - legs (pins and needles, stiffness, numbness, soreness) - feet (pins and needles, numbness) - face (slight numbness on right slide)
This spontaneous report was received from a consumer refers to an unspecified number of pubescent male patients of unspecified age. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with M-M-R II injection, (strength, dosage, route and lot# were not reported). Concomitant therapy was not reported. The consumer informed that on an unknown date an unspecified pediatrician told him that unspecified pubescent males experience more severe adverse reactions when given M-M-R II, also explained that the pediatrician told him that this experience was document in an unknown study. The outcome of the adverse reactions was unknown. Additional information is not expected because the reporter refused additional contact.
This spontaneous report as received from a physician refers to a 63 year old patient of unknown gender. On 14-OCT-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23, dose 0.5 ml (route, lot number and expiration date not reported). No adverse experiences had been observed or reported. This is one of several reports received from the same source. Additional information has been requested.
dehydrated; Dizziness; Headache; Sweaty; Stiff joints; Body aches; Diarrhea; Shortness of breath; This case was reported by a consumer via call center representative and described the occurrence of dehydration in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 23rd October 2020, the patient received Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On 23rd October 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced dehydration, dizziness, headache, sweating, stiff joint, general body pain, diarrhea and shortness of breath. On an unknown date, the outcome of the dehydration, dizziness, headache, sweating, stiff joint, general body pain, diarrhea and shortness of breath were not recovered/not resolved.   It was unknown if the reporter considered the dehydration, dizziness, headache, sweating, stiff joint, general body pain, diarrhea and shortness of breath to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. Caller was the husband of the patient and reported his wife received the Shingrix vaccine and flu vaccine in the left arm.  Caller reported that same night after receiving the vaccine his wife had shortness of breath, diarrhea, body aches, stiff joints, was sweaty, headache, dizziness, and dehydration and these are all still ongoing currently. The reporter did not consent to follow-up. The case had been linked with US2020212943 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020212943:same reporter
Day 1 (day after shot), sudden onset severe migraine, worsening widespread allodynia. Day 4 severe muscle spasm/cramping neck/upper back, Day 8 pain in teeth,, worsening muscle spasms, extreme/severe: fatigue, exercise & orthostatic intolerance, brain fog, Day 9 blurred vision, migraines, shortness of breath, restless legs, overheating, nausea, bloating, constipation. Between Day 1 and Day 7, symptoms were managed with Ibuprofen and overall function was essentially baseline. Medication as follows: MEDROL: 7/10-7/13 8mg, 7/14-7/20 16mg . PREDNISONE: 7/21-7/23 25mg, 7/24-7/28 30mg, 7/29-8/3 25mg, 8/4-8/6 20mg, 8/7-8/19 30mg, 8/20-8/25 20mg, 8/26-8/27 25mg, 8/28-8/29 30mg, 8/30 (today) 40mg. Decreasing prednisone below 30mg results in resurgence of symptoms.
Received Expired 2nd Booster beyond MFG Expiry date; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired 2nd Booster beyond MFG Expiry date) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired 2nd Booster beyond MFG Expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired 2nd Booster beyond MFG Expiry date) outcome was unknown.            No Concomitant medications were provided. It was reported that patient does not had any side effects and was very concerned. No treatment medications were provided.
feels sick; Does not feel good; complains of a headache.; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feels sick), FEELING ABNORMAL (Does not feel good) and HEADACHE (complains of a headache.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (feels sick), FEELING ABNORMAL (Does not feel good) and HEADACHE (complains of a headache.). At the time of the report, MALAISE (feels sick), FEELING ABNORMAL (Does not feel good) and HEADACHE (complains of a headache.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   Reporter did not allow further contact
Swelling and redness at injection site, about 3 inches in diameter. Swelling subsided 5 days after shot, but returned after day 9. No pain.
Information has been received from a nurse practitioner concerning a female patient who on an unspecified date was vaccinated with the first, second and third dose of Gardasil. Subsequently, the patient experienced amenorrhea for various durations, (up to several months, after receiving all three doses of Gardasil. The patient had "no pain, just no periods." The patient sought unspecified medical attention. The patient received DEPO PROVERA to induce a period several weeks after the first missing period. Subsequently, the patient recovered. No product quality complaint was involved. Amenorrhea was considered to be an other important medical event. Additional information has been requested.
pt exp an episode of stiffening @ 0600 on 14JUL96 p/feeding;no clonic movement;according to mom pt seemed out of touch;lasted for approx 30sec;seen in ER w/u for infect negative thus far;pt is recovered w/no obvious current problems;
spinning while lying on right side; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (spinning while lying on right side) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Vertigo (in her mid 20s which she takes medication for) and Dizziness.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VERTIGO (spinning while lying on right side). At the time of the report, VERTIGO (spinning while lying on right side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was on treatment for dizziness.  Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.
Patient said when she got home her arm started hurting, it swelled up a little and turned red. The issue resolved on its own and she is fine now.
Patient reported normal soreness in her arm the day of and after vaccination.  It faded, but she still notices that her arm is sore at the injection site (well below the shoulder) if she grabs or rubs the arm.  There is no soreness unless she grabs or rubs it.  The patient did mention that this was her first ever flu shot and she did receive the high dose shot, as appropriate for her age.
3SEP91 onset of severe rt sided h/a; emesis x 1; 4SEP91 awoke confused, devel generalized sz became hypotensive;
Hive-like bumps on hands (knuckles, between figers, joints, palms), elbows, toes, and on the palm of feet. Itchy and burning sensation.
COVID breakthrough case. The patient presented to the hospital on 9/14/21 claiming she had tested positive for COVID on 9/13/21. She is experiencing cough, migraine, SOB, and hypoxia. Patient placed on 3L of oxygen.
Patient reported "flu-like" symptoms after vaccination including fever-related shaking, body aches, and overall malaise.
stating adverse event to influenza vaccination. Right Deltoid area at injection site, red, warm, swollen and painful to the touch (5/10) and while at rest (2/10). Patient concerned that this is an adverse reaction to influenza vaccination. He has had 3 previous vaccinations with influenza without adverse event.
pt reports pain in right upper neck and down the right arm the next day after injection.  Injection site without redness/swelling or pain
pt recv vax 18JUL95 & on 13FEB97 pt devel disseminated varicella-like rash consisting of less than 50 lesions;7-10 days p/lesions devel pt recovered;
I tested "positive"; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I tested "positive") in an adult patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In August 2023, the patient experienced COVID-19 (I tested "positive"). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (I tested "positive") had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2023, SARS-CoV-2 test: Positive. In September 2023, SARS-CoV-2 test: (Negative) 15 days later tested negative., (Negative) 15 days later tested negative and (Negative) 15 days later tested negative..     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient received latest COVID booster. It has been reported that patient had received 4 of the recent Moderna vaccines, last one was around last October. Two weeks ago, patient tested positive, and took 5 days of treatment medication. And it has been reported that now about 15 days later patient tested negative 3 times on Sep-2023.   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2023: Live follow up has been appended.