chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received the moderna booster on 12/31/21. the next day he started having swelling in his shoulder. he came today (1/2/22) at about 10 am in for me to evaluate and help him decide whether to seek medical care today or if it was ok to wait for tomorrow. He had definite swelling over the clavical area on his left side, which was the side he was vaccinated on. It didn't hurt but was tender to the touch and was a diffuse swelling, not a hard knot.  he said it was continuing to progress in swelling from last night (1/1/21) to this morning (1/2/21). The injection site itself was not affected.  It appeared to be a swollen lymph node and I recommended that he circle the size, take a dose of ibuprofen appropriate to his size (he was about 6'4", maybe 220 lbs and had only been taking one 200 mg tablet). I recommended he take 600 mg qid or 800 mg bid and seek care tomorrow if no change or tonight if he experience rapid enlargement of the swelling, dizziness, confusion or any other signs of a blood clot (I showed him a website with what to watch for).  I just called the patient at 3 pm to check on him and he said he took an ibuprofen 800 mg and the swelling was down some.
pale, sweating, thready pulse;BP maintained @ 120/60;needed inj Decadron & DPH;
asthma; shortness of breath; This is a spontaneous report from a contactable consumer (patient). This consumer reported for himself that a 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated that he had asthma and got shortness of breath, wanted to know if he can take his inhaler when he takes the second dose. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Immediate headache followed by total body itching. Itching began 4-5 hours after dose. Itching lasting overnight into early morning.  Felt like hives, but skin did not break out into hives.; Immediate headache followed by total body itching. Itching began 4-5 hours after dose. Itching lasting overnight into early morning.  Felt like hives, but skin did not break out into hives.; Immediate headache followed by total body itching. Itching began 4-5 hours after dose. Itching lasting overnight into early morning.  Felt like hives, but skin did not break out into hives.; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received first dose of bnt162b2 (BNT162B2; lot number: EK5730), via an unspecified route of administration on 20Dec2020 14:00 on right arm , SINGLE DOSE for COVID-19 immunization.  Medical history included Known allergies: Contrast dye, sulfur drugs. The patient's concomitant medications were not reported. The patient previously took erythromycin and experienced Known allergies: Erythromycin. No COVID prior vaccination. The patient has not been tested for COVID-19 since the vaccination. On 20Dec2020 18:30, the patient experienced Immediate headache followed by total body itching. Itching began 4-5 hours after dose. Itching lasting overnight into early morning. Felt like hives, but skin did not break out into hives. The events was assessed as non-serious. The outcome of the events was recovered.
10 days post vaccines hives on legs and back general malaise. No cough or respiratory involvement (reported 7/16/07 by mother). Treated by mother with Benadryl and Claritin PO at home. Recurred one day later then resolved. Complete recovery as of 7/16/07.
Narrative: 79 year old male admitted on May 19 2022 with E. faecalis bacteremia with likely urinary source. On May 25 2022 patient was found to be COVID-19 positive and was hypoxic. He had received Pfizer vaccine x 2 on March 1 2021 and March 22 2021 at an outside facility. He was treated with dexamethasone 6 mg x 7 days and remdesivir 200 mg IV x 1 then 100 mg daily x 4 days. He completed his isolation on June 15 2022 and as discharged to SNF for management of other medical problems.
MINOR SWELLING AND REDNESS AT INJECTION SIGHT. NO ITCH, NO INDURATION. ICE PACK GIVEN.
Information has been received from a physician concerning a 54 year old male with no relevant medical history or allergies who on 01-JUL-2008 was vaccinated with a dose of ZOSTAVAX (lot number, injection site and route not reported).  On 04-JUL-2008 the patient experienced flank pain and rash.  The patient called the physician's office and VALTREX was prescribed.  The next day the patient recovered from the events.  According to the physician, flank pain and rash were considered to be other important medical events.  Additional information has been requested.
I am breastfeeding my 20 month old and she developed a rash on trunk. Maculopapular.
This case was reported by a physician via sales rep and described the occurrence of herpes zoster in a adult female patient who received Herpes zoster (Zoster vaccine) for prophylaxis. Co-suspect products included mepolizumab (Nucala) unknown for an unknown indication. On an unknown date, the patient received Zoster vaccine at an unknown dose. On 24th November 2017, the patient started Nucala 100 mg at an unknown frequency. On an unknown date, less than a year after receiving Zoster vaccine and Nucala, the patient experienced herpes zoster and back pain. The action taken with Nucala was unknown. On an unknown date, the outcome of the herpes zoster and back pain were unknown. It was unknown if the reporter considered the herpes zoster and back pain to be related to Zoster vaccine. The reporter considered the herpes zoster and back pain to be related to Nucala. Additional details were details updated as follow: The age at vaccination was not reported. The patient was vaccinated for zoster previously, received 6 doses of Nucala developed back pain which turned out to be shingles.  The healthcare professional (HCP) believes that this was related to the administration of Nucala.  The patient had to cancel next appointment on May 6th because of zoster infection. The patient followed up with physician in June.
Pt had redness and swelling in are of shot.  Hot to touch.  Pt was put on MOTRIN and BENADRYL.
My second vaccination........injection site red and warm and sore. I had severe body aches, joint aches, head aches, fatigue, low grade fever, productive cough. I felt like I had the flu. With my first vaccination I had slight joint aches and fatigue.
7-8hr post vax pt c/o splitting h/a, fever 102,chills & vomiting; 27OCT98 marked improvement w/in 24hr post vax;
Redness, warmth, itching at site- Prednisone and Keflez for 10 days.
Red slightly itchy rash on elbows, inside of mouth felt swollen and irritated, sore throat, arm slightly sore where the shot was given
This spontaneous report as received from a pharmacist refers to a 3 year old male patient. On 22-AUG-2017, the patient's brother was vaccinated with ROTATEQ, orally for prevention of rotavirus gastroenteritis. On 22-AUG-2017, the patient experienced secondary transmission. On 23-AUG-2017, the patient experienced pyrexia and headache. The outcome of headache, pyrexia and secondary transmission was reported as not recovered/not resolved. The relatedness between the adverse events and ROTATEQ was unknown. Additional information has been requested.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. No pertinent medical history was reported. On 22-SEP-2015, the patient was vaccinated with improperly stored ROTATEQ (lot # K016261 and expiration date 23-JUN-2016 or K007912 and expiration date 30-MAR-2016. No adverse effects reported. Additional information has been requested.
The patient has a history of rubella as a child and thinks she may have been vaccinated with MMR II; This spontaneous report was received from a nurse regarding a female patient of unknown age. No information was reported regarding the patient's concurrent conditions, medical history, and past drug reactions or allergies. Concomitant therapies included sterile diluent.  On an unspecified date, the patient was vaccinated with subcutaneously measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, lot# and expiry date were not provided) for prophylaxis.    On an unspecified date, as a child, the patient experienced rubella and she thought she might have been vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The patient did not seek for medical attention and she did not receive treatment for this event. It was unknown if any lab diagnostics or studies were performed. The outcome of rubella was not reported.  The reporter did not provide causality assessment between rubella and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).
Flue like, with chills which lasted throughout the day and pain at the injection site.  Next day, arm still sore but flu symptoms are gone.  Took aspirin several times.
CHEST TIGHTNESS; NOT BREATHE CORRECTLY; NOT GET WARM; EXTREME CHILLS/BODY SHOOK VIOLENTLY; FEVERISH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced chest tightness, not breathe correctly, not get warm, extreme chills/body shook violently, and feverish. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not get warm, extreme chills/body shook violently, and feverish, and had not recovered from chest tightness, and not breathe correctly. This report was non-serious.
HCP calling to report an AE regarding the MMR II vaccine. HCP reported that a patient was administered an improperly stored vaccine. Permission was provided to contact the HCP. AE case 02425114 filed. Case 02425105 filed. No additional AE/PQC rep; This spontaneous report was received from a nurse and referred to a patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-JUL-2023, the patient was vaccinated with an improperly stored vaccine as measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, lot #U029793, expiration date: 23-SEP-2023, administered for prophylaxis (strength, dose, and route of administration were not provided) (Product storage error).; Sender's Comments:  US-009507513-2307USA007771:
large red area mreasuring 3x2 inches; This spontaneous report as received from a Physician Assistant refers to a 40-year-old female patient.    The patient's medical history included anxiety, depression, asthma and hypothyroidism.    The patient had received unspecified asthma, anxiety, depression and hypothyroidism medications. The patient had drug allergy to mood medications. On 30-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S012246, expiry date: 10-FEB-2021) via intramuscular route for prophylaxis. The patient had sought medical attention.       On 02-OCT-2019, the patient was seen for a large red patch measuring 3x2 inches (injection site erythema). The patient was treated with ice and Ibuprofen (MOTRIN) and did not contact the office with any additional concerns. It was not known if the symptoms completely resolved or when they did resolve. No additional information provided.  The outcome of injection site erythema was reported as recovering/resolving. Causality was not reported.
Mist came out of the syringe/PQC Present?: Yes/there must have been a crack or something in it because otherwise no mist would come out; the patient had to be "stuck twice"; no other adverse events to the patient; This spontaneous report was received from a physician via a company representative referring to a currently 13 years old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On an unknown date, when the nurse attempted to administer a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # S020255, expiration date 09-DEC-2021, indication: prophylaxis; strength and route were not reported) to a patient, she noticed a mist came out of the syringe near the luer lock area while giving the injection, disposed of the syringe in the "sharps container", then gave another injection of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # and expiration date was not provided) to the patient, since the patient had to be "stuck twice" (syringe issue and incorrect dose administered). The healthcare provider said "there must have been a crack or something in it because otherwise no mist would come out." He stated there was no damage noted to any of the packaging or the syringe itself until the nurse saw the "mist." Product quality compliant involved. The healthcare provider reported they had had no other problems with any of the other pre-filled syringes of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The doctor stated no other adverse events to the patient. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate: manufacturercountry:; devicelotnumber: S020255; expirationdate: 09-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Loss of strength in upper arm. Muscle pain when attempting to raise left arm from my side. Only outer arm muscle affected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX, as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 03-JUL-2015, the patient was treated by the Clinic for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
pt recvd vax in 1991 pt failed to seroconvert; approx 1993 pt devel elevated SGOT & SGPT levels; No further details were provided;
I had a rash in my groin on my thigh and on my buttocks. The rash was giant weals that were really itchy and red. It was worse on the left side of my body.  It went away with Benadryl and return after it wore off.  I had to get a prescription for Steroids and it went down until it was gone after six days. I had not gotten any symptoms after the first dose.
Deafness-lt ear 50% loss of hearing, tinnitus, 12Apr91 poss cold prior to vaccince, put on cough syrup. Sxs much worse p/vax. Probably viral synd but pt insists much worse p/vax.
Information has been received from a certified medical assistant concerning a 34 year old female patient who 20+ years ago (approximately 1988) was vaccinated with RECOMBIVAX HB (lot # not reported).  The medical assistant reported that on a medical form that was completed in 2002, the patient listed that she experienced severe hypersensitivity reaction to RECOMBIVAX HB.  There was no information available about the dates, symptoms or treatment.  The medical assistant also reported that the patient recovered on an unspecified date.  No other information was available.  Additional information is not expected.
A non-serious spontaneous report of muscle pain, fever, and stomach pain has been received from a consumer, patient's parent, concerning a female child, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medications were not provided. The patient received one dose of FLUMIST on 09-Sept-2009. The patient experienced muscle pain, fever, and stomach pain on 12-Sept-2009. The patient was taking acetaminophen, and her body temperature was 102.5. The outcomes of the events were not provided. 1-3 All follow-up attempts have been made per our SOPs.  Information is not available.  19-Feb-2010.
Change in period. Heavier flow. Period twice in 1 month; Change in period. Heavier flow. Period twice in 1 month; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Change in period. Heavier flow. Period twice in 1 month) and HEAVY MENSTRUAL BLEEDING (Change in period. Heavier flow. Period twice in 1 month) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045b21a) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENSTRUATION IRREGULAR (Change in period. Heavier flow. Period twice in 1 month) and HEAVY MENSTRUAL BLEEDING (Change in period. Heavier flow. Period twice in 1 month). At the time of the report, MENSTRUATION IRREGULAR (Change in period. Heavier flow. Period twice in 1 month) and HEAVY MENSTRUAL BLEEDING (Change in period. Heavier flow. Period twice in 1 month) had not resolved.            Concomitant product use was not provided by the reporter.  Patient stated that she had a lot of spotting, not a normal amount, almost to the point that she was getting more than one period a month.  Treatment information was not provided.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported. The registered nurse reported that since 25-NOV-2015, the patients have been vaccinated with unspecified doses of VARIVAX (Merck) which were exposed to temperatures outside of the recommended range (lot # L008272, expiration date 11-MAR-2017) (Strength and route were not provided). Concomitant medication was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Around 7 hours after the shot the left side of my neck hurt a little along with a little sore throat.   That evening, I was really tired with body aches.  That night   I had deep body aches and vomited.  I also had a slight headache and coughing.  The worst part was the extreme body aches.  I felt like I had been hit by a truck.  On Saturday (shot was on Thursday), I?m better but my body is sore and I don?t have much energy.
Received flu shot on 10/15/10.  On 10/16/10 pt. became very ill with respiratory issues.  He had a fever for 5 days, a productive cough and body aches.  He was sick for two weeks.  On 11/11/10 he reported that he still had a non-productive cough that was not getting better.  He mentioned that he thought that he got sick from a flu shot one other time, but did not know when.  Called physician and will see him if he does not get better.  Does not have insurance.
tmj pain in my jaw; tmj pain in my jaw; This case was reported by a consumer and described the occurrence of temporomandibular joint disorder in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced temporomandibular joint disorder and jaw pain. On an unknown date, the outcome of the temporomandibular joint disorder and jaw pain were recovered/resolved.   It was unknown if the reporter considered the temporomandibular joint disorder and jaw pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, within 2 days, the patient began experiencing temporomandibular joint pain in his/her jaw, which had persisted over the next two weeks. The patient read that temporomandibular joint was one-way shingles might manifest so the patient was curious to know if the vaccine could have caused the pain to begin. The patient asked is this a side effect that had been reported before. The patient had seen both his/her dentist and doctor about the this and they believed the pain to be temporomandibular joint as well.
pt recvd vax;c/o soreness in lt arm from elbow to shoulder,progressed in severity;could not raise arm above shoulder;no redness,no decoloration;23jan95 still slightly sore
9/20/2017 11:25 AM swelling, redness, heat and blisters at injection site. 9/20/2017 - pt. had appt. with MD, MD advised if R, S inc in size to start antibiotics.
weakness; uncomfortable; crusty injection site; painful arm; tiredness; lump/lymph node in armpit; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), FEELING ABNORMAL (uncomfortable), VACCINATION SITE INDURATION (crusty injection site), VACCINATION SITE PAIN (painful arm) and FATIGUE (tiredness) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Enlarged prostate. Concurrent medical conditions included Drug allergy (allergic to  Tramadol and Plavix), Thyroid disorder and Cancer.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced ASTHENIA (weakness), FEELING ABNORMAL (uncomfortable), VACCINATION SITE INDURATION (crusty injection site), VACCINATION SITE PAIN (painful arm), FATIGUE (tiredness) and LYMPHADENOPATHY (lump/lymph node in armpit). At the time of the report, ASTHENIA (weakness), FEELING ABNORMAL (uncomfortable), VACCINATION SITE INDURATION (crusty injection site), VACCINATION SITE PAIN (painful arm), FATIGUE (tiredness) and LYMPHADENOPATHY (lump/lymph node in armpit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   other meds: concomitant medications include Vitamin D, Cancer medicines, enlarge prostate medicines, thyroid medicines, medicine to urinate and treatment medications include Antibiotics