chrisvoncsefalvay/vaers-outcomes huggingface dataset:
POSSIBLE CLOT IN THE LEFT ARM; PAIN IN THE LEFT ARM/SIDE; This spontaneous report received from a patient via a company representative concerned a 6 decade old female. 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: Unknown) 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 patient experienced possible clot in the left arm, and pain in the left arm/side, and was hospitalized (date unspecified). it was reported that the patient had reaction to the JnJ vaccine. She was  being watched closely and taken care of. Pain on the left arm/side. They think it as clot in the left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in the left arm/side and possible clot in the left arm was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: v0;20210456346-Covid vaccine ad26.cov2.s-Possible clot in the left arm. Follow-up received regarding Clinical Details. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  v0;20210456346-Covid vaccine ad26.cov2.s-Pain in left arm. Follow-up received regarding Clinical Details. This event(s) is labeled per RSI and is therefore considered potentially related.
At the time I had no issues with the vaccine not until I started my period. My cramps now are seriously painful I have never been in that much pain before on my period. Leading up to my period I had really bad headaches then I had one almost everyday when my period started. My stomach was super bloated to where my kid thought I had another baby in my stomach. I woke up everyday nauseous not really able to eat to much. My flow was heavier than I usually get as well.
Case number PHEH2014US016973 is an initial spontaneous report received from a pharmacist on 21 AUG 2014. This report refers to a patient of unknown demographics. Past medical history and concomitant medication were not reported. The patient was vaccinated with MENVEO (batch number: not reported) subcutaneously on 19 AUG 2014. On the same day, the patient was concomitantly vaccinated with an influenza vaccine (manufacturer and batch number: not reported). It was reported that the MENVEO was administered on one arm and the flu shot was administered on other arm. No adverse event was reported following this administration error (wrong route of administration).
Hours after receiving flu vaccine started having rash, difficulty breathing. Went to ER and diagnosed with anaphylaxis to flu vaccine.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender with inflammatory bowel disease. Medical history was not reported. On an unknown date in December 2014 the patient was vaccinated with PNEUMOVAX lot # K009809, expiration date: 16-MAY-2015, (strength, dosage, and route were not reported). Concomitant therapy was not reported. On an unknown date the patient developed redness and tenderness at the injectio site, the patient was seen by the physician the following day on an unspecified date and he/she had redness, tenderness and pain that radiated down the arm from the injection site. The physician determined to be a cellulitis. The patient was prescribed an unspecified antibiotic. There were not laboratories diagnostics performed. A lot check was requested for this adverse event. The outcome of the event was unknown. Additional information has been requested.
Pt developed about 6x4 cm oval erythema, maculo-papular area around shot site.
Received vaccine at 315 within less 1 hr. Chest tight which relieved immediately, than very itchy on arms/hands and dizzy swelling of hands and feet and numbness continued for 1-2 weeks. Hands also were red in color.
Hospitalization for acute on chronic hypoxic and hypercapnic respiratory failure secondary to COPD exacerbation and COVID-19 on dates 5/11/2022- 5/16/2022.  Treated with ascorbic acid, baricitinib, cholecalciferol, dexamethasone, remdesivir, and zinc.
Developed pain in left shoulder day after administration, also radiating to her neck and was worse at night and upon waking up in the morning. And she's still having pain, as pain increased days after receiving it.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On unknown dates the patient was vaccinated with 2 doses of PENUMOVAX23 6 days apart. One day after (date unspecified) after receipt of the second dose, the patient's arm swelled and she developed fever. Blood samples were taken and cultured revealing bacteremia due to gram positive bacteria. Patient outcome was unknown. Reporter did not assessed causality. Additional information has been requested.
Urticaria starting 2/5/07 in evening; progressively through 2/7/07.
pt recvd vax 16JUN95 & 20AUG95 devel a varicella-like rash;No further details were provided;
Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion); Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) in a 28-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  The reporter stated that their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
Initial report received from a healthcare professional on 22 August 2013. A female patient, had received intramuscular dose 1 of ADACEL vaccine (Lot number: U4586AA, anatomical site of administration was not reported) on an unspecified date. The patient was pregnant. The last menstrual period was on 08 December 2012. The patient's estimated date of delivery was reported on 25 October 2013. Patient's health during pregnancy, risk factors and concomitant medication were not reported. At the time of this report the patient had not experienced any adverse events. Documents held by sender: none.
This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns a 47-year-old, adult, female patient. On 16-Oct-2018, temperature excursion of the vaccine occurred. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019). The patient did not experience any adverse events after vaccination. The reporter assessed this case as non-serious. This case (201805014) was cross-linked to the case: 201805002 reported by the same reporter. Follow-up report received on 13-Nov-2018: The reporter refused to provide the patient's initials. The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The narrative and case comment were amended accordingly.
Patient asking for Pfizer stated first dose. Vaccine administered and after flagged Janssen was given from outside agency on March 18, 2021. Warning not shown until vaccine was already given. When questioned, patient stated was not happy with the coverage of Janssen and would like both Pfizer. Public health was consulted and advised no second pfizer dose. Appt for second dose cancelled and patient notified.
On the 3rd day she became a little off. Her walking became to a crawl then she had to use a walker a week later. She started losing control of her bladder.  Before the vaccine she was very healthy.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On an unknown date in 2017 (reported since 14-AUG-2017), the patient was vaccinated with improperly stored dose of VAQTA (lot # N003194, expiration date was not reported) (dosage and route of administration were not reported) for prophylaxis. The vaccine underwent temperature 32°F to 35°F (34.9F) for two minutes. Data logger was involved. There was no adverse effects reported.
Chest pain, low blood pressure, low oxygen saturation, high pulse, difficulty breathing, sweating, clammy, chest pain radiating into back. Was sent to ER via ambulance.
Patient experienced nausea sensation 10 minutes after receiving the vaccination. After 15 minutes from vaccination administration,  symptoms progressed into labor breathing, difficulty breathing, and throat closing
LOST 30 POUNDS; DIARRHEA; This spontaneous report received from a consumer concerned a male 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, route of admin, and batch number were not reported) dose was not reported, administered on 19-OCT-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On DEC-2022, the patient experienced diarrhea. On 19-JAN-2023, Laboratory data included: Colonoscopy Not reported. On an unspecified date, the patient experienced lost 30 pounds. Laboratory data (dates unspecified) included: Weight lost 30 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhea and lost 30 pounds was not reported. This report was non-serious. This case is a duplicate of 20230146524, 20230146842 and 20230146610. This case, from the same reporter is linked to 20230145473.
pt reported itchiness, swelling, and redness at injection site bigger than 1in. returned to urgent care for recheck. prescribed Pepcid, Claritin, and triamcinolone cream
pt vax 3/96 on 3/98 pt presented w/what m.d. felt was herpes zoster, 1 1/2'' strip of pink papular vesicles down leg only. 2 days later a few lesions remained inflamed & no new ones.
malaise, flu like symptoms x24 hr; headaches, moderate in degree x6-7 days; general muscle aches; sore throat
Patient was standing at our drop off window post-vaccination. She developed syncope and fell straight back onto her head. Patient says it wasn't a hard fall but pharmacy staff could tell that it was bad based on the loud thud that occurred. Patient sat for 15 minutes drinking water. Blood pressure was measured at 90/66. I (pharmacist) performed a horizontal gaze nystagmus test to determine if a concussion occurred. A nystagmus (involuntary jerking of the eyes) was present, so I gave the patient the option of waiting for an ambulance or going to an urgent care clinic. She opted to go to the local urgent care clinic.
my head it felt like it was burning; This case was reported by a consumer via interactive digital media and described the occurrence of burning sensation in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced burning sensation. On an unknown date, the outcome of the burning sensation was unknown.   It was unknown if the reporter considered the burning sensation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported The age group was not reported but was captured as adult as per vaccine indication. The patient received the Shingrix and within 7 to 10 days after the vaccination patient felt like head was burning.
Pt became pale, diaphoretic, after vaccine administered was given, sitting down, had not eaten all day BP 102/68 - 112/80 O2 98-100%.
Hives on face and back, and swollen lymph nodes happened about 90 minutes after I received the vaccine  I revived the vaccine on 3/11/21 at 4:30 pm Started having a reaction on 3/11/21 at 6:00 pm
Initial report was received from a consumer on 05 March 2013. A patient (age, birth date and gender not reported), who was 19-months-old at time of report, past medical history not reported, previously received an injection of PENTACEL, sanofi pasteur Ltd., (lot number, route, site, side and dose in series not reported) on an unspecified date. On an unspecified date (also reported as occurred last year), the patient had a seizure after PENTACEL vaccination. Laboratory or diagnostic tests and treatments were not reported. No additional information was provided. The patient's outcome was not reported. Documents held by sender: None.
This case was reported by a consumer via call center representative and described the occurrence of pain in a adult female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included sulfonamide allergy (severe reaction). Concomitant products included losartan potassium (Losartan). On 20th March 2018, the patient received SHINGRIX (intramuscular). On 20th March 2018, immediately after receiving SHINGRIX, the patient experienced pain, fever and swelling. The patient was treated with ibuprofen (Thyroid Medicaiton). On 30th March 2018, the outcome of the pain was recovered/resolved. On an unknown date, the outcome of the fever and swelling were recovered/resolved. The reporter considered the pain, fever and swelling to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain upon vaccination. The pain was intense for 3 days and lasted to a lesser degree for another week. The patient received Ibuprofen 800 mg about 3 hours and continued to take it for 3 days. The patient noted that the Ibuprofen masked a fever of 3 degrees above normal. The patient had a good pain tolerance otherwise and rarely gets sick. The patient had denied permission to contact their physician.
Welt at injection site, arm pain, headache, diarrhea, exhaustion, sore throat
R lower back, buttock, leg pain. Diminished mobility and response to pain stimulus, loss of sensation.  800mg Motrin TID 300mg Neurontin TID Neuro consult pending
Pt recvd Engerix-B on 15JUL91, 19AUG91 & 25JAN92; 31MAR92 titer levels revealed pt had not seroconverted;
This spontaneous report was received from an approximately 64 year old male patient regarding himself. The patient had no pertinent medical history and no drug reactions or allergies. On an unknown date, in November 2012 (reported as early November 2012), the patient was vaccinated with a dose of live ZOSTAVAX (lot number, expiry dose unspecified) intramuscularly (confirmed with consumer the therapy was intramuscularly). Concomitant medication included CELEBREX. Approximately on an unknown date in November 2012 (3 or 4 days after vaccination), the patient experienced pain in his arm that increased in intensity as time went on. It had been at least 2 months since he received the injection and he stated that when he turns his arm or reaches for something he gets severe, sharp pain that emanates from the injection site and radiates outward. He was going to take an adverse experience report and submit the information to the CDC. He sought a medical attention (saw his physician) and he was treated with VOLTAREN gel (manufacturer unknown), as needed. No laboratory tests were performed. The patient had not recovered from the event at the time of reporting. The relatedness for the event was unknown for live ZOSTAVAX. Additional information has been requested.
Covid arm rash 10 days after receiving the 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Covid arm rash 10 days after receiving the 1st shot) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Antidepressant discontinuation syndrome, CLONAZEPAM for Anxiety, LEVOTHYROXINE SODIUM (THYROXIN) for Hashimoto's thyroiditis.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Covid arm rash 10 days after receiving the 1st shot). At the time of the report, RASH (Covid arm rash 10 days after receiving the 1st shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   treatment include Applied Calamine lotion for the rash developed after the 1st dose.   This case was linked to US-MODERNATX, INC.-MOD-2021-089488 (E2B Linked Report). This case was linked to MOD-2021-089565 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089488:
Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm 197 protein) injection) was received from a healthcare professional regarding a 14 month old male patient who experienced an injection reaction characterized by pain, which caused him to limp. the patient received the fifth dose on 30-Aug-2003. The patient experienced an injection site reaction characterized by pain (injection site pain) in the left leg, which caused him to limp (gait abnormal). This lasted about ten days. The physician indicated that the child had completely recovered. See related cases: HQWYE362326AUG03 (The patient's fourth dose of Prevnar was inadvertently administered subcutaneously, no adverse event had occurred). No additional information was available at the date of this report.
Injection site pain/swelling, body aches, chills, generalized fatigue. Symptoms began roughly 18 hours post vaccination. Subsided 40 hours post vaccination. Now in good health.
Pt went to MD B/C she developed a full body rash (Both arms and hands) then neck was swelling. This occurred 2/19 PM. Pt received Medrol and CLARITIN on 2/22.
The vial was initially stored in the refrigerator on 11-Oct-2022 but vaccines were admistered on 16-Nov-2022 and 30-Nov-2022; No adverse event; Patient received bivalent doses after its beyond use date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received bivalent doses after its beyond use date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Oct-2022 but vaccines were admistered on 16-Nov-2022 and 30-Nov-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061f22a) for COVID-19 prophylaxis.     No Medical History information was reported.    In November 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 November 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received bivalent doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Oct-2022 but vaccines were admistered on 16-Nov-2022 and 30-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received bivalent doses after its beyond use date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Oct-2022 but vaccines were admistered on 16-Nov-2022 and 30-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received bivalent doses after its beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Oct-2022 but vaccines were admistered on 16-Nov-2022 and 30-Nov-2022).    No concomitant medication information was provided.  Dose administered after 30-day Use By Date or after manufacturer date of expiry   Vial size was reported as 2.5ml  The vial was initially stored in the refrigerator on 11-Oct-2022  Date(s) of administration of vaccine on 16-Nov-2022 for 5 patients and on 30-Nov-2022 for 3 patients in two different vials.  The vial did not undergo any temperature excursions.  No treatment medication were provided.  This case contains information for the 4th out of 8 patients.   This case was linked to US-MODERNATX, INC.-MOD-2022-680810, US-MODERNATX, INC.-MOD-2022-680811, US-MODERNATX, INC.-MOD-2022-680808 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-680810:Samer Reporter US-MODERNATX, INC.-MOD-2022-680811:Samer Reporter US-MODERNATX, INC.-MOD-2022-680808:Samer Reporter
Fully COVID vaccinated patient who admitted through emergency department with COVID positive test on 09/19/21.  Patients respiratory status continued to decline, he required CCU admission high flow oxygen, and subsquently BiPAP.  Medical team reviewed ongoing respiratory decline and grave status with patient and family who declined intubation.  Patient moved to comfort care and died on 10/02/21.
Light cramping and breakthrough menstrual bleeding (spotting) that afternoon and heavier the next morning (12/13). Resolved by noon 12 /13. Not distressing or disabling in any way.