chrisvoncsefalvay/vaers-outcomes huggingface dataset:
information has been received from a consumer concerning a 20 month old male patient, with a history of drug hypersensitivity to antibiotics, including neomycin and a food allergy to fish, who in approximately 1995 was vaccinated with a dose of MMR (second generation) when he was 18 months old. The reporter indicates that two months after receiving the dose of MMR (second generation) the patient had a seizure and was hospitalized. His mother reported that she then found out that the patient was allergic to neomycin. It was also reported that at the time of the patient's experience he was allergic to antibiotics but now he was not. Unspecified medical attention was sought. Additional information has been requested.
Patient received a dose of Pfizer-BioTech COVID-19 vaccine 2023-2024 formula for ages 6m-<5yr that was diluted with an expired diluent. Upon reconciling vaccine inventory for the end of the day Inventory Specialist and RN Nurse Manager discovered that an expired diluent was used to reconstitute the vaccine. The diluent used was 0.9% Sodium Chloride Injection, USP Lot number 35-035-DK, expiration date 11/01/2023. The vaccine itself was not expired. Patient's mother was contacted and made aware of error and that we would be reaching out to the vaccine manufacturer for guidance on if the child needs to be re-vaccinated. RN Nurse Manager contacted  the Pfizer manufacturer and they did not have any recommendations on if the patient should be re-vaccinated. Pfizer then advised RN to reach out for guidance of re-vaccination. Vaccine authority did not have an answer and referred RN to the emergency number. When RN spoke with them they referred RN to the County Board Of Health. When RN spoke to clinician there they did not have an answer and said RN should reach out to Pfizer or the vaccine authority. Due to the manufacture and vaccine authority not having any recommendations RN reached out to Immunization Coordinator and District 10 Clinical and Nursing Director for guidance. RN Nurse Manager/RN advised that the patient does not need to be re-vaccinated due to the vaccine not being expired and Pfizer and vaccine authority providing no recommendation to re-vaccinate. Patient's parent was then contacted and informed that her child did not need to be re-vaccinated. The patients mother verbalized understanding.
onset began w/a burning/itching of anterior aspect of both forearms; subsequent scratching  produced surface lesions;
Information has been received from a nurse/medical assistant concerning a 68 year old female with diabetes and vaginal yeast infection and no allergies who on 28-MAY-2008 was vaccinated with a dose of 0.5 ml zoster vaccine live (Oka/Merck) (lot number 659615/0162X) subcutaneously in the left deltoid. Concomitant therapy included (MSD), (GLUCOPHAGE XR), (BUSPAR) and (LAMISIL). On 28-MAY-2008 the patient developed rash under the neck and on both sides the breast. The rash is symmetric and looks like a V shape. The patient used cool compress and was treated with LIDOCAINE cream and (ATARAX). On 18-JUN-2008, the patient recovered from rash. Additional information is not expected. The physician had nothing further to add since the patient recovered from localized rash on chest.
Slightly swelling; Pain; This is a spontaneous report from a contactable consumer (reported for himself). A 72-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration, administered in Arm Right on 15Feb2021 (at the age of 72-year-old) 10:15 as 1st dose, single dose for covid-19 immunization. Medical history included hypothyroidism. patient had allergic to Pollen, variety of food. Concomitant medications included levothyroxine sodium (SYNTHROID); fluoxetine hydrochloride (PROZAC); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); calcium (CALCIUM); docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3 [DOCOSAHEXAENOIC ACID; EICOSAPENTAENOIC ACID; TOCOPHEROL]). It was reported that, 45 minute later the patient experienced slightly swelling, pain on 15Feb2021 11:00 . He was exposed 24 hours a day for 10 days to his husband 8 days after he had the vaccine. He (Husband) had a positive Covid test on 22Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 01Mar2021. Patient did not receive any treatment for events. On an unspecified date in 2021, the patient had recovered from the events.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
sleeping a ton; lymph nodes in armpit and neck were inflammed; headache; This spontaneous case was reported by a nurse and describes the occurrence of HYPERSOMNIA (sleeping a ton), LYMPHADENOPATHY (lymph nodes in armpit and neck were inflammed) and HEADACHE (headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-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 HYPERSOMNIA (sleeping a ton), LYMPHADENOPATHY (lymph nodes in armpit and neck were inflammed) and HEADACHE (headache). At the time of the report, HYPERSOMNIA (sleeping a ton), LYMPHADENOPATHY (lymph nodes in armpit and neck were inflammed) and HEADACHE (headache) outcome was unknown.        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.   Concomitant product information was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-034030 (Patient Link).
Persistent sneezing (seven or eight in a row, each two hours; Sinus infection; Congestion; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Persistent sneezing (seven or eight in a row, each two hours), SINUSITIS (Sinus infection) and NASAL CONGESTION (Congestion) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included CALCIUM, VITAMIN D [VITAMIN D NOS], VITAMIN C [ASCORBIC ACID] and FISH OIL for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced SNEEZING (Persistent sneezing (seven or eight in a row, each two hours), SINUSITIS (Sinus infection) and NASAL CONGESTION (Congestion). The patient was treated with PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED COLD & SINUS                                              runny nose) for Runny nose, at an unspecified dose and frequency. At the time of the report, SNEEZING (Persistent sneezing (seven or eight in a row, each two hours), SINUSITIS (Sinus infection) and NASAL CONGESTION (Congestion) outcome was unknown.        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.   Other concomitant medication included Assured sinus congestion.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: TOOK PATIENT'S VITALS TWICE, FIRST WAS BP 100/74 HR 64, SECOND BP 105/76 HR 71, FOLLOWED UP WITH PHONE CALL TO PATIENT AFTER 2 HOURS AND SHE WAS FEELING BETTER
Patient began to feel warm and flushed about 5 minutes after vaccination. Stated she could feel it going through her veins. Ambulance was called and 1st responders first arrived 10 minutes after call. No treatment was given. BP was elevated to 170/90. Water was given to patient. Patient was told to go to the local clinic for further evaluation.
She is hardly eating and forcing herself to eat; potential cancer spreading to the mesenteric membrane and omentum along with ascites present and getting worse/nodule below her laparoscopy scar (unspecified) and they think that is cancer; This is the spontaneous report received from Merck.  A contactable consumer reported a 68-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing metastatic uterine cancer, PD-L 1. The patient finished major surgery (unspecified) last May 2020, 6 rounds of doxorubicin hydrochloride (DOXIL) and CARBOPLATIN (maximum dosage allowed for weight as she was in good health otherwise) for unknown indication, 25 pelvic radiation treatments and 3 brachytherapy treatments (specific treatments and dates unknown). The patient was now on a break from all of her radiation treatments. About 3 weeks ago (in 2021), she noticed her abdominal muscles were sore. She was a distance swimmer and soreness was unusual. A week ago, she began feeling more bloated and gaining weight of 3 pounds around the abdomen. She started measuring her waist and it was growing (unspecified).CT scan on  11Feb2021 was read by a radiologist who reported potential cancer spreading to the mesenteric membrane and omentum along with ascites present and getting worse. Two oncologists also discussed the results and presented it to the tumor board for review and they were not positive about the radiologist report. She also had a nodule below her laparoscopy scar (unspecified) and they think that was cancer. The patient also was hardly eating and forcing herself to eat noted on unknown date. She was hopping KEYTRUDA can address this. She was inquiring about KEYTRUDA and if it would be okay to receive her second COVID-19 vaccine next week as she was also scheduled to receive her first dose of KEYTRUDA. Outcome of the event of hardly eating was unknown while not recovered for the remaining event.   Information on the lot/batch number has been requested.
Extremely sore right arm. Headache for 12 hours. Felt feverish and terrible, sleepy for 2 days, High blood glucose reading, loss of appetite
Rash and hives on face, neck, shoulders and chest beginning on 2/26/2021, the 5th day after shot and getting worse on 6th day after shot. Took antihistamine and applied cortisone cream.  Called dr. Office and spoke to nurse on call.  Periodically applied ice and soaked areas with cool water with baking soda.   Hives began to subside on 2/28/2021.
Fever 100.8F; vomiting; chills; night sweats; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Aug2021 08:30 (Lot number: FD8448) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "hashimotos" (unspecified if ongoing); "melanoma" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Past drug history included: Clindamycin, reaction(s): "allergy"; Sulfa, reaction(s): "allergy". Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number: FC3180, Vaccine location: right arm, administration time: 08:30), administration date: 10Aug2021, when the patient was 64 years old, for Covid-immunisation, reaction(s): "Burning sensation inside entire body". The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "not recovered", described as "Fever 100.8F"; VOMITING (non-serious) with onset 2021, outcome "not recovered", described as "vomiting"; CHILLS (non-serious) with onset 2021, outcome "not recovered", described as "chills"; NIGHT SWEATS (non-serious) with onset 2021, outcome "not recovered", described as "night sweats". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, vomiting, chills, night sweats.  Additional information: The patient was not received any other vaccine within four weeks of COVID-19 vaccine. The patient received other medications in two weeks was Synthroid 112mg. The adverse event was not resulted in emergency room or physician office visit. The vaccine was administered at Hospital facility. Prior vaccination, the patient was not infected with COVID-19. Post vaccination, the patient was not tested for COVID-19. The patient occupation reported as none of the above.  No follow-up attempts are possible. No further information is expected.
Information has been received from a licensed nurse practitioner referring to a 61 yeas old female patient with coronary artery disease, hypertension and hypothyroidism. The patient had unspecified reactions to azithromycin, benztropine mesylate (manufacturer unknown) dexamethazone, dolasetron mesylate, meperidine hydrochloride, phenothiazines, quinolone, sumatriptan, VIOXX. The patient had unspecified severe reaction to COMPAZINE, penicillin and hydrocodone caused the patient rash. SULA caused the patient a rash and facial swelling. On 25-SEP-2015 the patient was vaccinated with ZOSTAVAX (lot # L012476, expiration date 10-JUL-2016, dose and route were not reported. Concomitant therapies included aspirin (manufacturer unknown), calcium (unspecified) with vitamin d-3 (unspecified), levothyroxine sodium (manufacturer unknown) , lisinopril (manufacturer unknown) and simvastatin (manufacturer unknown). On 08-OCT-2015, the patient experienced rash and excruciating pain. On 10-OCT-2015 (reported as after two days), the pain was resolved. On 13-oCT-2015 the patient visited a physician and it was noted that the patient had multiple group lesions on the upper left back to midline and a vesicular   rash that was scabbing over. No treatment was given for the events and no lab diagnostics studies were performed. The outcome of vesicular rash and skin lesion was reported as recovering. The causality was not reported. This is one of the several reports from the same reporter concerning the same patient. Additional information has been requested.
This case was reported by a pharmacist via sales rep and described the occurrence of myalgia in a 57-year-old patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020) for prophylaxis. Previously administered products included ZOSTAVAX (received on 5th November 2015).  On 18th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced myalgia and influenza-like symptoms. On an unknown date, the outcome of the myalgia and influenza-like symptoms were unknown. The reporter considered the myalgia and influenza-like symptoms to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported, however, it could be 56 or 57 years. The patient was a hospital employee. The patient experienced the adverse events for 2 days. Concomitant medications, vaccination facility, and other specific details were unknown, as no further information was provided during the call. The reporter gave consent to be contacted for follow up information. This case was one of the 9 cases reported by the same reporter. The reporter stated over the phone that about half of the eight patients had experienced flu-like symptoms, one of which was another doctor who could not go to a work related event the next day because of the symptoms. It was unknown which of the eight patients was the concerned doctor.
Patient felt hot/dizzy after receiving covid 19 vaccine but we provided her a water, ice pack and monitored for 30 minutes and she was ok.
pt recv vax 22MAY97 & 4 days later devel bilat joint pain & swelling of the hands & wrists;tx w/OTC anti-inflammatories;pt is still exp sx;
pain near Salivary gland on the left side; This spontaneous case was reported by a consumer and describes the occurrence of SALIVARY GLAND PAIN (pain near Salivary gland on the left side) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced SALIVARY GLAND PAIN (pain near Salivary gland on the left side). On 18-Mar-2021, SALIVARY GLAND PAIN (pain near Salivary gland on the left side) had resolved.     No concomitant medication reported. No treatment medication reported.   This case was linked to MOD-2022-549092 (Patient Link).
FEBRILE SEIZURE ON 28APRIL2009, MOTHER OF PATIENT CALLED 911 AND WAS TAKEN TO THE ER BY AMBULANCE
Symptoms began 09/16/2005, mother stated arm swollen, red and hot to touch. By 09/17/2005 had drainage coming from 1 injection site which according to report was MMR. Went to ER and was given antibiotic. Has improved. No drainage now but does have rash under arms.
Patient presented to the ED and was subsequently hospitalized twice within 6 weeks of receiving COVID vaccination. First time was 04/06/2021 for shortness of breath/ COPD exacerbation. The second time was 04/17/2021 for Closed fracture of proximal end of left humerus.
arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 025B21A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm pain). At the time of the report, VACCINATION SITE PAIN (arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-390237 (Patient Link).
This spontaneous report as received from a medical assistant referring to an adult patient of unknown demographics. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency, expiry date and route of administration were not reported) (lot number M042599) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 degrees C to 1 degrees C for 8.25 hours. It was reported the exact temperature and time below 0 degrees C was: -1.9 degrees C for 15 minutes, -1.2 degrees C for 15 minutes, -1.0 degrees C for 15 minutes, -0.8 degrees C for 15 minutes, -0.4 degrees C for 15 minutes and -0.2 degrees C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
tested positive to COVID-19 on 8OCT2023; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (tested positive to COVID-19 on 8OCT2023) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 08-Oct-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (tested positive to COVID-19 on 8OCT2023). At the time of the report, COVID-19 (tested positive to COVID-19 on 8OCT2023) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported as unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient husband was stated that was staying in a health care center for rehab, but COVID-19 was spreading quickly through the facility and decided to take out but tested positive to covid-19. It could be a false positive since patient was not having any symptoms and a nurse said that it can be possible. Patient's husband wanted to know can vaccine itself to cause a false positive. No treatment medications were reported.   Reporter did not allow further contact
Non-itchy rash on the same arm that I got the vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE; formulation: solution for injection, Lot Number and expiry date was not reported), dose 1 via an unspecified route of administration on 10May2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in May2021, the patient experienced non-itchy rash on the same arm that I got the vaccine. The patient was just wondering, took the vaccine yesterday (a day before reporting), first dose, was this normal to get a non-itchy rash on the same arm that the patient got the vaccine. The clinical outcome of the event was unknown.  Limited information was available over the call as consumer hung up abruptly. , product details (LOT, expiration date,), purchase details and other details were unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recv vax on 11/12/98; on 11/13/98 pt exp vax site rx of redness, warmth, erythema, swelling & induration to elbow x 4 day
The Patient was given Pfizer as his second dose series but it should have been Moderna. His first dose was Moderna. He was vaccinated at 12:30pm and was observed for 15 minutes. He had no symptoms or adverse reactions.
confusion, covid + (test done in ER 7 days prior to admit). Pt complains of fever, congestion, cough, SOB and worsening confusion.  COVID Pneumonia. Due to length of COVID dx, oral abx, oral steroids, zinc given, no Remdisivir. PT on RA.