chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called the pharmacy  (6/5/21) to talk about his Moderna Covid vaccinations. He stated he felt drained and sluggish. He had his 1st dose on 5/5/21 and his 2nd dose on 6/2/21. In general he has had the following: Headache, dry mouth, body aches, nausea, and fatigue. I asked him how he felt  the day he called on 6/5/21 (3 days post his second dose). He stated that he still had a headache and was fatigued (he only felt like lying down). Patient is an employee here and wanted to know what he should do about returning to work. I referred him to store manager. I gave her his number and she was going to call him. He had spoken to managers before 6/5/21. I explained that these side effects are possible with vaccines and that some patients respond with more side effects than others or have a stronger response. However, I am filing  a VAERS because the patient mentioned that he had the following after his 2nd dose. He stated that about an hour after his vaccine on 6/2/21, he had hives and itching on his arms and neck and dry throat. He stated that he has used Benadryl and hydrocortisone to treat these symptoms. I asked him did he have any reaction after his 1st dose on 5/5/21. He stated that he had itching in his throat after the 1st one, but he thought it was just a dry throat and did not know if it was coming from the vaccine. As far as I know, 6/5/21 was the first day that the he had let anyone at the pharmacy know about any side effects. I told him to let his primary care doctor know this information that we discussed. I also recommended that he could take Tylenol if he wanted to do so.  Patient used a Doctor on Demand service through employee and provider prescribed aspirin 325 mg tablet once daily.
The morning after the vaccine, I had a really awful headache and swollen arm, that was incredibly touch-sensitive. Around 3 pm that day, 25 hours after the injection I was hit with severe nausea. About an hour later, I began vomiting and had diarrhea. For some time, I was unable to keep water down. I called a 24-hour nurse line, and they advised contacting my doctor's emergency line. I did, they said if I couldn't make it through the night without keeping water down I needed to go to the hospital. Luckily, right before bed I drank some water and was able to make it through the night. The next morning, I had a telehealth visit with someone from my doctors office to review symptoms. Today I have had waves of nausea, but no vomiting. I have had diarrhea, and I had a spontaneous period that was very heavy and two weeks early today (2 days post vaccine).
heart beat sky rocketed/Rapid heart rate; had chest pains (1st two hours after the shot); pain in the shot site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Mar2021 13:00 (Lot number: EN6203) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL, start date: 21Mar2021, stop date: 23Apr2021. The following information was reported: TACHYCARDIA (non-serious) with onset 21Mar2021 13:20, outcome "recovered" (2021), described as "heart beat sky rocketed/Rapid heart rate"; CHEST PAIN (non-serious) with onset 21Mar2021, outcome "unknown", described as "had chest pains (1st two hours after the shot)"; INJECTION SITE PAIN (non-serious) with onset 21Mar2021, outcome "unknown", described as "pain in the shot site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tachycardia.  Additional information: Patient know that there was a site where patient can provide feedback regarding COVID shot. Patient just cant seem to find it. Patient wanted to report that after the first shot heart beat sky rocketed and had chest pains (1st two hours after the shot) and pain in the shot site (typical response). Patient was an athlete and workout daily. It kept patient awake for the 1st two weeks because it hurt. Relevant test was none (everything was normal at last physical). Rapid heart rate (about 3-5min after shot Rapid heart rate remained escalated for at least 2 hours.  No follow-up attempts are possible. No further information is expected.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/27/2021 and 3/27/2021. Presented to ED on 9/11/2021 after patients son found him shallow breathing this morning and appears cyanotic and pushed on his chest which prompt patient to take a deep breath subsequently his color returned.   EMS upon arrival noted he was hypoxic, placed him on 15 L of non-rebreather. Patient states that he has symptom onset about 10 days ago.  He felt very fatigued, no appetite, generalized body ache, fever, cough and shortness of breath.  He also have nausea vomiting couple days ago this has improved.  He has some diarrhea a few days ago this is resolved. He continued to require high-flow oxygen and subsequently requiring mechanical ventilation on 9/20/21. He completed the 5 day course of remdesivir.  Patient also treated with IV antibiotic therapy.  Patient required vasopressor support. Determination made to initiate comfort care. The patient expired on 9/30/2021.
Immunization, INFANRIX,  given on 3-3-2009. Patient's mom noticed large, red swollen area on right upper arm on 3-5-2009. Patient seen today, 3/5/2009 at clinic and had large red induration on arm.
Heavy nausea  and severe headache within 3 hours still continuing 2 days later
Information has been received from a 26 year old female consumer with no pertinent medical history, for GARDASIL, a Pregnancy Registry product, it was reported that on 04-JUN-2009 she was vaccinated with the second dose of GARDASIL and 4 days later (08-JUN-2009) found out she was pregnant. There was no concomitant therapy. At the time of reporting, there was no AE reported. In approximately March 2009, the patient was vaccinated with the first dose of GARDASIL. There was no concomitant medication. Medical attention was not sought by the patient. Follow-up information has been received from an office staff person who reported that the patient terminated her pregnancy the same week she got the vaccine. She stated the practice did not know the patient was pregnant at the time of vaccine. The office staff person stated that the patient chose to terminate the pregnancy due to the vaccine. She had no further information to provide. Upon internal view, terminate the pregnancy was considered to be an other important medical event. Additional information is not expected.
Pt had episodes of vomiting for about 2-2 1/2 hours. Also had a very restless sleep.
on 3/5/2021 pt had massive unprovoked pulmonary embolism with right heart strain requiring thrombectomy
Shortly after receiving the vaccine patient developed BLE swelling and SOB.  Patient was then diagnosed with pericarditis.  She underwent pericardiectomy on 6/4/2021.  Subsequently she developed heart failure and renal failure and was admitted to ICU.  She was intubated and required dialysis.
Information has been received from a physician for the Pregnancy Registry for GARDASIL concerning a female with no pertinent medical history, drug reactions or allergies who on 29-MAY-2008 was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL.  There was no concomitant medication.  Subsequently the patient was determined to be pregnant.  Her LMP was 08-MAY-2008.  Expected date of delivery was 12-FEB-2009.  On 09-JUL-2008 the patient was seen in office.  A urine pregnancy test was positive for pregnancy and an ultrasound revealed a 6-week fetal gestation.  The physician reported that the patient may have had a spontaneous abortion, a miscarriage, as per the ultrasound.  Additional information has been requested.
This spontaneous report via a sales representative from a nurse who reported similar events for two patients. This is the first of two reports. A patient of unspecified age ethnicity and gender received the first dose of TRUMENBA (batch/lot# J29203, exp date 01JUN2016), intramuscular on 01FEB2016 at 04:52 PM at 0.5 ml single dose. The patient medical history and concomitant medications were not reported. The patient experienced severe redness, swelling in limb and arm and cannot move the arm on an unspecified date with outcome of recovered. The patient was treated for the events.  Follow up (16MAR2016): New information from the same contactable nurse included administration details (batch/lot #, expiration date; dosage; route, site and date of administration), outcome of the events. Follow-up attempts completed. No further information expected.
16 Year old patient given 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (16 Year old patient given 1st dose) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007021A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced OFF LABEL USE (16 Year old patient given 1st dose). On 11-Aug-2021, OFF LABEL USE (16 Year old patient given 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant drugs were provided.   Reporter did not allow further contact.
This spontaneous report as received from a physician refers to unspecified patients of unknown age and sex. Physician reported that RECOMBIVAX HB exposed to 74F for upwards of 4 months and the improperly stored vaccines had been being administered to unspecified patients on unspecified dates (strength, formulation, lot #, dose/frequency, route and duration were unspecified). It was unknown whether the patient had sought medical attention or not. The outcome was unknown. This was one of several reports that received from the same source. Additional information has been requested.
tingling of the tongue and side of the mouth w/o swelling or erythema.  Treated with 50mg diphenhydramine PO. at 1132  Patient discharged stable w/o new or worsening symptoms 50 minutes after shot time. ER precautions given.
2 days disseminated varicella rash, fingers, toes, arm, knees. Injection site no lesions (improved 3 days later).
I ended up on Sunday night (48 hours later) having a lot of contractions. More than 8 in an hour. I called the DR and they told me to go to LABOR/DELIVERY to be monitor contractions. They determined I was not going into pre-term labor. They gave me an injection to try to stop the contractions. It worked. They monitored for me a bit longer and I went home.  March 29, 2021 - estimated date of delivery; This is my third pregnancy. I have one other living child and one pregnancy ended in miscarriage.  I had developed gestational hypertension - after the vaccines.
Patient received Pfizer COVID vaccine on 7/23/21 and 8/13/21. On 10/11/21, patient is admitted to our facility for COVID-19 infection (she was exposed to COVID about 1 week previously by her unvaccinated caregiver) and general weakness due to her cancer history (no hypoxia). As of today (10/15/21), patient is still admitted in our med/surg unit.
Patient was accidentally given a duplicate dose of Moderna bivalent vaccine on 12/15/22. Patient received the initial bivalent booster on 9/28/22. Patient presented to the pharmacy without their vaccine record. Upon returning that evening with their record, it was discovered that the patient had already received the Moderna bivalent booster. The patient was counselled and reported feeling no adverse effects.
PM 12/1 onset of intermittent numbness and tingling midline posterior trunk "over my spine". continued intermittent paresthesias 12/2/09 in various parts of body, including trunk, all extremities, and face. no weakness, SOB, paralysis, loss of bowel/bladder control. no fever.  12/04/09 Vaccine record received for DOS 11/30/09  12/04/09 Neurology consult notes for DOS received for DOS 12/03/09. Impression: paresthesia/disesthesias  Pt c/o numbing and tingling of fingers, feet and shoulder, worsening of chronic back pain. Neurological exam was negative. Pt had paresthesia/disesthesias.
within maybe 4 days of getting the 1st in the series of shingles shot I developed a couple red spots in a line on the left side of my torso. They were kind of itchy/ painful but generally mild. They seemed like a mild case of shingles. I think the symptoms went away after less then 2 weeks. The scaring is barely discernible now. A nurse who got the shot recently complained of the same symptoms but on another place on her body.
3 inch by 6 inch red, raised, inflammed tissue at surrounding injection site.  Patient kept dermatologist appointment, was given 10mg cetirizine and topical clobetasol.  On 8/22 reaction had significantly subsided.
Headache, Myalgia, Arthralgia, Fever, Developed fever, HA, fatigue, myalgias, arthralgias, nasal congestion < 24 hrs after 2nd COVID 19 vaccine. Narrative:  Developed fever, HA, fatigue, myalgias, arthralgias, nasal congestion < 24 hrs after 2nd COVID 19 vaccine.
severe hives mainly on back hip and legs some on upper body. took Benadryl 50 mgs and applied Benadryl gel
Narrative:  60 yo male: Extensive GU hx including pubic synthesis oseo, recurrent groin abscess, chronic osteitis pubis, prostate ca s/p resection,8/5/15 dilation urethral stricture, bladder neck obstruction. Just returned from a 10 day vacation. Went to facility 6/17 (per remote data for cystitis, intramuscular abscess,ct scan, labs, general surgery consult, bactrim, oxycodone) and discharged home. Returned Friday. Trying to self-cath, but unable to get any or minimal urine out, severe urethral pain. Denies any nausea, vomiting, fever,chills, cp, soa, abnormal bms. Agency made aware pt died at home on 7/8/2021. Circumstances of death not given. Pt had received covid vaccinations on 2/4/21 & 3/5/21. Likely pt's death is not related to covid vaccinations.
Pt. states that after receiving the 2nd dose of Phizer 03/18/2021, started experiencing symptoms 04/21/2021 of right ear pain and right side of the head hurting. 04/22/2021 Primary visit recommended antibiotic/ nerve infection in gland. Urgent Care visit 04/25/2021 severe head pain/ Neurontin. 04/28/2021 Urgent Care visit/ spots located on back of the head, mouth, and face. Zoster Chicken Pox/ Hospitalized 3 days discharged home. Urgent Care visit 05/02/2021 trouble swallowing and loss of weight. Steroid prescribed at the time with recommendation for swallow test. Paralyzed vocal cord, ENT specialist and Neurologist Therapist recommended. Still continuing to experience symptoms.
Vomiting and diarrhea for 3 days. Low grade fevers. Persitant diarrhea for 4 weeks
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N001489 with expiry date 12-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Patient said on 7/11/15 that she had a flat red rash around the site of immunization injection the diameter of a baseball. She also felt achy with joints hurting a feverish. After taking otc Benadryl on 7/11/15 she felt better and the rash was much smaller.
Severe dry cough, temperate max = 99.4, hoarseness, headache, insomnia
Initial information received from a healthcare provider who is also the patient, on 13 January 2014. A 55 year old male patient had received his dose of FLUZONE (lot # UH900AC) on 06 January 2014, route and site of administration were not reported. On 09 January 2014, i.e. within 72 hours, the patient began to experience trigeminal neuralgia. The trigeminal neuralgia had lasted 4 days and was decreasing at the time of the report. The patient had no allergies and had a medical history of hypertension, hypercholesterolemia and kidney stones. The patient did not receive any other vaccinations within 4 weeks of FLUZONE administration. Laboratory tests and concomitant medications were not reported. The jaw pain was 98 percent better on 13 January 2014. The patient outcome was not recovered. Documents held by sender: None.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 12-MAY-2011, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-OCT-2012, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster. 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 has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Symptoms appeared 8-30-11. Cellulitis spread from deltoid to elbow (red/swollen and soreness).
No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date).    Concomitant Medication use information was not provided by reporter.  Pharmacist reports that the more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 monovalent and 20 bivalent) which were beyond the 30 day beyond use date.  Patient received vaccine at Pharmacy.  The lot 042J21A beyond use date of the vaccine was reported as 17 February 2022.  NDC number was reported.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow up received that contains significant information includes updated patient details, suspect product details and updated narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
parents described 4 episodes of tonic-like rxn, where pt stiffened up 1-2seconds but remained fully awake & alert; noted to have t105;
This case was reported by a pharmacist and described the occurrence of anaphylaxis in a subject of unspecified age and gender who was vaccinated with Dtpa, manufacturer unspecified, IPV, and MMR vaccine. The subject's medical history and concurrent medications were not provided. On an unspecified date the subject received an unspecified dose of Dtpa (unknown), an unspecified dose of IPV, and an unspecified dose of MMR vaccine. At an unspecified time after vaccination with Dtpa, IPV and MMR vaccine, the subject experienced anaphylaxis that required an emergency department visit. The pharmacist considered the event was clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified.
1st dose before pandemic, 2nd dose 02Nov2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 9CR25, expiry date 24th September 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received right before the pandemic).   On 2nd November 2022, the patient received the 2nd dose of Shingrix. On 2nd November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 23-JAN-2023 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the patient received first dose of Shingrix vaccine right  before the pandemic and the exact date was unknown.   The reporter stated that the patient did not receive the second dose until 02nd November 2022.   The reporter did not have the exact date or lot number information for the first dose.   The reporter did consent to follow up. Additional supportive information: The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
Fever, chills, muscle aches started approximately 12 hours after vaccination. Single episode of vomiting at 15 hours. Other symptoms resolved within 32 hours.
The day after the second dose, a small red bump first appeared on the stomach. 8:10 PM to spread all over the trunk of the body and spreads every day little by little covering the whole body. Bumps are very itchy.
Patient states he continues to experience muscle soreness and arm pain beginning the day vaccination. The pain began 1 day after immunization and continues 18 days post immunization.
Headache, slight fever, severe injection site pain that lasted 5 days (could hardly move arm or apply ice it was so sore), whole muscle swollen.
Reports that after shot was administered her arm was aching; she then developed rash on arm and body. Subsequent mouth swelling - all which are ongoing. On 12/6 reported (L) arm tingling - PCP and cardio says she is OK.