chrisvoncsefalvay/vaers-outcomes huggingface dataset:
81 year old white male in for flu and pneumonia. About 45 minutes later, patient began to feel sick at stomach (at friend's house), left to go home. When wife came home, he was lying on bed, cold and wet with sweat to touch, lips gray looking. complained of nausea and weakness. Wife called health department and was told to go to ER and call PMD and to let PHN know. She called back to say PMD told her to take patient to ER. PHN called patient back at 2:#0 PM. Wife said patient refused to go to hospital but is much better now; sitting up and eating. Stressed to her to take him to hospital if conditions worsens.
Elevated Liver enzymes; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC ENZYME INCREASED (Elevated Liver enzymes) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced HEPATIC ENZYME INCREASED (Elevated Liver enzymes). The patient was treated with NORETHINDRONE ACETATE at an unspecified dose and frequency. At the time of the report, HEPATIC ENZYME INCREASED (Elevated Liver enzymes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
"Had a 3-4 cm red welt at the injection site of my flu shot w/in 3 hours of receiving it. It itched! The treatment I used was to ice the area. The affected area was hard, red and slightly raised for 4 days, shrinking in size on the 3rd & 4th day."
Patient reported feeling hot, having a headache and developing some chest-tightness approximately 10 minutes after receiving the vaccine; because of allergy to Benadryl EMS transport to hospital advised
Since getting the vaccine, she has had fevers, body aches, joint pain, stomach pain, vomiting, lost of appetite, fatigue, and headaches.
This case was reported by a pharmacist and described the occurrence of extra dose administered in a patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown dose, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional information: A dose of quadrivalent flu vaccine (likely FLUARIX QIV) was administered to an adult patient one month after administration of the same vaccine to the same patient. No further info available at the time of reporting.
High fever, tiredness, body aches, headaches,  little shortness of breath carrying heavier objects( 30-40lbs)
Large knot at injection site and a small rash on 2/11/2021. Today (2/15) the knot is almost gone. The rash has been off and on. Today the rash is bigger, slightly raised and itchy.
This spontaneous report as received from a physician refers to approximately 8 years old male patient. The patient's medical history included sensitive skin. The patient had no drug allergies/reactions. On an unspecified date in 2006 approximately (when the patient was 1 year old) patient was vaccinated with VARIVAX (merck) dose one, dose (unspecified), frequency (unspecified), and route (unspecified). Second dose of VARIVAX (merck) was administered on an unspecified date when the patient was between 4 years and 6 years of age. No concomitant medication was reported. On 09-DEC-2013 the patient broke out with zoster. Patient sought medical attention at an unspecified physician's office on 09-DEC-2013 and was treated with a 7 day course of oral acyclovir. On 26-DEC-2013, patient presented himself to an unspecified physician with complaint of not feeling well and was hospitalized on same day (26-DEC-2013). On 26-DEC-2013 the patient was diagnosed with meningitis (hospitalization and medically significant). Treatment included an additional 2 weeks of IV acyclovir which was begun on 26-DEC-2013. Lumbar Puncture performed on 26-DEC-2013, resulted in 1,932 white cells. The results HSV (Herpes simplex virus) and PCR (polymerase chain reaction) obtained on 27-DEC-2013 were negative and the result of VZV (Varicella zoster virus) obtained on 30-DEC-2013 was negative. Patient was scheduled for discharge from hospital on 31-DEC-2013. The patient had no drug reactions/allergies. No product quality complaint was involved. Causality assessment was not provided. The outcome of events was reported as recovered (28-DEC-2013). No further information was provided. Upon internal review, the event of meningitis was considered to be medically significant. Additional information has been requested.
light headed, anxious, pt. advised to hydrate BP 86/48,  O2 98%, P=80.   Had a snack.  States that she feels better and wants to go home.   Accompanied by husband.
This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 20-NOV-2012 was vaccinated with an improperly stored dose of (Merck) PROQUAD (dose and route unknown), Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
pt complaining of numbness; arm same as injection 3 numb lasting 20 minutes two fingers back to normal;   pinky still feeling funny and itchy; pt becoming anxious now; c/o of feeling very tired; seen by MD to  be transferred to ER accompanied by nurse and physician
This spontaneous report as received from a pharmacist refers to a newborn (male) patient of unknown age. On 26-OCT-2012 at 13:04, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Narrative:  Patient got her second covid vaccine on 3/7 and on 3/16  reported that for the past couple days she has had a headache on and off. Called provider to report and see if this was a common finding.
Severe headache, body ache and joint pain all over body, numbness in feet and hands halfway up to fingertips and toes
On October 25 I noticed petechiae covering my back. I went to the doctor on the 26th and my platelets were at 36,000. I went to a hematologist on Tuesday and they were at 21,000.
I started having left-sided chest pain earlier today off and on, and when I pushed on my chest it hurt. I called my doctor to explain what happened and she said it sounds like costochondritis and that I should apply Voltaren Gel to the affected area and take Motrin or Naproxen, and call her back if symptoms stay the same or worsen after a few weeks.  She also instructed me to go ahead and report the reaction.
Patient reports having a history of anxiety. Stayed for 15 minutes, then went up to her apt. She came back down to report that she was having pain in her right breast (hx of Cancer in it) then it radiated to her right side down to her pelvic region. She reported feeling woozy/dizzy. She did not lose conciousness. HR was 80 regular, BP 164/92, lungs clear.
General aches and malaise developed systemic pinkened skin progressed to reddened. Developed dizziness, malaise worse, low grade temp of 100.00.
Two seizures approx 2 min long, generalized, clonic in nature w/postictal state;
3rd Moderna COVID vaccine given 10/28/21, lot # not known; pt resides in SNF (local Health and Rehab Center); positive for COVID on 10/3/22; given IV ABX, productive cough, O2 supplementation via NC; pt. found slumped over deceased in room; pt. expired in the SNF
Initial case was retrieved from the scientific literature on 06 November 2012. The following was copied verbatim from the literature case: "A 28-year-old man, with history of varicella as a child, was referred for a painful rash. He was in excellent health until about 2 weeks prior when he received an influenza vaccine. The following day, he noted the development of a cold sore on his lip. He was treated with over the counter medications. About 1 week later, he developed a burning-like pain across the mid-back and then noted a rash. Examination revealed a rash consistent with herpes zoster, just lateral to the midline of the back, at the level of T9. The remainder of the examination was normal. Setting: Outpatient. Results or Clinical Course: The rash had resolved. However, the patient continued to have pain and was started on gabapentin and provided with a TENs unit, which helped to resolve the pain. Discussion: Reactivation of the herpes virus appears to be influenced by age-related immunosenescence, disease-related immunocompromise, or iatrogenic immunosuppression. Studies have shown that the incidence of zoster increases 10-fold with age. It is estimated that approximately 50% of persons who live to age 85 will have an episode of zoster. The virus infects nerve endings in skin and migrates along sensory axons to establish latency in neurons within the regional ganglia. Once reactivation occurs, the virus can spread to other cells within the ganglion and thereby establish infection of the skin. Following viral reactivation, the dorsal spinal ganglion typically exhibits intense inflammation, accompanied by hemorrhagic necrosis of nerve cells. The ganglion undergoes eventual neuronal loss with subsequent fibrosis of afferent nerve fibers, particularly type C nociceptors. One of the goals of antiviral therapy is to reduce the incidence or severity of postherpetic neuralgia (PHN). Antiviral therapy likely reduces neural damage, which may contribute to the development of PHN. Several studies have demonstrated that treatment for herpes zoster reduced the duration and incidence of prolonged pain. Pain management should include use of standardized pain measures and the use of analgesics. If moderate to severe pain continues despite these interventions, steroids can be considered. Conclusions: There is no known case in the literature of the influenza vaccine leading to shingles. In this patient, the influenza vaccine appears to have reactivated the latent HSV-1 & HSV-3 viruses." The patient's outcome was not reported. Documents held by sender: none.
Initial information received on 19-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old male patient who had "extra hib" that was administered and hib portion of the PENTACEL only mixed with a vial of distilled water, while he received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTATEQ. The nurse called to report that Hib portion of the PENTACEL only mixed with a vial of distilled water that came with the MMR vaccination in the office. The pediatric doctor realized that the PENTACEL did not get reconstituted as recommended with the PENTACEL liquid component  correctly on 09Jun2018 to a male pediatric patient by another pediatric nurse at the office. This dose on 09Jun2018 was administer in the left thigh of the pediatric patient and this patient only received the HIB portion of the vaccine. The error was realized by the attending doctor and the mother was contacted to come in for a correct PENTACEL dose. Other vaccination administered that day to patient: ROTATEQ (by Merck.) The nurse calling today reported that a full single .5 ml dose PENTACEL vaccine was correctly administered on 17Jun2018 by herself since she is aware that the first vaccine is not valid. The attending doctor on 17Jun2018. She wanted us to know that the mother was concerned about the "extra HIB" that was administered due to this error with the PENTACEL and wanted to know if this "was harmful." Provided the nurse with our recommendations for this event and did discuss the Reconstitution Guide as a resource for the office staff. The Lot number to the PENTACEL HIB vial was C5439AA and the MMR diluent not available (another manufacturer and not available in computer.) The portion of the PENTACEL with the Polio, Diptheria and Pertussis that was NOT given on 09Jun2018 has a lot number of C5264AA. The nurse reported that she has the Lot number of C5438AA for the correctly administered PENTACEL from 17Jun2018 but did not have the liquid component of the vaccine Lot number because they only record the reconstituted lot number only in their records (Liquid portion LOT number with Polio, Diptheria and Pertussis NOT available for template.) This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
"after i got my pneumonia shot on Friday, my  arm go red and sore and I was chilling and could not get out of bed on Saturday. HPI: vet recieved pneumoccol vaccine on Friday and developed chills, fever,  pain, redness and swelling at injection site within 24 hours of injection..returns today for evaluation. Denies dizziness, fainting, headache,  blurred vision, weakness, fatigue, chest pain, shortness of breath, N/V/D.
Patient noticed swelling in armpit region of the arm that received the vaccine.  He was already utilizing ibuprofen and /or acetaminophen.  Patient reports swelling seems to be resolving as of Wed 2/17/21.
!st was Very sore muscle. tylenol did not help, Ice barely helped. Then Shivering for 3 hours. The the worst dizzy spell in my life with Nausea. Very tired everyday, the last day was 10/1/2020
Patient stated that 5 days after receiving the vaccine she would get this pain all over her body. She noticed swelling and red spots on her knuckles. She would be awoken with body ached that would last about a day and then go away. Patient stated that she had to deal with the pain from February to June.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 06-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N014759, expiration date 08-NOV-2017 (strength, dose and route of administration were not reported) for prophylaxis. It was reported that PROQUAD was reconstituted with properly stored sterile diluent (MERCK) lot number N011475, expiration date 08-AUG-2019. The temperature of excursion with PROQUAD was 15 to 46 Fahrenheit degrees during 11 hours and 30 minutes. Previous temperature of excursion was 15 to 46 Fahrenheit degrees for 12 hours and 45 minutes. The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1711USA006109: US-009507513-1711USA006081.
Outreach vaccination event at School.  20 MCV4 and 20 Tdap vaccines were taken to the event. Upon return to the Health Department clinic there was 5 Tdap and 8 MCV4 that were leftover. 14 students were vaccinated with both vaccines. Upon review of the vaccine inventory taken to this outreach event and the total number of students vaccinated, an error occurred.
Aches; Chills; Sweats; Exhaustion; Booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55 year-old male patient received bnt162b2 (BNT162B2), administration date 28Nov2021 15:00 (Lot number: FJ1620) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN5318), administration date: 20Apr2021, when the patient was 55 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN 5318), administration date: 30Mar2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 28Nov2021 15:00, outcome "unknown", described as "Booster dose"; PAIN (non-serious) with onset 29Nov2021 11:00, outcome "recovering", described as "Aches"; CHILLS (non-serious) with onset 29Nov2021 11:00, outcome "recovering", described as "Chills"; HYPERHIDROSIS (non-serious) with onset 29Nov2021 11:00, outcome "recovering", described as "Sweats"; FATIGUE (non-serious) with onset 29Nov2021 11:00, outcome "recovering", described as "Exhaustion". Therapeutic measures were not taken as a result of pain, chills, hyperhidrosis, fatigue. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Rash on both arms I had my first shot on my left and made the decision to have my second on my right
One day following Shingrix dose, arm became very red and swollen at injection site.  Reported burning like nerve pain, particularly when water hit the vaccinated arm.  When presenting to the pharmacy one week later, the injection site and approximately 2 inch surrounding area appeared to be scabbed over.
Patient can't lift left arm above shoulder (Partial loss of motion of left arm). As of 2/28 patient's arm is still painful.
Missed the recommended interval between doses/first dose 30Apr2021 and he missed the 2nd; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval between doses/first dose 30Apr2021 and he missed the 2nd) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval between doses/first dose 30Apr2021 and he missed the 2nd). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval between doses/first dose 30Apr2021 and he missed the 2nd) had resolved.        Concomitant medications were not reported. Treatment medications were not reported.
4-inch diameter red, raised, itchy patch around injection site appears on Day 8 after the vaccination injection.  Lasted 2-3 days then disappeared.
Pt brought back by w/c with (X-ray), HO/PMD. Dr. stated pt. OK now he noted pt fainted in her car with mom. Pt walk out with mom after injection of MENACTRA ever informed about possible reaction after MENACTRA, suggested to stay at waiting room a least 15 min but she walk out with mom B.P 90/60 no apparent problem back to home with after 15 min.
This spontaneous report was received from a pharmacist and refers a 55 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions and concomitant medication were not reported. It was stated that the pharmacy received the ZOSTAVAX on 15-JUL-2016. On 29-JAN-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 plaque-forming unit (PFU) injection, subcutaneously, 0.65 ml, lot # M014310, expiry date 26-MAY-2017 (anatomical location was not specified) for prophylaxis. On 22-MAR-2017, the pharmacy was audited by The Board of Pharmacy. The freezer temperature where ZOSTAVAX was stored was registered by the pharmacy thermometer as 2 Fahrenheit degrees, however the auditor's thermometer registered the temperature as 9 Fahrenheit degrees which was considered as a temperature excursion. The Board of Pharmacy auditor determined that the pharmacy's freezer thermometer should have been calibrated. Seven of the 10 doses of ZOSTAVAX that had undergone the temperature excursion had been administered to 7 patients between July 2016 and January 2017 (also reported as "over an 11 months period"). The remaining 3 doses were sent back for disposal. There was no previous temperature excursion. No adverse effect were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received.; Sender's Comments: US-009507513-1705USA006382: US-009507513-1705USA006383: US-009507513-1705USA006384: US-009507513-1705USA006385: US-009507513-1705USA006380: US-009507513-1703USA010654:
headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments  Concomitant medications not provided. Treatment information not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-080102; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080102:second dose of the same patient
Initial report received from a nurse on 03 December 2013. Medical history included thyroiditis, borderline high blood pressure. A 45 year old female patient had received a dose of FLUZONE (lot number unknown, intramuscularly on left deltoid on an unspecified date in 2011). On an unspecified date (2011), after receiving vaccine the patient developed a major swelling under her arm in the armpit area. The swelling was so large she had to hold er arm up., couldn't put it down to the side. She had generalized weakness and fever of 102 F. She was unable to work for one week. At the time of this report the outcome of adverse event were recovered.  Documents held by sender: none.