chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose given past the 12 hour post puncture time; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time). On 06-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter stated that dose was given past the 12hour post puncture time.  No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-327879 (Patient Link).
I had flu vaccines before - not unusual to feel 'off' for a day, but nothing significant. I decided to add the RSV vaccine this year because I am around my elderly (mid-80's) parents frequently. They are in an assisted living facility, so I am around other elderly people as well.  Boy, do I regret adding the RSV as I am assuming that is what caused the problem. Vaccinated on Thursday, NOV 9 at 3:15 pm.  I could feel the 'typical' flu vaccine reaction by 12 midnight that night. Nothing unusual at this point. Got up the next morning (Friday, NOV 10) to take my car to the dealership for some work.  As I waited for my car (about 2 hours) I began to feel worse and worse - headache, slight fever, body aches, fatigue.  By the time I got home - went straight to bed (12:30 pm or so). Symptoms continued to get worse. So much so that by that evening, I felt like I had a full-on flu infection. Body ache and headache so bad I could not sleep. On Saturday, NOV 11 I spent the entire day in bed, miserable.  Nausea set in so severely that I couldn't stand up without getting extremely nauseous. Threw up the medication and vitamins I take in the evening. Did not eat anything that day as I couldn't stomach the thought of food. Sunday, NOV 12 was more of the same, except now I had sinus/head cold symptoms as well. Sore throat, stuffy nose, coughing. Monday, NOV 13 was tolerable, but once I had what I had to do done, back to bed. Tuesday, Nov 14 the first relatively 'normal' day, however I still had lingering head cold symptoms. I have never lost so much time due to a vaccine nor have I ever felt sick for so long. Today (NOV 16) is really the first day I feel normal. One whole week later.
sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at the injection site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (sore arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-058023 (Patient Link).
This case was reported by a consumer via call center representative and described the occurrence of injection site joint pain in a 57-year-old male patient who received SHINGRIX for prophylaxis. On 7th August 2018, the patient received SHINGRIX. On 7th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site joint pain, back pain, limbs stiffness, headache and poor sleep. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site joint pain, back pain, limbs stiffness, headache and poor sleep were unknown. It was unknown if the reporter considered the injection site joint pain, back pain, limbs stiffness, headache and poor sleep to be related to SHINGRIX. Additional details were provided as follows: This case was reported via click to chat. The patient had contacted to ask if she can take ibuprofen 24 hours after receiving the SHINGRIX vaccine and would they interact typically. A day before reporting, the patient received the vaccine at 4:00 and stated that the effects of the vaccine were kicking her butt. The patient experienced shoulder pain at the injection site, back ache, leg stiffness, headache and did not sleep well night of vaccination. The product specialist informed the patient that as per the prescribing literature ibuprofen is not listed specifically and it stated that Drug Interactions: Immunosuppressive therapies may reduce the effectiveness of SHINGRIX. In addition, the product specialist stated that they were not allowed to give medical advice and referred the patient to her doctor (or pharmacist) as the primary resource for patient care. The patient replied that as per her research Ibuprofen was not immunosuppressive, and asked if that caused a different thought. The product specialist stated that then she might infer that it is not an immunosuppressive that it would reduce the effectiveness of SHINGRIX. The patient was informed that they did not have specific information on the use of Ibuprofen and SHINGRIX. The patient would be taken ibuprofen in about 15 minutes after vaccination. The patient provided contact details of the physician. The patient would be send a copy of the prescribing literature for SHINGRIX.
8/22/21  Vetreous Hemorrhage RIGHT EYE Treatment with Avastin  LEFT EYE vision unstable
feeling weak; Fatigued; Aching; She could not walk up the stairs in her home; Unable to sleep due to chills; Pain in the arm; made a cup of hot tea but vomited it up about 90 min later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 (Batch/Lot number: unknown) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High BP" (unspecified if ongoing); "Unilateral tumors on adrenal gland" (unspecified if ongoing); "known allergies: shellfish" (ongoing). Concomitant medication(s) included: HCTZ; NIFEDIPINE; TYLENOL. Vaccination history included: Bnt162b2 (1st dose, Left arm), administration date: 23Mar2021, for Covid-19 immunization. The following information was reported: ASTHENIA (non-serious) with onset 13Apr2021 21:30, outcome "not recovered", described as "feeling weak"; FATIGUE (non-serious) with onset 13Apr2021 21:30, outcome "not recovered", described as "Fatigued"; VOMITING (non-serious) with onset 13Apr2021, outcome "not recovered", described as "made a cup of hot tea but vomited it up about 90 min later"; CHILLS (non-serious) with onset 13Apr2021 21:00, outcome "not recovered", described as "Unable to sleep due to chills"; PAIN IN EXTREMITY (non-serious) with onset 13Apr2021 21:00, outcome "not recovered", described as "Pain in the arm"; PAIN (non-serious) with onset 13Apr2021 21:30, outcome "not recovered", described as "Aching"; GAIT DISTURBANCE (non-serious) with onset 13Apr2021 21:00, outcome "not recovered", described as "She could not walk up the stairs in her home". Therapeutic measures were not taken as a result of asthenia, fatigue, vomiting, chills, pain in extremity, pain, gait disturbance.  Additional information: At 9:30 pm on 13Apr2021 (day of 2nd vaccine dose), patient began feeling weak, fatigued, and aching, so much so that she had to stop what she was doing. She made a cup of hot tea but vomited it up about 90 min later. That night, she was unable to sleep due to chills, and was so weak that she could not walk up the stairs in her home. On the morning of 14Apr, she tried taking Tylenol twice, but vomited it up both times, at 5 am and 7:30 am. She continues to feel fatigued, weak, with a headache and pain in the arm she received the vaccine. It was reported that there was no covid prior vaccination. Patient not tested for covid post vaccination. There was no other vaccine in four weeks from vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
INJECTION SITE PAIN Narrative:  MILD INJECTION SITE PAIN, RESOLVED, NO MEDICATION NEEDED
It was reported that a female pt received a TD vaccination on 4/13,99. Reportedly, on 4/14/99, she experienced redness, swelling and pain at the injection site and limited range of movement in the shoulder area. The pt was reportedly treated with Medrol pack, Tylenol and compresses by physician at office. Follw-up #1 - Attempted one-year follow-up letter was sent to reporter on 25-Apr-2001, letter was returned to sender "unable to forward." Attempted to call the provided phone number for the reporter on 21-May-2001 and again on 25-May-2001, no answer. Researched on Internet: telephone number of residential/unlisted. Attempts are exhausted. This case is closed.
sore throat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jul-2021 and was forwarded to Moderna on 28-Jul-2021.    This spontaneous case was reported by a nurse and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) 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.   No concomitant medications were reported. No treatment medications were reported.
Expired dose administered to patients; Vial was initially stored in the refrigerator on 01 Dec 2021 and administered on 11 Jan 2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 01 Dec 2021 and administered on 11 Jan 2022) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 01 Dec 2021 and administered on 11 Jan 2022). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 01 Dec 2021 and administered on 11 Jan 2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications are provided. No treatment medications are provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Jan-2022: Significant follow-up appended includes patient identifiers, route of administration and additional event was added.
At 05:15 AM 12/3/09 Pt was sleeping with mother and mother - was awakened by jerking movement on left side arm and leg clench - left hand turning inward. Arm and leg kept jerking - child had blank stare would not respond - mom - called 911 - Taken to hospital and then to another hospital for 1 day stay.
passed out, later had chest pains, high blood pressure, high heart rate and was checked for a PE via catscan.  Still experience racing heart periodically almost 2 months later.
there have been no reported side effects; Medical Assistant reported that an expired dose of MMR-II was administered to a patient; This spontaneous report has been received from a medical assistant and refers to a 16-month-old female patient.  The patient's medical history, concurrent conditions and previous drug reactions or allergies were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 15-AUG-2022, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) at a dose of 0.5 ml subcutaneously 1 dose,  lot #T029549, expiration date: 10-SEP-2022 for prophylaxis (Expired product administered). It was mentioned that the suspect vaccine had not previous temperature excursions. It was stated that no side effects occurred (no adverse event).  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2209USA002318: US-009507513-2209USA002394:
RED 3 INCH LONG CIRCLE ON DELTOID AREA. WARM TO TOUCH.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-OCT-2014, the patient was vaccinated at a Medical Care center with ZOSTAVAX (lot number, dosage, and route of administration not provided),  as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about September 4, 2016, was treated at Medical Care Center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir and hydrocodone bitartrate and acetaminophen (VICODIN) for management of her persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
SWELLING AT THE SITE, SORENESS, HOT TO THE TOUCH, ITCHING AT SITE, BODY ACHES, SORENESS TO ENTIRE ARM
pt recvd vax;w/in 2 mon p/ dose 3 found to have elev liver enzymes;
Vomiting occurred about 4 hours later, lasted for 4 hours.  I am not all that convinced that it was vaccine, yet I thought it would be wise to report.  No rash from vaccine.
Information has been received from a physician, concerning a 66 year old male with allergy to penicillin, hypertension and a family history of Alzheimer, congestion heart failure and hypercholesterolaemia, who on 07-MAY-2008 was vaccinated with 0.65 mL of ZOSTAVAX (Lot #659760/0159X) SQ. Concomitant therapy included IM PNEUMOVAX 23. On 18-AUG-2008, the patient went to the office with rash, pain and swelling of the right side of his face and right side of forehead. At the time of the report, the patient was not recovered. No treatment; the patient being monitored. The patient sought medical attention into office. There was no product quality complaint. Additional information is expected.
tested positive for Covid; tested positive for Covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable Nurse (patient) reported that a 37 years old female patient received 2nd dose of BNT162B2 (Batch/lot number: EL1283/EH9899, Expiry Date: Mar2021) on 08Jan2021 at single dose on Left Deltoid, upper left arm for Covid-19 immunization. Medical history and concomitant drug were not reported. It was reported that patient received both doses of Covid vaccine and tested positive for Covid day 18 post second dose. She received the second dose on 08Jan2021. However, she tested positive for COVID-19 on 24Jan2021. She wanted to know if she will be an asymptomatic carrier in the future. Outcome of the event was unknown.  No follow-up attempts possible. No further information expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
17cm x 17cm raised redness. Warm to touch. On Rt. upper arm. Sore to touch. Received PNEUMOVAX 2/3/17. Observe. No treatment.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 24-APR-2013 the patient was vaccinated with ZOSTAVAX (lot # and exp date 03-APR-2013) (dose, route and anatomical location unspecified). The pharmacist reported that patient was vaccinated with ZOSTAVAX which had expired on 03-APR-2013. No adverse effect reported. Additional information has been requested.
Itchiness; Fatigue extreme; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness) and FATIGUE (Fatigue extreme) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included SUCRALFATE (CARAFATE), CARVEDILOL (COREG), ARIPIPRAZOLE (ABILIFY), PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), ALPRAZOLAM (XANAX), FLUTICASONE PROPIONATE (FLOVENT HFA) and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PRURITUS (Itchiness) and FATIGUE (Fatigue extreme). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch, at an unspecified dose and frequency and VITAMINS NOS at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchiness) and FATIGUE (Fatigue extreme) outcome was unknown.        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.
Vaccination prompted onset of menses (2 weeks early) and lasted for a duration of 3 weeks.
Swollen, red lower 2/3 of upper left arm. Per patient, she experienced pain beginning the day after the vaccines. She saw her MD 3 days later at which point some blood work was done which the patient said confirmed that it was a infection. She did not recall what blood work was done. MD started her on AUGMENTIN to treat the infection.
On Sunday 12/5, I woke up with a pain in my left chest.  It hurt to take a deep breathe.  I thought it would go away.  At approximate 6:00pm, it was very difficult to breathe.  I went to the emergency room and was admitted with blood clots in my lungs.  I stayed overnight.
Information has been received from a certified medical assistant (C.M.A.) concerning a 23 year old female with no pertinent medical history or drug reactions/allergies who on 11-JAN-2008 was vaccinated with her first dose of Gardasil (659439/1267U), 0.5mL intramuscularly.  There was no concomitant medication.  The patient experienced dizziness after the injection and stated that she felt "hot inside".  The patient was observed in the office for 20 minutes after the injection and then was released.  The patient then continued on to work.  She had called the office back an hour later stating that she was still "having that feeling".  Medical attention was sought, in the office and by telephone.  No lab diagnostics were performed.  The patient's outcome was not provided.  The product quality complaint unit was not involved.  Additional information has been requested.
Paresthesia, numbness, Myalgia in Arms and legs, insomnia, anxious, nausea, fatigue, high ANA, blood pressure and heart rate spikes.
This spontaneous report was received from a registered nurse who referred to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of VARIVAX subcutaneous injection, intramuscularly, lot# reported as N0220016 (confirmed to be an invalid lot #), expiration date reported as 17-JUL-2019 for prophylaxis. The nurse reported that the patient was vaccinated "intramuscularly rather than subcutaneously". No adverse effects were reported.
This case was reported by a physician and described the occurrence of Guillain-Barre syndrome in a 74-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included diabetes and hypertension. Concurrent medications included LISINOPRIL, SIMVASTATIN, LOFIBRA and METFORMIN. On 6 October 2011 the subject received a dose of FLULAVAL (.5 ml, unknown route, left arm). On 19 October 2011, 13 days after vaccination with FLULAVAL, the subject experienced body pain and chills. On 4 November 2011 the subject experienced Guillain Barre syndrome, went to the emergency room and was admitted to the hospital. On 11 November 2011, he was transferred to a rehabilitation center. On 23 December 2011, he was discharged with home care. The subject was hospitalised and the physician considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The physician considered the events were possibly related to vaccination with FLULAVAL.
Patient woke up on AM of 9-11-10 and had a rash of right arm (same as arm immunized), rash decreased with time.
Patient left from behind screen and went to sit in the waiting area and immediately became dizzy then she fainted.  At this time her mother said she has passed out before after receiving a vaccination.  We called 911 and she refused to go to the hospital.  When she left, she had regained her color and could stand and sit without being dizzy.  Both mother and patient said she was fine.