chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to a 67 year old female patient. The patient did not have medical history, concurrent conditions and drug reactions. On 25-APR-2016, the patient was vaccinated in her arm with a dose of PNEUMOVAX23 intramuscularly (strength, dose number, lot number and expiration date were not provided). The patient did not take concomitant medications. On 25-APR-2016, the patient experienced in her arm (unspecified if right or left) injection site swelling, injection site pain, injection site pruritus and had a six to eight inch area of redness around the injection site (injection site erythema). No treatment was given for the adverse events. No laboratory diagnostics studies were performed. The case did not involve cancer or overdose. The outcome of injection site pain, injection site erythema, injection site pruritus and injection site swelling was reported as not recovered. No product quality complaint was involved. Additional information has been requested.
Pt recvd vax & 6 hrs later about 7AM exp hives on face & chest; by 5PM spread down both legs & arms; went to ER hives dx; 28OCT92 12noon went to ER w/eyes swollen shut; itching, redness & swelling on face;
RAISED RED AREA SIZE OF A QUARTER- ON HER RT ANTERIOR THIGH. REACTION FROM VARICELLA VACCINE
I felt dizzy; I started shaking on my right side/ right leg is shaky; I got weak; my right leg is shaky, I'm not stable walking; I don't have the best appetite; nausea; I had headaches; I threw up; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I felt dizzy), TREMOR (I started shaking on my right side/ right leg is shaky), ASTHENIA (I got weak), GAIT DISTURBANCE (my right leg is shaky, I'm not stable walking) and DECREASED APPETITE (I don't have the best appetite) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, the patient experienced DIZZINESS (I felt dizzy), TREMOR (I started shaking on my right side/ right leg is shaky), ASTHENIA (I got weak), GAIT DISTURBANCE (my right leg is shaky, I'm not stable walking), DECREASED APPETITE (I don't have the best appetite), NAUSEA (nausea), HEADACHE (I had headaches) and VOMITING (I threw up). At the time of the report, DIZZINESS (I felt dizzy), TREMOR (I started shaking on my right side/ right leg is shaky), ASTHENIA (I got weak), GAIT DISTURBANCE (my right leg is shaky, I'm not stable walking), DECREASED APPETITE (I don't have the best appetite), NAUSEA (nausea), HEADACHE (I had headaches) and VOMITING (I threw up) had not resolved.            No relevant concomitant medications were reported.  No treatment information was provided.
Discomfort; Pain; sleeplessness; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort), PAIN (Pain) and INSOMNIA (sleeplessness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (Discomfort), PAIN (Pain) and INSOMNIA (sleeplessness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DISCOMFORT (Discomfort), PAIN (Pain) and INSOMNIA (sleeplessness) outcome was unknown. Not Provided          No concomitant medications were provided by the reporter.  The patient experienced same  symptoms after second shot was noted.   This case was linked to MOD-2021-075172 (Patient Link).
Vaccine breakthrough infection, mild/moderate symptoms; Vaccine breakthrough infection, mild/moderate symptoms; mild chest pain; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was Er8739, and expiration date was not reported), via an unspecified route of administration, administered in left arm on 02May2021 (Age at vaccination was 30 years) as dose 2, single for covid-19 immunisation at School or Student Health Clinic and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was Ep7533, and expiration date were not reported), via an unspecified route of administration, administered in left arm, on 11Apr2021 (Age at vaccination was 30 years) as dose 1, single for COVID-19 immunization at School or Student Health Clinic. The patient medical history was none. The patient did not have covid prior to vaccination. The patient's concomitant medications were not reported. The patient did not take other vaccine in four weeks and other medications in two weeks. On 04Oct2021 the patient experienced vaccine breakthrough infection, mild/moderate symptoms including fever, muscle aches, cough, congestion. On same date patient also experienced mild chest pain. On 06Oct2021 the patient underwent lab tests and procedures which included body temperature with result unknown and sars-cov-2 test having result positive with nasal Swab. Supportive care was taken as therapeutic measures. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
p/vax pt was snot feeling well;about 4hr later had T104;took to walk in center @ hosp dx rxn to vax;
Patient states 12 hours after 2nd injection she reported fever of 101.5, extensive shaking with chills, whole injection arm tingling, nauseated, and metal taste in mouth.  Admits to be taking Tylenol and Benadryl.  At the time of her reporting effects she continues to have stated effects.
Sore arm and hot that evening. The next day - body aches, prickly skin, joint pain, swollen lymph nodes (sore in armpits and behind ears), extreme tiredness, less alert, more irritable.
This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced upset stomach, tiredness and chills. On an unknown date, the outcome of the upset stomach, tiredness and chills were unknown. It was unknown if the reporter considered the upset stomach, tiredness and chills to be related to Shingrix. Additional Information: GSK Receipt Date: 20-APR-2022. Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced stomach upset, tiredness and chills.  The patient asked how long did the side effects of the booster usually last, Today (day of reporting) was his/her day after shot and felt some effects. The patient also asked was it generally safe to take tylenol, advil, excedrin for these symptoms. The patient didn't have a reaction with the first time so a little surprised this time. The patient did not wish to give all the information. Additional supportive information: The follow-up would not possible, as no contact, details were available.
This spontaneous report as received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On unspecified dates, the patients were inadvertently vaccinated with improperly stored VARIVAX lot # M014908 with expiration date: 25-MAR-2018 and lot # L045954 with expiration date: 17-NOV-2017 (dose and route were not provided). No adverse event was reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as there is not consent to follow-up.
Injection site is feeling hot; Feels like there is a knot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site is feeling hot) and VACCINATION SITE REACTION (Feels like there is a knot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical event).   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced VACCINATION SITE WARMTH (Injection site is feeling hot) and VACCINATION SITE REACTION (Feels like there is a knot). At the time of the report, VACCINATION SITE WARMTH (Injection site is feeling hot) and VACCINATION SITE REACTION (Feels like there is a knot) outcome was unknown. Not Provided          Concomitant product information was not provided. Treatment information was not provided.
Obvious circular 1.5cm diameter red circle at injection site (R) upper arm with variegated intermittently confluent warmth 5cm below along upper arm extending 3/4 around the arm at that level in a 10cm band. Tender along skin but not necessarily any deeper in muscle (R) shoulder with intact ROM although painful less ability with abduction. Treated with ZITHROMAX warm compress & fluids.
After receiving the second dose, had missed periods for 2 months, and have been another 3 months of irregular periods despite being on birth control for many years without issues. On March 19th, the morning after receiving dose two, I woke up with a high fever and such extreme malaise that I was unable to stand or walk for many hours. I run marathons and lift weights and am in extremely good shape, and I was too weak to even walk.
This spontaneous report as received from a medical assistant referring a current 5 year old male patient who was vaccinated with an expired dose 2 of M-M-R II, (lot # 667737/0603Z) (Expired date 23-APR-2012) on 31-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported.
Bell's Palsy that affects the right side of his face; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955), via an unspecified route of administration on 28Mar2021 at 16:45 (at the age of 50 years) at a single dose in the right arm for COVID-19 immunization. Medical history included overweight and high blood pressure. The patient's concomitant medication included an unspecified multivitamins. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 29Mar2021 at 17:00, the patient was diagnosed with a case of Bell's Palsy that affects the right side of his face. The event resulted in emergency room/department or urgent care. Prescription medications were given as treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.
Upper extremity tingling/pins and needles sensation 1 round soluMedrol pack
On 4/11/01, phone call received from parent. States child developed an elevated temperature, the evening of 4/4/01, post vax Prevnar #2. Pt continued with fever on 4/5/01 and then a rash developed. Parent called family MD and was advised to give Benadryl. Child continues with rash (on back) today, 4/11/01. She was advised to have child checked by family physician. Parent feels this is a reaction to Prevnar. Child received Prevnar #1 without any symptoms. On 4/15/01, parent did have child checked by MD and no known cause was determined. Continues with Benadryl and rash is improving.
Redness, swelling, and tenderness at injection site starting 1 day after shot and continuing 4 days later.
Within minutes of vaccination, patient experienced pain at the site of injection. Pain worsened as day progressed, to the point that it was difficult for patient to use arm. Pain continued through the night, but started improving the next morning. The next morning she woke up with hives covering her entire face. No swelling or difficulty breathing. Patient advised to notify her physician and seek immediate medical care if symptoms worsen.
On Monday, 3/26/01, 3 pts showed up at our clinic stating they had very sore arms secondary to their pneumovax shot on Saturday, 3/24/01. This pt was one unusual occurrence sent to you. Pt reported local reaction to shot at upper right deltoid which shows 4" X 4" area of erythema, warmth, soreness but no drainage, fever or chills, etc.
This spontaneous report as received from a Licensed Practical Nurse refers to a child patient of unknown gender and unknown age. Medical history, current conditions and drug reactions or allergies unspecified. On 28-APR-2014 the patient was vaccinated with VARIVAX (Merck) dose 2, 0.5 ml, subcutaneous (lot number and expiration date unspecified). Concomitant medications unspecified. On 28-APR-2014, patient received second dose of VARIVAX (Merck) that was improperly stored. No adverse effects reported. The nurse requesting stability for VARIVAX (Merck) (supported) in freezer at 6F for 66 hours due to unknown reason. Additional information has been requested.
4 pm injection 8 pm uncontrollable shaking continuing throughout night with chills ; sleeplessness with pain of muscles, joints, bones; tried eating at 8am Saturday part of English muffin and 3 slices banana 3 of strawberry, said felt dizzy and nausea , still shaking, then passed out, husband said he caught me,, held my shoulders and called my name, thought I stopped breathing, and tried to reach his phone to call an ambulance. I finally heard my name. opened my eyes. He helped me to the couch, where I threw up. lay longer shaking he helped me to bathroom where I went, and also threw up  twice more just water and ginger ale, also broke a fever, was soaked head to toe. on couch all day and nite until Sunday morning when I got up  with his help to bathroom , able to drink more water and have a scrambled egg and toast, some coffee
Extreme fatigue.  Muscle aches.  Cold-like symptoms. I will report again if symptoms worsen or if new symptoms arise.
Information has been received from a licensed vocational nurse (LVN) nurse concerning an unspecified number of unspecified patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not provided. On unspecified dates the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (strength, dose, frequency and route unknown, lot # K026666, expiration date 22-OCT-2017, lot # L044707, expiration date 06-OCT-2018). No adverse event was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.  Additional information has been requested.
Vial was left out for 70 hours on the 3:06 pm on Friday 08-Jul-2022, and dose administered; No adverse event; Vial was left out for 70 hours on the 3:06 pm on Friday 08-Jul-2022, and dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vial was left out for 70 hours on the 3:06 pm on Friday 08-Jul-2022, and dose administered), EXPIRED PRODUCT ADMINISTERED (Vial was left out for 70 hours on the 3:06 pm on Friday 08-Jul-2022, and dose administered) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-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-Jul-2022 at 10:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 11-Jul-2022 at 10:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was left out for 70 hours on the 3:06 pm on Friday 08-Jul-2022, and dose administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vial was left out for 70 hours on the 3:06 pm on Friday 08-Jul-2022, and dose administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vial was left out for 70 hours on the 3:06 pm on Friday 08-Jul-2022, and dose administered), EXPIRED PRODUCT ADMINISTERED (Vial was left out for 70 hours on the 3:06 pm on Friday 08-Jul-2022, and dose administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vial was left out for 70 hours on the 3:06 pm on Friday 08-Jul-2022, and dose administered) and NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vial was left out for 70 hours on the 3:06 pm on Friday 08-Jul-2022, and dose administered).    Concomitant medication list was not provided. It was reported that dose was administered more than 12(US)/24(CA) hours post puncture. Number of doses per vial was 1 vial. Date the vial was initially stored in the refrigerator was unknown, Date and time vial was first punctured was unknown. The vial was stored post puncture in the refrigerator. The vial underwent temperature excursions, total amount of time the vial was exposed to room temperature range was 70 hours. Storage condition at the time of the excursion was room temperature. The patient had not previously experienced this event. The event had not caused patient to seek medical care. Treatment information was not provided.
Within less than 1 min of vaccine, pt turned pale, felt faint, nauseous, and developed pain in chest w/burning sensation throughout her body, and sharp electric shock-like pain down spine, w/SOB. Almost sent to ER but symptoms subsided over the course of 30 min. Currently, has flu-like illness symptoms the day after the shot.
Pain to (L) deltoid, limited range of motion, pain with movement and when trying to reach something with (L) arm. X-ray was done shows wear and tear, degeneration. This happens after my flu shot.
? 5/21/21: Pulmonary Embolism o Presented with chest pain, abdominal pain, breathing problems o CT showed pulmonary embolism o Stable for outpatient anticoagulation. Started on 10 mg Eliquis BID x 7 days and then 5 mg BID thereafter.
Woke up in a lot of pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Medical history included ongoing fibromyalgia. The patient concomitant medications were not reported. The patient reported that two weeks ago (from the day of the report) she got the Pfizer Covid-19 vaccine shot, no exact date provided, and for about a week she did not have any side effects, but on 01Jun2021, she woke up in a lot of pain, has not improved and it has been 10 days. The patient said that she does have fibromyalgia, which was a pain disorder, was feeling quite well before she got the vaccine. The patient stated she was going to go see a doctor for the second time tomorrow. The patient also said that she feels like she had a bad case of the flu, took a lot of courage to get the vaccine, was so happy not to have side effects until now (as reported). The outcome of the event was not recovered.  Information on the lot/ batch number has been requested.
This spontaneous report as received from an unknown reporter refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II (lot # H020255, expiry date: 08-NOV-2014, therapy type, dose, route were unknown), which was improperly stored vaccine. This is one of several reports that received from the same source. Additional information is not expected.
Faint; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Faint) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Faint) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.  Very limited information regarding this event has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Numbness from left scapula (shoulder area) down left lateral upper extremity down to left pinky finger. On 10/6/15 reports numbness 90% better, left axillary lymph node swollen and painful and left shoulder and left elbow joint soreness. Erythema at injection site.
No Adverse reaction noted, client already had covid 19 pfizer bivalent vaccine already, nurse on duty(Myself) gave the pfizer bivalent booster again. Did not catch the fact the client already had the vaccine already.
This spontaneous report as received from a 60 year old female patient refers to herself who was an emergency nurse formerly. The patient's concurrent condition included high blood pressure, high cholesterol, high triglycerides and insomnia. The patient was allergic to PHENERGAN (reported as "finerigan") and COMPAZINE (reported as "composene"). On 07-JAN-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and dose were unknown, one time vaccine) subcutaneous. Concomitant therapies included LOVAZA, ZOCOR, atenolol, cholecalciferol, TRICOR, AMBIEN (reported as Anbian), SYSTANE, Prenatal vitamin. On 07-JAN-2015, the patient had an "about 3 1/2 by 1 inch dependent streak on her left posterior injection arm, at the injection site". The patient further stated that it was raised, red, itchy and "sensitive to the touch". On 08-JAN-2015, the patient stated that the vaccine injection site still had the "about 3.5 inch distal streak that looked like a burn from a curling iron but not like a blister or chicken pox like she had had as a child". The patient had sought for unspecified medical attention. The patient was not given treatment for the events at the time of report. The outcome of the events "about 3.5 inch distal streak that looks like a burn from a curling iron" was not recovered at the time of report. The outcome of the events "it was raised, red, itchy and sensitive to touch at the injection site" was unknown at the time of report. Additional information has been requested.