chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tender arm; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tender arm) and PAIN IN EXTREMITY (Sore arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy (Patient had a mastectomy in the left side in the past.). Concomitant products included LEVOTHYROXINE, LISINOPRIL, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and VITAMINS NOS for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Tender arm) and PAIN IN EXTREMITY (Sore arm). At the time of the report, TENDERNESS (Tender arm) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment details was not reported by the reporter.   This case was linked to MOD-2021-396038, MOD-2021-396130 (Patient Link).
Patient, aged 11 years 8 months, received dose of Pfizer COVID vaccine. VAgency completed due to patient's age.
INITIALLY HAD CHILLS, FOGGINESS, HEADACHE 5 DAYS FOLLOWING VACCINE.RAISED RASH APPEARED ON UPPER ARM OF INJECTED SITE ON DAY 6 AND PROCEEDED TO COVER WHOLE ARM OVER 3 DAYS.  FEVER 101. HEADACHE WORSENED. EXTREME FATIGUE.
administered an extra dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (2 dose schedule received on an unknown dates).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 2-May-2022 Reporter's comments: The clinic patient was administered an extra dose of Shingrix. The patient was fine and he only had general information. Follow-up from safety was asked to pharmacist through chat and he stated he only had general information and no further details to report. Additional Supportive Information: The patient received extra dose of Shingrix, which led to extra dose administered.
"Tennis ball" size area of swelling, erythema and warmth at site of injection (left arm). Advised ice and TYLENOL.
Starting having trouble breathing 1 week later 2 weeks later diagnosed with pneumonia  10 days later admitted to hospital with interstitial lung disease (never before diagnosed with that) Needed 24/7 oxygen  Passed away May 10/21
Administered vaccine that had been punctured more than 12 hours and placed in the refrigerator; Moderna Covid-19 vaccine was administered to a 4 year old that had been punctured more than 12 hours ago; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine was administered to a 4 year old that had been punctured more than 12 hours ago) and PRODUCT STORAGE ERROR (Administered vaccine that had been punctured more than 12 hours and placed in the refrigerator) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jul-2022 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2022 at 8:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine was administered to a 4 year old that had been punctured more than 12 hours ago). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that had been punctured more than 12 hours and placed in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine was administered to a 4 year old that had been punctured more than 12 hours ago) and PRODUCT STORAGE ERROR (Administered vaccine that had been punctured more than 12 hours and placed in the refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. The vial was initially stored in the refrigerator on 30-Jun-2022. The vial was first punctured on 26-Jul-2022 at 8:27 am. It was reported that vial had not undergone any temperature excursions. No treatment drug was reported.
This spontaneous report was received from a Healthcare worker refers to an unspecified patients of unknown demographics. It was reported that on an unknown date Since December 2014 the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, route, lot # and frequency unspecified). No concomitant medications were reported. Healthcare worker stated that on an unknown date, some complaints may have been made with regrets to sore arms but that's nothing out of the ordinary. Healthcare worker could not provide information regarding any specific patient (s) who may have experienced the symptom. She stated that they "always" received complaints regarding sore arms after administration of vaccines. No further information was provided. The outcome of sore arm and incorrect product storage was unknown. Causality assessment for the event sore arm not reported. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Patient reported pain down arm to wrist post injection. Went to orthopaedist and received cortisone injection.
Information has been received on 09-FEB-2018 from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 10-SEP-2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route 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 18-JUN-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of these malfunctions, 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, pain and suffering, and other damages. Additional information has been requested.
Large swollen lymph node-about size of golf ball in right armpit.  Very painful.
Swelling (size of softball), redness, itching, warm to touch. Blister developed; burst 9/22. Patient stated that she has received smallpox in the past and has experienced some of the same symptoms.
his arm has "turned green"; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE DISCOLOURATION (his arm has "turned green") in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (his arm has "turned green"). At the time of the report, VACCINATION SITE DISCOLOURATION (his arm has "turned green") 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.   No concomitant products was provided. No treatment products was provided. The caller stated that the patient's arm  turned green at his injection site in his left arm and started to go down the length of his arm.
Patient felt flushed and had some "restricted breath." No rashes or wheezing.  Vitals: BP 130/70, O2 sat 100% on RA, HR 78. Patient given PO Benadryl 50 mg and famotidine 20 mg @ 0920. Patient felt better @1000 and left with parents.
She received the vaccine today and learned afterward that she is pregnant; No additional AE; This spontaneous prospective pregnancy report has been received from a 29-year-old pregnant female patient, concerning herself.  The patient's medical history, obstetrical history, concurrent conditions, and historical drugs were not provided. Concomitant medications included vitamins Not Otherwise Specified (NOS).   On unknown dates in 2023 (also reported as "this year"), the patient was vaccinated with the 1st and 2nd doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered as Human Papilloma Virus (HPV) prevention (exact doses, lot numbers, expiration dates, routes of administration, and anatomical locations were not provided). On an unspecified date in June 2023, the patient became pregnant (Last menstrual period [LMP] was calculated as an unknown date in June 2023 [reported as "Approximately 4 weeks"], the pregnancy due date was not reported and could not be calculated). On 26-JUL-2023 (also reported as "today"), the patient received the 3rd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), and learned afterward that she was pregnant (Exposure during pregnancy). No additional information nor adverse event (AE) were reported.
2 days after vaccine - c/o myalgias with sore bruises on legs. Seen 9/4/07. Seen 9/6/07 - fairly extensive erythema nodosum (B) ant. lower legs.
1.5 wks p/flu vax pt felt weak & tired; pt devel numbness & tingling in hands & feet & described progressive weakness & feeling of paralysis; pt became SOB & devel chest pain which brought pt to hosp; p/admission, not amubulating, poss GBS;
PT had rash typical of chicken pox 4 mts post Varivax - immunization failure.
About 12 hours after the injection woke up and body was hurting all over, chills, body aches, felt feverish, temperature was 100.3F and really tired and hurting all over. Took Tylenol and returned to sleep. Woke up some hours later and took an Ibuprofen. rested for the rest of the day and now the only side effects is a little soreness on her injection mark. No other symptoms. Only the first 24 hours after the shot.
No adverse effects; patient received one dose of improperly stored ROTATEQ; This spontaneous report was received from a healthcare business professional regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies and concomitant therapies were not reported.  On 08-AUG-2019, the patient was vaccinated with one dose of improperly stored (product storage error) rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R025713, expiration date: 20-JUN-2020 (dose, unit were not reported) orally for prophylaxis. The vaccine was exposed to 33.9 Fahrenheit degrees (F) for 40 minutes. The previous temperature excursion included: total time and lowest temperature below 36 F (30.3F) for 90 hours and 7 minutes, total time and lowest temperature below 36 F (30.5F) for 1 hours and 45 minutes and total time and lowest temperature below 36 F (35.2F) for 2 hours and 5 minutes. Data logger was involved. No adverse effects were reported
they've tested positive on Covid-19 last 14Feb2021; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for 2 patients. This is the 1st of 2 reports. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 11Feb2021 (Lot number and expiration date was not reported) as single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient reported they've tested positive on covid-19 on 14Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Feb2021. The 2nd dose will be scheduled on 04Mar2021. They are asking if they still need to take the 2nd dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021214003 Same reporter/ product/event and Different patient
Severe muscle pain across upper back (felt like muscle was being pulled off bone, unable to sit up for longer than 10-15 minutes at a time without leaning on desk or needing to lay down), general muscle pain (not as severe) throughout the rest of my body.  Headache, fatigue (exhausted), brain fog, muscle tightness (unable to take a deep breath due to tightness...not short of breath). Swollen lymph nodes in right armpit, overall feeling exhausted.   Treatment: I just slept a lot, took Tylenol.  I have a doctors appointment today.  Outcome: Slowly getting better. Still have brain fog , fatigue (not exhausted anymore), muscle weakness (not the severe pain anymore).
Extreme body ache, enlarged red area around site, general poor feeling. Better in the AM, PM very sore, tired, etc. 3/2/2019  Redness and swelling around injection site dissipating, but still present. General body aches continue but diminished.
diarrhea, blood in stool/blackish in color, bloated abdomen, SOB, weakness
pt recv vax 10NOV97 & 20DEC97 noted rash;seen 20DEC97 measles rash & Koplik spots;T98.2;recv DPH & resolved;
sensation of swelling hands  Narrative:  Checked with personnel and was approved for vaccination with 30 minute  monitoring. At 1130, after receiving vaccine, patient reported dizzines and a  sensation of swelling in their hands. Stated to lead RN that their "heart is racing."  Leed RN assessed patient at 1130 1145 and 1155 with the following results.  1130: symptoms described as above . HR 125, BP 104/59, RR 18 1145:  symnotoms relieving HR 118, BP 109/66, RR 16 1155: HR 113 Patient reports  that they celebrated last night and didn't sleep much, as well as not having time to  eat or drink anyhthing this morning. Patient was given juice to drink and closely  monitored. After 30 minutes of monitoring the reported symptoms as stated above  subsided, although heart rate remained elevated. No signs of swelling, rash, or  reported tightness in chest/throat. Patient was released after 30 minutes and stated  that they felt better.
Patient went got home, by 6pm, heart started pounding, felt dizzy and weak--could hardly make it to another room.  Nose was running thick with mucus; mucus getting thicker so couldn't breathe.   Patient was also sweating and had chills.  Could hardly go to the restroom and felt like if was going to throw up. Patient had pounding heart and a bursting headache; felt like if eyeballs were going to pop.  Patient called the ambulance.  Patient went to Hospital and kept overnight for observation; they specified flu-like symptoms for diagnosis.   On 10/11, patient feeling better upon discharge except for headache. Recovered completely and has not gone to doctor.
Narrative: Pt received Moderna Covid #1 on 4/2/21. On 4/9/21, he was admitted to a facility with new onset seizures (noted recent diagnosis of biopsy positive astrocytoma of the brain). He discharged on 4/12/21 on levetiracetam 500mg bid and dexamethasone 6mg bid. On 4/16/21, he was readmitted with a superficial femoral blood clot and was initiated on heparin (dose unknown). On 4/20/21, family requested hospice care and on 4/21/21, he was approved for home hospice services. He passed away on 4/23/21. Time from vaccine to date of death was 21 days. No autopsy report available.
This spontaneous report was received from a medical assistant, concerning multiple patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD, lot #N010865, expiration date 01-OCT-2018, albumin status of recombinant human albumin (rHA) (strength, dose, frequency and route of administration were not reported) and with improperly stored doses of VARIVAX, lot #M000997, expiration date 07-JAN-2018 (strength, dose, frequency and route of administration were not reported) for prophylaxis. The vaccines were reconstituted with a properly stored sterile diluent (lot # and expiration date were not reported). The temperature excursion was reported as 15 °F to 46 °F (23.4°F) for a time frame of 2 hours and 57 minutes. Previous temperature excursion was reported as 6 °F to 14 °F (13.4 °F) for 2 hours. Digital data logger was involved to capture the temperature excursions. No product quality complaint (PQC) was involved. Follow-up information was received on 24-JUL-2018. Additional information has been requested. This is non-valid report due to lack of patient identifiers. Follow-up information was received on 24-JUL-2018 from the medical assistant who provided patient identifiers for the reported event. The patient was a 12-month-old male who on 24-JAN-2018 was vaccinated with improperly stored dose of VARIVAX lot #M040137 with the expiration date of 28-SEP-2018. At the time of the excursion, the vaccine was deemed stable. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA012551: US-009507513-1807USA012552: US-009507513-1807USA012553: US-009507513-1807USA012554: US-009507513-1807USA012555: US-009507513-1712USA013102.
Intermittent falling since vaccines given no swelling, redness or tenderness or fever. Sx had improved before appt on 5-17-15.
This spontaneous report as received from a physician refers to a 23 year old female patient. On an unknown date "a couple of years ago", the patient was vaccinated with the first dose of GARDASIL. Lot # and administration route were unknown. On 22-JAN-2014, the patient wished to receive her second dose of GARDASIL. No adverse effect reported. Additional information has been requested.
Oct. 29, 2009 Headache. Overall sick feeling. Oct. 30, 2009 Headache persistent. Right ear drainage. Lymph glands beneath right ear feel swollen. Eating is very painful in mouth and ears. Mouth and ear very tender. Oct. 31, 2009 Excruciating pain left ear and lymph nodes swollen, sore, feels like lump beneath ear lobe.
Pt received an expired vaccine.  Vaccine expired 7/5/21.  No adverse event noted
Confused, foggy about 15 minutes after receiving vaccine. Lasted about 7 hours.  I was unable to focus. Initially got a little better a few hours after the vaccination. Then got really foggy again. I had to leave work.
L Thigh injection with Prevnar & Varicella     3 1/2 x2 inch red area    dissipated with time approx 30 min. R Thigh with MMR/Hib/Hep A on Right red area 2 1/2 by 2inch - faded after 30 min
Patient had Moderna COVID-19 vaccine about 10 minutes prior to reaction and began having coughing and itchiness to her throat, difficulty breathing, chest tightness, the constant sensation to cough, and rash to trunk and upper extremities. ED physician ordered NS 1000 mL IV x1, albuterol HFA, diphenhydramine 50 mg IV x1, epinephrine 0.3 mg IM x1, famotidine 20 mg IV x1, guaifenesin-codeine 200/20 mg, and methylprednisolone 125 mg IV x1 while in ED.  Potassium chloride 20 mEq PO x1 also given to correct incidental hypokalemia. Pt improved, rash resolved, coughing resolved, lung sounds clear, O2Sat normal, and HR improved prior to discharge from SCH ED.  Patient given scripts for diphenhydramine, Epipen, and prednisone. Moderna COVID-19 vaccine was added to patient allergies in medical chart.
Client recieved her first HPV vaccine at the clinic and blacked out about 5-10 seconds after receipt of the vaccine.  She complained of headache and was pale.  We lay her on the ground, took her blood pressure (100/60) and gave her a snack since she had not eaten since breakfast.  She recovered after about 10 minutes on the floor and I had her sit in a chair for 10 minutes before leaving with both parents.
Body aches, neck ache, headache the evening after the vaccine. Symptoms slowly resolved over 4 days.
Patient had moderate swelling in the left upper arm and warm to touch. There is mild to warm erythema in the anterior, lateral, posterior and antecubital aspect of the upper arm. There was also orange peel induration in the posterior of the arm. Treatment of BENADRYL 25 mg Q6 hours. Ice pack on and off Q 20 minutes at a time.
Development of chronic hip pain in left hip which has not subsided in 10 months.  No previous injuries, wounds or pain in this area.  Dr. suspects development of Rheumatoid Arthritis.  Also swelling of legs and development of varicose veins over the past year where there were none before.  Treatment for hip - bloodwork, rheumatologist involved, physical therapy, exercises, tylenol.  Outcome of hip - ongoing, chronic, unresolved pain and decreased range of motion.  Leg treatment - bloodwork, compression socks.  Outcome of legs - ongoing swelling, tingling, unresolved
Pt reported dizziness, ringing in ears, and sweating right after administering vaccines. Symptoms lasted for 5-10 min. Resolved after few minutes. Gave water to drink. Physical assessment performed by RN the vaccine administering nurse includes, bilateral upper extremities strength checks; assessing ability to comprehend and follow instructions; and informal vision test by standing in the opposite corner of the room and asked patient to count my fingers which patient done correctly.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Batch/Lot number: unknown), on 05Feb2021 as dose 2, single (Batch/Lot number: unknown), on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 07Jun2022 as dose 4, (booster) single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jul2022) Positive; (13Jul2022) Negative; (14Jul2022) Negative; (15Jul2022) Negative; (18Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Employee tested positive for COVID on 07Jul2022 and took Paxlovir for 5 days. Tested negative on day 7, 8 and 9 and symptoms improved. symptoms returned on day 12 and employee tested positive again. symptoms are much worse now that when originally diagnosed.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Patient received COVID Moderna Booster on 11/18/22, called into the office today to report an adverse effect from vaccine. Patient reported a rash to both arms and legs starting on Saturday 11/19/22, after receiving the Moderna Booster.