chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 02-AUG-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) (strength and route were unknown) (lot#  N024562 and expiration date 06-MAR-2019) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959:
Small bumps/hives initially appearing only on the opposite arm of vaccine site where the arm bends. The bumps later appeared on the arm which received the vaccine and in small numbers on the chest. The raised bumps are red and itchy.
patient who received an expired dose of Tenivac, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Medical Information  (Reference number- 00482322) and transmitted to Sanofi on 18-Feb-2021.  This case involves a 38 years male patient who received an expired 0.5 ml dose of DIPHTHERIA AND TETANUS TOXOIDS [Tenivac] (batch number C5578AA and expiration date:28-Jan-2021) via intramuscular route in the left deltoid for prophylactic vaccination (Expired product administered) on 29-Jan-2021.  The patient's medical history, past medical treatment(s), vaccination(s), family history, risk factor were not provided.  No concomitant medication were given to the patient.  It was an actual medication error due to expired vaccine used (same day latency).  Also reported that : MA (medical assistant) wants to know if the patient needs to be revaccinated  The patient did not experience any side effects.   No treatment provided.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC 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.
One week after vaccination, the injection site became itchy. Then the skin turned red, swollen and warm to touch.
I21.11 ACUTE ST ELEVATION MI, RIGHT CORONARY ARTERY 4/9/2022 ACUTE ST ELEVATION MI, UNSPECIFIED    AORTIC VALVE STENOSIS I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 4/9/2022 ACUTE ST ELEVATION MI, UNSPECIFIED    AORTIC VALVE STENOSIS
Few hrs after getting shot at mid day,  lower back started aching.  By 10:00 p.m. my lower back, sides were in pain and abdominal muscles and stomach were like frozen in place.  Couldn't move anything and the area seemed to be swollen.  Had  lost appetite in late afternoon so had not eaten dinner, only liquids since figured I needed something.  Couldn't sleep, aspirin didn't help.  Next day around  noon my abdominal area was better and pain decreasing  on sides.  Still no desire to eat. Trouble sleeping,   2nd day after shot, still  lower back pain, feel bloated, no desire to eat.  Very little side pain.   Had slight headache   This third night after shot I could finally  sleep.  This fourth day I felt back to normal.  During all this time, the arm that had the shot never really bothered me
On 03/21/2022 - 06/24/2021 I felt nausea and fatigue. On 03/28/2022 I felt like I had a bug bite that was itchy, and it continued to back, under my arm and to my chest. I had a telemedicine call with my allergist, she looked at the rash and urged to go to urgent care and/or lotion she provided. I opted to go to the urgent care. The doctor at urgent care diagnosed as shingles and I was given an antiviral (acyclovir and gabapentin). It is very painful. Went to allergist instead of PCP as he knows my history the best.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment with Paxlovid from 12Feb2023 to 16Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Ive been having extreme shortness of breath, high pulse, get extremely winded from the slightest activity, cant work out like I usually did, cant run, cant walk long distances or do any activities.
HAS HX OF GRAVES DISEASE SINCE 2006. UNDER TREATMENT AND MEDICATION. NEEDED IMMUNIZATIONS TO OBTAIN JOB TO DO SONOGRAMS IN HOSPITAL. GIVEN IMMUNIZATIONS AT 0900 C/O OF FEELING NUMB AND TINGLING TO LT HAND GOING UP TO LT SHOULDER WITH SLIGHT BURNING SENSATION IN BACK OF HEAD WITH NUMBNESS AND TINGLING TO BACK OF HEAD AT 09:15. PULSE TAKEN AT 64BPM. AT 9:45 C/O OF NUMBNESS TO FACE. AT 9:50 C/O NUMBNESS AND TINGLING TO BOTH ARMS AND LT LEG. AT 9:50 BOTH ARMS AND LT LEG AND BACK OF HEAD WITH NUMBNESS AND TINGLING. AT 10:05 NUMBNESS AND TINGLING STARTING TO GO AWAY. AT 10:05 SYMPTOMS GOING AWAY. AT 10:10 LEFT AS SYMPTOMS RESOLVED AND ALMOST GONE. ADVISED TO SEE DOCTOR IF SYMPTOMS WORSEN OR RETURN.
Patient was given Pneumovax injection on the morning of the 11/1/02. That night he was seen in the ER with a swollen, red arm that was warm to the touch. The patient complained of nausea/vomiting and trouble using his arm. He was treated with ice and analgesics. He was seen at this clinic on 11/04/02 and reported that the redness has moved down arm and is somewhat numb. He was treated with Medrol and Keflex.
missed 2nd shot; This case was reported by a consumer via media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago 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 incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose which led to incomplete course of vaccination. It's 2 years since the 1st one. The patient enquired if he/she could receive one or two more shots. Follow-up would not be possible as no contact details provided.
Mild Guillain Barre Syndrome: Right extremities had loss of sensation and no control.  Speech impairment, not able to speak clearly or fluently.  Unable to understand what was being said by others.  Mild headache in someone who does not usually get headaches.  Photo-sensitivity to bright light.  First signs of symptoms occurred when standing and talking.  Meningococcal Conjugate Vaccine was administered earlier in the day at a routine visit to the doctor's office for Tb booster and TDaP, which were both administered at the same time.  After two hours of symptoms, I slept it off for 4-6 hours.  When I woke up everything was back to normal with slight soreness that went away after a few hours.  I was informed that my parents had called the hospital as my doctor was not available.  Hospital informed them that if the symptoms got worse that I was to come to the ER.  Symptoms did not progress from onset, but did stay the same as mentioned above for the entire two hours.
Mother called and stated child almost passed out about 10 min after inj. Also c/o ringing in ears, nausea and stomach ache - As I was talking to her his symptoms were resolving. Provider on that day also spoke to mom.
Swelling under left armpit; Tenderness; This is a spontaneous report from a non-contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3247) via an unspecified route, administered in Left Arm on 16Feb2021 at 13:15 (44-year-old at vaccination) as a Dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Facility type vaccine was reported as Workplace clinic. The patient had not received any other vaccine within 4 weeks prior to vaccination. The patient was not diagnosed with Covid prior vaccination.  The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3247) via an unspecified route, administered in Left Arm on 26Jan2021 at 13:00 (44-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. On 17Feb2021 at 17:00, the patient had experienced Swelling under left armpit with some tenderness. The patient was not tested for Covid post vaccination. No treatment received for resulted events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information was expected.
Developed moderate fever and whole body muscle sore as well as fatigue after about 10 hours of getting both the third (booster) dose of the Moderna Covid vaccine (left arm) and flu vaccine (right arm).  Also significant red swelling and pain at the injection site of Covid vaccine,  but the flu vaccine injection site has minimal redness/pain.  Took 2 aspirin around 12:30 mid night and fever continued (not getting worse ) about an hour after taking aspirin pills.
This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced missed period. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of missed period was not reported. This report was non-serious.
Diffuse myalgia and chills for 3 days, all subsided as soon as she took a Benadryl on day 3.
Information has been received from a healthcare worker referring to a 67 year old female patient. On 22-APR-2015 the patient was vaccinated with ZOSTAVAX lot # K023623 for prevention of shingles (dose, route and application site were not reported). Concomitant therapies included omeprazole (manufacturer unknown) and levothyroxine sodium (manufacturer unknown). On 23-APR-2015 the patient called the pharmacy to reported that she began to experienced nausea, headache, whole body aches, injection site rash and vomiting on 23-APR-2015 the day after receiving ZOSTAVAX. The patient visited an unspecified urgent care clinic on an unspecified date due to the symptoms and was given a prescription for unspecified antibiotics. The outcome of events was reported as ont recovered. The causality between ZOSTAVAX and the events was not reported. Additional information has been requested.
m in bed for the whole day; severe body aches all over; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (m in bed for the whole day), MYALGIA (severe body aches all over) and HEADACHE (headaches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT), DULOXETINE HYDROCHLORIDE (DULOXETINE [DULOXETINE HYDROCHLORIDE]), LEVOTHYROXINE SODIUM (SYNTHROID), SUCRALFATE, PANTOPRAZOLE, CLONAZEPAM, TRAZODONE and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 12-Mar-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 MOBILITY DECREASED (m in bed for the whole day), MYALGIA (severe body aches all over) and HEADACHE (headaches). At the time of the report, MOBILITY DECREASED (m in bed for the whole day), MYALGIA (severe body aches all over) and HEADACHE (headaches) 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.   Treatment included Neubilizer   This case was linked to MOD-2021-239098 (Patient Link).
Low-grade fever,  headache, loss of appetite, fatigue,  dizziness, moderate pain at the site of injection. Symptoms began approximately 12h after inoculation.
(R) arm developed swelling, redness extending to axillary area, and tenderness on 11/05/10 (1 1/2 to 2 days after receiving vaccine) reports no itching or other problems.
PI   Patient is a 67 year old male who presents with dizziness and left facial droop.  The patient reports that he woke up this morning and felt very unsteady on his feet and dizzy.  That has since subsided.  However, he noted some slurred speech and left facial droop.  He woke up at 7:30 AM.  He went to bed last night at 11 PM.  Last known well is 11 PM, as he woke up with his symptoms.  He reports some weakness of the left upper extremity and left lower extremity.  Acute left arm, leg, face weakness, slurred speech and buring eyes.  Symptoms came and went over 42 hour period.
She had a huge bruise on her arm after getting the shot. Then she developed a burning sensation inside of her stomach and both legs (very painful). She had an ultrasound on both legs and a CT of the abdomen. No blood clots found. They discovered a cyst on her liver, which she never had before.  At this time she still has pain and a burning sensation in her upper back, stomach and right leg. She is supposed to follow-up with a gastroenterologist for a colonoscopy.
Friday - Vaccine Saturday - tired, headache, just rundown feeling Sunday - felt fine until evening., then rash appeared and severe heartburn, swollen lymph node in left armpit (same as previous dose) Monday - felt fine until evening (rash from previous day decreased), then rash came back and severe heartburn with radiating chest pain and shooting pain in back between shoulder blades.  Doctor advised benadryl and zantac regularly. Went to ER around 9:30 after trying to go to bed early and chest pain being severe.  EKG and bloodwork didn't indicate heart attack, chest pain subsides, went home before seeing doctor due to test results and feeling better (and 7 hour wait to see doctor). Tuesday - slept for 8 hours, then woke up with rash worsening, pain in throat, face swollen, neck swollen, difficulty swallowing, went to urgent care and they prescribed steroids
I had sore throat, headache, running nose, cough, and congestion.  These lasted for about 10 days.  On Jan 3rd, I got tested positive for Covid-19.
1 day after the vaccination the Patient started with severe jaw pain with not improvement of the  symptoms after 2 weeks of the initial symptom.
Red, swollen eyes (resolved after 2 weeks); nasal congestion, skin pruritus persists
I had postnasal drip that caused a sore throat, congestion, runny nose, and a headache. I contacted my doctor and was prescribed prednisone and I also did a saline solution rinse. This lasted for about a week, and I am feeling better now.
hives; This is a spontaneous report from a contactable consumer (patient herself). A 68-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), via an unspecified route of administration in her upper arm on an unspecified date (doesn't recall the date, either end of March or beginning of April, Batch/Lot number was not reported) as a single dose for immunization. Medical history included high blood pressure and takes half a pill. Concomitant medications also included vitamins. It was reported that the patient had a reaction to PREVNAR 13 years ago and was considering the Pfizer COVID 19 vaccine. She wanted to know any similar ingredients. She had the Pfizer PREVNAR 13 pneumonia booster years ago on an unspecified date and 2-3 weeks after the vaccine she got hives for 2 months. It wouldn't go away and they were just in the low extremity, stomach and upper legs and her behind and nowhere else. She went to a couple of different doctors and a dermatologist and one didn't think it was hives and one said it was and gave her some medicine to take and put on it and it helped taking it away, it was hives. It was the last booster she got and they wanted her to get a booster for tetanus and she said "I don't think so." She had no idea what was in the PREVNAR 13 that might also be in the COVID vaccine. Patient asked if she can speak to someone to help her make a decision, she doesn't want to get it and get a reaction. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
rash on  both legs appeared one week after first vaccine on 2/16/21 and largely disappeared; the rash reappeared abut 5-6 days after second vaccine.
No adverse event; Expired dose administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient).    No concomitant medication information was provided. The vial was initially stored in refrigerator on 7-Jun-2022. The vial did not undergo any temperature excursions. The dates of administration of the vaccines was reported as 1Apr2022, 5Apr2022, 6Apr2022, 8Apr2022, 11Apr2022, 12Apr2022, 13Apr2022, 14Apr2022, 22Apr2022, 9Jun2022, 10Jun2022, 13Jun2022, 18Jun2022 and 22Jun2022.  The dates of vaccine administration were not reported and it was unknown whether patient took first, second or first and or second booster doses. No treatment medication information was provided.
swollen lymph nodes in stomach; his spleen is swollen; Severe abdominal cramping; his bowels have stopped working all together; dehydration; numbness in hands and feet; loss of appetite; vomiting; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes in stomach) and SPLENOMEGALY (his spleen is swollen) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes in stomach) (seriousness criterion hospitalization), SPLENOMEGALY (his spleen is swollen) (seriousness criterion hospitalization), ABDOMINAL PAIN (Severe abdominal cramping), FUNCTIONAL GASTROINTESTINAL DISORDER (his bowels have stopped working all together), DEHYDRATION (dehydration), HYPOAESTHESIA (numbness in hands and feet), DECREASED APPETITE (loss of appetite), VOMITING (vomiting), NAUSEA (nausea) and HEADACHE (headache). The patient was treated with ONDANSETRON (ZOFRAN MELT) for Vomiting, at a dose of 1 dosage form; DICYCLOVERINE HYDROCHLORIDE (BENTYL) for Pain, at a dose of 1 dosage form; MAGNESIUM for Constipation, at a dose of 1 dosage form and MACROGOL 3350 (MIRALAX) at a dose of 1 dosage form. At the time of the report, LYMPHADENOPATHY (swollen lymph nodes in stomach), SPLENOMEGALY (his spleen is swollen), ABDOMINAL PAIN (Severe abdominal cramping), FUNCTIONAL GASTROINTESTINAL DISORDER (his bowels have stopped working all together), DEHYDRATION (dehydration), HYPOAESTHESIA (numbness in hands and feet), DECREASED APPETITE (loss of appetite), VOMITING (vomiting), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.            Concomitant medication was not provided.  Treatment also included antibiotics.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a 56 year old female patient, concerning on herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 27-OCT-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 (administration route, anatomical location, lot number and expiration date were not reported) for prophylaxis.  On an unspecified date in October 2018, the patient developed itching around the injection site and then became itching all over the body which got red from scratching. It was reported that the patient took one BENADRYL which helped some (however discrepant information was reported as "not recovered). The causality assessment between the aforementioned events and the vaccination with PNEUMOVAX 23 was not provided.