chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 30-MAY-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 24-JUL-2012, the patient was inoculated with ZOSTAVAX (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a physician office (by an unspecified health care professional) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 20-JUN-2016, the patient was treated at a medical center (by an unspecified health care professional) for a blistering vesicular outbreak, which was diagnosed as shingles. On or about 30-JUN-2016, the patient sought subsequent treatment at an eye physicians office, for a persistent vesicular rash interfering with her eyes, which was diagnosed as herpes zoster eye disease. On or about 11-JUL-2016, the patient was further treated at the eye physicians office for ongoing and worsening interference of herpes zoster eye disease. The patient has been prescribed acyclovir for management of here painful and persistent condition. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient 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. Upon internal review, the events of Herpes zoster eye disease and Further treated for ongoing and worsening interference of herpes zoster eye disease were determined to be medically significant. Additional information has been requested.
rash on chest, neck and face started about 24 hours post vaccination. 48 hours later facial swelling and rash continued. Spoke to allergist and did a regiment of Claritin and bendaryl for three days which contained reaction.
17 weeks pregnant at time of 2nd vaccination, estimated due date October 18, 2021.  Symptoms included chills and fatigue that cleared within 36 hours. Arm soreness and slight bruising at site of injection cleared within a week.
This spontaneous report as received from a Healthcare worker refers to a 19 year old male patient. The Healthcare worker reported that on 25-JAN-2013 the patient received his first dose of GARDASIL injection (lot # H012670, expiration date 21-MAR-2015), 0.5 ml, intramuscular (anatomical location unspecified). The patient received the second dose of GARDASIL on 25-FEB-2013 and his third on 25-MAR-2013. No adverse effects reported. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 7 month old patient. On 26-APR-2013 the patient was vaccinated with the first dose of oral ROTATEQ (lot number not provided). No adverse event was reported. No product confusion was discovered. Additional information has been requested.
Red swollen area upper Left arm. Clindamycin, Diphenhydramine, Ibuprofen given.
Swelling, itching, redness, tenderness to pressure on left arm admin site. Approx 20x8cm mild induration, probably type II hypersensitivity.
Mr. Rommel received the second dose of Moderna COVID-19 vaccine on 04/17/2021,  notes it was administer very superiorly on shoulder. Pt felt no acute symptoms  after administration, but noted severe L shoulder pain three hours post- vaccination. Unable to move his shoulder at that time, and rated pain as 10/10.  Felt constant pain greatest at the greater tubercle of the humerus that radiated  diffusely down his L arm toward his wrist, with no involvement of the hand. Pt  was unable to move his arm and endorsed sleep disturbances due to the severity  of the pain. Denies loss of sensation, erythema, ecchymoses.
Severe, prolonged headache, lasting two days, starting the day after the vaccination.  Severe, debilitating pain and bleeding for the next menstrual cycle following vaccination - beginning 2 1/2 weeks after vaccination. This pain has led to vomiting, and inability to leave the house to attend to errands, or go to work.
Patient starting sweating, feeling a little lightheaded and had goose bumps with 30 minutes of vaccine. Patient took TYLENOL, rested and drank water and felt better. 10/30/09 Vaccination record received.
WARMTH; RIGHT ARM SWELLING LOCALIZED, HALF DOLLAR SIZED AND HARD TO CENTER; REDNESS; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced drug allergy when treated with morphine, and hydrocodone bitartrate/paracetamol for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-JUN-2021 07:38 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 18-JUN-2021, the subject experienced warmth. On 18-JUN-2021, the subject experienced right arm swelling localized, half dollar sized and hard to center. On 18-JUN-2021, the subject experienced redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm swelling localized, half dollar sized and hard to center, redness, and warmth. This report was non-serious.
4x5 centimeter, round, induration on outside of right upper arm. Possible reaction to Varicella vaccine.
Pulmonary embolism, pea, heart arrest x2. 0100 4/14, some up with difficulty breathing. O2 sats low 80's and tachycardia low 100's. 4/15, says in mid 90's yacht at mid 120' s. 4/15 increased diffficulty breathing. Went to ed. Troponin in 800's. Saddle pe discovered on ct. Clots in rt leg found also. 4/16 is removed pe, ir decided to let clots in let reabsorb. 4/17, ready to d/c, when acute onset of respiratory distress occured. Went into PEA x 's 2.  Back to ir to remove pe and place filter.
large area of erythema, swelling, tenderness.  cellulitis and pain. occured approximately 24 hours after vaccine administration.  treated with warm compress and Keflex.  to return for follow up in 24 hours.
Patient reported soreness within a couple hours of injection. She also reported fatigue, chills, foot cramps, nausea, loose stool, and lower digestive tract issues.  She's also had a headache that has been present as of current (10/10/20) but she said it has been getting better.
4/16/21 - First Dose, no reactions. 5/7/21 - Second Dose, no immediate reactions. 5/9/21 - Spotty rash all over front torso below neck to just below navel, and at lower back only. No raised or itchy. Lasted all day. Did not treat. 5/13/21 - Puffy lower lip, dry peeling skin at chin, cheeks, sides of eyes & nose. Some scabbing.  5/14/21 - Woke with extremely swollen, puffy eyes. Allergies? Have never had allergies before. Did not play with pets or change any soaps, detergents, etc. Taking Benadryl only and using Neosporin on dry spots on face. 6/4/21 - Started taking Zytrec 12-hour in the a.m., Benadryl before bedtime. 6/14/21 - Saw Dr to evaluate and discuss, prescribed Medrol 6-day pak, will continue with Zyrtec+Benadryl routine for 8 days. Seeing allergist for skin allergy testing.
Doctor sent the pt to us to the back to watch because she told them that she had allergic reactions to vaccines. I set her up on the heart monitor to watch her SPO2 and to take a BP, manually did HR and RR. I took these vitals every 10 mins for a half hour. Nothing happened and we sent her home.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medication were reported.  Pharmacist reported that they have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30 day beyond use date.   No treatment medication were reported.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, 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 experienced MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
This non-serious spontaneous case, initially received on 18-Sep-2018, from a pharmacist, concerning an adult, male patient of an unspecified age. On an unspecified date (reported as last year), the patient was administered FLUCELVAX QIVc (dose, route of administration, anatomical site, batch number and expiry date: not reported). On an unspecified date, after vaccination, the patient experienced a little pain but did not get any swelling. At the time of this report, the outcome of the event was not reported. This case 201803897 was cross-linked to the case: 201803895 (same patient). Non-significant follow-up received on 01-Oct-2018: The information regarding vaccination date of the suspect product and start date of the event 'a little pain' was not available. No amendments were done in the narrative.
Following morning of receiving the 2nd dose, i became very sick with a fever, chills, headache, nausea, fatigue, and blood in urine.
This spontaneous report as received from a pharmacist refers to a 73 year old female patient. The patient's concurrent condition included allergy to clindamycin and "penicillins". The patient had no pertinent medical history and did not take any concomitant medication. On 13-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX lot # J002865, expiry date 07-JUN-2014, intramuscularly in her unspecified arm (dose was not reported). On 13-SEP-2013, immediately following the administration of ZOSTAVAX, the patient began to experience pain at the injection site. The patient continued to experience the pain at the injection site for "about a year" following the administration. At the time of the report, the patient still was experiencing the tenderness at the site "from time to time" but it was not as bad as it was during that year (outcome - recovering). No treatment was given for the adverse event. No laboratory diagnostics studies were performed. The patient sought medical attention by visiting the pharmacy. The relatedness between the pain at the injection site and the ZOSTAVAX was not reported. Additional information has been requested.
Patient has rash on neck & chest. Rash developed overnight day after shot. Rash is red & hot to touch. "Feels like sunburn" per patient. Took ZYRTEC and small improvement.
"I got the flu shot (Wed 10/2/13.)  That Sat or Sun, I started getting a sore throat, cough; feel tired.  My right jaw is painful, TMJ, and right sided headache started the middle of last week.  Hurts to open my mouth.  I went to Urgent Care last Fri (10/11), and they did a strep test.  I don't think she went back deeply enough.  It came back negative, and they didn't do a culture.  She said maybe it's shingles, but I don't have a rash, and have never had shingles.  It was a waste of a visit.  I've been taking left-over Tylenol with Codeine because of the pain.  Take it after work around 6 PM.  I toss and turn at night, but it helps the pain.  It seems like the symptoms are worse at night and in the morning.  Not really coughing, the main problem is this right sided pain, rates 5/10 now.  I considered going to the dentist because of the jaw and lower back teeth pain, but I don't think it's that.  I think it's the swelling and the soreness.  Symptoms are staying the same.  I have had noc sweats."  No N/V, diarrhea or GI symptoms.
NO ADVERSE REACTION REPORTED. A PFIZER VACCINE WAS ADMISNISTERED TO A PATIENT AFTER BUD OF 7/22/22. PATIENT RECIEVED A PFIZER BOOSTER SHOT 5 DAYS AFTER BUD. The medical/safety team at Pfizer WAS CONTACTED AND indicated THE DISCOVERING PHARMACIST they do have stability but not efficacy data on the adult Pfizer vaccine beyond 72 days when stored in a refrigerator. They recommended that our rph contacts the CDC and inquires about repeating doses for these patients. Speaking with the CDC employees, our rph was given the same information as above and referred to the immunization division at the DOH.  Our rph contacted the DOH in the state, but she was asked to confer with either the pharmacy Medical Doctor or the standing order physician. Our rph was able to interact with the latter, and she was given the guidance of re-vaccinating . In the context of the guidance from the standing order physician, the patient will need to repeat the dose. Regular schedules for series completion/booster doses will be observed if/when warranted.
I had a pain in my leg, like a pinch in my nerve, it got worst & worst. In October when it got worst, I went to the doctor. And I had therapy, acupuncture, X-ray, MRI. On Feb 2nd I had a TIA (mini stroke), transient ischemic attack, I had numbness in my leg and arm and difficult speaking. I went to the ER and had a lot of tests. I have been with a Cardiologist. I will get an epidural to deal with the pain on my leg.
Initial report received from a healthcare professional on 06 October 2014. A 80-year-old female patient, had no known allergies, medical history and concomitant medications was not reported, had received a dose of FLUZONE HD batch number- U5041BA (dose, dose in series was not reported) intramuscularly in left deltoid on 03 October 2014. On 04 October 2014 one day after vaccination the patient experienced painful, 3x4 inch red bruised area about 4 inches below injection site on her left arm. Laboratory investigation was not performed and corrective treatment was not reported. At the time of this report the outcome of event was unknown. Documents held by sender: none.
Patient developed a fever of 103 to 104 degrees and severe diarrhea 3 to 4 days after receiving vaccine. The episode lasted 3 to 4 days.
Mistake was made in administering Bivalent Pfizer vaccine to 11 year old.
Vasovagal. Patient placed supine on exam table. Orthostatic vital signs. Released by Capt.
Localized reaction in the right upper extremity from immunization. KINRIX (Dtap and IPV), moderate erythema; induration, blisters.
herpes zoster/rash on the left side, mid-back that was very painful; Information was received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. In or around 05-SEP-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the pt suffered a rash on the left side, mid-back that was very painful, and the pt was diagnosed with herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX)vaccination, the pt's symptoms have resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX)), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the company's conduct, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Outcome of herpes zoster was reported as not resolved. The causal relationship of the event was reported as related to zoster vaccine live (ZOSTAVAX). The reporter considered herpes zoster to be a disabling event.
That evening at 08:00 pm, I had chills, very slight fever (right under 100 degrees); fatigue. Saturday, I woke up without any of those symptoms but a terrible headache on Saturday morning - I had to go to work. It was severe enough for me to not go to work. Headache remained up until yesterday. The headache was pretty severe on Saturday, Sunday and I went to the doctor on Monday or Tuesday. I went because of the length of time of the headache. No meds were prescribed. They offered a brain scan which I decline based on the Dr's explanation of what the scan really does. Dr told me to take Tylenol. It was a "cluster" headache - the right side of my head towards the low part of my neck. The headache was always at that location. Tylenol was enough to lower my headache from the moderate to a minor. I didn't take much of it. I have not had a headache today for the first time since that Saturday. Muscle pain on my upper chest wall - it felt like I had been bench pressing - that symptom was on Wednesday and Thursday of last week (14th and 15th).
12/16/2020 I experienced severe body aches and chills, severe headache, and I had a low grade temp about 95 instead of 96, I did have dizzyness about an hour after the shot and I developed a cough about 6 hours after shot, fatigue and wore out from the chills and body ache I alternated ibuprofen and tylenol for 24 hours. Today 12/18/2020 the cough is gone and I feel better
Information has been received from a registered pharmacist concerning a 70 year old male who on 9/14/05 was vaccinated with Pneumococcal 23v polysaccharide vaccine 0.5ml (lot 651523/0604R), IM. On 9/14/05 the pt experienced immediate local reaction with redness, swelling, and tenderness. The swelling progressed the length of the left arm (where the injection was given) and down the lateral chest wall on the left side. The pt did not have any itching but said the area ached. It was noted that the pt received Pneumococcal 23v polysaccharide vaccine injection 5 years earlier without incident. The pt was considered to be not recovered. The facility requested an investigation into lot 651523/0604R. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Fever + 99.2 degrees  (21 hours later continues. Nausea (occasional after 22 hours).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in right arm, as dose 2, single (Batch/Lot number: unknown), in right arm, as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Rhuematoid arthritus" (unspecified if ongoing), notes: Other medical history: Rhuematoid arthritus; "Known allergies: Yes" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti viral details included COVID 19 Treatment with Paxlovid. Treatment start date was reported as 12Sep2022 and treatment stop date was reported as 16Sep2022, Lot number:GE5197. Got Covid took Paxlovid at about third day took for 5 days, felt much better, like it was over. Then about a day or two later started having symptoms again, each day now symptoms are getting worse and she was sick again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.