chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant/office manager regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # R005869 and expiry date 23-OCT-2019) orally for prophylaxis(strength, dose and frequency were not reported). No adverse effects were reported. The reporter stated that, first excursion occurred on 21-DEC-2018. The product was stored at 1.6 degrees Celsius for 26 minutes and previous excursion was reported as 1.1 degrees Celsius for 1 hour 35 minutes. This case was reported due to digital data logger. No product quality complaint was filed. This is one of the several reports form the same reporter. Sender's Comments: US-009507513-1902USA004906: US-009507513-1902USA004907: US-009507513-1902USA004942.
Tinnitus-especially in Left ear.  Previously had a very mild Tinnitus in both ears prior to vaccine.  Woke up after 2nd vaccine with extreme tinnitus in left ear.  Extreme ringing and muffled hearing in left ear.  Right ear remains mild tinnitus.  Went to ENT physician and saw NP and had hearing test performed.  Mild hearing loss noted but no previous ear testing performed to compare results to.  No other interventions available at this time.
3.5x5.5 inch area of erythema and warmth at left arm around site of injection.
30 minutes are getting covid-19 vaccine she had numbness/tingling from her neck down to her low back along the spine, as well as left sided numbness/tingling to the arm and facial region.  This persisted for several hours.  She did go into Er on this.   ER: given fluids, solu-medrol, and Toradol. Discharged home.
As the night went on I started to feel more and more fatigued at work(more than would be normal). I left early and felt a little nauseated by the time I got home. I went to sleep within 2 hours(around 12am). I woke up about 5 hours later with extreme fever symptoms(chills, nausea, fatigue, soreness) and a very intense headache. I contracted Covid-19 in October 2020 and this was much like how I felt when I was sick with the virus, minus the cough. Everything was mostly cleared up by the evening however.
Patient had relatively acute onset of weakness, confusion with multiple falls occurring approximately 24-36 hours after Moderna booster.  Brought to the ED, temperature 100.7.  Patient was found to have elevated troponin, peaking 0.58 and then trending downward.  No EKG changes.  Also found to be dehydrated, have orthostasis.  She was in normal state of health without acute complaints at the time of her booster. Patient was admitted.  Underwent echocardiogram.  She was given IV fluids and supportive care.  She did not have any changes on her EKG and she did not have any evident decreased cardiac function.  Discharged after staying 2 nights in the hospital
Macular rash cheeks spreading to trunk and extremities temp 99.3 headache 7 days after vaccine given.
Sharp lower back pain with lumbar inflammation. Pain radiated down both legs with intensity that impacted mobility.  Pain has subsided after four days but remains present after 10.
Information has been received from a pharmacist concerning a 51 year old female patient with erythromycin allergy and no pertinent medical history who on 09-SEP-2009 was vaccinated with a 0.5mL dose of PNEUMOVAX 23 (lot# 662905/1162X) intramuscularly. On 09-SEP-2009 the patient developed a red circle 2-3 inches wide at the side of injection after vaccination. By 11-SEP-2009 the area had expanded to 10 inches wide. She was also experiencing pain in the arm, general achiness and fever. The patient contacted the pharmacist for medical attention. There were no lab diagnostic studies performed. At the time of the report, the patient had not recovered. Additional information has been requested. This is one of several reports from the same source.
Left deltoid with large erythematous 1/2- 2/3 arm.
Information has been received from a Registered Nurse concerning a 12 month old patient who on an unspecified date was vaccinated with the first dose of MMR II. It was reported that on an unspecified date following the vaccination the patient experienced redness and swelling. The outcome of the patient was not reported. Follow-up information was received from a Registered Nurse. In approximately October 2002 (based on patient's date of birth and age reported at vaccination), the patient was vaccinated with the first dose of MMR II and experienced swelling and redness after vaccination. This is one of several cases from the same source. Additional information has been requested.
I woke up the morning after my second shot with chills, light fever, exhaustion, nausea, and dizziness.  I noticed it at first when I woke up and then it got worse after an hour.  I went back to bed and slept for 5 straight hours.  I was starting to feel better around 9 pm that night.  I had light symptoms the next morning.  Not bad though.  Just nausea and little exhaustion. The next day I felt great like nothing had happened.
pain and swelling under arm that went into left breast swelling, becoming very firm and tight; pain and swelling under arm that went into left breast swelling, becoming very firm and tight; pain and swelling under arm that went into left breast swelling, becoming very firm and tight; pain and swelling under arm that went into left breast swelling, becoming very firm and tight; Fluid like sac under arm and down side of ribs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 13:45 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: cats" (unspecified if ongoing); "known allergies: tree pollen" (unspecified if ongoing); "known allergies: sulfa drugs" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient took concomitant medications. Past drug history included: Codeine, reaction(s): "known allergies: codeine"; Demerol, reaction(s): "known allergies: demerol"; Morphine, reaction(s): "known allergies: morphine". The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious), BREAST SWELLING (non-serious), BREAST DISCOMFORT (non-serious) all with onset 26Mar2021, outcome "not recovered" and all described as "pain and swelling under arm that went into left breast swelling, becoming very firm and tight"; BURSITIS (non-serious) with onset 26Mar2021, outcome "not recovered", described as "Fluid like sac under arm and down side of ribs". The events "pain and swelling under arm that went into left breast swelling, becoming very firm and tight", "pain and swelling under arm that went into left breast swelling, becoming very firm and tight", "pain and swelling under arm that went into left breast swelling, becoming very firm and tight", "pain and swelling under arm that went into left breast swelling, becoming very firm and tight" and "fluid like sac under arm and down side of ribs" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain in extremity, peripheral swelling, breast swelling, breast discomfort, bursitis.  Additional information: 1st shot, left arm 25Mar21. Next day pain and swelling under arm that went into left breast swelling, becoming very firm and tight. She could not wear a bra as it cut into the skin and left marks, could not put the arm down completely at her side as the swelling under the arm prevented that. Fluid like sac under arm and down side of ribs. Lasted at lease 7 days. Facility type vaccine: Other. Facility country:. If other vaccine in four weeks: No. Other medications in two weeks: OTC multi vitamin flaxseed oil capsules. If patient recovered: Not recovered. If treatment ae: No. If covid prior vaccination: Yes. If covid tested post vaccination: No.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
severe nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (severe nausea) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced NAUSEA (severe nausea). At the time of the report, NAUSEA (severe nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.
3: x 3 1/2" red, round, slightly raised rash at injection site of L thigh.
Developed fever the next day of 101 degrees F  Then developed diffuse itching on hands (both) neck, face and legs. More that night. Started on Friday and it is Sunday now
This case meets criteria for vaccine breakthrough review. Patient admitted for STEMI, subsequently found COVID+ on admission.  Per chart review, had been symptomatic with cough and "wrapped in a blanket" for a few days prior to admission.
left arm was sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm was sore at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A, 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-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 PAIN (left arm was sore at injection site). At the time of the report, VACCINATION SITE PAIN (left arm was sore at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-053888, MOD-2021-044440 (Patient Link).
This case was reported by a consumer via call center representative and described the occurrence of ear infection in a 88-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Concurrent medical conditions included post herpetic neuralgia and chronic obstructive pulmonary disease. On 11th November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced ear infection, sinus infection and bacterial infection. On an unknown date, the outcome of the ear infection, sinus infection and bacterial infection were unknown. It was unknown if the reporter considered the ear infection, sinus infection and bacterial infection to be related to SHINGRIX.  Additional details were provided as follows: The patient got her first SHINGRIX vaccination in November but could not get her 2nd dose scheduled on January 11 because she got an ear and sinus infection. She got the 2nd shot on 8th March 2019. Emergency room visit required.
I was given the vaccination in right arm.  Nurse said it would prick a little which it did.  Then as she pulled out the needle I felt a lot of pain in my arm. I had a reverse should replacement some years ago in that arm. Within 1-2 hours after the shot, I had a lot of pain in the back of my right thigh. I had a lot of trouble walking and pain which I continue to have.
itchy spots around my waist and on my back; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL9262, Expiration Date: May2021) via intramuscular route of administration, administered in left upper arm on 20Jan2021 at 18:30 (at the age of 63-year-old ) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included atenolol daily, taken for rapid heartbeat; celecoxib (CELEXA [CELECOXIB]) daily, taken for depression; bupropion hydrochloride (WELLBUTRIN) daily, taken for an unspecified indication; levothyroxine sodium (SYNTHROID) daily, taken for thyroid disorder and rosuvastatin daily, taken for blood cholesterol abnormal, start and stop date were not reported for all. The patient did not receive prior vaccination within four weeks. Four days after the first vaccine on 24Jan2021, the patient experienced itchy spots around the waist and on the back. Seriousness Criteria was reported as not serious. AE required visit to Physician Office (dermatologist). Relevant tests was none. The patient went to dermatologist and was given prescription for clobetasol to put on affected areas. The patient received treatment with Benadryl, Clobetasol 0.05 cream. The outcome of the event was recovered on unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Patient claims to have started having pain and limited mobility in his right shoulder after receiving shot in his upper deltoid.  He feels like the joint may have been impacted during vaccination but the pain never became worse or strong enough for him to seek medical treatment.  He said that the mobility and pain have slowly become less and less severe but still does have some soreness in the joint 3 weeks later but still does not feel that medical treatment is currently necessary.
Patient was given ADACEL subcutaneously in left forearm. Tuberculin was given intramuscular left deltoid. ADACEL was 0.1 mL and Tuberculin was 0.9 cc.
After the initial, typical, local reaction resolved on Day +3 post-vaccine, I had 4 days with no adverse effects at all.  On Day + 7 (1/5/2021) I woke at 6:00am with my injection site incredibly itchy, but no visible rash or swelling.  Within 2 hours, splotchy rash was overlying the injection site.  Gradually throughout the day, site became confluently red and began to swell.  Itching continued pretty intensely.  Swelling progressed until it was visible from across the room and skin changed texture in the area and feels almost like a thick, waxy, orange peel like texture.  No pain.    Itching resolved with 1 dose of zyrtec.  Did not return.  Redness and swelling persists.  Swelling seems to wax and wane.
06/29/02 noticed itching on bilateral forearms-noted a few isolated bumps/spots. Duration: 2 days. 07/02/02, noticed a swollen gland located lt cervical area. 07/03/02 awakened with red rash to face, chest and bilat upper extremities. Afebrile.
Numbness, tingling and weakness in right hand and right leg. Pain and tightness in neck and shoulders. Severe headache.
Fever, redness and swelling at injection site, approx 4" diameter upper left forearm.
At the beginning, left eye h/o retinal lesion, myopia.  Dark gray/black central cloudy area OS x 5-6 days.  Cloud stationary.  No flashes, HAs, ocular pain  (+) occas floaters)  Left eye vision 20/300+     After couple of weeks, the central dark cloudy area becomes lighter (light grey shade), a lot of floaters that looks like rain drops   Then went with Acupuncture treatment specifically designed for retina issues, 2 hours a day for  5 days.  Eye sight improved to 20/50 ish   2 months after the initial symptom occurs, still have many floaters shaped like circles.     No medication was given
Fever 104.8(R)F continual shrill crying for 4hrs & again for 1/5hrs during noc; redness, swelling & pain @ site of inject;
Patient developed a local reaction type 6 twenty-four hours after a SQ booster dose of the anthrax vaccine.  Erythema and swelling developed from the site of vaccination to below the elbow.  Topical steriods were used for pruritus and the swelling and erythema had resolved by 72 after onset of swelling.  No lost work days as a result of reaction.
Broke out with shingles 1/8/15 (L) scalp and (L) occipital area.
rash on sides & on one cheek & under chin, no fever; 2-3 spots size of quarter by knees across belly re-noticed this AM;
This case was reported by a pharmacist via call center representative and described the occurrence of stroke in a 49-year-old female patient who received SHINGRIX (batch number K2ZY4, expiry date 21st April 2021) for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 7th January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. In February 2019, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced stroke (serious criteria GSK medically significant), immunodeficiency (serious criteria GSK medically significant) and product supply issue. On an unknown date, the outcome of the stroke, immunodeficiency, shingles and product supply issue were unknown. It was unknown if the reporter considered the stroke, immunodeficiency and shingles to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient developed an episode of Shingles after receiving the first dose of SHINGRIX. The patient was diagnosed with Shingles in February 2019. The patient then reported that at some unspecified time after the shot that had a stroke. Vaccine supply, possible off-schedule dose and the patient was reporting to be immune suppressed was reported. No additional details were provided.
Rash scratch one day post vax, with no fever, treated with Benadryl.
Patient received the Pfizer vaccine on March 12, 2021 (which was thought to be his first COVID vaccination.) It was later learned that the patient  received his first dose of Moderna vaccine on Jan 21st, 2021 at his residential care home. He did not receive the 2nd dose of Moderna vaccine.
Left arm swelling one day after vaccine - improved by day of doctors visit on 8/19/09 left arm is 4 cm greater diameter. Received two, immunizations in left upper arm (deltoid) on 8/17/09.  Developed left arm swelling on 8/18/09  Improved by 8/19/09 but still present (left arm 4 cm greater in diameter, red, minimal tenderness).
light headed nausea dizziness   down on floor for 45 min to 1 hour
Narrative:  Admitted JAN 3,2022@21:01:20 Discharged JAN 11,2022@16:07 Assessment: 1. Acute-on-Chronic Diastolic Heart Failure 2. Acute Hypoxic Respiratory Failure 3. CKD Stage 3 67 yo male with PMH HTN, HLD, recently ESRD on HD (6/21-8/21) but now CKD 3a, DM, h/o prostate cancer, s/p right 2nd/3rd toe amputations, and left foot osteomyelitis, former smoker who presented to the Emergency Dept on 1/3/22 with worsening bilateral lower extremity edema and shortness of breath in setting of COVID complicated by acute hypoxic respiratory failure. He was admitted with Acute hypoxic respiratory failure secondary to COVID (Despite being COVID vaccinated x 2) with volume overload. Continued on home Lasix PO 40 mg BID. Completed Rocephin 1/8/2022 for CAP coverage. Completed 5 day course of remdesivir and dexamethasone and anticoagulated with Intermediate dose anticoagulation. Required 2L NC. Walk test on 1/10 with desat to 86% pm RA. Arranged for home O2 on discharge.
Initial and follow up information has been received from a pharmacist via a company representative, and refers to a 69 year old male patient. The patient's medical history and concurrent conditions were not reported. On 17-JUN-2014, the patient was vaccinated with a single dose of ZOSTAVAX 0.65 ml, subcutaneous (lot # J014811, expiration date 21-FEB-2015). No concomitant medications were reported. On 02-OCT-2015, the patient presented to a pharmacy with a case of shingles and a prescription for acyclovir. The patient sought medical attention by going to the pharmacy. At the time of the report, the outcome of shingles was reported as not recovered. The relatedness between shingles and ZOSTAVAX was not provided. No product quality complaint was involved. Additional information has been requested.
No unusual discomfort at the vaccine site at the time of administration. Later that day, the patient started noticing significant pain radiating down her arm. The pain spread to her forearm. She could not easily move the arm due to pain but was able to perform activities of daily living with great effort. The injection was administered on Wednesday. The patient approached me on Sunday stating that the pain was still significant but was improving. She stated that there was no visible sign of reaction at the injection site (redness, swelling, heat, or streaking). She could not take her jacket off to show me the site because of discomfort.
Within 6 hours of getting vaccine I had flu symptoms- chills, aches, headache, fever, tiredness. By 9pm I had a fever of 104 degrees and was dropping sweat, shaking, and very weak. Within 24 hours, I developed a rash on my chest ans torso area of little red bumps that were itchy and spreading throughout the day. The fever came and went on the second day. Terrible flu symptoms have lasted over 24 hours now.
36 hours after receiving the vaccination, I felt heart palpitations. The severity increased and lasted over two hours. I monitored my oxygen levels which were in the high 90s. 63 hours after receiving the vaccination, I woke with a severe headache. This lasted ten hours.
patient received 2 dose of flulaval on the same visit on 14th OCT 2022; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 11-year-old patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 3393T, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT).   On 14th October 2022, the patient received the 2nd dose of FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 14th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season, Flulaval Tetra Pre-Filled Syringe Device and FLULAVAL QUADRIVALENT, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-OCT-2022 Reporter's comment: Registered nurse had reported that the patient had received 2 dose of flulaval on the same visit on 14th October 2022. Hcp was ok for safety team to team call back for further information. The reporter had consented to follow up. Additional supportive information: The patient had received 2 dose of Flulaval on the same day, which had led to overdose.
Ordering physician  exited patient room and RN at nurses station and told nurse stated to please give patient the second pfizer covid dose in the series. RN went to other RN running shot clinic and requested COVID shot. Bivalent booster dose pulled from COVID shot clinic vaccine basket. RN went to patient room to administer vaccine. Vaccine administered to patient. RN then went back to COVID clinic station to scan vaccination. Vaccination that was administered to patient was scanned into system. Error message appeared that the scanned medication did not match the ordered medication.  At this time RN administering vaccine immediately went to supervising RN and MD to let them know what had happened. Bivalent booster was administered to patient when the second monovalent vaccine was ordered. Parents called by Dr. DO. Mother aware of vaccine administration error.
No lesions. Dx-Chicken pox (post vaccination). Tx: Acyclovir