chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Possible product temperature excursion issue; Patient administered moderna covid vaccine while temperature excursion was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Possible product temperature excursion issue) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Possible product temperature excursion issue) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Possible product temperature excursion issue) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the facility was unable to download the digital data logger, and the issue needs to be treated as a temperature excursion. The data logger that caller was unable to download were for the months of DEC2021, JAN2022, and FEB2022. Patients had been administered doses while the temperature excursion assessment was ongoing.  No treatments were reported.
1 day post 1st inject pt had muscle pain in lt arm of inject site. 2nd dose given in rt arm 25May90 uneventful
Parents described a non-urticarial. Mildly pruritic rash in evening following vaccine administration on 9/18/19. Rash faint pink located below clavicle & sternal region, back & lower arms. Negative: fever, malaise, upper respiratory symptoms, GI complaints, cough, sign/symptoms respiratory distress. Loratadine as needed on 9/24/19. Symptomatic care at home. Parents reported at planned subsequent visit. Rash gradually resolved. On 9/25/19 faint pink rash remained on sternal region only.
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In August 2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. Not Provided          No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-621185 (Patient Link).
Red, raised rash circling arm of injection site. Rash covered entire back. Rash in between breasts and upper stomach area. Fatigue and headache.
Day 1: Muscle aches, fatigue that persisted through 5 days after vaccination.  Day 6: Recipient awoke to aching joints localized to right arm with swelling and redness at right wrist and a burning sensation to the inner aspect of the right elbow.  Currently improved.
Pt with acute resp failure, COVID PNA, that developed symptoms 9 days prior to admit and ultimately received first vaccine 6 days prior toa admit, then shortly after progressed with other covid symptoms and was admitted. She decompensated while intp and was transferred to ICU for rising O2 needs, ultimately had to be intubated. Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle. Sx and IR consulted and did beside exploration of hematoma. Initially blood pressure responded but overnight continued with refractory hypotension. Maxed out vasopressin and levophed, hemodynamics deteriorated. Pt passed soon after(2/2).
Gradual onset retro-orbital facial pressure, glassy eyed followed by redness. Lump in throat - chest tightness, felt heated all over. SOLUMEDROL IV, BENADRYL 25 mg IV with good effect discharged with prednisone, BENADRYL & Z-pack.
Patient received 1st dose moderna 4 weeks ago, unable to seek care for second dose moderna, will provide patient with Pfizer as second dose, risk outweigh, need
Back and joint pain, stiffness, High temperature, Chills, Headache, Vomits (3).
Fever from 10:00 pm on 2/3 to around 4 pm on 2/5. Mild body ache. Chills. Fever over 100F until 11pm on 2/4. Started subsiding over night  and went away by 2/5. Had 2 NyQuil night time pills at 11 pm on 2/3. And another two on 2/4 at 11:30 am. No medications taken since.
Pt received Pfizer vaccines on 04/27/2021 and 06/08/2021. Pt presented to the ED on 11/16/21 with complains of cough, fever and SOB. Pt was found to be COVID positive with COVID pneumonitis. The pt did require supplemental oxygen.
Patient has a history of facial shingles and her PCM recommended the shingrix vaccine. She went AM 19JUL2019, uncomplicated injection. The next morning she woke with body aches and injection site edema/erythema/pain. Those symptoms improved, but over the weekend she also developed a diffuse maculopapular rash sparing the palms/soles that did not appear like hives. Slightly itchy. No other symptoms aside from mild diarrhea/abdominal that had resolved the day of her apt 23JUL2019. Has a sick contact with similar symptoms, but no rash.
My COVID-19 symptoms started on 02/09/2023 at night. I was completely blanked out. I had diarrhea which was extrema bad. My husband called an ambulance and I was taken to the hospital. They gave me regular infusions at the hospital. They also did COVID-19 tests and other tests as well. I didn't remember much. They can contact the hospital for more information. I had cough and they also prescribed antibiotics.
FOR ABOUT 24 HOURS I hAd FEVER, JOINT pAin, Burning EYes, DIGESTIVE PAIN. EVER SINCE, I CONTINUE TO HAVE mildLy BURnIng EYES ThaT REQUIRE USING EYE DROPS
This spontaneous report as received from a nurse refers to an unspecified number of patients. Demographic information was not provided. On 23-DEC-2013 the patients were vaccinated with a dose of VAQTA 25/0.5 U/ml which had been exposed to -5 degrees Celsius for 20 minutes which was not supported. Route, dose and lot number were not reported. No adverse effects were reported. This is 1 of 3 reports received from the same source (other case IDs 1312USA010886 and 1312USA012120). Additional information has been requested.
Information has been received from a physician's assistant concerning a 12 year old female with no reported medical history who on approximately 15-SEP-2007 was vaccinated with Gardasil. It was noted that this was not where the vaccine was administered, rather they were the patient's family physician. On 06-OCT-2007 the patient died in her sleep. No further information was provided. No lot number was given. Additional information has been requested.
Alopecia areata flared 3 weeks post vaccine after being dormant over 8.5 years. Half of eyebrow gone, needed 3 steroid injections in eyebrow to encourage hair regrowth.
Same as already entered.  Brown rash below injection site that?s unchanged after 17 days
information re: vaccination unavailable. Pt with concern for site erythema and edema at vaccination site left mid arm, worsening over the last 48 h with myalgia
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated by an unspecified healthcare provider with an expired PNEUMOVAX 23, dosing information, lot number and expiration date were not provided. No adverse effects were reported. Additional information is not expected.
Patient reports itching on bilateral legs, no redness or hives notes. Symptoms started approximately 10 minutes post vaccination. Patient observed for ~20 minutes, no further reactions notes.  Cleared by  EMS.  Patient advised if condition persists or worsens to contact PCP, call 911, or go to the nearest emergency room as needed.
Patient received Moderna dose #1 on 9/3/21 and second dose Moderna dose on 9/22/21. Says "Not Valid" for the second dose because it was given too early.
Worst headache of life slight relief from analgesic, nausea "dry heaves" lingering pain continues to use analgesic.
severe pain in right arm; mild erythema; diarrhea; headache; severe shaking chills; fever of 105.9 maximum; A spontaneous report was received from a healthcare professional who is also a 69-years-old male patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever of 105.9 maximum, severe shaking chills, severe pain in right arm, mild erythema, headache and diarrhea.  The patient's past medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (lot # 013L20A) on 20 Jan 2021.  On 17 Feb 2021, four hours prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (010M20A) intramuscularly in the left arm for prophylaxis of covid-19 infection.  On 17 Feb 2021, post vaccination, the patient began having low grade fever that rose to 105.9 that night.  The patient took Tylenol and it decreased to 103.  On 18 Feb 2021, the patient again developed night fever of 105 as well as severe shaking chills.  On 19 Feb 2021, patient's fever was 102 and they experienced Headache, severe pain in right arm, mild erthymea and diarrhea.  On 20 Feb 2021, patient had fever of 101.  On 21 Feb 2021, the patient's fever was 100 in the morning and decreased to 98-99 in the afternoon.  In the morning of 22 Feb 2021, the patient had fever of 99.1 with continued headaches and diarrhea.    Treatment details included Tylenol every 6 hours during the second and third day. Also, the patient's been drinking a lot of cold water and trying to keep themself in a cold environment.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not Applicable.  Outcome of events: On 22-feb-2021 Patient with fever outcome was resolved and recovered . 18-feb-2021 event Severe shaking chills was resolved and recovered. Headache, severe pain in right arm, mild erythema, diarrhea and pain in right arm outcome was not unknown or not provided.
Mom stated this AM pt woke up site was about a dollar size in redness and itched. Mom then gave Benadryl and redness and itching went away.
complications; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix, due to complications the patient did not received her 2nd dose yet. The patient disconnected the call before any additional details could be collected. The reporter did not consent to follow up.
Severe chest pain and throat pain started approximately 23 hours after vaccination. First episode lasted approximately 1 hour; the second episode occurred approximately 3 hours after the first episode and was so severe that I ended up hyperventilating. The hyperventilating led to many parts of my body become numb and my arms and hands became somewhat paralyzed. The pain and symptoms were so sever that an ambulance was called and I was taken to the hospital.
I am a nurse field case manager.  My first injection on 02/24/2021 Lot number L09L20A I have a somre arm and vomiting. I was nauseated at the smell of some foot.  24 hours later no problem.  Second injection on 03/24/2021 Lot 029l20A was worse as expected.  First the vomiting started, then the left arm to the fingers from the injection side was in pain. My body started hurting late in the evening.  I started keeping liquids down.  It is 24 hours later and my arm does not heart to the fingers just at  the injegction site.  I woke up to a headache which I believe cause my right eye to have blurry vision until the headache was gone. I remain anauseated.  I did not have a tempaturfever or signs of COVID.
pain, not discomfort, at point of injection lasting three days extending to wrist; extreme chills, shakes, headache, tiredness, dizziness
1st dose 18Nov2021, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18th November 2021).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 28-FEB-2023 Reporter's Comments: The registered pharmacist (RPH) reported two patient had not yet received their second doses of Shingrix (second dose not yet given). The health care professional (HCP) unable to provide additional adverse event details at this time. The  HCP gives consent for safety team follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case is linked with US2023032800, reported by same reporter.; Sender's Comments:  US-GSK-US2023032800:Same reporter
No additional AE's or PQC's noted; Caller reported a temperature excursion/ which was administered to multiple patients; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 26-MAR-2021, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 1 dosage form orally, lot # 1688825 and expiration date 24-NOV-2021, administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 47.7 degree fahrenheit (°F) for 8 minutes, 54 °F for 28 minutes and 47.8 °F for 12 minutes. Previous temperature excursions were reported with the following details: 61.9 °F for 9 hours and 21 minutes and 56.3 °F for 4 hours and 27 minutes.  The call was made due to a digital data logger. No adverse symptoms were reported. This is one of several cases from the same reporter; Sender's Comments:  US-009507513-2104USA003255: US-009507513-2104USA003252: US-009507513-2104USA003130:
Information has been received from a registered nurse (R.N.) concerning a 10 year old female patient who on 31-AUG-2010 was vaccinated with her second dose of VARIVAX (Merck) (Lot number 667293/0640Z). Concomitant medication included "allergy shots". The nurse reported that on 18-SEP-2010 the patient developed an itchy rash all over her body. At the time of report, the patient had not recovered from itchy rash all over her body. The patient sought medical attention by an office visit. Follow up information has been received from the registered nurse who stated that the female patient with not illness at the time of vaccination on 31-AUG-2010 in the afternoon received subcutaneously into the right arm the second dose of VARIVAX (Merck). The nurse reported that on 21-SEP-2010 the child had full varicella outbreak with multiple pox spread thought her body. On an unspecified date, the patient had recovered. Additional information is not expected.
Fever 103-104 from 07/16 to 07/20. Re-exam 07/17- no pustule findings. Fever broke 07/20
Bad Headache; body aches; fatigue; 101 fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number: EP7534; expiry date: unknown) as dose number unknown, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced bad headache, body aches, fatigue, and 101 fever. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
about 10 hours after receiving my second dose, I had tingling all on my left side and extreme joint pain.  I ran a 105.3 fever for 6 hours.  Full body aches and pains. I still (7 months later) have extreme joint pain all on my left side - Hip is the worst, followed by shoulder and then knee
Swelling of entire extremity (leg) associated with the injection. Heat, pain and swelling from the hip joint to the calf. Lasted for 5 days. 102.3 fever lasted for 1 day.
From 10/13/12 Pancreatitis 3 days after vaccine abdominal pain radiated to back feel worse after eating nausea, indigestion, acid reflux oily smelly stool, respiratory symptom.
This spontaneous report as received from a Medical assistant refers to a 64 year old female patient with no drug allergies or pertinent medical history who on 21-DEC-2009 the patient was vaccinated with ZOSTAVAX lot # 664277/0367Y, exp date 03-OCT-2010 (also reported as 30-JUL-2010), once, 0.5 ml, subcutaneous for she wanted to get it cause she had chicken pox as a child. Concomitant therapies included ALTACE, simvastatin (manufacturer unknown), FOSAMAX and hydrochlorothiazide (manufacturer unknown). The health care professional stated that the patient was seen in the office today 21-FEB-2014 and was "diagnosed with shingles". The medical assistant stated the "shingles started a week and a half ago" on approximately 11-FEB-2014. The medical assistant described that physician prescribed VALTREX. The outcome of event shingles was reported as not recovered/not resolved. Additional information has been requested.
Pfizer-BioNTech COVID-1 Vaccine Patient presented to ED 10 minutes after receiving COVID vaccine with mild redness around injection site and some chest tightness that may be attributed to being nervous and anxious over vaccination.  no erythema or swelling noted around injection site.  Patient had just worked 14 hours night shift. 0823 redness improved along with chest tightness.  IM dexamethasone 8 mg given in ED 0837 significantly improved after ED observation and stable for discharge Prescription for hydroxyzine 50 mg  po TID x 7 days Follow up with PCP
STROKE; This spontaneous report received from a consumer through a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: Unknown and expiry: Unknown) 1 total, dose (Dose number in series:1) and start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced stroke. The consumer reported as "The lady I work for had a stroke after getting hers. She's in a wheelchair for the rest of her life." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211251043 and 20211251833.; Sender's Comments: V0: 20211251030 - Stroke This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Received vaccine at out reach clinic, no concerns until today when jacket was removed and large bruise on rt arm at injection site and below, about 3 X 5 inches. Warm to touch, bruise does not hurt but injection site is sore. Did not notice bruise until today as no  electricity and did not remove  jacket until today at cardiologist, Dr. office. He Advised client to "Go to health department or Walk in clinic." Client came, will continue on to walk in clinic
Left arm was sore around site of injection, which is normal. But the pain got worse over the next few days instead of decreasing. After 4-5 days, the pain was sometimes even unbearable, not when touching (no pain when laying down on that arm!), but with certain arm movements or when laying down on the other arm. Went to doctor where nurse practitioner concluded it was probably a vaccine-induced neuritis since there was no pain when touching directly and no abscess or hematoma seen at ultrasound - prescribed some piroxicam. Pain improved slowly over following month, but still not completely back to normal on 02/24/10.
Sore throat (Pharyngolaryngeal pain), Nasal congestion, muscle ache (Myalgia), chills, sinus pressure (sinus headache), Headache
Information has been received from a health professional concerning a patient who on 12-DEC-2007, while receiving varicella virus vaccine live (Oka/Merck), did not receive the whole dose as a result of the vaccine administrator receiving a splash in the eye from the vaccine. Current patient status was not reported. A product quality complaint was not reported. This is one of two reports from the same source. Additional information has been requested.
allerg rxn to vax r/t underlying otitis per MD;p/vax pt gagging x2, crying, color pale pink, diaphoretic;resp WNL, no circumoral cyanosis;pulse strong;cool compress to neck;+emesis <50cc; p/vomit-pale,sleepy,diaphoretic;pt to ER  Annual follow up received on 10/20/00 provided no additional text or COSTARTS.
Patient received her Vaccine on 12/16/2020. Afterwards she developed symptoms of fever, chills, diarrhea, nausea, vomiting and headache that became worse over time and on day os presentation to our hospital on 1/2/2021 she was having photophobia. Current headache at time of admission had been persistent for over a week. Patient has no immunocompromising risk factors and was diagnosed with confirmed CMV meningitis. She was also admitted with transaminitis.
Left arm has rash, redness, swollen, warm to touch. Muscle pain/soreness, headache, feeling tired.