chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bone aiking, significant strong reaction; Received 3rd dose by error; This non-serious case was reported by a nurse via call center representative and described the occurrence of bone pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 29th August 2020) and Shingrix (received second dose on 23rd December 2020). Concomitant products included acetylsalicylic acid (Aspirin), bupropion hydrochloride (Wellbutrin) and nifedipine (Adalat).   On 15-MAR-2023, the patient received the 3rd dose of Shingrix. In MAR-2023, less than a week after receiving Shingrix, the patient experienced bone pain (Verbatim: Bone aiking, significant strong reaction). On 15-MAR-2023, the patient experienced extra dose administered (Verbatim: Received 3rd dose by error). In MAR-2023, the outcome of the bone pain was recovered/resolved. The outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the bone pain to be related to Shingrix.     It was unknown if the company considered the bone pain to be related to Shingrix.   Additional Information: GSK receipt date: 22-Mar-2023 The nurse reported that an immunocompetent patient that usually takes a few medications such as Prolistat, Vitamin D, Aspirin, Adalat, Wellbutrin and received by error a third dose of Shingrix and one day before the reporting day morning, the patient reported a significant strong reaction obviously, bone aching, but she was okay now.  No further details about this strong reaction was reported by the patient. The reporter consented to follow-up by email. The patient received third dose of Shingirx by error, which led to extra dose administered.
Patient presented with chest pain or shortness of breath. Outpatient VQ scan concerning for pulmonary embolism. Covid 19 positive. Significantly elevated d-dimer
pt recv vax 17MAR98 & erythematous, warm & tender 10 cm area surrounding inj site lt arm;
Information has been received from a RN concerning a 9 yr old male pt with Attention Deficit Disorder, developmental delay and a history of reactive airways disease, who on 30Jun98 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot 625476/0645H). There was no concomitant medication. It was noted that the pt was not ill at the time of vaccination. On 02Jun05 the pt developed 30 plus papular lesions. He was seen by the physician and given symptomatic treatment. There were no lab test performed. The pt recovered in mid June 2005. Additional information has been requested.
Rash; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received first dose bnt162b2 (Solution for injection), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and patient concomitant medications were not reported. The patient experienced rash on an unspecified date. The outcome of the event unknown.
Pt tested positive for COVID-19 at the nursing home and brought to hospital for dialysis.  Remained asymptomatic and on room air from COVID.
Legs stiff; Difficult to walk; Face numb; Face tingly and legs tingling; Face started twitching; Arm weak; Legs weak; Fatigue; Leg cramping/ leg cramp; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Leg cramping/ leg cramp), HYPOAESTHESIA (Face numb), PARAESTHESIA (Face tingly and legs tingling), MUSCLE TWITCHING (Face started twitching) and MUSCULAR WEAKNESS (Arm weak) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Flu vaccination: Flu vaccine. Past adverse reactions to the above products included Guillain Barre syndrome with Flu vaccine. Concurrent medical conditions included Lupus syndrome. Concomitant products included TOPIRAMATE (TOPAMAX) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced MUSCLE SPASMS (Leg cramping/ leg cramp) and FATIGUE (Fatigue). On 20-Feb-2021, the patient experienced HYPOAESTHESIA (Face numb), PARAESTHESIA (Face tingly and legs tingling), MUSCLE TWITCHING (Face started twitching), MUSCULAR WEAKNESS (Arm weak), MUSCULAR WEAKNESS (Legs weak) and GAIT DISTURBANCE (Difficult to walk). On 21-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Legs stiff). On 20-Feb-2021, MUSCLE TWITCHING (Face started twitching) and FATIGUE (Fatigue) had resolved. On 21-Feb-2021, MUSCULAR WEAKNESS (Arm weak) had resolved. At the time of the report, MUSCLE SPASMS (Leg cramping/ leg cramp), HYPOAESTHESIA (Face numb), PARAESTHESIA (Face tingly and legs tingling), MUSCULOSKELETAL STIFFNESS (Legs stiff) and GAIT DISTURBANCE (Difficult to walk) had not resolved and MUSCULAR WEAKNESS (Legs weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Initial additional information received on 28-Apr-2021: Reporter email address added
Blister on her Gum; Giant Blister on the Bottom Lip for 1 to 1.5 weeks; injection site hurt for 3 to 4 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GINGIVAL BLISTER (Blister on her Gum), LIP BLISTER (Giant Blister on the Bottom Lip for 1 to 1.5 weeks) and VACCINATION SITE PAIN (injection site hurt for 3 to 4 days) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced GINGIVAL BLISTER (Blister on her Gum), LIP BLISTER (Giant Blister on the Bottom Lip for 1 to 1.5 weeks) and VACCINATION SITE PAIN (injection site hurt for 3 to 4 days). On 23-Mar-2021, VACCINATION SITE PAIN (injection site hurt for 3 to 4 days) had resolved. On 29-Mar-2021, GINGIVAL BLISTER (Blister on her Gum) and LIP BLISTER (Giant Blister on the Bottom Lip for 1 to 1.5 weeks) had resolved.            Concomitant medication use was not reported.  Treatment information pertaining to these specific events was not reported.   It was noted by the patient that her dentist told her he has "not seen anything like it ever." It is unclear if the patient was actually seen and evaluated by her dentist.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Received vaccines on 10/09/2019, when awaking on 10/10/2019 her eyes were swollen shut, unable to open that day. Patient used ice to help control swelling. She started improving 10/14/2019 and today, 10/15/2019 is much better, able to see and only looks like she has bags under her eyes and still slightly swollen on upper eyelids.
No additional AE.; Caller reported that GARDASIL 9 that underwent a temperature excursion was administered; This spontaneous report has been received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On an unknown date in December 2022 (reported as between 06-DEC-2022 and 22-DEC-2022), the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot # 004648 is an invalid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and does not match any Company product (exact dose, dose number, route of administration, and anatomical location were not reported) for prophylaxis. On an unknown date before administration, the vaccine underwent a temperature excursion, however exact time and temperature of excursion were unknown. There was no previous temperature excursion. No additional adverse event was reported.
Patient was administered with moderna covid-19 vaccine for 6-11yrs of age instead of updated moderna bivalent booster
Received their first dose 4 months ago and have yet to receive their second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received their first dose 4 months ago and have yet to receive their second dose) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received their first dose 4 months ago and have yet to receive their second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received their first dose 4 months ago and have yet to receive their second dose) had resolved.        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.   Concomitant product use was not provided by the reporter. No treatment information was provided.
This case was reported by a pharmacist and described the occurrence of hives over whole body in a 78-year-old female subject who was vaccinated with Flu vaccine (manufacturer unspecified). Concurrent medical condition included arthritis, high cholesterol and an unspecified respiratory disorder. Concurrent medications included ADVAIR and VYTORIN. On the evening of 12 September 2008, the subject received the 1st dose of Flu vaccine (.5 ml, unknown) at a local hospital. On 12 September 2008, less than one day after vaccination with Flu vaccine, the subject experienced hives over her whole body and severe itching. The subject was treated with triamcinolone cream. The subject had previously received flu vaccinations with no prior adverse events. The pharmacist considered the events were clinically significant (or requiring intervention). At the time of reporting, the events were improved. The pharmacist considered the events were probably related to vaccination with Flu vaccine.
Patient arrives via EMS with complaint of nausea, vomiting, and diarrhea that started today.  Patient just had a positive COVID test today.  Patient states she felt fine yesterday.  Patient denies shortness of breath, does admit to an occasional cough.  Patient denies fever, chills, chest pain, or rash.  Patient lives at an ECF.
Began seeing flashes in my left eye.  Diagnosed with Posterior Vitros Detachment (PVD - gel separating from retina)), found round retinal hole; treatment > Laser retinopexy
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again.; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again.) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again.).    This case contains information for the 7th of 100 adult male patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  Nurse reported that an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again. The 100 adult male patients were involved.  Moderna COVID19 vaccine bivalent, dosage given in ml unknown to the HCP.   Treatment Medication use information was not provided by reporter.   This case was linked to MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-697752:Master case
MODERNA COVID VACCINE #3 GIVEN 11/22/21, LOT # 018F21A; pt was previously seen in ED with COPD exacerbation and was given ABX and steroids; pt back to ED with worsening SOB, chest tightness, weakness, fatigue, wheezing; pt had previously tested positive at clinic; AHRF; respiratory status guarded; O2 supplementation; given Solumedrol, ABX and DuoNeb; experienced A Fibrillation with RVR; placed in CCU; condition worsened; pt requested to DNI; later changed status to DNR and eventually comfort care; he did not want to wear his O2; pt passed away in the hospital
FLU-LIKE SYMPTOMS; SORENESS AND ACHES; REFUSING TO GET OUT OF BED; WILLINGNESS TO BE UP AND ABOUT VARIES; LIGHT FEVER; FATIGUE; ALMOST LIKE DRUNKENNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced flu-like symptoms, soreness and aches, refusing to get out of bed, willingness to be up and about varies, light fever, fatigue, and almost like drunkenness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu-like symptoms, light fever, soreness and aches, fatigue, refusing to get out of bed, willingness to be up and about varies and almost like drunkenness was not reported. This report was non-serious.
On Friday, February 5, the injection site became itchy, swollen and a red rash. I applied Benadryl spray and Calamine lotion to alleviate the itch. Today, Feb 9, I still have the itchiness, slight rash and the site is slightly swollen. On Saturday, Feb. 6, I noticed a pea size lump on my left neck about 1 inch above the collar bone.
Had low grade fever night of vaccine (midnight) until Monday. Had vaccine on Friday. Sat = started feeling swelling in area, redness, itching until today (Wed 6/17). Felt chills today 6/17.
Developed stomach ache approx 1-2 hrs after injection. Symptoms progressively worsened to include headache, nausea, tiredness, pain at injection site. Most severe symptoms was headache.
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: after patient reported facial tingling after 1st dose of Pfizer Covid vaccine I opted to pretreat with 10ml Benaryl 12.5mg/5ml liquid to prevent possible allergic reactions. Patient waited 15min & instructed to report back if any further reaction occurred after the 2nd dose RPh
Agitation after both doses of the Moderna COVID-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of AGITATION (Agitation after both doses of the Moderna COVID-19 vaccine) in an elderly patient of an unknown gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AGITATION (Agitation after both doses of the Moderna COVID-19 vaccine). At the time of the report, AGITATION (Agitation after both doses of the Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.   No treatment medications were reported.
plaintiffs allege that as a result of immun in JUL88; pt suffered permanent (unspecified) neurologic injuries;
Patient came and got his 2nd dose of Covid Vaccine Moderna on 5/19/2021. Today 5/25/2021, his wife came and informed us that he has been sick since he came back from his 2nd dose. She said that he has been seeing MD and receiving treatments for COVID symptoms, however he is not tested positive for COVID. He is currently on weekly IV injection according to the wife but she did not specify the symptoms or which IV he is on (beside saying he has COVID symptoms and on IV weekly at the MD)
On day one after an hour i felt little pain and irritation. Pain went away for a couple of days while taking Tylenol and Aleve.  About 3days later a bumpy patch appeared on the vaccinated area, after that I felt very fatigue, and bump swelled bigger each day, arm felt very hot and numb. I had ice packs on the area and that seemed to help. The vaccinated area is still puffed up but has gone down after 3 days from puffing up.
Pt had vaccine on 12/22.  Reported redness at injection site on 12/31 (9 days later).  A few hours later, pt experienced swelling tongue and blisters.  Advised to take benadryl and declined ED visit.  Friend will monitor.
Incorrect product storage; no additional AE reported; This spontaneous report was received from a medical assistant and refers to a 14-months-old female patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 28-JUL-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous for prophylaxis (dose, frequency, and anatomical injection site were not reported; lot number was reported as T007359, and upon internal review was determined not to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date was reported as 29-AUG-2021), with the first dose of hepatitis A virus vaccine inactivated (HAVRIX) intramuscular (IM) (lot number 1595K with an expiration date on 30-DEC-2021); with the third dose diphtheria toxoid, Hib conj vaccine (tet toxoid), pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (MRC-5), tetanus toxoid (PENTACEL) IM (lot number NJ227AAA with expiration date on 23-APR-2021); and with the third dose of pneumococcal 13v conj vaccine (CRM197) (PREVENAR 13) (for those three vaccines doses, frequencies, indications and anatomical injection site were not reported).  On an unknown date, the mentioned vaccines had a temperature excursion in freezer. No previous temperature excursions were reported. No digital data logger was involved. No adverse reaction was noted with the patient.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA008314: US-009507513-2008USA001768: US-009507513-2008USA009257: US-009507513-2008USA009258: US-009507513-2008USA009259:
Bell's palsy  On 1/11 Patient began experiencing tingling in his left jaw  On 1/18 he began experiencing aches in his teeth  On 1/22 paralysis of L side of his face, did not spare the forehead
One of two pts recvd DTP/OPV & exp inject site rxn which was red, swollen, hard & warm to the touch; no ATB were prescribed; No office visit;
DURING THE NIGHT AFTER VACCINE I DEVELOPED MODERATE LB PAIN, HEADACHE, NAUSEA, HAD 3 BOWEL MOVEMENTS REASONABLY WELL FORMED AND I FELT VERY WEAK AND UNWELL.  ACCORDING TO MY FITBIT I HAD AN ELEVATED HEART ALL NIGHT. MY USUAL RESTING HEART RATE IS ABOUT 52 I USUALLY SPEND THE NIGHT BELOW THAT 70% OF THE TIME. THE 1ST HALF OF NIGHT IT WAS  55-62 AROUND 3:00AM WENT UP TO 62-68 WHICH IS VERY UNUSUAL FOR ME AT NIGHT. I SLEPT OVER 9 HOURS AND AWOKE TIRED & NAUSEOUS. I TOOK AN ASPIRIN AND WENT BACK TO BED.
Initially just extreme tiredness, which over a 2-7 week period progressed to also include a significantly debilitating level of breathlessness and high heart rate during strenuous activity.  More recently, this appears to have resolved in large part.
A little sore on arm.; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP7533) via an unspecified route of administration in the right arm on 27Mar2021 at 11:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history, concomitant medications, allergies to medications, food or other products. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 27Mar2021 at 19:00 the patient experienced a little sore on arm. The event was reported as non-serious and did not require hospitalization; no treatment was provided for the event. The clinical outcome of a little sore on arm was recovering. It was also reported the patient had not been tested for COVID-19 since vaccination.  No follow-up attempts are needed; no further information is expected.
A mother reported that her son received vaccine on 2/26/00 and on 2/27/00 he developed an injection site reaction characterized by redness and swelling, reportedly the size of a softball. His symptoms have persisted.