chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse events reported.; Medical Assistant reports the administration of expired dose of VAQTA.; This non-valid spontaneous report was received from a medical assistant referring to an unknown patient of unknown age and gender. Information regarding the patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions/allergies was not provided.   On 12-JUN-2020, the patient was vaccinated with an expired dose of hepatitis a Vaccine, inactivated (VAQTA) pre-filled syringe, dose of 0.5 mL, lot number: S021094, expiration date: 18-MAY-2020 (dose number, route of administration and anatomical location was not provided) for prophylaxis (expired product administered). No additional information and no further details were provided. No additional adverse events reported (no adverse event).  This report is non-valid due to lack of patient's identifiers.  Follow up information was received on 07-JUN-2022 from a family medicine provider. The patient is a 5-year-old female.  On 12-JUN-2020, the patient was vaccinated with diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DIPHTHERIA TETANUS ACELLULAR PERTUSSIS) lot number: S021094, expiration date: 18-MAY-2020, administered in the right thigh (dose and route of administration were not provided) for prophylaxis.  On 12-JUL-2020, the hepatitis a Vaccine, inactivated (VAQTA) was administered in the right thigh. It was reported that on 21-APR-2022, the patient was vaccinated again with a dose of hepatitis a Vaccine, inactivated (VAQTA) (dose, lot#, expiration date, route and site of administration were not provided) for prophylaxis. No adverse events were reported.
PATIENT REFERS STRONG HEADACHE AND INSOMNIA BECAUSE OF THE HEADACHE
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 POOR QUALITY 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 POOR QUALITY 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, POOR QUALITY 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. Not Provided      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 POOR QUALITY 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).    No concomitant medications were reported. No treatment medications were reported.  This case contains information for the 22th of 100 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:MASTER  CASE
Severe back pain; vomited; gallbladder attack; severe inflammation reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2022 at 11:00 as dose 3 (booster), single (Lot number: FJ1614), in left arm for covid-19 immunisation. The patient's relevant medical history included: "C7 cervical radiculopathy" (unspecified if ongoing), notes: C7 cervical radiculopathy but no current symptoms; "possible gallbladder" (unspecified if ongoing), notes: possible gallbladder; "mid back pain felt across my bra line like someone is squeezing my rib cage very tightly" (unspecified if ongoing), notes: mid back pain felt across my bra line like someone is squeezing my rib cage very tightly. Concomitant medication(s) included: NAPROXEN. Past drug history included: Zyrtec, reaction(s): "Known allergies: Zyrtec", notes: Zyrtec antihistamine only 1/2 pill made me feel drugged. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Right, Vaccine Administration Time: 10:30 AM), administration date: 10Jul2021, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM), administration date: 19Jun2021, for COVID-19 Immunization. The following information was reported: BACK PAIN (non-serious) with onset 30Jan2022 at 17:00, outcome "recovered" (2022), described as "Severe back pain"; GALLBLADDER DISORDER (non-serious) with onset 30Jan2022 at 17:00, outcome "recovered" (2022), described as "gallbladder attack"; INFLAMMATION (non-serious) with onset 30Jan2022 at 17:00, outcome "recovered" (2022), described as "severe inflammation reaction"; VOMITING (non-serious) with onset 30Jan2022 at 17:00, outcome "recovered" (2022), described as "vomited". Therapeutic measures were not taken as a result of back pain, vomiting, gallbladder disorder, inflammation.  Additional information: Hours after the COVID booster, i had severe back pain and vomited repeatedly the pain was so bad. The back pain i thought was muscular because i had it before, possibly a gallbladder attack that i am checking into now. I felt like the booster set off a possible severe inflammation reaction. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. facility type vaccine was at Pharmacy or Drug Store. I stopped taking Naproxen 7 days before booster.  Follow-up attempts are completed. No further information is expected.
muscle and joint pain, nausea and stomach pain, shivering, fatigue, headache
pt recv vax; sz first noted; much fussier after longer one & up much of the noc with crying; meds given;pt is extremely delayed, severe mental retardation expected;
Left ear pain and inflammation, some inflammation right under the left ear on the neck, one  strong twinge on the left ear, ringing in the ear mostly at night and early in the morning. All those symptoms have remained present since 03/19/2021 till today 03/39/2021.
Started feeling "fuzzy" on Wed March 17 in the afternoon and felt warm.  (did not take temp at this time)  on Thursday March 18 around 11:30 am, laid  down until 2pm  as i was feeling "fuzzy".   took temp around 2pm .  it was 100.4  took advil and nyquil at bedtime (around 9pm)  on Friday March 19 around 10:30 felt a bit fuzzy but not warm.  .  Experienced some chills around 4:30 so i took some advil.  Around 7pm temp was 99.4.  On Saturday March 20 at 5:30am  took some advil as i was feeling warm.(did not take temp).  at 9:20 am temp was 98.1.  Went to Urgent care  as i was still feeling fuzzy.  They administered a covid test and checked breathing.  no issues found.
Booster caused tightness and soreness in arm at first, then spread up to shoulder, then to front of shoulder then across back of shoulder. Now, 2 months later, I have lost range of motion in that arm. I can use that arm but with limited movement.
Patient seen 9/24/02 for 9 month check up. Got hepatitis B #3, PPD and Prevnar #1. On 9/25/02, patient developed generalized red, maculopapular rash. No fever.
Debilitating migraine on right side of head that ran over my head, down to my eye and right cheek, and ear. Started the morning of the 5th and continued into early morning 7th.   Pain was paired with severe stabbing/burning pain in injection arms armpit (injected in left arm), and continued pain in upper right abdomen that is still present.
Pt c/o anxiety, tingling sensation in fingers and burning sensation in chest after receiving H1N1 vaccination. Pt assisted to quiet area; Hx/Vx taken while pt calmed down. Initial Vx = BP 157/105 SPO2 - 99% RA;  HR = 125 1655hrs; 1705hrs VX = BP140/93 SPO2 = 99% RA; HR = 102.
first dose: sore arm; first dose: headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 07Apr2021 15:45 (Lot number: EW0153, Expiration Date: Jul2021) at the age of 56 years as dose 1, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Apr2021, outcome "unknown", described as "first dose: sore arm"; HEADACHE (non-serious) with onset 07Apr2021, outcome "recovered" (08Apr2021), described as "first dose: headache". Therapeutic measures were taken as a result of headache.  Additional information: After first dose she had sore arm. She went back to work the next day and the sore arm lasted for 2 to 4 days. She also developed headache which started about an hour after the first dose. With the first she had a headache all night. She took Aleve and went to bed and fell asleep. The headache was gone when she woke up.  No follow-up attempts are possible. No further information is expected.
Arm sore immediately. By middle of the night:headache, body aches, upset stomach, shivering, weakness
This spontaneous report was received from a certified medical assistant, and refers to multiple unknown patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On multiple unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L043214, expiration date 30-AUG-2017 (dose, dose number, route and anatomical location were unspecified). No adverse effects reported. The temperature excursion was 30.6F during 25 hours, and was detected by a data logger. The reporter stated that there were no previous temperature excursions. Additional information has been requested.
sore arm; felt extremely sick.; stayed in bed for 24 hours.; extreme aches; flu-like symptoms; Even food did not taste right; extreme fatigue; hot and cold chills; nauseated a bit.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ILLNESS (felt extremely sick.), ASTHENIA (stayed in bed for 24 hours.), PAIN (extreme aches) and INFLUENZA LIKE ILLNESS (flu-like symptoms) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), ILLNESS (felt extremely sick.), ASTHENIA (stayed in bed for 24 hours.), PAIN (extreme aches), INFLUENZA LIKE ILLNESS (flu-like symptoms), TASTE DISORDER (Even food did not taste right), FATIGUE (extreme fatigue), CHILLS (hot and cold chills) and NAUSEA (nauseated a bit.). On 04-Feb-2021, PAIN IN EXTREMITY (sore arm), ILLNESS (felt extremely sick.), ASTHENIA (stayed in bed for 24 hours.), PAIN (extreme aches), INFLUENZA LIKE ILLNESS (flu-like symptoms), TASTE DISORDER (Even food did not taste right), FATIGUE (extreme fatigue), CHILLS (hot and cold chills) and NAUSEA (nauseated a bit.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Pt received PCV-13 vaccine, had adverse rxn. Night of vaccine, pt had leg pain, next morning woke up with swollen eyes, facial swelling, and continued leg pain, without hives on neck. Pt took OTC BENADRYL and APAP, symptoms resolved.
Reported to ER on 4/4/14 with left upper thigh localized reaction at injection site. Swelling, rash of upper (L) thigh. Cool compresses and TYLENOL for treatment (Rash was approx 9.5 cm x 6.5 cm).
Patient developed chest tightness, palpitations, and SOB approximately 8 min after vaccination. At 12min post-vaccination patient developed throat tightness/itching. 0.3mL epinephrine auto-injector was administered at the vaccination site and the patient was transported to the emergency department for further treatment. Patient reported epinephrine made her symptoms worse. Emergency Department provider diagnoses symptoms as anxiety and gave a dose of lorazepam which improved the patient's condition. The patient was discharged from the ED after being monitored for 4 hours with improvement in symptoms. No further treatment was given.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/9/2021 and 2/24/2021. Presented from nursing facility for respiratory distress, intubated in the ED and admitted for respiratory failure and septic shock. CT chest findings indicative of chronic aspiration peumonia and additionally positive for COVID 19. Patient received pressors and antibiotics. On 1/14/22, the patient was transitioned to comfort care and expired on 1/16/2022.
On the same day, I received the RSV shot in the same arm  .AREXVY Lot M2543 The following day, I had swelling and redness, itching and soreness in the arm.  It was hot to the touch.  I also had a headache. The heat, redness and itching still persists after three days.  I have used Tylenol and a cold compress.  Perhaps it is not wise to take both shots at the same time.
Flu vaccine administered 10/19/06 approx 10am mother phones at 1:30pm described red face and hives. Tylenol elixir and Benadryl prescribed. Call MD if worse, appt made for 10/20/2006 am.
Pt received PCV-7 #4 and Varivax L arm. Immediately, 1.5cm welt appeared. No respiratory distress. Benadryl given. No other problem, pt's parent.
04/18/05 given MMR 1, developed leg swelling on thigh around injection site. Fever to 101.0 degrees Fahrenheit.
scrape on hand got all swelled up; scrape on hand turn red; scrape on hand infected; joint soreness; muscle soreness; swelling all over; hard time breathing; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling all over), DYSPNOEA (hard time breathing), PERIPHERAL SWELLING (scrape on hand got all swelled up), ERYTHEMA (scrape on hand turn red) and INFECTION (scrape on hand infected) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hand injury (Patient had scrape on his hand that was 6 inches long and it was healing.).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced SWELLING (swelling all over), DYSPNOEA (hard time breathing), ARTHRALGIA (joint soreness) and MYALGIA (muscle soreness). On an unknown date, the patient experienced PERIPHERAL SWELLING (scrape on hand got all swelled up), ERYTHEMA (scrape on hand turn red) and INFECTION (scrape on hand infected). At the time of the report, SWELLING (swelling all over), DYSPNOEA (hard time breathing), ARTHRALGIA (joint soreness) and MYALGIA (muscle soreness) was resolving and PERIPHERAL SWELLING (scrape on hand got all swelled up), ERYTHEMA (scrape on hand turn red) and INFECTION (scrape on hand infected) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Information has been received from a pharmacist concerning a 20 year old female with pertinent medical history not reported and drug reactions/allergies reported as none who on an unspecified date was vaccinated with HPV rL1 6 11 18 VLP vaccine (yeast), 0.5 ml, IM. Concomitant medication was not reported. Approximately on week after vaccination, the patient reported that she experienced shingles. The outcome and causality of the event was not reported. Additional information has been requested.
C/O rash posterior thorax no hx egg allergy no hx problems eating eggs. Denies S.O.B. Pt took antihistamine. Fine erythematous papular rash mostly posterior thorax today 1/27/13.
Headache, erythema, wheal 6cm x 4.5 cm.  Warm to touch, patient applied hand to region.  Patient went to ER and was given antibiotics for the cellulitis.
Syringe leaked a quarter of the liquid during patient's vaccine administration; needle was tight enough separated from the syringe; This spontaneous case was reported by a health care professional and describes the occurrence of SYRINGE ISSUE (Syringe leaked a quarter of the liquid during patient's vaccine administration) and DEVICE CONNECTION ISSUE (needle was tight enough separated from the syringe) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced SYRINGE ISSUE (Syringe leaked a quarter of the liquid during patient's vaccine administration) and DEVICE CONNECTION ISSUE (needle was tight enough separated from the syringe). At the time of the report, SYRINGE ISSUE (Syringe leaked a quarter of the liquid during patient's vaccine administration) and DEVICE CONNECTION ISSUE (needle was tight enough separated from the syringe) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medication was not provided.  The treatment information was not provided.
Approximately 2 hours after the injection she developed a generalized, pruritic rash and became flushed in the face.  She took benadryl and "everything cleared up."
fatigue; drowsy; dizzy; weak; doesn't feel well; lost appetite; didn't sleep last night; muscle pain; don't feel comfortable; little pain (site of shot); This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), SOMNOLENCE (drowsy), DIZZINESS (dizzy), ASTHENIA (weak) and MALAISE (doesn't feel well) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced FATIGUE (fatigue), SOMNOLENCE (drowsy), DIZZINESS (dizzy), ASTHENIA (weak), MALAISE (doesn't feel well), DECREASED APPETITE (lost appetite), INSOMNIA (didn't sleep last night), MYALGIA (muscle pain), FEELING ABNORMAL (don't feel comfortable) and VACCINATION SITE PAIN (little pain (site of shot)). At the time of the report, FATIGUE (fatigue), SOMNOLENCE (drowsy), DIZZINESS (dizzy), ASTHENIA (weak), MALAISE (doesn't feel well), DECREASED APPETITE (lost appetite), INSOMNIA (didn't sleep last night), MYALGIA (muscle pain), FEELING ABNORMAL (don't feel comfortable) and VACCINATION SITE PAIN (little pain (site of shot)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pt recv vax 7JAN98 & 14JAN98 pt devel fever between 102 & 103;pt examined by MD who noted that lung were clear & only had a mild cough;MD reported that the flu is going around but the time frame was appropriate for vax related fever;
Wheezing, slight difficulty breathing, I took 2 puffs of my ventilin and Used my Flonase as my nose felt congested and also had a Hall?s cough drop and my breathing and overall. Symptoms improved
Pt began itching, turned red from head to toe, face & neck (lips) swollen, knots on neck, white knuckles, welts all over upper body, fast heartbeat, trouble breathing, gave EPIPEN & 50mg BENADRYL & called 911.