chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTAPIPVHIB, IPV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose of IPOL was administered to patient with no AE; Initial information regarding an unsolicited valid non-serious was received from other health professional via Agency (Reference number- 00614834) and transmitted to Sanofi on 25-May-2021.  This case involves a 4 years old female patient who was administered with 0.5 mL expired dose of suspect vaccine IPV (VERO) [IPOL] (lot R1B251M and expiry date: 13-Mar-2021) via intramuscular route in the right thigh (expired product administered) for prophylactic vaccination on 25-May-2021.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  The reporter asked whether dose needs repeating and wanted to know any adverse reaction to expect from receiving an additional dose of IPOL.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, the patient experienced no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: redness, swelling, hot to touch, the area was 15 cm in diameter at the injection site; a circular bubble in the middle, the area was 15 cm in diameter at the injection site; itching at the injection site, the area was 15 cm in diameter at the injection site; redness, swelling, itching, a circular bubble in the middle, hot to touch, the area was 15 cm in diameter at the injection site; Initial and additional information received on 27-May-2021 regarding an unsolicited valid  non-serious case received from a physician via Agency (Reference number- 00618732).  This case involves a four years old male patient who experienced redness, swelling, hot to touch, the area was 15 cm in diameter at the injection site (inflammation), circular bubble in the middle, the area was 15 cm in diameter at the injection site (blister), itching at the injection site, the area was 15 cm in diameter at the injection site (pruritus) and redness, swelling, itching, a circular bubble in the middle, hot to touch, the area was 15 cm in diameter at the injection site (vaccination site reaction), while he received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included POLIO VACCINE for prophylactic vaccination on 13-May-2021 at the same visit.  On 13-May-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5743AA, expiry date: 06-JUN-2022 via intramuscular route in the left thigh for prophylactic vaccination.  On 14-May-2021, the patient developed a non-serious redness, swelling, hot to touch, the area was 15 cm in diameter at the injection site (inflammation), circular bubble in the middle, the area was 15 cm in diameter at the injection site (blister), itching at the injection site, the area was 15 cm in diameter at the injection site (pruritus) and redness, swelling, itching, a circular bubble in the middle, hot to touch, the area was 15 cm in diameter at the injection site (vaccination site reaction) one day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Description: Health Care Professional called to report DAPTACEL has been causing chemical reaction in four patients. The caller stated that she has had four patients that developed the same injection site reaction after a vaccination with Daptacel and Doctors nurse called back stating they would like a replacement. Three of the patient received the same lot number for sure, the caller was not sure about the fourth patient. She will send pictures of the reaction areas of all of these patients. Product used, Still using product: No  No laboratories details reported.  The patient was treated with BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE] and cool compresses for all the events.  At time of reporting, the patient was recovered from all the events after five days.
Sex: M
Vaccine: DTAP
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site vesicles, Vaccination site warmth
Clinical narrative: redness; a circular bubble in the middle; swelling; itching; hot to touch; Initial information with live follow up regarding an unsolicited valid non-serious case from a physician via Agency (Reference number- 00618838) and transmitted to Sanofi on 27-May-2021.  This case is linked to cases 2021SA179435 and 2021SA179588 (same reporter).  This case involves a 03-year old male patient who had redness (vaccination site erythema), circular bubble in the middle (vaccination site mass), swelling (vaccination site swelling), itching (vaccination site pruritus) and hot to touch (vaccination site warmth), while he received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On 24-May-2021, the patient received 0.5 ml once dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5765BA and expiration date: 28-Aug-2022) via unknown route in unknown administration site for prophylactic vaccination.  On 25-May-2021, the patient developed a non-serious, redness (vaccination site erythema),  circular bubble in the middle (vaccination site mass), swelling (vaccination site swelling),  itching (vaccination site pruritus) and hot to touch (vaccination site warmth), 1 day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of the events was resolving.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Blood test, Chills, Choking, Computerised tomogram
Clinical narrative: First dose: my face went numb and tongue felt itchy 1.5 hours roughly for symptoms.  No common side effects; Second dose: calling it a panic attack. Racing heart, felt like I was passing out, mental fogging, trouble swallowing lasted about 1.5 - 2 hours. After 2nd dose I had the normal side effects, headache, chills, body aches fatigue.. After about 2 days of common side effects I noticed I was having trouble swallowing and it felt like I was being choked pulse food regurgitation and diarrhea.  It kept getting worse and worse after a week or so of hell I get an emergency endoscopy showing I have  eosinophilic esophagitis.  I?ve been put on all sorts of meds that are supposed to be treating this but nothing is working.  It?s been near a month now and 2 weeks have been on a hard core elimination diet  symptoms are persistent and discomfort it spreading to what feels like intestines, kidneys and possibly other locations I now have to go in for a colonoscopy soon as the meds should be working and discomfort is spreading.  Loads of headaches can?t sleep with all the discomfort.  Never hungry.  Possible permanent esophagus damage maybe more everything is still being diagnosed and no one is really finding any answers why.  For the last 6 years I?ve been on a health kick working out almost daily and eating very healthy.  No symptoms no warning  signs these one or more diseases it has all just started out of the blue post vaccine nothing else in my life has changed.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dizziness, Dysphagia, Endoscopy abnormal, Eosinophilic oesophagitis
Clinical narrative: First dose: my face went numb and tongue felt itchy 1.5 hours roughly for symptoms.  No common side effects; Second dose: calling it a panic attack. Racing heart, felt like I was passing out, mental fogging, trouble swallowing lasted about 1.5 - 2 hours. After 2nd dose I had the normal side effects, headache, chills, body aches fatigue.. After about 2 days of common side effects I noticed I was having trouble swallowing and it felt like I was being choked pulse food regurgitation and diarrhea.  It kept getting worse and worse after a week or so of hell I get an emergency endoscopy showing I have  eosinophilic esophagitis.  I?ve been put on all sorts of meds that are supposed to be treating this but nothing is working.  It?s been near a month now and 2 weeks have been on a hard core elimination diet  symptoms are persistent and discomfort it spreading to what feels like intestines, kidneys and possibly other locations I now have to go in for a colonoscopy soon as the meds should be working and discomfort is spreading.  Loads of headaches can?t sleep with all the discomfort.  Never hungry.  Possible permanent esophagus damage maybe more everything is still being diagnosed and no one is really finding any answers why.  For the last 6 years I?ve been on a health kick working out almost daily and eating very healthy.  No symptoms no warning  signs these one or more diseases it has all just started out of the blue post vaccine nothing else in my life has changed.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Pain, Palpitations
Clinical narrative: First dose: my face went numb and tongue felt itchy 1.5 hours roughly for symptoms.  No common side effects; Second dose: calling it a panic attack. Racing heart, felt like I was passing out, mental fogging, trouble swallowing lasted about 1.5 - 2 hours. After 2nd dose I had the normal side effects, headache, chills, body aches fatigue.. After about 2 days of common side effects I noticed I was having trouble swallowing and it felt like I was being choked pulse food regurgitation and diarrhea.  It kept getting worse and worse after a week or so of hell I get an emergency endoscopy showing I have  eosinophilic esophagitis.  I?ve been put on all sorts of meds that are supposed to be treating this but nothing is working.  It?s been near a month now and 2 weeks have been on a hard core elimination diet  symptoms are persistent and discomfort it spreading to what feels like intestines, kidneys and possibly other locations I now have to go in for a colonoscopy soon as the meds should be working and discomfort is spreading.  Loads of headaches can?t sleep with all the discomfort.  Never hungry.  Possible permanent esophagus damage maybe more everything is still being diagnosed and no one is really finding any answers why.  For the last 6 years I?ve been on a health kick working out almost daily and eating very healthy.  No symptoms no warning  signs these one or more diseases it has all just started out of the blue post vaccine nothing else in my life has changed.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Panic attack, Sleep disorder, X-ray
Clinical narrative: First dose: my face went numb and tongue felt itchy 1.5 hours roughly for symptoms.  No common side effects; Second dose: calling it a panic attack. Racing heart, felt like I was passing out, mental fogging, trouble swallowing lasted about 1.5 - 2 hours. After 2nd dose I had the normal side effects, headache, chills, body aches fatigue.. After about 2 days of common side effects I noticed I was having trouble swallowing and it felt like I was being choked pulse food regurgitation and diarrhea.  It kept getting worse and worse after a week or so of hell I get an emergency endoscopy showing I have  eosinophilic esophagitis.  I?ve been put on all sorts of meds that are supposed to be treating this but nothing is working.  It?s been near a month now and 2 weeks have been on a hard core elimination diet  symptoms are persistent and discomfort it spreading to what feels like intestines, kidneys and possibly other locations I now have to go in for a colonoscopy soon as the meds should be working and discomfort is spreading.  Loads of headaches can?t sleep with all the discomfort.  Never hungry.  Possible permanent esophagus damage maybe more everything is still being diagnosed and no one is really finding any answers why.  For the last 6 years I?ve been on a health kick working out almost daily and eating very healthy.  No symptoms no warning  signs these one or more diseases it has all just started out of the blue post vaccine nothing else in my life has changed.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: my right hand, index finger is in pain. when I bend my finger my knuckle area is in pain.  now my right hand is swollen in index finger area. and pain in my right arm
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus, Vertigo
Clinical narrative: First, I suffer from Chronic Tinnitus / Hearing Loss and occasional Vertigo.  The day following my vaccine, my tinnitus became significantly more intense and started "pulsating".  Best I can describe is the volume of the ringing pulses louder with my heartbeat.  In addition, I had two brief episodes of Vertigo within the past week whereas I normally get them no more than once or twice per year.   I'm unsure at this time whether a second shot will make it unbearable.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Somewhat sore arm and protruding swollen lymph node on left collarbone.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities, Neuralgia, Ultrasound scan, X-ray
Clinical narrative: 05/02/2021..started severe nerve pain from my right shoulder down to my elbow.                       *My Migraines have also increased !!!!!!!! Was given Gabapentin,Tizanidine, and Prednisone.                                                                                                          Sumatriptan  Tried heating pad, ice pack, icy hot. The only way I could get comfort from this horrific pain was laying down.  For 2 1/2 weeks I did nothing but lay down.   By 5/31/2021 my pain has started to let up and I can go for a longer period of time without pain.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site induration
Clinical narrative: Covid Arm; Hard, red, itchy area around the vaccine shot site.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Dizziness, Headache, Nausea
Clinical narrative: Nausea, Headache, Dizziness
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse events or product quality complaints reported.; a temperature excursion on PEDVAX HIB, the product was administered; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.         On 30-APR-2021, a temperature excursion occurred on haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB). On 14-MAY-2021, the patient was administered with the improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (1 time dose, strength, route and anatomical location were not reported, lot # T020615, expiration date 13-MAR-2023) for prophylaxis (product storage error). The vaccine administered experienced a temperature excursion of 47.51 degree Fahrenheit (F), with time frame 15 minutes. There was previous temperature excursion. A digital data logger was involved. No signs or symptoms were reported. No other adverse events or product quality complaints were reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered
Clinical narrative: patient had received the full series of MMRlI already, (no dates given) but was given a 3rd dose by mistake on 05/24/2021 as they were supposed to have received VARIVAX; on 05/24/2021 as they were supposed to have received VARIVAX; This spontaneous report was received from a healthcare worker referring to a patient of unknown age (adult) and gender. The patient's concomitant medication, concurrent condition and drug reactions/allergies were not provided.  On 24-MAY-2021, the patient had already received the full series of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) but was vaccinated with the third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route, lot# and expiration date were not provided) for prophylaxis by mistake. The patient's another suspect therapy included varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot# and expiration date were not provided) for prophylaxis which was supposed to be given on 24-MAY-2021.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient's wife. The patient received the Shingles vaccine and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Got my first Shingrix shot this past Tuesday / had sore arm at site; Fatigue; Headache; Some chills; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles last year.). Previously administered products included Moderna with an associated reaction of fatigue (received 2nd dose on an unknown date and had severe headache, some chills).   On 25th May 2021, the patient received the 1st dose of Shingrix. In May 2021, 1 day after receiving Shingrix, the patient experienced fatigue, headache and chills. On 25th May 2021, the patient experienced injection site pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain, fatigue, headache and chills were recovering/resolving.   It was unknown if the reporter considered the injection site pain, fatigue, headache and chills to be related to Shingrix.  Additional details were provided as follow: The patient self reported the case. The patient received 1st dose of Shingrix on past Tuesday (of reporting date) and experienced injection site pain same day in the evening. On the next morning, the patient experienced  fatigue, headache and chills but not as severe as after having 2nd dose of Moderna vaccine. The patient took Tylenol and drank plenty of water and felt 90 percent better. The patient was hoping, the second dose would be uneventful. No further information was provided.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Salivary hypersecretion
Clinical narrative: Red spots were breaking out / size of a pinhead; Very itchy; A clear liquid comes out of his mouth / when he sits still; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included sulfa drug (allergic to sulfa drug). Concurrent medical conditions included systemic antibacterial therapy.   On 31st March 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 5th April 2021, 5 days after receiving Shingrix, the patient experienced red rash, itchy rash and salivation. On an unknown date, the outcome of the red rash and itchy rash were not recovered/not resolved and the outcome of the salivation was recovered/resolved.   It was unknown if the reporter considered the red rash, itchy rash and salivation to be related to Shingrix.  Additional details were provided as follows:  The patient was allergic to sulfa drugs and antibiotic. The age at vaccination was not reported.  The patient received Shingrix vaccine in left arm and about five days later he noticed red spots were breaking out on both forearms and on his chest and they were the size of a pinhead and very itchy. The patient had also noticed a clear liquid comes out of his mouth for about 30 to 45 seconds when he sits still.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness presented a couple of days following; Experienced soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd March 2021, the patient received the 1st dose of Shingrix. On 22nd March 2021, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  Immediately after receiving 1st dose of Shingrix, patient experienced injection site soreness and couple of days following, experienced redness, which lasted for week. The reporter mentioned that,patient has not received the second dose yet. The reporter consent to follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Contusion, Diarrhoea, Fatigue
Clinical narrative: VOMITING; DIARRHEA; TEMPERATURE OF 99.6 F FEVER; BODY ACHES; DIME-SIZE, PUFFY, SWOLLEN, PAINFUL BRUISE THAT STARTED ON RIGHT LEG, SHOWED UP BELOW KNEE ON SHIN, THAT GOT REAL BAD THE NEXT DAY, WAS SORE, KEPT GETTING BIGGER AND WENT BEING AND ACROSS THE KNEE; HEADACHE; TIRED; STOMACH ACHE AFTER FEW HOURS OF VACCINATION AND NEXT DAY THE STOMACH ACHE GOT PRETTY BAD; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia, and shellfish allergy, and other pre-existing medical conditions included not allergic to iodine. The patient experienced drug allergy when treated with codeine, gabapentin, and morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-MAY-2021, the subject experienced stomach ache after few hours of vaccination and next day the stomach ache got pretty bad. On 26-MAY-2021, the subject experienced body aches. On 26-MAY-2021, the subject experienced dime-size, puffy, swollen, painful bruise that started on right leg, showed up below knee on shin, that got real bad the next day, was sore, kept getting bigger and went being and across the knee. On 26-MAY-2021, the subject experienced headache. On 26-MAY-2021, the subject experienced tired. On 27-MAY-2021, the subject experienced vomiting. On 27-MAY-2021, the subject experienced diarrhea. On 27-MAY-2021, the subject experienced temperature of 99.6 f fever. Laboratory data included: Body temperature (NR: not provided) 99.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach ache after few hours of vaccination and next day the stomach ache got pretty bad, body aches, vomiting, diarrhea, headache, tired, and temperature of 99.6 f fever on 28-MAY-2021, and had not recovered from dime-size, puffy, swollen, painful bruise that started on right leg, showed up below knee on shin, that got real bad the next day, was sore, kept getting bigger and went being and across the knee. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Vomiting
Clinical narrative: VOMITING; DIARRHEA; TEMPERATURE OF 99.6 F FEVER; BODY ACHES; DIME-SIZE, PUFFY, SWOLLEN, PAINFUL BRUISE THAT STARTED ON RIGHT LEG, SHOWED UP BELOW KNEE ON SHIN, THAT GOT REAL BAD THE NEXT DAY, WAS SORE, KEPT GETTING BIGGER AND WENT BEING AND ACROSS THE KNEE; HEADACHE; TIRED; STOMACH ACHE AFTER FEW HOURS OF VACCINATION AND NEXT DAY THE STOMACH ACHE GOT PRETTY BAD; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia, and shellfish allergy, and other pre-existing medical conditions included not allergic to iodine. The patient experienced drug allergy when treated with codeine, gabapentin, and morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-MAY-2021, the subject experienced stomach ache after few hours of vaccination and next day the stomach ache got pretty bad. On 26-MAY-2021, the subject experienced body aches. On 26-MAY-2021, the subject experienced dime-size, puffy, swollen, painful bruise that started on right leg, showed up below knee on shin, that got real bad the next day, was sore, kept getting bigger and went being and across the knee. On 26-MAY-2021, the subject experienced headache. On 26-MAY-2021, the subject experienced tired. On 27-MAY-2021, the subject experienced vomiting. On 27-MAY-2021, the subject experienced diarrhea. On 27-MAY-2021, the subject experienced temperature of 99.6 f fever. Laboratory data included: Body temperature (NR: not provided) 99.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach ache after few hours of vaccination and next day the stomach ache got pretty bad, body aches, vomiting, diarrhea, headache, tired, and temperature of 99.6 f fever on 28-MAY-2021, and had not recovered from dime-size, puffy, swollen, painful bruise that started on right leg, showed up below knee on shin, that got real bad the next day, was sore, kept getting bigger and went being and across the knee. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain, Pain in extremity, Sinus headache, Somnolence
Clinical narrative: SINUS WITH HEADACHE; DROWSINESS; FELT ACHY; SOAR ARM AFTER VACCINE; BRUISE ON THE ARM /COLOR BLUE; This spontaneous report received from a patient concerned a 53 year old female. 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, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced bruise on the arm /color blue. On 28-MAY-2021, the subject experienced soar arm after vaccine. On 29-MAY-2021, the subject experienced felt achy. On 31-MAY-2021, the subject experienced sinus with headache. On 31-MAY-2021, the subject experienced drowsiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bruise on the arm /color blue, and soar arm after vaccine on 01-JUN-2021, had not recovered from sinus with headache, and drowsiness, and the outcome of felt achy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: NOT FEELING WELL; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On JUN-2021, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not feeling well was not reported. This report was non-serious. This case, from the same reporter is linked to 20210604721.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: ABOUT 15 MINUTES AFTER THE VACCINE, FEELING TINGLY IN TOES/LEGS/LEFT ARM/RIGHT FINGERS AND STRONGER TINGLING IN THE LEFT FINGERS; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821288 expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 16:00 for prophylactic vaccination. Concomitant medications included metoprolol. On 02-JUN-2021, the subject experienced about 15 minutes after the vaccine, feeling tingly in toes/legs/left arm/right fingers and stronger tingling in the left fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from about 15 minutes after the vaccine, feeling tingly in toes/legs/left arm/right fingers and stronger tingling in the left fingers. This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, Urticaria
Clinical narrative: HIVES; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to seashells. The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, Laboratory data included: Allergy test (NR: not provided) Allergic to tomatoes, peanuts, pecans, and grass. On 03-MAY-2021, the subject experienced hives. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hives was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: FEVER; SLIGHTLY TIRED; This spontaneous report received from a patient 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, batch number: Unk) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 28-MAY-2021, the subject experienced fever. On 28-MAY-2021, the subject experienced slightly tired. Laboratory data included: Body temperature (NR: not provided) 37.6 maximum. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 29-MAY-2021, and slightly tired on 2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Nausea, Pyrexia, Tremor
Clinical narrative: EXTREME BODY HEAT; SHAKING ALL OVER MY BODY; CHILLS; NAUSEA; HIGH FEVER; This spontaneous report received from a patient 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, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced extreme body heat, shaking all over my body, chills, nausea, and high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme body heat, shaking all over my body, chills, nausea, and high fever. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: cold sores, one after another since first shot. Currently number 4
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: 2 blood clots in my lungs; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (2 blood clots in my lungs) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (2 blood clots in my lungs) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (2 blood clots in my lungs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Bone pain, Chest pain, Dyspnoea, Echocardiogram normal
Clinical narrative: ON 3 JUNE 2021 @ 1453, "25-year-old female who presents to the emergency department with 2 days of worsening left-sided chest pain associated with some myalgias shortness of breath she received her second covid vaccination on the first of June.  she also has some bilateral anterior shin pain soreness into her arms as well.  Denied any fever and a productive cough any nausea or diarrhea". Patient was admitted to ICU on 3 June for NSTEMI in setting of chest pain/SOB with elevated TnT. Significant elevation of TnT >3K with unremarkable ECG. TIMI score 1, grace 52. Given her age etiology concerning for possible Myocarditis but will start appropriate tx for NSTEMI and order formal TTE.....Patient has been diagnosed with Myopericarditis. The patient didn't have any significant changes on her EKG, however, she did have elevated troponins up to 3134 ng/L which trended down to 2455 ng/L on recheck.  Given the pleuritic nature of her chest discomfort, MD suspected Acute Myopericarditis.  She is still symptomatic and thus, MD recommended she take high-dose NSAIDs.  MD would not too keen on starting her on steroids and/or colchicine unless she doesn't get better on follow up evaluation.  Echocardiogram showed intact ejection fraction.  MD have sent off additional labs to look for other causes of myopericarditis.  The patient should also be on a low-dose of beta blocker and ACE inhibitor.  She'll follow with her primary care provider and cardiology.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Ejection fraction normal, Electrocardiogram normal, Intensive care, Laboratory test, Myalgia
Clinical narrative: ON 3 JUNE 2021 @ 1453, "25-year-old female who presents to the emergency department with 2 days of worsening left-sided chest pain associated with some myalgias shortness of breath she received her second covid vaccination on the first of June.  she also has some bilateral anterior shin pain soreness into her arms as well.  Denied any fever and a productive cough any nausea or diarrhea". Patient was admitted to ICU on 3 June for NSTEMI in setting of chest pain/SOB with elevated TnT. Significant elevation of TnT >3K with unremarkable ECG. TIMI score 1, grace 52. Given her age etiology concerning for possible Myocarditis but will start appropriate tx for NSTEMI and order formal TTE.....Patient has been diagnosed with Myopericarditis. The patient didn't have any significant changes on her EKG, however, she did have elevated troponins up to 3134 ng/L which trended down to 2455 ng/L on recheck.  Given the pleuritic nature of her chest discomfort, MD suspected Acute Myopericarditis.  She is still symptomatic and thus, MD recommended she take high-dose NSAIDs.  MD would not too keen on starting her on steroids and/or colchicine unless she doesn't get better on follow up evaluation.  Echocardiogram showed intact ejection fraction.  MD have sent off additional labs to look for other causes of myopericarditis.  The patient should also be on a low-dose of beta blocker and ACE inhibitor.  She'll follow with her primary care provider and cardiology.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis, Pain in extremity, Pleuritic pain, Troponin increased
Clinical narrative: ON 3 JUNE 2021 @ 1453, "25-year-old female who presents to the emergency department with 2 days of worsening left-sided chest pain associated with some myalgias shortness of breath she received her second covid vaccination on the first of June.  she also has some bilateral anterior shin pain soreness into her arms as well.  Denied any fever and a productive cough any nausea or diarrhea". Patient was admitted to ICU on 3 June for NSTEMI in setting of chest pain/SOB with elevated TnT. Significant elevation of TnT >3K with unremarkable ECG. TIMI score 1, grace 52. Given her age etiology concerning for possible Myocarditis but will start appropriate tx for NSTEMI and order formal TTE.....Patient has been diagnosed with Myopericarditis. The patient didn't have any significant changes on her EKG, however, she did have elevated troponins up to 3134 ng/L which trended down to 2455 ng/L on recheck.  Given the pleuritic nature of her chest discomfort, MD suspected Acute Myopericarditis.  She is still symptomatic and thus, MD recommended she take high-dose NSAIDs.  MD would not too keen on starting her on steroids and/or colchicine unless she doesn't get better on follow up evaluation.  Echocardiogram showed intact ejection fraction.  MD have sent off additional labs to look for other causes of myopericarditis.  The patient should also be on a low-dose of beta blocker and ACE inhibitor.  She'll follow with her primary care provider and cardiology.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Feeling hot, Tremor
Clinical narrative: Patient stated feeling hot after vaccination.  Mother states patient anxious before vaccine.  Transported to observation with help from paramedic.  1st vitals: BP 152/109, P 121, Resp. 19, O2 95%, 15 years old BS 85.  Shaking and crying.  No complaint of pain or difficulty breathing.  Second vitals: BP 138/86, P 107, T 98.7.  Mother decided to call for transport and observation.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Dizziness, Fatigue, Injection site pain
Clinical narrative: Injection site: sharp pain, swelling, stiffness Left arm: (injection site symptoms), shooting muscle pain from fingertips to occipital, very limited mobility in arm, wrist, shoulder, neck, sleeplessness, fatigue, dizziness,  Overall joint, muscle, tissue related pain due to previously identified chronic diagnose are exacerbated/intensified to the point of interference with expected daily activity
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Insomnia, Mobility decreased, Musculoskeletal stiffness, Myalgia
Clinical narrative: Injection site: sharp pain, swelling, stiffness Left arm: (injection site symptoms), shooting muscle pain from fingertips to occipital, very limited mobility in arm, wrist, shoulder, neck, sleeplessness, fatigue, dizziness,  Overall joint, muscle, tissue related pain due to previously identified chronic diagnose are exacerbated/intensified to the point of interference with expected daily activity
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Injection site: sharp pain, swelling, stiffness Left arm: (injection site symptoms), shooting muscle pain from fingertips to occipital, very limited mobility in arm, wrist, shoulder, neck, sleeplessness, fatigue, dizziness,  Overall joint, muscle, tissue related pain due to previously identified chronic diagnose are exacerbated/intensified to the point of interference with expected daily activity
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Flushing, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Patient fainted once, then almost again. Called 911 to have evaluated before leaving. Was feeling ok upon departure
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Patient fainted once, then almost again. Called 911 to have evaluated before leaving. Was feeling ok upon departure
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Additional Details: Extreme sweating, nausea & short fainting spell. Gave patient water and sugary snack. Mentioned he may not have eaten enough that morning
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot in leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in leg) in a female patient of an unknown age 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 THROMBOSIS (Blood clot in leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clot in leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Tremor
Clinical narrative: Patient is a 27 year old female referred to observation area after previously staying in observation area for 15 minutes.  Patient complained of having weakening, trembling of upper and lower extremities.  Encouraged pt. to relax, remain calm.   Fire Rescue called and arrived to scene for further evaluation.  Patient recovered from adverse event at 12:04pm.  Denies any pain, discomfort, trembling of all extremities, or weakness at this time.  Patient left observation area at 12:07pm via personal vehicle.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Autoimmune disorder, Pulmonary pain, Rash, Vomiting
Clinical narrative: autoimmune disorder; Lung pain; stomach pain; underskin rash; vomiting; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-May-2021 and was forwarded to Moderna on 28-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of AUTOIMMUNE DISORDER (autoimmune disorder) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (autoimmune disorder) (seriousness criterion medically significant), PULMONARY PAIN (Lung pain), ABDOMINAL PAIN UPPER (stomach pain), RASH (underskin rash) and VOMITING (vomiting). At the time of the report, AUTOIMMUNE DISORDER (autoimmune disorder), PULMONARY PAIN (Lung pain), ABDOMINAL PAIN UPPER (stomach pain), RASH (underskin rash) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.  Company Comment  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.; Sender's Comments: 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.