chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick for a week years ago; Initial information received on 28-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient) via social media.  This case involves a patient of an unknown demography who was sick for a week years ago (illness), while he/she received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick for a week years ago (illness, non-serious event) (Unknown latency) following the administration of INFLUENZA VACCINE.  No laboratories details reported.   It was not reported if the patient received a corrective treatment.  The outcome of event was unknown, at the time of reporting.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pneumonia
Clinical narrative: pneumonia; Initial information regarding an unsolicited valid serious case was received from a consumer (patient) via social media and transmitted to Sanofi on 12-Dec-2020.  This case involves a patient of unknown demographics who got pneumonia, after he/she received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiry date unknown) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (latency unknown), after the patient got the INFLUENZA VACCINE, the patient had pneumonia. The event was assessed as medically significant as per important medical event (IME) list.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown.  There will be no information regarding the batch number for the case.; Sender's Comments: This case involves patient of unknown age who had Pneumonia after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is known. Further information regarding previous vaccination, tolerance and laboratory tests ruling out alternate etiologies are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: I WOKE UP WITH DIARRHEA AND A CONSTANT HEADACHE THAT HASNT LEFT
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache at base of skull near spinal cord 3 hours after dose given
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: 12/15/2020 I felt terrible with muscle aches, shivering, chills, fever was 102.8,I took tylenol and ibuprofen (alternated) 24 hours after initial fever I ceased meds and fever was still 101.5, this morning I was 98.6. The course of the fever was 36 hours total
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site swelling
Clinical narrative: NVD, swelling at site and down to elbow. Pt states it was the PPSV23 vaccine.  Pt informed me of this when I was contacting her on 17 DEC 20 regarding the recall of Merck PNEUMOVAX23 prefilled syringes. Product recalled on 16Dec2020 (MMQC-20-1258).
Age: 21.0
Sex: F
Vaccine: DTAP
Symptoms: Intervertebral disc degeneration
Clinical narrative: DDD dvbd
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema of eyelid, Swelling of eyelid
Clinical narrative: after the vaccination, Patient experienced upper eye lid swelling and redness on her right eye
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Around 630pm I began to have a really bad had a bad headache, feverish and body aching.  Tenderness in the injection site area which eventually turned into full body aches and was tired.  No vomiting or nausea.  No redness at the site or injection site issues
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Approximately 15 minutes after receiving the HPV vaccine patient reported some numbness in her left hand. Patient is well appearing. She reports no dizziness or injection site pain. She states that she has "the smallest amount of tingling" at the base of her index, 3rd, and 4th fingers. She denies any numbness in her hand, arm or shoulder. Denies any tingling at any other location. Hand grasp strength strong and equal bilaterally. Injection site without any redness or swelling and in the correct deltoid injection site location. Patient was able to stand without assistance and reported no dizziness upon standing.    Provider notified. Mom to call office with any new or worsening symptoms.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Headache, Myalgia, Somnolence
Clinical narrative: Muscle ache, fatigue, drowsiness, brief confusion, bilateral headache, onset 11 AM,  duration 2-3 hours
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Dyspnoea, Hyperhidrosis, Mental status changes
Clinical narrative: Persistant cough, dyspnea, sweats, myalgias, mental staus changes and diarrhea, still resoving
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Persistant cough, dyspnea, sweats, myalgias, mental staus changes and diarrhea, still resoving
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pain in extremity
Clinical narrative: Stabbing pain in left arm after getting injection. Treated with Gabapentin
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Decreased appetite, Lethargy, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Fever of 103/104 extremely lethargic. Could not eat. Arm swelled and was extremely itchy. This lasted for 3-4 days.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pruritus, Eye swelling, Feeling hot, Ocular discomfort, Paraesthesia
Clinical narrative: 1145: Patient complained of minor left eye swelling.  Vital signs 99%, 83, 141/80. 1155: Vitals rechecked 1155 100%, 79, 112/80.  Patient has new complaints of itchy ears, facial "heat", and slight tingling in fingers.    1200: 25 mg of oral Benadryl given. 1211: per RN, patient states symptoms are resolving. 1230: Patient still feels slight eye discomfort, all other symptoms have resolved.  Patient states she feels comfortable leaving vaccination clinic, her son will be taking her home.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenopia, Burning sensation, Chest discomfort, Chest pain, Chills
Clinical narrative: 1145: Patient complained of minor left eye swelling.  Vital signs 99%, 83, 141/80. 1155: Vitals rechecked 1155 100%, 79, 112/80.  Patient has new complaints of itchy ears, facial "heat", and slight tingling in fingers.    1200: 25 mg of oral Benadryl given. 1211: per RN, patient states symptoms are resolving. 1230: Patient still feels slight eye discomfort, all other symptoms have resolved.  Patient states she feels comfortable leaving vaccination clinic, her son will be taking her home.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspepsia, Ear discomfort, Erythema, Eye irritation, Full blood count normal
Clinical narrative: 1145: Patient complained of minor left eye swelling.  Vital signs 99%, 83, 141/80. 1155: Vitals rechecked 1155 100%, 79, 112/80.  Patient has new complaints of itchy ears, facial "heat", and slight tingling in fingers.    1200: 25 mg of oral Benadryl given. 1211: per RN, patient states symptoms are resolving. 1230: Patient still feels slight eye discomfort, all other symptoms have resolved.  Patient states she feels comfortable leaving vaccination clinic, her son will be taking her home.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Metabolic function test normal, Nausea, Pain, Paraesthesia
Clinical narrative: 1145: Patient complained of minor left eye swelling.  Vital signs 99%, 83, 141/80. 1155: Vitals rechecked 1155 100%, 79, 112/80.  Patient has new complaints of itchy ears, facial "heat", and slight tingling in fingers.    1200: 25 mg of oral Benadryl given. 1211: per RN, patient states symptoms are resolving. 1230: Patient still feels slight eye discomfort, all other symptoms have resolved.  Patient states she feels comfortable leaving vaccination clinic, her son will be taking her home.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Periorbital oedema, Piloerection, Swelling of eyelid, Throat clearing, Vertigo
Clinical narrative: 1145: Patient complained of minor left eye swelling.  Vital signs 99%, 83, 141/80. 1155: Vitals rechecked 1155 100%, 79, 112/80.  Patient has new complaints of itchy ears, facial "heat", and slight tingling in fingers.    1200: 25 mg of oral Benadryl given. 1211: per RN, patient states symptoms are resolving. 1230: Patient still feels slight eye discomfort, all other symptoms have resolved.  Patient states she feels comfortable leaving vaccination clinic, her son will be taking her home.
Age: 0.75
Sex: M
Vaccine: UNK
Symptoms: Wrong product administered
Clinical narrative: On 11/30/2020 at 1:30 I brought my son into Pediatrics for what should have been his flu shot. I signed the paperwork for just his flu shot. The nurse came into the room and gave my son three vaccinations. Later that day my son began developing a rash. I contacted them and found out that they gave my son the wrong vaccinations. The problem is that they will not tell either myself or his pediatrician Dr . what they gave him. He still has this rash. His doctor doesn't know how to treat him without knowing what they gave him.  I have tried requesting this information. His primary care doctor has tried getting this information and we still don't know.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Generalised tonic-clonic seizure, Loss of consciousness, Muscle contractions involuntary
Clinical narrative: GRAND MAL SEIZURE, COUPLES OF SECOND LOSS OF CONSCIOUSNESS AND MUSCLE CONTRACTION REFER TO PEDIATRIC NEUROLOGIST AND ALLERGY IMMUNOLOGIST
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Name listed on paperwork - Recombinant Zoster, Right eye when blinking spiderwebs appear then they disappear,  vision has decreased in focus, when holding finger in front of face with right eye he sees wiggles /wavy around the finger. With left eye the outline in sharp. Has seen Ophthalmologist, neuro Ophthalmologist. Had the flu shot the same day, not information on the flu details.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Flank pain, Headache
Clinical narrative: Headache , dizziness, neck pain, left flank pain, fever 100.2 , chills,fatigue and muscle aches.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Pyrexia
Clinical narrative: Headache , dizziness, neck pain, left flank pain, fever 100.2 , chills,fatigue and muscle aches.
Age: 32.0
Sex: M
Vaccine: UNK
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: Injection given too high causing SIRVA
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: I noticed the injection site was sore, swollen and warm. As the day progressed headache, fatigue, joint, legs aching and feeling heavy tires. Also had a fever of 101.2.Around 9:30 pm on 12/16 started to feel better fever was down.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Limb discomfort, Pain in extremity, Pyrexia
Clinical narrative: I noticed the injection site was sore, swollen and warm. As the day progressed headache, fatigue, joint, legs aching and feeling heavy tires. Also had a fever of 101.2.Around 9:30 pm on 12/16 started to feel better fever was down.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: 12/15/2020My arm was really sore at first, and then my arm was worse the next day on 12/16/2020 as the morning went on my temperature felt like it was going up and down I felt body aches and felt really tired I had covid in June and it wasn't as bad as when I had it in June but it was still pretty bad, I also had a headache, I took tylenol and my fever broke but after a few hours my headache was worse and I started to take tylenol and ibuprofen. 12/17/2020 Under my left arm my lymph nodes are swollen but I feel much better and will go to work today 12/17/2020
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 12/15/2020My arm was really sore at first, and then my arm was worse the next day on 12/16/2020 as the morning went on my temperature felt like it was going up and down I felt body aches and felt really tired I had covid in June and it wasn't as bad as when I had it in June but it was still pretty bad, I also had a headache, I took tylenol and my fever broke but after a few hours my headache was worse and I started to take tylenol and ibuprofen. 12/17/2020 Under my left arm my lymph nodes are swollen but I feel much better and will go to work today 12/17/2020
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria, Rash maculo-papular, Urticaria, Vomiting
Clinical narrative: 1558- FluLaval 0.50 PF QUAD  Lot #: ZY9MJ Exp: 6/30/2021 was given to patient in the Left Vastus Lateralis.  1600- After receiving flu shot, CMA reports patient vomited once while walking down the hallway to the checkout desk. Upon walking back into room from the hallway patient is noted to have urticaria like areas on cheeks, right upper arm, and around injection site on left thigh. No shortness of breath or difficulty- breathing noted.- NP-C  1625- Patient has vomited once again, 2 mg of Zofran PO given.  1645- Patient reports she feels better, no vomiting noted. Mom walking to check out to check patient out, Older sister and patient staying in the room while mom checking out.  1655- Patient has vomited once again, after vomiting, urticaria noted to bilateral cheeks, and left forearm, maculopapular rash noted all over torso.  1700- Zofran 2 mg PO given.  1716- Patient was given Celestone - 1 cc (6mg/ml) IM R THIGH Lot # 0001207347  Exp:  11/18/2021  & Depo Medrol  40mg IM R THIGH Lot #: CL0815   Exp: 10/2021--steroid injection per MD instructions.   1750- Patient was released. Patient stated she felt better, and was only sleepy. No signs of distress noted, hives were gone, and patient stopped vomiting at this point. Patient pushed out to her vehicle in a wheelchair.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling cold, Heart rate increased
Clinical narrative: 40 min after shot experienced dizziness, feeling like was going to pass out, not coherent, BP high, fast heart rate, light headed. Got chills, freezing cold, shivering, and later in the day my ears were ringing. Extremely fatigued.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Incoherent, Tinnitus
Clinical narrative: 40 min after shot experienced dizziness, feeling like was going to pass out, not coherent, BP high, fast heart rate, light headed. Got chills, freezing cold, shivering, and later in the day my ears were ringing. Extremely fatigued.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Dizziness, Heart rate increased, Hyperhidrosis
Clinical narrative: Approximately 10 minutes after receiving the vaccine in the left arm, the patient began feeling lightheaded and had some chest heaviness. They became diaphoretic and at this point blood pressure and heart rate were checked. HR was elevated to 90 bpm from patient's baseline of approximately 60-65 bpm. Blood pressure was elevated at 150/100 mmHg. Pt was provided water and symptoms resolved. Patient was monitored an additional 30 minutes and did not have any recurrence of symptoms. Blood pressure and heart rate returned to baseline.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema, Pruritus
Clinical narrative: Redness, edema, and itching to the left arm approximately 12 hours after administration of vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: 12/7/20  Left arm extreme pain, could not bend elbow or lift arm. Took  2 ibuprofen  (200mg each) at 1:45; 1 at  2:35; 1 at 3:50, 1 at 9:10, 2 at 11:00pm 12/8/20  Shoulder pain. By afternoon, could bend elbow to 90*; Took 2 ibuprofen at 10:15am; 1 at 2:30pm; 2 at 11:30pm. 12/9/20  9:00am could touch shoulder with fingertips & lift arm 45* front & back; lift 35* to side.  Shoulder pain. Took 2 ibuprofen 10:15am 12/10/20  Shoulder still sore & stiff; took 2 ibuprofen at 10:00am.  Can lift arm to 90* front & side; can touch shoulder from the side. 12/11/20  Can lift arm 180* front &  135* side. Front of shoulder still feels stiff. 12/12/20  Some pain & stiffness  in front of upper arm & shoulder. 12/13/20  Arm  about  2 inches  short of full rotation. 12/14 - 12-17, 2020  Full movement, no pain.
Age: 60.0
Sex: M
Vaccine: FLUR4
Symptoms: Injection site movement impairment, Injection site pain, Sleep disorder
Clinical narrative: PATIENT HAS PERSITENT PAIN AT INJECTION SITE PREVENTING PATIENT TO RAISE ARM WITHOUT DISCOMFORT OR SLEEP WELL DUE TO PAIN.  THE PAIN ALSO IS AFFECTING THE PATIENT SPORADICALLY THROUGHOUT THE DAY.  THE PATIENT SAID HE VISITIED HIS PRIMARY CARE PHYSICIAN WHO GAVE SAMPLES OF ORAL AND TOPICAL ANTI-INFLAMATORY AGENTS HOWEVER HAS NOT RELIEVED HIS DISCOMFORT.  I RECOMMENDED A TOPICAL ANALGESIC LIDOCAINE PATCH TO USE AND CONTACTED THE PHYSICIAN TO INFORM OF MY RECOMMENDATION.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Incorrect route of product administration, Pruritus
Clinical narrative: Customer reports giving 0.1 ml PNEUMOVAX 23 intraderamally in error.; Customer reports giving 0.1 ml PNEUMOVAX 23 intraderamlly in error.; redness; itching; This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.        On 03-NOV-2020, the patient was vaccinated in error with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23),  0.1 milliliter, intradermally for prophylaxis (Lot # and expiration date were not reported).         The patient did not have any adverse events and  no additional information was provided.  This is a non-valid case due to lack of patient's identifiers.   Follow-up information was received on 15-DEC-2020 from the vaccine provider.  The 27-year-old (also reported as 38-year-old) female patient had no illness at the time of vaccination or pre-existing physician-diagnosed allergies, birth defects, or medical conditions. The temperature excursion of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not recorded by a data logger. She experienced itching and redness on an unspecified date in 2020. At the time of this report, the patient was recovered from the events.   The causality between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.   This case was previously considered non-valid due to lack of patient's identifiers, but upon receipt of follow-up it was determined that the case is now valid.
Age: 19.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No patients reported any additional adverse experiences; receiving the improperly stored vaccine; This spontaneous report as received from a medical assistant via a company representative refers to a 19-year-old male patient. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.    On 30-OCT-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot number: T014309, expiration date: 24-APR-2022; route of administration was not provided) 0.5 ml. No adverse event was reported.  This is one of the six reports from the same reporter.; Sender's Comments:  US-009507513-2011USA013379: US-009507513-2011USA013163: US-009507513-2011USA013620: US-009507513-2011USA013200: US-009507513-2011USA013293:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE/PQCs reported.; Caller reported the administration of Improperly Stored PROQUAD.; This spontaneous report was received from a consumer, referring to him/herself as a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 20-NOV-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T021639, which has been verified to be valid, expiration date reported an validated as 21-12-2021). The vaccine administered experienced a temperature excursion of -10 to 8 degrees Celsius (C) (-5.6C), for a time frame of 1 hour and 32 minutes as recorded by a data logger. There was no previous temperature excursion reported. No additional adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Cardiovascular disorder, Deafness, Herpes zoster, Post herpetic neuralgia
Clinical narrative: hearing loss; multiple outbreaks of herpes zoster; postherpetic neuralgia; cardiovascular event; This initial spontaneous report was received on 11-DEC-2020 from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 28-FEB-2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for long-term prevention of shingles and zoster related conditions (prophylaxis). Subsequently, the patient was treated by a provider for: multiple outbreaks of herpes zoster, post herpetic neuralgia, cardiovascular event, and hearing loss. The outcome of the events were not provided. Therefore, the causality for the events was related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of hearing loss (deafness) was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy; This initial spontaneous report was received on 11-DEC-2020 from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for long-term prevention of shingles and zoster related conditions (prophylaxis). Subsequently, the patient was treated by a physician for: Bell's palsy. The outcome of the event was not provided. Therefore, the causality for the events was related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of Bell's palsy was considered to be medically significant.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: The patient experienced substantial arm pain after vaccination; This spontaneous report as received from a pharmacist referring to a 72-year-old male patient. The patient's pertinent medical history was unknown by reporter. His drug reactions or allergies included gentamicin and neomycin, and his concomitant therapies included oxybutynin, tadalafil, propranolol hydrochloride, hydrochlorothiazide, tizanidine hydrochloride and primidone.      On 20-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) at a dose of 0.5 milliliter, intramuscular for prophylaxis (strength and anatomical location were not reported, lot # T017385 had been verified to be a valid number; expiration date 01-SEP-2021).      On 20-NOV-2020, the patient experienced substantial arm pain for an extended period of time (pain in extremity). His arm was sore for about 3 days following vaccination and he was recovered. The pharmacist stated that they give a lot of the vaccine and have never had people complain about the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) being so painful after administration.   The causality assessment between pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the aforementioned event not provided.     This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA006575:
Sex: U
Vaccine: FLUX, UNK, UNK, VARZOS
Symptoms: Arthralgia, Blister, Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; sore shoulder; blister; shingles blister; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis, PNEUMOCOCCAL PNEUMONIA VACCINE for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL PNEUMONIA VACCINE) for prophylaxis.   On an unknown date, the patient received Shingles vaccine, Influenza vaccine Quadrivalent unspecified season, PNEUMOCOCCAL PNEUMONIA VACCINE and PNEUMOCOCCAL PNEUMONIA VACCINE. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, shoulder soreness and blister. On an unknown date, the outcome of the vaccination failure and shoulder soreness were unknown and the outcome of the shingles and blister were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, shoulder soreness and blister to be related to Shingles vaccine. It was unknown if the reporter considered the shingles, shoulder soreness and blister to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were received as follows: The age at vaccination was not reported. The patient received flu vaccine, shingles vaccine, both kinds of pneumonia vaccine, and had sore shoulder. Also one shingles blister which lasted 2 days and went away. This case was considered as suspected vaccination failure as completion of primary vaccination schedule, time to onset and laboratory confirmation test were unknown at the time of reporting.  It was unknown if the reporter considered the shingles, shoulder soreness and blister to be related to Pneumococcal vaccine.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got deathly sick; Initial information was received on 22-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case involves patient (unknown demography) who got deathly sick (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got deathly sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Flushing, Heart rate irregular, Palpitations, Ventricular extrasystoles
Clinical narrative: Patient felt flushed, heart racing.  Had irregular rhythm.  Transported to Emergency Department.  Treated with epinephrine.  EKG performed, having pre-ventricular contractions.  Checked in to ED for further evaluation.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Patient was called to schedule her second dose, at which time she reported the following: Starting approximately 2 days after receiving her 1st dose, she developed itchy red hives. She reported this to her clinic via telephone, and a clinician (nurse?) advised her to treat them with hydrocortisone cream. She treated the spots with hydrocortisone, which greatly reduced the itching. All spots were limited to the truck and arm of her left (vaccinated) side.  She didn't recall how long it took for the spots to go away. The itchiness resolved with the hydrocortisone, at which point she stopped paying attention to them. Based on the potential for a heightened immune response, we advised her NOT to receive her second dose at the pharmacy, though she could pursue at a clinic or after a work-up from an allergy specialist.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: 12/02/2020 Chills/shivers -- worse in the night to morning, headache--more intense in morning day after with chills,  12/04/2020 chills subsided, headache less intense and time stronger than before. Headache still persistent. Tylenol dose taken and cold/flu (pharmacy brand) no complete relief.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, severe body aches, severe chills, still have symptoms this morning although less severe.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Diarrhea, Vomiting, Chills & Fever.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Paraesthesia
Clinical narrative: REPORTED: 1.  REDNESS AT THE INJECTION SITE. 2. EXCESSIVE SWELLING AT THE INJECTION SITE DESCRIBED AS "A KNOT"  THE SIZE OF " A HOCKEY PUCK" 3.  "TINGLING" IN HER FINGERS - THE TIPS OF ALL FINGERS ON LEFT HAND
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site rash, Nausea, Rash, Vomiting
Clinical narrative: Patient came to workplace clinic 12/17 @ 1215 saying she had a reaction to the COVID vaccination. She stated she took ibuprofen in the morning for the headache, however, rash was still present. N/V on 12/16 at night. Patient reported no throat swelling or SOB. Rash on injection site (left) arm and chest. Patient received Benadryl 50 mg po x 1 dose and Tylenol 500 mg po  x 1 dose. After Benadryl and Tylenol, patient felt better and was able to go back to work. recommended to go  home and rest.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Impaired work ability, Pain in extremity
Clinical narrative: Around 1 am dov, I started trembling very bad. Was weak and couldnt lift my head off the pillow. Then an hour later, I started feeling like I was getting a fever. I checked my temp, and I did have a fever. Trembling lasted a couple of hours.  I had extreme fatigue, had to lay down and stay home from work for 2 days cause of me being so weak and fatigue. Fever lasted on and off for a little over 24hrs.  Then after I got pass the fever, I have a really bad headache. I still have a headache. I took tylenol for the fever. Then last night, I took some Benadryl to calm the reactions.  My upper arm is still  a little swollen and is still sore.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Tremor
Clinical narrative: Around 1 am dov, I started trembling very bad. Was weak and couldnt lift my head off the pillow. Then an hour later, I started feeling like I was getting a fever. I checked my temp, and I did have a fever. Trembling lasted a couple of hours.  I had extreme fatigue, had to lay down and stay home from work for 2 days cause of me being so weak and fatigue. Fever lasted on and off for a little over 24hrs.  Then after I got pass the fever, I have a really bad headache. I still have a headache. I took tylenol for the fever. Then last night, I took some Benadryl to calm the reactions.  My upper arm is still  a little swollen and is still sore.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Asthenia, Cold sweat, Diarrhoea, Dizziness
Clinical narrative: 12/16/2020 episode of abdominal cramps I had a BM episode of loose stools and soon after that within seconds I started profusely sweating on my forehead and felt lightheaded and very weak, My wife noticed how much i was sweating my body was cool and clammy, episode lasted at least 5 mins if not more so I just laid down until I started feeling better. Once symptoms subsided I took 1000 mg of tylenol, Heavy head throughout the day.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Hyperhidrosis
Clinical narrative: 12/16/2020 episode of abdominal cramps I had a BM episode of loose stools and soon after that within seconds I started profusely sweating on my forehead and felt lightheaded and very weak, My wife noticed how much i was sweating my body was cool and clammy, episode lasted at least 5 mins if not more so I just laid down until I started feeling better. Once symptoms subsided I took 1000 mg of tylenol, Heavy head throughout the day.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling cold, Headache, Hyperhidrosis
Clinical narrative: 12/16/2020 episode of abdominal cramps I had a BM episode of loose stools and soon after that within seconds I started profusely sweating on my forehead and felt lightheaded and very weak, My wife noticed how much i was sweating my body was cool and clammy, episode lasted at least 5 mins if not more so I just laid down until I started feeling better. Once symptoms subsided I took 1000 mg of tylenol, Heavy head throughout the day.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Neck pain
Clinical narrative: Myalgias, headache, neck pain
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: Injection site soreness started about 3 hrs post-injection.  By that evening I was experiencing body aches & chills. I took Advil 400mg with dinner and felt okay for about 4 hours. As soon as the Advil wore off, body aches & chills returned. I did not take anymore Advil that night. My sleep was restless with body aches, chills, & pain at the injection site. I took my temperature during the night and was afebrile. I woke feeling tired with a mild headache. I took Advil after breakfast and currently feel okay.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep
Clinical narrative: Injection site soreness started about 3 hrs post-injection.  By that evening I was experiencing body aches & chills. I took Advil 400mg with dinner and felt okay for about 4 hours. As soon as the Advil wore off, body aches & chills returned. I did not take anymore Advil that night. My sleep was restless with body aches, chills, & pain at the injection site. I took my temperature during the night and was afebrile. I woke feeling tired with a mild headache. I took Advil after breakfast and currently feel okay.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time shortened, Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal, Basophil count normal
Clinical narrative: About 5 minutes after the vaccine developed chest tightness, increased work of breathing, palpitations and severe dizzyness.  Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring.  Released after about 4 hours and continue to take benadryl 50 mg PO q 4 hours.  Also developed red facial rash (unknown time) Pain at injection site began the morning after the injection.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Basophil percentage decreased, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal
Clinical narrative: About 5 minutes after the vaccine developed chest tightness, increased work of breathing, palpitations and severe dizzyness.  Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring.  Released after about 4 hours and continue to take benadryl 50 mg PO q 4 hours.  Also developed red facial rash (unknown time) Pain at injection site began the morning after the injection.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood chloride normal, Blood glucose normal, Blood magnesium normal, Blood osmolarity decreased, Blood potassium decreased
Clinical narrative: About 5 minutes after the vaccine developed chest tightness, increased work of breathing, palpitations and severe dizzyness.  Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring.  Released after about 4 hours and continue to take benadryl 50 mg PO q 4 hours.  Also developed red facial rash (unknown time) Pain at injection site began the morning after the injection.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood sodium normal, Blood urea nitrogen/creatinine ratio, Blood urea normal, C-reactive protein increased, Chest discomfort
Clinical narrative: About 5 minutes after the vaccine developed chest tightness, increased work of breathing, palpitations and severe dizzyness.  Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring.  Released after about 4 hours and continue to take benadryl 50 mg PO q 4 hours.  Also developed red facial rash (unknown time) Pain at injection site began the morning after the injection.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Eosinophil count normal, Eosinophil percentage decreased, Fibrin D dimer
Clinical narrative: About 5 minutes after the vaccine developed chest tightness, increased work of breathing, palpitations and severe dizzyness.  Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring.  Released after about 4 hours and continue to take benadryl 50 mg PO q 4 hours.  Also developed red facial rash (unknown time) Pain at injection site began the morning after the injection.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Glomerular filtration rate decreased, Haematocrit normal, Haemoglobin normal, Immature granulocyte count increased, Injection site pain
Clinical narrative: About 5 minutes after the vaccine developed chest tightness, increased work of breathing, palpitations and severe dizzyness.  Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring.  Released after about 4 hours and continue to take benadryl 50 mg PO q 4 hours.  Also developed red facial rash (unknown time) Pain at injection site began the morning after the injection.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio normal, Lymphocyte count normal, Lymphocyte percentage, Mean cell haemoglobin concentration decreased, Mean cell haemoglobin normal
Clinical narrative: About 5 minutes after the vaccine developed chest tightness, increased work of breathing, palpitations and severe dizzyness.  Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring.  Released after about 4 hours and continue to take benadryl 50 mg PO q 4 hours.  Also developed red facial rash (unknown time) Pain at injection site began the morning after the injection.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Mean cell volume normal, Mean platelet volume increased, Monocyte count normal, Monocyte percentage, N-terminal prohormone brain natriuretic peptide normal
Clinical narrative: About 5 minutes after the vaccine developed chest tightness, increased work of breathing, palpitations and severe dizzyness.  Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring.  Released after about 4 hours and continue to take benadryl 50 mg PO q 4 hours.  Also developed red facial rash (unknown time) Pain at injection site began the morning after the injection.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Neutrophil count normal, Neutrophil percentage, Palpitations, Platelet count normal, Protein total normal
Clinical narrative: About 5 minutes after the vaccine developed chest tightness, increased work of breathing, palpitations and severe dizzyness.  Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring.  Released after about 4 hours and continue to take benadryl 50 mg PO q 4 hours.  Also developed red facial rash (unknown time) Pain at injection site began the morning after the injection.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Red blood cell count normal, Red blood cell sedimentation rate increased, Red cell distribution width normal
Clinical narrative: About 5 minutes after the vaccine developed chest tightness, increased work of breathing, palpitations and severe dizzyness.  Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring.  Released after about 4 hours and continue to take benadryl 50 mg PO q 4 hours.  Also developed red facial rash (unknown time) Pain at injection site began the morning after the injection.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Troponin T normal, White blood cell count normal
Clinical narrative: About 5 minutes after the vaccine developed chest tightness, increased work of breathing, palpitations and severe dizzyness.  Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring.  Released after about 4 hours and continue to take benadryl 50 mg PO q 4 hours.  Also developed red facial rash (unknown time) Pain at injection site began the morning after the injection.
Age: 44.0
Sex: F
Vaccine: UNK
Symptoms: Feeling hot, Vertigo
Clinical narrative: 5 minutes after receiving the vaccine, room started to spin and I felt warm in my chest and felt like I was going to pass out
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pyrexia, Tachycardia
Clinical narrative: tachycardia, flushed,low grade fever
Age: 21.0
Sex: M
Vaccine: ANTH, YF
Symptoms: Injection site erythema, Papule
Clinical narrative: 5 RAISED PAPULES, SMALL, ABOUT 1CM IN DIAMETER, ON UPPER LIP, CHIN, AND NECK STARTING ABOUT 2 HOURS AFTER VACCINE ADMINISTRATION.  NO SOB, NO TONGUE SWELLING, NO SECONDARY ORGAN SYSTEM INVOVLEMENT.  RESOLVED AFTER 45 MINS OF OBSERVATION AND 50MG OF ORAL BENADRYL.  NO OTHER NEW EXPOSURES, FOOD OR OTHERWISE TODAY, THESE ARE BOTH OF HIS FIRST SHOT IN SERIES.  VERY SMALL LOCAL ERYTHEMA TO YF INJECTION SIDE ON LEFT UPPER ARM, ABOUT QUARTER SIZED ERYTHEMATOUS AREA, NOT RAISED, NO WHEAL, NOT WARM.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: My left arm was very sore and very painful to move and ached.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dysphonia, Pharyngeal swelling, Pruritus, Rash
Clinical narrative: Throat swelling, raspy voice, tachycardia, itching, anxiety, rash
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Throat swelling, raspy voice, tachycardia, itching, anxiety, rash
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hypoaesthesia, Pain in jaw
Clinical narrative: patient felt jaw pain, a strange taste (unable to describe), and numbness in her right arm  patient was monitered and symptoms resolved within 30 minutes of vaccine administration
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Malaise, Nausea, Pain
Clinical narrative: Nausea, fatigue, body aches, joint pain, malaise
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Wheelchair user
Clinical narrative: 40 year female received Pfizer-BioNTech COVID-19 Vaccine today  Patient reported prior h/o severe allergic reaction to influenza vaccine with eggs preservative.  She has received flu vaccine w/o egg w/o problem.  Due to her prior history of severe allergic reaction/ anaphylaxis to another vaccine, in this case flu vaccine with eggs, we should proceed with caution.  She was told we could defer vaccination until more information becomes available.  She opted to proceed with receiving Pfizer-BioNTech COVID-19 Vaccine and be observed for 30 minute observation period.  Patient developed throat tightening approximately 20 minutes after vaccination.  She received EpiPen within 1 minute of symptoms and was sent to ER immediately in wheelchair by nursing staff.  Patient was evaluated in ED and was hemodynamically stable.  She was given IV benadryl and was stable throughout observation
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dyspnoea, Flushing, Heart rate increased, Tachycardia
Clinical narrative: 1204 Patient became flushed and started saying she was having a difficult time "catching her breath".  She then became tachycardic (upper 90's- low 100's).  1205 Benadryl given (25mg).  Physician called down to clinic.  Vital signs obtained and showed increased BP (145/90) and pulse.  1214 Patient verbalized she was feeling a little better.  Monitoring continued until 1245, vital signs were improving and patient no longer had symptoms.  She was released at 1252 but encouraged to seek medical attention if she developed new symptoms or had symptoms reoccur.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea, Flushing, Rash
Clinical narrative: At 24 minutes after vaccination, pt experienced chest tightness, shortness of breath, cough, flushing, and rash on chest and neck.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Fatigue, Injection site pain, Malaise, Muscle spasms
Clinical narrative: woke up the next day and felt nauseated, could not stand up, my heart started racing, I had to lay down, felt cramping, extreme fatigue, felt overall sick, and the pain at the injection site. No fever. Just lasted that day. Feel better today.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations
Clinical narrative: woke up the next day and felt nauseated, could not stand up, my heart started racing, I had to lay down, felt cramping, extreme fatigue, felt overall sick, and the pain at the injection site. No fever. Just lasted that day. Feel better today.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Ear pain, Erythema, Influenza like illness
Clinical narrative: Patient reported severe adverse effects that she did not experience with first shot. Severe left arm swelling, pain and redness. On her left side from her neck to her ear was painful, couldn't turn neck, had headache, upper back pain and chills (flu -like sx) Received shot Monday evening and woke up Tues morning with symptoms that lasted 24 hours.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported severe adverse effects that she did not experience with first shot. Severe left arm swelling, pain and redness. On her left side from her neck to her ear was painful, couldn't turn neck, had headache, upper back pain and chills (flu -like sx) Received shot Monday evening and woke up Tues morning with symptoms that lasted 24 hours.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Bone pain, Pain in extremity
Clinical narrative: Feels like the side of shoulder was scraped. Pains shooting down to the elbow,  every time he moves.  If he touches the skin where the shot was given the bone hurts at that location.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria
Clinical narrative: during the administration of vaccine patient developed a wheal at the site on injection.  Pressure and message reduced the wheal.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Body temperature increased, Chills, Diarrhoea
Clinical narrative: Today I have really bad stomach cramps and diarrhea.  Yesterday I had a temp 101.2 with tylenol, chills, joint pain and really bad headache
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Today I have really bad stomach cramps and diarrhea.  Yesterday I had a temp 101.2 with tylenol, chills, joint pain and really bad headache