chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAP
Symptoms: Coinfection, Immune system disorder, Lyme disease
Clinical narrative: experienced lyme/co-infections; immune system collapsed; experienced lyme/co-infections; Initial information received on 30-Jan-2021 regarding an unsolicited valid serious case received from an other health professional.  This case involves adult patient who experienced lyme/co-infections (Lyme disease and coinfection), and immune system collapsed (immune system disorder), while patient received DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [TDAP ]and while treated with PANCREATIN [CREON].  It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical history, medical treatment, vaccination and family history were not provided.   On an unknown date, the patient started taking therapy of CREON (PANCREATIN) at dose and route unknown (with an unknown batch number) for unknown indication.  On an unknown date in October 2019, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS 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 a serious experienced lyme/co-infections (lyme disease) unknown latency following the first dose intake and following the last dose intake of PANCREATIN and unknown latency following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. This event was assessed as medically significant.  On an unknown date, the patient developed a non-serious immune system collapsed (immune system disorder) unknown latency following the first dose intake and following the last dose intake of PANCREATIN and unknown latency following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE.   On an unknown date in-Jan-2020, the patient developed a non-serious immune system collapsed (immune system disorder) and experienced lyme/co-infections (coinfection) unknown latency following the first dose intake and following the last dose intake of PANCREATIN and unknown latency following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE.   There were no lab data/results available.  Action taken of PANCREATIN (CREON) was unknown with respect to all the events.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for events.; Sender's Comments: This case involves adult patient who presented with Lyme disease, coinfection and immune system disorder after vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [TDAP] from unknown manufacturer and while being treated with PANCREATIN. The time to onset is unknown. There is, however, no information regarding patient's condition at time of vaccination, past history and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of an individual suspect cannot be assessed.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vital signs measurement
Clinical narrative: light headed Pt. in tent is felt lightheaded at 4:40pm after vaccine at observation site paramedics assessed pt. took vitals which were stable.  Monitored until symptoms subsided.  At 5:15pm pt. was released to go home.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Nothing major, just Constant Itchy Palms in both hands  Have taken Benadryl twice and that stops for a day or do Then it starts up again .  My question is will it eventually stop? Or will it get worse after my second dose?
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Headache, Insomnia, Myalgia
Clinical narrative: Fever 102 F, severe body aches, extreme joint pain, sharp muscle/tissue pain,  heavy fatigue, severe headache  Outcome: constant joint pain throughout body and extreme fatigue and insomnia
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Tissue irritation
Clinical narrative: Fever 102 F, severe body aches, extreme joint pain, sharp muscle/tissue pain,  heavy fatigue, severe headache  Outcome: constant joint pain throughout body and extreme fatigue and insomnia
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arteriosclerosis, Death, Hypertension
Clinical narrative: Patient expired 02/06/2021. COD as ruled by Coroner "Hypertensive and Atherosclerotic Cardiovascular Disease."
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Client c/o numbness and tingling of lips 25 minutes after receiving Pfizer vaccine.  Client seen and assessed by EMjS.  V.S. are B/P 143/79, HR 79, O2 96.  Client voiced that sensation had stopped after 5 minutes and was cleared to go home by EMS.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site reaction
Clinical narrative: Approx 6 hours post injection, a large, red, painful, hard, golf-ball sized swollen lump formed under the injection site apprx 3 inches in diameter. 12 hours post injection, the hard, red, painful blotch has increased to nearly 6 inches in diameter and is hot to the touch. Seems to be spreading down the arm. Pain radiates from the muscle in the arm at the injection site into the neck. Decreased strength in arm.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Muscular weakness, Neck pain, Pain
Clinical narrative: Approx 6 hours post injection, a large, red, painful, hard, golf-ball sized swollen lump formed under the injection site apprx 3 inches in diameter. 12 hours post injection, the hard, red, painful blotch has increased to nearly 6 inches in diameter and is hot to the touch. Seems to be spreading down the arm. Pain radiates from the muscle in the arm at the injection site into the neck. Decreased strength in arm.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Approx 6 hours post injection, a large, red, painful, hard, golf-ball sized swollen lump formed under the injection site apprx 3 inches in diameter. 12 hours post injection, the hard, red, painful blotch has increased to nearly 6 inches in diameter and is hot to the touch. Seems to be spreading down the arm. Pain radiates from the muscle in the arm at the injection site into the neck. Decreased strength in arm.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Chills with shivering for 5 hours, mild body aches, extreme fatigue for 48 hours, swollen and sore lymph nodes in both axilla that resolved in 24 hours, headache that resolved in 96 hours, swollen and painful lymph node  (size of a marble) above left clavicle that remains, required followup with primary care physician and is being monitored for the next month to determine if additional intervention will be needed.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Chills with shivering for 5 hours, mild body aches, extreme fatigue for 48 hours, swollen and sore lymph nodes in both axilla that resolved in 24 hours, headache that resolved in 96 hours, swollen and painful lymph node  (size of a marble) above left clavicle that remains, required followup with primary care physician and is being monitored for the next month to determine if additional intervention will be needed.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: extremely bad cramp in inner right thigh at 6am the next morning
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Eye swelling, Fatigue, Lip swelling, Myalgia
Clinical narrative: Moderna COVID?19 Vaccine EUA  After 6 hours of the 2nd dose, the body aches started.  24 hours after vaccine, still joints, fatigue, and muscle soreness.  My body left I was in a car accident.  Overall aches. 30 hours after,  bilateral swelling of under eyes. 36 hours after, under eye swelling spread to right upper and lower lip. 1 benadryl pill was taken
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Moderna COVID?19 Vaccine EUA  After 6 hours of the 2nd dose, the body aches started.  24 hours after vaccine, still joints, fatigue, and muscle soreness.  My body left I was in a car accident.  Overall aches. 30 hours after,  bilateral swelling of under eyes. 36 hours after, under eye swelling spread to right upper and lower lip. 1 benadryl pill was taken
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pyrexia
Clinical narrative: Started feeling unwell and developed chills as afternoon progressed.  Had fever 101, a 10/10 headache, my resting HR was anywhere from 122-140 bpm.  Took 4 advil and went to bed.  12 hours later woke up and feel completely normal again
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Left arm injection site became quite itchy and red which subsided on its own within 2-3 days. This happened about a week after the vaccine.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, headache for 48 hours
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site reaction, Rash erythematous, Rash papular
Clinical narrative: Red, raised rash on R arm in the region of the injection site. Painful to touch but not itchy.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Device malfunction, Syringe issue, Underdose
Clinical narrative: The vaccine leaked out between the connection of the needle and the syringe.  That connection was found to be loose despite attempting to tighten it.  Several other syringes within that same lot number had the same issues. Approximately 1/3 to 1/2 leaked out.   Moderna was called and advised that at this time, the vaccine recipient should not be revaccinated.
Age: 18.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Experienced body aches, chills, fever nearly 12 hours after receiving the vaccine. Symptoms carried on for 36 hours but were resolved/reduced with ibuprofen.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Cognitive disorder, Computerised tomogram head, Confusional state, Dementia
Clinical narrative: Found down - day after vaccination.  Fall, potentially acute encephalopathy / confusion, hypertension (potential for non-compliance with antihypertensive medications?) - patient with known severe to advanced dementia / mild cognitive impairment.  Likely related to hypertensive encephalopathy with post-COVID vaccine prodrome with underlying advanced dementia.  Situation: hospitalization after a fall and hypertension emergency Background: Pt is an 84 y/o female pt with a log history of dementia, has been able to live alone safely until most recent illness/hospitalization. Assessment: Pt received her 2nd COVID vaccine on Saturday.  On Sunday, pt's sister was unable to get a hold of her as her sister calls her daily due to her dementia.  After several phone calls, her sister went to pt's home and found pt on her bedroom floor.  There was   some blood found, not sure from where.  Sisiter was unable to get pt up so EMS was called and pt was taken to ED.  She was evaluated, her BP was very elevated, she was admitted and testing was done.  Head CT/MRI was unchanged.  X-ray of her R shoulder shows a vertical non-displaced fracture of the greater tuberosity of the proximal humerous, no surgical intervention is recommended at this time, pt instructed to wear a sling for now. Pt is discharged home with Home Care and family support.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Encephalopathy, Fall, Hypertension, Magnetic resonance imaging head, X-ray abnormal
Clinical narrative: Found down - day after vaccination.  Fall, potentially acute encephalopathy / confusion, hypertension (potential for non-compliance with antihypertensive medications?) - patient with known severe to advanced dementia / mild cognitive impairment.  Likely related to hypertensive encephalopathy with post-COVID vaccine prodrome with underlying advanced dementia.  Situation: hospitalization after a fall and hypertension emergency Background: Pt is an 84 y/o female pt with a log history of dementia, has been able to live alone safely until most recent illness/hospitalization. Assessment: Pt received her 2nd COVID vaccine on Saturday.  On Sunday, pt's sister was unable to get a hold of her as her sister calls her daily due to her dementia.  After several phone calls, her sister went to pt's home and found pt on her bedroom floor.  There was   some blood found, not sure from where.  Sisiter was unable to get pt up so EMS was called and pt was taken to ED.  She was evaluated, her BP was very elevated, she was admitted and testing was done.  Head CT/MRI was unchanged.  X-ray of her R shoulder shows a vertical non-displaced fracture of the greater tuberosity of the proximal humerous, no surgical intervention is recommended at this time, pt instructed to wear a sling for now. Pt is discharged home with Home Care and family support.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Pyrexia
Clinical narrative: tenderness at injection site, chills, headache, low fever (99.3), tired.  Lasted less than24 hours.   Took 2 acetaminophen.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Oropharyngeal pain, Pain
Clinical narrative: Soreness at site of injection and headache on the first day; sore throat, headache, and body aches on the second day following vaccination
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Fatigue, headache, muscle pain, and chills from 5:05-12am. With acetaminophen, symptoms lessened and woke up with no symptoms .
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site erythema, Injection site pain
Clinical narrative: The fist 48 hours had a sore shoulder. On the 7 1/2th day I felt a pinching sensation, slightly sore at injection point. This morning I noticed the injection site red and slightly more sore than usual.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Migraine, Nausea
Clinical narrative: Migraine started later that evening, on and off the next two days, nausea, chills migraine starting 72 hours later
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Feeling hot, Headache, Impaired work ability
Clinical narrative: The vaccine was given to me at seven o'clock on Friday night. I had a really bad time after that. I had headache, pain, cold sweating, tired, very ill, the pain did not let me sleep, overheated, I had to rest for two days and I did not go to work until Tuesday.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Malaise, Pain
Clinical narrative: The vaccine was given to me at seven o'clock on Friday night. I had a really bad time after that. I had headache, pain, cold sweating, tired, very ill, the pain did not let me sleep, overheated, I had to rest for two days and I did not go to work until Tuesday.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased
Clinical narrative: Temperature at 101 at 5 am on 2/18/2021
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: 1) HEADACHE, NAUSEA , FATIGUE - STARTED ABOUT 7:00PM ON 2/16 LASTED ABOUT 2 HOURS 2) ARTHRITIS FLARE UP -  WORSE ARTHRITIS PAIN EVER, OCCURED ABOUT 9:00PM ON 2/16, LASTED ABOUT 2 HOURS 3) SLIGHT SORENESS AT INJECTION SITE ON 2/17 IN MORNING
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever between 99.5 and 101, chills, shuvering, body aches, headache.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 8 days after the injection area became red , slightly puffy and itchy
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Covid Arm, circular reddened area on the arm.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Intermenstrual bleeding, Intrauterine contraception, Vaginal haemorrhage
Clinical narrative: The day after receiving my second dose of the Covid-19 vaccine I experienced bright red vaginal bleeding. I currently have an IUD in place and have no had a period ever since this device was placed (and also replaced twice). This is completely abnormal for me! I am still experiencing bleeding. No cramping or any other of the known side effects were experienced.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Paresthesia . Started in my left hand then progressed to involve bilateral arms and legs.  Gets worse at the end of the day. No other symptoms. No motor weakness noted so far
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Approx 16 hrs after the 2nd dose: fatigue, muscle pain, stabbing pain, nausea, headache, dizziness
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: Approx 16 hrs after the 2nd dose: fatigue, muscle pain, stabbing pain, nausea, headache, dizziness
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, UNK
Symptoms: Malaise, Pyrexia, Vaccination site pain
Clinical narrative: has not been feeling weel; running a fever of 100 degrees; had a "sore arm" from the injection; the "GARDASIL 9 did hurt; This spontaneous report as received from a company representative and refers to her daughter, a 11-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 03-FEB-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and meningococcal vaccine (unspecified); (exact doses, routes of administration, anatomical locations, lot # and expiration date were not reported for any of them); all for prophylaxis.     On the same date, she experienced vaccination site pain (reported as hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) did hurt) and she had "a sore arm" from the injection. Since 04-FEB-2021, she was not feeling well and had a fever of 100 degrees (units not provided). The outcome of the events was reported as not recovered.  The reporter considered vaccination site pain to be related to hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). The causality assessment between the rest of the events was not reported.     This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-2102USA003519:
Sex: F
Vaccine: MMR
Symptoms: Dysphagia, Dyspnoea, Pharyngeal swelling, Swelling face
Clinical narrative: could not swallow anything; jaw swelled; her throat swelled up; This spontaneous report was received from a female patient of unknown age who reported on herself via other company. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.     On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, 2-3 weeks after taking the vaccine, her throat swelled up and jaw swelled, she could breath but could not swallow anything and had to go to Emergency Room (ER). The outcome of the events was unknown. It was also reported that she was getting ready to get her COVID vaccine pretty soon but wanted to know about anything common in COVID vaccine and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  Causality assessment was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Blood test abnormal, Hypersensitivity, Hypertension, Rash papular, Urine analysis normal
Clinical narrative: raised rash on my entire legs and arms; allergic reaction; Elevated blood pressure; This case was reported by a consumer and described the occurrence of raised rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2020, the patient received the 1st dose of Shingrix. On 2nd January 2021, 32 days after receiving Shingrix, the patient experienced raised rash. In January 2021, the patient experienced allergic reaction and blood pressure high. On an unknown date, the outcome of the raised rash, allergic reaction and blood pressure high were unknown.   It was unknown if the reporter considered the raised rash, allergic reaction and blood pressure high to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient. The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient broke out with a raised rash on my entire legs and arms but no rash on my torso, face, feet, or hands. The patient did not had have fever, elevated blood pressure, no signs of an infection. The patient seek medical attention prior week to the report and blood and urine labs were drawn and all metabolic function is was normal. The patient inquired Is was it possible to had a very delayed allergic reaction and was concerned about taking the booster. The reporter had taken photo graphs which may help. The reporter consented to follow via mobile phone.
Sex: U
Vaccine: VARZOS
Symptoms: Impaired driving ability, Loss of personal independence in daily activities, Seizure
Clinical narrative: Seizure; Patient unable to drive for at least 6 mons to avoid repeat episode of seizure; This case was reported by a physician via sales rep and described the occurrence of seizure in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced seizure (serious criteria GSK medically significant) and activities of daily living impaired. On an unknown date, the outcome of the seizure and activities of daily living impaired were unknown.   It was unknown if the reporter considered the seizure and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced seizure post Shingrix dose. The patient would unable to drive for at least 6 months to avoid repeat episode of seizure. The reporter stated the patient was a fellow provider and not his patient and he had no further details. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Rash, Rash pruritic, Skin discolouration
Clinical narrative: Skin has pain, similar to bee stings; Rash on her wrists and inside her legs / Rash appeared purple-like in color. The rash also itched; purple-like in color; rash; This case was reported by a consumer and described the occurrence of skin pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced skin pain, itchy rash, skin discoloration and rash. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the skin pain, itchy rash, skin discoloration and rash were unknown.   It was unknown if the reporter considered the skin pain, itchy rash, skin discoloration and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she received dose 1 and after an unspecified period of time, she developed a rash on her wrists and inside her legs. The rash appeared purple-like in color. The rash also itched. The patient also noted that her skin has pain, similar to bee stings in the affected rash areas. The patient got some alleviation of symptoms by using antiviral medications, not specified. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Nausea
Clinical narrative: Headache; Nausea; Stomach pain / colon wasn't calming down; Diarrhea / colon wasn't calming down; This case was reported by a consumer via and described the occurrence of headache in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, nausea, stomach pain and diarrhea. On an unknown date, the outcome of the headache, nausea, stomach pain and diarrhea were recovered/resolved.   It was unknown if the reporter considered the headache, nausea, stomach pain and diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported, however it could be 60 years. The patient had her 1st dose in fall of 2018. The patient experienced headache, nausea, stomach pain and diarrhea following that dose.  The symptoms lasted for 2-3 days except for the stomach pain and diarrhea which lingered for about a week.  The patient described as her colon was not calming down. The reporter did not consent to follow-up. For tolerance of 2nd dose, refer case US2021AMR035701.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR035701:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Erectile dysfunction
Clinical narrative: informed them of the erection dysfunction; This case was reported by a nurse via call center representative and described the occurrence of erectile dysfunction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erectile dysfunction (serious criteria GSK medically significant). On an unknown date, the outcome of the erectile dysfunction was unknown.   It was unknown if the reporter considered the erectile dysfunction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced erection dysfunction after first dose, but nurse practitioner unsure if Shingrix caused this. The reporter enquired about any information on any studies showing erectile dysfunction after the first dose of Shingrix. The reporter unable to provide vaccine or patient details. The reporter did not consent to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Loss of consciousness, Nausea, Pyrexia
Clinical narrative: Passed Out; flushed; sleeping all day; kind of like a fever; nauseated; Headache; A spontaneous report was received from a healthcare professional (HCP) concerning a 72-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced passing out (loss of consciousness), flushed, sleeping all day, kind of like a fever, nausea and headache.  The patient's medical history was not reported.  Concomitant products known to have been used by the patient, within two weeks prior to the event, included pantoprazole.  On 02 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: 007M204) for prophylaxis of COVID-19 infection.  The patient stated that on 04 Feb 2021, the patient got up in the morning and didn't feel very well.  She stated that she was flushed, had a headache and a fever.  She had a coffee and sandwich and talked to her husband and then they got up and passed out.  They slept all day and did not feel well.  The patient stated that she was nauseated and felt like she had a fever and a real, dull headache.    Treatments for these events were not reported.  Action taken with mRNA-1273 in response to this event was not reported.  The outcome for the events passing out (loss of consciousness), flushed, sleeping all day, kind of like a fever, nausea and headache was unknown.; Reporter'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.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Passed Out; flushed; sleeping all day; kind of like a fever; nauseated; Headache; A spontaneous report was received from a healthcare professional (HCP) concerning a 72-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced passing out (loss of consciousness), flushed, sleeping all day, kind of like a fever, nausea and headache.  The patient's medical history was not reported.  Concomitant products known to have been used by the patient, within two weeks prior to the event, included pantoprazole.  On 02 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: 007M204) for prophylaxis of COVID-19 infection.  The patient stated that on 04 Feb 2021, the patient got up in the morning and didn't feel very well.  She stated that she was flushed, had a headache and a fever.  She had a coffee and sandwich and talked to her husband and then they got up and passed out.  They slept all day and did not feel well.  The patient stated that she was nauseated and felt like she had a fever and a real, dull headache.    Treatments for these events were not reported.  Action taken with mRNA-1273 in response to this event was not reported.  The outcome for the events passing out (loss of consciousness), flushed, sleeping all day, kind of like a fever, nausea and headache was unknown.; Reporter'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.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Bells Palsy symptoms; A spontaneous report was received from a consumer who was also a 65-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Bell's palsy symptoms/ facial paralysis.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included duloxetine hydrochloride.  On 29 Jan 2021, approximately seven days prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot# 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 04 Feb 2021, the patient went to the dentist and started to develop Bell's palsy symptoms afterwards. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, Bell's palsy symptoms, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. However, patient's unspecified dental procedure may have been contributory.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Pain
Clinical narrative: body aches, chills, fatigue, headache, dizziness--lasted approximately 36 hours
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dry skin, Electrocardiogram, Limb discomfort, Muscle tightness
Clinical narrative: Initially complained of left arm heaviness with 20 later progressed to bilateral jaw tightness,mild dizziness,denied CP , SOB. Handover to parametics,placed on cardiac monitor, NSR 78, EKG completed . BP 149/82 HR 78 O2  99%, skin dry. Shortly  after jaw pain subsided along with dizziness. PRN angio placed in right AC by parametics. Patient declined nurse to call her family member and transported to BMC- ER  fully alert and oriented x3.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pyrexia, Sluggishness, Swelling
Clinical narrative: Developed a fever of 101, pain and swelling in my shoulder, sluggish feeling.  Fever was gone the next day.  The only residual was pain in the shoulder.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: Needle retracted before full dose was given, less than half dose was administered.  Revaccinated in opposite arm according to  regs.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram, Feeling hot, Hyperhidrosis
Clinical narrative: P92 BP172/98 121/85 Diaphoretic, dizzy, hot. EMS evaluated EKG done transfer  to ER 5:35
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Red, itchy welt. Benedryl. 5 days
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: Red splotch on and near injection site, raised and warm to touch
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: Pharmacist did not perform intramuscular injection properly and underdosed - majority of injection was wasted (ran down patient arm) and did not go into muscle.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Feeling hot, Nausea
Clinical narrative: On 02/16   Low grade fever 99.2  feeling hot like   Nausea and diarrhea    Feeling Tired/weak     On 02/17  Still feeling a bit tired  some Nausea
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: On 02/16   Low grade fever 99.2  feeling hot like   Nausea and diarrhea    Feeling Tired/weak     On 02/17  Still feeling a bit tired  some Nausea
Age: 77.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Malaise, Pain, Pyrexia
Clinical narrative: Aches, slight fever, fatigue, feeling ill.  Lasted about 1 18/2 days.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anxiety, Headache, Tinnitus
Clinical narrative: H/a, ears ringing, stomach upset, anxious. EMS  evaluated. Stayed longer and felt better went home
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza, Nasal congestion
Clinical narrative: Mild flu symptoms: headache, tiredness, congestion
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Pain, Pyrexia
Clinical narrative: Headache fever chills bodyaches
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Mild itching, stiffness, redness around injection site. Covers an area approx 8 inches by 4 inches
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nasal congestion
Clinical narrative: CONGESTION, FATIGUE, HEADACHE, DIARRHEA; duration lasting 18 hrs; TYLENOL 1000MG ONE TIME DOSE, SUMATRIPTAN, Flonase nasal spray one time dose; effective
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Pt is G1P0. At the time she received the vaccine on 1/26/21 she was 13 weeks pregnant. She had normal 1st trimester ultrasound and normal prenatal labs. Her EDD is August 5, 2021.  On 2/9/21 she had a spontaneous miscarriage. No subsequent complications. No history of drug or alcohol abuse. No s/sx of other causes of a early 2nd trimester miscarriage. Of note the 1st trimester genetic testing was unable to be performed due to low fetal free cell DNA when she was at 10w. We were in the process of repeating the labs when the miscarriage happened.  No history of COVID infection, no s/sx of COVID infection at the time of the miscarriage or subsequently. She was not tested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dysarthria, Feeling drunk
Clinical narrative: Pt was at work, reported "feeling drunk".  Exhibited slight slurring of speech, jocular manner.  Was unsteady on her feet, "not lightheaded really but more like I had a few shots...  and I don't drink".   Pt was kept under observation for approx 30m from reporting onset of symptoms to supervisor.  Observed and interviewed at pharmacy.   Pt's daughter was notified to come pick her up.  Checked in with pt the following day, symptoms had resolved.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: SKIN  RASH OCCURRED 2 DAYS AFTER VACCINE WHICH PRESENTED ON TORSO, ARMS , UPPER LEGS AND GROIN AREA.  RASH DISSAPATED TWO DAYS LATER WITH SLIGHT ITCHINESS OF PRESENTED AREAS.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site mass, Injection site pain, Injection site rash, Lethargy
Clinical narrative: First vaccination on 01/19/2021; left arm - lump and rash around injection site approximately one week after injection. Both resolved within two days. Second vaccination on 02/16/2020; right arm - symptoms began night of injection; fever of 100.9; extreme headache and muscle pain, especially in posterior right thigh; lethargy. Took 400 mg of ibuprofen at 8pm on 02/17/2021. All symptoms resolved except for soreness at injection site as of 02/18/2021.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Macrocephaly, Pyrexia
Clinical narrative: First vaccination on 01/19/2021; left arm - lump and rash around injection site approximately one week after injection. Both resolved within two days. Second vaccination on 02/16/2020; right arm - symptoms began night of injection; fever of 100.9; extreme headache and muscle pain, especially in posterior right thigh; lethargy. Took 400 mg of ibuprofen at 8pm on 02/17/2021. All symptoms resolved except for soreness at injection site as of 02/18/2021.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills  started 9:00pm day of shot.  Chills, headache and fever throughout the night.   Following day of vaccine: Chills, fever 100.8 , slight headache
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patient broke out in hives.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Body aches, fever, headache, red painful swelling of left arm below injection site that increased and spread over 4 days
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body aches, fever, headache, red painful swelling of left arm below injection site that increased and spread over 4 days
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Axillary pain, Chills, Decreased appetite, Diarrhoea
Clinical narrative: 1st day: Swelling, redness,  pain in upper right arm, site of shot.  Swelled area measures 3x3?.  2nd day:  Swelling, redness & pain continues with migraine, chills, slight fever, body aches, extreme tiredness, slept most of the day, upset stomach, unable to eat much.  3rd day: Not as tired, fever & chills gone, redness, swelling & pain continues at injection site but now extends under my arm into the armpit area,  diarrhea started in the morning, continued throughout the day, face flushing, pain & swelling under my right arm, migraine returned.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Flushing, Hypersomnia, Injection site erythema, Injection site pain
Clinical narrative: 1st day: Swelling, redness,  pain in upper right arm, site of shot.  Swelled area measures 3x3?.  2nd day:  Swelling, redness & pain continues with migraine, chills, slight fever, body aches, extreme tiredness, slept most of the day, upset stomach, unable to eat much.  3rd day: Not as tired, fever & chills gone, redness, swelling & pain continues at injection site but now extends under my arm into the armpit area,  diarrhea started in the morning, continued throughout the day, face flushing, pain & swelling under my right arm, migraine returned.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lymphadenopathy, Migraine, Pyrexia
Clinical narrative: 1st day: Swelling, redness,  pain in upper right arm, site of shot.  Swelled area measures 3x3?.  2nd day:  Swelling, redness & pain continues with migraine, chills, slight fever, body aches, extreme tiredness, slept most of the day, upset stomach, unable to eat much.  3rd day: Not as tired, fever & chills gone, redness, swelling & pain continues at injection site but now extends under my arm into the armpit area,  diarrhea started in the morning, continued throughout the day, face flushing, pain & swelling under my right arm, migraine returned.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Tenderness
Clinical narrative: The pain is in the anterior aspect of her bilateral legs right> left. Of note, pt did have some left sided axillary LAD that started 5 days post vaccine and resolved spontaneously 3 days later. Pt also has some tenderness in the extensor surface of her right arm. Denies overlying skin changes.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Pallor, Tension headache
Clinical narrative: Chest and head tightness pale. EMS evaluated P90. O298% Lungs clear. Discharged home
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Chlamydia test negative, Condition aggravated, Fatigue, Headache
Clinical narrative: Fatigue (Dose 1 & 2) Headache  (Dose 1 & 2) Body aches  (Dose 1 & 2) Sweats  (Dose 2 only) Reynaud's flares while inside  (Dose 2 only) Aphthous Ulcers (Dose 2 only) Rash/Hives (Dose 1 only)
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex test negative, Hyperhidrosis, Nucleic acid test, Pain, Rash
Clinical narrative: Fatigue (Dose 1 & 2) Headache  (Dose 1 & 2) Body aches  (Dose 1 & 2) Sweats  (Dose 2 only) Reynaud's flares while inside  (Dose 2 only) Aphthous Ulcers (Dose 2 only) Rash/Hives (Dose 1 only)
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Raynaud's phenomenon, Trichomoniasis, Urticaria
Clinical narrative: Fatigue (Dose 1 & 2) Headache  (Dose 1 & 2) Body aches  (Dose 1 & 2) Sweats  (Dose 2 only) Reynaud's flares while inside  (Dose 2 only) Aphthous Ulcers (Dose 2 only) Rash/Hives (Dose 1 only)
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy
Clinical narrative: SWOLLEN LYMPH NODES (2 IN THE NECK, 1 LEFT LOWER PART OF HEAD), HEADACHE
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site rash, Vaccination site reaction
Clinical narrative: Large itchy red rash at vaccination site on left arm.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Immediate post-injection reaction, Lymph node pain, Lymphadenopathy
Clinical narrative: Immediately after shot a bruise appeared - it has faded away but now I have a red circle in the same area. A lympnode in my left armpit seems to be swollen and painful - this began on Monday 2/15/21
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiogenic shock, Chest pain, Computerised tomogram abnormal, Dizziness, Fatigue
Clinical narrative: Fever for 24 hours Chills Lightheaded Nausea Extreme fatigue Pain at site of shot  Chest pains New left axillary Adenopsthy -CT scan 2/11/21
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Injection site pain, Lymphadenopathy, Magnetic resonance imaging head
Clinical narrative: Fever for 24 hours Chills Lightheaded Nausea Extreme fatigue Pain at site of shot  Chest pains New left axillary Adenopsthy -CT scan 2/11/21
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pruritus
Clinical narrative: my arm was sore for about a day, had a headache for a couple of days and on Sunday i just started itching,
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Moderate chills, headache, body aches Chills resolved after six hours.  Headache and body aches continued for an additional day. We used acetaminophen over 36 hours.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Fever, body aches, rash on arm showed up after 24 hours
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Communication disorder, Condition aggravated, Confusional state
Clinical narrative: Prior to getting my vaccine I decided to pre-medicate about 30 minutes' prior with 50mg of Benadryl.  I received my second Covid Vaccine on Thursday 2/4/21.   After waiting about 25 minutes, I started to have tightness in my chest and coughing.  I notified staff.  They took me back to the observation room with a nurse.  At about 28 minutes, voice changed very raspy, chest tightness worse, I could not stop coughing and a very mottled rash on the arm of injection.  I was kind of out of it, like wanted to answer questions but really had to think about what I was trying to say and hard to find the answers.  They immediately took me to the ER where the doctor ordered and nurse administered Epinephrine....cont
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Feeling abnormal, Headache, Injection site pain
Clinical narrative: Prior to getting my vaccine I decided to pre-medicate about 30 minutes' prior with 50mg of Benadryl.  I received my second Covid Vaccine on Thursday 2/4/21.   After waiting about 25 minutes, I started to have tightness in my chest and coughing.  I notified staff.  They took me back to the observation room with a nurse.  At about 28 minutes, voice changed very raspy, chest tightness worse, I could not stop coughing and a very mottled rash on the arm of injection.  I was kind of out of it, like wanted to answer questions but really had to think about what I was trying to say and hard to find the answers.  They immediately took me to the ER where the doctor ordered and nurse administered Epinephrine....cont
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Livedo reticularis, Neck pain, Pain
Clinical narrative: Prior to getting my vaccine I decided to pre-medicate about 30 minutes' prior with 50mg of Benadryl.  I received my second Covid Vaccine on Thursday 2/4/21.   After waiting about 25 minutes, I started to have tightness in my chest and coughing.  I notified staff.  They took me back to the observation room with a nurse.  At about 28 minutes, voice changed very raspy, chest tightness worse, I could not stop coughing and a very mottled rash on the arm of injection.  I was kind of out of it, like wanted to answer questions but really had to think about what I was trying to say and hard to find the answers.  They immediately took me to the ER where the doctor ordered and nurse administered Epinephrine....cont
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pain in extremity
Clinical narrative: Approximately 12 hours after shot #2 - moderate malaise, chills, leg aches, slight headache.   Symptoms persisted for about 20-24 hours, gradually resolving.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pruritus
Clinical narrative: 2/4/21 at 4pm: arm soreness,  fatigue. 2/5/21 at approx. 4am: low fever (~100), chills, body aches, headaches, injection site was red, earlier symptoms continued. Persisted until  2/7. Tylenol taken 2x. Injection site on arm was itchy from  2/7-2/11 but redness at injection site went away.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: 2/4/21 at 4pm: arm soreness,  fatigue. 2/5/21 at approx. 4am: low fever (~100), chills, body aches, headaches, injection site was red, earlier symptoms continued. Persisted until  2/7. Tylenol taken 2x. Injection site on arm was itchy from  2/7-2/11 but redness at injection site went away.