chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Muscular weakness
Clinical narrative: feeling sick; body aches; Headache; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Apr2021 15:45 (Lot number: ER8733) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MALAISE (non-serious) with onset 02Apr2021 18:00, outcome "recovered" (Apr2021), described as "feeling sick"; PAIN (non-serious) with onset 02Apr2021 18:00, outcome "recovered" (Apr2021), described as "body aches"; HEADACHE (non-serious) with onset 02Apr2021 18:00, outcome "recovered" (Apr2021), described as "Headache"; FATIGUE (non-serious) with onset 02Apr2021 18:00, outcome "recovered" (Apr2021), described as "Fatigue". Therapeutic measures were not taken as a result of malaise, pain, headache, fatigue.  Additional information: The patient reported Few hours after the first dose started feeling sick, body aches head ache and fatigue, this lasted 48 hours. No other vaccine in four weeks. No other Medication in two weeks. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies. Other medical history reported none was in good health prior to vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: "had a little soreness" in their vaccinated arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65 year-old male patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as ""had a little soreness" in their vaccinated arms".  Additional information: PQC was not present. Patient wife reports that they had a new air-conditioning unit installed and kind of got sick with upper respiratory symptoms: "allergies, post-nasal drip, sinus infections" but have been prescribed an antibiotic and they're feeling much better. Patiet was due for their second dose 21May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Lymphadenopathy, Pain in extremity, Peripheral swelling
Clinical narrative: swelling to his armpit area on the side where the injection was given; Arm was pretty sore; large swelling under my armpit; my arm was pretty sore and then yesterday morning a large swelling under my armpit/ in the arm pit area in the arm where I got the shot; my arm was pretty sore and then yesterday morning a large swelling under my armpit/ in the arm pit area in the arm where I got the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm, administration date 10May2021 (Lot number: EWO158) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset May2021, outcome "unknown", described as "swelling to his armpit area on the side where the injection was given"; PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "unknown", described as "Arm was pretty sore"; PERIPHERAL SWELLING (non-serious) with onset May2021, outcome "unknown", described as "large swelling under my armpit"; INJECTION SITE PAIN (non-serious), INJECTION SITE SWELLING (non-serious) all with onset May2021, outcome "unknown" and all described as "my arm was pretty sore and then yesterday morning a large swelling under my armpit/ in the arm pit area in the arm where I got the shot".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: soreness for a couple of days, it was just like where he got the shot; soreness in the hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "soreness for a couple of days, it was just like where he got the shot"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in the hand".  Additional information: Soreness for a couple of days, it was just like where he got the shot. The reporter stated he just has a small question, he just wanted to check. The reporter stated after taking the vaccination, there was soreness in the hand. He asked can they use any pain killers or just use Tylenol. The patient verified it was the Pfizer Covid Vaccine he received. The patient stated he did have some soreness for a couple of days, it was just like where he got the shot, he felt some kind of soreness. The patient stated it started a couple of days and just went off and he is good now, he got it last week. The patient stated he just wanted to check on the medication, they said at the pharmacy they can take Tylenol. The patient asked is anything good or just Tylenol, he just wanted to check on the medication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had pain in extremity/soreness in the hand (non-serious), with outcome of not recovered. Additional information: Reporter stated his wife was having some soreness, he wanted to check on her behalf. Reporter stated his wife got it yesterday, so she's having a little bit more pain than he did. Reporter stated he just wanted to check on the medication. The pharmacy said they can take Tylenol. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling
Clinical narrative: Lymph nodes swollen on my neck/ 'huge lymph node' on neck on one side; I had some swelling in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 34 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 (Lot number: EW0179) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: KURVELO taken for contraception. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 06May2021, outcome "recovering", described as "Lymph nodes swollen on my neck/ 'huge lymph node' on neck on one side"; PERIPHERAL SWELLING (non-serious) with onset 06May2021, outcome "unknown", described as "I had some swelling in the arm". Therapeutic measures were taken as a result of peripheral swelling.  Additional Information: Patient states she called yesterday to report side effects after the first dose of pfizer covid vaccine (safety dept) and was told to call MI today for inquires she had. states she received first dose of the vaccine on 30Apr2021 but it wasnt until several days later on 06May2021 she developed 'huge lymph node' on her neck on one side ; states it is slowly going down. is this normal reaction? No Patient History. No Investigation Assessment. Additional Context Consumer stated, "I was giving you guys a call because my fiancé, he got his Covid vaccination today but I got mine last Friday but his vaccine provider said I should call you guys and report some symptoms that I am having which is I have some lymph nodes swollen on my neck so they said to give you guys a call to report it. Scheduled date for second dose: Consumer stated, 21May2021. Consumer stated, "When my boyfriend went to # to get the shot he told them about my symptom and person who administered the shot told him to tell me to give you guys a call so I could report that symptom." Consumer stated, "I am taking just Ibuprofen after the injection because I had some swelling in the arm so just some ibuprofen. Consumer stated, "I am not sure if you could let me know if that's the symptom you guys have heard, should I be concerned or should I go to the doctor. Consumer was informed about Pfizer Medical information department and was provided with the number. Consumer stated, "It was like that was the number for me to report and may be somebody could help me. I didn't know it was just to report."   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: She mentioned that she had a little pain for 2 days and then it was all good.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 14 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy to nut" (unspecified if ongoing), notes: walnuts, nuts and pecan. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose no -1). The following information was reported: PAIN (non-serious), outcome "recovered", described as "She mentioned that she had a little pain for 2 days and then it was all good."  Additional information: The patient had received both doses of the Pfizer vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: was fine after my first dose, experiencing only a slight circle of soreness around the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 16:30 (Lot number: ER8730) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Prolactin-producing pituitary tumour" (unspecified if ongoing); "known allergies: bees" (unspecified if ongoing); "known allergies: cats" (unspecified if ongoing); "known allergies: scorpions" (unspecified if ongoing); "known allergies: Spider bites" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "was fine after my first dose, experiencing only a slight circle of soreness around the injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional Information: Patient did not received any treatment for AE. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient did not receive any other vaccines within 4weeks prior to the COVID vaccine. No Other medication in two weeks. Device Date: 13May2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm/sore arm for a few days; Headache after a few days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program (159558). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Sore arm/sore arm for a few days"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "Headache after a few days". Additional information: The patient received both doses of the Pfizer-BioNTech Covid-19 Vaccine- 1st dose 04Mar2021 and 2nd dose was 18Mar2021. On the 1st dose she developed sore arm/ she had a sore arm for a few days and headache after a few days. On the 2nd dose she did not have any side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got really sick after first shot.; This is a spontaneous report received from a contactable reporter(s) The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Got really sick after first shot.". Therapeutic measures were not taken as a result of illness. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: developed tinnitus; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 12Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "developed tinnitus".  Additional Information: The patient received 1st Pfizer vaccine dose on 12Jan2021 and developed tinnitus. Patient had previously reported to VAERS and Pfizer. Patient is calling today about getting the 2nd dose. Patient needs a confirmation about does she need to repeat the first dose due to the length of time between dose 1 and 2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Overdose, Product preparation error, Vaccination site pain
Clinical narrative: The nurse administering the vaccine on Sunday mistakenly injected all of the liquid from an undiluted vial; Product concentrate not diluted; pain at the inoculation site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 23 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OVERDOSE (non-serious), outcome "unknown", described as "The nurse administering the vaccine on Sunday mistakenly injected all of the liquid from an undiluted vial"; PRODUCT PREPARATION ERROR (non-serious), outcome "unknown", described as "Product concentrate not diluted"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at the inoculation site". The events "the nurse administering the vaccine on sunday mistakenly injected all of the liquid from an undiluted vial", "product concentrate not diluted" and "pain at the inoculation site" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: A Distracted nurse gave the patient 6 doses of COVID vaccine in one shot. The patient was mistakenly given six doses of the Pfizer coronavirus vaccine all at once. The patient was released from a hospital on Monday without having suffered any apparent adverse reactions. On Sunday morning the patient was kept under observation for approximately 24 hours in the hospital's emergency room. She was given fluids, and anti-inflammatory and fever medications as preventative measures. The patient did not have fever and did not have any pain except for pain at the inoculation site, nor any other manifestations, was a bit frightened. She underwent blood tests regularly to monitor her immune response and determine whether she should still get the scheduled second dose after a number of weeks. The accident occurred because the nurse had an attention lapse. The nurse administering the vaccine on Sunday mistakenly injected all of the liquid from an undiluted vial. She thought that the dilution had taken place, they were both transparent liquids of the same density. Unfortunately, this contributed to the error. The incident occurred on an extremely busy day, during a period in which health workers were trying to administer as many vaccine doses as possible.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Feels like she is coming down with a cold; This is a spontaneous report received from a contactable reporter.  The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Feels like she is coming down with a cold".  Additional information: She stated that she took the first dose and is now waiting for second dose of the vaccine and she stated she feels as if she coming down with a cold. She wonders is it okay to take  the second dose or should she wait.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Feeling drunk, Nausea
Clinical narrative: feeling really really dizzy, like she is drunk or something; feeling really really dizzy, like she is drunk or something; nausea; really dizzy: getting worse/the nausea is still the same, they have been worsening; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11May2021 (Lot number: EW0176) at the age of 53 years as 1st dose, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), FEELING DRUNK (non-serious) all with onset 13May2021, outcome "unknown" and all described as "feeling really really dizzy, like she is drunk or something"; NAUSEA (non-serious) with onset 13May2021, outcome "not recovered", described as "nausea"; CONDITION AGGRAVATED (non-serious) with onset 13May2021, outcome "unknown", described as "really dizzy: getting worse/the nausea is still the same, they have been worsening".  Additional information: Caller received the Pfizer COVID 19 vaccine on Tuesday afternoon and "today" was feeling really really dizzy, like she was drunk or something. She felt very very dizzy and with nausea. Noticed feeling really really dizzy "today", in the morning, at 05:00 AM. Outcome of really really dizzy: getting worse, at 05:00 AM. She did not have nausea. Now she has a lot of nausea, like if wanted to vomit. States the nausea was the same as feeling really really dizzy, they are the same. She did not have any tests, she has not been sick, she was very well.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Paraesthesia
Clinical narrative: Tingling in both her inner thighs; Right ankle started swelling; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non-HCP) from medical information team for a Pfizer sponsored program (004756).  A 16-year-old female patient received bnt162b2 (BNT162B2), administration date 10May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "tingling in both her inner thighs"; JOINT SWELLING (non-serious) with onset 2021, outcome "unknown", described as "right ankle started swelling".  Additional information: The reporter called and asking for medical advice for a 16y/o female patient who received her first dose of the Pfizer BioNTech COVID 19 Vaccine on 10May2021. The patient experienced tingling in both her inner thighs and right ankle started swelling a few moments after vaccine administration. These side effects eventually subsided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: 1st dose: Arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 15:00 (Lot number: ER8736) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies: wasps" (unspecified if ongoing), notes: Known allergies Bactrim, wasps; "High blood pressure" (unspecified if ongoing), notes: other medical history High blood pressure, Mild asthma; "Mild asthma" (unspecified if ongoing), notes: other medical history High blood pressure, Mild asthma. The patient took concomitant medications. Past drug history included: Bactrim, reaction(s): "Allergies: Bactrim", notes: Known allergies Bactrim, wasps. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "not recovered", described as "1st dose: Arm pain". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: No other vaccine in four weeks. Other medications was taken in two weeks. No Covid prior vaccination. No Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Lethargy, Mobility decreased, Somnolence
Clinical narrative: went outside and planted and it took her 15 minutes when it should of taken her 5 minutes; severe lethargy; Severe Backache; head ache; Sleeps a lot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10May2021 09:00 (Lot number: EW0169) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: LETHARGY (non-serious) with onset 10May2021, outcome "not recovered", described as "severe lethargy"; BACK PAIN (non-serious) with onset 10May2021, outcome "not recovered", described as "Severe Backache"; HEADACHE (non-serious) with onset 10May2021, outcome "not recovered", described as "head ache"; SOMNOLENCE (non-serious) with onset 10May2021, outcome "not recovered", described as "Sleeps a lot"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "went outside and planted and it took her 15 minutes when it should of taken her 5 minutes". Therapeutic measures were taken as a result of lethargy, back pain, headache.  Additional information: Treatment: Bed and Tylenol, Rexall Sports Rubbing Alcohol Cream, Muscle Freeze like Icy Hot, Acetaminophen. AEs did not require a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks), AE(s) following prior vaccinations, Family Medical History Relevant to AE(s), Relevant Tests: None.  No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Fine motor skill dysfunction, Finger deformity, Mobility decreased
Clinical narrative: she developed a limp wrist, no dexterity and can not use her wrist.; she developed a limp wrist, no dexterity and can not use her wrist.; She developed a limp wrist, no dexterity and can not use her wrist.; Has a little bit of use of the fingers in the soft closed U formation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 84 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Batch/Lot number: unknown) at the age of 83 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ARTHROPATHY (non-serious), FINE MOTOR SKILL DYSFUNCTION (non-serious) all with onset 02May2021, outcome "recovering" and all described as "she developed a limp wrist, no dexterity and can not use her wrist."; MOBILITY DECREASED (non-serious) with onset 02May2021, outcome "recovering", described as "She developed a limp wrist, no dexterity and can not use her wrist."; FINGER DEFORMITY (non-serious) with onset 02May2021, outcome "unknown", described as "Has a little bit of use of the fingers in the soft closed U formation".  Additional information: Reporter stated that on 02May2021, patient developed a limp wrist, no dexterity and cannot move her wrist. Patient has a little bit of use of the fingers in the soft closed U formation. There was minimal improvement since this began. The patient was afraid to get her second shot on 21May2021. The patient was seen by her primary care provider and the doctor didn't have any idea about what was going on. The patient will be seeing a neurologist and neuro specialist on 14May2021. The patient takes a medication for hypertension and a blood thinner but does not know the details of these medications or any other daily medications that the patient takes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blepharospasm, Dry eye, Fatigue, Headache
Clinical narrative: tinnitus; anxiety feeling; Typical fatigue; strange headache; constant eye twitching and dryness which started 1/2 hr after shot; constant eye twitching and dryness which started 1/2 hr after shot; Random muscle twitches; tunnel hearing and vision; tunnel hearing and vision; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 16:45 (Lot number: ER8729) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "mitral valve prolapse" (unspecified if ongoing), notes: Other medical history: None/mitral valve prolapse. Concomitant medication(s) included: PROBIOTICS NOS; MAGNESIUM; ZINC; B12 [CYANOCOBALAMIN]; VIT D [COLECALCIFEROL]. The following information was reported: FATIGUE (non-serious) with onset 06Apr2021 17:15, outcome "not recovered", described as "Typical fatigue"; HEADACHE (non-serious) with onset 06Apr2021 17:15, outcome "not recovered", described as "strange headache"; DRY EYE (non-serious), BLEPHAROSPASM (non-serious) all with onset 06Apr2021, outcome "not recovered" and all described as "constant eye twitching and dryness which started 1/2 hr after shot"; MUSCLE TWITCHING (non-serious) with onset 06Apr2021, outcome "not recovered", described as "Random muscle twitches"; HYPOACUSIS (non-serious), VISUAL IMPAIRMENT (non-serious) all with onset 06Apr2021, outcome "not recovered" and all described as "tunnel hearing and vision"; ANXIETY (non-serious) with onset 06Apr2021 17:15, outcome "recovered" (2021), described as "anxiety feeling"; TINNITUS (non-serious) with onset 10Apr2021, outcome "not recovered", described as "tinnitus". The events "typical fatigue", "strange headache", "constant eye twitching and dryness which started 1/2 hr after shot", "constant eye twitching and dryness which started 1/2 hr after shot", "random muscle twitches", "tunnel hearing and vision", "anxiety feeling" and "tinnitus" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of fatigue, headache, dry eye, blepharospasm, muscle twitching, hypoacusis, anxiety, tinnitus.  Additional information: Typical fatigue, strange headache lasted about week 1/2, constant eye twitching and dryness which started1/2 hr after shot. Random muscle twitches, tunnel hearing and vision, anxiety feeling right after shot - subsided in a couple weeks. 4 days after shot developed tinnitus which has not subsided! Overall still not feeling 100%. Patient did not take any other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination: Unknown. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Muscle twitching, Tinnitus, Visual impairment
Clinical narrative: tinnitus; anxiety feeling; Typical fatigue; strange headache; constant eye twitching and dryness which started 1/2 hr after shot; constant eye twitching and dryness which started 1/2 hr after shot; Random muscle twitches; tunnel hearing and vision; tunnel hearing and vision; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 16:45 (Lot number: ER8729) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "mitral valve prolapse" (unspecified if ongoing), notes: Other medical history: None/mitral valve prolapse. Concomitant medication(s) included: PROBIOTICS NOS; MAGNESIUM; ZINC; B12 [CYANOCOBALAMIN]; VIT D [COLECALCIFEROL]. The following information was reported: FATIGUE (non-serious) with onset 06Apr2021 17:15, outcome "not recovered", described as "Typical fatigue"; HEADACHE (non-serious) with onset 06Apr2021 17:15, outcome "not recovered", described as "strange headache"; DRY EYE (non-serious), BLEPHAROSPASM (non-serious) all with onset 06Apr2021, outcome "not recovered" and all described as "constant eye twitching and dryness which started 1/2 hr after shot"; MUSCLE TWITCHING (non-serious) with onset 06Apr2021, outcome "not recovered", described as "Random muscle twitches"; HYPOACUSIS (non-serious), VISUAL IMPAIRMENT (non-serious) all with onset 06Apr2021, outcome "not recovered" and all described as "tunnel hearing and vision"; ANXIETY (non-serious) with onset 06Apr2021 17:15, outcome "recovered" (2021), described as "anxiety feeling"; TINNITUS (non-serious) with onset 10Apr2021, outcome "not recovered", described as "tinnitus". The events "typical fatigue", "strange headache", "constant eye twitching and dryness which started 1/2 hr after shot", "constant eye twitching and dryness which started 1/2 hr after shot", "random muscle twitches", "tunnel hearing and vision", "anxiety feeling" and "tinnitus" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of fatigue, headache, dry eye, blepharospasm, muscle twitching, hypoacusis, anxiety, tinnitus.  Additional information: Typical fatigue, strange headache lasted about week 1/2, constant eye twitching and dryness which started1/2 hr after shot. Random muscle twitches, tunnel hearing and vision, anxiety feeling right after shot - subsided in a couple weeks. 4 days after shot developed tinnitus which has not subsided! Overall still not feeling 100%. Patient did not take any other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination: Unknown. No known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Erection increased
Clinical narrative: had an erection since 2 weeks ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERECTION INCREASED (non-serious), outcome "unknown", described as "had an erection since 2 weeks ago".  Additional information: Consumer experienced a side effect following receiving a dose of the PFIZER-BIONTECH COVID-19 VACCINE. He mentioned that he had an erection since 2 weeks ago , that started after he got the vaccine. He would like to know if there are any ingredients of the vaccine that may have been the same ingredient that was in another Pfizer product (that causes erection) that may have caused that.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Chest discomfort, Chest pain, Electrocardiogram normal, Headache
Clinical narrative: Patient had a fever to 101.3 and headache following vaccine. The following morning, he reported to his mother that he had had chest pain during the night. The patient reported chest tightness, and a rapid heartbeat when he awoke from sleep.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Pyrexia, Troponin I increased
Clinical narrative: Patient had a fever to 101.3 and headache following vaccine. The following morning, he reported to his mother that he had had chest pain during the night. The patient reported chest tightness, and a rapid heartbeat when he awoke from sleep.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Night sweats
Clinical narrative: I experienced heavier than normal periods and night sweats for about three months after getting the Moderna vaccine. Normal periods have resumed and I no longer have night sweats.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Medication error
Clinical narrative: RN wrongly administered a Moderna vaccine to a patient scheduled to receive a high-dose flu vaccine. After discovering this medication error just occurred, staff quickly approached the patient and her relative regarding the situation. Previous two doses were Pfizer (this acted like an unintentional 3rd COVID-19 dose). No harm done to patient.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: The client reported that he received 1st dose of Janssen COVID vaccine (LOT#: 1821286) on 06/17/2021. Client reported dizziness, fever, sweating, and headache 7 hours after vaccination. Client stated dizziness lasted about 7 hours after onset. Client stated their last meal was at 10 am on 12/05/2021.  RN provided client with crackers. Client?s vital signs were a blood pressure of 150/88, an O2 saturation of 99%, and a heart rate of 86 beats per minute. The client denied any shortness of breath and any other signs and symptoms of anaphylaxis after first dose. Client stated he did not follow up with any providers after experiencing symptoms with his first dose. Client has no chronic conditions, no known allergies, and is not currently taking any medications.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Malaise
Clinical narrative: Autoimmune symptoms developed and progressed after receiving the 2nd vaccine. Positive ANA in July 2021 which was approximately 2.5 months after 2nd dose.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received second dose 7 days early.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cardiac discomfort, Chest pain, Pain in extremity
Clinical narrative: Patient felt as if she was having a heart attack. Pain in chest, arms and lower back.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Mechanical urticaria, Rash, Urticaria
Clinical narrative: Rash, urticaria, and dermatographism started about 2 weeks after I got the Moderna booster shot.  The reaction occurred in all body parts but would only affect a few body parts at a time.  Cold compress and benadryl helped in the beginning but benadryl was very sedating. My primary care doctor prescribed prednisone and triamcinolone cream to hold me over until I was able to see my allergist.  My allergist recommended to take Allegra 24 Hr 180 Mg tablets twice daily and have been continuously taking it this way since then.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received second dose 7 days early.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: Woke up the morning of 1/24 at the area of my injection site was red and swollen with enlarged lymph nodes. Redness lasted about two days then subsided however the lymph note lasted about 4 months. Felt achy at injection site and lymph nodes was very painful for about 4 weeks.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Ultrasound scan
Clinical narrative: Woke up the morning of 1/24 at the area of my injection site was red and swollen with enlarged lymph nodes. Redness lasted about two days then subsided however the lymph note lasted about 4 months. Felt achy at injection site and lymph nodes was very painful for about 4 weeks.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood glucose increased, Chest X-ray, Diabetes mellitus, Electrocardiogram, Glycosylated haemoglobin increased
Clinical narrative: The week prior to 1/19/2022 I was not feeling well- no specific symptoms- I was tested for COVID and test was negative.  On 1-19-2022 I experienced exteeme thirst, frequet urination and did not feel well.  I went to an Urgent Care clinic.  Mh blood sugar was over 600.  They sent me to Hospital Emergency Room.  I was treated for new onset diabetes and admitted.  Six months prior my A1C was 5.4- now it was 8.7.   I had been seen by my doctor every three months with lab tests and this was the first onset of symptoms with abnormal lab work.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Malaise, Pollakiuria, SARS-CoV-2 test negative, Thirst
Clinical narrative: The week prior to 1/19/2022 I was not feeling well- no specific symptoms- I was tested for COVID and test was negative.  On 1-19-2022 I experienced exteeme thirst, frequet urination and did not feel well.  I went to an Urgent Care clinic.  Mh blood sugar was over 600.  They sent me to Hospital Emergency Room.  I was treated for new onset diabetes and admitted.  Six months prior my A1C was 5.4- now it was 8.7.   I had been seen by my doctor every three months with lab tests and this was the first onset of symptoms with abnormal lab work.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: shoulder injury related to vaccine administration
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 11-year-old female patient given the Pfizer vaccine indicated for those 12 years and older.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain in extremity, Rash
Clinical narrative: Major pain in the left arm, the whole deltoid became sore and I was unable to lift my arm at its worst. I also developed some sort of skin rash on the upper arm. I was prescribed antibiotics and had no symptoms after taking the full course of medication. Onset of symptoms became noticeable within 24 hours, medication helped lessen symptoms within 3 days and after the full week, all symptoms were gone.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: Per nurse "when injecting patient with vaccine, needle was not on syringe appropriately and the majority of the medication was running down patient's arm therefore proper dose was not administered. The patient was informed of the situation. Doctor of the day was notified and advised to administer another full dose. Patient was given another dose of Janssen vaccine."
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cortisol, Blood test, Computerised tomogram, Dizziness, Echocardiogram
Clinical narrative: low blood pressure. a week later was almost about to pass out did blood works. got referred to cardiologist. was sent to neurologist . Participant was experiencing seizures.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Electroencephalogram, Hypotension, Magnetic resonance imaging, Seizure
Clinical narrative: low blood pressure. a week later was almost about to pass out did blood works. got referred to cardiologist. was sent to neurologist . Participant was experiencing seizures.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Tilt table test
Clinical narrative: low blood pressure. a week later was almost about to pass out did blood works. got referred to cardiologist. was sent to neurologist . Participant was experiencing seizures.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered vaccine beyond the published expiration date. Per Moderna Manufacterer, re-vaccination is not required, the vaccine was determined to still maintain the activity necessary to protect against Covid-19.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Retinal degeneration, Retinal tear, Scan
Clinical narrative: Bilateral retinal thinning and retinal hole in left eye.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered vaccine beyond the published expiration date. Per Moderna Manufacterer, re-vaccination is not required, the vaccine was determined to still maintain the activity necessary to protect against Covid-19.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered vaccine beyond the published expiration date. Per Moderna Manufacterer, re-vaccination is not required, the vaccine was determined to still maintain the activity necessary to protect against Covid-19.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chest pain, Dyspnoea, Electrocardiogram, Flatulence
Clinical narrative: Abdominal pain, ribs down to abdomen full of air, very painful, about an hour later, then moved up to my chest. I was very concerned. My husband took me to the hospital, there for 13 hours. I missed work for two days. This fall, I had trouble with shortness of breath.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Laboratory test, Pain
Clinical narrative: Abdominal pain, ribs down to abdomen full of air, very painful, about an hour later, then moved up to my chest. I was very concerned. My husband took me to the hospital, there for 13 hours. I missed work for two days. This fall, I had trouble with shortness of breath.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess drainage, Biopsy, Biopsy skin, Eczema, Groin abscess
Clinical narrative: I had no immediate symptoms of any kind after the 3rd (booster) shot.  Several weeks later, I developed a rash on both of my legs and plaques on my scalp.  They would not go away.  I was taking Leuflonimide for my rheumatoid arthrtis, which was new, so I asked the Doctor if I could stop taking it and she said yes (Dr. with Hospital).  I made an appointment with Dermatology and was told it was excema on my scalp and given Clobetasol ointment and liquid.  I also had abscesses in my groin which were drained - this was totally new as well and a uti.    All have resolved except for the sores (psoriasis) on my legs and the scabs on my scalp, which resist all.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, Rash, Scab, Skin lesion, Skin plaque
Clinical narrative: I had no immediate symptoms of any kind after the 3rd (booster) shot.  Several weeks later, I developed a rash on both of my legs and plaques on my scalp.  They would not go away.  I was taking Leuflonimide for my rheumatoid arthrtis, which was new, so I asked the Doctor if I could stop taking it and she said yes (Dr. with Hospital).  I made an appointment with Dermatology and was told it was excema on my scalp and given Clobetasol ointment and liquid.  I also had abscesses in my groin which were drained - this was totally new as well and a uti.    All have resolved except for the sores (psoriasis) on my legs and the scabs on my scalp, which resist all.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: I had no immediate symptoms of any kind after the 3rd (booster) shot.  Several weeks later, I developed a rash on both of my legs and plaques on my scalp.  They would not go away.  I was taking Leuflonimide for my rheumatoid arthrtis, which was new, so I asked the Doctor if I could stop taking it and she said yes (Dr. with Hospital).  I made an appointment with Dermatology and was told it was excema on my scalp and given Clobetasol ointment and liquid.  I also had abscesses in my groin which were drained - this was totally new as well and a uti.    All have resolved except for the sores (psoriasis) on my legs and the scabs on my scalp, which resist all.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was administered vaccine beyond the published expiration date. Per Moderna Manufacterer, re-vaccination is not required, the vaccine was determined to still maintain the activity necessary to protect against Covid-19.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered vaccine beyond the published expiration date. Per Moderna Manufacturer, re-vaccination is not required, the vaccine was determined to still maintain the activity necessary to protect against Covid-19.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache started 2/20/2022 at or around 11:00. Reminds me of the headache I experienced during covid.