chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pain in extremity
Clinical narrative: slight dizziness; fatigue; Arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Feb2021 11:00 (Lot number: EN6201) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "seizure disorder" (ongoing), notes: Patient medical history : Seizure disorder; "Asymmetrical cortical thinning of Right aypocampus lobe" (ongoing). Concomitant medication(s) included: DILANTIN [PHENYTOIN] taken for seizure, cortical dysplasia, start date: 02Jan2000 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st; Date: 27Jan2021; Time: 10:00 AM; Anatomical Site of injection: Left arm; Route of administration: Intramuscular; Batch/Lot number: EN5318), administration date: 27Jan2021, when the patient was 62 years old, for Covid-19 immunization, reaction(s): "minimal soreness in arm", "I had slight light headed". The following information was reported: DIZZINESS (non-serious) with onset 18Feb2021 11:10, outcome "recovered" (2021), described as "slight dizziness"; FATIGUE (non-serious) with onset 18Feb2021 11:10, outcome "recovered" (2021), described as "fatigue"; PAIN IN EXTREMITY (non-serious) with onset 18Feb2021 11:10, outcome "recovered" (2021), described as "Arm soreness".Therapeutic measures were not taken as a result of dizziness, fatigue, pain in extremity.  Additional information: The reported issue occurred after the use of Pfizer product. No Admission to hospital due to event (Does not include emergency room visit without further admission). The patient did not  received any treatment. Still experienced fine now. No any additional event information and not visited emergency room. Not any surgical treatment needed for the event. Reason to took Covid vaccine for stay alive. Name of product (Both commercial generic of Known): (bnt162b2) BNT162B2 covid vaccine. No other product(s) that were taken together with those indicated above. Shot 1 had slight light feeling about 20 min and a little arm soreness the next day for 2days. Not severe. About 5 on 10 scale. About 25 of pain he had from Shingrex. Shot 2: Slight dizziness and fatigue. No fever, chills etc. resolved in short time. Arm soreness a bit less 2nd time around. Felt fine. No any other vaccination within four weeks prior to the first administration date of the suspect vaccine. Autopsy information: No autopsy done, yet as still alive.  The information which are relevant to this case added in narrative. Other information already captured/added in cross referenced case:2021133667.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Very tired; Achy allover; Headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) for 1 day at the age of 78 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Event onset date: 02Feb2021), for COVID-19 immunization, reaction(s): "lightheadedness", "tingling", "swelling of tongue". The following information was reported: PAIN (non-serious) with onset 23Feb2021, outcome "recovered" (2021), described as "Achy allover"; HEADACHE (non-serious) with onset 23Feb2021, outcome "recovered" (2021), described as "Headaches"; FATIGUE (non-serious) with onset 24Feb2021, outcome "recovered" (2021), described as "Very tired". Therapeutic measures were taken as a result of pain, headache. Therapeutic measures were not taken as a result of fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; This is a spontaneous report received from a contactable reporter (Pharmacist).  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, Pain
Clinical narrative: sore throat; aches; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "HER2-" (unspecified if ongoing); "Breast cancer survivor HR+" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN taken for breast cancer, human epidermal growth factor receptor negative. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunisation. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; PAIN (non-serious), outcome "unknown", described as "aches"; FATIGUE (non-serious), outcome "unknown", described as "tiredness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Mild twinge of soreness in arm; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (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), outcome "unknown", described as "Mild twinge of soreness in arm"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown) 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 immunisation, reaction(s): "mild twinge of soreness in her arm". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: just had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 13Mar2021 (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: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "just had a sore arm".  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: ringing in ears since getting the Pfizer covid shot; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4264358 (Genentech).  A 84 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 was not reported. Concomitant medication included: ESBRIET. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "ringing in ears since getting the Pfizer covid shot".  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: sore arm; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 16Mar2021 (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 16Mar2021, outcome "unknown", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: sick; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 17Feb2021 (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: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site arm pain; This is a spontaneous report received from a contactable reporter (Pharmacist).  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in arm (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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site arm pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from non-contactable reporter (Other HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as DOSE 2, SINGLE for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache".  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Vaccination site pain
Clinical narrative: cold-like symptoms; arm hurt for a day (specially close to injection site); This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 11Mar2021 (Lot number: EN6208) at the age of 55 years 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) with onset 11Mar2021, outcome "unknown", described as "arm hurt for a day (specially close to injection site)"; NASOPHARYNGITIS (non-serious) with onset 15Mar2021, outcome "unknown", described as "cold-like symptoms".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: Patient stated that she just received her last Covid vaccine. Patient stated that she is tired and sleepy today; Patient stated that she just received her last Covid vaccine. Patient stated that she is tired and sleepy today; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (086396). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number- UNKNOWN), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious), SOMNOLENCE (non-serious) all with onset 12Mar2021, outcome "unknown" and all described as "Patient stated that she just received her last Covid vaccine. Patient stated that she is tired and sleepy today". Additional information: Patient reported for herself. Patient stated that she just received her last Covid vaccine. Patient stated that she is tired and sleepy today.  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, Peripheral swelling
Clinical narrative: arm is "a little swollen and sore; arm is "a little swollen and sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (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: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 15Mar2021, outcome "unknown" and all described as "arm is "a little swollen and sore".  Additional information: The patient wanted to know if they could take naproxen after receiving first dose on 15Mar2021, as their arm is "a little swollen and sore."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: ill all night last night; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (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: MALAISE (non-serious) with onset 15Mar2021, outcome "unknown", described as "ill all night last night".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (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: MUSCLE TWITCHING (non-serious), outcome "unknown", described as "twitching".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: gotten dizzy seemed like she had vertigo; gotten dizzy seemed like she had vertigo; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Feb2021 (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: DIZZINESS (non-serious), VERTIGO (non-serious) all with onset 20Feb2021, outcome "unknown" and all described as "gotten dizzy seemed like she had vertigo". Additional information: The patient was questioning whether to get 2nd dose or not. Went to website to look for help. Over 19 pages of people with same issues she has.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Irritability, Lymphadenopathy
Clinical narrative: glands under his neck are hard and swollen; tired; Irritable; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administration date Mar2021 (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: FATIGUE (non-serious) with onset 17Mar2021, outcome "unknown", described as "tired"; IRRITABILITY (non-serious) with onset 17Mar2021, outcome "unknown", described as "Irritable"; LYMPHADENOPATHY (non-serious) with onset 18Mar2021, outcome "unknown", described as "glands under his neck are hard and swollen".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Lot number: EN5318) as dose 2, 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) with onset 2021, outcome "unknown", described as "Mild pain at injection site".  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site swelling and soreness; soreness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 (Lot number: EL3247) at the age of 58 years 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 SWELLING (non-serious) with onset 24Feb2021, outcome "recovered with sequelae", described as "Injection site swelling and soreness"; VACCINATION SITE PAIN (non-serious) with onset 24Feb2021, outcome "recovered with sequelae", described as "soreness". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site pain.  Additional information: It was reported that no other vaccine was administered in four weeks. Reportedly, the other medications in four weeks were reported as none. No COVID was reported prior vaccination. The patient was not COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Tinnitus
Clinical narrative: Ringing in ears; Chills; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (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), outcome "unknown", described as "Ringing in ears"; CHILLS (non-serious), outcome "unknown", described as "Chills". Additional information: Clinical course: The experienced ringing in ears 5 days after the first BNT162B2 dose.  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: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Levaquin, reaction(s): "she is allergic to Levaquin"; Z-pack, reaction(s): "she is allergic to z-pack". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "sore arm". Therapeutic measures were taken as a result of pain in extremity. Additional information: The patient asked if she needs to take the 2nd dose of covid-19 vaccine since she is allergic to Levaquin and z-pack. She experienced a sore arm after the first dose and took Tylenol, scheduled for the second dose on 24Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Tiredness; Muscle pain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 18Mar2021 (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: FATIGUE (non-serious) with onset 18Mar2021, outcome "unknown", described as "Tiredness"; MYALGIA (non-serious) with onset 18Mar2021, outcome "unknown", described as "Muscle pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen/painful lymph node in neck on left side (same side as injection); Swollen/painful lymph node in neck on left side (same side as injection); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "Swollen/painful lymph node in neck on left side (same side as injection)".  Additional information: The symptoms occurred within 24 hours of receiving 2nd dose of vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: Pfizer-BioNtech COVID-19 Vaccine EUA  Fever, joint pain, swollen nymph nodes, arm pain.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Pfizer vaccine received on 12/28/2021,, stored incorrectly in Freezer rather than Fridge, transfered to fridge on 1/11/2022, 1/12/2022 rx manager noticed the mistake ,roprted to pdm, pdm contacted Pfizer ,Pfizer said that validity of vaccine is ok and another shot is not needed.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: The patient was mistakenly given a dose of Pfizer vaccine intended for a person 12 years or older when she should have been given a pediatric dose.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Pfizer vaccine received on 12/28/2021,, stored incorrectly in Freezer rather than Fridge, transfered to fridge on 1/11/2022, 1/12/2022 rx manager noticed the mistake ,roprted to pdm, pdm contacted Pfizer ,Pfizer said that validity of vaccine is ok and another shot is not needed.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Incorrect route of product administration, Lymphadenopathy, Peripheral swelling, Swelling
Clinical narrative: Vaccine administration 1/7/2022. Patient reported swelling on left arm, shoulder, neck up to ear and lymph nodes starting 1/9/2022. Also reported mild swelling on right shoulder. Patient believed the injection was administered high but in deltoid. She reported to ICU on 1/12/2022. She took Benadryl 12.5mg at 3 pm on 1/12/2022. She reported swelling (not resolving) but no redness, heat or fever. This was reported to the pharmacy 1/13/2022 via telephone.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Audiogram, Tinnitus
Clinical narrative: I have noticed a high pitched tone in my ears when it is quiet.  I have not lost any hearing.  I did have my hearing checked in 12/2021.  I do not recall noticing this with the first two shots, just after the booster in 11/2021.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Urticaria
Clinical narrative: Hives on arm.  Large skin welts on different parts of the body (back and arm). Sometimes on my rear neck.  This also occurred since the second dose of Moderna approximately one month after the second dose. I do not have a history of hives or allergies. I have diabetes but have been on diabetes medication for about two years consistently with no side effects related to skin. My diabetes has been maintained under control. Since the second dose, I have intermittent hives. Since the booster, I have had daily hives after about one week.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, Blood test, Computerised tomogram, Fatigue, Gout
Clinical narrative: petechia all over back welts on back and arms sudden weight loss from 175 to 136 in 1 week gout attack in big toe left foot (no history ever) profound fatigue lost taste (still can't taste after 6 months
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Petechiae, SARS-CoV-2 test negative, Urticaria, Weight decreased
Clinical narrative: petechia all over back welts on back and arms sudden weight loss from 175 to 136 in 1 week gout attack in big toe left foot (no history ever) profound fatigue lost taste (still can't taste after 6 months
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Intermenstrual bleeding
Clinical narrative: Patient experienced a breakthrough menstrual period one day after receiving vaccine. This period was heavier than usual and lasted about 5 days. Exactly two weeks after vaccination a menstrual period began that was heavier and painful than the patient has ever experienced. This patient has never had irregular or heavy periods and has taken hormonal birth control for 4 years.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash macular, Rash pruritic
Clinical narrative: PT started experiencing itching at 9:30pm that evening in opposite arm (right).  The following  day, had "spots"/rash developed. around 6pm on that arm and both sides of neck and face.  "spots" were itchy.  upon talking to mom, she looked and noticed spots on chest and back.  Nothing below waist line and nothing really on left arm (vaccinated arm).  no breathing issues.  Patient instructed to be given benadryl, watch rash, and page pediatrician.  Pediatrician said same...benadryl and watch rash
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pyrexia
Clinical narrative: Fever of 101, headache, joint pain,  fatigue for 24 hours
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Biopsy liver, Computerised tomogram abdomen, Hepatectomy, Magnetic resonance cholangiopancreatography
Clinical narrative: Constant Vomiting and abdominal pain. Leading to right hepatectomy.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Ultrasound scan, Vomiting
Clinical narrative: Constant Vomiting and abdominal pain. Leading to right hepatectomy.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Extreme dizziness and vertigo
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chest pain, Fatigue, Headache, Laboratory test abnormal
Clinical narrative: temperature to 100.1, fatigue headache on 1/11, followed by chest pain on 1/12. On 1/13 obtained labs with elevated troponin supporting myocarditis diagnosis. chest pain improving 1/13.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis, Troponin increased
Clinical narrative: temperature to 100.1, fatigue headache on 1/11, followed by chest pain on 1/12. On 1/13 obtained labs with elevated troponin supporting myocarditis diagnosis. chest pain improving 1/13.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: Diabetic patient with normal glucose readings between 120-190 reported having continuous readings of 280-400 for 10 days after booster (moderns).  Days 11-14, the glucose levels reduced to 220-280.  Patient is now taking Basaglar to reduce glucose levels.  Unknown if insulin is reducing levels, or if the side effects of the vaccine booster have worn off .
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Dizziness, Nausea
Clinical narrative: Sudden cold sweats + feeling faint and weak, nausea
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Retching, Vomiting
Clinical narrative: Patient woke up the next day, after sleeping late. He complained he didn't feel well.  He went to a storage unit with his older sister to help load boxes into her car. They had to stop and rush home. He vomited liquids until clear several times. Then he dry heaved.  Afterwards, he took 2 Ibuprofin, a total dose of 400mg. He went to bed the rest of the day.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes in left arm armpit.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Urticaria chronic
Clinical narrative: Chronic Uticaria 5 weeks after shot.  Hives continue 8 months post vaccine injection. To date no treatment has cured symptoms.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mechanical urticaria, Pruritus, Skin burning sensation, Skin swelling
Clinical narrative: Dermographia began on 12 days after receiving the booster shot. Began with intense skin itching every where. Upon touching or scratching the skin, it will turn red, get swollen, and either burn or itch very intensely. Hives also sometimes show up depending on the location (inner thighs, back of the neck, arms, etc.) The reaction has been happening since and is constant, except during sleep or meditation.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Dermographia began on 12 days after receiving the booster shot. Began with intense skin itching every where. Upon touching or scratching the skin, it will turn red, get swollen, and either burn or itch very intensely. Hives also sometimes show up depending on the location (inner thighs, back of the neck, arms, etc.) The reaction has been happening since and is constant, except during sleep or meditation.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Pain on the left side of chest when trying to get up from a sleeping position or when inhaling deeply.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (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 "cold".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Dissociation, Electroencephalogram normal, Emotional disorder, Fatigue
Clinical narrative: Symptoms begin suddenly. I experience extreme brain fog, disassociation, unable to focus my vision, spacing out, forgetfulness, fatigue, and absolute emotional numbness. The first time I have ever experienced this feeling was on July 21-22, 2021, which was 6 or 7 days after I received my first COVID19 Pfizer shot. The feeling lasted only half an hour and went away. Throughout the following months it came back once a month. However, in late December 2021, the feeling returned suddenly and would not go away for one week. It was the most intense brain fog and emotional/psychological shutdown I have ever experienced. Usually I am a happy and energetic person with no history of anxiety, depression, or other mental disorders. I also do not do any drugs. But when this feeling came I had no motivation (physical or psychological) to do anything, even to speak or to stand up. I felt confused, removed from reality, and very fatigued. I slept for 10-12 hours per day and woke up with the same dreadful feeling of disassociation and fatigue. It is a difficult feeling to describe in words. It feels terrifying, as though you have permanently gone crazy and cannot bring your sanity back, or like you are trapped in a state of extreme depression. Lastly, it feels like the brain has completely shut off your emotions, energy, and ability to communicate normally.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Memory impairment, Vision blurred
Clinical narrative: Symptoms begin suddenly. I experience extreme brain fog, disassociation, unable to focus my vision, spacing out, forgetfulness, fatigue, and absolute emotional numbness. The first time I have ever experienced this feeling was on July 21-22, 2021, which was 6 or 7 days after I received my first COVID19 Pfizer shot. The feeling lasted only half an hour and went away. Throughout the following months it came back once a month. However, in late December 2021, the feeling returned suddenly and would not go away for one week. It was the most intense brain fog and emotional/psychological shutdown I have ever experienced. Usually I am a happy and energetic person with no history of anxiety, depression, or other mental disorders. I also do not do any drugs. But when this feeling came I had no motivation (physical or psychological) to do anything, even to speak or to stand up. I felt confused, removed from reality, and very fatigued. I slept for 10-12 hours per day and woke up with the same dreadful feeling of disassociation and fatigue. It is a difficult feeling to describe in words. It feels terrifying, as though you have permanently gone crazy and cannot bring your sanity back, or like you are trapped in a state of extreme depression. Lastly, it feels like the brain has completely shut off your emotions, energy, and ability to communicate normally.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Spinal pain
Clinical narrative: Significant and persistent pain in neck area / upper spine; Significant and persistent pain in neck area / upper spine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 01:45 (Batch/Lot number: unknown) at the age of 40 years 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: NECK PAIN (non-serious), SPINAL PAIN (non-serious) all with onset Mar2021, outcome "unknown" and all described as "Significant and persistent pain in neck area / upper spine". The event "significant and persistent pain in neck area / upper spine" and "significant and persistent pain in neck area / upper spine" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of neck pain, spinal pain.  Additional information: Pfizer had permission to contact reporter about this report. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination but reporter stated, please ask the individual themselves. Patient had not been diagnosed with COVID-19 prior to vaccination and it was unknown if the patient was tested for COVID-19 since the vaccination. It was unknown if the patient had allergies to medications, food, or other products.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza, Myalgia
Clinical narrative: pain in muscle; regular feelings of the flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 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: MYALGIA (non-serious), outcome "unknown", described as "pain in muscle"; INFLUENZA (non-serious), outcome "unknown", described as "regular feelings of the flu".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A 58 year-old patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 03Mar2021 11:30 (Lot number: EN6203) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Flu vaccine", start date: 18Jan2021, stop date: 18Jan2021. Family history included: "High Blood pressure" (unspecified if ongoing), notes: Lisinopril; "Diabetes" (unspecified if ongoing), notes: metformin hcl,Pioglitazone. Concomitant medication(s) included: METFORMIN HCL taken for diabetes mellitus (ongoing); LISINOPRIL taken for hypertension (ongoing); PIOGLITAZONE taken for diabetes mellitus (ongoing). Vaccination history included: Bnt162b2, administration date: 10Feb2021, for COVID-19 immunization, reaction(s): "Injection site pain", "Injection site pain, swelling". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03Mar2021, outcome "recovered" (05Mar2021), described as "Injection site sore". Therapeutic measures were not taken as a result of vaccination site pain.Additional Information: Vaccine name: Flu vaccine, Manufacturer: Unknown, Batch/Lot: Unknown, Route: Intramuscular, Anatomical site of injection: Left shoulder, No. of previous doses: 1. Additional Information reported as Excruciating pain. Dose#01 Information: Date/Time: 10Feb2021/ 12;30 PM, Anatomical site pf injection: Left shoulder, Route of administration: Intramuscular and Batch/Lot number: EL8982. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: pain of the injection site; 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 patient.  A 19-years-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 09:15 (Lot number: EW0162) as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Apr2021, outcome "recovered" (2021), described as "pain of the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain.  Additional Information: The patient had no other vaccine in four weeks and no other medications in two weeks. The patient did not have COVID prior to vaccination and was not tested for COVID since the vaccination. No treatment was received for adverse event.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EL9262) as dose 1 single and administered in arm left (Lot number: EN9581) as dose 2 ,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) with onset 18Feb2021, outcome "recovered" (Feb2021), described as "Sore injection site"; FATIGUE (non-serious) with onset 19Feb2021, outcome "recovered" (Feb2021), described as "Fatigue"; PAIN (non-serious) with onset 19Feb2021, outcome "recovered" (Feb2021), described as "Body aches". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, pain.No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Fatigue, Oropharyngeal pain, Pain in extremity
Clinical narrative: sore throat,; decreased appetite; cough; fatigue; minor sore arm; This is a spontaneous report from a non-contactable consumer. A 14-year-old female patient received BNT162b2 (Pfizer-BioNTech COVID-19 mRNA Vaccine; Lot Number and Expiration date was unknown) via an unspecified route of administration on 17May2021 (at the age of 14-year-old) as dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown that if the patient had received any other vaccines within four weeks prior to the vaccination or not. On 18May2021, patient experienced minor sore arm, fatigue, sore throat, decreased appetite and cough. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient received treatment for the events. The outcome of the events minor sore arm, fatigue, sore throat, decreased appetite and cough were recovered on an unknown date in May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: In slide#2, reporter information removed since supplier only. Vaccination Facility Country added, and Leading sentence updated to "This is a spontaneous report from a non-contactable consumer."
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received COVID-19 Vaccine - Manufacturer Unknown, (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: FATIGUE (non-serious), outcome "unknown", described as "Tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.