chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Pain in extremity, Toothache
Clinical narrative: sharp shooting tooth pain; temperature; aching arm; chills; This is a spontaneous report from Pfizer sponsored Program. A contactable consumer (patient) is the reporter.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Aug2021 (Lot number: FA7485) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose #1 on 01Feb2021 about 14.00 in the left arm. Caller does not have NDC or dose to provide. States the CDC cards says lot S318, expiry May2021), administration date: 01Feb2021, when the patient was 73 years old, for COVID-19 IMMUNISATION; Bnt162b2 (dose #2 on 22Feb2021 about 11-12 in the left arm. Caller does not have NDC or dose to provide. States the card says lot S318, expiry May2021), administration date: 22Feb2021, when the patient was 73 years old, for COVID-19 IMMUNISATION, reaction(s): "temperature", "aching arm", "chills". The following information was reported: TOOTHACHE (non-serious) with onset 2021, outcome "recovering", described as "sharp shooting tooth pain"; BODY TEMPERATURE INCREASED (non-serious) with onset 2021, outcome "recovered" (2021), described as "temperature"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "aching arm"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of toothache, body temperature increased, pain in extremity, chills.  Additional information: Patient did not had Emergency Room visit or Physician Office visit. Patient did not had Prior Vaccinations within 4 weeks. Patient did not had any AE(s) following prior vaccinations. Patients Medical History and relevant tests were none.  Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Pain in extremity
Clinical narrative: temperature; aching arm; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 73-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 (Lot number: S318, Expiration Date: May2021) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose #1 on 01Feb2021 about 2pm in the left arm. Caller does not have NDC or dose to provide. States the CDC cards says lot S318, expiry May2021.), administration date: 01Feb2021, when the patient was 73 years old, for COVID-19 immunisation.  The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 22Feb2021, outcome "recovered" (2021), described as "temperature"; PAIN IN EXTREMITY (non-serious) with onset 22Feb2021, outcome "recovered" (2021), described as "aching arm"; CHILLS (non-serious) with onset 22Feb2021, outcome "recovered" (2021), described as "chills".  Additional Information: Patient History: No. Investigation Assessment: No. Agent relays the caller states after the second dose she had a temperature, chills and aching arm. States that the temperature, aching arm, and chills started by evening that same day, 22Feb2021 and cleared up by the end of the 2nd day, it lasted 24 plus hours. States for treatment she may have taken some Tylenol.  Follow-Up (31Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: pain; tingling in finger tips; This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP) communicated to Pfizer Sales Representative.  A 48 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: PAIN (non-serious), outcome "unknown", described as "pain"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling in finger tips".  Additional information: Description of Event: Pain and tingling in finger tips day after vaccine administered. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Jan2021 (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: PRURITUS (non-serious) with onset Jan2021, outcome "unknown", described as "itching".  Additional Information: The patient stated she already did a report with her first one because she had itching. The patient stated that to get the booster, but it is coming from the same vial as the first or second. She got things from Pfizer as a share holder that they are looking into the booster that will be for Delta and other strands. They are now saying to get the booster, but it is coming from the same vial as the first or second. The reporter states she is just asking a general question and not speaking of a specific lot number. She already got the first and second and they are only giving the booster at certain places. She asked the pharmacist who said it was not a booster it is a third shot because it is coming from the same vial as if getting the first or second. If this is saying it is only going to last 8 months, what will make the third last eight months if the first and second together only lasted 8 months. She doesn't want to put stuff in her body if it is not needed, but she doesn't not want to do if it is needed. This was back in Jan2021. Reporter clarified product as COVID vaccine.received second dose of bnt162b2 (BNT162B2), administration date on an unspecified date (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Limb discomfort, Pain in extremity, Vaccination site pain
Clinical narrative: So much pain that you can hardly lift your arm and this never happens with flu shots; So much pain that you can hardly lift your arm and this never happens with flu shots; She did report that she had injection site pain that was worse than any other vaccine she has received; She did report that she had injection site pain that was worse than any other vaccine she has received; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu shots (So much pain that you can hardly lift your arm and this never happens with flu shots), for immunization. The following information was reported: LIMB DISCOMFORT (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "So much pain that you can hardly lift your arm and this never happens with flu shots"; VACCINATION SITE PAIN (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "She did report that she had injection site pain that was worse than any other vaccine she has received".  Additional information: The patient stated that she received her first dose of the Pfizer Covid 19 vaccine two days ago. She did report that she had injection site pain that was worse than any other vaccine she has received. So much pain that you can hardly lift your arm and this never happens with flu shots. It did not hurt going in and it just hurt after. She confirmed that this has resolved. She reports everyone that she has talked to has experienced this and references hundreds of people. The patient asked the efficacy of the first shot percentage and how many days. The patient asked how long after second dose for maximum efficiency. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101076590 same reporter/product/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes in the armpit./swollen gland in my left armpit and now I get 2 swollen glands there into my right armpits; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 31Jul2021 (Lot number: FC3180) 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, Lot no: FA6780), administration date: 10Jul2021, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Aug2021, outcome "unknown", described as "Swollen lymph nodes in the armpit./swollen gland in my left armpit and now I get 2 swollen glands there into my right armpits".  No follow-up attempts are possible. No further information is expected.  Follow-up (18Aug2021): This is a follow-up spontaneous report from a contactable consumer. This male consumer (patient) reported: He received his second dose on 31Jul2021 and this past Sunday about 2 weeks, two days Swollen gland in left armpit and now get 2 swollen glands there his  right armpits  Follow-Up (31Aug2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Malaise, Pain in extremity
Clinical narrative: tummy ache; tired; my arm hurt too; I felt icky all weekend; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 03Jun2021 08:17 (Lot number: EW0183) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing), notes: Seasonal allergies year; "I have corn allergies" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 03Jun2021, outcome "unknown", described as "tummy ache"; FATIGUE (non-serious) with onset 03Jun2021, outcome "unknown", described as "tired"; PAIN IN EXTREMITY (non-serious) with onset 03Jun2021, outcome "unknown", described as "my arm hurt too"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "I felt icky all weekend".  Additional information: Prior vaccinations within 4 weeks was none.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion; Vaccine administered to patient after temperature excursion; Temperature excursion; Vaccine administered to patient after temperature excursion; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Lot number: EW0167, Expiration Date: 31Aug2021) 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: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) all with onset 2021, outcome "unknown" and all described as "Temperature excursion; Vaccine administered to patient after temperature excursion".  Additional information: It was reported temperature excursion on the Pfizer vaccine, the Covid vaccine. So, the first one is from, actually this is not the freezer, it is a refrigerator excursion and it happened 4 different times. The first time this was on 01Jul2021, it happened at 5:20 AM, the temperature went to 8.6 Celsius and it was there for about 10 minutes and then on 08Jul2021 at 1:05 AM, 8.28 degrees for 5 minutes and then on 20Jul2021 at 9:55 AM, 8.2 Celsius it lasted less than a minute and then 28Jul2021 at 9:25 AM, 8.4 Celsius, it lasted 10 minutes.The vaccine was administered to patient after excursion, reporter stated. Reporter stated did not had any patient's demographic details or medical history. The vaccination happened here in the district of on hospital campus.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo positional
Clinical narrative: Benign paroxysmal positional vertigo; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 30-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Jul2021 09:00 (Lot number: Ew0165) at the age of 30 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: VERTIGO POSITIONAL (non-serious) with onset 05Aug2021 08:00, outcome "not recovered", described as "Benign paroxysmal positional vertigo". The event "benign paroxysmal positional vertigo" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vertigo positional.  Additional information: No known allergies. No other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was no. Adverse event treatment was vestibular physical therapy. No hospitalization prolonged. Serious was no. Since the vaccination, the patient had not been tested for COVID-19. Device Date: 19Aug2021.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Fall, Feeling abnormal
Clinical narrative: Fell; couldn't get up; messed him up; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): LRN4172103.  A 55 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 55 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "high cholesterol" (unspecified if ongoing); "falls" (unspecified if ongoing); "feels like pins pricking" (unspecified if ongoing); "memory issues" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS; MODAFINIL; METFORMIN; GABAPENTIN; AMINOPYRIDINE; LOSARTAN; ATORVASTATIN CALCIUM; OXCARBAZEPINE; VITAMIN D NOS. The following information was reported: FALL (non-serious) with onset 15Apr2021, outcome "unknown", described as "Fell"; DYSSTASIA (non-serious) with onset 15Apr2021, outcome "unknown", described as "couldn't get up"; FEELING ABNORMAL (non-serious) with onset 15Apr2021, outcome "unknown", described as "messed him up".  Additional information: Case Details: Patient's past medical history included: high cholesterol, falls. Patient's concurrent condition included: feels like pins pricking, memory issues. Patient's concomitant medication included: Ocrevus, Modafinil, Metformin, Gabapentin, Aminopyridine, Losartan, Atorvastatin, Oxcarbazepine, Vitamin D. On unknown date, patient started therapy with Pfizer Covid 19 Vaccine for unknown indication. On 15Apr2021, it was reported that patient experienced: Fell, messed him up, couldn't get up. The outcome of the reported event(s) was Unknown. No further information was reported. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  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, Headache, Illness
Clinical narrative: fatigue; sick with headaches; sick with headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 2021 (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 2021, outcome "unknown", described as "fatigue"; HEADACHE (non-serious), ILLNESS (non-serious) all with onset 2021, outcome "unknown" and all described as "sick with headaches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101077096 same reporter/SD/AE, different patient
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 44-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FC3181), at the age of 44, in left arm, on Aug 11, 2021, at 13:30, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced a headache, onset Aug 12, 2021, at 13:30, with outcome of recovered (Aug 2021). Therapeutic measures were taken as a result of headache. Additional information: Prior to the vaccination, patient not diagnosed with COVID-19. Since the vaccination, patient not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. She took Tylenol for treatment. No follow-up attempts possible. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Neuralgia, Ocular discomfort
Clinical narrative: I had a pain in my left eye. Seemed like a nerve of some sort.; I had a pain in my left eye. Seemed like a nerve of some sort.; Seemed like a nerve of some sort. That led to my left eye not wanting to open; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 (Lot number: EW0182) at the age of 37 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: EYE PAIN (non-serious), NEURALGIA (non-serious) all with onset May2021, outcome "recovered" (May2021) and all described as "I had a pain in my left eye. Seemed like a nerve of some sort."; OCULAR DISCOMFORT (non-serious) with onset May2021, outcome "recovered" (May2021), described as "Seemed like a nerve of some sort. That led to my left eye not wanting to open". Therapeutic measures were not taken as a result of eye pain, neuralgia, ocular discomfort. Additional information: the patient was not pregnant at vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within in two weeks of vaccination. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Patient had not been tested since the vaccination. The Patient did not have known allergies. Facility where the most recent COVID-19 vaccine was administered was available. After receiving the first dose, the patient had a pain in her left eye. Seemed like a nerve of some sort. That led to her left eye not wanting to open, and then being forced to open. This eventually wore off. The adverse events did not result in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care or Hospitalization.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: My belly area feels cold, internally and externally to the touch. It feels as if there is an ice pack on my belly/ the same sensation has slightly started on the inside of my thighs just now.; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 08:30 (Lot number: EW0175) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Generalized anxiety disorder" (unspecified if ongoing); "depression" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: PAXIL [PAROXETINE HYDROCHLORIDE]; ESTRADIOL. Past drug history included: Bactrim, reaction(s): "Bactrim:Allergy"; Zithromax z-pack, reaction(s): "Zithromax Z-Pack:Allergy". Vaccination history included: Bnt162b2 (dose 1,single, Anatomical Location: Arm Left, lot number: EW0167, Time: 08:30), administration date: 28Jul2021, when the patient was 49 years old, for COVID-19 immunisation, reaction(s): "No adverse event". The following information was reported: FEELING COLD (non-serious) with onset 18Aug2021 13:00, outcome "not recovered", described as "My belly area feels cold, internally and externally to the touch. It feels as if there is an ice pack on my belly/ the same sensation has slightly started on the inside of my thighs just now.". Therapeutic measures were not taken as a result of feeling cold.  Additional Information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. Prior to vaccination, was the patient diagnosed with COVID-19 was reported as no. Since the vaccination, has the patient been tested for COVID-19 was reported as no. Reaction/event as reported by primary source: Reported Event: Patient belly area feels cold, internally and externally to the touch. It feels as if there was an ice pack on her belly. The location was roughly between the bottom of patient breasts down to her belly button. It started on the day she got her 2nd vaccine and it was continuing right now, the day after her vaccine. she didn't have this feeling with my first dose. It was not like body chills that come with fever. she have not had fever or body chills. Also, the same sensation has slightly started on the inside of her thighs just now. No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: vaccine was stored in the regular freezer /temperature excursion; it was administered to 18 patients; This is a spontaneous report received from contactable reporter(s) (Other HCP).   A 12 year-old female patient received bnt162b2 (BNT162B2), administration date 13Aug2021 (Lot number: EW0185, Expiration Date: Aug2021) at the age of 12 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: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 13Aug2021, outcome "unknown", described as "vaccine was stored in the regular freezer /temperature excursion"; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 13Aug2021, outcome "unknown", described as "it was administered to 18 patients".  Additional information: Clinical course include Registered nurse on the line calling about the Pfizer COVID-19 Vaccine, there was a temperature excursion. Initially she called Facility and was transferred to Medical Information. Initially she stated she did not think it was administered to patients, but she is calling back and said it was administered. The previous Reportum: EZ7JI0GQ. The vaccine was stored in the regular freezer 26Jul2021 and on 13Aug2021 which was day 18 of it being in the regular freezer it was administered to 18 patients. On 16Aug2021 it was administered to 5 patients, an don 17Aug2021 it was administered to 9 patients. Transfer agent confirmed the reporter did not specify the information regarding the patients. Caller initially confirmed to continue with safety report to report on each patient. This report was regarding patient who received vaccine on 13Aug2021.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: sore throat symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Jun2021 15:20 (Lot number: EW0183) at the age of 55 years as dose 2, single for covid-19 immunisation. Family history included: "Sciatic pain" (unspecified if ongoing); "upper lower back issue" (unspecified if ongoing); "lower and upper back issues" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Administration date: 09Jun2021, Administration time: 18:00, Anatomical site of injection: Left arm, Route of administration: intramuscular, Lot no: EW0182), administration date: 09Jun2021, when the patient was 55 years old, for COVID-19 immunisation, reaction(s): "pain". The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 14Jul2021, outcome "unknown", described as "sore throat symptoms". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Musculoskeletal stiffness, Pain in extremity, Vomiting
Clinical narrative: dizziness; cold sweats; stiff neck; vomiting; Sore arm first 24 hours; This is a spontaneous report received from contactable reporter(s) (Other HCP and Physician). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19Aug2021 16:45 (Lot number: EW0186) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid disease" (unspecified if ongoing); "kidney disease" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO taken for anxiety, start date: 20Jul2016 (ongoing); VITAMIN D NOS. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Aug2021, outcome "not recovered", described as "Sore arm first 24 hours"; DIZZINESS (non-serious) with onset 20Aug2021 15:00, outcome "not recovered", described as "dizziness"; COLD SWEAT (non-serious) with onset 20Aug2021 15:00, outcome "not recovered", described as "cold sweats"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 20Aug2021 15:00, outcome "not recovered", described as "stiff neck"; VOMITING (non-serious) with onset 20Aug2021 15:00, outcome "not recovered", described as "vomiting". Therapeutic measures were not taken as a result of pain in extremity, dizziness, cold sweat, musculoskeletal stiffness, vomiting.  Additional Information: patient did not have Covid prior vaccination and did not tested post vaccination. patient did not have known allergies. AE outcome was recovered with sequelae. The event did not require the initiation of new medication/other treatment procedure.  No follow-up attempts are needed. No further information expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: I tasted Really  bad the .; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18May2021 12:30 (Lot number: Ew0185) at the age of 33 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, SINGLE, Lot number: Ew0171, Administration date: 27Apr2021, Administration time: 12:00 PM, Arm: right), administration date: 27Apr2021, when the patient was 33 years old, for Covid-19 immunisation.  The following information was reported: TASTE DISORDER (non-serious) with onset 04Jul2021 12:00, outcome "recovered with sequelae", described as "I tasted Really  bad the pepsi/Coca-Cola.". Therapeutic measures were not taken as a result of taste disorder.  Additional Information: It was stated that there was no other vaccine in four weeks. There was no covid prior vaccination. There was no covid test post vaccination. There were no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Dizziness, Fatigue, Hot flush
Clinical narrative: Chills; Mania; Dizziness; Anxiety; Fatigue; Muscle aches; a lot of hot flashes to the point of sweating profusely; a lot of hot flashes to the point of sweating profusely; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Aug2021 17:00 (Lot number: FC3181) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Birth Control" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Covid prior vaccination: yes. Concomitant medication(s) included: LO LOESTRIN FE taken for contraception. The following information was reported: CHILLS (non-serious) with onset 09Aug2021, outcome "not recovered", described as "Chills"; MANIA (non-serious) with onset 09Aug2021, outcome "not recovered", described as "Mania"; DIZZINESS (non-serious) with onset 09Aug2021, outcome "not recovered", described as "Dizziness"; ANXIETY (non-serious) with onset 09Aug2021, outcome "not recovered", described as "Anxiety"; FATIGUE (non-serious) with onset 09Aug2021, outcome "not recovered", described as "Fatigue"; MYALGIA (non-serious) with onset 09Aug2021, outcome "not recovered", described as "Muscle aches"; HOT FLUSH (non-serious), HYPERHIDROSIS (non-serious) all with onset 09Aug2021, outcome "not recovered" and all described as "a lot of hot flashes to the point of sweating profusely". The events "chills", "mania", "dizziness", "anxiety", "fatigue", "muscle aches", "a lot of hot flashes to the point of sweating profusely" and "a lot of hot flashes to the point of sweating profusely" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of chills, mania, dizziness, anxiety, fatigue, myalgia, hot flush, hyperhidrosis.  Additional information: Patient did not take any other vaccine in four weeks. Patient received other medications in two weeks: Lo-Loestrin for Birth Control. Patient was tested COVID prior vaccination and patient did not tested COVID post vaccination. Patient did not have known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Mania, Myalgia
Clinical narrative: Chills; Mania; Dizziness; Anxiety; Fatigue; Muscle aches; a lot of hot flashes to the point of sweating profusely; a lot of hot flashes to the point of sweating profusely; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Aug2021 17:00 (Lot number: FC3181) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Birth Control" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Covid prior vaccination: yes. Concomitant medication(s) included: LO LOESTRIN FE taken for contraception. The following information was reported: CHILLS (non-serious) with onset 09Aug2021, outcome "not recovered", described as "Chills"; MANIA (non-serious) with onset 09Aug2021, outcome "not recovered", described as "Mania"; DIZZINESS (non-serious) with onset 09Aug2021, outcome "not recovered", described as "Dizziness"; ANXIETY (non-serious) with onset 09Aug2021, outcome "not recovered", described as "Anxiety"; FATIGUE (non-serious) with onset 09Aug2021, outcome "not recovered", described as "Fatigue"; MYALGIA (non-serious) with onset 09Aug2021, outcome "not recovered", described as "Muscle aches"; HOT FLUSH (non-serious), HYPERHIDROSIS (non-serious) all with onset 09Aug2021, outcome "not recovered" and all described as "a lot of hot flashes to the point of sweating profusely". The events "chills", "mania", "dizziness", "anxiety", "fatigue", "muscle aches", "a lot of hot flashes to the point of sweating profusely" and "a lot of hot flashes to the point of sweating profusely" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of chills, mania, dizziness, anxiety, fatigue, myalgia, hot flush, hyperhidrosis.  Additional information: Patient did not take any other vaccine in four weeks. Patient received other medications in two weeks: Lo-Loestrin for Birth Control. Patient was tested COVID prior vaccination and patient did not tested COVID post vaccination. Patient did not have known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: a swollen lymph node over a collarbone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Aug2021 11:45 (Lot number: VY8-10188-81590) at the age of 36 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: LYMPHADENOPATHY (non-serious) with onset 16Aug2021 20:45, outcome "not recovered", described as "a swollen lymph node over a collarbone". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient did not receive any other vaccine in four weeks. The patient not had covid prior to the vaccination and had not been tested post vaccination. The patient did not have any known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasal congestion, Paranasal sinus discomfort, SARS-CoV-2 test
Clinical narrative: headache; Nasal congestion; sinus pressure; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP).  A 23-year-old male patient received bnt162b2 (BNT162B2), administration date 02Feb2021 (Lot number: EM9809) at the age of 22 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: HEADACHE (non-serious) with onset 16Aug2021, outcome "recovering", described as "headache"; NASAL CONGESTION (non-serious) with onset 16Aug2021, outcome "recovering", described as "Nasal congestion"; PARANASAL SINUS DISCOMFORT (non-serious) with onset 16Aug2021, outcome "recovering", described as "sinus pressure"; FATIGUE (non-serious) with onset 16Aug2021, outcome "recovering", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, nasal congestion, paranasal sinus discomfort, fatigue.  Clinical course included "Nasal congestion, sinus pressure, fatigue, headache".  Additional Information: Patient did not have COVID infection prior vaccination. Patient was tested for COVID post vaccination. No other vaccine was administered in four weeks. No other medications were administered in two weeks.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Discomfort, Vaccination site pain
Clinical narrative: Soreness at injection site (left arm) which has worsened over time. Initial soreness was expected, but it has now been 4 months since the second dose and the discomfort still exists.; Soreness at injection site (left arm) which has worsened over time.  Initial soreness was expected, but it has now been 4 months since the second dose and the discomfort still exists.; the discomfort still exists.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 (Lot number: EN6207) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 15Apr2021, outcome "not recovered", described as "Soreness at injection site (left arm) which has worsened over time. Initial soreness was expected, but it has now been 4 months since the second dose and the discomfort still exists."; CONDITION AGGRAVATED (non-serious) with onset 15Apr2021, outcome "not recovered", described as "Soreness at injection site (left arm) which has worsened over time.  Initial soreness was expected, but it has now been 4 months since the second dose and the discomfort still exists."; DISCOMFORT (non-serious) with onset 15Apr2021, outcome "not recovered", described as "the discomfort still exists.". Therapeutic measures were not taken as a result of vaccination site pain, condition aggravated, discomfort.  Additional information: No vaccine in four weeks. Prior to vaccination no Covid was diagnosed. No Covid tested post vaccination. No known allergies. Soreness at injection site (left arm) which had worsened over time. Initial soreness was expected, but it had been 4 months at the time of report since the second dose and the discomfort still exists.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: She is having like a swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 68-year-old female patient received bnt162b2 (BNT162B2), administration date 13Aug2021 (Lot number: FC3181) at the age of 68 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: LYMPHADENOPATHY (non-serious) with onset Aug2021, outcome "unknown", described as "She is having like a swollen lymph nodes".  Additional information: Reporter seriousness for She is having like a swollen lymph node was reported as Unspecified. Reporter stated, "Okay, well basically it's not for me, my roommate she got Pfizer got last Friday and reporter got the Pfizer shot on Tuesday okay she had hers (Unclear) now for almost like 6 days was that normal, was it normal?" (As reported).  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: My left hand, the following three fingers: middle finger, ring finger and pinky are completely numb/When I touch them it's a dull pain; My left hand, the following three fingers: middle finger, ring finger and pinky are completely numb/When I touch them it's a dull pain; dose number: 2 vaccine date: 22Mar2021/ Dose number: 1 Administration date: 22Mar2021; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 (Lot number: EP7534) at the age of 58 years as dose 1, single and administered in arm left, administration date 22Mar2021 (Lot number: EW0170) as dose 2, single for covid-19 immunisation. Relevant medical history included: "seasonal allergies" (unspecified if ongoing); "allergies:animal fur and dust" (unspecified if ongoing); "allergies:animal fur and dust" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 22Mar2021, outcome "unknown", described as "dose number: 2 vaccine date: 22Mar2021/ Dose number: 1 Administration date: 22Mar2021"; HYPOAESTHESIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 06May2021, outcome "not recovered" and all described as "My left hand, the following three fingers: middle finger, ring finger and pinky are completely numb/When I touch them it's a dull pain". Therapeutic measures were not taken as a result of hypoaesthesia, pain in extremity.  Additional Information: Patient was not tested covid prior and post vaccination. No other vaccines were taken in four weeks. Other medical history: None.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: Starting throwing up, she is not feeling too good; Nausea; Vomiting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 20Aug2021 (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 21Aug2021 02:00, outcome "unknown", described as "Starting throwing up, she is not feeling too good"; NAUSEA (non-serious) with onset 21Aug2021 02:00, outcome "unknown", described as "Nausea"; VOMITING (non-serious) with onset 21Aug2021 02:00, outcome "unknown", described as "Vomiting".  Additional information: Reporter stated, "it's my wife (patient) she just got the Pfizer shot (Unspecified shot) yesterday, and around 2 o' clock this morning she started throwing up, she was not feeling too good. There was anything I can give her for nausea or vomiting?". Reporter is default as consumer or other non-health professional.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: My sister can't even raise her arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), 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: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "My sister can't even raise her arm".  Additional information: NDC number of Covid Vaccine: Unknown, UPC number of Covid Vaccine: Unknown, Reason for no lot number: of Covid Vaccine: Complainant hung up abruptly/transfer incomplete, Expiry Date of Covid Vaccine: Unknown. Consumer stated, "I had first dose Pfizer Covid shot (vaccine) and I had a bad reaction. I have been transfer three times, am I talking to the correct person. " (Further not clarified the previous Department name. Hence, captured as initial report in the tab). When probed for the concern, consumer stated, "I have arthritis and I also have a problem with my heart nothing serious but vaccine did cause in my body to trigger and impact to all my Medical problems. Muscle in my heart was very painful, trouble in breathing like it was that painful my Doctor can't even touch me in that area. He actually sent me to the Emergency Room after the Cardiogram, I never had arthritis attack in my life it looks like I have boxing gloves, my ankle were all swollen in both hands and also my feet, my ankle and my feet. I was unable to lay in bed because my hands were so swelled that I didn't have blood circulation in my hands. I have to get out of my bed and stand up. I did not sleep even 5 minutes, that is how bad, it was. This vaccine caused this problem within days having this vaccine I started feeling pain in my elbow, the pain started in my elbow and went into my arms into my hands and from everything went wrong. How am I supposed to have second vaccine when my body is acting this like they did not tell that the vaccine is safe? It is not safe for everyone, I have someone that use to play guitar and after the vaccine on the left arm he can't even press there cords, the string because he has no strength in his hands to even press to play his guitar. My sister can't even raise her arm. Why do they not tell people that the vaccine is not safe, did not do any research about medical history, some people have "died" (further not clarified) after the vaccine. Vaccine is causing me so much harm and nobody is giving me any answer, it is something like "conspiracy" (further not clarified) because they are not telling that vaccine is not safe, vaccine really very hurts me."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.