chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Blood grouping, Illness
Clinical narrative: all my family got sick. My brother and sister.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male 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), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "all my family got sick. My brother and sister.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: This consumer reported for a male patient (reporter's brother) in response to Non HCP letter sent in cross referenced case.    Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood grouping, Illness
Clinical narrative: All my family got sick after the second shot. My brother and sister; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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 (Dose Number: 1), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "All my family got sick after the second shot. My brother and sister". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity
Clinical narrative: administered 0.8 ml of the Pfizer COVID-19 vaccine instead of the 0.3 mls; sore arm; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team for a Pfizer sponsored program.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 20Sep2021 10:30 (Lot number: EWO167, Expiration Date: 25Sep2021) at the age of 32 years as dose 1, 0.8 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OVERDOSE (non-serious) with onset 20Sep2021, outcome "unknown", described as "administered 0.8 ml of the Pfizer COVID-19 vaccine instead of the 0.3 mls"; PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "not recovered", described as "sore arm".  Additional information:The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient did not receive any additional vaccines administered on Same date of the Pfizer Suspect.Causality relatedness: Pfizer Covid Vaccine: Sore arm - Related  No follow-up attempts are possible. No further information is expected.   Follow-Up (27Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Nausea
Clinical narrative: metalic taste; Nausea; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 46 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 26Jun2021 15:00 (Lot number: EW0198) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious) with onset 26Jun2021 15:00, outcome "recovered" (2021), described as "metalic taste"; NAUSEA (non-serious) with onset 26Jun2021 15:00, outcome "recovered" (2021), described as "Nausea". Therapeutic measures were not taken as a result of dysgeusia, nausea.  Additional Information: Patient did not provide information regarding the reported adverse event(s) with the use of the product. Patient is willing to be contracted again by Pfizer on the reported adverse event. Dose 2 administration date reported as 17Jul2021 on 15:00 at right deltoid with route intramuscular with lot number as FA6780. On 17Jul2021 15:00, patient experienced metallic taste as non serious with outcome recovered. No Treatment was received.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. A 52 year-old female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (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 (Her first dose of the Pfizer BioNTech Covid 19 vaccine on 25Feb2021), administration date: 25Feb2021, for Covid-19 immunization. The following information was reported: RASH (non-serious) with onset 08Apr2021, outcome "not recovered", described as "Rash"; URTICARIA (non-serious) with onset 08Apr2021, outcome "not recovered", described as "Hives". Additional information: On question, Allergist was calling on behalf of a patient, female, aged 52 who received her first dose of the Pfizer BioNTech Covid 19 vaccine on 25Feb2021 and the second dose on 18Mar2021. Three weeks later on 08Apr2021, she developed a persistent rash and hives. It was still ongoing but intermittent, it occurs in certain areas but has been all over. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. The lot number for [BNT162B2], was not provided and will be requested during follow up. Follow-up (01Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: This is a spontaneous report received from a noncontactable other HCP (patient). A 30-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 30, intramuscularly, in left arm, on Aug 30, 2021, at 10:00, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient developed hypoesthesia (more numbness in arms when sleep after the first dose), onset 2021, with outcome of recovering. No therapeutic measures taken as a result of hypoesthesia. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No other medications received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Migraine, Nausea, SARS-CoV-2 test
Clinical narrative: migraines; Daily Headaches; Nausea; Dizziness; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Feb2021 (Lot number: EL9266) as dose 1, single and administered in arm left, administration date 12Mar2021 (Lot number: EN6204) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 12Feb2021, outcome "not recovered", described as "Daily Headaches"; NAUSEA (non-serious) with onset 12Feb2021, outcome "not recovered", described as "Nausea"; DIZZINESS (non-serious) with onset 12Feb2021, outcome "not recovered", described as "Dizziness"; MIGRAINE (non-serious) with onset 06Mar2021, outcome "not recovered", described as "migraines". The events "daily headaches", "nausea", "dizziness" and "migraines" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, migraine. Therapeutic measures were not taken as a result of nausea, dizziness.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received any vaccine within 2 weeks of vaccination. Treatment was received and still ongoing. Prior to vaccination, Patient was not diagnosed with covid-19. Since the vaccination, patient has been tested for covid. No known allergies reported.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: My period cycle has been off since I received the 2nd vaccine. It has been early, late, lasted longer and shorter.; 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 right (Lot number: EW0181) as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Tomatoes, mangoes" (unspecified if ongoing), notes: known allergies: Tomatoes, mangoes.; "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex; "known allergies: metals" (unspecified if ongoing), notes: known allergies: metals; "known allergies: fragrance" (unspecified if ongoing), notes: known allergies: fragrance; "known allergies: cleaning products" (unspecified if ongoing), notes: known allergies: cleaning products; "known allergies: rubber" (unspecified if ongoing), notes: known allergies: rubber. The patient took concomitant medications. Vaccination history included: Bnt162b2 (product: COVID 19, lot number: EW0186, lot unknown: False, administration date: 19Jun2021, administration time: 01:00 PM, dose number:1, vaccine location: Right arm.), administration date: 19Jun2021, when the patient was 36 years old, for COVID-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 19Jul2021, outcome "unknown", described as "My period cycle has been off since I received the 2nd vaccine. It has been early, late, lasted longer and shorter.". Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient received list of Multi vitamin medications within two weeks of vaccination. She was not diagnosed with Covid-19 prior to vaccination. Since the vaccination, she has not been tested for Covid-19.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: After the second dose I am experiencing back pain; This is a spontaneous report received from a non-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 20Sep2021 10:30 (Batch/Lot number: unknown) at the age of 30 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Pfizer COVID 19 vaccine, lot_unknown, administrator route: Intramuscular, administration date: 30/Aug/2021, administration time: 10:00 AM, dose number: 1, vaccine location: Left arm), administration date: 30Aug2021, when the patient was 30 years old, for Covid-19 Immunization, reaction(s): "more numbing arms when I sleep". The following information was reported: BACK PAIN (non-serious) with onset 20Sep2021 22:45, outcome "recovering", described as "After the second dose I am experiencing back pain". Therapeutic measures were not taken as a result of back pain.  Additional information: Patient noticed more numbing arms when he sleep and the first dose. After the second dose he was experiencing back pain. Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, the patient was not tested for COVID-19, patient did not received any other vaccines within 4 weeks prior to the COVID vaccine, patient was not received any other medications within 2 weeks of vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Diarrhoea, Headache, Nausea
Clinical narrative: horrible headache; nausea; loss of appetite; diarrhea; The stomach issues; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pseudo tumor cerebri" (unspecified if ongoing), notes: Pseudo tumor cerebri; "Medullary sponge kidneys" (unspecified if ongoing). Concomitant medication(s) included: ACETAZOLAMIDE. Past drug history included: Morphine, reaction(s): "known allergies: Morphine", notes: known allergies: Morphine. The following information was reported: HEADACHE (non-serious) with onset 14Aug2021, outcome "not recovered", described as "horrible headache"; NAUSEA (non-serious) with onset 14Aug2021, outcome "not recovered", described as "nausea"; DECREASED APPETITE (non-serious) with onset 14Aug2021, outcome "not recovered", described as "loss of appetite"; DIARRHOEA (non-serious) with onset 14Aug2021, outcome "not recovered", described as "diarrhea"; ABDOMINAL DISCOMFORT (non-serious) with onset 14Aug2021, outcome "recovered", described as "The stomach issues". The events "horrible headache", "nausea", "loss of appetite", "diarrhea" and "the stomach issues" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of headache, nausea, decreased appetite, diarrhoea, abdominal discomfort.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that "Got my shot on Wednesday and by Saturday I had a horrible headache and nausea, loss of appetite and diarrhea. The stomach issues lasted a few days but headaches still on going. This happened with both shots and got worse with the second. This shot flared up my pseudo tumor cerebri.  Still having issues with headaches, eye sight and  brain fog." Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Off label use, Pain in extremity, Product use issue, Suppressed lactation
Clinical narrative: I am currently Breastfeeding; I am currently Breastfeeding; my left breast was very sore to the touch and hurt; I have significantly decreased my milk supply in my left breast only. I was producing 4-5 oz per breast, now my left breast is only producing less than 1 oz.; my left arm pit; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Sep2021 13:15 (Lot number: FD0809) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PROZAC. Past drug history included: Known allergies: none. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 14Sep2021 17:00, outcome "unknown" and all described as "I am currently Breastfeeding"; BREAST PAIN (non-serious) with onset 14Sep2021 17:00, outcome "not recovered", described as "my left breast was very sore to the touch and hurt"; SUPPRESSED LACTATION (non-serious) with onset 14Sep2021 17:00, outcome "not recovered", described as "I have significantly decreased my milk supply in my left breast only. I was producing 4-5 oz per breast, now my left breast is only producing less than 1 oz."; PAIN IN EXTREMITY (non-serious) with onset 14Sep2021 17:00, outcome "not recovered", described as "my left arm pit". The events "i am currently breastfeeding", "i am currently breastfeeding", "my left breast was very sore to the touch and hurt", "i have significantly decreased my milk supply in my left breast only. i was producing 4-5 oz per breast, now my left breast is only producing less than 1 oz." and "my left arm pit" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of breast pain, suppressed lactation, pain in extremity.  Additional information: The patient had not received any other vaccine within 4 weeks prior to COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID 19. Since the vaccination the patient had not tested for COVID 19.  No follow-up attempts are possible. No further information is expected.  Follow-up (18Oct2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101243499 mother/baby case
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient). Other case identifier: NVSC2021US213604. A 52-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Aug 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced dysgeusia (metallic taste), onset 2021, with outcome of unknown. The batch/lot number not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient). Other case identifier: GI-2021-10389. A 42-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 42, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced pain (vaccine hurt), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Menstruation delayed
Clinical narrative: Indigestion like symptoms; Started my period 2 days later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 (Batch/Lot number: unknown) at the age of 32 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 2021, outcome "unknown", described as "Started my period 2 days later"; DYSPEPSIA (non-serious) with onset 23Aug2021, outcome "unknown", described as "Indigestion like symptoms". Therapeutic measures were not taken as a result of menstruation delayed, dyspepsia.  Additional information: It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that after first Pfizer dose 23Aug2021 that day she experienced indigestion like symptoms but didn't think anything of it and started her period 2 days later. My second dose was 13Sep2021 and that day she experienced intense stomach cramps so bad they woke up through the night, that lasted 2 days, had diarrhea, then had period cramps which normally don't have due to birth control and started period again. Which is obviously early given the 3 week period between vaccines. No Treatment was not Received. The patient was not diagnosed with covid-19, prior to vaccination. The patient has not been tested for covid-19, since the vaccination. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dysmenorrhoea, Menstrual disorder
Clinical narrative: Had diarrhea; Started my period again. Which is obviously early given the 3 week period between vaccines; I had period cramps; I experienced intense stomach cramps so bad they woke me up through the night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 13Sep2021 (Batch/Lot number: unknown) at the age of 32 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL. Vaccination history included: Bnt162b2 (Dose:01, Anatomical location: Arm Left), administration date: 23Aug2021, when the patient was 32 years old, for COVID-19 immunization, reaction(s): "Indigestion like symptoms", "Started my period 2 days later". The following information was reported: DIARRHOEA (non-serious) with onset 13Sep2021, outcome "recovering", described as "Had diarrhea"; MENSTRUAL DISORDER (non-serious) with onset 13Sep2021, outcome "recovering", described as "Started my period again. Which is obviously early given the 3 week period between vaccines"; DYSMENORRHOEA (non-serious) with onset 13Sep2021, outcome "recovering", described as "I had period cramps"; ABDOMINAL PAIN UPPER (non-serious) with onset 13Sep2021, outcome "recovered" (Sep2021), described as "I experienced intense stomach cramps so bad they woke me up through the night". Therapeutic measures were not taken as a result of diarrhoea, menstrual disorder, dysmenorrhoea, abdominal pain upper.  Additional Information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination Tylenol. After my first Pfizer dose 23Aug2021 that day I experienced indigestion like symptoms but didn't think anything of it and started my period 2 days later. My second dose was 13Sep2021 and that day I experienced intense stomach cramps so bad they woke me up through the night, that lasted 2 days, had diarrhea, then I had period cramps which I normally don't have due to birth control and started my period again. Which is obviously early given the 3 week period between vaccines  Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Menstrual disorder, Product use issue
Clinical narrative: First dose made me get my period even though I am on continuous birth control and shouldn't get my period; I have been sick; Other vaccine same date vaccine date 02Mar2021; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 13:30 (Lot number: EN6205) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Primary immunodeficiency (CVID)" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Hydrocodone, reaction(s): "known allergies: Hydrocodone". The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 02Mar2021, outcome "unknown", described as "Other vaccine same date vaccine date 02Mar2021"; MENSTRUAL DISORDER (non-serious) with onset 08Sep2021, outcome "not recovered", described as "First dose made me get my period even though I am on continuous birth control and shouldn't get my period"; ILLNESS (non-serious) with onset 08Sep2021, outcome "not recovered", described as "I have been sick". Therapeutic measures were not taken as a result of menstrual disorder, illness.  Additional Information: Each dose I have been sick for about 2 weeks. The patient did not received any other vaccine in four weeks. The patient had no Covid prior vaccination. The patient did not tested Covid post vaccination.  Follow-up attempts are completed. No further information is expected..
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: my sugar spiked; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "my sugar spiked". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient asked how much sugar was in the Pfizer COVID vaccine, because there sugar spiked.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Somnolence, Vaccination site reaction
Clinical narrative: left arm became numb; tingling/pins needles; feeling asleep; in the area of injection about 5 inch circle of upper left arm directly in injection area; Numbness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13May2021 (Lot number: EW0182) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma as a child but no adult issues or treatment. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: EW0170, Lot unknown: False, administration date: Apr2021, dose number: 1, vaccine location: Left arm), administration date: Apr2021, when the patient was 47 years old, for Covid-19 immunization, reaction(s): "severe fatigue". The following information was reported: HYPOAESTHESIA (non-serious) with onset 16Aug2021, outcome "unknown", described as "left arm became numb"; PARAESTHESIA (non-serious) with onset 16Aug2021, outcome "unknown", described as "tingling/pins needles"; SOMNOLENCE (non-serious) with onset 16Aug2021, outcome "unknown", described as "feeling asleep"; VACCINATION SITE REACTION (non-serious) with onset 16Aug2021, outcome "unknown", described as "in the area of injection about 5 inch circle of upper left arm directly in injection area"; HYPOAESTHESIA (non-serious) with onset 16Aug2021, outcome "unknown", described as "Numbness". Therapeutic measures were not taken as a result of hypoaesthesia, paraesthesia, somnolence, vaccination site reaction, hypoaesthesia.  Additional information: Facility type was workplace clinic. No other vaccine in four weeks was administered. There was covid prior vaccination and was not tested for covid post vaccination. Patient took one a day vitamins in two weeks. Patient had no known allergies.   Follow-up attempts are completed. No further information is expected
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First dose: his arm hurt; 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 parent.  A 21 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 (Lot number: EW0185) at the age of 21 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Aug2021, outcome "recovered" (28Aug2021), described as "First dose: his arm hurt".  Additional information: Patient's Weight was 145 to 155 lbs and is a healthy young man. No History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available), No Additional Vaccines Administered on Same Date of the Pfizer Suspect. Adverse event did not required Emergency Room or Physician Office visit. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No AE(s) following prior vaccinations. Family Medical History Relevant to AE was not reported.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: severe pain in hands; tingling down both arms; constant muscle aches and pains; constant muscle aches and pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2, solution for injection), intramuscular (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "breast cancer" (unspecified if ongoing); "double mastectomy" (unspecified if ongoing), notes: double mastectomy; "hysterectomy" (unspecified if ongoing); "diabetes type 2" (unspecified if ongoing), notes: diabetes type 2. The patient took concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer/BioNTech, lot unknown=True, lot unknown reason=Not available/provided to reporter at the time of report completion, administrator route=Intramuscular, dose number=1), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "severe pain in hands"; PARAESTHESIA (non-serious), outcome "not recovered", described as "tingling down both arms"; MYALGIA (non-serious), PAIN (non-serious), outcome "not recovered" and all described as "constant muscle aches and pains". It was unknown if therapeutic measures were taken as a result of pain in extremity, paraesthesia, myalgia, pain. Additional information: Reported Event: Patient received 2 Pfizer doses reported severe pain in hands following second dose - feeling similar to that of hitting your hands hard against a table; tingling down both arms; constant muscle aches and pains. Symptoms started within days after receiving second dose. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination but unknown which medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19:Unknown.  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I have been sick for about 2 weeks; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: EN6955) for 1 day as dose 2, single for covid-19 immunisation. Relevant medical history included: "Primary immunodeficiency (CVID)" (unspecified if ongoing), notes: Primary immunodeficiency (CVID). The patient's concomitant medications were not reported. Past drug history included: Hydrocodone, reaction(s): "known allergies: Hydrocodone", notes: Hydrocodone. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, product=COVID 19, brand=Pfizer,, lot number=EN6205, administration time=13:30), when the patient was 29 years old, for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious) with onset 08Sep2021, outcome "not recovered", described as "I have been sick for about 2 weeks". Therapeutic measures were not taken as a result of illness.  Additional information: Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.  Follow-Up (05Oct2021): Follow-up attempts are completed. No further information is expected
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Peripheral swelling
Clinical narrative: swelling in the left foot which went down the next morning; a "burning feeling" in the back of her left arm from just above the elbow to her chest; pain is a surface level pain and has remain consistent from the evening of the vaccination until today 9/22/2021; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Sep2021 (Lot number: fc9182) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Diabetes; "tachycardia" (unspecified if ongoing), notes: tachycardia. Concomitant medication(s) included: METFORMIN; GLIPIZIDE; METOPROLOL; TRULICITY. Past drug history included: Vancomycin, reaction(s): "hives", notes: known allergies: Vancomycin (hives); Vancomycin, reaction(s): "known allergies: Vancomycin", notes: known allergies: Vancomycin (hives). The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 01Sep2021, outcome "recovered" (02Sep2021), described as "swelling in the left foot which went down the next morning"; BURNING SENSATION (non-serious) with onset 01Sep2021, outcome "not recovered", described as "a "burning feeling" in the back of her left arm from just above the elbow to her chest"; PAIN (non-serious) with onset 01Sep2021, outcome "not recovered", described as "pain is a surface level pain and has remain consistent from the evening of the vaccination until today 9/22/2021". The events "swelling in the left foot which went down the next morning", "a "burning feeling" in the back of her left arm from just above the elbow to her chest" and "pain is a surface level pain and has remain consistent from the evening of the vaccination until today 9/22/2021" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of peripheral swelling, burning sensation. Therapeutic measures were taken as a result of pain.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient). Other case identifier: 02010582. A patient (no qualifiers provided) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation.  Medical history and concomitant medications not reported. The patient experienced dizziness (dizzy), with outcome of unknown. Therapeutic measures were taken as a result of dizziness. Additional information: Patient received the Pfizer COVID-19 vaccine and had light side effects like dizzy spells after the first dose. Patient felt horrible and was debilitated for a week; took Tylenol for side effects. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report: US-PFIZER INC-202101252700 (same patient and reporter, different dose and event).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP. A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications  not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunization; reaction: dizzy spells. The patient experienced asthenia (debilitated for a week), with outcome of unknown. Therapeutic measures were taken as a result of asthenia. Additional information: She stated she felt "horrible" after the 2nd dose and took Tylenol for her side effects. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report: US-PFIZER INC-202101252699 (same patient and reporter, different dose and event).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Sep2021 (Lot number: 301308A) at the age of 59 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 (First dose: 15Aug2021 at 11:30, Lot: FO8448 or FD8448, then states it is FD8448, Dosage text: unknown dose, injection in left upper arm), administration date: 15Aug2021, when the patient was 59 years old, for Covid-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 06Sep2021, outcome "recovering", described as "swollen lymph nodes to her left side/lymph nodes that she noticed swollen is more on her left side, on her neck". Therapeutic measures were not taken as a result of lymphadenopathy. Additional information: The reporter stated that she was a teacher, and saw the news about people dying. Has second dose of Covid-19 vaccine on 05Sep2021. After the vaccine she has experienced swollen lymph nodes. She went to the doctor and was told that it was a possible side effect from the vaccine. First dose was more towards the outside of her upper arm and the second dose was more towards the inner side of her left arm. She does not know if it is a coincidence the lymph nodes that she noticed swollen is more on her left side, on her neck. She is curious why is it on that side, is it a coincidence that she noticed the swollen lymph nodes are on the same side she was given the injection. Vaccination Facility Type was pharmacy. Patient had not administered vaccine at military facility. Patient went to an urgent care. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Device physical property issue, Nipple disorder, Vaccination site movement impairment
Clinical narrative: vaccine ruined her implants/implant and boob are separated 2 days afterward; 2 days later her left arm was hard to move it; her left saline implant looked like a cow's nipple, breasts are like cow nipple, ruined chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "breast implant" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: DEVICE PHYSICAL PROPERTY ISSUE (non-serious), outcome "unknown", described as "vaccine ruined her implants/implant and boob are separated 2 days afterward"; VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious), outcome "unknown", described as "2 days later her left arm was hard to move it"; NIPPLE DISORDER (non-serious), outcome "unknown", described as "her left saline implant looked like a cow's nipple, breasts are like cow nipple, ruined chest".  Additional information: The patient received the 2nd dose of the Pfizer COVID-19 Vaccine in her left arm. She states that she had trouble moving her left arm and 2 days after the vaccine her saline breast implant was ruined. The patient's breasts are like cow nipple 2 days later. Now right, 2 days after as well. She states she will have to get reconstructive surgery to get implants out. The patient describes her breasts as being cow tits and now the patient had worst chest. You ruined chest. The patient states her left implant and boob are separated 2 days afterwards.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Menstrual disorder
Clinical narrative: headache; lightened up on the first 3 days but is still consistent.; menstrual cycle also stopped; chill; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Sep2021 14:00 (Lot number: FC3183) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "pseudo tumors" (unspecified if ongoing), notes: Note: Caller states that she has pseudotumors. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 03Sep2021, outcome "not recovered", described as "headache"; DIZZINESS (non-serious) with onset 03Sep2021, outcome "unknown", described as "lightened up on the first 3 days but is still consistent."; MENSTRUAL DISORDER (non-serious) with onset 03Sep2021, outcome "unknown", described as "menstrual cycle also stopped"; CHILLS (non-serious) with onset 03Sep2021, outcome "unknown", described as "chill". Therapeutic measures were taken as a result of headache.  Additional information: Vaccination Facility Type: Pharmacy. Prior Vaccinations within 4 weeks: None. AE(s) following prior vaccinations: None. Family Medical History Relevant to AE(s): None. History of all previous immunization with the Pfizer vaccine considered as suspect: None. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. AE(s) require a visit to Emergency Room and Physician Office: No. Called nurse hotline. Relevant Tests: None. Patient wanted to know how long they last as she has a residual headache that won't go way. She Stated that she has a high pain tolerance, it was more so annoying and won't go anywhere, not throbbing or aching, it was just there. Treatment taken with Tylenol Arthritis 650mg each. Serious: No. Investigation Assessment: No.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 41-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 41, in left arm, on Sep 20, 2021, at 15:00, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient experienced a menstrual disorder (menstrual cycle started night of vaccine), onset Sep 20, 2021, at 19:00, with outcome of unknown. No therapeutic measures taken as a result of menstrual disorder. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No other medications received by the patient within 2 weeks of vaccination. Prior to vaccination, patient not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Full blood count, Inappropriate schedule of product administration, Muscle twitching
Clinical narrative: I felt weakness in my legs; twitching in both legs; I got my second Pfizer shot, last Wednesday, about 6 weeks after my first shot; 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 15Sep2021 (Lot number: FC3184) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID", start date: Nov2020 (unspecified if ongoing), notes: I had COVID (Further Clarifications Unknown) last year in November. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), administration date: 26Jul2021, for COVID-19 immunisation. The following information was reported: ASTHENIA (non-serious) with onset 20Sep2021, outcome "not recovered", described as "I felt weakness in my legs"; MUSCLE TWITCHING (non-serious) with onset 20Sep2021, outcome "not recovered", described as "twitching in both legs"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 15Sep2021, outcome "unknown", described as "I got my second Pfizer shot, last Wednesday, about 6 weeks after my first shot". The events "i felt weakness in my legs" and "twitching in both legs" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of asthenia, muscle twitching.  No follow-up attempts are possible. No further information is expected.