chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: area on my left arm, where I received the shot kept hurting even after a month.; I have difficulty lifting anything with my left arm/ difficulty holding anything with my left arm; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 (Lot number: ew0175) at the age of 33 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19, brand=pfizer, lot number=er8731, lot unknown=False, administration date=16Apr2021, administration time=03:00 PM, dose number=1, vaccine location=Left arm, other vaccine same date detail: , other vaccine same date product= COVID, other vaccine same date lot number =ew0175, other vaccine same date vaccine date=16Apr2021, other vaccine same date dose number=2, other vaccine same date vaccine Location=left arm), administration date: 16Apr2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08May2021 17:00, outcome "not recovered", described as "area on my left arm, where I received the shot kept hurting even after a month."; LIMB DISCOMFORT (non-serious) with onset 08May2021 17:00, outcome "not recovered", described as "I have difficulty lifting anything with my left arm/ difficulty holding anything with my left arm". Therapeutic measures were not taken as a result of pain in extremity, limb discomfort.  Additional Information: Facility type vaccine: Pharmacy or Drug Store, Adverse event: area on my left arm, where she received the shot kept hurting even after a month. It kept hurting more, and more every week. Now, after 2.5 months of receiving second shot of Covid vaccine, she had difficulty lifting anything with her left arm. She had difficulty holding anything with her left arm.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: After 4.5 hours of having the shot I got spotting (period); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Jun2021 09:45 (Lot number: EW0181) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: PRENATAL [FOLIC ACID;IRON]. The following information was reported: INTERMENSTRUAL BLEEDING (non-serious) with onset 18Jun2021 14:30, outcome "unknown", described as "After 4.5 hours of having the shot I got spotting (period)". Therapeutic measures were not taken as a result of intermenstrual bleeding.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: before leaving the facility became dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date May2021 (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 ({product=COVID, 19, brand=Pfizer, lot_unknown=True,, lot_unknown_reason=Not, available/provided to reporter at the, time of report completion,, administration_date=May/2021,, dose_number=1}]), administration date: May2021, for Covid-19 immunization. The following information was reported: Dizziness(non-serious) with onset May2021, outcome "recovering", described as "before leaving the facility became dizzy". The event "before leaving the facility became dizzy" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of dizziness.  Follow up(26Jul2021): This is a follow up spontaneous report from contactable consumer in response to mail trail sent regarding the confirmation of below mentioned query.  Additional Information:I have to state, after looking at the document, I am not the patient. I am a Pfizer employee reporting a potential adverse event that was reported to me by a family member. I don't believe I can fill out the form as it appears to be addressed. Let me know more details if you have a desire for me to do something exceedingly different.Thank you for taking the time to contact Pfizer Inc., regarding experience(s) that occurred whilst taking a Pfizer product. We would like to ask you to provide some further information on the experience (s) you have reported and have attached a questionnaire we hope you will complete in this regard.Kindly fax or email the completed questionnaire to : fax Available.Thank you in advance for your assistance.Thank you once again for your cooperation. Response: I can't open the attachment. It says it needs a password.Also, I'm not a woman, I'm a man.Additionally, I didn't experience any issues with a Pfizer product, I was only providing information that was shared with me by a third party. Let me know if I am missing anything else here.  Information about lot/batch number was requested.No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Bowel movement irregularity
Clinical narrative: After the first vaccine I didnt have a bowel movement for 3 weeks. I finally had a normal BM the morning of 13May2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13May2021 (Lot number: EW0170) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: THYROXINE; CYMBALTA. The following information was reported: BOWEL MOVEMENT IRREGULARITY (non-serious) with onset 13May2021, outcome "unknown", described as "After the first vaccine I didnt have a bowel movement for 3 weeks. I finally had a normal BM the morning of 13May2021". Therapeutic measures were taken as a result of bowel movement irregularity.  Additional information: After the first vaccine she didn't have a bowel movement for 3 weeks. She finally had a normal BM the morning of 13May2021. CT scan showed that intestines were extremely inflamed. She don't eat meat or dairy. She took very good care of herself. She had a normal BM every morning up until she got the vaccine. She don't drink or smoke. The only new thing that's been introduced to her body was the vaccine. The treatment was enema, stool softener mag of citrate. No known allergies and no other medical history. 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 (22Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: After first dose, both hands felt numb from wrist to finger tips. After second dose the numbness has continued until today 10Jun2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2) (Lot number: EW0150) at the age of 72 years as dose 2, single and administered in arm left, administration date 22Mar2021 (Lot number: EP6955) 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: HYPOAESTHESIA (non-serious) with onset 22Mar2021, outcome "not recovered", described as "After first dose, both hands felt numb from wrist to finger tips. After second dose the numbness has continued until today 10Jun2021". Therapeutic measures were not taken as a result of hypoaesthesia.  Additional information: After first dose, both hands felt numb from wrist to finger tips. After second dose the numbness had continued until today 10Jun2021. Patient stated he had numbness in his hands from his wrist to the tip of his fingers and it had continued to this day. Patient states that was the only problem, no medication and he was okay otherwise. Patient stated the numbness in his hands started after the first vaccine and continued through the second dose and it was still there. Patient states he had gone for other check-ups and his physician said to him to call and give this information to Pfizer because it was unknown to them. Patient stated he did that online. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. The patient received no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Known allergies: No. Other Medical History: None.  Follow-up attempts are completed. No further information was expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Migraine, Uterine spasm
Clinical narrative: migraine beginning 6/12 which lasted for 24 hours; Unexplained uterine cramping; Menstruation delayed by a full week.; 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 11Jun2021 12:00 (Lot number: EW0191) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "chronic lyme disease" (unspecified if ongoing); "Allergies: wheat, barley, rye" (unspecified if ongoing), notes: wheat, barley, rye. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Product - COVID 19 , Brand - Pfizer, Lot number - EW0168, Lot unknown - False, Administration date  14May2021,, Administration time - 12:00 PM,, Vaccine location - Left arm,, Dose number - 1), administration date: 14May2021, for Covid-19 immunisation. The following information was reported: MIGRAINE (non-serious) with onset 12Jun2021 10:00, outcome "recovered" (2021), described as "migraine beginning 6/12 which lasted for 24 hours"; UTERINE SPASM (non-serious) with onset 12Jun2021 10:00, outcome "recovered" (2021), described as "Unexplained uterine cramping"; MENSTRUATION DELAYED (non-serious) with onset 12Jun2021 10:00, outcome "recovered" (2021), described as "Menstruation delayed by a full week.". Therapeutic measures were not taken as a result of migraine, uterine spasm, menstruation delayed.  Additional information: Migraine beginning 6/12 which lasted for 24 hours. Continued sporadically for several days. Unexplained uterine cramping beginning 6/12 and continued for several days. Menstruation delayed by a full week. Expected start date was 6/24. Actual start date 7/1. Facility type vaccine was Other. Patient did not receive other vaccine in four weeks or other medications in two weeks. Patient had no COVID prior vaccination. Patient did not tested COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Periarthritis
Clinical narrative: The general impact is that I have lack of mobility and chronic pain.; Partially frozen shoulder - both left & right; stiffness & muscle pain in other parts of body including legs around knees; The general impact is that I have lack of mobility and chronic pain.; stiffness & muscle pain in other parts of body including legs around knees; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 (Lot number: EW0158) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose1, single, Anatomical Location: Arm Left, Batch/lot number: ER2613), administration date: 27Mar2021, when the patient was 64 years old, for Covid-19 Immunization, reaction(s): "Fever", "Fatigue", "loss of appetite". The following information was reported: PAIN (non-serious), MOBILITY DECREASED (non-serious) all with onset 14Apr2021, outcome "not recovered" and all described as "The general impact is that I have lack of mobility and chronic pain."; PERIARTHRITIS (non-serious) with onset 14Apr2021, outcome "not recovered", described as "Partially frozen shoulder - both left & right"; MUSCULOSKELETAL STIFFNESS (non-serious), MYALGIA (non-serious) all with onset 14Apr2021, outcome "not recovered" and all described as "stiffness & muscle pain in other parts of body including legs around knees"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 10Apr2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The events "the general impact is that i have lack of mobility and chronic pain.", "partially frozen shoulder - both left & right", "stiffness & muscle pain in other parts of body including legs around knees", "the general impact is that i have lack of mobility and chronic pain." and "stiffness & muscle pain in other parts of body including legs around knees" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of pain, periarthritis, musculoskeletal stiffness, mobility decreased, myalgia.  Additional information: patient experienced Partially frozen shoulder - both left & right in addition to stiffness & muscle pain in other parts of body including legs around knees, etc. The general impact is that I have lack of mobility and chronic pain. Past drug history was not known but can be sensitive to drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. patient received Antibiotic about 2 weeks later on vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Erythema, Feeling hot, Headache, Lip swelling
Clinical narrative: headaches every day; An allergic reaction; uncontrollable itching on my knees , uncontrollable itching on my elbows and tops of both my feet; hives; redness; hotness; the right side of my lip was swollen; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (An allergic reaction), PRURITUS (uncontrollable itching on my knees , uncontrollable itching on my elbows and tops of both my feet), URTICARIA (hives), ERYTHEMA (redness) and FEELING HOT (hotness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced ALLERGY TO VACCINE (An allergic reaction), PRURITUS (uncontrollable itching on my knees , uncontrollable itching on my elbows and tops of both my feet), URTICARIA (hives), ERYTHEMA (redness), FEELING HOT (hotness) and LIP SWELLING (the right side of my lip was swollen). In May 2021, the patient experienced HEADACHE (headaches every day). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 22-Apr-2021 to 24-Apr-2021 for Allergy to vaccine, Itching, Hives, Redness, Feeling of warmth and Swollen lips, at a dose of 1 dosage form; IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing from May 2021 for Headache, at a dose of UNK dosage form; PARACETAMOL (TYLENOL) ongoing from May 2021 for Headache, at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) ongoing from May 2021 for Headache, at a dose of UNK dosage form. On 24-Apr-2021, ALLERGY TO VACCINE (An allergic reaction), PRURITUS (uncontrollable itching on my knees , uncontrollable itching on my elbows and tops of both my feet), URTICARIA (hives), ERYTHEMA (redness), FEELING HOT (hotness) and LIP SWELLING (the right side of my lip was swollen) had resolved. At the time of the report, HEADACHE (headaches every day) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown ), the reporter did not provide any causality assessment
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: headaches every day; An allergic reaction; uncontrollable itching on my knees , uncontrollable itching on my elbows and tops of both my feet; hives; redness; hotness; the right side of my lip was swollen; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (An allergic reaction), PRURITUS (uncontrollable itching on my knees , uncontrollable itching on my elbows and tops of both my feet), URTICARIA (hives), ERYTHEMA (redness) and FEELING HOT (hotness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced ALLERGY TO VACCINE (An allergic reaction), PRURITUS (uncontrollable itching on my knees , uncontrollable itching on my elbows and tops of both my feet), URTICARIA (hives), ERYTHEMA (redness), FEELING HOT (hotness) and LIP SWELLING (the right side of my lip was swollen). In May 2021, the patient experienced HEADACHE (headaches every day). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 22-Apr-2021 to 24-Apr-2021 for Allergy to vaccine, Itching, Hives, Redness, Feeling of warmth and Swollen lips, at a dose of 1 dosage form; IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing from May 2021 for Headache, at a dose of UNK dosage form; PARACETAMOL (TYLENOL) ongoing from May 2021 for Headache, at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) ongoing from May 2021 for Headache, at a dose of UNK dosage form. On 24-Apr-2021, ALLERGY TO VACCINE (An allergic reaction), PRURITUS (uncontrollable itching on my knees , uncontrollable itching on my elbows and tops of both my feet), URTICARIA (hives), ERYTHEMA (redness), FEELING HOT (hotness) and LIP SWELLING (the right side of my lip was swollen) had resolved. At the time of the report, HEADACHE (headaches every day) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown ), the reporter did not provide any causality assessment
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Neck pain, Pain in extremity
Clinical narrative: Neck hurting was reported as worsened.; The pain starts at the stem of the neck and goes into the head.; left arm is kind of hurting too; Neck hurting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Jul2021 (Lot number: EW0198) at the age of 68 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: Received 16Jun2021, lot EW01S6 or EW01SG, NDC and expiration date unknown), administration date: 16Jun2021, for COVID-19 Immunization. The following information was reported: NECK PAIN (non-serious) with onset 08Jul2021, outcome "not recovered", described as "Neck hurting"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Neck hurting was reported as worsened."; HEADACHE (non-serious), outcome "unknown", described as "The pain starts at the stem of the neck and goes into the head."; PAIN IN EXTREMITY (non-serious) with onset 08Jul2021, outcome "recovering", described as "left arm is kind of hurting too". Therapeutic measures were taken as a result of neck pain, condition aggravated, headache, pain in extremity.  Additional information: The caller was never going to get the shot but got it because of fear. This morning the caller got up and her neck hurt so back she had to use her hands to lift her head up. Is this a side effect of the vaccine and is it something that will go away? It is the stem of her neck that is bothering her. The caller is hurting so bad and is assuming that its from the vaccine. The caller has been taking Advil. The pain starts at the stem of the neck and goes into the head. The caller's left arm is kind of hurting too. The caller has never taken any type of vaccine except a small pox vaccine when she was a child. Is this normal?  No follow-up attempts are possible. No further information is expected.  Follow-Up (28Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: RIGHT LEG DEEP VEIN THROMBOSIS; PULMONARY EMBOLISM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient reported to be on no meds, with no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered in late JUL-2021 or early AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in JUL-2021 or AUG-2021, within 3 weeks of vaccination, the patient developed deep vein thrombosis (DVT) to right leg, and said DVT was reported to be half the length of the thigh. Then, 2 days after, patient experienced pulmonary embolism formed to right pulmonary artery, and during SEP-2021, patient was hospitalized for most of the month. Number of days of hospitalization was not reported. The patient had returned to work but was struggling, still had trouble breathing, struggles to be on their feet to work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right leg deep vein thrombosis, and pulmonary embolism. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220244732-COVID-19 VACCINE AD26.COV2.S-right leg deep vein thrombosis, pulmonary embolism. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Overweight, Pain, Pyrexia
Clinical narrative: his weight is too heavy; slight temperature; aches and pains; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient. A 74 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 10Mar2021 (Lot number: EN6205, Expiration Date: 30Jun2021) at the age of 73 years as dose 2, 0.3ml single and administered in arm left, administration date 17Feb2021 (Lot number: EL9266, Expiration Date: 31May2021) as dose 1, 0.3ml single for covid-19 immunisation. Relevant medical history included: "Type II Diabetes" (unspecified if ongoing), notes: Diagnosed about two years ago; "Verbatim: Triple bypass" (unspecified if ongoing), notes: This was about three years ago. The patient's concomitant medications were not reported. Vaccination history included: Flu shot (he mentions he had the flu shot and that was fine had a flu shot that was fine). The following information was reported: PYREXIA (non-serious) with onset 16Sep2021, outcome "unknown", described as "slight temperature"; PAIN (non-serious) with onset 16Sep2021, outcome "unknown", described as "aches and pains"; OVERWEIGHT (non-serious), outcome "unknown", described as "his weight is too heavy".  Additional information: Per caller he and his wife received the Pfizer Covid 19 Booster Vaccine on 16Sep2021. On 20Sep2021 they received a call from (Pharmacy Name Withheld) to inform them that due to a temperature excursion they would need to come back in for revaccination. They reached out to their HCP who also advised revaccination. He did try to schedule with (Pharmacy Name Withheld) online in which it would not proceed to schedule due to the showing of the last vaccine on 16Sep2021. Caller was concerned about the slight temperature, aches and pains experienced with the previous vaccine. The caller clarifies after him and his wife were vaccinated, they did in fact have pains, aches, and a slight fever just like they did with the first two shots. The caller clarifies after him and his wife were vaccinated, they did in fact have pains, aches, and a slight fever just like they did with the first two shots.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Nasopharyngitis, Nausea
Clinical narrative: Headache; Nausea; Fatigue; I was feeling like I was having cold; Arm is real swollen and it hurt a lot; its sore; Arm is real swollen and it hurt a lot; its sore; feeling sick; 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, administration date May2021 (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: HEADACHE (non-serious) with onset May2021, outcome "unknown", described as "Headache"; NAUSEA (non-serious) with onset May2021, outcome "unknown", described as "Nausea"; FATIGUE (non-serious) with onset May2021, outcome "unknown", described as "Fatigue"; NASOPHARYNGITIS (non-serious) with onset May2021, outcome "unknown", described as "I was feeling like I was having cold"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset May2021, outcome "unknown" and all described as "Arm is real swollen and it hurt a lot; its sore"; MALAISE (non-serious) with onset May2021, outcome "unknown", described as "feeling sick". Therapeutic measures were taken as a result of headache.  Additional Information: Consumer stated, Patient do have a concern. Patient had second dose of Pfizer Friday and the Friday in the evening, Patient didn't had anything, Saturday, had a headache, all day and Patient was taking something for that. Saturday night, Patient started feeling sick, Patient was able to work and Patient was feeling nausea and fatigue. Patient was feeling like I was having cold and also where they gave the shot, my arm is real swollen and it hurt a lot and I don't know patient didn't have an allergic reaction to anything, Patient not allergic but its sore (arm).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Headache; Nausea; Fatigue; I was feeling like I was having cold; Arm is real swollen and it hurt a lot; its sore; Arm is real swollen and it hurt a lot; its sore; feeling sick; 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, administration date May2021 (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: HEADACHE (non-serious) with onset May2021, outcome "unknown", described as "Headache"; NAUSEA (non-serious) with onset May2021, outcome "unknown", described as "Nausea"; FATIGUE (non-serious) with onset May2021, outcome "unknown", described as "Fatigue"; NASOPHARYNGITIS (non-serious) with onset May2021, outcome "unknown", described as "I was feeling like I was having cold"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset May2021, outcome "unknown" and all described as "Arm is real swollen and it hurt a lot; its sore"; MALAISE (non-serious) with onset May2021, outcome "unknown", described as "feeling sick". Therapeutic measures were taken as a result of headache.  Additional Information: Consumer stated, Patient do have a concern. Patient had second dose of Pfizer Friday and the Friday in the evening, Patient didn't had anything, Saturday, had a headache, all day and Patient was taking something for that. Saturday night, Patient started feeling sick, Patient was able to work and Patient was feeling nausea and fatigue. Patient was feeling like I was having cold and also where they gave the shot, my arm is real swollen and it hurt a lot and I don't know patient didn't have an allergic reaction to anything, Patient not allergic but its sore (arm).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dehydration, Feeling abnormal, Vomiting
Clinical narrative: Dehydration; have weird things happening to me almost daily / feel horrible 75 per cent of the time; no stamina / can not do anything like i used to / but now, i have been reduced to afternoon naps; severe vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (Dehydration), FEELING ABNORMAL (have weird things happening to me almost daily / feel horrible 75 per cent of the time), ASTHENIA (no stamina / can not do anything like i used to / but now, i have been reduced to afternoon naps) and VOMITING (severe vomiting) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEHYDRATION (Dehydration), FEELING ABNORMAL (have weird things happening to me almost daily / feel horrible 75 per cent of the time), ASTHENIA (no stamina / can not do anything like i used to / but now, i have been reduced to afternoon naps) and VOMITING (severe vomiting). At the time of the report, DEHYDRATION (Dehydration), FEELING ABNORMAL (have weird things happening to me almost daily / feel horrible 75 per cent of the time), ASTHENIA (no stamina / can not do anything like i used to / but now, i have been reduced to afternoon naps) and VOMITING (severe vomiting) outcome was unknown.            Concomitant medications were not reported.  Patient had to received emergency treatment due to sever vomiting and dehydration. It was 4 month later and had weird things happened to almost daily. Patient had no stamina, could not do anything like used to and felt horrible 75 percent of the time. He/she reduced to afternoon naps.   Treatment medications were not reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: severe headache; My left arm is extremely swollen, in comparison with my right arm is almost twice the size of the right arm; My left arm is numb; experiencing pain when I attempt to move my arm; rash all over my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 14:15 (Lot number: EW0178) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergic to latex" (unspecified if ongoing); "Allergic to dust" (unspecified if ongoing); "Allergic to mites" (unspecified if ongoing). The patient's concomitant medications were not reported.The following information was reported: HEADACHE (non-serious) with onset 05Nov2021 20:00, outcome "not recovered", described as "severe headache"; PERIPHERAL SWELLING (non-serious) with onset 05Nov2021 20:00, outcome "not recovered", described as "My left arm is extremely swollen, in comparison with my right arm is almost twice the size of the right arm"; HYPOAESTHESIA (non-serious) with onset 05Nov2021 20:00, outcome "not recovered", described as "My left arm is numb"; PAIN IN EXTREMITY (non-serious) with onset 05Nov2021 20:00, outcome "not recovered", described as "experiencing pain when I attempt to move my arm"; RASH (non-serious) with onset 05Nov2021 20:00, outcome "not recovered", described as "rash all over my body". Therapeutic measures were taken as a result of headache, rash. Therapeutic measures were not taken as a result of peripheral swelling, hypoaesthesia, pain in extremity.  Additional Information: Facility where the most recent COVID-19 vaccine was administered: Other. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Loratadine within 2 weeks of vaccination. The patient was not diagnosed with COVID prior to vaccination. The patient has not tested for COVID since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fluid retention, Rash erythematous, Swelling
Clinical narrative: Swelling with accumulation of fluid in from left armpit, down side of left breast to top of left side torso; Swelling with accumulation of fluid in from left armpit, down side of left breast to top of left side torso; Red rash from left shoulder, across chest and to top of torso; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP and Physician). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Nov2021 10:15 (Lot number: FH8027) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESCITALOPRAM. Vaccination history included: Bnt162b2 (Dose 1, single, Lot no: EP7534, vaccination location: left arm), administration date: 23Mar2021, when the patient was 60 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, single, Lot no: EW0161, vaccination location: left arm), administration date: 13Apr2021, when the patient was 60 years old, for Covid-19 immunization.  The following information was reported: SWELLING (non-serious), FLUID RETENTION (non-serious) all with onset 07Nov2021, outcome "not recovered" and all described as "Swelling with accumulation of fluid in from left armpit, downside of left breast to top of left side torso"; RASH ERYTHEMATOUS (non-serious) with onset 07Nov2021, outcome "recovered", described as "Red rash from left shoulder, across chest and to top of torso". The events "swelling with accumulation of fluid in from left armpit, downside of left breast to top of left side torso", "swelling with accumulation of fluid in from left armpit, downside of left breast to top of left side torso" and "red rash from left shoulder, across chest and to top of torso" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of swelling, fluid retention, rash erythematous.  Additional information: Patient has not taken any other vaccines within four weeks. Rash subsided but fluid seems to be migrating downside. Will be making a doctor appt. Prior to vaccination patient was not tested for covid-19 and not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Blood test, Herpes zoster, Pain in extremity, Rash
Clinical narrative: shingles; very few of the rash and blistering; very few of the rash and blistering; pain underneath the right armpit; 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 67 year-old female patient received bnt162b2 (COMIRNATY), administered in arm, administration date 04Apr2021 13:08 (Lot number: ER8729) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Shingles", start date: 2006 (unspecified if ongoing); "Cancer" (unspecified if ongoing); "Stress" (unspecified if ongoing); "Colon cancer", start date: 2005, stop date: 2005, notes: Colon surgery after 1st dose of chemo drug had cardiac shock + sepsis; "Shingles", start date: 2021 (ongoing), notes: In healing stage ,I will receive the 3rd booster shot when Cholesterol are gone.; "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: VALTREX, start date: 19Oct2021, stop date: 26Oct2021; ATORVASTATIN taken for blood cholesterol (ongoing). Past drug history included: Folfox + isovue  reaction, start date: 2005, reaction(s): "Drug reaction", notes: Cardiac shock+ sepsis Hives- isovue 300; Folfox + isovue reaction, start date: 2005, reaction(s): "Drug reaction", notes: Cardiac shock+ sepsis Hives- isovue 300. Vaccination history included: Bnt162b2 (First dose, Lot: EN6207), administration date: 14Mar2021, when the patient was 66 years old, for Covid-19 immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 19Oct2021, outcome "recovering", described as "shingles"; RASH (non-serious), BLISTER (non-serious) all with onset Apr2021, outcome "recovering" and all described as "very few of the rash and blistering"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovering", described as "pain underneath the right armpit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, blister, pain in extremity.  Additional information:  she started taking Valtrex for shingles on 19Oct2021 and finished the 7 day course on 26Oct2021. she was diagnosed with shingles on Tuesday 19Oct2021 and started taking the Valtrex that day and had very few of the rash and blistering and that seems to be the blistering is reduced and she had 5- 6 blisters; states she does still have the pain underneath the right armpit and the pain she believes is better but believes it is hard to has been taking the Advil 3-4 times per day and judge because she taking two of them but reduced it and cut the dose back to now only having to take 1 dose per day of two pills of Advil in the morning; states that come night she can feel the pain underneath her armpit and feels the Advil is masking the pain but still has the pain but it is fine with the Advil  No follow-up attempts are possible. No further information is expected.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vomiting
Clinical narrative: Fever that reached 102 degrees; Vomiting; This is a spontaneous report from a contactable consumer (Patient). An 5-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 11:45 (Lot number: FK5618) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Allergy: Amoxicillin". The following information was reported: PYREXIA (non-serious) with onset 14Nov2021 08:00, outcome "recovering", described as "Fever that reached 102 degrees"; VOMITING (non-serious) with onset 14Nov2021 08:00, outcome "recovering", described as "Vomiting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, vomiting.   Additional information: Facility type Vaccine= Public Health Clinic/Veterans Administration facility. if other vaccine in four weeks=No. other medications in two weeks=No. if treatment ae=No. if covid prior vaccination=No. if covid tested post vaccination=No. known allergies=Amoxicillin. other medical history=No.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hypersensitivity, Maternal exposure during pregnancy, Urticaria
Clinical narrative: She is 7 weeks pregnant; After 48 hours she experienced an allergic reaction of hives over about 65 percent of her body.; After 48 hours she experienced an allergic reaction of hives over about 65 percent of her body.; hives all over my body; '60'% of my body covered; 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 38 year-old female patient (pregnant) received bnt162b2 (COMIRNATY), administration date 29Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient was 7 weeks pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "swollen lymph nodes", "She is 7 weeks pregnant", "sore arm"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: MATERNAEXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "She is 7 weeks pregnant"; URTICARIA (non-serious), HYPERSENSITIVITY (non-serious), outcome "unknown" and all described as "After 48 hours she experienced an allergic reaction of hives over about 65 percent of her body."; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "hives all over my body; '60'% of my body covered". Therapeutic measures were taken as a result of urticaria, hypersensitivity, condition aggravated.  Additional information: Patient stated that after 48 hours of booster, she started to develop the hives all over my body, so I took anti-allergic medicine and its start to go away but then on Wednesday, anti-allergic effect, it's finishing it's come back. it's so 'itch' badly that I am trying to avoid itching in the I don't know what to do, so took another anti allergic drug 30 minutes ago and I went to see the physician today. OBGYN recommended to take Claritin, she had taken one pill. she also took Benadryl.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Haematoma
Clinical narrative: hematoma; This is a spontaneous report from a contactable consumer. This 65-Year-old female consumer (patient) reported for herself that:  A 65-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Feb2021 (Lot number: FF8841, Expiration Date: Jun2021) at the age of 64 years as dose 2, 0.3 ml single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (first dose, Lot Number / Expiry Date: EL3302/unknown, Route, Anatomical Location: unknown), administration date: 21Jan2021, when the patient was 64 years old, for COVID-19 immunization, reaction(s): "None". The following information was reported: HAEMATOMA (non-serious) with onset 11Feb2021, outcome "recovered" (21Feb2021), described as "hematoma". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The only reaction she had in 11Feb2021 when she received the vaccine, was that she had a hematoma. She got the shot in her left shoulder, and she got the hematoma in her right arm. Within 4 or 5 hours, she just looked down and had this very large hematoma on her forearm. It lasted a good 10 days, at least. Clarified that the caller received the second dose of the Covid vaccine in her left shoulder. Caller states she does not remember which location in her body that she received the first dose.  Event Details: She received the booster 03Nov2021, around 1:30 or 2:00 in the afternoon. Around 1:30 or 2:00 in the morning, she started vomiting and woke up from her sleep. Clarified that the caller was referring to 1:30 or 2:00 in the morning, going into the next day, 04Nov2021. The vomiting continued until Saturday morning. Along with that came very high fevers of 102. That lasted until Sunday. Along with that, came severe fatigue that lasted until Wednesday, until 10Nov2021. The nausea lasted until about 10Nov2021. The fevers started around the same time that the vomiting started, around 1:30, 2:00 in the morning, 04Nov2021. She states that her skin hurt as well. She had severe migraines and was putting ice on her forehead. It was probably from the fever. Outcome, fevers: She would say, she is pretty much back on track. Migraines: They lasted probably until around that Sunday and has recovered completely from those. Vomiting: lasted until Saturday and she has fully recovered from that. It was that night, or Wednesday morning that the vomiting started and was coming like 7 times. It was not like it was a one and done. It was horrible and she was dry heaving and she had just never been this sick.   She could not even tell when the last time was, she vomited before this. Nausea: She did feel nauseous until that Wednesday, it was for a week, she was nauseous. Treatment: She was taking Tylenol and she is predisposed to migraines, so she was taking Sumatriptan.   No follow-up attempts are possible. No further information is expected.