chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Nausea, Pain in extremity, Vertigo
Clinical narrative: could not walk from the leg pain for a period of time; leg pain; numbness after the first dose of the vaccine; vertigo; nausea; vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 45 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "vertigo"; Bnt162b2, for Covid-19 immunization, reaction(s): "numbness", "nausea", "Leg pain", "vomiting". The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "could not walk from the leg pain for a period of time"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "leg pain"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness after the first dose of the vaccine"; VERTIGO (non-serious), outcome "unknown", described as "vertigo"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; VOMITING (non-serious), outcome "unknown", described as "vomiting".  Additional information: She could not walk from the leg pain for a period of time. The event took place after use of product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: could not walk from the leg pain for a period of time; leg pain; numbness after the first dose of the vaccine; vertigo; nausea; vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 45 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "vertigo"; Bnt162b2, for Covid-19 immunization, reaction(s): "numbness", "nausea", "Leg pain", "vomiting". The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "could not walk from the leg pain for a period of time"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "leg pain"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness after the first dose of the vaccine"; VERTIGO (non-serious), outcome "unknown", described as "vertigo"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; VOMITING (non-serious), outcome "unknown", described as "vomiting".  Additional information: She could not walk from the leg pain for a period of time. The event took place after use of product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm".  Additional information: Age of patient: 68, unit: Unknown. For the first dose, sore arm for a day and a half.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: bad headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Regulatory Authority.  A male patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "bad headaches". Therapeutic measures were not taken as a result of headache.  Additional information: A contactable consumer reported for a male patient (husband) to report some adverse events experienced by her husband. The reporter mentioned that after her husband's 2nd shot of the vaccine (10Mar2021), he started experiencing bad headaches and wants to know if it's okay to take pain relievers. She also clarified that her husband didn't take any pain relievers yet. the reporter was not a Healthcare Professional (HCP). It was unknown whether the reporter's contact information available to you or a sub-contracted party or If the reporter is not the prescribing HCP.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Headache; I woke up with chills all day long; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 13:00 (Lot number: EN6208) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Verbatim: Blood pressure; "Thyroid" (unspecified if ongoing), notes: Verbatim: Thyroid. The patient took concomitant medications. Vaccination history included: Bnt162b2 (The first shot I did not get any reaction, For the first one, EN6200), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 11Mar2021 04:30, outcome "recovered" (Mar2021), described as "I woke up with chills all day long"; HEADACHE (non-serious), outcome "unknown", described as "Headache".  Additional Context: Consumer stated, The second shot for the COVID, 4:30 yesterday morning, I got the shot yesterday afternoon around 1 and 4:30 in the next morning I woke up with chills all day long until 6'o clock and I could not move off my couch. It says to report if you feels anything so that is what I am doing just reporting what I felt.", chills all day since 6:30 at night and a headache but do not need anything. The chills was the big thing. Consumer stated, "I took my blood pressure pills and thyroid pills. Consumer stated, I do not know, the thyroid is 'Levothyroxine' or something like that and the blood pressure is Alopine or something like that."  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitis and had ringing and buzzing in both of her ears; 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 left, administration date 11Mar2021 (Lot number: EN6208) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Tinnitus" (unspecified if ongoing), notes: Verbatim: Tinnitus; "citrus and nuts" (unspecified if ongoing); "citrus and nuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 12Mar2021, outcome "not recovered", described as "tinnitus and had ringing and buzzing in both of her ears".  Additional information: Patient stated she has not had treatment for the tinnitis and states if it is helpful to include that she has had tinnitis intermittently in the past and has not had this particular symptom of tinnitis with ringing and buzzing in both of her ears for a couple of years until this morning# states she retired about 4 years ago so if she had to estimate she would say the tinnitis she had prior to the vaccine as not something that was continuous but more intermittent and began about 6 years ago. patient stated she experienced tinnitis and had ringing and buzzing in both of her ears that began she estimates about 9:00 this morning on 12Mar2021 and the tinnitis is ongoing and it is continuous, but she would say it is moderate as opposed to horrible and remains the same as when the tinnitis began this morning. Patient stated the facility is a hospital about a mile from her home# states the wait was about 30 minutes because they asked her about sensitivity to medication or food sensitivities and she mentioned with citrus and nuts she has had instances of gasping for air and so she stayed for 30 minutes instead of 15 minutes at the facility and had no problems. additional vaccines administered on same date of the pfizer suspect reported as none. Event does not require to visit emergency room and physician office. 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.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  Additional Information: Patient and his wife both received first CoVax 02Mar2021, asked if could take Ibuprofen after receiving CoVax. Reported experiencing "Sore arm" after CoVax, and mentioned wife wants to take Ibuprofen because she has a ''sore back''.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: sore back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "sore back".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site hurt/ injection site soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 88 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 02Mar2021 (Lot number: EL9267) at the age of 88 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood pressure" (unspecified if ongoing); "Gas" (unspecified if ongoing); "Sleep" (unspecified if ongoing); "Relaxation" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] (ongoing); ATENOLOL taken for hypertension, start date: 2020 (ongoing); OMEPRAZOLE taken for flatulence (ongoing); AMLODIPINE taken for hypertension (ongoing); MIRTAZAPINE taken for sleep disorder, feeling of relaxation (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 02Mar2021, outcome "recovering", described as "injection site hurt/ injection site soreness".  Additional information: Anatomical location - right upper arm. Indication - COVID-19 vaccination. Aspirin: Been on it for a while. Been on it for a long time, in conjunction with the Atenolol. Atenolol: Started taking it about a year ago, been on this dose for less than a year. Omeprazole: Started it about a year ago. Amlodipine: Been on it for about 6 months. Mirtazapine: Been on it for more than a year. Reporter is a consumer that was calling about the Covid-19 vaccine and stated that she received the first dose of the vaccine on 02Mar2021. She said that her injection site hurt kind of off and on and did not know if she should report it. Event: The reporter said that yesterday and today, her injection site soreness started to improve stated that her symptom is improved but is still off and on. Return date for her second dose is the 23Mar2021. Reporter said that she wanted to know what she could take for pain. It is not just pain and aching, she just knows it was there and was hurting a little bit. Time the vaccination was given between 1400-1500 on 02Mar2021. Vaccination Facility Type: Hospital. Prior Vaccinations (within 4 weeks) none.  No follow-up attempts are possible. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Pain assessment, Pain in extremity, Vaccination site pain
Clinical narrative: injection site hurt/ injection site soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 88 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 02Mar2021 (Lot number: EL9267) at the age of 88 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood pressure" (unspecified if ongoing); "Gas" (unspecified if ongoing); "Sleep" (unspecified if ongoing); "Relaxation" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] (ongoing); ATENOLOL taken for hypertension, start date: 2020 (ongoing); OMEPRAZOLE taken for flatulence (ongoing); AMLODIPINE taken for hypertension (ongoing); MIRTAZAPINE taken for sleep disorder, feeling of relaxation (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 02Mar2021, outcome "recovering", described as "injection site hurt/ injection site soreness".  Additional information: Anatomical location - right upper arm. Indication - COVID-19 vaccination. Aspirin: Been on it for a while. Been on it for a long time, in conjunction with the Atenolol. Atenolol: Started taking it about a year ago, been on this dose for less than a year. Omeprazole: Started it about a year ago. Amlodipine: Been on it for about 6 months. Mirtazapine: Been on it for more than a year. Reporter is a consumer that was calling about the Covid-19 vaccine and stated that she received the first dose of the vaccine on 02Mar2021. She said that her injection site hurt kind of off and on and did not know if she should report it. Event: The reporter said that yesterday and today, her injection site soreness started to improve stated that her symptom is improved but is still off and on. Return date for her second dose is the 23Mar2021. Reporter said that she wanted to know what she could take for pain. It is not just pain and aching, she just knows it was there and was hurting a little bit. Time the vaccination was given between 1400-1500 on 02Mar2021. Vaccination Facility Type: Hospital. Prior Vaccinations (within 4 weeks) none.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I did not have any reaction with the first one other than headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received bnt162b2 (BNT162B2) (Lot number: EN6200) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Verbatim: Blood pressure; "Thyroid" (unspecified if ongoing), notes: Verbatim: Thyroid. Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder; ALOPINE taken for blood pressure abnormal. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "I did not have any reaction with the first one other than headache".  Additional information: Patient did not have any reaction with the first one other than headache.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Confusional state, Disorientation, Speech disorder
Clinical narrative: Having a lot of disorientation and confusion; Having a lot of disorientation and confusion; Trouble speaking; putting words in sentences together; 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), administration date 11Mar2021 (Batch/Lot number: unknown) as unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONFUSIONAL STATE (non-serious), DISORIENTATION (non-serious) all with onset Mar2021, outcome "unknown" and all described as "Having a lot of disorientation and confusion"; SPEECH DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "Trouble speaking; putting words in sentences together".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Significant pain; Muscular problems through my arm, back and upper leg, on the right side which is where I had the injection# it's hard to move; 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), administration date 08Mar2021 (Lot number: EN6201) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (about approximately I guess 3 weeks earlier I had the first shot, first shot EL1284), for COVID-19 immunisation. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Significant pain"; MYALGIA (non-serious), outcome "unknown", described as "Muscular problems through my arm, back and upper leg, on the right side which is where I had the injection# it's hard to move".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ligament sprain, Pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient) via a Pfizer-sponsored program (159558). A male patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history not reported. There were no concomitant medications. The patient had a ligament sprain/foot is swollen/it looks like a sprain, and pain/ache in the toe, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Malaise, Weight
Clinical narrative: Dizzy; Weak; Not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) at the age of 41 years as 1st dose, single. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "not recovered", described as "Dizzy"; ASTHENIA (non-serious), outcome "not recovered", described as "Weak"; MALAISE (non-serious), outcome "not recovered", described as "Not feeling well". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, asthenia, malaise.  Additional Information : Patient had an immediate reaction and currently still having reactions almost it was like side effects. Patient had it on Tuesday morning and still was dizzy, weak, just like not feeling well, so patient just recently get off the phone and insurance, like trying to get the nurse on the line and talk to primary care doctor, this number was in the packet that they sent me through, so patient calling all the numbers. Consumer was informed about the Role of Pfizer Drug Safety. Patient reported that patient thought patient was about 250 pounds. When probed for dose, Patient reported that was patient's first shot. When probed for route of administration, Patient reported patient received the shot in arm. When probed for any concomitant medication, Patient reported he took his prescription medicine that was it. The patient talked to primary care doctor, she told to take Tylenol and Benadryl, so patient need to go get that. Patient reported , patient did not have the card. Patient just realized that once patient got the shot usually they have to call 'EMF', so when the 'EMF' came over and the person have all our information, it was in the folder that they had taken from Wednesday from worksheet.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: They have several friends who had adverse reactions; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a (RA). A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 27Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ADVERSE REACTION (non-serious), outcome "unknown", described as "They have several friends who had adverse reactions".  Additional information: No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. Caller stated his wife, his mother in law and himself all received their 1st Pfizer dose on 27Feb and are scheduled to received their 2nd dose on Mar2020. They have several friends who had adverse reactions following their 2nd dose. Caller would like to have just one of them (himself/wife/mother in law) receive 2nd dose to see if they have a reaction and if they do not have a reaction, the remaining 2 will receive their 2nd dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary incontinence, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Urinary incontinence; Swollen, bump at injection site itching; Swollen, bump at injection site; Swollen, bump at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 76-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jan2021 14:00 (Lot number: EL0142) at the age of 76 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LAMOTRIGINE, start date: Oct2020 (ongoing), BUSPIRONE, start date: Mar2019 (ongoing), SYNTHROID, start date: 1992 (ongoing), MONTELUKAST, start date: 2020, LOSTATIN, start date: 2019, OMEPRAZOLE, start date: 2017, IRBESARTAN, start date: 2016, FAMOTIDINE, start date: 2017, CYTOMEL, start date: 2020 (ongoing). Vaccination history included: Bnt162b2 (1st dose, Batch/Lot number: EL0142, Time: 14:00), administration date: 10Jan2021, when the patient was 76 years old for Covid-19 immunisation, reaction(s): "Swollen, very sore, hot arm by injection site", "itching", "fever", "Very tired", "Achy", "Headache", "Diarrhea". The following information was reported: URINARY INCONTINENCE (non-serious) with onset 31Jan2021, outcome "recovered" (2021), described as "urinary incontinence", VACCINATION SITE PRURITUS (non-serious) with onset 31Jan2021, outcome "recovered" (2021), described as "swollen, bump at injection site itching", VACCINATION SITE MASS (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 31Jan2021, outcome "recovered" (2021) and all described as "swollen, bump at injection site". Therapeutic measures were not taken as a result of urinary incontinence, vaccination site pruritus, vaccination site inflammation, vaccination site swelling.  Additional information: Patient reported issue occurred after use of a Pfizer product. No surgical treatment needed for the event. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Emergency room or physician office visit was not required for any event. No admission to hospital due to the events. No prior vaccination within 4 weeks of covid-19 vaccine.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: hit me pretty hard; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2, Solution for injection) (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 (I got both vaccinations, Dose 1), for COVID-19 immunisation. The following information was reported: DISCOMFORT (non-serious), outcome "recovering", described as "hit me pretty hard".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Hypoaesthesia, Pain in extremity, Skin lesion
Clinical narrative: Painful bumps on only top pads of fingers; Area of skin was numb to touch, but painful without touching; Area of skin was numb to touch, but painful without touching; One thumb had a larger area that was raised, felt like blister, but not liquid filled; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Mar2021 16:00 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "unknown chronic infection" (unspecified if ongoing); "functional natural killer cell deficiency" (unspecified if ongoing), notes: untreated functional Natural Killer Cell Deficiency; "Mannose binding lectin deficiency" (unspecified if ongoing). Concomitant medication(s) included: FLUCONAZOLE. Past drug history included: Vancomycin, reaction(s): "rash"; Morphine, reaction(s): "rash". The following information was reported: SKIN LESION (non-serious) with onset 12Mar2021 07:00, outcome "unknown", described as "Painful bumps on only top pads of fingers"; HYPOAESTHESIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 12Mar2021 07:00, outcome "unknown" and all described as "Area of skin was numb to touch, but painful without touching"; BLISTER (non-serious) with onset 12Mar2021 07:00, outcome "unknown", described as "One thumb had a larger area that was raised, felt like blister, but not liquid filled". Therapeutic measures were not taken as a result of skin lesion, hypoaesthesia, pain in extremity, blister.  Additional information: The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with covid prior vaccination and not had been tested post vaccination. The patient had painful bumps on only top pads of fingers. Area of skin was numb to touch, but painful without touching. Not blisters, not rash. Only a few bumps on some fingertips, but not all. One thumb had a larger area that was raised, felt like blister, but not liquid filled.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Malaise
Clinical narrative: Severe pain at injection site; bad headache; dizziness; fatigue; not feeling well; weakness; shaking; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 11:30 (Lot number: EN6204) at the age of 56 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "gastroparesis" (unspecified if ongoing); "depression" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: COVID prior to vaccination . Concomitant medication(s) included: TRAZODONE; LAMICTAL; BUSPAR; WELLBUTRIN; PRILOSEC [OMEPRAZOLE]. Past drug history included: Demerol, reaction(s): "Known allergies:demerol". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 12Mar2021 22:00, outcome "recovering", described as "Severe pain at injection site"; HEADACHE (non-serious) with onset 12Mar2021 22:00, outcome "recovering", described as "bad headache"; DIZZINESS (non-serious) with onset 12Mar2021 22:00, outcome "recovering", described as "dizziness"; FATIGUE (non-serious) with onset 12Mar2021 22:00, outcome "recovering", described as "fatigue"; MALAISE (non-serious) with onset 12Mar2021 22:00, outcome "recovering", described as "not feeling well"; ASTHENIA (non-serious) with onset 12Mar2021 22:00, outcome "recovering", described as "weakness"; TREMOR (non-serious) with onset 12Mar2021 22:00, outcome "recovering", described as "shaking". Therapeutic measures were not taken as a result of vaccination site pain, headache, dizziness, fatigue, malaise, asthenia, tremor. Additional information: the patient did not receive other vaccines in 4 weeks. The patient was not tested for COVID-19 post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vaccination site pain
Clinical narrative: Severe pain at injection site; bad headache; dizziness; fatigue; not feeling well; weakness; shaking; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 11:30 (Lot number: EN6204) at the age of 56 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "gastroparesis" (unspecified if ongoing); "depression" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: COVID prior to vaccination . Concomitant medication(s) included: TRAZODONE; LAMICTAL; BUSPAR; WELLBUTRIN; PRILOSEC [OMEPRAZOLE]. Past drug history included: Demerol, reaction(s): "Known allergies:demerol". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 12Mar2021 22:00, outcome "recovering", described as "Severe pain at injection site"; HEADACHE (non-serious) with onset 12Mar2021 22:00, outcome "recovering", described as "bad headache"; DIZZINESS (non-serious) with onset 12Mar2021 22:00, outcome "recovering", described as "dizziness"; FATIGUE (non-serious) with onset 12Mar2021 22:00, outcome "recovering", described as "fatigue"; MALAISE (non-serious) with onset 12Mar2021 22:00, outcome "recovering", described as "not feeling well"; ASTHENIA (non-serious) with onset 12Mar2021 22:00, outcome "recovering", described as "weakness"; TREMOR (non-serious) with onset 12Mar2021 22:00, outcome "recovering", described as "shaking". Therapeutic measures were not taken as a result of vaccination site pain, headache, dizziness, fatigue, malaise, asthenia, tremor. Additional information: the patient did not receive other vaccines in 4 weeks. The patient was not tested for COVID-19 post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Migraine, Photophobia
Clinical narrative: Throbbing headache almost like a migraine; Throbbing headache almost like a migraine; light sensitivity; tiredness; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 (Lot number: EL3247) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), MIGRAINE (non-serious), outcome "not recovered" and all described as "Throbbing headache almost like a migraine"; PHOTOPHOBIA (non-serious), outcome "not recovered", described as "light sensitivity"; FATIGUE (non-serious), outcome "not recovered", described as "tiredness".  Additional information: The patient did not receive other vaccine in four weeks. The patient did not covid prior vaccination. The patient did not have covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Vaccination site pain, Vaccination site swelling
Clinical narrative: Ache/swelling at injection site; Ache/swelling at injection site; Body ache; chills; extreme tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 09:30 (Lot number: EL3248) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mild hypertension" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN; BYSTOLIC. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer/BioNTech, lot number=EL3247, lot unknown=False, administration date=19Feb2021, administration time=01:00 PM, vaccine location=Left arm, dose number=1), administration date: 19Feb2021, when the patient was 71 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 11Mar2021 23:00, outcome "recovered" (2021) and all described as "Ache/swelling at injection site"; PAIN (non-serious) with onset 11Mar2021 23:00, outcome "recovered" (2021), described as "Body ache"; CHILLS (non-serious) with onset 11Mar2021 23:00, outcome "recovered" (2021), described as "chills"; FATIGUE (non-serious) with onset 11Mar2021, outcome "recovered" (2021), described as "extreme tired". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, pain, chills, fatigue.  Additional Information: Prior to vaccination, patient was not diagnosed with Covid-19. Since the vaccination, patient has not been tested for Covid-19. Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. known allergies to NSAIDS.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Influenza like illness
Clinical narrative: Flu like symptoms; I am still sick and it is like the flu; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "not recovered", described as "Flu like symptoms"; ILLNESS (non-serious), outcome "not recovered", described as "I am still sick and it is like the flu".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: enlarged lymph nodes; felt achy; sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2021 15:15 (Lot number: El9262) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 05Feb2021 15:00, outcome "recovered with sequelae" (Feb2021), described as "enlarged lymph nodes"; PAIN (non-serious) with onset 05Feb2021 15:00, outcome "recovered with sequelae" (Feb2021), described as "felt achy"; PAIN IN EXTREMITY (non-serious) with onset 05Feb2021 15:00, outcome "recovered with sequelae" (Feb2021), described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, pain, pain in extremity.  Additional information: No other vaccine in four weeks. No covid prior vaccination. Took other medications in two weeks. Eight (8) days after first shot, the patient had enlarged lymph nodes and felt achy for 2 days. Very sore arm for about one day. The patient recovered with lasting effects. No treatment received. Covid tested post vaccination: Nasal Swab PCR on 08Mar2021: Negative.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Restlessness
Clinical narrative: Pain in or under the skull; Body-ache; restlessness; Fatigue; Injection site Pain; Pain in the right arm; Sporadic random bursts of pain in the head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Mar2021 08:15 (Lot number: EN6208) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Overweight" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for hypertension (ongoing); SIMVASTATIN taken for hypertension (ongoing); AMLODIPINE taken for hypertension (ongoing). Vaccination history included: Bnt162b2 (Product=COVID-19, brand=Pfizer, lot unknown=False, Batch/Lot number: EL9266, administration date=17Feb2021,, administration time=08:15 , vaccine location=Right arm,, dose number=1), administration date: 17Feb2021, when the patient was 54 years old, for Covid-19 Immunisation, reaction(s): "Injection site pain", "Body Ache", "Tiredness/Exhaustion feeling", "restlessness", "Headache". The following information was reported: FATIGUE (non-serious) with onset 11Mar2021, outcome "recovering", described as "Fatigue"; VACCINATION SITE PAIN (non-serious) with onset 11Mar2021, outcome "recovering", described as "Injection site Pain"; PAIN IN EXTREMITY (non-serious) with onset 11Mar2021, outcome "recovering", described as "Pain in the right arm"; HEADACHE (non-serious) with onset 11Mar2021, outcome "recovering", described as "Sporadic random bursts of pain in the head"; PAIN (non-serious), outcome "not recovered", described as "Pain in or under the skull"; PAIN (non-serious), outcome "unknown", described as "Body-ache"; RESTLESSNESS (non-serious), outcome "unknown", described as "restlessness". Therapeutic measures were not taken as a result of fatigue, vaccination site pain, pain in extremity, headache, pain, pain, restlessness.  Additional information: Facility type vaccine: Public Health Clinic facility. The patient did not receive any other vaccine within four weeks of vaccination. The patient had not Covid prior vaccination and not Covid tested post vaccination. Known allergies: No.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in or under the skull; Body-ache; restlessness; Fatigue; Injection site Pain; Pain in the right arm; Sporadic random bursts of pain in the head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Mar2021 08:15 (Lot number: EN6208) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Overweight" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for hypertension (ongoing); SIMVASTATIN taken for hypertension (ongoing); AMLODIPINE taken for hypertension (ongoing). Vaccination history included: Bnt162b2 (Product=COVID-19, brand=Pfizer, lot unknown=False, Batch/Lot number: EL9266, administration date=17Feb2021,, administration time=08:15 , vaccine location=Right arm,, dose number=1), administration date: 17Feb2021, when the patient was 54 years old, for Covid-19 Immunisation, reaction(s): "Injection site pain", "Body Ache", "Tiredness/Exhaustion feeling", "restlessness", "Headache". The following information was reported: FATIGUE (non-serious) with onset 11Mar2021, outcome "recovering", described as "Fatigue"; VACCINATION SITE PAIN (non-serious) with onset 11Mar2021, outcome "recovering", described as "Injection site Pain"; PAIN IN EXTREMITY (non-serious) with onset 11Mar2021, outcome "recovering", described as "Pain in the right arm"; HEADACHE (non-serious) with onset 11Mar2021, outcome "recovering", described as "Sporadic random bursts of pain in the head"; PAIN (non-serious), outcome "not recovered", described as "Pain in or under the skull"; PAIN (non-serious), outcome "unknown", described as "Body-ache"; RESTLESSNESS (non-serious), outcome "unknown", described as "restlessness". Therapeutic measures were not taken as a result of fatigue, vaccination site pain, pain in extremity, headache, pain, pain, restlessness.  Additional information: Facility type vaccine: Public Health Clinic facility. The patient did not receive any other vaccine within four weeks of vaccination. The patient had not Covid prior vaccination and not Covid tested post vaccination. Known allergies: No.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Nausea, Pain in extremity
Clinical narrative: Arms are slightly sore; Nauseated; I am not able to be lie down; I am totally prone but if I stand up it hurts again; 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), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Mar2021, outcome "unknown", described as "Arms are slightly sore"; NAUSEA (non-serious) with onset 11Mar2021, outcome "unknown", described as "Nauseated"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 11Mar2021, outcome "unknown", described as "I am not able to be lie down; I am totally prone but if I stand up it hurts again".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Top of my feet, they blown up on both of my feet only from top of the toes to the ankle; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 02Feb2021 (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 (1st dose), for Covid-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Top of my feet, they blown up on both of my feet only from top of the toes to the ankle".  Additional information: The patient reported that the patient got 2 shots, the second one was about 3 weeks ago and the only problem the patient had with it is that top of the feet kind of was blown up a little bit on each side.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Malaise
Clinical narrative: Compensating to the point that he can't even walk barely; Not doing well at all; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 89 year-old male patient received bnt162b2 (BNT162B2, Solution for injection), administration date 13Feb2021 (Lot number: EL3249) at the age of 89 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes; "Pace maker" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL. Vaccination history included: Bnt162b2 (1 st dose), administration date: 23Jan2021, when the patient was 89 years old, for Covid-19 Immunization. The following information was reported: GAIT DISTURBANCE (non-serious) with onset Feb2021, outcome "unknown", described as "Compensating to the point that he can't even walk barely"; MALAISE (non-serious) with onset Feb2021, outcome "unknown", described as "Not doing well at all". Therapeutic measures were not taken as a result of gait disturbance, malaise.  Additional information: Reporter stated, "Well I am calling on behalf of my father he is (Name withheld) he is having some side effects he had from his second vaccine on 13Feb2021 and he is just not doing well at all, he is compensating to the point that he can't even walk barely."  No follow-up attempts are possible. No further information is expected.