chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Bad cramps in my arm and my hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administration date 17Apr2021 (Batch/Lot number: unknown) at the age of 46 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 (dose 1, single), for COVID-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious) with onset 17Apr2021, outcome "unknown", described as "Bad cramps in my arm and my hand". Therapeutic measures were taken as a result of muscle spasms.  Additional Information: The events started about three and 4 hours after the vaccination. The patient took three paracetamol (TYLENOL) as treatment and wanted to know what to do about that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, Chills, Fatigue, Myalgia, Nausea
Clinical narrative: accompanied by nausea; muscle aches; very tired; slept most of the day; experiencing chills/shivering which worsened until 3am following morning; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 58 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 15Apr2021 09:00 (Lot number: EW0164) at the age of 58 years as dose 2, single for covid-19 immunization. Relevant medical history included: "hypothyroid" (unspecified if ongoing); "migraine" (not ongoing), notes: have diminished and rare; "postmenopausal" (unspecified if ongoing); "rosacea" (unspecified if ongoing); "Gravida 4" (unspecified if ongoing); "Para 2" (unspecified if ongoing). Concomitant medications included: SYNTHROID; VIT D3; CALCIUM. Past drug history included: Ampicillin, reaction: "known allergies: minor rashes"; Sulfonamide, reaction: "known allergies: minor rashes". Vaccination history included: BNT162B2 (Dose 1, Lot number: ER8732, Anatomical location: Left arm, Administration time: 08:00 AM), administration date: 25Mar2021, when the patient was 58 years old, for covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 15Apr2021 20:00, outcome "recovered" (18Apr2021), described as "experiencing chills/shivering which worsened until 3am following morning"; NAUSEA (non-serious) with onset 16Apr2021, outcome "recovered" (17Apr2021), described as "accompanied by nausea"; MYALGIA (non-serious) with onset 16Apr2021, outcome "recovered" (18Apr2021), described as "muscle aches"; FATIGUE (non-serious) with onset 16Apr2021, outcome "recovered" (18Apr2021), described as "very tired"; SOMNOLENCE (non-serious) with onset 16Apr2021, outcome "recovered" (18Apr2021), described as "slept most of the day". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, nausea, myalgia, fatigue and somnolence.  Additional information: On 15Apr at 8pm, patient began experiencing chills/shivering which worsened until 3am following morning (16Apr) and accompanied by nausea (no vomiting). For remainder of 16Apr continued with intermittent chills (at no time did she have a temperature over 101.5), muscle aches, very tired, slight nausea and limited intake to water only and slept most of the day. On 17Apr she was very tired, nausea resolved resumed light meals, chills only had occurred on 3 instances but much less severity than previous. On 18Apr, it was fully resolved. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: accompanied by nausea; muscle aches; very tired; slept most of the day; experiencing chills/shivering which worsened until 3am following morning; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 58 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 15Apr2021 09:00 (Lot number: EW0164) at the age of 58 years as dose 2, single for covid-19 immunization. Relevant medical history included: "hypothyroid" (unspecified if ongoing); "migraine" (not ongoing), notes: have diminished and rare; "postmenopausal" (unspecified if ongoing); "rosacea" (unspecified if ongoing); "Gravida 4" (unspecified if ongoing); "Para 2" (unspecified if ongoing). Concomitant medications included: SYNTHROID; VIT D3; CALCIUM. Past drug history included: Ampicillin, reaction: "known allergies: minor rashes"; Sulfonamide, reaction: "known allergies: minor rashes". Vaccination history included: BNT162B2 (Dose 1, Lot number: ER8732, Anatomical location: Left arm, Administration time: 08:00 AM), administration date: 25Mar2021, when the patient was 58 years old, for covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 15Apr2021 20:00, outcome "recovered" (18Apr2021), described as "experiencing chills/shivering which worsened until 3am following morning"; NAUSEA (non-serious) with onset 16Apr2021, outcome "recovered" (17Apr2021), described as "accompanied by nausea"; MYALGIA (non-serious) with onset 16Apr2021, outcome "recovered" (18Apr2021), described as "muscle aches"; FATIGUE (non-serious) with onset 16Apr2021, outcome "recovered" (18Apr2021), described as "very tired"; SOMNOLENCE (non-serious) with onset 16Apr2021, outcome "recovered" (18Apr2021), described as "slept most of the day". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, nausea, myalgia, fatigue and somnolence.  Additional information: On 15Apr at 8pm, patient began experiencing chills/shivering which worsened until 3am following morning (16Apr) and accompanied by nausea (no vomiting). For remainder of 16Apr continued with intermittent chills (at no time did she have a temperature over 101.5), muscle aches, very tired, slight nausea and limited intake to water only and slept most of the day. On 17Apr she was very tired, nausea resolved resumed light meals, chills only had occurred on 3 instances but much less severity than previous. On 18Apr, it was fully resolved. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Slight headache after the first vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date Mar2021 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "Slight headache after the first vaccine".  Additional information included: Patient stated the only reason she took the shot, was because she had health issues, and she thought she was protecting herself.  Patient stated she took the Pfizer shot, over the other vaccines, because she had respiratory issues, and didn't want to get sick.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea, Palpitations, Vaccination site erythema
Clinical narrative: I had two small 'valves' on my arm, why they were two at the injection site; it just keep more swollen; Nausea; Diarrhea; I was having chills; My heart was pounding so bad; I said the 'valves' is spreading, the swelling and like the blending together; the area is getting more red and swollen; 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 14Apr2021 (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: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "I had two small 'valves' on my arm, why they were two at the injection site; it just keep more swollen"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; CHILLS (non-serious), outcome "unknown", described as "I was having chills"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "I just had some soreness"; PALPITATIONS (non-serious), outcome "unknown", described as "My heart was pounding so bad"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "I said the 'valves' is spreading, the swelling and like the blending together; the area is getting more red and swollen".  Additional information: Patient had soreness, nausea, diarrhea, last night, was having chills but no fever according to the thermometer but my heart was pounding so bad like patient had already taken Tylenol. Patient was just afraid and don't want to take any like it bothers my liver but also suffered from allergies on a regular basis. So, was little concerned, it hasn't spread all over body. The 'valves' was spreading, the swelling and like the blending together, the area was getting more red and swollen so patient didn't know anything to do other than putting cold pack on it because that was not doing anything, like patient just don't want to put cortisone or something. Patient do have to take Claritin-D Daily and do have to take Benadryl sometimes at night, don't know if shampoo was going to make it worse, don't know if soaps.  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 swelling
Clinical narrative: I had two small 'valves' on my arm, why they were two at the injection site; it just keep more swollen; Nausea; Diarrhea; I was having chills; My heart was pounding so bad; I said the 'valves' is spreading, the swelling and like the blending together; the area is getting more red and swollen; 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 14Apr2021 (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: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "I had two small 'valves' on my arm, why they were two at the injection site; it just keep more swollen"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; CHILLS (non-serious), outcome "unknown", described as "I was having chills"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "I just had some soreness"; PALPITATIONS (non-serious), outcome "unknown", described as "My heart was pounding so bad"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "I said the 'valves' is spreading, the swelling and like the blending together; the area is getting more red and swollen".  Additional information: Patient had soreness, nausea, diarrhea, last night, was having chills but no fever according to the thermometer but my heart was pounding so bad like patient had already taken Tylenol. Patient was just afraid and don't want to take any like it bothers my liver but also suffered from allergies on a regular basis. So, was little concerned, it hasn't spread all over body. The 'valves' was spreading, the swelling and like the blending together, the area was getting more red and swollen so patient didn't know anything to do other than putting cold pack on it because that was not doing anything, like patient just don't want to put cortisone or something. Patient do have to take Claritin-D Daily and do have to take Benadryl sometimes at night, don't know if shampoo was going to make it worse, don't know if soaps.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "post op asexual", start date: 2014 (unspecified if ongoing), notes: had a surgery but a female now (7 years ago); "dystonia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore Arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Fatigue, Headache, Nausea
Clinical narrative: terrible nausea; headache; Was in bed 2 days; very tired; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 (Lot number: 3248) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Underactive thyroid" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication included: DOXYCYCLINE. Vaccination history included: bnt162b2 (Dose 1, single (Lot number: 3248) in the left arm at 10:00 AM), administration date: Mar2021, when the patient was 56 years old, for COVID-19 immunization, reactions: "Fever", "Chills", "Body aches", "Nausea", "Headache", "Very tired". The following information was reported: NAUSEA (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "terrible nausea"; HEADACHE (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "headache"; BEDRIDDEN (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Was in bed 2 days"; FATIGUE (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "very tired". Therapeutic measures were not taken as a result of nausea, headache, bedridden, fatigue.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received doxycycline within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies to medications, food, or other products. After second vaccine, the patient woke in the middle of the night with again terrible nausea and headache. She was in bed 2 days - very tired and extremely nauseous and terrible headache.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021423929 Same reporter, patient, and drug; Different dose and events
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Decreased appetite, Feeling hot, Nasopharyngitis, Nausea
Clinical narrative: very nauseated; didn't have an appetite; got cold; got hot; Reaction of side effects; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm (Lot number: Unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "History of migraines" (ongoing), notes: Verbatim: History of migraines; "Normal seasonal allergies" (not ongoing), notes: Verbatim: Normal seasonal allergies; "diagnosed allergies" (unspecified if ongoing), notes: Patient's Medical History; "compromised immune status" (unspecified if ongoing), notes: Patient's Medical History; compromised immune status; "respiratory illness" (unspecified if ongoing), notes: Patient's Medical History; respiratory illness; "chromosomal abnormalities" (unspecified if ongoing), notes: Patient's Medical History; genetic /chromosomal abnormalities; "endocrine abnormalities" (unspecified if ongoing), notes: Patient's Medical History; endocrine abnormalities; "obesity" (unspecified if ongoing), notes: Patient's Medical History; obesity. Family history included: "cancer" (unspecified if ongoing), notes: Patient's mother's side of the family it was like everyone had gotten cancer. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Lot/NDC/Expiry: Unknown, Dose: Unknown strength/volume/dose injection to unknown location, caller assumes an arm, at unknown time.), for Covid-19 immunization. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "very nauseated"; DECREASED APPETITE (non-serious), outcome "unknown", described as "didn't have an appetite"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "got cold"; FEELING HOT (non-serious), outcome "unknown", described as "got hot"; ADVERSE DRUG REACTION (non-serious), outcome "recovered", described as "Reaction of side effects".  Additional information: This is report 2 of 4. Daughter is the patient in this report.Caller's daughter called caller last night and when caller told daughter about her own side effects, daughter mentioned she knew that feeling because she had some of the same type of side effects herself. Caller does not know if patient had every side effect caller had ; but she knows patient was very nauseated, didn't have an appetite, got cold and got hot. No prior vaccinations done within 4 weeks. No AE(s) following prior vaccinations.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Malaise, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Headache; Not feeling well; His legs are warm; Has a stiff arm; The right arm he had the shot in is sore/It is pretty much sore all over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (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: HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "Headache"; MALAISE (non-serious) with onset Apr2021, outcome "unknown", described as "Not feeling well"; FEELING HOT (non-serious) with onset Apr2021, outcome "unknown", described as "His legs are warm"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Apr2021, outcome "unknown", described as "Has a stiff arm"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "The right arm he had the shot in is sore/It is pretty much sore all over".  Additional information: Patient and her husband received the Pfizer COVID-19 shot yesterday (at the time of report, 15Apr2021) and her husband was not feeling well today and she stated his legs are warm and he has a stiff arm. Reporter stated, she was calling for her husband. Reporter's husband and she went to have a shot the COVID-19 one and we went to the (redacted) University and we came back and last night her husband felt fine and she felt fine, arms are little bit stiff but she get up this morning and took a shower and she was feeling fine, no stiffness and nothing, Reporter's husband get up and he doesn't feel good, his legs are warm, he got a headache, the right arm he had the shot in is sore. He said it is pretty much sore all over. Confirmed the vaccine as first shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Pain in extremity
Clinical narrative: tenderness on armpit/ really sore on armpit; arm was sore; swollen lymph node; 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 female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypothyroid" (ongoing); "knee pain" (unspecified if ongoing); "nausea" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL taken for arthralgia. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 25Mar2021, for COVID-19 immunisation, reaction(s): "headache", "aches", "injection site soreness"; Flu shot, administration date: 2021, for influenza immunisation, reaction(s): "body was reacting to eggs". The following information was reported: AXILLARY PAIN (non-serious) with onset 16Apr2021, outcome "unknown", described as "tenderness on armpit/ really sore on armpit"; PAIN IN EXTREMITY (non-serious) with onset 16Apr2021, outcome "unknown", described as "arm was sore"; LYMPHADENOPATHY (non-serious) with onset 16Apr2021, outcome "unknown", described as "swollen lymph node". Therapeutic measures were taken as a result of axillary pain, pain in extremity, lymphadenopathy. Additional information: Treatment included paracetamol (TYLENOL). Patient's age was reported as 51, unit was unspecified. The patient was also concomitantly taking unspecified thyroid medications.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen gland under arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen gland under arm".  Additional information-This report is in reference to one of the two guys reporters husband went with to get his Covid 19 vaccine. While speaking of her husband's experience with the Covid 19 vaccine, she mentions that two other guys her husband went with on the same day to get their Covid 19 vaccines,  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: arms are little bit stiff; 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 15Apr2021 (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: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 15Apr2021, outcome "recovered" (16Apr2021), described as "arms are little bit stiff".  Additional Information: Patient stated that she and her husband recieved the Pfizer COVID-19 shot yesterday and her husband is not feeling well today and she stated his legs are warm and he has a stiff arm. Further she told, "she was calling for her husband. My husband and patient went to have a shot the COVID-19 one and we went to the University and we came back and last night my husband felt fine, patient felt fine, arms are little bit stiff but she get up this morning and took a shower and feeling fine, no stiffness and nothing, my husband get up and he doesn't feel good, his legs are warm, he got a headache, the right arm he had the shot in is sore. He said it is pretty much sore all over."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Head discomfort, Paraesthesia, Tinnitus
Clinical narrative: Persistent tinnitus starting 2 hours after vaccination.; ear fullness; Head pressure; Paraesthesia in fingers, toes and thigh; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 12Apr2021 14:30 (Lot number: ER8729) at the age of 38 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Mild seasonal allergies" (unspecified if ongoing). There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 12Apr2021 16:30, outcome "not recovered", described as "Persistent tinnitus starting 2 hours after vaccination."; EAR DISCOMFORT (non-serious) with onset 12Apr2021 15:00, outcome "not recovered", described as "ear fullness"; HEAD DISCOMFORT (non-serious) with onset 12Apr2021 15:00, outcome "not recovered", described as "Head pressure"; PARAESTHESIA (non-serious) with onset 12Apr2021 15:00, outcome "not recovered", described as "Paraesthesia in fingers, toes and thigh". The events "persistent tinnitus starting 2 hours after vaccination.", "ear fullness", "head pressure" and "paraesthesia in fingers, toes and thigh" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus, ear discomfort, head discomfort, paraesthesia.  Additional information: The patient was not pregnant at time of vaccination. The patient had no allergies to medications, food or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. The vaccine was administered in Pharmacy or Drug Store. Clinical course: Tinnitus lasting 3+ weeks (not resolved) favoring the right ear sometimes accompanied by ear fullness/head pressure. Paraesthesia in fingers, toes and thigh.   No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vaccination site swelling
Clinical narrative: arm started to pain him, the arm he got the shot in has pain and like swelling; arm started to pain him, the arm he got the shot in has pain and like swelling; was a little fatigued that day after the shot and feeling a bit tired; 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 male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Apr2021 (Lot number: Unknown) at the age of 72 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CHOLESTEROL; PROSTATE 1. The following information was reported: FATIGUE (non-serious) with onset 14Apr2021, outcome "unknown", described as "was a little fatigued that day after the shot and feeling a bit tired"; VACCINATION SITE SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 18Apr2021, outcome "unknown" and all described as "arm started to pain him, the arm he got the shot in has pain and like swelling".  Additional information: Concomitant medication included: blood pressure. Like everyone else that takes the shot, he is trying to avoid getting Covid 19. The patient got the Pfizer shot on Wednesday and he had a problem he had a little fatigue and it didn't bother him much. States yesterday he woke up and his arm started to pain him, the arm he got the shot in has pain and like swelling and wants to know what to do. His daughter told him it is one of the allergic symptoms that happen to some people. Caller is asking what he should do and would like advice. Caller is asking if we have any healthcare providers. He would like to let us know what symptoms he is suffering from and if anyone here can give advice on what to do with his arm he will gladly receive that. States making a report may help other people that need the help. He had the flu shot Nov2020 states that sometimes with flu shots he gets tired for a day or 2 and snaps out of it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: fatigue; Headache that began at back of head and progressed to the front of the head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Jan2021 (Lot number: EL9262) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 30Jan2021, outcome "recovered", described as "fatigue"; HEADACHE (non-serious) with onset 30Jan2021, outcome "recovered", described as "Headache that began at back of head and progressed to the front of the head". Therapeutic measures were taken as a result of fatigue, headache. Additional information: It was reported that the patient received dose 2 on an unspecified date on Feb2021. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was also unknown if patient was allergic to medications, food, and other products. The patient received Tylenol and Imitrex as treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was very sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). 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 "unknown", described as "arm was very sore".  Additional Information: The patient wanted to know if the vaccine causes glucose levels to rise or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Headache, Magnetic resonance imaging
Clinical narrative: Felt like she had a fever but never had fever; hands and feet were freezing cold; Head hurt a lot, felt like she had a head cold; Chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 09:00 (Lot number: ER8731) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Back surgery", start date: 15Mar2021, stop date: 15Mar2021; "Diabetes II" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for type 2 diabetes mellitus (ongoing). The following information was reported: FEELING ABNORMAL (non-serious) with onset 17Apr2021, outcome "recovering", described as "Felt like she had a fever but never had fever"; PERIPHERAL COLDNESS (non-serious) with onset 17Apr2021, outcome "recovering", described as "hands and feet were freezing cold"; HEADACHE (non-serious) with onset 17Apr2021, outcome "recovering", described as "Head hurt a lot, felt like she had a head cold"; CHILLS (non-serious) with onset 17Apr2021, outcome "unknown", described as "Chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: NDC number and expiry date: unknown. Metformin: Start date at least 3 years ago. Back surgery was not planned. They did MRI, Ultrasound and different type of x-ray on her back. On 17Apr2021, she got a lot of chills, felt like she had fever but never had fever, her hands and feet were freezing cold. It had been like that the last 2 days, till the 3rd day. Her head hurt a lot, felt like she had head cold. She asked if people are having a reaction to the Pfizer-BioNTech Covid-19 Vaccine 5 days after being administered the Pfizer-BioNTech Covid-19 Vaccine. She still felt like she has a mild fever, but she never had fever, she has taken her temperature; her head still kind of hurts. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect, prior vaccinations (within 4 weeks), AE(s) following prior vaccinations, family medical history relevant to AE(s) were reported as none. Time of onset (24-hour clock) of events: Unknown other than afternoon. No emergency room and physician office.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Ultrasound scan, X-ray
Clinical narrative: Felt like she had a fever but never had fever; hands and feet were freezing cold; Head hurt a lot, felt like she had a head cold; Chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 09:00 (Lot number: ER8731) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Back surgery", start date: 15Mar2021, stop date: 15Mar2021; "Diabetes II" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for type 2 diabetes mellitus (ongoing). The following information was reported: FEELING ABNORMAL (non-serious) with onset 17Apr2021, outcome "recovering", described as "Felt like she had a fever but never had fever"; PERIPHERAL COLDNESS (non-serious) with onset 17Apr2021, outcome "recovering", described as "hands and feet were freezing cold"; HEADACHE (non-serious) with onset 17Apr2021, outcome "recovering", described as "Head hurt a lot, felt like she had a head cold"; CHILLS (non-serious) with onset 17Apr2021, outcome "unknown", described as "Chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: NDC number and expiry date: unknown. Metformin: Start date at least 3 years ago. Back surgery was not planned. They did MRI, Ultrasound and different type of x-ray on her back. On 17Apr2021, she got a lot of chills, felt like she had fever but never had fever, her hands and feet were freezing cold. It had been like that the last 2 days, till the 3rd day. Her head hurt a lot, felt like she had head cold. She asked if people are having a reaction to the Pfizer-BioNTech Covid-19 Vaccine 5 days after being administered the Pfizer-BioNTech Covid-19 Vaccine. She still felt like she has a mild fever, but she never had fever, she has taken her temperature; her head still kind of hurts. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect, prior vaccinations (within 4 weeks), AE(s) following prior vaccinations, family medical history relevant to AE(s) were reported as none. Time of onset (24-hour clock) of events: Unknown other than afternoon. No emergency room and physician office.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Condition aggravated, Pain in extremity
Clinical narrative: The vaccine greatly exacerbated my neuropathy, causing burning pain in my legs and feet,; The vaccine greatly exacerbated my neuropathy, causing burning pain in my legs and feet,; pain in my feet; pain in my legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 09:15 (Batch/Lot number: unknown) at the age of 65 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "surgery", start date: 2017 (unspecified if ongoing), notes: benign spinal cord tumor that was removed 4 years ago.; "benign spinal cord tumor" (unspecified if ongoing), notes: benign spinal cord tumor that was removed 4 years ago. Concomitant medication(s) included: DULOXETINE; VITAMIN D [COLECALCIFEROL]; CALCIUM. The following information was reported: CONDITION AGGRAVATED (non-serious), BURNING SENSATION (non-serious) all with onset 19Mar2021 00:15, outcome "not recovered" and all described as "The vaccine greatly exacerbated my neuropathy, causing burning pain in my legs and feet,"; PAIN IN EXTREMITY (non-serious) with onset 19Mar2021 00:15, outcome "not recovered", described as "pain in my feet"; PAIN IN EXTREMITY (non-serious) with onset 19Mar2021 00:15, outcome "not recovered", described as "pain in my legs". Therapeutic measures were not taken as a result of condition aggravated, burning sensation, pain in extremity, pain in extremity.  Additional details: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. other medications in two weeks: Duloxetene, Multivitamin, Vitamin D, Calcium. if treatment ae: Prior to vaccination, the patient was not with COVID-19. the patient has been tested for COVID-19. known allergies: No. other medical history: None  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: sugar blood level very high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose-1, manufacturer-unknown), for Covid-19 immunization. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "sugar blood level very high". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information-Was the product used by the patient-Yes  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: Tired and I have been really weak; Feeling bad; had tiredness/Tired; Headache; I don't know if my heart has been fast but I could feel it; Dizziness; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 64 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 16Apr2021 (Lot number: EW0150, Expiration Date: 31Jul2021) at the age of 64 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Feeling unwell" (unspecified if ongoing), notes: before he took the shot; "Solid Masses on Lung" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 17Apr2021, outcome "unknown", described as "Feeling bad"; FATIGUE (non-serious) with onset 17Apr2021, outcome "unknown", described as "had tiredness/Tired"; HEADACHE (non-serious) with onset 17Apr2021, outcome "unknown", described as "Headache"; HEART RATE INCREASED (non-serious) with onset 17Apr2021, outcome "unknown", described as "I don't know if my heart has been fast but I could feel it"; DIZZINESS (non-serious) with onset 17Apr2021, outcome "unknown", described as "Dizziness"; ASTHENIA (non-serious), outcome "unknown", described as "Tired and I have been really weak". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  Consumer had the vaccine, the first one yesterday at noon. He felt fine all day. Today at around lunch time, he ate some pizza and had a beer. He has been feeling bad. He was querying if I he had the virus, could he be having symptoms because he had checked all the ones that were on the list. He had tiredness, a little bit of the headache, feeling unwell (Further not clarified if consumer was experiencing these symptoms, hence captured as event) and then it was fast heart, he doesn't know if his heart has been fast, but he felt it, dizziness, tired and have been really weak. He also stated he has been been trying to get a test for a long time to before he took the shot see if he has COVID because he has been feeling unwell. He did get a lung scan a couple weeks ago and they found some solid masses (History) in there since he used to work in a very bad environment. He got another lung scan scheduled in July.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Ventilation/perfusion scan
Clinical narrative: Tired and I have been really weak; Feeling bad; had tiredness/Tired; Headache; I don't know if my heart has been fast but I could feel it; Dizziness; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 64 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 16Apr2021 (Lot number: EW0150, Expiration Date: 31Jul2021) at the age of 64 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Feeling unwell" (unspecified if ongoing), notes: before he took the shot; "Solid Masses on Lung" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 17Apr2021, outcome "unknown", described as "Feeling bad"; FATIGUE (non-serious) with onset 17Apr2021, outcome "unknown", described as "had tiredness/Tired"; HEADACHE (non-serious) with onset 17Apr2021, outcome "unknown", described as "Headache"; HEART RATE INCREASED (non-serious) with onset 17Apr2021, outcome "unknown", described as "I don't know if my heart has been fast but I could feel it"; DIZZINESS (non-serious) with onset 17Apr2021, outcome "unknown", described as "Dizziness"; ASTHENIA (non-serious), outcome "unknown", described as "Tired and I have been really weak". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  Consumer had the vaccine, the first one yesterday at noon. He felt fine all day. Today at around lunch time, he ate some pizza and had a beer. He has been feeling bad. He was querying if I he had the virus, could he be having symptoms because he had checked all the ones that were on the list. He had tiredness, a little bit of the headache, feeling unwell (Further not clarified if consumer was experiencing these symptoms, hence captured as event) and then it was fast heart, he doesn't know if his heart has been fast, but he felt it, dizziness, tired and have been really weak. He also stated he has been been trying to get a test for a long time to before he took the shot see if he has COVID because he has been feeling unwell. He did get a lung scan a couple weeks ago and they found some solid masses (History) in there since he used to work in a very bad environment. He got another lung scan scheduled in July.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Joint range of motion decreased, Mobility decreased, Pain in extremity
Clinical narrative: it was a numb pain; couldn't lift his arm and his shoulder with his arm; couldn't lift his arm and his shoulder with his arm; left arm/ arm was sore; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in arm left, administration date 27Mar2021 (Lot number: EP6955) at the age of 44 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Flu shot, for immunisation, reaction: "arm was sore". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Mar2021, outcome "not recovered", described as "left arm/ arm was sore"; HYPOAESTHESIA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "it was a numb pain"; MOBILITY DECREASED (non-serious), JOINT RANGE OF MOTION DECREASED (non-serious) all with onset 30Mar2021, outcome "not recovered" and all described as "couldn't lift his arm and his shoulder with his arm". Therapeutic measures were taken as a result of pain in extremity, hypoaesthesia, mobility decreased, joint range of motion decreased.  Additional information: The patient reported that his arm was bothering him when he took the first dose. They gave the shot in his left arm and for two days, his arm was sore. So, he thought that it would be there and it was just like when you get a regular flu shot and your arm is sore from the shot. Third day, he couldn't lift his arm and his shoulder with his arm and till this date (at the time of report) it hurt. It was like when he was taking a shower and try to lift his left arm going over his right shoulder, it was sore and he didn't want to say painful but it was a numb pain like you want to bring your arm back because you don't want to stretch it so far. The patient further stated that it was like he could not lift it up all the way and he want to bring it down because it gives pain. Also, if he try to lift it up all the way and if he go to workout or say he lift something kind of heavy, he was not able to do with that arm. The patient used ibuprofen 200 mg for the events and he took two tablets.   No follow-up attempts are possible. No further information is expected.