chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Pain in extremity, Product administered at inappropriate site
Clinical narrative: he received the Pfizer covid vaccine in triceps muscle instead of the Deltoid./it was not administered on his deltoid, it was injected to another site on his lower arm/ tricep; sore arm; anxiety; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm, administration date 18Mar2021 (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: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), outcome "unknown", described as "he received the Pfizer covid vaccine in triceps muscle instead of the Deltoid./it was not administered on his deltoid, it was injected to another site on his lower arm/ tricep"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; ANXIETY (non-serious), outcome "unknown", described as "anxiety".  Additional information: Caller stated he received the Pfizer covid vaccine in triceps muscle instead of the Deltoid. Caller wanted to know would that effect the efficacy of the vaccine. He said has sore arm and some anxiety as his injection was not given in the deltoid muscle. He wants to report that it was not administered on his deltoid, it was injected to another site on his lower arm/ tricep. Caller wanted to know should he be concerned. Asked if there will be an issue with regards to the efficacy of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Malaise, Pain, Vaccination site pain
Clinical narrative: not feeling well/ feeling sick; Pain at the injection site; Felt kind of fluish; Body aches; Tired; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 13Mar2021 (Lot number: EN6207) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset Mar2021, outcome "not recovered", described as "not feeling well/ feeling sick"; VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "Pain at the injection site"; INFLUENZA LIKE ILLNESS (non-serious) with onset Mar2021, outcome "not recovered", described as "Felt kind of fluish"; PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "Body aches"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "Tired".  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Insomnia
Clinical narrative: tired; trouble sleeping/she was up the entire night/ she slept a little/cannot sleep; 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 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 13:00 (Lot number: EN5318) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "MS", start date: 2001 (unspecified if ongoing), notes: Verbatim: MS; "allergies" (unspecified if ongoing); "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious) with onset 04Mar2021, outcome "not recovered", described as "trouble sleeping/she was up the entire night/ she slept a little/cannot sleep"; FATIGUE (non-serious), outcome "unknown", described as "tired". Additional information: Received call from consumer regarding the Pfizer COVID vaccine. She received the first dose 2 weeks ago. That night she was up the entire night. She heard people just slept and she had the opposite. The next night, she slept a little. On the third night, she was up all night again. Now she is tired and cannot sleep. She had the reverse of what she has heard from everyone else. She is curious if this has happened to anyone else. There was no prescriber. It has improved but is still a problem. The injection did not hurt going in. She was unable to confirm if it was given intramuscularly. Time the vaccination was given: Unknown during day around 13:00. She has MS and read about lots of people with MS and no one had this. Everyone was just really tired afterwards. She does not have any information on any others that had those experiences. She was just speaking in generalities and did not have any further details to provide. Anatomical Location of Administration of Pfizer vaccine considered as suspect: Injected in left arm unable to confirm if in the muscle. Not a military facility. Was not able to sleep -21:00. She was up all night long tossing and turning. Felt wide awake and tired at the same time. She never slept the entire night. Really did not sleep again until the following night. The third night again, she did not sleep again.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 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: HEADACHE (non-serious) with onset Mar2021, outcome "not recovered", described as "headache". Additional information: Patient received his first dose of the Pfizer-Biontech Covid19 vaccine 02Mar2021. The following weekend he developed a headache and he's "had it ever since".  No follow-up attempts are possible. information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: keeps smelling sulfur but sulfur smell was not constant and not persistent; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in right arm, administration date 10Mar2021 12:30 (Lot number: EN6207) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAROSMIA (non-serious) with onset 13Mar2021, outcome "not recovered", described as "keeps smelling sulfur but sulfur smell was not constant and not persistent".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Vertigo
Clinical narrative: Vertigo; Nausea; 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 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (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: VERTIGO (non-serious), outcome "unknown", described as "Vertigo"; NAUSEA (non-serious), outcome "unknown", described as "Nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue
Clinical narrative: Very very tired/still wiped; Weak; Chills; This is a spontaneous report received from a 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 14Mar2021 15:00 (Lot number: ER753H) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COPD" (ongoing), notes: Diagnosed about 2 years ago; "Bipolar" (ongoing); "smokes" (ongoing). Concomitant medication(s) included: SEROQUEL taken for bipolar disorder (ongoing). The following information was reported: FATIGUE (non-serious) with onset 16Mar2021, outcome "recovering", described as "Very very tired/still wiped"; ASTHENIA (non-serious) with onset 16Mar2021, outcome "recovering", described as "Weak"; CHILLS (non-serious) with onset 16Mar2021, outcome "recovering", described as "Chills". Therapeutic measures were not taken as a result of fatigue, asthenia, chills.  Additional information: There were no additional vaccines administered and the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient also stated that she can't take penicillin. It was reported that patient still feel so tired and wiped. When she was asked to clarify what still wiped meant, she stated that she was very very tired, she felt weak, and that she had chills. She reported that the chills and weakness were really bad yesterday. She then stated she was feeling better today but was still a little tired, a little weak and had a little chills. Events did not result to emergency room and physician office visit.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Food intolerance, Gastrointestinal disorder, Taste disorder
Clinical narrative: GI changes; she doesn't have a taste for decaf coffee; uncomfortableness in my stomach /stomach upset; she hasn't been tolerating spicy foods; stomach ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  An 83 year-old female patient received bnt162b2 (BNT162B2), administration date 07Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "idiopathic immunosuppression" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "GI changes"; TASTE DISORDER (non-serious), outcome "unknown", described as "she doesn't have a taste for decaf coffee"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "uncomfortableness in my stomach /stomach upset"; ABDOMINAL PAIN UPPER (non-serious) with onset 18Mar2021, outcome "unknown", described as "stomach ache"; FOOD INTOLERANCE (non-serious), outcome "unknown", described as "she hasn't been tolerating spicy foods". Clinical course: The patient received both doses of her Pfizer-BioNTech Covid19 vaccine (last dose 07Mar2021). Since that time, she started noticing GI changes, she doesn't have a taste for decaf coffee (usually has 1 cup caffeinated and 1 cup decaf daily) and she hasn't been tolerating spicy foods, either. She describes it as "an uncomfortableness" in her stomach and because of her stomach upset she cannot enjoy her normal activities, stating that she had to stop her exercises, yesterday because her stomach was so upset. She also stated they symptoms occurred about 1 hour after eating her breakfast. Her other medical history includes idiopathic immunosuppression. She does not know if this was related to vaccination, but wanted to ask, "out of an abundance of caution".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Pain at the injection site; Headache; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) at the age of 45 years as dose 1, single and administered in arm right, administration date 18Mar2021 18:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Pain at the injection site"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "Headache"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "Fatigue". Therapeutic measures were not taken as a result of vaccination site pain, headache, fatigue. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 87 year-old female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BABY ASPIRIN. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: Unaddressed medical questions were forwarded to Medical Information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: His arm was very sore, more sore than the flu, and less sore than a tetanus shot; felt a little crumby; 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 60 year-old male patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "sinus issues" (unspecified if ongoing), notes: Verbatim: sinus issues. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "His arm was very sore, more sore than the flu, and less sore than a tetanus shot"; MALAISE (non-serious), outcome "unknown", described as "felt a little crumby".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Chills, Diarrhoea, Insomnia
Clinical narrative: since late yesterday, she started getting chills, diarrhea, upset stomach, and she is very weak; since late yesterday, she started getting chills, diarrhea, upset stomach, and she is very weak; since late yesterday, she started getting chills, diarrhea, upset stomach, and she is very weak; since late yesterday, she started getting chills, diarrhea, upset stomach, and she is very weak; couldn't sleep; 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 85 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 25Feb2021 (Batch/Lot number: unknown) at the age of 84 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood pressure" (unspecified if ongoing), notes: Verbatim: High Blood pressure. There were no concomitant medications. The following information was reported: ASTHENIA (non-serious), CHILLS (non-serious), DIARRHOEA (non-serious), ABDOMINAL DISCOMFORT (non-serious), outcome "unknown" and all described as "since late yesterday, she started getting chills, diarrhea, upset stomach, and she is very weak"; INSOMNIA (non-serious), outcome "unknown", described as "couldn't sleep".  Additional Information: The patient stated that she had an appointment for her second shot of the Pfizer COVID-19 vaccine. The patient reported that, " few days after the first dose her side effects were not severe but, since late yesterday, she started getting chills and couldn't sleep, diarrhea, upset stomach, and she is very weak". The patient said that she doesn't have any fever. The patient wanted to know if vaccination provider would give the shot even though she had those symptoms. The patient queried that, how to make another appointment for the Pfizer COIVD-19 vaccine. The patient stated that she has had so many blood draws and things lately that she doesn't remember which arm vaccine was received on. Her second dose was scheduled on 19Mar2021 at 2:15PM. The patient reported that she had problems with high blood pressure, it goes real high and she took 3 different medications for 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: Acrodynia, Back pain, Bone pain, Chills, Hot flush
Clinical narrative: On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday; On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday; On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday; On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday; On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday; On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday; On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday; The first two days she had a 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 female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (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 10Mar2021, outcome "unknown", described as "The first two days she had a sore arm"; OROPHARYNGEAL PAIN (non-serious), ACRODYNIA (non-serious), CHILLS (non-serious), HOT FLUSH (non-serious) all with onset 13Mar2021, outcome "unknown" and all described as "On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday"; BACK PAIN (non-serious), BONE PAIN (non-serious), MYALGIA (non-serious), outcome "unknown" and all described as "On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday".  Additional information: This (Age: 81; Unit: Unknown) female consumer reported for herself that received first dose of Pfizer Covid vaccine on 10Mar2021. The first two days she had a sore arm. On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and was having more complications everyday.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Pain in extremity
Clinical narrative: On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday; On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday; On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday; On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday; On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday; On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday; On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday; The first two days she had a 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 female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (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 10Mar2021, outcome "unknown", described as "The first two days she had a sore arm"; OROPHARYNGEAL PAIN (non-serious), ACRODYNIA (non-serious), CHILLS (non-serious), HOT FLUSH (non-serious) all with onset 13Mar2021, outcome "unknown" and all described as "On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday"; BACK PAIN (non-serious), BONE PAIN (non-serious), MYALGIA (non-serious), outcome "unknown" and all described as "On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday".  Additional information: This (Age: 81; Unit: Unknown) female consumer reported for herself that received first dose of Pfizer Covid vaccine on 10Mar2021. The first two days she had a sore arm. On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and was having more complications everyday.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Decreased appetite
Clinical narrative: stomach felt tight; has not had any appetite; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 16Mar2021 (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: ABDOMINAL DISCOMFORT (non-serious) with onset 17Mar2021, outcome "unknown", described as "stomach felt tight"; DECREASED APPETITE (non-serious) with onset 17Mar2021, outcome "unknown", described as "has not had any appetite". Additional information: Patient stated that he had his first dose of the Pfizer covid 19 vaccine on 16Mar2021. On the first day, his stomach felt tight and has not had any appetite since.   No follow-up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: body ache; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "body ache"; HEADACHE (non-serious), outcome "unknown", described as "Headache".  Additional Information: Reporter stated that the patient got her second shot yesterday and has body ache and headache is it alright to take Tylenol.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021326264 same reporter/drug/AE, different patients.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness to his arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "back pain" (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 "soreness to his arm". Additional information: the reporter was asking if the patient can take Tylenol or Ibuprofen for his back pain and if there is an amount of time that the patient has to wait before or after having his second vaccine dose to get a spinal block. The reporter stated that the patient has a history of back pain and received his first Pfizer Covid vaccine dose on 15Mar2021 and will be due for his second dose on 05Apr2021. The patient has had back issues for several years, and has received spinal injections and is due for a different spinal block on 25Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Bone densitometry, Bone scan, Computerised tomogram, Condition aggravated, Pain assessment
Clinical narrative: Minor pain right arm; Minor pain right arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 28Jan2021 14:00 (Lot number: EL3249) at the age of 73 years as 1st dose, single for covid-19 immunisation. Relevant medical history included: "Prostate cancer" (unspecified if ongoing). Concomitant medication(s) included: CYCLOBENZAPRINE; HYDROCHLOROTHIAZIDE. Past drug history included: Lupron, reaction(s): "Lupron: was wearing off". The following information was reported: PAIN IN EXTREMITY (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 29Jan2021, outcome "recovered" (Jan2021) and all described as "Minor pain right arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Medications that the patient received within 2 weeks of vaccination was 10mg of Cyclobenzaprine, 25mg of Hydrochlorothiazide. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He got the first vaccine on 28Jan2021, at (withheld) hospital in right shoulder. He only experienced minor pain in right arm that only lasted a day or two. That is the reaction he had to the vaccine. He would be happy to speak with anyone to report. The pain has subsided quite a bit, although it has not completely gone away. It is discouraging to have lack of energy and wanting to sleep all day.The patient had taken treatment drug tylenol for events occurred after second dose.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Prostatic specific antigen
Clinical narrative: Minor pain right arm; Minor pain right arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 28Jan2021 14:00 (Lot number: EL3249) at the age of 73 years as 1st dose, single for covid-19 immunisation. Relevant medical history included: "Prostate cancer" (unspecified if ongoing). Concomitant medication(s) included: CYCLOBENZAPRINE; HYDROCHLOROTHIAZIDE. Past drug history included: Lupron, reaction(s): "Lupron: was wearing off". The following information was reported: PAIN IN EXTREMITY (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 29Jan2021, outcome "recovered" (Jan2021) and all described as "Minor pain right arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Medications that the patient received within 2 weeks of vaccination was 10mg of Cyclobenzaprine, 25mg of Hydrochlorothiazide. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He got the first vaccine on 28Jan2021, at (withheld) hospital in right shoulder. He only experienced minor pain in right arm that only lasted a day or two. That is the reaction he had to the vaccine. He would be happy to speak with anyone to report. The pain has subsided quite a bit, although it has not completely gone away. It is discouraging to have lack of energy and wanting to sleep all day.The patient had taken treatment drug tylenol for events occurred after second dose.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt tired; 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 78 year-old female patient received bnt162b2 (BNT162B2), administration date 09Feb2021 (Batch/Lot number: unknown) as 1st dose, single and administration date 04Mar2021 (Batch/Lot number: unknown) as 2nd dose, 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), outcome "unknown", described as "felt tired". Additional information: it was reported that after the first dose of the vaccine her and her husband felt tired afterwards. Caller does not think it was attributed to the vaccine and states it was because they got up at 05:00 to go have the vaccine done. Otherwise had no side effects from either dose. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021310097 same reporter/drug, different patient.;US-PFIZER INC-2021310098 same reporter/drug, different patient/event.
Age: 59.0
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) from medical information team. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Shingles (Caller states she also received a shingles and had a bad reaction.), reaction(s): "bad reaction". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 18Mar2021, outcome "unknown", described as "sore arm".  Additional information: Caller states after receiving the vaccine yesterday she has a sore arm last night but otherwise no other side effects. Caller states she also received a shingles and had a bad reaction. Caller is 59 year old female.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Arm pain; Severe dizziness next day that lasted 3 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 11:30 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: ZOLOF. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Mar2021 13:00, outcome "not recovered", described as "Arm pain"; DIZZINESS (non-serious) with onset 10Mar2021 13:00, outcome "recovered" (13Mar2021), described as "Severe dizziness next day that lasted 3 days". Therapeutic measures were not taken as a result of pain in extremity, dizziness.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Zolof 200 mg. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products.  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: Mobility decreased, Neck pain, Pain, Spinal pain
Clinical narrative: The pain continued to get worse and spread to the point where my neck was very painful; pain on the side of my spine on the same side as the injection; pain grew much worse and spread to the other side of my spine; where my neck was very painful neck pain ,difficult to move; 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 (BNT162B2), administered in arm left, administration date 26Feb2021 14:30 (Lot number: En6203) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "pernicious anaemia" (unspecified if ongoing); "iron deficiency anaemia" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. The following information was reported: NECK PAIN (non-serious) with onset 27Feb2021 08:00, outcome "recovering", described as "The pain continued to get worse and spread to the point where my neck was very painful"; SPINAL PAIN (non-serious) with onset 27Feb2021 08:00, outcome "recovering", described as "pain on the side of my spine on the same side as the injection"; PAIN (non-serious) with onset 27Feb2021 08:00, outcome "recovering", described as "pain grew much worse and spread to the other side of my spine"; MOBILITY DECREASED (non-serious) with onset 27Feb2021 08:00, outcome "recovering", described as "where my neck was very painful neck pain ,difficult to move". Therapeutic measures were not taken as a result of neck pain, spinal pain, pain, mobility decreased.  Additional information: It was reported that, the morning after the vaccine she work up with neck and pain on the side of her spine on the same side as the injection. Over the course of the morning this pain grew much worse and spread to the other side of her spine. The pain continued to get worse and spread to the point where her neck was very painful and difficult to move. This gradually got better over the week but she continued to have mild soreness after. Patient took vaccine at public health clinic/veterans administration facility. Patient took Ibuprofen after the vaccine. Patient had no known allergies. Patient had no other vaccine in four weeks. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: had one bad day after receiving both vaccine doses; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovered", described as "had one bad day after receiving both vaccine doses".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: redness and pain at the injection site; redness and pain at the injection site; 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 female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Feb2021 13:00 (Lot number: EL9269) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 11Feb2021, outcome "recovered" (14Feb2021) and all described as "redness and pain at the injection site".  Additional information: The events did not require visit to physician office or ER. The patient had not received any other vaccines within 4 weeks prior vaccination. The patient had no additional vaccine administered on same date of BNT162B2 vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site rash
Clinical narrative: Light Rash Around the Injection Site; Left Arm; light redness around the injection site; 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 72-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Lot number: EN6205) at the age of 72 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 17Mar2021 10:30, outcome "unknown", described as "Light Rash Around the Injection Site; Left Arm"; PAIN IN EXTREMITY (non-serious) with onset 04Mar2021, outcome "recovered" (06Mar2021), described as "arm was very sore"; VACCINATION SITE ERYTHEMA (non-serious) with onset 17Mar2021, outcome "unknown", described as "light redness around the injection site". Therapeutic measures were taken as a result of vaccination site rash, pain in extremity, vaccination site erythema. Additional information: The patient had no prior vaccinations (within 4 weeks). The treatment received was Tylenol.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: just little bit soreness at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 14Feb2021 (Lot number: EL33) at the age of 70 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "just little bit soreness at the injection site".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: arm pain; flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Lot number: EN6198) 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild pain/soreness at the injection site; 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) (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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Mild pain/soreness at the injection site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Her body was hurting for 2 days and then it stopped; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Feb2021 15:00 (Lot number: EN6201) at the age of 78 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "pain" (unspecified if ongoing). Concomitant medication(s) included: HYDROCODONE taken for pain, start date: 2017 (ongoing); JANUVIA [SITAGLIPTIN] taken for diabetes mellitus (ongoing). Vaccination history included: Bnt162b2 (Lot: EN5318.She thinks it was administered in her left arm.), administration date: 02Feb2021, when the patient was 78 years old, for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 26Feb2021, outcome "recovered" (28Feb2021), described as "Her body was hurting for 2 days and then it stopped".  Additional Information: No additional vaccines was administered on same date of BNT162B2. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The event did not result to Physician Office and Emergency Room Visit .  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Exposure via breast milk, Irritability, Poor quality sleep
Clinical narrative: fussiness; feeds less; poor sleeping; my breastfed 7 month old daughter has not been herself since; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Mar2021 12:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLONASE ALLERGY RELIEF; ZYRTEC ALLERGY.  The following information was reported: IRRITABILITY (non-serious) with onset 14Mar2021 18:00, outcome "unknown", described as "fussiness"; DECREASED APPETITE (non-serious) with onset 14Mar2021 18:00, outcome "unknown", described as "feeds less"; POOR QUALITY SLEEP (non-serious) with onset 14Mar2021 18:00, outcome "unknown", described as "poor sleeping"; EXPOSURE VIA BREAST MILK (non-serious) with onset 14Mar2021 18:00, outcome "unknown", described as "my breastfed 7 month old daughter has not been herself since". Therapeutic measures were not taken as a result of irritability, decreased appetite, poor quality sleep, exposure via breast milk. Prior to vaccination the patient was not diagnosed with covid-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021291115 Baby/mother case
Sex: U
Vaccine: COVID19
Symptoms: Hangover, Headache
Clinical narrative: Headache; like he/she got a hangover; 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) (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: HEADACHE (non-serious), outcome "unknown", described as "Headache"; HANGOVER (non-serious), outcome "unknown", described as "like he/she got a hangover". Additional information: The patient gets a headache every day. The patient stated that he/she has been drinking like he/she got a hangover.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.