chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder due to a general medical condition
Clinical narrative: Twitches; not been sleeping or eating right; not been sleeping or eating right; nauseous from pain; his left calf has like a knot in it and it hurts/nauseous from pain / he is hurting; cramp on my left calf; 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. Other Case identifier(s): US-PFIZER INC-2021424408 (pfizer).  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Apr2021 (Lot number: ER8729) 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. The following information was reported: MUSCLE SPASMS (non-serious) with onset 08Apr2021, outcome "not recovered", described as "cramp on my left calf"; MUSCLE TWITCHING (non-serious) with onset 13Apr2021, outcome "not recovered", described as "Twitches"; SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION (non-serious), DECREASED APPETI TE (non-serious) all with onset 08Apr2021, outcome "not recovered" and all described as "not been sleeping or eating right"; NAUSEA (non-serious) with onset 08Apr2021, outcome "not recovered", described as "nauseous from pain"; PAIN (non-serious) with onset 08Apr2021, outcome "not recovered", described as "his left calf has like a knot in it and it hurts/nauseous from pain / he is hurting". Therapeutic measures were taken as a result of muscle spasms, pain.  Additional information: patient states that he got the shot on the 05Apr 2021 and by Wednesday  he has had a cramp in the calf of his left leg and it has hurt ever since then. Patient said that he went to bed fine and woke up with it. It has gone on for 7 days now. He states that he doesn't normally get cramps like that. He drinks plenty of water, takes magnesium and has been stretching. He has done everything possible and the cramp is still there. Patient states that nothing seems to work. He wants to know  if it would that be from the shot? He said that nothing seems to work. He states that his left calf has like a knot in it and it hurts. He states that it comes and goes when you rub it and massage it with Bengay or whatever  he has handy. He states that it goes away a little bit while using Bengay but it comes right back. He states that the only thing that kind of helps is a little bit of walking. He also states that he has not been sleeping or eating right since Thursday. He has been nauseous from the pain. He states that these side  effects are still on going and persisting. Patient also added that last night when he was sleeping he was woke up by two big twitches. No Emergency Room/Physician Office visit, no Prior Vaccinations (within 4 weeks). Bengay, patient states he was using Bengay on his cramp and it goes away for a little bit but then it comes right back. Lot number not queried.   No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 (Lot number: EP7534) at the age of 76 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 (1st dose), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 08Apr2021, outcome "recovered" (09Apr2021), described as "Slight Headache after second vaccine/Severe Headache"; MYALGIA (non-serious) with onset 08Apr2021, outcome "recovered" (09Apr2021), described as "Muscle Aches just like with the first shot"; PAIN (non-serious) with onset 2021, outcome "recovered" (09Apr2021), described as "pains"; HEADACHE (non-serious) with onset 16Mar2021, outcome "recovered" (17Mar2021), described as "Slight Headache after second vaccine". Additional information: Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. 78 year old Caller states she received 1st dose of the Pfizer Covid vaccine 22Feb2021 and second dose 16Mar2021. Why was the patient taking Covid 19 Vaccine. (Verbatim): Has pre-existing conditions and wanted to get the vaccine to not get Covid-19. Other Products: No. Patient History: No. Investigation Assessment: No. She got her second vaccination on 16Mar2021. She had a slight headache that same day and the next day it was gone. Then on 08Apr2021; 23 days after the second vaccine, she had severe headache and muscle aches like the ones she had from the first shot. States they lasted one day. The pains eased off that evening and were gone on 09Apr2021. She originally stated her first vaccine was on 22Apr2021 and her second on 16Apr2021. Weight: Reports as 179-180 pounds. Indication Continued: While discussing indication for Covid Vaccine caller states that she had some kind of episode 2 years ago in December before Covid-19 came out. She said she was very, very sick. Stated that the February after that was when Covid-19 came out. She said during her illness in that December she had every symptoms like Covid-19. Her doctor told her it probably wasn't Covid-19 and there was another flu that had come around. Stated the illness she experienced was severe enough that she went and set up her living trust. Stated she does not want Covid-19 if it was anything like that was. Concomitant Products, Medical Conditions, Investigations: Caller denies any medical conditions, medications, labs, testing, or treatments relevant to this report. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Physician Office: No. Patient's Medical History (Including any illness at time of vaccination): None. Family Medical History Relevant to AE(s): None. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tooth disorder
Clinical narrative: Caller boyfriend received the vaccine and then had some dental work done.; 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) (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: TOOTH DISORDER (non-serious), outcome "unknown", described as "Caller boyfriend received the vaccine and then had some dental work done".  Additional Information: No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. Below is the verbatim report. Caller boyfriend received the vaccine and then had some dental work done. She was wondering what her boyfriend could take for his pain since they were told by the vaccination site that he couldnt take Ibuprofen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Myalgia
Clinical narrative: headache; muscle pain; back pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day 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), outcome "unknown", described as "headache"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; BACK PAIN (non-serious), outcome "unknown", described as "back pain".  Additional information: Consumer reports that after first dose she had mild to moderate symptoms like headache, muscle pain and back pain. Consumer reports that she was being administered with second dose of Pfizers vaccine on 02Apr2021. Consumer reports that after second dose of vaccine she experienced pain in the knee, fever, chills, bone pain, headache, back pain and hands pain. Consumer reports that knee pain provokes her difficulty to walk, pain in hands is so intense that she is incapable of holding or grabbing things and back pain felt like if her back was going to break.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic, Pain in extremity, Therapeutic response unexpected
Clinical narrative: 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) (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Penicillin. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "both presented arm pain"; DERMATITIS ALLERGIC (non-serious), outcome "unknown", described as "develop an allergic skin reaction in forearms and face"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "During the call she mentioned that the vaccine eliminated some symptoms she had and made her feel better". The event "develop an allergic skin reaction in forearms and face" was evaluated at the physician office visit. Additional information: The patient developed an allergic reaction to the first dose of Pfizer's COVID-19 vaccine and wants to know if she can get the second dose. She and her husband received the vaccine last Friday, both presented arm pain, she was in a treatment with Penicillin which she suspended last Wednesday, after receiving the vaccine the patient and her husband went to eat seafood and short after the patient began to develop an allergic skin reaction in forearms and face, she went to see 2 different physicians who have given her different opinions about her allergic reaction; one of them stated it might be a reaction of vaccine with penicillin; another stated that it might be an allergic reaction to seafood since he do not think it is a reaction to Penicillin due to suspension of treatment by patient (more than 24 hours before vaccination). During the call she mentioned that the vaccine eliminated some symptoms she had and made her feel better. The patient went to the Hospital on Saturday. The patient also wants to know the risk for taking the second dose of the vaccine. No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: My period came a week earlier than it was supposed to, 3 weeks after my first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 13:45 (Lot number: EP6955) at the age of 20 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "depression" (unspecified if ongoing); "Known allergies: Peanuts" (unspecified if ongoing), notes: Known allergies: augmentin; "Known allergies: pistachios" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "Known allergies: augmentin". The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "recovered" (2021), described as "My period came a week earlier than it was supposed to, 3 weeks after my first shot". Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: The patient took no other vaccine in four weeks, had no covid prior vaccination, was not covid tested post vaccination. The patient stated that she had period came a week earlier than it was supposed to, 3 weeks after first shot. It was usually consistent. 2 days after she received the second shot, felt intense pain in lower abdomen towards the right side. This lasted for over 24 hours, making it difficult to sleep. She took ibuprofen and tylenol around the clock, usually do not experience cramps while on period. It was usually the week before or after, she was not sure if it was connected to receiving the vaccine, but she thought her experience might be of interest.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeding disorder, Pain, Pain in extremity, Spinal pain
Clinical narrative: No trouble with right arm. Can not move it; vomiting; Pain in stomach; pain in right arm that went from tip of finger to shoulder down my spin; pain in right arm that went from tip of finger to shoulder down my spin; pain in right arm that went from tip of finger to shoulder down my spin; Can't eat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Apr2021 09:30 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Had a sinus infection after last shot" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: covid-19 prior vaccination. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Product=COVID 19 , Brand =Pfizer, Lot unknown= False, Administration date=15Mar2021, Administration time=11:00 AM, Vaccine location=Left arm), administration date: 15Mar2021, when the patient was 60 years old, for Covid-19 Immunisation. The following information was reported: VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious) with onset 12Apr2021 16:00, outcome "not recovered", described as "No trouble with right arm. Can not move it"; VOMITING (non-serious) with onset 12Apr2021 16:00, outcome "not recovered", described as "vomiting"; ABDOMINAL PAIN UPPER (non-serious) with onset 12Apr2021 16:00, outcome "not recovered", described as "Pain in stomach"; PAIN IN EXTREMITY (non-serious), SPINAL PAIN (non-serious), PAIN (non-serious) all with onset 12Apr2021 16:00, outcome "not recovered" and all described as "pain in right arm that went from tip of finger to shoulder down my spin"; FEEDING DISORDER (non-serious) with onset 12Apr2021 16:00, outcome "not recovered", described as "Can't eat". The events "no trouble with right arm. can not move it", "vomiting", "pain in stomach", "pain in right arm that went from tip of finger to shoulder down my spin", "pain in right arm that went from tip of finger to shoulder down my spin", "pain in right arm that went from tip of finger to shoulder down my spin" and "can't eat" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vaccination site movement impairment, vomiting, abdominal pain upper, pain in extremity, spinal pain, pain, feeding disorder.  Additional information: No other vaccine in four weeks. The patient was not tested for covid-19 post vaccination. Patient went to doctor they told the patient they never heard of what patient was telling them. Patient stated she didn't have any issues with this arm before shot. Doctor said it's not near shot. It's not red or swollen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vomiting
Clinical narrative: No trouble with right arm. Can not move it; vomiting; Pain in stomach; pain in right arm that went from tip of finger to shoulder down my spin; pain in right arm that went from tip of finger to shoulder down my spin; pain in right arm that went from tip of finger to shoulder down my spin; Can't eat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Apr2021 09:30 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Had a sinus infection after last shot" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: covid-19 prior vaccination. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Product=COVID 19 , Brand =Pfizer, Lot unknown= False, Administration date=15Mar2021, Administration time=11:00 AM, Vaccine location=Left arm), administration date: 15Mar2021, when the patient was 60 years old, for Covid-19 Immunisation. The following information was reported: VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious) with onset 12Apr2021 16:00, outcome "not recovered", described as "No trouble with right arm. Can not move it"; VOMITING (non-serious) with onset 12Apr2021 16:00, outcome "not recovered", described as "vomiting"; ABDOMINAL PAIN UPPER (non-serious) with onset 12Apr2021 16:00, outcome "not recovered", described as "Pain in stomach"; PAIN IN EXTREMITY (non-serious), SPINAL PAIN (non-serious), PAIN (non-serious) all with onset 12Apr2021 16:00, outcome "not recovered" and all described as "pain in right arm that went from tip of finger to shoulder down my spin"; FEEDING DISORDER (non-serious) with onset 12Apr2021 16:00, outcome "not recovered", described as "Can't eat". The events "no trouble with right arm. can not move it", "vomiting", "pain in stomach", "pain in right arm that went from tip of finger to shoulder down my spin", "pain in right arm that went from tip of finger to shoulder down my spin", "pain in right arm that went from tip of finger to shoulder down my spin" and "can't eat" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vaccination site movement impairment, vomiting, abdominal pain upper, pain in extremity, spinal pain, pain, feeding disorder.  Additional information: No other vaccine in four weeks. The patient was not tested for covid-19 post vaccination. Patient went to doctor they told the patient they never heard of what patient was telling them. Patient stated she didn't have any issues with this arm before shot. Doctor said it's not near shot. It's not red or swollen.  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, Gout, Influenza like illness, Insomnia
Clinical narrative: Extreme fatigue; Days without sleep; Flare up of gout and in a foot; Flu like symptoms; 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), administered in arm left, administration date 16Mar2021 13:30 (Lot number: EN6204) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gout" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 18Mar2021 17:00, outcome "recovered with sequelae" (2021), described as "Extreme fatigue"; INSOMNIA (non-serious) with onset 18Mar2021 17:00, outcome "recovered with sequelae" (2021), described as "Days without sleep"; GOUT (non-serious) with onset 18Mar2021 17:00, outcome "recovered with sequelae" (2021), described as "Flare up of gout and in a foot"; INFLUENZA LIKE ILLNESS (non-serious) with onset 18Mar2021 17:00, outcome "recovered with sequelae" (2021), described as "Flu like symptoms". Therapeutic measures were not taken as a result of fatigue, insomnia, gout, influenza like illness. Additional information: Patient with Covid-19 prior to vaccination was unknown. Since the vaccination, patient has not been tested for Covid-19. Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Patient did not receive any other medications within 2 weeks of vaccination. No known allergies.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Fatigue; Sore upper arm at injection site; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 5 year-old female patient received bnt162b2 (BNT162B2), administration date 14Apr2021 (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: FATIGUE (non-serious) with onset 14Apr2021, outcome "unknown", described as "Fatigue"; VACCINATION SITE PAIN (non-serious) with onset 14Apr2021, outcome "unknown", described as "Sore upper arm at injection site". Therapeutic measures were not taken as a result of fatigue, vaccination site pain.  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, Pain
Clinical narrative: Experienced about 18 hours of aches and fatigue and just generally wanting to be in bed with a heating pad; Experienced about 18 hours of aches and fatigue and just generally wanting to be in bed with a heating pad; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (unknown if pregnant) 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: PAIN (non-serious), FATIGUE (non-serious), outcome "recovered" and all described as "Experienced about 18 hours of aches and fatigue and just generally wanting to be in bed with a heating pad". Therapeutic measures were not taken as a result of pain, fatigue.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome
Clinical narrative: postnasal drip; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female 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: UPPER-AIRWAY COUGH SYNDROME (non-serious), outcome "unknown", described as "postnasal drip".  Additional information: Medical Information: There were no unaddressed medical questions referred or forwarded to Medical Information. It was reported that Caller received 1st dose of Covid Vaccine. She wants to take a decongestant for postnasal drip. Also wanted to Know does Pfizer vaccine make you sleepy  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: There was blood dripping down her arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2, Solution for injection) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION COMPLICATION (non-serious), outcome "unknown", described as "There was blood dripping down her arm.". Additional Information: The patient reported that she just received her second dose a few minutes ago. There was blood dripping down her arm. She wanted to know if the efficacy of the vaccine is going to be impacted.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm hurt really bad; Tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (Formulation: Solution for injection), administration date 12Feb2021 (Lot number: EL9267, Expiration Date: 31May2021) at the age of 66 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Feb2021, outcome "recovered" (15Feb2021), described as "Arm hurt really bad"; FATIGUE (non-serious) with onset 13Feb2021, outcome "recovered" (15Feb2021), described as "Tired". Additional information: reporter states after her first vaccine, her arm hurt the next day really bad and she was tired and wanted to sleep and lounge around all day so she slept and then the next day her arm was a little sore on Sunday and then it was gone the next day. Second vaccine received on 5MAR2021. No vaccination prior to covid vaccination. Prior Vaccinations (within 4 weeks): None.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Only side effect of first vaccine was sore arm for a few days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Mar2021 10:00 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing), notes: Allergies to other products: demoral; "Allergies to medications" (unspecified if ongoing), notes: Allergies to medications; "food allergy" (unspecified if ongoing), notes: Allergies to food. Concomitant medication(s) included: TYLENOL; ZOLOFT. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Apr2021, outcome "recovered" (Apr2021), described as "Only side effect of first vaccine was sore arm for a few days". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient had not received any other vaccine within 4 weeks. Pregnant at the time of vaccination was no. List of any other medications the patient received within 2 weeks of vaccination: multi-vitamin, tylenol, Zoloft. Reported Event: Only side effect of first vaccine was sore arm for a few days. After second vaccine only side effect was sore breasts/lymph nodes on left side (opposite of the side she got the shot on) days 4-6 after shot. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Allergies to medications, food, or other products: demoral. Vaccine Facility information available. Race information was available. Location of injection information was available for all vaccines received on the same date. No treatment received for the adverse event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Headache, Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: severe headaches; lower back and stomach pain; lower back and stomach pain; right leg pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 15:15 (Lot number: EN6208) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing), notes: Penicillin Allergy. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 29Mar2021, outcome "recovered" (Apr2021), described as "severe headaches"; BACK PAIN (non-serious), ABDOMINAL PAIN UPPER (non-serious) all with onset 29Mar2021, outcome "recovered" (Apr2021) and all described as "lower back and stomach pain"; PAIN IN EXTREMITY (non-serious) with onset 29Mar2021, outcome "recovered" (Apr2021), described as "right leg pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (05Apr2021) unknown. Therapeutic measures were not taken as a result of headache, back pain, abdominal pain upper, pain in extremity.  Clinical course: The patient did not receive other vaccine in four weeks. The patient had not covid prior vaccination. The patient had covid tested post vaccination. The patient reported that two weeks after first dose, he started having severe headaches, lower back and stomach pain, and right leg pain. This lasted for 3 days and then went away. After reading today about the J and J blood clots and the symptoms to look out for he started to wonder if what he felt was similar in any way. The patient also reported that he understood these were completely different vaccines but the symptoms he felt were something he had not felt before.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: enlarged lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) 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 (COVID-19 Vaccine, First dose), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "enlarged lymph nodes".  Additional information: Caller was tested positive for COVID after receiving the first dose of the Pfizer vaccine. Caller read some information stating that the second dose should be administered 10 days after the infection. She also read information to delay the second dose for 90 days if you test positive for COVID before you get your fist dose. Caller wanted to know what was the recommended period to wait before you get your second dose if you test positive for COVID (90 days or 10 days). Caller also had two patients who had enlarged lymph nodes after getting their second dose of the Pfizer vaccine. I have two patient who had enlarged lymph nodes for 3 weeks. They have taken medications and consulted their doctors. Also want to know if Pfizer has any recommendations to bring down the enlarged lymph nodes and want to know how long this symptom last. "Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, is likely to have resulted from a robust vaccine-elicited immune response.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: enlarged lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2, solution for injection) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "enlarged lymph nodes". Therapeutic measures were taken as a result of lymphadenopathy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Erythema, Skin disorder
Clinical narrative: Bumps on legs /With the first shot, he thought the red bumps looked like a heat rash; Bumps on legs, like little red dots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 09:20 (Lot number: ER8727) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies to pencillin and sulfa based antibiotics" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement, start date: 2011 (ongoing). The following information was reported: SKIN DISORDER (non-serious) with onset 22Mar2021, outcome "not recovered", described as "Bumps on legs /With the first shot, he thought the red bumps looked like a heat rash"; ERYTHEMA (non-serious) with onset 22Mar2021, outcome "not recovered", described as "Bumps on legs, like little red dots". The events "bumps on legs /with the first shot, he thought the red bumps looked like a heat rash" and "bumps on legs, like little red dots" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of skin disorder, erythema.  Additional information: After the first shot on 22-MAR-2021 09:20, he had some bumps on his legs, like little red dots. He thought this was a heat rash, and did not think anything of it. With the first shot, he thought the red bumps looked like a heat rash. He never had reactions. The dermatologist said with his history she's 100% sure it's vaccine related. Emergency Room staff said it's a rash coming from the inside. They said they don't know much about rashes and that's why had to see a dermatologist. States he has pictures of his legs.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Headache
Clinical narrative: caller is having problems with her eyes; bad headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female 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: EYE DISORDER (non-serious), outcome "unknown", described as "caller is having problems with her eyes"; HEADACHE (non-serious), outcome "unknown", described as "bad headache".  Additional information: Patient stated that she got the first vaccine from Pfizer and that Pfizer gave her a sheet that says 4/13 but the whole time she was looking at the sheet she always saw 4/14 and she did not know why, might had trouble with her eyes. Patient was looking at the 4 in front and the 4 in the back. She always thought she was coming at 14, on the 14th. Patient always had this paper on her end table, it is ridiculous. Whole time, she does not know, maybe she was having problems with her eyes. She is seeing in reverse, so she does not know. Patient thought it was a 14 and not a 13. Patient does not know how to get a hold of the place where she got her first vaccine. Patient was already scheduled for her second dose and there was nothing to report. Patient had her first dose, but she does not had the second, she missed her second 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: Chills, Tremor
Clinical narrative: Chills; shaking; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm right (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: CHILLS (non-serious), outcome "unknown", described as "Chills"; TREMOR (non-serious), outcome "unknown", described as "shaking".  Additional information: Reporter mentioned some of her coworkers had side effects within 3 days   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Sore injection sight; headache; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 13:00 (Lot number: EP6955) at the age of 48 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Corminaty (Dose 1; 4:45PM, EP6955, Left arm), administration date: 18Mar2021, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "not recovered", described as "Sore injection sight"; HEADACHE (non-serious) with onset Apr2021, outcome "not recovered", described as "headache"; FATIGUE (non-serious) with onset Apr2021, outcome "not recovered", described as "fatigue". Therapeutic measures were taken as a result of vaccination site pain, headache, fatigue.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications patient received within 2 weeks of vaccination. Prior to vaccination, patient  was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. No allergies to medications, food, or other products. Seriousness criteria-Caused/prolonged hospitalization.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Maybe a little tired the next day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 76 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Maybe a little tired the next day".  Additional information: The patient stated that how wanted to continue using Premarin and looking for assistance. Stated that the patient was retired. The patient recently broke leg and have medical expenses as a result. It was clarified that patient was taking the Premarin .625mg tablets before broke leg. patient stated the patient have never had a problem with that and the patient have been Pfizer vaccinated. No problem, maybe a little tired the next day but sometimes that comes with 76 years.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Lingering headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 (Lot number: EL3247) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FISH OIL. The following information was reported: HEADACHE (non-serious) with onset 15Mar2021 12:00, outcome "recovered" (Mar2021), described as "Lingering headache". Therapeutic measures were not taken as a result of headache.  Additional information: It was reported that The awareness date is 15Mar2021 for adverse event report, which is 4 days after my 1st vaccine. The patient did not receive any other vaccines within 4 weeks, since the vaccination, the patient has been not tested for COVID-19. List of any other medications the patient received within 2 weeks of vaccination:tri-lo-sprintec, centrum multivitamin, fish oil.  Prior to vaccination, the patient was not diagnosed with COVID-19. No Allergies to medications, food, or other products.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: foggy headed; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 13:45 (Lot number: EP6955) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRI-LO-SPRINTEC; FISH OIL; MULTIVITAMIN (16). Vaccination history included: Bnt162b2 (product=COVID19, lot number=EL3247, administration time=13:45, vaccine Location=Left arm,, dose number=1), administration date: 11Mar2021, when the patient was 37 years old, for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 02Apr2021 07:00, outcome "recovered" (Apr2021), described as "foggy headed"; FATIGUE (non-serious) with onset 02Apr2021 07:00, outcome "recovered" (Apr2021), described as "tired". Therapeutic measures were not taken as a result of feeling abnormal, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had no known allergies.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Shot 1 - arm pain at injection site; 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 male patient received bnt162b2 (BNT162B2, Solution for injection), administered in arm left, administration date 24Mar2021 16:45 (Lot number: ER8732) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Shot 1 - arm pain at injection site".  Additional information: Patient has not been administered any other vaccines prior to 4 weeks and  patient has not been tested for COVID in post vaccination and patient took other medications in two weeks included Clopidogrel, Amlodipine, Simvastatin, Alprazolam.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: received second  dose of the pfizer covid vaccine yesterday and developed muscular pain during the night; 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 58 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for covid-19 immunisation. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "received second dose of the pfizer covid vaccine yesterday and developed muscular pain during the night".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Malaise, Pain in extremity
Clinical narrative: had some pain in his arm and now pain has gone away; weakness; he has been feeling fatigue and tiredness in general for 3 days; dizziness; malaise in his whole body; feels his feet are cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetic" (unspecified if ongoing); "COVID-19", start date: Dec2020, stop date: Dec2020, notes: contracted the Covid 19 infection in DEC 2020. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "had some pain in his arm and now pain has gone away"; ASTHENIA (non-serious), outcome "unknown", described as "weakness"; FATIGUE (non-serious), outcome "unknown", described as "he has been feeling fatigue and tiredness in general for 3 days"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; MALAISE (non-serious), outcome "unknown", described as "malaise in his whole body"; PERIPHERAL COLDNESS (non-serious), outcome "unknown", described as "feels his feet are cold". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information : Patient wants to know if the side effects that he is presenting are reported with the COVID-19 vaccine, he received the first dose on a Pharmacy, he is a diabetic patient, the day of the administration he presented pain in his arm that eventually went away (after 3 days), since 3 days ago until now the patient has presented weakness, fatigue and tiredness, dizziness y general body malaise similar to when he was infected with the COVID-19 virus (he had the infection in December), additionally he also developed cold feet, he is currently taking Tylenol. He also mentioned that he feels like he is "drugged with medications". Referred to his physician for treatment recommendation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.