chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 (Lot number: EN6199) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Adrenal insufficiency" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "tinnitus". The event "tinnitus" was evaluated at the physician office visit.  Additional information: Patient history with adrenal insufficiency It started in 2004 or 2005. On Nov2018 she weened off of steroids after being on them for a long time, and her adrenals kicked in. She has been totally off of steroids since then. Every 6 months she gets her cortisol and ACTH tested which is related to the adrenals, and everything is perfect. She is not sure when it started. It started a bit after she had the first shot. She was washing her hair and thought maybe there was water in her ear or something or she had an allergy. It wasn't like it is now. This never stops. With her first dose she didn't pay much attention to it. Around there everyone suffers with allergies. She has lived in Florida for 30 years and has never had allergies. The first time the tinnitus was very subtle. She is not sure when it started in between 05May2021 and 26May2021, she can't remember if it was an every day thing or just all of a sudden she felt something going on. It was more subtle after the first shot, then after the second shot boom. She didn't pay much attention to it, and it went away. It was not severe, just kind of there. She noticed it when she was washing her hair and she thought she had water in her ear. She went about her business and was happy she had no reaction from the first shot, but everyone said the second shot is what gets you. She thought maybe some people had reactions and not others. She went in optimistic she would be fine. Right when she just turned she felt a little off center. That happens too when she makes certain movements.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-Up (20Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: This individual called Pfizer earlier and reported never having an outbreak of her herpes since being vaccinated; 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 50 year-old female 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: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "This individual called Pfizer earlier and reported never having an outbreak of her herpes since being vaccinated".  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-2021684622 same reporter/drug/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in finger tips/ Trigger finger in middle finger; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Lot number: EW0161) as dose 1, single and administered in arm left, administration date 2021 (Lot number: EW0182) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; SINGULAIR. The following information was reported: PARAESTHESIA (non-serious) with onset 29Apr2021, outcome "recovered with sequelae", described as "Tingling in finger tips/ Trigger finger in middle finger". Therapeutic measures were not taken as a result of paraesthesia.  Additional information: The patient had no other vaccine within four weeks and other medications received within 2 weeks of vaccination included vitamins, synthroid, singular. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Adverse event: tingling in finger tips after first vaccine. Trigger finger in middle finger after second vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness
Clinical narrative: Since my 2 Pfizer Covid vaccinations I have noticed ongoing calf muscle tightness & right masseter & right neck muscle tightness that was not present before; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Jan2021 (Lot number: EN5318) at the age of 67 years as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MUSCLE TIGHTNESS (non-serious) with onset 25Feb2021, outcome "not recovered", described as "Since my 2 Pfizer Covid vaccinations I have noticed ongoing calf muscle tightness & right masseter & right neck muscle tightness that was not present before".  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes above left collar bone; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jun2021 09:45 (Lot number: EWO187) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN; ALPRAZOLAM. Vaccination history included: Bnt162b2 (Dose number=1, Lot number: EWO185, Administration date= 17May2021, Administration time: 09:15 PM, Vaccine location= Left arm), administration date: 17May2021, when the patient was 45 years old, for Covid-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 09Jun2021 22:00, outcome "not recovered", described as "Swollen lymph nodes above left collar bone". Therapeutic measures were not taken as a result of lymphadenopathy. Additional information- It was reported that patient did not receive any covid vaccine prior vaccination and did not undergo covid tested post vaccination. Patient had no known allergy.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Malaise, Pain
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient's grandmother), for a Pfizer sponsored program (159558). A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Jun 9, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunization. The patient experienced chills, pain/body ache and sore, malaise/felt sick and felt cold, onset Jun 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: headaches and  tired almost everyday; headaches and  tired almost everyday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 08:30 (Lot number: EW0162) at the age of 68 years as dose 1, single and administered in arm left, administration date 14May2021 08:30 (Lot number: EW0179) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious), FATIGUE (non-serious) all with onset 16Apr2021 11:00, outcome "not recovered" and all described as "headaches and  tired almost everyday". Therapeutic measures were not taken as a result of headache, fatigue.  Follow-up (23Jul2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported in response to Non HCP letter sent that included: Patient details, adverse events, vaccine details with LOT/Batch numbers   Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected.  Follow-Up (30Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I can still feel pain in my arm like they shot it in the vein instead of muscle.; This a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Apr2021 11:15 (Lot number: Ew0153) at the age of 29 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: PAIN IN EXTREMITY (non-serious) with onset 02May2021 11:15, outcome "not recovered", described as "I can still feel pain in my arm like they shot it in the vein instead of muscle.". Therapeutic measures were not taken as a result of pain in extremity. Additional information: Reported that arm where shot was administered was painful like they shot it in the vein instead of muscle. It had been 3 months since the shots and could feel pain in his arm. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. No known allergies. No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Neck mass
Clinical narrative: Painful lump in neck right besides clavicle bone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jun2021 16:00 (Lot number: Ew0180) at the age of 32 years as dose number unknown, single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NECK MASS (non-serious) with onset 13Jun2021 06:00, outcome "not recovered", described as "Painful lump in neck right besides clavicle bone". Therapeutic measures were not taken as a result of neck mass. Additional information: Patient had no known allergies. Patient reported had not diagnosed with COVID-19 prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not tested for COVID-19. The facility type vaccine: Pharmacy or drug store. The adverse event did not results in any seriousness criteria.  Follow-up attempts are completed. No further information expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Muscle pain in my left arm and shoulder; Limited movement; 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 14Apr2021 16:15 (Lot number: EW0153) at the age of 45 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: MYALGIA (non-serious) with onset 15Apr2021, outcome "not recovered", described as "Muscle pain in my left arm and shoulder"; MOBILITY DECREASED (non-serious) with onset 15Apr2021, outcome "not recovered", described as "Limited movement". Therapeutic measures were not taken as a result of myalgia, mobility decreased.  Additional information: Facility type vaccine was reported as Pharmacy or Drug Store. No known allergies. No other vaccine in four weeks. No other medications in two weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient reported that he still have muscle pain in arm and shoulder. No issues with the 2nd dose. Adverse event start time was 12:00 AM.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy/light-headed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26May2021 11:20 (Lot number: EW0180, Expiration Date: Aug2021) at the age of 77 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "slight dental procedure" (unspecified if ongoing), notes: Verbatim: Monday she went for a slight dental procedure. They did give her a little gas. It was a minor procedure but she was already feeling light-headed before this dental procedure.; "Blood pressure" (ongoing). Concomitant medication(s) included: CLONIDINE taken for blood pressure abnormal (ongoing); LOSARTAN taken for blood pressure abnormal (ongoing). The following information was reported: DIZZINESS (non-serious), outcome "not recovered", described as "dizzy/light-headed". Therapeutic measures were taken as a result of dizziness.  Additional Information: Concomitant drug Clonidine: She had no idea when she started taking it. It was about 20 years ago. If it was less than 150/90, take it 3 times a day. She takes 1 because she felt ok. Every once in a while, she would take 2 a day. She could not remember when this condition started. She just went to a clinic to have her eyes examined. They took her blood pressure. Vaccine was not Administered at a Facility. No history of any previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. Adverse event did not require a visit to Emergency Room/Physician Office. No vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine. No Adverse events following prior vaccinations. Relevant medical history (including any illness at time of vaccination) included Blood pressure. No relevant family medical history to adverse event. No relevant tests done. Treatment included Dramamine. She only took 1 pill about several days after. It may have been about a week ago. More or less.
Sex: U
Vaccine: COVID19
Symptoms: Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: her friend had the same experience:has herpes and since getting the Pfizer BioNTech COVID 19 vaccine she never had an outbreak of herpes; it's the outbreak I haven't had once since I have the Vaccine; Pre-existing condition improved; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "has herpes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "her friend had the same experience:has herpes and since getting the Pfizer BioNTech COVID 19 vaccine she never had an outbreak of herpes; it's the outbreak I haven't had once since I have the Vaccine"; PRE-EXISTING CONDITION IMPROVED (non-serious), outcome "unknown", described as "Pre-existing condition improved".  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-2021684622 Same reporter/ drug/ AE, different patient
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like aymptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jun2021 14:00 (Batch/Lot number: unknown) at the age of 12 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE Lot number: Unknown Anatomical site: Left arm Administration time: 13:00), administration date: 21May2021, when the patient was 12 years old, for COVID-19 immunisation. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 12Jun2021 07:00, outcome "not recovered", described as "Flu like aymptoms". Therapeutic measures were not taken as a result of influenza like illness.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any treatment for the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: the patient complains of a sore arm after getting their vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 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 "the patient complains of a sore arm after getting their vaccine". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Sore Arm; Fatigue for a few days; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29May2021 17:00 (Batch/Lot number: unknown) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. There were no concomitant medications. Past drug history included: None, notes: The patients past drug therapy was reported as no. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 29May2021 21:00, outcome "recovered with sequelae" (2021), described as "Sore Arm"; FATIGUE (non-serious) with onset 29May2021 21:00, outcome "recovered with sequelae" (2021), described as "Fatigue for a few days"; HEADACHE (non-serious) with onset 29May2021 21:00, outcome "recovered with sequelae" (2021), described as "Headache". Therapeutic measures were not taken as a result of pain in extremity, fatigue, headache.  Additional information: The patient had no known allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  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: Vertigo, Vertigo positional
Clinical narrative: Vertigo dizziness in the head where room appeared to be tilting; Benign Paroxysmal positional vertigo (BPPV); 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 09Jun2021 18:45 (Batch/Lot number: unknown) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "eye sight issue" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VERTIGO (non-serious) with onset 13Jun2021 07:00, outcome "not recovered", described as "Vertigo dizziness in the head where room appeared to be tilting"; VERTIGO POSITIONAL (non-serious) with onset 13Jun2021 07:00, outcome "not recovered", described as "Benign Paroxysmal positional vertigo (BPPV)". Therapeutic measures were not taken as a result of vertigo, vertigo positional.  Additional information: It was reported that, after the vaccine was administered on 09Jun. Series of Vertigo episode started from 13Jun morning as soon as he woke up. Vertigo dizziness in the head where room appeared to be tilting. This continued through out the day for every hour or so. Also upon trying to lie down or walk. Upon looking up online it was referred as Benign Paroxysmal positional vertigo (BPPV). As symptoms continues even today 14Jun, he was planning a physical therapy appointment next week to treat this issue. No Covid prior vaccination. No Covid tested post vaccination  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: Arm was more sore right now than in her first shot; 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 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm was more sore right now than in her first shot".  Additional information: Question: Caller had the second shot of the Pfizer COVID-19 vaccine yesterday and she wanted to know why she is reacting differently than when she had her first shot. Caller said her arm was more sore right now than in her first shot. Caller disconnected while I was asking for a call-back number. I was unable to ask first and last name due to the disconnect.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Pain under my armpit, swollen lymp nodes.; Pain under my armpit, swollen lymph nodes.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jun2021 09:15 (Lot number: EW0191) at the age of 41 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: AXILLARY PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 12Jun2021 06:00, outcome "recovering" and all described as "Pain under my armpit, swollen lymph nodes.". Therapeutic measures were not taken as a result of axillary pain, lymphadenopathy.  Additional information:"No other vaccine in 2 qnd 4 weeks. No covid prior vaccination. Not tested for covid post vaccination. No known allergies."  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Lethargy, Nausea
Clinical narrative: slept a lot; bad headache; nausea; lethargy; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2021 15:30 (Lot number: GL9265) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergy" (unspecified if ongoing), notes: Deet mosquito repellent. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS. Vaccination history included: Covid 19 (Dose: 1, Lot number=EK9231, administration time=06:30 PM, left arm.), administration date: 22Jan2021, for COVID-19 immunization. The following information was reported: HYPERSOMNIA (non-serious) with onset 13Feb2021, outcome "recovered" (2021), described as "slept a lot"; HEADACHE (non-serious) with onset 13Feb2021, outcome "recovered" (2021), described as "bad headache"; NAUSEA (non-serious) with onset 13Feb2021, outcome "recovered" (2021), described as "nausea"; LETHARGY (non-serious) with onset 13Feb2021, outcome "recovered" (2021), described as "lethargy". Therapeutic measures were not taken as a result of hypersomnia, headache, nausea, lethargy.  Additional information: The patient did not receive any other vaccine in four weeks. The patient did not have COVID-19 prior vaccination. The patient had not tested COVID-19 post vaccination. The patient had no other medical history. It was reported that the day after vaccine, the patient had bad headache and nausea, lethargy, slept a lot. For 1 full week she continued to get a bad headache and nausea every night for a week. She was starting to get worried, but then it finally dissipated. Shot was on a Friday afternoon and her last about of nausea and headache was the following Thursday evening.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), administration date 20May2021 (Lot number: EW0186) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Mar2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose no: 1, Lot number: EW0175), for COVID-19 immunization, reaction(s): "burning/tingling in my entire arm", "Chills", "Fatigue", "Headache", "Sweating", "swollen lymph node in my left armpit the size of a grapefruit", "Nausea", "Aches", "burning/tingling in my entire arm", "Fever". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm". The event "sore arm" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: She had a reaction of similar proportions to the second dose, which she was still trying to recover from now. She had chills, aches, headache, nausea, sore skin, fatigue & once took the shot in is the size of again my lymph made in the arm she had grapefruit, swollen & painful. Patient stated please consider with a lesser dose for people who had Covid or are Centre a certain weight. She felt there should had been an option for her to have a blood draw after the first dose useful scored high enough in antibodies. She could be considered fully vaxed. after one dose since she had Covid previously. stated it was healthy for her to have to go through that again or she would not be considered fully vaccinated. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: he had a 'tingly' sensation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received bnt162b2 (BNT162B2) (Lot number: EWO182) as dose 2, single and (Lot number: EWO175) 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: PARAESTHESIA (non-serious) with onset 10Jun2021, outcome "unknown", described as "he had a 'tingly' sensation". The event "he had a 'tingly' sensation" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of paraesthesia.  Additional information: It was unknown if other vaccine taken in four weeks, covid prior to vaccination and covid tested post vaccination  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: It was injected in her left arm in the muscle. It hurt.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 50 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Jan2021 (Batch/Lot number: unknown, Expiration Date: 31May2021) at the age of 50 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 18Jan2021, outcome "unknown", described as "It was injected in her left arm in the muscle. It hurt."  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021679424 same patient, different dose/AE
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Musculoskeletal stiffness
Clinical narrative: I have developed low back pain and stiffness; I have developed low back pain and stiffness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 25Apr2021 (Lot number: ew0171) at the age of 39 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: BACK PAIN (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset May2021, outcome "not recovered" and all described as "I have developed low back pain and stiffness". Therapeutic measures were not taken as a result of back pain, musculoskeletal stiffness.  Additional information: I have developed low back pain and stiffness. It got worse after 2nd dose of Pfizer. The stiffness was worse in the mornings and slowly gets litter better by the evening. The pain was worse on bending. The patient not received other vaccine in four weeks and Other medications in two weeks. The patient not had a covid prior vaccination and not tested for covid post vaccination. The patient not had an allergies.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), in 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of COVID-19 vaccine (manufacturer unknown), for COVID-19 immunization. The patient had malaise (felt ill after 2nd dose), onset 2021, with outcome of unknown. Additional information: Prior to vaccination, unknown whether patient was diagnosed with COVID-19. Since the vaccination, unknown whether patient tested for COVID-19. Unknown whether patient received any other vaccines within four weeks prior to the vaccination. This follow-up submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed and no further information expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: swollen lymph nodes in the left clavicle, in the left armpit and behind the neck in the lower left; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jun2021 15:15 (Lot number: EW0167) at the age of 17 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: LYMPHADENOPATHY (non-serious) with onset 10Jun2021, outcome "recovering", described as "swollen lymph nodes in the left clavicle, in the left armpit and behind the neck in the lower left". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient had no known allergies and other medical history. The patient did not had covid prior vaccination. The patient was tested for covid post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, SARS-CoV-1 test, Taste disorder
Clinical narrative: certain food as they taste bad and smell weird. Do not eat banana any more some food taste like dish soap smell.; certain foods taste very bad and I no longer eat/enjoy them; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Apr2021 (Lot number: EW0161) at the age of 76 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 ({product=COVID 19, brand=Pfizer , lot number=ER8730 , administration date=03Mar2021 , dose number=1 , vaccine location=Left arm), administration date: 03Mar2021, for covid 19 immunization. The following information was reported: TASTE DISORDER (non-serious) with onset May2021, outcome "not recovered", described as "certain foods taste very bad and I no longer eat/enjoy them"; PAROSMIA (non-serious), outcome "unknown", described as "certain food as they taste bad and smell weird. Do not eat banana any more some food taste like dish soap smell.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of taste disorder.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The taste of unrelated foods have become objectionable - no longer pleasant to eat. She lost her sense of taste when she contracted Covid but it came back about 80% before she had the vaccine. Now certain foods taste very bad and she no longer eat/enjoy them. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Known allergies: I pro.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Inappropriate schedule of product administration, Musculoskeletal stiffness, Pain
Clinical narrative: Date of start of drug: 06Jun2021, Dose Number: 1; Date of start of drug: 25Apr2021, Dose Number: 2; It got worse after 2nd dose of Pfizer. The stiffness is worse inthe mornings and slowly getts litter better by the evening. The pain is worse on bending.; I have developed low back pain and stiffness.; It got worse after 2nd dose of Pfizer. The stiffness is worse inthe mornings and slowly getts litter better by the evening. The pain is worse on bending.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 25Apr2021 (Lot number: ew0217) at the age of 39 years as dose 2, single and administration date 06Jun2021 (Lot number: ew0171) 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: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Date of start of drug: 06Jun2021, Dose Number: 1; Date of start of drug: 25Apr2021, Dose Number: 2"; MUSCULOSKELETAL STIFFNESS (non-serious), PAIN (non-serious) all with onset May2021, outcome "not recovered" and all described as "It got worse after 2nd dose of Pfizer. The stiffness is worse inthe mornings and slowly getts litter better by the evening. The pain is worse on bending."; BACK PAIN (non-serious) with onset May2021, outcome "not recovered", described as "I have developed low back pain and stiffness.". Therapeutic measures were not taken as a result of musculoskeletal stiffness, back pain, pain.  Additional information:  No other vaccine in four weeks. No other medications in two weeks. covid prior vaccination used. No covid tested post vaccination. No allergies and other medical history  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: increased migraines; increased migraines; 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 79 year-old female patient received bnt162b2 (BNT162B2), administration date May2021 (Lot number: EW0173) at the age of 79 years as dose 2,single for covid-19 immunisation. Relevant medical history included: "Chronic migraine" (unspecified if ongoing); "Allergy to amoxicillin" (unspecified if ongoing); "Shingles on her head", start date: 01Feb2021 (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ibuprofen for Shingles, notes: The caller had shingles on her head on 01Feb2021, she was on ibuprofen and gabapentin for it until 28May2021. The caller was on 300 mg a day of Gabapentin and she had gone down before the 28May2021, she tapered off of it.; Gabapentin for Shingles, notes: The caller had shingles on her head on 01Feb2021, she was on ibuprofen and gabapentin for it until 28May2021. The caller was on 300 mg a day of Gabapentin and she had gone down before the 28May2021, she tapered off of it. Vaccination history included: Bnt162b2 (First dose, Lot GR8736 or GR8136), administration date: 04May2021, when the patient was 79 years old, for Covid-19 immunization, reaction(s): "Migraine", "Dizziness". The following information was reported: MIGRAINE (non-serious) with onset 05May2021, outcome "not recovered", MIGRAINE (non-serious) with onset May2021, outcome "not recovered" and all described as "increased migraines". Therapeutic measures were taken as a result of migraine, migraine. No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Vaccination site pain
Clinical narrative: 4 weeks to the day after I got the second shot, my left arm got very sore at the injunction site and I got a horrible metallic taste in my mouth.  That was yesterday.  Both are still there today.; 4 weeks to the day after I got the second shot, my left arm got very sore at the injunction site and I got a horrible metallic taste in my mouth.  That was yesterday.  Both are still there today.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14May2021 12:30 (Lot number: EW0175) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC-D taken for hypersensitivity. Vaccination history included: Bnt162b2 (lot number ER8736, lot unknown False,  administration time 12:30 PM, dose number 1, vaccine location Left arm.), administration date: 22Apr2021, when the patient was 50 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), DYSGEUSIA (non-serious) all with onset 14Jun2021 09:30, outcome "not recovered" and all described as "4 weeks to the day after I got the second shot, my left arm got very sore at the injunction site and I got a horrible metallic taste in my mouth.  That was yesterday.  Both are still there today.". Therapeutic measures were not taken as a result of vaccination site pain, dysgeusia.  Additional information: facility type vaccine: Public Health Clinic. No other vaccine was taken in 4 weeks. No covid prior vaccination. No covid tested post vaccination. Other medical history was nothing significant.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: headache and fatigue for 24 hours; headache and fatigue for 24 hours; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 14 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), FATIGUE (non-serious), outcome "recovered" and all described as "headache and fatigue for 24 hours". Additional information: It was reported that brothers 14 and 15 yo males experienced headache and fatigue for 24 hours following second dose of vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: headache and fatigue for 24 hours; headache and fatigue for 24 hours; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 immunisation. The following information was reported: HEADACHE (non-serious), FATIGUE (non-serious), outcome "recovered" and all described as "headache and fatigue for 24 hours".  Additional Information:Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site, continual and worsening over the last 5 weeks.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 15:45 (Lot number: 8W172) at the age of 16 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Celiac disease" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Product:COVID 19, Brand: Pfizer, Lot number: EP7533, Administration time: 03:45, Dose number: 1, Vaccine location: Left arm), administration date: 16Apr2021, when the patient was 16 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 07May2021 15:45, outcome "not recovered", described as "Pain at the injection site, continual and worsening over the last 5 weeks.". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the Vaccination, the patient has not been tested positive for COVID-19. The patient took did not receive any other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.  Follow-up (14Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Respiratory rate
Clinical narrative: extremely exhausted/ tiring easily; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 07May2021 07:54 (Lot number: FB EW0171) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing), notes: I have epi pen. Concomitant medication(s) included: ADVIL COLD & SINUS; FLONASE [FLUTICASONE PROPIONATE]. Vaccination history included: Bnt162b2 (Dose: 1, 08:11 AM, Upper right arm, ROA: IM, Batch/Lot number: FB- EW 0158), administration date: 16Apr2021, when the patient was 60 years old, for Covid-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 07May2021, outcome "recovered" (May2021), described as "extremely exhausted/ tiring easily". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue.  Additional information: Facility type vaccine: Hospital. Patient was extremely healthy before vaccination. Other vaccine in four weeks: No. Other medications in two weeks reported in concomitant medications. Covid prior vaccination: No. Covid tested post vaccination: No. Patient had reported Adverse event which has been over a month since her second injection. Patient slept like a dead person and was exhausted when she woke up and recently had enough energy to workout.  No follow-up attempts are possible. No further information is expected.