chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MENB
Symptoms: Injection site pain, Vaccination site erythema, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter (healthcare professional). Patient (no qualifiers provided) received meningococcal group B rlp2086 (MENINGOCOCCAL GROUP B RLP2086), administered in arm left, administration date 14Jun2021 (Lot number: CN1583, Expiration Date: Aug2022) as dose number unknown, 0.5 ml single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "Left upper arm soreness and erythema". No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, SARS-CoV-2 test, Skin discolouration, Vaccination site pruritus
Clinical narrative: her arm immediately started itching, really badly/Just around the injection site.; maybe a little discoloration can't tell; injection site is itching; for felt like arm was falling asleep; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101057941.  A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Aug2021 (Lot number: EW0179) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: May2020 (unspecified if ongoing), notes: She had some weird side effects.; "Shingles" (unspecified if ongoing), notes: She has had shingles before. The patient's concomitant medications were not reported. The following information was reported: PRURITUS (non-serious) with onset 16Aug2021, outcome "not recovered", described as "her arm immediately started itching, really badly/Just around the injection site."; SKIN DISCOLOURATION (non-serious) with onset 16Aug2021, outcome "not recovered", described as "maybe a little discoloration can't tell"; VACCINATION SITE PRURITUS (non-serious) with onset 16Aug2021, outcome "not recovered", described as "injection site is itching"; PARAESTHESIA (non-serious) with onset 16Aug2021, outcome "recovering", described as "for felt like arm was falling asleep". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not have any family medical history relevant to adverse events. The facility where the most recent COVID-19 vaccine was administered was clinic. The vaccine was not administered at facility. No additional vaccines were administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received the first dose of the Pfizer COVID vaccine and her arm immediately started itching, really badly, maybe a little discoloration couldn't tell. It happened 10 minutes after the vaccination and it was an annoying itch. Just around the injection site. She felt itchiness. It was very itchy and she wanted to know if she could take Benadryl. The adverse event did not require a visit to Emergency Room or Physician Office. No relevant tests were done.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Flatulence, Pain in extremity
Clinical narrative: feeling winded; out of breath; feeling a little weak; barely sore arm; 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 53 year-old female patient received bnt162b2 (BNT162B2), administration date 05Aug2021 (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: FLATULENCE (non-serious) with onset Aug2021, outcome "unknown", described as "feeling winded"; DYSPNOEA (non-serious) with onset Aug2021, outcome "unknown", described as "out of breath"; ASTHENIA (non-serious) with onset Aug2021, outcome "unknown", described as "feeling a little weak"; PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "barely sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain, Vaccination site reaction
Clinical narrative: developed a boil under his arm which is painful/a little boil under the arm where he got the vaccine; developed a boil under his arm which is painful; arm is red; 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 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Aug2021 16:40 (Lot number: FC3181) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "Pre-diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN (ongoing); VALSARTAN (ongoing). Vaccination history included: Bnt162b2 (1st dose, Lot number: it is either FA9484 or FA4484, Given in left arm.), administration date: 23Jul2021, when the patient was 46 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE REACTION (non-serious) with onset 14Aug2021, outcome "not recovered", described as "developed a boil under his arm which is painful/a little boil under the arm where he got the vaccine"; PAIN (non-serious) with onset 14Aug2021, outcome "unknown", described as "developed a boil under his arm which is painful"; ERYTHEMA (non-serious) with onset 14Aug2021, outcome "not recovered", described as "arm is red".  Additional information: Caller wants to know if we have some information on the reported side effect and if he needs to put a cream on it or take a medicine. Caller also wanted to know if how long will the side effects last. He got his second dose of COVID19 vaccine last Friday. on Saturday he started developing a little boil under the arm where he got the vaccine. It is all covered in red. The boil feel firmer now. It is causing a lot of pain when he lets his arm hang. he took a shower a minute ago and it seems like the red is still there from bicep to chest. Caller clarified it has stayed the same. Pain: it started Saturday night. If it is just hanging there it hurts. When sleeping it causes him to change position because of the pain. Outcome of event: depends on how much pressure he puts on it. The weight of the arm hurts. If he puts more pressure on the pain persist. Saturday he noticed the pain about 12:00. It just started bothering him. By the time he was going to go to sleep the pain was more. Then he looked in the mirror and noticed the redness and the boil. Prior to vaccination, the patient was not diagnosed with COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Laboratory test
Clinical narrative: Massive Nose bleed; 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 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 (Lot number: EP7533) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anaphylactic shock" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "reaction to a bee or wasp" (unspecified if ongoing), notes: It was 6 months before the first dose of the Covid vaccine.; "Hospitalization" (unspecified if ongoing), notes: It was 6 months before the first dose of the Covid vaccine.; "Swelling" (unspecified if ongoing), notes: It was 6 months before the first dose of the Covid vaccine.; "not breathing" (unspecified if ongoing), notes: It was 6 months before the first dose of the Covid vaccine. Concomitant medication(s) included: ARMOUR THYROID taken for thyroid disorder (ongoing). The following information was reported: EPISTAXIS (non-serious) with onset 28Mar2021, outcome "recovered" (Mar2021), described as "Massive Nose bleed". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of epistaxis.  Additional information: Time of vaccination was reported as was early, around 08:30 or 09:00. Consumer reported that patient had been taking concomitant products Armour thyroid for many years, since she was 25. It was a low dose and need a prescription for it. It was a very little table, its like almost taking a drug, that could get at the drug store. No vaccination was reported prior to Pfizer vaccine. She had not had any since childhood. She did not take any vaccines at all. She just remembered in school rolling up and getting it, but that was it. She was sitting down in her car, driving. It just seemed odd to her and has not had nosebleeds in the past 20 to 30 years and it was always at night. She was used to standing up and would have to sit down. It was just weird. She leaned back and her sister was there as well. It was scary, like it just flew out of her nose. She leaned back, it was really creepy, like a faucet. She was just sitting there. It was like, if somebody just hit here in the nose, she would understand. She was driving, so she pulled over and leaned back.  No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: A little fever/Feeling like Fever; Tired; Just goes queasy/ Nausea; Sluggish; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 14 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Aug2021 (Lot number: FC3181) at the age of 14 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: SLUGGISHNESS (non-serious) with onset Aug2021, outcome "unknown", described as "Sluggish"; HEADACHE (non-serious) with onset Aug2021, outcome "unknown", described as "Headache"; PYREXIA (non-serious) with onset 16Aug2021, outcome "unknown", described as "A little fever/Feeling like Fever"; FATIGUE (non-serious) with onset 16Aug2021, outcome "unknown", described as "Tired"; NAUSEA (non-serious) with onset 16Aug2021, outcome "unknown", described as "Just goes queasy/ Nausea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of sluggishness, headache, pyrexia, fatigue, nausea.  Additional information: Patient received 2 Tylenol for reported event however not specified for which events he received treatment  No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: A little fever/Feeling like Fever; Tired; Just goes queasy/ Nausea; Sluggish; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 14 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Aug2021 (Lot number: FC3181) at the age of 14 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: SLUGGISHNESS (non-serious) with onset Aug2021, outcome "unknown", described as "Sluggish"; HEADACHE (non-serious) with onset Aug2021, outcome "unknown", described as "Headache"; PYREXIA (non-serious) with onset 16Aug2021, outcome "unknown", described as "A little fever/Feeling like Fever"; FATIGUE (non-serious) with onset 16Aug2021, outcome "unknown", described as "Tired"; NAUSEA (non-serious) with onset 16Aug2021, outcome "unknown", described as "Just goes queasy/ Nausea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of sluggishness, headache, pyrexia, fatigue, nausea.  Additional information: Patient received 2 Tylenol for reported event however not specified for which events he received treatment  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Electrocardiogram, Fatigue, Nausea, Sleep disorder
Clinical narrative: Fatigue; Nausea; didn't sleep very well; lot of pressure on her chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 18 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Aug2021 14:00 (Lot number: FD8448) at the age of 18 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mild gastritis", start date: Nov2020 (ongoing), notes: Verbatim: Mild gastritis. Concomitant medication(s) included: PROTONIX [OMEPRAZOLE] taken for gastritis. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 13Aug2021, outcome "recovering", described as "lot of pressure on her chest"; FATIGUE (non-serious) with onset 14Aug2021, outcome "not recovered", described as "Fatigue"; NAUSEA (non-serious) with onset 13Aug2021, outcome "recovering", described as "Nausea"; SLEEP DISORDER (non-serious) with onset 13Aug2021, outcome "unknown", described as "didn't sleep very well". The events "lot of pressure on her chest", "fatigue", "nausea" and "didn't sleep very well" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient did not visit to Emergency Room.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Muscle twitching, Pain
Clinical narrative: Last night I was shivering so bad that my teeth were even clattering; entire body aches; joints hurt so bad; muscles were twitching all over my body; chest got heawy; panic attack; armpits are swollen; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Last night I was shivering so bad that my teeth were even clattering"; PAIN (non-serious), outcome "unknown", described as "entire body aches"; ARTHRALGIA (non-serious), outcome "unknown", described as "joints hurt so bad"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "muscles were twitching all over my body"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "chest got heawy"; PANIC ATTACK (non-serious), outcome "unknown", described as "panic attack"; SWELLING (non-serious), outcome "unknown", described as "armpits are swollen". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Panic attack, Swelling
Clinical narrative: Last night I was shivering so bad that my teeth were even clattering; entire body aches; joints hurt so bad; muscles were twitching all over my body; chest got heawy; panic attack; armpits are swollen; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Last night I was shivering so bad that my teeth were even clattering"; PAIN (non-serious), outcome "unknown", described as "entire body aches"; ARTHRALGIA (non-serious), outcome "unknown", described as "joints hurt so bad"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "muscles were twitching all over my body"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "chest got heawy"; PANIC ATTACK (non-serious), outcome "unknown", described as "panic attack"; SWELLING (non-serious), outcome "unknown", described as "armpits are swollen". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: pain; rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 41 year-old female patient (not pregnant) received BNT162B2, administered in arm left, administration date 03Aug2021 (Lot number: PA7484) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "covid-19" (unspecified if ongoing); "Zoster Herpes" (unspecified if ongoing), notes: Diagnosed: Zoster Herpes in past. Took Valacyclovir 1 Gram; 7 days -blisters and pain subsided. Concomitant medication(s) included: METOPROLOL; ZOLPIDEM; DIAZEPAM; ESTRADIOL. Past drug history included: Valacyclovir, notes: Diagnosed: Zoster Herpes in past. Took Valacyclovir 1 Gram; 7 days -blisters and pain subsided. Vaccination history included: Bnt162b2 (product-COVID 19, brand-Pfizer, lot number-EW0198, lot unknown-False, administration date-13Jul2021, administration time-10:45 AM, dose number-1, vaccine location-Left arm), administration date: 13Jul2021, when the patient was 41 years old, for covid-19 immunisation, reaction(s): "shingles appeared on left side midline back to midline front". The following information was reported: PAIN (non-serious) with onset 15Aug2021, outcome "unknown", described as "pain"; RASH (non-serious) with onset 15Aug2021, outcome "unknown", described as "rash".  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Heart rate, Heart rate increased, SARS-CoV-2 test
Clinical narrative: Difficulty in breathing; increased heart rate; 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 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 (Lot number: EW0153) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seafood allergy" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D NOS; VITAMIN C [ASCORBIC ACID]. Vaccination history included: Bnt162b2 (lot number: ED6955, dose number: 1, vaccine location: Left arm), administration date: 19Mar2021, when the patient was 30 years old, for COVID-19 Immunization, reaction(s): "No reaction reported". The following information was reported: DYSPNOEA (non-serious) with onset 11Apr2021, outcome "recovered" (2021), described as "Difficulty in breathing"; HEART RATE INCREASED (non-serious) with onset 11Apr2021, outcome "recovered" (2021), described as "increased heart rate". The events "difficulty in breathing" and "increased heart rate" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, heart rate increased. Additional information: The patient was not received other vaccine in four weeks. No covid prior vaccination. Patient was covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Myalgia
Clinical narrative: A strange feeling with his chest; Muscle ache on his abdomen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (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: CHEST DISCOMFORT (non-serious), outcome "unknown", described as "A strange feeling with his chest"; MYALGIA (non-serious), outcome "unknown", described as "Muscle ache on his abdomen".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Fatigue, Headache, Nasopharyngitis
Clinical narrative: Left Arm pain, underarm pain; neck pain.; feeling like I have a sinus cold; Left Arm pain, underarm pain; shoulder pain; Feeling very tired; Headache; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Aug2021 08:00 (Lot number: FD8448) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Yes" (unspecified if ongoing), notes: Known Allergies: Yes. The patient took concomitant medications. The following information was reported: AXILLARY PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 15Aug2021 09:00, outcome "not recovered" and all described as "Left Arm pain, underarm pain"; NECK PAIN (non-serious) with onset 15Aug2021 09:00, outcome "not recovered", described as "neck pain."; NASOPHARYNGITIS (non-serious) with onset 15Aug2021 09:00, outcome "not recovered", described as "feeling like I have a sinus cold"; ARTHRALGIA (non-serious) with onset 15Aug2021 09:00, outcome "not recovered", described as "shoulder pain"; FATIGUE (non-serious) with onset 15Aug2021 09:00, outcome "not recovered", described as "Feeling very tired"; HEADACHE (non-serious) with onset 15Aug2021 09:00, outcome "not recovered", described as "Headache". Therapeutic measures were not taken as a result of axillary pain, neck pain, nasopharyngitis, pain in extremity, arthralgia, fatigue, headache.  Additional information: Patient did not administered other vaccine prior to Covid-19 vaccination. Patient was not tested positive since vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Left Arm pain, underarm pain; neck pain.; feeling like I have a sinus cold; Left Arm pain, underarm pain; shoulder pain; Feeling very tired; Headache; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Aug2021 08:00 (Lot number: FD8448) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Yes" (unspecified if ongoing), notes: Known Allergies: Yes. The patient took concomitant medications. The following information was reported: AXILLARY PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 15Aug2021 09:00, outcome "not recovered" and all described as "Left Arm pain, underarm pain"; NECK PAIN (non-serious) with onset 15Aug2021 09:00, outcome "not recovered", described as "neck pain."; NASOPHARYNGITIS (non-serious) with onset 15Aug2021 09:00, outcome "not recovered", described as "feeling like I have a sinus cold"; ARTHRALGIA (non-serious) with onset 15Aug2021 09:00, outcome "not recovered", described as "shoulder pain"; FATIGUE (non-serious) with onset 15Aug2021 09:00, outcome "not recovered", described as "Feeling very tired"; HEADACHE (non-serious) with onset 15Aug2021 09:00, outcome "not recovered", described as "Headache". Therapeutic measures were not taken as a result of axillary pain, neck pain, nasopharyngitis, pain in extremity, arthralgia, fatigue, headache.  Additional information: Patient did not administered other vaccine prior to Covid-19 vaccination. Patient was not tested positive since vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: chest tightness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A 13 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Jul2021 18:30 (Lot number: FA6780) at the age of 13 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: CHEST DISCOMFORT (non-serious) with onset 15Aug2021, outcome "not recovered", described as "chest tightness".  Additional Information: Patient did not receive any other vaccine within 4 weeks of covid vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Hypertension, Paraesthesia
Clinical narrative: Ears itchy; Ears tingly; Hives on left side of body; Elevated heart rate; Elevated blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date Jul2021 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "Ears itchy"; PARAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "Ears tingly"; URTICARIA (non-serious) with onset 2021, outcome "unknown", described as "Hives on left side of body"; HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "Elevated heart rate"; HYPERTENSION (non-serious) with onset 2021, outcome "unknown", described as "Elevated blood pressure". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reported as, within a few hours of getting the vaccine, her ears were itchy and tingly, in 48 hours, her arm hurt, and she broke out in hives on the left side of her body, the side she got the vaccine. Patient was not sure if it was her anxiety or a reaction to the vaccine, but she also had an elevated heart rate and high blood pressure. She consulted with her doctor, and he thought the hives on her left side, he believed to be an allergic reaction to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Ears itchy; Ears tingly; Hives on left side of body; Elevated heart rate; Elevated blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date Jul2021 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "Ears itchy"; PARAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "Ears tingly"; URTICARIA (non-serious) with onset 2021, outcome "unknown", described as "Hives on left side of body"; HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "Elevated heart rate"; HYPERTENSION (non-serious) with onset 2021, outcome "unknown", described as "Elevated blood pressure". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reported as, within a few hours of getting the vaccine, her ears were itchy and tingly, in 48 hours, her arm hurt, and she broke out in hives on the left side of her body, the side she got the vaccine. Patient was not sure if it was her anxiety or a reaction to the vaccine, but she also had an elevated heart rate and high blood pressure. She consulted with her doctor, and he thought the hives on her left side, he believed to be an allergic reaction to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Gingival bleeding, Gingival swelling, Headache
Clinical narrative: sore throat; headache; body aches; fever; chills; dizzy; bleeding gums; swollen gum; blisters in his mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 16 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 21Jul2021 (Lot number: FA7484) as dose 1, single and administration date 13Aug2021 (Lot number: FC3180) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Epilepsy" (unspecified if ongoing), notes: Epilepsy as a child then grew out of it. The patient's concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; HEADACHE (non-serious), outcome "unknown", described as "headache"; PAIN (non-serious), outcome "unknown", described as "body aches"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; GINGIVAL BLEEDING (non-serious) with onset 15Aug2021, outcome "not recovered", described as "bleeding gums"; GINGIVAL SWELLING (non-serious) with onset 15Aug2021, outcome "not recovered", described as "swollen gum"; ORAL MUCOSAL BLISTERING (non-serious) with onset 15Aug2021, outcome "not recovered", described as "blisters in his mouth". Therapeutic measures were taken as a result of gingival swelling.  Additional Information: They are trying to locate information on any adverse reactions for pediatric patients having swollen and/or bleedin gums and blisters in the mouth. Reporter did completed safety report on behalf of patient today. Reporter clarifies: "He's having all the other reactions as well- sore throat, headache, body aches, fever, chills, dizzy spells when he gets up sometimes in addition to the swollen, bleeding gums and blisters in his mouth. Stated to caller a search in my resources as well as the PI for the vaccine contains no information about swollen, bleeding gums and blisters in the mouth being reported as a side effect in either the 12-15 year old or 6 year old and older groups. Spoke from the PI: 6.2 Post Authorization Experience LAB-1457-11.0 Revised: 12 August 2021. Referred to HCP. Spoke from the attached FAQ: treatment advice/recommendations for adverse event. Swollen gums: Treatment oral  care mouth rinse. Vaccination Facility Type: Pharmacy. Epilepsy as a child then grew out of it. Reporter clarified this was the patient's medical history not the family.   No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Oral mucosal blistering, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: sore throat; headache; body aches; fever; chills; dizzy; bleeding gums; swollen gum; blisters in his mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 16 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 21Jul2021 (Lot number: FA7484) as dose 1, single and administration date 13Aug2021 (Lot number: FC3180) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Epilepsy" (unspecified if ongoing), notes: Epilepsy as a child then grew out of it. The patient's concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; HEADACHE (non-serious), outcome "unknown", described as "headache"; PAIN (non-serious), outcome "unknown", described as "body aches"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; GINGIVAL BLEEDING (non-serious) with onset 15Aug2021, outcome "not recovered", described as "bleeding gums"; GINGIVAL SWELLING (non-serious) with onset 15Aug2021, outcome "not recovered", described as "swollen gum"; ORAL MUCOSAL BLISTERING (non-serious) with onset 15Aug2021, outcome "not recovered", described as "blisters in his mouth". Therapeutic measures were taken as a result of gingival swelling.  Additional Information: They are trying to locate information on any adverse reactions for pediatric patients having swollen and/or bleedin gums and blisters in the mouth. Reporter did completed safety report on behalf of patient today. Reporter clarifies: "He's having all the other reactions as well- sore throat, headache, body aches, fever, chills, dizzy spells when he gets up sometimes in addition to the swollen, bleeding gums and blisters in his mouth. Stated to caller a search in my resources as well as the PI for the vaccine contains no information about swollen, bleeding gums and blisters in the mouth being reported as a side effect in either the 12-15 year old or 6 year old and older groups. Spoke from the PI: 6.2 Post Authorization Experience LAB-1457-11.0 Revised: 12 August 2021. Referred to HCP. Spoke from the attached FAQ: treatment advice/recommendations for adverse event. Swollen gums: Treatment oral  care mouth rinse. Vaccination Facility Type: Pharmacy. Epilepsy as a child then grew out of it. Reporter clarified this was the patient's medical history not the family.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Insomnia
Clinical narrative: Inflammation and extreme pain in my joints in my hands. Keep me awake at night.; Inflammation and extreme pain in my joints in my hands. Keep me awake at night.; Keep me awake at night.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22May2021 13:00 (Lot number: Eeo187) at the age of 58 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 (product=COVID 19,, Brand=Pfizer,, Lot number=Ewo171,, Lot unknown=False,, Administration date=01May2021,, Administration time=01:30 P.M., Dose number=1, Vaccine location=Left arm,), administration date: 01May2021, when the patient was 58 years old, for Covid-19 immunization. The following information was reported: ARTHRITIS (non-serious), ARTHRALGIA (non-serious) all with onset 02Jun2021, outcome "not recovered" and all described as "Inflammation and extreme pain in my joints in my hands. Keep me awake at night."; INSOMNIA (non-serious) with onset 02Jun2021, outcome "not recovered", described as "Keep me awake at night.". The events "inflammation and extreme pain in my joints in my hands. keep me awake at night.", "inflammation and extreme pain in my joints in my hands. keep me awake at night." and "keep me awake at night." were evaluated at the physician office visit. Therapeutic measures were not taken as a result of arthritis, arthralgia, insomnia.  Additional information: No other vaccine in four weeks No COVID prior vaccination No COVID tested post vaccination  Follow-Up (30Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: Shortness of breath; Chest pain; Chest discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Jun2021 (Lot number: EWO181) at the age of 23 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: DYSPNOEA (non-serious) with onset 25Jun2021, outcome "recovered" (2021), described as "Shortness of breath"; CHEST PAIN (non-serious) with onset 25Jun2021, outcome "recovered" (2021), described as "Chest pain"; CHEST DISCOMFORT (non-serious) with onset 25Jun2021, outcome "recovered" (2021), described as "Chest discomfort". The events "shortness of breath", "chest pain" and "chest discomfort" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of dyspnoea, chest pain, chest discomfort.  Additional information:Patient had no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Sneezing
Clinical narrative: sneezing; clogged nose; 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 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Aug2021 08:45 (Lot number: FC3180) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Diagnosed about 8 years ago. The patient's concomitant medications were not reported. The following information was reported: SNEEZING (non-serious) with onset 13Aug2021, outcome "not recovered", described as "sneezing"; NASAL CONGESTION (non-serious) with onset 13Aug2021, outcome "not recovered", described as "clogged nose".  Additional information: The caller was calling about the Pfizer covid vaccine. On Friday the caller had her first vaccination. Since then, the caller has been with her nose completely clogged and sneezing a lot. The caller event when she was waiting that's when she started sneezing and sneezing and sneezing and then her nose became clogged. Patient did not have Prior Vaccinations (within 4 weeks).  Follow-Up (25Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Pain in extremity, Vaccination site pain
Clinical narrative: left arm started hurting at the injection site/just soreness at site my second vaccination; felt the pain has gone from front to top to back over her scapula/has hurt cents then moves around the joint area; where the first vaccination was given started to hurt; feels like she has lost mobility and range of motion in the arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101067388 (Pfizer).  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Mar2021 (Lot number: EN6207) at the age of 68 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 Number: 01, Anatomical Location: Left arm, lot number:EN6198), administration date: 19Feb2021, when the patient was 68 years old, for Covid-19 Immunization, reaction(s): "She had just a little soreness for one day". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 12Mar2021, outcome "unknown", described as "left arm started hurting at the injection site/just soreness at site my second vaccination"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 2021, outcome "unknown", described as "feels like she has lost mobility and range of motion in the arm"; ARTHRALGIA (non-serious) with onset 12Mar2021, outcome "unknown", described as "felt the pain has gone from front to top to back over her scapula/has hurt cents then moves around the joint area"; PAIN IN EXTREMITY (non-serious) with onset 12Mar2021, outcome "unknown", described as "where the first vaccination was given started to hurt".  Additional information: There was no prior vaccinations within 4 weeks.There was no other relevant medical history including but not limited to these conditions, diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Contusion, Urine analysis
Clinical narrative: Start breaking out black and blue bruises all over my leg/come back the black blue bruises all over my hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Jul2021 (Lot number: EW0198) as dose 1,single and administered in arm left, administration date 13Aug2021 (Lot number: FC3181) as dose 2,single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (ongoing); "Acid Reflux" (unspecified if ongoing); "Migraine" (unspecified if ongoing). Concomitant medication(s) included: ERGOCALCIFEROL; CETIRIZINE; CHANTIX; CYCLOBENZAPRINE; MONTELUKAST; ATORVASTATIN taken for blood cholesterol; OMEPRAZOLE taken for gastrooesophageal reflux disease; AMLODIPINE taken for blood pressure measurement; CALCIUM; GABAPENTIN; ASPIRIN [ACETYLSALICYLIC ACID]; SUMATRIPTAN taken for migraine. The following information was reported: CONTUSION (non-serious) with onset 21Jul2021, outcome "not recovered", described as "Start breaking out black and blue bruises all over my leg/come back the black blue bruises all over my hand". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of contusion. No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Hypoaesthesia oral, Neck pain
Clinical narrative: Left side of lips went numb; Pain in neck, back, and knees; Pain in neck, back, and knees; Pain in neck, back, and knees; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jul2021 15:00 (Lot number: FA7484) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic kidney disease stage 3" (unspecified if ongoing), notes: Diagnosed for six years now. Only one kidney is affected.; "Problem with blood pressure", start date: Mar2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPOAESTHESIA ORAL (non-serious) with onset 28Jul2021, outcome "recovered" (28Jul2021), described as "Left side of lips went numb"; NECK PAIN (non-serious), BACK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 28Jul2021, outcome "recovered" (28Jul2021) and all described as "Pain in neck, back, and knees".  Additional Information for Other Conditions: Blood pressure doesn't go high. If she's laying down and gets up, it goes up and then goes back down. It makes her dizzy. Diagnosed this year, she thinks Mar2021, prior to her COVID-19 Vaccines. Caller was previously saying she had the COVID virus, clarified she has not been diagnosed with COVID-19 Virus. She was referring to the COVID-19 virus vaccine. Confirmed again she has not been diagnosed with COVID-19 virus.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: She just had sore knees; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 88 year-old female patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "AFib" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "not recovered", described as "She just had sore knees". Therapeutic measures were taken as a result of arthralgia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional Information: This is a spontaneous report from a contactable consumer based on information received by Pfizer (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-079913). This case was split from master case 202101062172 for a 88 years old patient taking COVID shots and experienced sore knees. She also had the COVID shots, and she was okay in January. She just had sore knees. Sometimes she put seven different topicals on it, like THC sometimes, and it was relieved for an hour or two. She was not going to take anything for it. No more medications. She has had this too long..