chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Paraesthesia
Clinical narrative: tingling in both hands and feet; more significantly after second dose; 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 in her 50's (unknown if pregnant) 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 1), for COVID-19 Immunization. The following information was reported: PARAESTHESIA (non-serious) with onset 02Apr2021, outcome "unknown", described as "tingling in both hands and feet"; CONDITION AGGRAVATED (non-serious) with onset 02Apr2021, outcome "unknown", described as "more significantly after second dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise
Clinical narrative: chills; didn't feel very well; headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  An adult 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: CHILLS (non-serious), outcome "unknown", described as "chills"; MALAISE (non-serious), outcome "unknown", described as "didn't feel very well"; HEADACHE (non-serious), outcome "unknown", described as "headaches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Malaise, Myalgia, Nausea
Clinical narrative: muscle pain; tiredness; generally feeling unwell (nausea and dizziness); generally feeling unwell (nausea and dizziness); generally feeling unwell (nausea and dizziness); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 09:30 (Lot number: EN6208) at the age of 74 years as dose 2,  single for covid-19 immunisation. Relevant medical history included: "dry eye" (unspecified if ongoing), notes: dry eye; "migraines" (unspecified if ongoing), notes: migraines; "scoliosis" (unspecified if ongoing), notes: scoliosis; "thyroid" (unspecified if ongoing), notes: thyroid; "osteoporosis" (unspecified if ongoing), notes: osteoporosis; "arthritis" (unspecified if ongoing), notes: arthritis; "allergy" (unspecified if ongoing), notes: Known allergies: yes. Concomitant medication(s) included: SYNTHROID; LIOTHYRONINE; VITAMIN D2; RESTASIS. Vaccination history included: Bnt162b2 (Lot number: EN6198, Lot unknown: False, Administration date: 24Feb2021, Administration time: 10:15 AM, Vaccine location: Left arm,, Dose number: 1, adverse event: Injection site pain, muscle pain next, adverse event start date:  25Feb2021), administration date: 24Feb2021, when the patient was 74 years old, for COVID 19 Immunisation, reaction(s): "Injection site pain"; Bnt162b2 (Lot number: EN6198, Lot unknown: False, Administration date: 24Feb2021, Administration time: 10:15 AM, Vaccine location: Left arm,, Dose number: 1, adverse event: Injection site pain, muscle pain next, adverse event start date:  25Feb2021), administration date: 24Feb2021, when the patient was 74 years old, for COVID-19 immunisation, reaction(s): "muscle pain", "slight fever". The following information was reported: MYALGIA (non-serious) with onset 18Mar2021, outcome "recovered" (2021), described as "muscle pain"; FATIGUE (non-serious) with onset 18Mar2021, outcome "recovered" (2021), described as "tiredness"; MALAISE (non-serious), NAUSEA (non-serious), DIZZINESS (non-serious) all with onset 18Mar2021, outcome "recovered" (2021) and all described as "generally feeling unwell (nausea and dizziness)". Therapeutic measures were not taken as a result of myalgia, fatigue, malaise, nausea, dizziness.  Additional Information: No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: mentions that she only had a sore arm with the first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 (Lot number: EN6201, Expiration Date: 30Jun2021) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Guillain Barre syndrome", start date: Feb2017 (unspecified if ongoing), notes: Additional Information for Other Conditions: IDIP which is chronic.; "Asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "mentions that she only had a sore arm with the first dose".  Additional information: The family medical history relevant to AE was reported as none. The concomitant product included IVIG treatment, one infusion every four weeks. Stated that, the patient's last dose before the second dose of the vaccine was on 15Mar2021. Additional vaccines administered on same date of the Pfizer suspect was reported as none. AE(s) following prior vaccinations were reported as none. It was reported that, the caller was called about the covid vaccine. Stated that, the caller had an adverse reaction to it, she filled out a report with Pfizer via text message but was unsure whether it went through so she was called today (unspecified date) to file a report. Stated that, the caller has Guillain Barre syndrome CPID and she needed a round of the IVIG in the hospital. Stated that, this reaction kicked the caller's you-know-what. Stated that, the patient took covid vaccine in right upper arm because she works at an elementary school. The caller mentioned that, she only had a sore arm with the first dose of the vaccine. Relevant tests were reported as none.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: arm pain; Headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Lot number: EW0150) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Mmr (NDC, LOT number and expiry date: Unknown), administration date: Dec2020, reaction(s): "localized reaction". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Apr2021, outcome "not recovered", described as "arm pain"; HEADACHE (non-serious) with onset 06Apr2021, outcome "not recovered", described as "Headache". Therapeutic measures were not taken as a result of pain in extremity, headache.  Additional Information: Additional Administered Vaccines  was reported as none. Prior Vaccinations (within 4 weeks) were none. Family Medical History Relevant to AE(s) was none. Reporter stated she was calling about the BioNTech COVID 19 vaccine. she stated she received the first dose today and she does not see anywhere in the paperwork for what she can take for side effects? she wanted to know if she could take Tylenol or Benadry? she stated she would call her doctor and follow up. reporter stated the side effects she is having is arm pain and headache. Event did not required a visit to Emergency Room or Physician Office.    No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: buzzing in ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EN6203) at the age of 74 years as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "buzzing in ears". Additional information: Clinical course: Event started about a week after first vaccination and continues until second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021386101 Same reporter, suspect drug, event; different patient.
Sex: U
Vaccine: COVID19
Symptoms: Mass, Pain
Clinical narrative: lump on my left hand; hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MASS (non-serious), outcome "unknown", described as "lump on my left hand"; PAIN (non-serious), outcome "unknown", described as "hurts".  Additional information: It was reported that, on 26th (unspecified date) patient took the vaccination, the Pfizer COVID vaccine. Reports that was the first one and today (at the time of report) patient see a lump on left hand. It's like not exactly the place where patient got the shot but it's little lower to that place and when patient put some pressure or rub that lump, the lump hurts.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: feeling really dizzy and light headed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: DIZZINESS (non-serious), outcome "unknown", described as "feeling really dizzy and light headed". Additional information: The patient stated to be perfectly fine before getting the vaccine and wanted to know if an appointment with a primary doctor was needed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Full blood count, Insomnia, Myalgia
Clinical narrative: can't sleep because of it; real persistent muscle pain since the shot; This is a spontaneous report received from a contactable reporter (Nurse).  A 61 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date Mar2021 (Batch/Lot number: unknown) at the age of 61 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Hypothyroid", start date: 2014 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Flu shot, for immunization, reaction: "muscle pain". The following information was reported: MYALGIA (non-serious) with onset Mar2021, outcome "not recovered", described as "real persistent muscle pain since the shot"; INSOMNIA (non-serious), outcome "unknown", described as "can't sleep because of it". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia. Additional information: Patient had his first shot 2 weeks ago and has had real persistent muscle pain since the shot. Reporter said she knows that most of the time this would go away pretty quick, but his hasn't let up and he is supposed to go back for his second shot next week, and he was not sure if he should. She said she advised him to hold off for now and she would look into getting more information for him. Reporter said the patient didn't have his vaccine card with him, and she is not sure where he had it done, said they were not provided with the NDC/LOT/EXP for his vaccine dose. Reported said the patient said he has been taking Ibuprofen and Aleve (UPC/LOT/EXP for Aleve and Ibuprofen unknown). She said today he told her he has been taking 1-2 Aleve every two hours, which she advised him to stop that. Patient has not had any other recent vaccinations or started any new medications. Reporter said patient did mention sometimes this happens when he gets the flu shot (NDC/LOT/EXP Unknown). Reporter said patient doesn't take the flu shot any more, she has tried to get him to take it, but he said he won't because of the side effects. Reporter said she asked the patient if those side effects were as bad as this, and he said the ones from the flu one goes away in a few days. She said their facility has never given the flu shot to him, so they have no record of it. Reporter said they drew labs today for blood count, but the last time they did was his thyroid on 15Mar2021, for which his TSH was slightly over but not bad, and that was the only lab done. Reporter assessed the patient's persistent muscle pain as not serious. She said patient said he can't sleep because of it. Reporter said the patient really just has pain; no fever, chills, or trouble breathing, nausea, or vomiting.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Limb discomfort, Pain in extremity
Clinical narrative: the reaction he had was so miniscule that it was nothing more than like walking out of the door and bumping into the corner; A little soreness in arm; discomfort in his arm was so slight; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administration date 11Mar2021 09:00 (Batch/Lot number: unknown) at the age of 78 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 11Mar2021, outcome "unknown", described as "A little soreness in arm"; LIMB DISCOMFORT (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "discomfort in his arm was so slight"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "the reaction he had was so miniscule that it was nothing more than like walking out of the door and bumping into the corner".  Additional information: Caller reported that he did not know that he had any discomfort in his arm until dinner time when he was putting an item away in the cupboard. Caller was reporting on his lady friend with whom received both doses of the Pfizer COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Pain in extremity
Clinical narrative: arm pain for a couple of days/Just a sore arm; salt/metal taste in my mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program (001774). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Apr2021 13:45 (Lot number: EP7533) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BENADRYL; FLONASE ALLERGY RELIEF; ZINC; VITAMIN D3; VITAMIN C ASC ACID. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunisation. The following information was reported: DYSGEUSIA (non-serious) with onset 06Apr2021 18:00, outcome "not recovered", described as "salt/metal taste in my mouth"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "arm pain for a couple of days/Just a sore arm".  Additional information: I have not had a fever or any other common side effects. I have a salt/metal taste in my mouth. I had arm pain for a couple of days. I got the shot on 03Apr2021, and I started getting the metal taste in my mouth on 06Apr2021. Everything tastes really salty. My smell has not been effected. Patient not received treatment for ae. Patient did not covid prior vaccination and covid tested post vaccination. Known allergies: Late, Patient did not receive other vaccine in fourweek. I got my 2nd shot yesterday, So far no side effects. Just a sore arm.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Vaccination site pain
Clinical narrative: soreness of the arm and headache; soreness of the arm and headache; tenderness around the site of the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 82 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: PAIN IN EXTREMITY (non-serious), HEADACHE (non-serious), outcome "unknown" and all described as "soreness of the arm and headache"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "tenderness around the site of the shot".  Additional information: Patient was not sure if it was the first or second shot or what it was, but that was the only thing. It might have been in the evening that she had tenderness around the site of the shot. That's all that she said anything about. She had medical issues but don't ask because caller had no idea what they are, but she definitely had some issues.  Caller Stated a lot of the people have received the vaccine (not sure if that was Pfizer or not) and experienced  soreness in the arm but no other problems, including her mothers sister 94 years old female, another 83 years old female who has other medical problems experienced soreness of the arm and headache. A different (young and old) age group of people experienced chills, did not feel right but it did not last long.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Lot number: ER2613) 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: VOMITING (non-serious) with onset 01Apr2021, outcome "unknown", described as "Vomiting"; DIARRHOEA (non-serious) with onset 01Apr2021, outcome "unknown", described as "Diarrhea".  Additional information: Patient age was reported as 81 (no units reported). Second dose was scheduled on 16Apr2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: tender arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (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: TENDERNESS (non-serious), outcome "unknown", described as "tender arms". It was unknown if therapeutic measures were taken as a result of tenderness.  Additional information: Patient took the 1st dose on 25Mar2021 and was experiencing tender arms. Patient wants to know if it was possible to experience adverse events over a week after taking the vaccine. Attempted to transfer to MI but call got disconnected. AE form created.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: Prior to taking vaccine #2, patient was fine. patient had no reaction other than fatigue.; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 11Mar2021 18:30 (Batch/Lot number: unknown) at the age of 33 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Hemiplegic migraine" (ongoing), notes: life-long hemiplegic migraine patient.; "mitral valve prolapse" (unspecified if ongoing). Concomitant medication(s) included: IMITREX; EXCEDRIN MIGRAINE. Past drug history included: Reglan, reaction(s): "known allergies". The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "Prior to taking vaccine #2, patient was fine. patient had no reaction other than fatigue.". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient has no Covid prior to vaccination.   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-2021380488 same reporter/patient/drug, different dose number/event
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity, Vision blurred
Clinical narrative: Blurry vision/I cannot see; Headache; Muscle pain; hurt arm, muscle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 01Apr2021 (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: VISION BLURRED (non-serious) with onset Apr2021, outcome "unknown", described as "Blurry vision/I cannot see"; HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "Headache"; MYALGIA (non-serious) with onset Apr2021, outcome "unknown", described as "Muscle pain"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "hurt arm, muscle".  Additional Information: Patient Pfizer shot yesterday for the first round and have the normal side effects like hurt arm, muscle and stuff like that but one side effect is it is listed is blurry vision extremely blurry vision. She wanted to know what should patient do. When paraphrased the concern, consumer stated, Muscle pain, the arm, some headache but that went way but blurry vision but my eyes would not focus. What should do. They says call your doctor if you experienced side effects. When told about the Pfizer Medical information department and asked to write down the number, consumer stated, I cannot see what I am writing so just give me 1 second to get another person because I cannot see.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Buzzing in ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "Buzzing in ears".  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-2021384196 Different patient, same product and event
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back pain before and it got worse after the second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "very bad back pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "back pain before and it got worse after the second dose".  Additional information: It was reported as asking if she can have a steroid shot because she was experiencing very bad back pain and she was informed not to take any shots after the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 21Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DUPIXENT. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "feeling tiredness".  Additional information: Covid vaccine taken on 21Mar2021 last shot on 11Apr2021 Pfizer  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Thirst, Tongue dry
Clinical narrative: Sore arm/ Feels Someone Pinching me; feels like there is tourniquet thing applied to my arm; Big red rash around the site; it is still swollen; Big red rash around the site; it is still swollen; Big red rash around the site; it is still swollen; Big Headache; Have Lot of Thirst; tongue often feel very harsh, my tongue feels dry; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm, administration date 24Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Vaccine Allergy" (unspecified if ongoing); "allergy to sting wasp" (unspecified if ongoing), notes: reaction for wasp sting,had strong reaction and face swollen. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm/ Feels Someone Pinching me; feels like there is tourniquet thing applied to my arm"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE RASH (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "Big red rash around the site; it is still swollen"; HEADACHE (non-serious), outcome "unknown", described as "Big Headache"; THIRST (non-serious), outcome "unknown", described as "Have Lot of Thirst"; TONGUE DRY (non-serious), outcome "unknown", described as "tongue often feel very harsh, my tongue feels dry"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue".  Additional information: The patient was allergic to vaccine and allergic to stings wasp and mentioned that should be careful for 2 nd dose. Patient don't know  that the symptom (had a lot of thirst and my tongue often feel very harsh, my tongue feels dry) which is related or not.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: Sore arm/ Feels Someone Pinching me; feels like there is tourniquet thing applied to my arm; Big red rash around the site; it is still swollen; Big red rash around the site; it is still swollen; Big red rash around the site; it is still swollen; Big Headache; Have Lot of Thirst; tongue often feel very harsh, my tongue feels dry; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm, administration date 24Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Vaccine Allergy" (unspecified if ongoing); "allergy to sting wasp" (unspecified if ongoing), notes: reaction for wasp sting,had strong reaction and face swollen. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm/ Feels Someone Pinching me; feels like there is tourniquet thing applied to my arm"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE RASH (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "Big red rash around the site; it is still swollen"; HEADACHE (non-serious), outcome "unknown", described as "Big Headache"; THIRST (non-serious), outcome "unknown", described as "Have Lot of Thirst"; TONGUE DRY (non-serious), outcome "unknown", described as "tongue often feel very harsh, my tongue feels dry"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue".  Additional information: The patient was allergic to vaccine and allergic to stings wasp and mentioned that should be careful for 2 nd dose. Patient don't know  that the symptom (had a lot of thirst and my tongue often feel very harsh, my tongue feels dry) which is related or not.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: is experiencing joint swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 06Mar2021 (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: Pfizer covid-19 vaccine (DOSE 1, SINGLE), administration date: 13Feb2021, for Covid 19 immunization. The following information was reported: JOINT SWELLING (non-serious) with onset 2021, outcome "unknown", described as "is experiencing joint swelling".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Headache
Clinical narrative: has been experiencing diarrhea since yesterday and until today/I have lots and lot of diarrhea; Headache; I feel little bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "has been experiencing diarrhea since yesterday and until today/I have lots and lot of diarrhea"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I feel little bad". Therapeutic measures were taken as a result of diarrhoea, headache, feeling abnormal.  Additional information: Patient has been experiencing diarrhea since yesterday and until today, he wanted to be assisted with his current situation. He got his first dose last Friday (02Apr2021) and his next dose will be on 23Apr2021. This is normal or something to do. it was Pfizer covid vaccine. he was calling because he feel little bad yesterday and today about you know that the headache and a lot of diarrhea he called you for information is this normal or not."When probed for did you took any treatment for the events consumer stated "no the paper they gave me in the hospital they tell me if you feel something vomit or diarrhea or fever take a Tylenol. I took a Tylenol."When probed for do you take any other medications consumer stated "I take for a longer time cholesterol pills but right now I took a Tylenol (Treatment) for diarrhea and headache."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Labyrinthitis, Malaise
Clinical narrative: They just say it's inner ear infection; Dizzy/Dizziness/Light-headed; Diarrhoea; got the runs; Headache; Nauseated; not doing good; sore arm; hurting like tetanus; Pain; Back cramps; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2021 (Batch/Lot number: unknown) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "lupus" (unspecified if ongoing); "Bipolar disorder" (unspecified if ongoing); "Blood clots" (unspecified if ongoing); "Sarcoid" (unspecified if ongoing). Concomitant medication(s) included: COUMADIN taken for thrombosis. The following information was reported: DIZZINESS (non-serious) with onset Mar2021, outcome "not recovered", described as "Dizzy/Dizziness/Light-headed"; DIARRHOEA (non-serious) with onset Mar2021, outcome "not recovered", described as "Diarrhoea; got the runs"; HEADACHE (non-serious) with onset Mar2021, outcome "not recovered", described as "Headache"; NAUSEA (non-serious) with onset Mar2021, outcome "not recovered", described as "Nauseated"; MALAISE (non-serious) with onset Mar2021, outcome "not recovered", described as "not doing good"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "not recovered", described as "sore arm"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "hurting like tetanus"; PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "Pain"; MUSCLE SPASMS (non-serious) with onset Mar2021, outcome "unknown", described as "Back cramps"; LABYRINTHITIS (non-serious), outcome "unknown", described as "They just say it's inner ear infection".  Additional information: Reporter seriousness for Dizzy, Light-headed, Diarrhoea, Headache, Nauseated, not doing good, sore arm,for hurting, got the runs: Unspecified. Reporter stated, She is dizzy, light headed, got the runs, got a headache, she s nauseated, Diarrhea. Persisting, we have not got any therapist so far. It is persisting. It has not gone away or has not gotten worse. It is still there. When asked for any other help, reporter stated, What do we do for the side effects. Reporter stated, "My question is she is having dizziness and nausea, and the runs and a headache, back cramps and she just feels terrible, her arms hurt for 2 days and she wants to go back to the emergency room because they just say that it's inner ear infection. And we want to know what we can do to get her out of the pain.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Pain, Pain in extremity
Clinical narrative: They just say it's inner ear infection; Dizzy/Dizziness/Light-headed; Diarrhoea; got the runs; Headache; Nauseated; not doing good; sore arm; hurting like tetanus; Pain; Back cramps; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2021 (Batch/Lot number: unknown) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "lupus" (unspecified if ongoing); "Bipolar disorder" (unspecified if ongoing); "Blood clots" (unspecified if ongoing); "Sarcoid" (unspecified if ongoing). Concomitant medication(s) included: COUMADIN taken for thrombosis. The following information was reported: DIZZINESS (non-serious) with onset Mar2021, outcome "not recovered", described as "Dizzy/Dizziness/Light-headed"; DIARRHOEA (non-serious) with onset Mar2021, outcome "not recovered", described as "Diarrhoea; got the runs"; HEADACHE (non-serious) with onset Mar2021, outcome "not recovered", described as "Headache"; NAUSEA (non-serious) with onset Mar2021, outcome "not recovered", described as "Nauseated"; MALAISE (non-serious) with onset Mar2021, outcome "not recovered", described as "not doing good"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "not recovered", described as "sore arm"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "hurting like tetanus"; PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "Pain"; MUSCLE SPASMS (non-serious) with onset Mar2021, outcome "unknown", described as "Back cramps"; LABYRINTHITIS (non-serious), outcome "unknown", described as "They just say it's inner ear infection".  Additional information: Reporter seriousness for Dizzy, Light-headed, Diarrhoea, Headache, Nauseated, not doing good, sore arm,for hurting, got the runs: Unspecified. Reporter stated, She is dizzy, light headed, got the runs, got a headache, she s nauseated, Diarrhea. Persisting, we have not got any therapist so far. It is persisting. It has not gone away or has not gotten worse. It is still there. When asked for any other help, reporter stated, What do we do for the side effects. Reporter stated, "My question is she is having dizziness and nausea, and the runs and a headache, back cramps and she just feels terrible, her arms hurt for 2 days and she wants to go back to the emergency room because they just say that it's inner ear infection. And we want to know what we can do to get her out of the pain.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: her eczema is flaring up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  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. The following information was reported: ECZEMA (non-serious), outcome "unknown", described as "her eczema is flaring up".  Additional information: Event: Patient received Pfizer Covid vaccination and MD advised to wait on her Dupixent dose until 2 weeks after 2nd dose of the vaccine. In the meantime, her eczema is flaring up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Back pain, Malaise, Nausea
Clinical narrative: Caller also experienced a little bit of nausea just this morning.; Caller started to feel weak and not that well yesterday until today.; Caller started to feel weak and not that well yesterday until today.; Caller experienced stomach ache, ache in her thigh muscle and lower back.; Caller experienced stomach ache, ache in her thigh muscle and lower back.; Caller experienced stomach ache, ache in her thigh muscle and lower back.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (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 (1st dose), for Covid-19 immunisation. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), PAIN IN EXTREMITY (non-serious), BACK PAIN (non-serious) all with onset 31Mar2021, outcome "not recovered" and all described as "Caller experienced stomach ache, ache in her thigh muscle and lower back."; ASTHENIA (non-serious), MALAISE (non-serious) all with onset 03Apr2021, outcome "not recovered" and all described as "Caller started to feel weak and not that well yesterday until today."; NAUSEA (non-serious) with onset 04Apr2021, outcome "not recovered", described as "Caller also experienced a little bit of nausea just this morning.".  Additional information: Patient completed the vaccination series on 30Mar2021. She experienced stomach ache, ache in her thigh muscle and lower back. She started to feel weak and not that well yesterday until today and also experienced a little bit of nausea just this morning. She stated that it is the fifth day of side effects. She wants to know how long these side effects will last and if it is related to the COVID-19 vaccine. Medical Information: Medical questions addressed by this program forwarded/referred to Medical Information.   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: Caller also experienced a little bit of nausea just this morning.; Caller started to feel weak and not that well yesterday until today.; Caller started to feel weak and not that well yesterday until today.; Caller experienced stomach ache, ache in her thigh muscle and lower back.; Caller experienced stomach ache, ache in her thigh muscle and lower back.; Caller experienced stomach ache, ache in her thigh muscle and lower back.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (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 (1st dose), for Covid-19 immunisation. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), PAIN IN EXTREMITY (non-serious), BACK PAIN (non-serious) all with onset 31Mar2021, outcome "not recovered" and all described as "Caller experienced stomach ache, ache in her thigh muscle and lower back."; ASTHENIA (non-serious), MALAISE (non-serious) all with onset 03Apr2021, outcome "not recovered" and all described as "Caller started to feel weak and not that well yesterday until today."; NAUSEA (non-serious) with onset 04Apr2021, outcome "not recovered", described as "Caller also experienced a little bit of nausea just this morning.".  Additional information: Patient completed the vaccination series on 30Mar2021. She experienced stomach ache, ache in her thigh muscle and lower back. She started to feel weak and not that well yesterday until today and also experienced a little bit of nausea just this morning. She stated that it is the fifth day of side effects. She wants to know how long these side effects will last and if it is related to the COVID-19 vaccine. Medical Information: Medical questions addressed by this program forwarded/referred to Medical Information.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Felt a rush of clarity in thinking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Felt a rush of clarity in thinking".  Additional information: It was reported that, as a retired researcher but still active scientifically the patient wanted to notify them regarding the patient's COVID-19 2nd shot. Stated that, the patient thought at first was imagining the effect, however after speaking with several pathologists and friends, the patient had seen a pattern. Stated that, on or about day 5 after the 2nd dose, they all had felt a rush of clarity in thinking. Stated that, during the past year there has been like a covid fog (whether depression or not) but out of nowhere their thinking both clearer and sharper has evolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.