chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Tenderness
Clinical narrative: earache opposite side of vaccine; tenderness on right side of my head not painful just sensitive to touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 (Lot number: EL9267) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart attack" (unspecified if ongoing), notes: other medical history: Heart attack 6 years ago but am in great condition no heart defects. Concomitant medication(s) included: VENLAFAXINE; LEVOTHYROXINE; IRBESARTAN; VIT C; TURMERIC [CURCUMA LONGA RHIZOME]. Vaccination history included: Bnt162b2 (Product=COVID 19, Brand=Pfizer, Lot No = EL9267, Lot unknown = False, Administration date=15Feb2021, Administrator time= 12:00 PM, Vaccine location=Left arm), administration date: 15Feb2021, when the patient was 70 years old, for COVID-19 IMMUNISATION, reaction(s): "Bleeding ear same side as vaccine", "earache opposite side". The following information was reported: EAR PAIN (non-serious), outcome "recovered" (2021), described as "earache opposite side of vaccine"; TENDERNESS (non-serious), outcome "recovered" (2021), described as "tenderness on right side of my head not painful just sensitive to touch". Therapeutic measures were not taken as a result of ear pain, tenderness. Additional information: No other vaccine in four weeks. Adverse event: Bleeding ear same side as vaccine 10 days later earache opposite side. 2nd vaccine earache opposite side of vaccine and tenderness on right side of my head not painful just sensitive to touch. No covid prior vaccination, no covid tested post vaccination and no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Fear
Clinical narrative: I'm scared to get the second one because of what I've read; 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 65 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 65 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: FEAR (non-serious), outcome "unknown", described as "I'm scared to get the second one because of what I've read".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm sore; 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 male patient received bnt162b2 (BNT162B2), administration date 21Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jan2021, outcome "unknown", described as "arm sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Myalgia, Pain in extremity
Clinical narrative: fatiqued/fatique still lingers on; muscle aches; sore arm; last night he woke up after 4 hrs of sleep in sweat; 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 77 year-old 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: FATIGUE (non-serious), outcome "unknown", described as "fatiqued/fatique still lingers on"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "last night he woke up after 4 hrs of sleep in sweat".  Additional information: Swap from FC  first time caller 77 yr. old male got first 6 days ago and since then he has been fatiqued and asking if this is normal. He also had muscle aches and sore arm immediately after the vaccine but fatique still lingers on. He states last night he woke up after 4 hrs. of sleep in sweat. Provided number and transferred to medical information, hold que. Due to hold time. Will fax to Pfizer.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: he had flu like symptoms; Sore arm; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 62-year-old male patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "renal cell cancer" (unspecified if ongoing), notes: Taking Sutent From 21Aug2020 to current; "covid-19 pneumonia", start date: 07Dec2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "he had flu like symptoms"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Sore arm".  Additional information: Patient continues to be on previously reported therapy hold since 07Dec2020 due to having Covid pneumonia. Patient states he is doing better but MD told him to not restart sutent (Pfizer) 50 mg once a day by mouth until a week after he got vaccinated for covid. Patient was taking sutent from 21Aug2020 to current for renal cell cancer. Patient states he got his first vaccine on 08Mar2021 and said he had flu like symptoms and sore arm afterwards. Unknown if MD is aware. No adverse effects from therapy hold reported. Patient states that the last time he was on sutent he had sensitive tongue. Unknown if MD is aware. No other information provided by reporter. Patient cycle is 4 weeks on and 2 weeks off.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: little tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 08Feb2021 (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 (Gotten very sick from her 1st Covid vaccination that resulted in a visit to the ER.), for COVID-19 immunisation, reaction(s): "very sick". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "little tired".  Additional information: NDC number, expiry date was not provided. She received her second vaccination on 08Feb2021 and was just a little tired but otherwise fine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore; 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 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "arm was sore".  Additional Information: No medical questions referred or forwarded to Medical Information  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Serology test
Clinical narrative: Experienced sever chills for approximately 2 hours; sore arm; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative for a Pfizer sponsored program. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administration date 29Dec2020 (Lot number: EJ1686) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "gastric bypass surgery", start date: 2011 (unspecified if ongoing); "hernia repair", start date: 2018 (unspecified if ongoing); "very low iron stores requiring infusions" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Experienced sever chills for approximately 2 hours"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021295270 Same patient, different drug / event
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Fatigue, Vaccination site pain
Clinical narrative: experienced mild upper arm tenderness at the injection site; experienced mild fatigue; increase in temperature (99.9 F); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 12Mar2021 11:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "valvular heart disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: Vaccination site tenderness (non-serious) with onset 12Mar2021 18:00, outcome "recovered" (Mar2021), described as "experienced mild upper arm tenderness at the injection site"; FATIGUE (non-serious) with onset 12Mar2021 18:00, outcome "recovered" (Mar2021), described as "experienced mild fatigue"; BODY TEMPERATURE INCREASED (non-serious) with onset 12Mar2021 18:00, outcome "recovered" (Mar2021), described as "increase in temperature (99.9 F)". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Vaccination site pain
Clinical narrative: pain in the injection site; experienced difficulty when sleeping at night; 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 male patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: Vaccination site pain (non-serious), outcome "unknown", described as "pain in the injection site"; INSOMNIA (non-serious), outcome "unknown", described as "experienced difficulty when sleeping at night".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Influenza, Pain
Clinical narrative: I woke up feeling like I have the flu (achy, tired, etc.); I woke up feeling like I have the flu (achy, tired, etc.); I woke up feeling like I have the flu (achy, tired, etc.); 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 11Mar2021 (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), administration date: Feb2021, for COVID-19 immunisation. The following information was reported: INFLUENZA (non-serious), PAIN (non-serious), FATIGUE (non-serious) all with onset 12Mar2021, outcome "unknown" and all described as "I woke up feeling like I have the flu (achy, tired, etc.)".  Additional information: I received the 1st COVID shot from Pfizer 3 weeks back and felt absolutely fine. I received the 2nd one yesterday and felt fine that day. Today, I woke up feeling like I have the flu (achy, tired, etc.) I am sure it is a 24-hour thing and being vaccinated is so worth it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: her daughter is experiencing stomach pain after the 1st dose; 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 parent.  A female patient received bnt162b2 (BNT162B2), administration date 06Mar2021 (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset Mar2021, outcome "unknown", described as "her daughter is experiencing stomach pain after the 1st dose".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: RELPAX (ongoing). The following information was reported: MIGRAINE (non-serious) with onset 12Mar2021, outcome "recovered" (12Mar2021), described as "migraine".  Additional information: patient experienced migraine in the morning of 12Mar2021, after taking the final dose of the Covid-19 vaccine. Proprietary medicinal product name: RELPAX eletriptan HBr, action taken with drug 4 dose not changed, Product Concentration: 40. Narrative case summary: Initial Source Narrative Information 12Mar21 12:51 PM Inbound call on 12Mar2021 at 10:27AM from primary reporter who is consumer refusing to disclose any contact information and on behalf of his wife taking RELPAX eletriptan HBr 40 mg manufactured by a Division of Pfizer, stating she started experiencing migraine in the morning of 12Mar2021 after taking the final dose of the Covid-19 vaccine on 11Mar2021. No RA 12Mar2021 at 12:37 PM Primary reporter is consumer (calling behalf of wife) at unknown phone number (consumer husband refuse to provide any demographic information to initial agent). Consumer called initially for medical information regarding RELPAX (eletriptan HBr) 40 mg manufactured by a Division of Pfizer additionally reported an adverse event. On 12Mar2021, consumer reported she (wife) started experiencing migraine in the morning of 12Mar2021 after taking the final dose of the Covid-19 vaccine on 11Mar2021." The patient felt the event was related to related use of RELPAX (eletriptan HBr) 40 mg. As of 12Mar2021, the event subsided, and use of RELPAX (eletriptan HBr) 40 mg continues. The patient had unknown changes in medications, medical history or lifestyle at the time of the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: sick; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date Feb2021 (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: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: congested; 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 12Mar2021 (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: NASAL CONGESTION (non-serious) with onset Mar2021, outcome "unknown", described as "congested".  Additional information: The patient got first dose 2 days ago. She was congested and wanted to know if it is okay to take a decongestant.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Circumstance or information capable of leading to medication error, Movement disorder, Vomiting
Clinical narrative: could hardly move; vomiting; chills; she took blood thinners; 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 10Mar2021 (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MOVEMENT DISORDER (non-serious), outcome "unknown", described as "could hardly move"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; CHILLS (non-serious), outcome "unknown", described as "chills"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "she took blood thinners".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back pain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 20Feb2021 (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: BACK PAIN (non-serious) with onset 13Mar2021, outcome "not recovered", described as "back pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Decreased appetite, Rhinorrhoea
Clinical narrative: Lost appetite; runny nose; back aches; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (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: DECREASED APPETITE (non-serious), outcome "unknown", described as "Lost appetite"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; BACK PAIN (non-serious), outcome "unknown", described as "back aches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Vaccination site pain
Clinical narrative: fatigue; nausea; Loose biles; injection site issues; headache; Achy injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 77-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Feb2021 14:12 (Lot number: EL9266, Expiration Date: 31May2021) at the age of 77 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Time (24hr): 02:12pm, Site and Route of injection: upper left arm, Route of administration: Intramuscular, Batch/Lot number: MHSVMC: Lot EL9265; Exp: 31May2021), administration date: 30Jan2021, when the patient was 77 years old, for COVID-19 Immunisation, reaction(s): "flu-like symptoms", "injection site pain", "redness", "pain/soreness", "itchiness", "Fatigue", "Nausea", "achy", "Injection site swelling", "Headache".The following information was reported: FATIGUE (non-serious) with onset 21Feb2021, outcome "unknown", described as "fatigue"; NAUSEA (non-serious) with onset 21Feb2021, outcome "unknown", described as "nausea"; DIARRHOEA (non-serious) with onset 21Feb2021, outcome "unknown", described as "Loose biles"; VACCINATION SITE REACTION (non-serious) with onset 21Feb2021, outcome "unknown", described as "injection site issues"; HEADACHE (non-serious) with onset 21Feb2021, outcome "unknown", described as "headache"; Vaccination site pain (non-serious) with onset 21Feb2021, outcome "unknown", described as " Achy injection site ". Therapeutic measures were not taken as a result of headache.Additional information: AE term about 24 hours. Batch number. Vaccination facility type was hospital. No prior vaccinations. No relevant tests. The patient experienced events in a.m on 21Feb2021. It was reported that AE required visit to: In bed fatigue, nausea, Loose biles, Achy injection site issues, headache.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: fatigue; nausea; Loose biles; injection site issues; headache; Achy injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 77-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Feb2021 14:12 (Lot number: EL9266, Expiration Date: 31May2021) at the age of 77 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Time (24hr): 02:12pm, Site and Route of injection: upper left arm, Route of administration: Intramuscular, Batch/Lot number: MHSVMC: Lot EL9265; Exp: 31May2021), administration date: 30Jan2021, when the patient was 77 years old, for COVID-19 Immunisation, reaction(s): "flu-like symptoms", "injection site pain", "redness", "pain/soreness", "itchiness", "Fatigue", "Nausea", "achy", "Injection site swelling", "Headache".The following information was reported: FATIGUE (non-serious) with onset 21Feb2021, outcome "unknown", described as "fatigue"; NAUSEA (non-serious) with onset 21Feb2021, outcome "unknown", described as "nausea"; DIARRHOEA (non-serious) with onset 21Feb2021, outcome "unknown", described as "Loose biles"; VACCINATION SITE REACTION (non-serious) with onset 21Feb2021, outcome "unknown", described as "injection site issues"; HEADACHE (non-serious) with onset 21Feb2021, outcome "unknown", described as "headache"; Vaccination site pain (non-serious) with onset 21Feb2021, outcome "unknown", described as " Achy injection site ". Therapeutic measures were not taken as a result of headache.Additional information: AE term about 24 hours. Batch number. Vaccination facility type was hospital. No prior vaccinations. No relevant tests. The patient experienced events in a.m on 21Feb2021. It was reported that AE required visit to: In bed fatigue, nausea, Loose biles, Achy injection site issues, headache.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain of skin
Clinical narrative: This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a Pfizer sales representative.A male patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "chills"; PAIN OF SKIN (non-serious) with onset Mar2021, outcome "unknown", described as "tender skin by touch"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "aches"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "slight headache".Additional information: Age:64; Units: Unknown (as reported.) No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pain in extremity
Clinical narrative: sore arm; mild sweats; mild chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 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 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "mild sweats"; CHILLS (non-serious), outcome "unknown", described as "mild chills".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness a day after receiving her COVID 19 vaccination; This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP) received by Pfizer from (Case ID: AE-2021-4453). The reporter is the patient. Other Case identifier(s): AE-2021-4453.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Mar2021 (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) with onset 07Mar2021, outcome "unknown", described as "arm soreness a day after receiving her COVID 19 vaccination".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Arm is sore". Additional information: The caller's wife got first dose this morning, arm is sore and would like to know what pain relievers she can take.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: common cold; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "common cold".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in jaw
Clinical narrative: neck pain; jaw pain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NECK PAIN (non-serious), outcome "unknown", described as "neck pain"; PAIN IN JAW (non-serious), outcome "unknown", described as "jaw pain". Therapeutic measures were taken as a result of neck pain, pain in jaw. Additional information: The patient took 3 Advil 200mg a total of 600mg a day and Tylenol 500mg for the events. The patient wants to know if that will interfere with the Pfizer Covid-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Gastric disorder, Illness, Muscle spasms
Clinical narrative: He got sick; Stomach was hurting hurting and so he ended up having terrible diarrhea; Stomach was hurting hurting and so he ended up having terrible diarrhea; Explosive throwing up; Muscle spasm for about 5 minutes; There is a stomach bug going around; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 08:45 (Batch/Lot number: unknown) at the age of 32 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.The following information was reported: ABDOMINAL PAIN UPPER (non-serious), DIARRHOEA (non-serious) all with onset 24Mar2021 19:00, outcome "unknown" and all described as "Stomach was hurting hurting and so he ended up having terrible diarrhea"; VOMITING (non-serious) with onset 24Mar2021 19:00, outcome "not recovered", described as "Explosive throwing up"; MUSCLE SPASMS (non-serious) with onset 24Mar2021 19:00, outcome "recovered" (2021), described as "Muscle spasm for about 5 minutes"; GASTRIC DISORDER (non-serious) with onset 24Mar2021 19:00, outcome "unknown", described as "There is a stomach bug going around"; ILLNESS (non-serious), outcome "unknown", described as "He got sick". Therapeutic measures were not taken as a result of abdominal pain upper, diarrhoea, vomiting, gastric disorder. Therapeutic measures were taken as a result of muscle spasms.  Additional Information: Reporter stated, husband got the shot yesterday morning at 08:45 and then last night at 7, he said his stomach was hurting and so he ended up having terrible diarrhea and explosive throwing up, he has muscle spasm for about 5 minutes, he has been throwing up previously for about 45 minutes. He got him some water and then his muscle spasm stop. There was a stomach bug going around, so he was trying to figure out did he had a bad reaction and he need to take the second vaccine or he is throwing up with the vaccine, just like normal throwing up, I am trying to find if he had a bad reaction or probably he just had a stomach bug. He had a first shot yesterday morning at 8:45. Reporter stated, He did not have a doctor. He is a police officer. No I do not. He got the card on him. When probed if patient had the COVID Vaccine as a preventive measure of COVID virus, reporter stated, Yes. Reporter stated, He woke up this morning and he was fine. He started throwing up at 6 pm. He got sick at about 7 pm and then throw up the last time at 1 am.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: He got sick; Stomach was hurting hurting and so he ended up having terrible diarrhea; Stomach was hurting hurting and so he ended up having terrible diarrhea; Explosive throwing up; Muscle spasm for about 5 minutes; There is a stomach bug going around; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 08:45 (Batch/Lot number: unknown) at the age of 32 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.The following information was reported: ABDOMINAL PAIN UPPER (non-serious), DIARRHOEA (non-serious) all with onset 24Mar2021 19:00, outcome "unknown" and all described as "Stomach was hurting hurting and so he ended up having terrible diarrhea"; VOMITING (non-serious) with onset 24Mar2021 19:00, outcome "not recovered", described as "Explosive throwing up"; MUSCLE SPASMS (non-serious) with onset 24Mar2021 19:00, outcome "recovered" (2021), described as "Muscle spasm for about 5 minutes"; GASTRIC DISORDER (non-serious) with onset 24Mar2021 19:00, outcome "unknown", described as "There is a stomach bug going around"; ILLNESS (non-serious), outcome "unknown", described as "He got sick". Therapeutic measures were not taken as a result of abdominal pain upper, diarrhoea, vomiting, gastric disorder. Therapeutic measures were taken as a result of muscle spasms.  Additional Information: Reporter stated, husband got the shot yesterday morning at 08:45 and then last night at 7, he said his stomach was hurting and so he ended up having terrible diarrhea and explosive throwing up, he has muscle spasm for about 5 minutes, he has been throwing up previously for about 45 minutes. He got him some water and then his muscle spasm stop. There was a stomach bug going around, so he was trying to figure out did he had a bad reaction and he need to take the second vaccine or he is throwing up with the vaccine, just like normal throwing up, I am trying to find if he had a bad reaction or probably he just had a stomach bug. He had a first shot yesterday morning at 8:45. Reporter stated, He did not have a doctor. He is a police officer. No I do not. He got the card on him. When probed if patient had the COVID Vaccine as a preventive measure of COVID virus, reporter stated, Yes. Reporter stated, He woke up this morning and he was fine. He started throwing up at 6 pm. He got sick at about 7 pm and then throw up the last time at 1 am.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Nausea
Clinical narrative: upset stomach with intermittent nausea; fatigue; upset stomach with intermittent nausea; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Mar2021 14:45 (Lot number: EN6203) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "cancer - ovarian", start date: 2013 (unspecified if ongoing); "cancer - breast", start date: 2015 (unspecified if ongoing); "allergies: penicillin" (unspecified if ongoing); "allergies: sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: CENTRUM MULTIGUMMIES; CALTRATE [CALCIUM CARBONATE]; ARIMIDEX. Past drug history included: Vancomycin, reaction(s): "allergies: vancomycin"; Codeine, reaction(s): "allergies: codeine". Vaccination history included: Bnt162b2 (dose number: 1, administration time: 10:00 AM, vaccine location: Right arm, lot number: EL3247), administration date: 18Feb2021, when the patient was 59 years old, for COVID-19 immunisation, reaction(s): "constant runny nose", "Fatigue", "constant watering eye". The following information was reported: ABDOMINAL DISCOMFORT (non-serious), NAUSEA (non-serious) all with onset 12Mar2021 02:00, outcome "recovering" and all described as "upset stomach with intermittent nausea"; FATIGUE (non-serious) with onset 12Mar2021 02:00, outcome "recovering", described as "fatigue"; DIARRHOEA (non-serious) with onset 12Mar2021 02:00, outcome "recovering", described as "diarrhea". Therapeutic measures were not taken as a result of abdominal discomfort, fatigue, nausea, diarrhea.  Additional Information: Prior vaccination patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Uncontrollable diarrhea... did not make it to a restroom.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly male patient received bnt162b2 (BNT162B2, Solution for injection), administration date 31Mar2021 09:30 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 31Mar2021 10:00, outcome "unknown", described as "Uncontrollable diarrhea... did not make it to a restroom.". Therapeutic measures were not taken as a result of diarrhea.  Additional information: Reporter stated, I became aware of the event on the same day it was reported. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination and unknown if the patient was tested for COVID-19 since the 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: Body temperature, Culture urine, Limb discomfort, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Difficulty Lifting Arm-moderate pain; Moderate Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Jan2021 14:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gallbladder", start date: 2012, stop date: 01Oct2012; "removal of gallbladder", start date: 01Oct2012, stop date: 01Oct2012, notes: removal of gallbladder (01Oct2012); "Cancerous prostate", start date: 2016, stop date: 06Mar2016; "Removal of Prostate", start date: Mar2016, stop date: Mar2016, notes: Removal of Prostate (06Mar2016 or 08Mar2016). The patient's concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 13Jan2021 20:00, outcome "unknown", described as "Difficulty Lifting Arm-moderate pain"; PAIN IN EXTREMITY (non-serious) with onset 13Jan2021 20:00, outcome "unknown", described as "Moderate Pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Dose: 2nd The patient later had second dose of BNT162B2 on 10Feb2021 at 12:00 via intramuscular route in left arm  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Extreme Diarrhea for 12 hours.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 09:00 (Lot number: EN6207) at the age of 66 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "Extreme Diarrhea for 12 hours." Additional information: The patient had no known allergies. The patient had not received any other vaccine within 4 weeks prior to Covid-19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No other vaccine in four weeks. Adverse event: dose 1, extreme diarrhea for 12 hours, somewhere between day 5-7. Does 2, extreme vomiting for 12 hours on day 4/5 (adverse event start date: 12Apr2021, 07:00 PM, resolving; Lot number: ER8732, 08Apr2021, 09:00 AM, left arm, dose number: 2). No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Somnolence
Clinical narrative: body aches; slept all day; 2nd shot-28Mar had chills; slight fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (Batch/Lot number: unknown) at the age of 67 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 (Dose Number: 01, Lot: EL9266), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 27Mar2021, outcome "recovered" (29Mar2021), described as "2nd shot-28Mar had chills"; PYREXIA (non-serious) with onset 27Mar2021, outcome "recovered" (29Mar2021), described as "slight fever"; PAIN (non-serious), outcome "recovered" (29Mar2021), described as "body aches"; SOMNOLENCE (non-serious) with onset 27Mar2021, outcome "recovered" (29Mar2021), described as "slept all day". Therapeutic measures were not taken as a result of chills, pyrexia, pain, somnolence.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Dyspepsia, Malaise
Clinical narrative: terrible diarrhea; indigestion; She did not feel good; she can not remember, she had symptoms from her stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 01May2021 (Batch/Lot number: unknown) at the age of 70 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 (Dose 1, single), for COVID-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset May2021, outcome "unknown", described as "terrible diarrhea"; DYSPEPSIA (non-serious) with onset May2021, outcome "unknown", described as "indigestion"; MALAISE (non-serious) with onset May2021, outcome "unknown", described as "She did not feel good"; ABDOMINAL DISCOMFORT (non-serious) with onset May2021, outcome "unknown", described as "she can not remember, she had symptoms from her stomach".  Additional information: She stated she had a really important question. She got the second dose this past Saturday, 01May2021. The next day or on Monday, she cannot remember, she had symptoms from her stomach.  She did not eat anything out of the way because she knows how she was. She did not feel good. Tuesday went by. She was not feeling good again. She had indigestion and did not eat enough to warrant it. It dawned on her that it could be the vaccine, but she was not sure. She had terrible diarrhea, like the runs and dysentery, the other day. She could see if she ate something that does this, like food.  She was not saying it was the vaccine, but she is wondering if this has ever been reported.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: only had mildly sore arm from first dose of vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Feb2021 11:15 (Lot number: EM9810) at the age of 78 years as 1st dose,single for covid-19 immunisation. Relevant medical history included: "Osteoporosis", start date: Nov2020 (unspecified if ongoing), notes: other_medical_history Osteoporosis,; "Bladder CA", start date: Nov2020 (unspecified if ongoing), notes: other_medical_history Osteoporosis, Bladder CA; "S/P Radical Cystectomy with Ileal Conduit Diversion", start date: Nov2020 (unspecified if ongoing), notes: S/P Radical Cystectomy with Ileal Conduit Diversion 11/2020.; "Ileal Conduit", start date: Nov2020 (unspecified if ongoing), notes: S/P Radical Cystectomy with Ileal Conduit Diversion 11/2020. Concomitant medication(s) included: ALENDRONATE SODIUM. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "only had mildly sore arm from first dose of vaccine". Therapeutic measures were not taken as a result of pain in extremity. Additional information: Prior to vaccination, was the patient diagnosed with COVID-19:No. Since the vaccination, has the patient been tested for COVID-19?:No . Allergies to medications, food, or other products: No.    No follow-up attempts are needed. No further information is expected.