chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arms were sore; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program.  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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arms were sore".  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). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Nausea, Pain
Clinical narrative: Gland swelling; Headache; body ache; fatigue; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 29Jan2021 (Lot number: EL8982) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: 1985 (ongoing). Concomitant medication(s) included: PROZAC, start date: 2017 (ongoing); ALBUTEROL [SALBUTAMOL], start date: 1985 (ongoing); WIXELA INHUB, start date: 1990 (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Lot Number: EL1284, Intramuscular, Deltoid, left arm, Time: 20:15), administration date: 11Jan2021, when the patient was 38 years old, for COVID-19 immunisation, reaction(s): "Gland Swelling in neck and clavicle". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 29Jan2021, outcome "recovered", described as "Gland swelling"; HEADACHE (non-serious) with onset 29Jan2021, outcome "recovered", described as "Headache"; PAIN (non-serious) with onset 29Jan2021, outcome "recovered", described as "body ache"; FATIGUE (non-serious) with onset 29Jan2021, outcome "recovered", described as "fatigue"; NAUSEA (non-serious) with onset 29Jan2021, outcome "recovered", described as "nausea". Therapeutic measures were not taken as a result of lymphadenopathy, headache, pain, fatigue, nausea.  Additional information: However, it was also reported that onset of events was 28Jan2021 (Pending clarification). Events did not result to hospital admission, physician office visit and emergency room visit.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This is a spontaneous report received from a contactable reporter (healthcare professional).  An 88 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 05Mar2021 11:30 (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 "recovered" (Mar2021), described as "arm 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: Headache
Clinical narrative: slight headache; 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 male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 03Mar2021 (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, SINGLE), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "slight headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tooth disorder
Clinical narrative: some problems with tooth; 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 male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 01Mar2021 (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: TOOTH DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "some problems with tooth". The event "some problems with tooth" was evaluated at the physician office visit. Additional information: The dentist prescribed amoxicillin as treatment for the event. The patient wanted to know if it's advisable to take antibiotics.  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: Pain
Clinical narrative: Achy all over; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date Feb2021 (Lot number: EL9264) at the age of 77 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 (Lot number: EL1283, arm left), administration date: Jan2021, when the patient was 77 years old, for COVID-19 immunisation, reaction(s): "Tiredness", "Headache", "Muscle pain", "Injection site red and hurting", "Injection site red and hurting", "it is still swollen, red, with a big red circle/size of 2 half dollars", "Hot to touch". The following information was reported: PAIN (non-serious) with onset 03Feb2021 21:00, outcome "unknown", described as "Achy all over".  Additional information: It was unknown if patient had prior vaccinations (within 4 weeks).  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in the left hand (side where the vaccine was injected); This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in the left hand (side where the vaccine was injected)".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "headache". Additional information: The reporter was querying if the patient could take Tylenol since the patient was currently having a headache.  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: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 13 vaccine, administration date: 25Jan2017, for immunisation, reaction(s): "shingles in right eye, on her face and head"; Flu vaccine, for immunisation, reaction(s): "sore arm". 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: Headache
Clinical narrative: massive headache; 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 05Mar2021 (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: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "massive headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swelling of the lymph nodes in armpits; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). 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: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swelling of the lymph nodes in armpits".  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: sore arm; This is a spontaneous report received from a non-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 08Mar2021 (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 09Mar2021, 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: Weight increased
Clinical narrative: weight gain; 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) (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: WEIGHT INCREASED (non-serious), outcome "unknown", described as "weight gain". Additional information: The patient also reported that she had a lot of side effects and all her symptoms were back (unspecified, as reported).  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
Clinical narrative: achy; 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) (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 (non-serious), outcome "unknown", described as "achy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: body aches; headache; This is a spontaneous report received from a contactable reporter (Pharmacist).  A male patient in his 60's received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: PAIN (non-serious), outcome "recovering", described as "body aches"; HEADACHE (non-serious), outcome "recovering", described as "headache". Additional information: Clinical course: Shot received at 10 AM and symptoms set in later in day, lasting through next morning before beginning to resolve.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: mild headaches after both shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: HEADACHE (non-serious), outcome "unknown", described as "mild headaches after both shots".  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
Clinical narrative: diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 24Feb2021 15:55 (Lot number: EN6202, Expiration Date: 30Jun2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for hypertension, start date: 1997 (ongoing); VERAPAMIL taken for hypertension, start date: 2016 (ongoing); CENTRUM VITAMINTS (ongoing). Vaccination history included: Bnt162b2 (Administration time: 15:45, Anatomical site of injection: Left upper arm, Route of administration: Intramuscular), administration date: 03Feb2021, when the patient was 56 years old, for COVID-19 immunisation, reaction(s): "Metallic taste". The following information was reported: DIARRHOEA (non-serious) with onset 25Feb2021 04:00, outcome "recovered", described as "diarrhea". Therapeutic measures were not taken as a result of diarrhoea.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Hidradenitis
Clinical narrative: she has mild COPD; Hidradenitis; 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. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "cyst under armpit" (unspecified if ongoing), notes: Treated with erythromycin and injected with cortisone. The patient's concomitant medications were not reported. The following information was reported: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "she has mild COPD"; HIDRADENITIS (non-serious), outcome "unknown", described as "Hidradenitis". Therapeutic measures were taken as a result of chronic obstructive pulmonary disease, hidradenitis.  Additional Information: She had Hidradenitis 2 weeks ago and needed to be injected with Cortisone and a supply of Erythromycin. She is due to have her 2nd dose on 26Mar2021. If it persists again, she wants to know if the medications will have interference with the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Mar2021 (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; Pfizer vaccine.), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "pain problems".  Additional information: Caller received the second dose of the Pfizer-BioNtech Covid-19 vaccine today, he would like to know if he can take Tylenol for pain problems that are not related to the vaccine. During post-call documentation potential AE was identified. He mentioned that his pain problems were not related to the vaccine, however, he did not mention if his pain problems are prior to the vaccine or if he has been taking Tylenol since before the vaccination.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: sore arm after Pfizer covid vaccination; HCP stated like tetanus shot it hurts really bad after getting it due the ingredient in it.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm after Pfizer covid vaccination"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "HCP stated like tetanus shot it hurts really bad after getting it due the ingredient in it.".  Additional information: Health care professional (HCP) reporting for a  patient. HCP wanted to know about the sore arm after Pfizer covid vaccination was it due to anything in the Pfizer covid vaccine or was it due to the way of administration. HCP stated like tetanus shot it hurts really bad after getting it due the ingredient in it. HCP also wanted to know about general side effects and difference in the age group, Pfizer covid vaccine and infertility, used of antipyretic and generals drug interaction with Pfizer covid vaccine, if the formulation for the second dose is still the same and any information about the booster dose, if vaccine can be given with other medications at the same site and sites of administration and arm use.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: some pain around the injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 79 year-old male patient received bnt162b2 (BNT162B2), administered in arm right (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 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "some pain around the injection site".  Additional Information: It was a sharp pain around the injection site that comes and goes.  It's not bothering him now, but this morning it was.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; 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 26Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization.   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 "not feeling well".  Additional information: The patient would like to ask for assistance to schedule an appointment for the second dose of the vaccine since he had problems with his internet. He received his first dose last 26Feb2021 and was supposed to return to the facility on 19Mar2021 but he was unable to because he is not feeling well.  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: but not feeling well.; 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 27Feb2021 (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 "but not feeling well.".  Additional information: It was reported that she will get the 2nd dose of Covid-19 Vaccine today 20Mar2021 but not feeling well. She wants to reschedule 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: Headache, Illness
Clinical narrative: she got sick; She has been experiencing headaches ever since after the first dose of the vaccine (for 3 weeks); 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. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021335060.  A 70-year-old female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "she got sick"; HEADACHE (non-serious), outcome "unknown", described as "She has been experiencing headaches ever since after the first dose of the vaccine (for 3 weeks)". Therapeutic measures were taken as a result of illness.  Additional information: The patient got sick and was prescribed azithromycin tablets. She wanted to know if it was okay if she takes the vaccine while on azithromycin. Her 2nd dose is on the 30 and it will be 1 day after stopping the medication. She would like to know if there will be any drug interactions.  Caller knew that it was very common to have a reaction (headaches) after the second dose of the vaccine; however, she would like to know if this has been reported also after the first dose and how long is this supposed to last (forever, 1 year). She read that when getting the Covid-19 vaccine you can take aspirin after the shot for headache but not before the injection. She is scheduled to receive the second shot dose of the vaccine and wanted to make sure she was doing everything right, she would like to know if she could take Aspirin. She would like to know if the percentage of participants who experienced headache in the clinical trials was higher after the second dose compared to the first dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body aches; This is a spontaneous report received from contactable reporter, Consumer. The reporter is the patient.  A 53-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 15:00 (Lot number: EN5318) at the age of 53 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 (lot number =EN5318, administration time=09:30 AM,, vaccine location =Left arm., dose number=1), administration date: 02Mar2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 24Mar2021 11:00, outcome "not recovered", described as "body aches". Therapeutic measures were not taken as a result of pain. Additional information included the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient has been not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101790907 Same patient, different dose and event.
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: My blood sugar was 300, it has never been like this before; It went from 300 to 207; 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 21Mar2021 (Lot number: EN6207) as dose 1, single for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset 23Mar2021, outcome "unknown", described as "My blood sugar was 300, it has never been like this before; It went from 300 to 207". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: After the vaccination on 23Mar2021 patient's blood glucose got up and it had never been like this before.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: sciatica attack; 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. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (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, SINGLE), administration date: 25Feb2021, for COVID-19 immunization. The following information was reported: SCIATICA (non-serious) with onset 2021, outcome "unknown", described as "sciatica attack". Therapeutic measures were not taken as a result of sciatica.  Additional information: Caller said that her concern would have "nothing to do with that" [vaccine]. Caller mentioned she has had a "sciatica attack" wherein she has a "really bad and severe pain on the back and legs". She was advised by the Pharmacy not to take Advil after the vaccination, and Caller seeking clarification on this. It was reported that Caller received her 1st dose last 25Feb2021 and she received her 2nd dose today 25Mar2021 which is more than 21 days apart from her 1st dose. She is experiencing a severe back pain or Sciatica. She did not take any medicine. Now, she wants to know if it is safe to take Advil.  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 mass, Gastritis, Illness, Malaise, Pancreatic cyst
Clinical narrative: fats in her stomach; cyst in her pancreas; gastritis; she is not feeling well; sick last night because of stomach issue,; 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 04Mar2021 (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: GASTRITIS (non-serious) with onset Mar2021, outcome "unknown", described as "gastritis"; MALAISE (non-serious) with onset Mar2021, outcome "unknown", described as "she is not feeling well"; ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "sick last night because of stomach issue,"; ABDOMINAL MASS (non-serious), outcome "unknown", described as "fats in her stomach"; PANCREATIC CYST (non-serious), outcome "unknown", described as "cyst in her pancreas".   Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: could not sleep after the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number, unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious), outcome "unknown", described as "could not sleep after the shot".  Information related Lot/batch has been requested.  Follow-up attempts are completed. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021337285 Same drug, same event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Chills, Somnolence
Clinical narrative: she experienced chills; slept the whole day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CHILLS (non-serious) with onset 20Mar2021, outcome "unknown", described as "she experienced chills"; SOMNOLENCE (non-serious) with onset 20Mar2021, outcome "unknown", described as "slept the whole day".  Additional information: She also called in to ask if the second dose would be more potent than the first. Her second dose was scheduled on 09Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Fall
Clinical narrative: Fell; Scheduled to get the 2nd on 03/25 (exactly 21 days apart); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (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: FALL (non-serious), outcome "unknown", described as "Fell"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "Scheduled to get the 2nd on 03/25 (exactly 21 days apart)". Therapeutic measures were taken as a result of fall.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Headache, Injection site pain, Lymphadenopathy
Clinical narrative: Exhaustion; Feel discomfort; Soreness at the site of injection; Tired; Swollen armpit on the side of the injection; Appears to be possibly swollen lymph nodes; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient in her 40's received bnt162b2 (BNT162B2) (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: ANTACID [ALUMINIUM HYDROXIDE;MAGNESIUM HYDROXIDE]. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Exhaustion"; DISCOMFORT (non-serious), outcome "unknown", described as "Feel discomfort"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "Soreness at the site of injection"; FATIGUE (non-serious), outcome "unknown", described as "Tired"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Swollen armpit on the side of the injection"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Appears to be possibly swollen lymph nodes"; HEADACHE (non-serious), outcome "unknown", described as "headache".  Clinical course: After second vaccine injection in the early afternoon, experienced exhaustion in the evening and, at night, started to feel discomfort and soreness at the site of injection (upper left arm). Still very tired the next morning. Woke up on second day with swollen armpit on the side of the injection. Felt uncomfortable. Appeared to be possibly swollen lymph nodes. Patient stated in follow-up that after booster shot of the Pfizer COVID vaccine, the site of injection started to hurt one hour later and felt exhausted the rest of the day. Also got a headache in the evening. These were similar symptoms to those experienced after second dose.  Additional information: Patient stated that I am in my 40s and female. No other medication taken other than OTC antacids and vitamins.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Exhaustion; Feel discomfort; Soreness at the site of injection; Tired; Swollen armpit on the side of the injection; Appears to be possibly swollen lymph nodes; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient in her 40's received bnt162b2 (BNT162B2) (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: ANTACID [ALUMINIUM HYDROXIDE;MAGNESIUM HYDROXIDE]. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Exhaustion"; DISCOMFORT (non-serious), outcome "unknown", described as "Feel discomfort"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "Soreness at the site of injection"; FATIGUE (non-serious), outcome "unknown", described as "Tired"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Swollen armpit on the side of the injection"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Appears to be possibly swollen lymph nodes"; HEADACHE (non-serious), outcome "unknown", described as "headache".  Clinical course: After second vaccine injection in the early afternoon, experienced exhaustion in the evening and, at night, started to feel discomfort and soreness at the site of injection (upper left arm). Still very tired the next morning. Woke up on second day with swollen armpit on the side of the injection. Felt uncomfortable. Appeared to be possibly swollen lymph nodes. Patient stated in follow-up that after booster shot of the Pfizer COVID vaccine, the site of injection started to hurt one hour later and felt exhausted the rest of the day. Also got a headache in the evening. These were similar symptoms to those experienced after second dose.  Additional information: Patient stated that I am in my 40s and female. No other medication taken other than OTC antacids and vitamins.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: Pain in arm; headaches; tiredness; Fogginess; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 52 year-old patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (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 24Mar2021, outcome "unknown", described as "Pain in arm"; HEADACHE (non-serious) with onset 24Mar2021, outcome "unknown", described as "headaches"; FATIGUE (non-serious) with onset 24Mar2021, outcome "unknown", described as "tiredness"; FEELING ABNORMAL (non-serious) with onset 24Mar2021, outcome "unknown", described as "Fogginess".  Follow-up attempts completed. No further information expected. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: he mentioned that he can easily breathe and some pain in his shoulders were relieved; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breathing difficult" (unspecified if ongoing); "Pain in shoulders" (unspecified if ongoing); "surgery" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number -1), for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "he mentioned that he can easily breathe and some pain in his shoulders were relieved".  Additional information: Patient had a favourable effect from the vaccine. Right after the second dose ,he praised the vaccine because it made it easier for him to breathe.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nail infection, Potentiating drug interaction
Clinical narrative: Infection on her toe nails.; Ask if she can take Doxycycline Antibiotic that her doctor prescribed for the infection; 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) (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: NAIL INFECTION (non-serious), outcome "unknown", described as "Infection on her toe nails."; POTENTIATING DRUG INTERACTION (non-serious), outcome "unknown", described as "Ask if she can take Doxycycline Antibiotic that her doctor prescribed for the infection".  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: still not feeling better after 7 days after 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 patient via from a Pfizer sponsored Support.   A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MALAISE (non-serious), outcome "not recovered", described as "still not feeling better after 7 days after 1st dose".  Additional information: she stated tomorrow will be 7 days after getting the 1st dose and she still is not feeling better. She stated she feels very sick.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nervousness, Wrong product administered
Clinical narrative: received both the Pfizer and Johnson & Johnson vaccine; nervous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program via Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; covid-19 vaccine janssen (COVID-19 VACCINE JANSSEN) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious), described as "received both the Pfizer and Johnson & Johnson vaccine"; NERVOUSNESS (non-serious), described as "nervous".  Additional information: Got covid vaccine. She received both the Pfizer and Johnson & Johnson vaccine. She is nervous that she received both vaccines.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: mild joint pain; felt tired; headache; 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. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 29Apr2021 (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: 10Apr2021, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; ARTHRALGIA (non-serious), outcome "unknown", described as "mild joint pain"; FATIGUE (non-serious), outcome "unknown", described as "felt tired".  Additional information:Currently (Withheld) is experiencing a headache after completing the vaccination series and asked if she can take Tylenol or Ibuprofen  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Synovial cyst
Clinical narrative: Patient instructed by doctor to stop xeljanz 4 days prior to and 4 days after covid vaccine.states that during that time she hurt more and developed a baker's cyst behind one knee.; Booster; This is a spontaneous report from a Pfizer-sponsored program A contactable Other health care professional reporting for a female (patient). A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE1, SINGLE for covid-19 immunisation. The patient's concurrent conditions included ongoing rheumatoid arthritis and lupus. The patient's concomitant medications were not reported. The patient reported that she hurt all the time. xeljanz was helping both the rheumatoid arthritis and lupus." The patient had less pain. The patient was instructed by doctor to stop XELJANZ 4 days prior to and 4 days after covid vaccine. The patient stated that during that time she hurt more and developed a baker's cyst behind one knee. Patient reports having increased pain in knee, getting injections in knee, and will re-evaluate effectiveness with md in the next 'couple of months.' no further details given. MD aware. Xeljanz XR 11mg once daily. The patient was unaware if MD was aware. Patient reports stopping Xeljanz 7 days before and 7 days after receiving covid vaccination doses MD instructions, last time was around booster dose about 1 month ago. Patient states noticing increase in pain during the time of missed doses, then back to baseline when taking Xeljanz again. Patient agrees it's hard to cope with rheumatoid arthritis and sometimes feels discouraged, also states she 'feels things more' with cold weather. no change in frequency since taking Xeljanz. md aware. The clinical outcome for the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Follow-up (10Aug2021&14Dec2021): This is a follow-up spontaneous report from a Pfizer Sponsored Program. A contactable other HCP and a contactable consumer (patient) reported that. New information received, includes 2 dosage regimens and booster event was added. narrative was added.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: he has had severe stomach pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An adult male patient received bnt162b2 (BNT162B2, Solution for injection), administration date 08May2021 (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, SINGLE), for COVID-19 Immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 09May2021, outcome "not recovered", described as "he has had severe stomach pain".  Additional information: Patient's sister (reporter) reported the age as 38 or 39 years old. Stomach ache was unbearable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.