chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: felt like someone punched her in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 (Lot number: EW0153) at the age of 58 years as dose 1,single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Apr2021, outcome "recovered" (09Apr2021), described as "felt like someone punched her in the arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The first vaccine felt like someone punched her in the arm: This was with the first vaccine. It started on the date she got the vaccine, felt like someone punched her bad. She clarified that it started on 07Apr2021. It lasted two days and then stopped on 09Apr2021. The Anatomical Location for vaccine: Her left arm she's a righty. Additional Vaccines Administered on Same Date of the Pfizer Suspect Product: None. Felt like someone punched her in the arm - It hurt maybe 10 minutes or 5 minutes after she got the shot. It got progressively worse, it was like that for 2 days, until it got better. She was expecting it the second time but nothing.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Tinnitus, Vaccination site pain
Clinical narrative: Site pain for both doses for less than 48 hours.; Tinnitus beginning 2 days after second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02May2021 08:30 (Lot number: Ew0167) as dose 2, single for covid-19 immunisation; multivitamins [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]) (Batch/Lot number: unknown). Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "chronic UTI" (unspecified if ongoing); "Lumbar Radiculopathy" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Macrobid, reaction(s): "known allergies: Macrobid". Vaccination history included: Bnt162b2 (Dose number=1, lot number=Ew0158,, administration time=08:30 AM,, vaccine location=Left arm), administration date: 11Apr2021, when the patient was 49 years old, for Covid-19 immunisation.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04May2021, outcome "not recovered", described as "Site pain for both doses for less than 48 hours."; TINNITUS (non-serious) with onset 04May2021, outcome "not recovered", described as "Tinnitus beginning 2 days after second dose". Therapeutic measures were not taken as a result of vaccination site pain, tinnitus.  Additional information: Other medications in two weeks: other daily prescriptions. Patient did not receive other vaccine in four weeks. Patient did not have covid prior vaccination nor tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: fatigue; headache; nausea; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 10Apr2021 10:30 (Lot number: EW0151) at the age of 16 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "mild exercise-induced asthma" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: IRON; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: FATIGUE (non-serious) with onset 11Apr2021 12:00, outcome "not recovered", described as "fatigue"; HEADACHE (non-serious) with onset 11Apr2021 12:00, outcome "not recovered", described as "headache"; NAUSEA (non-serious) with onset 11Apr2021 12:00, outcome "not recovered", described as "nausea"; PAIN IN EXTREMITY (non-serious) with onset 11Apr2021 12:00, outcome "not recovered", described as "sore arm". The events "fatigue", "headache", "nausea" and "sore arm" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of fatigue, headache, nausea, pain in extremity.  Additional Information: Facility type vaccine was Pharmacy or Drug Store. There were no other vaccine in four weeks. Patient took other medications in two weeks was Multivitamin. If covid tested post vaccination was No, there was no known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Intermittent explosive disorder
Clinical narrative: Aggressive Outbursts Syndrome; 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 parent.  A male patient received bnt162b2 (BNT162B2), administration date 05May2021 (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: INTERMITTENT EXPLOSIVE DISORDER (non-serious), outcome "unknown", described as "Aggressive Outbursts Syndrome".  Additional information: The patient's mother stated that appointment for second dose was scheduled on 26May and asked for assistance to set the second appointment for him at their house as he has Aggressive outburst syndrome.  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: Muscle spasms
Clinical narrative: she has had a cramp in her left foot; 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 Jan2021 (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: MUSCLE SPASMS (non-serious) with onset Jan2021, outcome "unknown", described as "she has had a cramp in her left foot".  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: Magnetic resonance imaging, Muscle spasms, Pain in extremity
Clinical narrative: she has had a cramp in her left foot; 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 Jan2021 (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: MUSCLE SPASMS (non-serious) with onset Jan2021, outcome "unknown", described as "she has had a cramp in her left foot".  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: Vaccination site pain
Clinical narrative: Pain injection site/lot of aches and pains: First dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 08Apr2021 (Lot number: EW0151) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma, Diagnosed when she was a kid.; "Follicular lymphoma", start date: Nov2010 (unspecified if ongoing), notes: Verbatim: follicular lymphoma, History: The caller has follicular lymphoma, its intermittent, and she has to get Rituxan infusions for it. Rituxan infusions- unknown lot, NDC, and expiration date for all doses received. After the first dose that the caller received she got really cold and chilled and her teeth were chattering. From there on she has had to get a steroid and a Benadryl infusion prior. Then the caller has to stay there for 6 hours getting the slow drip of the Rituxan.; "Blood pressure" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "reactions to latex, aspirin, and all the penicillins." (unspecified if ongoing); "reactions to latex, aspirin, and all the penicillins." (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for blood pressure abnormal; ALPRAZOLAM taken for anxiety. Past drug history included: Aspirin, notes: The caller has had reactions to latex, aspirin, and all the penicillins. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Apr2021, outcome "recovered" (Apr2021), described as "Pain injection site/lot of aches and pains: First dose". Therapeutic measures were taken as a result of vaccination site pain.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Eye pain, Fatigue, Pain in extremity
Clinical narrative: Eye pain- felt like eye strain or exhaustion in eyes; Dry eyes; Left arm pain; General exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 21Apr2021 11:45 (Lot number: EW0158) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies:Sulfa Drugs" (unspecified if ongoing). Concomitant medication(s) included: SLYND; ALLEGRA; IBUPROFEN. Vaccination history included: Bnt162b2 (Lot number- EW0150,, Administration date- 31Mar2021, 10:15 am,, Dose number- 1, Left arm), administration date: 31Mar2021, when the patient was 44 years old, for covid-19 immunisation. The following information was reported: EYE PAIN (non-serious) with onset 21Apr2021 19:00, outcome "recovered" (2021), described as "Eye pain- felt like eye strain or exhaustion in eyes"; DRY EYE (non-serious) with onset 21Apr2021 19:00, outcome "recovered" (2021), described as "Dry eyes"; PAIN IN EXTREMITY (non-serious) with onset 21Apr2021 19:00, outcome "recovered" (2021), described as "Left arm pain"; FATIGUE (non-serious) with onset 21Apr2021 19:00, outcome "recovered" (2021), described as "General exhaustion". Therapeutic measures were not taken as a result of eye pain, dry eye, pain in extremity, fatigue.  Additional Information: No Covid prior vaccination and not tested for Covid post vaccination. No other vaccine in four weeks  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Gastrointestinal disorder, SARS-CoV-2 test
Clinical narrative: Within 8 hours of the first dose I experience GI issues loss of appetite lasting about 5 days.; Within 8 hours of the first dose I experience GI issues loss of appetite lasting about 5 days.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 14:00 (Lot number: ER8732) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Some chronic GI issues, nothing formally diagnosed." (unspecified if ongoing). The patient took concomitant medications. The following information was reported: GASTROINTESTINAL DISORDER (non-serious), DECREASED APPETITE (non-serious), outcome "recovering" and all described as "Within 8 hours of the first dose I experience GI issues loss of appetite lasting about 5 days.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of gastrointestinal disorder, decreased appetite.  Additional Information: Facility type vaccine was doctor's office/urgent care. No other vaccine in four weeks. Patient taken other medications in two weeks. Adverse event within 8 hours of the first dose patient experience gastrointestinal issues loss of appetite lasting about 5 days. Within 6 days of the 2nd dose i experienced gastrointestinal issues lasting 4 days and still ongoing. also, have experience an unusual smell (off and on) during the same time frame. No covid prior vaccination. Patient tested covid post vaccination. Covid test post vaccination done by covid test type reported as nasal swab, covid test date conducted on 09may2021 and covid test result were negative. No known allergies. Other medical history reported as some chronic gastrointestinal issues, nothing formally diagnosed.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu-like symptoms".  Additional Information: it was having flu-like symptoms for three days following his first dose of the Pfizer vaccine. He did not have any symptoms following the second dose. AE identified on 5/7 as part of daily social media monitoring.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fluid retention, Peripheral swelling, Weight
Clinical narrative: Water retention arms, legs ankles, feet, torso, face/fluid retention was travelling from my extremities to my chest/torso and face; I had both legs and feet swell and gained 11lbs in fluid within 4hours of the receiving the Pfizer shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (001774). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 09Apr2021 17:00 (Lot number: EW1051) at the age of 58 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "acid reflux" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing), notes: hypothyroid due to eradiated thyroid; "hypertension" (unspecified if ongoing); "known allergies yes" (unspecified if ongoing), notes: known allergies yes; "immune system is "Overactive"" (unspecified if ongoing), notes: My immune system is "Overactive"; "autoimmune disorders" (unspecified if ongoing), notes: I have been diagnosed with 3 autoimmune disorders in the last 40 years. Concomitant medication(s) included: OMEPRAZOLE; SYNTHROID. The following information was reported: FLUID RETENTION (non-serious) with onset 12Apr2021 08:00, outcome "not recovered", described as "Water retention arms, legs ankles, feet, torso, face/fluid retention was travelling from my extremities to my chest/torso and face"; PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "recovered" (2021), described as "I had both legs and feet swell and gained 11lbs in fluid within 4hours of the receiving the Pfizer shot". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fluid retention, peripheral swelling.  Additional information: The patient stated that her immune system is "Overactive" already which is why she have been diagnosed with 3 autoimmune disorders in the last 40 years. This may be why her body overreacted to the shot. The fluid retention was travelling from her extremities to her chest/torso and face. The patient had no COVID-19 prior vaccination. The patient had not tested COVID post vaccination. The patient had known allergies. The patient had not received any other vaccine in four weeks. Patient was received treatment for AE.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Fatigue, SARS-CoV-2 test
Clinical narrative: Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administration date 06Mar2021 14:00 (Lot number: EL9266) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Vasculitis", start date: Oct2016 (ongoing); "COVID-19", start date: 08Feb2021 (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE taken for vasculitis, start date: 2016 (ongoing); PANTOPRAZOLE, start date: 2016 (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE. Batch number: Not provided on card, Lot number: EL9264. Time: 2pm), administration date: 30Jan2021, for COVID-19 immunization, reaction(s): "COVID-19", "Fatigue". The following information was reported: FATIGUE (non-serious) with onset 09Mar2021, outcome "recovered with sequelae", described as "Fatigue". The event "fatigue" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue.  Additional information: The patient did not had any family history. There was no autopsy information.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle pain; 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) (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: MYALGIA (non-serious), outcome "not recovered", described as "muscle 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: Insomnia, Myalgia
Clinical narrative: muscle pain all over the body; cant sleep; 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) (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, reaction(s): "muscle pain". The following information was reported: MYALGIA (non-serious), outcome "not recovered", described as "muscle pain all over the body"; INSOMNIA (non-serious), outcome "unknown", described as "cant sleep".  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: Asthenia, Feeling hot, Sensory disturbance, Vaccination site pain, Vaccination site pruritus
Clinical narrative: After a couple of weeks, she felt as if she has no strength and she seems different; After a couple of weeks, she felt as if she has no strength and she seems different; itchiness on the administration site (left arm); pain on the administration site (left arm); felt being hot on certain parts of her bodies; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 (Batch/Lot number: unknown) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Dermatographism" (unspecified if ongoing), notes: female who has a known history of Dermatographism. The patient's concomitant medications were not reported. Past drug history included: Propylene glycol, reaction(s): "Allergies", notes: Known allergies: Propylene Glycol. Vaccination history included: Tetanus (She stated that she is still quite unsure if the side effect she had experienced on her left arm was due to her getting shingle shots, tetanus shot on the past 3 years on the same arm.). The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 07Apr2021, outcome "unknown", described as "itchiness on the administration site (left arm)"; VACCINATION SITE PAIN (non-serious) with onset 07Apr2021, outcome "unknown", described as "pain on the administration site (left arm)"; FEELING HOT (non-serious) with onset 07Apr2021, outcome "unknown", described as "felt being hot on certain parts of her bodies"; ASTHENIA (non-serious), SENSORY DISTURBANCE (non-serious), outcome "unknown" and all described as "After a couple of weeks, she felt as if she has no strength and she seems different".  Additional information: The patient missed her second dose scheduled on 28Apr2021.   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: experiencing headaches in the last 2 days; 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 44 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), when the patient was 44 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "experiencing headaches in the last 2 days".  Additional information: The patient stated he just had second his Pfizer shot on Saturday and has been experiencing headaches and Wanted to know if this is normal. The patient was asking whether he could take Tylenol or Advil.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: ill; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "ill".  Additional information: consumer needs to cancel apt for husband for the second dose of the covid vaccine, unable to make the second apt. husband was ill, and the doctor recommending he doesn't get the second dose while ill, consumer didn't state if he got ill from the first dose of the vaccine or not. Reporter called her vaccination site or local health dept. to get the number for local rescheduling, also explained the vaccine timeline of 21days. 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: Vertigo
Clinical narrative: vertigo; 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 07Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), administration date: Jan2021, for COVID-19 Immunization, reaction(s): "she has had a cramp in her left foot". The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "vertigo".  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: Blood pressure increased, Blood pressure measurement, Magnetic resonance imaging, Vertigo
Clinical narrative: vertigo; 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 07Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), administration date: Jan2021, for COVID-19 Immunization, reaction(s): "she has had a cramp in her left foot". The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "vertigo".  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: Vaccination site pain
Clinical narrative: Injection sites were also sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 (Lot number: EW0150) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sleep Issues" (ongoing), notes: Started years ago; "Sleep apnea" (ongoing), notes: Started about 12 years ago; "Restless leg" (ongoing), notes: Patient has had for most of his life; "Penicillin Allergy" (unspecified if ongoing), notes: He has a history of having severe allergic reactions to the Penicillin family of medication. Concomitant medication(s) included: PENTAZOCINE taken for restless legs syndrome (ongoing); ATENOLOL taken for hypertension, start date: 2018 (ongoing); ATORVASTATIN taken for blood cholesterol, start date: 2020 (ongoing); ESZOPICLONE taken for anxiety (ongoing); BUPROPION taken for anxiety, sleep disorder (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 06Apr2021, outcome "unknown", described as "Injection sites were also sore".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: his right foot swelled up and felt painful; his right foot swelled up and felt painful; 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 2, single for covid-19 immunisation. Relevant medical history included: "Wounded Leg" (unspecified if ongoing), notes: He said he has a wounded leg; "big toe swelled up" (unspecified if ongoing), notes: after the first dose. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1), administration date: 23Feb2021, for Covid-19 immunization. The following information was reported: OEDEMA PERIPHERAL (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2021, outcome "unknown" and all described as "his right foot swelled up and felt painful".  Additional information: He said that he took the second dose on 30th (month not confirmed). He said that after the second dose, his right foot swelled up and felt painful and he said that both of his feet are sensitive. He would like to know if any other people are experiencing these same symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Headache
Clinical narrative: Headache; Fatigue; Diarrhea, and had cramping/stool was watery on the first day but not anymore.; Diarrhea, and had cramping.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), administration date 29Apr2021 09:30 (Lot number: EW0171) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure", start date: Jul2017 (ongoing), notes: Verbatim: High blood pressure; "Irritable bowel syndrome" (ongoing), notes: Verbatim: Irritable Bowel Syndrome. Concomitant medication(s) included: LISINOPRIL taken for hypertension, start date: Jul2017 (ongoing); NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL taken for contraception, start date: Mar2020 (ongoing). The following information was reported: DIARRHOEA (non-serious) with onset 29Apr2021, outcome "recovering", described as "Diarrhea, and had cramping/stool was watery on the first day but not anymore."; ABDOMINAL PAIN (non-serious) with onset 29Apr2021, outcome "recovering", described as "Diarrhea, and had cramping."; HEADACHE (non-serious) with onset 29Apr2021 09:45, outcome "recovered" (01May2021), described as "Headache"; FATIGUE (non-serious) with onset 29Apr2021, outcome "recovered" (01May2021), described as "Fatigue".  Additional information: Additional vaccines administered on same date of the Pfizer suspect was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. AE(s) following prior vaccinations was reported as none. Patient did not require to visit emergency room or physician office.    No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: He received the second dose of the vaccine 24 hours ago and now has a headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 10May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Ibuprofen for headache, reaction(s): "drug ineffective"; Acetaminophen for headache, reaction(s): "drug ineffective"; Excedrin for headache; Motrin for headache; Aleve for headache. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 11May2021, outcome "unknown", described as "He received the second dose of the vaccine 24 hours ago and now has a headache".  Additional information: Patient wanted to know if he can take any medications for headache and he mentioned that medications like Ibuprofen and acetaminophen were not effective for him. When he had headaches, he preferred to take EXCEDRIN, MOTRIN or ALEVE. Patient wanted to know for how long should he not use these medications. He received the second dose of the vaccine 24 hours ago and now has a headache, he stated that if he does not take his medication the headache does not go away.  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: Vaccination site pain
Clinical narrative: left arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Feb2021 (Batch/Lot number: unknown) at the age of 53 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "left arm soreness". Therapeutic measures were taken as a result of vaccination site pain.  Additional information:FOLLOW UP REPORT.Caller stated that he had both doses of Pfizer Covid vaccine. Stated that he had the second dose on 11 Mar and his lymph nodes in his neck was swollen, had nausea, lightheadedness and tiredness which he reported online to Pfizer. Stated that he has no reference number to provide. Stated that he reported the NDC, lot number and expiration date previously. Stated that he had the first dose in February. Reported today that before breakfast that he had not eaten or drank anything and his glands started swelling again. Wanted to know if he had come into contact with Covid or if something else is going on.Stated that his left gland is golf ball size. Stated that anytime he eats that it swells again. Stated that both palms of his hands felt like needles. Stated that his face gets extremely hot. Wanted to know if any recommendations other than seeing his primary care doctor. Does not have the NDC, lot or expiration to provide for the first dose.Reporter details: Is a pharmacy technician calling on behalf of self. Email address captured as provided.Event details: Stated that his hands felt like needles started at noon and went away in 30 minutes. Stated that with the first dose that he had left arm soreness 4-6 hours after the injection.Treatment: None. Stated that he has called the doctor but he has not returned his call yet. Stated that he used Tylenol and Ibuprofen every couple of hours and alternated it for left arm soreness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: In a lot of pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Advil. The following information was reported: PAIN (non-serious), outcome "unknown", described as "In a lot of pain".  Additional information: Caller states she has not received the second shot yet and was given prednisone pack for arthritis. Caller states the prednisone is 5 mg tablets that she will be taking by the time she receives the vaccine. Caller states she will start at ta higher dose but it will be down to the 5 mg by the time she received the second dose. Caller states her physician prescribed her Advil to treat her rheumatoid arthritis and he prescribed 8 tablets per day. Caller concerned about starting a regiment of prednisone before second dose and would like to know the possible adverse effects, clarified has had first shot, clarified has not yet started taking 5 mg prednisone, but caller would like to because they are in a lot of pain  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Facial discomfort
Clinical narrative: facial clicking; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program from 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: FACIAL DISCOMFORT (non-serious), outcome "unknown", described as "facial clicking". Additional information: The reporter believes she had a reaction after her 1st dose with facial clicking. She stated she told the nurse and they just gave her a bottle of water and didn't record anything. She was wanting to know if she should get her 2nd dose or not.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. .
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: she has felt unwell; back of thigh and lot of pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 04Mar2021 (Lot number: EN6201) 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, Lot number: EN9809, Expiry date: 30Jun2021), for Covid-19 immunization. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "she has felt unwell"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "back of thigh and lot of pain".  No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Blood iron decreased, Confusional state, Fatigue
Clinical narrative: Has low iron/She said she found out her iron was so low; She was just worn out, and fell asleep at a red light; She couldn't think straight at the time.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), administration date 26Jan2021 (Lot number: EK9231) at the age of 85 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (ongoing), notes: she had been Type 2 diabetic for about 8 years.she was pre-diabetic now. No further details.; "Blood pressure high" (ongoing), notes: Stated she hadn't had high blood pressure for very long. No further details provided. The patient's concomitant medications were not reported. The following information was reported: BLOOD IRON DECREASED (non-serious) with onset 2021, outcome "unknown", described as "Has low iron/She said she found out her iron was so low"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "She was just worn out, and fell asleep at a red light"; CONFUSIONAL STATE (non-serious) with onset 2021, outcome "unknown", described as "She couldn't think straight at the time.". The events "has low iron/she said she found out her iron was so low", "she was just worn out, and fell asleep at a red light" and "she couldn't think straight at the time." were evaluated at the physician office visit. Therapeutic measures were taken as a result of blood iron decreased, fatigue, confusional state. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dysmenorrhoea
Clinical narrative: this time she is having really bad cramps; this time she is having really bad cramps; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACINE), administration date 09May2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "She normally has mild cramps on her first day" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSMENORRHOEA (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "this time she is having really bad cramps". The event "this time she is having really bad cramps" and "this time she is having really bad cramps" was evaluated at the physician office visit. Therapeutic measures were taken as a result of dysmenorrhoea, condition aggravated. Additional information: Paracetamol (TYLENOL) and ibuprofen were not helping. The doctor said the vaccine might give her more cramps than usual.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria
Clinical narrative: The second shot was very mild up every 2 hours urinating; 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), administered in arm right, administration date 16Mar2021 15:00 (Lot number: EN6202) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Irritable bowel syndrome" (unspecified if ongoing), notes: Verbatim: Irritable bowel syndrome. Family history included: "High blood pressure" (unspecified if ongoing), notes: Verbatim: High blood pressure. Concomitant medication(s) included: OCUVITE AUGE; RALOXIFENE; VALSARTAN taken for hypertension; AMLOPINE taken for hypertension; LIPITOR [ATORVASTATIN]. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, lot number: EN6200-6202, Anatomical site- left arm), administration date: 23Feb2021, for COVID-19 Immunisation, reaction(s): "Was up all night urinating/starting urinating at midnight/excessive urination". The following information was reported: POLLAKIURIA (non-serious) with onset 2021, outcome "unknown", described as "The second shot was very mild up every 2 hours urinating". Therapeutic measures were not taken as a result of pollakiuria.  Additional Information: Concomitant Drugs: Drug name: OCUVITE Reason for use: eyes Route: pill, Drug name: Raloxifene Reason for use: breast Route: pill, Drug name: Valsartan Reason for use: High blood pressure Route: pill, Drug name: Amlodipine Reason for use: High blood pressure Route: pill, Drug name: Atorvastatin Route: pill. FIZER/BIONTECH COVID-19 Vaccine Details: Dose: 1st; Date: 23Feb2021; Time: 11:00AM; Anatomical Site of injection: Left arm; Route of administration: a needle; Batch/lot number: EN6200-6202, Dose: 2nd; Date: 16Mar2021; Time: 03:00PM; Anatomical Site of injection: Right arm; Route of administration: a needle.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021225826 same patient, drug, different dose and events
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). 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. Relevant medical history included: "Lung Cancer" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose.), for COVID-19 immunization.  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tiredness".  Additional Information: Patient received 2 COVID shots. Patient  feel that after the two weeks of tiredness following the second vaccine that patients breathing has improved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm on the injection site where vaccine was administered; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm, administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "kidney transplant", start date: Feb2021, stop date: Feb2021, notes: way back February, before getting the 1st dose of the vaccine. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "sore arm on the injection site where vaccine was administered". Additional information: The patient received the second dose about two weeks ago (at the time of report).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: discoloration at injection site after first dose of vaccine; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 18:15 (Lot number: ER8731) as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "Obesity" (unspecified if ongoing), notes: No; "arthritis" (unspecified if ongoing). Concomitant medication(s) included: POTASSIUM ACETATE; METOPROLOL TARTRATE; SIMVASTATIN; DIOVAN HCT.  The following information was reported: VACCINATION SITE DISCOLOURATION (non-serious) with onset Apr2021, outcome "not recovered", described as "discoloration at injection site after first dose of vaccine". Therapeutic measures were not taken as a result of vaccination site discolouration.  Additional information: No other vaccine was administered in four weeks. Patient did not have covid prior vaccination nor tested post vaccination. Patient had no Known allergies.  No follow-up attempts are possible. No further information is expected.