chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Pain, Pain in extremity
Clinical narrative: body ache; arm pain; feeling like I could have the flu; felt sick the next day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Jan2021 (Lot number: E1123 or E11283) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: ILLNESS (non-serious) with onset 24Jan2021, outcome "unknown", described as "felt sick the next day"; PAIN (non-serious), outcome "unknown", described as "body ache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "feeling like I could have the flu". Therapeutic measures were not taken as a result of illness, pain, pain in extremity, influenza like illness.  Additional information:Causality: Consumer stated, "Yes.".Reporter seriousness for feeling like I had the flu; I could have the flu: Unspecified.Reporter seriousness for Arm pain: Unspecified.Reporter seriousness for body ache: Unspecified.LOT#: Consumer stated, "E11283 that is twice. For the first one is. I do not know it is E1123 or E11283."Expiration date: Consumer stated, "I do not know. Does it say on the card."Other Medication: Consumer stated, "Thyroid medication. Levothyroxine(Further not appropriately clarified hence not captured)."Laboratory Test: Consumer stated, "None.".Treatment for Adverse Event: Consumer stated, "None.".Consumer stated, "Okay are we done.I thought you wanted to hear what the side effects were. For the first shot 23Jan21 just sick the next day 'meaning' body ache, feeling like I had the flu, arm pain and the same with the second shot 13Feb21. You know just sick the next day and then sore arm, painful arm, nausea, body ache feeling like I could have the flu and then the other one 28Sep21 just felt sick the next day nausea, vomiting that is it."Consumer was unwilling to complete the report. Thus further probing could no be done. Hence limited information available over the call.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: He has been rubbing the injection site and was told by his mother not do so; 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 male patient received bnt162b2 (BNT162B2), administration date 06Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: VACCINATION SITE DISCOMFORT (non-serious), outcome "unknown", described as "He has been rubbing the injection site and was told by his mother not do so".  Additional Information: Patient received the third dose of the Pfizer COVID-19 vaccine. He has been rubbing the injection site and was told by his mother not do so. Is it recommended to massage the injection site. He also wants if rubbing the injection site can reduce the effectiveness of the vaccine. Had just received booster shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pollakiuria, Renal pain
Clinical narrative: His kidneys are hurting; A lot of peeing/Was urinating every 20 or 30 minutes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 79 year-old male patient received bnt162b2 (BNT162B2), administration date 05Oct2021 (Batch/Lot number: unknown) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LASIX [FUROSEMIDE]. Vaccination history included: Bnt162b2 (1st dose), when the patient was 79 years old, for Covid-19 immunization; Bnt162b2 (2nd dose), when the patient was 79 years old, for Covid-19 immunization. The following information was reported: POLLAKIURIA (non-serious) with onset 06Oct2021, outcome "unknown", described as "A lot of peeing/Was urinating every 20 or 30 minutes"; RENAL PAIN (non-serious), outcome "unknown", described as "His kidneys are hurting".  Additional Information: Reports a lot of peeing following booster dose. Complains that his kidneys are hurting then when he pees it is better. Sits in his chair. Thinks it is relevant to the chair. Was urinating every 20 or 30 minutes. Lasix once a day in the morning. Put a pillow behind him. The caller states her husband was experiencing a lot of peeing after receiving the booster dose Pfizer Covid Vaccine. The caller states the patient received the Booster dose Pfizer Covid Vaccine yesterday, 05Oct2021 around 1330 or 1400. Today, 06Oct2021, the patient is peeing about every 30 minutes. Reporter states patient is fine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Magnetic resonance imaging, Vomiting
Clinical narrative: diarrhea; vomiting; 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 73 year-old female patient received bnt162b2 (COMIRNATY), administration date 05Feb2021 (Lot number: EL9262, Expiration Date: 31May2021) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (ongoing), notes: Verbatim: Arthritis; "Psoriatic arthritis", start date: 2001 (unspecified if ongoing), notes: Diagnosed around 2001, Psoriatic arthritis with Osteoarthritis..; "Osteoarthritis", start date: 2001 (unspecified if ongoing), notes: Diagnosed around 2001, Psoriatic arthritis with Osteoarthritis.. Concomitant medication(s) included: METHOTREXATE taken for psoriatic arthropathy (ongoing). Past drug history included: Clindamycin for allergic to clindamycin; Levaquin for allergic to Levaquin. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; VOMITING (non-serious), outcome "unknown", described as "vomiting". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: headache; Sore arm; 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 patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 18Aug2021 (Lot number: EW0169) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, Anatomical site of injection:  Right Arm, Route of administration: Intramuscular, Batch/Lot number: EW0161, Expiry date: Jul2021), administration date: 28Jul2021, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 19Aug2021, outcome "unknown", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 19Aug2021, outcome "unknown", described as "Sore arm".  Additional information: No new side effects noted with second shot only had a sore arm and a headache the next day.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Menstrual disorder, Vomiting
Clinical narrative: diarrhea; experienced eight menstrual cycles after getting vaccination; throwing up with menstrual cycle; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 12 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Jul2021 (Lot number: FW0198) at the age of 12 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (ongoing), notes: Patient history: ADHD (From: Unspecified To: Ongoing), Additional Information for Other Conditions: diagnosed since she was 4 years old; "to help sleep" (unspecified if ongoing), notes: Why was the patient taking Concomitant Products Melatonin (Verbatim): to help sleep. Concomitant medication(s) included: ADDERALL taken for attention deficit hyperactivity disorder (ongoing); MELATONIN taken for sleep disorder (ongoing). The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "experienced eight menstrual cycles after getting vaccination"; VOMITING (non-serious), outcome "unknown", described as "throwing up with menstrual cycle". Therapeutic measures were not taken as a result of diarrhoea, menstrual disorder, vomiting.  Additional information included: No investigation assessment was done. Reporter was calling about the Pfizer covid vaccine. Her daughter took the first dose on 22Jul2021 and after she took it, her first menstrual cycle after the vaccine, she started having diarrhea and throwing up. For her last three menstrual cycles since the first dose of the vaccine she get diarrhea and is throwing up. Prior to getting the vaccine reporter's daughter never had any problems with her menstrual cycle, she was always light one day, then a little heavier then a little heavier then its over. Reporter was asking if anyone has reported anything like that before, if it had been reported as a side effect of the vaccine. She had 8 periods prior to the vaccine and did not have this issue.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Euphoric mood, Gait disturbance, Headache
Clinical narrative: stiff neck; throwing up; could barely walk; weak in pain; felt high; feeling pains all over my body; chills; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 18:30 (Lot number: 30145BA) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. Concomitant medication(s) included: VIT D [COLECALCIFEROL]; ZINC. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No:  FD8448, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 10Sep2021, when the patient was 46 years old, for COVID-19 immunization. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 06Oct2021, outcome "not recovered", described as "stiff neck"; EUPHORIC MOOD (non-serious) with onset 04Oct2021 22:00, outcome "not recovered", described as "felt high"; PAIN (non-serious) with onset 04Oct2021 22:00, outcome "not recovered", described as "feeling pains all over my body"; CHILLS (non-serious) with onset 04Oct2021 22:00, outcome "not recovered", described as "chills"; HEADACHE (non-serious) with onset 04Oct2021 22:00, outcome "not recovered", described as "headache"; VOMITING (non-serious) with onset 05Oct2021, outcome "not recovered", described as "throwing up"; GAIT DISTURBANCE (non-serious) with onset 05Oct2021, outcome "not recovered", described as "could barely walk"; ASTHENIA (non-serious) with onset 05Oct2021, outcome "not recovered", described as "weak in pain". Therapeutic measures were not taken as a result of musculoskeletal stiffness, euphoric mood, pain, chills, headache, vomiting, gait disturbance, asthenia.  Additional information: After the shot at Monday night, she felt high then she started feeling pains all over my body, then chills and headache. Patient started throwing up on Tuesday all day along with the pains and headache, she could barely walk, still she was weak in pain and now have headache and stiff neck. No treatment received for the adverse events, patient did not receive any other vaccinations prior to covid vaccines, she was not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Vomiting
Clinical narrative: stiff neck; throwing up; could barely walk; weak in pain; felt high; feeling pains all over my body; chills; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 18:30 (Lot number: 30145BA) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. Concomitant medication(s) included: VIT D [COLECALCIFEROL]; ZINC. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No:  FD8448, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 10Sep2021, when the patient was 46 years old, for COVID-19 immunization. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 06Oct2021, outcome "not recovered", described as "stiff neck"; EUPHORIC MOOD (non-serious) with onset 04Oct2021 22:00, outcome "not recovered", described as "felt high"; PAIN (non-serious) with onset 04Oct2021 22:00, outcome "not recovered", described as "feeling pains all over my body"; CHILLS (non-serious) with onset 04Oct2021 22:00, outcome "not recovered", described as "chills"; HEADACHE (non-serious) with onset 04Oct2021 22:00, outcome "not recovered", described as "headache"; VOMITING (non-serious) with onset 05Oct2021, outcome "not recovered", described as "throwing up"; GAIT DISTURBANCE (non-serious) with onset 05Oct2021, outcome "not recovered", described as "could barely walk"; ASTHENIA (non-serious) with onset 05Oct2021, outcome "not recovered", described as "weak in pain". Therapeutic measures were not taken as a result of musculoskeletal stiffness, euphoric mood, pain, chills, headache, vomiting, gait disturbance, asthenia.  Additional information: After the shot at Monday night, she felt high then she started feeling pains all over my body, then chills and headache. Patient started throwing up on Tuesday all day along with the pains and headache, she could barely walk, still she was weak in pain and now have headache and stiff neck. No treatment received for the adverse events, patient did not receive any other vaccinations prior to covid vaccines, she was not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Muscle tightness, Pain in extremity, Ultrasound scan
Clinical narrative: After the first shot I began having a "pin point" pain in my lower left leg; a tightness in my left calf area/left leg feels heavy while walking; tightness sometimes extends to my upper thigh; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: EW0161) as dose 1, single and administered in arm left (Lot number: EW0173) as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Eggplant" (unspecified if ongoing), notes: known allergies: Eggplant. Concomitant medication(s) included: DOXYCYCLINE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Apr2021, outcome "not recovered", described as "After the first shot I began having a "pin point" pain in my lower left leg"; LIMB DISCOMFORT (non-serious) with onset 17Apr2021, outcome "not recovered", described as "a tightness in my left calf area/left leg feels heavy while walking"; MUSCLE TIGHTNESS (non-serious) with onset 17Apr2021, outcome "not recovered", described as "tightness sometimes extends to my upper thigh". The events "after the first shot i began having a "pin point" pain in my lower left leg", "a tightness in my left calf area/left leg feels heavy while walking" and "tightness sometimes extends to my upper thigh" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, limb discomfort, muscle tightness.  Additional information: No other vaccine in four weeks and Doxycycline Other medications in two weeks. No covid prior vaccination and no covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hunger
Clinical narrative: hungry; tired; 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 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: EN6202) at the age of 44 years as dose 1, single and administered in arm left, administration date 14Apr2021 (Lot number: EP7533) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Eosinophilic asthma" (ongoing), notes: Verbatim: Eosinophilic asthma, diagnosed for most of her life; "Fibromyalgia" (ongoing), notes: Verbatim: Fibromyalgia, diagnosed 10 years ago; "Hypothyroidism" (ongoing), notes: Verbatim: Hypothyroidism; "Overactive bladder" (ongoing), notes: Verbatim: Overactive bladder, diagnosed about 5 years ago. Concomitant medication(s) included: DUPIXENT taken for asthma (ongoing); TIZANIDINE HYDROCHLORIDE taken for asthma (ongoing); CELEBREX taken for fibromyalgia (ongoing); LEVOTHYROXINE taken for hypothyroidism (ongoing); MYRBETRIQ taken for hypertonic bladder (ongoing); RISPERDAL taken for bipolar disorder (ongoing); SEROQUEL taken for bipolar disorder (ongoing); LAMICTAL taken for bipolar disorder (ongoing); ATIVAN taken for bipolar disorder (ongoing); SINGULAIR taken for asthma (ongoing); ZONEGRAN taken for asthma (ongoing); TEGRETOL taken for bipolar disorder (ongoing); MELATONIN taken for sleep disorder; B12-VITAMIIN; DULERA; SPIRIVA RESPIMAT. The following information was reported: HUNGER (non-serious), outcome "recovered", described as "hungry"; FATIGUE (non-serious), outcome "recovered", described as "tired".  Additional information: Patient clarified that the first two shots she was absolutely fine, states the only symptoms she had was she was hungry, tired and wanted to rest a couple of days, nothing serious. Patient stated she was trying to wean down to a lower dose. Stated she takes two asthma inhalers regularly. Patient did not had any other vaccine within four weeks prior to first administration of covid-19 vaccination. Patients family medical history relevant to adverse event was provided. There was no any relevant Tests.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: nausea; Body aches; headache; chills; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) 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: NAUSEA (non-serious), outcome "unknown", described as "nausea"; PAIN (non-serious), outcome "unknown", described as "Body aches"; HEADACHE (non-serious), outcome "unknown", described as "headache"; CHILLS (non-serious), outcome "unknown", described as "chills".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Hours later he had a 4 hour period in which he experienced intense dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 (Lot number: EN6200) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Back problems" (unspecified if ongoing); "Degenerative disc disease" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ivermectin for skin broke out, reaction(s): "Allergies", notes: He is allergic to Ivermectin,.The following information was reported: DIZZINESS (non-serious) with onset 09Mar2021, outcome "recovered" (Mar2021), described as "Hours later he had a 4 hour period in which he experienced intense dizziness".  Additional information: Caller states that he is calling about Pfizer Covid Vaccine. He has had side effects from both shots, but the side effects were more severe after the second shot, he is a 72 year old male. He is wondering what to do about the booster shot, he is still having the problems, he is afraid the booster will make it worse. Caller agrees to do the safety report stating that he is all for getting information out there, as thinks this would also be helpful to anyone else if they were to experience this. After the first dose, 6 hours later he had a 4 hour period in which he experienced intense dizziness but then it went away and he had no more issues. Allergies: He is allergic to Ivermectin, his wife thought the kids had bed bug and so when it came in contact with him his skin broke out and that was years ago.The caller did confirm he is 72-year-old currently and was 71 when the event occurred.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is a little sore where the booster dose Vaccine was administered; 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 (Batch/Lot number: unknown) as dose 3 (booster), 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; Bnt162b2 (2nd dose), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "Arm is a little sore where the booster dose Vaccine was administered".  Additional information: The caller and the caller's husband received the booster dose Pfizer Covid Vaccine. The caller and the caller's husband also received the first two doses Pfizer Covid Vaccine and had no problems. The caller states she is not having any problems after receiving the booster dose Pfizer Covid Vaccine. The caller clarifies, the caller's arm is a little sore where the booster dose Pfizer Covid Vaccine was administered. Reporter stated patient was fine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from a contactable other HCP, for a Pfizer sponsored program (159558). A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had a headache (outcome unknown). The batch/lot number not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Lymphatic disorder, Peripheral swelling
Clinical narrative: armpit hurts; armpit hurts and is extremely swollen; it feels like a lymphatic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 Immunization; Bnt162b2 (Second dose), for Covid-19 Immunization. The following information was reported: AXILLARY PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "armpit hurts"; PERIPHERAL SWELLING (non-serious) with onset Oct2021, outcome "unknown", described as "armpit hurts and is extremely swollen"; LYMPHATIC DISORDER (non-serious) with onset Oct2021, outcome "unknown", described as "it feels like a lymphatic reaction".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Euphoric mood, Feeling drunk, Impaired driving ability, Inappropriate affect
Clinical narrative: feeling very drunk; intense euphoria; slurred speech; fits of giggling; unable to drive; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Oct2021 07:30 (Lot number: FF8841) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUOXETINE; NORETHINDRONE [NORETHISTERONE]; FLEXERIL [CEFIXIME]. Past drug history included: Amoxicillin, reaction(s): "Known allergies: amoxicillin"; Codeine, reaction(s): "Known allergies: codeine". Vaccination history included: Bnt162b2 (Previous dose product: Covid-19, Previous dose brand: Pfizer, Previous dose Lot number: EN6198, Previous dose Administration date= 01Mar2021, Previous Dose number=1, Previous dose Vaccine location= Left arm), administration date: 01Mar2021, when the patient was 37 years old, for Covid-19 immunization; Bnt162b2 (Previous dose product: Covid-19, Previous dose brand: Pfizer, Previous dose Lot number: ER2613, Previous dose Administration date= 22Mar2021, Previous Dose number=2, Previous dose Vaccine location= Left arm), administration date: 22Mar2021, when the patient was 37 years old, for Covid-19 immunization; Influenza vaccine (Other vaccine 4 weeks product: Influenza Vaccine, Other vaccine 4 weeks vaccine date: 22Sep2021, Other vaccine 4 weeks vaccine location: Left arm), administration date: 22Sep2021, when the patient was 37 years old.  The following information was reported: FEELING DRUNK (non-serious) with onset 06Oct2021 15:45, outcome "recovering", described as "feeling very drunk"; EUPHORIC MOOD (non-serious) with onset 06Oct2021 15:45, outcome "recovering", described as "intense euphoria"; DYSARTHRIA (non-serious) with onset 06Oct2021 15:45, outcome "recovering", described as "slurred speech"; INAPPROPRIATE AFFECT (non-serious) with onset 06Oct2021 15:45, outcome "recovering", described as "fits of giggling"; IMPAIRED DRIVING ABILITY (non-serious) with onset 06Oct2021 15:45, outcome "recovering", described as "unable to drive". Therapeutic measures were not taken as a result of feeling drunk, euphoric mood, dysarthria, inappropriate affect, impaired driving ability. It was reported that prior and post to vaccination the patient was not affected with Covid 19.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Sore arm; minor headache; minor fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 05Oct2021 13:30 (Lot number: FF2590) at the age of 59 years as dose 3 booster, single for covid-19 immunization. Relevant medical history included: "Asthma, diverticulitis, hay fever" (unspecified if ongoing); "Asthma, diverticulitis, hay fever" (unspecified if ongoing); "Asthma, diverticulitis, hay fever" (unspecified if ongoing). Concomitant medication(s) included: LORATADINE; IBUPROFEN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 10:45 AM, Route of Administration: Intramuscular), administration date: 15Mar2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 10:45 AM, Route of Administration: Intramuscular), administration date: 22Feb2021, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Oct2021 20:00, outcome "recovering", described as "Sore arm"; HEADACHE (non-serious) with onset 05Oct2021 20:00, outcome "recovering", described as "minor headache"; FATIGUE (non-serious) with onset 05Oct2021 20:00, outcome "recovering", described as "minor fatigue". Therapeutic measures were not taken as a result of pain in extremity, headache, fatigue.  Follow-up (22Oct2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort, Pain, Pain in extremity
Clinical narrative: her arm was sore; she felt tired; achy; Arm blew up like a baseball: This diminished over the 1st and was hardly noticeable, by the 2nd it was gone.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 22Dec2020 (Lot number: EJL685) at the age of 73 years as dose 1, single and administration date 12Jan2021 (Lot number: EL3248) 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm was sore"; FATIGUE (non-serious), outcome "unknown", described as "she felt tired"; PAIN (non-serious), outcome "unknown", described as "achy"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "Arm blew up like a baseball: This diminished over the 1st and was hardly noticeable, by the 2nd it was gone."  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Pain in extremity, Wrong technique in product usage process
Clinical narrative: injected the serum into one of my nerve and this is why my full arm is all numb and it is all numb for the month; why my full arm is all numb and it is all numb for the month; why my full arm is all numb and it is all numb for the month; My arm hurts; 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 63 year-old patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: ER8735, Expiration Date: 31Jul2021) at the age of 63 years as dose 1, single and administered in arm right, administration date 05Jun2021 (Lot number: EW0179, Expiration Date: 31Aug2021) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious), outcome "unknown", described as "injected the serum into one of my nerve and this is why my full arm is all numb and it is all numb for the month"; HYPOAESTHESIA ORAL (non-serious), HYPOAESTHESIA (non-serious), outcome "unknown" and all described as "why my full arm is all numb and it is all numb for the month"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My arm hurts". The events "why my full arm is all numb and it is all numb for the month", "why my full arm is all numb and it is all numb for the month" and "my arm hurts" were evaluated at the physician office visit. No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Insomnia, Limb discomfort, Vaccination site pain
Clinical narrative: Left arm falls asleep randomly; Bad burning sensation wakes me up in the middle of the night; Bad burning sensation wakes me up in the middle of the night; Still sore when I touch the spot of the injection; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10May2021 16:00 (Lot number: EW0176) at the age of 22 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (dose dose number=1, dose product=COVID 19, dose brand=Pfizer, dose lot number=EW0161, dose administration date=19Apr2021, dose administration time=04:00 PM, dose vaccine location=Left arm), administration date: 19Apr2021, when the patient was 22 years old, for Covid-19 immunization. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 16Jun2021 21:30, outcome "unknown", described as "Left arm falls asleep randomly"; BURNING SENSATION (non-serious), INSOMNIA (non-serious) all with onset 16Jun2021 21:30, outcome "not recovered" and all described as "Bad burning sensation wakes me up in the middle of the night"; VACCINATION SITE PAIN (non-serious) with onset 16Jun2021 21:30, outcome "unknown", described as "Still sore when I touch the spot of the injection". Therapeutic measures were not taken as a result of limb discomfort, vaccination site pain. Therapeutic measures were taken as a result of burning sensation, insomnia.  Additional Information: No other vaccine in four weeks. Other medications in two weeks was Birth control. No Covid prior vaccination. Covid was not tested post vaccination. Had no known allergies.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, T-lymphocyte count increased
Clinical narrative: T cell count abnormally high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "lost 60 to 70 lbs" (unspecified if ongoing), notes: who lost 60-70 lbs; "cholesterol down right" (unspecified if ongoing), notes: cholesterol down right. There were no concomitant medications. The following information was reported: T-LYMPHOCYTE COUNT INCREASED (non-serious), outcome "unknown", described as "T cell count abnormally high". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness and tingling starting in left arm and traveling to other libs and face; numbness and tingling starting in left arm and traveling to other libs and face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jul2021 (Lot number: FA7485) at the age of 24 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hemiplegic migraines" (unspecified if ongoing). Concomitant medication(s) included: PROPRANOLOL; AIMOVIG; AMITRIPTYLINE; SPRINTEC. The following information was reported: HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 27Jul2021, outcome "not recovered" and all described as "numbness and tingling starting in left arm and traveling to other libs and face". It was unknown if therapeutic measures were taken as a result of hypoaesthesia, paraesthesia. Additional information: The patient took dose 2 on 17Aug2021 administered on left arm and lot number FC3181. The patient did not receive any other vaccine within four weeks. The patient was covid prior to vaccination. The patient has not been tested for covid post vaccination. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Productive cough
Clinical narrative: After first shot, started getting phlegm and it kept coming; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (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: PRODUCTIVE COUGH (non-serious), outcome "not recovered", described as "After first shot, started getting phlegm and it kept coming".  Additional information: When patient called Pfizer, he was told the he was the only one who experienced phlegm after the first shot, so he just dropped it and did not think much of it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (parent). A 19-day-old patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FC3181), on Sep 10, 2021, at 12:45, and received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FF2588), on Oct 1, 2021, at 12:30; both single dose and transmammary, for COVID-19 immunisation. The mother of the patient was 30 years old at the time of vaccination. No medical history reported. Concomitant medication included dicloxacillin. The patient had exposure via breast milk/breastfeeding, onset Sep 15, 2021, with outcome of unknown. No follow-up attempts possible. No further information expected. Sender's comments: Linked report: US-PFIZER INC-202101327993 mother/baby case.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: continued sore area where shot was injected; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Feb2021 (Lot number: EL3247) 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, Batch/Lot No: EL3247), administration date: 15Jan2021, for covid 19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "continued sore area where shot was injected". Therapeutic measures were not taken as a result of vaccination site pain.  Follow-up (21Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Muscle spasms
Clinical narrative: Muscle spasms throughout the body (leg, thigh, arm, stomach); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Sep2021 04:00 (Lot number: FL3184) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ELDERBERRY EXTRACT; VITAMIN D [VITAMIN D NOS]. The following information was reported: MUSCLE SPASMS (non-serious) with onset 15Sep2021 22:00, outcome "not recovered", described as "Muscle spasms throughout the body (leg, thigh, arm, stomach)". The event "muscle spasms throughout the body (leg, thigh, arm, stomach)" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of muscle spasms. Additional information: No other vaccine was given in four weeks. Other medications in two weeks included Women's Daily multi-vitamin, Elderberry, Vitamin D.Treatment prescribed was muscle relaxer & blood work for event Muscle spasms. Patient did not have Covid prior to vaccination. Covid was not tested post vaccination No known allergies were reported.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Pain in extremity
Clinical narrative: stomach/GI issues; experienced arm soreness; 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 05Apr2021 (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: GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "stomach/GI issues"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "experienced arm soreness".  Additional information: They are both over the age of 65 and received their second Pfizer COVID 19 vaccine on 05Apr2021 Patient and her husband both were received second dose of Pfizer Covid 19 vaccine back in Apr2021. Is inquiring about the booster dose. Stated when she received the vaccine that she experienced arm soreness and had some stomach issues. Stated that she is calling about the booster because her husband is having an ankle replacement in 10 days. Stated that she wanted to know if it would be okay for both of them to receive the booster now or wait until after his surgery in case there are any side effects. Information confirmed as provided. This Report related to a study or programme, event dates was unspecified, Reason for no lot number of Pfizer Covid 19 vaccine was Caller unwilling to complete the report, Expiry Date of Pfizer Covid 19 vaccine Not Provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: I had mild body aches, and ~30 hours after Injection I got bad chills; I had mild body aches, and ~30 hours after Injection I got bad chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 09:30 (Lot number: FF8841) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "pennicillin" (unspecified if ongoing); "Known allergies: shrimp" (unspecified if ongoing); "Known allergies: hornet/wasp venom" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; FLUZONE HIGH DOSE, administration date 28Sep2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 01:30 PM), administration date: 20Mar2021, when the patient was 66 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 27Feb2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious), CHILLS (non-serious) all with onset 06Oct2021, outcome "recovered" (2021) and all described as "I had mild body aches, and ~30 hours after Injection I got bad chills". Therapeutic measures were not taken as a result of pain, chills.  Additional information: Patient received other vaccine in four weeks: Fluzone High Dose, Other medications in two weeks: Amlodipine, multi-vitamin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: She got a cold; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administration date 23Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "She got a cold". Additional information: Consumer is 50-year-old and got the first dose of the Pfizer Biontech covid 19 vaccine on 23Aug2021. She got a cold and went to get the vaccine as an impulse panic response. She did not get the second dose and does not plan to. She was calling to ask what the difference is in the body between the first and second dose. She declined to provide any further contact details aside from her first name and age. Agent states she assisted with her question. She declined to provide any contact details aside from her first name and age. it is a little disappointing that there is limited information and transfer agent only told her that the first dose primed the body. it is disappointing that there is not more details and requests to be transferred back.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.