chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Therapeutic response unexpected
Clinical narrative: the vaccine may have cleared up something in my MS; bloat all the time so, I have gas constantly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 14Jun2021 (Lot number: EW0180) as dose 2, single for covid-19 immunisation. Relevant medical history included: "multiple sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot Number: EW0186), administration date: 24May2021, for covid-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "the vaccine may have cleared up something in my MS"; ABDOMINAL DISTENSION (non-serious) with onset 2021, outcome "unknown", described as "bloat all the time so, I have gas constantly".  No follow-up attempts are possible. No further information is expected.  Follow-up (02Nov2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Malaise
Clinical narrative: Felt sick; bedridden; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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: MALAISE (non-serious), outcome "unknown", described as "Felt sick"; BEDRIDDEN (non-serious), outcome "unknown", described as "bedridden". Additional information: Felt sick after receiving Pfizer covid vaccine and was bedridden. Optional Information: Reported within required 24hr period. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngitis streptococcal
Clinical narrative: On 06Oct2021, had after the 2nd shot of the vaccine she got strep throat again which is not resolved; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 23 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 18:30 (Lot number: 301358A) at the age of 23 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose , Vaccine on 12Sep2021, lot 301308A, first shot of the vaccine she was getting strep throat), administration date: 12Sep2021, when the patient was 23 years old, for COVID-19 immunization, reaction(s): "strep throat". The following information was reported: PHARYNGITIS STREPTOCOCCAL (non-serious) with onset 06Oct2021, outcome "not recovered", described as "On 06Oct2021, had after the 2nd shot of the vaccine she got strep throat again which is not resolved". Therapeutic measures were taken as a result of pharyngitis streptococcal.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101224489 similar report from same reporter
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Dysphonia, Speech disorder, Vocal cord disorder
Clinical narrative: Approximately a week after receiving 2nd and 3rd dose of vaccine I lost my voice; it starts with very rough voice; it goes into literally like unable to speak; My vocal cords feel like easy to get tired; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Oct2021 10:00 (Lot number: FF8841) at the age of 47 years as dose 3 (booster), single and administered in arm left, administration date 19Mar2021 12:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "i am alergic to some food" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, Batch/Lot No: EN6198, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 26Feb2021, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: APHONIA (non-serious) with onset 2021, outcome "recovering", described as "Approximately a week after receiving 2nd and 3rd dose of vaccine I lost my voice"; DYSPHONIA (non-serious) with onset 2021, outcome "recovering", described as "it starts with very rough voice"; SPEECH DISORDER (non-serious) with onset 2021, outcome "recovering", described as "it goes into literally like unable to speak"; VOCAL CORD DISORDER (non-serious) with onset 2021, outcome "recovering", described as "My vocal cords feel like easy to get tired". Therapeutic measures were not taken as a result of aphonia, dysphonia, speech disorder, vocal cord disorder.  Additional information: facility type vaccine was Clinic. The patient took no other vaccine in four weeks, had no covid prior vaccination, had not covid tested post vaccination, he took no other medications in two weeks. The patient stated that approximately a week after receiving 2nd and 3rd dose of vaccine she lost her voice, it started with very rough voice, it went into literally like unable to speak. Her vocal cords felt like easy to get tired and after 2nd dose it lasted at least 1.5 months. No honey or vocal cords medicine helps it, but eventually it vanished on its own (events onset date: 2021). She got a booster, and it was happening again (events onset date for dose 3: 25Oct2021, event start time: 08:00 AM) and it was why she was only now realizing that it was related to COVID 19 vaccine last time. she must underline, never had a problem with losing voice or anything like that never.   No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: tenderness in her left arm for the first two doses; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Feb2021 12:15 (Lot number: EL3302) at the age of 75 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN; VITAMIN B12 [CYANOCOBALAMIN]; CALCIUM; CINNAMON. The following information was reported: TENDERNESS (non-serious) with onset 2021, outcome "unknown", described as "tenderness in her left arm for the first two doses". No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Tenderness
Clinical narrative: Second dose of the vaccine made her want to sleep; tenderness in her left arm for the first two doses; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Feb2021 12:15 (Lot number: EM9810) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN; VITAMIN B12 [VITAMIN B12 NOS]; CALCIUM; CINNAMON. Vaccination history included: Bnt162b2 (Dose number=1, Lot number=EL3302 , Anatomical location=Left arm, Route: Intramuscular, Time: 12:15), administration date: 02Feb2021, when the patient was 75 years old, for Covid-19 immunization. The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "Second dose of the vaccine made her want to sleep"; TENDERNESS (non-serious), outcome "unknown", described as "tenderness in her left arm for the first two doses". No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis
Clinical narrative: Fatigue; sweating; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 46 year-old patient received bnt162b2 (BNT162B2) (Lot number: 301558A) at the age of 46 years 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, No Events reported), for COVID-19 immunization; Bnt162b2 (Dose: 2, No Events reported), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweating"; CHILLS (non-serious), outcome "unknown", described as "chills".  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Muscle spasticity, Muscle twitching
Clinical narrative: My arm throbs or pulsates randomly.; My arm throbs or pulsates randomly.; Twitches in the muscle.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 (Lot number: FC3183) at the age of 19 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3183, Location of injection: Arm Left), administration date: 23Aug2021, when the patient was 19 years old, for Covid-19 immunization. The following information was reported: LIMB DISCOMFORT (non-serious), MUSCLE SPASTICITY (non-serious) all with onset 16Sep2021, outcome "not recovered" and all described as "My arm throbs or pulsates randomly."; MUSCLE TWITCHING (non-serious) with onset 16Sep2021, outcome "not recovered", described as "Twitches in the muscle.". Therapeutic measures were not taken as a result of limb discomfort, muscle spasticity, muscle twitching.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Birth Control. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Known allergies: yes.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I had no real side effects for first two shots. Just pain at site for a couple of days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 11:00 (Lot number: SW6208) at the age of 56 years as dose 1, single and administered in arm left, administration date 09Apr2021 11:00 (Lot number: EN6208) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Scallops" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Allergy". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "I had no real side effects for first two shots. Just pain at site for a couple of days.". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient told she had no real side effects for first two shots. Just pain at site for a couple of days. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle spasms, Peripheral swelling, Skin discolouration, Sunburn
Clinical narrative: Discoloration of lower legs (red and purple spotting); cramping in both legs randomly; numbness in right leg occasionally; lower legs slightly swollen; feeling like mild sunburn; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 (Lot number: ER8732) at the age of 33 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Left), administration date: 25Mar2021, for COVID-19 immunization. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset 18Apr2021, outcome "not recovered", described as "Discoloration of lower legs (red and purple spotting)"; MUSCLE SPASMS (non-serious) with onset 18Apr2021, outcome "not recovered", described as "cramping in both legs randomly"; HYPOAESTHESIA (non-serious) with onset 18Apr2021, outcome "not recovered", described as "numbness in right leg occasionally"; PERIPHERAL SWELLING (non-serious) with onset 18Apr2021, outcome "not recovered", described as "lower legs slightly swollen"; SUNBURN (non-serious) with onset 18Apr2021, outcome "not recovered", described as "feeling like mild sunburn". The events "discoloration of lower legs (red and purple spotting)", "cramping in both legs randomly", "numbness in right leg occasionally", "lower legs slightly swollen" and "feeling like mild sunburn" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of skin discolouration, muscle spasms, hypoaesthesia, peripheral swelling, sunburn.  Additional information: Patient had discoloration of lower legs (red and purple spotting), cramping in both legs randomly, numbness in right leg occasionally, lower legs slightly swollen and feeling like mild sunburn. Seeing a physician tomorrow in hopes that they will refer me to a cardiovascular specialist. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. No other vaccinations within four weeks. No other medications in two weeks. Patient not had Covid prior vaccination; Patient was tested Covid post vaccination. Patient had no known allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 16-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), May 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for  COVID-19 immunisation. The patient experienced chest pain (chest pain; lasted a few days), with outcome of recovered. Additional information: Reporter's 16-year-old son experienced side effects after his second Pfizer dose back in May. Side effects: chest pain; lasted a few days. Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: Left arm started to have tingling and numbness that spread throughout my shoulder down to the tips of my fingers. A burning, tingling, prickling sensation that''s also numbing at times as well and has; Left arm started to have tingling and numbness that spread throughout my shoulder down to the tips of my fingers. A burning, tingling, prickling sensation that''s also numbing at times as well and has; A burning, tingling, prickling sensation that's also numbing at times as well and has been occurring daily throughout the entire day since the 6thof October; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Sep2021 14:00 (Lot number: FC3184) at the age of 46 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 Number: 1, Batch/Lot No: FA7485, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 12Aug2021, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 06Oct2021 15:00, outcome "not recovered" and all described as "Left arm started to have tingling and numbness that spread throughout my shoulder down to the tips of my fingers. A burning, tingling, prickling sensation that''s also numbing at times as well and has"; BURNING SENSATION (non-serious) with onset 06Oct2021 15:00, outcome "not recovered", described as "A burning, tingling, prickling sensation that's also numbing at times as well and has been occurring daily throughout the entire day since the 6thof October". Therapeutic measures were not taken as a result of paraesthesia, hypoaesthesia, burning sensation.  Additional information: The patient did not receive any other vaccine in four weeks and any Other medications in two weeks. The patient did not had COVID prior vaccination and post vaccination, patient had not tested with Covid 19.No known allergies reported for the patient.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Arm pain at site of injection every so often.; This is a spontaneous report received from 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 left, administration date 28May2021 17:00 (Lot number: EW0182) at the age of 44 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 Number: 1, Batch/Lot No: ER8736, Location of injection: Arm Left, Vaccine Administration Time: 01:30 PM), administration date: 07May2021, when the patient was 44 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Arm pain at site of injection every so often.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain.  Follow-Up (01Nov2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: has been having headaches since that have not gone away; 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 26 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Oct2021, outcome "not recovered", described as "has been having headaches since that have not gone away". Additional information: Caller stated she was calling about the Pfizer Vaccine and had some questions about it; stated  she had the 1st vaccine last Thursday and had been having headaches since that had not gone away and wanted to ask if this was normal or at this point should she wait longer to go to the doctor or what to expect. Caller stated it had been a week and other than the headache she was fine and never really suffered from headaches so was pretty sure it was the vaccine and just wanted to see if this was normal; caller declined to complete the report. Since the vaccine dose she has had a headache everyday, back of head. How long will this last. She read it usually lasts for no more than 3 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; Fatigue; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). Reported in response to consumer letter sent via follow-up letter. The reporter is the patient.   A 68 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 03Mar2021 (Lot number: EN6205) at the age of 68 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Date/Time: 10Feb2021, Time: AM, Anatomical site of injection: arm, Route of administration: Intramuscular, Batch/Lot number: EN6201), administration date: 10Feb2021, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue".  Additional information: Dose:2nd, Date/Time: 03Mar2021 Time: AM, Site and Route of injection: Anatomical site of injection: ARM Route of administration: Intramuscular Batch/Lot number: EN6205, no prior vaccinations, no relevant tests and no specific relevant test for thromboembolic events with thrombocytopenia. Don't know what half these treatments. Unit 2 dose- headache + fatigue.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Diarrhoea, Fatigue, Insomnia
Clinical narrative: Make that joint pain worse; Did not sleep well last night; Nausea; Feels a little bit tired, described as draggy; Specifically joint pain in her Sacral Iliac joint that she has had before just flared up; Diarrhea; Nervous; 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 80 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Oct2021 (Batch/Lot number: unknown) at the age of 80  as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Colitis" (unspecified if ongoing); "Joint pain" (unspecified if ongoing), notes: she started with joint pain, has joint pain anyway. The patient's 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: ARTHRALGIA (non-serious) with onset Oct2021, outcome "unknown", described as "Specifically joint pain in her Sacral Iliac joint that she has had before just flared up"; DIARRHOEA (non-serious) with onset Oct2021, outcome "unknown", described as "Diarrhea"; NERVOUSNESS (non-serious) with onset Oct2021, outcome "unknown", described as "Nervous"; CONDITION AGGRAVATED (non-serious) with onset 27Oct2021, outcome "unknown", described as "Make that joint pain worse"; NAUSEA (non-serious) with onset Oct2021, outcome "unknown", described as "Nausea"; FATIGUE (non-serious) with onset Oct2021, outcome "unknown", described as "Feels a little bit tired, described as draggy"; INSOMNIA (non-serious) with onset 26Oct2021, outcome "unknown", described as "Did not sleep well last night". Therapeutic measures were taken as a result of arthralgia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Nervousness
Clinical narrative: Make that joint pain worse; Did not sleep well last night; Nausea; Feels a little bit tired, described as draggy; Specifically joint pain in her Sacral Iliac joint that she has had before just flared up; Diarrhea; Nervous; 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 80 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Oct2021 (Batch/Lot number: unknown) at the age of 80  as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Colitis" (unspecified if ongoing); "Joint pain" (unspecified if ongoing), notes: she started with joint pain, has joint pain anyway. The patient's 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: ARTHRALGIA (non-serious) with onset Oct2021, outcome "unknown", described as "Specifically joint pain in her Sacral Iliac joint that she has had before just flared up"; DIARRHOEA (non-serious) with onset Oct2021, outcome "unknown", described as "Diarrhea"; NERVOUSNESS (non-serious) with onset Oct2021, outcome "unknown", described as "Nervous"; CONDITION AGGRAVATED (non-serious) with onset 27Oct2021, outcome "unknown", described as "Make that joint pain worse"; NAUSEA (non-serious) with onset Oct2021, outcome "unknown", described as "Nausea"; FATIGUE (non-serious) with onset Oct2021, outcome "unknown", described as "Feels a little bit tired, described as draggy"; INSOMNIA (non-serious) with onset 26Oct2021, outcome "unknown", described as "Did not sleep well last night". Therapeutic measures were taken as a result of arthralgia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Nausea, Vaccination site pain, Vomiting
Clinical narrative: Unable to keep food down for the next day; Injection site pain.; Severe headache; nausea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 32 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 26Oct2021 17:00 (Lot number: EW0183) at the age of 32 years 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 Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), when the patient was 32 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), when the patient was 32 years old, for COVID-19 immunization; Flu shot (Flu shot). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26Oct2021, outcome "recovering", described as "Injection site pain."; HEADACHE (non-serious) with onset 26Oct2021, outcome "recovering", described as "Severe headache"; NAUSEA (non-serious) with onset 26Oct2021, outcome "recovering", described as "nausea"; VOMITING (non-serious) with onset 26Oct2021, outcome "recovering", described as "vomiting"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "Unable to keep food down for the next day". It was unknown if therapeutic measures were taken as a result of vaccination site pain, headache, nausea, vomiting.  Additional information: Prior to vaccination, was the patient diagnosed with COVID-19?:Unknown. Since the vaccination, has the patient been tested for COVID-19?:Unknown  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Vaccination site erythema, Vaccination site pain
Clinical narrative: he only got some pain on his arm where he got the injection; he only got some pain on his arm where he got the injection and it was a little red; 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 56 year-old male patient received bnt162b2 (COMIRNATY), administration date 01May2021 (Batch/Lot number: unknown) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "smoker" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset May2021, outcome "recovered" (May2021), described as "he only got some pain on his arm where he got the injection"; VACCINATION SITE ERYTHEMA (non-serious) with onset May2021, outcome "recovered" (May2021), described as "he only got some pain on his arm where he got the injection and it was a little red". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Body aches; fever; a little nausea; headache; pain and swelling at injection site; pain and swelling at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 10:00 (Batch/Lot number: unknown) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing), notes: Verbatim: Depression; "ADD" (unspecified if ongoing), notes: verbatim: ADD. Concomitant medication(s) included: ADDERALL. Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Arm Left), for COVID-19 immunization; Bnt162b2 (Dose Number: 1), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 26Oct2021 15:00, outcome "recovering", described as "Body aches"; PYREXIA (non-serious) with onset 26Oct2021 15:00, outcome "recovering", described as "fever"; NAUSEA (non-serious) with onset 26Oct2021 15:00, outcome "recovering", described as "a little nausea"; HEADACHE (non-serious) with onset 26Oct2021 15:00, outcome "recovering", described as "headache"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 26Oct2021 15:00, outcome "recovering" and all described as "pain and swelling at injection site". Therapeutic measures were not taken as a result of pain, pyrexia, nausea, headache, vaccination site pain, vaccination site swelling.  Additional information: Patient was not pregnant at the time of vaccination. Patient had not received other vaccines within 4 weeks prior to vaccination. Patient had received other medications antidepressants and Adderall within 2 weeks of vaccination. Patient was not diagnosed with covid-19 prior to vaccination. Patient was not tested with covid-19 since the vaccination. Patient had no known allergies. Patient had concomitant therapy.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Body aches; fever; a little nausea; headache; pain and swelling at injection site; pain and swelling at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 10:00 (Batch/Lot number: unknown) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing), notes: Verbatim: Depression; "ADD" (unspecified if ongoing), notes: verbatim: ADD. Concomitant medication(s) included: ADDERALL. Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Arm Left), for COVID-19 immunization; Bnt162b2 (Dose Number: 1), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 26Oct2021 15:00, outcome "recovering", described as "Body aches"; PYREXIA (non-serious) with onset 26Oct2021 15:00, outcome "recovering", described as "fever"; NAUSEA (non-serious) with onset 26Oct2021 15:00, outcome "recovering", described as "a little nausea"; HEADACHE (non-serious) with onset 26Oct2021 15:00, outcome "recovering", described as "headache"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 26Oct2021 15:00, outcome "recovering" and all described as "pain and swelling at injection site". Therapeutic measures were not taken as a result of pain, pyrexia, nausea, headache, vaccination site pain, vaccination site swelling.  Additional information: Patient was not pregnant at the time of vaccination. Patient had not received other vaccines within 4 weeks prior to vaccination. Patient had received other medications antidepressants and Adderall within 2 weeks of vaccination. Patient was not diagnosed with covid-19 prior to vaccination. Patient was not tested with covid-19 since the vaccination. Patient had no known allergies. Patient had concomitant therapy.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling hot, Feeling of body temperature change, Headache
Clinical narrative: Felt like she was gonna faint/Lil dizzy; My vision started getting dark; Sweating; Getting hot; Hearing is muffled/ kinda fuzzy; hot and cold; Headache; tired; 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 23 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 26Oct2021 (Lot number: FF2593) at the age of 23 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: 1, Lot: FE3592, ), administration date: 05Oct2021, when the patient was 23 years old, for COVID-19 Immunization. The following information was reported: FEELING HOT (non-serious) with onset 27Oct2021, outcome "unknown", described as "Getting hot"; HYPOACUSIS (non-serious) with onset 27Oct2021, outcome "unknown", described as "Hearing is muffled/ kinda fuzzy"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset Oct2021, outcome "unknown", described as "hot and cold"; DIZZINESS (non-serious) with onset 27Oct2021, outcome "unknown", described as "Felt like she was gonna faint/Lil dizzy"; VISUAL IMPAIRMENT (non-serious) with onset 27Oct2021, outcome "unknown", described as "My vision started getting dark"; HYPERHIDROSIS (non-serious) with onset 27Oct2021, outcome "unknown", described as "Sweating"; HEADACHE (non-serious) with onset Oct2021, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset Oct2021, outcome "unknown", described as "tired".  Additional information: Caller said she was standing up for a while then all of a sudden, she started getting hot and started sweating for 15 minutes when the room is not even hot. Then all of a sudden, caller felt a lil dizzy and her vision in which her eyes were opened but felt like closing and started getting dark, almost all the way black. Caller added that her hearing is muffled when other people are talking it sounded kinda fuzzy. It sounded weird when other people were talking and I felt like I was going to faint but I have never fainted before and felt like I was going to faint.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoacusis, Visual impairment
Clinical narrative: Felt like she was gonna faint/Lil dizzy; My vision started getting dark; Sweating; Getting hot; Hearing is muffled/ kinda fuzzy; hot and cold; Headache; tired; 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 23 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 26Oct2021 (Lot number: FF2593) at the age of 23 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: 1, Lot: FE3592, ), administration date: 05Oct2021, when the patient was 23 years old, for COVID-19 Immunization. The following information was reported: FEELING HOT (non-serious) with onset 27Oct2021, outcome "unknown", described as "Getting hot"; HYPOACUSIS (non-serious) with onset 27Oct2021, outcome "unknown", described as "Hearing is muffled/ kinda fuzzy"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset Oct2021, outcome "unknown", described as "hot and cold"; DIZZINESS (non-serious) with onset 27Oct2021, outcome "unknown", described as "Felt like she was gonna faint/Lil dizzy"; VISUAL IMPAIRMENT (non-serious) with onset 27Oct2021, outcome "unknown", described as "My vision started getting dark"; HYPERHIDROSIS (non-serious) with onset 27Oct2021, outcome "unknown", described as "Sweating"; HEADACHE (non-serious) with onset Oct2021, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset Oct2021, outcome "unknown", described as "tired".  Additional information: Caller said she was standing up for a while then all of a sudden, she started getting hot and started sweating for 15 minutes when the room is not even hot. Then all of a sudden, caller felt a lil dizzy and her vision in which her eyes were opened but felt like closing and started getting dark, almost all the way black. Caller added that her hearing is muffled when other people are talking it sounded kinda fuzzy. It sounded weird when other people were talking and I felt like I was going to faint but I have never fainted before and felt like I was going to faint.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Depression, Feeling abnormal, Pain
Clinical narrative: little sore; Depression; weaker; weird physical problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "little sore"; DEPRESSION (non-serious) with onset 2021, outcome "unknown", described as "Depression"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "weaker"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "weird physical problems". Therapeutic measures were taken as a result of depression.  Additional information: Caller apologizes as she states she did not explain this correctly to the transferring agent. The caller wants it known the depression is nothing from the vaccine, they don't feel this has anything to do with the vaccine though it is confirmed this occurred after getting both shot. This started within the last few weeks. There are other things going on with him and they are not worried that this has anything to do with the vaccine. It was noted, with the depression issues he was having and the medication he was on, he was waiting to get the booster. She wants to get the booster shot but wants to make sure she cant give him anything that she may experience after getting the shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: Inject site tiredness; Headache; Muscle ache; Arm pain; Nausea; Vaginal pain; Vaginal cyst; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 13:00 (Lot number: Fc3183) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Doxycycline, reaction(s): "known allergies: Doxycycline"; Sulfa, reaction(s): "known allergies: Sulfa", notes: Verbatim: Sulfa; Oxycontin, reaction(s): "known allergies: OxyContin". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fd8448, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 11Sep2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE DISCOMFORT (non-serious) with onset 05Oct2021 12:00, outcome "unknown", described as "Inject site tiredness"; HEADACHE (non-serious) with onset 05Oct2021 12:00, outcome "unknown", described as "Headache"; MYALGIA (non-serious) with onset 05Oct2021 12:00, outcome "unknown", described as "Muscle ache"; PAIN IN EXTREMITY (non-serious) with onset 05Oct2021 12:00, outcome "unknown", described as "Arm pain"; NAUSEA (non-serious) with onset 05Oct2021 12:00, outcome "unknown", described as "Nausea"; VULVOVAGINAL PAIN (non-serious) with onset 05Oct2021 12:00, outcome "unknown", described as "Vaginal pain"; VAGINAL CYST (non-serious) with onset 05Oct2021 12:00, outcome "unknown", described as "Vaginal cyst"; FATIGUE (non-serious) with onset 05Oct2021 12:00, outcome "unknown", described as "Tiredness". The events "inject site tiredness", "headache", "muscle ache", "arm pain", "nausea", "vaginal pain", "vaginal cyst" and "tiredness" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of vaccination site discomfort, headache, myalgia, pain in extremity, nausea, vulvovaginal pain, vaginal cyst, fatigue. Additional Information: There was no other vaccine in four weeks. There was no covid prior vaccination, neither tested for covid post vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the event was treatment.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaginal cyst, Vulvovaginal pain
Clinical narrative: Inject site tiredness; Headache; Muscle ache; Arm pain; Nausea; Vaginal pain; Vaginal cyst; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 13:00 (Lot number: Fc3183) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Doxycycline, reaction(s): "known allergies: Doxycycline"; Sulfa, reaction(s): "known allergies: Sulfa", notes: Verbatim: Sulfa; Oxycontin, reaction(s): "known allergies: OxyContin". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fd8448, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 11Sep2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE DISCOMFORT (non-serious) with onset 05Oct2021 12:00, outcome "unknown", described as "Inject site tiredness"; HEADACHE (non-serious) with onset 05Oct2021 12:00, outcome "unknown", described as "Headache"; MYALGIA (non-serious) with onset 05Oct2021 12:00, outcome "unknown", described as "Muscle ache"; PAIN IN EXTREMITY (non-serious) with onset 05Oct2021 12:00, outcome "unknown", described as "Arm pain"; NAUSEA (non-serious) with onset 05Oct2021 12:00, outcome "unknown", described as "Nausea"; VULVOVAGINAL PAIN (non-serious) with onset 05Oct2021 12:00, outcome "unknown", described as "Vaginal pain"; VAGINAL CYST (non-serious) with onset 05Oct2021 12:00, outcome "unknown", described as "Vaginal cyst"; FATIGUE (non-serious) with onset 05Oct2021 12:00, outcome "unknown", described as "Tiredness". The events "inject site tiredness", "headache", "muscle ache", "arm pain", "nausea", "vaginal pain", "vaginal cyst" and "tiredness" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of vaccination site discomfort, headache, myalgia, pain in extremity, nausea, vulvovaginal pain, vaginal cyst, fatigue. Additional Information: There was no other vaccine in four weeks. There was no covid prior vaccination, neither tested for covid post vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the event was treatment.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Myalgia
Clinical narrative: Muscle ache in his both arms where both dose vaccines injected; unable to sleep on his right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "Muscle ache in his both arms where both dose vaccines injected"; INSOMNIA (non-serious), outcome "unknown", described as "unable to sleep on his right arm".  Additional information: The patient had consistent muscle aches in his right arm where the vaccine was injected.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.