chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tinnitus, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Severe muscle pain at site at 48hrs, soreness about 4" below injection site, eased by day 7; Severe muscle pain at site at 48hrs, soreness about 4" below injection site, eased by day 7; Couldn't lift arm from shoulder, but could from elbow; Fever - low grade (99-100°F) - 7days; Chills; Body Aches - even when fever gone; Severe fatigue even after full nites sleep; Tinnitus - this continued full 3wks; Had to force myself to eat, Bfast & Dinner at least, every day; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 63-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6203, Expiration date: not reported) via an unspecified route of administration, administered in left arm on 04Mar2021 at 09:00 (at the age of 63-years-old) as dose 1, single for covid-19 immunization. Medical history included Chronic migraines. Concomitant medication(s) included paraffin (MINERAL), start and stop date were not reported. Patient received other medications in two weeks was Mineral and Vitamins supplements. The patient previously took tylenol and experienced drug allergies. On 04Mar2021 at 14:00, patient experienced severe muscle pain at site at 48hrs, soreness about 4" below injection site, eased by day 7, couldn't lift arm from shoulder, but could from elbow, fever - low grade (99-100°f) - 7days, chills, body aches - even when fever gone, severe fatigue even after full nites sleep, tinnitus - this continued full 3wks, Had to force myself to eat, Bfast & Dinner at least, every day. Patient did not received any treatment. On 04Mar2021, patient underwent lab tests and procedures which included body temperature: low grade (99-100°f) fahrenheit. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks. Since the vaccination, the patient had not been tested for COVID-19. The outcome of all events was recovered with sequelae.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Heavy menstrual bleeding, Vaginal haemorrhage
Clinical narrative: Spotting around Ovulation was reported as worsened; Caller states it seems more pronounced and heavier this second month; experiencing spotting around the ovation time; This is a spontaneous report from a contactable consumer. This female consumer (reported for herself):  A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0183), via unspecified route of administration, in left arm on 20May2021 (at the age of 28-year-old) as a dose 2, single for COVID-19 immunization. The patient medical history included anxiety. The concomitant medication of the patient included escitalopram oxalate (LEXAPRO) for anxiety. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number:EW0158), via unspecified route of administration on 29Apr2021, as a dose 1, single for COVID-19 immunization. On 04Jun2021 the patient experienced spotting around the ovation time. On an unspecified date of Jul2021 patient reported that it was worsened and also reported that it seems more pronounced and heavier this second month. The patient reported that she had a change in her menstrual cycle. Patient had both doses of the vaccine and for the past 2 months, she has had a similar thing that had never happened before. Patient stated that she had spotting around ovulation and it seems odd and she was not sure how much data was being reported about it.The patient was more pronounced and heavier in second month. Patient also stated that the second time she was noticing it and this time it was more obvious. Patient stated that last month she didn't write down exactly how long, but it was a short one day thing in June and then she got her period 2 weeks later so that would check out and on Monday it was day 17 of her cycle and she had spotting. The patient queried if there was a way to access any mass collection of information on her side effect. The patient not received any treatment for spotting around the ovation time. The outcome for spotting around the ovation time and it seems more pronounced and heavier this second month was not recovered. The outcome for spotting around ovulation was reported as worsened was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Balance disorder, Body temperature, Decreased appetite, Fatigue
Clinical narrative: I was very ill; balance issues; very unsteady; extreme fatigue,; loss of appeitie; fever of 99-100.3; This is a spontaneous report from a contactable consumer (patient herself). A 64-years-old non pregnant non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8729), via an unspecified route of administration, administered in left arm on 14Apr2021 at 14:00 (at the age of 64-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included type 2 diabetes and covid-19. Patient had no known allergies. Concomitant medications included levothyroxine taken for thyroid hormones, colecalciferol (VITAMIN D [COLECALCIFER-OL]) taken for bone density abnormal and multivitamin. Patient did not receive any other vaccine in four weeks. Patient did not tested for covid post vaccination. On 19Apr2021 at 07:00, less than 1 week post vaccine, the patient reported she was very ill, balance issues, very unsteady, extreme fatigue, loss of appetite and fever of 99-100.3. This lasted about 3 weeks. The patient underwent lab tests and procedures which included body temperature which was 99-100.3 on 19Apr2021, antibody test: result not reported and many lab test: result not reported on an unspecified date. The patient received treatment for events which included many labs including antibody testing. The outcome of all the events was recovered on an unspecified date on 2021.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Laboratory test, Malaise, Pyrexia
Clinical narrative: I was very ill; balance issues; very unsteady; extreme fatigue,; loss of appeitie; fever of 99-100.3; This is a spontaneous report from a contactable consumer (patient herself). A 64-years-old non pregnant non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8729), via an unspecified route of administration, administered in left arm on 14Apr2021 at 14:00 (at the age of 64-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included type 2 diabetes and covid-19. Patient had no known allergies. Concomitant medications included levothyroxine taken for thyroid hormones, colecalciferol (VITAMIN D [COLECALCIFER-OL]) taken for bone density abnormal and multivitamin. Patient did not receive any other vaccine in four weeks. Patient did not tested for covid post vaccination. On 19Apr2021 at 07:00, less than 1 week post vaccine, the patient reported she was very ill, balance issues, very unsteady, extreme fatigue, loss of appetite and fever of 99-100.3. This lasted about 3 weeks. The patient underwent lab tests and procedures which included body temperature which was 99-100.3 on 19Apr2021, antibody test: result not reported and many lab test: result not reported on an unspecified date. The patient received treatment for events which included many labs including antibody testing. The outcome of all the events was recovered on an unspecified date on 2021.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Gout, Joint swelling
Clinical narrative: This is a spontaneous report from a contactable HCP (physician). A 64-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EL9267), via an unspecified route of administration, on Feb 10, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Historical vaccine included the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EL3246), via an unspecified route of administration, on Jan 21, 2021, single dose, for COVID-19 immunization. On an unspecified date in Feb 2021 (after the second dose), patient had generalized joint pain for 12 hours. On an unspecified date in Jun 2021, patient experienced gout-type symptoms/gout-type of reaction in both big toe joints. Big toe joints are red and swollen. The patient developed gout-type symptoms that started a month ago, and affect both great toe joints per HCP. Because his big toe joints were red and swollen, he was treated with  colchicine, diclofenac, ibuprofen, steroid injections and local anesthetic injection (therapeutic measures). The patient was wondering if gout, idiopathic joint pain and swelling of the joints had been reported after the administration of the Pfizer COVID-19 vaccine. The patient was not an alcoholic. He does not consume large amounts of alcohol. He eats no red meat but has had this horrible reaction in the joints since the vaccination. The outcome of the generalized joint pain recovered on an unspecified date in Feb 2021; while the outcome of all the other events: unknown. Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pruritus, Rash erythematous
Clinical narrative: lower torso started itching; broke out with red bumps that are filled with fluid kind of like a blister; broke out with red bumps that are filled with fluid kind of like a blister; This is a spontaneous report from a contactable consumer (patient, self-reported).  A 67-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0181 and expiry date: 30Jun2021), via an unspecified route of administration, in Arm Left, on 30Jun2021 at 02:00 PM (at the age of 67-year-old), as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included HBP (Blood pressure high), depression, osteoarthritis and penicillin allergy. Concomitant medications included benazepril, meloxicam and citalopram. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 04Jul2021 at 8:00 AM, the 4th day after the inj the patient lower torso started itching and broke out with red bumps that are filled with fluid kind of like a blister and she itch constantly, it is very uncomfortable. This is the sixth day and they have went away. The AE did not result in emergency room or physician office visit. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unspecified date.  Information about lot/batch number has been requested.  Follow-Up (27Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Eczema, Swelling face
Clinical narrative: extreme dryness; eczema like rash; extreme facial swelling for prolonged 6 days; This is a spontaneous report from a contactable consumer (patients mother) reported for a female patient (reporters daughter). A 16-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0180, Expiration date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on 24Jun2021 (age at vaccination was 16 years) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were unknown. On an unspecified date the patient experienced extreme dryness, extreme facial swelling for prolonged 6 days and eczema like rash. Patients reaction was so long it lasted 6 days. Facial swelling broke out eczema like rash. Patient was kept on Benadryl for 24 hours for 6 days. On the 6th day the swelling went off. Swelling was gone and rash is causing extreme dryness. Therapeutic measures were taken as a result of extreme facial swelling for prolonged 6 days and eczema like rash.She has been to two Doctors for extreme facial swelling. The outcome of the events extreme dryness and eczema like rash was unknown and the event extreme facial swelling for prolonged 6 days was recovered on an unspecified date.  Follow up attempts are Possible. Further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Full blood count, Rheumatoid factor
Clinical narrative: experienced joint pain (worse in her hands and fingers than anywhere else, she will have it in her knees, but hands and fingers are the worst ones); This is a spontaneous report from a contactable consumer or other non hcp. This report received from a Pfizer sponsored program.   A 30-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0150) via an unspecified route of administration, administered in left arm, on 08Apr2021 (at the age of 30-year-old) as dose 1, single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Historical vaccine included flu vaccine, via an unspecified route of administration, on unspecified date in Oct2021, for immunization. The patient not received additional vaccines administered on same date of the Pfizer suspect. The patient not received prior vaccination within four weeks. The patient stated, she received the first dose of the Pfizer COVID-19 vaccine on 08Apr2021 and afterwards she experienced joint pain and she will not be getting the second dose. The patient stated, her doctor told her to call to see if the joint pain will go away and if this is a normal side effect from the vaccine. The patient asked, if there are other people that have reported joint pain as a side effect that has lasted for months or if there is any data regarding this. The patient clarified, she decided she is not getting the second dose, the doctor said to call to see if joint pain goes away ever and if this is normal, the doctor did not know what to do, the doctor wanted bloodwork, which she had done, and the bloodwork was normal, the doctor was unsure what to do. The patient stated, joint pain was a day or two after the vaccine, she got it on 08Apr2021. The outcome varies, it was bad for a while, then she thought it was better, but it comes back again. It seems to be worse in her hands and fingers than anywhere else, she will have it in her knees, but hands and fingers are the worst ones. The outcome of the event joint pain (worse in her hands and fingers than anywhere else, she will have it in her knees, but hands and fingers are the worst ones) was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Neck pain
Clinical narrative: very sore shoulder and neck; very sore shoulder and neck; headache; This is a spontaneous report from a contactable consumer (patient) reported herself. A 70-years-old female patient received BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route, administered in right arm on 17May2021 at 11:00 (at the age of 70-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history included hypertension, bad kidney, bad lungs, bad heart, bad liver from an unknown date and unknown if ongoing. She had no family history. Concomitant medication included 17 pills a day (further not clarified). No other vaccines within 4 weeks prior to COVID-19 vaccine. On an unspecified date, the patient experienced very sore shoulder and neck, headache. The outcome of events was unknown.   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: Ageusia, Condition aggravated
Clinical narrative: can't taste anything was reported as worsened; can't taste anything was reported as worsened; This is a spontaneous report from a contactable consumer or other non hcp (patient herself).  A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0186), dose 2 via an unspecified route, administered in left arm on 06Jul2021 at 14:15 (at the age of 37-years-old)  as dose 2, single for covid-19 immunisation. Medical history included menstruation irregular from an unknown date and unknown if ongoing. There were no concomitant medications. Previously the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via intramuscular route on 15Jun2021 (at the age of 37-years-old) (Batch/Lot number: EW0172) as dose 1, single for covid-19 immunisation. On 07Jul2021, the patient reported she she can't taste anything was reported as worsened. She took her second shot yesterday and today she can't taste anything. The patient got the shot yesterday at about 2:15 pm. Now the caller and her boyfriend were having breakfast and she can't taste the syrup on her pancakes or eggs but may be able to taste some salt in the ham. The event can't taste anything was reported as worsened. The outcome of both the events was not recovered at the time of this report.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Condition aggravated, Gait disturbance, Insomnia, Pain in extremity
Clinical narrative: feel like influenza; joint pain; fatigue; This is a spontaneous report from a contactable consumer or other non-healthcare professional.   A 45-years-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0158), via an unspecified route of administration, administered in Arm Left on 02Jul2021 at 11:06 (age at the time of vaccination was 45 years) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced feel like influenza, joint pain and fatigue. The outcome of all the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Vitamin D
Clinical narrative: feel like influenza; joint pain; fatigue; This is a spontaneous report from a contactable consumer or other non-healthcare professional.   A 45-years-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0158), via an unspecified route of administration, administered in Arm Left on 02Jul2021 at 11:06 (age at the time of vaccination was 45 years) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced feel like influenza, joint pain and fatigue. The outcome of all the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Influenza
Clinical narrative: feel like influenza; joint pain; fatigue; This is a spontaneous report from a contactable consumer or other non-healthcare professional.   A 45-years-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0158), via an unspecified route of administration, administered in Arm Left on 02Jul2021 at 11:06 (age at the time of vaccination was 45 years) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced feel like influenza, joint pain and fatigue. The outcome of all the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low grade fever; This is a spontaneous report from a contactable consumer or other non-health care professional (patient herself). A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0196, Expiry Date: Unknown) via an unspecified route of administration in left arm on 29Jun2021 (at the age of 50-year-old) as dose 1, single for COVID-19 immunization. Patient medical history included osteomyelitis bacterial (E coli infection in titanium rods in lumbar spine, prior to vaccine, diagnosed in OCT 2010) from Oct2010 and ongoing. The concomitant medications were not reported. The patient experienced low grade fever on 07Jul2021 (reported as this morning). The report is not related to a study or programme. No investigation assessment done. she wanted to know if it is possible for the fever to come a week after the vaccination. Patient is asking is this be a side effect of the Pfizer vaccine. States the low-grade fever has started today, states it has been up and down today but is persisting. The clinical outcome of the event low grade fever was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Off label use, Product use issue
Clinical narrative: Caller reported that she asked the provider if the patients had received the Moderna or Pfizer Covid- 19 vaccines and the provider informed her that it was a mix of the two; Caller reported that she asked the provider if the patients had received the Moderna or Pfizer Covid- 19 vaccines and the provider informed her that it was a mix of the two; shingles; This is a spontaneous report from a contactable consumer or or other non-healthcare professional. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown, Expiration date: Not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization and co-suspect Moderna (COVID-19 VACCINE MRNA (MRNA 1273)), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced caller reported that she asked the provider if the patients had received the Moderna or Pfizer Covid- 19 vaccines and the provider informed her that it was a mix of the two. She reported that she was diagnosed with shingles and the health care provider asked if she had gotten the Covid-19 vaccine. She reported that the health care provider said that she's had other people, including her mother, the patient, who had gotten the Covid-19 vaccine and wound up with shingles. She reported that she asked the provider if the patients had received the Moderna or Pfizer Covid-19 vaccines and the provider informed her that it was a mix of the two. She reported that the provider stated that her mother or some other relative, and 2 other patients in the last day or so, were diagnosed with shingles after receiving the Covid-19 vaccine. She reported that the provider didn't specify if the patients had received one or the other vaccine. She declined to complete safety report as she was unable to provide further details for the patient or the other 2 patients that were diagnosed with shingles after receiving the Covid-19 vaccine. She stated that she just knew that she was obligated to report the adverse event as the Pfizer Covid-19 vaccine had been mentioned. Report filed with minimal information provided by her. No investigation assessment was not provided. The clinical outcome of the Caller reported that she asked the provider if the patients had received the Moderna or Pfizer Covid- 19 vaccines and the provider informed her that it was a mix of the two were unknown.  Information about batch/Lot number had been requested.  Follow-up (18Aug2021): 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.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Night sweats
Clinical narrative: night sweats; sore joints; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A adult male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8732, Expiry date: not reported), via intramuscular route of administration in left arm on 02Apr2021 as dose 2, single for covid-19 immunization. Medical history included infectious mononucleosis (Re-occurrence of symptoms experienced when subject had mononucleosis 30 years ago). Patient had no known allergy or other medical history. Concomitant medication(s) included vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and post the vaccination, the patient was not tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6207, Expiry date: not reported), via intramuscular route of administration in left arm on 12Mar2021 as dose 1, single for covid-19 immunization. On 05Apr2021, the patient experienced night sweats, sore joints and fatigue. The events did not result in physician office visit/ emergency room visit. No therapeutic measures were taken in response to the events. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Severe joint pain in bilateral hands, fingers, wrists; This is a spontaneous report from a contactable nurse, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an intramuscular route of administration in the left arm on 07Apr2021 at 11:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin (PCN) and sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medication.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an intramuscular route of administration in the left arm on 17Mar2021 at 15:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation and also received clarithromycin (BIAXIN) and paroxetine hydrochloride (PAXIL); both for unknown indication on unknown date and experienced drug allergy. On 14Apr2021, the patient experienced severe joint pain in bilateral hands, fingers, and wrists. The symptoms started approximately 7 days post vaccination and continued to date. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe joint pain in bilateral hands, fingers, wrists was not resolved at the time of this report.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Menstruation irregular, SARS-CoV-2 test, Swelling face
Clinical narrative: Facial swelling; extreme exhaustion; headache; skipped period; This is a spontaneous report from a contactable consumer (patient). A 37-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0191), via an unspecified route on 16Jun2021 at 17:30 (at the age of 37-years) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications included venlafaxine, vitamin D from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0182), via an unspecified route on 26May2021 at 17:30 (at the age of 37-years) as dose 1, single in the left arm for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced facial swelling, extreme exhaustion, headache and skipped period on 16Jun2021 at 23:00. Patient did not receive treatment for events. The patient underwent lab tests and procedures which included nasal swab was positive on 28May2021. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, SARS-CoV-2 test, Sensation of foreign body
Clinical narrative: Ball in my throat; Migraine; This is a spontaneous report from a contactable consumer (patient) reported in response to Non- Health Care Professional Letter. This consumer reported that a 35-year-old female patient received second dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8736), via intramuscular route of administration, administered in left arm on 05May2021 at 10:40 (at the age of 35-year-old) as dose 2, single dose for COVID-19 immunisation. The patient's medical history included sensitivity to food allergies that has been out grown from childhood. There were no concomitant medications. The patient's family medical history included food allergy. Prior vaccinations (within four week) were reported as none. Vaccine facility type was reported as pharmacy or Drug Store and vaccine administered was not at military facility. The patient previously received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0151), via intramuscular route of administration, administered in left arm on 07Apr2021 at 15:35PM as dose 1, single for COVID-19 immunisation. After first dose of bnt162b2 vaccine, the patient experienced allergic reaction, stomach cramps, stomach was really sore, injection site was really sore and injection site was really itchy, lips were swollen, couldn't close mouth, itchy, hives on buttocks, hips, chest area and nauseated. On 07May2021, the patient when eating seafoods had severe pain and experienced migraine . On 11Jun2021, the patient ate a small peanut of scrambled eggs and then throat started to feel funny (ball in my throat). On 21May2021, the patient underwent lab tests and procedures which included SARS-CoV-2 test: negative. The clinical outcome of events migraine and ball in my throat was reported as not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Pain, Pain in extremity, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 60-year-old female reported she received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine,  solution for injection, batch/lot# not reported), at the age of 60, via an unspecified route of administration, on Monday, Jul 5, 2021, single dose, for COVID-19 immunisation. Medical history included arthritis. The patient's concomitant medications not reported. Historical vaccine included the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation and didn't have any symptoms. On an unspecified date, patient experienced a swollen/bloated feeling, had a sore arm, felt achy and had discomfort. Reportedly, her diet has been the same. She has been exercising the same and nothing is different in her lifestyle. She wants to know how long the side effects last and if this has been reported. The outcome of the events: unknown. Information about batch/lot number requested.
Age: 64.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Muscular weakness, Pain, Paraesthesia, Temperature intolerance
Clinical narrative: weakness on the arms; mild pain; Increase sensitivity to heat and cold on hands; Tingling sensation on hands; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0168) via an unspecified route of administration in the left arm on an unknown date in May2021 (at the age of 64-year-old) as dose 2, single for COVID-19 immunization. Other suspect medications included rosuvastatin calcium (CRESTOR) for unknown indication from an unknown date. The patient medical history included atherosclerosis from an unknown date and unknown if ongoing. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EV0721) via an unspecified route of administration, administered in left arm on an unknown date in Apr2021 (at the age of 64-year-old) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date in Jun2021, the patient experienced tingling sensation on hands, weakness on the arms, mild pain and increase sensitivity to heat and cold on the hands when holding a cup. The patient attributed these to CRESTOR but with CRESTOR the patient never had a tingling sensation, usually more pronounce when the patient woke up in the morning. The patient had no idea if this has anything to do with the vaccine, but thought it will be a good idea to let us know. The patient had been getting better but stopped CRESTOR. The patient will resume taking it. The patient had not visited emergency room or physician office or other healthcare professional office/clinic due to the event. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome tingling sensation on hands, weakness on the arms, mild pain and increase sensitivity to heat and cold on the hands when holding a cup was recovering. Follow-up attempts completed. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Erythema, Skin exfoliation, Sunburn
Clinical narrative: Received a sunburn on the left side of my chest. It was bright red. Very unusual for my skin. Its 2 weeks later and the redness hasnt went away and it is dry and peeling.; Received a sunburn on the left side of my chest. It was bright red. Very unusual for my skin. Its 2 weeks later and the redness hasnt went away and it is dry and peeling.; Received a sunburn on the left side of my chest. It was bright red. Very unusual for my skin. Its 2 weeks later and the redness hasnt went away and it is dry and peeling. Received a sunburn on the left side of my chest. It was bright red. Very unusual for my skin. Its 2 weeks later and the redness hasnt went away and it is dry and peeling.; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non-pregnant female patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302) dose 2 via an unspecified route of administration, administered in Arm Right on 04Feb2021 07:00 as DOSE 2, SINGLE for covid-19 immunisation (at the age of 48 years). The patient medical history was not reported. Concomitant medications included omeprazole (PRILOSEC [OMEPRAZOLE]); macrogol 3350 (MIRALAX) taken for an unspecified indication, start and stop date were not reported received these other medications in two weeks. Historical vaccine included bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302) dose 1 via an unspecified route of administration, administered in Arm Right on 14Jan2021 07:30AM as DOSE 1, SINGLE for covid-19 immunization. The patient was not pregnant at time of vaccination. The patient did not received other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. The patient experienced on 04Jul2021 she was on vacation. Patient was swimming in a pool and received a sunburn on the left side of her chest. It was bright red. Very unusual for her skin. Its 2 weeks later and the redness hasn't went away and it is dry and peeling. Her sister experienced the same thing. We are from 2 different states and can only see that that we both received the Pfizer shot and have that in common. Normally a sunburn turns into a tan after a few days. It's been 2 weeks and 3 weeks for her sister and not much color change. The patient did not received any treatment for the events. The clinical outcome of all the events were recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, SARS-CoV-2 test
Clinical narrative: I am having joint pain through-out my body.Especially, elbows, neck and lower back.Extreme tiredness; I am having joint pain through-out my body.Especially, elbows, neck and lower back.Extreme tiredness; This is a spontaneous report from a contactable consumer (patient herself). A 61-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8739; Expiration Date: unknown) via an unspecified route of administration, administered in Arm Left on 01Apr2021 12:00 (at the age of 61-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included drug hypersensitivity (allergy to sulfer based drugs) from an unknown date and unknown if ongoing. Concomitant medications included thyroid medication (not specified any medicine/drug). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On an unspecified date in May2021 patient reported that she was having joint pain through-out her body especially, elbows, neck and lower back and had extreme tiredness. AEs resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient had received treatment for AEs. The patient underwent lab tests and procedures which included SARS-COV-2 test (Nasal Swab; Rapid test) post the vaccination on an unspecified date in Apr2021 which was negative. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Cough, Echocardiogram, Electrocardiogram, Palpitations
Clinical narrative: heart palpitations/heart pounding; cough; wheezing; This is a spontaneous report from a contactable consumer or other non hcp. An elderly non pregnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0158), via an unspecified route of administration, administered in Arm Left on 07Apr2021 17:00 as DOSE 1, SINGLE for covid-19 immunisation at Public Health Clinic facility. No covid prior vaccination. Medical history included arthritis, osteoporosis, blood cholesterol increased, Allergies from lipitor, robaxin, fosamax, IV contrast and surgical glue. Concomitant medications included PRAVASTATIN, CLARITIN, CENTRUM SILVER, D3, CALCIUM. The patient did not received any other vaccine in four week. The patient experienced heart palpitations/ heart pounding, cough, wheezingon 15Apr2021. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Covid tested post vaccination by nasal swab test. The patient underwent lab tests and procedures which included chest x-ray: unknown result, echocardiogram: unknown result, electrocardiogram: unknown result on unspecified date, sars-cov-2 test: negative on 22Apr2021. The clinical outcome of the events was not recovered.  Follow-Up (03Sep2021): Follow-up attempts are completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Wheezing
Clinical narrative: heart palpitations/heart pounding; cough; wheezing; This is a spontaneous report from a contactable consumer or other non hcp. An elderly non pregnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0158), via an unspecified route of administration, administered in Arm Left on 07Apr2021 17:00 as DOSE 1, SINGLE for covid-19 immunisation at Public Health Clinic facility. No covid prior vaccination. Medical history included arthritis, osteoporosis, blood cholesterol increased, Allergies from lipitor, robaxin, fosamax, IV contrast and surgical glue. Concomitant medications included PRAVASTATIN, CLARITIN, CENTRUM SILVER, D3, CALCIUM. The patient did not received any other vaccine in four week. The patient experienced heart palpitations/ heart pounding, cough, wheezingon 15Apr2021. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Covid tested post vaccination by nasal swab test. The patient underwent lab tests and procedures which included chest x-ray: unknown result, echocardiogram: unknown result, electrocardiogram: unknown result on unspecified date, sars-cov-2 test: negative on 22Apr2021. The clinical outcome of the events was not recovered.  Follow-Up (03Sep2021): Follow-up attempts are completed. No further information was expected.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 16-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-healthcare professional.  This case is linked to cases 2021SA345659 and 2021SA349459(CLUSTER).  This case involves Adult female patient who experienced flu (influenza) while received INFLUENZA VACCINE.  The patient's past medical treatments, vaccinations, concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "My ex wife got the flu shot twice in her life. Both times she got the flu. My co worker got the flu shot twice. Both times she got the flu. My daughter got the flu shot, and she got the flu. I Haven't had a vaccine in over 50 years, not going to start taking one now. Haven't had the flu in over 20 years until a vaccinated family member gave it to me."  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 16-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer or non-healthcare professional via social media.  This case is linked to cases 2021SA349452(Cluster).  This case involves female patient who experienced flu (influenza) while receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event (flu).  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy with no AE; Initial information received on 12-Oct-2021 regarding an unsolicited valid non-serious case received from a physician..  This case involves adult female patient who was pregnant (Exposure during pregnancy) while receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].   Data regarding this pregnancy were received prospectively, i.e, before pregnancy outcome was known.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient medical history included cardiac disorder, sexually transmitted disease and earning difficulties, congenital malformations, and environmental exposures.  At the time of the event, the patient had ongoing thyroid disorder, asthma, and hypersensitivity.  The patient medical history, medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.  On 11-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT7315MA and expiry date: not reported] via an intramuscular route in unknown administration site for prophylactic vaccination.  On an unknown date, for the patient reported a non-serious event pregnancy (Exposure during pregnancy) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was unknown to consent to be contacted patient and patient physician.  It is unknown if the patient experienced any additional symptoms/events  Action taken with QUADRIVALENT INFLUENZA VACCINE was not applicable.  At time of reporting, the outcome was unknown for the event pregnancy.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.