chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Herpes simplex
Clinical narrative: Previously I had one outbreak a year. In three weeks after dose I had 4-5; In the weeks after my second dose I have had almost continuous outbreak of hsv1.; This is a spontaneous report received from a contactable consumer (Patient). A 58-years-non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Er2613) via unspecified route of administration in arm left on 25Mar2021 10:00 (at the age of 58-years-old) as single dose for COVID-19 immunization. Medical history included asthma and covid-19 all from an unknown date and unknown if ongoing. Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Enen6200) via unspecified route of administration in arm left on 04Mar2021 11:30 (at the age of 58-years-old) as single dose for COVID-19 immunization. Patient has known allergies: sulfa. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, liothyronine (LIOTHYRONINE) taken for an unspecified indication, progesterone (PROGESTERONE) taken for an unspecified indication all within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Within weeks after second dose patient had almost continuous outbreak of hsv1. Previously had one outbreak a year but in 3 weeks (29Mar2021) after dose patient had 4-5. On 22April sought treatment and have been on medication to suppress the virus. It has been successful but required higher dose of valacyclovir to stop outbreaks. Patient realized vaccine didn't give me this but something in vaccine or body activated hsv1 in big way. Patient reported the adverse event to Doctor or other healthcare professional office/clinic visit. Patient received treatment for the adverse event (Medicine). Outcome of the event is recovering.   Device Date: 29May2021.  Follow-Up (29Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Herpes zoster, Pain, Rash
Clinical narrative: Rash; Light headache; Achiness; shingles; This is a spontaneous report from a contactable consumer or other non-HCP. A 34-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0186), intramuscular, administered in Left Arm on 21May2021 02:45 as DOSE 2, SINGLE, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0173) intramuscular, administered in Left Arm on 30Apr2021 02:45 as DOSE 1, SINGLE (at the age of: 34-year-old) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination and post vaccination, patient had tested with covid 19. The patient previously took percocet [oxycodone hydrochloride;oxycodone terephthalate;paracetamol] and experienced allergy. On an unspecified date the patient experienced rash, light headache, achiness. On 24May2021 17:00 the patient experienced shingles. Therapeutic measures were taken as a result of shingles as Antibiotic. The outcome of event shingles was recovering while outcome of rest all events was unknown.  Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Left arm injection suite i have extreme pain which started yesterday. it only last 15 seconds or so; This is a spontaneous report received from a contactable consumer via COVAES. A 75-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in Arm Left on 12Mar2021 (at the age 75-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medication was not reported. The patient experienced left arm injection suite I have extreme pain which started yesterday. It only last 15 seconds or so on 28May2021. Outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.  Follow-Up (29Jun2021): Follow-up attempts are completed. No further information is expected.  Follow-Up 05Jul2021: Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Chills, Diarrhoea
Clinical narrative: aches; fever; chills; extreme stomach pain; back pain; joint pain/Sore finger joints and achy feeling in lower back gets worse at night but is still with me.; very loose stools; This is a spontaneous report from a contactable consumer. This 68-year-old-female consumer (patient) reported for herself that she received bnt162b2 (BNT162B2 solution for injection), via an unspecified route of administration, administered in Arm Left on 23Mar2021 12:30 (Batch/Lot Number: EN6208) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, was the patient diagnosed with COVID-19 and Since the vaccination, has the patient been tested for COVID-19 was no. The patient experienced aches , fever, chills, extreme stomach pain on an unspecified date, back pain, joint pain/sore finger joints and achy feeling in lower back gets worse at night but is still with me and very loose stools on 02Apr2021.  Reported as I had the expected aches, fever and chills for about a day. I did have extreme stomach pain for about 12 hours also. But around 02Apr started having back pain and joint pain and very loose stools. Sore finger joints and achy feeling in lower back gets worse at night but is still with me.  Don't know if this is related but it seemed suspicious.  Had a visit with my doctor for a yearly and mentioned back pain. No treatment was received for adverse event.  The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: aches; fever; chills; extreme stomach pain; back pain; joint pain/Sore finger joints and achy feeling in lower back gets worse at night but is still with me.; very loose stools; This is a spontaneous report from a contactable consumer. This 68-year-old-female consumer (patient) reported for herself that she received bnt162b2 (BNT162B2 solution for injection), via an unspecified route of administration, administered in Arm Left on 23Mar2021 12:30 (Batch/Lot Number: EN6208) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, was the patient diagnosed with COVID-19 and Since the vaccination, has the patient been tested for COVID-19 was no. The patient experienced aches , fever, chills, extreme stomach pain on an unspecified date, back pain, joint pain/sore finger joints and achy feeling in lower back gets worse at night but is still with me and very loose stools on 02Apr2021.  Reported as I had the expected aches, fever and chills for about a day. I did have extreme stomach pain for about 12 hours also. But around 02Apr started having back pain and joint pain and very loose stools. Sore finger joints and achy feeling in lower back gets worse at night but is still with me.  Don't know if this is related but it seemed suspicious.  Had a visit with my doctor for a yearly and mentioned back pain. No treatment was received for adverse event.  The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue
Clinical narrative: Fatigue; Chills; Diarrhea; This is a spontaneous report from a non-contactable consumer (Patient) via Pfizer sales representative. A male patient of an unspecified age received second dose of BNT162B2 (COMIRNATY; Solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history included COVID-19 from 2020 to an unknown date. The patient's concomitant medications were not reported. They had covid about a year before they had the vaccine. On an unspecified date, patient experienced fatigue, chills and diarrhea. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Electric shock
Clinical narrative: Experienced an electric shock; She thinks she has an allergy to the vaccine since she had three marks on her back like on the skin; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6208, Expiration date: Unknown) via an unspecified route of administration on 19Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that she received the second dose on 07Apr2021; the lot number is EW0153, unknown NDC number and expiry. In 2021 the patient experienced an electric shock, and she thinks she has an allergy to the vaccine since she had three marks on her back like on the skin. Caller stated she got the vaccine the first and second dose and on the first dose, she had experienced an electric shock, but she thinks she has an allergy to the vaccine since she had three marks on her back like on the skin. Caller stated Pfizer should send her straight to the doctor since the marks happened after the second vaccine. There was no product complaint to this report. A medical information request was there. The clinical outcome of the events was unknown.  follow-up attempts are possible, additional information has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Mammogram
Clinical narrative: Pt describes a severe centrally location headache, lasting more than; This is a spontaneous report from a contactable other healthcare professional. A 70-years-old non-pregnant female patient received bnt162b2 (Pfizer COVID 19, Solution for injection, Lot Number: EL3246), via an unspecified route of administration on 17Mar2021 (at the age of 70-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of bnt162b2 (COVID VACCINE) on 24Feb2021 (at the age of 69-years-old) for Covid-19 Immunization and had no adverse reaction. Patient describes a severe centrally location headache, lasting more than a month. The patient admits to having mammogram 5 days after vaccine date 17Mar2021, believes it to be related. The patient underwent lab tests and procedures which included mammogram was believes it to be related on 22Mar2021. The event resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if patient received any treatment for adverse event. The outcome of event was resolved on 2021.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I was sick on the week; This is a spontaneous report from a Pfizer-sponsored program, contactable consumer (patient). A patient of unspecified age and gender received first dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE),via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization .The patient medical history and concomitant medications were not reported.  On an unspecified date the patient stated that i was sick on the week. Patient reported that "Today I was supposed to have the appointment for my second vaccine but I did get, I was sick on the week". The outcome of event was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: she had mild symptoms, chills for about a half an hour and that was it; This is a spontaneous report received from a contactable female consumer. This consumer reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE,SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The Historical Vaccine (1st dose) include Covid-19 immunization. The patient experienced she had mild symptoms, chills for about a half an hour and that was it on an unspecified date. The outcome of the event was resolved on an unspecified date.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Herpes zoster, Inappropriate schedule of product administration, Myalgia
Clinical narrative: inapproriate schedule of vaccine administration; Shingles; Fever; chills; muscle aches; fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 1 (Lot Number: er8731 expiry date was not reported) via an unspecified route of administration at arm Left on 16Apr2021 16:00 as a single dose, dose 2 (Lot Number: ew0182 expiry date was not reported) via an unspecified route of administration arm Left on 16Apr2021 (inappropriate schedule of vaccine administration) as a single dose for covid-19 immunization (age at vaccination:60-year-old). Medical history included appendicitis, hysterectomy, gallbladder disorder from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (LEVOXYL), ginkgo biloba (GINKO [GINKGO BILOBA]), magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfa [sulphanilamide] and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. on 24May2021 12:00 the patient experienced shingles, fever, chills, muscle aches, fatigue. Therapeutic measures were taken valacyclovir as a result of shingles, fever, chills, muscle aches, fatigue. Outcome of the events was not recovered.   Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: inapproriate schedule of vaccine administration; Shingles; Fever; chills; muscle aches; fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 1 (Lot Number: er8731 expiry date was not reported) via an unspecified route of administration at arm Left on 16Apr2021 16:00 as a single dose, dose 2 (Lot Number: ew0182 expiry date was not reported) via an unspecified route of administration arm Left on 16Apr2021 (inappropriate schedule of vaccine administration) as a single dose for covid-19 immunization (age at vaccination:60-year-old). Medical history included appendicitis, hysterectomy, gallbladder disorder from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (LEVOXYL), ginkgo biloba (GINKO [GINKGO BILOBA]), magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfa [sulphanilamide] and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. on 24May2021 12:00 the patient experienced shingles, fever, chills, muscle aches, fatigue. Therapeutic measures were taken valacyclovir as a result of shingles, fever, chills, muscle aches, fatigue. Outcome of the events was not recovered.   Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Herpes zoster, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Shingles outbreak on right side of head above right eye with pain; pain; Headache; Fever; This is a spontaneous report from a contactable consumer or other non-health care professional, the patient himself. A 14-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0182) via an unspecified route of administration on 27May2021 (age at vaccination: 14-years-old) as dose 1, single for covid-19 immunization, at Pharmacy or Drug Store. Medical history included asthma from an unknown date and unknown if ongoing. No known allergies were reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included as the patient received medications within 2 weeks of vaccination reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28May2021, patient experienced shingles outbreak on right side of head above right eye with pain, headache and fever. The events were reported as non-serious. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. The patient received treatment for the adverse events which included Valacyclovir, Prednisone, Ibuprofen and Tylenol. Patient underwent lab tests with nasal swab for Sars-Cov2 results negative on 02Jun2021. The outcome of the events was not recovered at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Bursitis, Pain
Clinical narrative: joint pain; feels like bursitis; became painful and weak; became painful and weak; This is a spontaneous report received from a contactable consumer or other non hcp via a Regulatory Authority. A 59-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: #R8727), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 09:00 (at the age 97-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included fibromyalgia, glucose tolerance impaired, limb injury (Had a previous injury there decades ago) from an unknown date. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, has the patient been did not tested for COVID-19. The patient experienced joint pain, feels like bursitis, became painful and weak, became painful and weak on 10Apr2021. It was reported that "General joint pain and a few days later in left arm (shot arm) at deltoid feels like bursitis) became painful and weak. Had a previous injury there decades ago. After second shot overall joint pain increased and left arm got worse (second shot in right arm) Sacroiliac became very inflamed and painful (site of other old injury) Then right deltoid pain (feels like bursitis) Still battling mild to severe pain over a month after second shot. Some daily vertigo moments but dissipating". Outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bursitis, Inflammation, Pain in extremity, Vertigo
Clinical narrative: overall joint pain increased/Sacroiliac became very inflamed; left arm got worse; Then right deltoid pain (feels like bursitis; Some daily vertigo moments, but dissipating.; Sacroiliac became very inflamed; This is a spontaneous report from a contactable consumer. This 59-year-old male consumer (patient) reported for himself that he received bnt162b2 (BNT162B2 solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included arthralgia and fibromyalgia and diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The historical include vaccine include BNT162B2 (dose number: 1, lot number:  #R8727, administration time: 09:00 AM, vaccine location: Left arm) at 59 years for COVID-19 immunisation and experienced General joint pain, weak, and bursitis on 08Apr2021. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was no, and patient received within 2 weeks of vaccination was No. Prior to vaccination, was the patient diagnosed with COVID-19 and Since the vaccination, has the patient been tested for COVID-19 was no. known allergies was no. The patient experienced overall joint pain increased/sacroiliac became very inflamed, left arm got worse, then right deltoid pain, some daily vertigo moments, but dissipating and sacroiliac became very inflamed on 10Apr2021. General joint pain and a few days later in left arm (shot arm) at deltoid feels like bursitis) became painful and weak. Had a previous injury there decades ago. After second shot overall joint pain increased and left arm got worse (second shot in right arm) Sacroiliac became very inflamed and painful (site of other old injury) Then right deltoid pain (feels like bursitis) Still battling mild to severe pain over a month after second shot. Some daily vertigo moments, but dissipating. The outcome of the events was unknown.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: patients received the vaccine that was stored for longer than 2 weeks in the freezer; patients received the vaccine that was stored for longer than 2 weeks in the freezer; This is a spontaneous report from contactable other health care professional reported similar events for 12 patients. This report is the 3rd of 12 reports. A 14-year-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0177, Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on 02Jun2021 (at the age of 14-year-old) as single dose for COVID-19 immunisation at Doctor's Office/Urgent Care. The patient medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received the vaccine that was stored for longer than 2 weeks in the freezer on an unspecified date. It was reported, HCP explained that patients received the vaccine that was stored for longer than 2 weeks in the freezer. Their vaccine should have been removed from the freezer on 01Jun2021. However, it stayed longer in the freezer. The patient received the vaccine on 02Jun2021 (which was one day over the allowed 2 weeks in the freezer. The outcome for all events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021664910 similar report from same reporter
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Spotting vaginal bleeding; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 13May2021 01:30 (at the age of 50-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient had no took any past drug. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 13May2021 13:30, the patient experienced spotting vaginal bleeding. The outcome of event was not recovered.  Information on the lot/batch, further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Nervousness, Stress
Clinical narrative: Stress; extreme muscle tension at the base of her skull where the shoulder blades; nervous; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 21May2021 (Batch/Lot Number: EW0186) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first shot of Pfizer two weeks and five days ago on 21May2021 and was scheduled to get her second dose for Friday. She had noticed something that she did not know if it's related to the vaccine or not, and she was concerned about it before she goes and gets a second dose. She had some extreme muscle tension at the base of her skull where the shoulder blades- like right where the back meets the neck. The patient experienced extreme tension at the base of the skull and wanted to know if that was a common side effect and if she takes the second dose will it get worse. Patient states that it was localized to one area and she was not sure if it was due to stress because everyone was under more stress because of COVID. She just did not know if she would have taken the vaccine if she had the tension, and she did not know if its just stress. Patient wanted to know if this was a common side effect being reported, wonders if it will get worse after the second dose. Patient states shes nervous now. Caller wanted to know if she should get the second dose. The patient was informed that we cannot provide treatment information, patient was referred to health care provider. Patient states she has limited time available and was concerned if this was a reaction or should she get another dose. Outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cold sweat
Clinical narrative: icy cold sensation in the chest; icy cold sensation in the chest; This is a spontaneous report from a contactable consumer or other non hcp.     A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Expiry Date: unknown, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Expiry Date: unknown, Lot number: unknown), via an unspecified route of administration, administered on unspecified date for COVID-19 immunisation. The patient stated an icy cold sensation in the chest could be a side effect for the administration of the second dose of the Pfizer's COVID-19 vaccine on an unspecified date. The Consumer reports that she was administered with the second dose of the Pfizer's COVID-19 vaccine and that night she woke up in panic with an icy cold sensation in the chest and she had to call the #. The outcome of event was unknown.  Information about batch/Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest pain, Chills, Fatigue, Hypoaesthesia
Clinical narrative: having flashing in his eye; numbness in finger and toes; stomach ache; fever; chest pain; body chills; fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 13-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 13-year-old) as single dose (dose number unknown) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced having flashing in his eye, numbness in finger and toes, stomach ache, fever, chest pain, body chills, fatigue. Reporter is calling to report possible allergic reaction for her son after receiving Pfizer vaccine. Reporter states he had the vaccine on Monday and last night he started having flashing on both eyes, numbness in fingers and toes, stomach ache, fever, chest pain, body chills, and fatigue. Reporter states that she knows some of the symptoms are common but are the chest pain, flashing on both eyes, numbness of finger and stomach ache is unusual. The outcome of all events was unknown.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Photopsia, Pyrexia
Clinical narrative: having flashing in his eye; numbness in finger and toes; stomach ache; fever; chest pain; body chills; fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 13-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 13-year-old) as single dose (dose number unknown) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced having flashing in his eye, numbness in finger and toes, stomach ache, fever, chest pain, body chills, fatigue. Reporter is calling to report possible allergic reaction for her son after receiving Pfizer vaccine. Reporter states he had the vaccine on Monday and last night he started having flashing on both eyes, numbness in fingers and toes, stomach ache, fever, chest pain, body chills, and fatigue. Reporter states that she knows some of the symptoms are common but are the chest pain, flashing on both eyes, numbness of finger and stomach ache is unusual. The outcome of all events was unknown.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness/lightheadedness; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 via an unspecified route of administration on 26May2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient experienced dizziness/light headedness on 06Jun2021 (11 days after). Asking if this is a normal reaction from the vaccine second dose is scheduled on 16Jun2021. Caller asked is it ok if I take the second dose in Jul2021. I'm not sure when the primary care doctor is available. Is there a time limit. Since I am experiencing dizziness/light headedness do you think I should get the second dose. The outcome of event was not recovered.   Information about the Lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Nausea, Oropharyngeal pain
Clinical narrative: I have been having pain my chest; Nausea; Sore throat; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection), unknown single dose (Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date as a single dose, for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient got vaccinated with the Pfizer vaccine on Saturday and had to do a questionnaire that would he/she take any antibody and he/she said he doesn't know because he was not concerned a couple of weeks ago and got some blood work taken and they asked him if he wants to get some antibody infusion and he/she said yeah but wasn't like too sure what it. They told him/her that it would guarantee like if he/she got cold that he wouldn't die. So he/she got that infusion then. The patient reported that he/she experiencing some side effects from Saturday. Had pain in chest, nausea and sore throat. The outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for vaccine/BNT162B2.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Nausea
Clinical narrative: Last night my stomach twisted around I couldn't turn over; Nauseous; Tired; Dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A patient of unspecified age and gender received bnt162b2 (BNT162B2, Formulation: Solution for injection), via an unspecified route of administration in Jun2021 (Batch/Lot number: unknown) as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced last night my stomach twisted around I could not turn over, nauseous, tired and dizziness in Jun2021. It was reported that patient was wondering, does it take, patient got the first shot 6 days ago and was feeling nauseous and tired and enquired is it usually take that long for effects to come. The patient stated feeling nauseous, last night the stomach twisted around and could not turn over. The patient had to hold by the stomach and turn self over thats over. The patient was wondering if thats part of the symptoms of the shot and also had like dizziness this is the 6th day since patient got the shot. The patient enquired if thats part of the shot and does it take a week for symptoms to effect and wanted to know that it take 6 days to get the effects of the shot and also stated that patient do not have the card and got a paper they gave at the store. Consumer hung up abruptly. Hence, limited information available over the call. The outcome of events last night my stomach twisted around I could not turn over, nauseous and tired was unknown. The outcome of event dizziness was not recovered.  Follow-up attempts are needed; information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Product preparation error, Vaccination site swelling
Clinical narrative: She got the undiluted vaccine; She got the undiluted vaccine; Swelling at the arm site; This is a spontaneous report from a contactable consumer behalf of the patient. A 20-year-old female patient received bnt162b2 (manufacturer: Unspecified; NDC number, UPC number and Expiry Date: Unknown), via an unspecified route of administration in the arm on 09Jun2021 at 9:00 AM as unknown dose of 2ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 09Jun2021, who reported behalf of the patient reported that about an hour ago from the vaccine clinic that she got the shot from. And they told her that she got 2 milliliters of the vaccine. They did not dilute it as they were supposed to dilute it, so she got the undiluted vaccine and they wanted to tell her that. And so the patient was asking is there anything special that we need to be looking out for or there's anything they need to be doing differently. Obviously, she told them you can't, now you can't take that vaccine back obviously, but she don't think that there's anything particularly special that we be looking out for, unless obviously if she had like sort of anaphylactic response which she had not, she said that she was having swelling at the arm site in Jun2021 but they don't think that's totally abnormal, but I did not know if you guys had a, I figure that this had happened before, she did not know if she had any other comments that she could pass along to this patient. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever has been steadily rising in spite of Motrin, it's now at 103, and 103.5; This is a spontaneous report from a contactable consumer (patient's parent). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient previously took bnt162b2 (BNT162B2), dose 1 single for covid-19 immunization. The patient experienced fever has been steadily rising in spite of motrin, it's now at 103, and 103.5 (on an unspecified date with outcome of unknown.The patient underwent lab tests and procedures which included body temperature: 103 on unspecified date, body temperature: 103.5 on unspecified date, body temperature: 104 fahrenheit on unspecified date. Reporter stated, that the daughter got her second dose of COVID 19 vaccine yesterday, and her fever yesterday at 4 or 4:10 something like that, and her fever has been steadily rising in spite of Motrin, it's now at 103, and 103.5. And felt really concerned if something that was normal, and queried if the daughter needs to be taken to the hospital, or what else need to done?"Reporter stated her daughter was having almost 104 (degree Fahrenheit) fever with the vaccine on the second dose (Unspecified vaccine) and I wanted to check whether that's, can be very high, The reporter that stated that one can get heat up' but (incomplete sentence).Therapeutic measures were taken as a result of fever has been steadily rising in spite of motrin, it's now at 103, and 103.5 (pyrexia).The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: have some numbness in my left arm but I have some numbness in my right fingers; This is a spontaneous report from a contactable consumer or other non health professional reporting for herself.   A female non-pregnant patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE); Lot/batch no: unspecified) via unspecified route in the left arm, as a dose 1, single on an unspecified date for COVID-19 immunization. Medical history included arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient stated that had some numbness, both shot in her left arm but she had some numbness in her right fingers, also stated that she was elderly and had arthritis pretty badly so that may not be anything to do with shot. The reporter seriousness was unspecified for the event. The clinical outcome for the event was unknown.  Information about batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Injection site extravasation, Underdose, Vaccination site erythema, Vaccination site pain, Vaccination site vesicles
Clinical narrative: oozing blisters at the injection site, as well as redness and pain; oozing blisters at the injection site, as well as redness and pain; oozing blisters at the injection site, as well as redness and pain; she did not get the dose and maybe the dose came out; she did not get the dose and maybe the dose came out; This is a spontaneous report from a contactable pharmacist via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER COVID 19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 07Jun2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller stated she has a patient who had the vaccine on Monday, 07Jun2021. She has oozing blisters at the injection site, as well as redness and pain on an unspecified date in Jun2021. The caller stated that the nurse the patient went to said she did not get the dose and maybe the dose came out on Jun2021, so now the patient wants another dose of the vaccine. The caller stated she does not want to give her another dose until she has more information. The caller wanted to know WHY the patient would be having oozing blisters and pain. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: nausea and chills for couple days; nausea and chills for couple days; This is a spontaneous report received from Moderna Therapeutics. A male patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced nausea and chills for couple days on an unspecified date. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Magnetic resonance imaging, X-ray
Clinical narrative: first dose she was fine, just tired; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, on an unspecified date as DOSE 1, SINGLE for Covid-19 immunisation. The patient concomitant medications were not reported. Patient medical history reported as Spinal stenosis, Penicillin allergy, Clindamycin allergy. Patient previously received chicken pox shot and reported pneumonia, flu shot, Fluzone. She has had an MRI and X-rays. After the first dose she was fine, just tired and that after the second dose, she was very tired but was fine for quite awhile. She never got the chicken pox when she was younger and she got the chicken pox shot and got pneumonia. She inquired how do you to see genetics. She found out a blood test to see if she might have an autoimmune system situation. Patient reported that she took the flu shot, the Fluzone one without the egg. She had her second dose of the Covid-19 vaccine on 03Mar2021. She had her first dose 3 weeks prior to that, as scheduled. Patient reported that the MRI showed that she has stenosis but nothing happening there. She reported that she also had X-rays done. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: first dose, dizzy; first dose, dizzy like all the energy went out of her foot; This is a spontaneous report from a contactable consumer (Patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EN6205), dose 1 via an unspecified route of administration, administered in Upper Arm Left on 26Apr2021 11:00 (at the age of 79-years-old) as dose 1, single for covid-19 immunization. The patient medical history included she was allergic to Penicillin. After taking that for about 50 years she had an allergy to the Penicillin vaccine, and she came home and she got hives on her chest and neck and up on her face. She confirms it was Penicillin vaccine. That has been about 20 some years ago. The patient had no other medical history. The patient had no family history. The patient's concomitant medication(s) included cyanocobalamin (VIT B12) taken for immune system disorder from Mar2021, ergocalciferol (VIT D) taken for an unspecified indication from Mar2021 and zinc taken for cataract, macular degeneration. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks) and any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No adverse events following prior vaccinations. The patient took the first one 26May2021 and within an hour she got dizzy and like all the energy went out her foot and then she was over it, within 30 minutes she was fine and was like she never knew she took it after that. She is a mother and a grandmother, and a great grandmother and she debated about this because she was not too sure about it but she watched and listened every day at noon they talked about it and she does not think she would have survived if she got COVID. She confirms she got it for prevention of COVID. The adverse event not required visit to physician office and Emergency Room. She was thinking about going to doctor to see him, but she kept thinking she would start feeling better. She tries to walk every day. No relevant test done. She takes vitamins to keep herself healthy, she takes B12 and then she takes Vitamin D and Zinc. Zinc: She had problems with her eyes to start with. She confirms that's why she started the Zinc; she says she has cataracts and macular degeneration. She confirms she had those prior to using the Zine. She was going to have cataract surgery 04Aug2021. She just got this herself the doctor did not tell her to, she has enough trouble with her eyes. She takes it for her eyes, she has problems with her eyes. Vitamin B12: She was taking that way before the shot. She had a bone scan, and it showed her bones were deteriorating from get older so that is why she started taking it. Vitamin D: She says the bottle says 125 mg (5000 mcg). She says she started mar 2021 that was when she had her wellness check. No further information provided. The outcome of the events was recovered on 26Apr2021.  Follow up is excepted. Additional information has been requested.