chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Musculoskeletal discomfort
Clinical narrative: Felt tired; Back hurts; Pop in neck and back; Pop in neck and back; Headache; Cramps, sometimes in his legs and hands; Feels weak sometimes; Has a little bit of pain in his chest; Body hurt, reclarified, joints hurt; This is a spontaneous report from a contactable male consumer reported for himself. A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown, Expiration date: unknown), via unspecified route, on 03May2021 (at the age of 62-year-old) as 2nd dose, single dose for COVID-19 immunization. Patient previously received the first dose of BNT162B2 vaccine on an unspecified date (lot/batch and expiry date unknown). The patient medical history and concomitant medications were not reported. On 03May2021, after the vaccination, the first day patient felt tiredness, later (unspecified date in May2021) the patient explained his body hurt- reclarified as joints hurt, back hurts, pop in his neck and back, headache, cramps sometimes his legs and hands, feels weak sometimes, little bit of pain in his chest. Caller stated he has waited for his effects to go away, but it has been a month. Caller stated his body hurt, reclarified as joints hurt, and it was not going away (not recovered). The outcome of the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pain, Pain in extremity
Clinical narrative: chest pain; chest pain, near his arms like the upper the pectoral muscle like and it not just the site where he get the vaccine; bad pain in the both sides; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on an unspecified date as UNKNOWN DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced chest pain, near his arms like the upper the pectoral muscle like and it not just the site where he get the vaccine, bad pain in the both sides. The outcome of event was unknown.  Information on Lot/Batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nervousness, Rash
Clinical narrative: The rash is coming and going on her chest, arm where she had the shot, and to her elbow and part of her back.; it was making her nervous and was not a good feeling; it was making her nervous and was not a good feeling; This is a spontaneous report from a contactable consumer A 55-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 23Apr2021 01:00 as single dose for covid-19 immunisation. Medical history included allergies and allergy to plants (she was just allergic to everything - grass and flowers, so she took Zyrtec every night.Sometimes, she needed one in the morning and one at night because her allergies were very bad). The patient's concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for allergies as 5 mg, 120 mg something like that. The patient previously took dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Apr2021, as single dose for covid-19 immunisation. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that since she had the second dose, she had been having a rash and it was bothering her. This started when she had the second rash, she was not sure the date. She was taking Benadryl and it was coming and going, it was making her nervous and was not a good feeling. The rash was coming and going on her chest, arm where she had the shot and to her elbow and part of her back. It was on her chest and the other side, just like one line from the elbow like a rectangle to the the other arm. The reporter stated that she carried her EpiPen with her in case that happened. She stated that what she was facing was uncomfortable. The reporter stated that they would have told her that she would have this side effect and then she could have made the decision to get the vaccine, she inquired if she had to go to the physician. Therapeutic measures were taken as a result of the event rash is coming and going on her chest, arm where she had the shot, and to her elbow and part of her back. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Developed rash and striations at injected left lower arm but not at injection site; This is a spontaneous report from a contactable consumer. A 15-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot number and Expiry Date was not reported), dose 2 via an unspecified route of administration in arm on an unspecified date as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number and Expiry Date was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st DOSE, SINGLE DOSE for COVID-19 immunization. On an unspecified date, It was reported that consumers granddaughter received second Pfizer vaccine on Friday. Today after 48 hours later she started having that Covid arm, she developed a rash but it's not at the site but the injection site's her lower arm, the lower arm on the injected arm, she had her shot in her left arm. I was really just looking at an information to see if they have any already know from (vaccine), so I wanted to report the reaction. She has like striations on the lower left arm the injected arm. I need to report that as well as to see if they, I looked up, I was googling to see CDC (not clarified) information to see if there was any advice on how to treat certain reaction. Seriousness of the event is reported as unspecified. Outcome of the event was reported as unknown.     Follow-up attempts are needed; information about lot/batch number requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Arm got sore; Headache; Tiredness; Muscle pain; This is a spontaneous report from a contactable consumer (patient). This is report 1 of 2. Caller also reported information for her husband who is the patient in report 2 of 2.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), via an unspecified route of administration on 06Jun2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced minor side effects after vaccination. On 06Jun2021, the patient arm got sore on night. On an unspecified date in Jun2021, the patient experienced headache, tiredness and muscle pain. She thought these were just normal symptoms and called to ask if she can take Ibuprofen to see if she could knock this headache and muscle pain out. The outcome for the events was unknown.   Information on the lot/batch number has been requested
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report a stimulated report from a contactable reporter Physician reporting on behalf of multiple patients. This is 1 of 6patients reported. A patient of unspecified age and gender 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 as unknown, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced shingles. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021666292 same reporter/drug/AE, different patient;US-PFIZER INC-2021666293 same reporter/drug/AE, different patient;US-PFIZER INC-2021666294 same reporter/drug/AE, different patient;US-PFIZER INC-2021666296 same reporter/drug/AE, different patient;US-PFIZER INC-2021666295 same reporter/drug/AE, different patient
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Burning mouth syndrome
Clinical narrative: Burning Mouth Syndrome: Hard palate and Tip of Tongue; This is a spontaneous report from non-contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0150) via an unspecified route of administration in right arm on 01Apr2021 at 13:30 (age at vaccination 72-year-old) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination patient did not receive any other vaccines within 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been not been tested for COVID-19. On 07Apr2021, patient experienced burning mouth syndrome: hard palate and tip of tongue. Began 1 week after 1st vaccine dose and had not gone away. It was reported that device date was 07Jun2021. No treatment was given for the event. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable physician via a sales representative. A patient of unspecified age and gender received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced shingles following vaccination. It was reported that on COVID 19 vaccine 6 patients developed shingles following vaccination. Event took place after use of product. The outcome of the event was unknown.   Information about Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021666246 same reporter/drug/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable physician. This Physician reported for a behalf of 6-patients. This report was received via a sales representative. A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on an unspecified date. The clinical outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021666246 same reporter/drug/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable Physician via a sales representative. This is one of 5th case out of 6th Patients. A patient of unspecified age and gender received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced shingles on an unspecified date. It was reported that on COVID 19 vaccine 6 patients developed shingles following vaccination. Event took place after use of product. The outcome of event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021666246 same reporter/drug/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable physician reporting on behalf of 6 patients. This is the 6th of 6 patients reported. A patient of unspecified age and gender 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 as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced shingles. It was reported that event took place after use of product. The outcome of the event was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021666246 same reporter/drug/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Sore throat; Cold; This is a spontaneous report from a contactable consumer (patient mother) from Pfizer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported) via an unspecified route of administration on 17May2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that just 3 days ago the patient got a cold and sore throat. The reporter was wondering if she still takes the 2nd one, she is supposed to get it today. The outcome of the events was unknown.  Limited information was available over the call.  Information about batch/lot number has been requested.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 102.5 fever day 1 poster vax 2; This is a spontaneous report from a contactable consumer (on behalf of patient). A 12-years-old female patient received second dose of bnt162b2 (COVID VACCINE, formulation: solution for injection, Batch/Lot number: unknown, Expiry date: unknown), via an unspecified route of administration on an unspecified date (at the age of 12-years) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation.The patient received first dose of bnt162b2 (COVID VACCINE) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced 102.5 fever day 1 poster vax 2. The patient underwent lab tests and procedures which included body temperature: 102.5. Outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Inappropriate schedule of product administration, Joint swelling, Vertigo
Clinical narrative: Vertigo fir 8 weeks After approximately 5 weeks after #2; both ankles swollen; Light headed & dizzy all the time.; 14Apr2021 dose number=1/28Apr2021, dose number=2; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration, administered in Arm Left on 28Apr2021 14:00 (at the age of 62-year-old) as, single dose for covid-19 immunisation. The patient medical history was reported as none. The patient didnot have any allergies. The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 administered in left arm on 14Apr2021 01:00PM for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28May2021 the patient experienced vertigo fir 8 weeks after approximately 5 weeks after #2, both ankles swollen light headed & dizzy all the time. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. No treatment received for the events vertigo fir 8 weeks after approximately 5 weeks after #2, both ankles swollen, light headed & dizzy. The events were considered as non-serious by the reporter. The outcome of the events vertigo fir 8 weeks after approximately 5 weeks after #2, both ankles swollen, light headed & dizzy all the time were not resolved and unknown for other event.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Axillary mass, Breast mass, Lymphadenopathy, Pain in extremity
Clinical narrative: Lumps popped up on right side of breast; Soreness in the arm; Caller states what's going on with her is she is having come concerns about the first dose; Bumps in her armpit; And she thinks they're swollen lymph nodes.; This is a spontaneous report from Pfizer Sponsored Program. A female consumer (patient) reported for herself. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunization.The patient medical history and concomitant medications were not reported. On an unspecified date two weeks after patient received her first one, the patient started having soreness in the arm, also stated then she had bumps in her armpit, lumps popped up on right side of breast and she thinks they are swollen lymph nodes, they are closer to the breast .The patient does have an appointment for the lumps to be looked at on her breast.She had some concerns about the first dose, said lumps popped up, not sure they are related to the Pfizer vaccine. The patient stated that she has lumps on the side of her right breast, and she does not know if that was due to coronavirus.The patient wanted to get some clarity before her appointment tomorrow for Pfizer and wanted to know if she should get the second dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Limb mass, Tenderness
Clinical narrative: I have a lump on my collarbone (left side, same side as where I got my shot). It's tender and it feels like a ball that can move when I press on it.; I have a lump on my collarbone (left side, same side as where I got my shot). It's tender and it feels like a ball that can move when I press on it.; I have a lump on my collarbone (left side, same side as where I got my shot). It's tender and it feels like a ball that can move when I press on it.; This is a spontaneous report from a contactable consumer (patient, self-reported). A  female patient (age at vaccination: 28 year) received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 06Jun2021, as a single dose for COVID-19 immunization at pharmacy or drug store. The patient was not pregnant at the time of vaccination. The patient's medical history included gastritis. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she had a lump on her collarbone (left side, same side as where she got her shot). It's tender and it felt like a ball that could move when she press on it on 07Jun2021. The patient did not receive any treatment for the events. Device date was 07Jun2021. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Skin irritation, Urticaria
Clinical narrative: skin irritation or hives; Rash; hives like skin irritation; This is a spontaneous report from a contactable consumer. This unspecified age and gender patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications were not reported. On an unspecified date patient experienced minor hives like skin irritation below the injection site and rash. Patient stated that I do not need any medical assistance. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Muscle tightness
Clinical narrative: Huge bruise on his arm/giant bruise on his whole bicep; Muscle knot; This is a spontaneous report from a contactable consumer or other non healthcare professional. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 29May2021 (Batch/Lot Number: EW0187; Expiration Date: 31Aug2021) as 2ND DOSE, SINGLE for covid-19 immunization. Historical vaccination included the patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 29May2021 (Batch/Lot Number: EW0173; Expiration Date: 31Aug2021) as Single for covid-19 immunization. The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced huge bruise on his arm/giant bruise on his whole bicep and muscle knot on an unspecified date.Outcome of the events was unknown.  No follow-up attempts are possible. No further information is exected.
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Headache; Low grade fever; Nausea; Arm pain; Fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 12-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache, low grade fever, nausea, arm pain and fatigue on an unspecified date about 12 hours after receiving Pfizer Covid vaccine. It was reported that the event took place after use of product. The clinical outcome of the events was unknown.  Information about batch/Lot number has been requested.
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; Low grade fever; Nausea; Arm pain; Fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 12-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache, low grade fever, nausea, arm pain and fatigue on an unspecified date about 12 hours after receiving Pfizer Covid vaccine. It was reported that the event took place after use of product. The clinical outcome of the events was unknown.  Information about batch/Lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Biopsy, Rash
Clinical narrative: I had a severe rash for three weeks after I took the Covid vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, "the patient had a severe rash for three weeks after the Covid vaccine. She was not sure if it due to her recent biopsy or caused by the Covid vaccine. She would like to know if there was a trial for skin reaction(s) to the Covid vaccine". Outcome of the event was unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: drowsiness and he couldn't stay awake; This is a spontaneous report from a contactable consumer (Patient). A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 26Apr2021 as 1st dose, single dose for covid-19 immunisation. Medical history included narcolepsy [use of Adderall (amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, dextroamphetamine sulfate), and use of generic Adderall for "at least 15 years" (relative to 21May2021)]. Concomitant medications included vitamin d nos (VITAMIN D NOS); omeprazole (OMEPRAZOLE; for 10 to 20 years); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for narcolepsy and daily vitamins. On 03May2021, Patient had slept for 4 days since starting it, also described as drowsiness and he couldn't stay awake. He thought there might be a tiny chance the drowsiness could be from the COVID vaccine, but he thought if the drowsiness was from the vaccine it would not last as long as it had. The drowsiness and being unable to stay awake were ongoing, as he had "slept for almost 3 weeks". On 17May2021, patient received his second dose of the COVID vaccine. The outcome of events was not recovered.   Information about batch/Lot number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Blood test, Musculoskeletal discomfort, Pain
Clinical narrative: I am having some long term achiness in my left arm it is gone into my shoulder and joint; I am having some long term achiness in my left arm it is gone into my shoulder and joint; the right side is hurting too; This is a spontaneous report from a contactable consumer (patient herself). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0150/Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 01Apr2021 at 14:00 (at the age of 76-years-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation at Hospital. Medical history included diabetes mellitus from an unknown date and unknown if ongoing (Verbatim: Diabetes), hypertension from an unknown date and unknown if ongoing (Verbatim: high blood pressure), blood cholesterol increased from an unknown date and unknown if ongoing (Verbatim: High cholesterol). Concomitant medication(s) included metformin (METFORMIN) taken for diabetes mellitus, lisinopril (LISINOPRIL) taken for an unspecified indication, atorvastatin (ATORVASTATIN) taken for blood cholesterol, acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication, pravastatin (PRAVASTATIN) taken for an unspecified indication and insulin (INSULIN) taken for an unspecified indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6206/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm right on 10Mar2021 at 15:00 for covid-19 immunisation. Consumer stated that, patient having some long term achiness in his left arm it is gone into his shoulder and joint and he had Rotator pesto (Not alpha spelled, further clarification unknown) long time ago but he know its not torn he haven't done any thing, and the right side is hurting too, both arm kind of hot, he don't know if its the vaccine but its both arm, right one not too bad, left one so bad, applied cream with lidocaine on it. Consumer stated that, for the treatment of the events he taken Tylenol, and he put Aspercreme with lidocaine. The patient underwent lab tests and procedures which included blood test was unknown on an unspecified date. Therapeutic measures were taken for the events. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: the patient had pain in her hands and knees; the patient had pain in her hands and knees; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASL2021083699). This case was split from master case 2021653604 for a patient taking BNT162B2 and experienced "the patient had pain in her hands and knees".   This non-serious solicited report (USASL2021083699) was reported to Amgen on 28May2021 by a consumer from a commercial program (PSP00180b, PSP00046b) and involved a  female who received bnt162b2 (BNT162B2, Solution for injection) on 02Apr2021 as single dose for COVID-19 immunization. No historical medical condition was reported. The patient's current medical condition included ongoing rheumatoid arthritis. The patient's concomitant medications included Enbrel for rheumatoid arthritis and methotrexate. No co-suspect medications were reported. On 02Apr2021, the patient took COIVD-19 vaccine. Five days later on 07Apr2021, the patient had pain in her hands and knees. The patient stated that her Enbrel has stopped working since she took the covid-19 vaccine. The patient's doctor advised that the vaccine was the reason her Enbrel was no longer working for her. The patient's nurse practitioner (NP) removed methotrexate from her regimen however patient was still having discomfort. The patient stated it was fighting the Enbrel and attacking everything inside her. No treatment information was received. Follow up has been requested for lot number. Outcome of the event was unknown.  No follow- up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Arthritis had gone away; This is a spontaneous report from a contactable consumer (patient's neighbor). A 7-decade-old (patient is in her sixties) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. Medical history included arthritis. The patient's concomitant medications were not reported. The reporter while providing a positive effect for himself and the Pfizer COVID 19 shot stated that he heard from another person who was in her sixties that a similar thing had happened to her. It was not as fast but similar. Her kids thought it was from the Pfizer shot. She felt great. He had spoken to the son of the neighbor next door, at his cottage. It was reported that patient's arthritis had gone away. The clinical outcome of the event was unknown.   Follow-up attempts are needed. Information about lot/batch number requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021667417 Same reporter/drug/AE and different patients.;US-PFIZER INC-2021582573 Same reporter/drug/AE and different patients.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First Dose: Sore Arm; This is a spontaneous report from a contactable consumer (patient's spouse). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection), via an unspecified route of administration on an unknown date as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced sore arm. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021665145 same reporter/ product, different patient.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Nasopharyngitis, Pyrexia
Clinical narrative: My head was always heavy; I had lot of cold; headache and fever; My head was always heavy; I had lot of cold; headache and fever; My head was always heavy; I had lot of cold; headache and fever; head was always heavy; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: EW0176 and Expiration date was not reported) via an unspecified route of administration, in right arm, on 21Apr2021 (at the age of 67 years) and second dose of BNT162B2 (lot number: EW0176) on 04May2021, as a single dose for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. On an unknown date, consumer stated 'she took the COVID vaccine, the first one was not bad because her head was always heavy, she had lot of cold and a headache and fever. Reporter seriousness for her head was always heavy; she had lot of cold; headache and fever were unspecified. Outcome of the event was reported as unknown.   Information on lot and batch number is available. Other information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: I had vaginal bleeding but I just had my periods like a week and a half ago; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (Pfizer COVID-19 Vaccine, Solution for injection) via an unspecified route of administration on an unspecified date (NDC/UPC number: Unknown, Expiry date: Unknown) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, the patient had vaginal bleeding, but she just had periods like a week and a half ago. Consumer stated, "she had first Covid vaccine shot today and after she got home several hours later, noticed that she had vaginal bleeding but had periods like a week and a half ago. So, she was just wondering, what she should do about that". Consumer was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department and provided with the number. In response to probing for safety report, consumer stated, "No, not right now". Further probing could not be initiated as consumer was unwilling to further answer the questions. Hence, product details (LOT number, expiration date, NDC number, UPC number), purchase details and other details were unknown and limited information was available over the call. Outcome of the event was unknown.  Information regarding the Lot/Batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I was tired, the first vaccine seems to be worst for me; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: EN6202), via an unspecified route of administration, on 25Feb2021 (at the age of 50-year-old) as second dose , single dose, for covid-19 immunization. The patient did not have any prior vaccination within 4 weeks and was not sure if she had COVID-19 in the past. She also mentioned that she was part of the clinical trial for the Pfizer COVID-19 vaccine. The patient's medical history included blood pressure high. The patient's concomitant medication included metoprolol taken for blood pressure high, at dose of 25mg, twice a day. On an unknown date in Feb-2021, the patient said that "I was tired, the first vaccine seems to be worst for me". The patient mentioned that she had taken both vaccines and she did not consider it a bad reaction. The patient mentioned that "I was in clinical trials. The outcome of the event was unknown.  Follow-up attempts needed. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 3 inmates that were fully vaccinated with the Pfizer covid 19 vaccine and have contracted covid.; 3 inmates that were fully vaccinated with the Pfizer covid 19 vaccine and have contracted covid.; This is a spontaneous report from a contactable pharmacist via medical information team. A 36-years-old male patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: en5318), via an unspecified route of administration on unspecified date as 1st dose, single dose and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: el8982), via an unspecified route of administration on unspecified date as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, reporter had 3 inmates that were fully vaccinated with the Pfizer COVID19 vaccine and had contracted COVID. He asked if there were any issues with specific lot numbers: el8982, en5318. He did not have any information to provide for the inmates. The events were assessed as serious (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test: contracted COVID. The outcome of the events was reported as unknown.; Sender's Comments: Based on the information currently available the lack of efficacy of a vaccine BNT162B2 cannot be excluded. The case will be reassessed if any new information is available.,Linked Report(s) : US-PFIZER INC-2021665561 same reporter/drug/event, different patient;US-PFIZER INC-2021669261 same reporter/drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Second Dose: sick for 5 days with the same symptoms as when he had full blown Covid; This is a spontaneous report from a contactable consumer (patient's spouse). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was diagnosed with Covid 19 on an unknown date. The patient was not related to a study program. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On an unknown date (after second of vaccine), the patient was sick for 5 days with the same symptoms as when he had full blown Covid. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021665145 same reporter/ product, different patient.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Ear pruritus, Pruritus, Rash macular
Clinical narrative: itching all over, even in her ears; feeling short of breath; Chest hurting; itching all over, even in her ears; skin was red from scratching it, but thought it had been somewhat blotchy, too, on her legs; This is a spontaneous report from a contactable consumer (patient's grandmother/Guardian). A 15-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0167, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 19May2021 at 16:30 hours as 1st dose, single dose (at the age of 15-years-old) for COVID-19 immunization. Medical history included seasonal allergy and allergy to cats (from an unknown date and unknown if ongoing). Patient had no covid prior vaccination. Concomitant medication included clonidine extended release (ER) at a dose of 0.1 mg daily taken for an unspecified indication, start and stop date were not reported. Patient was not covid tested post vaccination. 0n 19May2021 at 19:45 hours (about 3 hours after receiving her shot), patient complained of itching all over, even in her ears, patient also mentioned her chest hurting and feeling short of breath. Patient was not sure whether her skin was red from scratching it, but thought it had been somewhat blotchy, too, on her legs, possibly because that was the area uncovered so she could see it. The blotchiness and chest pain resolved quickly, but the itchiness continued. Patient also complained of stomach pain, which occurred after patient's grandmother gave her a loratadine. The loratadine settled the itching down, but patient reported nausea the next morning and shortness of breath, as well. Patient received Claritin 24 Hr for the events as treatment. The outcome of the skin was red from scratching it, but thought it had been somewhat blotchy, too, on her legs and chest hurting was recovered on May-2021 and recovered for rest of the events in 2021  Follow up needed, further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Tinnitus
Clinical narrative: ringing in the ears; had like throbbing inside the ear; This is a spontaneous report from a contactable consumer (patient's grandfather). A 16-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number not provided), via an unspecified route of administration on an unspecified date May2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not provided. It was reported that patient received Pfizer Vaccine like two and a half weeks ago and what happened is that he developed ringing in the ears and he had like throbbing inside the ear. Now, I am concerned because he is due to get his second vaccine, this Friday (10Jun2021). Should he get the second vaccine? The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Dizzy; Fever; Headache; Chills; Nausea; This is a spontaneous report from a contactable consumer or other non-health care professional. Reported regarding a 13-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0165) via intramuscular route of administration and administered in left arm on 06Jun2021 as single dose for COVID-19 immunization. She took the first dose of Pfizer vaccine prior, that was the second shot. The patient medical history and concomitant medications were not reported. Reporters daughter gets the second dose of Pfizer vaccine yesterday (distorted voice) she had a fever, headache, chills and then she was dizzy. reporter called the doctors office he told me it was normal with the vaccine, then today patient called them and the person patient talked to said, because she is dizzy take her to the ER, taking her and they told me to call and report her side effect. It was unknown that Investigation Assessment performed or not. Therapeutic measures were taken as a result of fever, headache, chills, nausea with Tylenol. The outcome of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Lymphadenopathy, Product use issue
Clinical narrative: Caller's 13 year old son has an enlarged lymph node, later clarified as above his left clavicle.; Age:13 year; This is a spontaneous report from a contactable consumer or other non hcp (patient's parent).  A male patient(reporter's son) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: number was not reported), via an unspecified route of administration on an unspecified date at an unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced caller's 13 year old son has an enlarged lymph node, later clarified as above his left clavicle. Reporter states that in between the vaccines, his for this son has an enlarged lymph node, later clarified as above his left clavicle. Reclarified, reporter stated that in the absence of having the vaccine, he is learning that a single swollen lymph node can be something to be concerned about, and could be an infection, or something more serious. Reporter stated that he asked his son's pediatrician yesterday about this as event, and the doctor stated he hadn't read anything about this type of swollen lymph node being reported in this age group. Reporter stated his son had bloodwork, and it came back normal and his son is going to get a chest X-ray. On an unspecified date the patient underwent lab tests and procedures which included blood test: normal. Out-come of the events was unknown.  Information about the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested positive on June 1st; I tested positive on June 1st; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration date was not reported), via an unspecified route of administration on 28Apr2021 as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously patient took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Apr2021 for COVID-19 immunization. It was reported that patient got the Pfizer Vaccine on 07Apr2021, second shot on 28Apr2021. Patients wife and patient visited another country. Patients wife has the Johnson & Johnson vaccine. Patients wife tested positive for COVID-19 on 26May2021. Patient tested positive on 01Jun2021 and Patients wife's aunt, who had one shot of Sinovac, tested positive a few days later. That's three vaccinated people spreading it to each other. Patient wanted to make aware of this, as the vaccines seem to be ineffective at preventing infection by whatever strain we got. The outcome of the events was unknown.  Information about batch/Lot number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Weight increased
Clinical narrative: Pain in right elbow; A lot of weight gain; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 56-year-old female patient received unknown dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for Injection), via an unspecified route on an unknown date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that she did not know if it was Cosentyx or the COVID-19 shot. On an unknown date, patient experienced pain in her right elbow and a lot of weight gain but doesn't know if it is middle age or Cosentyx. The outcome of the events was unknown.  Additional information has been requested and will be provided as it becomes available.