chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Some pain where the injection was in that arm; Fever is 101 degrees Fahrenheit; Little headache; A little bit of dizziness; This is a spontaneous report from a contactable consumer or other non hcp. A 26-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, (Batch/Lot Number: EW0186) via an unspecified route of administration, administered in Arm Left on 19May2021 13:30 (Age at Vaccination 26-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No prior Vaccinations (within 4 weeks). On 20May2021 Some pain where the injection was in that arm, Fever is 101 degrees Fahrenheit, Little headache, and A little bit of dizziness It was reported that Caller was calling on behalf of his girlfriend who received the first dose of the Pfizer Covid-19 vaccine yesterday afternoon. Caller states that she did not have any adverse reactions at the time or throughout the day that they were able to tell. Caller states she woke up experiencing side effects this morning, in which the side effects appear to be listed as common adverse reactions. Caller stated the person administering the vaccine told his girlfriend that if she was to get a fever, she should go to the emergency room. Caller states her fever is 101 degrees Fahrenheit. Reporter stated his girlfriend was fine yesterday and had no immediate side effects and then she woke up today and has a 101 Fever, a little bit of dizziness, some pain where the injection was in that arm, and a little headache. Treatment: Reporter stated after he took his girlfriend's temperature, he gave her 2 Ibuprofen pills. 101 Fever, a little bit of dizziness, some pain where the injection was in that arm, and a little headache. The patient underwent lab tests and procedures which included pyrexia 101 Fever on 20May2021. The outcome of the event was not recovered.  No Follow-up attempts completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Facial pain, Fatigue, Headache
Clinical narrative: Tired; Shortness of breath with slight exertion; Increased swelling in face; Increased swelling in hands, legs; Increased swelling in ankle; Weight gain; Sensitive mouth; Slight fever; Headache; Pain in ankles; Pain in face; Pain in hands, legs/ sore arm; This is a spontaneous report from a contactable other HCP of pharmacy reported for a consumer.  A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date (at the age of 52-year-old) as dose 2, single for covid-19 immunization. Medical history included renal cancer. The patient concomitant medications were not provided. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date (at the age of 52-year-old) as dose 1, single for covid-19 immunization and experienced no reaction on previous exposure to vaccine. Patient also had Sutent 50 mg/daily orally for 4 weeks on, 2 weeks off at start Oct2020 to current, 50 mg/daily for 2 weeks on, 1 week off per md verbal order since Jan2021 for renal cancer. Written order now matches as of May2021. On an unspecified date, patient experienced being tired, shortness of breath with slight exertion, increased swelling, pain in hands and legs, sore arm, pain in ankles, pain in face, weight gain, sensitive mouth, slight fever, headache after second covid vaccine 2 weeks ago but that was better seeing, with lab next week and plans to discuss. The outcome of the events was reported as unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Oral pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Tired; Shortness of breath with slight exertion; Increased swelling in face; Increased swelling in hands, legs; Increased swelling in ankle; Weight gain; Sensitive mouth; Slight fever; Headache; Pain in ankles; Pain in face; Pain in hands, legs/ sore arm; This is a spontaneous report from a contactable other HCP of pharmacy reported for a consumer.  A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date (at the age of 52-year-old) as dose 2, single for covid-19 immunization. Medical history included renal cancer. The patient concomitant medications were not provided. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date (at the age of 52-year-old) as dose 1, single for covid-19 immunization and experienced no reaction on previous exposure to vaccine. Patient also had Sutent 50 mg/daily orally for 4 weeks on, 2 weeks off at start Oct2020 to current, 50 mg/daily for 2 weeks on, 1 week off per md verbal order since Jan2021 for renal cancer. Written order now matches as of May2021. On an unspecified date, patient experienced being tired, shortness of breath with slight exertion, increased swelling, pain in hands and legs, sore arm, pain in ankles, pain in face, weight gain, sensitive mouth, slight fever, headache after second covid vaccine 2 weeks ago but that was better seeing, with lab next week and plans to discuss. The outcome of the events was reported as unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Weight increased
Clinical narrative: Tired; Shortness of breath with slight exertion; Increased swelling in face; Increased swelling in hands, legs; Increased swelling in ankle; Weight gain; Sensitive mouth; Slight fever; Headache; Pain in ankles; Pain in face; Pain in hands, legs/ sore arm; This is a spontaneous report from a contactable other HCP of pharmacy reported for a consumer.  A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date (at the age of 52-year-old) as dose 2, single for covid-19 immunization. Medical history included renal cancer. The patient concomitant medications were not provided. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date (at the age of 52-year-old) as dose 1, single for covid-19 immunization and experienced no reaction on previous exposure to vaccine. Patient also had Sutent 50 mg/daily orally for 4 weeks on, 2 weeks off at start Oct2020 to current, 50 mg/daily for 2 weeks on, 1 week off per md verbal order since Jan2021 for renal cancer. Written order now matches as of May2021. On an unspecified date, patient experienced being tired, shortness of breath with slight exertion, increased swelling, pain in hands and legs, sore arm, pain in ankles, pain in face, weight gain, sensitive mouth, slight fever, headache after second covid vaccine 2 weeks ago but that was better seeing, with lab next week and plans to discuss. The outcome of the events was reported as unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Pain in extremity, Pruritus
Clinical narrative: Whole body itching/itching all over his body; Headache; Arm sore; Nauseated; Feeling unwell; tired/under the weather for 3 days after the vaccine; This is a spontaneous report from a contactable consumer(parent). A 14-year-old male patient received first dose bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: EW0176), via an unspecified route of administration on 15May2021 (age at the vaccination was 14-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications. On an unknown date May2021, the patient experienced Feeling unwell; tired/under the weather for 3 days after the vaccine. On an unknown date, the reported stated that none of the patient symptoms that were not listed as possible symptoms that confused the reporter was the itching because when the reporter was reading it through a media and reporter was reading carefully and it was not that the patient had itching at the site of the injection but his like whole body was itching. The patient not had a rash or any swelling or anything like that. The patient had a headache, arm sore and nauseated but nothing else other than itching. The reporter stated her son did not had hives or breathing difficulties or any anaphylactic like reactions. The reporter wanted to know was contraindication to getting the Pfizer covid 19 vaccines. No treatment medication was received for the adverse events. The outcome of the event itching was resolved (lasted around 4 days) on an unknown date 2021. The outcome of the other events was unknown.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Rash on leg; Fever; This is a spontaneous report from a contactable consumer. This consumer reported for a 17-year-old female patient (sister).  A 17-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: ER8736, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 17May2021 as dose 2, single for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2(PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EW0170, Expiry date: reporter stated, "I have a date it's 26Apr2021 for the first one. No there is no expiration date) via an unspecified route of administration, on 26Apr2021 as dose 1, single for COVID-19 immunization. On 18May2021, the patient experienced fever. On 19May2021, patient experienced rash on leg. Reporter reported that we got the vaccine two days ago and my sister had a fever yesterday and today she woke up with a rash on her legs. We just want to know if we should be concerned or not or if it is actually something normal, we were just wondering about it. Reporter stated, she started experiencing the rash today, yesterday she had a fever. Treatment for Adverse event: Reporter stated, she said that she took some medicine for fever. We think it is because of that we just want to make sure that it wasn't something more serious. Reporter stated, she said she took Tylenol and Advil for the treatment of the event fever 2 times yesterday, 500 mg each for Tylenol, Advil 200 mg. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Lymphocyte count, Lymphocyte count increased, White blood cell count, White blood cell count increased
Clinical narrative: White blood cell count increased / elevated white blood cells to 12.6 K/microliter; Absolute lymphocyte count increased / elevated Absolute Lymphocytes to 5.7 1000cells/micro; This is a Spontaneous report based on the information received by Pfizer from Abbvie (Mfr. Control No. :21K-163-3904052-00) from a non-contactable consumer (patient). A 85-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 16Feb2021 as dose 2, single for COVID-19 immunization. The patient also received co-suspect ibrutinib (IMBRUVICA), oral from an unspecified date in 2016 (Batch/Lot number was not reported) to an unspecified date, at 420 mg, 1x/day (1 in 1 D), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date in 2020, at 280 mg, 1x/day (1 in 1 D), oral from an unspecified date in 2020 (Batch/Lot number was not reported) and ongoing, at 140 mg, 1x/day (1 in 1 D) for chronic lymphocytic leukaemia (CLL). The patient medical history included chronic lymphocytic leukaemia (CLL), no alcohol use, non smoker, and no illicit drug use. Concomitant medications included zinc (ZINC), quercetin (QUERCETIN), clonazepam (CLONAZEPAM), and iodine (IODINE). Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 28Jan2021 as dose 1, single for COVID-19 immunization. Patient was not enrolled in a COVID-19 vaccine trial. It was reported on 05May2021, the patient experienced "white blood cell count increased / elevated white blood cells to 12.6 K/microliter" and "absolute lymphocyte count increased / elevated Absolute Lymphocytes to 5.7 1000cells/micro". The patient underwent lab tests and procedures which included lymphocyte count: 5.7 1000cells/micro and white blood cell count: 12.6 K/microliter on 05May2021. The events were reported as non-serious. The outcome of events was unknown. The reporter's causality for the events of elevated white blood cells to 12.6 K/microliter and elevated absolute lymphocytes to 5.7 1000cells/micro was not provided for ibrutinib (IMBRUVICA) and BNT162B2. Action taken for co-suspect ibrutinib (IMBRUVICA) was reported as dose decreased for first and second regimen and dose not changed for third regimen.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Off label use, Vaccination site pain, Vertigo, Vomiting
Clinical narrative: first dose of Modernas COVID vaccine on 17Apr2021 and received Pfizers COVID vaccine yesterday, 19May2021; first dose of Modernas COVID vaccine on 17Apr2021 and received Pfizers COVID vaccine yesterday, 19May2021; vertigo; throwing up; severe pain on the left arm (where vaccine was administered); This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 19May2021 as DOSE 2 (INITIAL PFIZER DOSE), SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of MODERNA COVID-19 VACCINE (Batch/Lot number was not reported), on 17Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. On 19May2021, the patient experienced first dose of Moderna's covid vaccine on 17Apr2021 and received Pfizer's covid vaccine yesterday, 19May2021, on an unspecified date in 2021 patient experienced vertigo, throwing up, severe pain on the left arm (where vaccine was administered). Patient wanted to know if this was something he should be concerned about or if this is normal and clarified if these side effects are normal even if he had received a Moderna vaccine as the first dose. The outcomes of events were unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Arthralgia, Dizziness, Dysphagia, Ear pain
Clinical narrative: Swollen and burning in my Neck; I can't swallow very well; Swollen and burning in my Neck; I can't swallow very well; White patch on tongue and green patches on tonsils; Fatigue; White patch on tongue and green patches on tonsils/ Feel pain and heaviness on my tonsils when I talk hurts like somebody is digging into my tonsils with a knife to cut off; Feel pain and heaviness on my tonsils when I talk hurts like somebody is digging into my tonsils with a knife to cut off; Swollen lymph nodes; Loss of voice; Ear pain; Knee pain; Itchiness all over; Sickness; Pain in my body; Dizziness; Nose are clogged; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/ lot number was not reported), via an unspecified route of administration on 02Apr2021 10:00 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.On an unspecified date the patient mentioned everything changed in her body; she had white patch on tongue and green patches on the tonsils ever since she had the first shot. She suddenly felt something like swollen to her neck and burning in her neck. She started to feel like her neck. She can't swallow very well, and she checked in mirror, she saw that it was swollen that's why she can't swallow which she never experienced before. Neck swollen up, supposedly the lymph node swollen because her voice changed. She was itching all over and she felt sickness and fatigued. She also reported Pain in her body, loss of voice, ear pain, knee pain and dizziness. She went to couple of doctors for this but nobody could help her and she don't know what to do. She was still experiencing side effects of the vaccine and felt like she had some type of bread piece chopped in her mouth and then her nose was clogged and she was great before she took the vaccine. Now she also feels pain on her tonsils, heaviness on her tonsils and sometimes when she talk to her family over on the phone whenever her tonsils hurts more and more and she felt heaviness on them and pain was like somebody is digging into my tonsils with a knife to cut off. She already got her second dose but she was experiencing crazy side effects of it after the first one and second one. She was still experiencing it although her first shot was taken on 02Apr2021 at 10:00 and my second on 05May2021 at 10:18. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Lymphadenopathy, Nasal congestion, Oropharyngeal discomfort
Clinical narrative: Swollen and burning in my Neck; I can't swallow very well; Swollen and burning in my Neck; I can't swallow very well; White patch on tongue and green patches on tonsils; Fatigue; White patch on tongue and green patches on tonsils/ Feel pain and heaviness on my tonsils when I talk hurts like somebody is digging into my tonsils with a knife to cut off; Feel pain and heaviness on my tonsils when I talk hurts like somebody is digging into my tonsils with a knife to cut off; Swollen lymph nodes; Loss of voice; Ear pain; Knee pain; Itchiness all over; Sickness; Pain in my body; Dizziness; Nose are clogged; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/ lot number was not reported), via an unspecified route of administration on 02Apr2021 10:00 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.On an unspecified date the patient mentioned everything changed in her body; she had white patch on tongue and green patches on the tonsils ever since she had the first shot. She suddenly felt something like swollen to her neck and burning in her neck. She started to feel like her neck. She can't swallow very well, and she checked in mirror, she saw that it was swollen that's why she can't swallow which she never experienced before. Neck swollen up, supposedly the lymph node swollen because her voice changed. She was itching all over and she felt sickness and fatigued. She also reported Pain in her body, loss of voice, ear pain, knee pain and dizziness. She went to couple of doctors for this but nobody could help her and she don't know what to do. She was still experiencing side effects of the vaccine and felt like she had some type of bread piece chopped in her mouth and then her nose was clogged and she was great before she took the vaccine. Now she also feels pain on her tonsils, heaviness on her tonsils and sometimes when she talk to her family over on the phone whenever her tonsils hurts more and more and she felt heaviness on them and pain was like somebody is digging into my tonsils with a knife to cut off. She already got her second dose but she was experiencing crazy side effects of it after the first one and second one. She was still experiencing it although her first shot was taken on 02Apr2021 at 10:00 and my second on 05May2021 at 10:18. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Swelling, Tongue discolouration, Tonsillar disorder
Clinical narrative: Swollen and burning in my Neck; I can't swallow very well; Swollen and burning in my Neck; I can't swallow very well; White patch on tongue and green patches on tonsils; Fatigue; White patch on tongue and green patches on tonsils/ Feel pain and heaviness on my tonsils when I talk hurts like somebody is digging into my tonsils with a knife to cut off; Feel pain and heaviness on my tonsils when I talk hurts like somebody is digging into my tonsils with a knife to cut off; Swollen lymph nodes; Loss of voice; Ear pain; Knee pain; Itchiness all over; Sickness; Pain in my body; Dizziness; Nose are clogged; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/ lot number was not reported), via an unspecified route of administration on 02Apr2021 10:00 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.On an unspecified date the patient mentioned everything changed in her body; she had white patch on tongue and green patches on the tonsils ever since she had the first shot. She suddenly felt something like swollen to her neck and burning in her neck. She started to feel like her neck. She can't swallow very well, and she checked in mirror, she saw that it was swollen that's why she can't swallow which she never experienced before. Neck swollen up, supposedly the lymph node swollen because her voice changed. She was itching all over and she felt sickness and fatigued. She also reported Pain in her body, loss of voice, ear pain, knee pain and dizziness. She went to couple of doctors for this but nobody could help her and she don't know what to do. She was still experiencing side effects of the vaccine and felt like she had some type of bread piece chopped in her mouth and then her nose was clogged and she was great before she took the vaccine. Now she also feels pain on her tonsils, heaviness on her tonsils and sometimes when she talk to her family over on the phone whenever her tonsils hurts more and more and she felt heaviness on them and pain was like somebody is digging into my tonsils with a knife to cut off. She already got her second dose but she was experiencing crazy side effects of it after the first one and second one. She was still experiencing it although her first shot was taken on 02Apr2021 at 10:00 and my second on 05May2021 at 10:18. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Swelling, Vaccination site pain
Clinical narrative: ache/pain; my left arm has still been tender and achy at injection site; Tingling began in left hand-thumb and next two fingers intermittent; sometimes fills swollen but doesn't appear to be; This is a spontaneous report received from a contactable consumer (patient herself). A 74-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6202), via an intramuscular route of administration, administered in deltoid left on 05Mar2021 (age at the vaccination was 74-year-old) as dose 2, single for COVID-19 immunisation in doctor's office/urgent care. The patient medical history included ILD (interstitial lung disease) and colon cancer from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior vaccination. Concomitant medications included Alendronate sodium (ALENDRONATE), Venlafaxine, Diazepam, Oxygen, Colecalciferol (VIT D3) for an unspecified indication, start and stop date were not reported were received within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. The patient previously took motrin and experienced allergy. Historical vaccine included, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN9581), via an intramuscular route of administration, administered in deltoid left on 12Feb2021 (age at vaccination was 74-year-old) as dose 1, single for COVID-19 immunisation and had no issues. On an unspecified date in May2021, the patient experienced ache/pain, her left arm has still been tender and achy at injection site, tingling began in left hand-thumb and next two fingers intermittent (tingling was now still in hand/fingers area but moving up arm to just below injection site) and sometimes fills swollen but doesn't appear to be. The patient visited physician office as a result of events. Therapeutic measures were taken as a result of event ache/pain included Tylenol for other events no therapeutic measures were taken. Since the vaccination, the patient was not tested positive with COVID-19. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disease recurrence, Pyrexia, Tooth infection
Clinical narrative: tooth reinfection/got infected in 2018 and it was like a slow infection, started prior to the vaccine, states it was reinfected between the two doses; got infected in 2018 and it was like a slow infection, started prior to the vaccine, states it was reinfected between the two doses; fever and chills; fever and chills; This is a spontaneous report from a contactable consumer (patient) reported that:  A 78-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6202), via an intramuscular route of administration, administered in Arm Left on 25Feb2021 (At the age of 78 years) as DOSE 1, SINGLE for covid-19 immunisation. second dose was administered on18Mar2021. Medical history included thyroid cancer from 1979 to an unknown date, her thyroid was removed surgically and is on hormone replacements, root canal infection from 2018 to an unknown date, it was like a slow infection started prior to the vaccine, it was reinfected between the two doses, Car accident prior to the pandemic leading to back surgery, visual impairment since before vaccines, head and neck cancer and was a brain tumor survivor. Patient states she has had a horrible reaction to the Shingrex vaccine in the past, states she gets vaccines for everything, The patient's concomitant medications were not reported. On an unspecified date, the patient had experienced tooth reinfection, chills a nd fever. The patient stated that she will get shots in her weaker arm as she had a broken wrist and nerve damage, stated this was prior to the vaccines. The outcome of the events were unknown.   Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non healthcare professional. A 37 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 30Apr2021 12:00 (Batch/Lot Number: EW0175) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 12:00 (Batch/Lot Number: ER8729) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced muscle pain causing myalgia and low fever on 01May2021 with outcome of recovered.  Follow up (20May2021): This is a follow up spontaneous report from a contactable consumer. This 37-year-old female consumer (patient) reported that: The Batch/Lot Number and adverse events were updated.   Follow-up (24Jun2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This is a spontaneous report from a contactable consumer or other non health care professional. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient also received tofacitinib citrate (XELJANZ XR, Batch/Lot Number: EE7546, oral) from an unspecified date to an unspecified date, at 11 mg, 1x/day for an unspecified indication. The patient medical history included rheumatoid arthritis. Concomitant medications included alendronate sodium hydrate, budesonide, formoterol fumarate (SYMBICORT), meloxicam, pridinol mesilate (MELOXICAM - PRIDINOL TEVA), famotidine, sulfasalazine, all taken for unknown indications from an unknown date. The patient previously took aspirin and experienced allergy, penicillin g procaine and experienced allergy, enbrel and experienced allergy. It was reported that Patient advised that when she took the covid vaccine she became very sick and cold not take her meds for 7 days. The reporter assessed the event as non-serious. Reporter consider event caused by suspect product was not known. The action taken in response to the event for tofacitinib citrate was unknown. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: All over body aches; severe headache; fever for 3 days so far; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EW0168) via an unspecified route of administration, administered in the left arm on 15May2021 17:00 (at the age of 52 year old) as dose number unknown, single for COVID-19 immunisation at pharmacy or drug store. Patient was not pregnant at the time of vaccination. Medical history included covid-19 (if covid prior vaccination: Yes). Patient had no known allergies. Concomitant medication(s) included bupropion, sertraline. No other vaccines were given within 4 weeks. Since the vaccination the patient had not been tested for COVID-19. On 16May2021 02:00 the patient experienced all over body aches, severe headache, fever for 3 days so far. The patient underwent lab tests and procedures which included sars-cov-2 test resulted yes on an unknown date, body temperature: result: unknown on 16May2021. No treatment was received. Events were not assessed as serious. The clinical outcome of the events all over body aches, severe headache was reported as not recovered and fever for 3 days so far was reported as recovered on May2021.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: a patient received a first dose of Pfizer covid vaccine and now has received his second dose as Moderna; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that we have a situation at one of our pharmacies where a patient received a first dose of Pfizer covid vaccine and now has received his second dose as Moderna vaccine. Asking for the guidance on what we need to do. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient reported for herself). A patient, of unspecified age, received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EW0182), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Historical vaccine included the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Reportedly, eight days after the second dose, patient experienced some rashes on her arms and they expanded to other parts like stomach, back and legs. The outcome for the event: unknown. No follow-up attempts completed. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Blood test, Inflammation, Lymphadenopathy, Physical examination
Clinical narrative: Inflammation; my lymph nodes were swollen but I also have like this lymph node near my collar bone/Swollen lymph node next to collar base; Armpit soreness; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 42-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot Number: EW0183, Expiration date: not reported) via intramuscular, administered at hospital in left arm on 17May2021 at 11:00 (at the age of 42-years-old) as dose 2, single for covid-19 immunization. Medical history included, GERD/Acid Reflux start from Oct2020 to ongoing, Melanoma start and stop on Oct2008, Stage 1- surgery cancerous removed mole. Family medical history includes Autoimmune disease (e.g. diabetes), colon cancer, heart disease. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE; Lot Number: EW0171), via Intramuscular in the right arm on 24Apr2021 at 13.00 (at the age of 42-years-old) as a single dose for COVID-19 immunization. Concomitant medication(s) included omeprazole (OMEPRAZOLE) taken Every other day by oral/mouth for gastrooesophageal reflux disease from Nov2020 to May2021; colecalciferol (VIT D [COLECALCIFEROL) taken for an unspecified indication, start and stop date were not reported. On 17May2021, patient experienced armpit soreness, on 19May2021 at 09.00, my lymph nodes were swollen but i also have like this lymph node near my collar bone/swollen lymph node next to collar base visited to physician office, On an unspecified date, inflammation. Patient did not received any treatment. Two days after receiving the second Pfizer dose, I noticed a lump on my collarbone not too far from the site where I received the injection. The lump was large and felt hard. Later in the day, I noticed it would move up and down and disappear. For two weeks now, it still pops out but moves and disappear behind the collarbone. It has decreased in size and is very mobile. The nurse told me it can take 2-4 weeks to dissolve. On an unspecified date, patient underwent lab tests and procedures which included on an unspecified date, blood test: came back fine, physical examination: came back great. The outcome of event inflammation was unknown rest all events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion
Clinical narrative: Same bruising on bridge of nose; Random bruises on arms; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0172; Expiration Date: 31Aug2021), via an unspecified route of administration in left arm on 27Apr2021 (at the age of 40-year) as dose 2, single for COVID-19 immunization. Medical history included ongoing factor v leiden mutation which she was diagnosed at 25 years old and takes Baby Aspirin and had no issues for years. The patients concomitant medications were none. The historical vaccines include bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0150; Expiration Date: 31Jul2021), via an unspecified route of administration in left arm on 06Apr2021 as dose 1, single for COVID-19 immunization. On an unspecified date in May2021 the patient randomly started to experience bruising that started in the left arm. It was in the forearm where an IV would typically be put in the vein. There were 3 or 4 bruises there. It started in her right arm and they are all about the same size, ranging from the size of a Nickel to the size of a quarter. They were all similar in colour. On 18May2021 she woke up and had one on the inner side of the left side and bridge of her nose. This was highly unusual. It was the same appearance, was the same size and same discoloration. The patient felt it was odd and felt like when you hit your arm and have random bruising. There were too many random bruises and she does not usually really bruise easily.  The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Night sweats, Pyrexia, Spleen disorder
Clinical narrative: lymphadenopathy; had swollen spleen; night sweats; slight fever; This is a spontaneous report from a contactable consumer (patient's brother-in-law). An unknown age of male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: not reported) on unspecified date for covid-19 immunisation. On an unspecified date the patient experienced lymphadenopathy, swollen spleen, night sweats and slight fever. The reporter reported that the patient's brother-in-law received the Pfizer covid vaccine second dose. He's been in and out of the hospital for about a month now, this is the 3rd time. They were thinking throughout this time it could by lymphoma. They did a biopsy and was negative. There are doctors that said all along it wasn't lymphoma. Now they are back to thinking it was the vaccine. The patient wanted to know about the 0.8% of lymphadenopathy. The outcome of the events was unknown.  Follow-up (21May2021): This is a follow-up spontaneous report from a contactable consumer included: Reporter details were added.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Inflammation, Insomnia, Malaise, Neck pain
Clinical narrative: didnt feel well; arm inflammation; pain all night in my neck and my back; pain all night in my neck and my back; I could not sleep; terrible fever; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional via medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 12May2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. She started having side effects 4 days later. On 16May2021, the patient did not felt well, had arm inflammation, pain all night in her neck and her back, she could not sleep, had terrible fever. She asked if she need to get tested for corona virus. Outcome of the event terrible fever was not resolved and outcome of rest all events were unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: didnt feel well; arm inflammation; pain all night in my neck and my back; pain all night in my neck and my back; I could not sleep; terrible fever; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional via medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 12May2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. She started having side effects 4 days later. On 16May2021, the patient did not felt well, had arm inflammation, pain all night in her neck and her back, she could not sleep, had terrible fever. She asked if she need to get tested for corona virus. Outcome of the event terrible fever was not resolved and outcome of rest all events were unknown.  Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain assessment
Clinical narrative: Right now, it has almost been like 25 days, shoulder is in pain; This is a spontaneous report from a contactable consumer (patient) or other non-health professional.  A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8733), via an unspecified route of administration, on 03Apr2021 (at the age of 51-year-old), in arm right (right shoulder), as dose 2, single for COVID-19 immunization.Medical history included his leg is also broken from an unknown date and unknown if ongoing. There were no concomitant medications. Patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199), via an unspecified route of administration, on 11Mar2021 (at the age of 51-year-old), in left shoulder, as dose 1, single for COVID-19 immunization. On unspecified date patient experienced Right now, it has almost been like 25 days, shoulder is in pain. Patient had made an appointment with another Doctor to check out his shoulder and to take a picture with an X-ray. Right now, the patient's shoulder is in pain. Patient did not know what was going on with his shoulder, so he made an appointment with the doctor. Patient reported that something inside, but not too much pain. After two days, the pain was powering forward. Patient reported that his pain is a 6 on a 1-10 scale and almost like 25 days, not sure what day this began. Patient stated this is ongoing and he does not know if it has improved, is persisting or worsened. Patient clarified that his leg was broken prior to receiving either dose of the Pfizer Covid 19 Vaccine. On unspecified date the patient underwent lab tests and procedures which included pain assessment: 6, his pain is a 6 on a 1-10 scale. The clinical outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: developed a huge bruise on the injection site; This is a spontaneous report from a contactable consumer or other non hcp. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL3302) via an unspecified route of administration, administered in left upper arm, on 21Jan2021 (at the age of 58 year), as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EK9231) via an unspecified route of administration, administered in left upper arm, on 31Dec2020 (at the age of 58 year), as dose 1, single for COVID-19 immunization. The patient stated, she was calling about the COVID-19 vaccine. The patient stated, she had the first shot on 31Dec2020 and the second shot on 21Jan2021. The patient stated, she has been reading about delayed reactions and all of a sudden about a week ago, on unspecified date in 2021 she has a huge bruise where the injection site was, and it is getting bigger and darker. The patient asked, she wants to know if this could be part of a delayed reaction. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Headache, Insomnia
Clinical narrative: Loss of energy; Stomachache; Difficulty sleeping; Headache; This is a spontaneous report based on the information received by Pfizer from Abbvie (Mfr. Control No: 21K-163-3898875-00). This is a spontaneous report from a contactable physician. A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single (at the age of 42-years-old) for covid-19 immunisation and adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at for hidradenitis. The patient medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unspecified date the patient experienced loss of energy, stomachache, difficulty sleeping and headache. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: a month later the itching started; This is a spontaneous report from a contactable consumer (patient). A female patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EP7534, Expiry date: unknown), via unspecified route on 05Feb2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. On 05Feb2021, the patient received the last dose of Covid-19 vaccine. On 05Mar2021, the patient started experiencing itching. The patient asked if someone reported severe itching after receiving the vaccine. The patient think that symptoms because of lymphoma and thinks that it may be causing them. The outcome of the events was unknown.  No follow-up attempts were completed; information about lot/batch number cannot be obtained.