chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Mild headaches; This is a spontaneous report from a contactable consumer (patient himself). A 81-year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 15Feb2021 (at the age of 80-year old) as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient took 1st dose of 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 (at the age of 80-year-old) as 1st dose, single dose for covid-19 immunisation. The patient stated that he got his second dose of the Pfizer Covid-19 Vaccine last 15Feb2021, but he was still experiencing headaches even after a few months. He wanted to know if headaches were among the reported adverse events (AEs) after getting the PFIZER-BIONTECH Covid-19 Vaccine. No information on headache as an AE on post-authorization experience. The patient stated it was mild headaches. Never used to ever get headaches but he gets them since his 2nd shot. The reporter stated that the events as non-serious. The outcome of the event was not resolved.  Information about lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Skin discolouration
Clinical narrative: Caller developed a tiny little area which is grayish somehow like a bruise on her left arm, on the same arm where she got the vaccine; Caller developed a tiny little area which is grayish somehow like a bruise on her left arm, on the same arm where she got the vaccine; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date: not provided), dose 2 via an unspecified route of administration, on 01Jun2021 at 07:30 (age at the time 75-year-old), as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date: not provided), dose 1 via an unspecified route of administration, on an unspecified route (age at the time 75-year-old), as single dose for COVID-19 immunization. On 01Jun2021, the patient experienced a tiny little area which was grayish somehow like a bruise on her left arm, on the same arm. It was reported that, she was just alarmed as what she had read on the vaccination sheet was just injection site redness and not that one like patient. The patient would like to know if there were reports like the side-effect she had experienced. The outcome of the events was unknown.  Information on lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Pain to hands; Pain to wrists; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient did not have any history of arthritis or joint pains. The patient's concomitant medications were not reported. The patient had pain to hands and wrists on an unspecified date. Patient wanted to know are these side effects caused by the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site pain
Clinical narrative: pain to the injection site and feeling of needles poking around injection site; feeling of needles poking around injection site; This is a spontaneous report from a contactable consumer (patient herself). A 56-year-old female patient received the second dose of 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 (at the age of 56-year-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: 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. On an unknown date, the patient reported "pain to the injection site and feeling of needles poking around injection site (vaccination site discomfort) was a side effect. The patient reported that ever since receiving the second dose of the Pfizer COVID vaccine almost 5 weeks ago, she had pain to the injection arms, but only at the injection site. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymph node pain, Pain in extremity
Clinical narrative: I had stabbing pains in my legs and feet; Sharp needling pain, sharp pains and will go away on the top of my ankle and back and behind knees (where the lymph nodes are)/body aches (sharp pains in the area lymph node areas); Chills; fatigue; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Formulation: Solution for injection, Lot number: not reported), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included Guillain-barre syndrome, inflammation of muscle, muscles got weak, the sun turned green, it took a week for it to go away, allergy to cats and sulfur and heavy dust. Family history included her husband was allergic to everything and her son has lots allergies (not drug allergies) but he was allergic to nature. Her son took Claritin for allergies (but not when he got the vaccine) and she had sharp pains in the area lymph node areas in her early 20s with thimerosal derivative in it. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced stabbing pains in her legs and feet, sharp needling pain, sharp pains and will go away on the top of her ankle and back and behind knees (where the lymph nodes are)/body aches (sharp pains in the area lymph node areas), chills and fatigue. Patient stated, she had side effects too. She did not have chest pain. Information on taking antihistamines with the vaccine was not clear. She had a side effect after the first dose of the vaccine. Should she get the second dose. The prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your doctor/healthcare provider about what you have experienced/are experiencing. The outcome of the events was unknown.  No further follow up attempts needed. No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic shock
Clinical narrative: Anaphylactic shock; This is a spontaneous report from a contactable retired nurse (mother) reported on behalf of the patient. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number was not reported) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history included COVID-19 and drug induced coma and forgetfulness. The caller stated that his son had the long haul symptoms of COVID-19. The caller stated that her son used to be a multitasker, used to do two or three things at a time, a couple of conversations at once and he could no longer do this. The caller stated that her son was also very forgetful. The patient concomitant medications were not reported. The patient experienced an anaphylactic shock and had a same rash on arms (rash as the caller experienced) after receiving the first dose of the vaccine. The caller son showed his arms to his mother and had the same kind of distribution of those little round rashes which the caller also experienced. The caller son arms looked like the callers. The caller stated that after her son received the first dose Pfizer Covid Vaccine, he could not breathe. The caller stated that her son was definitely lucky and he was still at the vaccination facility and the persons at the facility handled it. The caller stated that her son will not take the second dose Pfizer Covid Vaccine. The case was considered as serious due to the event (anaphylactic shock). The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The event anaphylactic shock was considered related to suspect drug based on strong temporal association and known safety profile of the drug.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Went to the Internist and had the kind of rash all over body; This is a spontaneous report from a contactable nurse (reported for her girlfriend). A female patient of an unspecified age received BNT162B (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection) 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 went to the Internist and had the kind of rash all over body. The outcome of the event was unknown.  Information on the lot/batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: patient was able to stick a magnet to the injection site/magnetic effects at the injection; This is a spontaneous report from a contactable consumer (patient's wife) via medical information team. A male patient (spouse) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on 11May2021 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was able to stick a magnet to the injection site/magnetic effects at the injection site on an unspecified date. The outcome of the event unknown.  No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021634416 Same reporter/drug/event, different patients
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Arthralgia, Contusion, Pain in extremity
Clinical narrative: First dose: Her arm was sore; bruise; It has been almost 80 days, and she is still having extreme pain, in every part of her joints.; Her period stopped after she got the covid vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP7537), via intramuscular route of administration, administered in Left Arm on 24Mar2021 14:00 (at the age of 50-years-old) as 1st Dose, Single Dose for COVID-19 immunization. The patient's medical history included migraine, she takes migraine medication as needed. The patient's concomitant medications were not reported. The reporter stated that on an unspecified date in 2021, It has been almost 80 days, and she is still having extreme pain, in every part of her joints. On 25Mar2021, first dose: Her arm was sore: It lasted for three or four days. on an unspecified date in 2021, It hurt like a bruise would, but there was no bruise. on an unspecified date in 2021, her period stopped after she got the covid vaccine. Her period has always been really heavy. The patient last had her period a month before the covid vaccine. The patient thought she would let it be for a while. The patient went and saw her OBGYN (obstetrics and gynaecology), and he said that she could call Pfizer and report about it. Her OBGYN told her that a lot of women are having interruptions with their period, some women's periods are not coming back, or are coming back heavier. The patient's last period was 10Feb2021. The patient uses a period tracking app. The patient's period was 84 days late. The patient did not undergo any laboratory test. The event her period stopped after she got the covid vaccine included physician Office Visit. The outcome for the events was unknown.   Follow-up attempts are possible, additional information has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Headache, Pruritus, Pyrexia
Clinical narrative: speech difficulties (couldn't think of words, slurred words); Blurry eyesight; fever; clammy skin; headache; fatigue; itching skin; loss the ability to focus eyesight on phone, computer screen or books.; This is a spontaneous report from a Non-Contactable consumer (patient).  A 40-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3302), via unspecified route of administration in the Left arm, on 25May2021 at 10:30 AM, as a single for COVID-19 immunisation. Medical history included Hypothyroid. Concomitant medications included armour, liothyronine and spironolactone. The patient had no known allergies. On 25May2021 at 02:30 AM, the patient experienced Blurry eyesight, fever, clammy skin, headache, fatigue, itching skin, speech difficulties (could not think of words, slurred words), loss the ability to focus eyesight on phone, computer screen or books. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. The patient was not tested for COVID-19 post vaccination. The patient did not received treatment for the events. The outcome of the events was recovered with lasting effects.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder, Vision blurred
Clinical narrative: speech difficulties (couldn't think of words, slurred words); Blurry eyesight; fever; clammy skin; headache; fatigue; itching skin; loss the ability to focus eyesight on phone, computer screen or books.; This is a spontaneous report from a Non-Contactable consumer (patient).  A 40-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3302), via unspecified route of administration in the Left arm, on 25May2021 at 10:30 AM, as a single for COVID-19 immunisation. Medical history included Hypothyroid. Concomitant medications included armour, liothyronine and spironolactone. The patient had no known allergies. On 25May2021 at 02:30 AM, the patient experienced Blurry eyesight, fever, clammy skin, headache, fatigue, itching skin, speech difficulties (could not think of words, slurred words), loss the ability to focus eyesight on phone, computer screen or books. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. The patient was not tested for COVID-19 post vaccination. The patient did not received treatment for the events. The outcome of the events was recovered with lasting effects.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Headache, Vaccination site pain
Clinical narrative: Headache; Left arm sore from injection; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 33-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration, administered in left arm on an unspecified date (Lot number and expiry date was not reported) as single dose for COVID-19 immunization. The patient's medical history included rheumatoid arthritis, upper respiratory infections and she was diagnosed in 2004. Stated that she recovered completely from stopping Methotrexate and Enbrel. Stated that she stopped taking Enbrel in late 2004 then she switched from Enbrel to Humira in 2004-2005. When she took Enbrel and used to get huge bruises on her legs that everything was black and blue. Temporary stop on Methotrexate in 2008-2010 due to being in remission. Stated that she had a permanent stop on Methotrexate injections a couple of years before. Stated that she took it for a 9-month window. The patient's Concomitant medication included Tofacitinib citrate (XELJANZ XR). On 08Mar2021 the patient experienced headache, left arm sore from injection. The patient underwent lab test and procedures which included blood test: result unknown an unspecified date. The patient took Tylenol as a therapeutic measure for the events. The outcome of the headache was recovered on 09Mar2021. The other event was recovered on 11Mar2021.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Severe migraine; This is a spontaneous report from a non-contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 10May2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 01Jun2021 (reported as today), the patient experienced severe migraine. She wanted to know if she can take Advil but fully aware as well that they should not take medicines in between doses so should she wait 1 more week after taking the 2nd dose. The outcome of the event was unknown.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Nausea, Pain, Sensory loss
Clinical narrative: Nausea; Body ache; Loss of feeling in the left arm; I have numbness and loss of feeling in left arm; Tightening in my fingers.; This is a spontaneous report received from a contactable male consumer (patient). A 33-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0176, Expiration date: unknown), via unspecified route, on 27may2021 over left arm (at the age of 33-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Her second is scheduled on 17jun2021. No other vaccines were taken prior 4 weeks. Family medical history was reported as blood pressure. On 30may2021 at 10:00, 3 days 10 hours after the vaccination, the patient experienced Nausea, Body ache, Loss of feeling in the left arm, numbness in left arm, Tightening in my fingers. The reporter assessed all events as non-serious. She wanted to know if the presented reactions are normal or not. She also asked about the need of meeting a doctor. The outcome of all the events was unknown.  No follow-up attempts possible. No further information expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Sinus pain, Swelling face
Clinical narrative: At 36 hrs post 2nd dose severe left jaw and maxillary sinus pain overnight. At 72 hrs post 2nd dose dermal fillers injected February 3rd under eye, on right side became lumpy. A lump and then a ridge; eye puffiness; eye swelling; This is a spontaneous report from a contactable other hcp. A 63-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: ER8735), via an unspecified route of administration, administered in Arm Left (at age of 63 years) on 12Apr2021 12:00 as 2nd dose, single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY), fluticasone propionate (FLONASE ALLERGY RELIEF). The patiently previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 15Mar2021 as 1st dose, single dose for covid-19 immunisation (at the age of 63 years). No other vaccine in four weeks was given to patient. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. It was reported that at 36 hours post 2nd dose severe left jaw and maxillary sinus pain overnight. At 72 hours post 2nd dose dermal fillers injected February 3rd under eye, on right side became lumpy. A lump and then a ridge developed, as well as bilateral under eye puffiness. This prompted an initial visit to dentist with follow up, oral surgeon. Visit to D.O. Regarding filler bumps. Then visit to dermatologist for unresolved bump/ridge and under eye swelling. Finally, a visit to plastic surgeon. The outcome of the events was reported as not recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, sinus pain, eye swelling, face swelling cannot be completely ruled out. The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethic committees, and Investigators, as appropriate.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Malaise, Mobility decreased
Clinical narrative: feeling exhausted/fatigue/he felt tired; not feeling well/feels crummy; body aches; fever/temperature was 99.1; running nose; stuffy head; a little weak; barely could get out of bed; sore throat; This is a spontaneous report from a contactable consumer (parent) via medical information team reported for a 17-year-old male patient (son). A 17-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration on 29May2021 11:00 as single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for COVID-19 immunisation. It was reported that caller was calling about his son who recently had his second covid vaccine. He had the first one, no issues and the second shot on Saturday at 11 am. Patient was feeling exhausted/fatigue/he felt tired on 30May2021, not feeling well, body aches, fever all in 2021, took Advil for it and felt normal. still has running nose, stuffy head, sore throat all in 2021. Since then he has felt worse. Each day, he has symptoms. He was feeling a little weak, body aches and temperature was 99.1 and he feels crummy all in 2021. He doesn't know what it seems like, we all had the vaccine. We had Moderna was it normal to have these symptoms. It didn't onset for a couple days later and now its Wednesday he received it on Saturday. He felt a little crummy then on Sunday worse. He wants to know if that's normal or if it continues for another day take him to the doctor. What should he be doing or looking for and today he barely could get out of bed in 2021. The outcome of event malaise was not recovered, for fatigue, general body pain, fever was recovering, for remaining events was unknown.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Rhinorrhoea, Upper respiratory tract congestion
Clinical narrative: feeling exhausted/fatigue/he felt tired; not feeling well/feels crummy; body aches; fever/temperature was 99.1; running nose; stuffy head; a little weak; barely could get out of bed; sore throat; This is a spontaneous report from a contactable consumer (parent) via medical information team reported for a 17-year-old male patient (son). A 17-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration on 29May2021 11:00 as single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for COVID-19 immunisation. It was reported that caller was calling about his son who recently had his second covid vaccine. He had the first one, no issues and the second shot on Saturday at 11 am. Patient was feeling exhausted/fatigue/he felt tired on 30May2021, not feeling well, body aches, fever all in 2021, took Advil for it and felt normal. still has running nose, stuffy head, sore throat all in 2021. Since then he has felt worse. Each day, he has symptoms. He was feeling a little weak, body aches and temperature was 99.1 and he feels crummy all in 2021. He doesn't know what it seems like, we all had the vaccine. We had Moderna was it normal to have these symptoms. It didn't onset for a couple days later and now its Wednesday he received it on Saturday. He felt a little crummy then on Sunday worse. He wants to know if that's normal or if it continues for another day take him to the doctor. What should he be doing or looking for and today he barely could get out of bed in 2021. The outcome of event malaise was not recovered, for fatigue, general body pain, fever was recovering, for remaining events was unknown.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: swollen lymph node under the left armpit; the lymph node used to hurt a lot but now it is just really big; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A 17-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: ER8733) on 02Apr2021 at Noon (age the age of 17-years-old) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EW0170), on 26Apr2021, both doses via an unspecified route of administration, administered in left arm as single dose for COVID-19 immunization. Patient medical history included no other illness except that he usually gets fever after vaccines, no vaccine in particular, just after most vaccines, he gets a fever. There was no history of any previous immunization with Pfizer Vaccine and no additional vaccines administered on same date of vaccination. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Apr2021 (next day after first dose), when woke up, patient experienced swollen lymph node under the left armpit (the same arm he got vaccine), and lymph node used to hurt a lot but now it was just really big. It was still there a month later when he was getting his second dose. The patient mother stated that they wanted to see the doctor to see how bad her son symptoms were and because of pain but the doctor told them to call Pfizer and stated that family doctor does not want to see them because there is nothing that they can do. The events not required any visit to emergency room or physician office. No relevant tests were done. There was no investigation assessment. Reporter stated that he was wondering if this is still normal to be there. The patient did not receive any treatment for the events. The outcome of the event swollen lymph node under the left armpit was not resolved, while outcome of the event lymph node used to hurt a lot but now it was just really big was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Crohn's disease, Pain
Clinical narrative: CROHN'S DISEASE FLARE UP; pain; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer (Mfr. Control Number: 21K-163-3906742-00). A 46-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for Moderate to Severe Adult Crohn's Disease. Patient previously received 1st dose COVID-19 Vaccine (BNT162B2) for COVID-19 immunisation on unknown date.  The patient medical history was not reported.  The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient experienced crohn's disease flare up and pain on an unspecified date with outcome of unknown. The reporter reported the events as non-serious. The action taken in response to the events for bnt162b2 was not applicable, for adalimumab was unknown.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the events of CROHN'S DISEASE FLARE UP and PAIN was not provided. Causality for bnt162b2: the reporter considered the event Crohn's disease aggravated was possibly related to bnt162b2, causality for event pain was not reported.  The reporter's assessment of the causal relationship of the event pain with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A causal association between BNT162B2 and pain cannot be completely excluded based on temporal association and the limited information provided in the report. The reported Crohn's disease flare up is likely due to an underlying medical condition and unrelated to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: experienced numbness on the left side of face; This is a spontaneous report received from a contactable pharmacist. A 39-year-old female patient received fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Age at time of vaccination 39-years-old) as single dose for COVID-19 immunization. The patient medical history, concomitant medications were not reported. Caller has a patient who had the first dose of the Pfizer-BioNTech COVID-19 Vaccine and experienced numbness on the left side of face all the way to the arms that lasted for 2 hours. Patient is a 39-year-old female. She is asking if the patient can still get the second dose. The outcome of event was recovered on an unspecified date.  Information about Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Pruritus, Rash
Clinical narrative: small rash; some itchiness all over his body; It has not gone away and seems to be getting worse.; This is a spontaneous report from a contactable consumer (patient himself). A 69-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 12Apr2021 as SINGLE DOSE for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) for COVID-19 immunization. On an unspecified date patient stated that he received the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine on 12Apr2021. Afterwards, he had a small rash and some itchiness all over his body. He said it has not gone away and seems to be getting worse. He said that has already contact his HCP and was told to take Benadryl or topical solution to treat his symptoms but he still wants to seek guidance from Pfizer. Outcome of event Condition worsened was unknown and not recovered for other events.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Pain at injection site; Achy; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer (patient spouse) reported that an unspecified aged male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single dose and dose 2 via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunization. Medical history included COVID virus and was hospitalized, previous to getting the vaccine. The patient's concomitant medications were not reported. On an unspecified date it was reported as patient's spouse stated that her husband had both of his vaccines, confirmed as the Pfizer COVID vaccine later in the report. He had pain at the injection site and was achy. She stated that her husband had the COVID virus also and was hospitalized, previous to getting the vaccine. She stated that his events were minor and declines to complete a report for him. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Herpes zoster, Pain, Pruritus, Rash macular
Clinical narrative: I was feeling achy and itchy on upper right side of back/Achiness spread to underarm in the next couple days; I was feeling achy and itchy on upper right side of back; I had a few tiny pimple looking spots; red blotches appeared between my back and underarm; shingle; This is a spontaneous report from a contactable consumer (patient herself). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0168), via an unspecified route of administration, administered in Arm Left on 19May2021 at 14:00 (at the age of 42-years-old) as unknown, single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included spironolactone; escitalopram oxalate (LEXAPRO); cannabidiol and (vitamins nos). The patient had no other vaccine in four weeks. The patient not had covid prior vaccination. Consumer stated that, few days after vaccination she was feeling achy and itchy on upper right side of back. She had a few tiny pimple looking spots, but nothing looked concerning. Achiness spread to underarm in the next couple days and then raised red blotches appeared between her back and underarm. Achiness and itching now spread to side of right breast. Doctor's office diagnosed her today with shingles. On 23May2021, the patient experienced Few days after vaccination, I was feeling achy and itchy on upper right side of back/Achiness spread to underarm in the next couple days, I was feeling achy and itchy on upper right side of back, I had a few tiny pimple looking spots but nothing looked concerning. Achiness spread to underarm in the next couple days and then raised red blotches appeared between my back and underarm. Achiness and itching now spread to side of right breast. Therapeutic measures were taken as a result of events and treatment included with Starting an antiviral for 7 days. The patient had not tested covid post vaccination. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Feeling abnormal, Inflammation, Peripheral swelling
Clinical narrative: swollen feet; Soreness in bones; a lot of inflammation; felt bad; This is a spontaneous report from a contactable nurse (patient's wife). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: Not reported, Expiration date: Not reported), dose 1 via an unspecified route of administration on an unspecified date in Mar2021 and dose 2 via an unspecified route of administration on an unspecified date both as single dose for COVID-19 immunization. The patient medical history and the concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced swollen feet, soreness in bones, a lot of inflammation, felt bad. Reporter stated she is a Registered Nurse and just has a quick question that any nurse would have and could answer. She had read where Moderna vaccines had reports of patients developing cardiomyopathy after the vaccine administration. Reporter wanted to know if Pfizer has had the same reports. Reporter stated she was calling about her husband. Reporter stated her husband had the normal side effects like soreness in his bones and he had a lot of inflammation. Reporter stated what she is calling about is that she assessed him like she is always assessing patients and his feet were swollen. She stated she asked him about it and he stated that it was like that after his last shot. That is when she read that Moderna has the issues with cardiomyopathy. She just looked and he had the Pfizer. She stated she was thankful of that. Reporter stated she did not want to classify seriousness of events as she is just calling to ask a question. Reporter was unsure of dates of the adverse events, stating it happened after both doses. Event outcomes were not provided. Reporter stated she did not want to put the seriousness criteria in a category. Reporter stated that she just wanted to ask the question and did not see the need to put these down as they are the normal side effects from the shots. She stated her husband had swelling in his feet and he never had swelling before. Reporter stated again that she just wants to ask the question and doesn't see the need to put these down as they are the normal side effects from the shots. Reporter stated her husband has had both doses of the vaccine. He had bad reactions to both shots but he always has reactions. Reporter stated her husband gets the flu every year and has reactions to the shot. Reporter stated her husband had bad reactions to both doses of the Pfizer vaccine. Reporter stated she had the shot and couldn't even feel it go in they did such a good job. Outcome of the events were reported as unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Nasopharyngitis
Clinical narrative: very strong cold; had a lot of cough; nose is congested; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 1 via an unspecified route of administration on 07May2021 (Lot number: unknown) as single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient felt more or less, she was due to get the second dose of Pfizer's COVID-19 vaccine on Friday 28May, but she had a cold, a strong cold, a very strong cold on an unspecified date. That day she couldn't go out, she had not received the vaccine, she was having a lot of cough and her nose was congested, she had asked question as could she get vaccinated with these symptoms. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Condition aggravated, Headache, Nausea, Rhinorrhoea
Clinical narrative: headache; runny nose; nausea; soreness around the injection site/ 3 to 4 inches below the injection site; pain seems to be getting worse; he can touch his arm and it doesn't feel sensitive at the location.; a constant ache deep in his arm, like in the bone; This is a spontaneous report from a contactable consumer (patient).   A 72-years-old male patient received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown) via an unspecified route of administration in unspecified arm at single dose for covid-19 immunization at the mall. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer Covid-19 vaccine on 06Apr2021 and received the second dose on 27Apr2021. He reported experiencing several side effects for 36 days after administration of the vaccine such as headache, runny nose, soreness around the injection site that was described to be 3 to 4 inches below the injection site, and nausea. He was not sure if the nausea he was experiencing was related to the vaccine. He could touch his arm and it does not feel sensitive at the location. He described a constant ache deep in his arm, like in the bone, and stated the pain was most evident when he raises his elbow to shoulder height. The pain he was experiencing was in the administration arm and described the pain to be in the middle of his arm that has lasted 36 days. He stated if the pain gets any worse than it was then, he will consult with his doctor. That pain seems to be getting worse. He does not believe a needle broke off in his arm. He once experienced a needle break off in his foot during a lidocaine injection between his big toes. He was hoping to find more in-depth information. The outcome of event headache, runny nose, nausea, bone pain and sensation loss were unknown and vaccination site pain and condition aggravated was not recovered.  Information on the lot/batch number and Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Sensory loss, Vaccination site pain
Clinical narrative: headache; runny nose; nausea; soreness around the injection site/ 3 to 4 inches below the injection site; pain seems to be getting worse; he can touch his arm and it doesn't feel sensitive at the location.; a constant ache deep in his arm, like in the bone; This is a spontaneous report from a contactable consumer (patient).   A 72-years-old male patient received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown) via an unspecified route of administration in unspecified arm at single dose for covid-19 immunization at the mall. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer Covid-19 vaccine on 06Apr2021 and received the second dose on 27Apr2021. He reported experiencing several side effects for 36 days after administration of the vaccine such as headache, runny nose, soreness around the injection site that was described to be 3 to 4 inches below the injection site, and nausea. He was not sure if the nausea he was experiencing was related to the vaccine. He could touch his arm and it does not feel sensitive at the location. He described a constant ache deep in his arm, like in the bone, and stated the pain was most evident when he raises his elbow to shoulder height. The pain he was experiencing was in the administration arm and described the pain to be in the middle of his arm that has lasted 36 days. He stated if the pain gets any worse than it was then, he will consult with his doctor. That pain seems to be getting worse. He does not believe a needle broke off in his arm. He once experienced a needle break off in his foot during a lidocaine injection between his big toes. He was hoping to find more in-depth information. The outcome of event headache, runny nose, nausea, bone pain and sensation loss were unknown and vaccination site pain and condition aggravated was not recovered.  Information on the lot/batch number and Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury, Pain, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had them twice within a year / Same place both times... / left back under arm to shoulder blade to spine; Hurt; Itched; Mild cases but left nerve damage; This case was reported by a consumer via media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, pruritus and nerve damage. On an unknown date, the outcome of the vaccination failure, shingles, pain, pruritus and nerve damage were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain, pruritus and nerve damage to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported. The patient had shingles twice within a year after the patient had the shot a year before. Both times, shingles were on left back under arm to shoulder blade to spine. Shingles hurt and itched but the patient did not experience blister. The patient had mild cases but left nerve damage. The patient used dermoplast antiseptic and pain relieving spray. It was the only thing that worked. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset was unknown.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR121438:Same reporter