chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Drug interaction, Tooth abscess
Clinical narrative: has an abscess on her tooth; some reactions with her heart and blood thinner medications; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 73-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation. Medical history included heart and blood disorder condition. The patient concomitant medication included heart and blood thinner medications. On an unspecified date, the patient had an abscess on her tooth and wanted to know if there are complications with that and getting the vaccine as patient due to get 2nd dose of vaccine. The patient also mentioned that she was having some reactions with her heart and blood thinner medications. The patient asked if there are any interactions with her heart medications and blood thinners with the vaccine to cause her reactions. It was reported that, the patient was referred to health care profession and informed when vaccinating persons with increased bleeding risk, providers often avoid giving intramuscular injections (not just this vaccine) or choose alternative routes because of the risk for hematoma formation after injections. The Pfizer-BioNTech COVID-19 Vaccine should only be administered as an intramuscular injection. The outcome of event was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: This is a spontaneous report from a contactable consumer or other non health professional (patient). A female patient of an unspecified age received BNT162B2 (COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took 1 dose of BNT162B2 (COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1 ST DOSE, SINGLE DOSE for covid-19 immunisation. It was reported that, the patient had quite a reaction with the second dose of the COVID-19 vaccine which made her really sick. She wants to know if the booster dose of the vaccine contains the same ingredients. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Pain, Vaccination site mass
Clinical narrative: This is a spontaneous report from a contactable consumer or other non health professional (patient). A female patient of an unspecified age received BNT162B2 (COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took 1 dose of BNT162B2 (COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1 ST DOSE, SINGLE DOSE for covid-19 immunisation. It was reported that, the patient had quite a reaction with the second dose of the COVID-19 vaccine which made her really sick. She wants to know if the booster dose of the vaccine contains the same ingredients. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Feeling abnormal, Lymph nodes scan abnormal, Nodule, Swelling
Clinical narrative: Caller stated she had a CT scan and was told the lymph nodes are reactive.; Caller stated she did not pay attention; Caller stated they are hard, round nodules; Noticed swelling in her neck; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 67-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection, Lot number and Expiration date were not reported), via an unknown route of administration on 03Mar2021 as, single dose for covid-19 immunisation. Medical history included, on 24Jan2021 she woke up and had swollen lymph glands on the same side, had wrist surgery on an unknown date. The patient's concomitant medications were not reported. The patient received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection, Lot number and Expiration date were not reported), dose 1 via an unknown route of administration on an unknown date in Feb2021 as single dose for covid-19 immunisation. The patient previously took doxycycline. The patient reported that, she did not paid attention and one morning she was brushing her teeth and noticed swelling in her neck. It was reported that since 03Mar2021 she had the hard, round nodules and swelling in her neck. She had a CT scan and was told the lymph nodes are reactive. The patient reported that the HCP was not sure why they are there and had made a case via a conference to see if this was from the vaccine or not. HCP told that it could be correlated to the immune system. The patient wanted to ask how many other people reported the same thing. The outcome of events was unknown.  Follow up information has been requested.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: This is a spontaneous report from a contactable consumer. This 91-year-old female consumer (patient) reported for herself that she received bnt162b2 (COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 06May2021 (at the age of 91-year-old) at 1st dose single for COVID-19 immunization. The patient was scheduled for her second dose tomorrow. The patient medical history and concomitant medications were not reported. On May2021, after the first dose the patient experienced metallic taste that tasted iodine, patient mentioned that it went away immediately. It was reported that patient did not provide her prescribing physicians information. Patient wanted to know if this has been a reported side effect of the vaccine and if so, should she proceed in getting her second dose. Her physician advised her to proceed in taking the second dose. Response: Spoke as per attached (Off-Label or No Info) (v15.0). No info found as per the CONS-what are the risks of the vaccine (v7.0) and the updated FACT SHEET FOR RECIPIENTS AND CAREGIVER, under WHAT ARE THE RISKS OF THE COVID-19 VACCINE. Also spoke from the FAQ-COVID-19 Vaccine-receiving second dose after side effect from first dose (v1.0) stating that "The decision to receive the second dose for any other reason cannot be made by . We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knew your health situation and has access to information that can better help inform this decision. Referred to HCP for best clinical recommendation. The outcome of event was recovered on May2021. Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Gait disturbance, Lymphadenopathy, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old female patient received the first dose of BNT162B2(COVID-19 VACCINE, formulation: solution for injection, (Batch/Lot number was not reported) via an unspecified route of administration on 14May2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 14May2021 the patient experienced barely walk (gait disturbance). In May2021, for a good 8-9 days under armpit and breast side of vaccine, swollen (swelling), still feeling pain and tenderness (pain), still feeling pain and tenderness (tenderness), pain under my arm pit (axillary pain), still tired (fatigue), lymph node swollen (lymphadenopathy). The patient was still tired and feel like it's not her, still pain under my arm pit, breast is not swollen, it's a little tender, not like it was last week. Still tired, pain under armpit, not going away, it's tolerable but not comfortable.  After this experience, the patient was hesitant to get the second dose. Her appointment was scheduled on 04June2021. The doctor said to wait an extra week. The clinical outcome for I could barely walk was unknown, and the clinical outcome for the events swelling, still feeling pain and tenderness, still pain under my arm pit, still tired, lymph node swollen was not recovered. Information on lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tenderness
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old female patient received the first dose of BNT162B2(COVID-19 VACCINE, formulation: solution for injection, (Batch/Lot number was not reported) via an unspecified route of administration on 14May2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 14May2021 the patient experienced barely walk (gait disturbance). In May2021, for a good 8-9 days under armpit and breast side of vaccine, swollen (swelling), still feeling pain and tenderness (pain), still feeling pain and tenderness (tenderness), pain under my arm pit (axillary pain), still tired (fatigue), lymph node swollen (lymphadenopathy). The patient was still tired and feel like it's not her, still pain under my arm pit, breast is not swollen, it's a little tender, not like it was last week. Still tired, pain under armpit, not going away, it's tolerable but not comfortable.  After this experience, the patient was hesitant to get the second dose. Her appointment was scheduled on 04June2021. The doctor said to wait an extra week. The clinical outcome for I could barely walk was unknown, and the clinical outcome for the events swelling, still feeling pain and tenderness, still pain under my arm pit, still tired, lymph node swollen was not recovered. Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Mean cell haemoglobin, Mean cell haemoglobin decreased, Mean platelet volume, Mean platelet volume decreased
Clinical narrative: This is a spontaneous report from a contactable physician. A female patient of an unspecified age received first dose of BNT162B2(COVID-19 VACCINE; formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04May2021 as single dose for covid-19 immunisation. The patient s medical history and concomitant medications were not reported. On unspecified day on May2021 the patient went to urgent care to be treated for chest tightness, Her CBC showed her MCH slightly decreased, mean platelet volume decreased to 9.1, and her WBC increased at 11.4. She is concerned that it might not be safe for her to get the second dose this Saturday 29May2021 with her WBC being elevated. The patient wanted to know if it is expected that the WBC level will increase after this vaccine. The patient underwent lab tests and procedures which included mean cell hemoglobin, slightly decreased, mean platelet volume: 9.1, Mean platelet volume decreased to 9.1, white blood cell count: 11.4. WBC increased at 11.4. Therapeutic measures were taken as a result of the patient recently went to urgent care to be treated for chest tightness. No further information found for increased WBCs/lymphocytes. The outcome of the events were unknown. Follow up attempts are needed. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count increased
Clinical narrative: This is a spontaneous report from a contactable physician. A female patient of an unspecified age received first dose of BNT162B2(COVID-19 VACCINE; formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04May2021 as single dose for covid-19 immunisation. The patient s medical history and concomitant medications were not reported. On unspecified day on May2021 the patient went to urgent care to be treated for chest tightness, Her CBC showed her MCH slightly decreased, mean platelet volume decreased to 9.1, and her WBC increased at 11.4. She is concerned that it might not be safe for her to get the second dose this Saturday 29May2021 with her WBC being elevated. The patient wanted to know if it is expected that the WBC level will increase after this vaccine. The patient underwent lab tests and procedures which included mean cell hemoglobin, slightly decreased, mean platelet volume: 9.1, Mean platelet volume decreased to 9.1, white blood cell count: 11.4. WBC increased at 11.4. Therapeutic measures were taken as a result of the patient recently went to urgent care to be treated for chest tightness. No further information found for increased WBCs/lymphocytes. The outcome of the events were unknown. Follow up attempts are needed. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from contactable consumer (patient wife) reported for patient (reporters husband). This report 3 of 3. A male patient of an unspecified age received bnt162b2 (COVID-19 MRNA VACCINE Solution for injection Lot/Batch number was not reported) via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. While caller (patient wife) was reporting symptoms, her daughter had experienced after the COVID vaccine, said that her husband went the same day as she did and felt nothing but had a little sore arm but did provide any further details. The clinical outcome of the event was unknown. Follow-up attempts are needed. further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Eructation, Ultrasound abdomen
Clinical narrative: bloating; burping; diarrhea; This is a spontaneous report from a contactable physician reported for 2 patients, this is for the 2nd of the 2 patients.  A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 25Apr2021 (at the age of 50-year-old) (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Solution for injection) on an unknown date for covid-19 immunization. It was reported that, Patient received her 2nd Pfizer vaccine dose on 25Apr21, Since her 2nd dose she experienced bloating, burping and diarrhea for over a month now, on an unspecified date. Physician reported that, Patient had no pain and her abdominal ultrasound was normal. Also reported that, If that continued, Physician would do CT scan in couple of weeks but he thought it was related to the vaccine. Ethylene Glycol is an ingredient and it is stool softener. So that all made sense." Outcome of the events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) :  same reporter/drug/AE with different patient
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling abnormal, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This is one of the 3 cases from same reporter. A 48-years-old female patient received second dose of bnt162b2 (COVID-19 mRNA VACCINE, Solution for injection, Lot /Batch Number: ER8736 and expiry date was not reported) via an unspecified route of administration in left deltoid at left upper shoulder on 17May2021 (at age 48-years-old) as a single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. No relevant family medical history was reported. No Prior Vaccinations within 4 weeks. No additional vaccine was administered on same date. Patient had previously received first dose of vaccine (LOT: ER8733; EXP: unknown) in left upper shoulder on 26Apr2021 and experienced fatigue. On 18May2021 (1 day after vaccination), patient was just tired (fatigue) and arm hurt really bad/ Her arm was really sore. She had gotten it in the left arm. She didn't throw up or anything. She was also dizzy and nauseous. Around lunch time, around noon, it really picked up and she got the chills for a short period of time, low grade fever and body aches. On an unknown date in May2021 (reported as the for the next day) She felt lousy. By around noon the next day she was back to normal. She worked half the day and ended up taking the rest of the day off and the next day off to recover. She wasn't scared or worried. No Treatment was received. Patient did not visit emergency room or physician office. Reporter seriousness for all events was unspecified. On an unspecified date in May2021, the patient resolved from the event "felt lousy". The outcome of other events was unknown. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This is one of the 3 cases from same reporter. A 48-years-old female patient received second dose of bnt162b2 (COVID-19 mRNA VACCINE, Solution for injection, Lot /Batch Number: ER8736 and expiry date was not reported) via an unspecified route of administration in left deltoid at left upper shoulder on 17May2021 (at age 48-years-old) as a single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. No relevant family medical history was reported. No Prior Vaccinations within 4 weeks. No additional vaccine was administered on same date. Patient had previously received first dose of vaccine (LOT: ER8733; EXP: unknown) in left upper shoulder on 26Apr2021 and experienced fatigue. On 18May2021 (1 day after vaccination), patient was just tired (fatigue) and arm hurt really bad/ Her arm was really sore. She had gotten it in the left arm. She didn't throw up or anything. She was also dizzy and nauseous. Around lunch time, around noon, it really picked up and she got the chills for a short period of time, low grade fever and body aches. On an unknown date in May2021 (reported as the for the next day) She felt lousy. By around noon the next day she was back to normal. She worked half the day and ended up taking the rest of the day off and the next day off to recover. She wasn't scared or worried. No Treatment was received. Patient did not visit emergency room or physician office. Reporter seriousness for all events was unspecified. On an unspecified date in May2021, the patient resolved from the event "felt lousy". The outcome of other events was unknown. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site warmth
Clinical narrative: This is a spontaneous report from a non-contactable consumer or other non hcp. A 63-years-old female patient received bnt162b2 (BNT162B2; Solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history included ongoing psoriasis, ongoing restless legs syndrome, uterine leiomyoma from an unknown date and unknown if ongoing , cyst from an unknown date and unknown if ongoing , primary progressive multiple sclerosis from an unknown date, ongoing ear infection , ongoing glucose tolerance impaired , ongoing fibromyalgia. Concomitant medication(s) included ocrelizumab (OCREVUS), clonazepam (KLONOPIN), apremilast (OTEZLA), metformin (METFORMIN) and duloxetine (DULOXETINE) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient had a big lump the size of a lemon at the injection site which led to vaccination site reaction and vaccination site warmth. She described the lump as hard and hot. The clinical outcome of the events was recovering. No further information was reported. Information about batch/ lot number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer (patient's Mother) reported for a 20-year-old female patient (reporters daughter). A 20-years-old female patient received first dose of BNT162B2 (COVID-19 VACCINE, Formulation: Solution for injection, lot number: ER8733; Expiration date: Jul2021) via an unspecified route of administration, administered in Arm upper Right on 29Apr2021 13:30 (at the age of 20-year-old) as 1st dose single for COVID-19 immunization. The patient medical history (including any illness at time of vaccination) were not reported. The concomitant medication included Sometimes, the patient will mix up Calm, which is like magnesium. She mixes a teaspoon with water. It is not something her patient drinks every day, it is like a supplement mineral. She didn't give it to her for days before, maybe even a week. The patient received her last vaccine was the flu vaccine on unspecified date on September. Patient had not had any allergies and no family history relevant to adverse events. The reporter stated that her daughter just finished college and has to work at a day care this summer. They just had an outbreak in April and thought after that, it might be a good idea to make sure her daughter is protected, especially when she goes back to college in the fall, they are not doing remote anymore and caller wanted her to be protected. The patient experienced sore arm on an unspecified date. After the first dose of vaccination on 29Apr2021 and had no reaction at all. She had a little sore arm but it was no big deal (stated by reporter). She had a little sore arm. She had not any blood work done recently. She had her yearly check up last September. The outcome of event was recovered. Information on lot number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient) or other non-hcp. A patient of unspecified age and gender received BNT162B2 (COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 09May2021 as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced left shoulder is still tender where I had the shot at, it is still tender. The clinical outcome of the event was unknown. Follow up attempts needed. Further information is expected
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Pruritus, Rash
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-healthcare professional. An 82-years-old female patient received second dose of BNT162B2 (COVID-19 mRNA VACCINE, Formulation: Solution for injection, batch/lot number: not reported) via an unspecified route of administration on 04May2021 as single for COVID-19 immunisation. The patient received first dose of bnt162b2 (BNT162B2) on 04Apr2021. The patient medical history and concomitant medications were not reported. A week after administration of second dose of vaccination, the patient had a measles-like condition on her skin, all over the body. It was described as not like a rash but more like measles, it started small and spreading like measles or a chickenpox where in it looked like blood patches and it has been getting worse and bigger and itching from inside out and has been eating her up. She has already consulted her general doctor and dermatologist and had 3 biopsy to see what else they can do. The dermatologist said that they had a report filed on this but no reference number and that the caller should also report. The caller also added that she felt bad because she was the one who had her mother get vaccinated, where in she could have just stayed in the house and not catch the disease. Caller is asking for any advise on how to improve her mother's condition since it has been getting worse by the day. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient of unspecified age received bnt162b2 (COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration on an unknown date as unknown, single for COVID-19 immunisation. On an unknown date, the patient experienced headache, fever, chill, muscle pain and low energy. The outcome of all the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient himself). A 39-year-old male consumer received bnt162b2 (BNT162B2, COVID-19 VACCINE; formulation: Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration on Friday, 21May 2021 (at the age of 39-years-old) as Unknown dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported. On the day of vaccination, he felt a slight numbness of the face, on the right side, above the eyebrow and the outside corner of eye and ending up in the jaw, he was let it go at that time when he leaving the vaccination center, But these days he felt that tingling or numbness again. Also felt tingling in hand. Patient was asked whether any reports on this. Events were considered as non serious. The outcome of the both events was reported as not recovered. Information about lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site swelling, redness, itching and a knot at the injection site; injection site swelling, redness, itching and a knot at the injection site; injection site swelling, redness, itching and a knot at the injection site; injection site swelling, redness, itching and a knot at the injection site; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 35-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 18May2021 (35-years-old at the time of vaccination) as first dose, single for COVID-19 immunization. Medical history included allergic to Zithromax, allergic to Sulfa and seasonal allergy. The patient concomitant medications were not reported. On May2021, the patient experienced injection site swelling, redness, itching and a knot at the injection site. Patient states it went away but then came back 8 days later. Patient would like to know if it is normal for side effects to go away and then come back. Patient states she does not have a provider right now to call and see about side effects. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Oedema peripheral, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 56-year-old female patient received first dose of BNT162B2 (COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on Monday 24May2021 (age at vaccination: 56 years) at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 24May2021 night, the patient started feeling tingling in her left foot. Patient stated that tingling went away for a little bit but came back worse.  The patient felt like the toes were on fire.  On an unspecified date in May2020, the patient stated that she also has edema in her left leg. Patient was asking whether this was a normal reaction after the vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: This is a spontaneous report from a contactable female consumer reported for herself. A female patient of an unspecified age received first dose of bnt162b2 (COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose in the right arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced a burnt rubber smell. Patient reported that she received her second dose of vaccine in April. One week after her first dose caller began to start experiencing a burnt rubber smell. patient would like to know if that side effect has been reported. The outcome of event was unknown. Response: Reviewed package inset section (6.1 Clinical Trials Experience) Revised: 19May2021; Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unknown age received bnt162b2 (COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unknown route of administration on an unknown date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced slight chest pain. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional. A 63-year-old female patient received second dose of BNT162B2 (COVID-19 VACCINE, Solution for injection, Lot number  and Expiration date was not reported), via an unspecified route of administration on 25May2021 (at the age of 63-years-old) as single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient also received first dose of BNT162B2 (COVID-19 VACCINE , Solution for injection, Lot number and Expiration date was not reported). On an unspecified date the patient had experienced swelling and hotness at injection site. The patient stated that the swelling was in the size of a marble and has been larger and growing. She is asking if this is normal. The outcome of events was unknown. Information about batch/ lot number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp.  A 76-years-old female patient received bnt162b2 (COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20May2021 as 1 st dose single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient is a 76-year-old female patient who received her 1st dose of the COVID Vaccine a week ago today, 20May2021. She mentioned that she experienced basically every side effect on the fact sheet except nausea. She had fever, chills, injection site swelling. injection site redness and warmness, swollen lymph nodes under her left arm, body aches, joint pains, tiredness, headaches, and a general feeling of unwellness. She mentioned that this lasted for 5 days and all came in gradually and not all at once. She is better now as of calling. She was asking if this is to be expected with the 2nd dose as well. The patient enquired whether using a heating pad would affect the effectiveness of the vaccine. The outcome of the events fever, chills, injection site swelling, injection site redness and warmness, swollen lymph nodes under her left arm, body aches, joint pains, tiredness, headaches, and general feeling of unwellness were recovered. Information on the lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp.  A 76-years-old female patient received bnt162b2 (COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20May2021 as 1 st dose single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient is a 76-year-old female patient who received her 1st dose of the COVID Vaccine a week ago today, 20May2021. She mentioned that she experienced basically every side effect on the fact sheet except nausea. She had fever, chills, injection site swelling. injection site redness and warmness, swollen lymph nodes under her left arm, body aches, joint pains, tiredness, headaches, and a general feeling of unwellness. She mentioned that this lasted for 5 days and all came in gradually and not all at once. She is better now as of calling. She was asking if this is to be expected with the 2nd dose as well. The patient enquired whether using a heating pad would affect the effectiveness of the vaccine. The outcome of the events fever, chills, injection site swelling, injection site redness and warmness, swollen lymph nodes under her left arm, body aches, joint pains, tiredness, headaches, and general feeling of unwellness were recovered. Information on the lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp.  A 76-years-old female patient received bnt162b2 (COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20May2021 as 1 st dose single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient is a 76-year-old female patient who received her 1st dose of the COVID Vaccine a week ago today, 20May2021. She mentioned that she experienced basically every side effect on the fact sheet except nausea. She had fever, chills, injection site swelling. injection site redness and warmness, swollen lymph nodes under her left arm, body aches, joint pains, tiredness, headaches, and a general feeling of unwellness. She mentioned that this lasted for 5 days and all came in gradually and not all at once. She is better now as of calling. She was asking if this is to be expected with the 2nd dose as well. The patient enquired whether using a heating pad would affect the effectiveness of the vaccine. The outcome of the events fever, chills, injection site swelling, injection site redness and warmness, swollen lymph nodes under her left arm, body aches, joint pains, tiredness, headaches, and general feeling of unwellness were recovered. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain
Clinical narrative: body aches; nausea; tiredness; This is a spontaneous report from a non-contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 26May2021 as single dose. Historical vaccination included dose 1 of bnt162b2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported)on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reportedly, patient was asking if she is allowed to take her birth control pills regularly after getting her second vaccine dose. Patient reports that she got her second dose of the vaccine yesterday and wanted to make sure she could still take them. patient asking if body aches, nausea and tiredness are normal, how long the symptoms will last and what should I take for the symptoms. Patient reports that she received her second vaccine dose yesterday and reports having read the material from the Pfizer website about possible side effects but now asking if body aches, nausea and tiredness are normal, how long the symptoms will last and what should I take for the symptoms. On an unspecified date, the patient experienced body aches, nausea and tiredness. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: skin rash, described as hives, that has continued to become worse and "doesn't seem to be going away; skin rash, described as hives, that has continued to become worse and "doesn't seem to be going away; skin rash, described as hives, that has continued to become worse and "doesn't seem to be going away; This is a spontaneous report from a contactable consumer (Caregiver reported for his daughter).   A 20-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and expiration were not reported), via an unspecified route of administration on 18May2021 (at the age of 20 years) at single dose for COVID -19 immunisation.   The patient medical history and concomitant medications were not reported. The patient had earlier received first dose of BNT162B2 (Batch/Lot number and expiration was not reported), via an unspecified route of administration on unspecified date as first dose, at single dose for covid-19 immunisation.   Reporter (mother of the patient) had called on behalf of his 20 year old daughter, (name withheld), who received the, the patient had a skin rash, described as hives, that had continued to become worse and "doesn't seem to be going away." Reporter stated that he reported her reaction to their dermatologist online and read online that reaction was rare, but some people had experienced it. Re-porter had enquired about for any resources regarding the side effect that she is experiencing. The outcome for both the events was unknown.   Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: have a smell and taste of decaying fruit; have a smell and taste of decaying fruit; This is a spontaneous report from a contactable consumer reported for herself. A 32-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (vaccination at the age of 32 years) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unknown date for covid-19 immunization. The patient reported that she had both doses of the Pfizer COVID Vaccine. After the second dose, she reported to have a smell and taste of decaying fruit on unknown date. She wants to know if other people have reported that as a side effect and if there is anything she must do. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Contusion, Epistaxis, Peripheral swelling
Clinical narrative: Swollen arm; bruising; Nosebleeds; chest pain; This is a spontaneous report received from Pfizer-Sponsored Program Regulatory Authority reported by a contactable female consumer (patient). A female patient of an unspecified age received bnt162b2 (COVID-19 Vaccine - Manufacturer Unknown Solution for injection Batch/Lot number was not reported) via unspecified route of administration on 10Apr2021 as unknown, single for covid-19 immunization. Medical history and concomitant medications were not reported. On 19Apr2021, the patient experienced adverse effects a few days after including swollen arm, bruising, nosebleeds and chest pain in which she had to go to the emergency room (ER). The clinical outcome of all events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Product leakage, Pyrexia, Swelling, Underdose
Clinical narrative: swollen; mild fever; she did not receive full dose because she felt leaking on her arm; she did not receive full dose because she felt leaking on her arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient. A female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: UNKNOWN), via an unspecified route of administration on 08May2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162b2 on an unspecified date as a single dose for COVID-19 immunization without any issues. It was reported that after second dose administration on 08May2021, half of the dose possibly given according to patient she did not receive full dose because she felt leaking on her arm. The patient stated that she had swollen and mild fever after second dose. The Caller would like to know if they should do a tither test on patient to check for antibodies to vaccine and if the patient should be revaccinated. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Human chorionic gonadotropin, Menstruation irregular
Clinical narrative: she has not had her period yet since 07Mar2021 or 56 days; This is a spontaneous report received from a contactable female consumer reported for herself. A 24-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/Lot number: Unknown, Expiration date: Unknown), via an unspecified route on 23Apr2021 (age at vaccination: 24-year-old) as a single dose for covid-19 immunization. The patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/Lot number: Unknown, Expiration date: Unknown), via an unspecified route on 24Mar2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, patient reported that she has not had her period yet since 07Mar2021 or 56 days. The patient underwent lab test and procedure which included blood drawn for HCG and had been negative for being pregnant. The patient was asking if this is normal or has anyone reported the same side effect. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Depressed mood, Fatigue, Vaccination site pain
Clinical narrative: Feeling down a little bit emotionally; Soreness in the left arm, where he received the injection; Persistent fatigue that becomes overwhelming at times, feeling tired, periods of exhaustion; This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Not reported) via an unspecified route of administration on 18May2021 (at the age of 69-years-old) in left arm as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in May2021, patient experienced soreness in the left arm, where he received the injection, having persistent fatigue that became overwhelming at times, felt tired, felt down a little bit emotionally, periods of exhaustion out of the blue which were periodic, not all the time and the events had gone for probably 5 to 6 days. The events were assessed as non-serious. Patient reported that he will receive the second dose on 03Jun2021 or 06Jun2021, (earlier than the recommended 3-week period) and he asked if he should wait for side effects to resolve before receiving the second dose. He also provided his prescribing physician's information. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Depression, Diplopia, Dizziness, Fatigue
Clinical narrative: fatigue; brain fog; depressed; anxious; double vision; dizziness; This is a spontaneous report from a contactable Nurse (mother) reported for her son. A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown), 1st dose, via an unspecified route of administration on 16Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller which was a mother of patient was inquiring about the side effects which had been experienced by her 46-year-old son since receiving the first dose of the vaccine. She stated that 1-2 weeks after the first dose patient began having fatigue and brain fog. Gradually since then he has become depressed and anxious. She also mentions double vision and dizziness. Caller has questions regarding if these side effects have been reported. Patient inquired about the best way patient can stay updated on the vaccine as new information comes out. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: fatigue; brain fog; depressed; anxious; double vision; dizziness; This is a spontaneous report from a contactable Nurse (mother) reported for her son. A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown), 1st dose, via an unspecified route of administration on 16Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller which was a mother of patient was inquiring about the side effects which had been experienced by her 46-year-old son since receiving the first dose of the vaccine. She stated that 1-2 weeks after the first dose patient began having fatigue and brain fog. Gradually since then he has become depressed and anxious. She also mentions double vision and dizziness. Caller has questions regarding if these side effects have been reported. Patient inquired about the best way patient can stay updated on the vaccine as new information comes out. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.