chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Decreased appetite, Pyrexia
Clinical narrative: chills; lack of energy and appetite; lack of energy and appetite; mild fever; sore arm at injection site; This is a spontaneous report from a contactable consumer. This 32-year-old male consumer (patient) reported that:    A 32-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0151) via an unspecified route of administration in Arm Left on 13Apr2021 at 10:30 AM (age at vaccination: 32-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730) via an unspecified route of administration in Arm Left on 23Mar2021 at 10:30 AM (Age at Vaccination: 32-years-old) as DOSE 1, SINGLE for COVID-19 immunisation and experienced Sore arm at injection site. On 13Apr2021 at 18:00 (on the evening of the same day) patient experienced a mild fever and sore arm at injection site. Next day (14Apr2021) patient had fever, chills, lack of energy and appetite. Patient didn't received treatment for AE. The lab test and procedure includes fever: mild on 13Apr2021 and Fever: Unknown on 14Apr2021. The clinical outcome of the event was recovered on unspecified date on 2021.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: chills; lack of energy and appetite; lack of energy and appetite; mild fever; sore arm at injection site; This is a spontaneous report from a contactable consumer. This 32-year-old male consumer (patient) reported that:    A 32-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0151) via an unspecified route of administration in Arm Left on 13Apr2021 at 10:30 AM (age at vaccination: 32-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730) via an unspecified route of administration in Arm Left on 23Mar2021 at 10:30 AM (Age at Vaccination: 32-years-old) as DOSE 1, SINGLE for COVID-19 immunisation and experienced Sore arm at injection site. On 13Apr2021 at 18:00 (on the evening of the same day) patient experienced a mild fever and sore arm at injection site. Next day (14Apr2021) patient had fever, chills, lack of energy and appetite. Patient didn't received treatment for AE. The lab test and procedure includes fever: mild on 13Apr2021 and Fever: Unknown on 14Apr2021. The clinical outcome of the event was recovered on unspecified date on 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact, Lip swelling
Clinical narrative: Contact dermatitis; Lip swelling; This is a spontaneous report from a contactable physician. This physician reported for female (patient) that: A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced contact dermatitis and lip swelling. The reporter stated that a patient had a reaction to Pfizer's COVID vaccine and was asking if there may be information regarding if the patient should receive the second dose of the vaccine. The reporter stated that the patient had 2 types of reactions; the 1st reaction was worsening of contact dermatitis (where she was not concerned about it) and the 2nd reaction (which occurred 12 to 14 hours after the vaccine) was lip swelling with no hives or urticaria. The lip swelling resolved within a few hours without any treatment (type 1 hypersensitivity reaction). The reporter stated she thinks it was ok for the patient to receive the second dose but wanted to know if there was any additional information. The outcome of the event Lip swelling was recovered on an unspecified date while other event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Nausea, Pyrexia, Rash
Clinical narrative: he was frantic; Nauseous; Rash on his arm; Slight fever; This is a spontaneous report from a contactable consumer.  A 92-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single (age at vaccination 92 years) for covid-19 immunisation. Medical history of the patient since an unknown date was type II diabetic and that on the past month he had pneumonia and was supposed to be treating with a nebulizer for congestion and cough as he had a pulmonary infection. The patient's concomitant medications were not reported. The patient received vaccine yesterday and today, on an unspecified date he had felt nauseous, he was frantic, had a rash on his arm and had a slight fever of 100.3 degree F. Stated that he did not eat, he had calmed down and fever was gone. The patient underwent lab tests and procedures which included pyrexia as 100.3 °F on an unknown date. The outcome of the events was unknown for nausea and rash and for the rest was recovered on an unknown date.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chapped lips, Dyspnoea, Eye swelling, Headache, Hypoaesthesia
Clinical narrative: Eye swole shut; short of breath; numbness in toes; lips tingling and cracking; lips tingling and cracking; light sensitivity; major headaches; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 38-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 26Apr2021 01:00 (at the age of 38 years old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient had no medical history and no concomitant medications. No known allergies were reported. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient had not received any other vaccine within 4 weeks. The patient had not received any other medication within 2 weeks. The reporter reported that, on 27Apr2021 06:45 allergic reaction that has been progressing for 5 days now. Eye swole shut, short of breath, lips tingling and cracking, light sensitivity, major headaches and numbness in toes. As a treatment patient received a steroid shot and a prescription. The events resulted in emergency room/department or urgent care. The outcome for the events was recovering.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral, Photophobia
Clinical narrative: Eye swole shut; short of breath; numbness in toes; lips tingling and cracking; lips tingling and cracking; light sensitivity; major headaches; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 38-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 26Apr2021 01:00 (at the age of 38 years old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient had no medical history and no concomitant medications. No known allergies were reported. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient had not received any other vaccine within 4 weeks. The patient had not received any other medication within 2 weeks. The reporter reported that, on 27Apr2021 06:45 allergic reaction that has been progressing for 5 days now. Eye swole shut, short of breath, lips tingling and cracking, light sensitivity, major headaches and numbness in toes. As a treatment patient received a steroid shot and a prescription. The events resulted in emergency room/department or urgent care. The outcome for the events was recovering.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Flushing, Insomnia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-healthcare professional, (patient). A female patient, of an unspecified age, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on an unspecified date, in Apr 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On an unspecified date in Apr 2021, patient experienced a feeling of flush/hot face and shoulder; and fatigue. Patient was unable to sleep. She said she felt flushed - like a red face/face felt hot. Patient felt hot spots on different parts of her body and it had been about two weeks. Patient still felt flushed. The outcome of felt hot spots on different parts of her body: not recovered. The outcome of the other events: unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Fatigue, Hypoaesthesia, Lymphadenopathy
Clinical narrative: presented pain in her arm from her shoulder to her wrist; presented pain in her arm from her shoulder to her wrist; she feels fatigue; she developed a lump in her armpit that is really painful; she developed a lump in her armpit that is really painful; she feels numbness in her arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. on an unspecified date following vaccination, the patient experienced presented pain in her arm from her shoulder to her wrist, fatigue, she developed a lump in her armpit that is really painful, and she feels numbness in her arm. These events resulted in the emergency room visit. The patient was informed that they were side effects due to vaccination, and if the events persisted, she would be required to visit emergency room again or visit her physician. The outcome of the events was unknown at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: presented pain in her arm from her shoulder to her wrist; presented pain in her arm from her shoulder to her wrist; she feels fatigue; she developed a lump in her armpit that is really painful; she developed a lump in her armpit that is really painful; she feels numbness in her arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. on an unspecified date following vaccination, the patient experienced presented pain in her arm from her shoulder to her wrist, fatigue, she developed a lump in her armpit that is really painful, and she feels numbness in her arm. These events resulted in the emergency room visit. The patient was informed that they were side effects due to vaccination, and if the events persisted, she would be required to visit emergency room again or visit her physician. The outcome of the events was unknown at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Sleep disorder
Clinical narrative: Couldn't breath like someone put pillow on my face and I couldn't get air and woke me from a sound sleep and ended up not feeling; Couldn't breath like someone put pillow on my face and I couldn't get air and woke me from a sound sleep and ended up not feeling; This is a spontaneous report from a non-contactable consumer (patient).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: ER8737) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported, after the vaccine one, Pfizer 1st vaccination, 6 days later in evening of the first shot she awoke about 7 hours later after she went to sleep at night she could not breath like someone put a pillow on her face and she could not get air and it woke her from a sound sleep, 5 days later she ended up not feeling, meaning that was she had her symptom 5 days later and her husband got the shot same exact time ended up with a incapacitating bout of vertigo and she was calling to see if they had any other report of these kind (side effects). The outcome of both the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Bad, Severe Rash head to toe; within 30 minutes of injection; lasted for 2 weeks.; This is a spontaneous report from a contactable consumer (Patient). A 69-year-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: unknown, Expiry date: Not Provided), via an unspecified route of administration on unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, within 30 minutes of injection of the Covid Vaccine, patient experienced bad, severe rash. The rash was from her head to her toe and lasted for two weeks. She is a holistic person and not a fan of western medicine. She would not take the second dose. The rash was miserable, and she took Benadryl. Patient mentioned that her daughter is a nurse, and she also went to the clinic. Physician's Assistant at the clinic said not to take the second dose. The outcome of bad, severe rash lasted for two weeks on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Lightheaded; Chills; Muscles are sore; Fever; Arm is really sore; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8736, NDC number and Expiry date: unknown) via an unspecified route of administration on 26Apr2021 at 08:50 or 08:55 (at the age of 56-year-old) in right arm as dose 1, single for covid-19 immunisation. Patient had received the vaccination at clinic. Medical history included immune system disorder, hot flush, hair disorder all from an unknown date and unknown if ongoing. Patient did not administer any additional vaccines and did not have any prior vaccinations within 4 weeks. Patient reported that she had soreness of the arm following the previous vaccination (Vaccine/Brand Name: Shingles vaccine, manufacturer unknown, vaccination date: Jan2021). Concomitant medications included biotin (BIOTIN) taken for hair disorder, start and stop date were not reported; elderberry [sambucus nigra] (ELDERBERRY [SAMBUCUS NIGRA]) taken for immune system disorder from an unspecified start date and ongoing; curcuma longa (TURMERIC [CURCUMA LONGA]) taken for immune system disorder from an unspecified start date and ongoing; zingiber officinale (GINGER [ZINGIBER OFFICINALE]) taken for immune system disorder, hot flush from an unspecified start date and ongoing. Caller reported that she has been taking all the medication for over a year. On 26Apr2021 the patient experienced chills, lightheaded, muscles were sore, fever and arm was really sore. It was reported that her muscles were sore, and she had fever in the middle of the night on 26Apr2021. Inquired if the chills, light-headedness, sore muscles, and fever were symptoms that were normal for the Covid-19 vaccine. She reported that her chills were little better but still there, light-headedness was little worse. Caller reported that she doesn't think that she had fever at time of call on 27Apr2021. Caller reported that she was pretty sure that she had fever last night on 26Apr2021, but she didn't take her temperature, reported later in the call that her arm was really sore from the Covid-19 vaccine. Caller reported that she was not looking forward to the second dose of the Covid-19 vaccine. The outcome of the events chills and pain in extremity was recovering, dizziness and myalgia was not recovered whereas for fever was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Had the second shot and I have got a little bit of fever; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A patient of unspecified age and gender received second 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 dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included 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 dose 1, single for COVID-19 immunization. The patient experienced had the second shot and had got a little bit of fever. Patient stated was it common to get a fever from the second shot. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram, Swelling face
Clinical narrative: slight swelling of inside face cheeks; This is a spontaneous report from a contactable consumer (patient) reported for self. A 58-year-old patient of an unspecified gender received BNT162B2 (BNT162B2, Solution for injection, Lot Number: EN6207), dose 1 via intramuscular route, administered in arm left on 16Mar2021 08:15 as DOSE 1, SINGLE (at the age of 58) for covid-19 immunization (Hospital). Medical history included seasonal allergies from 16Feb2021 and ongoing, bacterial rash-abdomen from 12Dec2020 to 31Mar2021 Finally saw dermatologist for this rash on Mar 4, applied clindamycin phosphate topical solution USP 1% until 31Mar2021. Concomitant medication included clindamycin phosphate (strength 1%) taken for skin bacterial infection from 04Mar2021 to 31Mar2021. The patient previously took levothyroxine orally from 2012 and ongoing at 75mg for hypothyroidism, atorvastatin from 2020 and ongoing at 20mg for high cholesterol, esomeprazole from 2012 and ongoing at 40mg for Acid Reflux-GERD, calcium from 2021 for Esomprazole reduces calcium, magnesium from 2020, zinc from 2020, iron from 2012 at 65mg, Mometasone nasal spray from 2018, Vitamin D3 2000 from 2012. The patient experienced a slight swelling of inside face cheeks after 1st dose of vaccine on 2021 with outcome of recovered. The patient underwent lab tests and procedures which included CAT scan-Neck+Throat: no obstruction on 15Apr2021 Trouble swallowing, face swelling, tongue swelling. The outcome of the event was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Dizziness, Dysgeusia, Dyspnoea
Clinical narrative: taste of metal in his mouth; lightheaded; sick to his stomach; Shortness of breath; little sick but nothing major; stomach ache; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 63-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EW0172), via an unspecified route of administration, administered in left deltoid on 28Apr2021 at 15:00 (at the age of 63-year-old) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks to the COVID vaccine. Patient did not had adverse events following prior vaccinations. It was also reported that there was no family medical history relevant to adverse events. Patient previously took first dose of BNT162B2 (lot number: EW0158, vaccine location: left upper shoulder) on an unspecified date at 15:00 for covid-19 immunisation. It was reported that patient was tested positive for covid prior to vaccination. On 30Apr2021 the patient was little sick but nothing major, where he states that he experienced taste of metal in his mouth, lightheaded, stomach ache, sick to his stomach and shortness of breath. He says he took a nice nap and felt better. Where the patient mentioned onset time of metallic taste in mouth started at night and later in the day probably around 15:00 for other events. Patient did not visit emergency room and physician office regarding the events. That patient says he called because of the taste of metal and that it was making him sick to his stomach. Outcome of dysgeusia was not recovered. Outcome of all the other events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: taste of metal in his mouth; lightheaded; sick to his stomach; Shortness of breath; little sick but nothing major; stomach ache; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 63-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EW0172), via an unspecified route of administration, administered in left deltoid on 28Apr2021 at 15:00 (at the age of 63-year-old) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks to the COVID vaccine. Patient did not had adverse events following prior vaccinations. It was also reported that there was no family medical history relevant to adverse events. Patient previously took first dose of BNT162B2 (lot number: EW0158, vaccine location: left upper shoulder) on an unspecified date at 15:00 for covid-19 immunisation. It was reported that patient was tested positive for covid prior to vaccination. On 30Apr2021 the patient was little sick but nothing major, where he states that he experienced taste of metal in his mouth, lightheaded, stomach ache, sick to his stomach and shortness of breath. He says he took a nice nap and felt better. Where the patient mentioned onset time of metallic taste in mouth started at night and later in the day probably around 15:00 for other events. Patient did not visit emergency room and physician office regarding the events. That patient says he called because of the taste of metal and that it was making him sick to his stomach. Outcome of dysgeusia was not recovered. Outcome of all the other events was recovering.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Gait disturbance, Movement disorder, Muscle spasms
Clinical narrative: shortness of breath; dizziness off and on; muscle spasms; cannot walk; can barely move; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 61-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. Medical history included spinal surgery. The patient's concomitant medications were not reported. On unspecified date patient experienced, shortness of breath, dizziness off and on, muscle spasms, cannot walk, can barely move. Patient reported that, reschedule his second covid vaccination which was schedule on 05May. The outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itching sensation; rash on her body; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced itching sensation, rash on her body it was reported that patient received the second dose of the COVID-19 vaccine a month ago and for 4 days now the patient experienced itching sensation and rash on her body, she had to put alcohol on her skin and take showers to get rid off the itching. The patient visited the physician office for the events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lacrimation increased, Pyrexia, Rhinorrhoea, Urticaria
Clinical narrative: Runny nose; Eyes full of tears; Fever; Little hives inside her nose; Headache; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information Team. A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 27Apr2021 as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Enquired that, the caller requested a translator. Stated that, the caller got her first Pfizer covid vaccine on 27Apr2021 and three days later, on an unspecified date in 2021, the patient was experiencing a runny nose, eyes full of tears, little hives inside her nose, fever and headache but the headache was gone. Was this a side effect, should she call her doctor. The caller stated that, she already reported this to the safety. The outcome of the events for headache was recovered on an unspecified date in 2021 while for the other events was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Axillary pain, Limb discomfort, Pain
Clinical narrative: Body aches everywhere; Can hardly use his arm that he got the injection in; Has no taste or smell; Has no taste or smell; Weird stabby pain underneath his left armpit; His arm hurts so bad; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0161) via an unspecified route of administration, administered in Arm Right on 28Apr2021 as dose 1, single for covid-19 immunization.  Medical history included diabetes mellitus from 2020 and ongoing Verbatim: Diabetes, asthma from an unknown date and unknown if ongoing Verbatim: Asthma, ongoing neuropathy peripheral Verbatim: Neuropathy in feet. Concomitant medications included Metformin taken for diabetes mellitus from 2020 to an unspecified stop date; Gabapentin taken for neuropathy peripheral, start and stop date were not reported.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021, patient experienced body aches everywhere, can hardly use his arm that he got the injection in, has no taste or smell, has no taste or smell, weird stabby pain underneath his left armpit, his arm hurts so bad. The events did not result in emergency room or physician office visit. The outcome of the event his arm hurts so bad was unknown and the outcome of the other events was not recovered.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Body aches everywhere; Can hardly use his arm that he got the injection in; Has no taste or smell; Has no taste or smell; Weird stabby pain underneath his left armpit; His arm hurts so bad; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0161) via an unspecified route of administration, administered in Arm Right on 28Apr2021 as dose 1, single for covid-19 immunization.  Medical history included diabetes mellitus from 2020 and ongoing Verbatim: Diabetes, asthma from an unknown date and unknown if ongoing Verbatim: Asthma, ongoing neuropathy peripheral Verbatim: Neuropathy in feet. Concomitant medications included Metformin taken for diabetes mellitus from 2020 to an unspecified stop date; Gabapentin taken for neuropathy peripheral, start and stop date were not reported.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021, patient experienced body aches everywhere, can hardly use his arm that he got the injection in, has no taste or smell, has no taste or smell, weird stabby pain underneath his left armpit, his arm hurts so bad. The events did not result in emergency room or physician office visit. The outcome of the event his arm hurts so bad was unknown and the outcome of the other events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Soreness around the injection site; Body soreness; Chills; Fever of 101.7; This is a spontaneous report from a contactable consumer (patient). A 20-years-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number EW0153 and expiry date: 31Jul2021), via an unspecified route of administration, on an unspecified date, as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, approximately 16 hours after receiving the vaccine, the patient experienced localized soreness around the injection site, body soreness, chills, and a fever of 101.7. On an unspecified date, the patient underwent lab tests and procedures which included body temperature which was about 101.7. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Cough, Influenza
Clinical narrative: got sick with bronchitis; got sick with Flu; coughing; This is a spontaneous report from a contactable consumer (patient). A 72-year-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: PFEN6207, Expiration date and NDC number was unknown) via an unspecified route of administration, administered in left arm on 18Mar2021 at 11:30 hours as dose 1, single (at the age of 72-year-old) for COVID-19 immunisation. Medical history included cancer unspecified, blood pressure (both from unknown date to unknown if ongoing) and ongoing diabetes. Patient concomitant medication included patient was taking a cancer pill and sees a cancer doctor, sugar pill and blood pressure pill. Patient had no previous immunization with the Pfizer vaccine considered as suspect. Patient had no additional vaccines administered on same date of the Pfizer Suspect. Patient had no prior vaccinations (within 4 weeks). On an unspecified date of 2021, patient got sick with bronchitis and got sick with flu. Patient was nervous with everything. On an unspecified date of 2021, patient was coughing already, and got checked out and patient was okay. Patient added that her house has electric, and no heater and the snow came in and it was cold. Patient used to be 5 foot 6 inches, but now was 5 foot 5 inches. Patient weighs less than 180 pounds, as she put herself on diet. Patient could not get the second dose, missed the second dose. Patient added that she was not that bright and was slow. Patient was in the emergency room and had bronchitis. Patient had no emergency room and physician office visit for the events. Patient had no relevant tests for all the events. The outcome of all the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Severe pain in her left wrist and it's difficult to open it; This is a spontaneous report from a contactable consumer (patient's child).  An 84 years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown), via an unspecified route of administration on 30Apr2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On 01May2021, the patient experienced severe pain in her left wrist, and it was difficult to open it. The reporter stated that his 84-year-old mother (consumer) received the Pfizer vaccine on Friday approximately at 11:30 am. She just called him today, she reported starting an about 24 hours afterwards she was developing severe pain in her left wrist, and it was difficult to open it. The reporter asked whether it was a normal vaccine side effect or not. The outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Pain, Pruritus, Urticaria
Clinical narrative: Itching; Headache; Hives around the injection site; Soreness in her body including her arms, neck, lower back; Had a lot of soreness and redness around the where the injection was given; Had a lot of soreness and redness around the where the injection was given; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0173; Expiration Date: 31Aug2021), via intramuscular, administered in Arm Left on 03May2021 12:10 (at the age of 60-year-old) as DOSE 1, SINGLE for covid-19 immunisation. No prior Vaccinations (within 4 weeks). Medical history included nervous system disorder from an unknown date and unknown if ongoing Verbatim: Neurological issues, influenza from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The next day, she broke out in hives. She had a headache and a lot of soreness in her body including her arms, neck, lower back, especially in the lower back area. She think that might be it, she doesn't know. She is also itching. on 05May2021. She has been taking allergy medication, clarified as Zyrtec 24HR (LOT: 8210030, Expiry: Jul 2023). The outcome of headache was not recovered, and rest of all events outcome was unknown.  Description of Product Complaint: Description of complaint: Caller is calling in regards to the first dose of the Pfizer COVID-19 vaccine. She had a lot of soreness and redness around the where the injection was given. She woke up the next day with hives around the injection site. She had itching. She has been taking allergy medication, clarified as Zyrtec 24HR. She took the Zyrtec this morning. She mentions she is still red where she had the vaccine.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Itching; Headache; Hives around the injection site; Soreness in her body including her arms, neck, lower back; Had a lot of soreness and redness around the where the injection was given; Had a lot of soreness and redness around the where the injection was given; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0173; Expiration Date: 31Aug2021), via intramuscular, administered in Arm Left on 03May2021 12:10 (at the age of 60-year-old) as DOSE 1, SINGLE for covid-19 immunisation. No prior Vaccinations (within 4 weeks). Medical history included nervous system disorder from an unknown date and unknown if ongoing Verbatim: Neurological issues, influenza from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The next day, she broke out in hives. She had a headache and a lot of soreness in her body including her arms, neck, lower back, especially in the lower back area. She think that might be it, she doesn't know. She is also itching. on 05May2021. She has been taking allergy medication, clarified as Zyrtec 24HR (LOT: 8210030, Expiry: Jul 2023). The outcome of headache was not recovered, and rest of all events outcome was unknown.  Description of Product Complaint: Description of complaint: Caller is calling in regards to the first dose of the Pfizer COVID-19 vaccine. She had a lot of soreness and redness around the where the injection was given. She woke up the next day with hives around the injection site. She had itching. She has been taking allergy medication, clarified as Zyrtec 24HR. She took the Zyrtec this morning. She mentions she is still red where she had the vaccine.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown, Expiry Date: Unknown) via an unspecified route of administration on Thursday an unspecified date in 2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced minor side effects of muscle pain, joint pain on an unspecified date in 2021. Patient was trying to find out is how long do the side effects continue after the first shot. The clinical outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: The day after I got my first Pfizer shot I have the same similar dry cough; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included hypertension. The concomitant medications were not reported. The patient previously took Lisinopril for reported indication high blood pressure and experienced dry cough. On an unspecified date, the patient reported event described as the day after got first Pfizer shot had the same similar dry cough. Where the patient experienced cough post dose 1 vaccination. The patient mentioned that she had her first Pfizer shot on 14th and then on the 8th she was supposed to get her second shot but she had. Patient got a dry cough, had first Pfizer shot (unspecified vaccine) on 14th and then on the 8th was supposed to get second shot but had, have had high blood pressure and had when first got on high blood pressure medicine, had Lisinopril which caused the dry cough and dealt with that for 3 months and then they switched medicines. Since the day after got first Pfizer shot have the same similar dry cough. Patient asked whether in Pfizer vaccination, was there any ingredients similar to what would be in Lisinopril. The outcome of the event dry cough was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Influenza like illness, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Tiredness; Excess pain like I had the flu, body was aching all over; Experiencing itching around the injection site, got too bad; still swollen; bruise; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,solution for injection,lot Number was EW0164, expiry date was not reported), dose 2 via an unspecified route of administration on 26Apr2021 as (Age at vaccination was 56 years) DOSE 2, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication(s) included calcium carbonate, acetylsalicylic acid (ASPIRIN (E.C.)), tocopherol (VITAMIN E AL), vitamins Nos (DAILY VITAMINS), calcium carbonate, colecalciferol (VITAMIN D 2000), calcitriol, simvastatin, diltiazem, loratadine, esomeprazole magnesium, omeprazole (PRILOSEC), diltiazem hydrochloride (CARTIA) taken for an unspecified indication and metformin taken for diabetes mellitus, start and stop date were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number was not reported, expiry date was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. On an unspecified date, the patient experienced tiredness, excess pain like she had the flu, body was aching all over, experiencing itching around the injection site, got too bad, swollen, bruise. Patient had taken extra strength Tylenol and some Motrin and she kind of rested for whatever that have been. She felt better she took a hot bath and everything because her body was aching all over. So, than yesterday she felt better from those aches and pain than she start experiencing itching around the injection site, she mean just itching. So, it got too bad that she went and found some hydrocortisone and put it on my shoulder and it was still swollen and then it was itching and aching. Patient had received treatment for the events. So, then she took an ice pack, no she took some alcohol and rub on it and then now it still feels itching but it's a big bruise. Is that normal? She put some cream on it and she took some Motrin and she had been rubbing alcohol on the top of her arm. The clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea
Clinical narrative: Runny nose; Coughing; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Not clear, Expiry date: unknown), via an unspecified route of administration on 13Apr2021 as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on 16Mar2021 as a single dose for covid-19 immunization. On an unspecified date, patient experienced runny nose and little coughing. The only thing patient need to know was, does patient need to seek other medical attention. That was all patient need to know. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Epistaxis
Clinical narrative: Nose Bleed; This is a spontaneous report from a contactable consumer (patient, self-reported).  A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that an hour after her first shot of the Pfizer Covid 19 vaccine, she experienced nosebleed on an unspecified date. She did go to an ER to get her blood tested and was told that everything looks normal and stated that she is unsure if her nose bleed is just a coincidence since the weather was hot. She spoke to her doctor already about this and referred her still to Pfizer and asking if she could take her second dose of the vaccine. The patient did not know the name of the doctor as it was only a triage doctor and asking if she could only take the first shot of the vaccine. The AE resulted in Emergency room. The lab test and procedure included blood test: everything look normal on unspecified date. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Epistaxis
Clinical narrative: Nose Bleed; This is a spontaneous report from a contactable consumer (patient, self-reported).  A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that an hour after her first shot of the Pfizer Covid 19 vaccine, she experienced nosebleed on an unspecified date. She did go to an ER to get her blood tested and was told that everything looks normal and stated that she is unsure if her nose bleed is just a coincidence since the weather was hot. She spoke to her doctor already about this and referred her still to Pfizer and asking if she could take her second dose of the vaccine. The patient did not know the name of the doctor as it was only a triage doctor and asking if she could only take the first shot of the vaccine. The AE resulted in Emergency room. The lab test and procedure included blood test: everything look normal on unspecified date. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.