chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count decreased
Clinical narrative: Bleeding starts 1 day after dose given; large blood in urine output at night; increased lethargy; WBC and Hgb drop; WBC and Hgb drop; This is a spontaneous report from a contactable consumer (the patient). The consumer reported similar events for herself with two doses. This is the second of two reports. A 53-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0161) via an unspecified route of administration, administered in Arm Left on 21Apr2021 10:15 at age of 53-year-old at single dose for COVID-19 immunisation. Medical history included PNH anemia since 2006 and known allergies: Latex, sulfamethoxazole trimethoprim (BACTRIM). The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Concomitant medications (received within 2 weeks of vaccination) included iron, cyanocobalamin (VITAMIN B12) and one a day women vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Er8732) via an unspecified route of administration in left arm on 26Mar2021 10:15 AM at age of 53-year-old for COVID-19 immunisation. Minor side effects after first dose but did have some spotting blood in urine at night. Told MD and was told to proceed with dose 2. After second dose on 22Apr2021 23:00, large blood in urine output at night and increased lethargy. Bleeding starts 1 day after dose given. Lasted less than 1 week but white blood cell (WBC) and haemoglobin (Hgb) decreased/drop (22Apr2021). The events resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The outcome of the events was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021529122 same patient/drug, similar AE, different dose of vaccine
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Hot flush, Mechanical urticaria, Nausea
Clinical narrative: feeling like I was going to pass out; Left side of left wrist turned very red, while in the middle of my wrist large white pockets of fluid appeared, looking like I had a large worm inside. Pockets have gone down but are still visible after 6 days.; while in the middle of my wrist large white pockets of fluid appeared, looking like I had a large worm inside.; severe hot flashes; chills; felt like I wanted to vomit; This is a spontaneous report from a contactable consumer or other non hcp. A 80-years-old female patient received first dose of bnt162b2 (BNT162B2 Solution for injection) via an unspecified route of administration, administered in arm left on 12May2021 12:00 (Batch/Lot number was not reported) as first dose, single for COVID-19 immunization. Medical history included obesity, atrial fibrillation, cardiac failure from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took sulphonamides, beta methasone, prilosec. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. The patient was not hospitalized. On 12May2021 at 12:00 AM, Left side of left wrist turned very red, while in the middle of my wrist large white pockets of fluid appeared, looking like large worm inside. Pockets have gone down but are still visible after 6 days. The worst part, was that got severe hot flashes then chills, feeling like I was going to pass out. Then felt like wanted to vomit. This went on for 24 hours, but now has seemed to stop. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: feeling like I was going to pass out; Left side of left wrist turned very red, while in the middle of my wrist large white pockets of fluid appeared, looking like I had a large worm inside. Pockets have gone down but are still visible after 6 days.; while in the middle of my wrist large white pockets of fluid appeared, looking like I had a large worm inside.; severe hot flashes; chills; felt like I wanted to vomit; This is a spontaneous report from a contactable consumer or other non hcp. A 80-years-old female patient received first dose of bnt162b2 (BNT162B2 Solution for injection) via an unspecified route of administration, administered in arm left on 12May2021 12:00 (Batch/Lot number was not reported) as first dose, single for COVID-19 immunization. Medical history included obesity, atrial fibrillation, cardiac failure from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took sulphonamides, beta methasone, prilosec. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. The patient was not hospitalized. On 12May2021 at 12:00 AM, Left side of left wrist turned very red, while in the middle of my wrist large white pockets of fluid appeared, looking like large worm inside. Pockets have gone down but are still visible after 6 days. The worst part, was that got severe hot flashes then chills, feeling like I was going to pass out. Then felt like wanted to vomit. This went on for 24 hours, but now has seemed to stop. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: shingles; Rash has developed since receiving the vaccine; Feeling quite sore; This is a spontaneous report from a non-contactable consumer via a Pfizer sales representative. A 47-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date as an unknown dose number, at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on an unspecified date. It was also reported that rash has developed on an unspecified date since receiving the vaccine and that the patient was feeling quite sore. The patient was due to attend her physician on 13May2021.The outcome of the events was unknown. The event shingles was considered as medically significant.  No follow up attempts needed.  No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia oral
Clinical narrative: burning in her legs from the knee down/burning sensation in her left thigh/Intermittent burning sensations throughout her body in different spots; lower lip has intermittent numbness; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 12May2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported that since receiving her Pfizer-BioNTech COVID-19 vaccine on 12May2021. On 13May2021, she woke up with burning in her legs, from the knee down, that went away. Then she got a severe burning sensation in her left thigh. She reports that the burning sensation was ongoing but describes it as "Intermittent burning sensations throughout her body in different spots". She also reports her lower lip has intermittent numbness. The outcome of burning sensation (PT) was not recovered while for other event was unknown.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain, Pain in extremity
Clinical narrative: sore arm; a shooting pain towards her armpit going down her arm; chills; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection), via an unspecified route of administration on 16May2021 (at an age of 41-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in May2021, the patient experienced sore arm, a shooting pain towards her armpit going down her arm, chills, diarrhea. Consumer reported that after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine yesterday, 16May2021, she had a sore arm, a shooting pain towards her armpit going down her arm, chills and diarrhea. She said she took Advil for her arm discomfort, but was told by a friend that she should not have taken the medication. She also said she was told that she should have taken Tylenol instead of Advil. She called to seek guidance regarding this. Consumer also said that in all the forms she has, there was no information about taking medications at the same time with taking the vaccine. Therapeutic measures were taken as a result of sore arm, a shooting pain towards her armpit going down her arm. The clinical outcome of the sore arm, a shooting pain towards her armpit going down her arm, chills, diarrhea were unknown.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: metallic taste; This is a spontaneous report from a Pfizer-sponsored program support from a contactable consumer (patient).   A 63 years old male patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, lot. EN5318) at single dose, on an unspecified date, for COVID-19 immunization. Relevant medical history and concomitant medications were unknown. The patient previously, on 19Feb2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, for COVID-19 immunization. After the first dose, the patient experienced soreness at point of injection. On an unspecified date, after the second dose, the patient experienced strong metallic taste. Clinical outcome of the adverse event was unknown at time of this report.   No follow-up attempts are needed, no further information expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: armpit swelled up; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration, in right arm on 13May2021 at 12:00 PM (at the age of 31-years-old) as 2nd dose, single for COVID-19 immunization. Medical history included Tylenol allergy. Concomitant medications include release dietary supplements. The patient was not pregnant. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date as first dose, single for COVID-19 immunization. The patient's armpit swelled up in the same side that he got the injection on 16May2021 (reported as three days after 2nd dose). The events were reported as non-serious. The patient did not receive any treatment for the event. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: flu symptoms; This is a spontaneous report from a non-contactable consumer (patient). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 05Feb2021 13:15 (at the age of 42-years-old) as 2nd dose, single for COVID-19 immunization. Medical history included irritable bowel syndrome and zinc allergy. The patient's concomitant medications were not reported. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. The patient experienced flu symptoms after the second dose on 27Feb2021 07:00. The events were reported as non-serious. The patient did not receive any treatment for the events. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Feeling abnormal, Headache, SARS-CoV-2 test
Clinical narrative: I was tired all the time; head ache; not hunger; lost 14 lbs; I didn't want to get out of bed/I didn't have any will to do anything.A shower was an effort; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number- er8736), via an unspecified route of administration on 26Apr2021 13:00 (at the age of 65-years-old) as unknown dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. No other vaccine was given in four weeks. Prior to vaccination the patient was not diagnosed with COVID-19. The patient reported that she didn't want to get out of bed, was tired all the time, headache, not hunger, lot 14 lbs, did not have the will to do anything and a shower was an effort on 27Apr2021 08:00 AM. The events were reported as non-serious. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included nasal swab: negative on 05May2021. The outcome of the events was recovering.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: I was tired all the time; head ache; not hunger; lost 14 lbs; I didn't want to get out of bed/I didn't have any will to do anything.A shower was an effort; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number- er8736), via an unspecified route of administration on 26Apr2021 13:00 (at the age of 65-years-old) as unknown dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. No other vaccine was given in four weeks. Prior to vaccination the patient was not diagnosed with COVID-19. The patient reported that she didn't want to get out of bed, was tired all the time, headache, not hunger, lot 14 lbs, did not have the will to do anything and a shower was an effort on 27Apr2021 08:00 AM. The events were reported as non-serious. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included nasal swab: negative on 05May2021. The outcome of the events was recovering.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Headache, Hypoacusis, SARS-CoV-2 test, Tinnitus
Clinical narrative: Hearing go out and tinnitus in one ear intermittently for 2 weeks; Hearing go out and tinnitus in one ear intermittently for 2 weeks; Muscle jerking in arm, stomach, and one toe; Headache; This is a spontaneous report from a contactable other health care professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8731), via an unspecified route of administration in the left arm on 10Apr2021 at 00:00 (at the age of 41-years-old), 1st dose, single, for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. The vaccine was administered at hospital. On 11Apr2021 at 13:00, the patient experienced hearing went out, tinnitus in one ear intermittently for two weeks; muscle jerking in arm, stomach, and in one toe and headache. The patient underwent lab tests and procedures which included nasal swab COVID-SARS PCR test: negative on 21Apr2021. The events were reported as non-serious. No treatment was received for the events. The outcome of the events was recovered on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Lactose intolerance
Clinical narrative: Thought diarrhea might be due to lactose intolerance; Diarrhea; This is a spontaneous report from a contactable consumer (patient's son) via Medical Information Team. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date, 1st dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In May2021 (last 2-3 days), the patient had diarrhea and the reporter took her to the doctor on 17May2021 and he asked if the patient had diarrhea (first occurrence) on that day and it had stopped in May2021. The reporter thought it might be due to lactose intolerance because the patient had a lot of ice cream. The patient did not have any signs of COVID-19 and they did not test her for COVID-19 at the doctor's office. The reporter was concerned because after they left the doctor's office they stopped and got something to eat. The patient was eating a lot of the dipping sauce and she had diarrhea (second occurrence) on 17May2021 at night. On 18May2021, at night, the patient was supposed to go and get second dose of the COVID-19 vaccine. The reporter was enquiring whether the patient was safe to receive the second dose or reschedule it. The outcome for the first occurrence of the event diarrhea was recovered in May2021 and that of second occurrence was unknown. The outcome of the event lactose intolerance was unknown.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Body aches; Headache; Nausea; Fever; Dizziness; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), via an unspecified route of administration in the left arm on 17May2021 at 17:30 (at the age of 27-years-old), 2nd dose, single, for COVID-19 immunization. Medical history included bronchitis, COVID-19, penicillin allergy and exercise endured asthma. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown) administered via an unspecified route of administration on 26Apr2021 at 17:30 (at the age of 27-years-old), 1st dose, single for COVID-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19 but did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. The vaccine was administered at a pharmacy or drug store. On 18May2021 at 09:00, the patient experienced body aches, headache, nausea, fever, dizziness, and injection site pain. The events were reported as non-serious. The patient received unspecified over the counter medication and nurse directed to take rest. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Body aches; Headache; Nausea; Fever; Dizziness; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), via an unspecified route of administration in the left arm on 17May2021 at 17:30 (at the age of 27-years-old), 2nd dose, single, for COVID-19 immunization. Medical history included bronchitis, COVID-19, penicillin allergy and exercise endured asthma. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown) administered via an unspecified route of administration on 26Apr2021 at 17:30 (at the age of 27-years-old), 1st dose, single for COVID-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19 but did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. The vaccine was administered at a pharmacy or drug store. On 18May2021 at 09:00, the patient experienced body aches, headache, nausea, fever, dizziness, and injection site pain. The events were reported as non-serious. The patient received unspecified over the counter medication and nurse directed to take rest. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Irritability
Clinical narrative: I'm really weak and grouchy; I'm really weak and grouchy; This is a spontaneous report from a contactable consumer (patient). An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration in left arm on 17May2021 at 14:00  (at the age of 18-years-old) as 1st dose, single for COVID-19 immunization. Medical history included shrimp allergy. Concomitant medication included Ibuprofen. The patient was vaccinated at Hospital. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient reported that he was really weak and grouchy on 17May2021 17:00. The events were reported as non-serious. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Neck pain, Potentiating drug interaction, Vasodilatation, Vein disorder
Clinical narrative: bulging veins in wrists and hands; experiencing side effects with her veins looking like they are bulging in her legs, feet and ankles at first and they are now spreading to her hands.; Neck pain; Caller states the Vitamin E supplement that she takes can have a blood thinner property so she is not sure if that could have caused her reaction; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 17May2021 (Batch/Lot Number: EW0183; Expiration Date: 31Aug2021) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included hypersensitivity and arthritis. Concomitant medication(s) included D-flame, Vitamin E, daily dose. The patient she has been experiencing side effects last night with her veins looking like they are bulging in her legs, feet and ankles at first and they are now spreading to her hands on 17May2021 22:00 and this morning the veins in her wrists and hands are bulging as well on 18May2021. She takes a daily supplement something like a multivitamin and she would like to know if the ingredients in the supplement could have caused an interaction with the vaccine? She states the Vitamin E supplement that she takes can have a blood thinner property so she is not sure if that could have caused her reaction. Ingredients of the supplement include holy basil 250 mg, turmeric 100 mg, ginger 100 mg, green tea 100 mg, baikal skullcap 50 mg, bromelain extract 100 mg, resveratrol 10 mg, berberine 5 mg and boswellia 100 mg. States the dosages provided are for two capsules and she only take one so it would be half. She said she really had bad neck pain last night on 17May2021. It was severe but went away after dinner. It was last evening, and she noticed it around 10:00pm. Took Tylenol before bed. She had nuclear stress test result unknown on 05May2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of event for bulging veins in wrists and hands was not resolved and for rest of the events it was unknown.  Follow up needed, further information has been requested.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: Fever - 103 degrees and tired; Fever - 103 degrees and tired; This is a spontaneous report from a contactable consumer (patient). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0168), intramuscular in left arm on 17May2021 15:00 (at the age of 12-years-old) as first dose, single for COVID-19 immunization. Medical history was none. The patient had no known allergies. Concomitant medication included fexofenadine hydrochloride (ALLEGRA). Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks prior. The patient experienced fever - 103 degrees and tired on 18May2021 12:00. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. Outcome of the event was unknown.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Extremely sore arm, can not move it at all without people in pain; Extremely sore arm, can not move it at all without people in pain; This is a spontaneous report from a contactable consumer (patient).  A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was unknown and expiration date was not reported), via an unspecified route of administration, in Left Arm on 17May2021 at 19:00 (at the age of 22-years old) at first dose, single for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient experienced extremely sore arm, can not move it at all without people in pain on 18May2021 after the first dose and did not had any other side effects. The event was reported as non serious. No treatment was received for the event. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Joint stiffness, Muscle tightness
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), intramuscularly in right arm on 27Apr2021 at 11:30 (at the age of 62-years-old), 2nd dose, single, for COVID-19 immunization. Medical history included anaphylactic allergies to peanuts and all its products. Concomitant medication included unspecified vitamins. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported) administered intramuscularly on 06Apr2021 at 11:30, 1st dose, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. The vaccine was administered at hospital. On 28Apr2021 at 00:00, the patient felt like there was a 6 to 8-inch-wide rubber band that was too small and tight around her knees, wrists, elbows, ankles, and feet. The patient had a lot of pain in all joint areas, in between each joint there were waves of being extremely achy and there were waves of a tingling feeling, for example like when the foot falls asleep. The patient reported that the pain was so much, and she just laid still in bed the next 20 hours without moving much. On 29Apr2021, the following day after the pain, the patient was just wrenched and exhausted. The patient had a big stuffy and achy in the head area. On 18May2021, at night the patient felt every sensation came back, but not as severe as earlier. The events were reported as non-serious. No treatment was received for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Upper respiratory tract congestion
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), intramuscularly in right arm on 27Apr2021 at 11:30 (at the age of 62-years-old), 2nd dose, single, for COVID-19 immunization. Medical history included anaphylactic allergies to peanuts and all its products. Concomitant medication included unspecified vitamins. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported) administered intramuscularly on 06Apr2021 at 11:30, 1st dose, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. The vaccine was administered at hospital. On 28Apr2021 at 00:00, the patient felt like there was a 6 to 8-inch-wide rubber band that was too small and tight around her knees, wrists, elbows, ankles, and feet. The patient had a lot of pain in all joint areas, in between each joint there were waves of being extremely achy and there were waves of a tingling feeling, for example like when the foot falls asleep. The patient reported that the pain was so much, and she just laid still in bed the next 20 hours without moving much. On 29Apr2021, the following day after the pain, the patient was just wrenched and exhausted. The patient had a big stuffy and achy in the head area. On 18May2021, at night the patient felt every sensation came back, but not as severe as earlier. The events were reported as non-serious. No treatment was received for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Somnolence
Clinical narrative: stiff neck and headache; extreme fatigue after second dose; stiff neck and headache; falling asleep in the chair; This is a spontaneous report from a contactable consumer (patient's wife). A male patient in his 60s received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EW0173), via an unspecified route, administered in left arm on 12May2021, as second dose, single for COVID-19 immunization. The patient did not have relevant medical history and did not receive concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EP6955), via an unspecified route, in Apr2021, as first dose, single for COVID-19 immunization and experienced headache and really stiff necks. On an unknown date in May2021, the patient experienced stiff neck and headache which the patient expected as it occurred after the first dose. On an unknown date in May2021, the patient experienced extreme fatigue for several days after the second dose, more than normal, and the patient was falling asleep in the chair. The outcome was unknown for the reported events at the time of reporting.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021565416 same patient/reporter/suspect; different dose/AE
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Nausea
Clinical narrative: Fever (103.4); chills; nausea; injection site pain; fatigue; severe headache; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0179), dose 2 via an unspecified route of administration in left arm on 15May2021 15:15 (at the age of 33-years-old) as second dose, single for COVID-19 immunization. The patient medical history was not reported. The patient have no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0172), dose 1 via an unspecified route of administration in left arm on 25Apr2021 03:30 PM (at the age of 33-years-old) as first dose, single for COVID-19 immunization. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks nor any other medications within two weeks prior. The patient experienced fever (103.4), chills, nausea, injection site pain, fatigue and severe headache on 16May2021 04:00. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. Outcome of the events was resolving.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Fever (103.4); chills; nausea; injection site pain; fatigue; severe headache; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0179), dose 2 via an unspecified route of administration in left arm on 15May2021 15:15 (at the age of 33-years-old) as second dose, single for COVID-19 immunization. The patient medical history was not reported. The patient have no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0172), dose 1 via an unspecified route of administration in left arm on 25Apr2021 03:30 PM (at the age of 33-years-old) as first dose, single for COVID-19 immunization. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks nor any other medications within two weeks prior. The patient experienced fever (103.4), chills, nausea, injection site pain, fatigue and severe headache on 16May2021 04:00. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. Outcome of the events was resolving.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Vaccination site joint movement impairment, Vaccination site joint pain, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number- EQ0170), via an unspecified route of administration in left arm on 30Apr2021 08:00 (at the age of 38-years-old) as 2nd dose, single for COVID-19 immunization. Medical history included amoxicillin allergy, penicillin allergy and allergy to sulfa drugs. The patient's concomitant medications were not reported. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number- EP7533), via an unspecified route of administration in left arm in Apr 2021 08:00 (at the age of 38-years-old) as 1st dose, single for COVID-19 immunization. The patient experienced left arm joint muscle pain at site of injection, moderate, limiting use and full body joint pain in knees, back and ankles, moderate, limiting use on 06May2021 12:00 AM. The events were reported as non-serious. The patient did not receive any treatment for the events. The outcome of the events was not recovered.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Dyspepsia
Clinical narrative: Strange metallic taste in my mouth and heartburn; Strange metallic taste in my mouth and heartburn; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was ewo153 and expiration date was not reported), via an unspecified route of administration, in Left Arm on 26Apr2021 (at the age of 63-year-old) at 10:00 at 1ST DOSE, single for covid-19 immunization. Medical history included mitral valve prolapse and osteoarthritis. Concomitant medications included venlafaxine hydrochloride (EFFEXOR) 75mg and colecalciferol (VITAMIN D [COLECALCIFEROL]) 5000 ui received within 2 weeks of vaccination. The patient previously took iodine and erythromycin and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Patient was not pregnant at the time of vaccination. The patient experienced strange metallic taste in her mouth and heartburn on 26Apr2021 at 10:15 after the first dose. The events were reported as non-serious. No treatment was received for the events. The outcome of the events was recovered in Apr2021.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0182), via an unspecified route of administration in the left arm on 14May2021 at 12:00 (at the age of 55-years-old), 1st dose, single, for COVID-19 immunization. The patient had no medical history. Concomitant medication included quetiapine fumarate (SEROQUEL). The patient previously took zithromax z-pack and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. On 15May2021 at 07:00, the patient started experiencing severe back pain and on 18May2021 she developed a weltish rash all over her lower back. As of the day of report, the patient was still experiencing back pain. The events were reported as non-serious and resulted in doctor or other healthcare professional office/clinic visit. The patient had three visits to chiropractor to relieve back pain. The patient had not been tested for COVID-19 since vaccination. The outcome of the event severe back pain was not recovered and that of another event was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vaginal haemorrhage
Clinical narrative: Vaginally bleeding x4 days; diarrhea x 2 mornings; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0179 and expiration date was not reported), via an unspecified route of administration in right arm, on 13May2021 at 10:30 (at the age of 46 years old) as 1st dose, single for COVID-19 immunization in a hospital. Medical history included colon polyps, bipolar II disorder, inattentive add and early cardio disease. Concomitant medications included sertraline hydrochloride (ZOLOFT); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); sulfamethoxazole (+) trimethoprim (BACTRIM) and ibuprofen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was never tested for COVID-19. The patient experienced vaginal bleeding for 4 days and diarrhea for 2 mornings on 15May2021 at 10:00. The events were assessed as non-serious by the reporter. No treatment was received by the patient regarding these events. The outcome of these events was recovering at the time of report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye swelling, Headache, Hypersensitivity, Lip swelling
Clinical narrative: Tingling in face; headache; sneezing; itching; light headness and dizzy; lips swelling; eye swelling; like an allergies; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0173 and expiration date was not reported), via an unspecified route of administration in right arm, on 11May2021 at 10:45 (at the age of 66 years old) as first dose, single for COVID-19 immunization in a hospital. Medical history included stage 3 kidney disease, systemic lupus erythematosus, high blood pressure and thyroidectomy. The patient's known allergies: penicillin. The patient previously took dilaudid and prednisone; and experienced drug allergy. Concomitant medications included levothyroxine sodium (SYNTHROID); hydroxychloroquine sulfate (PLAQUENIL); metoprolol; famotidine and alprazolam (ALPRAZ). The patient was not pregnant at the time of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The patient experienced tingling in face, headache, sneezing, itching, light headedness/dizzy, lips swelling, eye swelling and had like an allergies on 19May2021 at 09:00. This case was considered non-serious and no treatment was given for these events. The outcome of these events was not recovered at the time of report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Sneezing
Clinical narrative: Tingling in face; headache; sneezing; itching; light headness and dizzy; lips swelling; eye swelling; like an allergies; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0173 and expiration date was not reported), via an unspecified route of administration in right arm, on 11May2021 at 10:45 (at the age of 66 years old) as first dose, single for COVID-19 immunization in a hospital. Medical history included stage 3 kidney disease, systemic lupus erythematosus, high blood pressure and thyroidectomy. The patient's known allergies: penicillin. The patient previously took dilaudid and prednisone; and experienced drug allergy. Concomitant medications included levothyroxine sodium (SYNTHROID); hydroxychloroquine sulfate (PLAQUENIL); metoprolol; famotidine and alprazolam (ALPRAZ). The patient was not pregnant at the time of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The patient experienced tingling in face, headache, sneezing, itching, light headedness/dizzy, lips swelling, eye swelling and had like an allergies on 19May2021 at 09:00. This case was considered non-serious and no treatment was given for these events. The outcome of these events was not recovered at the time of report.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Covid arm. red blotchy arm on arm that had shot; This is a spontaneous report from a non-contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 65 years old, at single dose on 15May2021 13:45 for covid-19 immunisation. The patient had no known allergies. The patient was not diagnosed with covid-19 prior to vaccination. The patient experienced covid arm, red blotchy arm on arm that had shot on an unspecified date. The patient had not been tested for covid-19 since the vaccination. No treatment was received. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Hyperhidrosis, Lymph node pain, Lymphadenopathy
Clinical narrative: high fever - 102 F; very swollen and painful lymph nodes in left armpit and right but not as bad sweaty feet; very swollen and painful lymph nodes in left armpit and right but not as bad sweaty feet; very swollen and painful lymph nodes in left armpit and right but not as bad sweaty feet; abnormal horrific headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0179 and expiration date was not reported), via an unspecified route of administration in left arm, on 17May2021 at 14:30 (at the age of 40 years old) as second dose, single for COVID-19 immunization in a Public Health Clinic/Veterans Administration facility. The patient's medical history was not reported. The patient previously took prochlorperazine maleate (COMPAZINE) and experienced drug allergy. Concomitant medications included esomeprazole sodium (NEXIUM) and celecoxib (CELEXA). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0172 and expiration date was not reported), via an unspecified route of administration in left arm, on Apr2021 at 10:30 (at the age of 40 years old) as first dose, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19 and post-vaccination, the patient was tested for COVID-19 with nasal swab and the result was negative on 16Apr2021. The patient experienced high fever with a temperature of 102 F, very swollen and painful lymph nodes in left armpit and right but not as bad sweaty feet and abnormal horrific headache on 17May2021 at 14:30. This case was considered as non-serious and no treatment was given to the patient for these events. The outcome of these events was recovering at the time of report.