chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Pyrexia
Clinical narrative: Low BP and Above normal temp; above normal temp; This is a spontaneous report received from a contactable consumer (patient). This 62-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0151) via an unspecified route of administration on 11Apr2021 (at the age of 62-years-old) as a single dose in the left arm for COVID-19 immunizations. Medical history included pollen allergies, high blood pressure (BP), low iron, low vitamin D, and allergies to sulfa, penicillin, and nickel. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient took unspecified concomitant medications. The patient previously received dose 1 of BNT162B2 (lot number EP6955) on 21Mar2021 as a single dose in the left arm for COVID-19 immunization. On 13Apr2021 at 16:00 the patient experienced low blood pressure and above normal temperature. The patient visited a doctor or other healthcare professional office/clinic as a result of the events. The patient reported treatment was  check blood pressure and temperature twice daily. The outcomes of low blood pressure and above normal temperature were recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Facial numbness especially lips and tongue; Facial numbness especially lips and tongue; This is a spontaneous report from a contactable consumer (patient). This 42-Year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8737) via an unspecified route of administration in the left arm on 08Apr2021 at 13:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included cat allergy from an unknown date and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the 4 weeks prior to the COVID vaccine. The patient had no concomitant medications. The patient reported that on 08Apr2021 at 16:00 she experienced facial numbness especially lips and tongue which lasted a few weeks. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of facial numbness especially lips and tongue were recovering. It was also reported that since vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata, Off label use, Product use issue
Clinical narrative: Alopecia Areata, 2 spots on head; Thinning eyebrow; Was breastfeeding when I received the vaccine; Was breastfeeding when I received the vaccine; This is a spontaneous report received from a contactable consumer (patient). This consumer (patient) reported information for both mother and baby. This is the maternal case. This 30-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP7533) via an unspecified route of administration in the left arm on 05Apr2021 at 16:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history, allergies, or concomitant medications. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the 4 weeks prior to the COVID vaccine. On 25Apr2021 at 09:00 the patient experienced alopecia areata 2 spots on her head, and thinning eyebrow. The patient reported she was breastfeeding when she received the vaccine, then stopped breastfeeding "cold turkey" three days after receiving the vaccine. The events resulted in a physician office visit, and the patient was treated with a steroid injection. The clinical outcomes of alopecia areata 2 spots on head and thinning eyebrow were not recovered. The clinical outcomes of was breastfeeding when she received the vaccine were unknown. It was also reported that since vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021487595 baby case
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Chills, Lymphadenopathy, Pyrexia
Clinical narrative: fever; chills; Lymphadenopathy; This is a spontaneous report received from a contactable consumer (the patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the vaccine yesterday at 17:30 (unspecified date). The patient stated she has experienced "every side effect", fever, chills, lymphadenopathy. Her fever was currently 102.5 Fahrenheit. She has been taking paracetamol (TYLENOL).  She asked at what point should she seek a healthcare professional. The outcome of fever was not recovered. The outcome of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Chills, Dizziness, Feeling hot, Headache
Clinical narrative: fever; chills; Lymphadenopathy; This is a spontaneous report received from a contactable consumer (the patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the vaccine yesterday at 17:30 (unspecified date). The patient stated she has experienced "every side effect", fever, chills, lymphadenopathy. Her fever was currently 102.5 Fahrenheit. She has been taking paracetamol (TYLENOL).  She asked at what point should she seek a healthcare professional. The outcome of fever was not recovered. The outcome of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphadenopathy, Pyrexia, Tinnitus
Clinical narrative: fever; chills; Lymphadenopathy; This is a spontaneous report received from a contactable consumer (the patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the vaccine yesterday at 17:30 (unspecified date). The patient stated she has experienced "every side effect", fever, chills, lymphadenopathy. Her fever was currently 102.5 Fahrenheit. She has been taking paracetamol (TYLENOL).  She asked at what point should she seek a healthcare professional. The outcome of fever was not recovered. The outcome of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature increased, Fatigue, Headache, Lymphadenopathy, Myalgia
Clinical narrative: fever; chills; Lymphadenopathy; This is a spontaneous report received from a contactable consumer (the patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the vaccine yesterday at 17:30 (unspecified date). The patient stated she has experienced "every side effect", fever, chills, lymphadenopathy. Her fever was currently 102.5 Fahrenheit. She has been taking paracetamol (TYLENOL).  She asked at what point should she seek a healthcare professional. The outcome of fever was not recovered. The outcome of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: fever; chills; Lymphadenopathy; This is a spontaneous report received from a contactable consumer (the patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the vaccine yesterday at 17:30 (unspecified date). The patient stated she has experienced "every side effect", fever, chills, lymphadenopathy. Her fever was currently 102.5 Fahrenheit. She has been taking paracetamol (TYLENOL).  She asked at what point should she seek a healthcare professional. The outcome of fever was not recovered. The outcome of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Tiredness; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 57-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration on 24Mar2021 12:18 as 1st dose, single for covid-19 immunization. Medical history included drug hypersensitivity. The patients concomitant medications were not reported. Patient had not administered any additional vaccine on the date of Pfizer vaccine. Patient family history was reported as none. On 24Mar2021, The patient experienced tiredness and headache. Patient received her second dose of BNT162B2 (Lot: EW0161) on 14APR2021. The events were recovered on 26Mar2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Vomiting
Clinical narrative: vomiting; weak; This is a spontaneous report received from a contactable consumer (the patient). A 36-year-old female patient received the second dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the vaccine this past Wednesday (unspecified date). She has been weak and vomiting. She has not been able to get anything done. She would like to know if this as an excuse to miss work, and how long will side effects last. The outcome of events was not recovered.   No follow-up attempts are possible; information about lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Tongue disorder, Urticaria
Clinical narrative: Caller states she still has tiny bumps on her toungue and it feels like she ''burned it on hot liquid''; When I got home I had hives on my neck and jaw, I woke up and all down the left side of my neck and heading to my chest area were hives again; This is a spontaneous report received from a contactable consumer (patient herself). A 56-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not reported) via an unspecified route of administration on the right side (unspecified) on 30Apr2021 (at the age of 56-year-old) at single dose for COVID-19 immunisation. Relevant medical history was not reported. Historical vaccine included the first dose of BNT162b2, administered at the age of 56-year-old and with no events reported. Concomitant medications were not reported. The patient reported that on 30Apr2021 when she got home she had hives on her neck and jaw, so she washed the area and it went away. Then, at midnight, she woke up and all down the left side of her neck and heading to her chest area there were hives again. She took Benedryl and it went away. She still had bumps on her tongue and it felt like she "burned it on hot liquid", as reported. Benedryl relieved the tongue discomfort. Urticaria resolved on 30Apr2021, while outcome of bumps tongue was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Fever; headaches; Fatigue; This is a spontaneous report received from a contactable consumer. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a reaction after second dose: fever, headaches, fatigue, that persisted for several days after. The outcome of events was recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Mar2021 (Batch/Lot number was not reported) as unknown, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient developed shingles on 30Apr2021 with outcome of unknown. He read on the internet that this was happening a lot. His doctor gave him prescription, Acyclovir for one week.   No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number not reported) as unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to report a side effect, patient got shingles from the COVID vaccine on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I got sick with COVID; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (herself and her husband). This is the first of two reports.  A 47-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0161, expiration date: 31Jul2021), via an unspecified route of administration on 17Apr2021 (at the age of 47-years-old) at 1st dose, single in the left arm for COVID-19 immunization. Medical history included hypothyroidism. The patient's concomitant medications were not reported. The patient wanted to know if she was supposed to get her 2nd vaccine which was scheduled on 06May2021. The patient got her 1st vaccine on 17Apr2021. On 23Apr2021, the patient got sick with COVID. The patient reported that she and her husband both got the vaccine, and both got the virus. The patient did not receive any treatment but underwent home quarantine. Outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021502285 same reporter/drug/event, different patient
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Vertigo; Nausea; Dizziness; This is a spontaneous report from contactable consumer (patient).   A 61-year-old female patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EW0176 or EW0178, Expiration date: 31Aug2021) on 11May2021, at 16:00, at single dose, in the left upper arm, for COVID-19 immunisation. Relevant medical history included allergies to codeine. The patient previously, on an unspecified date, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EW0164, Expiration date: 31Aug2021) 0.3 ml, single dose, in left upper arm, for COVID-19 immunisation. Concomitant medications included topical steroid-name unknown, stopped 2 days before this report. Medic said to not be concerned because it was a topical cream. On 11May2021, the patient experienced dizziness after getting the vaccine. Sat there a few minutes and felt better, got up and walked to the sitting area. She sat for 30 minutes, got up and drove home. She had seen the medic prior to getting the shot because she has allergies to codeine. On 12May2021, around 02:00 am, the patient developed severe dizziness, vertigo and nausea. Treatment was none. The patient did not recover from vertigo, while clinical outcome of the other events was unknown. Seriousness criteria was not reported for the events.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Condition aggravated, Contusion, Dysstasia
Clinical narrative: it feels bruised and hurt; it was difficult to stand on her leg; Numbness and burning below the knee; Numbness and burning below the knee; hard to walk; Joint pain; Left upper leg pain totally increased after vaccination; Left upper leg pain totally increased after vaccination; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration in arm left, on 30Apr2021 at 09:52 AM at 72 years (Lot Number: EW0164), as single dose, for COVID-19 immunisation. Medical history included ongoing leg pain. Concomitant medication included rosuvastatin calcium (unknown manufacturer). The patient previously took unspecified statins which caused arthralgia and pain, and pravastatin 40 mg which caused arthralgia. The patient experienced left upper leg pain totally increased after vaccination (non-serious) on 01May2021 with outcome of unknown , it feels bruised and hurt (non-serious) on an unspecified date with outcome of unknown, it was difficult to stand on her leg (non-serious) on an unspecified date with outcome of unknown, numbness and burning below the knee (non-serious) on an unspecified date with outcome of unknown, hard to walk (non-serious) on an unspecified date with outcome of unknown, joint pain (non-serious) on an unspecified date with outcome of unknown. Patient took some ibuprofen which only relieved the pain a little bit.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Pain in extremity
Clinical narrative: it feels bruised and hurt; it was difficult to stand on her leg; Numbness and burning below the knee; Numbness and burning below the knee; hard to walk; Joint pain; Left upper leg pain totally increased after vaccination; Left upper leg pain totally increased after vaccination; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration in arm left, on 30Apr2021 at 09:52 AM at 72 years (Lot Number: EW0164), as single dose, for COVID-19 immunisation. Medical history included ongoing leg pain. Concomitant medication included rosuvastatin calcium (unknown manufacturer). The patient previously took unspecified statins which caused arthralgia and pain, and pravastatin 40 mg which caused arthralgia. The patient experienced left upper leg pain totally increased after vaccination (non-serious) on 01May2021 with outcome of unknown , it feels bruised and hurt (non-serious) on an unspecified date with outcome of unknown, it was difficult to stand on her leg (non-serious) on an unspecified date with outcome of unknown, numbness and burning below the knee (non-serious) on an unspecified date with outcome of unknown, hard to walk (non-serious) on an unspecified date with outcome of unknown, joint pain (non-serious) on an unspecified date with outcome of unknown. Patient took some ibuprofen which only relieved the pain a little bit.   No follow-up attempts are needed. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: blood shot eye/Blood shot eye on same side that she got vaccine; This is a spontaneous report from a contactable consumer reporting for herself..   A 81-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 08May2021 (Batch/Lot Number: EW0168) as  single dose for covid-19 immunisation  .  Medical history included ongoing gastrooesophageal reflux disease , hypertension , ongoing anxiety. The patient received the first dose of BNT 162B2 vaccine on 27Mar2021 and experienced a fall. Concomitant medications included omeprazole (OMEPRAZOLE) taken for gastrooesophageal reflux disease from an unspecified start date and ongoing.  The patient experienced blood shot eye/blood shot eye on same side that she got vaccine  on 11May2021 with outcome of not recovered.  Follow up information has been requested.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dermatitis, Dizziness, Headache, Malaise
Clinical narrative: Had inflammation on face red as a beet; Malaise; had arm hurt, Left arm; Headache; Weakness; Dizziness; This is a spontaneous report from a contactable consumer (patient).  An 80-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 28Apr2021 07:30am, at the hospital, (at the age of 80-years-old) as single dose for Covid-19 immunisation. Medical history included eczema from an unknown date and unknown if ongoing, drug hypersensitivity to penicillin (about 21 years old, Inflammation and redness, system gets flush), sulfonamide derivatives. The patient previously took aspirin (e.c.), keflex, sulfur, cellcept and experienced hypersensitivity to all. Concomitant medication included dupilumab (DUPIXENT) taken for eczema, start and stop date were not reported. The patient had inflammation on face, red as a beet, (dermatitis) (non-serious) on an unspecified date with outcome of unknown , malaise (non-serious) on an unspecified date with outcome of unknown, had arm hurt, left arm (pain in extremity) (non-serious) on an unspecified date with outcome of unknown , headache (non-serious) on an unspecified date with outcome of unknown , weakness (non-serious) on an unspecified date with outcome of unknown , dizziness (non-serious) on an unspecified date with outcome of unknown. The clinical course was as follows, at about 4pm the patient went outside, he "felt flushed, but didn't look in the mirror a friend told me to put sunblock on. I looked at my face and saw my face beet red. I just laid down, my arm felt bad, like a Charlie horse, like someone smacked me in the arm." Caller states his symptoms are, "basically inflammation through the body, then headache, weakness, dizziness, malaise, one good thing, no fever or nausea. Some uneasiness, vacillation, physical weakness. The patient don't drink alcohol, drink water and took Tylenol after the vaccine.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Had inflammation on face red as a beet; Malaise; had arm hurt, Left arm; Headache; Weakness; Dizziness; This is a spontaneous report from a contactable consumer (patient).  An 80-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 28Apr2021 07:30am, at the hospital, (at the age of 80-years-old) as single dose for Covid-19 immunisation. Medical history included eczema from an unknown date and unknown if ongoing, drug hypersensitivity to penicillin (about 21 years old, Inflammation and redness, system gets flush), sulfonamide derivatives. The patient previously took aspirin (e.c.), keflex, sulfur, cellcept and experienced hypersensitivity to all. Concomitant medication included dupilumab (DUPIXENT) taken for eczema, start and stop date were not reported. The patient had inflammation on face, red as a beet, (dermatitis) (non-serious) on an unspecified date with outcome of unknown , malaise (non-serious) on an unspecified date with outcome of unknown, had arm hurt, left arm (pain in extremity) (non-serious) on an unspecified date with outcome of unknown , headache (non-serious) on an unspecified date with outcome of unknown , weakness (non-serious) on an unspecified date with outcome of unknown , dizziness (non-serious) on an unspecified date with outcome of unknown. The clinical course was as follows, at about 4pm the patient went outside, he "felt flushed, but didn't look in the mirror a friend told me to put sunblock on. I looked at my face and saw my face beet red. I just laid down, my arm felt bad, like a Charlie horse, like someone smacked me in the arm." Caller states his symptoms are, "basically inflammation through the body, then headache, weakness, dizziness, malaise, one good thing, no fever or nausea. Some uneasiness, vacillation, physical weakness. The patient don't drink alcohol, drink water and took Tylenol after the vaccine.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: pain in left leg/pain a little bit in her left leg; has difficulty walking; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 11May2021 at 11:00 (Batch/Lot Number: EW0168) as 2nd DOSE, SINGLE for covid-19 immunization. Medical history included knee replacement. The patient's concomitant medications was not reported. The patient experienced pain in left leg/ pain a little bit in her left leg and has difficulty walking on 12May2021 at 09:00. Reporter states she got the Pfizer COVID19 shot yesterday for her 2nd dose and had been feeling fine after the shot and then this morning all of a sudden she was feeling pain in left leg/pain a little bit in her left leg; states she had a knee replacement. States the pain began around 9:00am this morning and she was ok when she first got up and was doing things and all of a sudden she gets up from the couch and there the pain was. States the feeling that occurred this morning was a little bit down her leg and up on her thigh and she has difficulty walking; states this feeling is ongoing and she can't say it is pain but more of not being able to put weight on it and more like something with the nerves and it is affecting something in her leg. States the pain is ok and she can take aspirin and that will take care of it and she has taken Tylenol; states she tried to take Naproxen and not Tylenol and the Naproxen did not do a single thing and she put her foot down and tried to walk and it was very sketchy and she wants to know if there have been any reactions like that reported. Therapeutic measures were taken as a result of pain in left leg/ pain a little bit in her left leg and has difficulty walking. The outcome of the events was unknown. The patient received first dose of BNT162B2 for Covid-19 immunization on 20Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Myalgia, Pain
Clinical narrative: pain in her lower back that is "a lot stronger" than what it normally is/She said that the pain in her lower back is a little stronger than it normally is; She gets pain all the time.; muscle pain; This is a spontaneous report from a contactable consumer (patient).  An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 30Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included osteoporosis, sciatica, pain in extremity, back pain. The patient's concomitant medications were not reported. The patient experienced pain in her lower back that is "a lot stronger" than what it normally is/she said that the pain in her lower back is a little stronger than it normally is (non-serious) in May2021 with outcome of not recovered, she gets pain all the time (non-serious) in 2021 with outcome of unknown and muscle pain (non-serious) in 2021 with outcome of unknown.  The patient stated that she normally suffers from osteoporosis and sciatica where the pain goes to her legs. However, since receiving her first dose, she has been experiencing pain in her lower back that is "a lot stronger" than what it normally is (she specified that she noticed the back pain getting worse around 5 days after the vaccine). Caller mentions that she has taken injections for the pain in the past and now feels that she is going to have to go back to get them again. Caller states she read that muscle pain and joint pain can occur with the vaccine but she is not sure if that is what is happening to her and would like to know if this is a side effect of the vaccine. She stated also that it can cause joint pain and muscle pain and said that this was muscle pain. She states that she is unsure about getting her second dose of the vaccine because of her side effects. Caller mentions that she has taken the flu vaccine for years and never had any side effects. The patient had not recovered from the back pain aggravated; the outcome of the other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Decreased appetite, Fatigue, Gait disturbance, Nausea
Clinical narrative: developed a rash that itches and burns on her hip, bursa and under her breast; developed a rash that itches and burns on her hip, bursa and under her breast; developed a rash that itches and burns on her hip, bursa and under her breast; pain/hurting; tired; lack of appetite; nausea; can hardly walk; This is a spontaneous report from a contactable consumer (patient's daughter).   A 78 year old female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 07May2021 (Batch/Lot number was not reported) as single dose  for covid-19 immunisation  .  Medical history included , fibromyalgia , herpes zoster (Had shingles 4 times before). On 16Apr2021 the patient received the first dose of BNT162B2 vaccine.     The patient's concomitant medications were not reported.  The patient  developed a rash that itches and burns on her hip, bursa and under her breast  on 09May2021 with outcome of unknown ,  pain/hurting  on 09May2021 with outcome of unknown , tired  on 09May2021 with outcome of unknown , lack of appetite  on 09May2021 with outcome of unknown , nausea on 09May2021 with outcome of unknown , can hardly walk  on 09May2021 with outcome of unknown.     No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash
Clinical narrative: developed a rash that itches and burns on her hip, bursa and under her breast; developed a rash that itches and burns on her hip, bursa and under her breast; developed a rash that itches and burns on her hip, bursa and under her breast; pain/hurting; tired; lack of appetite; nausea; can hardly walk; This is a spontaneous report from a contactable consumer (patient's daughter).   A 78 year old female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 07May2021 (Batch/Lot number was not reported) as single dose  for covid-19 immunisation  .  Medical history included , fibromyalgia , herpes zoster (Had shingles 4 times before). On 16Apr2021 the patient received the first dose of BNT162B2 vaccine.     The patient's concomitant medications were not reported.  The patient  developed a rash that itches and burns on her hip, bursa and under her breast  on 09May2021 with outcome of unknown ,  pain/hurting  on 09May2021 with outcome of unknown , tired  on 09May2021 with outcome of unknown , lack of appetite  on 09May2021 with outcome of unknown , nausea on 09May2021 with outcome of unknown , can hardly walk  on 09May2021 with outcome of unknown.     No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Ear, nose and throat examination, Taste disorder
Clinical narrative: flavors started changing; loss of taste; This is a spontaneous report from a contactable consumer (patient).  A 50-year-old (she just turned 50) female patient received bnt162b2 (BNT162B2), dose 1 on an unspecified date (Batch/Lot number was not reported) as single dose (at age not specified if 49- or 50-year-old), and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose at the age of 50-year-old for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. Historical vaccine included: bnt162b2 (BNT162B2), dose 1 on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient experienced flavors started changing on her and they continued to change, loss of taste on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included ear, nose and throat examination: normal.   The course of events was as follows: She started to notice a decrease in her taste after her first dose but it was not much, she was still able to taste salty things but for example she was eating a sandwich and she was not sure what kind of sandwich it was, she was having in and out with salt and sweet. Then she had her second dose and she noticed as time passed that her sense of taste has become less and less and not it was hard for her to taste salt, everything just became dull and duller and duller. She cannot tell if she was eating something crunchy like an apple or a turnip or something.  She went to an ENT on 12May2021as she realized flavors started changing on her and they continued to change and they put a tube up her nose and into her ears and said that visually everything looked normal and that there did not appear to be any cause for this loss of taste upon their exam. Now, it was hard to decipher to her what she is eating.  She was concerned. The doctor said they are going to give her some vitamins and see if it helps. They asked if she had been vaccinated and when she said yes they told her to contact Pfizer as Pfizer would know more information that they did because the doctor said it was not on side effects listed. She wished to know if this has been reported and queried how long can this side effects last and if it is temporary. She stated no misconduct was done in administering the vaccine.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: he broke out in a rash all over his body; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on May2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. In May2021, the patient experienced he broke out in a rash all over his body. The patient reported that he just had his first dose 6 days ago and 2 days ago, he broke out in a rash all over his body. He took some antihistamine and was advised by his doctor to address his concerns. The patient stated he doesn't know if he should get the second dose of the vaccine and asked if he should get the second dose of the Pfizer vaccine or perhaps should he get another vaccine like the Moderna. Outcome of event was unknown.  Follow-up attempts are needed; information about lot/batch number can be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection
Clinical narrative: Herpes breakout; This is a spontaneous report from a contactable consumer (patient). This contactable consumer reported 2 reports for different patients. This is one of the 2 reports. A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced herpes breakout (non-serious) on 10May2021 with outcome of not recovered. The event was considered as non serious by the reporter.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pruritus
Clinical narrative: Itching like a severe allergic reaction and all over her body she feels like itching; Nausea; Had a lot of body ache; occasional chills; This is a spontaneous report from a Pfizer-sponsored program, COVAX US Support. A contactable consumer (patient's husband) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 07May2021 (lot number: not known) at 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 1st dose, single (lot number: unknown), taken three weeks ago (cannot provide exact date) for COVID-19 immunization. The reporter said his wife had her second shot of a vaccine this last Friday (07May2021) and the next day (08May2021), she had a lot of body ache and occasional chills. Yesterday (11May2021), she was complaining of itching like a severe allergic reaction and all over her body she feels like itching and she started to have nausea in late part of night. They spoke to the doctor (not reported whether the patient or reporter visited physician office or not) and they told him to give her Benadryl (treatment) for the itching but he was wondering, how long the symptoms, should they expect them to last? Perhaps, should they take some action like they get a help from emergency room? He was asking a question if he should take her to the emergency room. The husband called on behalf of his wife, they took the 1st dose three weeks ago (can't provide the exact date), and they took the 2nd dose last 07May2021. He didn't have any reaction, but he would like to report the reaction that his wife had. His wife experienced body ache, occasional chills, itching, and nausea. He also advised that his wife was prescribed to take Benadryl by her doctor. The outcome of all events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Eye swelling, Hypersensitivity, Pharyngeal swelling, Pruritus
Clinical narrative: suffered a reaction; allergies; eyes got swollen even her throat which restricted her breathing; eyes got swollen even her throat which restricted her breathing; eyes got swollen even her throat which restricted her breathing; itching of the body; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-.  A female patient of unspecified age receivedBNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 29Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient suffered a reaction; allergies, eyes got swollen even her throat which restricted her breathing, itching of the body with outcome of unknown.   The clinical course was reported as follows: She experienced the adverse reaction after getting like a week after getting the 1st dose on 29Apr2021 she said her eyes get swollen even her throat after getting the first dose she got a reaction a adverse reaction like her eyes got swollen even her throat which restricted her breathing and afterwards also itching of the body.  The patient stated that " I received the Pfizer vaccine on 29Apr2021 and I did not have any reaction immediately after however I suffered a reaction last night when I know it's been a little over week since I received it but due to the fact that I have never had I have never had any food for allergies I have never had any junk allergies I am concerned and wondering if my reaction that I had was due to the vaccine because I am due to get the second dose on the 28th which is next week. I am not sure if somehow it could be connected to the vaccine. I wonder it could have been late reaction to the vaccine whether or not I should go ahead and get the second dose".  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Heart rate, Heart rate increased, Hypertension
Clinical narrative: headache; tingling to tongue lips and mouth; bp (blood pressure) 160/90; P107 (Pulse) RR (respiratory rate) 18; P107 (Pulse) RR (respiratory rate) 18; This is a spontaneous report from a contactable nurse. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 33-year-old, intramuscular, administered in left arm on 13May2021 10:00 (Lot Number: ew0183) as 1st dose single for COVID-19 immunisation. The patient has no medical history. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine and other medications within 2 weeks of vaccination. On 13May2021 at 10:00, shortly after her Pfizer vaccine she developed a headache and tingling to tongue lips and mouth. No swelling noted no hives noted. The patient was given 25mg PO (oral) diphenhydramine (BENADRYL) for the headache and tingling to tongue lips and mouth per protocol and EMS (Emergency Medical Services) called. Patient was speaking in full sentences. The patient's VSS (vital signs stable), BP (blood pressure) 160/90, P (pulse) 107, RR (respiratory rate) 18, RA (respiratory) 99% all on 13May2021. The patient was in no acute distress and reports tingling not getting worse. Patient was transported to HMH (health level) ED (emergency department) for evaluation. The events resulted in Emergency room/department or urgent care. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Paraesthesia oral, Respiratory rate, Respiratory rate increased, Vital signs measurement
Clinical narrative: headache; tingling to tongue lips and mouth; bp (blood pressure) 160/90; P107 (Pulse) RR (respiratory rate) 18; P107 (Pulse) RR (respiratory rate) 18; This is a spontaneous report from a contactable nurse. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 33-year-old, intramuscular, administered in left arm on 13May2021 10:00 (Lot Number: ew0183) as 1st dose single for COVID-19 immunisation. The patient has no medical history. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine and other medications within 2 weeks of vaccination. On 13May2021 at 10:00, shortly after her Pfizer vaccine she developed a headache and tingling to tongue lips and mouth. No swelling noted no hives noted. The patient was given 25mg PO (oral) diphenhydramine (BENADRYL) for the headache and tingling to tongue lips and mouth per protocol and EMS (Emergency Medical Services) called. Patient was speaking in full sentences. The patient's VSS (vital signs stable), BP (blood pressure) 160/90, P (pulse) 107, RR (respiratory rate) 18, RA (respiratory) 99% all on 13May2021. The patient was in no acute distress and reports tingling not getting worse. Patient was transported to HMH (health level) ED (emergency department) for evaluation. The events resulted in Emergency room/department or urgent care. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Skin laceration, Wound haemorrhage
Clinical narrative: cut in the finger and had to go to ER/cut his finger at work; He could not get bleeding to stop/ cutting his finger at work; This is a spontaneous report from a contactable other healthcare professional (also the mother of the patient) from a Pfizer-sponsored program.   A 22-years-old male patient (reported as weight: 140-145pounds) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Deltoid Left (reported as around between 11 or 12) on 10May2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (Pfizer Covid 19 vaccine) on 18Apr2021 (Sunday) for COVID-19 immunization. It was reported that the patient had the second dose on 10May2021 (Monday) of the covid 19 vaccine had to go to ER and was hospitalized due to cutting his finger at work on 12May2021. The patient took a tetanus shot last night and she wants assurance that he should not be receiving other vaccines after the second dose. She is also concerned and asking if the tetanus will interfere with the efficacy of the vaccine. It was clarified that the patient was not admitted to the hospital, he went to emergency room late last night into the early morning. Confirms he went to ER on 12May2021.She thinks it was probably administered in his left deltoid because he is right handed. He is a healthy young man. For the treatment tetanus shot and gauze bandage with anticoagulant in it since he could not get stitched. He could not get bleeding to stop and then went to ER. Not life threatening. The events resulted in emergency room visit. The events were considered medically significant by the reporter. The outcome of the events was unknown.   Information on the lot/batch number has been requested.