chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Pyrexia
Clinical narrative: tested positive; fever; chills; cough; This is a spontaneous report from a contactable physician. A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported) on 28Jan2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that after getting first dose the patient subsequently developed fever, chills and cough 1-2 days later (unknown date in 2021). They tested him for COVID-19 and he tested positive on 02Feb2021. Patient had high risk criteria for severe infection so they proceeded with giving him Bamlanivimab infusion on 03Feb2021. They were waiting 90 days now post infusion prior to vaccinating him. It was enquired that since how much time would have lapsed since getting his first vaccine, should patient start the series over or does he just need one more dose. Therapeutic measures were taken as a result of fever, chills, cough and tested. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Skin swelling
Clinical narrative: Under arm sore and puffy; Under arm sore and puffy; swollen lymph nodes; This is a spontaneous report from a contactable consumer (Patient). A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 11Mar2021 18:45 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation.  Medical history included hypertension, shellfish allergy. The patient's concomitant medications were not reported.  On 16Mar2021, patient experienced under arm sore and puffy, swollen lymph nodes. Outcome of events was not recovered.   No follow-up attempts are possible. No further information is expected
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Pounding headache; Chills; Body ache; Mild nausea; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EN6206), via an unspecified route of administration, administered in the left arm on 13Mar2021 14:30 (at the age of 46-years-old) as 2nd dose, single dose 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. The patient has no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (lot number: EL9266) via an unspecified route of administration, administered in the left arm on 23Feb2021 13:30 for COVID-19 immunization. On 14Mar2021 03:00, the patient experienced pounding headache, chills, body ache, mild nausea, and fatigue. The patient did not receive treatment for the events. The events lasted for about a day and a half. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: injection site tenderness; headache; Chills; nausea; Fever; This spontaneous report from a contactable Consumer (patient).   A 40-year-old female consumer reported that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN6201), on 16Feb2021 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included ibuprofen (ADVIL 12 HOUR) for an unspecified indication.  The patient experienced injection site tenderness on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of unknown , chills on an unspecified date with outcome of unknown , nausea on an unspecified date with outcome of recovered on an unknown date and fever on an unspecified date with outcome of unknown.   No follow up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021296244 Same patient, same drug, different dose
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm tenderness at injection site; This is a spontaneous report from a contactable consumer.  A consumer of unknown age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on 12Mar2021 at single dose for COVID-19 immunization. The patient received the first dose of vaccine on an unknown date. The patient reported arm tenderness at injection site 24 hours after immunization. Tenderness has resolved on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue, Hypersensitivity, Illness
Clinical narrative: her right arm and her whole body was very painful; right shoulder injury; her whole body was very painful; neurological head pain; allergy; muscle twitching all over her body for the whole day; nausea; loss appetite/ no appetite; sick; dizziness; fatigue; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had experienced severe events right after her first dose which included nausea, loss appetite/ no appetite, sick, dizziness, and fatigue. The patient then mentioned that the next morning after the first dose (on 12Mar2021), she experienced muscle twitching all over her body for the whole day. A couple of days later (unspecified date), her right arm and her whole body was very painful. The patient took lots of medication after her first dose of the vaccine for her right shoulder injury (unspecified date) and she added that she was taking antibiotics as well. The patient took the following medications after her first dose of the vaccine: ethambutol, erythromycin, rifabutin and Bactrim. The patient then stated that she took topiramate for neurological head pain, thyroid pill, birth control pill, muscle relaxant (unspeciifed) and omeprazole for allergy on an unspecified date. The outcome of the events was unknown.  Information on batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Limb injury, Muscle twitching, Nausea, Neuralgia, Pain
Clinical narrative: her right arm and her whole body was very painful; right shoulder injury; her whole body was very painful; neurological head pain; allergy; muscle twitching all over her body for the whole day; nausea; loss appetite/ no appetite; sick; dizziness; fatigue; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had experienced severe events right after her first dose which included nausea, loss appetite/ no appetite, sick, dizziness, and fatigue. The patient then mentioned that the next morning after the first dose (on 12Mar2021), she experienced muscle twitching all over her body for the whole day. A couple of days later (unspecified date), her right arm and her whole body was very painful. The patient took lots of medication after her first dose of the vaccine for her right shoulder injury (unspecified date) and she added that she was taking antibiotics as well. The patient took the following medications after her first dose of the vaccine: ethambutol, erythromycin, rifabutin and Bactrim. The patient then stated that she took topiramate for neurological head pain, thyroid pill, birth control pill, muscle relaxant (unspeciifed) and omeprazole for allergy on an unspecified date. The outcome of the events was unknown.  Information on batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her right arm and her whole body was very painful; right shoulder injury; her whole body was very painful; neurological head pain; allergy; muscle twitching all over her body for the whole day; nausea; loss appetite/ no appetite; sick; dizziness; fatigue; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had experienced severe events right after her first dose which included nausea, loss appetite/ no appetite, sick, dizziness, and fatigue. The patient then mentioned that the next morning after the first dose (on 12Mar2021), she experienced muscle twitching all over her body for the whole day. A couple of days later (unspecified date), her right arm and her whole body was very painful. The patient took lots of medication after her first dose of the vaccine for her right shoulder injury (unspecified date) and she added that she was taking antibiotics as well. The patient took the following medications after her first dose of the vaccine: ethambutol, erythromycin, rifabutin and Bactrim. The patient then stated that she took topiramate for neurological head pain, thyroid pill, birth control pill, muscle relaxant (unspeciifed) and omeprazole for allergy on an unspecified date. The outcome of the events was unknown.  Information on batch/lot number has been requested.
Sex: F
Vaccine: COVID19, UNK, UNK, UNK, UNK
Symptoms: Dyspnoea, Off label use, Pain
Clinical narrative: Shortness of breath; She is hurting right now; Hydrocortisone for arthritis/ Methylprednisolone for arthritis; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown dose number, single dose for COVID -19 immunisation; hydrocortisone, route of administration, start and stop date, batch/lot number and dose were not reported for arthritis; methylprednisolone, route of administration, start and stop date, batch/lot number and dose were not reported for arthritis; adalimumab (HUMIRA), via an unspecified route of administration, from an unspecified date (batch/lot number not reported) to an unspecified  date at 2 DF (dosage form) (2 doses) for an unspecified indication; and leflunomide, route of administration, start and stop date, batch/lot number and dose were not reported for arthritis. The patient's medical history and concomitant medications were not reported.  The patient experienced shortness of breath and hurting on an unspecified date. Patient reported that she used to be on Humira but stopped it because it gave her shortness of breath. She takes Methylprednisolone, Leflunomide, and Hydrocortisone for her arthritis.  Patient was wondering if these medications interfere with the COVID shot.  She has already reported the Humira incident. She only took two doses of it. She had to stop because it gave her shortness of breath. Patient was wondering if any of her medications will interfere with the COVID vaccine. The family doctor told the patient to wait a week before the shot, but the Rheumatologist said okay to get the vaccine with her medications. The patient was hurting right now. She was trying to find some cream in the pharmacy. The action taken in response to the events for hydrocortisone, methylprednisolone and leflunomide was unknown; and for adalimumab was permanently withdrawn on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Rhinorrhoea
Clinical narrative: runny nose; coughing; mild diarrhea; This is a spontaneous report from from a contactable consumer (patient).   A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, on unknown date as single dose for covid-19 immunisation. Medical history and the concomitant medications were not reported. The patient experienced a runny nose which might be associated with his sinus problem, coughing, and mild diarrhea on unspecified date. The outcome was unknown. The events were assessed as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: headache; feeling nauseous; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer-sponsored program.   A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose at an unspecified age for COVID-19 immunisation.  The patient medical history was and concomitant medications were not reported.  The patient experienced headache and feeling nauseous on an unspecified date. The events were considered non serious. The outcome of events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Heart rate, Heart rate increased
Clinical narrative: injection in her knee and she was hurt by the injection; heart rate began to rise; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 18Feb2021 (Batch/Lot number was not reported) as 2nd dose, single dose for COVID-19 immunisation; and cortisone (manufacturer unknown), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient received Pfizer Covid-19 vaccine first dose on 28Jan2021, and 2nd dose on 18Feb2021. Four weeks later she received a cortisone injection in her knee, and she was hurt by the injection. Her heart rate began to rise, and she was wondering if that was from the Pfizer Covid-19 vaccine or from the Cortisone or from the diabetes. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number could not be requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm sore; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown dose, single dose for COVID-19 immunization; tofacitinib citrate (XELJANZ XR), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 11 mg for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced arm sore on an unspecified date. Patient stated, "I took the Pfizer shot and it made my arm sore." The action taken in response to the event for tofacitinib citrate was unknown. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu-like symptoms; Headache; High Fever; Vomiting; Chills; Body aches; This is a spontaneous report from a contactable consumer (patient).  A 67-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: EL3982; Expiration Date: May2021) as single dose for covid-19 immunisation. Patient received first dose of vaccine on 14Jan2021.  Medical history included  type 1 diabetes mellitus, hepatic cirrhosis. Family Medical History included: Lung Cancer, ovarian Cancer. The patient's concomitant medications were not reported. On an unspecified date, patient experienced flu-like symptoms, headache, high fever, vomiting , chills, body aches. Outcome of events was recovered.    No follow up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Flu-like symptoms; Headache; High Fever; Vomiting; Chills; Body aches; This is a spontaneous report from a contactable consumer (patient).  A 67-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: EL3982; Expiration Date: May2021) as single dose for covid-19 immunisation. Patient received first dose of vaccine on 14Jan2021.  Medical history included  type 1 diabetes mellitus, hepatic cirrhosis. Family Medical History included: Lung Cancer, ovarian Cancer. The patient's concomitant medications were not reported. On an unspecified date, patient experienced flu-like symptoms, headache, high fever, vomiting , chills, body aches. Outcome of events was recovered.    No follow up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Pain in extremity
Clinical narrative: 2 brief spells of rapid heart beat; Sore Arm; This is a spontaneous report from a contactable consumer (patient).  A 75-years-old female patient received BNT162B2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 05Feb2021 (Batch/Lot Number: EL8982), age at vaccination of 75-years-old, as single dose, for covid-19 immunisation.  Medical history was none. The patient was not pregnant and was not pregnant at the time of vaccination.  The patient received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 13Jan2021 08:30 (Batch/Lot Number: EL3249), age at vaccination of 75-years-old, as single dose, for covid-19 immunisation. The patient's concomitant medications were not reported.  The patient experienced 2 brief spells of rapid heart beat on 05Feb2021 (30 min of dose 2) and sore arm on 05Feb2021. No visit to emergency room nor physician office required. No treatment was given for the event heart rate increased. Vaccine facility type: health dept. The outcome of the event sore arm was unknown while the patient was recovered from the event heart rate increased on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint stiffness, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: joint and leg pain, beyond stiffness, elbow and knee pain; joint and leg pain, beyond stiffness, elbow and knee pain; joint and leg pain, beyond stiffness, elbow and knee pain; joint and leg pain, beyond stiffness, elbow and knee pain; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on the left arm on 13Mar2021 16:00 (lot number: ERJ6207) at the age of 56 years old as 2nd dose, single for COVID-19 immunisation. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient had no known allergies. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on the left arm on 14Feb2021 19:00 (lot number: EN6201) at the age of 56 years old as 1st dose, single for COVID-19 immunisation. The patient didn't have COVID prior to vaccination. Since the vaccination the patient hadn't been tested for COVID. The patient didn't receive other vaccines in four weeks. On 14Mar2021 14:00 (the following day after the second dose), the patient had continued joint and leg pain, beyond stiffness, elbow and knee pain. No treatment was received by the patient. The patient thought that the symptoms would go away and assumed a few days is no usual but had persisted. The patient then mentioned that at the evening of 14Mar2021, the joint pain became more evident. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Infection, Localised infection
Clinical narrative: Infection in both arm and back of neck; Infection in both arm and back of neck; This is a spontaneous report from a contactable consumer (Patient). This consumer reported in response to Non-HCP letter sent to cross reference case another dose.   A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration in left arm on 13Jan2021 at 11:30 as single dose for COVID-19 immunization. Medical history and Concomitant medications not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FV9231), on 23Feb2020 (as reported) at 8:50 for COVID-19 immunization. On an unspecified date, the patient experienced infection in both arm and back of neck. The events did not require a visit to Emergency Room/Physician Office. There were no predisposing factors and no culture performed. No antipyretic used. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Inflammation, Tendon disorder, Ultrasound Doppler
Clinical narrative: left hand became inflamed; My left shoulder joint was hurting, down to my finger tips. it was mostly in my left hand/each and every joint in my left hand were hurting; tendons felt like they needed to be oiled. they were squeaking; This is a spontaneous report from a contactable consumer (patient) . This 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number LW0158) via an unspecified route of administration in the left arm on 16Apr2021 at 15:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. 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. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number ER8733) in 2021, reported as 16Apr2021, for COVID-19 immunisation. The patient reported that five days after he got the second shot in his left arm, on 21Apr2021, his left hand became inflamed. He reported his left shoulder joint was hurting down to his fingertips, reporting it was mostly in his left hand; further stating he couldn't make a fist or hold anything in that hand for a little over 10 days and each and every joint in his left hand was hurting. He reported being unable to hold a pencil in that hand, further stating he had to open and close his hand all day long just to use it. He also stated his tendons felt like they needed to be oiled, reporting they were squeaking. The patient stated that after the day 11, about one finger at a time was feeling better, and the following day another finger was feeling better. He stated his hand was not "100%" where he was before he got the second vaccine. He stated he got blood work done and "all" came back negative and he had a doppler done which also came back negative. He stated he was in constant contact with his primary care physician (PCP) and they were both concluding that it was a result of the shot. The events required a physician office and emergency room visit. The events were reported as non-serious and did not require hospitalization. The clinical outcomes of left hand became inflamed, his left shoulder joint was hurting down to his fingertips, it was mostly in his left hand/each and every joint in his left hand was hurting, and tendons felt like they needed to be oiled/they were squeaking were not recovered. It was also reported that since vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Body temperature, Lymphadenopathy, Neck mass
Clinical narrative: swollen lymph nodes; pain on the injection side in my lower neck it feels like a bump; pain on the injection side in my lower neck it feels like a bump; I have the same pain in my armpit with the same bump feeling; I have the same pain in my armpit with the same bump feeling; fever; This is a spontaneous report received from a non-contactable consumer (patient). This 39-year-old female patient received a dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME; lot number EW0185) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she thought she possibly developed swollen lymph nodes because she had pain on the injection side in her lower neck and it felt like a bump; she also had the same pain in her armpit with the same bump feeling. She also reported a fever between 100 and 101. The events were reported as non-serious and did not require hospitalization. The clinical outcomes of pain on the injection side in her lower neck it felt like a bump, she had the same pain in her armpit with the same bump feeling, and fever were unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pyrexia
Clinical narrative: swollen lymph nodes; pain on the injection side in my lower neck it feels like a bump; pain on the injection side in my lower neck it feels like a bump; I have the same pain in my armpit with the same bump feeling; I have the same pain in my armpit with the same bump feeling; fever; This is a spontaneous report received from a non-contactable consumer (patient). This 39-year-old female patient received a dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME; lot number EW0185) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she thought she possibly developed swollen lymph nodes because she had pain on the injection side in her lower neck and it felt like a bump; she also had the same pain in her armpit with the same bump feeling. She also reported a fever between 100 and 101. The events were reported as non-serious and did not require hospitalization. The clinical outcomes of pain on the injection side in her lower neck it felt like a bump, she had the same pain in her armpit with the same bump feeling, and fever were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: low grade fever; chills; body aches; This is a spontaneous report from a contactable consume. This 23-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EWD179) via an unspecified route of administration in the left arm on 15May2021 at 10:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination the patient was not 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. Prior to vaccination the patient received the first dose of BNT162B2 (lot number EW0169) on 24Apr2021 at 10:00 (at the age of 23-years-old) in the left arm for COVID-19 immunisation; and montelukast sodium (SINGULAIR) from an unknown date for an unknown indication and experienced drug allergy. On 15May2021 at 22:00 the patient experienced low-grade fever, chills and body aches. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of low-grade fever, chills, and body aches were not recovered. 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: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; fever at 100.2F; Pain in arm; headache; nausea; This is a spontaneous report from a contactable consumer or other non HCP.  A 13-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0167) intramuscular, administered in Arm Left on 15May2021 17:00 (at the age of 13-years-old) as 1st dose, single dose for covid-19 immunisation at store. The patient had no other medical history and no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On an unspecified date of May2021, the patient experienced pain in arm, headache, nausea, fever at 100.2F. The patient did not received treatment for the adverse event. The outcome of the events was unknown.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Inappropriate age at vaccine administration; fever at 100.2F; Pain in arm; headache; nausea; This is a spontaneous report from a contactable consumer or other non HCP.  A 13-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0167) intramuscular, administered in Arm Left on 15May2021 17:00 (at the age of 13-years-old) as 1st dose, single dose for covid-19 immunisation at store. The patient had no other medical history and no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On an unspecified date of May2021, the patient experienced pain in arm, headache, nausea, fever at 100.2F. The patient did not received treatment for the adverse event. The outcome of the events was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: I have chill first then body ache but its mild; I have chill first then body ache but its mild; This is a spontaneous report from a contactable healthcare professional (patient). This 38-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 15May2021 at 10:15 (at the age of 38-years-old) as a single dose for COVID-19 immunization. Medical history included allergies to certain type of antibiotic medicines. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included metronidazole from an unknown date for an unknown indication. The patient previously received dose 1 of BNT162B2 (lot number EW0164) on 24Apr2021 at 10:15 as a single dose in the left arm for COVID-19 immunization. On 16May2021 at 13:00 the patient had chill first then body ache but it was mild. The patient did not receive any treatment for the events. The outcomes of chill and body ache 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Acne, Blood glucose decreased, Dysmenorrhoea, Epistaxis
Clinical narrative: sweaty hands; bad dull headache in middle of brain; Gas bloating; Drop in blood sugar; acne on my cheeks; period was late; injection site hurt; Little red zits with no heads; mild nose bleeds started in right nostril; my period is late and i have weird cramping; This is a spontaneous report from a contactable consumer (patient). This  37- year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 03Apr2021 at 12:00 (as reported) as a single dose in the right arm for COVID-19 immunization. Medical history was none. 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. Concomitant medications included magnesium, calcium, vitamin D3, and probiotics from unknown dates for unspecified indications and omega 3 from an unknown date to two weeks prior to the second shot for an unknown indication. The patient did not have any known allergies. The patient previously received dose 1 of BNT162B2 on 03Apr2021 at 12:00 (as reported) as a single dose in the left arm for COVID-19 immunization. On 05May2021 at 09:00 (as reported), the patient experienced first day very bad dull headache in middle of brain, second day sweaty hands. She also experienced drop in blood sugar, and gas bloating. She was due to get her menstrual cycle 13May2021 or a day or two prior in schedule. A few days after the second dose she had acne on her cheeks, little red zits with no heads. She never had those before. Two weeks after the second dose her injection site hurt similar to the second day or that second dose. It was her right arm this time where she got the second dose. It was on and off for 3 to 4 days. She had mild nose bleeds that started in the right nostril mainly in the morning. She had done nothing different including no changes to the environment. It lasted about a week. Now (on an unspecified date) her period was late and she had weird cramping. She was not sexually active; no risk of pregnancy. The patient did not receive any treatment for the events. The outcomes of headache, sweaty hands, drop in blood sugar, gas bloating, acne, zits, injection site hurt, nose bleeds, period was late, and cramping were recovering with lasting effects. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Menstruation delayed, Rash macular, Vaccination site pain
Clinical narrative: sweaty hands; bad dull headache in middle of brain; Gas bloating; Drop in blood sugar; acne on my cheeks; period was late; injection site hurt; Little red zits with no heads; mild nose bleeds started in right nostril; my period is late and i have weird cramping; This is a spontaneous report from a contactable consumer (patient). This  37- year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 03Apr2021 at 12:00 (as reported) as a single dose in the right arm for COVID-19 immunization. Medical history was none. 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. Concomitant medications included magnesium, calcium, vitamin D3, and probiotics from unknown dates for unspecified indications and omega 3 from an unknown date to two weeks prior to the second shot for an unknown indication. The patient did not have any known allergies. The patient previously received dose 1 of BNT162B2 on 03Apr2021 at 12:00 (as reported) as a single dose in the left arm for COVID-19 immunization. On 05May2021 at 09:00 (as reported), the patient experienced first day very bad dull headache in middle of brain, second day sweaty hands. She also experienced drop in blood sugar, and gas bloating. She was due to get her menstrual cycle 13May2021 or a day or two prior in schedule. A few days after the second dose she had acne on her cheeks, little red zits with no heads. She never had those before. Two weeks after the second dose her injection site hurt similar to the second day or that second dose. It was her right arm this time where she got the second dose. It was on and off for 3 to 4 days. She had mild nose bleeds that started in the right nostril mainly in the morning. She had done nothing different including no changes to the environment. It lasted about a week. Now (on an unspecified date) her period was late and she had weird cramping. She was not sexually active; no risk of pregnancy. The patient did not receive any treatment for the events. The outcomes of headache, sweaty hands, drop in blood sugar, gas bloating, acne, zits, injection site hurt, nose bleeds, period was late, and cramping were recovering with lasting effects. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Skin rash and ankles and hands; This is a spontaneous report  from a contactable consumer (patient). This 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 14May2021 at 16:00 (at the age of 20-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included hypothyroid. 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 vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) and "BCP." The patient did not have any known allergies. On 16May2021 at 10:00 the patient experienced skin rash on ankles and hands. The event was reported as non-serious. The patient was not hospitalized for the event. The patient did not receive any treatment for the event. The outcome of skin rash was recovering. It was also reported that since the vaccination the patient was not tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, Malaise, Rash
Clinical narrative: like a metal taste; rash on my arms; don't feel great after; headaches; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced like a metal taste, rash on my arms, don't feel great after and headaches. It was reported that the patient got vaccination (unspecified vaccine) and has like a metal taste and didn't know if it was a side effect from the vaccination. It was also reported that the patient developed a rash on her arms; one arm cleared up but the other one has just a light rash. She didn't feel real great after the vaccination last week and got headaches at least once a week. The outcome of the event rash on her arms was recovering while the outcome of the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Muscle spasms
Clinical narrative: I am having like muscle spasm at my back, on my right back; my back is just killing me my lower right back; I am so much in pain right now; This is a spontaneous report from a contactable consumer(patient). A patient of an unspecified age and gender received BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration on 14May2021 as second dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown) on 23Apr2021 as the first dose, single for COVID-19 immunisation. On 14May2021, after waiting for a little bit after the shot, the patient experienced having like muscle spasm at back, on right back, felt that "my back is just killing me my lower right back" and was in so much pain (reported as right now). The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: got chills; fever; headache; This is a spontaneous report from a contactable consumer. A 13-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 14May2021 (Batch/Lot number was not reported) as first dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 14May2021 at night, patient got chills, fever, and headache. The patient's mother gave her 1 Tylenol. By 1:30 am, her fever was 103, her mother gave her two Tylenol and fever went to 100. At 7:30 am, 15May2021, her fever was back to 103 and her mother gave her two Tylenol again, fever went back to 100. At 3:25 am on 16May2021, fever was 103.5. Her mother gave her two Tylenol and went back to 100. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Investigation
Clinical narrative: On 14May2021 had tingling in right forearm, then throughout the days it travelled/ on 22May2021, bumps appeared on her right hand and arm/ a test and results on 25May2021 was shingles; This is a spontaneous report from a contactable consumer (patient).  A 35-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 08May2021 13:30 (at the age of 35 years old) (Lot Number: EW0162) as first dose, single dose for COVID-19 immunisation. Medical history included type 2 diabetes from an unknown date and unknown if ongoing. The patient did not have COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included glipizide, metformin, insulin glargine (BASAGLAR) and Vitamins; all taken for unspecified indication, start and stop date were not reported. Six days after 1st dose (14May2021), patient had tingling in right forearm, then throughout the days it travelled. In the morning of 22May2021, bumps appeared on her right hand and arm. On 24May2021, doctor did a test and results on 25May2021 was shingles. Tingling was random but happened throughout body on both sides. Patient was given antiviral meds (valacyclovir). The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did got tested for COVID post vaccination. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bone pain, Diarrhoea, Gait disturbance, Pain in extremity
Clinical narrative: Ulcer pain since I got the shot; Cant walk anymore, the pain is in my legs, in my feet, in my arms, I cant walk anymore; the pain is in my legs, in my feet, in my arms/fingers hurt; I had diarrhea and I had to throw up; I had diarrhea and I had to throw up; back hurts; all my bones are hurting; This is a spontaneous report from a contactable consumer (patient). This 86-year-old female patient received 1st dose of BNT162B2 (lot# ER8732) at the age of 86 years old, on 26Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. Patient experienced Ulcer pain since got the shot. Cant walk anymore, the pain is in her legs, in her feet, in her arms (if take a pain killer it do not work). She cannot drive car nor go no places. Also Diarrhea, Had to throw up. Since I got this shot the first day I got, for 4 days I had diarrhea and I had to throw up, well I have never seen this in my life because when I throw it up it was (not clear), it was like two. Now I got this shot on 03/26 and now I am in ulcer pain, I cant walk, all my bones are hurting, I cant drive my car anymore, I cant go no place. I am 86 years old and all by myself. I dont know what to do I am in pain. My leg hurts I hardly can walk, my back hurts, my arms hurt, my fingers hurt. I dont know what I have to do. I am 86 years old and I live by myself and I dont know what to do. The first shot I got was on (03/36) and I had no problem with this one, but the second one I got is killing me (refer to AER#2021630678)." Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.