chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Lymphadenopathy, Myalgia, Nausea, Vomiting
Clinical narrative: Extreme body aches muscles and joints; Extreme body aches muscles and joints; Headache; extreme swollen lymph nodes in axil area traveling to Brest and back; Nausea; vomiting; Dizziness; lethargy; Unable to move arm with injection site huge lump; Unable to move arm with injection site huge lump; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female non-pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 at 14:15 (at the age of 43-years-old) as a DOSE 2, SINGLE for covid-19 immunisation. Patient medical history included fibromyalgia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took ace inhibitors and experienced drug hypersensitivity. No other vaccine was received in four weeks. The patient did not have covid prior vaccination and not tested for covid post vaccination. On 05Mar2021, the patient experienced extreme body aches muscles and joints, headache, extreme swollen lymph nodes in axil area traveling to breast and back, nausea, vomiting, dizziness, lethargy, unable to move arm with injection site huge lump. It was reported that, on 05Mar2021 at 04:00 PM the patient had extreme body aches muscles and joints. Headache extreme swollen lymph nodes in axil area traveling to breast and back. Nausea and vomiting. Dizziness and lethargy. Unable to move arm with injection site huge lump. No treatment was received for the events. Outcome of the events were recovered with sequelae in 2021(Recovered with lasting effects).  No follow-up attempts are possible; information about lot/batch number cannot been obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021168274 same patient, different shot/event
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Malaise, Nausea, Pruritus
Clinical narrative: Large knot at injection site; pain at injection site; skin redness the size of a half dollar along with itching; headache; nausea; malaise; skin redness the size of a half dollar along with itching; This is a spontaneous report from a contactable Nurse (patient). A 57-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6206; Expiration Date: Jun2021), via an unspecified route of administration in right arm on 07Mar2021 10:45 (at the age of 57-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included diabetes, sjogrens syndrome, HTN, mixed connective tissue and hyperlipidaemia. The patient was allergic to Amoxicillin. Other medications was received in two weeks. The patient previously received first dose of BNT162B2 (solution for injection, Batch/Lot number: EM9809; Expiration Date: Jun2021), via unspecified route of administration in right arm on 12Feb2021 at 11:00 as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 07Mar2021 at 12:00, the patient experienced large knot at injection site with pain at injection site, skin redness the size of a half dollar along with itching. That was still present 3 days post injection. A few hours post injection had headache nausea and malaise which resolved after a 3hour nap. Therapeutic measures were not taken. The outcome of all the events was reported as not resolved.  No follow-up attempts are possible information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain
Clinical narrative: Large knot at injection site; pain at injection site; skin redness the size of a half dollar along with itching; headache; nausea; malaise; skin redness the size of a half dollar along with itching; This is a spontaneous report from a contactable Nurse (patient). A 57-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6206; Expiration Date: Jun2021), via an unspecified route of administration in right arm on 07Mar2021 10:45 (at the age of 57-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included diabetes, sjogrens syndrome, HTN, mixed connective tissue and hyperlipidaemia. The patient was allergic to Amoxicillin. Other medications was received in two weeks. The patient previously received first dose of BNT162B2 (solution for injection, Batch/Lot number: EM9809; Expiration Date: Jun2021), via unspecified route of administration in right arm on 12Feb2021 at 11:00 as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 07Mar2021 at 12:00, the patient experienced large knot at injection site with pain at injection site, skin redness the size of a half dollar along with itching. That was still present 3 days post injection. A few hours post injection had headache nausea and malaise which resolved after a 3hour nap. Therapeutic measures were not taken. The outcome of all the events was reported as not resolved.  No follow-up attempts are possible information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Hyperhidrosis, Illness, Nasopharyngitis
Clinical narrative: very very sick; pains in her chest like nothing I've ever felt before; she couldn't breathe; she was so cold; her body ached so bad; fever; changed pajamas three times due to sweating; This is a spontaneous report from a contactable consumer(patient) reported for herself that: A 54-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Mar2021 at 18:05 as single dose for covid-19 immunisation. Medical history included penicillin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient's Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date as single dose for covid-19 immunisation and experienced the events I was very very very sick, splitting headaches, chills, aches, freezing and she has a 102 fever. Patient reported she received her 2nd dose Friday on 12Mar2021 night at 18:05 and on Saturday 13Mar2021 at approximately noon, she became very very sick from the vaccine. She stated it was to the point that if I was at home, I would have to go to the emergency room at Medical Centre, but I was out on a soccer field refereeing. She stated that she had pains in her chest like nothing I have ever felt before. She states that she couldn't breathe, and she had to pull down her mask and try to take a deep breath. She stated It was bad later that night she reported that she was so cold, and her body ached so bad she got a fever and had to changed pajamas three times due to sweating. She stated It was bad, so there is something in that vaccine that people need to know about. She reported once the game was over and she sat down, she felt better. She stated that she has a penicillin allergy, and they believe that is the only thing that caused her to react this way. She stated Did you also know Pfizer make penicillin. Maybe there is some in the vaccine. This case assessed as non-serious by the reporter. The outcome of the events was reported as recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: very very sick; pains in her chest like nothing I've ever felt before; she couldn't breathe; she was so cold; her body ached so bad; fever; changed pajamas three times due to sweating; This is a spontaneous report from a contactable consumer(patient) reported for herself that: A 54-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Mar2021 at 18:05 as single dose for covid-19 immunisation. Medical history included penicillin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient's Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date as single dose for covid-19 immunisation and experienced the events I was very very very sick, splitting headaches, chills, aches, freezing and she has a 102 fever. Patient reported she received her 2nd dose Friday on 12Mar2021 night at 18:05 and on Saturday 13Mar2021 at approximately noon, she became very very sick from the vaccine. She stated it was to the point that if I was at home, I would have to go to the emergency room at Medical Centre, but I was out on a soccer field refereeing. She stated that she had pains in her chest like nothing I have ever felt before. She states that she couldn't breathe, and she had to pull down her mask and try to take a deep breath. She stated It was bad later that night she reported that she was so cold, and her body ached so bad she got a fever and had to changed pajamas three times due to sweating. She stated It was bad, so there is something in that vaccine that people need to know about. She reported once the game was over and she sat down, she felt better. She stated that she has a penicillin allergy, and they believe that is the only thing that caused her to react this way. She stated Did you also know Pfizer make penicillin. Maybe there is some in the vaccine. This case assessed as non-serious by the reporter. The outcome of the events was reported as recovering.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate abnormal, Pain in extremity, Pulse abnormal, Supraventricular tachycardia
Clinical narrative: supraventricular tachycardia; her pulse was racing and then slow, fluctuating; uneven beats in her heart; some soreness in her arm; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EM9810) intramuscular, administered in Deltoid Left on 06Feb2021 as dose 1, single for covid-19 immunisation (vaccinated at 70-years age). Medical history included ongoing high cholesterol (Verbatim: High cholesterol), Breast cancer, hypothyroidism, blood pressure. Concomitant medication included ongoing Exemestane taken for breast cancer from Jun2020 to an unspecified stop date; ongoing levothyroxine sodium (SYNTHROID) taken for hypothyroidism 125mcg 5 times a week. 100mcg 2 times a week (Tuesday and Saturday)Once a day by mouth - Thinks she started it around 1999; ongoing hctz (Hydrochlorothiazide) taken for blood pressure 25mg once a day by mouth, ongoing lisinopril taken for blood pressure 40mg once a day by mouth- Probably been on it since around 1993. It was reported that patient had the first vaccine on 06Feb2021 and she was in her usual state of health aside from some soreness in her arm. On 26Feb2021, she developed tachycardia and had uneven beats in her heart. Patient stated she reported cardiac effects she and her husband (73 years old) experienced after taking the Pfizer covid Vaccine. She had supraventricular tachycardia (SVT) 20 days after the first dose that lasted for 2 weeks. her pulse was racing and then slow, fluctuating. She and her husband received first dose on 06Feb2021 and second dose on 01Mar2021. The patient received the treatment for the events. Lab test included heart rate: uneven beats on 26Feb2021. The clinical outcome of the events supraventricular tachycardia was resolved on 13Mar2021, remaining all other events were resolving.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: 104 degree fever for three days.; Severe headache for four days.; This is a spontaneous report from a contactable consumer or other non hcp. A 36-years-old female patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No was not reported), via an unspecified route of administration, administered in Arm Right on 05Mar2021 09:00 as 1stdose, single for covid-19 immunisation. A 36-years-old female patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No was not reported), via an unspecified route of administration, administered in Right arm on 05Mar2021 as 2nddose, single for covid-19 immunisation. Patient is not pregnant. Medical history included thyroid cancer from an unknown date and unknown if ongoing Other medical history: Thyroid cancer, food allergy from an unknown date and unknown if ongoing Known allergies: Hazelnuts. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported.  The patient experienced 104-degree fever for three days on 06Mar2021 02:00, severe headache for four days.  The patient underwent lab tests and procedures which included pyrexia: 104 degree   on 06Mar2021 104-degree fever for three days. Outcome of the events was recovered.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Vaccination site mass
Clinical narrative: soreness under left arm with a 2 inch lump; soreness under left arm with a 2 inch lump; she also had muscle soreness in her left arm that had; This is a spontaneous report from a contactable consumer.   A 50-years-old non pregnant female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on an unknown date), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 13:15(Age at vaccination 50 years old) (Batch/Lot Number: EN6207) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not received other medications the patient received within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 Prior to vaccination, not tested positive for the covid-19. Patient was not allergies to medications, food, or other products. On 19Mar2021, the patient had her first Pfizer COVID-19 Vaccine 2 days ago on 17Mar2021. She said she had the COVID-19 Vaccine in her left arm. She said today (19Mar2021) she had a swollen lump in her left arm area that was about a 2 inch radius. She said she was calling to report her lump to Pfizer. On 17Mar2021, the patient also had muscle soreness in her left arm that had started overnight. Patient clarified the muscle soreness and swollen lump were under her left arm in her left armpit area. Outcome for the events limb mass¸ pain in extremity was not recovered, and for the event myalgia was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Skin mass, Tenderness
Clinical narrative: Swollen right elbow; Soft mass of something under the skin at the outside of the elbow. Very tender at first. Not so much now, but still reddish and swollen; Soft mass of something under the skin at the outside of the elbow. Very tender at first. Not so much now, but still reddish and swollen; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number not provided), via an unspecified route of administration in the right arm on 20Mar2021 at 09:15 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient received unspecified medications within 2 weeks of vaccination. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number not provided) via an unspecified route of administration in the right arm on 27Feb2021 at 19:30, (at the age of 68-years-old), as a single dose for COVID-19 immunisation. 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-19 vaccine. Since the vaccination, the patient had not tested for COVID-19. On 20Mar2021 at 16:00, the patient experienced swollen right elbow, soft mass of something under the skin at the outside of the elbow which was very tender at first. The patient reported that the mass was reddish and swollen and not much tender at the time of the report. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events.The clinical outcome of the events swollen elbow, tenderness and mass was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: Had about a 3 inch circumference red spot at the area of injection; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on 11Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced had about a 3 inch circumference red spot at the area of injection (noticed last evening) on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Emphysema, Heart rate increased
Clinical narrative: could not breathe; had a fast beating heart; felt very dizzy; advanced stage Emphysema; This is a spontaneous report from a contactable consumer or other non-health care professional via a Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date (8 hours after the vaccination), the patient experienced "could not breathe", had a fast beating heart, felt very dizzy, advanced stage emphysema. It was reported that the side effects started 8 hours after first dose. She stated she felt like she was going to die. She cancelled her second appointment because she feared the side effects from first dose. The outcome of all events was  unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Dehydration, Diarrhoea, Dizziness
Clinical narrative: could not breathe; had a fast beating heart; felt very dizzy; advanced stage Emphysema; This is a spontaneous report from a contactable consumer or other non-health care professional via a Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date (8 hours after the vaccination), the patient experienced "could not breathe", had a fast beating heart, felt very dizzy, advanced stage emphysema. It was reported that the side effects started 8 hours after first dose. She stated she felt like she was going to die. She cancelled her second appointment because she feared the side effects from first dose. The outcome of all events was  unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Heart rate increased, Nasopharyngitis, Nausea
Clinical narrative: could not breathe; had a fast beating heart; felt very dizzy; advanced stage Emphysema; This is a spontaneous report from a contactable consumer or other non-health care professional via a Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date (8 hours after the vaccination), the patient experienced "could not breathe", had a fast beating heart, felt very dizzy, advanced stage emphysema. It was reported that the side effects started 8 hours after first dose. She stated she felt like she was going to die. She cancelled her second appointment because she feared the side effects from first dose. The outcome of all events was  unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: could not breathe; had a fast beating heart; felt very dizzy; advanced stage Emphysema; This is a spontaneous report from a contactable consumer or other non-health care professional via a Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date (8 hours after the vaccination), the patient experienced "could not breathe", had a fast beating heart, felt very dizzy, advanced stage emphysema. It was reported that the side effects started 8 hours after first dose. She stated she felt like she was going to die. She cancelled her second appointment because she feared the side effects from first dose. The outcome of all events was  unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Throat clearing, Throat tightness
Clinical narrative: throat clearing; shortness ofbreath; Difficulty breathing; Throat tightness; This is a spontaneous report received from a non-contactable Healthcare Professional. A 34-years old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: EN6207), via an unspecified route of administration on 18Mar2021 (at the age of 34-year old) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 18Mar2021, during his 15-minute waiting period after the injection, the patient began to experience difficulty breathing and throat tightness. Patient denied rash, hives, welts, difficulty swallowing, throat tightness, hoarseness, stridor, itching, light-headedness, dizziness, facial swelling, lip swelling and tongue swelling. Patient complains of frequent throat clearing and shortness of breath. Treatment included water. It was reported that the patient discharged, stable to go home and follow up with PCP. The clinical outcome of the events difficulty breathing and throat tightness, frequent throat clearing and shortness of breath was unknown at the time of reporting.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Patient Country added. 2. The denied events were deleted from event tab. 3. Lead sentence updated as This is a spontaneous report received from a non-contactable Healthcare Professional. 4. Final sentence updated as No follow-up attempts are possible. No further information is expected. 5. Narrative removed sentence 'The events did not resulted in Doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.' since not reported on source.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Fatigue, Headache, Muscular weakness
Clinical narrative: experiencing a lump at the injection site like half an egg, area is hard and has heat; experiencing a lump at the injection site like half an egg, area is hard and has heat; weakness in limbs; fatigue; mild dizziness; fever of 101; mild headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age (Age: 72; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 28Mar2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on an unknown date for COVID-19 immunisation. On an unknown date in Mar2021, the patient experienced weakness in limbs, fatigue, mild dizziness, fever of 101, mild headache while on an unspecified date, experiencing a lump at the injection site like half an egg, area is hard and has heat. IT was reported that Caller stated that prior to 3 o clock Monday it was like any other day. Caller stated the side effects of weakness in limbs, fatigue, mild dizziness, fever of 101 and mild headache went away in 24 hours like everybody said. Caller stated she has heard others have had headaches like migraines. Caller stated that she still was experiencing a lump at the injection site like half an egg, area was hard and has heat. Caller stated that it was half of what it was on Tuesday. Caller wanted to know should she be concerned, is this normal. Caller stated her brother did not have any side effects. The patient underwent lab tests and procedures which included body temperature: 101 on an unknown date. The outcome for event mild headache was recovering while all events outcomes was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site mass, Vaccination site pain
Clinical narrative: experiencing a lump at the injection site like half an egg, area is hard and has heat; experiencing a lump at the injection site like half an egg, area is hard and has heat; weakness in limbs; fatigue; mild dizziness; fever of 101; mild headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age (Age: 72; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 28Mar2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on an unknown date for COVID-19 immunisation. On an unknown date in Mar2021, the patient experienced weakness in limbs, fatigue, mild dizziness, fever of 101, mild headache while on an unspecified date, experiencing a lump at the injection site like half an egg, area is hard and has heat. IT was reported that Caller stated that prior to 3 o clock Monday it was like any other day. Caller stated the side effects of weakness in limbs, fatigue, mild dizziness, fever of 101 and mild headache went away in 24 hours like everybody said. Caller stated she has heard others have had headaches like migraines. Caller stated that she still was experiencing a lump at the injection site like half an egg, area was hard and has heat. Caller stated that it was half of what it was on Tuesday. Caller wanted to know should she be concerned, is this normal. Caller stated her brother did not have any side effects. The patient underwent lab tests and procedures which included body temperature: 101 on an unknown date. The outcome for event mild headache was recovering while all events outcomes was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Freezing phenomenon, Headache, Limb discomfort
Clinical narrative: freezing with chills, and turned up the heat.; node on my arm; Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it.; Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it.; Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it.; freezing with chills; freezing with chills; Nausea; slight headache; This is a spontaneous report from a contactable consumer(Patient). A 79-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 29Mar2021 12:30 (at the age of 79 years) as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date was not reported), first dose via an unspecified route of administration, administered on 01Mar2021 as single for COVID-19 immunisation. Patient states she had the second shot yesterday and adds she didn't have any side effects from the first one. After the second one, by 20: 00PM she had nausea for about an hours and a slight headache that went away by the time she went to bed. Then early the next morning she was freezing with chills, and turned up the heat. Adds she didn't have all that with the first one. Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it. She is asking is all this a normal side effect. Mentions she took her temperature and she doesn't have a fever. Patient Clarifies she received the first dose of the Pfizer COVID 19 vaccine on 01Mar2021 in the afternoon in the left arm and the second dose on 29Mar2021 at 12: 30PM in the left arm. Patient further stated that "I got a node on my arm and it has fluid in it and I didn't have that before, so I'm concerned about it." The outcome of the events Nausea, slight headache was recovered on 29Mar2021 while the freezing with chills was recovered on 30Mar2021. While the outcome of the rest of the events were unknown.  No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: freezing with chills, and turned up the heat.; node on my arm; Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it.; Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it.; Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it.; freezing with chills; freezing with chills; Nausea; slight headache; This is a spontaneous report from a contactable consumer(Patient). A 79-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 29Mar2021 12:30 (at the age of 79 years) as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date was not reported), first dose via an unspecified route of administration, administered on 01Mar2021 as single for COVID-19 immunisation. Patient states she had the second shot yesterday and adds she didn't have any side effects from the first one. After the second one, by 20: 00PM she had nausea for about an hours and a slight headache that went away by the time she went to bed. Then early the next morning she was freezing with chills, and turned up the heat. Adds she didn't have all that with the first one. Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it. She is asking is all this a normal side effect. Mentions she took her temperature and she doesn't have a fever. Patient Clarifies she received the first dose of the Pfizer COVID 19 vaccine on 01Mar2021 in the afternoon in the left arm and the second dose on 29Mar2021 at 12: 30PM in the left arm. Patient further stated that "I got a node on my arm and it has fluid in it and I didn't have that before, so I'm concerned about it." The outcome of the events Nausea, slight headache was recovered on 29Mar2021 while the freezing with chills was recovered on 30Mar2021. While the outcome of the rest of the events were unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis, Lymphadenopathy
Clinical narrative: lymph nodes of the collar bone area and armpit inflamed; Swollen lymph nodes; This is a spontaneous report from a contactable consumer. A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), dose 2 via an unspecified route of administration, administered in Arm Right on 30Mar2021 as a single dose for covid-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included atorvastatin calcium; sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]); glipizide. On 31Mar2021, she was in the Emergency Room after getting some side effects due to the Pfizer covid vaccine. She mentions that she got the first dose on 09Mar and the second 30Mar and within 20 h of receiving the second dose she got the lymph nodes of the collar bone area and armpit inflamed and swollen lymph nodes. Therapeutic measures were taken as a result of lymph nodes of the collar bone area and armpit inflamed (lymphadenitis), swollen lymph nodes (lymphadenopathy) with some Advil yesterday and on night on 31Mar2021 and some Tylenol. Outcome of the event was not recovered. No follow up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: Menstrual cycle began two weeks early; Menstrual cycle has not stopped; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 19Mar2021 at 14:15 (at the age of 27-year-old), as dose 1, single for COVID-19 immunization. Medical history included shellfish allergy and fish allergy. Concomitant medication received within 2 weeks of vaccination included ethinylestradiol, levonorgestrel (MARLISSA) for birth control from an unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021, the day after vaccination, the patient had menstrual cycle which was two weeks early. On an unknown date in Mar2021, the menstrual cycle had not stopped. The patient did not receive any treatment for the event experienced. The event neither resulted in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. The clinical outcome of the event menstrual cycle, which was two weeks early and had not stopped was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Event Onset Latency left as auto-calculated value for event Menstrual cycle shortened.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Ear pain, Hypoacusis, Mass, Oropharyngeal pain
Clinical narrative: a mass under my right neck area, this has developed into a solid mass which has ever since extended downwards towards my sternum and clavicle area; It is ejecting pains into my middle right ear which has caused a partial deafness in that ear; It is ejecting pains into my middle right ear which has caused a partial deafness in that ear; had issues with swallowing anything, including my own saliva; fever; body aches; sore throat; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in the left arm on 23Mar2021 at 15:00 (at the age of 51-year-old), dose 1, single for COVID-19 immunisation. Medical history included allergy and there were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. On an unspecified date, the patient got fever, body aches, sore throat. Five days after that he observed a mass under his right neck area, this had developed into a solid mass which had ever since extended downwards towards his sternum and clavicle area. The mass felt tender with protruding ends. It was not very painful; however, it was ejecting pains into his middle right ear which caused a partial deafness in that ear. Initially, the patient had issues with swallowing anything including his own saliva, the problem of swallowing had ever since dissipated. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: a mass under my right neck area, this has developed into a solid mass which has ever since extended downwards towards my sternum and clavicle area; It is ejecting pains into my middle right ear which has caused a partial deafness in that ear; It is ejecting pains into my middle right ear which has caused a partial deafness in that ear; had issues with swallowing anything, including my own saliva; fever; body aches; sore throat; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in the left arm on 23Mar2021 at 15:00 (at the age of 51-year-old), dose 1, single for COVID-19 immunisation. Medical history included allergy and there were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. On an unspecified date, the patient got fever, body aches, sore throat. Five days after that he observed a mass under his right neck area, this had developed into a solid mass which had ever since extended downwards towards his sternum and clavicle area. The mass felt tender with protruding ends. It was not very painful; however, it was ejecting pains into his middle right ear which caused a partial deafness in that ear. Initially, the patient had issues with swallowing anything including his own saliva, the problem of swallowing had ever since dissipated. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Joint swelling, Migraine-triggered seizure
Clinical narrative: migralepsy migraine; Head ache; nausea; fatigue; blisters in mouth; swelling of joints and face; swelling of joints and face; severely ill; This is a spontaneous report from a contactable consumer. A 45-year-old female non-pregnant patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 02Apr2021 at 10:30 AM, at patient age of 45-year-old, as single dose (Lot number Erb8733) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included migralepsy migraine and arthritis. Known allergies included cefalexin monohydrate (KEFLZ), amoxicillin, penicillin, alprazolam (XANAX), ondansetron (ZOFRAN), cantaloupe. The patient's concomitant medications included naproxen sodium (ALEVE), cucurbita pepo oil (PUMPKIN SEED OIL). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 12Mar2021 at 10:30 AM, at patient age of 45-year-old, as single dose (Lot number En6206) for COVID-19 immunization and no reaction on previous exposure to vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the second dose of bnt162b2 on 02Apr2021. The patient stated that "I think they tried to poison me". On 02Apr2021 at 16:00 PM, the patient experienced headache, set off migralepsy migraine, nausea, fatigue, blisters in mouth, swelling of joints and face, severely ill and only out of bed short periods at a time for two days now. The patient did not receive treatment. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.  Follow-Up (28Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oral mucosal blistering, Swelling face
Clinical narrative: migralepsy migraine; Head ache; nausea; fatigue; blisters in mouth; swelling of joints and face; swelling of joints and face; severely ill; This is a spontaneous report from a contactable consumer. A 45-year-old female non-pregnant patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 02Apr2021 at 10:30 AM, at patient age of 45-year-old, as single dose (Lot number Erb8733) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included migralepsy migraine and arthritis. Known allergies included cefalexin monohydrate (KEFLZ), amoxicillin, penicillin, alprazolam (XANAX), ondansetron (ZOFRAN), cantaloupe. The patient's concomitant medications included naproxen sodium (ALEVE), cucurbita pepo oil (PUMPKIN SEED OIL). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 12Mar2021 at 10:30 AM, at patient age of 45-year-old, as single dose (Lot number En6206) for COVID-19 immunization and no reaction on previous exposure to vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the second dose of bnt162b2 on 02Apr2021. The patient stated that "I think they tried to poison me". On 02Apr2021 at 16:00 PM, the patient experienced headache, set off migralepsy migraine, nausea, fatigue, blisters in mouth, swelling of joints and face, severely ill and only out of bed short periods at a time for two days now. The patient did not receive treatment. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.  Follow-Up (28Jul2021): Follow-up attempts are completed. No further information is expected.