chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urine analysis
Clinical narrative: Bloodly urine; gfr to 42 (from >60); kidney damage; Now stage 3b kidney dosease; This is a spontaneous report from a contactable Other HCP(patient). A 33-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 28Jan2021 14:00 (Batch/Lot Number: EL3302) at the age of 33-year-old, as single dose for covid-19 immunisation. Medical history included hypothyroidism. The patient previously received first dose of bnt162b2 on 06Jan2021 02:00 PM(lot number: El1284) at the age of 33-year-old at right arm for Covid-19 immunization. There was no other vaccine in four weeks. The patient had no covid prior vaccination. The patient had no known allergies. Concomitant medication included levothyroxine taken for an unspecified indication, start and stop date were not reported. The patient experienced bloodly urine on 29Jan2021 16:00 with outcome of not recovered, gfr to 42 (from >60) on 29Jan2021 16:00 with outcome of not recovered, kidney damage on 29Jan2021 16:00 with outcome of not recovered, now stage 3b kidney disease on 29Jan2021 16:00 with outcome of not recovered. Events resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage]. Treatment received for the event on 30Jan2021. Covid test type post vaccination was Nasal Swab with unknown results.; Sender's Comments: The reported bloodly urine, GFR decreased, kidney damage, now stage 3b kidney disease are unlikely related to the COVID19 vaccine, BNT162B2, administration. More information regarding the patient's underlying medical condition is required for the Company to make a more meaningful causality assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Thrombosis
Clinical narrative: Blood clot; Elevated blood pressure; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular on 15Sep2021 (Batch/Lot Number: FE3592) (at the age of 50-years-old) as dose number unknown, single for COVID-19 immunisation. The patient has no relevant medical history and there were no concomitant medications. The patient had no prior vaccination (within four weeks). On an unspecified date in Sep2021, the patient reported possible blood clot and elevated blood pressure after receiving the COVID shot and said she was going to the emergency room. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: she was so sick after the second dose; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration on an unspecified date (at the age of 77-year-old) as single dose for COVID-19 immunization. Medical history, concomitant medications of the patient were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration on an unspecified date in Feb2021 (at the age of 77-year-old) as single dose for COVID-19 immunization. On an unspecified date after receiving second dose of vaccination patient was so sick. Patient was interested in getting the booster dose and asked if the there was a special diet or certain medications she should avoid before getting the dose. Patient asked if she should receive a smaller dose for her weight and height and how long she should wait to get the dose. Outcome of the event was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Asthenia, Diarrhoea, Dyspepsia
Clinical narrative: had an episode so painful she was moaning, her stomach really hurt; Watery diarrhea; Dry heaves; Weakness; stomach bloated; terrible sweats; she was frozen, she was freezing cold and shaking, had to warm up; Nauseated; Gas; shaking; the upper part of her stomach was on fire; her stomach was really sore/her stomach really hurt; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201, Expiration date not reported), via an unspecified route of administration, administered in right arm on 24Feb2021 14:00 (at the age of 76 years) as dose 2, single for covid-19 immunization. Medical history included high blood pressure diagnosed about 15 years ago, from an unknown date and unknown if ongoing. Family medical history relevant to events reported as no. The patient's concomitant medications were not reported. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262) via an unspecified route of administration, administered in right arm on 04Feb2021 around 14:00 (at the age of 76 years) as dose 1, single for covid-19 immunization, received flu shot with which patient experienced unspecified adverse event and pneumonia vaccine, both on an unknown date. Patient did not receive any vaccinations within 4 weeks. On an unknown date in 2021, about 3 or 4 days after vaccination, patient experienced watery diarrhea, dry heaves that were so bad that she felt the upper part of her stomach was on fire, weakness, really really weak, gas, and her stomach was bloated up like she was 3 or 4 months pregnant, terrible sweats and had to put a cold compress on her face so she did not pass out, then after that she was frozen, she was freezing cold and shaking, had to warm up, she was really nauseated which she supposed caused the dry heaves. It was reported that, patient did not have a temperature and could taste and smell, however, she did get very sweaty. It took her three weeks and patient had to take a lot of medicine and antacid for her stomach. She was still really weak, and it took her a while to get back her strength. She recovered mostly by Mar2021, and her stomach was really sore. In May2021 patient kept taking this stuff for her stomach and doctor though it was ok. On an unknown date in May2021, she had an episode so painful she was moaning, her stomach really hurt, and she had to lay down. Events resulted in visit to physician office. Therapeutic measures were taken as a result of events and patient received unspecified treatments. The outcome of all the events was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Flatulence, Hyperhidrosis, Moaning, Nausea
Clinical narrative: had an episode so painful she was moaning, her stomach really hurt; Watery diarrhea; Dry heaves; Weakness; stomach bloated; terrible sweats; she was frozen, she was freezing cold and shaking, had to warm up; Nauseated; Gas; shaking; the upper part of her stomach was on fire; her stomach was really sore/her stomach really hurt; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201, Expiration date not reported), via an unspecified route of administration, administered in right arm on 24Feb2021 14:00 (at the age of 76 years) as dose 2, single for covid-19 immunization. Medical history included high blood pressure diagnosed about 15 years ago, from an unknown date and unknown if ongoing. Family medical history relevant to events reported as no. The patient's concomitant medications were not reported. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262) via an unspecified route of administration, administered in right arm on 04Feb2021 around 14:00 (at the age of 76 years) as dose 1, single for covid-19 immunization, received flu shot with which patient experienced unspecified adverse event and pneumonia vaccine, both on an unknown date. Patient did not receive any vaccinations within 4 weeks. On an unknown date in 2021, about 3 or 4 days after vaccination, patient experienced watery diarrhea, dry heaves that were so bad that she felt the upper part of her stomach was on fire, weakness, really really weak, gas, and her stomach was bloated up like she was 3 or 4 months pregnant, terrible sweats and had to put a cold compress on her face so she did not pass out, then after that she was frozen, she was freezing cold and shaking, had to warm up, she was really nauseated which she supposed caused the dry heaves. It was reported that, patient did not have a temperature and could taste and smell, however, she did get very sweaty. It took her three weeks and patient had to take a lot of medicine and antacid for her stomach. She was still really weak, and it took her a while to get back her strength. She recovered mostly by Mar2021, and her stomach was really sore. In May2021 patient kept taking this stuff for her stomach and doctor though it was ok. On an unknown date in May2021, she had an episode so painful she was moaning, her stomach really hurt, and she had to lay down. Events resulted in visit to physician office. Therapeutic measures were taken as a result of events and patient received unspecified treatments. The outcome of all the events was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Retching, Tremor
Clinical narrative: had an episode so painful she was moaning, her stomach really hurt; Watery diarrhea; Dry heaves; Weakness; stomach bloated; terrible sweats; she was frozen, she was freezing cold and shaking, had to warm up; Nauseated; Gas; shaking; the upper part of her stomach was on fire; her stomach was really sore/her stomach really hurt; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201, Expiration date not reported), via an unspecified route of administration, administered in right arm on 24Feb2021 14:00 (at the age of 76 years) as dose 2, single for covid-19 immunization. Medical history included high blood pressure diagnosed about 15 years ago, from an unknown date and unknown if ongoing. Family medical history relevant to events reported as no. The patient's concomitant medications were not reported. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262) via an unspecified route of administration, administered in right arm on 04Feb2021 around 14:00 (at the age of 76 years) as dose 1, single for covid-19 immunization, received flu shot with which patient experienced unspecified adverse event and pneumonia vaccine, both on an unknown date. Patient did not receive any vaccinations within 4 weeks. On an unknown date in 2021, about 3 or 4 days after vaccination, patient experienced watery diarrhea, dry heaves that were so bad that she felt the upper part of her stomach was on fire, weakness, really really weak, gas, and her stomach was bloated up like she was 3 or 4 months pregnant, terrible sweats and had to put a cold compress on her face so she did not pass out, then after that she was frozen, she was freezing cold and shaking, had to warm up, she was really nauseated which she supposed caused the dry heaves. It was reported that, patient did not have a temperature and could taste and smell, however, she did get very sweaty. It took her three weeks and patient had to take a lot of medicine and antacid for her stomach. She was still really weak, and it took her a while to get back her strength. She recovered mostly by Mar2021, and her stomach was really sore. In May2021 patient kept taking this stuff for her stomach and doctor though it was ok. On an unknown date in May2021, she had an episode so painful she was moaning, her stomach really hurt, and she had to lay down. Events resulted in visit to physician office. Therapeutic measures were taken as a result of events and patient received unspecified treatments. The outcome of all the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Anxiety, Blood test, Mouth swelling, Peripheral swelling
Clinical narrative: her face got swollen; Feet swollen; She is worried and don''t want to take her Vaccine second dose; allergic to one of the ingredient of the vaccine; mouth is swollen one side; This is a spontaneous report from a contactable consumer reporting for her friend. This consumer reported similar events for 02 patients. This is the 2nd of 02 reports.  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No prior vaccination within four weeks. On an unspecified date in 2021, the patient took first dose vaccine a few days ago and after that her face got swollen and mouth got a little bit out one side, allergic to one of the ingredient of the vaccine, her face is swollen and her mouth is swollen one side, is it like paralysis you know, feet swollen and she was worried and don't want to take her vaccine second dose. No treatment for adverse event, she just took Ibuprofen. On an unspecified date, blood test was done but result was on line. Patient had her annual check. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: her face got swollen; Feet swollen; She is worried and don''t want to take her Vaccine second dose; allergic to one of the ingredient of the vaccine; mouth is swollen one side; This is a spontaneous report from a contactable consumer reporting for her friend. This consumer reported similar events for 02 patients. This is the 2nd of 02 reports.  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No prior vaccination within four weeks. On an unspecified date in 2021, the patient took first dose vaccine a few days ago and after that her face got swollen and mouth got a little bit out one side, allergic to one of the ingredient of the vaccine, her face is swollen and her mouth is swollen one side, is it like paralysis you know, feet swollen and she was worried and don't want to take her vaccine second dose. No treatment for adverse event, she just took Ibuprofen. On an unspecified date, blood test was done but result was on line. Patient had her annual check. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Goitre, Musculoskeletal stiffness, Myalgia, Off label use
Clinical narrative: Chest pains; Thyroid throbbing; Thyroid swelling; Muscle pains; Muscle stiffness; BNT162B2 and Influenza vaccine given on 09Sep2021; BNT162B2 and Influenza vaccine given on 09Sep2021; This is a spontaneous report from a contactable consumer (patient). This is the first of the two reports.    A 38-year-old male patient (age at vaccination: 38-year-old) received bnt162b2 (BNT162B2 also reported as Covid-19 vaccine brand Pfizer, lot 301307A), via an unspecified route of administration in left arm on 09Sep2021 12:00 as dose 2, single for Covid-19 immunisation; influenza vaccine (lot unknown), via an unspecified route of administration in right arm on 09Sep2021 as dose 2, single for immunisation. Medical history included Hashimoto's autoimmune. Concomitant medication included INFLUENZA VACCINE on 19Aug2021 for immunisation. The patient previously took AUGMENTIN [amoxicillin sodium;clavulanate potassium] and had drug allergy. The patient experienced chest pains, thyroid throbbing, thyroid swelling , muscle pains and muscle stiffness all on 10Sep2021 09:00. Events resulted in Emergency room and clinic visits.  He had treatment of steroid, anti inflammatory drugs administered IV. The outcome of events was not recovered.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Product use issue, Thyroid disorder
Clinical narrative: Chest pains; Thyroid throbbing; Thyroid swelling; Muscle pains; Muscle stiffness; BNT162B2 and Influenza vaccine given on 09Sep2021; BNT162B2 and Influenza vaccine given on 09Sep2021; This is a spontaneous report from a contactable consumer (patient). This is the first of the two reports.    A 38-year-old male patient (age at vaccination: 38-year-old) received bnt162b2 (BNT162B2 also reported as Covid-19 vaccine brand Pfizer, lot 301307A), via an unspecified route of administration in left arm on 09Sep2021 12:00 as dose 2, single for Covid-19 immunisation; influenza vaccine (lot unknown), via an unspecified route of administration in right arm on 09Sep2021 as dose 2, single for immunisation. Medical history included Hashimoto's autoimmune. Concomitant medication included INFLUENZA VACCINE on 19Aug2021 for immunisation. The patient previously took AUGMENTIN [amoxicillin sodium;clavulanate potassium] and had drug allergy. The patient experienced chest pains, thyroid throbbing, thyroid swelling , muscle pains and muscle stiffness all on 10Sep2021 09:00. Events resulted in Emergency room and clinic visits.  He had treatment of steroid, anti inflammatory drugs administered IV. The outcome of events was not recovered.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Near death experience, Ocular discomfort, Ovarian enlargement, Pain, Peripheral swelling
Clinical narrative: she presented swelling in her ovaries and waist; swelling in her ovaries; she feels that "she is dying"; severe pain; the presence of "a ball" in her right hand; internal pressure in her left eye; This is a spontaneous report from a contactable consumer (patient) or other non HCP. A 61-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 06May2021 13:45 (Batch/Lot Number: EW010050) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. On 2021, she feels that "she is dying," she presented swelling in her ovaries and waist, severe pain, the presence of "a ball" in her right hand, internal pressure in her left eye, swelling in her ovaries. It was informed that it was the Pfizer vaccine but she is not sure since she was only given "one little bottle" and another acquaintance of hers was given "two little bottles") in (withheld) on 06May2021, at 1:45 pm. Three days later she presented swelling in her ovaries and waist (similar to "as if she had a child") she also has pain and feels "a ball down there", severe pain in the areas already mentioned along with pain in her right hand, the presence of "a ball" in her right hand and internal pressure in her left eye. Due to the previously mentioned she had to go to the emergency room where after they did some studies on her she ended up not being treated. The patient has been taking naproxen for pain but her symptoms have remained for two months. An (name) of hers has had the same symptoms but she also had bleeding after receiving "two little bottles" of the vaccine. (name) should have received her second dose in July. She is in so much pain that she cannot travel to her place of work or to receive medical attention in another state, she mentioned that she feels that "she is dying". Therapeutic measures were taken as a result of severe pain (pain). The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: she presented swelling in her ovaries and waist; swelling in her ovaries; she feels that "she is dying"; severe pain; the presence of "a ball" in her right hand; internal pressure in her left eye; This is a spontaneous report from a contactable consumer (patient) or other non HCP. A 61-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 06May2021 13:45 (Batch/Lot Number: EW010050) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. On 2021, she feels that "she is dying," she presented swelling in her ovaries and waist, severe pain, the presence of "a ball" in her right hand, internal pressure in her left eye, swelling in her ovaries. It was informed that it was the Pfizer vaccine but she is not sure since she was only given "one little bottle" and another acquaintance of hers was given "two little bottles") in (withheld) on 06May2021, at 1:45 pm. Three days later she presented swelling in her ovaries and waist (similar to "as if she had a child") she also has pain and feels "a ball down there", severe pain in the areas already mentioned along with pain in her right hand, the presence of "a ball" in her right hand and internal pressure in her left eye. Due to the previously mentioned she had to go to the emergency room where after they did some studies on her she ended up not being treated. The patient has been taking naproxen for pain but her symptoms have remained for two months. An (name) of hers has had the same symptoms but she also had bleeding after receiving "two little bottles" of the vaccine. (name) should have received her second dose in July. She is in so much pain that she cannot travel to her place of work or to receive medical attention in another state, she mentioned that she feels that "she is dying". Therapeutic measures were taken as a result of severe pain (pain). The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Apraxia, SARS-CoV-2 test
Clinical narrative: Apraxia of the Eye Lids; This is a spontaneous report from a contactable consumer (patient). A 17-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185), via an unspecified route of administration on 14May2021 (at the age of 17-years-old) as dose 2, single for COVID-19 immunisation. The patient previously received the first dose of bnt162b2 (lot number ER8737) on 03Apr2021 for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no relevant medical history and no known allergies.  There were no concomitant medications. The patient experienced apraxia of the eye lids on 03Jun2021. The patient did not receive treatment for event. The patient underwent lab tests and procedures which included Nasal Swab: negative on an unspecified date. The outcome of event was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neuropathy peripheral, Pain in extremity
Clinical narrative: ceased to left lower extremity neuropathy; pain in big toe; Grade 2 myalgia in Left lower extremity; This is a spontaneous report from a contactable other hcp (patient). A 43-year-old female (non-pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at the age of 43-year-old, dose 1 intramuscular, administered in Arm Left on 21Sep2021 10:30 (Batch/Lot Number: FF8839) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included cervical cancer treatment 2010, low immune system, and known allergies: Iodine Contrast. There were no concomitant medications. On 21Sep2021 12:30, the patient experienced Grade 2 myalgia in Left lower extremity for 5 minutes, ceased to left lower extremity neuropathy with pain in big toe. No treatment was received. The outcome of event myalgia was recovered on 21Sep2021 12:35 while other events were not recovered.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event "left lower extremity neuropathy" cannot be completely excluded based on temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This patient has had a breakthrough COVID infection.; This patient has had a breakthrough COVID infection.; This is a spontaneous report from a contactable consumer (Pfizer colleague). This consumer reported similar events for two patients. This is the 2nd of two reports. An adult female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unknown date via an unknown route for Covid-19 immunization. Medical history and concomitant drug were not provided. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. This patient had had a breakthrough COVID infection on 18Sep2021. It was unknown if treatment received. Covid test on 20Sep2021 was positive. Outcome of the event was resolving.   The report was assessed as non-serious.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101234262 same reporter/product/event, different patients
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle atrophy, Muscle disorder, Myalgia, Pruritus
Clinical narrative: Muscle atrophy; Indention in arm muscle; Normal muscle soreness; Itchy feeling; This is a spontaneous report from a contactable consumer (patient):   A 58-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 19Aug2021 at 14:00 (Lot Number: FC3187), at the age of 58 years old, as 2nd single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had received the 1st single dose of BNT162b2 on 29Jul2021 at 14:00 (lot number: FA6780) administered in the left arm. The patient had not received any other vaccines within 4 weeks prior to the BNT162b2 vaccination. Prior to vaccination, the patient had not been diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient reported having normal muscle soreness and then 'approximately week' (as reported) itchy feeling. The onset date of the events was provided as 28Aug2021. At the time of the reporting the patient stated having a muscle atrophy and indention in arm muscle (as reported, onset date not specified). No treatment was required for the reported events. The outcome of the muscle soreness and itchiness was not specified, while the patient had not recovered from the muscle atrophy and indention in arm muscle at the time of the reporting. According to the reporter (patient), the reported events were non-serious.   Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypersensitivity, Pain in extremity, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Allergic reaction; significant localized swelling; hot and hard to the touch consuming all of deltoid down to elbow; hot and hard to the touch consuming all of deltoid down to elbow; hot and hard to the touch consuming all of deltoid down to elbow; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: 30135BA) via an unspecified route of administration in left arm on 19Sep2021 (at the age of 35-year-old) at single dose for COVID-19 immunisation. Relevant medical history included asthma. The patient had no known allergies. Concomitant medications were not reported. On 20Sep2021 the patient experienced allergic reaction, significant localized swelling, hot and hard to the touch consuming all of deltoid down to elbow. The events were non-serious and treatment, if any, was unknown. It was reported that the patient had no COVID nor received COVID diagnosis prior to vaccination and was tested for COVID post vaccination through nasal swab on 17Sep2021 (as reported), resulting negative. The events were not resolved at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Allergic reaction; significant localized swelling; hot and hard to the touch consuming all of deltoid down to elbow; hot and hard to the touch consuming all of deltoid down to elbow; hot and hard to the touch consuming all of deltoid down to elbow; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: 30135BA) via an unspecified route of administration in left arm on 19Sep2021 (at the age of 35-year-old) at single dose for COVID-19 immunisation. Relevant medical history included asthma. The patient had no known allergies. Concomitant medications were not reported. On 20Sep2021 the patient experienced allergic reaction, significant localized swelling, hot and hard to the touch consuming all of deltoid down to elbow. The events were non-serious and treatment, if any, was unknown. It was reported that the patient had no COVID nor received COVID diagnosis prior to vaccination and was tested for COVID post vaccination through nasal swab on 17Sep2021 (as reported), resulting negative. The events were not resolved at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Disease recurrence, Feeling abnormal, Headache
Clinical narrative: flared up my pseudo tumor cerebri; flared up my pseudo tumor cerebri; horrible headache; nausea; loss of appetite; diarrhea; issues with eyes sight; brain fog; This is a spontaneous report from a contactable other HCP (patient). This is the 1st of 2 reports, for the second dose. A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration and administered in left arm at age of 41-years, on 01Sep2021 16:30 (Lot Number: FC3181) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Pseudo tumor cerebri and medullary sponge kidneys. Concomitant medication included acetazolamide at 500 mg Er. The patient previously took morphine and experienced allergy. Historical Vaccine included the first dose of bnt162b2 on an unknown date as DOSE 1, SINGLE for Covid-19 immunisation and experienced horrible headache and nausea, loss of appetite and diarrhea on 14Aug2021. No other vaccines within 4 weeks prior to the COVID vaccine received. The patient experienced flared up with pseudo tumor cerebri, horrible headache, nausea, loss of appetite, diarrhea, issues with eyes sight and brain fog, and all started in Sep2021. Adverse events resulted in "Doctor or other healthcare professional office/clinic visit". No hospitalization or prolonged. No treatment received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events nausea, loss of appetite and loss of appetite was recovered in Sep2021; of remains events was not recovered.  The clinical course was reported as follows: Got my shot on Wednesday and by Saturday I had a horrible headache and nausea, loss of appetite and diarrhea. The stomach issues lasted a few days but headaches still on going. This happened with both shots and got worse with the second. This shot flared up my pseudo tumor cerebri.  Still having issues with headaches, eye sight and brain fog.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events idiopathic intracranial hypertension and disease recurrence and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101242585 same patient/product, different dose/events.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Idiopathic intracranial hypertension, Nausea, Visual impairment
Clinical narrative: flared up my pseudo tumor cerebri; flared up my pseudo tumor cerebri; horrible headache; nausea; loss of appetite; diarrhea; issues with eyes sight; brain fog; This is a spontaneous report from a contactable other HCP (patient). This is the 1st of 2 reports, for the second dose. A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration and administered in left arm at age of 41-years, on 01Sep2021 16:30 (Lot Number: FC3181) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Pseudo tumor cerebri and medullary sponge kidneys. Concomitant medication included acetazolamide at 500 mg Er. The patient previously took morphine and experienced allergy. Historical Vaccine included the first dose of bnt162b2 on an unknown date as DOSE 1, SINGLE for Covid-19 immunisation and experienced horrible headache and nausea, loss of appetite and diarrhea on 14Aug2021. No other vaccines within 4 weeks prior to the COVID vaccine received. The patient experienced flared up with pseudo tumor cerebri, horrible headache, nausea, loss of appetite, diarrhea, issues with eyes sight and brain fog, and all started in Sep2021. Adverse events resulted in "Doctor or other healthcare professional office/clinic visit". No hospitalization or prolonged. No treatment received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events nausea, loss of appetite and loss of appetite was recovered in Sep2021; of remains events was not recovered.  The clinical course was reported as follows: Got my shot on Wednesday and by Saturday I had a horrible headache and nausea, loss of appetite and diarrhea. The stomach issues lasted a few days but headaches still on going. This happened with both shots and got worse with the second. This shot flared up my pseudo tumor cerebri.  Still having issues with headaches, eye sight and brain fog.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events idiopathic intracranial hypertension and disease recurrence and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101242585 same patient/product, different dose/events.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a solicited report from a contactable consumer (patient) and healthcare professional, based on the information received by Pfizer (manufacturer control number: 2021SA284825).   A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose on Mar2021 (lot number and expiration ate not reported) at dose 1, single, then second dose on Apr2021 (lot number and expiration date not reported) at dose 2, single; both via an unspecified route of administration at the age of 63-years-old for COVID-19 immunisation; and teriflunomide (AUBAGIO 14 mg coated tablet), via oral from 12Jul2021 and ongoing at 14 mg, four times a day (QD) for multiple sclerosis. Medical history included ongoing multiple sclerosis. The patient's concomitant medications were not reported. On 26Aug2021, the patient tested positive for COVID-19 (drug ineffective). It was stated that they wanted to start the patient on an intravenous medication Regen-COV and used Lexicomp for interactions and recommended to the physician. The patient was calling from her doctor's office as she tested positive for COVID-19 after she had her Pfizer COVID-19 vaccine. The patient was prescribed with antibiotics and some other unspecified medications as treatments for the events. The events were ongoing. The patient called to ask if it was okay to take the medications given by her doctor with teriflunomide. As of time of report, teriflunomide was continued. The patient underwent SARS-CoV-2 test on 26Aug2021 with positive result. No additional information at the time of report. The events resulted in physician office visit and therapeutic measures were given as a result of the events. The action taken in response to the events for teriflunomide was unknown. Outcome of the events was not recovered.   The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: found out my wife was positive. She had both Pfizer shots; found out my wife was positive. She had both Pfizer shots; This is a spontaneous report from a contactable consumer (husband).   A female patient of an unspecified age received bnt162b2 (BNT162B2, lot unknown), via an unspecified route of administration on an unspecified date as dose 1, single; bnt162b2 (BNT162B2, lot unknown) via an unspecified route of administration on an unspecified date as dose 2, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The husband informed that he found out his wife was positive and she had both Pfizer shots on an unspecified date. The outcome event was unknown.  The lot number was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Malaise, Off label use
Clinical narrative: She just got the COVID booster shot; She just got the COVID booster shot; Doesnt feel good; This is a spontaneous report from a contactable pharmacist. A 80-years-old female patient received third dose of bnt162b2 (BNT162B2, solution for injection, (Batch/Lot number: not reported) via an unknown route of administration on an unknown date as dose 3, single for covid-19 immunisation. The patient medical history was not reported. The patient previously received first and second dose of bnt162b2 (BNT162B2, solution for injection, (Batch/Lot number: not reported) via an unknown route of administration on an unknown date for covid-19 immunisation. The patient's concomitant medications were not reported.  On an unknown date, the patient experienced she just got the covid booster shot and doesnt feel good. The outcome of all the events was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Haemorrhage urinary tract, Illness, Pulmonary thrombosis, Rash macular
Clinical narrative: Urinated a blood clot; Dry cough; Red bloches on my body; Became ill; developed 5 blood clots that ended up in my lungs; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient had his second Pfizer shot the middle of Jan2021, in Mar2021 patient urinated a blood clot in the same month he began to have a dry cough and red bloches on his body. As the summer progressed (in 2021) patient became ill to make a long story short he developed 5 blood clots that ended up in his lungs. Patient was a very healthy 70 years old male until he received Covid shot. Patient knew no one wants to admit to the shot creating any problems but he really believed the shot caused him problems. Outcome of events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Haemorrhage, Ocular discomfort, Ovarian enlargement, Pain
Clinical narrative: bleeding; she presented swelling in her ovaries and waist; severe pain; the presence of "a ball" in her right hand; internal pressure in her left eye; she presented swelling in her ovaries and waist; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received first dose of BNT162B2 on 05Jun2021 1:45 pm at single dose for COVID-19 immunization. Medical history was not reported and concomitant medications were none. Patient was given "two little bottles"). Patient has had the same symptoms (swelling in ovaries and waist, severe pain, the presence of "a ball" in her right hand and internal pressure in left eye) but she also had bleeding after receiving "two little bottles" of the vaccine. Patient should have received her second dose in July. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: bleeding; she presented swelling in her ovaries and waist; severe pain; the presence of "a ball" in her right hand; internal pressure in her left eye; she presented swelling in her ovaries and waist; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received first dose of BNT162B2 on 05Jun2021 1:45 pm at single dose for COVID-19 immunization. Medical history was not reported and concomitant medications were none. Patient was given "two little bottles"). Patient has had the same symptoms (swelling in ovaries and waist, severe pain, the presence of "a ball" in her right hand and internal pressure in left eye) but she also had bleeding after receiving "two little bottles" of the vaccine. Patient should have received her second dose in July. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypotension
Clinical narrative: They have a patient who after the 1st dose he got low blood pressure and they had to call an ambulance; This is a spontaneous report from a non-contactable consumer or other non hcp.   A male patient of an unspecified age received bnt162b2 (BNT162B2), PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications. It was reported that, the patient experienced they have a patient who after the 1st dose got low blood pressure and they had to call an ambulance on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement: unknown results on low blood pressure.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: If someone is fully vaccinated and goes around someone who tests positive for the covid; If someone is fully vaccinated and goes around someone who tests positive for the covid; This is a spontaneous report from a non-contactable consumer via a Pfizer sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient was fully vaccinated and who tests positive for the covid, should he wait a week to get tested for covid. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Rash
Clinical narrative: a rash all over my body; bad allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 05Aug2021 (Batch/Lot Number: FC318U; Expiration Date: 05Aug2021) at the of 26-years-old as dose 1, single for covid-19 immunisation. The patient has no medical history. There were no concomitant medications. On an unspecified date in Aug2021, the patient experienced a bad allergic reaction to the vaccine. The patient had a rash all over her body and is hesitant to take the second dose. The patient put cream (reported clotrimazole cream or something like that). The patient also reported he went to the urgent care where she was given a steroid shot which he believed was some cream (as reported). The outcome of the events was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.