chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging head abnormal, Nausea, Pain, Platelet count
Clinical narrative: On April 6, started having nausea and stomach pain. On April 8th had fever (100F), chills, body aches and headaches. On april 9th headache got intense and no more fever. On april 10 keep having intense headache and went to ER. A CBC show low platelets level (25K) and got admitted to Hospital the morning after. A Head CT Scan was negative. On April 11 through 13 platelets levels going up slowly. On April 14th Intense Headache came back and was performed a Head CT Scan was performed with positive result. Another CT Scan with contrast and MRI the day after confirmed positive result for a blood clot in the head. Transfers to ICU for 5 days. Transferred to Regular Room for two days. Diagnosed with Vaccine-Induced Immune Thrombotic Thrombocytopenia.  Released with Xarelto 20mg and Medrol 4mg for 7 days treatment with follow up in a week. Also schedule appointments with Neurologist and Hematologist.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Pyrexia, Thrombocytopenia, Venogram, Venogram abnormal
Clinical narrative: On April 6, started having nausea and stomach pain. On April 8th had fever (100F), chills, body aches and headaches. On april 9th headache got intense and no more fever. On april 10 keep having intense headache and went to ER. A CBC show low platelets level (25K) and got admitted to Hospital the morning after. A Head CT Scan was negative. On April 11 through 13 platelets levels going up slowly. On April 14th Intense Headache came back and was performed a Head CT Scan was performed with positive result. Another CT Scan with contrast and MRI the day after confirmed positive result for a blood clot in the head. Transfers to ICU for 5 days. Transferred to Regular Room for two days. Diagnosed with Vaccine-Induced Immune Thrombotic Thrombocytopenia.  Released with Xarelto 20mg and Medrol 4mg for 7 days treatment with follow up in a week. Also schedule appointments with Neurologist and Hematologist.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Anticoagulant therapy, Cerebral thrombosis, Chills, Computerised tomogram head abnormal
Clinical narrative: On April 6, started having nausea and stomach pain. On April 8th had fever (100F), chills, body aches and headaches. On april 9th headache got intense and no more fever. On april 10 keep having intense headache and went to ER. A CBC show low platelets level (25K) and got admitted to Hospital the morning after. A Head CT Scan was negative. On April 11 through 13 platelets levels going up slowly. On April 14th Intense Headache came back and was performed a Head CT Scan was performed with positive result. Another CT Scan with contrast and MRI the day after confirmed positive result for a blood clot in the head. Transfers to ICU for 5 days. Transferred to Regular Room for two days. Diagnosed with Vaccine-Induced Immune Thrombotic Thrombocytopenia.  Released with Xarelto 20mg and Medrol 4mg for 7 days treatment with follow up in a week. Also schedule appointments with Neurologist and Hematologist.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Full blood count abnormal, Headache, Intensive care, Magnetic resonance imaging head abnormal, Nausea
Clinical narrative: On April 6, started having nausea and stomach pain. On April 8th had fever (100F), chills, body aches and headaches. On april 9th headache got intense and no more fever. On april 10 keep having intense headache and went to ER. A CBC show low platelets level (25K) and got admitted to Hospital the morning after. A Head CT Scan was negative. On April 11 through 13 platelets levels going up slowly. On April 14th Intense Headache came back and was performed a Head CT Scan was performed with positive result. Another CT Scan with contrast and MRI the day after confirmed positive result for a blood clot in the head. Transfers to ICU for 5 days. Transferred to Regular Room for two days. Diagnosed with Vaccine-Induced Immune Thrombotic Thrombocytopenia.  Released with Xarelto 20mg and Medrol 4mg for 7 days treatment with follow up in a week. Also schedule appointments with Neurologist and Hematologist.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Platelet count decreased, Pyrexia, Scan with contrast abnormal, Thrombosis with thrombocytopenia syndrome
Clinical narrative: On April 6, started having nausea and stomach pain. On April 8th had fever (100F), chills, body aches and headaches. On april 9th headache got intense and no more fever. On april 10 keep having intense headache and went to ER. A CBC show low platelets level (25K) and got admitted to Hospital the morning after. A Head CT Scan was negative. On April 11 through 13 platelets levels going up slowly. On April 14th Intense Headache came back and was performed a Head CT Scan was performed with positive result. Another CT Scan with contrast and MRI the day after confirmed positive result for a blood clot in the head. Transfers to ICU for 5 days. Transferred to Regular Room for two days. Diagnosed with Vaccine-Induced Immune Thrombotic Thrombocytopenia.  Released with Xarelto 20mg and Medrol 4mg for 7 days treatment with follow up in a week. Also schedule appointments with Neurologist and Hematologist.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood count abnormal, Cavernous sinus thrombosis, Computerised tomogram, Computerised tomogram head abnormal, Fibrin D dimer
Clinical narrative: On April 6, started having nausea and stomach pain. On April 8th had fever (100F), chills, body aches and headaches. On april 9th headache got intense and no more fever. On april 10 keep having intense headache and went to ER. A CBC show low platelets level (25K) and got admitted to Hospital the morning after. A Head CT Scan was negative. On April 11 through 13 platelets levels going up slowly. On April 14th Intense Headache came back and was performed a Head CT Scan was performed with positive result. Another CT Scan with contrast and MRI the day after confirmed positive result for a blood clot in the head. Transfers to ICU for 5 days. Transferred to Regular Room for two days. Diagnosed with Vaccine-Induced Immune Thrombotic Thrombocytopenia.  Released with Xarelto 20mg and Medrol 4mg for 7 days treatment with follow up in a week. Also schedule appointments with Neurologist and Hematologist.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Fibrin D dimer increased, Full blood count, Magnetic resonance imaging, Magnetic resonance imaging head abnormal, Platelet count
Clinical narrative: On April 6, started having nausea and stomach pain. On April 8th had fever (100F), chills, body aches and headaches. On april 9th headache got intense and no more fever. On april 10 keep having intense headache and went to ER. A CBC show low platelets level (25K) and got admitted to Hospital the morning after. A Head CT Scan was negative. On April 11 through 13 platelets levels going up slowly. On April 14th Intense Headache came back and was performed a Head CT Scan was performed with positive result. Another CT Scan with contrast and MRI the day after confirmed positive result for a blood clot in the head. Transfers to ICU for 5 days. Transferred to Regular Room for two days. Diagnosed with Vaccine-Induced Immune Thrombotic Thrombocytopenia.  Released with Xarelto 20mg and Medrol 4mg for 7 days treatment with follow up in a week. Also schedule appointments with Neurologist and Hematologist.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Thrombocytopenia, Venogram, Venogram abnormal
Clinical narrative: On April 6, started having nausea and stomach pain. On April 8th had fever (100F), chills, body aches and headaches. On april 9th headache got intense and no more fever. On april 10 keep having intense headache and went to ER. A CBC show low platelets level (25K) and got admitted to Hospital the morning after. A Head CT Scan was negative. On April 11 through 13 platelets levels going up slowly. On April 14th Intense Headache came back and was performed a Head CT Scan was performed with positive result. Another CT Scan with contrast and MRI the day after confirmed positive result for a blood clot in the head. Transfers to ICU for 5 days. Transferred to Regular Room for two days. Diagnosed with Vaccine-Induced Immune Thrombotic Thrombocytopenia.  Released with Xarelto 20mg and Medrol 4mg for 7 days treatment with follow up in a week. Also schedule appointments with Neurologist and Hematologist.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Headache, Vomiting
Clinical narrative: Stroke; Vomiting; Nose bleed; Woke up with severe headache; Woke up with severe headache; This is a spontaneous report from a Pfizer sponsored program, Pfizer RXPathways. A contactable consumer (patient) reported a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 01Apr2021 at 12:00 PM (at noon), at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. At 02:00 AM on 06Apr2021, the patient woke up with severe headache. The patient started vomiting and had nose bleed at around 07:00 AM and had a stroke at 11:00 AM that day (06Apr2021). The patient was not sure if this is related but timing causes her to worry. The patient needed someone to tell her if she should take second dose on Wednesday. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Epistaxis, Headache, Vomiting
Clinical narrative: Stroke; Vomiting; Nose bleed; Woke up with severe headache; Woke up with severe headache; This is a spontaneous report from a Pfizer sponsored program, Pfizer RXPathways. A contactable consumer (patient) reported a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 01Apr2021 at 12:00 PM (at noon), at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. At 02:00 AM on 06Apr2021, the patient woke up with severe headache. The patient started vomiting and had nose bleed at around 07:00 AM and had a stroke at 11:00 AM that day (06Apr2021). The patient was not sure if this is related but timing causes her to worry. The patient needed someone to tell her if she should take second dose on Wednesday. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Epistaxis, Headache, Middle insomnia, Vomiting
Clinical narrative: Stroke; Vomiting; Nose bleed; Woke up with severe headache; Woke up with severe headache; This is a spontaneous report from a Pfizer sponsored program, Pfizer RXPathways. A contactable consumer (patient) reported a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 01Apr2021 at 12:00 PM (at noon), at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. At 02:00 AM on 06Apr2021, the patient woke up with severe headache. The patient started vomiting and had nose bleed at around 07:00 AM and had a stroke at 11:00 AM that day (06Apr2021). The patient was not sure if this is related but timing causes her to worry. The patient needed someone to tell her if she should take second dose on Wednesday. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral venous sinus thrombosis
Clinical narrative: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S; This spontaneous report received from a consumer via a company representative (source: media relations), concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, frequency 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that, on an unspecified date, the patient passed away as a result of complications after receiving covid-19 vaccine ad26.cov2.s. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: 20210458982-Covid-19 vaccine ad26.cov2.s-complications after receiving covid-19 vaccine ad26.cov2.s. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Death, Thrombosis
Clinical narrative: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S; This spontaneous report received from a consumer via a company representative (source: media relations), concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, frequency 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that, on an unspecified date, the patient passed away as a result of complications after receiving covid-19 vaccine ad26.cov2.s. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: 20210458982-Covid-19 vaccine ad26.cov2.s-complications after receiving covid-19 vaccine ad26.cov2.s. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Anxiety, Areflexia, Blood sodium increased, Brain herniation, Cerebral haemorrhage
Clinical narrative: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S; This spontaneous report received from a consumer via a company representative (source: media relations), concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, frequency 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that, on an unspecified date, the patient passed away as a result of complications after receiving covid-19 vaccine ad26.cov2.s. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: 20210458982-Covid-19 vaccine ad26.cov2.s-complications after receiving covid-19 vaccine ad26.cov2.s. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral mass effect, Coma scale abnormal, Computerised tomogram head abnormal, Computerised tomogram head normal, Condition aggravated
Clinical narrative: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S; This spontaneous report received from a consumer via a company representative (source: media relations), concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, frequency 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that, on an unspecified date, the patient passed away as a result of complications after receiving covid-19 vaccine ad26.cov2.s. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: 20210458982-Covid-19 vaccine ad26.cov2.s-complications after receiving covid-19 vaccine ad26.cov2.s. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Endotracheal intubation, Headache, Migraine, Nausea, Photophobia
Clinical narrative: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S; This spontaneous report received from a consumer via a company representative (source: media relations), concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, frequency 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that, on an unspecified date, the patient passed away as a result of complications after receiving covid-19 vaccine ad26.cov2.s. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: 20210458982-Covid-19 vaccine ad26.cov2.s-complications after receiving covid-19 vaccine ad26.cov2.s. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Pupil fixed, Seizure, Subarachnoid haemorrhage, Unresponsive to stimuli
Clinical narrative: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S; This spontaneous report received from a consumer via a company representative (source: media relations), concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, frequency 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that, on an unspecified date, the patient passed away as a result of complications after receiving covid-19 vaccine ad26.cov2.s. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: 20210458982-Covid-19 vaccine ad26.cov2.s-complications after receiving covid-19 vaccine ad26.cov2.s. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Venogram normal, Vomiting
Clinical narrative: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S; This spontaneous report received from a consumer via a company representative (source: media relations), concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, frequency 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that, on an unspecified date, the patient passed away as a result of complications after receiving covid-19 vaccine ad26.cov2.s. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: 20210458982-Covid-19 vaccine ad26.cov2.s-complications after receiving covid-19 vaccine ad26.cov2.s. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Adverse event
Clinical narrative: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S; This spontaneous report received from a consumer via a company representative (source: media relations), concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, frequency 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that, on an unspecified date, the patient passed away as a result of complications after receiving covid-19 vaccine ad26.cov2.s. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: 20210458982-Covid-19 vaccine ad26.cov2.s-complications after receiving covid-19 vaccine ad26.cov2.s. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Activated partial thromboplastin time, Blood fibrinogen, Blood sodium, Cerebral haemorrhage, Cerebral venous sinus thrombosis
Clinical narrative: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S; This spontaneous report received from a consumer via a company representative (source: media relations), concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, frequency 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that, on an unspecified date, the patient passed away as a result of complications after receiving covid-19 vaccine ad26.cov2.s. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: 20210458982-Covid-19 vaccine ad26.cov2.s-complications after receiving covid-19 vaccine ad26.cov2.s. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Coma scale, Computerised tomogram head, Fibrin D dimer, Headache, Heparin-induced thrombocytopenia test
Clinical narrative: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S; This spontaneous report received from a consumer via a company representative (source: media relations), concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, frequency 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that, on an unspecified date, the patient passed away as a result of complications after receiving covid-19 vaccine ad26.cov2.s. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: 20210458982-Covid-19 vaccine ad26.cov2.s-complications after receiving covid-19 vaccine ad26.cov2.s. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Hypernatraemia, International normalised ratio, Laboratory test, Loss of consciousness, Photophobia
Clinical narrative: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S; This spontaneous report received from a consumer via a company representative (source: media relations), concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, frequency 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that, on an unspecified date, the patient passed away as a result of complications after receiving covid-19 vaccine ad26.cov2.s. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: 20210458982-Covid-19 vaccine ad26.cov2.s-complications after receiving covid-19 vaccine ad26.cov2.s. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Platelet count, Prophylaxis of nausea and vomiting, SARS-CoV-2 test, Seizure, Thrombocytopenia
Clinical narrative: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S; This spontaneous report received from a consumer via a company representative (source: media relations), concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, frequency 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that, on an unspecified date, the patient passed away as a result of complications after receiving covid-19 vaccine ad26.cov2.s. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: 20210458982-Covid-19 vaccine ad26.cov2.s-complications after receiving covid-19 vaccine ad26.cov2.s. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Venogram
Clinical narrative: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S; This spontaneous report received from a consumer via a company representative (source: media relations), concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, frequency 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that, on an unspecified date, the patient passed away as a result of complications after receiving covid-19 vaccine ad26.cov2.s. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: 20210458982-Covid-19 vaccine ad26.cov2.s-complications after receiving covid-19 vaccine ad26.cov2.s. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: COMPLICATION AFTER RECEIVING COVID-19 VACCINE AD26.COV2.S
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Dizziness, Dry throat, Headache
Clinical narrative: fainting; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; dry throat; intense thirst; difficulty swallowing; vertigo; cloudy vision; waves of nausea; weak/numb hands; weak/numb hands; uncontrollable shaking; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 18Apr2021 at 09:45 (Batch/Lot Number: EW0164) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took pneumococcal vaccine for immunisation and experienced allergy, tylenol and experienced allergy, codeine and experienced allergy. The patient experienced fainting, hot burning sensation down left arm from injection site to wrist, dry throat, intense thirst, difficulty swallowing, vertigo, cloudy vision, waves of nausea, weak/numb hands, uncontrollable shaking; all on 18Apr2021 with outcome of recovered in Apr2021. No treatment received for the events. All events resulted in doctor or other healthcare professional office/clinic visit.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Injection site pain, Nausea, Paraesthesia oral, Thirst
Clinical narrative: fainting; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; dry throat; intense thirst; difficulty swallowing; vertigo; cloudy vision; waves of nausea; weak/numb hands; weak/numb hands; uncontrollable shaking; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 18Apr2021 at 09:45 (Batch/Lot Number: EW0164) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took pneumococcal vaccine for immunisation and experienced allergy, tylenol and experienced allergy, codeine and experienced allergy. The patient experienced fainting, hot burning sensation down left arm from injection site to wrist, dry throat, intense thirst, difficulty swallowing, vertigo, cloudy vision, waves of nausea, weak/numb hands, uncontrollable shaking; all on 18Apr2021 with outcome of recovered in Apr2021. No treatment received for the events. All events resulted in doctor or other healthcare professional office/clinic visit.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation, Throat tightness, Tremor, Vertigo
Clinical narrative: fainting; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; dry throat; intense thirst; difficulty swallowing; vertigo; cloudy vision; waves of nausea; weak/numb hands; weak/numb hands; uncontrollable shaking; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 18Apr2021 at 09:45 (Batch/Lot Number: EW0164) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took pneumococcal vaccine for immunisation and experienced allergy, tylenol and experienced allergy, codeine and experienced allergy. The patient experienced fainting, hot burning sensation down left arm from injection site to wrist, dry throat, intense thirst, difficulty swallowing, vertigo, cloudy vision, waves of nausea, weak/numb hands, uncontrollable shaking; all on 18Apr2021 with outcome of recovered in Apr2021. No treatment received for the events. All events resulted in doctor or other healthcare professional office/clinic visit.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Dry throat, Dysphagia, Feeling hot, Hypoaesthesia
Clinical narrative: fainting; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; dry throat; intense thirst; difficulty swallowing; vertigo; cloudy vision; waves of nausea; weak/numb hands; weak/numb hands; uncontrollable shaking; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 18Apr2021 at 09:45 (Batch/Lot Number: EW0164) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took pneumococcal vaccine for immunisation and experienced allergy, tylenol and experienced allergy, codeine and experienced allergy. The patient experienced fainting, hot burning sensation down left arm from injection site to wrist, dry throat, intense thirst, difficulty swallowing, vertigo, cloudy vision, waves of nausea, weak/numb hands, uncontrollable shaking; all on 18Apr2021 with outcome of recovered in Apr2021. No treatment received for the events. All events resulted in doctor or other healthcare professional office/clinic visit.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Nausea, Syncope, Thirst, Tremor
Clinical narrative: fainting; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; dry throat; intense thirst; difficulty swallowing; vertigo; cloudy vision; waves of nausea; weak/numb hands; weak/numb hands; uncontrollable shaking; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 18Apr2021 at 09:45 (Batch/Lot Number: EW0164) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took pneumococcal vaccine for immunisation and experienced allergy, tylenol and experienced allergy, codeine and experienced allergy. The patient experienced fainting, hot burning sensation down left arm from injection site to wrist, dry throat, intense thirst, difficulty swallowing, vertigo, cloudy vision, waves of nausea, weak/numb hands, uncontrollable shaking; all on 18Apr2021 with outcome of recovered in Apr2021. No treatment received for the events. All events resulted in doctor or other healthcare professional office/clinic visit.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain, Vertigo, Vision blurred
Clinical narrative: fainting; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; dry throat; intense thirst; difficulty swallowing; vertigo; cloudy vision; waves of nausea; weak/numb hands; weak/numb hands; uncontrollable shaking; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 18Apr2021 at 09:45 (Batch/Lot Number: EW0164) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took pneumococcal vaccine for immunisation and experienced allergy, tylenol and experienced allergy, codeine and experienced allergy. The patient experienced fainting, hot burning sensation down left arm from injection site to wrist, dry throat, intense thirst, difficulty swallowing, vertigo, cloudy vision, waves of nausea, weak/numb hands, uncontrollable shaking; all on 18Apr2021 with outcome of recovered in Apr2021. No treatment received for the events. All events resulted in doctor or other healthcare professional office/clinic visit.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Face injury, Loss of consciousness, Nausea, Neck pain
Clinical narrative: passed out; extreme nausea; hit the bathroom floor; have a cut lip; extreme chills; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left arm on 18Apr2021 10:45 (Lot Number: EW0164) as single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome and allergy. Concomitant medications included chlordiazepoxide, clidinium bromide (LIBRAX), Multi-Vitamin, colecalciferol (D3), ascorbic acid (VIT C), fish oil. No other vaccine was received in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient received first dose of BNT162B2 (lot# ER2613) in left arm on 27Mar2021 12:00 PM for COVID-19 immunization. The patient experienced extreme nausea 19Apr2021 00:30, then he passed out and hit the bathroom floor. The patient woke up a few moments later, when her wife found him. The patient had a cut lip. The patient then had extreme chills for 30-60 minutes. The events resulted in doctor or other healthcare professional office/clinic visit. It's unknown if treatment was received. The outcome of events was recovering.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Fall, Lip injury, Loss of consciousness, Nausea
Clinical narrative: passed out; extreme nausea; hit the bathroom floor; have a cut lip; extreme chills; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left arm on 18Apr2021 10:45 (Lot Number: EW0164) as single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome and allergy. Concomitant medications included chlordiazepoxide, clidinium bromide (LIBRAX), Multi-Vitamin, colecalciferol (D3), ascorbic acid (VIT C), fish oil. No other vaccine was received in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient received first dose of BNT162B2 (lot# ER2613) in left arm on 27Mar2021 12:00 PM for COVID-19 immunization. The patient experienced extreme nausea 19Apr2021 00:30, then he passed out and hit the bathroom floor. The patient woke up a few moments later, when her wife found him. The patient had a cut lip. The patient then had extreme chills for 30-60 minutes. The events resulted in doctor or other healthcare professional office/clinic visit. It's unknown if treatment was received. The outcome of events was recovering.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia, Tinnitus
Clinical narrative: Tinnitus; severe headache; Fever; arm pain; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8734), via an unspecified route of administration, administered in left arm on 10Apr2021 09:00 AM (at 56-year-old, not pregnant at the time of vaccination) at single dose for COVID-19 immunisation. Medical history included known allergies: Sulfa drugs. No prior history of tinnitus or auditory disorder. No covid prior vaccination. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955), via an unspecified route of administration, administered in left arm on 19Mar2021 09:00 AM (at 56-year-old) at single dose for COVID-19 immunisation. No other vaccine in four weeks. No other medications in two weeks. On 10Apr2021 07:00 PM, the onset of symptoms began 10 hours after the second dose injection, including severe headache, fever, arm pain, fatigue, and tinnitus. All symptoms persisted intensely for 24 hours, then started to lift with the exception of headache and tinnitus. The headache resolved at about 48 hours. Tinnitus remains severe and consistent since the day of the shot. The events resulted in disability or permanent damage. No treatment was received for the events. The outcome of the events was not recovered. No Covid tested post vaccination.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Chills, Fatigue, Hypersomnia, Mobility decreased
Clinical narrative: Patient admitted to Hospital on 4/16/2021 with 2 weeks of generalized weakness, chills, poor oral intake and nonproductive cough. Chest x-ray shows consolidation. Patient tested for covid-19 which returned positive on 4/18/21. Patient remained hospitalized and started on steroids and vitamin c/e after covid testing returned positive. Patient respiratory status worsened requiring high flow nasal cannula and BiPAP as needed. Patient did not want to be intubated and decided to go to comfort care. Patient passed away on 5/3/21 in the hospital.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Patient admitted to Hospital on 4/16/2021 with 2 weeks of generalized weakness, chills, poor oral intake and nonproductive cough. Chest x-ray shows consolidation. Patient tested for covid-19 which returned positive on 4/18/21. Patient remained hospitalized and started on steroids and vitamin c/e after covid testing returned positive. Patient respiratory status worsened requiring high flow nasal cannula and BiPAP as needed. Patient did not want to be intubated and decided to go to comfort care. Patient passed away on 5/3/21 in the hospital.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Bilevel positive airway pressure, COVID-19, Chest X-ray abnormal, Chills
Clinical narrative: Patient admitted to Hospital on 4/16/2021 with 2 weeks of generalized weakness, chills, poor oral intake and nonproductive cough. Chest x-ray shows consolidation. Patient tested for covid-19 which returned positive on 4/18/21. Patient remained hospitalized and started on steroids and vitamin c/e after covid testing returned positive. Patient respiratory status worsened requiring high flow nasal cannula and BiPAP as needed. Patient did not want to be intubated and decided to go to comfort care. Patient passed away on 5/3/21 in the hospital.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Death, Hypophagia, Lung consolidation, Respiratory disorder
Clinical narrative: Patient admitted to Hospital on 4/16/2021 with 2 weeks of generalized weakness, chills, poor oral intake and nonproductive cough. Chest x-ray shows consolidation. Patient tested for covid-19 which returned positive on 4/18/21. Patient remained hospitalized and started on steroids and vitamin c/e after covid testing returned positive. Patient respiratory status worsened requiring high flow nasal cannula and BiPAP as needed. Patient did not want to be intubated and decided to go to comfort care. Patient passed away on 5/3/21 in the hospital.