chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Musculoskeletal chest pain, Nausea, Pain, Pain assessment
Clinical narrative: migraine at rhe base of my Head; My heart rate rose to around 133 just laying down; extremely nauseous; inability to control temperature regulation; stomach began to have a really intense stabbing pains; Not the worst pain I have experienced but definitely not pleasent; lethargic; getting extremely cold and then hot within a matter of minutes; Her ribs and lungs hurt; Her ribs and lungs hurt; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received second dose bnt162b2 (Pfizer COVID 19 vaccine), via an unspecified route of administration, administered in Arm Left on 24Feb2021 10:15 (Lot Number: EN6202) as single dose for COVID-19 immunisation. Medical history included known allergies to Red dye, postural orthostatic tachycardia syndrome (POTS), heart murmur, Wilkies syndrome. The patient was not pregnant. There were no concomitant medications. The patient did not take other medications in two weeks. The patient previously took Excedrin and experienced allergies. The patient previously received first dose bnt162b2 (Pfizer COVID 19 vaccine), via an unspecified route of administration, administered in Arm Left on 03Feb2021 09:45 AM (Lot Number: EL9269) for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. On 24Feb2021 at around 7:00pm she started getting a migraine at the base of her head. She then was lethargic, and became extremely nauseous. She started getting extremely cold and then hot within a matter of minutes (inability to control temperature regulation). Her heart rate rose to around 133 just laying down. Her ribs and lungs hurt. And her stomach began to have a really intense stabbing pains. At one point it felt as if she could feel every cell in her body if that makes sense. Not the worst pain she had experienced but definitely not pleasant. On a scale of 1 to 10 (10 being run over by a car and 1 being a paper cut) she would say it was a 5-6. The patient did not receive treatment for the events. Facility type vaccine was facility. The patient did not have COVID prior vaccination and did not have COVID test post vaccination. The outcome of the events was recovered on an unspecified date.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary pain, Temperature regulation disorder
Clinical narrative: migraine at rhe base of my Head; My heart rate rose to around 133 just laying down; extremely nauseous; inability to control temperature regulation; stomach began to have a really intense stabbing pains; Not the worst pain I have experienced but definitely not pleasent; lethargic; getting extremely cold and then hot within a matter of minutes; Her ribs and lungs hurt; Her ribs and lungs hurt; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received second dose bnt162b2 (Pfizer COVID 19 vaccine), via an unspecified route of administration, administered in Arm Left on 24Feb2021 10:15 (Lot Number: EN6202) as single dose for COVID-19 immunisation. Medical history included known allergies to Red dye, postural orthostatic tachycardia syndrome (POTS), heart murmur, Wilkies syndrome. The patient was not pregnant. There were no concomitant medications. The patient did not take other medications in two weeks. The patient previously took Excedrin and experienced allergies. The patient previously received first dose bnt162b2 (Pfizer COVID 19 vaccine), via an unspecified route of administration, administered in Arm Left on 03Feb2021 09:45 AM (Lot Number: EL9269) for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. On 24Feb2021 at around 7:00pm she started getting a migraine at the base of her head. She then was lethargic, and became extremely nauseous. She started getting extremely cold and then hot within a matter of minutes (inability to control temperature regulation). Her heart rate rose to around 133 just laying down. Her ribs and lungs hurt. And her stomach began to have a really intense stabbing pains. At one point it felt as if she could feel every cell in her body if that makes sense. Not the worst pain she had experienced but definitely not pleasant. On a scale of 1 to 10 (10 being run over by a car and 1 being a paper cut) she would say it was a 5-6. The patient did not receive treatment for the events. Facility type vaccine was facility. The patient did not have COVID prior vaccination and did not have COVID test post vaccination. The outcome of the events was recovered on an unspecified date.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood glucose, Blood glucose decreased, Diarrhoea, Discomfort, Pain
Clinical narrative: He was a diabetic /sugar was 120/this morning about 8:30ish it was 99.3 now 98.3; diarrhea; discomfort in his body; aching; soreness in arm; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm on 23Feb2021 (at the age of 72-year-old) at single dose for covid-19 immunisation. Medical history included ongoing diabetic (his sugar was 120) and urinating. The patient's concomitant medications were not reported. The patient was referred here by a nurse practitioner in their other department. The patient would like to know if any of these particular symptoms experienced are related to the Covid vaccine. When the patient first got it on 23Feb2021 the patient had some soreness in arm and discomfort in his body, aching. It lasted until the next day on 24Feb2021 and then went away. He didn't have any problems until 11pm last night on 25Feb2021. He was a diabetic and he was urinating every hour on the hour sometimes twice an hour. His sugar was 120 on an unspecified date. This morning (on 26Feb2021) the patient had diarrhea. Also this morning (on 26Feb2021) about 8:30ish it was 99.3 now 98.3. The outcome of the events some soreness in arm and discomfort in his body, aching was recovered on 24Feb2021 and of the other events was unknown.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: He was a diabetic /sugar was 120/this morning about 8:30ish it was 99.3 now 98.3; diarrhea; discomfort in his body; aching; soreness in arm; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm on 23Feb2021 (at the age of 72-year-old) at single dose for covid-19 immunisation. Medical history included ongoing diabetic (his sugar was 120) and urinating. The patient's concomitant medications were not reported. The patient was referred here by a nurse practitioner in their other department. The patient would like to know if any of these particular symptoms experienced are related to the Covid vaccine. When the patient first got it on 23Feb2021 the patient had some soreness in arm and discomfort in his body, aching. It lasted until the next day on 24Feb2021 and then went away. He didn't have any problems until 11pm last night on 25Feb2021. He was a diabetic and he was urinating every hour on the hour sometimes twice an hour. His sugar was 120 on an unspecified date. This morning (on 26Feb2021) the patient had diarrhea. Also this morning (on 26Feb2021) about 8:30ish it was 99.3 now 98.3. The outcome of the events some soreness in arm and discomfort in his body, aching was recovered on 24Feb2021 and of the other events was unknown.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Diarrhoea, Discomfort, Insomnia, Pain in extremity
Clinical narrative: He was a diabetic /sugar was 120/this morning about 8:30ish it was 99.3 now 98.3; diarrhea; discomfort in his body; aching; soreness in arm; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm on 23Feb2021 (at the age of 72-year-old) at single dose for covid-19 immunisation. Medical history included ongoing diabetic (his sugar was 120) and urinating. The patient's concomitant medications were not reported. The patient was referred here by a nurse practitioner in their other department. The patient would like to know if any of these particular symptoms experienced are related to the Covid vaccine. When the patient first got it on 23Feb2021 the patient had some soreness in arm and discomfort in his body, aching. It lasted until the next day on 24Feb2021 and then went away. He didn't have any problems until 11pm last night on 25Feb2021. He was a diabetic and he was urinating every hour on the hour sometimes twice an hour. His sugar was 120 on an unspecified date. This morning (on 26Feb2021) the patient had diarrhea. Also this morning (on 26Feb2021) about 8:30ish it was 99.3 now 98.3. The outcome of the events some soreness in arm and discomfort in his body, aching was recovered on 24Feb2021 and of the other events was unknown.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pollakiuria, Pyrexia
Clinical narrative: He was a diabetic /sugar was 120/this morning about 8:30ish it was 99.3 now 98.3; diarrhea; discomfort in his body; aching; soreness in arm; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm on 23Feb2021 (at the age of 72-year-old) at single dose for covid-19 immunisation. Medical history included ongoing diabetic (his sugar was 120) and urinating. The patient's concomitant medications were not reported. The patient was referred here by a nurse practitioner in their other department. The patient would like to know if any of these particular symptoms experienced are related to the Covid vaccine. When the patient first got it on 23Feb2021 the patient had some soreness in arm and discomfort in his body, aching. It lasted until the next day on 24Feb2021 and then went away. He didn't have any problems until 11pm last night on 25Feb2021. He was a diabetic and he was urinating every hour on the hour sometimes twice an hour. His sugar was 120 on an unspecified date. This morning (on 26Feb2021) the patient had diarrhea. Also this morning (on 26Feb2021) about 8:30ish it was 99.3 now 98.3. The outcome of the events some soreness in arm and discomfort in his body, aching was recovered on 24Feb2021 and of the other events was unknown.  Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node under left arm pit; This is a spontaneous report from a contactable other hcp (patient).   A 34-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration, administered in the left arm on 19Feb2021  (at the age of 34-years-old) as a single dose for COVID-19 immunisation.  Medical history included allergy to penicillins from an unknown date and unknown if ongoing.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162b2 on an unknown date (Lot Number: unknown) via an unspecified route of administration for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced swollen lymph node under left arm pit on 19Feb2021 with outcome of unknown.  The patient did not receive any treatment for the event. The outcome of the event, swollen lymph node under left arm pit was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Headache, Musculoskeletal stiffness, Pruritus
Clinical narrative: Left Eye swelling; Severe Itching all over; Severe Headache; Stiff neck; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient she received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6198) via an unspecified route of administration in the left arm on 26Feb2021 at 16:30 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included variable immune deficiency, asthma, and eosinophilic esophagitis (EOE). Allergies to medications included amoxicillin, erythromycin, clindamycin, ciprofloxacin (CIPRO), sulfamethoxazole/ trimethoprim (BACTRIM), and oxycodone/ paracetamol (PERCOCET). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 26Feb2021 at 17:15, the patient experienced left eye swelling, severe itching all over, severe headache, and stiff neck. The patient was not treated for left eye swelling, severe itching all over, severe headache, and stiff neck. The clinical outcome of left eye swelling, severe itching all over, severe headache, and stiff neck was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Person reported having sore arm 2 days after the administration of the Pfizer vaccine; This is a spontaneous report received from non-contactable consumer. A male of unspecified age received BNT162b2 (solution for injection; Lot reported Unknown expiry not provided) as a single dose via unspecified route on an unspecified date in Feb2021 for COVID-19 immunisation. There was no medical history, concomitant medications or past drug history reported. It was unknown if the patient received any other vaccination within four weeks prior to the COVID vaccine. It was also unknown if the patient was diagnosed with COVID prior to the vaccination. On an unspecified date in Feb2021, two days post vaccination the patient experienced a sore arm. It was unknown if the patient was tested for COVID since being vaccinated. It was unknown if treatment was received. The outcome of the event, sore arm, was recovered on an unspecified date.  No follow-up attempts are possible; information about lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Joint pain on left wrist and ankle; Joint pain on left wrist and ankle; swelling; This 79- year-old female patient contactable consumer, who reported for herself, received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EN5318), via an unspecified route of administration, on 30Jan2021 at 09:15 AM as a single dose for COVID-19 immunization, in left arm, in Doctor's office/urgent care. Patient is not pregnant. She has had no other vaccines on the same day or in the past 4 weeks. The patient did not have COVID-19 prior to the vaccine. Relevant medical history included: Cancer, high blood pressure, cholesterol. Patient has a known allergies: Iodine. Patient taking unspecified concomitant medications. On 02Feb2021, the patient experienced Joint pain on left wrist and ankle, swelling. The clinical outcome of the events was not recovered. It was reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: had a "strong reaction" to the first dose of the Pfizer-BioNTech COVID-19 vaccine\really bad allergic reaction after her first dose; This is a spontaneous report from a Pfizer-sponsored Program.  A contactable consumer reported that a 37-year-old female patient (reporter's daughter) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included iodine allergy from an unknown date and unknown if ongoing, cat and environmental allergies to animal from an unknown date and unknown if ongoing, environmental allergies from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported.  The reporter is 70 years old, has medical conditions including asthma and COPD for which she takes steroid medications.  She said she received her first dose of the Pfizer-BioNTech COVID-19 vaccine on 10Feb2021. She explained she had slight pain in her arm, [her] heart was racing, and [she] felt her heartbeat was faster. She described this experience as nothing out of control. She explained she does have this problem, [her] heart raises easily with different things. She added her 37-year-old daughter who is very healthy, had a strong reaction to the first dose of the Pfizer-BioNTech COVID-19 vaccine. She specified it was to the point where they almost had to give her an EpiPen injection. She explained her daughter's face, tongue and lips swell. She said it was a little better, but when she off the [vaccination] site, it got worst and she was given 1c.c. of Depo-Medrol, a corticosteroid, which got it under control. She mentioned the only time her daughter had a similar severe allergic reaction was with iodine, a colorant dye, or contrast dye. She then explained her daughter also has cat and environmental allergies. She then mentioned her daughter was worried because she is also nursing her baby. She expressed her concerns as to whether or not they should receive the second dose. She stated her second dose is scheduled on 03Mar2021. She asked: will steroids, injectable steroids, EpiPen and epinephrine interfere with the vaccine's efficacy? The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021230246 same reporter, different patient, same product, and different event (Baby case)
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: I had my second shot in my thigh February 11. I had a mild inflammation for 2 days and then nothing. But my right arm continues to throb.; This is a spontaneous report from a contactable consumer. A 76-year-old female consumer reported started to receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: unknown), via an unspecified route of administration on 11Jan2021, as single dose for covid-19 immunisation. Concomitant medication included Losartan 50mg. The patient had first dose on 20 Jan 2021.the patient is allergic to sulfar. The patient experienced mild inflammation for 2 days and then nothing after second dose. But her right arm continues to throb.  The outcome of event was not recovered.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: cold symptoms; sore throat; headache; lightheadedness; This is a spontaneous report from a Pfizer-sponsored program  from a contactable female consumer (the patient). This female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 , single dose via an unspecified route of administration on 15Feb2021 for COVID-19 vaccination. There was no relevant medical history reported. Concomitant medications were not reported. In Feb2021, the patient experienced lightheadedness for 5 minutes. On 19Feb2021, the patient experienced headache for 24 hours and cold symptoms and sore throat on 22Feb2021. The clinical outcome of lightheadedness, headache, cold symptoms and sore throat was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Rash
Clinical narrative: rash on body and chest / his second shot the same thing happened only worse; rash on body and chest / his second shot the same thing happened only worse; This is a spontaneous report from a contactable physician. A 7-decade-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unknown date as a single dose arm for COVID-19 IMMUNIZATION and experienced a rash on body and chest 36 hours after receiving first shot and it eventually cleared up. Relevant medical history and concomitant medication were not provided. On an unknown date, when patient got his second shot, the patient experienced experienced a rash on body and chest, described as, the same thing happened only worse, so he sought care from the provider. The outcome of the event rash on body and chest was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Loss of personal independence in daily activities, Muscle rigidity, Muscular weakness, Myalgia
Clinical narrative: 30 hours post vaccine developed diffuse symmetric muscle pain. Muscles became rock hard/10/10 pain at night; rigidity; diffuse muscle weakness; Unable to get out of bed or up from chair without assistance; weakness; This is a spontaneous report from a contactable physician. A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Jan2021 13:00 (Batch/Lot Number: EL8982) as SINGLE DOSE for covid-19 immunisation. Medical history included hyperlipidaemia. Concomitant medications included rosuvastatin; escitalopram; ubidecarenone (CO Q 10 [UBIDECARENONE]); colecalciferol (VIT D3); all taken for an unspecified indication, start and stop date were not reported. The patient previously took augmentin and experiencedknown allergies. On 26Jan2021 19:00, 30 hours post vaccine developed diffuse symmetric muscle pain. Muscles became rock hard/rigidity. Over next week developed diffuse muscle weakness. Proximal worse than distal. Unable to get out of bed or up from chair without assistance. Persisted for over 6 weeks: 10/10 pain at night. Muscle pain, weakness, rigidity. The events were assessed as serious (hospitalization, and disability). Number of days in the hospital: 1. Therapeutic measures were taken as a result of the events. No covid prior vaccination, and no COVID tests post vaccination. The outcome of the events was not recovered.; Sender's Comments: Based on known safety profile and/or temporal association, the contribution of the suspect drug to the onset of events 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain assessment
Clinical narrative: 30 hours post vaccine developed diffuse symmetric muscle pain. Muscles became rock hard/10/10 pain at night; rigidity; diffuse muscle weakness; Unable to get out of bed or up from chair without assistance; weakness; This is a spontaneous report from a contactable physician. A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Jan2021 13:00 (Batch/Lot Number: EL8982) as SINGLE DOSE for covid-19 immunisation. Medical history included hyperlipidaemia. Concomitant medications included rosuvastatin; escitalopram; ubidecarenone (CO Q 10 [UBIDECARENONE]); colecalciferol (VIT D3); all taken for an unspecified indication, start and stop date were not reported. The patient previously took augmentin and experiencedknown allergies. On 26Jan2021 19:00, 30 hours post vaccine developed diffuse symmetric muscle pain. Muscles became rock hard/rigidity. Over next week developed diffuse muscle weakness. Proximal worse than distal. Unable to get out of bed or up from chair without assistance. Persisted for over 6 weeks: 10/10 pain at night. Muscle pain, weakness, rigidity. The events were assessed as serious (hospitalization, and disability). Number of days in the hospital: 1. Therapeutic measures were taken as a result of the events. No covid prior vaccination, and no COVID tests post vaccination. The outcome of the events was not recovered.; Sender's Comments: Based on known safety profile and/or temporal association, the contribution of the suspect drug to the onset of events 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Death
Clinical narrative: COVID-19 INFECTION (COVID-19, COVID-19) This spontaneous report received from a consumer via a company representative and concerned a patient of unspecified age and sex. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient developed covid-10 infection. On an unspecified date, the patient died from covid-19. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Dyspnoea, Fatigue, Headache, Nausea
Clinical narrative: WORSENING OF FLUID IN THE LUNG (Lung edema, Pulmonary oedema) WORSENING OF LOW OXYGEN LEVEL (Oxygen saturation low, Oxygen saturation decreased) HARD TO BREATH WORSENING (Difficulty breathing, Dyspnoea) VOMITING (Vomiting, Vomiting) NAUSEA (Nausea, Nausea) PAIN IN THE HEAD (Head pain, Headache) TIRED (Tiredness, Fatigue) This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease (COPD), heart condition, neuropathy, and diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 08-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the patient started symptoms and was tired. The patient had swollen face, nausea, vomiting and pain in the head. On 10-MAR-2021, the patient's symptoms got worse which included worsening of fluid in the lung, worsening of low oxygen level, hard to breath worsening and was admitted to the hospital. The patient was in hospital at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from worsening of low oxygen level, swollen face, and worsening of fluid in the lung, had not recovered from hard to breath worsening, and the outcome of nausea, vomiting, pain in the head and was tired was not reported. This report was serious (Hospitalization Caused / Prolonged).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation decreased, Pulmonary oedema, Swelling face, Vomiting
Clinical narrative: WORSENING OF FLUID IN THE LUNG (Lung edema, Pulmonary oedema) WORSENING OF LOW OXYGEN LEVEL (Oxygen saturation low, Oxygen saturation decreased) HARD TO BREATH WORSENING (Difficulty breathing, Dyspnoea) VOMITING (Vomiting, Vomiting) NAUSEA (Nausea, Nausea) PAIN IN THE HEAD (Head pain, Headache) TIRED (Tiredness, Fatigue) This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease (COPD), heart condition, neuropathy, and diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 08-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the patient started symptoms and was tired. The patient had swollen face, nausea, vomiting and pain in the head. On 10-MAR-2021, the patient's symptoms got worse which included worsening of fluid in the lung, worsening of low oxygen level, hard to breath worsening and was admitted to the hospital. The patient was in hospital at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from worsening of low oxygen level, swollen face, and worsening of fluid in the lung, had not recovered from hard to breath worsening, and the outcome of nausea, vomiting, pain in the head and was tired was not reported. This report was serious (Hospitalization Caused / Prolonged).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Nausea, Oxygen saturation
Clinical narrative: WORSENING OF FLUID IN THE LUNG (Lung edema, Pulmonary oedema) WORSENING OF LOW OXYGEN LEVEL (Oxygen saturation low, Oxygen saturation decreased) HARD TO BREATH WORSENING (Difficulty breathing, Dyspnoea) VOMITING (Vomiting, Vomiting) NAUSEA (Nausea, Nausea) PAIN IN THE HEAD (Head pain, Headache) TIRED (Tiredness, Fatigue) This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease (COPD), heart condition, neuropathy, and diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 08-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the patient started symptoms and was tired. The patient had swollen face, nausea, vomiting and pain in the head. On 10-MAR-2021, the patient's symptoms got worse which included worsening of fluid in the lung, worsening of low oxygen level, hard to breath worsening and was admitted to the hospital. The patient was in hospital at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from worsening of low oxygen level, swollen face, and worsening of fluid in the lung, had not recovered from hard to breath worsening, and the outcome of nausea, vomiting, pain in the head and was tired was not reported. This report was serious (Hospitalization Caused / Prolonged).
Sex: F
Vaccine: COVID19
Symptoms: Cardiovascular symptom, Vaccination complication
Clinical narrative: HEART ATTACK SYMPTOMS (Heart attack, Myocardial infarction) This spontaneous report received from a consumer concerned a female of unspecified age. 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)  dose,  1 total ,  start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be required for this case. No concomitant medications were reported. The patient got the J&J shot Wednesday and on Thursday afternoon, she was admitted to hospital with heart attack symptoms. They kept her overnight, done all test they could on her heart and it all came back good. Doctor said it was reaction to her shot. The action taken with covid-19 vaccine ad26 .cov2 .s was not applicable. The outcome of heart attack symptoms was not reported. The reporter considered the causality between covid-19 vaccine ad26 .cov2 .s and heart attack symptoms as related. Company causality between covid-19 vaccine ad26 .cov2 .s and heart attack symptoms was possible. This report was serious  (Hospitalization Caused / Prolonged).
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: SWELLING OF THE UPPER LIP  (Lip swelling,  Lip swelling)  FACIAL SWELLING  (Facial swelling,  Swelling face) SORE ARM  (Pain in arm,  Pain in extremity) This spontaneous report received from a patient  (health care professional)  concerned a female of unspecified age. The patent's height,  and weight were not reported. The patient's concurrent conditions included cat allergy,  food allergy,  and dye allergy. The patient received covid-19 vaccine ad26.cov2.s  (suspension for injection,  route of admin not reported,  batch number:  Unk) dose was not reported,  administered on 12-MAR-2021  10:35 for prophylactic vaccination.  The batch number was not reported and has been requested.  No concomitant medications were reported. On 12-MAR-2021,  after receiving the vaccine,  the patient experienced sore arm,  swelling of the upper lip and facial swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient had not recovered from sore arm,  swelling of the upper lip,  and facial swelling.  This report was serious  (Life Threatening) .  Version 1 created to amend previously reported information on 12-MAR-2021.  Upon review following information was amended:  The events sore arm,  swelling of the upper lip,  and facial swelling upgraded to serious with seriousness criteria as Life threatening.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pharyngeal swelling
Clinical narrative: SHORTNESS OF BREATH (Shortness of breath, Dyspnoea) THROAT SWELLING (Throat swelling, Pharyngeal swelling) The spontaneous report received from a patient concerned a female of unspecified age. 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) dose was not reported, administered on Right arm on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced shortness of breath, and was hospitalized (date unspecified). On MAR-2021, the subject experienced throat swelling. The patient was treated every 4 hours .Treatment medications (dates unspecified) included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the throat swelling and shortness of breath was not reported. The reporter did not provided causality between covid-19 vaccine ad26.cov2.s and throat swelling and shortness of breath was possible. This report was serious (Hospitalization Caused / Prolonged).
Sex: U
Vaccine: COVID19
Symptoms: Acute pulmonary oedema, Body temperature increased, Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased
Clinical narrative: ACUTE PULMONARY EDEMA  (Acute pulmonary edema, Acute pulmonary oedema)  FEVER  (Fever, Pyrexia) This spontaneous report received from a physician concerned a patient of unspecified age and unspecified sex.  The patient's weight, height, and medical history were not reported. The patient received JNJ78436735 (Ad26.COV2.S) (suspension for injection,  route of admin not reported,  batch number:  Unknown, expiry: UNKNOWN) dose was not reported,  administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. It was reported by HCP that the patient was admitted to hospital on MAR-2021, the patient experienced acute pulmonary edema with symptoms (shortness of breath(SOB) , questionable bloody sputum) and was intubated in emergency room (ER) where he developed troponin level of 65, ejection fraction of 30% baseline was 50 to 55%, and fever. Laboratory data included:  Body temperature 101.7 tympanic,  Echocardiogram ejection fraction of 30% baseline was 50 to 55%, and Troponin level of 65.  The  treatment of intubation was administered for acute pulmonary edema. The days of hospitalization was not known. The action taken with JNJ78436735  (Ad26.COV2.S)  was not applicable.  The outcome of the acute pulmonary edema and fever was not reported.  This report was serious  (Hospitalization Caused / Prolonged, and Life Threatening).
Sex: U
Vaccine: COVID19
Symptoms: Endotracheal intubation, Pyrexia, Troponin
Clinical narrative: ACUTE PULMONARY EDEMA  (Acute pulmonary edema, Acute pulmonary oedema)  FEVER  (Fever, Pyrexia) This spontaneous report received from a physician concerned a patient of unspecified age and unspecified sex.  The patient's weight, height, and medical history were not reported. The patient received JNJ78436735 (Ad26.COV2.S) (suspension for injection,  route of admin not reported,  batch number:  Unknown, expiry: UNKNOWN) dose was not reported,  administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. It was reported by HCP that the patient was admitted to hospital on MAR-2021, the patient experienced acute pulmonary edema with symptoms (shortness of breath(SOB) , questionable bloody sputum) and was intubated in emergency room (ER) where he developed troponin level of 65, ejection fraction of 30% baseline was 50 to 55%, and fever. Laboratory data included:  Body temperature 101.7 tympanic,  Echocardiogram ejection fraction of 30% baseline was 50 to 55%, and Troponin level of 65.  The  treatment of intubation was administered for acute pulmonary edema. The days of hospitalization was not known. The action taken with JNJ78436735  (Ad26.COV2.S)  was not applicable.  The outcome of the acute pulmonary edema and fever was not reported.  This report was serious  (Hospitalization Caused / Prolonged, and Life Threatening).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hypotension, Injection site pain, Nausea
Clinical narrative: FAINTING (Fainting, Syncope) LOW BLOOD PRESSURE (Low blood pressure, Hypotension) VOMITING (Vomiting, Vomiting) SHAKY (Shaking, Tremor) CHILLS (Chills, Chills) HEADACHE (Headache, Headache) FEVER (Fever, Pyrexia) NAUSEA (Nausea, Nausea) PAIN AT INJECTION SITE (Injection site pain, Injection site pain) This spontaneous report received from a consumer concerned a female of unspecified age. 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) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced fainting. On 11-MAR-2021, the patient experienced low blood pressure and pain at injection site. On 12-MAR-2021, the patient experienced vomiting, shaky, chills, headache, fever and nausea. It was reported that, the patient had bad reaction within few minutes after receiving the vaccine low blood pressure and fainting. Later, the patient was taken into stretcher, monitored vitals onsite and 45 minutes later, she drove home. The patient felt ok last night. At the time of this report, the patient was shaky, had chills, fever, nausea, vomiting, headache and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting, and low blood pressure on MAR-2021, was recovering from shaky, chills, nausea, and vomiting, had not recovered from headache, and pain at injection site, and the outcome of fever was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and fainting, low blood pressure, shaky, has chills, fever, nausea, vomiting, headache, injection site pain as related. Company causality between covid-19 vaccine ad26.cov2.s and fainting, low blood pressure, shaky, has chills, fever, nausea, vomiting, headache, injection site pain was possible. This report was serious (Other Medically Important Condition).
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Syncope, Tremor, Vomiting
Clinical narrative: FAINTING (Fainting, Syncope) LOW BLOOD PRESSURE (Low blood pressure, Hypotension) VOMITING (Vomiting, Vomiting) SHAKY (Shaking, Tremor) CHILLS (Chills, Chills) HEADACHE (Headache, Headache) FEVER (Fever, Pyrexia) NAUSEA (Nausea, Nausea) PAIN AT INJECTION SITE (Injection site pain, Injection site pain) This spontaneous report received from a consumer concerned a female of unspecified age. 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) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced fainting. On 11-MAR-2021, the patient experienced low blood pressure and pain at injection site. On 12-MAR-2021, the patient experienced vomiting, shaky, chills, headache, fever and nausea. It was reported that, the patient had bad reaction within few minutes after receiving the vaccine low blood pressure and fainting. Later, the patient was taken into stretcher, monitored vitals onsite and 45 minutes later, she drove home. The patient felt ok last night. At the time of this report, the patient was shaky, had chills, fever, nausea, vomiting, headache and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting, and low blood pressure on MAR-2021, was recovering from shaky, chills, nausea, and vomiting, had not recovered from headache, and pain at injection site, and the outcome of fever was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and fainting, low blood pressure, shaky, has chills, fever, nausea, vomiting, headache, injection site pain as related. Company causality between covid-19 vaccine ad26.cov2.s and fainting, low blood pressure, shaky, has chills, fever, nausea, vomiting, headache, injection site pain was possible. This report was serious (Other Medically Important Condition).
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Rash, Seizure
Clinical narrative: This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient is not on any medication and has no known drug allergy. The patient received COVID-19 vaccine AD26.COV2.2 (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021. No concomitant medications were reported. Patient got the Janssen COVID shot on March 9th Tuesday and then experienced headache started same day and Wednesday 10th March, took TYLENOL and headache recovered, then seizure on 11th Mar, went to the ER and spoke to the doctor on reporting day. Consumer also started patient experiencing rash and extreme pain on both arms and hands on reporting day 12th Mar and getting worse. On 09-MAR-2021, the subject experienced headache Treatment medications (dates unspecified) included: paracetamol. The action taken with COVID-19 vaccine AD26.COV2.S was not applicable. The patient recovered from seizure, and headache, and had not recovered from rash on arms and hands, and extreme pain in both hands and arms. This report was serious (Other Medically Important Condition).
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Gait disturbance, Hypertension
Clinical narrative: HIGH BLOOD PRESSURE (Blood pressure high, Hypertension) CHEST TIGHTNESS (Chest tightness, Chest discomfort) DIZZINESS (Dizziness, Dizziness) STAGGERING FROM WALKING (Staggering gait, Gait disturbance) This spontaneous report received from a patient concerned unspecified age female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, copd, thyroid problem, severe arthritis, non-alcoholic user, and non-smoker, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: not reported) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021 patient received covid-19 vaccine yesterday and she experienced high blood pressure (180/120 mmhg), her chest got tight, she was dizzy Laboratory data included: Blood pressure (NR: not provided) 180/120 mmHg. On 13-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 152/106 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high blood pressure, and the outcome of chest tightness, dizziness and staggering from walking was not reported. The reporter provided possible causality assessment. Company causality between JNJ78436735 (Ad26.COV2 .S) and high blood pressure, chest tightness, dizziness and staggering from walking was possible. This report was serious (Other Medically Important Condition).