chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Disability, Dyspnoea, Electrocardiogram, Feeling cold
Clinical narrative: paralyzed 13 hours later; daughter does not have full strength in her legs; left arm goes numb; has shortness of breath; always feels cold; chest pain; cannot feel hot or cold; She reports her daughter has to use braces and a wheelchair and is unable to work/she is aware of with this same type of reaction, including a girl in (withheld) and a guy in (withheld; This is a spontaneous report from a contactable consumer (patient's mother). A 33-years-old patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 14Apr2021 (33-years-old at the time of vaccination) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. After vaccination, the patient was paralyzed 13 hours later, she reports her daughter has to use braces and a wheelchair and is unable to work/she is aware of with this same type of reaction, including a girl in (withheld) and a guy in (withheld), daughter does not have full strength in her legs, left arm goes numb, cannot feel hot or cold, has shortness of breath, always feels cold, chest pain. She states her daughter has been in and out of the hospital and is still having issues 2 months after the Pfizer covid-19 vaccine injection. She reports a cardiologist saw "something" on an EKG and that her daughter has also seen a neurologist and several other doctors. On an unspecified date, the patient underwent lab tests and procedures which included electrocardiogram. The outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Paralysis, Thermohypoaesthesia
Clinical narrative: paralyzed 13 hours later; daughter does not have full strength in her legs; left arm goes numb; has shortness of breath; always feels cold; chest pain; cannot feel hot or cold; She reports her daughter has to use braces and a wheelchair and is unable to work/she is aware of with this same type of reaction, including a girl in (withheld) and a guy in (withheld; This is a spontaneous report from a contactable consumer (patient's mother). A 33-years-old patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 14Apr2021 (33-years-old at the time of vaccination) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. After vaccination, the patient was paralyzed 13 hours later, she reports her daughter has to use braces and a wheelchair and is unable to work/she is aware of with this same type of reaction, including a girl in (withheld) and a guy in (withheld), daughter does not have full strength in her legs, left arm goes numb, cannot feel hot or cold, has shortness of breath, always feels cold, chest pain. She states her daughter has been in and out of the hospital and is still having issues 2 months after the Pfizer covid-19 vaccine injection. She reports a cardiologist saw "something" on an EKG and that her daughter has also seen a neurologist and several other doctors. On an unspecified date, the patient underwent lab tests and procedures which included electrocardiogram. The outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Infected with Covid-19; Infected with Covid-19; This is a spontaneous report from a contactable consumer or other non hcp.   A 47-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 25Apr2021 09:15 (Batch/Lot Number: EW0176) as single dose, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04Apr2021 09:30 (Batch/Lot Number: ER8737) as single dose for COVID-19 immunisation.  Medical history included Testicular Cancer from 1999 to an unknown date. The patient's concomitant medications were not reported. The patient has no known allergies. The patient infected with Covid-19 on 07Jun2021 09:30. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Jun2021 Nasal Swab, sars-cov-2 test: positive on 12Jun2021 Nasal Swab. Event occurred in a country different from that of the reporter. No treatment was received for the adverse events. The patient was not diagnosed with Covid prior vaccination and has been tested via Nasal Swab for Covid post vaccination. The outcome of the events was not resolved.  Batch and lot number was obtained. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rheumatoid arthritis, Swelling
Clinical narrative: Rheumatoid arthritis that is going from bad to worst.; Swelling; Nausea; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as 1st dose, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on an unspecified date as 2nd dose, single both for covid-19 immunisation. The patient medical history included autoimmune disorder for which as treatment she received a shot of steroids and a prednisone packet, for a good time that kept the thing going but at times, she felt like she might not be able to walk, during the treatment but she was able to stand up and rheumatoid arthritis. The patient concomitant medications were not reported. On an unknown date, the patient experienced rheumatoid arthritis that was going from bad to worse, swelling and nausea. Reportedly, patient indicated to have swelling and nausea and stated that her symptoms reminded her of rheumatoid arthritis that was going from bad to worst. Patient stated that she would see her cardiologist and Primary care physician this month. She wants to be prescribed with Pfizer medications, she stated that she knows to much about Humira and Methotrexate as previous acquaintances. Patient also stated that when you get older you cannot hear anything. Patient wanted to know if Pfizer makes medications for inflammation and auto-immune diseases. The reporter assessed the case as non-serious. The outcome of all the events was unknown.  Information about batch/Lot number has been requested.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Confusional state, Dizziness, Gait disturbance, Pallor
Clinical narrative: thought she was having a stroke; Not able to walk on her own; almost fainted/about to passed out; Dizzy/felt very dizzy; Confused; Very pale; Vertigo; This is a spontaneous report from a contactable consumer (patient reported for herself). A 50-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0182, Expiration date: 02Jun2023, NDC number was unknown), via an unspecified route of administration, administered in left arm on 09Jun2021 as 1st dose, single for covid-19 immunisation. Patients had no medical history (including any illness at time of vaccination) and had no relevant family medical history. No concomitant medications were used by the patient. Patient had no prior vaccinations (within 4 weeks). Patient was going on vacation, so her daughters wanted her to get the vaccination. On an unspecified date of Jun2021, in the evening patient noticed she was dizzy. It got worse by an unspecified date of Jun2021. On unspecified date of Jun2021, patient's coworker sent her to the emergency room because they thought she was having a stroke and noticed that she was confused and very pale and about to passed out. Patient also called the nurse in charge and they also thought she was having a stroke because she was confused. Patient felt very dizzy. Patient was eating lunch and got up to get an apple and almost fainted. Patient was not hospitalized, she waited 7 hours in the emergency room and left without being seen. Patient stated it was a long wait, and a lot of people were waiting, and she asked before she left and there were still 10 people in front of her. On unspecified date of Jun2021 in morning, patient noticed that she was not able to walk on her own and she was still dizzy. On an unspecified date of Jun2021, patient went to see one of the doctors at the clinic. Doctor could not see her, but a nurse practitioner saw her and prescribed her something for vertigo. Patient stated that she was confused lately. Patient had emergency room visit and no physician office visit. No relevant tests were performed. The outcome of all the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Vertigo
Clinical narrative: thought she was having a stroke; Not able to walk on her own; almost fainted/about to passed out; Dizzy/felt very dizzy; Confused; Very pale; Vertigo; This is a spontaneous report from a contactable consumer (patient reported for herself). A 50-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0182, Expiration date: 02Jun2023, NDC number was unknown), via an unspecified route of administration, administered in left arm on 09Jun2021 as 1st dose, single for covid-19 immunisation. Patients had no medical history (including any illness at time of vaccination) and had no relevant family medical history. No concomitant medications were used by the patient. Patient had no prior vaccinations (within 4 weeks). Patient was going on vacation, so her daughters wanted her to get the vaccination. On an unspecified date of Jun2021, in the evening patient noticed she was dizzy. It got worse by an unspecified date of Jun2021. On unspecified date of Jun2021, patient's coworker sent her to the emergency room because they thought she was having a stroke and noticed that she was confused and very pale and about to passed out. Patient also called the nurse in charge and they also thought she was having a stroke because she was confused. Patient felt very dizzy. Patient was eating lunch and got up to get an apple and almost fainted. Patient was not hospitalized, she waited 7 hours in the emergency room and left without being seen. Patient stated it was a long wait, and a lot of people were waiting, and she asked before she left and there were still 10 people in front of her. On unspecified date of Jun2021 in morning, patient noticed that she was not able to walk on her own and she was still dizzy. On an unspecified date of Jun2021, patient went to see one of the doctors at the clinic. Doctor could not see her, but a nurse practitioner saw her and prescribed her something for vertigo. Patient stated that she was confused lately. Patient had emergency room visit and no physician office visit. No relevant tests were performed. The outcome of all the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received Pfizer Covid vaccine 2nd dose on 13Apr2021 diagnosed positive COVID-19 on 15Jun2021; Received Pfizer Covid vaccine 2nd dose on 13Apr2021 diagnosed positive COVID-19 on 15Jun2021; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: EP6955) via an unspecified route of administration on 13Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for covid-19 immunisation. The patient received Pfizer Covid vaccine 2nd dose on 13Apr2021 diagnosed positive COVID-19 on 15Jun2021. On15Jun2021, patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: His dad took the shot and died 3 days later, mucked up his arteries, his heart; This is a spontaneous report from a contactable consumer (patient son).  A 64-year-old male patient received second dose of BNT162B2 on 15May2021 (at age of 64-year-old) at single dose for COVID-19 immunization. Medical history included Heart Condition (around 1997-1999), High Blood Pressure (all about the same time), Aneurysm (about 2017, 2015-2017 area. He wants to say 2015, because he was there when he found out about them) and open heart surgery (about 1997, 1995, somewhere around there). Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 05Apr2021 (at age of 64-year-old) for COVID-19 immunization. Family Medical History Relevant to AE(s): Caller states not that he knows of. All he knows from the emergency technician is that it looked like he went back to his car and his dog was in the car and he dropped dead. According to you guy's thing, it says muscle cramps, muscle pains and chest pains are all side effects of this and he does believe that the vaccine contributed to the chest pain which contributed to the heart attack that exploded his heart. He states his dad took the shot and died 3 days later (18May2021, also reported as died on Memorial day weekend. He died on Sunday). Caller stated the coroner's has already stated that he died by the coronavirus shot and mucked up his arteries, his heart. It is pretty sad. He was doing something he enjoyed, watching the races, gets up takes two steps, falls dead in his tracks. Vaccination Facility Type was hospital. He does not know Additional Vaccines Administered on Same Date of the Pfizer Suspect, but he highly doubts it. Events not require a visit to Emergency Room or Physician Office.   Information about lot/batch number is requested.; Reported Cause(s) of Death: His dad took the shot and died 3 days later, mucked up his arteries, his heart: Death
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died 3-5 days after getting the Pfizer COVID vaccine; This is a spontaneous report from a contactable consumer. An elderly female patient received bnt162b2 (Pfizer COVID vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated that her aunt, who was going to be 100 years old, died 3-5 days after getting the Pfizer COVID vaccine. Consumer stated that they were healthy people. She stated that she is a transfusion medical specialist. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on lot/batch number has been requested.; Reported Cause(s) of Death: Died 3-5 days after getting the Pfizer COVID vaccine
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Eating disorder, Restlessness, Sleep disorder
Clinical narrative: appetite not there; Cough worsened; can't sleep at night; she cannot even eat; Because of cough she can't rest; This is a spontaneous report received from a contactable other hcp (patient). A 52-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/Lot Number: EL9262) via an unspecified route of administration on 21Jan2021 (Age at the vaccination 52-year-old) as single dose for COVID-19 immunization. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot: EN6201) on 11Feb2021 as single dose for COVID-19 immunization. Medical history included sleeping problem. Concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced appetite not there, cough worsened, can't sleep at night, she cannot even eat and because of cough she can't rest. Caller states she got the Pfizer vaccine in January and she had been coughing ever since, it had been terribly worse. The doctor got her started on Tessalon Perles. Caller wanted to find out what she can do because she was so desperate because she can't sleep at night from coughing so much. Cough started a few months ago, in January, after the vaccine. It waked her up at night. She stated cough was almost disabling because she cannot even eat. It gets in the way of her eating. She cannot eat anything but sip coffee. She only had a small cup of coffee a day. When the caller was asked about details on the event, can't eat, caller states she does eat, but her appetite was not there. Caller clarified she was just started on Tessalon Perles to help with cough. Caller states the medication was not contributing to the cough. She started that it so it could help with the cough. Caller states she already had sleeping problem, but she was sleeping with her medication. Because of cough she can't rest or sleep. Therapeutic measures were taken as a result of cough worsened and can't sleep at night. The outcome of events was not recovered. The outcome of the events she cannot even eat and Because of cough she can't rest was unknown.  The event relatedness was reported as related for can't sleep at night and appetite not there.; Sender's Comments: Based on the information provided in the narrative, the causal association between the suspect drug and the 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Pyrexia
Clinical narrative: Caller states he has now tested positive for COVID-19 and he has had symptoms for a couple days; Caller states he has now tested positive for COVID-19 and he has had symptoms for a couple days; Caller states he has a progressively increasing temperature everyday he had a temperature of 104 yesterday; This is a spontaneous report from a contactable consumer (patient). A male patient of 67-year-old received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiry date was not reported), dose 2 via an unspecified route of administration on an unspecified date (at the age of 66-year-old) as 2ND DOSE, SINGLE; and then dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, that he participated in a clinical trial for Pfizer COVID vaccine. He originally received two placebos and then received two doses of the actual vaccine. States he has now tested positive for COVID-19 and he has had symptoms for a couple days. He would like to know if there is a specific test, he could take to see if he received the actual Pfizer COVID vaccine? He states he has a progressively increasing temperature everyday he had a temperature of 104 yesterday and his doctor advised him to take Tylenol, Ibuprofen and to stay hydrated. He had no side effects after receiving the vaccine and he had more side effects after receiving the placebos. Outcome of event for Covid-19 was recovered and for the other events it was unknown.  Information about lot or batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Headache, Incorrect dose administered, Overdose, Pain in extremity
Clinical narrative: They made a mistake giving my doses and they gave me more dose than I was supposed to get; not gave me the right dose; They made a mistake giving my doses and they gave me more dose than I was supposed to get; not gave me the right dose; dull burning sensation in her chest and congestion.; sore injection arm; dull burning sensation in her chest and congestion.; I had headache yesterday after getting the vaccine and then I woke up to headache today; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0183), via an unspecified route of administration on 18Jun2021 at 09:00 (at the age of 33-years-old) as 2nd dose, single for covid-19 immunization. The patient medical history was none. The patient did not take any concomitant products. The patient did not receive any prior vaccination. The patient received first dose of BNT162B2 for COVID-19 immunization on unspecified date. On 18Jun2021, the patient experienced that patient reported that she received her second Pfizer Covid vaccine dose yesterday 18Jun2021 and was given more than the recommended dose. After her second dose on 18Jun2021 she also reported a sore injection arm that same night reported a dull burning sensation in her chest and congestion. She further stated that that they made a mistake and that was just giving my doses yesterday, they gave me way more than what I was supposed to get. They told her to monitor her symptom from the day because she never heard anyone stated have like burning sensation (in chest), she knew that was caused from not giving the right dose. The patient further added that first dose just a sore arm but after the dosage yesterday (second dose) she had a very sore arm than the first. She had headache yesterday after getting the vaccine and then she woke up to headache the next day. Upon follow up (19Jun2021) lot number added, and event headache was added. The patient did not receive any treatment for the events. The clinical outcome for the events was unknown while outcome for headache was not recovered.  Follow-up(19Jun2021): This is a follow-up spontaneous report from a contactable consumer. Added new information regarding Other Products: No, Patient History: No, Investigation Assessment: No, when probed for second shot vaccine LOT#, consumer stated, "LOT#EW018 then may be 3." Any Prior Vaccination: No, added new event, I had headache yesterday after getting the vaccine and then I woke up to headache today." When probed for any treatment for the problems (events), consumer stated, "No."  Information on Lot/Batch number was available. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary congestion
Clinical narrative: They made a mistake giving my doses and they gave me more dose than I was supposed to get; not gave me the right dose; They made a mistake giving my doses and they gave me more dose than I was supposed to get; not gave me the right dose; dull burning sensation in her chest and congestion.; sore injection arm; dull burning sensation in her chest and congestion.; I had headache yesterday after getting the vaccine and then I woke up to headache today; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0183), via an unspecified route of administration on 18Jun2021 at 09:00 (at the age of 33-years-old) as 2nd dose, single for covid-19 immunization. The patient medical history was none. The patient did not take any concomitant products. The patient did not receive any prior vaccination. The patient received first dose of BNT162B2 for COVID-19 immunization on unspecified date. On 18Jun2021, the patient experienced that patient reported that she received her second Pfizer Covid vaccine dose yesterday 18Jun2021 and was given more than the recommended dose. After her second dose on 18Jun2021 she also reported a sore injection arm that same night reported a dull burning sensation in her chest and congestion. She further stated that that they made a mistake and that was just giving my doses yesterday, they gave me way more than what I was supposed to get. They told her to monitor her symptom from the day because she never heard anyone stated have like burning sensation (in chest), she knew that was caused from not giving the right dose. The patient further added that first dose just a sore arm but after the dosage yesterday (second dose) she had a very sore arm than the first. She had headache yesterday after getting the vaccine and then she woke up to headache the next day. Upon follow up (19Jun2021) lot number added, and event headache was added. The patient did not receive any treatment for the events. The clinical outcome for the events was unknown while outcome for headache was not recovered.  Follow-up(19Jun2021): This is a follow-up spontaneous report from a contactable consumer. Added new information regarding Other Products: No, Patient History: No, Investigation Assessment: No, when probed for second shot vaccine LOT#, consumer stated, "LOT#EW018 then may be 3." Any Prior Vaccination: No, added new event, I had headache yesterday after getting the vaccine and then I woke up to headache today." When probed for any treatment for the problems (events), consumer stated, "No."  Information on Lot/Batch number was available. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: They made a mistake giving my doses and they gave me more dose than I was supposed to get; not gave me the right dose; They made a mistake giving my doses and they gave me more dose than I was supposed to get; not gave me the right dose; dull burning sensation in her chest and congestion.; sore injection arm; dull burning sensation in her chest and congestion.; I had headache yesterday after getting the vaccine and then I woke up to headache today; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0183), via an unspecified route of administration on 18Jun2021 at 09:00 (at the age of 33-years-old) as 2nd dose, single for covid-19 immunization. The patient medical history was none. The patient did not take any concomitant products. The patient did not receive any prior vaccination. The patient received first dose of BNT162B2 for COVID-19 immunization on unspecified date. On 18Jun2021, the patient experienced that patient reported that she received her second Pfizer Covid vaccine dose yesterday 18Jun2021 and was given more than the recommended dose. After her second dose on 18Jun2021 she also reported a sore injection arm that same night reported a dull burning sensation in her chest and congestion. She further stated that that they made a mistake and that was just giving my doses yesterday, they gave me way more than what I was supposed to get. They told her to monitor her symptom from the day because she never heard anyone stated have like burning sensation (in chest), she knew that was caused from not giving the right dose. The patient further added that first dose just a sore arm but after the dosage yesterday (second dose) she had a very sore arm than the first. She had headache yesterday after getting the vaccine and then she woke up to headache the next day. Upon follow up (19Jun2021) lot number added, and event headache was added. The patient did not receive any treatment for the events. The clinical outcome for the events was unknown while outcome for headache was not recovered.  Follow-up(19Jun2021): This is a follow-up spontaneous report from a contactable consumer. Added new information regarding Other Products: No, Patient History: No, Investigation Assessment: No, when probed for second shot vaccine LOT#, consumer stated, "LOT#EW018 then may be 3." Any Prior Vaccination: No, added new event, I had headache yesterday after getting the vaccine and then I woke up to headache today." When probed for any treatment for the problems (events), consumer stated, "No."  Information on Lot/Batch number was available. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Rheumatoid arthritis
Clinical narrative: Following the first shot of the Pfizer COVID-19 vaccine, I began to experience painful joint pain throughout my entire body. I asked my doctor about the joint pain and was advised that the vaccine sometimes will cause the body to go a little haywire after getting the vaccine but will likely go away shortly. I received the second dose while still experiencing extreme joint pain. It has been approximately three months now and I am still experiencing extreme joint pain. I was healthy before and had confirmed COVID-19 in November of 2020. I recovered from Covid-19 with no residual issues amd now have an advanced stage of Rheumatoid Arthritis following the two doses of COVID-19 Pfizer vaccines.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Myocarditis, Troponin increased
Clinical narrative: Dyspnea Myocarditis, transferred to hospital for further management
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Disturbance in attention, Fatigue, Feeling abnormal, Flushing
Clinical narrative: I received my first covid vaccine 03/18/2021 Lot #047A21A. After that vaccine I had headaches and a flushed face and was very tired. I an not a headache person so this is new to me. This continues. I received my second covid vaccine 04/19/2021. Since that vaccine, I have had continued headaches, am tired and have had brain fog.  Trouble concentrating and focusing.  I even had to see a neurologist.  These symptoms continue as well. I was just diagnosed with a DVT 06/23/2021. This all is new to me and I believe are all related to my covid vaccines.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Laboratory test, Ultrasound scan abnormal
Clinical narrative: I received my first covid vaccine 03/18/2021 Lot #047A21A. After that vaccine I had headaches and a flushed face and was very tired. I an not a headache person so this is new to me. This continues. I received my second covid vaccine 04/19/2021. Since that vaccine, I have had continued headaches, am tired and have had brain fog.  Trouble concentrating and focusing.  I even had to see a neurologist.  These symptoms continue as well. I was just diagnosed with a DVT 06/23/2021. This all is new to me and I believe are all related to my covid vaccines.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiomegaly, Chest X-ray, Dyspnoea, Echocardiogram, Immune system disorder
Clinical narrative: Enlarged Heart , Hives,  shortness of breath,  immune system compromised
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Enlarged Heart , Hives,  shortness of breath,  immune system compromised
Sex: M
Vaccine: VARCEL
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: missed dose; No additional adverse events reported. No; This spontaneous report was received from a physician, referring to a 17-year-old male patient. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.     On an unknown date in June of 2003, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose details, strength, route, lot# and expiration date were not provided) for prophylaxis. patient did not receive second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (product dose omission issue). No additional adverse events reported.
Sex: U
Vaccine: VARZOS
Symptoms: Immobile
Clinical narrative: they were immobile from around 5 pm to 12 am; This case was reported by a consumer via other manufacturer and described the occurrence of immobile in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced immobile (serious criteria GSK medically significant). On an unknown date, the outcome of the immobile was unknown.   It was unknown if the reporter considered the immobile to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient was immobile from around 5 pm to 12 am. This case had been linked with case US2021AMR134286, as reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR134286:Same reporter
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received a 2nd dose of Menveo on 16th June 2021/1st dose in 2016; Received a 2nd shot of Menveo but they only administered the liquid portion; Received a 2nd shot of Menveo but they only administered the liquid portion; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA568A, expiry date May 2022) for prophylaxis.   Previously administered products included Menveo (1st vaccination occurred on 2016).   On 16th June 2021, the patient received the 2nd dose of Menveo. On 16th June 2021, unknown after receiving Menveo, the patient experienced extra dose administered, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the extra dose administered, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: All patients identifiers were reported as well as batch Number and expiration Date, expiry date was reported as May of 2022. The patient had received 2nd shot of Menveo but they had only administered the liquid portion, which led to extra dose administered, inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Its been over a year since the first vaccine; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date a year ago prior to reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patients did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The Health care professional reported that patients had received 1st dose of Shingrix more than a year ago. The health care professional inquired that if they can restart the Shingrix series. No further details were provided. The reporter consented to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: Powder component was reconstituted with sterile water; Powder component was reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-month-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA417A, expiry date 30th September 2021) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at the vaccination was not reported. No patient initials provided. The nurse reported that a patient was administrated with Menveo and powder component was reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.  No vaccination date provided. No adverse event was reported. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was administrated with a 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number GL79C, expiry date 13th November 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received on an unknown date) and Shingrix (2nd dose of Shingrix received on an unknown date).   On 16th June 2021, the patient received the 3rd dose of Shingrix. On 16th June 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient received with a 3rd dose of Shingrix , which led to extra dose administered. No adverse event was reported. The reported batch number gl796 was not found in sales data sheet, hence was updated to GL79C. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. No concomitant medications were reported. On an unspecified date, the subject experienced covid-19 test positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Influenza, Oxygen saturation, Pneumonia
Clinical narrative: Had covid; Pneumonia; having pain it feel like a razor blade sticking through his back; Feels like he has the flu; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) and COVID-19 (Had covid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced COVID-19 (Had covid) (seriousness criterion hospitalization). On 12-Apr-2021, the patient experienced INFLUENZA (Feels like he has the flu). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant) and BACK PAIN (having pain it feel like a razor blade sticking through his back). The patient was hospitalized on 12-Mar-2021 due to COVID-19, and then on 12-Apr-2021 due to PNEUMONIA. The patient was treated with IBUPROFEN for Flu, at a dose of 1600 mg once a day. At the time of the report, PNEUMONIA (Pneumonia), COVID-19 (Had covid), INFLUENZA (Feels like he has the flu) and BACK PAIN (having pain it feel like a razor blade sticking through his back) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Oxygen saturation: 75 % (Low) 75%.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. Patient stated that he was treated with oxygen support during hospitalization.  On 12-Mar2021, patient had covid and was in hospital on oxygen. Patient was released and went back in the hospital for 4 days with covid an pneumonia. Patient went back to hospital on 12-Apr-2021 and was put on oxygen and was told his oxygen level was 75 percent. Patient stated since 12-Apr-2021.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Impaired driving ability, Visual field defect
Clinical narrative: Lost peripheral vision and can not drive anymore; Lost peripheral vision and can not drive anymore; Stroke; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure (Controlled).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). On an unknown date, the patient experienced IMPAIRED DRIVING ABILITY (Lost peripheral vision and can not drive anymore) and VISUAL FIELD DEFECT (Lost peripheral vision and can not drive anymore). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) had not resolved and IMPAIRED DRIVING ABILITY (Lost peripheral vision and can not drive anymore) and VISUAL FIELD DEFECT (Lost peripheral vision and can not drive anymore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided. Patient had about 8 strokes from the date of administration of the vaccine. Patient was yet to take the second dose. Company Comment: Very limited information regarding these events has been provided at this time. No follow up is possible.   This case was linked to MOD-2021-219228 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Deafness, Pyrexia, Tinnitus
Clinical narrative: Minor hearing loss; Ringing in his left ear (tinnitus); Fever ranging from 104.2 to 105.2 degrees F; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (Minor hearing loss) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced DEAFNESS (Minor hearing loss) (seriousness criterion medically significant), TINNITUS (Ringing in his left ear (tinnitus)) and PYREXIA (Fever ranging from 104.2 to 105.2 degrees F). The patient was treated with PARACETAMOL (TYLENOL) on 23-Apr-2021 for Fever, at a dose of 1 dosage form and PREDNISONE for Tinnitus and Hearing loss, at a dose of UNK dosage form. At the time of the report, DEAFNESS (Minor hearing loss) had not resolved, TINNITUS (Ringing in his left ear (tinnitus)) outcome was unknown and PYREXIA (Fever ranging from 104.2 to 105.2 degrees F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Body temperature: 104.7 (High) 104.7 degree Fahrenheit at 06:00 AM and 105.2 (High) 105.2 degree Fahrenheit at 2-3 PM. On 24-Apr-2021, Body temperature: 104.2 (High) 104.2 degree Fahrenheit at 03:00 AM.         Concomitant product use was not provided. Patient saw ear, nose and throat (ENT) specialist who advised him prednisone for four weeks and steroid drops for 2 weeks but the hearing did not come back, so patient stopped using medications. Patient had 3 different hearing test over few weeks.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-220405 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine was expired with no adverse event; Initial information was received on 17-Jun-2021 regarding an unsolicited valid non-serious case from a other health professional (Inquiry number: 00647078).  It was reported that an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (Suspension For Injection) was administered to a patient (age and gender not reported), on an unknown date for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.