chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Chills, Feeding disorder, Illness, Myalgia
Clinical narrative: Couldn't eat while was sick; Slept all day; sick; Heavy duty arm pain and couldn't lift his arm over his ears; Shivering/chills; Muscle aches; Nausea; This is a spontaneous report from a contactable consumer. This consumer reported for a patient. A 69-year-old male patient (age at vaccination: 69 year) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0172 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 10Jun2021 at 12:30, as a single dose for COVID-19 immunization. The patient's medical history included blood pressure, cholesterol, ongoing pulmonary issues, he had Covid, and residual problems. Concomitant medications were not reported. historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0172 and expiry date was not reported), via an unspecified route of administration, on 21May2021, as a single dose for COVID-19 immunization. The patient took Covid-19 Vaccine because he had a 98-year-old father and would like to see him. The patient had chills, shivering, muscle aches, nausea on 10Jun2021, and he slept all day on 11Jun2021. Saturday night he started to feel better. He was laid up from Thursday night until Saturday. He was in bed for almost 20 hours shivering. He was feeling better. He had Covid antibodies too. He needed to see people, and in order to see people he would only be embraced if he was vaccinated so he got the vaccine in order to be social. He was in bed freezing and sleeping. He had pretty heavy-duty arm pain and couldn't lift his arm over his ears. He started to complain of arm pain probably within 2 hours of the injection, and as more time passed the worse it got. At first it was like his arm was killing him, then he could barely lift his arm. By Thursday night he was shivering. In Arizona it was in the triple digits. He had 2 blankets, a comforter, and a sheet under than on him and he was shivering to the point where she had to lay on him to keep him warm. That lasted all night long and was just miserable. Then he got up for 5 or 10 minutes on Friday, then he was in bed the entire day until Saturday. It was unbelievable. They were so busy being sick they couldn't help each other. He looked pretty good by Saturday mid-morning at like 11:00 or so. The patient couldn't eat while was sick. On Saturday he made a cup of tea, toast, and an English muffin. He was definitely feeling better Saturday morning, and by Saturday afternoon he was pretty much himself. He was under a pulmonologist's care. He was seen by infection disease initially then he was put under the pulmonologist's care. He had X-rays to see how his lungs were doing, and they worked in conjugation with his primary physician. Outcome of the events was recovering.  Follow up attempts are possible further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Somnolence, X-ray
Clinical narrative: Couldn't eat while was sick; Slept all day; sick; Heavy duty arm pain and couldn't lift his arm over his ears; Shivering/chills; Muscle aches; Nausea; This is a spontaneous report from a contactable consumer. This consumer reported for a patient. A 69-year-old male patient (age at vaccination: 69 year) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0172 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 10Jun2021 at 12:30, as a single dose for COVID-19 immunization. The patient's medical history included blood pressure, cholesterol, ongoing pulmonary issues, he had Covid, and residual problems. Concomitant medications were not reported. historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0172 and expiry date was not reported), via an unspecified route of administration, on 21May2021, as a single dose for COVID-19 immunization. The patient took Covid-19 Vaccine because he had a 98-year-old father and would like to see him. The patient had chills, shivering, muscle aches, nausea on 10Jun2021, and he slept all day on 11Jun2021. Saturday night he started to feel better. He was laid up from Thursday night until Saturday. He was in bed for almost 20 hours shivering. He was feeling better. He had Covid antibodies too. He needed to see people, and in order to see people he would only be embraced if he was vaccinated so he got the vaccine in order to be social. He was in bed freezing and sleeping. He had pretty heavy-duty arm pain and couldn't lift his arm over his ears. He started to complain of arm pain probably within 2 hours of the injection, and as more time passed the worse it got. At first it was like his arm was killing him, then he could barely lift his arm. By Thursday night he was shivering. In Arizona it was in the triple digits. He had 2 blankets, a comforter, and a sheet under than on him and he was shivering to the point where she had to lay on him to keep him warm. That lasted all night long and was just miserable. Then he got up for 5 or 10 minutes on Friday, then he was in bed the entire day until Saturday. It was unbelievable. They were so busy being sick they couldn't help each other. He looked pretty good by Saturday mid-morning at like 11:00 or so. The patient couldn't eat while was sick. On Saturday he made a cup of tea, toast, and an English muffin. He was definitely feeling better Saturday morning, and by Saturday afternoon he was pretty much himself. He was under a pulmonologist's care. He was seen by infection disease initially then he was put under the pulmonologist's care. He had X-rays to see how his lungs were doing, and they worked in conjugation with his primary physician. Outcome of the events was recovering.  Follow up attempts are possible further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A little soreness on my left arm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: ER8727), via an unspecified route of administration, in arm left on 24Mar2021, as single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a little soreness on left arm. The outcome of the event was unknown.  The second dose was taken on 14Apr2021 PFIZER EW0151. Information on lot/batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: supposed to have his second dose on 06May2021 but he missed it; This is a spontaneous report from a contactable consumer or other non hcp Pfizer-sponsored program COVAX US Support. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown, expiration date not reported) via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced supposed to have his second dose, but he missed it on 06May2021. Outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Having itchy armpits 3 days after her first dose; Had a bit of a sore arm after her first dose; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced having itchy armpits 3 days after her first dose, had a bit of a sore arm after her first dose. Patient wanted to know if she should get her second dose of covid-19 vaccine. The outcome of events was unknown.  Information about batch/lot number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: I was sleepy for three days; This is a spontaneous report from a contactable Nurse (reported for herself). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0179), first dose via an unspecified route of administration, administered in left arm on 21May2021 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. Medical history included hepatic cirrhosis ("Liver cirrhosis"), mental disorder ("Psychiatric issues"), impaired gastric emptying ("Gastroparesis") all from an unknown date and unknown if ongoing. No investigation assessment was reported. The patient's concomitant medications were not reported. It was reported that the nurse stated, so the first dose it was just she was sleepy since an unspecified date in May2021 for three days, she did not feel so hard horrible. Nurse stated causality between event and suspect vaccine as "oh definitely".On an unspecified date in 2021, the outcome of the event was reported as recovered.  Information on Lot/Batch number is available; Further information has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Illness
Clinical narrative: was in bed for 2 weeks. She could hardly move around; Since taking first vaccine, was ill for several weeks; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 09:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus (had for about 6 years), hypertension from Apr2021 and ongoing, ongoing depression (had since teenager), nephrectomy from 06Jul2020 to an unknown date, ongoing blood cholesterol, ongoing hypersensitivity. Concomitant medication(s) included montelukast sodium (SINGULAIR) taken for hypersensitivity from an unspecified start date and ongoing; pravastatin (PRAVASTATIN) taken for blood cholesterol from an unspecified start date and ongoing; venlafaxine hydrochloride (EFFEXOR) taken for depression from an unspecified start date and ongoing; losartan potassium (COZAAR) taken for hypertension from Mar2021 and ongoing. Caller reported that she got the first shot at 9:30 in the morning at work. She had an appointment at 14:00 with the diabetes specialist. It was about a 20 minutes drive. Caller said that about 10 minutes into the appointment, she had to cut the appointment short and call her son to come get her. She was in bed for 2 weeks. She could hardly move around. Then for the last week before the second shot, she was better but it persisted. It was reported that since taking first vaccine, was ill for several weeks (29Mar2021). She was scared to get the second shot. She had seen her doctor. Treatment was received for the event since taking first vaccine, was ill for several weeks (illness) was to drink plenty of liquids and rest. Outcome of the events were reported as unknown.  Information regarding the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Gastroenteritis viral, Headache, Somnolence
Clinical narrative: After second shot, could not get her blood sugars below 400; headache; had a stomach virus; sleepy; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old female patient received BNT162B2 (BNT162B2, PFIZER-BIOECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 19Apr2021 09:30 (age at vaccination: 60-year-old) as second dose, single for covid-19 immunization. Medical history included ongoing type 2 Diabetes (she had it for about 6 years) and high blood pressure from Apr2021 and ongoing, ongoing depression (she had it since she was a teenager), kidney removed from 06Jul2020 to an unknown date, ongoing blood cholesterol, and ongoing bad allergies. Historical vaccine included BNT162B2 on 29Mar2021 (at the age of 60 years, Dose: 1, Time: 09:30, anatomical location: left arm) for covid-19 immunization. Concomitant medication included montelukast sodium (SINGULAIR); pravastatin; venlafaxine hydrochloride (EFFEXOR) at 150 mg taken for depression, start and stop date were not reported; losartan potassium (COZAAR) at 100 mg taken for high blood pressure from Mar2021 to an unspecified stop date. it was reported that After the second shot, she was feeling wonderful, but since then she can not get her sugars below 400. On 14Jun2021 morning she drank. She had breakfast like she was supposed to. She drank tea. She put 1/4 cup sugar per gallon in the tea. Her blood sugar was 311. she stated that she had seen the diabetic doctor regularly. She talked to lots of friends who are diabetic and other people who couldn't get their sugars down, she contacted friends and on looked on social media and they were having the same problem. she stated that she felt like a guinea pig. she went to the doctor after about 2 days. She did not know the dated. She told the doctor that she was dying. The doctor told her that her body was responding to the vaccine. She was sent home. She was told to drink plenty of liquids and rest. she stated that she did not have any treatment for her high sugars. She was watching what she ate. She added that she thought she had a stomach virus. She drank tea. She got sleepy. She had a headache. Her blood sugar was 311 this morning. she stated that her blood sugars were over 300 about 2 weeks after getting the second shot. She complained to her doctor and her diabetes doctor about the sugars. They wanted to put her on medications she could not take. This had never done this before. She cannot get her blood sugars down. It happened since she took the vaccine. She said her friends cannot get blood sugars below 300. The patient underwent lab tests and procedures which included blood sugar: 311 on 14Jun2021. The outcome for the event After second shot, could not get her blood sugars below 400 was reported as not resolved and for remaining events was unknown.  Information about batch/Lot number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Malaise
Clinical narrative: he just felt like crap; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received second Dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 29Aug2020 (age at vaccination 70-year-old) as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) on 08Aug2020 (age at vaccination 70-year-old) via an unspecified route of administration at single dose for COVID-19 Immunization. It has been 290 days since he got the second dose of the vaccine and he has just tested negative for antibodies and he had the same test 6 months ago at the doctor and tested positive for antibodies. Caller was calling about the COVID vaccine. He said he was a trial participant, and it has been 290 days since he got the vaccine, he clarified since he got the second dose, he said he was 10 months out and he has just tested negative for antibodies. He only knew his first vaccine was on 08Aug2020 and the second one was on 29Aug2020 and they notified him when they broke the blind that he did get the vaccine which he already knew then because he got sick. He clarifies he did not get sick, he just felt like crap. There was no medications medical conditions or lab results, it was all the same medications as it was when he had the initial blood test 6 months ago when he was positive for the antibodies. No further information provided. The patient underwent lab tests and procedures which included Antibody test which showed positive test 6 months ago and negative after 290 days since he got the second dose of the vaccine. The outcome of event was unknown.  Information about lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Hyperhidrosis, Pain
Clinical narrative: Chills; Sweat; she could not move without hurting; She could not get out of bed her body felt like it was weighted like it had 100 pounds weight on it; She had fever ; fever of 102 and it last for three day; This is a spontaneous report from a contactable other hcp (patient). A 55-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection) via an unspecified route of administration, administered in right arm on 11Jun2021 (at the age of 55-year-old) (Lot Number: EW0180) as 2nd dose, single dose for covid-19 immunization. Medical history included liver cirrhosis, psychiatric issues and gastroparesis. The patient's concomitant medications were not reported. The patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), administered in left arm dose 1, single dose via an unspecified route of administration on 21May2021 (Batch/Lot Number: EW0179) for covid-19 immunisation and she felt sleepy for three days. On an unspecified date, the patient experienced chills and sweat. On 12Jun2021, she could not move without hurting, could not get out of bed her body felt like it was weighted like it had 100 pounds weight on it and fever of 102 and it last for three day. Patient stated, events did not worsen, no it get slightly better. Patient stated, as far as Pfizer concern or whomever are there any blood works that she should get or have taken to see if I have reaction?. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit, last for three day on an unspecified date. Therapeutic measures were taken as a result of she could not move without hurting with Tylenol. The outcome of events was unknown. Causality reported as pee reporter was reported as definitely.  Information on Lot/Batch number was available. Additional information has been requested
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills; Sweat; she could not move without hurting; She could not get out of bed her body felt like it was weighted like it had 100 pounds weight on it; She had fever ; fever of 102 and it last for three day; This is a spontaneous report from a contactable other hcp (patient). A 55-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection) via an unspecified route of administration, administered in right arm on 11Jun2021 (at the age of 55-year-old) (Lot Number: EW0180) as 2nd dose, single dose for covid-19 immunization. Medical history included liver cirrhosis, psychiatric issues and gastroparesis. The patient's concomitant medications were not reported. The patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), administered in left arm dose 1, single dose via an unspecified route of administration on 21May2021 (Batch/Lot Number: EW0179) for covid-19 immunisation and she felt sleepy for three days. On an unspecified date, the patient experienced chills and sweat. On 12Jun2021, she could not move without hurting, could not get out of bed her body felt like it was weighted like it had 100 pounds weight on it and fever of 102 and it last for three day. Patient stated, events did not worsen, no it get slightly better. Patient stated, as far as Pfizer concern or whomever are there any blood works that she should get or have taken to see if I have reaction?. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit, last for three day on an unspecified date. Therapeutic measures were taken as a result of she could not move without hurting with Tylenol. The outcome of events was unknown. Causality reported as pee reporter was reported as definitely.  Information on Lot/Batch number was available. Additional information has been requested
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Memory impairment
Clinical narrative: memory has been affected; memory loss; This is a spontaneous report from a contactable consumer (patient) reported for himself via a Pfizer-sponsored program COVAX US Support. A 64-year-old male patient received BNT162B2 (Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on 07Apr2021 as single dose and dose 2 via an unspecified route of administration on 28Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient memory has been affected and had memory loss. The patient stated he received the first dose of the vaccine on 07Apr2021 and the second dose on 28Apr2021. He has noticed since then his memory has been affected every single day. He had gone to a neurologist who has scheduled an MRI and EEG. He was unsure if his memory loss was related to the vaccine or related to his work with acrylic paint. He was asking for Pfizer's recommendation regarding memory loss. The outcome of the events was unknown.  Information about batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Illness
Clinical narrative: Terribly ill since the second vaccine; Her heart; This is a spontaneous report from a contactable consumer. A 17-year-old female patient received (BNT162B2, formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND Dose, SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2, formulation: Solution for injection) for COVID-19 Immunization. The patient experienced terribly ill since the second vaccine and her heart on an unspecified date. The outcome of the events were unknown.  Information on lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Fatigue, Illness, Somnolence
Clinical narrative: Have been very sick ever since; Extreme tiredness; coughing; Could not stay awake; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program. A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 27May2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. It was reported that, patient have been very sick ever since on an unspecified date in 2021. On an unspecified date in 2021, the patient experienced extreme tiredness, coughing and could not stay awake which are the major side effects. Went to two different doctors already and had major testing. Patient was now scheduled to see an infectious doctor. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Disturbance in attention, Dizziness
Clinical narrative: Still feeling dizzy; Dizzy; Not able to concentrate on his work; Weakness; This is a spontaneous report from a contactable consumer (patient himself). A 29-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), intramuscularly in right arm on 01Jun2021 (at the age of 29-year-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), intramuscularly in right arm on 12May2021 (at the age of 29-year-old) as a single dose for COVID-19 immunization and had fever. The patient did not receive any other vaccines 4 weeks prior to COVID-19 vaccination. It was reported that, patient stated, he had his second dose of COVID Vaccine like 12 days ago. So he was still feeling dizzy on an unspecified date in 2021, and he was not able to concentrate on his work on an unspecified date in 2021. So he just wanted to know how long it would last. Patient stated that he experienced side effects mostly after the second shot. Patient had ibuprofen after the vaccine. Patient was still experiencing dizzy and was not able to concentrate on his work. Patient experienced only dizzy, weakness on an unspecified date in 2021. No investigation assessment. The outcome of the events was unknown.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer (Patient). A 29-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; FORMULATION: solution for injection, lot number was not reported) via intramuscular route of administration in Arm Right on 12May2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had not received any vaccination 4 weeks prior to COVID-19 vaccine. On an unspecified date in May2021, the patient experienced Fever. Patient received treatment with paracetamol for the reported event. Reporter seriousness for Fever was unspecified. Patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; FORMULATION: solution for injection, lot number was not reported), via intramuscular route of administration in Arm Right on 01Jun2021 for covid-19 immunization. The outcome of event was recovered on an unspecified date in May2021.  Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: dizziness; fatigue; weakness; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on an unspecified date for covid-19 immunisation. On an unspecified date, the patient experienced dizziness, fatigue, and weakness. The report received as, the patient states he got the second dose of the Pfizer COVID-19 vaccine two weeks ago and wants to know how long his side effects of dizziness, fatigue, and weakness will last. The patient called his doctor, and they told the patient to wait a couple of weeks. Outcome of the events was unknown.  Information about batch/ lot number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Premenstrual pain
Clinical narrative: premenstrual cramps; This is a spontaneous report from a contactable healthcare professional, the patient. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL6205) intramuscular on 12Mar2021 at 14:00 as a single dose for COVID-19 immunization. Medical history included anxiety, depression and Attention deficit hyperactivity disorder (ADHD), 8 months without a menstrual cycle. Ongoing concomitant medications included clonazepam for anxiety, bupropion for depression from an unspecified date reported as over 2 years ago, atenolol for ADHD from an unspecified date reported as over 15 years ago. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EM9810) intramuscular on 19Feb2021 (at the age of 46-years-old) for COVID-19 immunization and experienced menstrual cycle (after 8 months without a menstrual cycle, 12 hours post vaccine she experienced bleeding and 2 weeks later a full menstrual cycle), vomit, nausea, headache, body ache. On an unspecified date in May2021 (also reported as 3 months after the 1st vaccination), the patient experienced premenstrual cramps which were consistent for over a week. The clinical outcome of premenstrual cramps was not resolved. The patient considered that BNT162B2 had a causal effect to the event.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021213340 same patient/ drug, different dose/ event
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lymphadenopathy, Pyrexia
Clinical narrative: armpit lymph node swelling; low grade fever (99.4-100F); This is a spontaneous report from a contactable consumer (patient). A 33-year-old female non-pregnant patient received bnt162b2 (BNT162B2) dose 2 via an unspecified route of administration administered in left arm on 16Mar2021 08:30 (Lot Number: EN6206) as single dose for COVID-19 immunisation. Medical history included human papilloma virus infection. No known allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 administration administered in left arm on 23Feb2021 08:30 (lot# EN6201) for COVID-19 Vaccination and experienced mild pain at injection site in 2021. The patient experienced low grade fever (99.4-100F, duration also reported as 36 hours) on 16Mar2021 19:00, armpit lymph node swelling on 18Mar2021 (reported as 48 hours post 2nd dose injection). The patient was treated with acetaminophen (TYLENOL). The outcome of events was recovering.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: FLU4
Symptoms: Platelet count decreased, Red blood cell count decreased
Clinical narrative: Patient had low platelet and low red blood cells; Patient had low platelet and low red blood cells; Initial information regarding an unsolicited valid non-serious case was received from Consumer/non-hcp (healthcare professional) via Medical Information (Reference number- 00628775) and transmitted to Sanofi on 04-Jun-2021.   This case involves a female patient who had low platelet and low red blood cells (platelet count decreased) and low platelet and low red blood cells (red blood cell count decreased) while receiving vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (lot number and expiry date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient had a non-serious low platelet (platelet count decreased) and low red blood cells (red blood cell count decreased) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  The reporter states that she takes the Fluzone flu vaccine from Sanofi every year. she is aware of "many, many, many people" who took the mRNA vaccine and, in the future, don't want to take the mRNA vaccine as their booster. she is being inappropriately labeled as vaccine hesitant or an antivaxxer, but she is just waiting for a protein-based COVID-19 vaccine. She is asking that when Sanofi is finished asking for EUA status and makes its distribution decision to please set come vaccines aside for US consumers. She states that there are people with pre-existing medical conditions that are waiting for the protein-based vaccine because of side effects related to the nucleic acid vaccines. She states that she doesn't want thrombocytopenia, so she doesn't want to take the Johnson and Johnson vaccine.  Laboratory data was not reported.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the reported events.  There will be no information on the batch number for this case.
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient recieved expired ActHIB with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00628862) and transmitted to Sanofi on 04-Jun-2021.  This case involves a 3 years old male patient who received a 0.5 mL expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ263AAA and expiry date: 02-Jun-2021) via intramuscular route in the left deltoid (expired product administered) for prophylactic vaccination on 03-Jun-2021.  The patient's medical history, past medical treatment(s), past vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A), PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for immunization.  The reporter asked Is the protocol to revaccinate or is there a grace period in the expiration date since it was expired by only 1 day, what is a live vaccine and Is ActHib a live vaccine.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, the patient experienced no adverse event.   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 the 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.
Age: 29.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: 29 year old male patient received expired dose of Tenivac with no adverse event; Initial and additional information regarding an unsolicited valid non-serious case was received on 04-Jun-2021 and 7-Jun-2021 from a pharmacist via Agency (Reference number- 00628884).  This case involves a 29-year-old male patient who was vaccinated with 0.5 mL (standard) expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] [lot U6187AA, expiry date: 06-Feb-2021] via intramuscular route at left deltoid for prophylactic vaccination (expired product administered).  Caller with question on whether dose needs repeating and whether they had any safety data to provide regarding expired dose.  The patient's medical history, past medical treatments, and family history were not provided. No concomitant therapy was given.  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  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 the 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.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Incorrect route of product administration
Clinical narrative: patient received Tenivac intravenously in error with no adverse event; Initial information received on 07-Jun-2021 regarding an unsolicited valid  non-serious case from a pharmacist and physician.  This case involves a 27 years old female patient who was vaccinated with 0.5 ml dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (once, total, lot number:C5779AA, expiration Date :02-Oct-2022) via intravenously in error  in an unknown administration site for prophylactic vaccination on 07-Jun-2021 (incorrect route of product administration).    The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided.  No concomitant medication was given to the patient.   It was an actual medication error due to inappropriate route of vaccination (same day latency).  It was reported that a Pharmacist wanting to know any information with administering Tenivac intravenously due to having a medical student pushing the vaccine through a peripheral intravenous site and the clinic was calling the manufacturer for guidance.   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 the 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.
Age: 0.75
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of Acthib was given to patient yesterday with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from Consumer/non-hcp (healthcare professional) via Medical Information  (Reference number- 00632469) and transmitted to Sanofi on 08-Jun-2021.  This case involves a 9 months old male patient who received a 0.5 mL expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ266AAA and expiry date: 05-Jun-2021) via intramuscular route in the right thigh (expired product administered) for prophylactic vaccination on 07-Jun-2021.  The patient's medical history, past medical treatments, past vaccinations and family history were not provided.   Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE), PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  The reporter asked for recommendations.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, the patient experienced no adverse event.  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 the 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.
Age: 4.0
Sex: F
Vaccine: MNQ
Symptoms: Medication error, Wrong product administered
Clinical narrative: given Menactra and not the prescribed Polio vaccine due to the Menactra was placed in the Polio vaccine storage box with no ae; Initial information was received on 08-Jun-2021 regarding an unsolicited valid non-serious case from other health professional (Agency Inquiry number: 00632999).  It was reported that 0.5 ml of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Suspension For Injection) (lot number: U6919AA, expiry date: 13-Apr-2022) was administered to a four year old female patient and not the prescribed polio vaccine due to the menactra was placed in the polio vaccine storage box, on 08-Jun-2021 via intramuscular route in right deltoid for prophylactic vaccination (wrong product administered).  It was a case of actual medication error due to wrong vaccine administered.  The consumer did not get the Polio vaccine at the time of this report.  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.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Pain in extremity, Pyrexia
Clinical narrative: Fever, arm pain, passing out
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Large red rash on arm appear a week after getting my first vaccine.  Itchy and sore.  Arm was sore for two/three days after shot and I was extremely tired for a day or two after the first shot.  Scheduled to get next dose on July 7th
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Sleep disorder, Tinnitus
Clinical narrative: Pulsating tinnitus. Starting May 5 duration 2-3 hours, recurred several times a week. Subsided May 29. Returned June 10 for a few hours. Recurred June 17 and woke me from sleep. Causing insomnia. So far pulsing has lasted 6 hours.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Eczema
Clinical narrative: Eczema outbreak on my arms and hands
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: got 1 dose in fall of 2019. Then COVID happened. And I never got dose #2.; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received  on an unknown date in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not applicable for this report. The patient did not receive 2nd dose of shingrix due to covid 19 which led to social problem. The reporter inquired could he/she still get that dose. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: sore/swollen arm; sore/swollen arm; bad headache; so red arm; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 11th June 2021, the patient received the 2nd dose of Shingles vaccine. On 11th June 2021, less than a day after receiving Shingles vaccine, the patient experienced swelling arm, pain in arm, headache and erythema of extremities. On an unknown date, the outcome of the swelling arm, headache and erythema of extremities were not recovered/not resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the swelling arm, pain in arm, headache and erythema of extremities to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received 2nd dose of shingles vaccine and experienced arm was very sore and bad headache and so red and swollen arm.  The reporter inquired could he/she take Advil, if so, how often also could ice or heat compress. The follow up would not possible as no contact details were available.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: administrated with an incomplete dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 4-year-old male patient who received HAV (Havrix) (batch number 7HJ74, expiry date 21st August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th June 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 14th June 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate dose of vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received incomplete dose of Havrix, which led to inappropriate dose of vaccine administered. No adverse events reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / on 06Apr2019 / had not been able to come back / until recently; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 6th April 2019, batch number-BF4J5 and expiration date-5th July 2021).   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, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter mentioned that Patient had not been able to come back for several reasons until recently and now was wondering how to go about this. The reporter consented to follow up. The Healthcare professional agreed to follow up via email address.