chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Dizziness, Gait disturbance
Clinical narrative: Coughing; feeling dizzy and Lightheadedness; Weakness; Trouble Walking; This is a spontaneous report from a contactable consumer reporting for herself.    A 70-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 11:40 (Batch/Lot Number: ER8733) as single dose  for covid-19 immunisation (age at vaccination 70 years) .  The patient medical history and  concomitant medications were not reported.  The patient experienced coughing  on 27Mar2021 with outcome of recovered on the same day , feeling dizzy and lightheadedness  on 27Mar2021 with outcome of recovered on the same day , weakness  on 27Mar2021 with outcome of recovered on the same day, trouble walking  on 27Mar2021 with outcome of recovered on the same day.  Course of the event: The patient  stated that five to seven minutes after the shot, she started coughing. She started talking to the nurse in the waiting room and she said lets have you sit down. The patient stated she then started feeling dizzy and lightheaded, and needed to lie down. They had no cots in the clinic, so she had to lie on the floor. The patient stated she had weakness and trouble walking. The patient stated this was all over in 3 hours and her family took her back to her care and she drove herself home. The patient  stated she had a severe reaction to the first shot and the clinic refused to give her the second dose.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Haematuria, Haemorrhage, Pain in extremity
Clinical narrative: urinating blood; might be a UTI; arm pain; fatigue; blood clots; he started bleeding after the first shot; This is a spontaneous report from a contactable consumer, the patient. This 63-year-old male patient reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3249) on 18Feb2021 (also reported as 17Feb2021) (at the age of 63-years-old) via an unspecified route as a single dose for COVID-19 immunization. Medical history included enlarged prostate, urinary health issues (gets up in the middle of the night), and has glasses as he had cataract surgery last year (2020) so he lost his close-up vision. Concomitant medications were not reported. On 18Feb2021, the patient got his first shot. Three weeks later, he had an episode of urinating blood and blood clots profusely. The patient stated the amount of blood and blood clots was scary at best. The patient reached out to his daughter who is a nurse who advised him to go to the Emergency Room (ER). He reached out to the nurse hotline as well, which recommended that he go to the emergency room that day as well. He went to the ER (it was a Sunday). They did a blood test, a sonogram or some kind of sonogram, and a urine sample. They also flushed the patient's bladder out with a catheter. This emergency room visit determined that it might be a urinary tract infection (UTI) and started him on antibiotics. The patient confirmed he was not admitted to the hospital. The patient then made an appointment with his doctor because that was on a weekend. He saw his doctor who referred him to a urologist. The patient also reported that he did have the normal arm pain and fatigue the second day or the day after the shot. The patient reported 11Mar2021 or 12Mar2021 was when he started bleeding after the first shot, he was unsure of the exact date, and stated he went to the hospital on 14Mar2021. The patient reported he is going to the doctor today (21Apr2021), to see the urologist but the urologist is going to do a scope in his bladder because that is the only thing that they cannot see. The clinical outcome of events urinating blood, blood clots, UTI, bleeding, arm pain, and fatigue was unknown.; Sender's Comments: Linked Report(s) :PFIZER INC-2021471072 same patient/reporter, different AE/2nd dose
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound scan, Urinary tract infection, Urine analysis
Clinical narrative: urinating blood; might be a UTI; arm pain; fatigue; blood clots; he started bleeding after the first shot; This is a spontaneous report from a contactable consumer, the patient. This 63-year-old male patient reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3249) on 18Feb2021 (also reported as 17Feb2021) (at the age of 63-years-old) via an unspecified route as a single dose for COVID-19 immunization. Medical history included enlarged prostate, urinary health issues (gets up in the middle of the night), and has glasses as he had cataract surgery last year (2020) so he lost his close-up vision. Concomitant medications were not reported. On 18Feb2021, the patient got his first shot. Three weeks later, he had an episode of urinating blood and blood clots profusely. The patient stated the amount of blood and blood clots was scary at best. The patient reached out to his daughter who is a nurse who advised him to go to the Emergency Room (ER). He reached out to the nurse hotline as well, which recommended that he go to the emergency room that day as well. He went to the ER (it was a Sunday). They did a blood test, a sonogram or some kind of sonogram, and a urine sample. They also flushed the patient's bladder out with a catheter. This emergency room visit determined that it might be a urinary tract infection (UTI) and started him on antibiotics. The patient confirmed he was not admitted to the hospital. The patient then made an appointment with his doctor because that was on a weekend. He saw his doctor who referred him to a urologist. The patient also reported that he did have the normal arm pain and fatigue the second day or the day after the shot. The patient reported 11Mar2021 or 12Mar2021 was when he started bleeding after the first shot, he was unsure of the exact date, and stated he went to the hospital on 14Mar2021. The patient reported he is going to the doctor today (21Apr2021), to see the urologist but the urologist is going to do a scope in his bladder because that is the only thing that they cannot see. The clinical outcome of events urinating blood, blood clots, UTI, bleeding, arm pain, and fatigue was unknown.; Sender's Comments: Linked Report(s) :PFIZER INC-2021471072 same patient/reporter, different AE/2nd dose
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood alkaline phosphatase, Blood cholesterol, Chest pain, Dizziness, Eosinophil count
Clinical narrative: Feeling terrible all over; aching all over; his urine started smelling bad; Hepatitis C; His chest was also hurting; Dizzy; his arm hurt just from the shot.; This is a spontaneous report from a contactable consumer (patient).   A 60-year-old male patient (weight: 83.91 kg, height: 178 cm) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. ER8734, Expiration date: 31Jul2021) at single dose, in the right upper arm, on 10Apr2021 at 14:00, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included arachnoiditis adhesive chronic from an unspecified date, in 1999 and ongoing, ulcerative colitis from an unspecified date, in 1996 and ongoing, chronic sinusitis from an unspecified date, venous reflux disease from an unspecified date and ongoing and polyps from an unspecified date (7 surgeries performed from polyps. Last surgery was Mar2016). The patient preciously, on 20Mar2021, at 14:00, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EP7534, Expiration date: 31Jul2021) in the right deltoid, at single dose, on for COVID-19 immunisation. He was good after the first shot, he had no problems. Concomitant medications were unknown. On 10Apr2021, the patient experienced dizzy ("after the second dose they got home and that evening while getting up off the couch, he got really dizzy") and his arm hurt just from the shot. On 13Apr2021, he developed chest pain (his chest was also hurting) and had hepatitis C ("he got blood work done and just got it back and was told he has hepatitis C"). On 20Apr2021, his urine started smelling bad. On an unspecified date, the patient also experienced generalised aching ("aching all over") and was feeling terrible all over. Relevant laboratory test, performed on an unspecified date, showed the following value: alkaline phosphate high, blood cholesterol high, eosinophil count 5.4 %, hepatitis C positive, low density lipoprotein (LDL) high and infectious mononucleosis (Mono) 13.5. The patient recovered from vaccination site pain on 10Apr2021, recovered from dizzy on 14Apr2021 and recovered from chest pain on 20Apr2021. The patient did not recover from hepatitis C and urine abnormal. Clinical outcome of feeling bad and generalised aching was unknown at time of this report.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hepatitis C, Infectious mononucleosis, Low density lipoprotein, Pain
Clinical narrative: Feeling terrible all over; aching all over; his urine started smelling bad; Hepatitis C; His chest was also hurting; Dizzy; his arm hurt just from the shot.; This is a spontaneous report from a contactable consumer (patient).   A 60-year-old male patient (weight: 83.91 kg, height: 178 cm) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. ER8734, Expiration date: 31Jul2021) at single dose, in the right upper arm, on 10Apr2021 at 14:00, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included arachnoiditis adhesive chronic from an unspecified date, in 1999 and ongoing, ulcerative colitis from an unspecified date, in 1996 and ongoing, chronic sinusitis from an unspecified date, venous reflux disease from an unspecified date and ongoing and polyps from an unspecified date (7 surgeries performed from polyps. Last surgery was Mar2016). The patient preciously, on 20Mar2021, at 14:00, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EP7534, Expiration date: 31Jul2021) in the right deltoid, at single dose, on for COVID-19 immunisation. He was good after the first shot, he had no problems. Concomitant medications were unknown. On 10Apr2021, the patient experienced dizzy ("after the second dose they got home and that evening while getting up off the couch, he got really dizzy") and his arm hurt just from the shot. On 13Apr2021, he developed chest pain (his chest was also hurting) and had hepatitis C ("he got blood work done and just got it back and was told he has hepatitis C"). On 20Apr2021, his urine started smelling bad. On an unspecified date, the patient also experienced generalised aching ("aching all over") and was feeling terrible all over. Relevant laboratory test, performed on an unspecified date, showed the following value: alkaline phosphate high, blood cholesterol high, eosinophil count 5.4 %, hepatitis C positive, low density lipoprotein (LDL) high and infectious mononucleosis (Mono) 13.5. The patient recovered from vaccination site pain on 10Apr2021, recovered from dizzy on 14Apr2021 and recovered from chest pain on 20Apr2021. The patient did not recover from hepatitis C and urine abnormal. Clinical outcome of feeling bad and generalised aching was unknown at time of this report.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Urine odour abnormal
Clinical narrative: Feeling terrible all over; aching all over; his urine started smelling bad; Hepatitis C; His chest was also hurting; Dizzy; his arm hurt just from the shot.; This is a spontaneous report from a contactable consumer (patient).   A 60-year-old male patient (weight: 83.91 kg, height: 178 cm) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. ER8734, Expiration date: 31Jul2021) at single dose, in the right upper arm, on 10Apr2021 at 14:00, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included arachnoiditis adhesive chronic from an unspecified date, in 1999 and ongoing, ulcerative colitis from an unspecified date, in 1996 and ongoing, chronic sinusitis from an unspecified date, venous reflux disease from an unspecified date and ongoing and polyps from an unspecified date (7 surgeries performed from polyps. Last surgery was Mar2016). The patient preciously, on 20Mar2021, at 14:00, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EP7534, Expiration date: 31Jul2021) in the right deltoid, at single dose, on for COVID-19 immunisation. He was good after the first shot, he had no problems. Concomitant medications were unknown. On 10Apr2021, the patient experienced dizzy ("after the second dose they got home and that evening while getting up off the couch, he got really dizzy") and his arm hurt just from the shot. On 13Apr2021, he developed chest pain (his chest was also hurting) and had hepatitis C ("he got blood work done and just got it back and was told he has hepatitis C"). On 20Apr2021, his urine started smelling bad. On an unspecified date, the patient also experienced generalised aching ("aching all over") and was feeling terrible all over. Relevant laboratory test, performed on an unspecified date, showed the following value: alkaline phosphate high, blood cholesterol high, eosinophil count 5.4 %, hepatitis C positive, low density lipoprotein (LDL) high and infectious mononucleosis (Mono) 13.5. The patient recovered from vaccination site pain on 10Apr2021, recovered from dizzy on 14Apr2021 and recovered from chest pain on 20Apr2021. The patient did not recover from hepatitis C and urine abnormal. Clinical outcome of feeling bad and generalised aching was unknown at time of this report.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Fatigue, Haematuria, Haemorrhage, Pain in extremity
Clinical narrative: blood clots; urinating blood; arm pain; fatigue; he started bleeding from the second one; This is a spontaneous report from a contactable consumer, the patient. This 63-year-old male patient reported that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6206) on 17Mar2021 (at the age of 63-years-old) via unspecified route as a single dose for COVID-19 immunization. Medical history included enlarged prostate, urinary health issues (gets up in the middle of the night), has glasses as he had cataract surgery last year (2020) so he lost his close-up vision. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EL3249) on 18Feb2021 (also reported as 17Feb2021) (at the age of 63-years-old) via unspecified route as a single dose for COVID-19 immunization and experienced urinating blood and blood clots profusely, UTI, bleeding, arm pain, and fatigue. The patient received his second shot on 17Mar2021 and almost to the date three weeks later, had the same incident with urinating blood and passing blood clots. He waited an extra day because he could not go to the bathroom and then he went to the ER that same day so that they could flush him out. He also had an appointment on that same day with his urologist. A CT scan was done at the ER and then in the afternoon he went to the doctor. The doctor did a catheter flush. The patient was unclogged but he was passing blood. The patient also reported that he did have the normal arm pain and fatigue the second day or the day after the shot. He has no other adverse reactions at this time. The patient reported 11Apr2021 or 12Apr2021 was when he started bleeding from the second one (shot). He went to the hospital on 14Apr2021. The patient confirmed he was not admitted. The patient reported he is going to the doctor today (21Apr2021) to see the urologist but the urologist is going to do a scope in his bladder because that is the only thing that they cannot see. The clinical outcome of the events urinating blood, blood clots, bleeding, arm pain, and fatigue was unknown. The patient stated he does not know if this is an issue, however, it coincided with both of his shots. The patient was calling to see if this is something that has been seen or if it is in his head.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021470922 same  patient/reporter, different AE/first dose
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots; urinating blood; arm pain; fatigue; he started bleeding from the second one; This is a spontaneous report from a contactable consumer, the patient. This 63-year-old male patient reported that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6206) on 17Mar2021 (at the age of 63-years-old) via unspecified route as a single dose for COVID-19 immunization. Medical history included enlarged prostate, urinary health issues (gets up in the middle of the night), has glasses as he had cataract surgery last year (2020) so he lost his close-up vision. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EL3249) on 18Feb2021 (also reported as 17Feb2021) (at the age of 63-years-old) via unspecified route as a single dose for COVID-19 immunization and experienced urinating blood and blood clots profusely, UTI, bleeding, arm pain, and fatigue. The patient received his second shot on 17Mar2021 and almost to the date three weeks later, had the same incident with urinating blood and passing blood clots. He waited an extra day because he could not go to the bathroom and then he went to the ER that same day so that they could flush him out. He also had an appointment on that same day with his urologist. A CT scan was done at the ER and then in the afternoon he went to the doctor. The doctor did a catheter flush. The patient was unclogged but he was passing blood. The patient also reported that he did have the normal arm pain and fatigue the second day or the day after the shot. He has no other adverse reactions at this time. The patient reported 11Apr2021 or 12Apr2021 was when he started bleeding from the second one (shot). He went to the hospital on 14Apr2021. The patient confirmed he was not admitted. The patient reported he is going to the doctor today (21Apr2021) to see the urologist but the urologist is going to do a scope in his bladder because that is the only thing that they cannot see. The clinical outcome of the events urinating blood, blood clots, bleeding, arm pain, and fatigue was unknown. The patient stated he does not know if this is an issue, however, it coincided with both of his shots. The patient was calling to see if this is something that has been seen or if it is in his head.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021470922 same  patient/reporter, different AE/first dose
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lip disorder, Lip swelling, Musculoskeletal stiffness, Neck pain, Oral mucosal eruption
Clinical narrative: stiffness in her neck; pain neck; rash all over her neck/rash has gone on to her face; breaking out in hives through out her body; lip is swollen; bumps underneath her lip; rash is going inside her mouth; This is a spontaneous report from a contactable consumer (patient). This 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER8731, expiration date 31Jul2021, on 14Apr2021 at single dose for COVID-19 immunization. Family history included lupus, COPD, diabetes which her mother had and she basically got it so she could be around her mother. Concomitant medication was none. The patient had the shot last Wednesday (14Apr2021) and then by Saturday (17Apr2021) she had severe neck pain and stiffness in her neck, she couldn't move her neck. The pain was ongoing. She had no rash on her arm but she had rash all over her neck and she went to the doctor and they gave her a steroid shot because they thought maybe it could be something different. She had the steroid and she still breaking out in hives through out her body. They gave her a steroid shot on Monday (19Apr2021) but the rash had gone on to her face, her lip was swollen, there were bumps underneath her lip and the rash was going inside her mouth and even though she got the steroid shot she was still breaking out in new hives. She said she was going to have to go and go back to work she thought this was going to be quick and it was not. She did not have the name of the steroid injection or have a lot expiration to provide. They also gave her Naproxen for the stiffness in her neck and a muscle relaxer. The outcome of stiffness in her neck, pain neck and rash all over her neck/rash has gone on to her face was not resolved. The outcome of other events was unknown.  No follow-up attempts are possible. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: stiffness in her neck; pain neck; rash all over her neck/rash has gone on to her face; breaking out in hives through out her body; lip is swollen; bumps underneath her lip; rash is going inside her mouth; This is a spontaneous report from a contactable consumer (patient). This 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER8731, expiration date 31Jul2021, on 14Apr2021 at single dose for COVID-19 immunization. Family history included lupus, COPD, diabetes which her mother had and she basically got it so she could be around her mother. Concomitant medication was none. The patient had the shot last Wednesday (14Apr2021) and then by Saturday (17Apr2021) she had severe neck pain and stiffness in her neck, she couldn't move her neck. The pain was ongoing. She had no rash on her arm but she had rash all over her neck and she went to the doctor and they gave her a steroid shot because they thought maybe it could be something different. She had the steroid and she still breaking out in hives through out her body. They gave her a steroid shot on Monday (19Apr2021) but the rash had gone on to her face, her lip was swollen, there were bumps underneath her lip and the rash was going inside her mouth and even though she got the steroid shot she was still breaking out in new hives. She said she was going to have to go and go back to work she thought this was going to be quick and it was not. She did not have the name of the steroid injection or have a lot expiration to provide. They also gave her Naproxen for the stiffness in her neck and a muscle relaxer. The outcome of stiffness in her neck, pain neck and rash all over her neck/rash has gone on to her face was not resolved. The outcome of other events was unknown.  No follow-up attempts are possible. No further information expected.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Pityriasis lichenoides et varioliformis acuta, Skin reaction
Clinical narrative: PLEVA skin reaction; Initial information received on 16-Apr-2021 regarding an unsolicited valid non-serious case from a non health care professional (Patient's father) via Media Information (inquiry reference number: 00565102).  This case involves a 7 years old male patient who had PLEVA skin reaction after receiving INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  Patient's parents stated that their son was not allergic to eggs, and that they were pretty sure he was not allergic to latex, or at least a latex allergy was not something that had ever come up.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 22-Sep-2011, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (total, lot VH460AA and expiration date not reported) via intramuscular route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious PLEVA skin reaction (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  It was reported that patient's father was asking for a list of ingredients for the 2011-2012 season flu vaccine. The reason he was asking, was that his son had a skin reaction to that vaccine, and since his son will be getting a Covid-19 (coronavirus disease) vaccine soon, probably the Pfizer, they want to compare ingredients and try to avoid a recurrence of the skin reaction.  No laboratory data reported.  Patient's father stated that the PLEVA was treated for a few months with medications (unspecified).  The patient recovered from the event on an unknown date.  It was reported that patient's parents stated that the adverse reaction was reported at the time to the pediatrician and to the Centers for Disease Control (CDC).
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient recieved Menactra that was expired with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via agency (Reference number- 00573158) and transmitted to Sanofi on 22-Apr-2021.  This case involves an 18 years old female patient who received a 0.5 mL expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (once) (lot U6586AA and expiry date: 14-Apr-2021) via unknown route at an unknown administration site (expired product administered) for prophylactic vaccination on 22-Apr-2021.  Medical history, past medical treatment(s), past vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation.  It was an actual medication error case due to expired vaccine used (latency: same day).   The reporter wanted to know if there was in wiggle room for expiration date of product and would it affect the HPV vaccine that was given concomitantly?  At the time of reporting, the patient experienced no specific 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: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation issue
Clinical narrative: The patient received only the diluent of ACTHIB, no AE; Initial information was received on 26-Apr-2021 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 2 months old female patient who received only the diluent of HIB (PRP/T) VACCINE [ACT-HIB] 0.5 ml (lot UJ405AAA, expiry date: 08-Oct-2021) via intramuscular route in the right thigh for prophylactic vaccination on 12-Apr-2021 (Product preparation issue)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX), ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate reconstitution technique (latency same day)  At the time of report, no adverse event was reported.  One of the nurse gave only gave the diluent of ACTHIB and asked if they could give the HIB with another diluent.  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.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient received Menactra when it was already expired/no AE; Initial information was received on 27-Apr-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of unknown age and gender who was vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (batch number U6586AA and expiry date 14-Apr-2021) via an unknown route at an unknown administration site on 20-Apr-2021 for prophylactic vaccination (expired product administered).  Caller would like to know if she need to re-dose MENACTRA.   The patient's past medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used (latency was on same day).  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: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 year old male patient was administered dose of QUADRACEL with no reported adverse event; Initial information received on 27-Apr-2021 regarding an unsolicited valid non-serious case received from a physician via nurse.  This case involves a two year old male patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (Product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 21-Apr-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5851AA and expiry date: 25-Mar-2023) (Frequency: once) via an intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (same day latency).  At the time of report no adverse event was 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 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: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: Not sure when it actually started, as I had fever like symptoms the day after, but ever since I have had a ringing in my ears.   With background noise or doing some kind of activity it sufficiently distracts me from it but it's quite clear in the morning and night.   Hasn't gotten better or worse.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Lips tingling, vitals wnl. Given water.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Hypersomnia, Pyrexia
Clinical narrative: By the 3rd day after I staryed feeling chronic fatigue and had a fever. By day four, I couldn't get out of bed. I literally slept for 40 of the next 48 hours waking up with fever and chills, but so week I didn't want to get out of bed.  After 2 days in bed I started to feel better and by the end of the 6 th of May I had fully recovered. I hope.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Pruritus
Clinical narrative: Itchniness, BPs 137/97 (pulse 112), 137/82 (pulse 105). Benadryl 25 mg PO, 50 mg IM given.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness. Vitals wnl.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pfizer Covid vaccine administered to 15 year old.  Patient and/or mom falsified information on consent and release form stating patient's DOB was 1 year before pt's real DOB and age was 1 year older than patient's real age.  * * * NO adverse reaction reported. * * *
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Arm soreness from vaccine site to elbow started 5/5 around 6pm and is persistent as of 5/7 3am.  Very severe headache, fever, and chills 5/5 6pm until 5/6 10am. Moderate headache persisted and is unresolved as of 5/7 3am.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Cough, Headache, Nasopharyngitis, Paranasal sinus hypersecretion
Clinical narrative: I felt fine following the 2nd shot, for 48 hours, but unusally tired so I knew it must have been the shot. The next day my sinuses became burning and I assumed it was hayfever because I had experienced some symptoms of that for the previous two weeks. But the next day, Tues., it was worst, like a bad cold (which all of this "reaction" may have been), but then the next 3 days I could barely get out of bed--and that's unusual because I run every day and nothing stops me. I had bad headaches for 5 days or so and that included coughing, from a dry cough at first to a very wet cough and very large thick segments of gelled mucous coming out of my sinuses, something I've never seen before. After almost two weeks I felt much better but was still coughing, and now three weeks later I'm still really tired, can't think as tightly as usual.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: I felt fine following the 2nd shot, for 48 hours, but unusally tired so I knew it must have been the shot. The next day my sinuses became burning and I assumed it was hayfever because I had experienced some symptoms of that for the previous two weeks. But the next day, Tues., it was worst, like a bad cold (which all of this "reaction" may have been), but then the next 3 days I could barely get out of bed--and that's unusual because I run every day and nothing stops me. I had bad headaches for 5 days or so and that included coughing, from a dry cough at first to a very wet cough and very large thick segments of gelled mucous coming out of my sinuses, something I've never seen before. After almost two weeks I felt much better but was still coughing, and now three weeks later I'm still really tired, can't think as tightly as usual.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Headache, Nasal discomfort, Nasopharyngitis
Clinical narrative: I felt fine following the 2nd shot, for 48 hours, but unusally tired so I knew it must have been the shot. The next day my sinuses became burning and I assumed it was hayfever because I had experienced some symptoms of that for the previous two weeks. But the next day, Tues., it was worst, like a bad cold (which all of this "reaction" may have been), but then the next 3 days I could barely get out of bed--and that's unusual because I run every day and nothing stops me. I had bad headaches for 5 days or so and that included coughing, from a dry cough at first to a very wet cough and very large thick segments of gelled mucous coming out of my sinuses, something I've never seen before. After almost two weeks I felt much better but was still coughing, and now three weeks later I'm still really tired, can't think as tightly as usual.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paranasal sinus hypersecretion, Productive cough, SARS-CoV-2 test, Thinking abnormal
Clinical narrative: I felt fine following the 2nd shot, for 48 hours, but unusally tired so I knew it must have been the shot. The next day my sinuses became burning and I assumed it was hayfever because I had experienced some symptoms of that for the previous two weeks. But the next day, Tues., it was worst, like a bad cold (which all of this "reaction" may have been), but then the next 3 days I could barely get out of bed--and that's unusual because I run every day and nothing stops me. I had bad headaches for 5 days or so and that included coughing, from a dry cough at first to a very wet cough and very large thick segments of gelled mucous coming out of my sinuses, something I've never seen before. After almost two weeks I felt much better but was still coughing, and now three weeks later I'm still really tired, can't think as tightly as usual.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Nausea, light-headed, diaphoretic. Vitals wnl.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Lethargy, Tinnitus
Clinical narrative: Severe tinnitus,  some hearing loss in right ear. Lethargy.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Fatigue, Lymphadenopathy
Clinical narrative: Diarrhea  Fever Stomach ache Lymph nodes underarm severely swollen  Fatigue  Weak
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Diarrhea  Fever Stomach ache Lymph nodes underarm severely swollen  Fatigue  Weak
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Nausea
Clinical narrative: Nausea (empty stomach). Given 4 ounces juice, 8 oz. water, graham crackers. BPs 78/35 (pulse 54), 90/42 (pulse 66). O2 sat 99%.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus in my left ear
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swelling
Clinical narrative: Neck/throat swelling. Given Benadryl 25 mg PO. Vitals wnl.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Paraesthesia, Somnolence
Clinical narrative: Treatment went swimmingly, how my body reacted to it though because of my chronic pain was not great. chills and tingling constantly for 24 hours, pains shooting from the areas I've been diagnosed to my head, to my hands and fingers, and the rest of my body. Because of the additional pain, more exhaustion, so I need more sleep.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstrual disorder
Clinical narrative: Period has become extremely worse.   Headache ever since taking the shot
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Diarrhoea, Flatulence, Injection site pain, Pyrexia
Clinical narrative: The first night, I had mild diarrhea and a fever.  The next day, I had mild soreness in my arm near the injection site, chest discomfort and gas, largely concentrated in my chest, on the same side as my heart.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Vomiting
Clinical narrative: 5 hrs after second dose started feeling extremely tired, took a 2 hr nap, then body aches started then bad chills  set in then 12 hrs after second dose I puked.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Skin discolouration
Clinical narrative: fatigue headache dizziness skin blemishes
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest pain, Immediate post-injection reaction, Paraesthesia, Sensory disturbance
Clinical narrative: Intense tingling sensation in my head, spine and face immediately.  My face still has a constant tingling sensation. A week after my vaccine, I had an intense burning sensation in my chest and spine that kept me up all night. I went to urgent care the next day. It felt like someone had put icy/hot on my body. That sensation comes and goes, but the face tingling has remained constant since my shot.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Feeling abnormal, Hyperhidrosis
Clinical narrative: Chills body swats extreme aches and fatgue loss of appetite brain fog. Sleeplessness Started 05/02 and continues today. It hasnt gotten better
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Chills body swats extreme aches and fatgue loss of appetite brain fog. Sleeplessness Started 05/02 and continues today. It hasnt gotten better
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: 12 hours after the second dose of the Moderna vaccine I experienced fever, body aches, and chills
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Myalgia, Nausea
Clinical narrative: Flu-like symptoms including chills, fatigue, muscle soreness, nausea. No fever. Symptoms lasted roughly 24hrs.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: patient fainted
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Rhinorrhoea, Sneezing
Clinical narrative: Nose congestion, sneezing and running nose.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Disorientation, Fatigue, Feeling hot, Insomnia
Clinical narrative: Night after vaccine (4/30/2021 to 5/1/2021): had trouble sleeping despite being tired (atypical for me), felt overly warm (atypical for me) 5/1/2021, 8am: woke up feeling disoriented, fell back asleep 5/1/2021, 11:30am: woke up and could not fall back asleep, even though I still felt tired. Felt very overheated, had migraine headache, felt sore in hips, knees, and neck. Treated migraine with 2 tablets of 220mg naproxen sodium. Fell back asleep around 12:15pm and slept till 2:30pm. Felt better when I woke up.  5/1/2021, 6:00pm: headache returned, felt drowsy. Napped for approximately 1hr 45min. Woke up and headache was still bothersome. Took 2 more tablets of 220mg naproxen sodium. Headache faded.  5/2/2021: mild headache and soreness persisted on and off until the evening.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Neck pain, Somnolence
Clinical narrative: Night after vaccine (4/30/2021 to 5/1/2021): had trouble sleeping despite being tired (atypical for me), felt overly warm (atypical for me) 5/1/2021, 8am: woke up feeling disoriented, fell back asleep 5/1/2021, 11:30am: woke up and could not fall back asleep, even though I still felt tired. Felt very overheated, had migraine headache, felt sore in hips, knees, and neck. Treated migraine with 2 tablets of 220mg naproxen sodium. Fell back asleep around 12:15pm and slept till 2:30pm. Felt better when I woke up.  5/1/2021, 6:00pm: headache returned, felt drowsy. Napped for approximately 1hr 45min. Woke up and headache was still bothersome. Took 2 more tablets of 220mg naproxen sodium. Headache faded.  5/2/2021: mild headache and soreness persisted on and off until the evening.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Aggression, Blood creatine phosphokinase increased, Delusion, Hypertension, Hypomania
Clinical narrative: History of schizoaffective disorder, otherwise well-controlled, developed worsening delusions and possible neuroepileptic malignant syndrome the day after his 1st vaccination and again after his 2nd vaccination. Had not had any manic or delusions in the 4 years prior. The day after his 1st vaccination he developed new delusions and hypomania that resolved after 2 weeks. After his second vaccination he was hospitalized the next day with mania, delusions, aggression, hypertension, tachycardia.  Required chemical sedation for mania.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Mania, Red blood cells urine positive, Sedation, Tachycardia, White blood cell count increased
Clinical narrative: History of schizoaffective disorder, otherwise well-controlled, developed worsening delusions and possible neuroepileptic malignant syndrome the day after his 1st vaccination and again after his 2nd vaccination. Had not had any manic or delusions in the 4 years prior. The day after his 1st vaccination he developed new delusions and hypomania that resolved after 2 weeks. After his second vaccination he was hospitalized the next day with mania, delusions, aggression, hypertension, tachycardia.  Required chemical sedation for mania.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Oropharyngeal pain, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Cough  Headache  Sore throat  Congestion or running nose
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Cough  Headache  Sore throat  Congestion or running nose
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Hot flush, Migraine, Myalgia, Pain in extremity
Clinical narrative: I for my 2nd shot on may 5th 2021 at 5pm. By 1130pm I developed a headache and pushing on my left side neck on the back side (same side I got my shot also) by 1130pm. It turned into a migraine. I took Imitrex 100mg and fell asleep and it went away. At the exact same time last night on 5/6 around 110pm a headache started caused by the same muscle ache on my left back neck. I can push on one spot and the headache gets much worse. I took 50mg Imitrex an hour ago. It's bow 457am 5/7 and the headache went right away. I'm now having hot flashes and had to take my shirt off. Not sure if it's the medication or both. This is unusual for me to feel hot when it's 58F outside and 71F inside. That means something unusual is giving me headache/migraine/muscle pain in neck/hot flashes. My Imitrex never causes hot flashes. Thank you. P. S the first shot had no reaction other then soar arm. Which I have now also.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Vaccination complication
Clinical narrative: all covid symptoms
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Pain, Pain in extremity, Rash macular
Clinical narrative: Day 1- no mark, day 2- swollen and painful to touch, outline of Bain aid that was removed the day prior at injection site., day 3 large red blotch on arm.  Painful to touch and painful to move arm.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, COVID-19 pneumonia, Computerised tomogram, Cough, Headache
Clinical narrative: pain, HA, cough, loss of taste, COVID-19 pneumonia  remdesivir and dexamethasone
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain, HA, cough, loss of taste, COVID-19 pneumonia  remdesivir and dexamethasone
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: No signs or symptoms reported.; Nurse reported at temperature excursion on PEDVAX HIB that was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.   On an unknown date, the patient was vaccinated with improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot No: S036823 has been confirmed to be valid, expiration date was reported as 24-MAR-2021, but upon internal validation established as 31-MAR-2022, strength, dose, route, frequency and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature range above 9°C (10.63 °C) and below 2 (0.0) °C, during a time frame of 4 hours and 20 minutes. No previous temperature excursions reported. There was no data logger. The onset date was reported as 02-MAR-2021.