chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Headache, Heart rate increased, Metabolic function test, Pain in extremity
Clinical narrative: I have small fiber neuropathy; I have other symptoms; it hurt really bad and I told him to take it out of my arm and he did, but I believe he hit a nerve or something in my arm; Pain in the ears; Headache; Pain you know the fire in my feet and my legs; Heart beats fast; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 51-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: ER8730) via an unspecified route of administration and administered in left arm on 05Apr2021 (at the age of 51-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient took the Pfizer vaccine (COVID Vaccine) on 05Apr2021 and she went to the emergency room not long after that and then she went to ask a doctor not long after that and just went to a neurologist. She told that she had small fiber neuropathy (on an unspecified date in Apr2021) and called the Pharmacist at pharmacy where she had the vaccine and told them what had happened. When the man gave her the vaccine it hurt really bad (on an unspecified date in Apr2021). The patient told him to take it out of her arm and he did, but she believed he hit a nerve or something in her arm, pain in the ears, headache, pain you know the fire in her feet and legs, heart beats fast, shot in her left arm, it hurt really bad (on an unspecified date in Apr2021). The patient stated the patient did not take the second vaccine because of this problem. She did not have any of these problems until and after she took the vaccine, whole day 'without any side' effects. The patient was  taking medication, Gabapentin (treatment). She had to go back in two weeks. She did not know why all this was happening. The patient was fine until she took the vaccine. The patient underwent lab tests and procedures which included she took 5 or 6 vials of blood when reporter was there on Thursday, not sure what all she was testing with unknown result. Was in the hospital (further clarification unknown) in April they did do a CBC, Differential Metabolic Panel, Urinalysis, Drug screen, EKG, Chest x-ray. They did all sort of stuff. When reporter went to the (voice not clear) doctor they did an ultrasound on her legs and said that her veins were okay and then the neurologist said that the nerves (incomplete sentence). Therapeutic measures were taken as a result of events with gabapentin take 100 mg three times a day for a week and then (voice not clear) it up to more than that for the second week and more than that for the third week (further not clarified). The outcome of events was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021744526 similar report from same reporter
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Small fibre neuropathy, Ultrasound scan, Urine analysis, Vaccination site pain
Clinical narrative: I have small fiber neuropathy; I have other symptoms; it hurt really bad and I told him to take it out of my arm and he did, but I believe he hit a nerve or something in my arm; Pain in the ears; Headache; Pain you know the fire in my feet and my legs; Heart beats fast; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 51-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: ER8730) via an unspecified route of administration and administered in left arm on 05Apr2021 (at the age of 51-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient took the Pfizer vaccine (COVID Vaccine) on 05Apr2021 and she went to the emergency room not long after that and then she went to ask a doctor not long after that and just went to a neurologist. She told that she had small fiber neuropathy (on an unspecified date in Apr2021) and called the Pharmacist at pharmacy where she had the vaccine and told them what had happened. When the man gave her the vaccine it hurt really bad (on an unspecified date in Apr2021). The patient told him to take it out of her arm and he did, but she believed he hit a nerve or something in her arm, pain in the ears, headache, pain you know the fire in her feet and legs, heart beats fast, shot in her left arm, it hurt really bad (on an unspecified date in Apr2021). The patient stated the patient did not take the second vaccine because of this problem. She did not have any of these problems until and after she took the vaccine, whole day 'without any side' effects. The patient was  taking medication, Gabapentin (treatment). She had to go back in two weeks. She did not know why all this was happening. The patient was fine until she took the vaccine. The patient underwent lab tests and procedures which included she took 5 or 6 vials of blood when reporter was there on Thursday, not sure what all she was testing with unknown result. Was in the hospital (further clarification unknown) in April they did do a CBC, Differential Metabolic Panel, Urinalysis, Drug screen, EKG, Chest x-ray. They did all sort of stuff. When reporter went to the (voice not clear) doctor they did an ultrasound on her legs and said that her veins were okay and then the neurologist said that the nerves (incomplete sentence). Therapeutic measures were taken as a result of events with gabapentin take 100 mg three times a day for a week and then (voice not clear) it up to more than that for the second week and more than that for the third week (further not clarified). The outcome of events was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021744526 similar report from same reporter
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Feeling like having Flu; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program.  A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EW0178 and expiration date: not reported), via an unspecified route of administration, on 18Jun2021 (at the age of 50-year-old), as DOSE 2, SINGLE for covid-19 immunization. Medical history included ongoing Psychiatric issue but nothing physical. The patient's concomitant medications included some psychiatric medication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EW0177and expiration date: not reported), via an unspecified route of administration, on 28May2021 (at the age of 50-year-old), as DOSE 1, SINGLE for covid-19 immunization and had no reaction. The patient was feeling like having a flu on 19Jun2021.  Patient don't want to report anything or sign up for anything just want to know if it's okay to take Tylenol. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dry throat, Erythema, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via unspecified route of administration on 17Apr2021 as single dose for COVID-19 immunization. Medical history, concomitant medication or past drug history of the patient were not reported. On 17Apr2021, 17 minutes after receiving first dose of vaccination, patient had a severe reaction and developed dry throat, swelling of the lips, hands, mouth, and tongue. She also experienced numbness of her tongue as well. Patient was initially given benadryl, steroids, and currently taking Zyrtec 30mg, and Pepcid 40mg. On an unspecified date in 2021, patient had nine "flare-ups" since first dose, her flare-ups has "itchy skin", skin redness and "feels like a sunburn", inside of her mouth feels tingling and numb, cheek numbness, and her lips swell. Patient had total of 9 reactions and 6 rounds of steroids since. HCP said that she may be reacting to the polyethylene glycol (PEG). She did see an allergist. PEG seems to be in her life a lot, deodorant, hairspray, toothpaste, etc., so she stated that she had been exposed to it a lot and had since removed it as much as possible. Reports that she went to a 2nd allergist to figure out what it was. Therapeutic measures taken in response to the event included benadryl, steroids, Zyrtec 30mg, and Pepcid 40mg. Outcome of the events were unknown. Follow-up attempts are needed. Information on Lot/Batch number can be requested.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Mouth swelling, Paraesthesia oral, Peripheral swelling, Pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via unspecified route of administration on 17Apr2021 as single dose for COVID-19 immunization. Medical history, concomitant medication or past drug history of the patient were not reported. On 17Apr2021, 17 minutes after receiving first dose of vaccination, patient had a severe reaction and developed dry throat, swelling of the lips, hands, mouth, and tongue. She also experienced numbness of her tongue as well. Patient was initially given benadryl, steroids, and currently taking Zyrtec 30mg, and Pepcid 40mg. On an unspecified date in 2021, patient had nine "flare-ups" since first dose, her flare-ups has "itchy skin", skin redness and "feels like a sunburn", inside of her mouth feels tingling and numb, cheek numbness, and her lips swell. Patient had total of 9 reactions and 6 rounds of steroids since. HCP said that she may be reacting to the polyethylene glycol (PEG). She did see an allergist. PEG seems to be in her life a lot, deodorant, hairspray, toothpaste, etc., so she stated that she had been exposed to it a lot and had since removed it as much as possible. Reports that she went to a 2nd allergist to figure out what it was. Therapeutic measures taken in response to the event included benadryl, steroids, Zyrtec 30mg, and Pepcid 40mg. Outcome of the events were unknown. Follow-up attempts are needed. Information on Lot/Batch number can be requested.
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via unspecified route of administration on 17Apr2021 as single dose for COVID-19 immunization. Medical history, concomitant medication or past drug history of the patient were not reported. On 17Apr2021, 17 minutes after receiving first dose of vaccination, patient had a severe reaction and developed dry throat, swelling of the lips, hands, mouth, and tongue. She also experienced numbness of her tongue as well. Patient was initially given benadryl, steroids, and currently taking Zyrtec 30mg, and Pepcid 40mg. On an unspecified date in 2021, patient had nine "flare-ups" since first dose, her flare-ups has "itchy skin", skin redness and "feels like a sunburn", inside of her mouth feels tingling and numb, cheek numbness, and her lips swell. Patient had total of 9 reactions and 6 rounds of steroids since. HCP said that she may be reacting to the polyethylene glycol (PEG). She did see an allergist. PEG seems to be in her life a lot, deodorant, hairspray, toothpaste, etc., so she stated that she had been exposed to it a lot and had since removed it as much as possible. Reports that she went to a 2nd allergist to figure out what it was. Therapeutic measures taken in response to the event included benadryl, steroids, Zyrtec 30mg, and Pepcid 40mg. Outcome of the events were unknown. Follow-up attempts are needed. Information on Lot/Batch number can be requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Muscular weakness, Pain in extremity, Sleep disorder
Clinical narrative: Initially unable to use her right arm/Unable to physically lift her arm; Experienced weakness in her left arm, which is disrupting her sleep; Experienced weakness in her left arm, which is disrupting her sleep; Numbness, affecting her muscles in the left upper quadrant, although her lower arm hurts, she was sent to the cardiologist; Numbness, affecting her muscles in the left upper quadrant, although her lower arm hurts, she was sent to the cardiologist; This is a spontaneous report from a contactable consumer (patient, self-reported). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on Jan2021, as a single dose for COVID-19 immunization. The patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on Feb2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on an unspecified date, she was initially unable to use her right arm, but this resolved within 2-3 days. She has experienced weakness in her left arm, which was disrupting her sleep. She was unable to physically lift her arm and asked if this was a side effect of the vaccine. The patient asked to figure out how to get rid of this and which doctor did she need to see. She shared she saw her HCP in April. She continued, before she started running to all of these doctors, she really needed to find out what she was dealing with. She saw her HCP in April, because of the numbness, affecting her muscles in the left upper quadrant, although her lower arm hurts, she was sent to the cardiologist. She went through several tests with the cardiologist. They did not find anything wrong there. She just going down this path-its too much. She was hoping you have another idea besides going to all different doctors. If you have other people who have this and now it has been resolved. The patient asked on clinical trials was arm weakness a side effects and received her second shot in other arm and did not expect to be six months in to not using her arm, shared that she did not go to the doctor regularly and last went three years ago. The patient recommended HCP to continue following up with health care provider team. The events resulted in physician office visit. Outcome of the event initially unable to use her right arm/Unable to physically lift her arm was resolved on an unspecified date and for all other events, it was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching of the skin; This is a spontaneous report from a contactable consumer (patient), from a Pfizer sponsored program.  A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on an unspecified date as Unknown, Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.It was reported that, the patient received the Pfizer Covid 19 Vaccine three weeks ago.The last few days she has experienced itching of the skin, denied a rash.The outcome of the event was unknown.  Information on lot/batch number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity, Peripheral swelling
Clinical narrative: experiencing the burning sensation in "weird places" ex. hand and fingers, ankle to knee; She reported a symptom of a baseball/softball side swollen knot on her L shoulder/top of arm. The knot hurt but it was tolerable.; She reported a symptom of a baseball/softball side swollen knot on her L shoulder/top of arm. The knot hurt but it was tolerable.; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 10Mar2021 (age at the time of vaccination was 81-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) on 17Feb2021 for COVID-19 immunization. On unspecified date, she reported a symptom of a baseball/softball side swollen knot on her L shoulder/top of arm. The knot hurt but it was tolerable. She reports putting ice packs on the knot for treatment and after 3-4 weeks it gradually got smaller. The Consumer reports that she is still experiencing the burning sensation in "weird places" ex. hand and fingers, ankle to knee. She states that the feeling doesn't bother her but just wants to know if others have reported this same symptom. Treatment included ice packs for the event "she reported a symptom of a baseball/softball side swollen knot on her L shoulder/top of arm. Outcome of the events burning sensation and Peripheral swelling was unknown while pain in arm was reported as recovering.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: had a high fever; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable consumer or other non-health care professional (Patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient called to report adverse events of the Pfizer vaccine and told that on an unspecified date, he had a high fever. Outcome for the event unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received an extra dose (first dose 1/29/21, next dose on 6/2/21) in error, with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Global Medical Information (GMI) inbound (reference number-00643752) and transmitted to Sanofi on 16-Jun-2021.  This case involves a patient (demographics not provided) who received a first dose (dose 1) of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination on 29-JAN-2021 and received next dose of suspect  DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: C5631AA and expiry date: 27-NOV-2021) via unknown route in unknown administration site for prophylactic vaccination on 02-JUN-2021 in error (Extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was case of actual medication error due to extra dose administered.  The reporter wanted to know are there any concerns or need for a repeat dosage or any additional monitoring is needed.  At, the time of reporting no adverse event is 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.
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: DAPTACEL vaccine may have been administered to an adult, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from pharmacist via Medical Information (Reference number- 00643980).  This case involves adult and unknown gender patient who may have been administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  It was case actual medication error due to product administered to patient of inappropriate age [Latency: on the same day].   It was reported that, Health care professional states that she had found a discrepancy in their vaccine count- she was not sure yet, but a DAPTACEL vaccine may have been administered to an adult.  At the time of report, no adverse event was reported.  It was not reported if the patient received a corrective treatment for the 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. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: This case involves a 2 months old male patient who received 0.5 ml dose of DTAP -IPV portion and not the HIB portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] due to the products not being mixed together (lot: powder: UJ425AA, expiry date: 21-May-2022) via intramuscular route in the left thigh for prophylactic vaccination on 14-Jun-2021 (Product preparation issue). Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE, ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE 13V 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. The caller stated that the liquid portion of PENTACEL was given to a 2-month-old infant. The vaccine was not reconstituted and caller wanted to know if the infant needed to be revaccinated. The patient only had the DTAP -IPV portion and not the HIB portion due to the products not being mixed together. 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: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was injected with the expired dose of ActHIB with no reported adverse event; Initial information was received on 18-Jun-2021 regarding an unsolicited valid non-serious case from a physician.  This case involves one-year-old male patient who received expired of 0.5 ml fourth dose HIB (PRP/T) VACCINE [ACT-HIB] [lot number: UJ320AAB and expiry date: 13-Jun-2021] via an intramuscular route in right thigh on 15-Jun-2021 for prophylactic vaccination (expired product administered).  Concomitant medications included VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) for Prophylactic vaccination.  Medical history, medical treatment, vaccination, and family history were not provided.  It was an actual medication error due to expired vaccine used (latency: same day).  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 guidelines. 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: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired ACTHIB was administered to patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00647532) and transmitted to Sanofi on 18-Jun-2021.  This case involves a 15 months old male patient who received 0.5 mL expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot U6789AA and expiry date: 06-Jun-2021) via intramuscular route in right thigh (expired product administered) for prophylactic vaccination on 18-Jun-2021.  The patient's medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for immunization.  The reporter asked does there need to be re-administered. The reporter also stated the Acthib, Diluent and Carton all had different expiration dates and asked why they are all different.  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: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received an extra dose of ADACEL with no adverse event; Initial information was received on 21-Jun-2021 regarding an unsolicited valid non-serious case from other health professional (Agency Inquiry number: 00649777).  It was reported that a 12-year-old male patient received an 0.5 ml extra dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Oral solution) (lot number: C5631AA, expiry date: 27-Nov-2021)on an unknown date for prophylactic vaccination (extra dose administered).  It was a case of actual medication error due to extra dose administered.  The patient took his last ADACEL vaccine in January of this year (2021).  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.
Sex: F
Vaccine: TTOX
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; Initial information was received on 21-Jun-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 13 years old female patient who had an allergic reaction (hypersensitivity) after receiving TETANUS TOXOID.  Medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing medical history of allergy to horse serum   On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious allergic reaction (hypersensitivity) (unknown latency) following the administration of TETANUS TOXOID.  The caller reported she had an allergy to horse serum. As per her doctor she could receive a tetanus vaccine as long as it did not have horse serum, which she thought they stopped using  No laboratory data was provided.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Age: 29.0
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received Imovax and was 10 days late in getting her second dose with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from pharmacist  via Agency (Reference number- 00650123) and transmitted to Sanofi on 21-Jun-2021.  This case involves a 29-year-old female patient who received RABIES (HDC) VACCINE [IMOVAX RABIES] and was 10 days late in getting her second dose.  The patient past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 01-Jun-2021, the patient received a dose of suspect RABIES (HDC) VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.   It was case of actual medication error due to inappropriate schedule of product administration [Latency: on the same day].   It was reported that, was it okay that the patient was 10 days late or if they need to restart the series. Patient visit to clinic on 01-Jun-2021.  At the time of report, no adverse event was reported.  It was not reported if the patient received a corrective treatment for the 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.  There will be no information available on the batch number for this case.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Erythema, Heart rate increased, Peripheral swelling, Pruritus
Clinical narrative: Upper arm was swollen, red and hot; Upper arm was swollen, red and hot; Upper arm was swollen, red and hot; Heart rate was fast; Chest tight; Itching; This spontaneous case was received on 13-Jun-2021 from Communications (reference number: SEQW21-01429), reported by other non-health professional (consumer) and concerned a 24-year-old, female patient.  The patient had no medical history and was not taking any concomitant medications.  On 13-Nov-2017, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; anatomical location: deltoid, route of administration: intramuscular and dose: 0.5 ml) for influenza prophylaxis. The batch number reported was 01644611A.   On the same day, after receiving Afluria Quadrivalent, patient's upper arm was swollen, red and hot, her heart rate was fast, chest tight and she developed mild itching.  On an unknown date, at urgent care, the patient received prednisone, Bactrim DS (sulfamethoxazole, trimethoprim) and Benadryl (Diphenhydramine hydrochloride) as treatment.  On 22-Nov-2017, the patient recovered from the events.  The reporter assessed the event to be related to Afluria Quadrivalent. The reporter stated that the patient had reaction to 2017 vaccine.   The case was assessed as non-serious.  Company comment: A 24-year-old, female patient was vaccinated with Afluria Quadrivalent. On the same day, after receiving Afluria Quadrivalent, patient's upper arm was swollen, red and hot, her heart rate was fast, chest tight and she developed mild itching. On an unknown date, at urgent care, the patient received prednisone, Bactrim DS (sulfamethoxazole, trimethoprim) and Benadryl (Diphenhydramine hydrochloride) as treatment. Causality is assessed as possibly related for all events. The events of erythema, peripheral swelling and feeling hot may suggest cellulitis, however, Brighton collaboration criteria for cellulitis at injection site could not be assessed due to insufficient information provided.; Reporter's Comments: Consumer had reaction to 2017 vaccine.; Sender's Comments: A 24-year-old, female patient was vaccinated with Afluria Quadrivalent. On the same day, after receiving Afluria Quadrivalent, patient's upper arm was swollen, red and hot, her heart rate was fast, chest tight and she developed mild itching. On an unknown date, at urgent care, the patient received prednisone, Bactrim DS (sulfamethoxazole, trimethoprim) and Benadryl (Diphenhydramine hydrochloride) as treatment. Causality is assessed as possibly related for all events. The events of erythema, peripheral swelling and feeling hot may suggest cellulitis, however, collaboration criteria for cellulitis at injection site could not be assessed due to insufficient information provided.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Upper arm was swollen, red and hot; Upper arm was swollen, red and hot; Upper arm was swollen, red and hot; Heart rate was fast; Chest tight; Itching; This spontaneous case was received on 13-Jun-2021 from Communications (reference number: SEQW21-01429), reported by other non-health professional (consumer) and concerned a 24-year-old, female patient.  The patient had no medical history and was not taking any concomitant medications.  On 13-Nov-2017, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; anatomical location: deltoid, route of administration: intramuscular and dose: 0.5 ml) for influenza prophylaxis. The batch number reported was 01644611A.   On the same day, after receiving Afluria Quadrivalent, patient's upper arm was swollen, red and hot, her heart rate was fast, chest tight and she developed mild itching.  On an unknown date, at urgent care, the patient received prednisone, Bactrim DS (sulfamethoxazole, trimethoprim) and Benadryl (Diphenhydramine hydrochloride) as treatment.  On 22-Nov-2017, the patient recovered from the events.  The reporter assessed the event to be related to Afluria Quadrivalent. The reporter stated that the patient had reaction to 2017 vaccine.   The case was assessed as non-serious.  Company comment: A 24-year-old, female patient was vaccinated with Afluria Quadrivalent. On the same day, after receiving Afluria Quadrivalent, patient's upper arm was swollen, red and hot, her heart rate was fast, chest tight and she developed mild itching. On an unknown date, at urgent care, the patient received prednisone, Bactrim DS (sulfamethoxazole, trimethoprim) and Benadryl (Diphenhydramine hydrochloride) as treatment. Causality is assessed as possibly related for all events. The events of erythema, peripheral swelling and feeling hot may suggest cellulitis, however, Brighton collaboration criteria for cellulitis at injection site could not be assessed due to insufficient information provided.; Reporter's Comments: Consumer had reaction to 2017 vaccine.; Sender's Comments: A 24-year-old, female patient was vaccinated with Afluria Quadrivalent. On the same day, after receiving Afluria Quadrivalent, patient's upper arm was swollen, red and hot, her heart rate was fast, chest tight and she developed mild itching. On an unknown date, at urgent care, the patient received prednisone, Bactrim DS (sulfamethoxazole, trimethoprim) and Benadryl (Diphenhydramine hydrochloride) as treatment. Causality is assessed as possibly related for all events. The events of erythema, peripheral swelling and feeling hot may suggest cellulitis, however, collaboration criteria for cellulitis at injection site could not be assessed due to insufficient information provided.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered Lot#047B21A, but lot#008C21A(exp: 5/20/2021) was logged on forms.Lot#047B21A expired on 5/13/2021.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: Kidney started hurting the next morning
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Bradycardia, Cardioversion, Echocardiogram, Electrocardiogram
Clinical narrative: Sometime within the next 30 days patient started experiencing cold hands and feet, exercise intolerance, and heart palpitations. By May of 21 she was hospitalized after having sustained HR of 279 requiring cardiac conversion and is now in need of a heart ablation. She also has bradycardia events while sleeping along with living most of her life in tachycardia.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Electrocardiogram ambulatory, Exercise tolerance decreased, Palpitations, Peripheral coldness
Clinical narrative: Sometime within the next 30 days patient started experiencing cold hands and feet, exercise intolerance, and heart palpitations. By May of 21 she was hospitalized after having sustained HR of 279 requiring cardiac conversion and is now in need of a heart ablation. She also has bradycardia events while sleeping along with living most of her life in tachycardia.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered Lot#047B21A, but lot#008C21A(exp: 5/20/2021) was logged on forms.Lot#047B21A expired on 5/13/2021.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Dizziness, Headache, Intermenstrual bleeding, Lymphadenopathy
Clinical narrative: Neck tightening (immediate but was most likely the lymph nodes reacting and not allergy), 35 minutes after receiving the vaccine, tingling tongue and lips, tongue swelling with difficulty speaking. These went away as soon as I got close to the hospital so I did not seek medical treatment. 45 minutes after receiving vaccine, headache and lymph node swelling. 30 hours after receiving the vaccine rashon arm that started out as small hives and then grew to a rash 4 inches side and 2 inches tall and this lasted for 5 days. The rash was so inflamed that an ice pack could not cool the skin. Dizziness for 2 days.  Hives on left foot the 3rd day that went away quickly and hives on right food on the 4th day after receiving the vaccine that went away quickly. Excessive thirst the first 2 days and dry mouth. Bleeding/spotting for 5 days even though my period had ended 2 days prior to receiving the vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Paraesthesia oral, Rash, Swollen tongue, Urticaria
Clinical narrative: Neck tightening (immediate but was most likely the lymph nodes reacting and not allergy), 35 minutes after receiving the vaccine, tingling tongue and lips, tongue swelling with difficulty speaking. These went away as soon as I got close to the hospital so I did not seek medical treatment. 45 minutes after receiving vaccine, headache and lymph node swelling. 30 hours after receiving the vaccine rashon arm that started out as small hives and then grew to a rash 4 inches side and 2 inches tall and this lasted for 5 days. The rash was so inflamed that an ice pack could not cool the skin. Dizziness for 2 days.  Hives on left foot the 3rd day that went away quickly and hives on right food on the 4th day after receiving the vaccine that went away quickly. Excessive thirst the first 2 days and dry mouth. Bleeding/spotting for 5 days even though my period had ended 2 days prior to receiving the vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Neck tightening (immediate but was most likely the lymph nodes reacting and not allergy), 35 minutes after receiving the vaccine, tingling tongue and lips, tongue swelling with difficulty speaking. These went away as soon as I got close to the hospital so I did not seek medical treatment. 45 minutes after receiving vaccine, headache and lymph node swelling. 30 hours after receiving the vaccine rashon arm that started out as small hives and then grew to a rash 4 inches side and 2 inches tall and this lasted for 5 days. The rash was so inflamed that an ice pack could not cool the skin. Dizziness for 2 days.  Hives on left foot the 3rd day that went away quickly and hives on right food on the 4th day after receiving the vaccine that went away quickly. Excessive thirst the first 2 days and dry mouth. Bleeding/spotting for 5 days even though my period had ended 2 days prior to receiving the vaccine.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash, Rhinorrhoea
Clinical narrative: Runny Nose, Headache and a rash that spread to to neck, down the chest and breast are this happen 3 hours after she received the vaccine.  Clinician ordered OTC Hydrocortisone 1% to be applied on the rash.
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood test, Chills, Colitis microscopic, Colonoscopy, Culture stool
Clinical narrative: Fever, chill, tired, diarrhea  Fever, chill, and tiredness all cleared up with 8 hours. The diarrhea persists (9 weeks). Current diagnosis is microscopic colitis and I will be beginning a course of steroids to stop the inflammation
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Diarrhoea, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever, chill, tired, diarrhea  Fever, chill, and tiredness all cleared up with 8 hours. The diarrhea persists (9 weeks). Current diagnosis is microscopic colitis and I will be beginning a course of steroids to stop the inflammation
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered Lot#047B21A, but lot#008C21A(exp: 5/20/2021) was logged on forms.Lot#047B21A expired on 5/13/2021.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: shivering, fever, tiredness, sore arm
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Additional Details: patient experienced swelling soreness, warmth and pain at injection site
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Intracranial aneurysm
Clinical narrative: A friend of the patient called us today to inform us that the patient had recently passed away from a brain aneurysm. The friend asked it it were possible that this occurrence was somehow related to patient receiving his covid vaccination. The friend did not have a lot of information about the occurrence; he only stated that the patient's brain aneurysm was about 6 weeks after his 2nd dose of the covid vaccine. Patient was not a regular patient of ours so we have no additional medical history for him. We administered his first Moderna vaccine on 4-2-2021, and he returned for his second dose on 4-30-2021. I assured the friend I would report this to VAERS and thanked him for reaching out to us on behalf of patient.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: Fatigue, vomiting, chills, dizzy, sore swollen arm.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fatigue, vomiting, chills, dizzy, sore swollen arm.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Extreme menstrual irregularity and menorrhagia. Start of symptoms on April 12 cut short average 28-29 day cycle to only 21 days (March 22 to April 11). Cycle starting April 12 began with 6-day period, and full cycle only lasted 10 days ? including 2 days of spotting during the 4 non-period days. Following cycle began April 22 with a 6-day period, but full cycle extended to 32 days. Following cycle began May 24 with a 12-day period with extreme heavy bleeding, and full cycle was short at only 23 days. Most recent cycle began June 16 and currently on Day 10 of an extremely heavy period. On Days 7-9 of the current period, I would estimate blood loss of at least 70-100 grams each day, given usage rate of feminine hygiene products.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Burning sensation, Condition aggravated, Dizziness
Clinical narrative: I got dizzy and experienced pain under my rib cage after 20 mins of getting the vaccine. Then I felt exhausted. I had severe upper arm pain at the injection shot. I was having symptoms of a UTI infection so I went to the doctor. They did a urine test and gave me antibiotics for it. I ended up getting thrush after 2 days of taking antibiotics. I had to go back to the doctor to get rid of the thrush. It made my chronic pain worse and in my lower back I felt a burning sensation. I had pain all over my body joints. The pain didn't go away until a month or 6 weeks later. The day after receiving the shot, the left side of my body was in pain. Then the next day I had pain on the right side of my body.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Musculoskeletal chest pain, Pain, Urine analysis
Clinical narrative: I got dizzy and experienced pain under my rib cage after 20 mins of getting the vaccine. Then I felt exhausted. I had severe upper arm pain at the injection shot. I was having symptoms of a UTI infection so I went to the doctor. They did a urine test and gave me antibiotics for it. I ended up getting thrush after 2 days of taking antibiotics. I had to go back to the doctor to get rid of the thrush. It made my chronic pain worse and in my lower back I felt a burning sensation. I had pain all over my body joints. The pain didn't go away until a month or 6 weeks later. The day after receiving the shot, the left side of my body was in pain. Then the next day I had pain on the right side of my body.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Transcription medication error
Clinical narrative: Administered with 008C21A on 5/21, date updated to 5/20 in system. Vaccine was administered on 5/20/21 but logged after 12:00am on 5/21/2021.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received the dose after manufacturer recommended freezer storage duration.