chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received vaccinations of Fluzone QIV NP that expired, with no adverse event; Pregnant woman received vaccinations of Fluzone QIV NP that expired on 30-Jun-2021, with no AE; Initial information regarding an unsolicited valid non-serious case was received from other Health Professional via Medical Information (Reference number- 00768512) and transmitted to Sanofi on 14-Sep-2021.  This case involves a 32-year-old female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] after she received expired dose at 32 weeks of pregnancy, during third pregnancy trimester (expired product administered and exposure during pregnancy).  Data regarding this pregnancy were received prospectively.  The date of last menstrual period was reported as 06-Feb-2021.  The estimated due date is 18-Nov-2021.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  The patient had no previous pregnancy/ies.  On 14-Sep-2021, the patient received a 0.5 mL first dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ702AA and expiry date: 30-Jun-2021) via intramuscular route in the right deltoid for prophylactic vaccination (expired product administered and exposure during pregnancy).  It was an actual medication error case due to expired vaccine used and vaccine exposure during pregnancy (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: 66.0
Sex: U
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received QUADRIVALENT INFLUENZA VACCINE instead of FLUZONE HIGH-DOSE QUADRIVALENT with no reported adverse event; Initial information was received on 14-Sep-2021 regarding an unsolicited valid non-serious case from pharmacist and non-healthcare professional via call center via Medical Information (Reference number- 00768700).  This case involves a 66 years old patient of unknown gender who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong vaccine administered (latency: same day).  At the time of reporting, no adverse event reported.  It was reported "The caller would like to know what the next steps are for the patient and if it is recommended that the patient get a second shot of the regular dose or a second shot of the high dose Fluzone."  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.
Sex: U
Vaccine: MNQ
Symptoms: Syringe issue, Underdose
Clinical narrative: MENACTRA to a patient but only injected about 0.4mL instead of 0.5mL full dose. The 0.1mL was expelled out from the needle with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (Reference number- 00768862) and transmitted to Sanofi on 14-Sep-2021.  This case involves an unknown age and gender patient who vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot and expiry date not reported) but only injected about 0.4ml instead of 0.5ml full dose and 0.1ml was expelled out from the needle via unknown route at an unknown administration site on an unknown date for prophylactic vaccination (incorrect dose administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to incomplete dose administered (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 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.  There will be no information available on batch number for this case.
Age: 64.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Medical Assistant inadvertently gave a vaccine DAPTACEL to patient instead of ADACEL with no adverse evnt; Initial information was received on 14-Sep-2021 regarding an unsolicited valid non-serious case received from a other healthcare professional and physician via Medical information (under reference number -00768917).  This case involves a 64-year-old female patient who was accidentally vaccinated with DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [ADACEL] with no adverse event (Wrong product administered).  The patient's medical history past medical treatment, vaccination, concomitant medication and family history were not provided.   On 19-Aug-2021, the patient received a 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number C5765BA and expiry date 28-08-2022) via intramuscular route in the left arm for prophylactic vaccination (Wrong product administered).  It was reported "They want to make sure it's okay and when/if to vaccinate patient with the correct vaccine?".  There were no laboratory data/results available.  It was case of an actual medication error due to wrong vaccine administered (latency was on 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 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: FLU4
Symptoms: Feeling abnormal, Immediate post-injection reaction, Paranoia
Clinical narrative: and it made her feel/think weird; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional (patient) via Medical Information (Reference number- 00770570) and transmitted to Sanofi on 15-Sep-2021.  This case involved an unknown age female patient who feel/think weird (feeling abnormal) while receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Relevant 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 INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious feel/think weird (feeling abnormal) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported "Caller is a patient that was wanting to know more about the ingredients in our FLUZONE QIV vaccine. Patient unsure if she received it from MDV (multidose vial) or not, and could not give me date she received vaccine. She asked about "nano-particles" and how she had done research online about how we are putting them in our vaccines without disclosing that information. She then accused us of tracking her and her kids through the vaccine. Caller states she could feel the vaccine in her and she could now think of something and it would show up on her phone later in the day. Caller refused to give most demographic information other than name and phone number. Caller ended call after I listed the ingredients in the prescribing information for her and let her know I had no other information in regard to what she was asking for. Was not able to offer survey".   No relevant laboratory data was provided.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: local site swelling, redness, warmth; local site itching; Initial information received on 15-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Agency (under the reference 00770771).  This case is linked to case 2021SA305481 (cluster).  This case involved a 27 years old female patient who had local site swelling, redness, warmth (inflammation) and itching (pruritus), after receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  The patient had no other vaccinations at the time of report.  On 07-Sep-2021, the patient received a first dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (0.5 ml, lot U6969AB and Expiration date: 03-Apr-2023, frequency: once, dose: 1) via intramuscular route in the right deltoid for prophylactic vaccination.  On an unknown date, the patient developed a non-serious local site swelling, redness, warmth (inflammation) and itching (pruritus), (unknown latency) following the administration of vaccine.  It was reported "Caller states that she is calling to add some information to a previously reported. Refer to inquiry 00766640. Caller states that they recently started giving out Adacel with lot: U6969AB, Expiration date: 03/04/2023 and NDC: 49281-0400-89. They have never had an issue with Adacel until this particular lot. There are 5 doses in the box and 4 have been given. Three 3 people has had a reaction. and they have all been the same. It is local site swelling, redness, warmth and itching. Caller states that they have stopped giving the lot number. "  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site erythema, Vaccination site inflammation, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: local site swelling, redness, warmth; local site swelling, redness, warmth; local site swelling, redness, warmth; local site swelling, redness, warmth; local site itching; Initial information was received on 15-Sep-2021 regarding an unsolicited valid non-serious case received from a Consumer. This case involves a 34-year-old female patient who experienced local site swelling, redness and warmth (Vaccination site swelling, Vaccination site erythema, Vaccination site warmth) and diagnosed with (Vaccination site inflammation) and local site itching (Vaccination site pruritus) while receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 07-Sep-2021, the patient received a 0.5 ml (total) dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot U6969AB and expiry date 03-Apr-2023] via intramuscular route in the left deltoid for prophylactic vaccination.  On 07-Sep-2021 the patient developed non-serious local site swelling, redness and warmth (Vaccination site swelling, Vaccination site erythema, Vaccination site warmth) and diagnosed with (Vaccination site inflammation) and local site itching (Vaccination site pruritus) on the same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported "They recently started giving out Adacel. They have never had an issue with Adacel until this particular lot. There are 5 doses in the box and 4 have been given. Three 3 people has had a reaction. and they have all been the same. It is local site swelling, redness, warmth and itching. Caller states that they have stopped giving the lot number'.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.    At the time of report, the outcome of events was unknown.
Sex: U
Vaccine: DTAPIPVHIB, FLU4, HIBV, IPV, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: vaccine were exposed to 16.8 F Celsius for 3 and a half hours /no AE; Initial information received on 15-Sep-2021 regarding an unsolicited valid non-serious case received from an other health professional and consumer non health care professional via Medical Information (Reference number- 00771168).  This case was considered as non-valid due to no involvement of patient.  This case involved vaccines POLIOMYELITIS VACCINE (INACTIVATED) [IPOL], DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL], MENINGOCOCCAL VACCINE [MENACTRA], DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [ADACEL], HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] AND QUADRIVALENT INFLUENZA VACCINE [QUADRIVALENT INFLUENZA VACCINE] (lot number and expiry date not reported) were exposed to 16.8 f celsius for 3 and a half hours /no adverse event (product storage error).  It was potential medication error case due to product storage error temperature too low.  It was not reported whether any patient had received the product and experienced any 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: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Contusion
Clinical narrative: Dark purple bruise about the size of a quarter; Worried about not getting the full benefit of the vaccine due to incorrect administration; This spontaneous case was received on 14-Sep-2021 from other non-health professional (consumer) via Med Communications (reference number: SEQW21-02224) and concerned a 63-year-old female patient.  The patient had no relevant medical history and was not taking any concomitant medications. The patient's historical vaccines included two shots of an unspecified Covid vaccine in the same arm.   On 08-Sep-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular and indication: not reported). The batch number was not reported.  On 09-Sep-2021, one day after receiving Flucelvax Quadrivalent, the patient developed a dark purple bruise about the size of a quarter.   On an unspecified date in Sep-2021, the patient was worried about not getting the full benefit of the vaccine due to incorrect administration (explicitly coded as 'Product administration error'). There were no treatment measures associated with the event.  The outcome of the events was not reported.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: A 63-year-old patient was administered Flucelvax Quadrivalent. One day after receiving the vaccine, the patient developed a dark purple bruise about the size of a quarter. Reportedly, the patient was worried about not getting the full benefit of the vaccine due to incorrect administration. Product administration error is assessed as unrelated per company's conventions.; Sender's Comments: A 63-year-old patient was administered Flucelvax Quadrivalent. One day after receiving the vaccine, the patient developed a dark purple bruise about the size of a quarter. Reportedly, the patient was worried about not getting the full benefit of the vaccine due to incorrect administration. Product administration error is assessed as unrelated per company's conventions.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Blood test, Chest pain, Electrocardiogram
Clinical narrative: Immediate and sudden numbness and tingling in left hand/fingers 8/15/2021 Extreme pain in left arm, left  armpit, side of left neck , numbness and tingling in left elbow and hand/fingers 8/18/21 Extreme Pain in left side of chest, left arm , left armpit, and left side of neck 8/25/21 Extreme pain in the left arm, left shoulder, and  left side of neck
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neck pain, Pain in extremity, Paraesthesia, Ultrasound scan
Clinical narrative: Immediate and sudden numbness and tingling in left hand/fingers 8/15/2021 Extreme pain in left arm, left  armpit, side of left neck , numbness and tingling in left elbow and hand/fingers 8/18/21 Extreme Pain in left side of chest, left arm , left armpit, and left side of neck 8/25/21 Extreme pain in the left arm, left shoulder, and  left side of neck
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Diarrhoea, Dyspnoea
Clinical narrative: Three days after receiving my first Pfizer shot, I started having chest pain and shortness of breath. I ended up being off of work for 9 days. During that time, I have had an echo, holter monitor placed, chest xray, blood work, a covid test which was negative, fever 102 on and off for the 9 days I was off of work. Nausea, vomiting, diarreah, and my blood pressure resting is 150/108 and I am a healthy person and is never sick. Headaches as well. My heart now has irregular beats and I am being referred to a cardiologist.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram ambulatory, Headache, Heart rate irregular, Impaired work ability
Clinical narrative: Three days after receiving my first Pfizer shot, I started having chest pain and shortness of breath. I ended up being off of work for 9 days. During that time, I have had an echo, holter monitor placed, chest xray, blood work, a covid test which was negative, fever 102 on and off for the 9 days I was off of work. Nausea, vomiting, diarreah, and my blood pressure resting is 150/108 and I am a healthy person and is never sick. Headaches as well. My heart now has irregular beats and I am being referred to a cardiologist.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test negative, Vomiting
Clinical narrative: Three days after receiving my first Pfizer shot, I started having chest pain and shortness of breath. I ended up being off of work for 9 days. During that time, I have had an echo, holter monitor placed, chest xray, blood work, a covid test which was negative, fever 102 on and off for the 9 days I was off of work. Nausea, vomiting, diarreah, and my blood pressure resting is 150/108 and I am a healthy person and is never sick. Headaches as well. My heart now has irregular beats and I am being referred to a cardiologist.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain
Clinical narrative: Headache: 7 days and counting Body ache  7 days and counting Joint pain  7 days and counting Fatigue  7 days and counting
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Left arm  is swollen and itchy
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Skin hyperpigmentation
Clinical narrative: Sever dermatitis to the body left arm chest stomach flank, resulting in hyper pigmentation
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Left arm injection site pain when touched for approx. 5 days. No treatment needed.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: Some fatigue and weakness since getting Pfizer vaccine for COVID-19 (not present before getting vaccinated).
Age: 40.0
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: developed a rash down face and neck; This spontaneous report was received from a nurse referring to a 40 years old female patient. No illness at the time of vaccination was reported. No known drug allergies was reported. Information about pertinent medical history and concomitant medication was unknown.     On 09-AUG-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# T025369, expiration date 01-DEC-2022; strength and dose were not reported) intramuscularly  in the right deltoid for prophylaxis.    On the same day, 30 minutes after being administered the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient developed a rash down her face and neck. The patient sought medical attention. The patient was administered acrivastine (BENADRYL) which had addressed the problem. It was unknown if lab diagnostics or studies were performed or not. The patient had recovered from the event on unknown date in August 2021. The reporter consider the event to as attributable to the vaccine. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T025369; expirationdate: 01-DEC-2022; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccine breakthrough infection
Clinical narrative: Shingles/had a breakthrough shingles attack after the first shot; Costly but so worth it to avoid that pain!; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient stated that there was a vaccine for shingles and had a breakthrough shingles attack after the first shot. The patient never want that stuff again. The patient also took the new and improved vaccine and stated that it was costly but worth it to avoid that pain.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: NEEDLE WAS VERY PAINFUL GOING IN.; DARK LINE / where THE INJECTION SITE WAS.; BLEEDING DOWN MY ARM.; REDNESS; SWELLING; MY BICEP IS EXTREMELY SORE--; This case was reported by a consumer and described the occurrence of injection site pain in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included visual impairment.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain, injection site discoloration, injection site hemorrhage, injection site erythema, injection site swelling and pain in arm. On an unknown date, the outcome of the injection site pain, injection site discoloration, injection site hemorrhage, injection site erythema, injection site swelling and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site discoloration, injection site hemorrhage, injection site erythema, injection site swelling and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient was visually impaired and thus reported in caps and large bold font. The patient received 1st dose of Shingrix and experienced redness and swelling and also had dark line measuring approximately 1 and half inch running diagonally across his/her left bicep at injection site. The patient reported that the needle was very painful and there was bleeding at time of vaccination. The patient's bicep was extremely sore, much more than he/she expected. The patient enquired about the dark line and also enquired that the pharmacist injected her vaccine correctly.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: NEEDLE WAS VERY PAINFUL GOING IN.; DARK LINE / where THE INJECTION SITE WAS.; BLEEDING DOWN MY ARM.; REDNESS; SWELLING; MY BICEP IS EXTREMELY SORE--; This case was reported by a consumer and described the occurrence of injection site pain in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included visual impairment.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain, injection site discoloration, injection site hemorrhage, injection site erythema, injection site swelling and pain in arm. On an unknown date, the outcome of the injection site pain, injection site discoloration, injection site hemorrhage, injection site erythema, injection site swelling and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site discoloration, injection site hemorrhage, injection site erythema, injection site swelling and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient was visually impaired and thus reported in caps and large bold font. The patient received 1st dose of Shingrix and experienced redness and swelling and also had dark line measuring approximately 1 and half inch running diagonally across his/her left bicep at injection site. The patient reported that the needle was very painful and there was bleeding at time of vaccination. The patient's bicep was extremely sore, much more than he/she expected. The patient enquired about the dark line and also enquired that the pharmacist injected her vaccine correctly.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: given an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 60-year-old female patient who received HAV (Havrix) (batch number unknown, expiry date 11th September 2021) for prophylaxis.   On 14th September 2021, the patient received Havrix. On 14th September 2021, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: This case was reported by the nurse. The age at vaccination was not reported. The nurse reported that a patient had been given an expired dose of Havrix on 14th September 2021 and vaccine expiration date was 11th September 2021,which led to expired vaccine used. The nurse reported that no more information available to reporter since the information had been given to them by someone else. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the diluent component of SHINGRIX; received only the diluent component of SHINGRIX; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number ZJ432, expiry date 27th May 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as the age at vaccination was not reported. The patient received only the diluent component of Shingrix, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The vaccine was given by different nurses from the facility. The health care professional had not identified which were the patients who received only the diluent component of Shingrix at the time of the reporting. No further details were provided. The reporter consented to follow up by email since the reporting nurse was not always at her desk. This case is one of 7 cases reported by same reporter. Sender's Comments:  US-GLAXOSMITHKLINE-US2019103287: same reporter US-GLAXOSMITHKLINE-US2021AMR199621: Original Case : US2021199083 US-GLAXOSMITHKLINE-US2021AMR199620:Original Case : US2021199083 US-GLAXOSMITHKLINE-US2021AMR199619:Original Case : US2021199083 US-GLAXOSMITHKLINE-US2021AMR199618:Original Case : US2021199083 US-GLAXOSMITHKLINE-US2021AMR199617:Original Case : US2021199083 US-GLAXOSMITHKLINE-US2021AMR199616:Original Case : US2021199083
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: have not received the second dose yet.; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 29th June 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient had not received the 2nd dose of Shingrix, which led to incomplete course of vaccination.  The VAERS details reported for 1st dose of Shingrix. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: DEVELOPED BLOOD CLOTS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, and batch number: Unknown, expiry: Unknown ) dose was not reported, 1 in total, administered on 16-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 16-SEP-2021, the patient took the covid shot and developed blood clots and now patient had to take Xarelto. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of developed blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210933744-COVID-19 VACCINE AD26.COV2.S.- Developed blood clots. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Eye pain, Fatigue, Headache, Pruritus
Clinical narrative: ITCHY SKIN IRRITATION ON LEFT ARM; LOSS OF APPETITE; FATIGUE(LOW ENERGY LEVELS); URINARY INCONTINENCE; FEVERISH; ACHY FOREHEAD; ACHY EYES; MILD RASH; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included: appendectomy, and concurrent conditions included: antibiotic allergy. The patient experienced drug allergy when treated with epinephrine, promethazine, and tramadol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On SEP-2021, the patient experienced mild rash. On 08-SEP-2021, the patient experienced urinary incontinence. On 08-SEP-2021, the patient experienced achy eyes. On 08-SEP-2021, the patient experienced feverish. On 08-SEP-2021, the patient experienced achy forehead. On 09-SEP-2021, the patient experienced loss of appetite. On 09-SEP-2021, the patient experienced fatigue (low energy levels). On 13-SEP-2021, the patient experienced itchy skin irritation on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from urinary incontinence, achy eyes, feverish, and achy forehead on 09-SEP-2021, loss of appetite, and fatigue(low energy levels) on 11-SEP-2021, and mild rash on SEP-2021, and the outcome of itchy skin irritation on left arm was not reported. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Urinary incontinence
Clinical narrative: ITCHY SKIN IRRITATION ON LEFT ARM; LOSS OF APPETITE; FATIGUE(LOW ENERGY LEVELS); URINARY INCONTINENCE; FEVERISH; ACHY FOREHEAD; ACHY EYES; MILD RASH; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included: appendectomy, and concurrent conditions included: antibiotic allergy. The patient experienced drug allergy when treated with epinephrine, promethazine, and tramadol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On SEP-2021, the patient experienced mild rash. On 08-SEP-2021, the patient experienced urinary incontinence. On 08-SEP-2021, the patient experienced achy eyes. On 08-SEP-2021, the patient experienced feverish. On 08-SEP-2021, the patient experienced achy forehead. On 09-SEP-2021, the patient experienced loss of appetite. On 09-SEP-2021, the patient experienced fatigue (low energy levels). On 13-SEP-2021, the patient experienced itchy skin irritation on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from urinary incontinence, achy eyes, feverish, and achy forehead on 09-SEP-2021, loss of appetite, and fatigue(low energy levels) on 11-SEP-2021, and mild rash on SEP-2021, and the outcome of itchy skin irritation on left arm was not reported. This report was non-serious.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a vaccine which was more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medications were not provided by the reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: Lethargic for 1 day; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic for 1 day) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Reaction:elevated blood pressure -- doctor had prescribed new med, stopped taking immediately, years ago). Concomitant products included QUINAPRIL for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LETHARGY (Lethargic for 1 day). At the time of the report, LETHARGY (Lethargic for 1 day) had resolved.            The reporter stated that she took Vitamins one time after vaccination.   This case was linked to MOD-2021-029398 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Suspected COVID-19, Vaccination complication, Vomiting
Clinical narrative: Very concerned about negative side effects from the Moderna second dose vaccination; Sick; Covid symptoms; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Very concerned about negative side effects from the Moderna second dose vaccination), ILLNESS (Sick), SUSPECTED COVID-19 (Covid symptoms), NAUSEA (Nausea) and VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Very concerned about negative side effects from the Moderna second dose vaccination), ILLNESS (Sick), SUSPECTED COVID-19 (Covid symptoms), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, VACCINATION COMPLICATION (Very concerned about negative side effects from the Moderna second dose vaccination), ILLNESS (Sick), SUSPECTED COVID-19 (Covid symptoms), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved.            Consumer stated his fiance was sick for  4 days after 2nd vaccine. Her adverse event which consisted of nausea, vomiting, and other Covid symptoms. Reporter stated from his knowledge she had recovered.  No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-319901, MOD-2021-319901 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow-up received on 15 Sep 2021contains information included reporter contact details, New events and outcome of event vaccination complication updated to recovered.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Cold sweat, Flushing, Heart rate increased, Pruritus
Clinical narrative: Clammy, severe facial itching, fast heartbeat, face flushed.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: In June 2021, several weeks after my second Moderna vaccine, I noticed that my hair was falling out in one spot. My hairdresser also commented about my hair loss in July. The hair loss continued and worsened and spread throughout the summer. I have had previous incidents of Alopecia Areata, but nothing to this extent. I am currently being treated with scalp steroid injections and topical treatments.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received mixed dose series of Pfizer (1) and Moderna (2)
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Laboratory test, Paralysis, Sensory loss
Clinical narrative: 3 days later my husband completely lost feeling on his left side and ended up with three strokes at once and three more we can have later has been since left after sit in a facility he spent 6 weeks in the hospital when it first happened and like I said it's paralyzed now and I'm not facility and I'm having a hard time getting insurance for him for long-term care
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Borrelia test, Chest X-ray, Chills
Clinical narrative: Persistent Cough Flu - 2 weeks after first dose Persistent chills Fever Persistent headaches  Joint aches Occasional episodes of shortness of breath
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Cough, Dyspnoea, Full blood count, Headache
Clinical narrative: Persistent Cough Flu - 2 weeks after first dose Persistent chills Fever Persistent headaches  Joint aches Occasional episodes of shortness of breath
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza, Legionella test, Pyrexia, Respiratory viral panel, SARS-CoV-2 test
Clinical narrative: Persistent Cough Flu - 2 weeks after first dose Persistent chills Fever Persistent headaches  Joint aches Occasional episodes of shortness of breath
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Photophobia, Vision blurred
Clinical narrative: blurred vision, brain fog, light sensitivity, dizziness
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Asthenia, Blood creatinine increased, Blood sodium decreased, COVID-19
Clinical narrative: Hospitalized 9/18/2021; COVID-19 positive on 9/13/2021; fully vaccinated  Patient is a 91-year-old woman with past medical history of diastolic congestive heart failure, aortic stenosis, coronary artery disease, pulmonary hypertension, hypertension, chronic atrial fibrillation not on anticoagulation, history of TIA, seizures, type 2 diabetes and history of chronic hyponatremia due to fluid overload.  Presented to the emergency department as she was not feeling well and experiencing generalized weakness and shortness of breath.  She got tested positive for COVID on 09/13/2021.  In the emergency department patient was febrile at 38.6° F otherwise hemodynamically stable.  She was able to breathe comfortably on room air.  Her labs were consistent with sodium of 125 and urine analysis was positive for urinary tract infection.  Since patient was complaining of urinary frequency over the past few days she was started on IV Rocephin for possible cystitis.  In the absence of hypoxia she did not receive Decadron or remdesivir.  She received regeneron monoclonal antibody infusion while she was hospitalized here during this admission.  Repeat labs showed improvement in sodium levels at 1:30 a.m. however patient's kidney function was altered with some AKI with creatinine of 1.2 to and GFR of 41. She will need repeat BMP on Monday to reassess her kidney function and sodium levels.  Her AKI could be related to fluid overload from the monoclonal antibody infusion that she received.  PCP to follow patient's BMP.  She was evaluated at the time of discharge for the need of home oxygen and did not require any oxygen per Pulmonary Rehab. She was discharged home with home care services on 9/19/21.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray abnormal, Dyspnoea, Glomerular filtration rate decreased, Lung infiltration, Malaise
Clinical narrative: Hospitalized 9/18/2021; COVID-19 positive on 9/13/2021; fully vaccinated  Patient is a 91-year-old woman with past medical history of diastolic congestive heart failure, aortic stenosis, coronary artery disease, pulmonary hypertension, hypertension, chronic atrial fibrillation not on anticoagulation, history of TIA, seizures, type 2 diabetes and history of chronic hyponatremia due to fluid overload.  Presented to the emergency department as she was not feeling well and experiencing generalized weakness and shortness of breath.  She got tested positive for COVID on 09/13/2021.  In the emergency department patient was febrile at 38.6° F otherwise hemodynamically stable.  She was able to breathe comfortably on room air.  Her labs were consistent with sodium of 125 and urine analysis was positive for urinary tract infection.  Since patient was complaining of urinary frequency over the past few days she was started on IV Rocephin for possible cystitis.  In the absence of hypoxia she did not receive Decadron or remdesivir.  She received regeneron monoclonal antibody infusion while she was hospitalized here during this admission.  Repeat labs showed improvement in sodium levels at 1:30 a.m. however patient's kidney function was altered with some AKI with creatinine of 1.2 to and GFR of 41. She will need repeat BMP on Monday to reassess her kidney function and sodium levels.  Her AKI could be related to fluid overload from the monoclonal antibody infusion that she received.  PCP to follow patient's BMP.  She was evaluated at the time of discharge for the need of home oxygen and did not require any oxygen per Pulmonary Rehab. She was discharged home with home care services on 9/19/21.