chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history.   In 2010, the patient was vaccinated with a dose of the zoster vaccine live (ZOSTAVAX) (lot number, expiration date, anatomical location and administration route were not reported) at a clinic, for the long-term prevention of shingles and/or zoster-related conditions. On an unspecified date, subsequent to the patient's zoster vaccine live (ZOSTAVAX inoculation, patient was treated by a physician for shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization (on an unknown date), physician care, monitoring, treatment, medications, and supplies. By the time of the report, the patient did not recover from shingles. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 15 months old female patient was administered a dose of Daptacel on 18-Feb-2020, before realizing the vaccine was expired on 30-Jan-2020/No AE; Initial information received on 18-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old female patient who was administered a 0.5ml fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] on 18-Feb-2020, before realizing the vaccine was expired on 30-Jan-2020 (lot C5367AA) via intramuscular route in the left thigh for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB).  It was an actual medication error due to expired vaccine used.  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 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: 3.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Three year patient received Adacel vaccine instead of Tdap vaccine/ No AE; Three year patient received Adacel vaccine instead of Tdap vaccine/ No AE; Initial information received on 18-Feb-2020 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a three-year-old female patient who vaccinated with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.   Medical history, medical treatment, vaccination and family history were not provided.  On 17-Feb-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [4th dose in DTP series, lot C5556AA, expiry date: 03-Dec-2020] via an intramuscular route at the right thigh instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (TDAP) produced by unknown manufacturer for prophylactic vaccination.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  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 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: M
Vaccine: RAB
Symptoms: Blood test, Extra dose administered, No adverse event
Clinical narrative: Patient received 38 Imovax vaccines in the past three months/ No AE; Initial and follow up information was received on 20-Feb-2020 and on 21-Feb-2020 regarding an unsolicited valid non-serious case from a other health care professional.  This case involves a 42 years old male patient who from Nov-2019, received 38 doses of vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] (lot number not reported via unknown route in unknown administration site for an unknown indication in past three months (extra dose administered)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing delusion (patient was delusional and during his states he believes that he has contracted rabies).  The reporter stated that the patient had not been bitten but was cleaning in an area with bats and thinks he has rabies and in the last three months has had a total of 38 rabies injections from different facilities he has checked into in the new area.   It was of actual medication error case due to extra dose administered.  Relevant laboratory test results included: Blood test - In Sep- 2019 and in Oct-2019:  [Unknown] (had blood draws to show that patient didn't have rabies).  At the time of reporting, 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 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.  Information on the batch number was requested.  After the internal review on 04-Mar-2020, the case 2020SA047837 was identified to be a duplicate of the 2020SA051321. Hence the case 2020SA051321 qualified for deletion and all information has merged in retained case 2020SA047837.
Age: 4.0
Sex: U
Vaccine: FLU3, FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administration of Fluzone Quadrivalent to a 4 year-old, but now they have realized that it was actually High-Dose/no ae; administration of Fluzone Quadrivalent to a 4 year-old, but now they have realized that it was actually High-Dose/no ae; administration of Fluzone Quadrivalent to a 4 year-old, but now they have realized that it was actually High-Dose/no ae; Initial information received on 20-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 year old patient who was given 0.5mL of dose 1 of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ290AA, of Expiration date: 09-JUN-2020) via unknown route at left leg for prophylactic vaccination instead of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on 31-Jan-2020 (wrong product administered, Product administered to patient of inappropriate age and overdose).  Medical history, concomitant, medical treatment, vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination, VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination; DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for prophylactic vaccination and POLIO VACCINE (POLIO) for prophylactic vaccination.  It was a case of actual medication error case due to wrong product administered, inappropriate age at vaccine administration and overdose.  The patient had no adverse effect at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Menactra was given on 19-feb-2020 to female nonpregnant/no AE; Initial information received on 21-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (office staff).  It was reported that 16 years old nonpregnant female patient received a 0.5 ml dose of expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered) on 19-feb-2020 for prophylactic vaccination via intramuscular route at the left deltoid [lot U6015AA and expiry date 06-OCT-2019].  Medical history, concomitant therapy,medical treatment(s), vaccination(s) and family history were not provided.  It was of actual medication error case due to expired vaccine used.  At the time of reporting, 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 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: U
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: parent wanted a 1-year old child to receive a preservative free (without thimerosal) Fluzone Quadrivalent dose but the child was given a dose from the Fluzone Quadrivalent multi-dose vial, no AE; Initial information received on 25-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 12 months old patient who received a dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot UJ223AB, expiry date: 30-Jun-2020) via unknown route in unknown administration site for prophylactic vaccination instead of preservative free (without thimerosal) INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] dose.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to wrong vaccine administered.  At the time of reporting, 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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 68 year old male received a dose of Adacel / no AE; Initial information received on 28-Feb-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 68 years old male patient who received 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6512AA (Expiry date 23-Oct-2021) via intramuscular route in the right arm for Prophylactic vaccination on 19-Feb-2020.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate age at vaccine administration.   At a time of reporting no adverse event was reported.  It was reported that pharmacist reported that a 68 year old male received a dose of Adacel due to this is the only Tdap presentation that the pharmacy carries.  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: M
Vaccine: YF
Symptoms: Headache
Clinical narrative: headache; Initial information received on 28-Feb-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves male patient (of unknown demographics) who experienced headache (headache), while he received vaccine YELLOW FEVER VACCINE and while treated with DUPILUMAB [DUPIXENT].  Medical history, concomitant, medical treatment, vaccination and family history were not provided.   On an unknown date, the patient started taking DUPIXENT (DUPILUMAB) dosage unknown (with an unknown batch number) for prophylactic vaccination. On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE produced by unknown manufacturer (lot number not reported, of unknown Expiration date) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious headache (headache) of Unknown latency following the first dose intake and of Unknown latency following the last dose intake of DUPILUMAB.The patient developed a non-serious headache of Unknown latency following the administration of YELLOW FEVER VACCINE.  Laboratory data was not provided.  Final diagnosis was headache.  It was not reported if the patient received any corrective treatment.  On an unknown date, the patient outcome is not reported for the event.  Information on the batch number is requested.
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 6 month old male patient received Quadracel vaccine, no AE; Initial information was received on 02-Mar-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a six month old male patient who received 0.5 mL first dose DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5656AA and expiry date: 13-Aug-2021) via an intramuscular route in the right thigh for prophylactic vaccination on 10-Feb-2020.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB), INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT), and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation, on 10-Feb-2020.  It was actual medication error case due to inappropriate age at vaccine administration.  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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 84.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 84 years old was vaccinated with Menactra, no AE; Initial information received on 02-Mar-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 84 year old male patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number and Exp. Date not reported) via unknown route in an unknown administration site for prophylactic vaccination in 2020.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration.  It was reported that a patient who was 84 years old can have a second vaccination with Menactra, if his first (at another pharmacy) was done less than 30 days ago. He was at increased risk due to an infusion of Soliris he has to have 0.5 ml Menactra.  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 holders 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.  Information on the batch number was requested.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: the patient received expired Dapacel vaccine, no adverse event; Initial information was received on 02-Mar-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to 2020SA058733 and 2020SA057112 (same reporter).  This case involves a 32-months-old female patient who received a fourth dose of 0.5 ml of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5367AA and expiry date: 30-Jan-2020) via an intramuscular route in the left arm for prophylactic vaccination, on 13-Feb-2020 (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.   It was a case of actual medication error due to expired vaccine used.  At the time of reporting, 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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: patient received under the age of 65 years Fluzone High-Dose vaccine, no AE; patient received under the age of 65 years Fluzone High-Dose vaccine, no AE; Initial information was received on 03-Mar-2020 regarding an unsolicited valid non-serious case from a consumer.   This case involves a patient who was under 65 year of age received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination on unknown date.  Medical history, medical treatment, vaccination and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.   At the time of reporting, 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 holders 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.  Information on the batch number was requested.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eye irritation, Fatigue, Heart rate increased, Ocular hyperaemia
Clinical narrative: fast heart rate; eye redness; eye redness with a burning sensation/they were going to fall out; coughing; felt like throat was "constricting"; remarkably unusual tiredness; Initial information received on 04-Mar-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a female patient of unknown age who experienced fast heart rate (heart rate increased), eye redness (ocular hyperaemia), coughing (cough), felt like throat was "constricting" (throat tightness) and remarkably unusual tiredness (fatigue), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history included Drug hypersensitivity and Hypersensitivity.  Past medical treatment(s), vaccination(s) and family history were not provided.  On 28-Feb-2020, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious fast heart rate (heart rate increased), eye redness (ocular hyperaemia), coughing (cough), felt like throat was "constricting" (throat tightness) and remarkably unusual tiredness (fatigue) as diagnosis and eye redness with a burning sensation/they were going to fall out (eye irritation) as symptoms of eye redness (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Laboratory data was not reported.  Final diagnosis was heart rate increased, redness of eyes, burning sensation in eye, coughing, throat tightness and tiredness.  Corrective treatment: allergy pill.  The patient had not recovered from tiredness and recovered from heart rate increased, redness of eyes, burning sensation in eye, coughing, throat tightness on an unknown date.  Information on the batch number was requested.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: fast heart rate; eye redness; eye redness with a burning sensation/they were going to fall out; coughing; felt like throat was "constricting"; remarkably unusual tiredness; Initial information received on 04-Mar-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a female patient of unknown age who experienced fast heart rate (heart rate increased), eye redness (ocular hyperaemia), coughing (cough), felt like throat was "constricting" (throat tightness) and remarkably unusual tiredness (fatigue), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history included Drug hypersensitivity and Hypersensitivity.  Past medical treatment(s), vaccination(s) and family history were not provided.  On 28-Feb-2020, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious fast heart rate (heart rate increased), eye redness (ocular hyperaemia), coughing (cough), felt like throat was "constricting" (throat tightness) and remarkably unusual tiredness (fatigue) as diagnosis and eye redness with a burning sensation/they were going to fall out (eye irritation) as symptoms of eye redness (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Laboratory data was not reported.  Final diagnosis was heart rate increased, redness of eyes, burning sensation in eye, coughing, throat tightness and tiredness.  Corrective treatment: allergy pill.  The patient had not recovered from tiredness and recovered from heart rate increased, redness of eyes, burning sensation in eye, coughing, throat tightness on an unknown date.  Information on the batch number was requested.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Condition aggravated, Dry skin, Eczema, Rash erythematous
Clinical narrative: Vaccine given in the afternoon. That evening erythematous dry rash appeared bilateral legs, arms, trunk. Eczema appearing but much worse than previous flare ups. Resolved within a couple days
Age: 21.0
Sex: F
Vaccine: TYP
Symptoms: Chills, Diarrhoea, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative
Clinical narrative: Developed fever 99.0 chills, diarrhea and vomiting within 24 hours after taking 1st dose.
Age: 21.0
Sex: F
Vaccine: TYP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Developed fever 99.0 chills, diarrhea and vomiting within 24 hours after taking 1st dose.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Rash
Clinical narrative: developed rash on both arms, chest , upper abdomen and back .  vital signs monitored, Benadryl 50 mgs given.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Blood creatinine increased, Blood pressure increased, Caesarean section, Exposure during pregnancy, Pre-eclampsia
Clinical narrative: G2P2(now) delivered via urgent cesarean on 3/2/2020 at 29 weeks and 2 days after being admitted for severe preeclampsia on 2/27/2020, hours after Tdap administration. Prior to administration, BP 122/88 on 2/27/2020 at 0900, hours later (1417) BP 158/102 and 166/110 (1449). Highest BP during antepartum hospitalization 203/131. No history of preterm delivery, first baby delivered vaginally at 41 weeks. Readmitted 3/9/2020 for continued issues with elevated BPs despite multiple oral blood pressure medications (300mg Labetalol BID, 90mg Procardia XL BID).
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Premature delivery, Protein urine present
Clinical narrative: G2P2(now) delivered via urgent cesarean on 3/2/2020 at 29 weeks and 2 days after being admitted for severe preeclampsia on 2/27/2020, hours after Tdap administration. Prior to administration, BP 122/88 on 2/27/2020 at 0900, hours later (1417) BP 158/102 and 166/110 (1449). Highest BP during antepartum hospitalization 203/131. No history of preterm delivery, first baby delivered vaginally at 41 weeks. Readmitted 3/9/2020 for continued issues with elevated BPs despite multiple oral blood pressure medications (300mg Labetalol BID, 90mg Procardia XL BID).
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Ear pain, Injection site pain, Nausea
Clinical narrative: Within first hour - Pain at injection site radiating up to the ear, and down the arm, tingling down the arm and into the first three fingers of left hand.  Four hours after the shot - onset of intense stomach pain and nausea, continued for next 6 hours. Seven hours after the shot - low grade fever, chills and shivers. 18 hours after the shot - still 99 F fever, body aches.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Within first hour - Pain at injection site radiating up to the ear, and down the arm, tingling down the arm and into the first three fingers of left hand.  Four hours after the shot - onset of intense stomach pain and nausea, continued for next 6 hours. Seven hours after the shot - low grade fever, chills and shivers. 18 hours after the shot - still 99 F fever, body aches.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site induration
Clinical narrative: Underlying hardened skin induration at site of injection  of size 5x3cm by day 3 Improving and decreased in size to 2x1cm by day 7 Pt seen at clinic on both  the above days
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: SHOTS ADM ON TUESDAY3/3/20. ON SATURDAY PT C/O REDNESS AND ITCHING, FOLLOWED BY HIVES ON LT SHOULDER AREA. HIVES SUBSIDED, BUT STILL HAD REDNESS AND ITCHING WHEN PT RETURNED TO CLINIC  ON 3/10/2020 TO REPORT REACTION.
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration given outside of recommended guidelines. Patient was 15 weeks, 0 days.
Age: 80.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site nodule, Injection site pruritus
Clinical narrative: Pt came to the pharmacy and complained of having a knot at the injection site where she received this particular reaction. She said it was large when she was first vaccinated and it seems like it's going down. Upon examination, it could be very well possible that when the pharmacist was trying to administer the vaccine, they may have hit a blood vessel which could have resulted in the knot. Pt told me she didn't have any pain but the injection site was itching. I advised her to use the benadryl or hydrocortisone cream for the itch and we will revisit in a week to check for the reaction.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt reports getting diagnosed with shingles approximately 7 days after getting the shingrix vaccine.  This was the first dose.  She has had a  previous episode of shingles in the past.  The location was the abdomen and much of it was beneath the skin according to the patient.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Antinuclear antibody negative, C-reactive protein normal, Joint range of motion decreased, Loss of personal independence in daily activities, Periarthritis
Clinical narrative: L shoulder capsulitis, began day of vaccination, severe, limited ROM and activities of daily living. No other joints affected. Minimal improvement with NSAIDS, acetaminophen and amitryptiline. kenalog injection given 3/10/20, will assess improvement next month.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Rheumatoid factor negative
Clinical narrative: L shoulder capsulitis, began day of vaccination, severe, limited ROM and activities of daily living. No other joints affected. Minimal improvement with NSAIDS, acetaminophen and amitryptiline. kenalog injection given 3/10/20, will assess improvement next month.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient had redness, swelling, hot to touch, pain in arm. I recommended to Patient to use an ice pack on the area every 2 hours for 10-15 minutes. Patient went to walk in clinic with PCP on 3/6. Patient was instructed to alternate between heat and ice. The swelling and pain started to reduce into the weekend on 3/7.  I saw patient today on 3/10 and no signs of redness, swelling, or pain.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Patient called the pharmacy on 3/10/20 saying her right arm was sore the day after the flu shot was given on 2/19/20, and about a week ago her arm really started hurting..felt like spasms she described it as. Mentioned she has Rheumatoid arthritis as well so not sure what the cause is..advised patient to ice and take acetaminophen otc which she said she was doing. She has an appointment with her doctor this Thursday 3/12/20.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Dyspepsia, Pain, Pain in extremity
Clinical narrative: Within 20 minutes of leaving pharmacy I had a BAD burning sensation in my stomach and the whole 25 minutes driving home, I began to ache, hurt all over, my arm hurt ALOT and this was the way I felt for the next 6 day,s then it left my body. This is why I have not taken the second Shingle shot.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: swollen, red arm from injection site almost down to elbow and also felt warm to touch
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Tremor
Clinical narrative: for three days. redness and soreness on left upper arm just below injection site. At 6:30 PM on 2/27/2020 had severe shakes, and chills. Lasted about three hours. Still felt effects for about 24 hours
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: Headache, joint pain throughout body, tiredness, and muscle pain throughout arm that received immunization, started day after immunization and headache/pain unrelieved by Advil.
Age: 0.5
Sex: M
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Mom sts noticed hives 1 week after administration of medication.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Diarrhoea, Syncope
Clinical narrative: stomach cramps, diarrhea and fainting four hours after and after eating Arbys
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Influenza, Injection site reaction, Malaise, Myalgia
Clinical narrative: Three days after the patient received the Shingrix vaccine, she felt very ill, no fever, had cold sweats, muscle soreness all over her body, red rash approx 2 finger widths wide located 2 inches below her injection site, and general cold/flu symptoms. The patient was not sure if she was experiencing an adverse reaction from the vaccine or also had contracted a cold. Symptoms were managed with acetaminophen and ice pack for her arm. The symptoms resolved on the 4th day. No additional medical treatment was sought. She wished to report the event.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Rash erythematous
Clinical narrative: Three days after the patient received the Shingrix vaccine, she felt very ill, no fever, had cold sweats, muscle soreness all over her body, red rash approx 2 finger widths wide located 2 inches below her injection site, and general cold/flu symptoms. The patient was not sure if she was experiencing an adverse reaction from the vaccine or also had contracted a cold. Symptoms were managed with acetaminophen and ice pack for her arm. The symptoms resolved on the 4th day. No additional medical treatment was sought. She wished to report the event.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Blister, Immediate post-injection reaction
Clinical narrative: As soon as the vaccine was administered and up to this date one or two blisters will appear on the skin.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Patient received Tdap, boostrix or adacel, unknown by reporter. Urticaria started approximately 34 hours after injection, no other new exposures/allergens
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Biopsy skin abnormal, Lichen striatus, Rash
Clinical narrative: Rash to left side of body. Where immunizations gave seen by dermatology and biopsy done Diagnosed with Lichen Striatus, likely caused by the vaccines. Patient got rash 1 wk after MMR/Varicella given.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chills, Feeling cold, Night sweats, Pain, Pyrexia
Clinical narrative: Pt received Menveo and Trumenba on 3/9/2020. About 1' later pt. C/O severe chills. "Could not get warm". Mother did not take temp then gave Motrin. During night pt woke up in sweats. In am 3/10/2020 had temp over 101. Motrin given. No rash, No swelling redness at inj site. C/O general body aches. Had fever this pm as well. Mother not sure how high as thermometer not working correctly.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Blood thyroid stimulating hormone, Epstein-Barr virus antibody, Fatigue, Full blood count, Headache
Clinical narrative: Vaccine given (R) deltoid 2/27/2020 9 am (approximately) within 24 hrs arm felt heavy she couldn't life (R) arm + sensitivity/painful arm to touch, esp @ injection site. Pt 2/29/19 AM vomited upon waking + fever > 102.5; she slept entire day - managed fever. 2/29/20 evening red circle around injection site appeared with density underneath. Developed extreme fatigue/HA. Symptoms lessen in intensity but not resolving. Neg flu test 3/6/2020.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperaesthesia, Hypersomnia, Influenza virus test negative, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Vaccine given (R) deltoid 2/27/2020 9 am (approximately) within 24 hrs arm felt heavy she couldn't life (R) arm + sensitivity/painful arm to touch, esp @ injection site. Pt 2/29/19 AM vomited upon waking + fever > 102.5; she slept entire day - managed fever. 2/29/20 evening red circle around injection site appeared with density underneath. Developed extreme fatigue/HA. Symptoms lessen in intensity but not resolving. Neg flu test 3/6/2020.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site reaction, Laboratory test, Limb discomfort, Metabolic function test
Clinical narrative: Vaccine given (R) deltoid 2/27/2020 9 am (approximately) within 24 hrs arm felt heavy she couldn't life (R) arm + sensitivity/painful arm to touch, esp @ injection site. Pt 2/29/19 AM vomited upon waking + fever > 102.5; she slept entire day - managed fever. 2/29/20 evening red circle around injection site appeared with density underneath. Developed extreme fatigue/HA. Symptoms lessen in intensity but not resolving. Neg flu test 3/6/2020.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Mononucleosis heterophile test, Pain in extremity, Pyrexia, Thyroxine free, Vomiting
Clinical narrative: Vaccine given (R) deltoid 2/27/2020 9 am (approximately) within 24 hrs arm felt heavy she couldn't life (R) arm + sensitivity/painful arm to touch, esp @ injection site. Pt 2/29/19 AM vomited upon waking + fever > 102.5; she slept entire day - managed fever. 2/29/20 evening red circle around injection site appeared with density underneath. Developed extreme fatigue/HA. Symptoms lessen in intensity but not resolving. Neg flu test 3/6/2020.
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Headache, Injection site swelling, Urticaria
Clinical narrative: PREVNAR 13 vaccine, severe swelling injection site from elbow to shoulder, difficulty breathing, headache and hives, required course of prednisone, nebulizer and inhaler
Age: 67.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain
Clinical narrative: Patient states pain since date of administration on 10/14/19. Has been to see Dr and he is having her have xrays and then steroid shot/possible physical therapy.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Condition aggravated, Fibromyalgia, Incomplete course of vaccination, Insomnia
Clinical narrative: I received the first vaccine injection in a series of two for the Shingles. My Fibromyalgia muscle and joint pain became increasingly worse. It got to the point where I could not get a good night's rest due to pain. After much suffering I realized that I was due for my second shingles vaccine. That is when I became aware that my pain progressed after the first injection. I am not getting the second injection and I hope this pain goes away. The two step Shingles vaccine is not for those with autoimmune disease. This is my opinion.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: I received the first vaccine injection in a series of two for the Shingles. My Fibromyalgia muscle and joint pain became increasingly worse. It got to the point where I could not get a good night's rest due to pain. After much suffering I realized that I was due for my second shingles vaccine. That is when I became aware that my pain progressed after the first injection. I am not getting the second injection and I hope this pain goes away. The two step Shingles vaccine is not for those with autoimmune disease. This is my opinion.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hypersomnia, Influenza like illness, Myalgia
Clinical narrative: Given second dose of shingrix 50 MCG inj (IM) VL 10pk on 03/06/2020. By that evening I was nauseous had flu like symptoms, as well as a sore swollen arm. The next day I had fever, chills, headache, muscle pain, and slept all day with nightmares. Thankfully these symptoms were relieved by the following day. I had not experienced these symptoms with my first injection 6 months prior to my second.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Nightmare, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Given second dose of shingrix 50 MCG inj (IM) VL 10pk on 03/06/2020. By that evening I was nauseous had flu like symptoms, as well as a sore swollen arm. The next day I had fever, chills, headache, muscle pain, and slept all day with nightmares. Thankfully these symptoms were relieved by the following day. I had not experienced these symptoms with my first injection 6 months prior to my second.
Age: 76.0
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Influenza like illness, Vision blurred
Clinical narrative: 12 hr flu like symtoms - lack of energy, focus, and chills
Age: 66.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pain, Injection site warmth, Tachycardia
Clinical narrative: Diaphoretic Tachycardic Large area of erythema to injection site, warm, painful Tx Benadryl, Keflex
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Skin problem/rash Fever Dx: 1) acute urticarial. Tx: Improved with Benadryl 6mg x 1 in clinic 2) Eruption b/l arm, b/l post angle of jaw improved post Benadryl. Monitor x 24 hrs. ER if not improving or facial swelling
Sex: U
Vaccine: VARZOS
Symptoms: Eczema
Clinical narrative: Eczema; This case was reported by a consumer via call center representative and described the occurrence of eczema in an unknown number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced eczema. On an unknown date, the outcome of the eczema was unknown.   It was unknown if the reporter considered the eczema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. The reporter reported that he/she knew at least two other people who experienced eczema after receiving shingrix.
Age: 61.0
Sex: M
Vaccine: FLU4, FLUX, FLU4
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture abnormal
Clinical narrative: Loss of use of my legs  Guillain - Barre - Syndrome
Age: 61.0
Sex: M
Vaccine: FLU4, FLUX, FLU4
Symptoms: Guillain-Barre syndrome, Laboratory test, Lumbar puncture, Musculoskeletal disorder
Clinical narrative: Loss of use of my legs  Guillain - Barre - Syndrome
Age: 61.0
Sex: M
Vaccine: FLU4, FLUX, FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Loss of use of my legs  Guillain - Barre - Syndrome
Age: 65.0
Sex: M
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Bronchoalveolar lavage, Chest X-ray normal, Computerised tomogram thorax abnormal, Lung disorder, Malaise
Clinical narrative: showed Bilateral Pneumonia; a sinus infection; out mucus from my lungs; This case was reported by a consumer via call center representative and described the occurrence of bilateral pneumonia in a 65-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included mepolizumab (Nucala) unknown (batch number Unknown, expiry date unknown) for an unknown indication.   The patient's past medical history included ex-smoker. Previously administered products included Nucala (started Nucala 9 moths ago). Concurrent medical conditions included sinus disorder.   On 29th January 2020, the patient received the 2nd dose of Shingles vaccine. In January 2020, the patient started Nucala at an unknown dose and frequency. On 30th January 2020, 1 days after receiving Shingles vaccine and less than a month after starting Nucala, the patient experienced bilateral pneumonia (serious criteria hospitalization and GSK medically significant), sinus infection and bronchial mucus plug. The patient was treated with prednisone and levofloxacin (Levaquin). On an unknown date, the outcome of the bilateral pneumonia, sinus infection and bronchial mucus plug were recovering/resolving.   It was unknown if the reporter considered the bilateral pneumonia, sinus infection and bronchial mucus plug to be related to Shingles vaccine and Nucala.  Additional details were provided as follows: The reporter stated that, the patient had statrted Nucala 9 months ago and got it once a month at doctor's office. The patient received Nucala between 10th and 15th january 2020. The reporter stated that, next day after vaccination with dose of Shingrix, the patient experienced Pneumonia symptoms. The reporter reported that, the patient's primary health care professional first diagnosed it as sinus infection since, the patient always had sinuses problems. The patient had CT scan  with contrast, and it showed bilateral pneumonia. The patient was prescribed Levaquin 750 and Prednisone. The patient was hospitalised for 1 day, as an ambulatory patient to get a bronchial flush. The reporter stated that, till the time of reporting, the patient was recovering. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Pneumonia, Scan with contrast, Sinusitis
Clinical narrative: showed Bilateral Pneumonia; a sinus infection; out mucus from my lungs; This case was reported by a consumer via call center representative and described the occurrence of bilateral pneumonia in a 65-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included mepolizumab (Nucala) unknown (batch number Unknown, expiry date unknown) for an unknown indication.   The patient's past medical history included ex-smoker. Previously administered products included Nucala (started Nucala 9 moths ago). Concurrent medical conditions included sinus disorder.   On 29th January 2020, the patient received the 2nd dose of Shingles vaccine. In January 2020, the patient started Nucala at an unknown dose and frequency. On 30th January 2020, 1 days after receiving Shingles vaccine and less than a month after starting Nucala, the patient experienced bilateral pneumonia (serious criteria hospitalization and GSK medically significant), sinus infection and bronchial mucus plug. The patient was treated with prednisone and levofloxacin (Levaquin). On an unknown date, the outcome of the bilateral pneumonia, sinus infection and bronchial mucus plug were recovering/resolving.   It was unknown if the reporter considered the bilateral pneumonia, sinus infection and bronchial mucus plug to be related to Shingles vaccine and Nucala.  Additional details were provided as follows: The reporter stated that, the patient had statrted Nucala 9 months ago and got it once a month at doctor's office. The patient received Nucala between 10th and 15th january 2020. The reporter stated that, next day after vaccination with dose of Shingrix, the patient experienced Pneumonia symptoms. The reporter reported that, the patient's primary health care professional first diagnosed it as sinus infection since, the patient always had sinuses problems. The patient had CT scan  with contrast, and it showed bilateral pneumonia. The patient was prescribed Levaquin 750 and Prednisone. The patient was hospitalised for 1 day, as an ambulatory patient to get a bronchial flush. The reporter stated that, till the time of reporting, the patient was recovering. The reporter consented to follow up.