chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; One patient received one dose of PROQUAD that was improperly stored; This spontaneous report was received from a licensed practical nurse refers to a patient of an unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. Concomitant therapy included sterile diluent.     On 13-AUG-2019, the patient was vaccinated with one dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S003868 (expiration date: 08-AUG-2020) for prophylaxis (route and dosage details were not reported) (product storage error). Diluent (unknown lot number and expiration date) used to reconstitute was stored properly. The vaccine was stored at a temperature of -13.4 Celsius (C) for a time frame of 2 hours. There was no previous temperature excursion reported. The call was because of a data logger. The patient did not experience any adverse effects. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects; 17-year-old patient received adult dose of VAQTA on 8/14/2019; This spontaneous report was received from a nurse concerning to a 17 year old patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.   On 14-AUG-2019, the patient was vaccinated with a adult dose of hepatitis a vaccine, inactivated (VAQTA) (product administered to patient of inappropriate age), lot # S007265 has been verified to be a valid lot number for hepatitis a vaccine, inactivated, expiration date reported  and establish as 07-JUL-2020, for prophylaxis (strength, dose and route of administration were not provided).  No adverse effects reported.
Age: 0.17
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; A 9 week old female infant was inadvertently administered PNEUMOVAX 23; This spontaneous report was received from a medical assistant concerning a 9 week old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications or drug reactions/allergies. On 14-AUG-2019, the patient was inadvertently administered pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in her left thigh (product administered to patient of inappropriate age), lot # S01224 expiration date 10-FEB-2021 for prophylaxis (strength, dose and route of administration were unknown). No adverse effects reported.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; 8/15/2019, one male patient was administered improperly stored VARIVAX; 8/15/2019, one male patient was administered improperly stored VARIVAX; This spontaneous report was received from a Medical Assistant and refers to a 16 year old male patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 15-AUG-2019, the patient was administered improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S003448 with expiration date of 04-FEB-2021, for prophylaxis (route and frequency were not reported). The varicella virus vaccine live (oka/merck) (VARIVAX) dose was reconstituted with properly stored sterile diluent (DILUENT MRK) (lot R022280 with expiration date of 06-OCT-2019). No adverse effects reported.       It was stated that the vaccine underwent a temperature excursion of 6°F (degrees Fahrenheit) to 14°F (14 F) for 15 minutes and 15°F to 46°F(29 F) for 1 hour; 32°F to 35°F (34.68) for 6 hours. No previous temperature excursion was done. The call was because of a "data logger".
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: hives a few days later all over her chest and stomach; This spontaneous report was received from a physician via company representative and refers to a female patient of unknown age. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.      On 12-APR-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 1 dosage form for prophylaxis (dose, strength, route of administration, lot# and expiration date were not reported).  On an unknown date in April 2019 (reported as a few days later) the patient experienced hives all over her chest and stomach.  The outcome of urticaria was reported as recovered approximately 2 weeks after. Causal relationship between  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and urticaria was unknown.
Sex: U
Vaccine: MMR, UNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse effect reported; patient received M-M-R II via intramuscular route; This spontaneous report was received from a Pharmacy intern refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, drug reactions and allergies were not reported. On 15-AUG-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, anatomical locations and dosage information were unknown) of lot # R035701, expiration date 09-DEC-2020, via intramuscular route for prophylaxis (incorrect route of product administration). Other suspect therapies included sterile diluent (strength, dosage information, indication, route and anatomical location were unknown) of lot # S003613, expiration date 22-JUL-2021. No adverse effects reported. The outcome of incorrect route of product administration was unknown. No product quality complaint reported.
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient's husband. The patient received the first dose of the Shingrix vaccine around May of 2019 and had headache. The reporter was not willing to provide any additional information. The reporter did not consent to follow up. This case has been linked with case US2019145715, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Nonspecific reaction
Clinical narrative: had a bad reaction; This case was reported by a nurse via call center representative and described the occurrence of nonspecific reaction in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced nonspecific reaction. On an unknown date, the outcome of the nonspecific reaction was recovered/resolved.   It was unknown if the reporter considered the nonspecific reaction to be related to Shingrix.  Additional case details were reported as follows: This case was reported by a retired nurse for her friend. The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The reporter stated, the patient had a bad reaction to Shingrix dose and was better in 2 days.   The reporter did not have specific details on what the reaction was. The reporter gave permission to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th March 2019, the patient received Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient's wife. The patient experienced  injection site pain and no other events after receiving vaccine. This case has been linked with case US2019GSK063670, reported by the same reporter.
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient had received the 2nd dose of Bexsero and experienced a sore arm for a few days.
Sex: U
Vaccine: TDAP
Symptoms: Injection site reaction
Clinical narrative: Unknown adverse events; This case was reported by a other health professional via call center representative and described the occurrence of injection site reaction in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 53BF4, expiry date 14th August 2021) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, less than 4 months after receiving Boostrix, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the physicians from the pediatric unit reported adverse reactions to a specific lot number for the product. The reporter consented to follow up. This case has been linked with cases US2019145738, US2019145742, reported by the same reporter.
Age: 69.0
Sex: F
Vaccine: MEA, VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore; Very Tired; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included MEASLES VIRUS VACCINE LIVE ATTENUATED (MEASLES) for prophylaxis.   On 28th May 2019, the patient received the 1st dose of Shingrix and MEASLES. On 29th May 2019, 1 days after receiving Shingrix, the patient experienced pain in arm and fatigue. On 30th May 2019, the outcome of the pain in arm and fatigue were recovered/resolved.   It was unknown if the reporter considered the pain in arm and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient stated that her arm was sore after vaccination but she does not know which arm received the Shingrix product or the measles product. The patient also felt fatigued. The reporter gave permission for her physician to be contacted. The reporter was unable to provide any additional information.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient Shingrix around May of 2019 and had a sore arm.  He did not know the date. He was not willing to provide any additional information and caller disconnected the call.  He did not provide his address. The reporter did not consent to follow up. This case is linked with US2019145717, reported by same reporter.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 47JA3, expiry date 27th April 2020) for prophylaxis.   On 28th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The healthcare professional stated that patient received 1st dose and was treated for shingles. The reporter asked whether patient need the 2nd dose. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Malaise
Clinical narrative: weak; sick; . This case was reported by a consumer via call center representative and described the occurrence of weakness in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2018, the patient received the 1st dose of Shingrix. In April 2019, less than 5 months after receiving Shingrix, the patient experienced sickness. On an unknown date, the patient experienced weakness. On an unknown date, the outcome of the weakness and sickness were recovered/resolved.   It was unknown if the reporter considered the weakness and sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced weakness for a couple of days and got sick for a couple of months, for that reason, the patient did not have 2nd dose of Shingrix until 7.5 months after 1st dose. The patient had 2nd dose the day of reporting. The patient did not want to elaborate on what he meant by being sick. The patient did not want to answer any further questions. The patient did not consent to follow up. This case has been linked with case US2019AMR146262, reported by same reporter.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Foetal growth restriction, Foetal heart rate disorder
Clinical narrative: Hearbeat faint; Vaccine exposure during pregnancy; This is a spontaneous prospective case, initially received from other non- health professional on 08-Aug-2019, concerning a 27-year-old female patient.   The patient's obstetrical history included two previous pregnancies with no stillbirth or miscarriage. Birth defect or congenital anomaly in any previous pregnancy was not reported. The patient's maternal or paternal medical history relevant to pregnancy was not reported.  The patient's medical history included amenorrhea and the patient was Rh negative.The patient's historical drug included oral contraceptives.   The patient's last menstrual period was not reported.  On 08-Aug-2019, the patient was administered intramuscular Afluria Quadrivalent [influenza Vaccine, batch number: not reported, dose: 0.5 ml, expiry date: not reported and anatomical location: deltoid] (explicitly coded as vaccine exposure during pregnancy) for influenza prophylaxis.   On unknown date, the patient experienced heartbeat faint and as reported not growing, but details were not specified.  The outcome of the event of faint was not reported.  The patient's expected date of delivery was reported as 21-Oct-2019.  Company Comment: The patient experienced syncope after vaccination with the suspect product Afluria Quadrivalent (influenza Vaccine). Reportedly, vaccination occurred during pregnancy. There is a lack of information regarding therapy dates and reaction onset dates, however the occurrence of adverse reaction was reported after exposure to the suspect product, making chronology unclear but plausible. Medical history of pregnant state may have contributed to development of the event. No diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal relationship between the suspect product and the event syncope is assessed as related and as not related per company conventions for exposure during pregnancy.; Reporter's Comments: The patient experienced syncope after vaccination with the suspect product Afluria Quadrivalent (influenza Vaccine). Reportedly, vaccination occurred during pregnancy. There is a lack of information regarding therapy dates and reaction onset dates, however the occurrence of adverse reaction was reported after exposure to the suspect product, making chronology unclear but plausible. Medical history of pregnant state may have contributed to development of the event. No diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal relationship between the suspect product and the event syncope is assessed as related and as not related per company conventions for exposure during pregnancy.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: Tdap was administered IV instead of IM.  Ordered at the same time as morphine IV.  RN scanned both at bedside at same time but mixed up routes of administration when administering.  Both were in prefilled syringes, and she knew which to give which route of administration, but she mixed them up in her hands
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: MA MISTAKENLY GAVE THIS PATIENT THE BEXSERO VACCINE WHEN HE WAS ACTUALLY DUE FOR MENACTRA.  MESSAGE LEFT WITH MOTHER TO INFORM OF VACCINE ERROR AND I HAVE NOT BEEN ABLE TO REACH HER.  SPOKE WITH OUR LOCAL IMMUNIZATION MANAGER AT THE HEALTH DEPARTMENT AND SHE STATES THAT THE CHILD SHOUL D NOT RECEIVE THE 2ND DOSE AT THIS TIME. HE WILL NEED TO RESTART SERIES AT AGE 16.  HE STILL NEEDS TO COME IN AND GET MENACTRA. WILL CONTINUE TO TRY AND REACH PARENT.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Eyelid margin crusting, Feeling abnormal, Pain, Sinus disorder
Clinical narrative: Throat tight, sinus swollen, eyes swollen and matted . General feeling of ache.  I took Benadryl and Tylenol to relieve some symptoms. This morning I still don?t feel very good. I am better than last night.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Throat tightness
Clinical narrative: Throat tight, sinus swollen, eyes swollen and matted . General feeling of ache.  I took Benadryl and Tylenol to relieve some symptoms. This morning I still don?t feel very good. I am better than last night.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Fatigue, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient called pharmacy 08/19/19 -  She stated that she recieved the vaccine Friday 08/16/19 around 4pm.   She said the next day her arm was swollen and sore at injection site.  She said she felt tired and achy.   She took ibuprofen.  The next day (sunday) she felt still tired and achy and as a nurse, recognized the first signs of cellulitis.  She went to urgent care to receive steroid and an antibiotic.  Monday morning she started to feel better and arm looked improved.
Sex: F
Vaccine: MMR
Symptoms: Splenectomy
Clinical narrative: had a splenectomy for an unspecified reason; This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported.   On unknown dates, in 1997 and in 2007, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot#, expiration date, dosage information, route of administration and anatomical locations were unknown) for prophylaxis. The vaccine was reconstituted with a sterile diluent (lot#, expiration date, dosage information, route of administration, indication and anatomical locations were unknown). On an unknown date, the patient had splenectomy for an unspecified reason. The reporter could not clarify if the patient had the splenectomy before or after the vaccination. The outcome of splenectomy was unknown.   The reporter's causality assessment was not reported.  This is a non-valid case due to lack of patient identifier.  Follow-up information was received from a pharmacist on 16-AUG-2019. It was reported that the patient is a female and the age of patient was 18 or 19 years old. She was going into collage. The information was received through a phone call from "upstairs" floor nurse.  Upon internal review, the event of splenectomy was considered to be medically significant.
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Pneumonia viral, Pyrexia
Clinical narrative: PNEUMONIA FROM A VIRUS; FEVER; COUGH; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine (live, attenuated)), via nasal route for the last 5 years for a severe fainting reaction to needles, can not take the flu shot. The mother reported that her son received the Flumist Quadrivalent in Oct or Nov-2017.    On the first day of school, Aug-2018, reporter stated that her son came home with a fever (preferred term: Pyrexia) and he had a cough (preferred term: Cough).    Reporter stated that patient was diagnosed with pneumonia from a virus (preferred term: Pneumonia viral).     The patient recovered from the events of fever, cough and pneumonia from a virus on an unspecified date.     The events were considered non-serious.     The reporter considered the following event unrelated to treatment with Flumist Quadrivalent (influenza vaccine (live, attenuated)): pneumonia from a virus, fever and cough.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Injection site swelling
Clinical narrative: pain at injection site; arm was red throughout the entire arm; swelling at injection site / arm was puffy; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (For tolerance to 1st dose refer linked case US2019AMR146569).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site swelling, injection site pain and erythema of extremities. On an unknown date, the outcome of the injection site swelling and erythema of extremities were recovered/resolved and the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site swelling, injection site pain and erythema of extremities to be related to Shingrix.  Additional information received were as follows: This case was reported by the patient who himself/herself was a Pharmacist. The age at vaccination was not reported. The patient did not experienced swelling or pain other than just where injection was given. The patient inquired, what do you considered a severe reaction to the vaccine. The patients arm was puffy and red throughout the entire arm and hand for over a week. The patient inquired, should he/she have not taken the 2nd dose with this kind of reaction. The patient decided to take the 2nd dose and got basically no reaction but was prepared for possible more severe response.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site reaction
Clinical narrative: Unknown adverse event; This case was reported by a other health professional via call center representative and described the occurrence of injection site reaction in a patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, less than 4 months after receiving Kinrix, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Kinrix.  Additional details were provided as follows: The age at vaccination was not reported. The purchaser on the line stating there are physicians from the pediatric Unit reporting adverse reactions to specific lot numbers for the product.  The patient had injection site reactions to Kinrix.  The reporter consented to follow up. The reporter did not have any further details for the patient. The PQC Form was considered an adverse event only.  No product complaint was reported. This case linked with US2019145738, reported by same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles / Shingles rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The pharmacist called to report that the patient experienced Shingles.  The patient experienced Shingles rash on legs. The reporter consented to follow up.
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Decreased appetite
Clinical narrative: loss of strength/ Weakness; no appetite; This case was reported by a consumer via call center representative and described the occurrence of strength loss of in a 92-year-old male patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced strength loss of and appetite absent. On an unknown date, the outcome of the strength loss of and appetite absent were unknown.   It was unknown if the reporter considered the strength loss of and appetite absent to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient called and reported having loss of strength, loss of appetite, and weakness after receiving unknown Flu Vaccine. The reporter consented to follow up. The reporter did not have product name, lot number or expiration date.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site reaction
Clinical narrative: Unknown adverse event; This case was reported by a other health professional via call center representative and described the occurrence of injection site reaction in a patient who received DTPa-IPV (Kinrix) (batch number PP9L5, expiry date 16th October 2021) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, less than 2 months after receiving Kinrix, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Kinrix.  Additional details were provided as follows: The age at vaccination was not reported. The purchaser on the line stating there are physicians from the pediatric Unit reporting adverse reactions to specific lot numbers for the product.  The patient had injection site reactions to Kinrix.  The reporter consented to follow up. The reporter did not have any further details for the patient.  The PQC Form was considered an adverse event only.  No product complaint was reported. This case linked with US2019AMR146592, reported by same reporter.
Sex: U
Vaccine: TDAP
Symptoms: Injection site reaction
Clinical narrative: Unknown adverse events; This case was reported by a other health professional via call center representative and described the occurrence of injection site reaction in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 53BF4, expiry date 14th August 2021) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, less than 4 months after receiving Boostrix, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Boostrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient identifiers details were unknown. The patient had injection site reactions to Boostrix. The reporter reported adverse reactions to a specific lot number for the product. The adverse event details were unknown. The reporter did not have any further details for any of the patient. The reporter gave permission to follow up. This case had been linked to the case US2019145738, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness
Clinical narrative: weakness in the legs; This case was reported by a nurse via call center representative and described the occurrence of lower extremities weakness of in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced lower extremities weakness of. On an unknown date, the outcome of the lower extremities weakness of was recovered/resolved.   It was unknown if the reporter considered the lower extremities weakness of to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that she experienced leg weakness that lasted for about one month after the dose. The reporter reported that she had not gotten the 2nd dose of Shingrix till the time of reporting because of how she reacted to the 1st dose of Shingrix. The reporter was about to get a new physician and was okay if any follow up was sent to herself at the time of reporting.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain management, Rash
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date 21st September 2021) for prophylaxis.   Previously administered products included steroid shot (received in the patients neck).   On 21st June 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. The pharmacist on the chat reporting that, 3 weeks before the reporting the patient went to pain management to get a steroid shot in the back and they noticed a shingles rash on her back. At the time of reporting, the rash seems to have cleared and dried up. Not bothering or itching the patient. The reporter consented to follow up. All details as provided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema
Clinical narrative: Vaccine Administered at Inappropriate Site/Route; Large Red Area On Right Arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 477S3, expiry date 17th October 2021) for prophylaxis.   On 6th August 2019, the patient received the 1st dose of Shingrix (subcutaneous). On 6th August 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In August 2019, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix on the right arm via subcutaneously, which led to intramuscular formulation administered by other route. Less than week after vaccination, the patient experienced a large red area on right arm. The reporter wanted to know how to proceed. The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Pruritus, Swelling face
Clinical narrative: Swollen red face and itchy. Extreme fatigue
Age: 8.0
Sex: M
Vaccine: MMRV
Symptoms: Eye pain, Pyrexia
Clinical narrative: 103 Degree fever, Pains in eyes
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Pruritus, Rash, Throat tightness, Urticaria
Clinical narrative: hives/rash, itching, closing of the throat, pins/needles up and down the arm
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash, Rash pruritic
Clinical narrative: itchy rash all over body
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Heart rate increased, Injection site pain, Palpitations
Clinical narrative: I initially noticed that my face and chest were slightly read about 90 minutes after the injection.  The soles of my feet began to itch and then, very quickly, my face, ears, upper torso and arms (down to finger tips), suddenly turned bright red (think ripe tomato).  My skin became exceedingly warm,  and I got the chills.  My pulse was elevated and I could feel my heart pounding.  It spread to my legs somewhat, but not as much as my upper torso. The soles of my feet continued to itch.  I did not have a fever at any point. I took some acetaminophen  and got under the covers to warm up.  I slept for about 2 hours, at which time the symptoms seem to have receded somewhat although the injection site became sore.    Now, one day later, the symptoms are completely gone except that my are is exceedingly sore at the injection site.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: I initially noticed that my face and chest were slightly read about 90 minutes after the injection.  The soles of my feet began to itch and then, very quickly, my face, ears, upper torso and arms (down to finger tips), suddenly turned bright red (think ripe tomato).  My skin became exceedingly warm,  and I got the chills.  My pulse was elevated and I could feel my heart pounding.  It spread to my legs somewhat, but not as much as my upper torso. The soles of my feet continued to itch.  I did not have a fever at any point. I took some acetaminophen  and got under the covers to warm up.  I slept for about 2 hours, at which time the symptoms seem to have receded somewhat although the injection site became sore.    Now, one day later, the symptoms are completely gone except that my are is exceedingly sore at the injection site.
Age: 1.67
Sex: F
Vaccine: HEPA
Symptoms: Cough, Crying, Decreased appetite, Diarrhoea, Head banging
Clinical narrative: Excessive crying, sleeplessness, trouble with sleeping, unable to sleep, runny nose, cough, sneeze, nasal congestion, chest congestion, diarrhea, mood swings including head banging, loss of appetite.
Age: 1.67
Sex: F
Vaccine: HEPA
Symptoms: Insomnia, Mood swings, Nasal congestion, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Excessive crying, sleeplessness, trouble with sleeping, unable to sleep, runny nose, cough, sneeze, nasal congestion, chest congestion, diarrhea, mood swings including head banging, loss of appetite.
Age: 1.67
Sex: F
Vaccine: HEPA
Symptoms: Sneezing
Clinical narrative: Excessive crying, sleeplessness, trouble with sleeping, unable to sleep, runny nose, cough, sneeze, nasal congestion, chest congestion, diarrhea, mood swings including head banging, loss of appetite.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Alopecia, Fatigue, Headache, Hypoaesthesia
Clinical narrative: the form doesnt allow me to state it was Gardasil 4 /  within 12 months, patient developed stomach pains, weakness in her limbs and fatigue. It led to severe leg numbness, which then came of went, along with bouts of fatigue and headaches. With stress and activities - the symptoms reappear to a point she needs bedrest and medical attention . through other medical people, we  just where told of the connection between the vaccine and these horrible symptoms.    Been years of struggle with these symptoms with little help.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Laboratory test, Muscular weakness, Pain in extremity
Clinical narrative: the form doesnt allow me to state it was Gardasil 4 /  within 12 months, patient developed stomach pains, weakness in her limbs and fatigue. It led to severe leg numbness, which then came of went, along with bouts of fatigue and headaches. With stress and activities - the symptoms reappear to a point she needs bedrest and medical attention . through other medical people, we  just where told of the connection between the vaccine and these horrible symptoms.    Been years of struggle with these symptoms with little help.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient presented with hives all over the body. Medrol dose pack, zyrtec and aveeno bath prescribed. Patient will follow up with PCP
Age: 62.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Mobility decreased, Musculoskeletal stiffness, Pain in extremity, Paraesthesia
Clinical narrative: Ten days after receiving the vaccine I woke up with extremely sore and stiff arms, hands and fingers.  I could not straighten my right arm for two days.  The elbow, wrist and finger joints were extremely sore.  Three months later and I continue to have joint pain in the same areas and now have pins/needles sensation.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Left arm moderate pain and slight swelling; low grade fever and chills; muscle and joint paint.  Resolved within 24 hours.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Left arm moderate pain and slight swelling; low grade fever and chills; muscle and joint paint.  Resolved within 24 hours.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site on arm was red and swollen. She indicated it was also painful. No heat was there.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: full body ache, 101 fever, chills, severe headache
Age: 56.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Headache, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Pt received two shots on Friday. She developed a rash at injection site, it is warm to the touch and very painful. She also has a head ache, fever, body aches and chills. Pts temp during visit was 98.7. I verbally discussed the symptoms with dr. and he agreed to evaluate the pt.   Dr. recommendation was to ice the area, rest, continue ibuprofen and drink water.
Age: 56.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Pt received two shots on Friday. She developed a rash at injection site, it is warm to the touch and very painful. She also has a head ache, fever, body aches and chills. Pts temp during visit was 98.7. I verbally discussed the symptoms with dr. and he agreed to evaluate the pt.   Dr. recommendation was to ice the area, rest, continue ibuprofen and drink water.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Blister, Body temperature increased, Erythema, Injection site pain, Rash
Clinical narrative: Presented with erythematous skin lesion on L lateral thigh 24 hours after vaccine injection at the site on 8/12, with development of fluid filled blisters in middle. No drainage, but lesion is firm and warm to the touch.Pt had elevated temperature of 99.8 with development of rash. The rash is 10cm by 7.8cm this morning per measurement by home-health nurse, who reports that it has gotten more red since this morning. The pt is bearing weight on the leg and very active during the interview. The site is tender to palpation. Denies rhinorrhea, cough, pale extremity, change in behavior, decreased voiding, decreased stooling, vomitting, diarrhea, or similar lesions elsewhere on body.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Skin lesion, Skin warm
Clinical narrative: Presented with erythematous skin lesion on L lateral thigh 24 hours after vaccine injection at the site on 8/12, with development of fluid filled blisters in middle. No drainage, but lesion is firm and warm to the touch.Pt had elevated temperature of 99.8 with development of rash. The rash is 10cm by 7.8cm this morning per measurement by home-health nurse, who reports that it has gotten more red since this morning. The pt is bearing weight on the leg and very active during the interview. The site is tender to palpation. Denies rhinorrhea, cough, pale extremity, change in behavior, decreased voiding, decreased stooling, vomitting, diarrhea, or similar lesions elsewhere on body.
Age: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Crying, Diarrhoea, Pyrexia, Urticaria
Clinical narrative: Hives, crying for hours, high fever & diarrhea.  All subsided within a 2 days
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects reported; one MMR II vial from a box of 10 vials was missing a flip cap; A dose of MMR II was administered to an unspecified patient by intramuscular route instead of subcutaneous route.; This spontaneous report as received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 14-JUN-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R036582, expiration date 17-DEC-2020, (strength, dosage and frequency were not provided) for prophylaxis, by intramuscular route instead of subcutaneous route (incorrect route of product administration). No adverse effects were reported.  Follow-up information has been received from the pharmacist on 14-JUN-2019. The pharmacist called to report one measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vial from a box of 10 vials was missing a flip cap. It was reported that the cap had fell off and was at the bottom inside the box. No doses were missed. The outcome of the product quality complaint and the relatedness between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) were not reported.  Additional information has been received from a different pharmacist on 13-AUG-2019, who reported that the lot number for the compliant measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) with the missing flip cap, was R031628 (expiration date 01-NOV-2020).  Follow up information was received from a pharmacist on 15-AUG-2018. It was reported that the product complaint documented was discovered because the product information supplied in the carton of lot # R036582, was  accidentally misplaced by the pharmacy staff. Therefore, it was verified that the product did not have any quality defect.  Follow up information was received from a pharmacist on 14-AUG-2018. The pharmacist mentioned that when he initially picked the phone, he thought that the call was about the male patient (initially gender was unknown) who was having trouble with his insulin pen, but it was determined to be a misuse" an unrelated other company adverse event for the same patient for which product quality complaint was also filed. (Thus the patient's gender was updated to male and case was considered as valid.)
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: noadverse effect were reported; the patient was inadvertently administered one dose of expired ZOSTAVAX; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 22-JUL-2019, the patient was inadvertently vaccinated with one dose of expired zoster vaccine live (ZOSTAVAX) 1 dose, lot# R020227 has been verified to be a valid lot number, expiration date 29-JUN-2019 (exact dose, site, route of administration were not reported) for prophylaxis. No adverse effects were reported. The nurse verified that the product had not had any temperature excursions. The outcome of the event was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect; Patient was inadvertently administered a dose of VARIVAX, that was expired; This spontaneous report as received from an office manager refers to a patient of unknown demographics. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. The patient's concomitant therapy included sterile diluent (DILUENT MRK INJ).  On 08-AUG-2019, the patient was inadvertently vaccinated with a dose of expired varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency and route were not reported) (lot # M021317, expiry date: 07-AUG-2019) for prophylaxis (expired product administered). No adverse effects were reported. No product quality complaint was involved.  Lot number [M021317] is an invalid lot number for varicella virus vaccine live (oka/merck).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Improperly stored dose of VARIVAX; This spontaneous report was received from a nurse refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, past drugs and allergies were unknown. Concomitant therapies included sterile diluent.  On 12-AUG-2019, the patient was vaccinated with one improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R027995 and expiration date: 01-OCT-2020) for prophylaxis. No adverse effects were reported. The sterile diluent that was used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was stored properly. The temperature excursion was seen at temperature of 6-degree Fahrenheit to 14-degree Fahrenheit (7.5 F) for 30 minutes. Previous temperature excursion was noted at temperature of 6-degree Fahrenheit to 14-degree Fahrenheit (10 F) for 28 minutes. This call was because of digital data logger. The outcome of product storage error was unknown.