chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Pallor
Clinical narrative: After the injection was given, the mother, sibling and I discussed the patient's family and baseball team. Other small talk took approx 10 minutes and then the family started toward the checkout area as they then visited with other staff members - usual for them as they are long standing patients. After approx 15 minutes, the patient became pale and started to fall - his mother caught him by the arm and they sat on a nearby bench by the reception/check out area. The patient reclined on the bench with his feet elevated. The MD was called and examined the patient. A cold pack was placed on his head and sips of gatoraide were taken. The patient started to slowly feel better and MD discharged him. approx 20.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Injection site pain, Lethargy
Clinical narrative: Flu-like symptoms of fever, chills, aches/pains, slight headache, lethargy, pain at site of injection.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Flu-like symptoms of fever, chills, aches/pains, slight headache, lethargy, pain at site of injection.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergies/reactions and concomitant therapies were not reported. On 26-MAR-2019, the patient was vaccinated with VARIVAX (dose, dose number, route of administration and anatomical site of vaccination were not reported; lot # R006220 and expiration date on 29-FEB-2020) and with PROQUAD (dose, dose number, route of administration and anatomical site of vaccination were not reported; lot # R015739 and expiration date on 02-DEC-2019) (product administration error); both administered for prophylaxis. The vaccines were administered with an sterile diluent. No adverse effect reported.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of adverse drug reaction in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown. It was unknown if the reporter considered the adverse drug reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of SHINGRIX and was looking for additional information due to possible unspecified reaction. The patient refused to provide additional information as she would like to share the information only with the manufacturer. This information had not been reported to the Food and Drug Administration. No further specifics or symptoms were provided. No further adverse event information was provided. The patient gave consent to be followed up.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Pain, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of general body pain in a female patient who received SHINGRIX for prophylaxis. On 25th March 2019, the patient received SHINGRIX. On 26th March 2019, 1 days after receiving SHINGRIX, the patient experienced general body pain, fever and feeling cold. On an unknown date, the outcome of the general body pain, fever and feeling cold were not recovered/not resolved. It was unknown if the reporter considered the general body pain, fever and feeling cold to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient got the SHINGRIX shot day before reporting, and since morning the day of reporting she had body aches and pain, feeling cold and her body temperature was 100.2 F. The patient asked was that normal.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Liver function test abnormal
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of liver function test abnormal in a 76-year-old female patient who received SHINGRIX (batch number 455KD, expiry date 4th May 2021) for prophylaxis. On 4th February 2019, the patient received the 1st dose of SHINGRIX. On 11th February 2019, 7 days after receiving SHINGRIX, the patient experienced liver function test abnormal. On an unknown date, the outcome of the liver function test abnormal was unknown. It was unknown if the reporter considered the liver function test abnormal to be related to SHINGRIX. Additional details were provided as follows: The patient received dose of SHINGRIX on left deltoid and one week after experienced weird liver function test values. The patient previously has had normal liver lab values. Lab Comments: Previously, the patient had normal liver lab values. One week after receiving her dose of SHINGRIX, the patient had weird liver function test values.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included Shingles vaccine (received in October 2018). On 22nd March 2019, the patient received the 1st dose of SHINGRIX. On 24th March 2019, 2 days after receiving SHINGRIX, the patient experienced pain in arm and neck pain. On an unknown date, the outcome of the pain in arm and neck pain were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and neck pain to be related to SHINGRIX. Additional details were provided as follows: Previously, the patient received a shingles vaccination that was not SHINGRIX, the patient was unable to verify brand. After receiving 1st SHINGRIX dose on Friday, the patient experienced an achy arm and neck. On Sunday, symptoms of achy arm and neck got started and had not resolved. The patient did not consent to follow-up with physician.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable consumer for a patient enrolled in a Pfizer-sponsored program, this report regards an event part of the medical history of the patient. An adult female patient received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history included pneumonia when she was a baby. Concomitant medications were not reported. The patient experienced pneumonia on an unspecified date with outcome of unknown. Pfizer is a marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the country of incidence. This may be a duplicate report if another marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities. The information on the lot number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received PREVNAR 13; (batch number unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient received PREVNAR 13 injection a week a go and arm was still hurting since an unspecified date. The outcome of the event was unknown. Information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine a week before the time of reporting. The pharmacist reported that on an unspecified date, the patient's arm still hurts after receiving vaccine. The outcome of the event was not recovered. Information on the lot number has been requested.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Hypersensitivity, Nasopharyngitis, Skin warm
Clinical narrative: This is a spontaneous report from a contactable healthcare professional via a Pfizer sales representative. An 18-year-old female patient received TRUMENBA, lot number: S56024, expiration date 28Feb2019, via an unspecified route of administration on 07Sep2018 at single dose for immunisation. The patient medical history was not reported. Concomitant medication included SYMBICORT. The patient experienced described her symptoms as similar to a cold, her arm was hot and allergic reaction on an unspecified date. The outcome of the event was unknown.
Sex: F
Vaccine: TD
Symptoms: Allergy to vaccine
Clinical narrative: Based on additional information received on 01-Apr-2019, this case initially considered as non-case was upgraded to valid case. Initial information received on 18-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse that time case process as non-case, Additional information was received on 01-Apr-2019 non-case to valid case updated because allergic reaction occurred due TENIVAC. This case involves Adult female patient who experienced allergic to the diphtheria component, while she received vaccine TENIVAC. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious allergic to the diphtheria component (allergy to vaccine) (Unknown latency) following the administration of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult. (Other relevant tests included no lab data.) Final diagnosis was allergic to the diphtheria component. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergic to the diphtheria component. Follow up information received from Nurse on 01-Apr-2019. Based on Additional information case from non-case to valid case updated. List of documents held by send one.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 01-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 32 years old male patient who received vaccine ADACEL. The patients past medical history and family history were not provided. The patient did not receive any concomitant medication. On 21-Feb-2019, the patient received injection of suspect ADACEL lot U5531AA, expiry date 21-Jan-2019 via unknown route in the left deltoid. It was an actual medication error due to expired vaccine used. It was reported that patient received expired ADACEL vaccine on 21-Feb-2019 which was expired on 21-Jan-2019. It was unknown whether patient experienced any adverse reaction after the injection. 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 and Module VI of the 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. List of documents held by sender- none.
Sex: F
Vaccine: MEN
Symptoms: Meningitis, Sudden death, Vaccination failure
Clinical narrative: Initial information received on 29-Mar-2019 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional by phone. This case involves a 19 years old female patient who died suddenly from meningitis, while received vaccine MENINGOCOCCAL VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL VACCINE produced by unknown manufacturer (lot number, expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a serious meningitis (meningitis) (reported as serogroup A), following the administration of MENINGOCOCCAL VACCINE. This event was leading to death. It was reported that the patient had been given the meningococcal vaccine but still contracted the deadly disease. It was also a case of suspected vaccination failure. No lab data was reported. Final diagnosis was (fatal) died suddenly from meningitis. It was not reported if the patient received a corrective treatment. The Patient died on an unknown date from meningitis. It was unknown if an autopsy was done. Documents held by the sender: None.; Sender's Comments: This case corresponds to a poorly documented consumer report. Patient reportedly had received meningococcal vaccine for which the name and manufacturer were unknown. The patient died due to meningitis (reported as serogroup A) an unspecified amount of time after vaccination. Clinical details- such as latency from vaccination, medical history, clinical details surrounding the reported event, vaccination details, the name of the specific vaccine administered, and diagnostic work-up- are lacking to allow adequate medical assessment.; Reported Cause(s) of Death: Meningitis.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Expired product administered
Clinical narrative: Initial information received on 01-Apr-2019 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a five-years-old female patient who received vaccine DAPTACEL. The patients past medical history, treatments and family history were not provided. Concomitant vaccination included Hepatitis A Vaccine on unknown date. On 01-Apr-2019, the patient received a 0.5ml dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine lot C5169AA, expiry date 16-Mar-2019 via unknown route in the right anterior lateral thigh. It was an actual medication error due to expired vaccine used. It was reported that patient received a dose of expired DAPTACEL on 01-Apr-2019 which was expired on 16-Mar-2019. It was unknown whether patient experienced any adverse reaction after the injection. 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. List of documents held by sender- none.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 01-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional. This case involves Child patient (age and gender unknown) who accidentally received expired vaccine DAPTACEL. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received a 0.5ml dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine lot number, expiry date not reported via unknown route in unknown administration site. It was an actual medication error due to expired vaccine used. It was reported that accidentally gave an expired dose of DAPTACEL to a child. It was unknown whether patient experienced any adverse reaction after the injection. 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. List of documents held by sender- none.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 01-Apr-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a patient of an unknown demographics who received vaccine Diphtheria, Tetanus and Acellular Pertussis Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site on an unknown date. 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 Expired vaccine used. It was reported that Expired DtaP given to patient. It was unknown if any adverse event was occurred. 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. Documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 01-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 years old male patient who received vaccine PENTACEL and reported that patient had delay in his PENTACEL schedule, did not receive PENTACEL at age 15 to 18 months as scheduled. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine (lot number, expiry date, dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to Booster dose missed. It was unknown whether adverse event occurred after the injection. 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. List of documents held by sender: none.
Sex: U
Vaccine: TD
Symptoms: Contraindication to vaccination
Clinical narrative: Initial information received on 28-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a patient of unknown demography who received vaccine TENIVAC and reported TENIVAC latex contraindications. The patient's past medical history included Rubber sensitivity. The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult lot number not reported via unknown route in unknown administration site. It was a case of contraindication to vaccination. It was unknown whether adverse event occurred after the injection. 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. List of documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 1 day after vaccine developed redness and swelling at injection site. Was given BENADRYL. Next day redness and swelling worsened and 2 other raised spots developed on (L) forearm. Started on KEFLEX and Prednisone. More spots developed on (L) arm. Evaluated in ER for concern of cellulitis.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Blood thyroid stimulating hormone, Chest X-ray, Chest pain, Confusional state, Decreased appetite
Clinical narrative: Fever, HA, muscle weakness, body aches, confusion, tachycardia, SOB, chest pain, lethargy, dizziness, nausea, decreased appetite, loose stools, blurred vision. Lethargy began shortly after vaccine administration. Other symptoms worsened over next week, and then the employee was evaluated at a urgent care center after 6 days of symptoms. She has also been evaluated by PCP and Ophthalmology.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Diarrhoea, Differential white blood cell count, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: Fever, HA, muscle weakness, body aches, confusion, tachycardia, SOB, chest pain, lethargy, dizziness, nausea, decreased appetite, loose stools, blurred vision. Lethargy began shortly after vaccine administration. Other symptoms worsened over next week, and then the employee was evaluated at a urgent care center after 6 days of symptoms. She has also been evaluated by PCP and Ophthalmology.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Fibrin D dimer, Full blood count, Headache, Influenza A virus test, Influenza B virus test
Clinical narrative: Fever, HA, muscle weakness, body aches, confusion, tachycardia, SOB, chest pain, lethargy, dizziness, nausea, decreased appetite, loose stools, blurred vision. Lethargy began shortly after vaccine administration. Other symptoms worsened over next week, and then the employee was evaluated at a urgent care center after 6 days of symptoms. She has also been evaluated by PCP and Ophthalmology.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Lethargy, Metabolic function test, Mononucleosis heterophile test, Muscular weakness, Nausea
Clinical narrative: Fever, HA, muscle weakness, body aches, confusion, tachycardia, SOB, chest pain, lethargy, dizziness, nausea, decreased appetite, loose stools, blurred vision. Lethargy began shortly after vaccine administration. Other symptoms worsened over next week, and then the employee was evaluated at a urgent care center after 6 days of symptoms. She has also been evaluated by PCP and Ophthalmology.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Pain, Pyrexia, Tachycardia, Vision blurred
Clinical narrative: Fever, HA, muscle weakness, body aches, confusion, tachycardia, SOB, chest pain, lethargy, dizziness, nausea, decreased appetite, loose stools, blurred vision. Lethargy began shortly after vaccine administration. Other symptoms worsened over next week, and then the employee was evaluated at a urgent care center after 6 days of symptoms. She has also been evaluated by PCP and Ophthalmology.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injection site inflammation, Injection site pain
Clinical narrative: Pt claims she has pain around the injection area, inflamed, very tired, pt got KEFLEX rx from doctor.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain in arm.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: SWELLING, REDNESS, WARM TO TOUCH FROM INJECTION SITE DOWN TO ELBOW. SYMPTOMS RESOLVED AFTER 10 DAYS.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Loss of personal independence in daily activities, Nuclear magnetic resonance imaging, Periarthritis, Rotator cuff repair
Clinical narrative: Shot administered at top of shoulder. More painful during administration than normal. Pain continued to get worse. It became difficult to take off a shirt or put on deodorant. Returned to pharmacy on 11/13/2018 to talk to the pharmacist about the pain. They dismissed any issue and suggested ibuprofen. Started taking max daily dose of ibuprofen and pain continued to worsen. Called PCP on 12/12/2018. Doctor was on vacation until after the holidays. Called specialist on 12/13/2018 and was seen on 12/18/2018. Also had imaging (MRI, x-rays) on 12/18/2018. Was diagnosed with impingement syndrome and early frozen shoulder and given two cortisone shots during the same appointment. Was ordered to continue ibuprofen and begin physical therapy. Saw no improvement after 3 weeks and was given another round of cortisone shots. Was given another 3 weeks to improve and then surgery was recommended. Subacromial decompression surgery occurred on 3/25/2019. Recovery is ongoing.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Rotator cuff syndrome, X-ray
Clinical narrative: Shot administered at top of shoulder. More painful during administration than normal. Pain continued to get worse. It became difficult to take off a shirt or put on deodorant. Returned to pharmacy on 11/13/2018 to talk to the pharmacist about the pain. They dismissed any issue and suggested ibuprofen. Started taking max daily dose of ibuprofen and pain continued to worsen. Called PCP on 12/12/2018. Doctor was on vacation until after the holidays. Called specialist on 12/13/2018 and was seen on 12/18/2018. Also had imaging (MRI, x-rays) on 12/18/2018. Was diagnosed with impingement syndrome and early frozen shoulder and given two cortisone shots during the same appointment. Was ordered to continue ibuprofen and begin physical therapy. Saw no improvement after 3 weeks and was given another round of cortisone shots. Was given another 3 weeks to improve and then surgery was recommended. Subacromial decompression surgery occurred on 3/25/2019. Recovery is ongoing.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain in extremity, Post herpetic neuralgia, Swelling
Clinical narrative: Symptoms of post herpetic neuralgia over the R occipital distribution similar to a previous herpes zoster irruption. There were no obvious lesions but my scalp felt as if there was localized swelling.  The symptoms are persisting three weeks after onset but are not severe. The symptoms began approximately 3-4 weeks following the immunization and after the initial symptoms of arm pain, myalgias and fatigue resolved.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Localized redness, warmth and induration at the site of the injection beginning about 20-22 hours after vaccine injection. Patient evaluated talked with doctor on call around 6 pm on 4/02/19, was instructed to give diphenhydramine and observe overnight. Patient seen in the office at 2pm on 4/03/2019. Parent and patient reported that redness had increased since the evening before. Patient had redness, swelling and increased warmth in the upper anterolateral L arm, with an area of induration at the medial margin. Patient prescribed hydroxyzine, (told to discontinue diphenhydramine), cool compresses, and pain control with acetaminophen or ibuprofen with instruction to follow up the follow day. Patient instructed to seek immediate medical care if fever/chills/sweats occur.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Chills, Fatigue, Injection site pain, Myalgia
Clinical narrative: Profoundly tired, chills, right side of right breast sore, muscle aches, generally and at injection site.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram, Flank pain, Full blood count, Herpes zoster, Metabolic function test
Clinical narrative: Began to have severe right sided pain-constant-pain increased next day and went to Urgent care and diagnosed with probable kidney. Stone-pain worse next day and went to ED-told same thing. On the third day, rash developed, and realized I had shingles. Saw PCP and prescribed antiviral.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Nephrolithiasis, Rash, Urine analysis
Clinical narrative: Began to have severe right sided pain-constant-pain increased next day and went to Urgent care and diagnosed with probable kidney. Stone-pain worse next day and went to ED-told same thing. On the third day, rash developed, and realized I had shingles. Saw PCP and prescribed antiviral.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Pain in extremity, Pruritus, Rash
Clinical narrative: Headache for 2 days. Right arm pain. Mild case of shingles on right shoulder and right side of back  appeared to be a rash itched. Also a small amount of rash on left shoulder.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, TDAP
Symptoms: Arthropathy, Discomfort, Immediate post-injection reaction, Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient has (L) arm pain from upper arm to the shoulder and around to the back of the arm. She is having limited ROM of the shoulder due to discomfort. There is a pulling sensation when she reaches up and forward or backwards. Onset is immediately follow receiving 3 vaccinations at her CPE 11/2018. Patient referred to ortho to rule out underlying shoulder disorder and impingement.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, TDAP
Symptoms: Rotator cuff syndrome, Sensory disturbance, X-ray limb
Clinical narrative: Patient has (L) arm pain from upper arm to the shoulder and around to the back of the arm. She is having limited ROM of the shoulder due to discomfort. There is a pulling sensation when she reaches up and forward or backwards. Onset is immediately follow receiving 3 vaccinations at her CPE 11/2018. Patient referred to ortho to rule out underlying shoulder disorder and impingement.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistance and refers to a patient of unknown age and gender. Patient's current conditions, medical history, concomitant medications, drug allergies or reactions were not reported. On 13-MAR-2019, the patient was vaccinated with M-M-R II,  lot # R028523, expiration date 04-OCT-2019, intramuscularly (strength, dose, frequency, and anatomical site of administration were not provided) for prophylaxis ( incorrect route of product administration). Sterile diluent lot number R002058 was mentioned. No adverse events were reported. The outcome of the event was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 01-APR-2019, the patient was vaccinated with an improperly stored dose of PROQUAD, subcutaneously, lot # R024015, expiration date 19-FEB-2020 for prophylaxis (dose was not reported) (product storage error). The administered dose of the vaccine experienced a temperature excursion of 6 degrees F to 14 degrees F (-14 degrees C to -10 degrees C) (14.1F) for 7 hours and 35 minutes, as recorded by a data logger. The administered dose of the vaccine experienced a previous temperature excursion of 6 degrees F to 14 degrees F (-14 degrees C to -10 degrees C) (14.1F) during a time frame of 10 hours and 35 minutes. No adverse effects were reported. The outcome of the event product storage error was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes virus infection
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of herpes virus infection in a 71-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included herpes virus infection (had a history of Herpes). On 25th March 2019, the patient received SHINGRIX. On 28th March 2019, 3 days after receiving SHINGRIX, the patient experienced herpes virus infection. On an unknown date, the outcome of the herpes virus infection was not recovered/not resolved. It was unknown if the reporter considered the herpes virus infection to be related to SHINGRIX. Additional information was provided as follows: The age at vaccination was not reported, however it could be 70 or 71 years. The patient did not have lot or expiration date. The patient received SHINGRIX and he developed a herpes outbreak on his chin. The event was ongoing at the time of this report.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Eyelids pruritus, Pain, Pain in extremity, Rash generalised, Urticaria
Clinical narrative: Patient complained of urticaria, rash over his whole body, pain with chewing, itchy eye lids, and his R arm hurting, which all started on the next morning, a Friday. The itching and rash kept him up during the night time and he got little sleep afterward. He contacted the clinic Monday morning when it felt worse. On 3/28/19, spoke with him to prepare this report, and he stated he was doing much better, after starting treatment with BENADRYL and ADVIL on 3/25/19.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Flushing, Injection site erythema, Injection site warmth
Clinical narrative: Patient had redness of the arm around the injection site, traveling down the left arm. The area of redness felt hot and patient also reported flushing of the face that evening. The redness in the arm lasted approximately 4 days. Patient took BENADRYL OTC to help with the redness along with applying ice to the injection site.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Feeding disorder
Clinical narrative: Patient woke at 1 am at night following the immunization the previous afternoon. Extreme chills - unable to talk. Muscle and joint pain - unable to get out of bed. Light sensitivity and dizzy  - stayed in a dark room. Unable to eat or drink. Brain fog. Stayed in bed the next day. Felt better the second day out and by the third was weak but was able to go out of the house.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Mobility decreased, Myalgia, Photophobia, Speech disorder
Clinical narrative: Patient woke at 1 am at night following the immunization the previous afternoon. Extreme chills - unable to talk. Muscle and joint pain - unable to get out of bed. Light sensitivity and dizzy  - stayed in a dark room. Unable to eat or drink. Brain fog. Stayed in bed the next day. Felt better the second day out and by the third was weak but was able to go out of the house.
Age: 1.25
Sex: M
Vaccine: HEPA
Symptoms: Condition aggravated, Febrile convulsion, Irritability, Otitis media acute, Pyrexia
Clinical narrative: Patient got a shot on 7/2/2018 in the evening around 3:30-4pm. On 7/3/2018 around 9-10 am, he start having a low fever (his body very warm but the temperature isn't touch 98-99 yet. Around 3-4 pm, he got fussy and a little cranky. I use cloth with warm water to wipe his body such as armpit to make sure his temperature isn't go high. At 6pm, I checked his temperature under armpit, it is around 99.9. I was nursing him and he just had seizure right in my arm. I called 911 and we went to the hospital. After that, I gave him ibuprofen as the doctor said. However, he still have fever. So On 7/5/2018, I went to hospital again and this time diagnosis as Left acute otitis media.
Age: 1.25
Sex: M
Vaccine: HEPA
Symptoms: Seizure, Skin warm
Clinical narrative: Patient got a shot on 7/2/2018 in the evening around 3:30-4pm. On 7/3/2018 around 9-10 am, he start having a low fever (his body very warm but the temperature isn't touch 98-99 yet. Around 3-4 pm, he got fussy and a little cranky. I use cloth with warm water to wipe his body such as armpit to make sure his temperature isn't go high. At 6pm, I checked his temperature under armpit, it is around 99.9. I was nursing him and he just had seizure right in my arm. I called 911 and we went to the hospital. After that, I gave him ibuprofen as the doctor said. However, he still have fever. So On 7/5/2018, I went to hospital again and this time diagnosis as Left acute otitis media.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abscess, Contusion, Feeling cold, Headache, Lymphadenopathy
Clinical narrative: After 3 hours started getting expected adverse events including fever, cold shakes, headache. After 8 hours after the vaccination, developed 2 enlarged lymph nodes on left armpit the size of golf balls. Patient could not put arm down against side of body since nodes were so large. The nodes were not red, and the texture was solid rather than tissue. Next day went to doctor and was only told keep an eye on it. For 2 days, continued with fever, shakes and headache. As abscess receded started bruising from armpit all the way to side of trunkit was 7 inches long and wide. The bruise was initially black/blue/red. Bruise is not spreading anymore and now turning yellow at the edges as it is starting to disappear. The bruise was sore but not painful. Patient went back to doctor on 4/1 and told he had never seen a reaction like it.  Patient can send pictures in case it is helpful. There were no issues after the first dose of the SHINGRIX vaccine. Patient reports that at the end of September she had a slight case of shingles; she went to dermatologist who confirmed it was a shingles outbreak. She had conflicted recommendations as to whether she could receive Shingles vaccine and when; first dose was administered in the winter. On 3/26, the patient was prescribed Metoprolol 25mg for situational high blood pressure that was identified during visit.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: After 3 hours started getting expected adverse events including fever, cold shakes, headache. After 8 hours after the vaccination, developed 2 enlarged lymph nodes on left armpit the size of golf balls. Patient could not put arm down against side of body since nodes were so large. The nodes were not red, and the texture was solid rather than tissue. Next day went to doctor and was only told keep an eye on it. For 2 days, continued with fever, shakes and headache. As abscess receded started bruising from armpit all the way to side of trunkit was 7 inches long and wide. The bruise was initially black/blue/red. Bruise is not spreading anymore and now turning yellow at the edges as it is starting to disappear. The bruise was sore but not painful. Patient went back to doctor on 4/1 and told he had never seen a reaction like it.  Patient can send pictures in case it is helpful. There were no issues after the first dose of the SHINGRIX vaccine. Patient reports that at the end of September she had a slight case of shingles; she went to dermatologist who confirmed it was a shingles outbreak. She had conflicted recommendations as to whether she could receive Shingles vaccine and when; first dose was administered in the winter. On 3/26, the patient was prescribed Metoprolol 25mg for situational high blood pressure that was identified during visit.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Starting approximately three days after the first injection, my left shoulder started hurting. The shot was administered in my left upper arm intramuscularly. It is now a month later and my left shoulder still hurts when I move it and when I touch it.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Hypersomnia, Pain in extremity, Pyrexia
Clinical narrative: Chills, extreme shivering, 100°fever started in 23 hours and lasted about 10 hours. Took tylenol.  Also have very sore arm with  large red spot. Painful to lay on. Slept 9 1/2 hours at night then 3 hour nap the next day.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Almost immediately after injection left arm began to hurt, tingling in left arm and hand. Continued for several hours and for the next few days, still slight tingling off and on to this date, but not quite as adverse as first few days.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Patient stated the vaccine injection hurt more than usual. She noticed nerve pain in her right arm that has lasted several months. She went to her doctor and received a Rx for ibuprofen. She stated her perception of the administration was higher on the arm than she typically receives.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: PATIENT REPORTED APPROXIMATELY 24 HOURS AFTER RECEIVING VACCINE SHE DEVELOPED REDNESS ABOUT 3 INCHES IN DIAMETER THAT WAS SWOLLEN AND HOT TO THE TOUCH. PATIENT WAS INSTRUCTED TO MONITOR REDNESS AND REPORT BACK IF REDNESS DID NOT IMPROVE OR WORSENED.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Eczema, Erythema, Pain
Clinical narrative: Patient said she got redness and pain 3 days after vaccination and then she got eczema on her arm.
Age: 36.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Swelling
Clinical narrative: Patient presented to the pharmacy stating that after she received the vaccine her shoulder was swollen, she had a 'knot' at the vaccine site, pain in the upper right arm, warmth, redness and itching. She states the symptoms are improving but she is still having itching at the infection site. She reports improvement with itching upon taking BENADRYL.
Age: 36.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Vaccination site nodule
Clinical narrative: Patient presented to the pharmacy stating that after she received the vaccine her shoulder was swollen, she had a 'knot' at the vaccine site, pain in the upper right arm, warmth, redness and itching. She states the symptoms are improving but she is still having itching at the infection site. She reports improvement with itching upon taking BENADRYL.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Significant pain followed by swelling and redness around the injection site; systemic reaction with flu like symptoms- aches, weakness, and fever. Flu like symptoms have gotten better but the pain and swelling on the injection arm are still present. Tylenol was taken.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Significant pain followed by swelling and redness around the injection site; systemic reaction with flu like symptoms- aches, weakness, and fever. Flu like symptoms have gotten better but the pain and swelling on the injection arm are still present. Tylenol was taken.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Patient received PREVNAR 13 in left deltoid. Experienced pain a few hours after. Patient went to MD and diagnosis was possible tendonitis after injection.
Age: 33.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: 33 YOF pt presented to the clinic on 4-1-19 for PPD and Tdap, HBV, MMR and Varicella vaccines. Pt was seen and counseled by Clinician. Vaccines on right side administered by clinician and vaccines and PPD on left side administered by CA. On 4-3-19 pt developed edema and erythema on left upper arm with central vesicular lesions. Pt presented on 4-3-19 at 6:35 PM for PPD reading (administered on left FA 01. mL intradermal inj, lot # C5563AB exp date 3/14/21). She then mentioned she had developed symptoms on the left upper arm. She denied SOB, chest pain, difficulty breathing or sensation of shocking. Localized edema and erythema noted. Area warm and tender to the touch. Blanching noted. No drainage. Erythema has poor margins but it measures approximately 7x7 cm. Centrally vesicular rash was noted. No drainage. Left upper arm diameter was 31 cm and right upper right diameter 30 cm. Pt in no distress. Pt was advised on 4-1-19 and today to go to ER in case of an emergency or localized reaction. Pt verbalized understanding. She left the clinic to go to an ER. She declined EMS activated. No distress observed upon discharge.
Age: 33.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Pallor, Rash vesicular
Clinical narrative: 33 YOF pt presented to the clinic on 4-1-19 for PPD and Tdap, HBV, MMR and Varicella vaccines. Pt was seen and counseled by Clinician. Vaccines on right side administered by clinician and vaccines and PPD on left side administered by CA. On 4-3-19 pt developed edema and erythema on left upper arm with central vesicular lesions. Pt presented on 4-3-19 at 6:35 PM for PPD reading (administered on left FA 01. mL intradermal inj, lot # C5563AB exp date 3/14/21). She then mentioned she had developed symptoms on the left upper arm. She denied SOB, chest pain, difficulty breathing or sensation of shocking. Localized edema and erythema noted. Area warm and tender to the touch. Blanching noted. No drainage. Erythema has poor margins but it measures approximately 7x7 cm. Centrally vesicular rash was noted. No drainage. Left upper arm diameter was 31 cm and right upper right diameter 30 cm. Pt in no distress. Pt was advised on 4-1-19 and today to go to ER in case of an emergency or localized reaction. Pt verbalized understanding. She left the clinic to go to an ER. She declined EMS activated. No distress observed upon discharge.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Erythema, Skin burning sensation, Skin warm
Clinical narrative: Patient reported mild GI distress, redness of face and ears, and feeling like her skin was "on fire". She said she did not know if she had a fever; she was at work and did not have access to a thermometer. But she reported that a co-worker touched her skin and said she felt warm to the touch.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Local reaction, Pruritus, Skin warm
Clinical narrative: Pt received vaccine Sat 3/30. She began to feel local reaction on Sunday. It was at its worst on Tuesday and better today (Wednesday 4/3/19). Today it was about a 3 inch circle, red, warm, and itching.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt received vaccine Sat 3/30. She began to feel local reaction on Sunday. It was at its worst on Tuesday and better today (Wednesday 4/3/19). Today it was about a 3 inch circle, red, warm, and itching.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain
Clinical narrative: The patient's daughter called in and reported that the patient was in a lot of pain and had reduced mobility in her arm. She reported no swelling or redness at the site. When asked, they had not tried any home remedies to treat the pain. TYLENOL, ibuprofen, and a cold compress was recommended. The doctor's office will be informed tomorrow and will instruct patient how to proceed.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Hypoaesthesia, Injection site discolouration, Pain in extremity, Weight bearing difficulty
Clinical narrative: Patient complains of left arm pain, numbness, weakness, unable to bear weight since having flu vaccination 2/15/19. Site on left deltoid appears yellow halo around it, not visually swollen or red.  Patient does not have MD to seek care from.