chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: HEPA, VARZOS
Symptoms: Dizziness, Hyperhidrosis, Hypopnoea, Malaise, Unresponsive to stimuli
Clinical narrative: Patient was going to get three vaccinations. He started with Shingrix and then the Havrix was administered in the other arm. He had no past reactions with shots and had flu vaccinations with us in the past. After a few minutes, he was feeling light headed and dizzy. He was visibly sweating and was leaning forward. Instructed him to lean back in case of passing out. I asked him if he wanted a water or anything to eat since he was not feeling well. He said he had not eaten anything today and was just dizzy.   Told him we should probably hold off on getting any more shots today since he was not feeling well. He voiced understanding. He was asking me about shingles and why exactly they call it that. After about 2-5 minutes of talking, he started to lose awareness and his eyes were not responsive. My technician called 911 and for manage to help out if needed. Patients wife was near and I explained the situation. I suggested an epi-pen to be administered because patient was non-responsive. Breathing was visible but was shallow and sounded muffled. The pen was administered and about 5 minutes later the patient was alert and responsive. Sweating had lessened.    Medical help arrived and patient did not want to go to the hospital. They took blood pressure which was low. We gave him some water and some mints in case blood glucose was a factor. Patient did not want to leave in ambulance if though medical help recommended this in case epinepherine wore off.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Penile erythema
Clinical narrative: Penile redness, edema/ swelling Left thigh redness and swelling
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; female patient was inadvertently administered PROQUAD before discovery of the data logger malfunction; This spontaneous report has been received from a medical assistant referring to a 4 year old female patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, and concurrent conditions was not provided. Concomitant therapies included sterile diluent.      On 17-FEB-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S021623 with expiration date of 09-JAN-2021 (strength, frequency, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. No adverse effects.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: the patient was "7 weeks pregnant" at time she received first dose of GARDASIL 9./ the patient received second dose of GARDASIL 9  on 11/12/2019; This spontaneous prospective pregnancy report was received from a business/individual referring to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.   On 10-SEP-2019 the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R030453, expiration date was not reported, but upon internal validation established as 23-JUL-2021; dose, frequency and route were not reported) for prophylaxis. The patient was 7 weeks pregnant at time she received first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exposure during pregnancy). The patient received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R030453, expiration date was not reported, but upon internal validation established as 23-JUL-2021) on 12-NOV-2019. The patient was not aware she was pregnant when she received doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient was now 31 weeks pregnant. Last menstrual period (LMP) was assumed as 23-JUL-2019, date of conception was assumed as 06-AUG-2019 and the estimated due date (EDD) was 28-APR-2020. Pregnancy outcome was pending.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects were reported in the patient; patient received a dose of VARIVAX following a temperature excursion; This spontaneous report was received from a medical assistant, referring to patient of unknown age and gender. The patient's pertinent concurrent conditions, pertinent medical history, concomitant medications and previous drugs reactions or allergies were not provided.  On an unspecified date in January 2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)  (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; lot number S024369 has been verified to be a valid, expiration date reported and validated as 08-JUN-2021) as prophylaxis. No adverse effects were reported for the patient.  According to the reporter, the temperature excursion was between 6 degrees Fahrenheit to 14 degrees Fahrenheit (-14 degrees Celsius to -10 degrees Celsius) (9.8 degrees Fahrenheit) for a time frame of two hours on an unspecified date (product storage error), without any previous temperature excursion; which was detected by a digital data logger.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE information provided; administered the first dose ofGARDASIL 9 on 4/30/2019 and was administered the second dose ofGARDASIL 9 on 2/20/2020; This spontaneous report was received from a pharmacist referring to a 29 years old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 30-APR-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose details, route, lot # and expiration date were not reported) for prophylaxis. On 20-FEB-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). The patient had not received the third dose yet. No additional adverse event information was provided.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity, Paraesthesia, Tenderness
Clinical narrative: Patient feeling pain/tenderness in her wrist. Tingling feeling has spread down to her fingers. Patient did feel soreness in arm the day after the shot but that has since subsided. About one week after the shot is when her wrist started to bother her.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: C-reactive protein normal, Full blood count normal, Headache, Metabolic function test, Pyrexia
Clinical narrative: Fever developed 24 hrs after injection. Fever and global headache without photophobia then occurred daily from 2/13/2020 through 2/27/2020.  Patient reported temp of 101 F (oral) each evening.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: Fever developed 24 hrs after injection. Fever and global headache without photophobia then occurred daily from 2/13/2020 through 2/27/2020.  Patient reported temp of 101 F (oral) each evening.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Neuralgia, Pain in extremity, Rash, Rotator cuff syndrome
Clinical narrative: Pain at injection site followed by a linear rash below injection site.  Rash resolved over 2 weeks but right Deltoid pain persisted with some pain going down the forearm.  It seemed to be a nerve type of pain.  Over the past month, it remains sore with palpation and I feel an impingement type of pain with flexion at end range.  This still persists.  I talked to pharmacy and they did not feel this is a side effect of the shingle shot.  I have no other injury to the left arm or shoulder.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: severe nausea, chills, fever, muscle aches - lasting 2 1/2 days
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Mechanical urticaria, Urticaria chronic
Clinical narrative: chronic urticarial with new onset dermatographia and possible angioedema
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Patient did not experience any adverse reactions to this immunization. Patient was administered a vaccine that expired in 20 Jan 2020. When I originally keyed the vaccines in stock into ASIM's I keyed in 20 Jun 2020. I spoke with the patient 15 minutes after administration and there were not any signs and symptoms of an adverse reaction, but I did notify her that I had administered an expired vaccine and to report any abnormalities in that area.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Pain
Clinical narrative: painful and redness which spread. mom did do cold compress
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Confusional state, Dizziness, Fall, Feeling abnormal, Head injury
Clinical narrative: Patient received above vaccinations and staff advised patient to rest in exam room for 15 minutes prior to departure.  I was called to room several minutes later.  Per mom, child was feeling light headed after the vaccines so she advised him to go ahead and put his head between his legs.  He felt worse and slumped forward and fell off exam table onto the floor striking his head.  It is unknown to me how long he was unresponsive, but from observations from staff, was very little time.  When I arrived from next door exam room, his eyes were open, giving me eye contact but was not speaking.  He seemed mildly confused/dazed for about 3 minutes.  He also had pallor.  No cyanosis.  Regular breathing pattern.  No seizure activity.  Gradually he improved over several minutes and was oriented.  He was gradually repositioned every several minutes before departing office (i.e. sitting on floor against wall, sitting in chair, standing with mom and walking brief steps) to ensure he was no longer feeling lightheaded.  He complained of head pain and neck pain.  I advised observation for few hours at ER due to mechanism of fall and head trauma.  Parent complied and child was observed in the ER.   He had one episode of vomiting  en route to the ER.  He was at his baseline in the ER.  No neurological deficits.  No studies were done at the ER.  He received anti-nausea medication in the ER..  He was discharged home from the ER approximately 4 hours after incident.  Mom did not have follow up concerns of child after that day.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Headache, Neck pain, Pallor, Unresponsive to stimuli, Vomiting
Clinical narrative: Patient received above vaccinations and staff advised patient to rest in exam room for 15 minutes prior to departure.  I was called to room several minutes later.  Per mom, child was feeling light headed after the vaccines so she advised him to go ahead and put his head between his legs.  He felt worse and slumped forward and fell off exam table onto the floor striking his head.  It is unknown to me how long he was unresponsive, but from observations from staff, was very little time.  When I arrived from next door exam room, his eyes were open, giving me eye contact but was not speaking.  He seemed mildly confused/dazed for about 3 minutes.  He also had pallor.  No cyanosis.  Regular breathing pattern.  No seizure activity.  Gradually he improved over several minutes and was oriented.  He was gradually repositioned every several minutes before departing office (i.e. sitting on floor against wall, sitting in chair, standing with mom and walking brief steps) to ensure he was no longer feeling lightheaded.  He complained of head pain and neck pain.  I advised observation for few hours at ER due to mechanism of fall and head trauma.  Parent complied and child was observed in the ER.   He had one episode of vomiting  en route to the ER.  He was at his baseline in the ER.  No neurological deficits.  No studies were done at the ER.  He received anti-nausea medication in the ER..  He was discharged home from the ER approximately 4 hours after incident.  Mom did not have follow up concerns of child after that day.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Aphasia, Confusional state, Fall, Feeling abnormal, Head injury
Clinical narrative: Patient received above vaccinations and staff advised patient to rest in exam room for 15 minutes prior to departure.  I was called to room several minutes later.  Per mom, child was feeling light headed after the vaccines so she advised him to go ahead and put his head between his legs.  He felt worse and slumped forward and fell off exam table onto the floor striking his head.  It is unknown to me how long he was unresponsive, but from observations from staff, was very little time.  When I arrived from next door exam room, his eyes were open, giving me eye contact but was not speaking.  He seemed mildly confused/dazed for about 3 minutes.  He also had pallor.  No cyanosis.  Regular breathing pattern.  No seizure activity.  Gradually he improved over several minutes and was oriented.  He was gradually repositioned every several minutes before departing office (i.e. sitting on floor against wall, sitting in chair, standing with mom and walking brief steps) to ensure he was no longer feeling lightheaded.  He complained of head pain and neck pain.  I advised observation for few hours at ER due to mechanism of fall and head trauma.  Parent complied and child was observed in the ER.   He had one episode of vomiting  en route to the ER.  He was at his baseline in the ER.  No neurological deficits.  No studies were done at the ER.  He received anti-nausea medication in the ER..  He was discharged home from the ER approximately 4 hours after incident.  Mom did not have follow up concerns of child after that day.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Headache, Loss of consciousness, Nausea, Neck pain, Posture abnormal
Clinical narrative: Patient received above vaccinations and staff advised patient to rest in exam room for 15 minutes prior to departure.  I was called to room several minutes later.  Per mom, child was feeling light headed after the vaccines so she advised him to go ahead and put his head between his legs.  He felt worse and slumped forward and fell off exam table onto the floor striking his head.  It is unknown to me how long he was unresponsive, but from observations from staff, was very little time.  When I arrived from next door exam room, his eyes were open, giving me eye contact but was not speaking.  He seemed mildly confused/dazed for about 3 minutes.  He also had pallor.  No cyanosis.  Regular breathing pattern.  No seizure activity.  Gradually he improved over several minutes and was oriented.  He was gradually repositioned every several minutes before departing office (i.e. sitting on floor against wall, sitting in chair, standing with mom and walking brief steps) to ensure he was no longer feeling lightheaded.  He complained of head pain and neck pain.  I advised observation for few hours at ER due to mechanism of fall and head trauma.  Parent complied and child was observed in the ER.   He had one episode of vomiting  en route to the ER.  He was at his baseline in the ER.  No neurological deficits.  No studies were done at the ER.  He received anti-nausea medication in the ER..  He was discharged home from the ER approximately 4 hours after incident.  Mom did not have follow up concerns of child after that day.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Syncope, Vomiting
Clinical narrative: Patient received above vaccinations and staff advised patient to rest in exam room for 15 minutes prior to departure.  I was called to room several minutes later.  Per mom, child was feeling light headed after the vaccines so she advised him to go ahead and put his head between his legs.  He felt worse and slumped forward and fell off exam table onto the floor striking his head.  It is unknown to me how long he was unresponsive, but from observations from staff, was very little time.  When I arrived from next door exam room, his eyes were open, giving me eye contact but was not speaking.  He seemed mildly confused/dazed for about 3 minutes.  He also had pallor.  No cyanosis.  Regular breathing pattern.  No seizure activity.  Gradually he improved over several minutes and was oriented.  He was gradually repositioned every several minutes before departing office (i.e. sitting on floor against wall, sitting in chair, standing with mom and walking brief steps) to ensure he was no longer feeling lightheaded.  He complained of head pain and neck pain.  I advised observation for few hours at ER due to mechanism of fall and head trauma.  Parent complied and child was observed in the ER.   He had one episode of vomiting  en route to the ER.  He was at his baseline in the ER.  No neurological deficits.  No studies were done at the ER.  He received anti-nausea medication in the ER..  He was discharged home from the ER approximately 4 hours after incident.  Mom did not have follow up concerns of child after that day.
Age: 7.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: There was no adverse event, Patient did not have any reaction or pain, Im reporting a vaccine given by error.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test normal, Burning sensation, Electrocardiogram, Increased upper airway secretion
Clinical narrative: Next morning after shot; 1.flemme in throat so thick could not cough it up, It is still there today.  Same problem every morning when wake up AM. Saw Dr.'s and took prescriptions that were given but it has never left. 2.Legs and knees swell up and in bad pain.  Saw Dr. and said to take Gabapentin. .When go to bed around 10 PM Pain comes about the middle of the night every night and is still there legs burn and feet burn every night.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Laboratory test, Pain in extremity, Peripheral swelling, Productive cough
Clinical narrative: Next morning after shot; 1.flemme in throat so thick could not cough it up, It is still there today.  Same problem every morning when wake up AM. Saw Dr.'s and took prescriptions that were given but it has never left. 2.Legs and knees swell up and in bad pain.  Saw Dr. and said to take Gabapentin. .When go to bed around 10 PM Pain comes about the middle of the night every night and is still there legs burn and feet burn every night.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Cardiac murmur, Headache, Malaise, Tinnitus
Clinical narrative: Patient's wife called the pharmacy today (3/5) and stated that after receiving the vaccination patient did not feel well for a few days but that within a few days his blood pressure went up to 180/110. He was throwing up with a headache and ringing in his ears. He went in to his cardiologist and they said he had a heart murmur which had not been detected previously.  The cardiologist instructed the wife to let us (the pharmacy) know about the reaction which is what she did today. I am not sure which cardiologist the patient sees.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Patient's wife called the pharmacy today (3/5) and stated that after receiving the vaccination patient did not feel well for a few days but that within a few days his blood pressure went up to 180/110. He was throwing up with a headache and ringing in his ears. He went in to his cardiologist and they said he had a heart murmur which had not been detected previously.  The cardiologist instructed the wife to let us (the pharmacy) know about the reaction which is what she did today. I am not sure which cardiologist the patient sees.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: day after injection, slightly raised and red area around injection site but began to travel down his arm to his bicep. patient reported that it was slightly itchy but seemed to be getting better. Was told to monitor rash and call his doctor with any worsening symptoms.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Dyspnoea, Incorrect route of product administration, Localised infection
Clinical narrative: Flu vaccine administered through IV instead of IM. No signs or symptoms at the time of administration. 5 hours after administration patient became SOB and had elevated temperature. MD states symptoms not from flu vaccine but from arm infection.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal stiffness
Clinical narrative: pt received vaccine at about 3:50pm and went over to shop rite across the street. Pt said at about 45 mins later she started to get stiff neck. pt is complaining of pain from back of her neck to left side of the shoulder. Pt states she started feeling something coming soon as she left pharmacy.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Patient had injection site redness, felt warm, and patient mentioned mild pain and itchiness. Suggested patient use ibuprofen/tylenol and ice the area to help decrease the swelling. Also suggested use of benadryl tabs and/or cream
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Confusional state, Dizziness, Loss of consciousness, Syncope
Clinical narrative: Patient recieved firsts dose of shingrix vaccine, was a little nervous about getting a vaccine due to fear of needless. Allergies were confirmed, manufacturer was called to confirm no presence of egg albumin--patient recieved vaccine in left arm. Patient initally seemed okay, spoke to patient for about 5 miutes to ensure ok since patient was extremely nervous. Within 5 minutes or so patient reported being dizzy, spoke to patient again to make sure he was ok and sat to monitor for potential ADR's. Within a few minutes, patient vent into vaso vagal syncpe lost consciousness for a few seconds and regained. Paramedics were called immediatelly to the scene. Patient upon becoming alert was a little confused reporting he "fell asleep" then cintunued feeling light headed. Paramedics arrived within minutes, patient blood pressure dropped significantly (reports he normally has a low blood pressure) upon speaking to the patient he reports this is normal occurence for him upon administrations of vaccinations (or anything injectable). Patient refused hospital admission, paramedics monitored patient until blood pressure went up and patient was released and walked out of the store to go home without paramedic assistance.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pyrexia, Swelling
Clinical narrative: Second dose- two months from the first shot.   Significant swelling, three days of fever, headaches, nausea
Age: 52.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Immobile, Musculoskeletal pain
Clinical narrative: Patient states he has had prolonged shoulder pain since the immunization and is immobilized.
Age: 52.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Product administered at inappropriate site, Rotator cuff syndrome
Clinical narrative: Patient states he has had prolonged shoulder pain since the immunization and is immobilized.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, X-ray limb
Clinical narrative: Patient reports prolonged left shoulder pain, which has grown progressively worse since the injection.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Chills, Pain
Clinical narrative: Patient reported chills and body aches that started the day of vaccination and continued the following day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: Bad headache, fatigue, chills, slight nausea.  Did not test for fever.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Diarrhoea, Gait inability, Vaccination site erythema, Vaccination site oedema, Vomiting
Clinical narrative: Diarrhea x 5 days Vomiting x 1 episode 24 hrs later Would not walk x 48 hrs after vaccine erythema & edema at site of vaccine x 48 hrs No other contact or person at home with gastroenteritis symptoms
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMRV, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: Fevers and rash, no treatment, patient rash has improved. Sent to Allergist
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: RASH
Age: 40.0
Sex: F
Vaccine: FLUR4
Symptoms: Rash
Clinical narrative: Rash
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient claims he's experiencing extreme arm pain and weakness in his left arm. Tylenol and ibuprofen has not helped. Patient claims he's unable to lift or sleep ,
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Insomnia, Muscular weakness, Pain in extremity
Clinical narrative: Patient claims he's experiencing extreme arm pain and weakness in his left arm. Tylenol and ibuprofen has not helped. Patient claims he's unable to lift or sleep ,
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Chills
Clinical narrative: developed a fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th February 2020, the patient received Shingrix (intramuscular). On 13th February 2020, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient reported that it took the pharmacist 30 minutes to mix the vaccine.  The patient received Shingrix and developed a fever the next day. The fever comes back every evening and went away. Reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: developed a fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th February 2020, the patient received Shingrix (intramuscular). On 13th February 2020, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient reported that it took the pharmacist 30 minutes to mix the vaccine.  The patient received Shingrix and developed a fever the next day. The fever comes back every evening and went away. Reporter consented to follow up.
Age: 53.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: The day after the immunization patient reported pain, redness and swelling around the site of the injection. Two days after the immunization patient reported having a fever and a hard knot at the site of the injection. Patient went to urgent care and was diagnosed with cellulitis. Patient was treated with cephalexin and the problem resolved.   The pharmacist who administered the vaccine reported a defect with the syringe. As the pharmacist was removing the needle from the patient's arm the connection between the lauer-lock and the prefilled glass syringe failed and the mechanism fell apart. The defect was reported to Merck.
Age: 53.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Syringe issue
Clinical narrative: The day after the immunization patient reported pain, redness and swelling around the site of the injection. Two days after the immunization patient reported having a fever and a hard knot at the site of the injection. Patient went to urgent care and was diagnosed with cellulitis. Patient was treated with cephalexin and the problem resolved.   The pharmacist who administered the vaccine reported a defect with the syringe. As the pharmacist was removing the needle from the patient's arm the connection between the lauer-lock and the prefilled glass syringe failed and the mechanism fell apart. The defect was reported to Merck.
Age: 53.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: The day after the immunization patient reported pain, redness and swelling around the site of the injection. Two days after the immunization patient reported having a fever and a hard knot at the site of the injection. Patient went to urgent care and was diagnosed with cellulitis. Patient was treated with cephalexin and the problem resolved.   The pharmacist who administered the vaccine reported a defect with the syringe. As the pharmacist was removing the needle from the patient's arm the connection between the lauer-lock and the prefilled glass syringe failed and the mechanism fell apart. The defect was reported to Merck.
Sex: U
Vaccine: HEPA, MMR, PNC13, MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE information provided.; The patient was inadvertently administered an expired dose of M-M-R II; This spontaneous report was received from a office manager referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.  On 24-FEB-2020, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of administration; lot number R002049  has been verified to be a valid, expiration date reported and validated as 22-JAN-2020) as prophylaxis (expired product administered). The sterile diluent was not expired. No temperature excursion was reported and no adverse event was reported for the patient.
Sex: U
Vaccine: HEPA, MMR, PNC13, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE information provided.; The patient was inadvertently administered an expired dose of M-M-R II; This spontaneous report was received from a office manager referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.  On 24-FEB-2020, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of administration; lot number R002049  has been verified to be a valid, expiration date reported and validated as 22-JAN-2020) as prophylaxis (expired product administered). The sterile diluent was not expired. No temperature excursion was reported and no adverse event was reported for the patient.
Age: 52.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Immobile, Musculoskeletal pain
Clinical narrative: The injection was placed in my shoulder joint well above the deltoid muscle. My doctor referred me to an orthopedist who confirmed that I have a rotary cuff injury. The orthopedist has ordered an MRI which I have not yet received. My wife was also injured in exactly the same way and has also been referred to the orthopedist. I witnessed her injection which was also placed directly in the shoulder joint at a downward angle. The person who administered the injection is a student Pharmacy Technician. There was no direct supervision. Pharmacy technician was very deliberate and specific about where she placed the injections on both me and my wife. The receptionist at my orthopedist's office said another man was just there with a shoulder injury from a flu vaccine at pharmacy. I don't know why anyone would do something like this intentionally, but I firmly believe it was intentional.
Age: 52.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Product administered at inappropriate site, Rotator cuff syndrome
Clinical narrative: The injection was placed in my shoulder joint well above the deltoid muscle. My doctor referred me to an orthopedist who confirmed that I have a rotary cuff injury. The orthopedist has ordered an MRI which I have not yet received. My wife was also injured in exactly the same way and has also been referred to the orthopedist. I witnessed her injection which was also placed directly in the shoulder joint at a downward angle. The person who administered the injection is a student Pharmacy Technician. There was no direct supervision. Pharmacy technician was very deliberate and specific about where she placed the injections on both me and my wife. The receptionist at my orthopedist's office said another man was just there with a shoulder injury from a flu vaccine at pharmacy. I don't know why anyone would do something like this intentionally, but I firmly believe it was intentional.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Myalgia
Clinical narrative: (REPORTED BY PATIENT'S HUSBAND, WHO WAS PICKING UP PRESCRIPTIONS FOR HER FROM URGENT CARE.) FULL BODY MUSCLE ACHES AND PAINS STARTING THE DAY AFTER THE VACCINATION. PAINS WERE MOST SEVERE IN NECK, WORSENING TODAY (2 DAYS POST VACCINATION). PATIENT PRESENTED TO URGENT CARE DUE TO SEVERITY OF MUSCLE PAIN/SPASM. WAS PRESCRIBED HYDROCODONE 5/325 AND TIZANIDINE 4MG.
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Chest pain, Cough, Pneumonia, Pyrexia
Clinical narrative: left lung pneumonia; congestive heart failure; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or around 15-APR-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date in 2016, shortly after receiving zoster vaccine live (ZOSTAVAX), she suffered chest pain, cough and fever. The patient was hospitalized and diagnosed with left lung pneumonia and congestive heart failure. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the events to be disabling. Upon internal review, the events of left lung pneumonia and congestive heart failure were considered to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects were reported in fue patient.; Patient received a dose of VARIVAX following a temperature excursion; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies.  On an unknown date in January 2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), (lot No. S024369 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date reported as 06-AUG-2021, but upon internal validation established as 08-JUN-2021) for prophylaxis (dosage schedule, anatomical location and route of administration were not reported) (product storage error). The vaccine was reconstituted with diluent MRK (lot number and expiration date were not reported).    The administered dose of the vaccine experienced a temperature excursion of 6°F to 14°F (-14°C to-10°C) (9.8F) degrees Fahrenheit for 2 hours, as recorded by a data logger. There was no adverse event reported in the patient.
Sex: F
Vaccine: VARZOS
Symptoms: Basal ganglia haemorrhage, Dysarthria, Pain in extremity, Unresponsive to stimuli, Vomiting
Clinical narrative: right basal ganglia intracerebral hemorrhage; slurred speech; vomiting; severe left lower extremity pain; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 19-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered slurred speech, vomiting and severe left lower extremity pain. The patient went unresponsive and suffered right basal ganglia intracerebral hemorrhage. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events slurred speech, vomiting, severe left lower extremity pain, right basal ganglia intracerebral hemorrhage was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the events slurred speech, vomiting, severe left lower extremity pain, right basal ganglia intracerebral hemorrhage to be disability.  Upon internal review, the event right basal ganglia intracerebral hemorrhage was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Acute left ventricular failure, Atrial fibrillation, Cardiac failure congestive, Dyspnoea, Herpes zoster
Clinical narrative: paroxysmal atrial fibrillation; acute on chronic diastolic (congestive) heart failure; hypertensive heart disease with heart failure; hypertensive heart disease with heart failure; shingles; Information has been received from a lawyer referring to a male patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 18-NOV-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered a painful itchy rash on his back and was diagnosed with shingles. The patient also experienced severe shortness of breath and was hospitalized and diagnosed with paroxysmal atrial fibrillation, acute on chronic diastolic (congestive) heart failure, and hypertensive heart disease with heart failure. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events shingles, paroxysmal atrial fibrillation, acute on chronic diastolic (congestive) heart failure and hypertensive heart disease with heart failure was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the events shingles, paroxysmal atrial fibrillation, acute on chronic diastolic (congestive) heart failure and hypertensive heart disease with heart failure to be disability. Upon internal review the events paroxysmal atrial fibrillation, acute on chronic diastolic (congestive) heart failure and hypertensive heart disease with heart failure was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Hypertensive heart disease, Rash, Rash pruritic
Clinical narrative: paroxysmal atrial fibrillation; acute on chronic diastolic (congestive) heart failure; hypertensive heart disease with heart failure; hypertensive heart disease with heart failure; shingles; Information has been received from a lawyer referring to a male patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 18-NOV-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered a painful itchy rash on his back and was diagnosed with shingles. The patient also experienced severe shortness of breath and was hospitalized and diagnosed with paroxysmal atrial fibrillation, acute on chronic diastolic (congestive) heart failure, and hypertensive heart disease with heart failure. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events shingles, paroxysmal atrial fibrillation, acute on chronic diastolic (congestive) heart failure and hypertensive heart disease with heart failure was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the events shingles, paroxysmal atrial fibrillation, acute on chronic diastolic (congestive) heart failure and hypertensive heart disease with heart failure to be disability. Upon internal review the events paroxysmal atrial fibrillation, acute on chronic diastolic (congestive) heart failure and hypertensive heart disease with heart failure was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Vision blurred, Vitreous detachment
Clinical narrative: posterior vitreous detachment of both eyes; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a male patient of unknown age. His concurrent conditions, medical history and concomitant medications were not provided. In or around 18-NOV-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dose, injection anatomical location and route of administration were not reported), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), he suffered blurry vision and was diagnosed with posterior vitreous detachment of both eyes (vitreous detachment). As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), his symptoms had resulted in physical limitations not present prior to using the vaccine. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, he had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for the event was not recovered. The reported considered the vitreous detachment was related to zoster vaccine live (ZOSTAVAX).  It was considered that the vitreous detachment was a disabling event.  Upon internal review, the vitreous detachment was a medically significant event.