chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness, Nausea
Clinical narrative: LAST NIGHT AT 12:45AM HE GOT UP TO GO TO THE BATHROOM, FELT QUEEZY, WEAK, BLACKED OUT, FELL TO THE FLOOR, WOKE UP ON THE FLOOR. DENIES ANY SPINNING DIZZINESS. EVEN SITTING IN CHAIR FEELS WEAK LIKE HE IS GOING TO FALL OVER. REPORTS HEADACHE, BANDLIKE WRAPPING AROUND BACK TO SIDES OF HEAD. HAS BEEN GOING ON SINCE YESTERDAY WHEN HE RECEIVED VACCINES. NO DOCUMENTED FEVER BUT DID HAVE CHILLS LAST NIGHT, HE IS FEELING BETTER THAN HE DID LAST NIGHT. FEELING BETTER BUT NOT COMPLETELY WELL.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: PATIENT DEVELOPED HIVES "ALL OVER" LATER IN THE EVENING, AFTER GETTING PNEUMOCOCCAL VACCINE. (AM) "ITCHY" PO BENADRYL PO CLARITIN BENADRYL CREAM
Sex: F
Vaccine: VARZOS
Symptoms: Pharyngeal swelling, Urticaria
Clinical narrative: 72 hours after her second Shingrix vaccination, patient had to access the ER for hives and throat swelling where she received epinephrine, Benadryl and "something else"  The pharmacy used Shingrix Lot 52R7X, with adjuvant Lot 92NA4, on 9.13.2019. Patient reported incident to pharmacy today, 9.19.2019.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Upper arm swollen & itchy at site of injection. Swollen 10cm x 5 - red & hot to touch. Seen by provider given shot of Kenalog 40mg IM. incident started 1 HR after administration or vaccine. Cold compress given. After several Hrs after Kenalog site & swelling Administered got better No more itch less redness patient was prescribed steroid by mouth & loratadine for Allergic reaction.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Patient came to the pharmacy on 9/18/19 indicating to the pharmacist on duty that their right upper arm had swollen from their shoulder to their elbow and it had been worse prior to coming into the pharmacy. The pharmacist on duty instructed the patient to take Benadryl for the swelling.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Mother states 4-5 hours after receiving vaccination she noticed redness around injection site. Patient has been complaining of soreness and pain. Mother states over night redness spread and swelling around site appeared.
Age: 49.0
Sex: M
Vaccine: MMR, MNQ
Symptoms: Pruritus, Rash, Rash papular
Clinical narrative: Patient had a gen rash over arms & legs 2 days after vaccine with MMR/menactra He came to clinic 8 days after rash, by while rash had cleared mostly. Rash was papular very discrete, looked like insect bites. No SOB or anaphylaxis or any other Sx.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Patient felt no symptoms/pain. Right arm began to swell at injection site. Instructed Patient's wife to take patient to the urgent care center across the street.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Cold sweat, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Pt got flu vaccination, then his wife was vaccinated. We chatted for several minutes afterwards & then they walked off. He was drinking a Capri Sun that I discarded for him. Several moments later his wife came back & said he fainted. We rolled him on his side & called 911. When he came to, he said this hadn't happened in about 15 years He was extremely pale, not disoriented. He said he had once fainted watching his wife get an injection and had fainted with other vaccinations but not the flu vaccine. We placed a towel under his head and used wet sponges to cool him down. He was clammy & sweating. His Blood pressure was 140/84 Pulse 58 He never mentioned prior to vaccination that he had previously fainted with other vaccines or that he had previously fainted watching his wife. EMS came and took over. I do not know if he actually went to the hospital or not.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Computerised tomogram head normal, Gait disturbance, Hypoaesthesia, Nausea
Clinical narrative: patient given flu shot at pharmacy at 8:00 pm on 9-11-19. Woke up following morning (9-12-19) with left sided numbness, mild nausea, unsteady gait
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Patient vomited shortly after Receiving Fluarix QUAD vaccination.
Age: 33.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: R deltoid pain and swelling worsening in 2 days after vaccination  Rx Benadryl and epi pen PRN
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Pt called to discuss reaction after flu vaccine today. C/o (L) shoulder itching with hives. Hives starting to go away + area red; no swelling, no pain, no SOB, no swelling of lips/tongue or throat.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test abnormal, Gait inability, Pain in extremity
Clinical narrative: Woke up one morning about 7-10 days after receiving vaccine and could not walk. Intense pain in both feet. Joints in both hands, elbows, and knees also greatly affected. Saw Podiatrist who sent me to Rheumatologist who made diagnosis after blood test. Presently on methotrexate and prednisone.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Chills, Erythema, Headache, Hypoaesthesia
Clinical narrative: Headache, chills, body aches, vomiting for 12 hours then hands (and feet) turned red + numb. Red rash up to mid-shen
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Rash erythematous, Urinary tract infection, Urine analysis abnormal, Vomiting
Clinical narrative: Headache, chills, body aches, vomiting for 12 hours then hands (and feet) turned red + numb. Red rash up to mid-shen
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray
Clinical narrative: Headache, chills, body aches, vomiting for 12 hours then hands (and feet) turned red + numb. Red rash up to mid-shen
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Peripheral swelling
Clinical narrative: redness at injection site, swelling of left arm. applied heat, swelling went down.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Malaise
Clinical narrative: Patient said so deathly ill refused to get 2nd recommended shot in the series.
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Skin warm, Swelling
Clinical narrative: Quarter sized raised area, warm to touch. Itching, localized to site
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: N & V after injection  Fever T=102.1 the following morning resolved w/ advil 200mg x 1 dose frontal headache
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pruritus, Swelling, Swelling face
Clinical narrative: The next morning after receiving the vaccine, she began to experience facial swelling and redness that progressed to severe swelling, itching in her neck, chest and face by the next day.
Age: 79.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Body temperature increased, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Red swollen arm (left arm), 100 degree temp, pain in left arm  Pt told to use Tylenol, ice packs, & Benadryl to reduce pain/swelling
Age: 10.0
Sex: F
Vaccine: MMR
Symptoms: Loss of personal independence in daily activities, Malaise, Pyrexia, Rash
Clinical narrative: Patient was in school when I got called to pick her up on Tuesday, Sept. 10. The school said she was not feeling well. She had a fever that ranged from 100-101 and had spots that appeared on her stomach. She also had it on her pubic bone and they went away after 6 days.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: severe itching; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number BB24A, expiry date 26th September 2021) for prophylaxis.   On 30th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was recovered/resolved.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional case details were reported as follows: The patient received first dose of Shingrix and experienced severe itching that was resolved. The reporter gave permission to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: severe itching; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number BB24A, expiry date 26th September 2021) for prophylaxis.   On 30th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was recovered/resolved.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional case details were reported as follows: The patient received first dose of Shingrix and experienced severe itching that was resolved. The reporter gave permission to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Headache, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: stomach pain; got a rash half the size the upper arm; arm got hard as a rock; painful arm; hot arm; nausea; headache; This case was reported by a consumer via call center representative and described the occurrence of induration in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes.   On 20th August 2019, the patient received the 1st dose of Shingrix. On 20th August 2019, less than a day after receiving Shingrix, the patient experienced induration, pain in arm and extremities hot feeling of. On an unknown date, the patient experienced nausea, headache, stomach pain and rash. The patient was treated with analgesic, nos (Pain Medication). On an unknown date, the outcome of the induration, pain in arm, extremities hot feeling of, nausea and headache were recovered/resolved and the outcome of the stomach pain was not recovered/not resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the induration, pain in arm, extremities hot feeling of, nausea, headache, stomach pain and rash to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix and wants her money returned.  After getting the vaccine, her arm got hard as a rock, extremely painful and hot. That lasted for 7 days. She was on pain medication and that did nothing. It was so hot that it would melt the ice within minutes. She also experienced nausea that lasted 3 to 4 days.  She experienced headache, that lasted 3 days.  She had to lay down because of the headache. She also experienced stomach pain and she still has it.  She got a rash half the size the upper arm. The patient mentioned that she did file this report with VAERS. The patient requested reimbursement for vaccine due to adverse event. Per process explained that the company would not reimburse her for the vaccine. The patient was upset and said that she did not want to share any persona information with our company.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Muscular weakness, Nausea, Rash erythematous, Vomiting
Clinical narrative: stomach pain; got a rash half the size the upper arm; arm got hard as a rock; painful arm; hot arm; nausea; headache; This case was reported by a consumer via call center representative and described the occurrence of induration in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes.   On 20th August 2019, the patient received the 1st dose of Shingrix. On 20th August 2019, less than a day after receiving Shingrix, the patient experienced induration, pain in arm and extremities hot feeling of. On an unknown date, the patient experienced nausea, headache, stomach pain and rash. The patient was treated with analgesic, nos (Pain Medication). On an unknown date, the outcome of the induration, pain in arm, extremities hot feeling of, nausea and headache were recovered/resolved and the outcome of the stomach pain was not recovered/not resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the induration, pain in arm, extremities hot feeling of, nausea, headache, stomach pain and rash to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix and wants her money returned.  After getting the vaccine, her arm got hard as a rock, extremely painful and hot. That lasted for 7 days. She was on pain medication and that did nothing. It was so hot that it would melt the ice within minutes. She also experienced nausea that lasted 3 to 4 days.  She experienced headache, that lasted 3 days.  She had to lay down because of the headache. She also experienced stomach pain and she still has it.  She got a rash half the size the upper arm. The patient mentioned that she did file this report with VAERS. The patient requested reimbursement for vaccine due to adverse event. Per process explained that the company would not reimburse her for the vaccine. The patient was upset and said that she did not want to share any persona information with our company.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Emotional distress, Feeling hot, Headache, Induration
Clinical narrative: stomach pain; got a rash half the size the upper arm; arm got hard as a rock; painful arm; hot arm; nausea; headache; This case was reported by a consumer via call center representative and described the occurrence of induration in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes.   On 20th August 2019, the patient received the 1st dose of Shingrix. On 20th August 2019, less than a day after receiving Shingrix, the patient experienced induration, pain in arm and extremities hot feeling of. On an unknown date, the patient experienced nausea, headache, stomach pain and rash. The patient was treated with analgesic, nos (Pain Medication). On an unknown date, the outcome of the induration, pain in arm, extremities hot feeling of, nausea and headache were recovered/resolved and the outcome of the stomach pain was not recovered/not resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the induration, pain in arm, extremities hot feeling of, nausea, headache, stomach pain and rash to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix and wants her money returned.  After getting the vaccine, her arm got hard as a rock, extremely painful and hot. That lasted for 7 days. She was on pain medication and that did nothing. It was so hot that it would melt the ice within minutes. She also experienced nausea that lasted 3 to 4 days.  She experienced headache, that lasted 3 days.  She had to lay down because of the headache. She also experienced stomach pain and she still has it.  She got a rash half the size the upper arm. The patient mentioned that she did file this report with VAERS. The patient requested reimbursement for vaccine due to adverse event. Per process explained that the company would not reimburse her for the vaccine. The patient was upset and said that she did not want to share any persona information with our company.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain in extremity, Rash
Clinical narrative: stomach pain; got a rash half the size the upper arm; arm got hard as a rock; painful arm; hot arm; nausea; headache; This case was reported by a consumer via call center representative and described the occurrence of induration in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes.   On 20th August 2019, the patient received the 1st dose of Shingrix. On 20th August 2019, less than a day after receiving Shingrix, the patient experienced induration, pain in arm and extremities hot feeling of. On an unknown date, the patient experienced nausea, headache, stomach pain and rash. The patient was treated with analgesic, nos (Pain Medication). On an unknown date, the outcome of the induration, pain in arm, extremities hot feeling of, nausea and headache were recovered/resolved and the outcome of the stomach pain was not recovered/not resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the induration, pain in arm, extremities hot feeling of, nausea, headache, stomach pain and rash to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix and wants her money returned.  After getting the vaccine, her arm got hard as a rock, extremely painful and hot. That lasted for 7 days. She was on pain medication and that did nothing. It was so hot that it would melt the ice within minutes. She also experienced nausea that lasted 3 to 4 days.  She experienced headache, that lasted 3 days.  She had to lay down because of the headache. She also experienced stomach pain and she still has it.  She got a rash half the size the upper arm. The patient mentioned that she did file this report with VAERS. The patient requested reimbursement for vaccine due to adverse event. Per process explained that the company would not reimburse her for the vaccine. The patient was upset and said that she did not want to share any persona information with our company.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: AppRox 30 minutes after Receiving Shingrix - Pt experienced nausea, RestRictive BReathing and Local Reaction
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Myalgia, Nausea
Clinical narrative: AppRox 30 minutes after Receiving Shingrix - Pt experienced nausea, RestRictive BReathing and Local Reaction
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Local reaction, Nausea
Clinical narrative: AppRox 30 minutes after Receiving Shingrix - Pt experienced nausea, RestRictive BReathing and Local Reaction
Age: 5.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Crying, Disorientation, Emotional distress, Musculoskeletal stiffness, Screaming
Clinical narrative: Awoke from sleep screaming and crying; Awoke from sleep screaming and crying; Body went stiff; Awoke in morning acted normally with no recollection of the event in the night; Urinated on himself; Disorientated; This case was reported by a nurse via sales rep and described the occurrence of screaming in a 5-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On 9th September 2019 11:03, the patient received Fluarix Quadrivalent 2019-2020 season. On 9th September 2019 22:30, 11 hrs 27 min after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced screaming, crying, stiffness, urination involuntary and disorientation. In September 2019, the patient experienced losing memory in mornings. On an unknown date, the outcome of the screaming, crying, stiffness and losing memory in mornings were unknown and the outcome of the urination involuntary and disorientation were recovered/resolved.   It was unknown if the reporter considered the screaming, crying, stiffness, urination involuntary, disorientation and losing memory in mornings to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The case reported by patient's mother. The patient received fluarix at approx. 11:03am, at 10:30 pm on 9th September 2019, the patient awoke from sleep screaming and crying, body went stiff, urinated on himself, episode lasted 2 minutes, remained disorientated for another 8 minutes, slept normally afterwards through the night, awoke in morning on 10th September 2019, acted normally with no recollection of the event in the night.  The reporter agreed to follow up.
Age: 5.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Tremor, Urinary incontinence
Clinical narrative: Awoke from sleep screaming and crying; Awoke from sleep screaming and crying; Body went stiff; Awoke in morning acted normally with no recollection of the event in the night; Urinated on himself; Disorientated; This case was reported by a nurse via sales rep and described the occurrence of screaming in a 5-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On 9th September 2019 11:03, the patient received Fluarix Quadrivalent 2019-2020 season. On 9th September 2019 22:30, 11 hrs 27 min after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced screaming, crying, stiffness, urination involuntary and disorientation. In September 2019, the patient experienced losing memory in mornings. On an unknown date, the outcome of the screaming, crying, stiffness and losing memory in mornings were unknown and the outcome of the urination involuntary and disorientation were recovered/resolved.   It was unknown if the reporter considered the screaming, crying, stiffness, urination involuntary, disorientation and losing memory in mornings to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The case reported by patient's mother. The patient received fluarix at approx. 11:03am, at 10:30 pm on 9th September 2019, the patient awoke from sleep screaming and crying, body went stiff, urinated on himself, episode lasted 2 minutes, remained disorientated for another 8 minutes, slept normally afterwards through the night, awoke in morning on 10th September 2019, acted normally with no recollection of the event in the night.  The reporter agreed to follow up.
Age: 5.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Amnesia, Crying, Disorientation, Musculoskeletal stiffness, Screaming
Clinical narrative: Awoke from sleep screaming and crying; Awoke from sleep screaming and crying; Body went stiff; Awoke in morning acted normally with no recollection of the event in the night; Urinated on himself; Disorientated; This case was reported by a nurse via sales rep and described the occurrence of screaming in a 5-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On 9th September 2019 11:03, the patient received Fluarix Quadrivalent 2019-2020 season. On 9th September 2019 22:30, 11 hrs 27 min after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced screaming, crying, stiffness, urination involuntary and disorientation. In September 2019, the patient experienced losing memory in mornings. On an unknown date, the outcome of the screaming, crying, stiffness and losing memory in mornings were unknown and the outcome of the urination involuntary and disorientation were recovered/resolved.   It was unknown if the reporter considered the screaming, crying, stiffness, urination involuntary, disorientation and losing memory in mornings to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The case reported by patient's mother. The patient received fluarix at approx. 11:03am, at 10:30 pm on 9th September 2019, the patient awoke from sleep screaming and crying, body went stiff, urinated on himself, episode lasted 2 minutes, remained disorientated for another 8 minutes, slept normally afterwards through the night, awoke in morning on 10th September 2019, acted normally with no recollection of the event in the night.  The reporter agreed to follow up.
Age: 5.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Urinary incontinence
Clinical narrative: Awoke from sleep screaming and crying; Awoke from sleep screaming and crying; Body went stiff; Awoke in morning acted normally with no recollection of the event in the night; Urinated on himself; Disorientated; This case was reported by a nurse via sales rep and described the occurrence of screaming in a 5-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On 9th September 2019 11:03, the patient received Fluarix Quadrivalent 2019-2020 season. On 9th September 2019 22:30, 11 hrs 27 min after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced screaming, crying, stiffness, urination involuntary and disorientation. In September 2019, the patient experienced losing memory in mornings. On an unknown date, the outcome of the screaming, crying, stiffness and losing memory in mornings were unknown and the outcome of the urination involuntary and disorientation were recovered/resolved.   It was unknown if the reporter considered the screaming, crying, stiffness, urination involuntary, disorientation and losing memory in mornings to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The case reported by patient's mother. The patient received fluarix at approx. 11:03am, at 10:30 pm on 9th September 2019, the patient awoke from sleep screaming and crying, body went stiff, urinated on himself, episode lasted 2 minutes, remained disorientated for another 8 minutes, slept normally afterwards through the night, awoke in morning on 10th September 2019, acted normally with no recollection of the event in the night.  The reporter agreed to follow up.
Age: 86.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Aspiration joint abnormal, Injection site pain
Clinical narrative: Pseudogout of left shoulder; Severe Pain in Left Shoulder; This case was reported by a pharmacist via call center representative and described the occurrence of pseudogout in a 86-year-old male patient who received Herpes zoster (Shingrix) (batch number TB2PK, expiry date 5th October 2021) for prophylaxis.   On 10th September 2019, the patient received the 1st dose of Shingrix. On 10th September 2019, 2 hrs after receiving Shingrix, the patient experienced pseudogout (serious criteria hospitalization) and shoulder pain (serious criteria hospitalization). On an unknown date, the outcome of the pseudogout and shoulder pain were unknown.   It was unknown if the reporter considered the pseudogout and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The reporter inquired about any information on any cases reported of a reaction to Shingrix. The patient received Shingrix on left deltoid. The patient experienced severe pain in the left shoulder. On 12th September 2019, the patient was diagnosed Pseudogout of left shoulder. At the time of reporting, the patient was still in the hospital. The reporter consented to follow up.
Age: 86.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chondrocalcinosis pyrophosphate, Injection site pain
Clinical narrative: Pseudogout of left shoulder; Severe Pain in Left Shoulder; This case was reported by a pharmacist via call center representative and described the occurrence of pseudogout in a 86-year-old male patient who received Herpes zoster (Shingrix) (batch number TB2PK, expiry date 5th October 2021) for prophylaxis.   On 10th September 2019, the patient received the 1st dose of Shingrix. On 10th September 2019, 2 hrs after receiving Shingrix, the patient experienced pseudogout (serious criteria hospitalization) and shoulder pain (serious criteria hospitalization). On an unknown date, the outcome of the pseudogout and shoulder pain were unknown.   It was unknown if the reporter considered the pseudogout and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The reporter inquired about any information on any cases reported of a reaction to Shingrix. The patient received Shingrix on left deltoid. The patient experienced severe pain in the left shoulder. On 12th September 2019, the patient was diagnosed Pseudogout of left shoulder. At the time of reporting, the patient was still in the hospital. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient developed swelling, redness and pain on the underside of the right arm just above the elbow.; Patient developed swelling, redness and pain on the underside of the right arm just above the elbow.; Patient developed swelling, redness and pain on the underside of the right arm just above the elbow.; This spontaneous report was received from a pharmacist regarding to a 70 year old female patient. The patient's medical history and concomitant medications were not reported. Concurrent condition included seizure disorder which was well controlled on her medication.  On 16-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) initial injection, via intramuscular in the right arm, lot # R018841 and expiry date reported 06-APR-2020, for prophylaxis. The pharmacist stated that later on 16-SEP-2019, the patient experienced swelling (peripheral swelling), redness (erythema) and pain (pain in extremity) on the underside of the right arm just above the elbow. The patient went to see the pharmacist on 18-SEP-2019, because of the swelling, redness and pain persistent although the were improved in the last two days. The patient did not take any treatment for adverse events and there was no cancer, product quality issue and overdose. The causality assessment between suspect product and events were not provided.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient developed swelling, redness and pain on the underside of the right arm just above the elbow.; Patient developed swelling, redness and pain on the underside of the right arm just above the elbow.; Patient developed swelling, redness and pain on the underside of the right arm just above the elbow.; This spontaneous report was received from a pharmacist regarding to a 70 year old female patient. The patient's medical history and concomitant medications were not reported. Concurrent condition included seizure disorder which was well controlled on her medication.  On 16-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) initial injection, via intramuscular in the right arm, lot # R018841 and expiry date reported 06-APR-2020, for prophylaxis. The pharmacist stated that later on 16-SEP-2019, the patient experienced swelling (peripheral swelling), redness (erythema) and pain (pain in extremity) on the underside of the right arm just above the elbow. The patient went to see the pharmacist on 18-SEP-2019, because of the swelling, redness and pain persistent although the were improved in the last two days. The patient did not take any treatment for adverse events and there was no cancer, product quality issue and overdose. The causality assessment between suspect product and events were not provided.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient's mother came to pharmacy in the drive thru to pick up antibiotic for daughter on 9/18/19.  During consultation with RPH mom expressed concern over daughter's vaccination.  She said daughter had immediate pain in her arm after vaccine was administered and her shoulder and arm hurt for days.  She had never had a reaction to a vaccine before.  After a few days patient was seen by her doctor and may have been told that vaccine was administered incorrectly.  Patient's pain has gotten better but will come back at times and be very painful again.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Abdominal pain upper, Erythema, Eye irritation, Nausea, Pain in extremity
Clinical narrative: Within 30 minutes of receiving the vaccine she began feeling very sick to her stomach. Upon returning home she began vomiting. The vomiting has not completely resolved after 24 hours, but she is able to keep small amounts of food and fluid down, after 18 hours. Her arm is red and sore, as expected, but the redness and swelling appear to be spreading upward, toward the shoulder. If it continues, medical advice/intervention will be sought. Her eyes are puffy and burning, which she describes as being unlike anything she has experienced before. The arm that received the injection shook uncontrollably for ~12-16 hours, and the tremor has not completely resolved after 31 hours. She describes the stomach pain as severe, describing an 8/10 jumping to a 10/10 when vomiting and several minutes after. Total number of vomiting episodes ~10
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Periorbital swelling, Peripheral swelling, Tremor, Vomiting
Clinical narrative: Within 30 minutes of receiving the vaccine she began feeling very sick to her stomach. Upon returning home she began vomiting. The vomiting has not completely resolved after 24 hours, but she is able to keep small amounts of food and fluid down, after 18 hours. Her arm is red and sore, as expected, but the redness and swelling appear to be spreading upward, toward the shoulder. If it continues, medical advice/intervention will be sought. Her eyes are puffy and burning, which she describes as being unlike anything she has experienced before. The arm that received the injection shook uncontrollably for ~12-16 hours, and the tremor has not completely resolved after 31 hours. She describes the stomach pain as severe, describing an 8/10 jumping to a 10/10 when vomiting and several minutes after. Total number of vomiting episodes ~10
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Neck pain, Pain, Pain in extremity
Clinical narrative: Pain on left side of neck radiating to lower left wrist and hand.
Age: 16.0
Sex: M
Vaccine: UNK
Symptoms: Rash
Clinical narrative: patient received vaccine and got a rash all over body the next day that did not go away for about a month
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex test negative
Clinical narrative: lab values for HSV-2 were less than 0.9 values which is negative value; the male patient received ZOSTAVAX, then had oral sex with wife (unspecified date) and wife thought she had Herpes Simplex 2.; Herpes Simplex 2.; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not provided.  On an unspecified date in 2019 (reported as recently), her husband was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, unit, batch/lot#, expiration date and route were not reported) for prophylaxis. On an unspecified date in 2019 (reported as recently), her husband had lip swelling and hives after received zoster vaccine live (ZOSTAVAX) (captured in MARRS# 1908USA008686).   Then She had oral sex with her husband on an unspecified date (Exposure via semen) and she thought she had herpes simplex 2. The patient was treated with valacyclovir hydrochloride (VALTREX). The patient's lab values for herpes simplex viruses (HSV)-2 were less than 0.9 values which was negative value. It was unknown if her lab values for HSV-2 were negative before or after treatment with valacyclovir hydrochloride (VALTREX). The outcome of events was not reported.  Causality between the events and zoster vaccine live (ZOSTAVAX) was not reported.; Sender's Comments:  US-009507513-908USA008686:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored dose of PEDVAXHIB was administered to the patient; No adverse effect; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergies/ reactions and concomitant medications were not provided.   On 21-AUG-2019, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), 1 dosage form (strength, formulation, frequency, route were unknown) ( lot# S000352 and expiration date 17-OCT-2021) for prophylaxis. On an unknown date, the patient was administered with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (product storage error) and no adverse event was reported.  The temperature excursion was 1.2 degrees Celsius for 41 minutes; however, the vaccine did not have a previous temperature excursion and this call was not a data logger.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness, Visual impairment
Clinical narrative: Visoon loss; Transient vision disturbance; Information has been received from a lawyer regarding a case in litigation, referring to a male pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or about 01-AUG-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) at a pahrmacy for its intended purpose: the prevention of shingles. On an unknown date, the pt suffered and was diagnosed with transient vision disturbance of right eye and vision loss. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt suffered painful, serious, progressive, permanent, and incurable injuries and damages, and required extensive medical care and treatment. The pt also suffered significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The pt had incurred and would continue to incur medical expenses and other economic harm . At the time of the report, the outcome of blindness and visual impairment was considered as not recovered. The lawyer considered visual impairment and blindness to be related to Zoster Vaccine Live (ZOSTAVAX).   Upon internal review, blindness was determined to be medically significant and all the pt experiences were considered as disabling due to the severe and permanent incurable injuries.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medications. On or about 07-NOV-2012, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for the long-term prevention of shingles and zoster-related injuries. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the events was unknown. As a direct and proximate result of Plaintiff's use of the zoster vaccine live (ZOSTAVAX) vaccine, Plaintiff had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The event shingles was considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; one dose of an improperly stored vaccine, VARIVAX, was administered to one patient; Assistant confirmed route of administration was "intramuscular" .; This spontaneous report was received from a medical assistant and refers to an identifiable patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 11-SEP-2019, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 ml, intramuscularly, lot # S002877, expiration date 29-JAN-2021, for prophylaxis. The sterile diluent (lot # S000130, expiration date 23-AUG-2021) used to reconstitute the vaccine was stored in the correct storage temperature range. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 8.1 Fahrenheit degrees for 20 minutes. The digital data logger was involved in recording the temperature excursion details. There were previous excursions of 8.1 Fahrenheit degrees for 17 minutes and 9.5 Fahrenheit degrees for 21 minutes reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; The patient received improperly stored VARIVAX; This spontaneous report was received from a medical assistance concerning to a 5 year old patient. The patient medical history, concurrent conditions and concomitant medications were not reported.     On 15-JUL-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot # R023513 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck) expiration date reported and establish as 16-AUG-2020) (strength, dose, frequency and route of administration were not reported); it was reported that a sterile diluent properly stored was used to reconstituted the varicella virus vaccine live (oka/merck) (VARIVAX).        The administered dose of the vaccine experienced a temperature of -14° to -10° Celsius (C) for 46 minutes. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effect was reported.; Sender's Comments:  US-009507513-1909USA006939: US-009507513-1909USA007177: US-009507513-1909USA007118:
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: minor tenderness, swelling and reddness at the injection site; minor tenderness, swelling and reddness at the injection site; minor tenderness, swelling and reddness at the injection site; This spontaneous report was received from a pharmacist via company representative referred to an approximately 66-year-old male patient. The patient's pertinent medical history, and drug reactions/allergies were not reported. The concomitant medications included zoster rge vaccine (mammalian)(SHINGRIX) and flu vaccine (not specified). On an unknown date in August 2019 (reported as 3 or 4 weeks ago from the date of reporting), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection (lot # R033079 has been verified to be a valid lot number, expiration date reported as June 2020, but upon internal validation established as 06-JUN-2020) for prophylaxis (route, dose, were not reported). On 18-SEP-2019, the patient experienced minor tenderness, swelling and reddness at the injection site (vaccination site pain, vaccination site erythema and vaccination site swelling) after receiving suspect product along with concomitant medications. The patient saw the pharmacist. The patient did not receive any treatment for the events. The outcome of vaccination site pain, vaccination site erythema and vaccination site swelling was reported as recovered/resolved (on 18-SEP-2019). The reporter did not provide any causality assessment. Product quality complaint was not involved.
Sex: U
Vaccine: RV5
Symptoms: Bronchospasm, Laryngospasm
Clinical narrative: laryngospasms; Bronchospasm; laryngospasms; Bronchospasm; This spontaneous report was received from a nurse prescriber refers to a patient of unknown demographics. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date approximately in MAY-2019 (about 5 months ago), the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (strength, dosage information, lot# and expiration date were unknown) first dose, via oral route for prophylaxis. On the same day after the first dose, the patient experienced laryngospasms that changed to bronchospasm while in office. The patient received albuterol dose likely through a nebulizer as a treatment and the patient recovered while in office. The nurse referred the patient to a pulmonary doctor, but the parent decided not to take patient to pulmonary doctor and they felt patient was recovered. On an unknown date approximately in July 2019 (also reported as "about 2 to 3 months ago"), the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dosage information, lot# and expiration date was unknown) second dose, via oral route for prophylaxis. experienced laryngospasm and bronchospasm. On the same day after the second dose, the patient again experienced laryngospasms that changed to bronchospasm while in office. The patient received albuterol dose likely through a nebulizer as a treatment and the patient recovered while in office. The outcome of laryngospasm and bronchospasm was resolved. The reporter's causality was unknown. No product quality complaint (PQC) reported.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Pyrexia
Clinical narrative: fever; chills; sweating; This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced fever, chills and sweating. On an unknown date, the outcome of the fever, chills and sweating were recovered/resolved.   It was unknown if the reporter considered the fever, chills and sweating to be related to Shingrix.  Additional details were provided as follows: The patient reported that, after vaccination with dose of Shingrix, had severe reaction as fever, chills and sweating. The patient had fever of 105 to 106 and went down to 100 by day 5. The patient had  chills and sweating for the period of 5 days. The patient ask to doctor, if he or she could receive the 2nd dose of Shingrix. The patient's doctor said, it was up to him or her( the patient).
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Nausea; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced nausea. On an unknown date, the outcome of the nausea was recovered/resolved.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter's friend received dose of Shingrix and next day after vaccination experienced nausea. The reporter stated that, the nausea resolved within 1 day. The reporter did not provide additional details. For the tolerance of 2nd dose, refer case US2019167041, reported by same reporter. This was 3 of 4 reports provided by the same reporter.