chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Light case of shingles; Sore arm; Flu-like symptoms; a rash (under her left breast; a rash (under her left breast) that was painful, itchy; Tiredness / Fatigue; Headache; Nausea; Abdominal pain; Body aches / a rash that was painful; itchiness all over (mainly back and head)\Itch burning; a rash that was burning; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included bronchitis. Concomitant products included calamine lotion (Calamine) and topical antibiotic (nos) (Antibiotic Ointment (Trade Name Unknown)).   On 22nd September 2020, the patient received the 1st dose of Shingrix. On 23rd September 2020, 1 days after receiving Shingrix, the patient experienced shingles, pain in arm, influenza-like symptoms, painful rash, itchy rash, tiredness, headache, nausea, abdominal pain, general body pain, generalized pruritus and burning sensation. On an unknown date, the outcome of the shingles, influenza-like symptoms, painful rash, itchy rash, tiredness, headache, nausea, abdominal pain, general body pain and generalized pruritus were recovering/resolving and the outcome of the pain in arm was recovered/resolved and the outcome of the burning sensation was unknown.   It was unknown if the reporter considered the shingles, pain in arm, influenza-like symptoms, painful rash, itchy rash, tiredness, headache, nausea, abdominal pain, general body pain, generalized pruritus and burning sensation to be related to Shingrix.  Additional details were provided as follows:  The patient experienced light case of shingles. The patient has been healthy most of her life and has only really been sick twice in her life. The day after receiving the vaccine, the patient experienced a sore arm (but nothing around the injection site) for a few days, flu-like symptoms, a rash (under her left breast) that was painful, itchy, and burning; tiredness, fatigue, headache, nausea, abdominal pain, body aches, and itchiness all over (mainly back and head).  The rash has gotten better and was clearing up. The patient was feeling much better compared to a week before reporting.  The patient might have contracted the shingles from her sister who recently recovered from it.  Not all information was available. The reporter did not consent to follow-up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Arthralgia, Headache, Injected limb mobility decreased, Laboratory test
Clinical narrative: diagnosed with TGA - transient global amnesia; she remembered nothing; felt nauseous; headache in the back of her head; arm was sore/pain in her shoulder / arm was sore; aches and pains/pain in her shoulder and neck; pain in her shoulder and neck / had pain her neck; pain in her shoulder and neck / had pain her neck and shoulder; could hardly lift it / couldn't lift her left arm; This case was reported by a consumer via call center representative and described the occurrence of transient global amnesia in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number JC55P, expiry date 19th September 2022) for prophylaxis.   On 23rd July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 23rd July 2020, less than a day after receiving Shingrix, the patient experienced transient global amnesia (serious criteria hospitalization), memory loss, nausea, headache, pain in arm, pain, injected limb mobility decreased, neck pain and shoulder pain. On 26th July 2020, the outcome of the pain in arm, pain, neck pain and shoulder pain were recovered/resolved. On an unknown date, the outcome of the transient global amnesia, nausea and headache were unknown and the outcome of the memory loss and injected limb mobility decreased were recovered/resolved.   It was unknown if the reporter considered the transient global amnesia, memory loss, nausea, headache, pain in arm, pain, injected limb mobility decreased, neck pain and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm. On 28th July 2020, 5 days later, the patient found herself in the emergency room and was diagnosed with TGA - transient global amnesia.  The patient spent overnight in the hospital and had a lot of tests and was released the following day.  The morning of her vaccination, she was fine and then she went to clean the shower and she remembered nothing after that point.  She came out of the bathroom and her husband said that she went to get her shoes which she always put under her coffee table and she kept repeating an asking, are these my shoes.  Later that day around 1:30 PM, they had no eaten yet and she felt nauseous and had a headache in the back of her head.  The patient ate some noodle soup but did not remember and her husband brought out some banana bread and she couldn't remember that she had baked it the day before.  At the time of reporting, her memory issues were resolved.  The patient also reported that for the first 3 days after the vaccination, her arm was sore, and she couldn't lift her left arm.  She also had pain her neck and shoulder which all resolved.  The reporter consented to follow up. The batch number of Shingrix was reported as 5C55P which was corrected to JC55P as per sales data sheet.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Neck pain, Pain, Pain in extremity, Transient global amnesia
Clinical narrative: diagnosed with TGA - transient global amnesia; she remembered nothing; felt nauseous; headache in the back of her head; arm was sore/pain in her shoulder / arm was sore; aches and pains/pain in her shoulder and neck; pain in her shoulder and neck / had pain her neck; pain in her shoulder and neck / had pain her neck and shoulder; could hardly lift it / couldn't lift her left arm; This case was reported by a consumer via call center representative and described the occurrence of transient global amnesia in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number JC55P, expiry date 19th September 2022) for prophylaxis.   On 23rd July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 23rd July 2020, less than a day after receiving Shingrix, the patient experienced transient global amnesia (serious criteria hospitalization), memory loss, nausea, headache, pain in arm, pain, injected limb mobility decreased, neck pain and shoulder pain. On 26th July 2020, the outcome of the pain in arm, pain, neck pain and shoulder pain were recovered/resolved. On an unknown date, the outcome of the transient global amnesia, nausea and headache were unknown and the outcome of the memory loss and injected limb mobility decreased were recovered/resolved.   It was unknown if the reporter considered the transient global amnesia, memory loss, nausea, headache, pain in arm, pain, injected limb mobility decreased, neck pain and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm. On 28th July 2020, 5 days later, the patient found herself in the emergency room and was diagnosed with TGA - transient global amnesia.  The patient spent overnight in the hospital and had a lot of tests and was released the following day.  The morning of her vaccination, she was fine and then she went to clean the shower and she remembered nothing after that point.  She came out of the bathroom and her husband said that she went to get her shoes which she always put under her coffee table and she kept repeating an asking, are these my shoes.  Later that day around 1:30 PM, they had no eaten yet and she felt nauseous and had a headache in the back of her head.  The patient ate some noodle soup but did not remember and her husband brought out some banana bread and she couldn't remember that she had baked it the day before.  At the time of reporting, her memory issues were resolved.  The patient also reported that for the first 3 days after the vaccination, her arm was sore, and she couldn't lift her left arm.  She also had pain her neck and shoulder which all resolved.  The reporter consented to follow up. The batch number of Shingrix was reported as 5C55P which was corrected to JC55P as per sales data sheet.
Age: 69.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Asthenia, Disorientation, Dizziness, Syncope
Clinical narrative: fainted; disoriented; dizzy / felt dizzy; weak; This case was reported by a pharmacist via call center representative and described the occurrence of fainting in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number EG3A3, expiry date 10th December 2021) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX 23) for prophylaxis.   On 25th September 2020, the patient received the 1st dose of Shingrix (injection) and PNEUMOVAX 23. On 26th September 2020, 1 days after receiving Shingrix, the patient experienced fainting (serious criteria hospitalization and GSK medically significant), disorientation (serious criteria hospitalization), dizziness (serious criteria hospitalization) and weakness (serious criteria hospitalization). On an unknown date, the outcome of the fainting, disorientation, dizziness and weakness were recovered/resolved.   It was unknown if the reporter considered the fainting, disorientation, dizziness and weakness to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient received Shingrix and a pneumonia vaccine on the same day. It was reported that the next day that the patient got weak, disoriented, dizzy, and fainted. The patient was taken to the hospital where he remained for three days. The patient was recovered and the HCP wanted to know if the Shingrix followed by the pneumonia vaccine would have caused this to happen.   The reporter did not consent to follow-up. There was discrepancy in vaccination date of pneumovax 13, it was captured as 25th September 2020.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020198013:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Feeling hot, Loss of consciousness
Clinical narrative: Patient feels warm and passed out after Shingrix first shot; experimented warm but no fever; experimented warm but no fever; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st October 2020, the patient received the 1st dose of Shingrix. On 2nd October 2020, 1 days after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), feeling hot and dizziness. On an unknown date, the outcome of the passed out, feeling hot and dizziness were unknown.   It was unknown if the reporter considered the passed out, feeling hot and dizziness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the HCP needed information about common adverse event after Shingrix doses due there was a no-immunocompromised patient who experimented warm but no fever after Shingrix 1st shot. The patient felt warm and passed out after Shingrix. The reporter consented to follow up.
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Loss of consciousness, Mobility decreased, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Swollen painful armpit; arm pit painful; difficult to lift her arm; Passed out; fever of 101 degrees; Inappropriate age at vaccine administration; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 44-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 30th September 2020, less than a day after receiving Shingrix, the patient experienced fever and inappropriate age at vaccine administration. On 1st October 2020, the patient experienced passed out (serious criteria GSK medically significant). On 2nd October 2020, the patient experienced local swelling, axillary pain and mobility decreased. On 2nd October 2020, the outcome of the passed out was recovered/resolved. On an unknown date, the outcome of the fever, local swelling, axillary pain and mobility decreased were not recovered/not resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the passed out, fever, local swelling, axillary pain and mobility decreased to be related to Shingrix.  Additional case details were reported as follows: The patient reported case for herself. The patient received her 2nd dose of Shingrix on Wednesday in unknown arm, which led to age at vaccine administration. Within 4 hours, she developed a fever of 101 degrees.  The patient still had a fever although it was not as high. The patient was passed out yesterday and had recovered from that. On day of reporting her arm pit was swollen and painful and it was difficult to lift her arm. The lot number and expiry date was unknown.   This was a medication error with harm. The reporter did not consent to follow up
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Swollen painful armpit; arm pit painful; difficult to lift her arm; Passed out; fever of 101 degrees; Inappropriate age at vaccine administration; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 44-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 30th September 2020, less than a day after receiving Shingrix, the patient experienced fever and inappropriate age at vaccine administration. On 1st October 2020, the patient experienced passed out (serious criteria GSK medically significant). On 2nd October 2020, the patient experienced local swelling, axillary pain and mobility decreased. On 2nd October 2020, the outcome of the passed out was recovered/resolved. On an unknown date, the outcome of the fever, local swelling, axillary pain and mobility decreased were not recovered/not resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the passed out, fever, local swelling, axillary pain and mobility decreased to be related to Shingrix.  Additional case details were reported as follows: The patient reported case for herself. The patient received her 2nd dose of Shingrix on Wednesday in unknown arm, which led to age at vaccine administration. Within 4 hours, she developed a fever of 101 degrees.  The patient still had a fever although it was not as high. The patient was passed out yesterday and had recovered from that. On day of reporting her arm pit was swollen and painful and it was difficult to lift her arm. The lot number and expiry date was unknown.   This was a medication error with harm. The reporter did not consent to follow up
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injected limb mobility decreased, Pain in extremity, Product administered at inappropriate site, Product prescribing error
Clinical narrative: cannot raise her arm up.; left arm is now sore; was told to come back to get her second injection in two weeks; first Shingrix vaccine on September 4, 2020 / today / received her second injection; injection was given near her left arm shoulder joint; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 2nd October 2020, the patient received the 2nd dose of Shingrix. On 2nd October 2020, less than a day after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced injected limb mobility decreased, pain in arm, drug prescribing error, drug dose administration interval too short and vaccine administered at inappropriate site. On an unknown date, the outcome of the injected limb mobility decreased, pain in arm, drug prescribing error, drug dose administration interval too short and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself. On 4th September 2020, the patient received 1st dose of Shingrix. The patient was told to come back to get her 2nd dose in two weeks, which led to drug prescribing error. The patient received 2nd dose near her left arm shoulder joint, which led to drug dose administration interval too short and vaccine administered at inappropriate site. The patient's left arm was sore and could not raise her arm up. The patient was referred to her physician and provided MI number for her physician. The reporter did not consent to follow-up.
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Blister
Clinical narrative: blisters on hands and arms; This case was reported by a nurse via sales rep and described the occurrence of blister in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 7SK92, expiry date 19th June 2022) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number J3T44, expiry date 30th June 2021) for prophylaxis.   On 21st September 2020, the patient received the 1st dose of Shingrix and the 1st dose of Fluarix Quadrivalent 2020-2021 season. In September 2020, 1 week after receiving Shingrix and Fluarix Quadrivalent 2020-2021 season, the patient experienced blister. On an unknown date, the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the blister to be related to Shingrix and Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose of Shingrix in right deltoid arm and Fluarix in left deltoid arm on 21st September 2020 and a week later experienced the symptoms.  The patient experienced blisters on hands and arms.  The reporter consented to follow up. The case has been linked with US2020199114, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020199114:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Middle insomnia, Pain in extremity, X-ray normal
Clinical narrative: constant pain in the arm of the injection / pain as severe / sharp sticking pain; cannot raise her arm; at night, it wakes her up; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received in March 2020 on unknown date suffered no adverse reactions).   In June 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm, injected limb mobility decreased and nocturnal awakening. Shingrix was continued with no change. On an unknown date, the outcome of the pain in arm, injected limb mobility decreased and nocturnal awakening were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, injected limb mobility decreased and nocturnal awakening to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with 2nd dose of Shingrix in beginning of June. After vaccination patient experienced constant pain in the arm of the injection which continues till the time of reporting. The patient described the pain as severe, calling it a sharp sticking pain.  She cannot raise her arm and at night, it waked her up should she roll over onto her arm. The patient had a virtual doctor visit due to Covid 19 and also had an x-ray which showed nothing in the bone.  The reporter consent to follow up.
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: under the age of 18 years old patient administered of FLUBLOK QUADRIVALENT, no AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves patient (unknown demographic) (under the age of 18 years old) who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to product administered to patient of inappropriate age (on same day latency).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 81.0
Sex: F
Vaccine: FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given the 2 Influenza Vaccine's at our local pharmacy. They were both administered into her Left Deltoid on 8/24/20 and 9/28/20. We have been unable reach the patient at this time. 10-6-20-pt contacted by pharmacy; no side effects.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMRV
Symptoms: Blister, Rash
Clinical narrative: Mother reported visible vesicles/ rash on trunk, back, arms and legs on 10/8/2020
Age: 45.0
Sex: F
Vaccine: FLUR4
Symptoms: Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Severe arm pain, arm tenderness, arm swelling, all in the arm that the vaccination was given, hurt enough to keep up at night/wake up at night
Age: 75.0
Sex: M
Vaccine: FLUA4
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever 100 Degrees,  Chills and muscle aches.
Age: 53.0
Sex: F
Vaccine: FLU4, TDAP, VARZOS, FLU4, TDAP, VARZOS
Symptoms: Back pain, Body temperature increased, Headache, SARS-CoV-2 test negative, Tenderness
Clinical narrative: Received call from client on 10/5/2020. Has been having lower back pain with legs painful to touch since 1/01/2020. Verbalized it hurts to shave my legs. Has been taking Ibuprofen every 6 hours. Advised to call PCP who ordered cortisone 20 mg tablets daily x10 days and Ibuprofen 600mg every 6 hours. Client also tested for COVID. 10/6/2020 Client now reports severe headaches. 10/07/2020 Client called that she continues with severe headaches. Tested negative for COVID. 10/08/2020 Called client who continues with headaches and developed temp of 100.8 last night. Took Aleve tablets with some relief of headache. Verbalized back and legs have been better since 10/07/2020.
Age: 53.0
Sex: F
Vaccine: FLU4, TDAP, VARZOS, FLU4, TDAP, VARZOS
Symptoms: Back pain, Body temperature increased, Computerised tomogram head normal, Headache, SARS-CoV-2 test negative
Clinical narrative: Received call from client on 10/5/2020. Has been having lower back pain with legs painful to touch since 1/01/2020. Verbalized it hurts to shave my legs. Has been taking Ibuprofen every 6 hours. Advised to call PCP who ordered cortisone 20 mg tablets daily x10 days and Ibuprofen 600mg every 6 hours. Client also tested for COVID. 10/6/2020 Client now reports severe headaches. 10/07/2020 Client called that she continues with severe headaches. Tested negative for COVID. 10/08/2020 Called client who continues with headaches and developed temp of 100.8 last night. Took Aleve tablets with some relief of headache. Verbalized back and legs have been better since 10/07/2020.
Age: 53.0
Sex: F
Vaccine: FLU4, TDAP, VARZOS, FLU4, TDAP, VARZOS
Symptoms: Tenderness
Clinical narrative: Received call from client on 10/5/2020. Has been having lower back pain with legs painful to touch since 1/01/2020. Verbalized it hurts to shave my legs. Has been taking Ibuprofen every 6 hours. Advised to call PCP who ordered cortisone 20 mg tablets daily x10 days and Ibuprofen 600mg every 6 hours. Client also tested for COVID. 10/6/2020 Client now reports severe headaches. 10/07/2020 Client called that she continues with severe headaches. Tested negative for COVID. 10/08/2020 Called client who continues with headaches and developed temp of 100.8 last night. Took Aleve tablets with some relief of headache. Verbalized back and legs have been better since 10/07/2020.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Discomfort, Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient received PPSV23 on 10/5/2020. She returned to the pharmacy on 10/720 with severe redness and swelling of the arm. Patient reported discomfort (itching, fever, chills) not relieved by OTC medications and stated she may seek medical attention if symptoms do not improve. Pharmacist discussed that some redness, pain, swelling may be normal with this type of vaccine but patient's reaction was pretty significant.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Patient received PPSV23 on 10/5/2020. She returned to the pharmacy on 10/720 with severe redness and swelling of the arm. Patient reported discomfort (itching, fever, chills) not relieved by OTC medications and stated she may seek medical attention if symptoms do not improve. Pharmacist discussed that some redness, pain, swelling may be normal with this type of vaccine but patient's reaction was pretty significant.
Age: 1.58
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient had High fever 102, severe swelling of right thigh at injection sight with redness.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Erythema, Pain in extremity, Skin warm
Clinical narrative: Pt called to notify us of an approximately 4" oval-shaped red, hot place that has developed in her arm about 2-3" below where the Fluzone HD shot was administered on 10/6/20. She stated it is not really painful at this time. She also stated that she did not see anything in the direct area where the flu shot was actually administered. She stated that she noticed soreness in the arm develop on Tuesday 10/8/20 in the evening and then the red spot developed on her arm on Wednesday 10/7/20. She stated her temperature usually runs around 98 regularly. She took it at 5 am today 10/8/20 and it was 99.1. She repeated her temperature again today 10/8/20 around 10:30am and it was down to 97. The patient was counseled to closely monitor her symptoms and use Tylenol/ice as appropriate. The patient was also counseled to contact her physician if she was concerned or if any additional symptoms presented or worsened. The patient was also counseled to notify us of any changes or worsening of symptoms. The patient seemed satisfied with the resolution at this time.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: vomiting right after vaccine was administered
Age: 48.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Lethargy, Rash
Clinical narrative: Patient started feeling very lethargic the morning after receiving the vaccine. He denied having a fever. He stated that he is now feeling better (10/8/2020) and not as lethargic, but he has developed a rash on the side of the arm the size of a baseball.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Influenza like illness, Injection site erythema, Injection site pruritus
Clinical narrative: Patient reported flu like symptoms and felt like she was going to faint the next day after she received vaccine. This lasted 3-4 days. Tuesday following the vaccine administration she reported a red itchy arm that went from the site down to her elbow
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Abnormal behaviour, Crying, Induration, Pyrexia, Screaming
Clinical narrative: Note: Unknown what the exact rotavirus vaccine was. Will have to verify with pediatrician. The evening of the day of the vaccination, put baby got a fever and cried uncontrollably, in a different way than she has every cries before. Stomach hard. Screaming nonstop for a couple hours.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Dysstasia, Fall, Feeling hot
Clinical narrative: by evening felt flu like, hot, chills, 100.5 temp, nauseous, very bad headache throwing covers on and off all night restless cud not sleep, got up husband saw me unsure if passed out of what, when tired to stand up fell forward head first into floor and landed on cheek about 3:30 am, he got me back into bed laid there fittfully until early am to get up and call the Dr.  Dr took till 4:30 pm to return my calls
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Head injury, Headache, Influenza like illness, Nausea, Neck pain
Clinical narrative: by evening felt flu like, hot, chills, 100.5 temp, nauseous, very bad headache throwing covers on and off all night restless cud not sleep, got up husband saw me unsure if passed out of what, when tired to stand up fell forward head first into floor and landed on cheek about 3:30 am, he got me back into bed laid there fittfully until early am to get up and call the Dr.  Dr took till 4:30 pm to return my calls
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Restlessness, Sleep disorder, Spinal X-ray
Clinical narrative: by evening felt flu like, hot, chills, 100.5 temp, nauseous, very bad headache throwing covers on and off all night restless cud not sleep, got up husband saw me unsure if passed out of what, when tired to stand up fell forward head first into floor and landed on cheek about 3:30 am, he got me back into bed laid there fittfully until early am to get up and call the Dr.  Dr took till 4:30 pm to return my calls
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Passing out
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: CSF test, Electroencephalogram, Febrile convulsion, Full blood count, Metabolic function test
Clinical narrative: Patient developed fever and had 4 febrile seizures beginning the morning of October 6th, approximately 15 hours after vaccines were given.  She was first transported to a local ED, where she had another seizure and was given lorazepam.  She was then transported to the hospital via emergency transport and experienced another seizure like episode, was given another benzodiazepine.  she arrived in  ED and had an additional seizure, and was given another dose of ativan.  She was admitted toMed/Surg unit and stayed there for 2 days under observation and an EEG was also performed.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Pyrexia, SARS-CoV-2 test negative, Urine analysis
Clinical narrative: Patient developed fever and had 4 febrile seizures beginning the morning of October 6th, approximately 15 hours after vaccines were given.  She was first transported to a local ED, where she had another seizure and was given lorazepam.  She was then transported to the hospital via emergency transport and experienced another seizure like episode, was given another benzodiazepine.  she arrived in  ED and had an additional seizure, and was given another dose of ativan.  She was admitted toMed/Surg unit and stayed there for 2 days under observation and an EEG was also performed.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Hypersomnia, Impaired work ability, Musculoskeletal chest pain, Myalgia
Clinical narrative: I had the shot Tues aft. at my store pharmacy. Later that night I noticed mild muscle pain and a slight fever, but this is not unusual for me. I usually have a mild reaction to the flu vaccine, and it only lasts about a day. However, the pain spread to my ribs and was bad enough to wake me during the night, and by the Wed morning I was in a lot of discomfort. I went into the bathroom to take my usual pills, and immediately vomited them up, along with the glass of water I drank. I called out from work and returned to bed, where I slept pretty much all day and was too nauseous to eat or drink. The next morning  (Thu) I was feeling a little better, though not well enough to go to work. I was able to eat a bit of toast and some tea, but nothing more substantial. Friday I was mostly well, and then by the weekend I had pretty much recovered, except for some lingering nausea, which comes and goes, and may be unrelated. This is the worst reaction I've ever had to the flu vaccine, and a doctor friend of mine suggested I report it. I'm sorry I don't have more info, but it was given at the store pharmacy. My husband and daughter received theirs at the same time and were fine.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pyrexia, Sleep disorder, Vomiting
Clinical narrative: I had the shot Tues aft. at my store pharmacy. Later that night I noticed mild muscle pain and a slight fever, but this is not unusual for me. I usually have a mild reaction to the flu vaccine, and it only lasts about a day. However, the pain spread to my ribs and was bad enough to wake me during the night, and by the Wed morning I was in a lot of discomfort. I went into the bathroom to take my usual pills, and immediately vomited them up, along with the glass of water I drank. I called out from work and returned to bed, where I slept pretty much all day and was too nauseous to eat or drink. The next morning  (Thu) I was feeling a little better, though not well enough to go to work. I was able to eat a bit of toast and some tea, but nothing more substantial. Friday I was mostly well, and then by the weekend I had pretty much recovered, except for some lingering nausea, which comes and goes, and may be unrelated. This is the worst reaction I've ever had to the flu vaccine, and a doctor friend of mine suggested I report it. I'm sorry I don't have more info, but it was given at the store pharmacy. My husband and daughter received theirs at the same time and were fine.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Body temperature decreased, Body temperature increased, Chest discomfort, Chills
Clinical narrative: Within 2 hours of vaccination, I was feeling pressure in my upper chest and developed a persistent cough.  My eyes became dry and itchy, felt swollen.  In another couple hours my head was foggy. I felt weak and had stabbing body aches. Within 12 hours of vaccination the chest pressure increased to a concerning degree; I had a runny nose, felt chills; my temp had gone from 98.2 to 100. Six hours later it was 96.  Next day the chills and stabbing body aches were gone. My eyes were still itchy.  My hands were swollen. The cough continued. I took Lung Tonic to decrease the pressure feeling in my chest; it did.  Later that day my temp returned to 98. The next day I felt better but began coughing up globs of yellow mucus. That continued 2 or 3 more days.  Currently, 10 days post-vaccination, my hands are still swollen, my eyes are still a bit itchy feeling, and the cough is minimal.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dry eye, Eye pruritus, Eye swelling, Feeling abnormal
Clinical narrative: Within 2 hours of vaccination, I was feeling pressure in my upper chest and developed a persistent cough.  My eyes became dry and itchy, felt swollen.  In another couple hours my head was foggy. I felt weak and had stabbing body aches. Within 12 hours of vaccination the chest pressure increased to a concerning degree; I had a runny nose, felt chills; my temp had gone from 98.2 to 100. Six hours later it was 96.  Next day the chills and stabbing body aches were gone. My eyes were still itchy.  My hands were swollen. The cough continued. I took Lung Tonic to decrease the pressure feeling in my chest; it did.  Later that day my temp returned to 98. The next day I felt better but began coughing up globs of yellow mucus. That continued 2 or 3 more days.  Currently, 10 days post-vaccination, my hands are still swollen, my eyes are still a bit itchy feeling, and the cough is minimal.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Peripheral swelling, Productive cough, Rhinorrhoea, Secretion discharge
Clinical narrative: Within 2 hours of vaccination, I was feeling pressure in my upper chest and developed a persistent cough.  My eyes became dry and itchy, felt swollen.  In another couple hours my head was foggy. I felt weak and had stabbing body aches. Within 12 hours of vaccination the chest pressure increased to a concerning degree; I had a runny nose, felt chills; my temp had gone from 98.2 to 100. Six hours later it was 96.  Next day the chills and stabbing body aches were gone. My eyes were still itchy.  My hands were swollen. The cough continued. I took Lung Tonic to decrease the pressure feeling in my chest; it did.  Later that day my temp returned to 98. The next day I felt better but began coughing up globs of yellow mucus. That continued 2 or 3 more days.  Currently, 10 days post-vaccination, my hands are still swollen, my eyes are still a bit itchy feeling, and the cough is minimal.
Age: 66.0
Sex: F
Vaccine: FLUA4, PPV, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Patient states the following day after she received the two vaccinations (Patient also received shingrix on the other arm), she had redness and warmth 4 inches below injection site (right deltoid). Patient states she did not have any pain. It continued to grow in size the following day. Patient states seeing provider on 10/8/2020 and was diagnosis with cellulitis according to patient. Patient was prescribed cephalexin 500 mg capsules to take 3 times daily for 7 days. Size of area was about 3x2 inches at the time of picking up prescription at 10:10 am.
Age: 66.0
Sex: F
Vaccine: FLUA4, PPV, PPV
Symptoms: Injection site rash, Rash
Clinical narrative: Patient states the following day after she received the two vaccinations (Patient also received shingrix on the other arm), she had redness and warmth 4 inches below injection site (right deltoid). Patient states she did not have any pain. It continued to grow in size the following day. Patient states seeing provider on 10/8/2020 and was diagnosis with cellulitis according to patient. Patient was prescribed cephalexin 500 mg capsules to take 3 times daily for 7 days. Size of area was about 3x2 inches at the time of picking up prescription at 10:10 am.
Age: 67.0
Sex: F
Vaccine: FLUC4
Symptoms: Malaise, Nausea, Neck pain, Pain in extremity
Clinical narrative: Patient was given the flucelvax shot. Described experiencing arm pain, neck pain, nausea, and general malaise.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Presyncope
Clinical narrative: Pt received 11 year vaccines and had a vasovagal episode.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: PATIENT COMPLAINED OF NUMBNESS FROM ELBOW DOWN TO FINGER TIPS IN LEFT ARM.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Approximately 9  hours after vaccine administration patient had small hives on right arm. Hives grew worse and spread to both arms, abdomen, bilateral legs, face and neck. 24 hours later she called telehealth and was placed on OTC antihistamines. On Monday ( 4 days after injection) morning she called me (employee health) and was sent to provider for continued hives and  itching. She did not have any difficulty breathing or airway problems. The provider gave her a course of Prednisone to taper and Vistaril for itching. Today, (7days after injection) she is doing better and reports condition is improving.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Syncope twice with possible seizure activity; Syncope twice with possible seizure activity; This spontaneous report was received from a healthcare professional via FDA referring to an 18 years old male patient. The patient's concurrent condition and medical history were not provided. Information of the patient's adverse event following previously vaccination was unknown. Concomitant medication included diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL).  On 05-AUG-2019 at 11:55, 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) (lot# R025730, expiration date not reported, but upon internal validation established as 18-JUN-2021; dose detail and strength were not provided) intramuscularly in the left arm for prophylaxis. On 05-AUG-2019 at 11:55, the patient experienced syncope twice with possible seizure activity. Emergency room/department or urgent care was visited. The outcome of syncope and seizure was unknown.     The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Follow-up information was received from the healthcare professional on 05-OCT-2020. Since the reporter did not have the patient's details, was unable to provide any information. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry: ; devicelotnumber: R025730; expirationdate: 18-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 1.08
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: PNEUMOVAX 23 given to a 13 months old instead of PREVNAR 13; no reaction was noted in the child; This spontaneous report was received from a physician via company representative referring to a 13 months old female patient. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reaction or allergy were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, batch/lot# and expiration date were unknown, strength and route were not reported) for prophylaxis instead of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) (wrong vaccine administered). No reaction was noted. The outcome of the event was not reported.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no further AE reported; temperature excursion on Varivax and reported that it was administered to a patient; This spontaneous report was received from a medical assistant and refers to a 1-year-old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 10-SEP-2020, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml (reported as 05 milliliter) lot # S038701, expiration date 01-DEC-2021 (route of administration was not provided) for prophylaxis. The vaccine was exposed to -9.6 degrees Celsius for 1 hour 15 minutes. No previous temperature excursions were reported. Digital data logger was involved. No adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Flank pain, Muscular weakness, Myelitis transverse, Peroneal nerve palsy
Clinical narrative: Lower back pain with left side flank pain accompanied with left lower extremity weakness and foot drop, was diagnosed with transverse myelitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around August 2013, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for its intended purpose; the prevention of shingles (herpes zoster) (prophylaxis).Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered lower back pain with left sided flank pain accompanied with left lower extremity weakness and foot drop. The patient was diagnosed with transverse myelitis (myelitis transverse). As a direct and proximate results of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations do not present prior to using zoster vaccine live (ZOSTAVAX). Also, experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Also, the patient sustained severe and permanent personal injuries. Therefore, 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. Also, suffered and incurred damages, including medical expenses, the loss of accumulations, and other economic and non-economic damages.The outcome of the event was not recovered.  Upon internal review, the event myelitis transverse was considered to be medically significant and disability.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; one patient received a dose of expired PNEUMOVAX 23; This spontaneous report was received from a pharmacist and refers to a female patient of an unknown age. There was no information about the patient's concurrent condition, concomitant medication and medical history provided. The report refers to one patient and one combination product.  On 01-OCT-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot number: R034249, expiration date: 07-AUG-2020, for prophylaxis (exact dose and route of administration were not provided) which was properly stored. No additional adverse events reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: R034249; expirationdate: 07-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability