chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Mobility decreased
Clinical narrative: 1. September 9 at 2:30 p.m., I had tingling in my left forearm, left palm and my left pinky became numb. This lasted 4 days.  2. My left arm became very sore starting at 4 p.m.; by 9 p.m. I could barely lift my left arm parallel to the ground and could barely undress myself. This lasted 5 days. 3.  I became weak, fatigued, dizzy, nauseous, and all of my joints started to ache. By 9:00 p.m on 9/9/19, my nose became very stuffy, my face hurt like a sinus infection, my thinking became foggy, my speech became difficult to sequence, and I had delayed motor skills. These symptoms lasted 13 days! 4. A dull headache started 9./9/19 and it became a migraine on 9/12/19. The severe migraine with extreme nausea lasted 9/11-9/18. I still get a severe headache occasionally and it is September 29. 5. I had severe chills and sweats 9/9/19-9/10/19. 6. I developed cellulitis in my left arm. It began 9/9/19 in the pm. and was diagnosed and treated with antibiotics by my doctor on 9.11/19. It was NOT at the injection site, rather is was in my bicep BELOW where the injection was given and went to the under side of my arm and into my left arm pit. My doctor, put me on Cefadroxil 500 MG capsules 2 capsules by mouth twice a day for 5 days to treat the cellulitis.  7. As of September 29, 2019, I am still very weak and fatigued, my joints still ache, I get a severe headache out of the blue that wakes me out of a sound sleep at times, and I'm still slightly nauseous.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site pain, Injection site warmth
Clinical narrative: Patient had a big bruise at the site of injection. It was a little hot at the touch. And when touching it with pressure it was painful.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia, Skin warm
Clinical narrative: redness, soreness, of deltoid muscle ; warm to touch
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: pt states contracted shingles as a result of the vaccine. Pt states dx confirmed by Dr. Pt was prescribed Valtrex by MD
Age: 51.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Patient said that around 8:00 pm on 9/28/19 he noticed some redness and a bump at injection site and this morning on 9/29/19 he said it changed to this fluid filled blister a little less than a dime in size at the injection site only. He said he has some tenderness at the site also.  The patient does not have a primary doctor so I instructed him to go to an urgent care or ER if the reaction gets worse or does not go away in a couple days. I also told him to keep the area clean and cover the blister with a gauze pad to help keep it from opening. I also instructed him to take benadryl tablets if  the reaction gets worse.    The patient will be contacted within a couple of days for followup.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient had swelling on the arm from injection site to just above the elbow.  It is also hot and painful.  She stated she was able to move it (raise the arm) on Saturday which she wasn't able to do Friday evening. She spoke with her doctor on Sunday and he said to continue with benadryl and tylenol. She still has swelling and redness around elbow but it is not as hot or as painful as before.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Swelling size of an egg, a red spot about 1 1/2 times the size of a silver dollar and a white spot in the center at the injection site similar to a hornet sting/bite.  It feels hot and on the 2nd and 3rd day became itchy and sore to the touch along with other muscle and joint pain.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Swelling size of an egg, a red spot about 1 1/2 times the size of a silver dollar and a white spot in the center at the injection site similar to a hornet sting/bite.  It feels hot and on the 2nd and 3rd day became itchy and sore to the touch along with other muscle and joint pain.
Age: 30.0
Sex: M
Vaccine: FLUC4
Symptoms: Lip swelling, Oropharyngeal pain, Urticaria
Clinical narrative: Patient's mom called on phone 9/29/19 at 10PM to say her son got flu shot yesterday and developed some concerning symptoms. We are not sure if it is from the flu shot or something else. Symptoms included: sore throat, swollen lips, hives on body. Symptoms have been gradually developing since yesterday.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Malaise, Myalgia, Pyrexia
Clinical narrative: Onset of chills and fever of 100 within two hrs of shot,  24 hrs later fever rose to 101, 36 hrs later 99.5.  Muscle aches, general weakness and sick feeling, no swelling, red or tenderness noticed at injection sight. 48 hrs all symptoms completely gone.  High fever scary for someone in excellent health!
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patients arm is red, swollen and painful
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Insomnia, Limb discomfort, Musculoskeletal stiffness
Clinical narrative: The evening of vaccine, Tues night, Arm very sore-difficulty sleeping despite Ibuprofen 600mg - Shoulder very stiff Wed through now feels like "frozen shoulder" No redness not hot to touch. 9/27 Can't life arm (Right) and sore. Contacted Dr. and recommended heat and cold and take ibuprofen. Pt took Acetaminophen Last night. 9/29 called patient and stated doing much better and icing Right arm as instructed by DR.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Memory impairment, Speech disorder
Clinical narrative: Aphasia/ difficulty getting her words out when talking; Memory impairment/ has no memory of what else happened after arriving home; Dizziness; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA # 755082) refers to a 18-year-old female patient. There was no information about the patient's concomitant medications and medical history provided. The patient's concurrent condition included endometriosis. On 21-JUN-2018, the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose and frequency was unknown) lot No. N032284 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date not reported, but upon internal validation established as 22-SEP-2020, intramuscularly in the left arm for prophylaxis. On 21-JUN-2018, 20 minutes after vaccination, the patient felt dizzy, brushed it off, went to work and 20 minutes after initial symptoms became dizzier and had difficulty getting her words out when talking and felt like she was going to be faint, but she did not faint. She reported that she had no memory of what else happened after arriving her home. She felt asleep and woke up the next morning back at baseline (aphasia, memory impairment and dizziness). It was reported she did not seek any medical attention for the events. The outcome of aphasia, memory impairment and dizziness were reported as resolved. Causality assessment was not reported.   Follow up information has been received from the Physician via FDA on 08-AUG-2019.  The patient's historical drug included penicillin. The patient had drug allergy to penicillin. On 21-JUN-2018 at 16:48, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at the physician's office urgent care or hospital. On 21-JUN-2018 at 17:08, the patient experienced the events.   Follow-up information has been received on 26-SEP-2019.   An inbound telephone call was received from staff at physician's office stating that the physician was unable to determine the patient without date of birth or any other patient identifiers.
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Chest pain, Fatigue
Clinical narrative: Serum Sickness; This case was reported by a pharmacist via call center representative and described the occurrence of serum sickness in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 3L999, expiry date 8th November 2021) for prophylaxis.   On 7th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In September 2019, less than 3 weeks after receiving Shingrix, the patient experienced serum sickness (serious criteria hospitalization). On an unknown date, the outcome of the serum sickness was unknown.   It was unknown if the reporter considered the serum sickness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient experienced serum sickness after getting Shingrix vaccine On 21st September 2019, at evening, the pharmacy was notified that patient had been in the ICU (intensive care unit) due to serum sickness and had still not been discharged till the time of reporting. No further details were provided.  The reporter stated that, she reported the event to VAERS.
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Injection site pain, Intensive care, Pain in extremity, Serum sickness
Clinical narrative: Serum Sickness; This case was reported by a pharmacist via call center representative and described the occurrence of serum sickness in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 3L999, expiry date 8th November 2021) for prophylaxis.   On 7th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In September 2019, less than 3 weeks after receiving Shingrix, the patient experienced serum sickness (serious criteria hospitalization). On an unknown date, the outcome of the serum sickness was unknown.   It was unknown if the reporter considered the serum sickness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient experienced serum sickness after getting Shingrix vaccine On 21st September 2019, at evening, the pharmacy was notified that patient had been in the ICU (intensive care unit) due to serum sickness and had still not been discharged till the time of reporting. No further details were provided.  The reporter stated that, she reported the event to VAERS.
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Intensive care, Serum sickness
Clinical narrative: Serum Sickness; This case was reported by a pharmacist via call center representative and described the occurrence of serum sickness in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 3L999, expiry date 8th November 2021) for prophylaxis.   On 7th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In September 2019, less than 3 weeks after receiving Shingrix, the patient experienced serum sickness (serious criteria hospitalization). On an unknown date, the outcome of the serum sickness was unknown.   It was unknown if the reporter considered the serum sickness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient experienced serum sickness after getting Shingrix vaccine On 21st September 2019, at evening, the pharmacy was notified that patient had been in the ICU (intensive care unit) due to serum sickness and had still not been discharged till the time of reporting. No further details were provided.  The reporter stated that, she reported the event to VAERS.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Nausea, Tenderness, Vomiting
Clinical narrative: nausea; Vomitting; headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2019 11:00, the patient received Shingrix. On 17th September 2019, less than a day after receiving Shingrix, the patient experienced headache. On 18th September 2019 11:00, the patient experienced nausea and vomiting. On 20th September 2019, the outcome of the headache, nausea and vomiting were recovered/resolved.   It was unknown if the reporter considered the headache, nausea and vomiting to be related to Shingrix.  Additional details were provided as follows: The patient experienced severe headache within 24 hours after receiving vaccine. The patient also experienced vomiting and nausea. The patient did not consent to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: nausea; Vomitting; headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2019 11:00, the patient received Shingrix. On 17th September 2019, less than a day after receiving Shingrix, the patient experienced headache. On 18th September 2019 11:00, the patient experienced nausea and vomiting. On 20th September 2019, the outcome of the headache, nausea and vomiting were recovered/resolved.   It was unknown if the reporter considered the headache, nausea and vomiting to be related to Shingrix.  Additional details were provided as follows: The patient experienced severe headache within 24 hours after receiving vaccine. The patient also experienced vomiting and nausea. The patient did not consent to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Neck pain, Pain in extremity, Vomiting
Clinical narrative: nausea; Vomitting; headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2019 11:00, the patient received Shingrix. On 17th September 2019, less than a day after receiving Shingrix, the patient experienced headache. On 18th September 2019 11:00, the patient experienced nausea and vomiting. On 20th September 2019, the outcome of the headache, nausea and vomiting were recovered/resolved.   It was unknown if the reporter considered the headache, nausea and vomiting to be related to Shingrix.  Additional details were provided as follows: The patient experienced severe headache within 24 hours after receiving vaccine. The patient also experienced vomiting and nausea. The patient did not consent to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Nausea, Tenderness, Vomiting
Clinical narrative: Vomiting; sore left arm; Neck pain; Severe headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2019 11:00, the patient received the 1st dose of Shingrix. In September 2019, 16 hrs after receiving Shingrix, the patient experienced headache. On 18th September 2019, the patient experienced neck pain and pain in arm. On 18th September 2019 11:00, the patient experienced vomiting. The patient was treated with paracetamol (Tylenol), ibuprofen (Advil) and paracetamol (Tylenol Suppository). On 18th September 2019 23:00, the outcome of the vomiting was recovered/resolved. On an unknown date, the outcome of the headache, neck pain and pain in arm were unknown.   It was unknown if the reporter considered the headache, neck pain, vomiting and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient received first Shingrix injection on 17th September 2019 at 11 am.  Early Wednesday morning between 3 and 4 AM she woke up with a severe headache, she took Tylenol and Advil, and it finally went away.  When the patient got up that morning, she felt okay except her left arm was sore from the injection.  At about 11 am she started vomiting and the headache came back which she took a Tylenol suppository.  She reported vomiting about seven to eight times, and it lasted until 11 pm that night.  The caller requested information about side effects that had been experienced by others, and if she would experience the same side effects with her second Shingrix dose. The caller declined in providing her Doctor of Medicine's information, but would provide at a later date.  The patient had an appointment with her Doctor of Medicine's in a couple of weeks.  The reporter did not consent to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Vomiting; sore left arm; Neck pain; Severe headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2019 11:00, the patient received the 1st dose of Shingrix. In September 2019, 16 hrs after receiving Shingrix, the patient experienced headache. On 18th September 2019, the patient experienced neck pain and pain in arm. On 18th September 2019 11:00, the patient experienced vomiting. The patient was treated with paracetamol (Tylenol), ibuprofen (Advil) and paracetamol (Tylenol Suppository). On 18th September 2019 23:00, the outcome of the vomiting was recovered/resolved. On an unknown date, the outcome of the headache, neck pain and pain in arm were unknown.   It was unknown if the reporter considered the headache, neck pain, vomiting and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient received first Shingrix injection on 17th September 2019 at 11 am.  Early Wednesday morning between 3 and 4 AM she woke up with a severe headache, she took Tylenol and Advil, and it finally went away.  When the patient got up that morning, she felt okay except her left arm was sore from the injection.  At about 11 am she started vomiting and the headache came back which she took a Tylenol suppository.  She reported vomiting about seven to eight times, and it lasted until 11 pm that night.  The caller requested information about side effects that had been experienced by others, and if she would experience the same side effects with her second Shingrix dose. The caller declined in providing her Doctor of Medicine's information, but would provide at a later date.  The patient had an appointment with her Doctor of Medicine's in a couple of weeks.  The reporter did not consent to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Neck pain, Pain in extremity, Vomiting
Clinical narrative: Vomiting; sore left arm; Neck pain; Severe headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2019 11:00, the patient received the 1st dose of Shingrix. In September 2019, 16 hrs after receiving Shingrix, the patient experienced headache. On 18th September 2019, the patient experienced neck pain and pain in arm. On 18th September 2019 11:00, the patient experienced vomiting. The patient was treated with paracetamol (Tylenol), ibuprofen (Advil) and paracetamol (Tylenol Suppository). On 18th September 2019 23:00, the outcome of the vomiting was recovered/resolved. On an unknown date, the outcome of the headache, neck pain and pain in arm were unknown.   It was unknown if the reporter considered the headache, neck pain, vomiting and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient received first Shingrix injection on 17th September 2019 at 11 am.  Early Wednesday morning between 3 and 4 AM she woke up with a severe headache, she took Tylenol and Advil, and it finally went away.  When the patient got up that morning, she felt okay except her left arm was sore from the injection.  At about 11 am she started vomiting and the headache came back which she took a Tylenol suppository.  She reported vomiting about seven to eight times, and it lasted until 11 pm that night.  The caller requested information about side effects that had been experienced by others, and if she would experience the same side effects with her second Shingrix dose. The caller declined in providing her Doctor of Medicine's information, but would provide at a later date.  The patient had an appointment with her Doctor of Medicine's in a couple of weeks.  The reporter did not consent to follow up.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Neuralgia
Clinical narrative: on 9/19 pm Lump & ARM began to swell (pain) 9/20 Pain more severe from injection site to lower arm - Flu Symptons began Achy, Pain, dizziness, cold sweats -(Fainted) 9/21 - Continued Pain, sickness 9/22 - Pain moved down all the way to fingers 9/23 - WENT TO DOC. 9/23 - Saw Doc - Severe Pain in full arm - Sent to sonogram Told injection hit a nerve. Given 2 medications (ARM warm to Touch) *TRAMADOL HCL 50 Mgs * GaBAPENTIN 100 Mg Doc Suggested applying ice pack 9/23 - 9/29 - IN BED 11 Days 9/30/2019 (TODay) Continued pain in arm not as severe. Moving arm better Follow up DOC visit scheduled 10/2/2019 @ 2:20 pm.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cold sweat, Dizziness, Influenza, Injection site pain, Malaise
Clinical narrative: on 9/19 pm Lump & ARM began to swell (pain) 9/20 Pain more severe from injection site to lower arm - Flu Symptons began Achy, Pain, dizziness, cold sweats -(Fainted) 9/21 - Continued Pain, sickness 9/22 - Pain moved down all the way to fingers 9/23 - WENT TO DOC. 9/23 - Saw Doc - Severe Pain in full arm - Sent to sonogram Told injection hit a nerve. Given 2 medications (ARM warm to Touch) *TRAMADOL HCL 50 Mgs * GaBAPENTIN 100 Mg Doc Suggested applying ice pack 9/23 - 9/29 - IN BED 11 Days 9/30/2019 (TODay) Continued pain in arm not as severe. Moving arm better Follow up DOC visit scheduled 10/2/2019 @ 2:20 pm.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Mass, Nerve injury, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: on 9/19 pm Lump & ARM began to swell (pain) 9/20 Pain more severe from injection site to lower arm - Flu Symptons began Achy, Pain, dizziness, cold sweats -(Fainted) 9/21 - Continued Pain, sickness 9/22 - Pain moved down all the way to fingers 9/23 - WENT TO DOC. 9/23 - Saw Doc - Severe Pain in full arm - Sent to sonogram Told injection hit a nerve. Given 2 medications (ARM warm to Touch) *TRAMADOL HCL 50 Mgs * GaBAPENTIN 100 Mg Doc Suggested applying ice pack 9/23 - 9/29 - IN BED 11 Days 9/30/2019 (TODay) Continued pain in arm not as severe. Moving arm better Follow up DOC visit scheduled 10/2/2019 @ 2:20 pm.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Skin warm, Syncope, Ultrasound scan
Clinical narrative: on 9/19 pm Lump & ARM began to swell (pain) 9/20 Pain more severe from injection site to lower arm - Flu Symptons began Achy, Pain, dizziness, cold sweats -(Fainted) 9/21 - Continued Pain, sickness 9/22 - Pain moved down all the way to fingers 9/23 - WENT TO DOC. 9/23 - Saw Doc - Severe Pain in full arm - Sent to sonogram Told injection hit a nerve. Given 2 medications (ARM warm to Touch) *TRAMADOL HCL 50 Mgs * GaBAPENTIN 100 Mg Doc Suggested applying ice pack 9/23 - 9/29 - IN BED 11 Days 9/30/2019 (TODay) Continued pain in arm not as severe. Moving arm better Follow up DOC visit scheduled 10/2/2019 @ 2:20 pm.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient is not over 65 years old. Patient was given fluzone High dose by accident due to incorrect birth date put into computer system.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is not over 65 years old. Patient was given fluzone High dose by accident due to incorrect birth date put into computer system.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: Patient is not over 65 years old. Patient was given fluzone High dose by accident due to incorrect birth date put into computer system.
Age: 30.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: mild swelling, blotchy erythema, severe pain in the area of Pneumovax vaccination no reaction on the other arm where influenza vaccine was given
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Pain and swelling at injection site, malaise, nausea, low grade fever
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Mouth swelling, Pharyngeal swelling, Rash
Clinical narrative: Patient experienced a rash and swelling in the throat and mouth shortly after receiving the vaccine. She took benadryl and used her ProAir inhaler which resolved the symptoms. Pt's husband is an EMT, so she did not feel it necessary to go to a medical facility for treatment.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, X-ray limb normal
Clinical narrative: Starting within 12 hours, moderate muscle soreness in center of upper left arm (not near injection site). Within 24 hours pain became severe and constant. Treated with ice and OTC NSAIDs with little relief. Xray taken 9/23 to rule out broken bone. Office visit 9/27 - received prescriptions for antibiotic and percoset and order for MRI. MRI is scheduled for 10/2 (today is 9/30).
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Lethargy, Myalgia, Nasopharyngitis, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Cold like symptoms: Runny nose, head cold, Scratchy throat. Lethargy, muscle aches, congestion,
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Throat irritation
Clinical narrative: Cold like symptoms: Runny nose, head cold, Scratchy throat. Lethargy, muscle aches, congestion,
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: The patient had a blood work after the immunization were the titer showed  zero improvement with her immunity; This spontaneous report was received from a currently 57-year-old female consumer referring to herself. The patient's concurrent conditions included high blood pressure and a drug reaction or allergy to sulfa and azithromycin drug. There was no information about the patient's medical history. Concomitant medication included high blood pressure medicine.  In approximately August 2019 (reported as about a month ago), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for measles, mumps, rubella prevention (strength, dosage schedule, route of administration, lot number and expiration date were not reported). The patient was vaccinated because she would be traveling outside of the country and because her titer reveled that she had little immunity to the rubella virus. The patient had a blood work after the immunization were the titer showed  zero improvement with her immunity. The patient did not receive any treatment for the event. The patient soghlt edical attention by speaking with a physician. At the time of the report, the patient had not recovered from the event.  The causal relationship between the event and the vaccine was not reported.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Ear infection, Ear pain, Erythema, Headache, Injection site erythema
Clinical narrative: The patient also complained of headache, sinus congestion and left ear pain/left ear infection; The patient also complained of headache, sinus congestion and left ear pain; Injection site erythema; Injection site swelling; The patient also complained of headache, sinus congestion and left ear pain; This spontaneous report was received from a registered nurse refers to a 31 year old (also reported as 33 year old) non-pregnant female patient. The patient's pertinent medical history included smoker and hashimoto thyroiditis. The patient's drug reactions/allergies was reported as none. Concomitant therapies included levothyroxine sodium(SYNTHROID).     On 27-AUG-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # R034248 with expiry date of 07-AUG-2020) (strength and dose were not reported) intramuscularly in the left arm for smoking history(prophylaxis). On 27-AUG 2019, the patient experienced erythema and swelling at the injection site especially noted after working at her salon, which progressed over a 48 hour period. On the same day, the patient also experienced headache, sinus congestion and left ear pain. She was seen by her doctor on 29-AUG-2019 and diagnosed with injection-site erythema and a left ear infection. The patient was treated with meloxicam as needed for pain and amoxicillin 875 mg twice a day for 7 days for the ear infection and told to rest, ice the injection site and call if the erythema and swelling increased further at the injection site or within the next two weeks if not better. Laboratory diagnostics performed was reported as none. The outcome of ear infection, headache, injection site swelling, injection site erythema and sinus congestion was reported as recovered on an unknown date in 2019(recovery date also reported as no phone call from the patient as of 09-SEP-2019). The causality assessment was not provided by the reporter. No product quality complaint was filed.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Sinus congestion
Clinical narrative: The patient also complained of headache, sinus congestion and left ear pain/left ear infection; The patient also complained of headache, sinus congestion and left ear pain; Injection site erythema; Injection site swelling; The patient also complained of headache, sinus congestion and left ear pain; This spontaneous report was received from a registered nurse refers to a 31 year old (also reported as 33 year old) non-pregnant female patient. The patient's pertinent medical history included smoker and hashimoto thyroiditis. The patient's drug reactions/allergies was reported as none. Concomitant therapies included levothyroxine sodium(SYNTHROID).     On 27-AUG-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # R034248 with expiry date of 07-AUG-2020) (strength and dose were not reported) intramuscularly in the left arm for smoking history(prophylaxis). On 27-AUG 2019, the patient experienced erythema and swelling at the injection site especially noted after working at her salon, which progressed over a 48 hour period. On the same day, the patient also experienced headache, sinus congestion and left ear pain. She was seen by her doctor on 29-AUG-2019 and diagnosed with injection-site erythema and a left ear infection. The patient was treated with meloxicam as needed for pain and amoxicillin 875 mg twice a day for 7 days for the ear infection and told to rest, ice the injection site and call if the erythema and swelling increased further at the injection site or within the next two weeks if not better. Laboratory diagnostics performed was reported as none. The outcome of ear infection, headache, injection site swelling, injection site erythema and sinus congestion was reported as recovered on an unknown date in 2019(recovery date also reported as no phone call from the patient as of 09-SEP-2019). The causality assessment was not provided by the reporter. No product quality complaint was filed.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; patient was administered an expired dose of VAQTA; This spontaneous report was received from a nurse referring to a 12 month old patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     On 10-SEP-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated( VAQTA) lot # R027431 (verified to be a valid lot number), expiration date reported and established as 08-SEP-2019, for prophylaxis. No adverse event was reported.
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Sings of fever and injection site swelling; Sings of fever and injection site swelling; This spontaneous report was received from a pharmacy technician, a 30-year-old male patient reporting on himself. His medical relevant history was not reported.  The patient's concurrent conditions included diabetes and hyperlipidemia. His concomitant medications included rosuvastatin, lisinoplril and insulin lispro (HUMALOG). The patient had no drug reactions or allergies.   On 11-SEP-2019, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PENUMOVAX 23), intramuscularly, (strength, dose, frequency, lot number and expiration date were unknown by reporter) for prophylaxis.   On 12-SEP-2019 (also reported as "the following date"), the patient experienced having signs of fever (pyrexia) and injection site swelling. The reporter also stated that self-blood glucose checks were performed to him, at home.   At the reporting time, the patient was recovering from the aforementioned events.   The reporter did not assess the causal relationship between Pneumococcal Vaccine, Polyvalent (23-valent) (PENUMOVAX 23) and the events occurrence.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; patient recieved improperly stored VARIVAX; This spontaneous report was received from a nurse practitioner referring to a male patient of unknown age. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not reported.   On 23-SEP-2019, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot #S012039, expiration date: 17-APR-2021(strength, dose, schedule and route of administration were unknown) for prophylaxis (product storage error). The varicella virus vaccine live (Oka/Merck) (VARIVAX) was reconstituted with properly stored sterile diluent (lot # S015238, expiry date 08-MAR-2022. No adverse effect reported.  The vaccine underwent temperature excursion below -9 degree Celsius to 8 degree Celsius (0.84 C) for a duration of 8 hours. There was no previous temperature excursion. There was an involvement of data logger. No product quality complaints (PQC) were involved.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No adverse effect; administered a dose ofVARIVAX, on 9/24/2019, that had been improperly stored; This spontaneous report was received from a vaccine coordinator, also reported as office manager regarding a patient of unknown age. The patient's concurrent conditions, pertinent medical history, drug reactions or alleries and concomitant medication were not reported. On 24-SEP-2019, the patient was inadvertently administered with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R035222, expiry date: 04-DEC-2020 or lot # S008692, expiration date: 21-MAR-2021 or lot # S019463 has been verified to be a valid lot number, expiration date reported as 24-JAN-2021, but upon internal validation established as 24-JUN-2021 (exact dose, strength, route of administration and anatomical location were not reported) for prophylaxis (product storage error). All the lots of varicella virus vaccine live (oka/merck)(VARIVAX) were reconstituted with a well stored sterile diluent. The vaccine underwent temperature excursion of 27.1 degree Fahrenheit for a duration of 40 minutes. There was no previous temperature excursion. There was an involvement of a data logger. No product quality complaints were involved.
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Malaise, Product quality issue
Clinical narrative: Became sick afterwards; Local paediatrician sent me at the first vial so i tested and turned out to be positive altogether 16 vial; This spontaneous report was received from a consumer via social media refers to a patient of unknown age. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis. On an unknown date, the patient received the "faux" placebo of HPV vaccine and became sick (malaise) afterwards. There was no saline placebo it was a faux placebo. The physician reported in social media regarding product quality complain "Local paediatrician sent me at the first vial so reporter tested and turned out to be positive (altogether 16 vial) (product quality issue)". The outcome of malaise and product quality issue was unknown. Reporter's causality was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patient was inadvertently administered a dose of PROQUAD that had been improperly stored; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided.   On 24-SEP-2019, the patient was inadvertently vaccinated with  improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R030805 (verified to be a valid lot number), expiration date reported and established as 22-APR-2020 and lot #S003326 (verified to be a valid lot number), expiration date reported and established as 02-AUG-2020, both for prophylaxis and reconstituted with a properly stored sterile diluent. Both lots were improperly stored at 27.1°F during a time frame of 40 minutes. The call was because of a data logger. No adverse effect neither previous temperature excursions were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Nurse reports the administration of one dose of an improperly stored vaccine,; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and historical drugs were not reported.  On 10-SEP-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) per oral route with lot # R030924 and expiration date 10-JUL-2020 for prophylaxis.   The administered dose of vaccine experienced the temperature excursion of 0.24 degrees Celsius (multiple) for 5 hours and 30 min. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: fever; red spots that move around the whole shoulder; This spontaneous report as received from a consumer, an elderly male patient of currently 91 years old. The patient's pertinent medical history, history of drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date approximately in 2014 (also reported as "4-5 years ago"), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) vial, 1 dose (strength, frequency, lot # and expiry date was not reported) via subcutaneous route (also reported as underneath the skin) for prophylaxis. On an unknown date approximately in 2018, the patient experienced fever (pyrexia) and he was hospitalized on 04-FEB-2018 for the same. On an unknown date, the patient also developed "red spots that moved around the whole shoulder" (generalised erythema) after receiving zoster vaccine live (ZOSTAVAX). The patient sought medical attention by talking with physician. It was reported that no treatment was provided for the adverse events. No lab diagnostics/ studies were performed and no product quality complaint was reported. The outcome of the events, pyrexia and generalised erythema was reported as not recovered. Causality assesement was not provided by the reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: rash on my left arm only, the arm I got my shot; hives; This case was reported by a consumer via call center representative and described the occurrence of hives in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st August 2019, the patient received the 1st dose of Shingrix. In August 2019, 2 days after receiving Shingrix, the patient experienced hives. On an unknown date, the patient experienced rash. On an unknown date, the outcome of the hives was recovered/resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the hives and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient stated that had hives that cleared up but now at the time of reporting experiencing a rash on left arm.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: minor swelling at the site of vaccine injection; rash; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site swelling and injection site rash. On an unknown date, the outcome of the injection site swelling and injection site rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling and injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient asked the duration required to completely recover from rash and swelling which occurred at injection site and if any treatment needed for that. The patient did not provided demographic details and preferred to remain anonymous.
Sex: M
Vaccine: FLU4
Symptoms: Biopsy skin normal, Culture negative, Foreign body reaction, Injection site discharge, Reaction to excipient
Clinical narrative: Foreign body reaction to something in the vaccine; Foreign body reaction to something in the vaccine; Developed a draining area; This case was reported by a physician via sales rep and described the occurrence of injection site discharge in a 4-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) for prophylaxis.   In November 2018, the patient received Fluarix Quadrivalent 2018-2019 season. In January 2019, between 2 and 3 months after receiving Fluarix Quadrivalent 2018-2019 season, the patient experienced injection site discharge. On an unknown date, the patient experienced foreign body reaction and reaction to excipient. On an unknown date, the outcome of the injection site discharge, foreign body reaction and reaction to excipient were unknown.   It was unknown if the reporter considered the injection site discharge, foreign body reaction and reaction to excipient to be related to Fluarix Quadrivalent 2018-2019 season.  Additional case details were provided as follows: The age at vaccination was not reported but it could be 3 years or 4 years. In November 2018, the patient received Fluarix quadrivalent. Subsequently developed a draining area in general area of where vaccine was administered in January 2019.  Biopsy was done by a pediatric dermatologist which showed negative culture and the dermatologist thought the patient likely had a foreign body reaction to something in the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Head titubation, Tremor
Clinical narrative: Mild chills / Shivering; Hands, arms, head were shaking so hard; head were shaking so hard; This case was reported by a consumer and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2019 14:30, the patient received the 2nd dose of Shingrix. In September 2019, 12 hrs 30 min after receiving Shingrix, the patient experienced chills, tremor and head tremor. On an unknown date, the outcome of the chills was unknown and the outcome of the tremor and head tremor were recovering/resolving.   It was unknown if the reporter considered the chills, tremor and head tremor to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The patient received 2nd dose of Shingrix on day before reporting at 2:30pm.  The patient woke up at 3:00 am with mild chills. By 3:30am the chills were much worse. The patient's hands, arms, head were shaking so hard. It was alarming. By the 5:00 am the shivering/shaking had calmed (very slight shivering).  The patient read about the side effects and hoping that the shivering doesn't return.  The patient concerns were long term side effects. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash pruritic, Urticaria
Clinical narrative: rash on her back, neck, shoulders and under her arms and was itchy; whelps; Possible Shingles; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax and Shingrix with an associated reaction of erythema (1st dose received on an unknown date and had whelps and swelling at the injection site, for tolerance refer case US2019170013).   On 14th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced itchy rash, welts and shingles. The patient was treated with hydrocortisone and benadryl (nos) (Benadryl). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the itchy rash, welts and shingles were recovering/resolving.   It was unknown if the reporter considered the itchy rash, welts and shingles to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient received Zostavax a long time ago but she never had issues with the Zostavax. On the past Saturday (before the reporting date), the patient had her 2nd dose of Shingirx at the pharmacy.   She stated, she now had a rash on her back, neck, shoulders and under her arms. It was itchy and had whelps.  The patient reported the events to the pharmacy, where she got the vaccine and they advised to call GlaxoSmithKline and also to take Benadryl and use hydrocortisone cream.   The patient was wondered, these events could be Shingles, so she was referred to her physician for follow- up. The patient consented to follow up and also provided her physician's details.