chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Peripheral swelling, Skin warm, Vomiting
Clinical narrative: vomited within a few minutes of receiving vaccines. felt warm and diaphoretic.  vomited x 1 and felt better. awoke .  Awoke next morning  -pain under arms. Looked normal. Applied a warm rag . went to school.  When he arrived home after school, noted swelling under left arm.  in our office the following day,  normal VS. Normal face and normal ROM of neck.  No cervical nodes. Distal left & right arms normal. Proximal area of right & left deltoids with mild, slightly tender induration . No erythema.   Left axilla swollen but soft. Mild tenderness. + 1 cm tender axillary node.. Full ROM of upper extremities.  No rash.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received on 09-APR-2019 from a lawyer regarding a case in litigation concerning a female patient (age unknown).  The patient's medical history, concurrent conditions and concomitant medication use were not provided.  The patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions.  In 2010, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (lot# and route not specified) by a pharmacist.  On an unspecified date, the patient was treated by a physician for shingles as a result of vaccination with zoster vaccine live (ZOSTAVAX).  The outcome was not provided.   Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received on 09-APR-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the Zoster Vaccine Live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 15-OCT-2013, the patient was administered the Zoster Vaccine Live (ZOSTAVAX) (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. On an unknown date, the patient was treated by a physician at a physician's office for the following injuries resulting from the patient's Zoster Vaccine Live (ZOSTAVAX) use: herpes zoster. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related.   Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 03-AUG-2011, at age 66, the patient was administered the ZOSTAVAX by a pharmacist (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician at a hospital for the following injury resulting from his ZOSTAVAX use: herpes zoster ophthalmicus. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster ophthalmicus is unknown. Upon internal review, herpes zoster ophthalmicus was determined to be medically significant. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Injection site erythema, Injection site pain, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 14th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 1 ml. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 14th August 2018, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced overdose. On 15th August 2018, the patient experienced injection site pain and injection site erythema. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the overdose and product supply issue were unknown. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient's paperwork from pharmacy stated that she received 1.00 ml dose of SHINGRIX vaccine in the left deltoid, which led to an overdose. On 15th August 2018, next day after vaccination, the patient experienced pain and redness at the site of injection which lasted for 2 weeks. The patient had not been able to get the 2nd dose due to availability issue and would follow up with her pharmacy to make sure if she received the correct dosage. The patient's Pharmacy was telling her that they would get the vaccine, but they were not getting it and would not get it any time this year. The patient was looking if she would get 2nd dose of SHINGRIX anywhere around town. The patient was worried about the delay in 2nd dose, even though there was a demand of SHINGRIX. It appeared that the events were reported during the call. The reporter did not consent to follow-up. No further details were provided.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperaesthesia teeth, Malaise, Pain in extremity, Pain in jaw
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 9th April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th April 2019, 2 hrs after receiving SHINGRIX, the patient experienced pain in arm, general malaise and headache. On 10th April 2019, the patient experienced jaw pain and sensitivity of teeth. On an unknown date, the outcome of the pain in arm, general malaise, headache, jaw pain and sensitivity of teeth were unknown. It was unknown if the reporter considered the pain in arm, general malaise, headache, jaw pain and sensitivity of teeth to be related to SHINGRIX. Additional details were provided as follows: The lot number was not known. The patient received SHINGRIX around 10 AM in the left arm. On day two of vaccination, the patient reported lower left jaw pain. The patient had seen her dental professional 2 weeks ago before reporting and had a regular exam with x rays and all was normal. The patient also reported an increased sensitivity to all her teeth to cold and sweets. The reporter did not give consent to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray dental normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 9th April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th April 2019, 2 hrs after receiving SHINGRIX, the patient experienced pain in arm, general malaise and headache. On 10th April 2019, the patient experienced jaw pain and sensitivity of teeth. On an unknown date, the outcome of the pain in arm, general malaise, headache, jaw pain and sensitivity of teeth were unknown. It was unknown if the reporter considered the pain in arm, general malaise, headache, jaw pain and sensitivity of teeth to be related to SHINGRIX. Additional details were provided as follows: The lot number was not known. The patient received SHINGRIX around 10 AM in the left arm. On day two of vaccination, the patient reported lower left jaw pain. The patient had seen her dental professional 2 weeks ago before reporting and had a regular exam with x rays and all was normal. The patient also reported an increased sensitivity to all her teeth to cold and sweets. The reporter did not give consent to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 8th April 2019, the patient received the 1st dose of SHINGRIX .5 ml. On 8th April 2019, less than a day after receiving SHINGRIX, the patient experienced tiredness, pain in arm and rash. On an unknown date, the outcome of the tiredness, pain in arm and rash were not reported. It was unknown if the reporter considered the tiredness, pain in arm and rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's husband. On 8th April 2019, the patient received 1st dose of SHINGRIX in left arm and complained of arm pain, spots on the arm, and feeling tired. Call ended before asking if symptoms were resolved and consent to follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 22nd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On 22nd August 2018, less than a day after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site erythema. On 23rd August 2018, the patient experienced injection site pain, headache, nausea and fatigue. On an unknown date, the patient experienced drug dose administration interval too long. On 25th August 2018, the outcome of the headache, nausea and fatigue were recovered/resolved. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the injection site erythema, injection site pain, headache, nausea and fatigue to be related to SHINGRIX. Additional details were provided as follows: The injection site became a little red that evening. However, the next day she noticed that the redness was a circle about the size of a small lemon and it was sore. These symptoms lasted for three weeks. At around 9:00 or 10:00 am the next day after receiving the vaccine, the reporter indicated that she had a headache and nausea. These symptoms lasted for two days. Then she felt fatigue which resolved on 25th August 2018, The reporter indicated that she was late to get her second dose of the SHINGRIX vaccine, which led to lengthening of the vaccination schedule. The reporter gave consent to follow up. The reporter given permission for her physician to be contacted.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 22nd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On 22nd August 2018, less than a day after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site erythema. On 23rd August 2018, the patient experienced injection site pain, headache, nausea and fatigue. On an unknown date, the patient experienced drug dose administration interval too long. On 25th August 2018, the outcome of the headache, nausea and fatigue were recovered/resolved. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the injection site erythema, injection site pain, headache, nausea and fatigue to be related to SHINGRIX. Additional details were provided as follows: The injection site became a little red that evening. However, the next day she noticed that the redness was a circle about the size of a small lemon and it was sore. These symptoms lasted for three weeks. At around 9:00 or 10:00 am the next day after receiving the vaccine, the reporter indicated that she had a headache and nausea. These symptoms lasted for two days. Then she felt fatigue which resolved on 25th August 2018, The reporter indicated that she was late to get her second dose of the SHINGRIX vaccine, which led to lengthening of the vaccination schedule. The reporter gave consent to follow up. The reporter given permission for her physician to be contacted.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 78-year-old female patient who received SHINGRIX (batch number 4X733, expiry date 8th March 2021) for prophylaxis. On 9th April 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 10th April 2019, 1 days after receiving SHINGRIX, the patient experienced injection site rash and injection site erythema. On an unknown date, the outcome of the injection site rash and injection site erythema were recovering/resolving. It was unknown if the reporter considered the injection site rash and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received dose of SHINGRIX at 9:50 am. Either the next day or the day after, the patient experienced a red rash that forms a band around the injection site. It had improved but had not resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 63-year-old female patient who received SHINGRIX (batch number 2YN4S, expiry date 9th July 2021) for prophylaxis. On 9th April 2019, the patient received the 1st dose of SHINGRIX. On 9th April 2019, less than a day after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and within 24 hours developed a rash on the left chest. The patient did not describe the rash as painful or itchy, just stated she had a rash.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Flushing, Pruritus, Rash generalised, Urticaria
Clinical narrative: Rash started morning of 4-17-19. All over body rash with red welts that come and go. Complains of very itchy scalp, trunk and extremities. Cheeks are flush and red. Denies shortness of breath and swelling of lips and face. Treated for urticaria. Given 10 mg/mL of DECADRON IM on left buttock in office and given a prescription for Hydroxyzine HCL syrup 10 mg/5mL orally, every 8 hours as needed for 7 days. Referral made to allergist for further investigation. Encouraged to go to the ER is she experienes shortness of breath or facial swelling.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea, Haematochezia, Irritability, Occult blood positive, Pyrexia
Clinical narrative: History of GERD, fussy, fever, diarrhea, blood in stool - MOC will observe child at home
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Cortical dysplasia, Crying, Electroencephalogram abnormal, Epilepsy, Infantile spasms
Clinical narrative: Parents reported that infant had 24 hours of prolonged crying following above vaccinations (did not occur with 2 month vaccinations). Approximately 1 month following above vaccinations, infant presented with infantile spasms and has subequently developed refractory epilepsy and has been found to have cortical dysplasia. Parents concerned that vaccination triggered onset of seizures, report submitted at their request.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Laboratory test normal, Pyrexia, Seizure, Tracheitis
Clinical narrative: was well after vaccine visit until he had his 1st seizure on 8/5/17.  no fever at that time.   In ER was 103.6.   No additional seizures.   All labs unremarkable.  NO trach culture but dx was tracheitis and he was started on amoxicillin.  Mom has diary of fevers: 8/6 tamp 100.7 8/7 temp 101.2 8/8 101.7;  Developed a cough  8/9 102.1 8/10 101.8
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Crying
Clinical narrative: Parents report that patient was crying and inconsolable for 3 1/2 hours. He received Tylenol before the immunizations and also during the incident.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site haemorrhage, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Tenderness and swelling at site of 4 yo deltoid vaccines on 7/21/17 while  on amoxicillin for scarlatiniform rash. Afebrile. Mom reports there was blood at the time of the vaccines. on exam, significant induration and warmth of entire right upper arm.  Not tender. Distal pulses intact. Full ROM of arm.  Referred to ER for cellulitis vs  hematoma vs vaccine reaction.  Changed from amoxicillin to Keflex for likely cellulitis.  Problem resolved.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Extreme malaise, extreme fatigue, headache, upset stomach, swelling, redness and pain at injection site.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Malaise
Clinical narrative: Extreme malaise, extreme fatigue, headache, upset stomach, swelling, redness and pain at injection site.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Respiratory tract congestion
Clinical narrative: Extreme congestion  and difficulty breathing the next day. Had some dexamethasone at home, took a dose  and felt better. Feels fine now.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia, Nasopharyngitis, Pyrexia
Clinical narrative: Event of shot was fine. Felt fine in the evening. Woke up today with ache in muscles and feverish and it feels like a flu or cold.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: patient received adose of MMR II via the intramuscular route; No adverse effects reported; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding patient's pertinent medical history, drug reactions or allergies and concomitant medications was reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), intramuscularly (instead of subcutaneously), (dose, injection site, lot# and expiration date were not provided) for prophylaxis.  There was no adverse event reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received on 09-APR-2019 from a lawyer regarding a case in litigation concerning a male patient (age unknown).  The patient's medical history, concurrent conditions and concomitant medication use were not provided.  The patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions.  In 2011, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (lot# and route not specified) by a healthcare provider.  On an unspecified date, the patient was treated by a healthcare provider for herpes zoster as a result of vaccination with zoster vaccine live (ZOSTAVAX).  The outcome was not provided.   Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in jaw
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 5th April 2019, the patient received the 2nd dose of SHINGRIX. In April 2019, less than a week after receiving SHINGRIX, the patient experienced chills, pain and jaw pain. The patient was treated with ibuprofen (Unknown Manufacturer). On an unknown date, the outcome of the chills and pain were recovered/resolved and the outcome of the jaw pain was unknown. It was unknown if the reporter considered the chills, pain and jaw pain to be related to SHINGRIX. Additional case details were provided as follows: The patient received the dose of SHINGRIX and experienced chills, pain and pain in jaw similar to TMJ (Temporomandibular joint). No further information was provided due to the connection lost.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Inappropriate schedule of product administration, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (received 1st dose in 2018, refer case US2019GSK070650). On 10th April 2019, the patient received the 2nd dose of SHINGRIX. On 10th April 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm, headache and drug dose administration interval too long. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the headache and drug dose administration interval too long were unknown. It was unknown if the reporter considered the pain in arm and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received 2nd dose last night, but he was told he was right around 7 months, which led to drug dose administration interval too long. The caller also stated that his arm hurts and he has bad a headache. His arm was a little sore afterwards was still sore and hurting last night and this morning. The reporter clarified he has been having headaches off and on, he just went over the coast and back and goes over mountains and back to sea level. So that was why he has a headache.
Age: 57.0
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age, Spleen disorder, Splenectomy
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of spleen disorder in a 57-year-old female patient who received BEXSERO for prophylaxis. On 22nd February 2019, the patient received the 1st dose of BEXSERO. On 22nd February 2019, unknown after receiving BEXSERO, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced spleen disorder. On an unknown date, the outcome of the spleen disorder and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the spleen disorder to be related to BEXSERO. Additional details were reported as follows: A 57 year old patient received BEXSERO, which led to inappropriate age at vaccine administration. On an unknown day after vaccination, the patient had splenectomy. No symptoms were reported. The nurse did not know the lot number or expiry date.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Malaise, Pain, Rash, Rash erythematous
Clinical narrative: I spend a miserable day yesterday with soreness, and feeling sick. Today I woke up and my chest is covered in a red rash.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: Patient not sure if vaccination was on 3/25 or 3/26. Patient received the vaccine around mid-day; adverse events started 2 or 3 hours later. Per patient, around vaccine injection area turned bright red (6x6 inch), it was itchy and there were little bumps (about 7) in area. Patient called pharmacy to report adverse events and told problems should resolve within a couple of days. Also called doctor and was told not to take the 2nd shot. It took about 10-14 days to resolve completely; it was the worse the fist 24 hours and stayed in that peak for 5-6 days and then lessened. Patient did not take any medications just avoided itching.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Burning pain in the right upper arm with redness and swelling
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Influenza like illness
Clinical narrative: Patient received SHINGRIX vaccine in (L) deltoid on 4/15/19 at approximately 10:30 am. Flu-like symptoms started less than 12 hrs. later at approx. 8 pm: chills, body aches, HA, loss of appetite, fatigue lasting until 4/17/19. Rash started on 4/16/19 in the morning with increasing swelling and pain since. Now measuring 12cm x 12cm rash.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Swelling
Clinical narrative: Patient received SHINGRIX vaccine in (L) deltoid on 4/15/19 at approximately 10:30 am. Flu-like symptoms started less than 12 hrs. later at approx. 8 pm: chills, body aches, HA, loss of appetite, fatigue lasting until 4/17/19. Rash started on 4/16/19 in the morning with increasing swelling and pain since. Now measuring 12cm x 12cm rash.
Age: 37.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and swelling to the site (L) upper arm) progressively getting worse with increased swelling, redness and itching, only at the site. Seen in ER 4/13/19. D/C home.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt states that itching & redness began at site (L) arm 3 days after receiving vaccine
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Cold sweat, Malaise, Pyrexia
Clinical narrative: Fever & Cold Sweats, Malaise
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: C-reactive protein, Cytomegalovirus test, Epstein-Barr virus test, Fatigue, Feeling cold
Clinical narrative: Grandmother complains that patient has had fatigue beginning 1 month after vaccination and is not improving. Patient was energic and never still and now grandmother states he mostly sits. Also complains of being cold all the time. Wears multiple layers of clothing and sleeps with 6 blankets. Grandmother states this began after vaccination.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Full blood count, Metabolic function test, Red blood cell sedimentation rate, Thyroid function test
Clinical narrative: Grandmother complains that patient has had fatigue beginning 1 month after vaccination and is not improving. Patient was energic and never still and now grandmother states he mostly sits. Also complains of being cold all the time. Wears multiple layers of clothing and sleeps with 6 blankets. Grandmother states this began after vaccination.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Groin pain, Injection site erythema, Pain
Clinical narrative: slight arm redness  at injection site with body aches  and lower back pain radiating to groin.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Lymphadenopathy, Oral herpes, Peripheral swelling
Clinical narrative: SHINGRIX given 4-4-19, redness and swelling of left arm 4-5-19 to 4-6-19. On 4/10/19 at 10 am Fever of 99 degrees F, swollen face & glands on Right side, started in right corner of mouth ? cold sore but by night broke out to inside and right side of cheek broke out, by 4-13-19 pt reported pink on his cheek. As 4-17-19 mostly scabbed over. Pt concerned so went to PCP on 4-17-19 told shingles but no testing done. Pt reports hx of chicken pox. As of 4-18-19 mostly scabbed over per pt.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Scab, Swelling face
Clinical narrative: SHINGRIX given 4-4-19, redness and swelling of left arm 4-5-19 to 4-6-19. On 4/10/19 at 10 am Fever of 99 degrees F, swollen face & glands on Right side, started in right corner of mouth ? cold sore but by night broke out to inside and right side of cheek broke out, by 4-13-19 pt reported pink on his cheek. As 4-17-19 mostly scabbed over. Pt concerned so went to PCP on 4-17-19 told shingles but no testing done. Pt reports hx of chicken pox. As of 4-18-19 mostly scabbed over per pt.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: SHINGRIX given 4-4-19, redness and swelling of left arm 4-5-19 to 4-6-19. On 4/10/19 at 10 am Fever of 99 degrees F, swollen face & glands on Right side, started in right corner of mouth ? cold sore but by night broke out to inside and right side of cheek broke out, by 4-13-19 pt reported pink on his cheek. As 4-17-19 mostly scabbed over. Pt concerned so went to PCP on 4-17-19 told shingles but no testing done. Pt reports hx of chicken pox. As of 4-18-19 mostly scabbed over per pt.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Oral herpes, Pyrexia, Rash, Scab, Swelling face
Clinical narrative: SHINGRIX given 4-4-19, redness and swelling of left arm 4-5-19 to 4-6-19. On 4/10/19 at 10 am Fever of 99 degrees F, swollen face & glands on Right side, started in right corner of mouth ? cold sore but by night broke out to inside and right side of cheek broke out, by 4-13-19 pt reported pink on his cheek. As 4-17-19 mostly scabbed over. Pt concerned so went to PCP on 4-17-19 told shingles but no testing done. Pt reports hx of chicken pox. As of 4-18-19 mostly scabbed over per pt.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Chills, Pyrexia
Clinical narrative: Fever 101.4, joint pain, low back pain, chills.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Patient presented in good health and was wanting her vaccine. After 30 seconds to 1 minute of receiving the vaccine, patient complained of feeling lightheaded and soon fainted. She was sitting down in a chair at the time and I caught her before she could fall and hit the ground. I lowered her to the ground and elevated her feet. I had my staff call 911 to have paramedics come and evaluate her. She soon regained consciousness and was talkative with me. She mentioned that she never had a history of fainting before and that she had barely eaten in the morning before the shot. Once paramedics arrived, they lowered her feet and helped her sit up in another chair. She was released from their care several minutes later.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dysphagia, Pain, Pharyngeal swelling, Swelling face
Clinical narrative: Patient received vaccine on 4/4/19, the next felt chills, body aches. At dinner time patient felt face swelling, throat, swelling and had a hard time swallowing. Patient went to urgent care, was told to go home and take BENADRYL, SYRTEC, and PEPCID for 3 days. Patient has no after affects.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site swelling, Rash
Clinical narrative: PT BROKE OUT INT A RASH 2 HOURS AFTER RECIEVING VACCINES. LEFT THIGH SLIGHTLY SWOLLEN. PT CAME INTO OFFICE TODAY FOR DR TO LOOK AT. WAITING ON A CALL BACK FROM THE HEALTH DEPARTMENT FOR FURTHER INSTURCTIONS.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: fever, shivers, ache all over, intense, pounding headache
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Approximately 2 weeks after his first immunization, (early February 2019) he developed an "itchy rash" across his abdomen and some on his lower back. He reports that "rash and itching" went away "about 2 weeks ago" (early April 2019). Denies ever having pain with the rash.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Blood test, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Red and swollen, the area is hot to touch and hard. It has spread from injection site downward and upward into groin. It is hurting my son and looks terrible.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of influenza like illness (1st dose received on 4th August 2018. Please refer the case US2019065834). On 4th April 2019, the patient received the 2nd dose of SHINGRIX. On 4th April 2019, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too long. In April 2019, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms and drug dose administration interval too long were unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient experienced flu like symptoms. The patient two months late for 2nd dose, which led to lengthening of the vaccination schedule.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 4th August 2018, the patient received the 1st dose of SHINGRIX. On 4th August 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient experienced flu like symptoms. For tolerance after 2nd dose, refer case US2019GSK070470.
Age: 76.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: UrticariaPruritus
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion, Pyrexia, Rash
Clinical narrative: Rash - 4/15/19 Fever - 4/17/19 -> 103-104 Febrile Sz - 4/17/19 - ED eval
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Blister, Erythema, Oedema, Pruritus
Clinical narrative: Over the next week following the injection, pt developed progressive itching, edema, erythema and eventually blistering of the L arm. Pt presented with these sxs on 4/11/19, at which time photographs were taken and pt was sent to the ER where she received intravenous steroids with resolution of sxs.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: THE PATIENT INFORMED THAT SHE GOT HER FIRST VACCINE IN JANUARY. WE ADMINISTERED THE VACCINE ON 3/20. THE PATIENT CALLED BACK AN INFORMED US THAT SHE ACTUALLY GOT IT IN FEBRUARY. WE CALLED GSK AND THEY INFORMED US THAT AS LONG AS THE PATIENT GOT HER FIRST VACCINE 4 WEEKS AFTER THE FIRST DOSE THAT EVERYTHING WAS OKAY AND THERE WAS NO NEED TO REPEAT ANY DOSES IN THE SERIES. THE PATIENT HAD NO SYMPTOMS OR ADVERSE REACTIONS THAT SHE EXPERIENCED.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Pyrexia
Clinical narrative: Fever between 99.8 and 100.3; Chills. I'm not seeking treatment other than OTC fever reducer.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: The pt came in to let me know that she had gone to her doctor due to swelling and redness on arm where she recieved the injection and the doctor diagnosed her with cellulitus. I called the doctor office to confirm diagnosis.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Fatigue, Injection site pain, Malaise, Rash
Clinical narrative: Pt started experiencing pain at the injection site. A consistent light pick rash started developing around her arm following the injection and still has not gone away at day 5 after the dose. She experienced fatigue and not feeling well after the shot too. She said the rash is itchy and there is a hot burning sensation. Pt was advised to get hydrocortisone cream to rub on area and continue taking Benadryl for the itching until she sees the md on 4-19-19.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Pt started experiencing pain at the injection site. A consistent light pick rash started developing around her arm following the injection and still has not gone away at day 5 after the dose. She experienced fatigue and not feeling well after the shot too. She said the rash is itchy and there is a hot burning sensation. Pt was advised to get hydrocortisone cream to rub on area and continue taking Benadryl for the itching until she sees the md on 4-19-19.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: Approx. 3 minutes after receiving vaccinations, patient had a syncopal event that was witnessed by me (the provider). The patient was OK initially after receiving the vaccine, was moving arms around as directed, and was given a lollipop to eat. Without warning, the patient lost consciousness and fell from the exam table where he was sitting. He was unconscious for approx. 30 seconds before an ammonia packet was opened, waved under the patient's nose, and he regained consciousness. 9-1-1 was called since patient hit his head when he fell off of the table. EMTs recommended that patient go to ED for a CT scan. Per coworker who worked the next day, the patient's mother returned and advised that the patient was fine. 1 additional attempt was made to follow up with the patient from this office on 4/17/19 without a returned phone call.
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Aggression, Balance disorder, Crying, Depressed mood, Emotional disorder
Clinical narrative: Mom reports pt had increasing emotional and balance problems. He was combative and "challenging" per mom. He has been crying with sadness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Blood culture, Cellulitis, Full blood count, Injection site erythema, Injection site swelling
Clinical narrative: L leg received that received KINRIX injection reportedly cleaned in sterile technique as usual prior to injection. On 4/3/19, left thigh became erythematous in small area of a few centimeters, and by the afternoon of 4/4/19, the leg become almost completely erythematous and swollen. He was referred and admitted to Medical Center, where he was treated for cellulitis with IV clindamycin, and he subsequently improved and was discharged on 4/5/19 in the afternoon. He continued antibiotics afterwards (prescribed 10 day course and was confirmed to have completed 7 days at follow up) with significant improvement.
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Abnormal behaviour, Pyrexia
Clinical narrative: Pt developed fever of 101 axillary. The next day it was 100.6. Denies localized redness. Pt "not acting quite right" per mom.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site pruritus, Pruritus, Urticaria
Clinical narrative: within 3 to 4 minutes after the vaccine was given the patient started Itching his face and developed urticaria on his face Benedryl 1.25 ml was given the patient responded to the benedryl  and the urticaria on his face went away he was still itching on his left thigh waited 15 more mins then that stopped there was no lip swelling and lungs were clear
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Patient reports that her arm swelled up the size of a baseball and that she ran a fever and was in bed for 2 days.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Limb discomfort, Musculoskeletal stiffness
Clinical narrative: Patient reports that her arm is stiff, sore, and could hardly move it.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: Patient is 65 Years Old Female presents with complaint saw skin rash at injection site after two days of injection.  Received PCV13 on   3/12/2019.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Paraesthesia
Clinical narrative: Patient had large localized site reaction measuring 16 cm x 19 cm area of erythema, redness, warmth and tenderness on left upper deltoid area which started 1 day after vaccine administration. On day 2 after vaccine administration, he woke in the morning at 8 am with "pins and needles" sensation in the left hand and 2nd-5th fingers which did not resolve with shaking his hand to increase circulation. On exam, he has strong equal bilateral radial pulses. His skin on his hands are warm, pink and dry bilaterally with normal skin turgor. His sensation in his left hand is intact to light touch. He has excellent grip strength. At time of filing VAERS report, he has had symptoms for 5.5 hours without any improvement or worsening.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site bruising, Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Patient began to experience flu like symptoms a few hours after the vaccine that lasted for a week. He also experienced a red welt below the injection site, in addition to a circular bruise at the actual injection site.
Age: 80.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Arthralgia, Headache, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Pt experienced flu-like symptoms for aprox 24 hours. Included headache, feeling shaky, tender skin (whole body), joint aches, especially the neck. Redness and swelling at Tdap injection site (limited to injection site only). Pt reports steady improvement 24 hours later.
Age: 80.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Nervousness, Pain of skin
Clinical narrative: Pt experienced flu-like symptoms for aprox 24 hours. Included headache, feeling shaky, tender skin (whole body), joint aches, especially the neck. Redness and swelling at Tdap injection site (limited to injection site only). Pt reports steady improvement 24 hours later.
Age: 41.0
Sex: M
Vaccine: MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given Men B (BEXSERO) when he was supposed to receive Hep B. Patient was notified. No adverse effects.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Insomnia, Nausea, Neck pain
Clinical narrative: My arm is moderately painful, which interfered with sleeping. I feel fatigued, my neck aches, I have a headache, and at times I feel nauseated.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: My arm is moderately painful, which interfered with sleeping. I feel fatigued, my neck aches, I have a headache, and at times I feel nauseated.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Limb discomfort, Peripheral swelling
Clinical narrative: Swelling and redness at injection site. Patient came back to the pharmacy, arm was red, swollen and sore according to patient.  He stated that the swelling was getting worse,  I suggested that he try taking  some benadryl  to see if that might help if it was an allergic reaction. Or if it continues to get worse to go to the MD.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Blood pressure increased, Chills, Dizziness, Injected limb mobility decreased
Clinical narrative: Five hours after receiving this shot,  my site of injection became swollen, red, raised, hot  and my shoulder and  arm became VERY painful. I was unable to move this arm. Unable to sleep on that side of my body during that night.  The next day I felt unwell. I felt sick to my stomach. then I experienced chills (around 5:00 PM on 4/17/2019) fever of 100. the morning of 4/19/2019 I again well unwell. My blood pressure started to rise (my BP in the doctor's office two days before was 121/92. Now it was 136/98, 146/97, and after icing the back of my neck, 128/93.  Felt sick to my stomach and dizzy.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Malaise, Musculoskeletal pain
Clinical narrative: Five hours after receiving this shot,  my site of injection became swollen, red, raised, hot  and my shoulder and  arm became VERY painful. I was unable to move this arm. Unable to sleep on that side of my body during that night.  The next day I felt unwell. I felt sick to my stomach. then I experienced chills (around 5:00 PM on 4/17/2019) fever of 100. the morning of 4/19/2019 I again well unwell. My blood pressure started to rise (my BP in the doctor's office two days before was 121/92. Now it was 136/98, 146/97, and after icing the back of my neck, 128/93.  Felt sick to my stomach and dizzy.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: Five hours after receiving this shot,  my site of injection became swollen, red, raised, hot  and my shoulder and  arm became VERY painful. I was unable to move this arm. Unable to sleep on that side of my body during that night.  The next day I felt unwell. I felt sick to my stomach. then I experienced chills (around 5:00 PM on 4/17/2019) fever of 100. the morning of 4/19/2019 I again well unwell. My blood pressure started to rise (my BP in the doctor's office two days before was 121/92. Now it was 136/98, 146/97, and after icing the back of my neck, 128/93.  Felt sick to my stomach and dizzy.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Aches and fever all day 4/17/19 from 2nd dose of SHINGRIX. Patient was recovering without continuation of symptoms on 4/18/19.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Arthralgia, Back pain, Chills
Clinical narrative: 4:30 a.m. awoke with arm pain and nausea. Developed general fatigue throughout morning and  upset stomach around 10:30. 11:30 developed shivering, fever, horrible head pain, twinges of back and hip pain, intense stomach cramps and deep fatigue. Next day, primarily just fatigue and drowsiness.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: 4:30 a.m. awoke with arm pain and nausea. Developed general fatigue throughout morning and  upset stomach around 10:30. 11:30 developed shivering, fever, horrible head pain, twinges of back and hip pain, intense stomach cramps and deep fatigue. Next day, primarily just fatigue and drowsiness.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: 4:30 a.m. awoke with arm pain and nausea. Developed general fatigue throughout morning and  upset stomach around 10:30. 11:30 developed shivering, fever, horrible head pain, twinges of back and hip pain, intense stomach cramps and deep fatigue. Next day, primarily just fatigue and drowsiness.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Fluid retention, Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness of upper left arm extending to inside arm and down approximately 6 inches from injection site.  Resembling fluid under the skin around margins of redness.  Physician recommended one week treatment of Zyrtec and Tylenol or Ibuprofen.