chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (lot #N021583 and expiration date: 18-NOV-2019). In October 2017 (reported as on 17-OCT-2017, 19-OCT-2017, 26-OCT-2017 or 27-OCT-2017, the patient was vaccinated with unspecified doses of improperly stored VARIVAX (dose, units, frequency and route not reported) (lot # N019133 and expiration date: 22-JUN-2019). Reporter informed that, there was multiple temperature excursions for the VARIVAX as follows, on 02-OCT-2017, temperature excursion was at 14 F for the duration of 2 hours, on 03-OCT-2017, temperature excursion was at 16.7 F for the duration of 2 hours, on 04-OCT-2017, temperature excursion was at 16.7 F for the duration of 1 hour, on 05-OCT-2017, temperature excursion was at 16.7 F for the duration of 1 hour, on 10-OCT-2017, temperature excursion was at 17.1 F for the duration of 0.5 hours, on 11-OCT-2017, temperature excursion was at 18.1 F for the duration of 4 hours, on 16-OCT-2017, temperature excursion was at 19.2 F for the duration of 1 hour, on 17-OCT-2017, temperature excursion was at 19.40 F for the duration of 2 hours, on 18-OCT-2017, temperature excursion was at 17.40 F for the duration of 1 hour, on 19-OCT-2017, temperature excursion was at 21.90 F for the duration of 1 hour, on 20-OCT-2017, temperature excursion was at 17.10 F for the duration of 2 hours, on 24-OCT-2017, temperature excursion was at 5.80 F for the duration of 0.5 hours, On 25-OCT-2017, temperature excursion was at 8.20 F for the duration of 0.5 hours, on 26-OCT-2017, temperature excursion was at 17.80 F for the duration of 0.5 hours, on 27-OCT-2017, temperature excursion was at 14.40 F for the duration of 1 hour, On 30-OCT-2017, temperature excursion was at 16.90 F for the duration of 2 hours and on 31-OCT-2017, temperature excursion was at 14.40 F for the duration of 1 hour. It was reported that there was multiple previous excursions for the VARIVAX. Reporter did not state that sterile diluent was improperly stored. No adverse effects reported. No product quality complaint was involved. No further information was provided. This is one of the 8 reports (Same reporter link). Sender's Comments: US-009507513-1802USA003097: US-009507513-1802USA005084: US-009507513-1802USA005086: US-009507513-1802USA005090: US-009507513-1802USA005087: US-009507513-1802USA005088: US-009507513-1802USA005089: US-009507513-1802USA005088: US-009507513-1802USA007559.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (lot #N021583 and expiration date: 18-NOV-2019). In October 2017 (reported as on 17-OCT-2017, 19-OCT-2017, 26-OCT-2017 or 27-OCT-2017, the patient was vaccinated with unspecified doses of improperly stored VARIVAX (dose, units, frequency and route not reported) (lot # N019133 and expiration date: 22-JUN-2019). Reporter informed that, there was multiple temperature excursions for the VARIVAX as follows, on 02-OCT-2017, temperature excursion was at 14 F for the duration of 2 hours, on 03-OCT-2017, temperature excursion was at 16.7 F for the duration of 2 hours, on 04-OCT-2017, temperature excursion was at 16.7 F for the duration of 1 hour, on 05-OCT-2017, temperature excursion was at 16.7 F for the duration of 1 hour, on 10-OCT-2017, temperature excursion was at 17.1 F for the duration of 0.5 hours, on 11-OCT-2017, temperature excursion was at 18.1 F for the duration of 4 hours, on 16-OCT-2017, temperature excursion was at 19.2 F for the duration of 1 hour, on 17-OCT-2017, temperature excursion was at 19.40 F for the duration of 2 hours, on 18-OCT-2017, temperature excursion was at 17.40 F for the duration of 1 hour, on 19-OCT-2017, temperature excursion was at 21.90 F for the duration of 1 hour, on 20-OCT-2017, temperature excursion was at 17.10 F for the duration of 2 hours, on 24-OCT-2017, temperature excursion was at 5.80 F for the duration of 0.5 hours, On 25-OCT-2017, temperature excursion was at 8.20 F for the duration of 0.5 hours, on 26-OCT-2017, temperature excursion was at 17.80 F for the duration of 0.5 hours, on 27-OCT-2017, temperature excursion was at 14.40 F for the duration of 1 hour, On 30-OCT-2017, temperature excursion was at 16.90 F for the duration of 2 hours and on 31-OCT-2017, temperature excursion was at 14.40 F for the duration of 1 hour. It was reported that there was multiple previous excursions for the VARIVAX. Reporter did not state that sterile diluent was improperly stored. No adverse effects (no adverse event) reported. No product quality complaint was involved. No further information was provided. This is one of the 8 reports (Same reporter link). Sender's Comments: US-009507513-1802USA003097: US-009507513-1802USA005084: US-009507513-1802USA005085: US-009507513-1802USA005090: US-009507513-1802USA005089: US-009507513-1802USA005087: US-009507513-1802USA005088: US-009507513-1802USA007559.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (lot #N021583 and expiration date: 18-NOV-2019). In October 2017 (reported as on 17-OCT-2017, 19-OCT-2017, 26-OCT-2017 or 27-OCT-2017, the patient was vaccinated with unspecified doses of improperly stored VARIVAX (dose, units, frequency and route not reported) (lot # N019133 and expiration date: 22-JUN-2019). Reporter informed that, there was multiple temperature excursions for the VARIVAX as follows, on 02-OCT-2017, temperature excursion was at 14 F for the duration of 2 hours, on 03-OCT-2017, temperature excursion was at 16.7 F for the duration of 2 hours, on 04-OCT-2017, temperature excursion was at 16.7 F for the duration of 1 hour, on 05-OCT-2017, temperature excursion was at 16.7 F for the duration of 1 hour, on 10-OCT-2017, temperature excursion was at 17.1 F for the duration of 0.5 hours, on 11-OCT-2017, temperature excursion was at 18.1 F for the duration of 4 hours, on 16-OCT-2017, temperature excursion was at 19.2 F for the duration of 1 hour, on 17-OCT-2017, temperature excursion was at 19.40 F for the duration of 2 hours, on 18-OCT-2017, temperature excursion was at 17.40 F for the duration of 1 hour, on 19-OCT-2017, temperature excursion was at 21.90 F for the duration of 1 hour, on 20-OCT-2017, temperature excursion was at 17.10 F for the duration of 2 hours, on 24-OCT-2017, temperature excursion was at 5.80 F for the duration of 0.5 hours, On 25-OCT-2017, temperature excursion was at 8.20 F for the duration of 0.5 hours, on 26-OCT-2017, temperature excursion was at 17.80 F for the duration of 0.5 hours, on 27-OCT-2017, temperature excursion was at 14.40 F for the duration of 1 hour, On 30-OCT-2017, temperature excursion was at 16.90 F for the duration of 2 hours and on 31-OCT-2017, temperature excursion was at 14.40 F for the duration of 1 hour. It was reported that there was multiple previous excursions for the VARIVAX. Reporter did not state that sterile diluent was improperly stored. No adverse effects (no adverse event) reported. No product quality complaint was involved. No further information was provided. This is one of the 8 reports (Same reporter link). Sender's Comments: US-009507513-1802USA003097: US-009507513-1802USA005084: US-009507513-1802USA005085: US-009507513-1802USA005086: US-009507513-1802USA005088: US-009507513-1802USA005089: US-009507513-1802USA005090: US-009507513-1802USA005088: US-009507513-1802USA007559.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to 66 years old a male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date in 2016, reported as "two years ago", the patient was vaccinated with a dose of ZOSTAVAX vial 19400 PFU, for vaccination (dose, route of administration, anatomical location, lot number and expiration date were not reported), other suspect therapies included sterile diluent (manufacturer unknown) (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unspecified date in 2016, reported as "a day after receiving ZOSTAVAX", the patient developed zoster ophthalmicus. It was reported that the patient visited an ophthalmologist and subsequently recovered from the event on an unknown date. It was unknown by the reporter if treatment was given for the adverse event and also if laboratories were performed. The reporter did not assess the causal relationship between therapy with ZOSTAVAX and the aforementioned event. Upon internal review the event ophthalmic herpes zoster was considered to be medically significant.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pyrexia
Clinical narrative: Pain in injection point which is typical. However, I developed a severe headache, and fever after the injection. The headache continues.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: 10 minutes after receiving Flu vaccine and while parents were currently getting their flu vaccines client had a vasovagal syncope episode. Client was held in father's arms when occurred. Laid down on exam table and lower extremities raised. Ammonia Pearl inhalant used. Feet elevated. Cold compress to back of neck. Apical strong. Breathing stable. Non verbal. BP 84/60. Responded  and juice and crackers given. Father refused blood sugar test. Called Dr. to report incident. Walked out independently.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Pyrexia, Skin warm
Clinical narrative: Mild fever and perhaps sleep disruption. Mild fever lasted 2 days. Very red, hot reaction over most of my upper arm, which is still present (although not as red) after five days. Mild itching remains.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Pain, Rash
Clinical narrative: Mild fever and perhaps sleep disruption. Mild fever lasted 2 days. Very red, hot reaction over most of my upper arm, which is still present (although not as red) after five days. Mild itching remains.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Mild fever and perhaps sleep disruption. Mild fever lasted 2 days. Very red, hot reaction over most of my upper arm, which is still present (although not as red) after five days. Mild itching remains.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Pyrexia, Sleep disorder
Clinical narrative: Mild fever and perhaps sleep disruption. Mild fever lasted 2 days. Very red, hot reaction over most of my upper arm, which is still present (although not as red) after five days. Mild itching remains.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Rash generalised, Rash vesicular
Clinical narrative: Patient called the pharmacy and complained about rash and blisters like chickenpox all over her body on 2/19/2018. She was wondering if it is normal reaction from SHINGRIX that she was given on 1/23/2018. I recommended her to see her doctor to evaluate the reaction and called the patient on the night for follow-up. According to the patient, her doctor told her that it might not reaction from SHINGRIX. She has been on Methotrexate for psoriasis and stopped it recently. Her doctor drew her blood for lab to be make sure about it and for the second dose of SHINGRIX whether she can receive it or not. I asked her if her doctor prescribed or recommended any medications for the rash like antihistamine and she said he does not and she is doing fine now. I asked her let us know about the blood work result too. She sounds like she is really okay now.
Age: 65.0
Sex: M
Vaccine: TDAP
Symptoms: Biopsy skin, Lichen sclerosus, Scar, Scleroderma, Vaccination site scar
Clinical narrative: Two Doctors, at different locations, and Assistant, diagnosed Lichen Sclerosus  ET Atrophicus. At last appointment, Doctor 2 gave a verbal diagnosis of scleroderma as well. Photo images of scaring (scars) on lower trunk and at vaccination site are available through Assistant who took images when performing biopsies. Pneumonia vaccine in 2008 is only other vaccine I have been given since then! No one in my extended family ever had these diseases.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Approximately ten minutes after administering the VARIVAX vaccine child had a red area around vaccine site. The area was approximately an inch by a half an inch in size. He was watched for 20 minutes. Area was less red and looks like it may bruise. Mom had BENADRYL and 3/4 teaspoon was given.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Vertigo
Clinical narrative: Besides having a sore arm the major problem I'm experiencing is vertigo like. I have this feeling 24x7. It's worse in the mornings and constant all day.
Age: 48.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Mass
Clinical narrative: Almost immediately a lump occurred. Nurse notified.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Injected limb mobility decreased, Peripheral swelling, Skin warm, Swelling
Clinical narrative: Had redness, swelling and increased warmth within 2-3 hrs after shot and had difficulty moving and lifting left arm over next 2-3 days. Right arm has some redness and swelling after injection but resolved. Guardian just told us of event on 1-30-19 prior to giving booster vaccines.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, PPV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a health professional refers to a 12 month old (also reported as less than 1 year old) female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 first dose, lot # N019348, expiration date 08-FEB-2019, in the left vastus, intramuscularly (dose was not reported) for prophylaxis. On the same day, the patient was concomitantly vaccinated with FLUZONE, M-M-R II, VARIVAX and VAQTA. The patient received PNEUMOVAX 23 instead of Pneumococcal conjugate vaccine (PCVB). The patient was called back to office for observation. No adverse event was observed, however the outcome of adverse event was also reported as recovered.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (lot #N021583 and expiration date: 18-NOV-2019). On 01-NOV-2017 or 21-NOV-2017 the patient was vaccinated with unspecified doses of improperly stored VARIVAX (dose, units, frequency and route not reported) (lot # N019133, expiration date: 22-JUN-2019 or lot # N017700, expiration date: 09-JUN-2019). Reporter informed that, there was multiple temperature excursions for the VARIVAX as follows, on 03-NOV-2017, temperature excursion was at 14.40 F for the duration of 1 hour, on 06-NOV-2017, temperature excursion was at 15.60 F for the duration of 1.5 hours, on 07-NOV-2017, temperature excursion was at 19.20 F for the duration of 1 hour, on 13-NOV-2017, temperature excursion was at 20.50 F for the duration of 1 hour, on 15-NOV-2017, temperature excursion was at 13.90 F for the duration of 1 hour, on 16-NOV-2017, temperature excursion was at 15.40 F for the duration of 2 hours, on 20-NOV-2017, temperature excursion was at 19.90 F for the duration of 1 hour, on 27-NOV-2017, temperature excursion was at 5.60 F for the duration of 1 hour, on 28-OCT-2017, temperature excursion was at 6 F for the duration of 1 hour, on 29-OCT-2017, temperature excursion was at 16.50 F for the duration of 1 hour and on 30-OCT-2017, temperature excursion was at 6 F for the duration of 1 hour. It was reported that there was multiple previous excursions for the VARIVAX. Reporter did not state that sterile diluent was improperly stored. No adverse effects (no adverse event) reported. No product quality Complaint was involved. No further information was provided. Sender's Comments: US-009507513-1802USA003097: US-009507513-1802USA005088: US-009507513-1802USA005084: US-009507513-1802USA005087: US-009507513-1802USA005086: US-009507513-1802USA005085: US-009507513-1802USA005090: US-009507513-1802USA007559.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This non-valid spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 05-JUN-2017 or 08-JUL-2017 or 22-JUL-2017, patient was vaccinated with improperly stored GARDASIL 9 (dose, units, frequency and route not reported) (lot# k08421 and expiration date: 12-SEP-2018). Reporter informed that, there were multiple temperature excursions for the with GARDASIL 9 as follows. On 01-JUN-2017, temperature excursion was at 32.00 degree Celsius (C) for 6 hours, on 14-JUN-2017, temperature excursion was at 33.00 C for 2 hours, on 22-JUN-2017, temperature excursion was at 28.00 C for 8 hours, on 07-JUL-2017, temperature excursion was at 32.00 C for 6 hours and on 18-JUL-2017, temperature excursion was at 31.00 C for 0.5 hours. On 02-AUG-2017 or 18-AUG-2017, patient was vaccinated with improperly stored PROQUAD (dose, units, frequency and route not reported) (lot# N55860 and expiration date: 02-MAR-2018). Reporter informed that, there were multiple temperature excursions for PROQUAD as follows. On 05-JUL-2017, temperature excursion was at 36.00 C for 12 hours, on 18-JUL-2017, temperature excursion was at 46.00 C for 5 hours and on 29-JUL-2017, temperature excursion was at 42.00 C for 1.5 hours. No product quality compliant was involved. Sender's Comments: US-009507513-1802USA005084: US-009507513-1802USA005085: US-009507513-1802USA005090: US-009507513-1802USA005086: US-009507513-1802USA005087: US-009507513-1802USA005088: US-009507513-1802USA005089: US-009507513-1802USA003097: US-009507513-1802USA005089: US-009507513-1802USA005085: US-009507513-1802USA005086: US-009507513-1802USA005087.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 16-FEB-2018, the patient was vaccinated with the third dose of improperly stored PEDVAXHIB 1 DF, lot # N024569 with expiration date 07-FEB-2020, for prophylaxis (route of administration was not provided). It was reported that the vaccine was exposed to a temperature of 52 Fahrenheit degrees for 2 hours and 56 minutes. No adverse effects were reported. No previous temperature excursion was reported. A digital data logger was involved.
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Vomiting
Clinical narrative: On this date I had 2 immunizations, one in each arm: SHINGRIX 50mcg (Zoster vaccine recombinant A) and FLUZONE HD PR 17-18 (influenza virus vac split H). 24 hrs of chills, vomiting, body aches, and headaches. On 1/27/2018 I went to pharmacy to have a flu vaccination. On the form I was asked to check the vaccine I was going to received and I asked about the new (I was told improved shingles vaccine) and whether I could have that at the same time as the flu shot. The pharmacist said that I could. A few hours later, I started to get chills, achiness, nausea and vomiting. 24 hours later I started to feel a little better. I'm hesitant to have the second shingles shot for fear that it will produce similar symptoms.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose normal, Fall, Syncope
Clinical narrative: Client received flu vaccine and then sat in chair while she watched her younger sister, father and mother get their flu shots. Younger sister had a syncope episode while watching mother receive her flu shot. While taking care of younger sister patient fell off chair onto floor with while having vasovagal syncope. Patient was carried to another client room and placed on a client bed. Syncope episode less than 1 minute and then client was awake and oriented. Ammonia pearl inhalant used. She continued to lie down for another 20 minutes. Client walked independently out of client with family. Pediatrician, Dr. called and informed of episode.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Employee received vaccine on Friday and by Sunday she said she had welts on scalp and ears.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Patient's entire top 1/2 of arm swelled up and was extremely tender and painful from 2/18 until the morning of 2/20.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: About 5 days after receiving PREVNAR 13, patient experienced rash, swelling, redness, itching and pain at site.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient's arm is sore when raised in a certain position or putting her arm back while putting on clothes.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 30 year old patient of an unknown gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL 9 (dose, units, frequency and route not reported) (lot # and expiration date not reported). On an unspecified date, it was reported that, patient received second dose of GARDASIL 9 at an unspecified location (inappropriate dose of vaccine administered). No adverse effects were reported and no additional information was provided. No product quality complaint was involved.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 1 year old patient. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On 15-FEB-2018, the patient was vaccinated with two doses of VARIVAX (dosing details, lot # and expiry date unknown) for prophylaxis. No known adverse effects reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a consumer regarding a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date at an unspecified time, the patient was vaccinated with PNEUMOVAX 23 injection (lot#, expiry date and dosage details not reported) for prophylaxis. On an unknown date, the patient was in "rehab" (adverse event). The type of rehabilitation or need for rehabilitation could not be confirmed. The outcome of the event was unknown. The reporter had questions about the need for re-vaccination with PNEUMOVAX 23. The reporter did not provide any causality assessment. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: TTOX
Symptoms: Anaphylactic reaction
Clinical narrative: Initial unsolicited report received from a healthcare professional (PAC) via other company (pfizer) (under manufacturer report number:2017520126) on 08-Feb-2018. This case involves a female patient of unknown age, who was vaccinated with a dose of TETANUS TOXOID (TETANUS VACCINES) (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Medical history included clindamycin allergy- Ruptured blood vessel to Clindamycin, amotrigine allergy- Tremors. On an unknown date, following the vaccination, patient had anaphylaxis. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event, anaphylaxis. List of documents held by sender: none; Sender's Comments: Patient developed Anaphylaxis after vaccination. Time to onset is unknown. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), allergic history, previous similar episodes as well as allergy testing to identify the culprit allergen are needed to further assess this case. Based on the information available, a role of the vaccine cannot be assessed.
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Wrong drug administered
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a male patient who received BOOSTRIX (batch number TB2R2, expiry date 2nd December 2019). On 6th February 2018, the patient received BOOSTRIX. On 6th February 2018, unknown after receiving BOOSTRIX, the patient experienced wrong vaccine administered. In February 2018, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm and wrong vaccine administered were unknown. It was unknown if the reporter considered the pain in arm to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. According to pharmacist, the patient's wife believed that she did not receive the BOOSTRIX vaccine on 6th February 2018. On that day her husband (patient) received PNEUMOVAX and she received BOOSTRIX, according to pharmacist. However, the patient's arm hurt afterward and hers did not, and this males the wife believe the vaccines were switched. Thus, the patient received BOOSTRIX instead of PNEUMOVAX, which led to wrong vaccine administered. On February 2018, less than a week after receiving BOOSTRIX, the patient experienced pain in arm. The patient did not receive any GSK vaccine as per pharmacist. The wife wanted to receive another dose of BOOSTRIX but had not yet received it.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Discomfort, Hypoaesthesia, Injection site joint pain, Injection site pain
Clinical narrative: Within 15-20 min left arm, side of face, left leg numb. Of course site (left) discomfort. Numbness gone by next morning. Site pain which has continued - still feels sore as when received shot, shoulder pain-joint can still feel where needle went in.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Dyspnoea, Headache, Malaise, Pruritus
Clinical narrative: Bad itching, bad rash, hard time breathing, coughing, can hardly talk, fever, headaches, still not well!
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Speech disorder
Clinical narrative: Bad itching, bad rash, hard time breathing, coughing, can hardly talk, fever, headaches, still not well!
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a 21-year-old female patient who received BEXSERO. On 10th February 2018, the patient received the 2nd dose of BEXSERO. On 10th February 2018, less than a day after receiving BEXSERO, the patient experienced injection site pain. On 14th February 2018, the patient experienced fever. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the fever was unknown. The reporter considered the injection site pain to be related to BEXSERO. It was unknown if the reporter considered the fever to be related to BEXSERO. Additional details were provided as follows: Four days after receiving vaccination, the patient's body temperature was recorded as 101.8 degree. The university had an outbreak of meningitis B and each student was required to have the vaccine. The patient experienced soreness at the injection site and was getting better when she went to the doctor on the 14th February 2018. This was all of the information that could be provided.
Age: 49.0
Sex: F
Vaccine: HEPA
Symptoms: Dysgeusia, Muscle tightness, Musculoskeletal stiffness, Paraesthesia, Paraesthesia oral
Clinical narrative: Within 5 minutes of receiving HAVRIX vaccine, pt noticed a "funny taste" in her mouth along with a tingling sensation in both arms and upper lip. Pt also reported that her shoulders and neck felt stiff. Pt given an ice pack to apply on her shoulders and neck to alleviate the tension. Pt monitored for 30 minutes and reported that she felt better. The taste in her mouth dissipated after 15 minutes. Pt advised to watch for SOB, wheezing, bronchospasms, lip and throat swelling.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Diet refusal, Injection site erythema, Injection site swelling, Vomiting projectile
Clinical narrative: My son got his 2 month shots at 10:30ish and around 2 hours later he projectile vomited his whole bottle that he ate after his shots were received. Ever since then he has projectile vomited every bottle and it is now 1 pm the next day. And he's refusing a bottle.  Also in his right leg where he got one shot is very red and has a bump the size of a quarter. He has no fever. I'm scared he's going to become dehydrated. His doctor said that him puking isn't from the vaccines but I know they are.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Irritability, Pyrexia, Rash erythematous, Teething
Clinical narrative: Mom reports child woke up with red spots the morning of 02-20-2018. Reports child has a few red spots on her forehead, around her neck, back and tummy area. Mom reports red spots ranging in size from the tip of a pen to a pencil eraser. Spots are raised, not fluid filled. Denies child scratching at these areas. Mom reports on 02-17-2018 child ran a low grad fever of 99.0 F and was winy all day. Reports child is eating good, having good wet diapers, regular bowel movements and sleeping normally. Mom reports child is also teething, giving TYLENOL as needed.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered
Clinical narrative: Patient received two doses of HIB. One from the PENTACEL and one from PEDVAXHIB. PENTACEL was given in right thigh, and PEDVAXHIB was given in left thigh.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13
Symptoms: Rash
Clinical narrative: When the caregiver arrived at my clinic on 1/4/2018 I administered vaccines to his child. Immediately after administering the recommended vaccinations, he informed me that he remembered that the previous time the patient had received vaccinations (7/13/2017), that patient had a rash at home in the evening and the patient had the rash for "a while". I asked further how long and he stated less than a month. It didn't seem like the rash bothered the patient and that is why he did not take him to be evaluated. I informed him of the signs and symptoms applicable to bringing a child for further evaluation and he verbalized understanding. I also explained that the next time he has a rash, or any symptom, to bring the patient in for evaluation at a providers office, and if it is non-urgent, to an urgent care. But that if he feels it is an emergency situation, or the child is having visible breathing difficulty, to take him to the emergency room or call 911. I also informed him that if anything happened to the client after today's vaccinations, to give us a call to inform be so I can complete another report and follow-up. Finally I stated that he needed to stay in the clinic for 30 minutes so I could observe the patient further. Caregiver verbalized understanding.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Headache, Pruritus, Rash, Rash macular, Urticaria
Clinical narrative: Started with some itchiness around 7 PM. When arrived home and took clothes off, noticed red blotchy areas on arms, torso, legs, and stomach. Took some BENADRYL with some relief, but after the BENADRYL wears off, symptoms return. Also had a headache that was relieved with GOODY'S powder and rest. Still with complaints of itchiness and hives that comes and goes on 2/20/18.
Age: 11.0
Sex: F
Vaccine: IPV, MNQ, TD
Symptoms: Eye movement disorder, Loss of consciousness, Pallor
Clinical narrative: Patient passed out face first into the chest and arms of her father which then I assisted her down on the floor and yelled out for help to the other clinicians. She lost color and her eyes rolled up and to the back of her head. Head was placed on a pillow and legs elevated on a chair and ice packs were applied to back of head and forehead. Orange juice was given to the patient. Patient was helped off the floor into a nearby chair once symptoms subsided.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Skin warm
Clinical narrative: Pt said she experienced body aches, fever, and chills the evening after she received the shot. She said that her arm was warm to the touch but no redness in the area. She said that the symptoms persisted until Sunday 2/18/2018 evening.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Burning sensation, Feeling hot, Peripheral swelling
Clinical narrative: Patient states that she felt very hot and arm was burning. She said that her arm got swollen to the size of a grapefruit.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of PREVNAR 13 (lot number and expiration date: unknown) intramuscular in the left deltoid on 08Feb2018 12:30 at a single dose for immunization (doctor suggested this because of her age). The patient medical history was not reported. The patient stated that she has some medical conditions, but nothing she feels is relevant and declined to provide more details. There were no concomitant medications. No vaccines were administered in the last 4 weeks. The patient previously received a tetanus vaccine shot and was allergic to tetanus. It was reported that when she was 3 years old she had a reaction to what her mother thought was a tetanus shot and she had to be hospitalized (she thinks it was a DTP vaccine). The patient received a shot on Thursday, 08Feb2018, she had a horrific experience with it. She couldn't move her left arm for 3 days and she was all swollen. She broke out in a rash from shoulder to elbow and around her arm. She took pictures of it. It was extremely painful. It was also itchy where she received the injection. She talked to her doctor and he told her to go to the emergency room. She didn't want to so she talked to a nurse and talked to their doctor line. They gave her some good advice and she had to take it easy over the weekend. On 11Feb2018, she had a knot in her left arm where she received the shot. On an unspecified date, it still hurt when she moves her arm. The swelling had gone down, but the pain and the knot in her shoulder had not. The events did not require a visit to the emergency room or physician office. She did not want to go to the doctor's office because they were going to charge her for it and she felt it was all their fault. She asked if the delivery system of this shot is a diphtheria serum because she read that it is. She has had it on her medical chart since she was 3 years old that she is allergic to tetanus. She asked if this was the same shot and if PREVNAR 13 has diphtheria in it. She was very upset with her doctor because they have known about her allergies all along. She stated that this was her first time ever receiving the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) vaccine. She had one in October that was the first vaccine of the series, but it had a different name and she could not remember the name of it. She did not have a reaction to that vaccine. Outcome of could not move her left arm was resolved with sequelae; the patient had recovered with lasting effects from not being able to move her arm. The event of left arm swollen was resolved on 13Feb2018. It still hurts when she moves her arm and she has a knot in her arm at the injection site. The itchiness described by the caller was persisting, but it comes and goes. The knot in her left arm, itchy where she received the injection and still hurts when she moves her arm were not recovered while the rash was recovering. The patient denied any medical testing. Information on batch and lot number has been requested.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Angiogram, Computerised tomogram, Headache, Laboratory test, Lumbar puncture
Clinical narrative: I ended up with meningitis, spent time in the hospital. Was out of work for 8 weeks. Traveled to a specialist. I had a horrible headache the entire time. Had to be taken off of all my medications completely.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Meningitis, Nuclear magnetic resonance imaging
Clinical narrative: I ended up with meningitis, spent time in the hospital. Was out of work for 8 weeks. Traveled to a specialist. I had a horrible headache the entire time. Had to be taken off of all my medications completely.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Contusion, Erythema, Induration, Influenza like illness
Clinical narrative: 02/20/18 and 2:13P spk w/pt she states shortly after inj. she felt like her arm was had like a rock, very painful, and itchy. The next day down to her elbow was painful, bruised, and some redness. That night she got flu like symptoms, fever, chills, felt like muscle damage. She didn't go to hospital or an urgent care to be evaluated. Now 7 days post inj. she is better, bruising is turning yellow, mild soreness. I offered her an appointment however she refused. I did inform pt she might not want to get another PCV 23 vaccine, and that we would be sending a report to VAERS. Pt states she understands and didn't have any further questions. Under signature: Signed by Medical Assistant on 2/20/2018 2:37:11 PM.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Muscle injury, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: 02/20/18 and 2:13P spk w/pt she states shortly after inj. she felt like her arm was had like a rock, very painful, and itchy. The next day down to her elbow was painful, bruised, and some redness. That night she got flu like symptoms, fever, chills, felt like muscle damage. She didn't go to hospital or an urgent care to be evaluated. Now 7 days post inj. she is better, bruising is turning yellow, mild soreness. I offered her an appointment however she refused. I did inform pt she might not want to get another PCV 23 vaccine, and that we would be sending a report to VAERS. Pt states she understands and didn't have any further questions. Under signature: Signed by Medical Assistant on 2/20/2018 2:37:11 PM.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Painful, swollen, red and hard at injection site, becoming worse each day following. Area of erythema and warmth on 2/16/18 measures 10 cm by 8 cm posterior aspect left upper arm; Hardened and raised area measuring 6 cm by 8 cm noted in the area with erythema.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Adverse event began on 02/18/2018. Right posterior arm reported over the phone to be red and itchy. Worse the following day on 2/19/18 and worse and larger area of redness on 2/20/18.  Advised to seek medical attention at an Urgent Care.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: PATIENT DEVELOPED SHINGLES RASH FEW DAYS LATER. HE HAS SEEN MD AND RECEIVED ANTI VIRAL MEDICATION.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Musculoskeletal chest pain
Clinical narrative: PATIENT DEVELOPED SHINGLES RASH FEW DAYS LATER. HE HAS SEEN MD AND RECEIVED ANTI VIRAL MEDICATION.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Incomplete course of vaccination, Tenderness
Clinical narrative: PATIENT DEVELOPED SHINGLES RASH FEW DAYS LATER. HE HAS SEEN MD AND RECEIVED ANTI VIRAL MEDICATION.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, C-reactive protein abnormal, Inflammation, Injection site pain, Joint stiffness
Clinical narrative: Soreness at injection site continues as of 2/20/18. Extreme pain in each shoulder requiring 2 ER visits to Hospital. Swelling of hands, feet, joint pain and stiffness. Inflammation numbers very high. No previous symptoms prior to the shot. Inflammation, pain and stiffness continues.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Laboratory test abnormal, Musculoskeletal pain, Peripheral swelling, Rheumatoid factor
Clinical narrative: Soreness at injection site continues as of 2/20/18. Extreme pain in each shoulder requiring 2 ER visits to Hospital. Swelling of hands, feet, joint pain and stiffness. Inflammation numbers very high. No previous symptoms prior to the shot. Inflammation, pain and stiffness continues.
Age: 39.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: C-reactive protein, Drug trough level, Full blood count, Injection site cellulitis, Metabolic function test
Clinical narrative: Patient was seen and treated in ER for bi-lateral upper arm cellulitis, requiring IV vancomycin over a course of 8 hours for 3 days.
Age: 39.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: X-ray limb
Clinical narrative: Patient was seen and treated in ER for bi-lateral upper arm cellulitis, requiring IV vancomycin over a course of 8 hours for 3 days.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Hypertension, Peripheral swelling
Clinical narrative: Woke up day after receiving vaccine, felt dizzy, had high blood pressure, later in the day and the day after patient noticed swelling in arm.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Patient experienced a headache starting 02/11/18 and continuing intermittently to the present 02/20/18. Acetaminophen has helped to relieve the pain.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea
Clinical narrative: Pt requested vaccine, received counseling and review of VIS, and was vaccinated IM with first dose of SHINGRIX. Counseled to stay in waiting room for 15-20 minutes following vaccination, but patient left to shop. She returned in ten minutes to report she felt "out of breath". Pt evaluated and pharmacist found no symptoms of respiratory distress (BP 138/82, 68 bpm, and 14 respirations).  Pt had excellent color and negative for respiratory exertion. Pt has history of anxiety and stated this type of reaction often occurs when she tries new medication. She improved to baseline with observation and in an isolated, quiet environment (in counseling room). Pharmacist followed up with her later in the afternoon (4 pm) and she stated she was fine.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Blood glucose, Cold sweat, Dizziness, Fall, Head injury
Clinical narrative: After the immunization he sat there for about 2 minutes then he got up and came to the register. He had syncope fainted and fell down hitting his head on the floor. He immediately regained consciousness but was pale and clammy. He had a bump on the back of his head and he was very dizzy and nauseated and vomited several times. We called the EMS and they checked his vitals and blood sugar. His mother drove him to the ER.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of consciousness, Nausea, Pallor, Syncope, Vomiting
Clinical narrative: After the immunization he sat there for about 2 minutes then he got up and came to the register. He had syncope fainted and fell down hitting his head on the floor. He immediately regained consciousness but was pale and clammy. He had a bump on the back of his head and he was very dizzy and nauseated and vomited several times. We called the EMS and they checked his vitals and blood sugar. His mother drove him to the ER.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site streaking, Injection site swelling, Injection site warmth
Clinical narrative: Patient said that the night of the shot it was a little swollen and hot to the touch. It hurt to lay on it. On the 13th, he called me back and reported having striations up and down his arm around the spot where he got his shot and said that it hurt really bad. He was going to take a ZYRTEC and try and get ice on it. On the 15th, I spoke with him and he said that he had called his doctor on the 14th. He said that the swelling had gone down and the pain was much better after sleeping for several hours, but he was still taking ZYRTEC.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Muscle spasms
Clinical narrative: She received flu vaccine 3 weeks ago. Immediately after injxn she felt tingling in her L fingers and turned pale. The pallor resolved after drinking water. The tingling improved. However, that night her L back started having spasms requiring ibuprofen and ice. She had low energy and extreme nausea for a few days. Arm was hurting "like a normal flu shot." Since then, tingling returned and has been waxing and waning. The tingling involves all 5 fingers in their entirety. She never had fever. Since the injxn she's had difficulty moving L shoulder and it feels it's worsening. The pain in shoulder is so severe. The pain wakes her at night if she sleeps on L side. She's exhausted. She believes strongly she had chemical reaction to the vaccine.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Pallor, Paraesthesia, Sleep disorder
Clinical narrative: She received flu vaccine 3 weeks ago. Immediately after injxn she felt tingling in her L fingers and turned pale. The pallor resolved after drinking water. The tingling improved. However, that night her L back started having spasms requiring ibuprofen and ice. She had low energy and extreme nausea for a few days. Arm was hurting "like a normal flu shot." Since then, tingling returned and has been waxing and waning. The tingling involves all 5 fingers in their entirety. She never had fever. Since the injxn she's had difficulty moving L shoulder and it feels it's worsening. The pain in shoulder is so severe. The pain wakes her at night if she sleeps on L side. She's exhausted. She believes strongly she had chemical reaction to the vaccine.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: On 2/14/18 Received Tdap and MENACTRA in left deltoid after discussing with guardian and informed of no history of previous reactions to vaccines. 2/15/18 school Nurse called and said had small area of redness and swelling - F/U calls 2/16 and 2/20. 2/20/18 (L) arm swelling and redness resolved and now normal.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Crying, Gait disturbance, Injection site erythema, Injection site movement impairment, Injection site reaction
Clinical narrative: On 2/20 woke up in middle of night crying in pain, would not move or ambulate on (L) thigh where immunizations given. Father gave APAP for pain. (L) leg/upper thigh visibly swollen, mild erythema at injection site, and muscle hardness at site today (2/20/18) at 1100 on exam. Will go ice and MOTRIN to help with swelling.