chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: RAB
Symptoms: Asthenia, Fatigue, Tremor
Clinical narrative: Initial unsolicited report received from a consumer on 17-Aug-2017. This case involves 38-year-old male patient who was vaccinated with a first, second, third and fourth dose of IMOVAX (batch number unknown by reporter) for bat exposure in shoulder area via intramuscular route on 21-Jul-2017, 24-Jul-2017, 28-Jul-2017, and 04-Aug-2017 respectively. Illness at time of vaccination reported as bat exposure. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) denied by the patient. The patient received concomitant vaccine as first dose of HUMAN RABIES IMMUNOGLOBULIN (HRIG) (batch number unknown) in thigh and deltoid on 21-Jul-2017. On 11-Aug-2017, 21 days following the vaccination, the patient developed fatigue weakness, shakiness in fingers and toes 7 days post the last dose of rabies vaccine. The patient's laboratory data and corrective treatment were not reported. The events outcome was unknown. List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial unsolicited case received from a health care professional (medical assistant) on 17 Aug 2017. This case is linked with 2017SA152887 same reporter. This case involves a four months old male patient, who was vaccinated with first dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) date of Aug-2017 (on 11-Aug-2017 one patient or 14-Aug-2017 ). The patient also received a dose of VARICELLA VACCINE (LIVE) (VARICELLA), and a dose of MEASLES, MUMPS AND RUBELLA VACCINE (MMR) (Batch number, expiry date not reported, dose in series unknown, site of administration not reported) both vaccines were administered via intramuscular route on an unknown date. The patient had no illness at the time of vaccination, and pre-existing physician diagnosed allergies, birth defects, medical conditions were not provided. Concomitant medications were not reported, and any other vaccinations within 4 weeks of vaccinations was unknown. On an unknown date, following the vaccinations, the patient developed redness and swelling at the injection site. The patient was seen in the emergency room. No relevant laboratory examinations were performed. As a corrective treatment the patient was encouraged to do warm soaks and diphenhydramine hydrochloride (Benadryl). The outcome of the event was unknown. List of documents held by sender: none.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Muscle tightness, Muscular weakness
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) via a practice Manager on 18-Aug-2017. This case involves a 41-year-old female patient who was vaccinated with a dose of ADACEL (Batch number: U5748AA, expiration date: 23-Aug-2019, dose and dose in seires were not reported) intramuscularly in the left deltoid on 09-Aug-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) reported that the patient had celiac disease and thyroid issues. The patient did not have any illness at the time of vaccination. Concomitant medications were not reported. On an unknown date in Aug-2017, a few days after vaccination, the patient developed swelling of the injection site on the left deltoid, experienced muscle weakness in the left arm and a tightness in the left side of her neck. The patient required emergency room (ER)/ doctor visit. Laboratory investigations were reported as none. Corrective treatment was not reported. On an unknown date, the patient was recovered from all the events. List of documents held by sender: none.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, RV1
Symptoms: Eye movement disorder, Nuclear magnetic resonance imaging, Nystagmus, Ophthalmological examination normal, Tremor
Clinical narrative: Five days after her vaccinations her eyes started to roll under and shake up and down. I thought she was having seizures but they diagnosed her as having Nystagmus. I want to add that she had an eye exam the same day that she received the vaccinations and doctor said her eyes looked great.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Blood electrolytes, Chills, Depressed level of consciousness, Diplopia, Electrocardiogram
Clinical narrative: After vaccine had a "hot flash" but went away, same evening of injection at 6 pm felt general malaise went to bed early, woke up next day very ill, woke up to go to the bathroom and almost passed out, severe vertigo, nausea, double vision, headache, chills and lower leg muscle twitching that would not subside, taken to ER that am, received 1 liter of fluids and medication for vertigo, multiple labs and EKG done, DX serum sickness. It lasted total of 10 days, a few days after ER, returned to ER as I developed what was dx as local reaction in addition to the systemic one right trapezius inflammation that tracked to right side of neck with pocket of edema, I had some intermit left sided mainly, paresthesia legs arm and facial may have been due to migraine that was triggered. I am an RN and was deeply concerned over my hypersensitivity reaction to this injection. Very scary!! I am not happy about it nor the medical bills that have resulted.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count, Haematocrit, Haemoglobin, Headache, Hot flush
Clinical narrative: After vaccine had a "hot flash" but went away, same evening of injection at 6 pm felt general malaise went to bed early, woke up next day very ill, woke up to go to the bathroom and almost passed out, severe vertigo, nausea, double vision, headache, chills and lower leg muscle twitching that would not subside, taken to ER that am, received 1 liter of fluids and medication for vertigo, multiple labs and EKG done, DX serum sickness. It lasted total of 10 days, a few days after ER, returned to ER as I developed what was dx as local reaction in addition to the systemic one right trapezius inflammation that tracked to right side of neck with pocket of edema, I had some intermit left sided mainly, paresthesia legs arm and facial may have been due to migraine that was triggered. I am an RN and was deeply concerned over my hypersensitivity reaction to this injection. Very scary!! I am not happy about it nor the medical bills that have resulted.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Inflammation, Laboratory test, Liver function test, Local reaction
Clinical narrative: After vaccine had a "hot flash" but went away, same evening of injection at 6 pm felt general malaise went to bed early, woke up next day very ill, woke up to go to the bathroom and almost passed out, severe vertigo, nausea, double vision, headache, chills and lower leg muscle twitching that would not subside, taken to ER that am, received 1 liter of fluids and medication for vertigo, multiple labs and EKG done, DX serum sickness. It lasted total of 10 days, a few days after ER, returned to ER as I developed what was dx as local reaction in addition to the systemic one right trapezius inflammation that tracked to right side of neck with pocket of edema, I had some intermit left sided mainly, paresthesia legs arm and facial may have been due to migraine that was triggered. I am an RN and was deeply concerned over my hypersensitivity reaction to this injection. Very scary!! I am not happy about it nor the medical bills that have resulted.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Migraine, Muscle twitching, Myocardial necrosis marker, Nausea
Clinical narrative: After vaccine had a "hot flash" but went away, same evening of injection at 6 pm felt general malaise went to bed early, woke up next day very ill, woke up to go to the bathroom and almost passed out, severe vertigo, nausea, double vision, headache, chills and lower leg muscle twitching that would not subside, taken to ER that am, received 1 liter of fluids and medication for vertigo, multiple labs and EKG done, DX serum sickness. It lasted total of 10 days, a few days after ER, returned to ER as I developed what was dx as local reaction in addition to the systemic one right trapezius inflammation that tracked to right side of neck with pocket of edema, I had some intermit left sided mainly, paresthesia legs arm and facial may have been due to migraine that was triggered. I am an RN and was deeply concerned over my hypersensitivity reaction to this injection. Very scary!! I am not happy about it nor the medical bills that have resulted.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema, Paraesthesia, Serum sickness, Vertigo
Clinical narrative: After vaccine had a "hot flash" but went away, same evening of injection at 6 pm felt general malaise went to bed early, woke up next day very ill, woke up to go to the bathroom and almost passed out, severe vertigo, nausea, double vision, headache, chills and lower leg muscle twitching that would not subside, taken to ER that am, received 1 liter of fluids and medication for vertigo, multiple labs and EKG done, DX serum sickness. It lasted total of 10 days, a few days after ER, returned to ER as I developed what was dx as local reaction in addition to the systemic one right trapezius inflammation that tracked to right side of neck with pocket of edema, I had some intermit left sided mainly, paresthesia legs arm and facial may have been due to migraine that was triggered. I am an RN and was deeply concerned over my hypersensitivity reaction to this injection. Very scary!! I am not happy about it nor the medical bills that have resulted.
Age: 21.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Patient was given MMR and Varicella on the 28th of Aug 2017 came in the 29th of Aug 2017 with the.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Screaming, Urticaria
Clinical narrative: Full body hives. The hives would pop up, after a few minutes they would go away and return in other locations. He had these on face, neck, arms, legs, trunk and feet. He also screamed continuously for 2.5 hours. I was instructed to give antihistamine which helped. The hives persisted for 1 week. Then went away.
Age: 67.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Diarrhoea
Clinical narrative: Had diarrhea from 8/16/2017-8/21/2017.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Hyperhidrosis, Pallor, Presyncope
Clinical narrative: Received four vaccines, almost fainted. Pale, diaphoretic.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Dysarthria, Electrocardiogram normal, Hypoaesthesia, Metabolic function test normal
Clinical narrative: Within 5 minutes of giving the vaccine, patient presented with feeling dizzy, numbness, slurred speech, skin rash on chest and wheezing. He was sent to ER by EMS. In route was given BENADRYL. Per mother's information within about 40 minutes of being in the hospital was back to normal. In the hospital he was observed for about 6 hours.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Rash, Wheezing
Clinical narrative: Within 5 minutes of giving the vaccine, patient presented with feeling dizzy, numbness, slurred speech, skin rash on chest and wheezing. He was sent to ER by EMS. In route was given BENADRYL. Per mother's information within about 40 minutes of being in the hospital was back to normal. In the hospital he was observed for about 6 hours.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Cellulitis-like redness and swelling and pain from site of injection to elbow joint lasting 2 days and starting to abate on the third day.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Rash
Clinical narrative: Cellulitis-like redness and swelling and pain from site of injection to elbow joint lasting 2 days and starting to abate on the third day.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to patients of unknown age. In 2017 the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M040412 for prophylaxis. On 01-JAN-2017 the patients experienced incorrect product storage. No adverse event. Sender's Comments: US-009507513-1708USA011304: US-009507513-1708USA011305.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Polymerase chain reaction positive, Rash, Scab, Varicella virus test positive
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 months old female patient. There was no medical history and drug allergies. On 06-MAR-2017 the patient was vaccinated with VARIVAX (lot # M037008, Expiry date : 25-AUG-2018) 0.5 ml, subcutaneously in the right upper thigh for prophylaxis. Concomitant therapies included desonide, probiotics (unspecified), TYLENOL and MOTRIN. On 09-AUG-2017, the patient developed a "significant crusty rash on the left side of her back, her left arm and the left side of her chest". On 15-AUG-2017, the patient saw her unspecified "family doctor" due to the rash. The unspecified "family doctor" prescribed Acyclovir (manufacturer unspecified) as treatment on the same day. The nurse stated the "family doctor" also performed a "varicella/zoster PCR" which came back as "positive for shingles" on 17-AUG-2017. Nurse specifically requested to send samples for testing. On 23-AUG-2017, Varicella Zoster Virus Identification Program (VZVIP) polymerase chain reaction (PCR Results) - VACCINE STRAIN. At the reporting time, the outcome of rash and herpes zoster was reported as recovering/resolving. The reporting physician did not provide the causality assessment for the events.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX lot # M038350 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to an unknown number of patients of an unknown age. On unknown dates in 2017 (reported as starting on or after 11-MAY-2017), the patients were vaccinated with GARDASIL 9 for prophylaxis. On unknown dates, the patients experienced incorrect product storage. No adverse effect was reported. The outcome of incorrect product storage was unknown. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1708USA011804: US-009507513-1708USA011803:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. On 24-AUG-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # N012489, expiration date 17-OCT-2018 (dose, route of administration and anatomical location were not reported) for prophylaxis. No adverse events were reported. Sender's Comments: US-009507513-1708USA011793.
Age: 53.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to an unknown number of patients of unknown age. On unknown dates in 2017 (reported as starting on or after 11-MAY-2017), the patients were vaccinated with PNEUMOVAX 23 for prophylaxis. On unknown dates, the patients experienced incorrect product storage. No adverse effect was reported. The outcome of incorrect product storage was unknown. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1708USA011654: US-009507513-1708USA011804:
Age: 57.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to an unknown number of patients of unknown age. On unknown dates in 2017 (reported as starting on or after 11-MAY-2017), the patients were vaccinated with RECOMBIVAX HB for prophylaxis. On unknown dates, the patients experienced incorrect product storage. No adverse effect was reported. The outcome of incorrect product storage was unknown. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1708USA011803: US-009507513-1708USA011654:
Sex: M
Vaccine: PNC13
Symptoms: Condition aggravated, Hypertension, Rash generalised, Urticaria
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 68-year-old male patient received PREVNAR 13, via an unspecified route of administration in Aug2017 at 0.5ml single dose for immunisation. The patient also started apixaban (Eliquis) at the same time at unknown dose for an unspecified indication. Medical history included atrial fibrillation and hypertension from an unknown date and unknown if ongoing. The patient broke out in hives or a rash all over his body in Aug2017. The doctors thought it was the apixaban causing the rash, so they discontinued the apixaban and started him on warfarin. He was also treated with steroids and the rash slowly went away. Seven or eight days before reporting, the patient broke out in severe hives and rash all over the body again. He was treated with steroids again. The hives and rash are a little better now, but they are not gone. The pharmacist considered the events Medically significant and unrelated to apixaban but related to pneumococcal 13-val conj vac (dipht crm197 protein).; Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of "hives/rash all over his body " cannot be fully excluded considering the known adverse event profile of PREVNAR 13. Co-administration with apixaban may also provide an explanation for the event.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist received from a Pfizer sales representative. A 67-year-old female patient received PREVNAR 13 (NDC number: 00005197102, lot R49357, exp.date 31May2018) at 0.5 ml single dose via intramuscular route in her left arm, on 09Aug2017 18:30. On unknown date the patient also received the first dose of FLUAD (lot 178502, exp.date 01Apr2018) via intramuscular route in the right arm. Relevant medical history was Diabetes. On 09Aug2017 the patient experienced a bump on her arm, painful bump in her arm, her arm was really hurts and her arm is hard to move. The outcome of the events was not recovered.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Rash generalised
Clinical narrative: This is a spontaneous report from a contactable nurse. A 4-month-old female patient received second dose of PREVNAR 13 (lot#: S31241, expiry date: 30Jun2018), via an unspecified route of administration at left thigh on 21Aug2017 at 0.5 ml, single for routine vaccination/immunisation. The patient's medical history was none. The family history included asthma, diabetes and high blood pressure. Concomitant medication included PEDIARIX (lot#: 924Y3, expiry date: 11Aug2019, manufacture: GlaxoSmithKline), ACTHIB (lot#:UI773AA, expiry date: 29May2018, manufacture: Sanofi Pasteur), rotavirus vaccine (lot#: 9JE4H, expiry date: 22Oct2018, manufacture: GlaxoSmithKline), all at unknown dose on 21Aug2017 for immunization. The patient previously took first dose of PREVNAR 13 (lot number: R48402, expiration date: 30Apr2018) in her right vastus lateralis on 19Jun2017 at age of 2 months old for immunization and had no reaction. In the evening of 22Aug2017, the patient developed a fine pinpoint rash from head to toe, including the bottoms of her feet. The patient's parents did not indicate whether or not the rash has gotten any worse since appearing or not. The outcome of the event was unknown.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Dry skin, Rash generalised
Clinical narrative: This is a spontaneous report from a contactable nurse. A 4-month-old female patient received second dose of PREVNAR 13 (lot#: S31241, expiry date: 30Jun2018), via an unspecified route of administration at left thigh on 21Aug2017 at 0.5 ml, single for routine vaccination/immunisation. The patient's medical history was none. The family history included asthma, diabetes and high blood pressure. Concomitant medication included PEDIARIX (lot#: 924Y3, expiry date: 11Aug2019, manufacture: GlaxoSmithKline), ACTHIB (lot#:UI773AA, expiry date: 29May2018, manufacture: Sanofi Pasteur), rotavirus vaccine (lot#: 9JE4H, expiry date: 22Oct2018, manufacture: GlaxoSmithKline), all at unknown dose on 21Aug2017 for immunization. The patient previously took first dose of PREVNAR 13 (lot number: R48402, expiration date: 30Apr2018) in her right vastus lateralis on 19Jun2017 at age of 2 months old for immunization and had no reaction. In the evening of 22Aug2017, the patient developed a fine pinpoint rash from head to toe, including the bottoms of her feet. The patient's parents did not indicate whether or not the rash has gotten any worse since appearing or not. The outcome of the event was unknown.
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain, Rash, Swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer Company representative. A female patient of an unspecified gender and race received the first dose of TRUMENBA at single dose for immunization. Medical history and concomitant medication were unknown. On unknown date the patient experienced a rash, along with redness, pain and swelling. The outcome of the events was unknown.
Age: 11.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Non-viable vaccine d/t temperature excursion too warm.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Hypotonia, Musculoskeletal stiffness, Nausea, Pallor
Clinical narrative: Child was extremely anxious about getting vaccination. Nurse spent 5+ minutes with patient prior to vaccination to try and calm the patient. Patient was informed to stay on exam table for 15 minutes, not to get up, and could lay down if she wanted. Approximately 5 minutes after being given the HPV vaccine, mom came out of the exam room asking for a nurse. Nurse  responded and entered the room to find patient on the floor on her knees in front of the chair she had been sitting in. Patient was awake and pale and was able to get back into the chair with some assistance. Mother reported that patient was sitting in her chair and then her arm went stiff to her side and her neck went limp and began to snore. Second nurse entered with the vitals machine and took patients vitals and pt reported feeling nauseous. Doctor was notified and came to the exam room to find that vital signs were normal and he provided patient with a glass of water. 30 minutes post vaccination pt was assessed again by Doctor. Patient reported that all nausea and dizziness had subsided. Mother reported that child has fainted 3 times prior d/t seeing blood.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Snoring, Syncope
Clinical narrative: Child was extremely anxious about getting vaccination. Nurse spent 5+ minutes with patient prior to vaccination to try and calm the patient. Patient was informed to stay on exam table for 15 minutes, not to get up, and could lay down if she wanted. Approximately 5 minutes after being given the HPV vaccine, mom came out of the exam room asking for a nurse. Nurse  responded and entered the room to find patient on the floor on her knees in front of the chair she had been sitting in. Patient was awake and pale and was able to get back into the chair with some assistance. Mother reported that patient was sitting in her chair and then her arm went stiff to her side and her neck went limp and began to snore. Second nurse entered with the vitals machine and took patients vitals and pt reported feeling nauseous. Doctor was notified and came to the exam room to find that vital signs were normal and he provided patient with a glass of water. 30 minutes post vaccination pt was assessed again by Doctor. Patient reported that all nausea and dizziness had subsided. Mother reported that child has fainted 3 times prior d/t seeing blood.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Eye swelling, Rash generalised, Rash pruritic
Clinical narrative: Pt had vaccinations on 8/24/17. Dad reports that pt developed an itchy rash on entire body on 8/27/17. Did not appear to be like a chickenpox rash. It resolved within 24 hours. No fever. On 8/28/17, child had swollen eyes and some redness on skin under her eyes. The child went out of town on 8/25/17 and returned on 8/28/17. The swelling and redness around eyes have come and gone from 8/28 through today 8/29/17. Dad brought pt in today to report symptoms. He had given pt CLARTIN last night. Denies any fever, malaise or other symptoms. No current rash. Still has mildly swollen eyes. She is smiling, talkative and in no distress. Instructed dad to take child to her pediatrician. He agreed to do so.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Syncopal episode, smelling salts, monitored for 15 min, 120ml water to drink.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Shingles (facial).
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Developmental delay, Pyrexia
Clinical narrative: High fever for up to two days after receiving vaccine, developmental delay soon followed.
Age: 18.0
Sex: F
Vaccine: HPVX, MENB
Symptoms: Arthralgia, Chills, Pain, Pyrexia, Rash
Clinical narrative: Pt received 1st HPV June 23, 2017 - had slight prickly itchy rash on deltoid lasted a few days. Pt received HPV #2 and TRUMENBA #1 8/18/17. On 8/22/17 pt had knee pains and achy. On 8/23/17 pt was moving into college (freshman) and had low grade fevers/chills. Took 400 mg Ibuprofen.
Age: 18.0
Sex: F
Vaccine: HPVX, MENB
Symptoms: Rash pruritic, Swelling face
Clinical narrative: Pt received 1st HPV June 23, 2017 - had slight prickly itchy rash on deltoid lasted a few days. Pt received HPV #2 and TRUMENBA #1 8/18/17. On 8/22/17 pt had knee pains and achy. On 8/23/17 pt was moving into college (freshman) and had low grade fevers/chills. Took 400 mg Ibuprofen.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Pruritus, Urticaria
Clinical narrative: Mother contacted office, patient had itching and hives to extremities. Sent to urgent care, was given script for MEDROL DOSEPAK. Mother contacted for follow up and states did not fill, gave patient children's BENADRYL syrup instead, states hives are resolving on 8/28/17.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site warmth in a 19-year-old female patient who received BEXSERO (batch number 159001A, expiry date 31st March 2018). On 11th August 2017, the patient received the 1st dose of BEXSERO. On 17th August 2017, 6 days after receiving BEXSERO, the patient experienced injection site warmth, erythema and induration. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site warmth, erythema and induration were unknown. The reporter considered the injection site warmth to be related to BEXSERO. It was unknown if the reporter considered the erythema and induration to be related to BEXSERO. Additional details were reported as follows: The patient received BEXSERO in right deltoid and experienced redness, mild induration and injection site warm to touch. On 17th August 2017, the patient visited physician due to an appointment to receive other vaccines and made the physician aware of the reactions associated with the BEXSERO vaccine. At the time of reporting the outcome was unknown. Healthcare professional told the patient to take BENADRYL and wait for 5 to 6 days to go to the physician/ hospital. The reporter would like a follow up.
Sex: U
Vaccine: MMR
Symptoms: Accidental exposure to product, No adverse event, Occupational exposure to product, Syringe issue
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 17-AUG-2017 the patient was vaccinated with M-M-R II for prophylaxis. Concomitant therapies included sterile diluent. On 17-AUG-2017, 1 day after onset of therapy the patient experienced accidental exposure to product, occupational exposure to product and syringe issue. On an unknown date the patient experienced no adverse event. The outcome of occupational exposure to product, no adverse event, syringe issue and accidental exposure to product is unknown. The reporter considered accidental exposure to product, occupational exposure to product, no adverse event and syringe issue to be not related to M-M-R II. Sender's Comments: US-009507513-1708USA008230.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to patients of unknown age. In 2017 the patients were vaccinated with improperly stored doses of M-M-R II lot # L039613 for prophylaxis. Other suspect therapies included sterile diluent. No adverse event.; Sender's Comments:  US-009507513-1708USA011305: US-009507513-1708USA004309:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to patients of unknown age. In 2017 the patients were vaccinated with improperly stored doses of ROTATEQ lot # M019707, oral for prophylaxis. No adverse event. Sender's Comments: US-009507513-1708USA004309: US-009507513-1708USA011304.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Expired product administered, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 20 year old female patient. On 26-AUG-2017 the patient was vaccinated with VARIVAX lot # L011085 in the left arm for prophylaxis. Other suspect therapies included sterile diluent and M-M-R II. On 26-AUG-2017 the patient experienced expired product administered. On 27-AUG-2017, 28 days after onset of therapy the patient experienced rash. The outcome of rash and expired product administered is unknown. The reporter considered expired product administered to be not related to M-M-R II, VARIVAX and sterile diluent.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other refers to a three patients of unknown ages. On 17-AUG-2017, one unspecified patient was vaccinated with an improperly stored dose of ZOSTAVAX, and on 21-AUG-2017, two unspecified patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # M037015, expiration date 22-NOV-2017) for prophylaxis. Concomitant therapies included sterile diluent. No adverse effects reported.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Actinic keratosis, Atelectasis, Injection site nodule, Squamous cell carcinoma, Staphylococcal infection
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a 70 years old female patient received the first single dose of PREVNAR 13 on 15Jun2015, for immunization. Medical history included chronic kidney disease stage 3 ongoing from 2008 and acute kidney failure from 2014 but they straightened that out. The reporter mentioned also about an unspecified ACE inhibitor that gave her a cough while she was in the hospital for acute kidney failure in 2014. However, she had complications. She was in the hospital for a week and had shakes, sweats, severe fatigue, cough from ACE inhibitors, dizziness, headache, and went right into pneumonia. She got pneumonia and had severe shortness of breath, so those things plus respiratory infection. Illness at time of vaccination included pneumonia in right lower lobe which was detected with an X-ray on 04Jun2015. The patient was still very sick when she received the vaccine. Due to pneumonia they had to give her 7 antibiotics and all of the sudden she ended up with squamous cell carcinoma, actinic keratosis, and staphylococcus aureus. The reporter was unable to provide all antibiotic names, they were mostly LEVAQUIN 500 mg and cephalexin. She only got one shot of pneumococcal 13-val conj vac (dipht crm197 protein). She did not get it before she got pneumonia and they said that was why she needed it. Then, since an unspecified date in 2015, she was sick for 8 months after. Sickness resolved with sequelae in Mar2016 with lasting effects of atelectasis and a 4 mm nodule in the area where the pneumonia was.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales Representative. A patient of unspecified age, race, ethnicity and gender received PREVNAR 13 at single dose via an unspecified route of administration on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. The patient experienced redness on the injection site on an unspecified date. Outcome was unknown. No follow-up attempts are possible. No further information is expected.
Age: 1.0
Sex: F
Vaccine: MMRV, UNK
Symptoms: Blood test, Pyrexia, Rash, Streptococcus test
Clinical narrative: Low grade fever (100.4) for a day with rash (looks like Measles rash) for a week.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema multiforme
Clinical narrative: Erythema Multiforme.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling abnormal, Limb mass, Mobility decreased, Tenderness
Clinical narrative: Patient reports feeling terrible, difficult to get out of bed on Sunday 8/27. Presents to pharmacy on 8/28, right arm is red, tender, with palpable lump.
Age: 16.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Non-viable vaccine d/t temperature excursion too warm.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Resident developed redness and itching at injection site requiring BENADRYL prn. This developed within 2-3 hours after receiving vaccine.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Peripheral swelling, Urticaria
Clinical narrative: Pt had standard pain in the left arm after the shots, then 24 hours later the arm began to swell and to have welts. Pain worsened approximately 36 hours after shots (monday night). Pt states she started self-medicating with Benadryl on Monday when symptoms began; they have not worsened and she has continued benadryl and wants to add ibuprofen for pain. Pt asked that pharmacist notify primary care physician of vaccinations (since not previously indicated on her patient questionnaire) and of the adverse event. Office notified as requested
Age: 0.42
Sex: M
Vaccine: UNK
Symptoms: Wrong drug administered
Clinical narrative: He was giving patient vaccine that is made for 4-6 year olds instead of the DTaP-PEDIARIX that he was supposed to get.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Developed itching on neck before leaving facility. On 08-29-2017 noted diffuse non vesicular, nonpapular rash on arms and front of chest. No other area of body noted. Parent stated had also eaten shrimp, but never had shrimp allergy before. No fever, or malaise, just itching.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Swelling face
Clinical narrative: Patient complaint of left side of cheek swollen on 8/28/17. Advised to see physician.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Swelling in the bicep area. The area was hot and swollen. It was swollen to where it was just puffy not tight per patient.
Age: 13.0
Sex: F
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Non-viable vaccine d/t temperature excursion too warm.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Hypersomnia
Clinical narrative: Chills, low grade fever, total lethargy, loss of appetite, weakness, lightheaded, swelling area of injection, I slept almost constantly for a day and a half. This is extremely unusual for me. I never nap, yet all I could do was sleep. On 8/28/2017 at my daughter's urging, I phoned my physician's office and spoke with his nurse. She said I should feel better today, if not and injection site worse, to call again. I did awake feeling considerable better. Injection site still sore, though less so than past few days.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Lethargy, Pyrexia
Clinical narrative: Chills, low grade fever, total lethargy, loss of appetite, weakness, lightheaded, swelling area of injection, I slept almost constantly for a day and a half. This is extremely unusual for me. I never nap, yet all I could do was sleep. On 8/28/2017 at my daughter's urging, I phoned my physician's office and spoke with his nurse. She said I should feel better today, if not and injection site worse, to call again. I did awake feeling considerable better. Injection site still sore, though less so than past few days.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Dyspnoea, Headache, Heart rate increased, Hyperaesthesia
Clinical narrative: Severe joint pain, severe headache, difficulty breathing, heart beating fast, swelling and severe pain at injection site. Overall sensitivity to touch over entire body. Frequent trips to the bathroom during the night to urinate (over 10). Twenty four hours after initial injection site of injection is very sore and swollen.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Nocturia
Clinical narrative: Severe joint pain, severe headache, difficulty breathing, heart beating fast, swelling and severe pain at injection site. Overall sensitivity to touch over entire body. Frequent trips to the bathroom during the night to urinate (over 10). Twenty four hours after initial injection site of injection is very sore and swollen.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site hypoaesthesia
Clinical narrative: Patient came in for MENVEO shot, five days later came back with numbness in the area.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Anti-transglutaminase antibody, Blood thyroid stimulating hormone, Dizziness, Full blood count, Metabolic function test
Clinical narrative: Per Dr's Medical Assistant: [?8/?29/?2017 3:18 PM]: AFTER I GIVE THE LAST SHOT (HPV) PROBABLY AFTER 2-3 MINUTES, DOCTOR ASK HER TO SIT IN THE CHAIR TO LET HER MOTHER SIT ON BED, BUT I SAW HER GOING BACKWARDS LIKE LAYING DOWN AND DR WAS NEXT TO HER SO SHE HOLD HER AND HELP HER LAYING DOWN PREVENTING NOT TO FALL BECAUSE SHE WAS AT THE EDGE OF THE BED, AND DOCTOR ASK ME TO GET THE GLUCOLA AND SHE WAS TALKING SAYING THAT SHE WAS LIGHTHEADED.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillan Barre Syndrome.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Influenza, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient called pharmacy on 8/28/17 and reported: "The day after I got the shots, I came down with the flu...The skin around the injections is red, tender, and a little swollen...The swollen red area is about the size of 1/3 a sheet of paper. The swelling/redness was the worst the day after the shots, and has been improving since, but is still the majority of my upper arm." Upon questioning, patient clarified "coming down with the flu" as muscle aches, fatigue, and general malaise. I explained that these reactions, while severe, were within the normal spectrum of expected AEs. Recommended the use of an OTC pain reliever for arm soreness and instructed patient to contact us again if symptoms worsened or if the swelling and erythema didn't continue to improve. I called and left a voicemail for the patient at 2:24pm on 8/29/17 requesting a follow-up, but have not heard back.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise, Myalgia
Clinical narrative: Patient called pharmacy on 8/28/17 and reported: "The day after I got the shots, I came down with the flu...The skin around the injections is red, tender, and a little swollen...The swollen red area is about the size of 1/3 a sheet of paper. The swelling/redness was the worst the day after the shots, and has been improving since, but is still the majority of my upper arm." Upon questioning, patient clarified "coming down with the flu" as muscle aches, fatigue, and general malaise. I explained that these reactions, while severe, were within the normal spectrum of expected AEs. Recommended the use of an OTC pain reliever for arm soreness and instructed patient to contact us again if symptoms worsened or if the swelling and erythema didn't continue to improve. I called and left a voicemail for the patient at 2:24pm on 8/29/17 requesting a follow-up, but have not heard back.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Electromyogram normal, Hypoaesthesia, Increased tendency to bruise, Neurological examination normal, Orthopaedic examination normal
Clinical narrative: Left arm pain, constantly dull and sharp from the time of the injection. Symptoms are exacerbated with direct pressure and extremity movement. There is also intermittent numbness and tingling down into the fingers.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Left arm pain, constantly dull and sharp from the time of the injection. Symptoms are exacerbated with direct pressure and extremity movement. There is also intermittent numbness and tingling down into the fingers.
Age: 22.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 22.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Unevaluable event
Clinical narrative: Cellulitis.
Age: 13.0
Sex: M
Vaccine: HEP, HEPA, IPV, MNQ
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Large (about 7in by 4in) redness and swelling to left arm. Warm to touch. At time of this report it has been 2 days length of reaction.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Depressed level of consciousness, Laboratory test, Pallor, Seizure
Clinical narrative: ** Did fine w the shot given by Dr. and then shortly later while leaving office pt had vasovagal syncope and was pale,  weak, then very transient seizure noted on rt side w decreased LOC while being attended to by myself and staff- he was given water, ice pack, legs elevated, vitals stable but 911 called and paramedics arrived - pt  will be taken to ER for eval. Note - mom reports he passed out after a blood draw in the past also.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: ** Did fine w the shot given by Dr. and then shortly later while leaving office pt had vasovagal syncope and was pale,  weak, then very transient seizure noted on rt side w decreased LOC while being attended to by myself and staff- he was given water, ice pack, legs elevated, vitals stable but 911 called and paramedics arrived - pt  will be taken to ER for eval. Note - mom reports he passed out after a blood draw in the past also.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Severe swelling at injection site, felt "hot" to the touch. Swelling continued for 3 days.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Blood heavy metal increased, Blood pressure increased, Blood test, Body temperature increased, Computerised tomogram abdomen
Clinical narrative: The following day, I experienced visual changes, noted by difficulty using computer or focusing, after working approx. 3 hours, BP increase, HR increased and temperature increased, per nurse at work. Face flushed and numbness was noted in middle of face and in hands and feet. Nausea, dizziness, and feeling faint followed. Went to PCP, then ER. Blood work completed and sent home. Symptoms continued and vision and sensation worsened. Returned to PCP and ER multiple times. More test completed. I was seen by Neurology, Neuro Ophthalmology and Cardiology, but were unable to diagnose problem.  Consulted with Dr. for Nutritional counseling and he had a Heavy Metals test performed which revealed high levels of Aluminum in my system. Now being treated with oral Chelation supplements and symptoms are starting to lessen.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram pelvis, Computerised tomogram thorax, Dizziness, Flushing, Heart rate increased
Clinical narrative: The following day, I experienced visual changes, noted by difficulty using computer or focusing, after working approx. 3 hours, BP increase, HR increased and temperature increased, per nurse at work. Face flushed and numbness was noted in middle of face and in hands and feet. Nausea, dizziness, and feeling faint followed. Went to PCP, then ER. Blood work completed and sent home. Symptoms continued and vision and sensation worsened. Returned to PCP and ER multiple times. More test completed. I was seen by Neurology, Neuro Ophthalmology and Cardiology, but were unable to diagnose problem.  Consulted with Dr. for Nutritional counseling and he had a Heavy Metals test performed which revealed high levels of Aluminum in my system. Now being treated with oral Chelation supplements and symptoms are starting to lessen.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Lumbar puncture, Nausea, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain
Clinical narrative: The following day, I experienced visual changes, noted by difficulty using computer or focusing, after working approx. 3 hours, BP increase, HR increased and temperature increased, per nurse at work. Face flushed and numbness was noted in middle of face and in hands and feet. Nausea, dizziness, and feeling faint followed. Went to PCP, then ER. Blood work completed and sent home. Symptoms continued and vision and sensation worsened. Returned to PCP and ER multiple times. More test completed. I was seen by Neurology, Neuro Ophthalmology and Cardiology, but were unable to diagnose problem.  Consulted with Dr. for Nutritional counseling and he had a Heavy Metals test performed which revealed high levels of Aluminum in my system. Now being treated with oral Chelation supplements and symptoms are starting to lessen.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging spinal, Syncope, Vision blurred, Visual impairment
Clinical narrative: The following day, I experienced visual changes, noted by difficulty using computer or focusing, after working approx. 3 hours, BP increase, HR increased and temperature increased, per nurse at work. Face flushed and numbness was noted in middle of face and in hands and feet. Nausea, dizziness, and feeling faint followed. Went to PCP, then ER. Blood work completed and sent home. Symptoms continued and vision and sensation worsened. Returned to PCP and ER multiple times. More test completed. I was seen by Neurology, Neuro Ophthalmology and Cardiology, but were unable to diagnose problem.  Consulted with Dr. for Nutritional counseling and he had a Heavy Metals test performed which revealed high levels of Aluminum in my system. Now being treated with oral Chelation supplements and symptoms are starting to lessen.
Age: 25.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness
Clinical narrative: After patient received flu shot, he passed out.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: 8/24/17 had one spot that she thought was a bug bite (itchy, red) at time of reporting she had a diffuse rash ankles to neck. Itchy and red no pain.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Urticaria
Clinical narrative: Large red welt, that the pharmacy was notified about and has continued to grow. Patient used a marker 8/28 to outline it, and it has grown 1/4 inch since yesterday.