chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Eyelid oedema
Clinical narrative: Left eye swollen shut, right eye slightly swollen within 15 minutes after vaccines administered. No respiratory symptoms. BENADRYL given.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Ear pain, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: Pt states she began having fever, chills, sore throat, body aches and earaches on 6/10/14. Was seen by PCP and given antibiotic but s/s persist to present. States has been somewhat improved. But still feels fatigue. No longer has fever.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Pt states she began having fever, chills, sore throat, body aches and earaches on 6/10/14. Was seen by PCP and given antibiotic but s/s persist to present. States has been somewhat improved. But still feels fatigue. No longer has fever.
Age: 1.32
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Arthropod bite, Blood culture, Borrelia test, Culture urine, Full blood count normal
Clinical narrative: Patient presented 6/25/14 with fever, and insect bite.
Age: 1.32
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: Patient presented 6/25/14 with fever, and insect bite.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Redness and swelling on local leg. Heat, hard to the touch. Tender. Red rash spreading. Treated with anti-histamine, ice, elevation.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site warmth, Rash erythematous
Clinical narrative: Redness and swelling on local leg. Heat, hard to the touch. Tender. Red rash spreading. Treated with anti-histamine, ice, elevation.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site induration, Injection site rash
Clinical narrative: Right thigh cellulitis, induration, rash per emergency room notes 6-15-2014. Given ROCEPHIN (ceftriaxone) (737.5 mg IM) IM 6/15/2014. Seen 6/15/2014 in ER for following, seen 6/24/2014 at clinic for f/u.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician to a patient of unknown age and gender. Pertinent medical history and drug reactions or allergies were unspecified. On 16-JUN-2014 (reported as "today") the patient was vaccinated with an improperly stored VAQTA (strength, dose, route, dose number and lot number were not reported). Concomitant medication was unspecified. No adverse events reported at the time of this report. The outcome of the event was unknown. This is one of several reports received from the same reporter. The physician also reported that on an unknown date another patient was vaccinated with improperly stored M-M-R II (see MARRS 1406USA008465). Additional information is not expected.
Age: 35.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Skin papilloma
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 35 year old male patient. On 09-DEC-2011, the patient was vaccinated with his first dose of GARDASIL, .5 ml, intramuscular and experienced inappropriate age of vaccination. On 16-JAN-2012 the patient was vaccinated with his second dose of GARDASIL, .5 ml, intramuscular. About one month later, the patient experienced warts on his hands. The patient received treatment including "freezing lesions off and prescribing ALDARA." The patient declined to receive the third dose of GARDASIL. The outcome of warts and inappropriate age of vaccination is unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician to a patient of unknown age and gender. Pertinent medical history and drug reactions or allergies were unspecified. On an unknown date the patient was vaccinated with an improper stored M-M-R II (strength, dose, route, dose number and lot number were not reported). Concomitant medication was unspecified. No adverse events reported at the time of this report. The outcome of the event was unknown. The physician also reported that another patient may have been vaccinated with improperly stored VAQTA (see MARRS 1406USA010224). This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information of patient's medical history, concurrent conditions or concomitant drugs was provided. On 20-JUN-2014 the patient was vaccinated with an expired dose of RECOMBIVAX HB, 5mcg/0.5ml, intramuscularly at unspecified site, lot# reported as H018635, expiration date 16-DEC-2013. The rest prefilled syringe had been used and discarded, no lot# and expiration dates provided for them. The reporter stated that the carton was previously opened and the mix could have been user error. The carton was a multidose single dose syringe carton without perforation. It was stored in a fridge. It was unspecified what date was the carton first opened and was not sealed when the nurse first opened it. It was unknown who opened the carton first. The mix was noticed on 20-JUN-2014 by the reporting nurse. All nurses and medical assistants in the building had access to the product and reportedly did not inadvertently cause the mix. The product was obtained from the hospital pharmacy and delivered by the hospital carrier. There were no noticed damage on the shipping carton or carton's contents on the arrival. The patient did not miss a dose due to the PQC. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient of unspecified age and gender. On 09-AUG-2013, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # J002618, exp date: 01-MAR-2015, 0.5 milliliter (ml), subcutaneous (strength and indication not reported). The (Oka/Merck) VARIVAX had been stored at -10 C (celsius) (above recommended temperature range in product information) since July 2013. No adverse effects reported. It was unspecified if the patient sought medical attention. this is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients. On unknown dates the patients were vaccinated with doses of ROTATEQ (lot #, expiration date, dose and route unspecified) that were exposed to temperatures outside of the proper storage range. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.54
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 2 year old male patient. On 16-MAY-2014 the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX, lot # unknown, 0.5 ml, subcutaneous. On 28-MAY-2014, the patient was seen in the emergency room (ER) at hospital for a fever of 105F and rash. In the ER the patient was administered ibuprofen, TYLENOL and acyclovir. The outcome of the events was reported as recovered on an unspecified date in 2014. The causality of the events and therapy with (Oka/Merck) VARIVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 09-JUN-2014 the patient was vaccinated with a properly stored, expired dose of VAQTA, 0.5 ml, intramuscular injection (lot# 671235/0984AA, expiration date: 10-MAY-2014). Concomitant medications and other relevant history were not reported. No adverse effects were reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site reaction, Injection site urticaria, Skin hypertrophy
Clinical narrative: This spontaneous report was received from a 62 year old female patient, who is also a physician, reporting on herself. Medical history was not reported. On 18-JUN-2014 the patient was vaccinated with ZOSTAVAX, intradermal, in the proximal region of her upper arm, dosage, lot number, expiration date were not reported. Concomitant therapy was not reported. The reporter informed that she believed that the ZOSTAVAX received on 18-JUN-2014 may have been administered intradermally. She also reported that could feel fluid entering a small space at time of injection and it was painful. Beginning on 20-JUN-2014 she developed wheal measuring 3 inches by 2 inches along with thickening to the injection site, the events remains ongoing. The patient's outcome with the event was not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to unspecified number of patients of unknown age and gender with no pertinent medical history reported. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, Lot # and route of administration were not reported). Concomitant medications, drug reactions and allergies were not reported. On an unknown date the patients developed rash at the site of ZOSTAVAX injection. Each of those patients started BENADRYL on unknown date as a treatment. It was unknown if any laboratory diagnostic studies were performed and if the patients sought medical attention. The outcome of patients developed rash at the site of ZOSTAVAX injection was reported as recovered/resolved on an unspecified date. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unspecified date in 2003 the patient was vaccinated with a PNEUMOVAX 23 (dose, route, lot number not reported) and subsequently with a second dose of PNEUMOVAX 23 (dose, route, lot number not reported) on a unspecified date in 2004. The pharmacist reported that the patient received two doses of PNEUMOVAX 23 when the patient was under the age of 65 years old. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patient of unknown age. The patient was administered a dose of ZOSTAVAX (dose, route of administration and indication were not provided) (lot # and expiration date were not reported) twice in the past five years on unspecified date. The patient was older than 50 years old when each dose of ZOSTAVAX was administered. No adverse events were reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: This case was reported by a pharmacy via claims benefit management company and described the occurrence of adverse reaction in a female subject of unspecified age who was vaccinated with FLUARIX quadrivalent (GlaxoSmithKline). On 6 October 2013 the subject received unspecified dose of FLUARIX Quadrivalent (unknown details). In 2013, within months after vaccination with FLUARIX Quadrivalent, the subject experienced adverse reaction. At the time of reporting the outcome of the event was unspecified. Follow up information received on 08 January 2014 via pharmacist who clarified that the 21-year old subject felt lightheaded after five to 10 minutes after receiving FLUARIX on 06 October 2013. At the time of the report no other information was provided, the outcome of the lightheadedness was unknown.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of raised red bump at injection site in a 46-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to isoniazid. On 3 October 2013 the subject received the 1st dose of FLUARIX (.5 ml, unknown route, left arm). On the evening of 3 October 2013, within hours of vaccination with FLUARIX, the subject experienced raised red bump at injection site (described as "raised red spots", pink/red area at injection site, warmness to touch at injection site, injection site tenderness (described as "sore arm"), tingling on side of face (described as "tingling on the left side of face"), and injection site hives. The subject reported that on the evening after she received her first flu shot she experienced 2 raised red spots on her arm. By the next morning, it had become prominent and she had a large hive that was warm and tender to touch. It continued to spread and the subject sought medical attention at an urgent care office "on Saturday" (2 days after the vaccination) and was told she had an allergic reaction. She also experienced some tingling on the left side of her face. At the time of reporting the events were improved. The subject described still having a "pinkish tinge with some tenderness" and "very little swelling remaining." Follow up was received from pharmacy via claims benefit management company on 3 December 2013. The pharmacy reported the lot number of the FLUARIX administered.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Paraesthesia
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of raised red bump at injection site in a 46-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to isoniazid. On 3 October 2013 the subject received the 1st dose of FLUARIX (.5 ml, unknown route, left arm). On the evening of 3 October 2013, within hours of vaccination with FLUARIX, the subject experienced raised red bump at injection site (described as "raised red spots", pink/red area at injection site, warmness to touch at injection site, injection site tenderness (described as "sore arm"), tingling on side of face (described as "tingling on the left side of face"), and injection site hives. The subject reported that on the evening after she received her first flu shot she experienced 2 raised red spots on her arm. By the next morning, it had become prominent and she had a large hive that was warm and tender to touch. It continued to spread and the subject sought medical attention at an urgent care office "on Saturday" (2 days after the vaccination) and was told she had an allergic reaction. She also experienced some tingling on the left side of her face. At the time of reporting the events were improved. The subject described still having a "pinkish tinge with some tenderness" and "very little swelling remaining." Follow up was received from pharmacy via claims benefit management company on 3 December 2013. The pharmacy reported the lot number of the FLUARIX administered.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Local swelling
Clinical narrative: I had a shingles vaccine shot on 5/21/14. My arm swelled up from the injection spot (upper arm) to the tip of my fingers. I experienced extreme pain in my elbow, wrist and fingers. I was given a product by Merck. After two weeks I went to my Dr. who put me on a 4mg pak of methylpred on 6/6/14. When I got off of that the swelling was improved and the pain greatly reduced. Within a few days the pain and swelling returned. Today 6/17/14 the swelling and pain is back. This has been going on for almost a month.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Injection site swelling, Local swelling
Clinical narrative: I had a shingles vaccine shot on 5/21/14. My arm swelled up from the injection spot (upper arm) to the tip of my fingers. I experienced extreme pain in my elbow, wrist and fingers. I was given a product by Merck. After two weeks I went to my Dr. who put me on a 4mg pak of methylpred on 6/6/14. When I got off of that the swelling was improved and the pain greatly reduced. Within a few days the pain and swelling returned. Today 6/17/14 the swelling and pain is back. This has been going on for almost a month.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 59 year old female patient. There was not medical history, drug reactions or allergies. On 09-JUN-2014 the patient was vaccinated with ZOSTAVAX plaque-forming units (PFU) lot # K000726, expiration date 09-JAN-2015, in the arm, route and dosage were not reported. There was not concomitant therapy. The pharmacist informed that in approximately June 2014 the patient developed a three inch red, raised area around the injection site and mentioned the redness crept down the patient's arm. The pharmacist requested a lot check for the ZOSTAVAX in question and inquired, if is it still to continue using the ZOSTAVAX the patient sought medical attention by contacted pharmacist. The events were treated with clindamycin, prednisone. There were not laboratories studies performed. The patient's outcome with the events was recovering. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 59 year old female patient. There was not medical history, drug reactions or allergies. On 09-JUN-2014 the patient was vaccinated with ZOSTAVAX plaque-forming units (PFU) lot # K000726, expiration date 09-JAN-2015, in the arm, route and dosage were not reported. There was not concomitant therapy. The pharmacist informed that in approximately June 2014 the patient developed a three inch red, raised area around the injection site and mentioned the redness crept down the patient's arm. The pharmacist requested a lot check for the ZOSTAVAX in question and inquired, if is it still to continue using the ZOSTAVAX the patient sought medical attention by contacted pharmacist. The events were treated with clindamycin, prednisone. There were not laboratories studies performed. The patient's outcome with the events was recovering. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Convulsion, Eye movement disorder, Moaning, Mydriasis, Respiratory arrest
Clinical narrative: My son grabbed my wrist just after the vaccine. His eyes rolled to the back. His pupils were fully dilated. He was lying down with his eyes open, fully dilated and he stopped breathing. The doctor was in the room with his back to us. I alerted the doctor. I had 2 younger children with me. I removed them from the room and got a nurse. As she opened the door we saw my son having a seizure. He was yelling and moaning. It ended. When getting ready to leave the office about 1/2 hr later he vomited. After another 1/2 hour he had a violent vomit attack and then he was all better.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Screaming, Staring, Vomiting
Clinical narrative: My son grabbed my wrist just after the vaccine. His eyes rolled to the back. His pupils were fully dilated. He was lying down with his eyes open, fully dilated and he stopped breathing. The doctor was in the room with his back to us. I alerted the doctor. I had 2 younger children with me. I removed them from the room and got a nurse. As she opened the door we saw my son having a seizure. He was yelling and moaning. It ended. When getting ready to leave the office about 1/2 hr later he vomited. After another 1/2 hour he had a violent vomit attack and then he was all better.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Local swelling, Pyrexia
Clinical narrative: Fever to 102, red patch at vaccination site, arm swollen. Symptoms lasted two days, were better by 6/19/2014.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Adenovirus test positive, Blood culture negative, Cardiac arrest, Cardiac murmur, Cardio-respiratory arrest
Clinical narrative: Patient had fever of approx 101 on eve of date received vaccines, then had an episode described as eyes staring off and whole body going limp for 5 sec followed by all 4 extremity stiffening that lasted couple of seconds. He then returned to normal with total episode time ~10 sec. He then had another similar episode the following afternoon with return to normal. The eve following receiving vaccination mom heard loud scream from child's room. She picked up child who was awake, alert. He then had another episode of eyes staring followed by going limp. This time he did not return to baseline and stopped breathing. EMS was called. Patient was in cardiac arrest. Required chest compressions upon arrival to ED. Patient coded for 35 min. To pediatric ICU, vent dependent with severe neurological impairment s/p prolonged cardiopulmonary arrest. Patient was terminally extubated.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Culture urine negative, Death, Electrocardiogram abnormal, Hypotonia, Intensive care
Clinical narrative: Patient had fever of approx 101 on eve of date received vaccines, then had an episode described as eyes staring off and whole body going limp for 5 sec followed by all 4 extremity stiffening that lasted couple of seconds. He then returned to normal with total episode time ~10 sec. He then had another similar episode the following afternoon with return to normal. The eve following receiving vaccination mom heard loud scream from child's room. She picked up child who was awake, alert. He then had another episode of eyes staring followed by going limp. This time he did not return to baseline and stopped breathing. EMS was called. Patient was in cardiac arrest. Required chest compressions upon arrival to ED. Patient coded for 35 min. To pediatric ICU, vent dependent with severe neurological impairment s/p prolonged cardiopulmonary arrest. Patient was terminally extubated.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Musculoskeletal stiffness, Nervous system disorder, Nuclear magnetic resonance imaging abnormal, Pyrexia, Respiratory arrest
Clinical narrative: Patient had fever of approx 101 on eve of date received vaccines, then had an episode described as eyes staring off and whole body going limp for 5 sec followed by all 4 extremity stiffening that lasted couple of seconds. He then returned to normal with total episode time ~10 sec. He then had another similar episode the following afternoon with return to normal. The eve following receiving vaccination mom heard loud scream from child's room. She picked up child who was awake, alert. He then had another episode of eyes staring followed by going limp. This time he did not return to baseline and stopped breathing. EMS was called. Patient was in cardiac arrest. Required chest compressions upon arrival to ED. Patient coded for 35 min. To pediatric ICU, vent dependent with severe neurological impairment s/p prolonged cardiopulmonary arrest. Patient was terminally extubated.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Resuscitation, Screaming, Staring
Clinical narrative: Patient had fever of approx 101 on eve of date received vaccines, then had an episode described as eyes staring off and whole body going limp for 5 sec followed by all 4 extremity stiffening that lasted couple of seconds. He then returned to normal with total episode time ~10 sec. He then had another similar episode the following afternoon with return to normal. The eve following receiving vaccination mom heard loud scream from child's room. She picked up child who was awake, alert. He then had another episode of eyes staring followed by going limp. This time he did not return to baseline and stopped breathing. EMS was called. Patient was in cardiac arrest. Required chest compressions upon arrival to ED. Patient coded for 35 min. To pediatric ICU, vent dependent with severe neurological impairment s/p prolonged cardiopulmonary arrest. Patient was terminally extubated.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Wrong drug administered
Clinical narrative: PT WAS GIVEN ANTHRAX INSTEAD OF PPD IN THE LEFT FOREARM.  PT HAS NOT EXPERIENCED ANY SYMPTOMS AT THIS TIME.  HE HAS A LOCAL RED AREA AT INJECTION SITE WITH NO OTHER SYMPTOMS.
Age: 21.0
Sex: F
Vaccine: HEP, HEPA, MNQ, TD, YF
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea and vomiting began the evening of 06/25/14 and continued throughout the night into the following morning. The patient also experienced fever and chills. The patient took two Tylenol Extra Strength (500mg) tablets every four hours for 3 doses and reported a temperature of 99.5 degrees Fahrenheit after the third dose.
Age: 1.06
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Rash on face, back, trunk and legs.  No fever.  Eating and drinking fine. Not crying, seems to be playing normal.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Abdominal pain, Convulsion, Injection site reaction, Pyrexia, Vomiting
Clinical narrative: Leg where Kinrix was placed looked like she had been stung by bees. Fever elevated highest was 102. Had three seizures. Vomiting and abdominal pain.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Pain, Rash, Rash papular
Clinical narrative: Patient arrived to clinic with 2 small clusters of pink papular rash, 1 cluster on her abdomen, and one on her back. Rash was in a dermatomal pattern. She described the rash as "painful and burning." She was given Valtrex 1 gm BID for 7 days and a topical analgesic was suggested to the patient.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Skin lesion
Clinical narrative: Patient arrived to clinic with 2 small clusters of pink papular rash, 1 cluster on her abdomen, and one on her back. Rash was in a dermatomal pattern. She described the rash as "painful and burning." She was given Valtrex 1 gm BID for 7 days and a topical analgesic was suggested to the patient.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site was red, swollen, and hot to touch on left upper arm. Pt has no fever, site has no drainage, no difficulty in ROM or breathing. Swelling increased within 72 hours, MD prescribed Omnicef 250/5 suspension: 1 tsp BID for 5 days, and 1 tab of Benadryl QHS. Advised father to take temp daily and return to Health Dept on Monday AM.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient developed fever, nausea, vomiting, diarrhea after vaccination; reported to doctor's office 2 days later. Treated with OTC antipyretic and antidiarrheal.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Abnormal dreams, Application site irritation, Drug interaction, Hot flush
Clinical narrative: This case was reported by a consumer and described the occurrence of vivid dreams in a 61-year-old male subject who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medications included unknown (unspecified medications). Co-suspect medication included Equate NTS 21 mg, Clear patch over a period of 31 days for smoking cessation. In 2013 the subject received a dose of Influenza vaccine unspecified (unknown). The subject started the Nicotine on 7 November 2013. Less than one month after vaccination with Influenza vaccine unspecified and Nicotine, the subject experienced vivid dreams and drug interaction. The subject also reported application site irritation on the area where he applies the Nicotine patch. The subject reported that he is using the Equate 21 milligram patch and it is causing him to have vivid dreams and the area he places the patch is irritated. The subject reported drug interaction and stated that he feels it could be a mix of the flu shot he got and the patch causing him to get too much nicotine. At the time of reporting the events were resolved. Follow up called received 19 December 2013. Consumer reported receiving a HCP form from GSK. Consumer reported an additional AE of him telling his wife while using the product he felt like he was having hot flashes.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer and described the occurrence of sick in a female subject of unspecified age who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). A physician or other health care professional has not verified this report. In 2003, "about 10 years ago" the subject received a dose of Influenza vaccine unspecified (unknown details). In 2003, "about 10 years ago" and at an unspecified time after vaccination with Influenza vaccine unspecified, the subject experienced sick. The subject stated that "when the companies started adding mercury to the vaccine, she has been sick for a week after getting a flu vaccine, so she stopped having them." At the time of reporting the event was resolved.
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Erythema, Injection site reaction
Clinical narrative: This case was reported by a physician and described the occurrence of injection site reaction in a female subject of unspecified age who was vaccinated with FLUARIX (trivalent or quadrivalent unspecified) (GlaxoSmithKline). In 2013 the subject received a dose of FLUARIX (unknown details). On an unknown date, within months of vaccination with FLUARIX, the subject experienced injection site reaction, body temperature increased (described as "heightened body temperature") and erythema of cheek (described as "red cheeks"). No additional details were provided at the time of reporting. At the time of reporting the outcome of the events were unspecified.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of hard to breath in a 46-year-old female subject who was vaccinated with Influenza vaccine unspecified (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included thyroidectomy. Concurrent medical conditions included allergy to sulfa drugs, asthma and mycin allergy. The subject reported that she "has an allergy to mycin antibiotics" and that she received "a typhoid or cholera vaccination many years ago, which had a mycin in it", and "had a reaction like this" one that she reported on 17 October 2013. Concurrent medications included Simvastatin, Nexium, Janumet, VICTOZA, Cymbalta, Desipramine, Pro-Air and Advair. Co-suspect medication included Benadryl. On 17 October 2013 at 14:45 the subject received a of Influenza vaccine unspecified (unknown details, left arm). The subject knew she received a "GSK flu vaccine" but was unsure of which formulation. On the night of 17 October 2013, within hours of vaccination with Influenza vaccine unspecified, the subject experienced hard to breath, extensive swelling of vaccinated limb, red around injection site, injection site warmth, and pain around injection site. When the subject experienced the difficulty breathing, she reported that "she thought it might be her asthma so she tried her inhaler but it did not help." It was unclear which inhaler the subject used to treat the difficulty breathing; however, the subject reported a concurrent inhaler of Proair. The subject "took some Benadryl and went to bed." On 18 October 2013, when the subject "woke up. she had difficulty breathing again, so she took more Benadryl." The pain and swelling at the injection site had "continued to get worse throughout the day. The injection site swelling was "swollen up 6 inches [152.4 millimeters] around the site." The subject has consulted with her healthcare professional but has not been evaluated at the time of reporting. The subject will consider going to the emergency room if "it continues to get worse." On 18 October 2013, within the same day as vaccination with Influenza vaccine unspecified, the subject experienced nausea. The subject reported that "she started to have nausea today which is just constant." The subject was treated with inhaler (Unknown bronchial inhaler) and Benadryl. At the time of reporting on 18 October 2013 at 13:55, the difficulty breathing had resolved. The subject reported that "she had not had difficulty breathing since this morning." At the time of reporting the events of extensive swelling of the vaccinated limb, red around injection site, injection site warmth, and pain around injection site were worse. At the time of reporting, the outcome of event of nausea was unresolved.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Nausea
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of hard to breath in a 46-year-old female subject who was vaccinated with Influenza vaccine unspecified (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included thyroidectomy. Concurrent medical conditions included allergy to sulfa drugs, asthma and mycin allergy. The subject reported that she "has an allergy to mycin antibiotics" and that she received "a typhoid or cholera vaccination many years ago, which had a mycin in it", and "had a reaction like this" one that she reported on 17 October 2013. Concurrent medications included Simvastatin, Nexium, Janumet, VICTOZA, Cymbalta, Desipramine, Pro-Air and Advair. Co-suspect medication included Benadryl. On 17 October 2013 at 14:45 the subject received a of Influenza vaccine unspecified (unknown details, left arm). The subject knew she received a "GSK flu vaccine" but was unsure of which formulation. On the night of 17 October 2013, within hours of vaccination with Influenza vaccine unspecified, the subject experienced hard to breath, extensive swelling of vaccinated limb, red around injection site, injection site warmth, and pain around injection site. When the subject experienced the difficulty breathing, she reported that "she thought it might be her asthma so she tried her inhaler but it did not help." It was unclear which inhaler the subject used to treat the difficulty breathing; however, the subject reported a concurrent inhaler of Proair. The subject "took some Benadryl and went to bed." On 18 October 2013, when the subject "woke up. she had difficulty breathing again, so she took more Benadryl." The pain and swelling at the injection site had "continued to get worse throughout the day. The injection site swelling was "swollen up 6 inches [152.4 millimeters] around the site." The subject has consulted with her healthcare professional but has not been evaluated at the time of reporting. The subject will consider going to the emergency room if "it continues to get worse." On 18 October 2013, within the same day as vaccination with Influenza vaccine unspecified, the subject experienced nausea. The subject reported that "she started to have nausea today which is just constant." The subject was treated with inhaler (Unknown bronchial inhaler) and Benadryl. At the time of reporting on 18 October 2013 at 13:55, the difficulty breathing had resolved. The subject reported that "she had not had difficulty breathing since this morning." At the time of reporting the events of extensive swelling of the vaccinated limb, red around injection site, injection site warmth, and pain around injection site were worse. At the time of reporting, the outcome of event of nausea was unresolved.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Hypersensitivity, Injection site discomfort, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itching, discomfort at site of injection. Body aches, headache. Seen 6/26 in ER - diagnosed allergic rxn - MEDROL dose pak and hydroxyzine prescribed.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Redness, swelling, itching, discomfort at site of injection. Body aches, headache. Seen 6/26 in ER - diagnosed allergic rxn - MEDROL dose pak and hydroxyzine prescribed.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Redness, swelling, itching, discomfort at site of injection. Body aches, headache. Seen 6/26 in ER - diagnosed allergic rxn - MEDROL dose pak and hydroxyzine prescribed.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Redness, swelling, itching, discomfort at site of injection. Body aches, headache. Seen 6/26 in ER - diagnosed allergic rxn - MEDROL dose pak and hydroxyzine prescribed.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cough, Influenza, Malaise
Clinical narrative: This case was reported by a consumer (patient) and described the occurrence of influenza in a female subject of unspecified age who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified), pneumonia vaccine  (non-gsk). A physician or other health care professional has not verified this report. Concurrent medical conditions included disability. Concurrent medications included SPIRIVA, Inhaler and Aspirin. Co-suspect medication included ADVAIR multi dose powder inhaler (inhaled), unknown dosing for problem breathing. On 18 October 2013 the subject received a dose of Influenza vaccine unspecified (unknown route/dose, unknown arm) and a dose of Pneumonia vaccine (Non-GSK) (unknown route/dose, unknown arm). The subject received the flu vaccine in one arm and the pneumonia vaccine in the other arm. On 20 October 2013, 2 days after vaccination with Influenza vaccine unspecified and Pneumonia vaccine (Non-GSK), the subject experienced influenza. On 22 October 2013, the patient started Fluticasone propionate+salmeterol xinafoate. On 23 October 2013, 5 days after vaccination with Influenza vaccine unspecified and Pneumonia vaccine (Non-GSK) and 1 day after starting Fluticasone propionate+salmeterol xinafoate the patient experienced cough. On 24 October 2013, 6 days after vaccination with Influenza vaccine unspecified and Pneumonia vaccine (Non-GSK) and 2 days after starting Fluticasone propionate+salmeterol xinafoate, the subject experienced did not feel well. The subject reported that she received "a dead flu vaccine" and even though the flu vaccine was "dead serum", the subject reported that she "must have gotten the flu from it". The subject just started ADVAIR this Tuesday (22 October 2013). Last Friday (18 October 2013), the subject received a pneumonia shot and a flu vaccine and thinks she started to get the flu on Sunday (20 October 2013). Beginning yesterday (23 October 2013), the subject started coughing and she was still coughing today (24 October 2013) and currently does not feel that great. At the time of reporting the events were unresolved.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Malaise, Vaccination failure
Clinical narrative: This case was reported by a consumer (wife of subject) and described the occurrence of influenza in a male subject of unspecified age who was vaccinated with Influenza vaccine (unspecified) (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included asthma, chronic pneumonia and unknown cause of death. The consumer reported that her husband was "no longer living" at the time of reporting. At the time of the adverse event reported, the subject was living and had the concurrent conditions of asthma and chronic pneumonia. The subject had received "live flu vaccine once and got sick as a dog." On an unspecified date the subject received unspecified dose of Influenza vaccine (unspecified) (unknown details). At an unspecified time after vaccination with Influenza vaccine (unspecified), the subject experienced influenza, got sick and vaccination failure. The subject's wife reported that he "would get sick and get the flu every time he would get a flu shot and then eventually pass the flu on to his wife" (the reporter, see case A1046926A). The manufacturers of the flu shots he received were unknown. No additional details were provided. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were unspecified. After the next vaccination with Influenza vaccine (unspecified) the events recurred. Specific details were not reported. The consumer documented another case with influenza vaccine unspecified. See A1046926A for details on the other case.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Atypical pneumonia, Oral candidiasis, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in an adult female patient who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified), pneumococcal vaccine (non-gsk). A physician or other health care professional has not verified this report. The patient's medical history included foot surgery and hospitalization. Concurrent medical conditions included asthma and ulcerative colitis. Co-suspect medication included ATIVAN multi dose powder inhaler, ADVAIR HFA inhaler and SYMBICORT. Concurrent medications inculded PROVENTIL HFA, Symbicort, VENTOLIN HFA, DULERA, Probiotic and Prednisone. On an unknown date, the patient started ADVAIR multi dose powder inhaler 500/50 Diskus (inhaled) at 1 puff (s), variable dosing. The patient stated that she has taken ADVAIR DISKUS for many years. She stated that she has had thrush while on ADVAIR, even after rinsing her mouth. The patient stated that she takes ADVAIR DISKUS one puff in the morning and two puffs at night. She used to take ADVAIR 500/50 mcg; however, her physician decreased the strength of ADVAIR to 250/50 mcg which helped decreased the thrush. She said that she normally gets thrugh within 24 hours of her first dose of ADVAIR and her physician prescribes fluconazole tablets for 10 days to treat the thrush. The patient was currently taking Fluconazole and a generic mouth rinse to treat the thrush and her physician advised her to eat yogurt after taking ADVAIR to prevent thrush. She stated that when she has thrush. She stated that her prescriber sometimes switches her from ADVAIR DISKUS to ADVAIR HFA. She does not have thrush on ADVAIR HFA, but she said that her physician stated that ADVAIR HFA is not as effective. The patient provided very limited information. At the time of reporting, the oral thrush was unresolved. In October 2013 the patient received a dose of Influenza vaccine unspecified (unknown, unknown arm) and unspecified dose of Pneumococcal vaccines (Non-GSK) (unknown, unknown arm). The patient reported she date in 2013, within months after vaccination with Influenza vaccine unspecified and Pneumococcal vaccines (Non-GSK), the patient experienced oral fever of 103 degrees and walking pneumonia. The fever resolved after three days. At the time of reporting the oral thrush was unresolved and the outcome of the walking pneumonia was unspecified.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb, Joint swelling, Local swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of extensive swelling of vaccinated limb in a 74-year-old female subject who was vaccinated with FLUARIX TETRA (GlaxoSmithKline). Concurrent medical conditions included aspirin allergy and sulfa allergy. Concurrent medications included COUMADIN, Diltiazem, Spironolactone and Atenolol chlorthalidone. On 29 November 2013 at 11:00 the subject received a dose of FLUARIX TETRA (.5 ml, unknown, left arm). On 30 November 2013, 1 day after vaccination with FLUARIX TETRA, the subject experienced swelling in her left wrist and lower part of arm. At the time of reporting the events were improved. The pharmacist considered the events were probably related to vaccination with FLUARIX TETRA.
Sex: F
Vaccine: FLU4
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via a pharmacy claims management company and described the occurrence of adverse event(s) in a female subject of unspecified age who was vaccinated with FLUARIX TETRA (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 3 October 2013 the subject received a dose of FLUARIX TETRA (unknown). On an unspecified date in 2013, within months after vaccination with FLUARIX TETRA, the subject experienced adverse event(s). At the time of reporting the outcome of the event(s) was unspecified.
Sex: U
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a pharmacy via a pharmacy claims management company and described the occurrence of adverse reaction in a subject of unspecified age and gender who was vaccinated with FLUARIX Quadrivalent (GlaxoSmithKline). On 29 January 2014 the subject received a dose of FLUARIX Quadrivalent (unknown). On an unspecified date in 2014, within months of vaccination with FLUARIX Quadrivalent, the subject experienced adverse reaction. At the time of reporting the outcome of the event was unspecified.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Local reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of redness below injection site in a 55-year-old female subject who was vaccinated with FLUARIX Quadrivalent (GlaxoSmithKline). Concurrent medical conditions included allergy to PERCODAN, codeine allergy, TREXIMET allergy and sensitivity to latex. Concurrent medications included WELLBUTRIN, ACIPHEX, SINGULAIR, Doxepin and RHINOCORT. On 4 September 2013 (after 12:30) the subject received a dose of FLUARIX Quadrivalent (.5 ml, unknown route, left arm). On 5 September 2013, 1 day after vaccination with FLUARIX Quadrivalent, the subject experienced redness below injection site. The healthcare professional indicated that the event was considered to be a local injection site reaction. At the time of reporting the event was unresolved. The healthcare professional considered the event was possibly related to vaccination with FLUARIX Quadrivalent. Follow up received on 25 September 2013. The healthcare professional documented that the events resolved on 9 September 2013, 5 days after onset of redness below injection site. The healthcare professional indicated that FLUARIX Quadrivalent was the suspect product. The healthcare professional did not consider the event serious.