chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Crepitations, Joint range of motion decreased, Nuclear magnetic resonance imaging, Pain in extremity, Pyrexia
Clinical narrative: Extreme soreness in arm, decreased range of motion. Popping.  Fever--prescribed antibiotics, then fever went away.
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received FLULAVAL QUADRIVALENT (batch number A3AD2, expiry date May 2017). Previously administered products included Ondansetron. On 8th November 2016, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 8th November 2016, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced pain in arm and vaccine administered at inappropriate site. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. The reporter considered the pain in arm to be possibly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: the patient received a dose of FLULAVAL QUADRIVALENT in her left arm and experienced pain that was radiating down the arm to hand. The pain was specific to arm of injection. The patient felt as though the shot was given too high and was administered into the bursa. This led to an administration of vaccine at an inappropriate site.
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Drug administered at inappropriate site, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received FLULAVAL QUADRIVALENT (batch number A3AD2, expiry date May 2017). Previously administered products included Ondansetron. On 8th November 2016, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 8th November 2016, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced pain in arm and vaccine administered at inappropriate site. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. The reporter considered the pain in arm to be possibly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: the patient received a dose of FLULAVAL QUADRIVALENT in her left arm and experienced pain that was radiating down the arm to hand. The pain was specific to arm of injection. The patient felt as though the shot was given too high and was administered into the bursa. This led to an administration of vaccine at an inappropriate site.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Dizziness, Flushing, Malaise, Nausea, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 19-year-old male patient who received BEXSERO. On 10th November 2016, the patient received BEXSERO (intramuscular). On 10th November 2016, 1 hr after receiving BEXSERO, the patient experienced allergic reaction, dizziness, stomach cramps, runny nose, skin warm, pruritus, neck swelling, nausea and hives. The patient was treated with BENADRYL. On an unknown date, the outcome of the allergic reaction, dizziness, stomach cramps, runny nose, skin warm, pruritus, neck swelling, nausea and hives were recovering/resolving. The reporter considered the allergic reaction, dizziness, stomach cramps, runny nose, skin warm, pruritus, neck swelling, nausea and hives to be almost certainly related to BEXSERO. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by the mother of the patient. The patient experienced an allergic reaction described as dizziness, nausea, stomach cramps, light headedness, hives, feeling warm to the touch, itching, raised skin swelling around the neck, and runny nose about an hour after receiving a dose of BEXSERO. The patient was taken to the emergency room and was given BENADRYL. The batch number of BEXSERO vaccine was unknown.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Skin warm, Swelling face, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 19-year-old male patient who received BEXSERO. On 10th November 2016, the patient received BEXSERO (intramuscular). On 10th November 2016, 1 hr after receiving BEXSERO, the patient experienced allergic reaction, dizziness, stomach cramps, runny nose, skin warm, pruritus, neck swelling, nausea and hives. The patient was treated with BENADRYL. On an unknown date, the outcome of the allergic reaction, dizziness, stomach cramps, runny nose, skin warm, pruritus, neck swelling, nausea and hives were recovering/resolving. The reporter considered the allergic reaction, dizziness, stomach cramps, runny nose, skin warm, pruritus, neck swelling, nausea and hives to be almost certainly related to BEXSERO. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by the mother of the patient. The patient experienced an allergic reaction described as dizziness, nausea, stomach cramps, light headedness, hives, feeling warm to the touch, itching, raised skin swelling around the neck, and runny nose about an hour after receiving a dose of BEXSERO. The patient was taken to the emergency room and was given BENADRYL. The batch number of BEXSERO vaccine was unknown.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Abdominal pain upper, Dizziness, Hypersensitivity, Local swelling, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 19-year-old male patient who received BEXSERO. On 10th November 2016, the patient received BEXSERO (intramuscular). On 10th November 2016, 1 hr after receiving BEXSERO, the patient experienced allergic reaction, dizziness, stomach cramps, runny nose, skin warm, pruritus, neck swelling, nausea and hives. The patient was treated with BENADRYL. On an unknown date, the outcome of the allergic reaction, dizziness, stomach cramps, runny nose, skin warm, pruritus, neck swelling, nausea and hives were recovering/resolving. The reporter considered the allergic reaction, dizziness, stomach cramps, runny nose, skin warm, pruritus, neck swelling, nausea and hives to be almost certainly related to BEXSERO. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by the mother of the patient. The patient experienced an allergic reaction described as dizziness, nausea, stomach cramps, light headedness, hives, feeling warm to the touch, itching, raised skin swelling around the neck, and runny nose about an hour after receiving a dose of BEXSERO. The patient was taken to the emergency room and was given BENADRYL. The batch number of BEXSERO vaccine was unknown.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Pruritus, Rhinorrhoea, Skin warm, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 19-year-old male patient who received BEXSERO. On 10th November 2016, the patient received BEXSERO (intramuscular). On 10th November 2016, 1 hr after receiving BEXSERO, the patient experienced allergic reaction, dizziness, stomach cramps, runny nose, skin warm, pruritus, neck swelling, nausea and hives. The patient was treated with BENADRYL. On an unknown date, the outcome of the allergic reaction, dizziness, stomach cramps, runny nose, skin warm, pruritus, neck swelling, nausea and hives were recovering/resolving. The reporter considered the allergic reaction, dizziness, stomach cramps, runny nose, skin warm, pruritus, neck swelling, nausea and hives to be almost certainly related to BEXSERO. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by the mother of the patient. The patient experienced an allergic reaction described as dizziness, nausea, stomach cramps, light headedness, hives, feeling warm to the touch, itching, raised skin swelling around the neck, and runny nose about an hour after receiving a dose of BEXSERO. The patient was taken to the emergency room and was given BENADRYL. The batch number of BEXSERO vaccine was unknown.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt complained of redness, itchiness, and warmth at site of injection.
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Injection site pain
Clinical narrative: Initial unsolicited case received from a nurse ates on 08 Nov 2016. This case involves a female patient (age not reported) who was immunized with a dose of FLUZONE HIGH DOSE (Batch number: UI659AB Expiry date: 29 Mar 2017, dose and route of administration was not reported) in right deltoid on an unspecified date and time frame. The patient medical history and concomitant medications were not reported. On an unknown date reported as two days after vaccination the patient presented with a tender hematoma radiating down right upper arm. The patient required emergency room or doctor visit. The patient lab tests and corrective treatment was not reported. The outcome of the event was unknown. List of the documents held by the sender: none.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia
Clinical narrative: Initial unsolicited report received from a health care professionalon 09 November 2016. This case involves a 73-year-old female patient who was vaccinated with FLUZONE HD intramuscularly (batch number: UI664AA, expiry date: 06 April 2017, dose and dose in series were not reported) in the left deltoid on 26 October 2016. The reporter denied the patient having any illness at time of vaccination. She had dry eyes but no known allergies. No further information was reported regarding patient's medical history. Concomitant medications were not reported. On 31 October 2016, 5 days post-vaccination, the patient had developed metallic taste in her mouth. Laboratory investigations and corrective treatment were not reported. The event were resolved on 31 October 2016 (reported as 'symtom was resolved at the time the patient contacted the reporter'). List of documents held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2015343690) on 09 November 2016. This case involves a patient (gender and age at onset of event was not reported) who received TETANUS TOXOID (dose, dose in series, batch number and expiry date of product, route and site of administration were not reported) on an unspecified date. The patient's medical history included allergy to adhesive and penicillin (with potassium). Concomitant medications were not reported. On an unspecified date and duration following the vaccination, the patient experienced allergy to vaccine. Laboratory data and corrective treatment were not reported. The outcome of the event were unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Erythema
Clinical narrative: Initial unsolicited report received from a consumer (self) via other company, Pfizer (Reference number-2016497647) on 09 November 2016. This case involves an adult patient (Age and sex was not reported) who was vaccinated with INFLUENZA VACCINE (Flu shot) (lot number, expiration date, dose, dose in series, route of administration and site of administration were not reported) on an unspecified day. Patient's medical history and concomitant medications were not reported. On an unknown day, unspecified timeframe following the vaccination, the patient had developed little redness over arm. Laboratory investigations and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial unsolicited report received from a physician on 10 November 2016. This case involves a 55-year-old female patient who was vaccinated with a dose of Adacel (Batch number: U5502AA, expiry date: 24 November 2018, dose, dose in series and route of administration were not reported) in right deltoid on 01 November 2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as none. Illness at the time of vaccination was also reported as none. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were reported as unknown. On 01 November 2016 in the evening, same day following the vaccination, the patient had developed pain at injection site which was persistent and had continued for nine days. The patient was unable to abduct her right arm greater than 90 degrees. She was rating her pain a 9 out of scale of 10. There was no redness, warmth or swelling at injection site. It was reported that the patient had received prior doses of Adacel. The patient required emergency room (ER)/ doctor visit. Laboratory investigations were reported as none. Corrective treatment was not reported. The outcome of events was reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Colitis, Computerised tomogram abnormal, Computerised tomogram intestine, Culture urine negative
Clinical narrative: Initial unsolicited report received from a physician on 09 November 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of Fluzone High dose (Batch number: UI697AB, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed abdominal pain, diarrhea and mild thickening of colon (suspected colitis) (showed by CT scan). Patient's lab test were normal, stool tests were negative and urine culture was normal. Patient received intravenous (IV) fluids as corrective treatment. On an unspecified date, in two days the patient recovered from all the events. Upon internal review, the company decided to consider the case serious because of important medical events mild thickening of colon (suspected colitis). List of documents held by sender: none. Sender's Comments: This case concerns a female patient who developed abdominal pain and diarrhea after receiving INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that the imaging study (CT scan) showed mild thickening of colon with impression as suspected colitis. Details regarding latency from vaccination, medical history of the patient, vaccination history, concomitant medications, immune status of the patient and reporter causality were not reported. However details regarding latency, medical history of the patient, concurrent conditions, vaccination history, concomitant medications, immune status of the patient and other etiologies would be helpful to further assess this case.
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Gastrointestinal wall thickening, Stool analysis normal
Clinical narrative: Initial unsolicited report received from a physician on 09 November 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of Fluzone High dose (Batch number: UI697AB, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed abdominal pain, diarrhea and mild thickening of colon (suspected colitis) (showed by CT scan). Patient's lab test were normal, stool tests were negative and urine culture was normal. Patient received intravenous (IV) fluids as corrective treatment. On an unspecified date, in two days the patient recovered from all the events. Upon internal review, the company decided to consider the case serious because of important medical events mild thickening of colon (suspected colitis). List of documents held by sender: none. Sender's Comments: This case concerns a female patient who developed abdominal pain and diarrhea after receiving INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that the imaging study (CT scan) showed mild thickening of colon with impression as suspected colitis. Details regarding latency from vaccination, medical history of the patient, vaccination history, concomitant medications, immune status of the patient and reporter causality were not reported. However details regarding latency, medical history of the patient, concurrent conditions, vaccination history, concomitant medications, immune status of the patient and other etiologies would be helpful to further assess this case.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Severe pain in left arm followed by inability to raise or move arm.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Severe pain in arm. Inability to move or raise arm.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal pain, Diarrhoea haemorrhagic, Irritability
Clinical narrative: Fussiness the evening following vaccine, perceived abdominal pain, two episodes of bloody diarrhea.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Fatigue, Malaise, Pyrexia
Clinical narrative: Patient states fever, fatigue, and overall not feeling well.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Adverse event
Clinical narrative: Adverse effect of other viral vaccines, initial encounter on 2016-11-11.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram, Syncope
Clinical narrative: Chest pain, shortness of breath, syncope.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Myalgia, Pyrexia, Urine analysis
Clinical narrative: Severe muscle pain in left arm from top of shoulder to elbow resulting in inability to move the arm.  Fever discovered by 9:30 PM. Fever of 101.9 at the highest.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Blood pressure fluctuation, Diarrhoea, Epistaxis, Erythema, Headache
Clinical narrative: Nosebleeds, fluctuations in blood pressure, diarrhea, vomiting, red streaks on arm, headache.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Nosebleeds, fluctuations in blood pressure, diarrhea, vomiting, red streaks on arm, headache.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swelling and Redness in left arm beginning the evening after immunization and continuing for 4 days. No additional treatment sought, reaction resolved on its own.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure systolic increased, Dizziness, Dry mouth, Dysgeusia, Dyspnoea
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 61 year old female patient. The patient's medical history included a rash across her stomach which she thought was shingles and so went to the doctor on 15-NOV-2016 prior to receiving ZOSTAVAX and was informed that she didn't have shingles. So, she wanted to get the vaccine. On the same day (15-NOV-2016), she was vaccinated with one dose of ZOSTAVAX (lot # M034766 and expiry date: 26-OCT-2017), 1 ml, subcutaneously. On the same day, within seconds of vaccination, she experienced cotton mouth, weird taste, blurry vision, dizziness, numbing in and around her mouth, felt funny and had trouble breathing. An ambulance was called and the paramedics took her in it because they were concerned about her blood pressure which was "through the roof". Her systolic pressure was in 200's and diastolic pressure was unknown. The reporter stated that her vision was coming back but she still felt dizzy while sitting up. The patient was given 25 mg of liquid BENADRYL and had started to feel better but was still experiencing symptoms. It was also reported that she started feeling better prior to receiving BENADRYL. As of 15-NOV-2016, the patient continued to experience the events even though they were improving. The causal relationship was not reported. The reporter considered the events to be serious due to other medically important and hospitalization. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Hypoaesthesia oral, Vision blurred
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 61 year old female patient. The patient's medical history included a rash across her stomach which she thought was shingles and so went to the doctor on 15-NOV-2016 prior to receiving ZOSTAVAX and was informed that she didn't have shingles. So, she wanted to get the vaccine. On the same day (15-NOV-2016), she was vaccinated with one dose of ZOSTAVAX (lot # M034766 and expiry date: 26-OCT-2017), 1 ml, subcutaneously. On the same day, within seconds of vaccination, she experienced cotton mouth, weird taste, blurry vision, dizziness, numbing in and around her mouth, felt funny and had trouble breathing. An ambulance was called and the paramedics took her in it because they were concerned about her blood pressure which was "through the roof". Her systolic pressure was in 200's and diastolic pressure was unknown. The reporter stated that her vision was coming back but she still felt dizzy while sitting up. The patient was given 25 mg of liquid BENADRYL and had started to feel better but was still experiencing symptoms. It was also reported that she started feeling better prior to receiving BENADRYL. As of 15-NOV-2016, the patient continued to experience the events even though they were improving. The causal relationship was not reported. The reporter considered the events to be serious due to other medically important and hospitalization. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blindness, Dizziness, Dysgeusia, Dyspnoea, Hypertension
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 61 year old female patient. The patient's medical history included a rash across her stomach which she thought was shingles and so went to the doctor on 15-NOV-2016 prior to receiving ZOSTAVAX and was informed that she didn't have shingles. So, she wanted to get the vaccine. On the same day (15-NOV-2016), she was vaccinated with one dose of ZOSTAVAX (lot # M034766 and expiry date: 26-OCT-2017), 1 ml, subcutaneously. On the same day, within seconds of vaccination, she experienced cotton mouth, weird taste, blurry vision, dizziness, numbing in and around her mouth, felt funny and had trouble breathing. An ambulance was called and the paramedics took her in it because they were concerned about her blood pressure which was "through the roof". Her systolic pressure was in 200's and diastolic pressure was unknown. The reporter stated that her vision was coming back but she still felt dizzy while sitting up. The patient was given 25 mg of liquid BENADRYL and had started to feel better but was still experiencing symptoms. It was also reported that she started feeling better prior to receiving BENADRYL. As of 15-NOV-2016, the patient continued to experience the events even though they were improving. The causal relationship was not reported. The reporter considered the events to be serious due to other medically important and hospitalization. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia oral
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 61 year old female patient. The patient's medical history included a rash across her stomach which she thought was shingles and so went to the doctor on 15-NOV-2016 prior to receiving ZOSTAVAX and was informed that she didn't have shingles. So, she wanted to get the vaccine. On the same day (15-NOV-2016), she was vaccinated with one dose of ZOSTAVAX (lot # M034766 and expiry date: 26-OCT-2017), 1 ml, subcutaneously. On the same day, within seconds of vaccination, she experienced cotton mouth, weird taste, blurry vision, dizziness, numbing in and around her mouth, felt funny and had trouble breathing. An ambulance was called and the paramedics took her in it because they were concerned about her blood pressure which was "through the roof". Her systolic pressure was in 200's and diastolic pressure was unknown. The reporter stated that her vision was coming back but she still felt dizzy while sitting up. The patient was given 25 mg of liquid BENADRYL and had started to feel better but was still experiencing symptoms. It was also reported that she started feeling better prior to receiving BENADRYL. As of 15-NOV-2016, the patient continued to experience the events even though they were improving. The causal relationship was not reported. The reporter considered the events to be serious due to other medically important and hospitalization. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure systolic increased, Dizziness, Dry mouth, Dysgeusia, Dyspnoea
Clinical narrative: Weird taste in mouth, numbing of mouth, vision loss. Trouble breathing, dizziness, high blood pressure.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Hypoaesthesia oral, Vision blurred
Clinical narrative: Weird taste in mouth, numbing of mouth, vision loss. Trouble breathing, dizziness, high blood pressure.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blindness, Dizziness, Dysgeusia, Dyspnoea, Hypertension
Clinical narrative: Weird taste in mouth, numbing of mouth, vision loss. Trouble breathing, dizziness, high blood pressure.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia oral
Clinical narrative: Weird taste in mouth, numbing of mouth, vision loss. Trouble breathing, dizziness, high blood pressure.
Age: 72.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 72-year-old female patient received PREVNAR 13, via an unspecified route of administration in the arm, on 13Oct2016, at single dose, for immunisation and INFLUENZA, via an unspecified route of administration in the arm, on 13Oct2016, at unspecified posology, for immunisation. Relevant medical history included spina bifida from 1943 and ongoing (born with spina bifida), back problems (related to spina bifida), allergy multiple (allergic to all antibiotics and a lot of stuff), gallbladder disorder in Sep2016 (she was in the emergency room overnight and was already scheduled for surgery on 25Oct2016), bladder disorder and soreness. Concomitant medications were not reported. The patient previously received an unspecified number of flu shots and pneumonia shots for immunisation and they have caused arm soreness for a day or so. The patient's arms get sore after shots in Oct2016 with outcome of recovered on 15Nov2016.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Grip strength decreased, Hyperhidrosis, Injection site pain, Pyrexia, Thirst
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 10 October 2016. This case involves a 70-year-old female patient who was vaccinated with first dose of FLUZONE HD intramuscularly (batch number, expiry date of product, dose, dose in series and site of administration were not reported) on 04 October 2016. The patient had a medical history of arthritis. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects were reported as none. The patient had not received any other vaccination within four weeks of above vaccination. Other concomitant medications were unknown. On 07 October 2016, 3 days following vaccination, the patient started shivering. On afternoon of 08 October 2016, 4 days after vaccination, patient began shaking violently, could not control her arms and hands, was thirsty but could hold a cup. The patient could not warm up or stop shaking which lasted for 45 min and had 101.2 degree F fever. Tylenol stopped fever. At 2 am on 09 October 2016, 5 days after vaccination, she had a 100.2 degree F fever. After medication, fever broke with sweating. On late afternoon of 09 October 2016, she again started shivering and fever was 100 degree F. On 09 Oct 2016, five days following vaccination, the patient reported her arm was pretty sore at injection site without redness heat or swelling. Laboratory data was reported as none. The patient received corrective treatment with Tylenol for fever. The outcome of the events was reported as unknown. List of documents held by sender: none. Follow up unsolicited report received from a pharmacist on 07 November 2016. The patient had a medical history of hyperthyroidism. Any other vaccination within 4 weeks prior was reported as none. Concomitant medications include Premarin, levothyroxine, Celebrex and Allegra. It was reported as patient was thirsty but could not hold a cup and patient arm was mildly sore. The patient was vaccinated with 0.5 ml dose of FLUZONE HD (batch number UI663AB, expiry date of product 04-APR-2017) on left upper arm. On 10 October 2016, 6 days after vaccination, the patieint had a 100.2 degree F fever from 2:00 am and 5:00 pm. on 11 October 2016, the patient had no fever. On 12 October 2016, at 10:00 am the patient had fever of 100.3 degree F fever. It was reported that on 11 October 2016, the physician had priscribed prednisone for 5 Days. It was reported that the patient had began with prednisone at afternoon. On 13, 14, 15 and 16 of October 2016, the patient had no fever and the event was recovered. List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 10 October 2016. This case involves a 70-year-old female patient who was vaccinated with first dose of FLUZONE HD intramuscularly (batch number, expiry date of product, dose, dose in series and site of administration were not reported) on 04 October 2016. The patient had a medical history of arthritis. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects were reported as none. The patient had not received any other vaccination within four weeks of above vaccination. Other concomitant medications were unknown. On 07 October 2016, 3 days following vaccination, the patient started shivering. On afternoon of 08 October 2016, 4 days after vaccination, patient began shaking violently, could not control her arms and hands, was thirsty but could hold a cup. The patient could not warm up or stop shaking which lasted for 45 min and had 101.2 degree F fever. Tylenol stopped fever. At 2 am on 09 October 2016, 5 days after vaccination, she had a 100.2 degree F fever. After medication, fever broke with sweating. On late afternoon of 09 October 2016, she again started shivering and fever was 100 degree F. On 09 Oct 2016, five days following vaccination, the patient reported her arm was pretty sore at injection site without redness heat or swelling. Laboratory data was reported as none. The patient received corrective treatment with Tylenol for fever. The outcome of the events was reported as unknown. List of documents held by sender: none. Follow up unsolicited report received from a pharmacist on 07 November 2016. The patient had a medical history of hyperthyroidism. Any other vaccination within 4 weeks prior was reported as none. Concomitant medications include Premarin, levothyroxine, Celebrex and Allegra. It was reported as patient was thirsty but could not hold a cup and patient arm was mildly sore. The patient was vaccinated with 0.5 ml dose of FLUZONE HD (batch number UI663AB, expiry date of product 04-APR-2017) on left upper arm. On 10 October 2016, 6 days after vaccination, the patieint had a 100.2 degree F fever from 2:00 am and 5:00 pm. on 11 October 2016, the patient had no fever. On 12 October 2016, at 10:00 am the patient had fever of 100.3 degree F fever. It was reported that on 11 October 2016, the physician had priscribed prednisone for 5 Days. It was reported that the patient had began with prednisone at afternoon. On 13, 14, 15 and 16 of October 2016, the patient had no fever and the event was recovered. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Adverse reaction
Clinical narrative: Initial unsolicited report received from a Physician via other company (Pfizer) on 07 November 2016. (Manufacturer report number: 2016493474) This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (dose, batch number, expiration date site and route of administration was not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following vaccination patient had a reaction. Lab data and corrective treatment were not reported. Outcome of event was not reported. List of documents held by sender: none.
Age: 29.0
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 29 year old female patient. The patient did not have any pertinent disease history. The patient had a medical chart history of an allergy to CECLOR (no details or dates were available about this allergic reaction). The patient was pregnant with last menstrual period (LMP) 11-APR-2016 and estimated date of delivery (EDD) 16-JAN-2017. The patient was using PRENATE PIXIE (manufacturer unspecified) therapy which was started on 07-MAY-2016. On 19-OCT-2016, at gestation age of 27 weeks and 1 day, the patient was vaccinated with a dose of vaccinated with GARDASIL 9 (dose and route unknown; lot number was reported as M021407 with expiration date 30-APR-2018) and influenza virus vaccine (unspecified) (dose, route, lot# and expiration date unknown). No known adverse effects were reported. Pregnancy outcome was pending. The fetal outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to three unknown patients of unknown gender and age. The patients' pertinent medical history, concomitant medications, drug reactions and allergies were not reported. On an unspecified date, the patients were vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, lot#, and expiration date were not reported). On the same day, the patients were administered additionally a dose of unspecified influenza virus vaccine (reported as flu vaccine). Both vaccines were administered in the same arm in all three patients. On an unknown date, the patients experienced severe flu like symptoms, consisting of high fever and chills. The patients sought medical attention but it was unknown if treatment was given for the event. Outcome of adverse event was not reported. The relatedness between the event was not reported. Additional information is not expected as there was no consent to contact the reporter.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Aphasia, Electrocardiogram normal, Electroencephalogram normal, Hemiplegia, Intensive care
Clinical narrative: Patient had a seizure on the morning of 10/22. The day after getting the flu shot. She had to be air lifted to hospital where she was in ICU for a few days. When she was taken off the vent and woke up she was paralyzed on her Right side and unable to speak. The MRI, EEG, EKG, Spinal tap and other test came back negative. We are currently on the therapy floor due to the paralysis. The doctors are puzzled as to why she still has all of these symptoms.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test normal, Lumbar puncture normal, Mechanical ventilation, Nuclear magnetic resonance imaging normal, Seizure
Clinical narrative: Patient had a seizure on the morning of 10/22. The day after getting the flu shot. She had to be air lifted to hospital where she was in ICU for a few days. When she was taken off the vent and woke up she was paralyzed on her Right side and unable to speak. The MRI, EEG, EKG, Spinal tap and other test came back negative. We are currently on the therapy floor due to the paralysis. The doctors are puzzled as to why she still has all of these symptoms.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on left arm, back, right side, and leg. occurred a week after the vaccine was given. no additional treatment sought.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed a shingles rash on her back.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: My right upper arm and shoulder were extremely painful. My range of motion seemed limited, due to "shocks-of-pain" with certain movements.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patients arm is sore, hard, and red where the injection was given.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Lethargy, Pyrexia
Clinical narrative: Intense leg pain, Lethargic, High Fever.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Lip swelling, Pharyngeal oedema, Swelling face
Clinical narrative: Swelling to face, lips, throat, difficulty breathing, given Solumedrol in Urgent Care, monitored.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Guillain-Barre syndrome, Pyrexia, Vomiting
Clinical narrative: TIRED, VOMITING, FEVER.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Neck pain
Clinical narrative: Patient stated that he had some pain in the back of his head and upper neck. After 20 minutes patient still reported to have some pain. He left the pharmacy after 30 minutes.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Guillain-Barre syndrome
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of Guillain Barre syndrome in a 49-year-old male patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, several  days after receiving Influenza vaccine, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant), difficulty breathing and weakness. On an unknown date, the outcome of the Guillain Barre syndrome, difficulty breathing and weakness were unknown. It was unknown if the reporter considered the Guillain Barre syndrome, difficulty breathing and weakness to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. In 2002, the patient received influenza vaccine (unknown brand). A few days after receiving the Influenza vaccine, the patient experienced Guillain-Barre syndrome. The Guillain-Barre syndrome was described as weakness occurring and breathing problems. The patient went to the hospital (details unknown). The patient stated that, since 2002 he had various other immunizations but not the Flu shot, and no adverse symptoms were occurred. However, there was no documentation of any vaccinations received for this patient since 2002. The healthcare professional called to ask about the incidence of Guillain-Barre syndrome occurring with administration of the BOOSTRIX vaccine, as the healthcare professional was considering possibly giving the BOOSTRIX vaccine to the patient.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of anaphylactic reaction in a 39-year-old female patient who received FLUARIX QUADRIVALENT (batch number 7FF3N, expiry date 30th June 2017). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, 30 min after receiving FLUARIX QUADRIVALENT, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). The patient was treated with EPI PEN, BENADRYL, ZYRTEC and steroids NOS. On an unknown date, the outcome of the anaphylactic reaction was recovered/resolved. It was unknown if the reporter considered the anaphylactic reaction to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient was admitted to the emergency room (ER). The patient stated that no other vaccines were taken that day and all symptoms have since resolved. No further information was reported regarding the event.
Sex: U
Vaccine: PPV
Symptoms: Adverse event, Extra dose administered
Clinical narrative: This spontaneous report was received from a pharmacist concerning an unspecified patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unspecified date in March 2016, the patient received a dose of PNEUMOVAX 23 (strength, dose, route of administration, lot number and expiration date were not reported). On an unspecified dates in October 2016, the patient received another dose of PNEUMOVAX 23 while the patient was hospitalized for an unspecified reason (Adverse event). At the time of the report, the outcome for the unspecified adverse event was not reported. The causality between the PNEUMOVAX 23 and the event was not reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Nausea, Pain
Clinical narrative: NAUSEOUS, extreme headache, body aches.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity, X-ray
Clinical narrative: Pain in arm (not at injection site), unable to move arm freely.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a patient who received FLUARIX QUADRIVALENT. Previously administered products included Flu vaccine with an associated reaction of adverse reaction (for tolerance refer case US2016GSK169625). On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced injection site swelling, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site warmth and injection site erythema were unknown. The reporter considered the injection site swelling, injection site warmth and injection site erythema to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient's age at vaccination was not provided. The reporter had limited details regarding vaccination. This was the 4th case of 6 cases reported by the same reporter. This case was linked with US2016GSK169625, for same patient.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site irritation, Rash generalised, Throat tightness, Urticaria
Clinical narrative: This case was reported by other health professional via call center representative and described the occurrence of injection site redness in a 56-year-old male patient who received FLUARIX QUADRIVALENT (batch number H3S5D, expiry date 31st May 2017). Concurrent medical conditions included bicuspid aortic valve (The patient reported that he had this all his life), overweight and back disorder. Concomitant products included nutritional supplement (Probiotics), MICARDIS, fish oil, whey protein (Immunocal), LESCOL, calcium and Testosterone cream. On 25th October 2016, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 26th October 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site redness, generalized rash, tiredness, generalized urticaria, wheezing, throat tightness and injection site irritation. On an unknown date, the outcome of the injection site redness, generalized rash, tiredness, generalized urticaria, wheezing, throat tightness and injection site irritation were not recovered/not resolved. The reporter considered the injection site redness and injection site irritation to be probably related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the generalized rash, tiredness, generalized urticaria, wheezing and throat tightness to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient reported that he was a retired paramedic. The patient received Multivitamin as a concomitant medication. The patient received a dose of FLUARIX QUADRIVALENT in her left deltoid. The patient experienced rash, welts and hives on body. The patient planned to continue follow up with his physician on an unknown date. The patient sent pictures of the welts he experienced on his right arm on the date of reporting (pictures provided were 30 minutes a part, before and after).
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: This case was reported by other health professional via call center representative and described the occurrence of injection site redness in a 56-year-old male patient who received FLUARIX QUADRIVALENT (batch number H3S5D, expiry date 31st May 2017). Concurrent medical conditions included bicuspid aortic valve (The patient reported that he had this all his life), overweight and back disorder. Concomitant products included nutritional supplement (Probiotics), MICARDIS, fish oil, whey protein (Immunocal), LESCOL, calcium and Testosterone cream. On 25th October 2016, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 26th October 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site redness, generalized rash, tiredness, generalized urticaria, wheezing, throat tightness and injection site irritation. On an unknown date, the outcome of the injection site redness, generalized rash, tiredness, generalized urticaria, wheezing, throat tightness and injection site irritation were not recovered/not resolved. The reporter considered the injection site redness and injection site irritation to be probably related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the generalized rash, tiredness, generalized urticaria, wheezing and throat tightness to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient reported that he was a retired paramedic. The patient received Multivitamin as a concomitant medication. The patient received a dose of FLUARIX QUADRIVALENT in her left deltoid. The patient experienced rash, welts and hives on body. The patient planned to continue follow up with his physician on an unknown date. The patient sent pictures of the welts he experienced on his right arm on the date of reporting (pictures provided were 30 minutes a part, before and after).