chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Paraesthesia, Rash vesicular, Tenderness
Clinical narrative: Tenderness; headache; tired; bad shivering for about 1 ½ hours. (AE: Shivering); rash / tender in touch / no itching / 5 inches away from injection site/rash on arm/Vesicular rash/it feels like shingles; it tingles; feeling ill; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 5th October 2020, the patient received the 2nd dose of Shingrix. On 5th October 2020, 8 hrs after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced shivering. On 6th October 2020, the patient experienced headache and tiredness. In October 2020, the patient experienced vesicular rash, tingling and feeling unwell. On an unknown date, the patient experienced tenderness. On an unknown date, the outcome of the vesicular rash, tingling and tenderness were unknown and the outcome of the shivering was recovered/resolved and the outcome of the headache, tiredness and feeling unwell were not recovered/not resolved.   It was unknown if the reporter considered the vesicular rash, shivering, headache, tiredness, tingling, tenderness and feeling unwell to be related to Shingrix.  Additional details were reported as follows: The reporter is the patient herself. The patient 2nd dose of shingrix and experienced bad shivering for about 1 and half hour, headache, tired, rash almost like shingles, does not looked like shingles, but feels it, because it tingles. The patient described rash as tender in touch with no itching. The reporter mentioned that, rash was not at injection site, but was in same arm, 5 inches away from injection site and felt still ill at the day of reporting. The patient also experienced aches, was tired and flu like symptoms which lasted for 36 hours after receiving 1st dose of shingrix 2 months ago. Lot and expiration date were not provided. The reporter did not consent to follow up. For tolerance of 1st dose, refer case US2020201539.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020201539:same reporter
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Arthralgia, Chills, Paraesthesia, Pyrexia, Skin burning sensation
Clinical narrative: chills; low grade fever; sever joint pain; burning scalp; paresthesias; This case was reported by a physician and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 2nd October 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, 7 hrs after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced chills, fever, joint pain, burning sensation scalp and paresthesia. On an unknown date, the outcome of the chills, fever, joint pain, burning sensation scalp and paresthesia were recovered/resolved.   It was unknown if the reporter considered the chills, fever, joint pain, burning sensation scalp and paresthesia to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows:  The age at vaccination was not reported. The patient suffered chills, low grade fever, severe joint pain and burning scalp paresthesia than began 7 hours after injection and peaked 12 hours after inject, resolving 3 hours after peak. He had an influenza injection at the same time. The reporter reported questions to VAERS site as, did dare to take the second vaccination in the series I should note, his symptoms were severe enough he almost went to the hospital because of the degree of pain.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Erythema, Headache, Injection site erythema, Injection site warmth
Clinical narrative: Shoulder to elbow it was red; Warm to the touch; 3-4 inch area around injection site; Red / 3-4 inch area around injection site; Itching; Pain; Headache; Unspecified gastrointestinal issues (GI); This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingrix with an associated reaction of herpes zoster (1st dose received on unknown date. refer case US2020AMR203749).   On 8th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced erythema, injection site warmth, injection site erythema, pruritus, pain, headache and gastrointestinal discomfort. On an unknown date, the outcome of the erythema, pruritus, pain and headache were not recovered/not resolved and the outcome of the injection site warmth was unknown and the outcome of the injection site erythema and gastrointestinal discomfort were recovered/resolved.   It was unknown if the reporter considered the erythema, injection site warmth, injection site erythema, pruritus, pain, headache and gastrointestinal discomfort to be related to Shingrix.  Additional details were as follows: Pharmacist reported that an 85 year old female patient received the 2nd dose of shingrix on 8th October,2020 and experienced events like her shoulder to elbow it was red and has gone down but it was still red and warm to the touch and  3-4 inch area around injection site. Also she experienced some itching, pain, headache and unspecified gastrointestinal issues (GI) and The GI issues have resolved. The itching, pain, and headache are ongoing. The reporter consented to follow up. This case has been linked to US2020AMR203749 case.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR203749:
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus
Clinical narrative: Shoulder to elbow it was red; Warm to the touch; 3-4 inch area around injection site; Red / 3-4 inch area around injection site; Itching; Pain; Headache; Unspecified gastrointestinal issues (GI); This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingrix with an associated reaction of herpes zoster (1st dose received on unknown date. refer case US2020AMR203749).   On 8th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced erythema, injection site warmth, injection site erythema, pruritus, pain, headache and gastrointestinal discomfort. On an unknown date, the outcome of the erythema, pruritus, pain and headache were not recovered/not resolved and the outcome of the injection site warmth was unknown and the outcome of the injection site erythema and gastrointestinal discomfort were recovered/resolved.   It was unknown if the reporter considered the erythema, injection site warmth, injection site erythema, pruritus, pain, headache and gastrointestinal discomfort to be related to Shingrix.  Additional details were as follows: Pharmacist reported that an 85 year old female patient received the 2nd dose of shingrix on 8th October,2020 and experienced events like her shoulder to elbow it was red and has gone down but it was still red and warm to the touch and  3-4 inch area around injection site. Also she experienced some itching, pain, headache and unspecified gastrointestinal issues (GI) and The GI issues have resolved. The itching, pain, and headache are ongoing. The reporter consented to follow up. This case has been linked to US2020AMR203749 case.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR203749:
Sex: U
Vaccine: VARZOS
Symptoms: Bedridden, Pain
Clinical narrative: pain so bad after the first Shingrix dose; could not get out of bed for a week; This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and bedridden. Shingrix was discontinued. On an unknown date, the outcome of the pain was unknown and the outcome of the bedridden was recovered/resolved.   It was unknown if the reporter considered the pain and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Patients experienced pain so bad that they could not get out of bed for a week and they declined to receive the second dose. No further details were provided. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202994:same reporter
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: pt states red rash at injection site that is moving down her arm-no pain reported
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Rash erythematous
Clinical narrative: Red rash on upper arm but not at injection site
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Ongoing fever (100degs) > 2 days; pain, swelling and redness at injection site; headache; fatigue; general aches
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Ongoing fever (100degs) > 2 days; pain, swelling and redness at injection site; headache; fatigue; general aches
Age: 16.0
Sex: U
Vaccine: MENB
Symptoms: Asthenia, Gait disturbance, Syncope
Clinical narrative: Patient was given first dose of Meningococcal B (Pfizer/Wyeth) by MA. She was then escorted to exit door by MA who noted patient walking differently. MA alerted LPN of patient status. Patient states that she felt weak and faint. Patient was assisted to a row of chairs to recline and elevate legs. Ice pack was place on back head, cool cloth to forehead, juice box and crackers given.  5:12pm: BP 120/60 P59 O2sat 99% laying 5:20pm: BP 120/70 P81 O2sat 99% sitting 5:30pm: BP 120/72 P88 O2sat 99% standing Patient reported feeling fie and ready to leave. Father was outside in car. Patient escorted to the car without incident.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Neck pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm became red, swollen, warm to touch. Given Benadryl and Pepcid that day. Next day arm was sore up to neck but redness area was improving.  Two days later no symptoms, redness resolved, pain resolved.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Hypersomnia, Injection site reaction, Injection site swelling
Clinical narrative: Developed swelling at the injection site along with red splotches, rash-like on arm down to elbow and other areas of body.  Also was very fatigued, slept more and had no energy for 3 weeks post vaccination.  Client phoned her provider to ask if she should receive the second dose of the shingles vaccine-provider stated yes.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: Developed swelling at the injection site along with red splotches, rash-like on arm down to elbow and other areas of body.  Also was very fatigued, slept more and had no energy for 3 weeks post vaccination.  Client phoned her provider to ask if she should receive the second dose of the shingles vaccine-provider stated yes.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Herpes zoster, Intensive care
Clinical narrative: Patient received vaccine on 10/8, on 10/13 patient experienced severe chest pain and was hospitalized in the ICU, then was diagnosed with the shingles.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Injection site urticaria, Pruritus, Pyrexia
Clinical narrative: Itching, redness, fever and hives at injection site
Age: 36.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Chills, Exposure during pregnancy, Hyperhidrosis, Influenza virus test negative, Pancytopenia
Clinical narrative: Developed severe chills/sweating 48 hours after vaccine. Afebrile. Was seen in urgent care, found to be tachycardic and sent to ER for further eval. Blood work showed pancytopenia. Negative for COVID, paro, and flu. No other cause for pancytopenia identified. Patient remain pregnant and was told baby is doing fine.
Age: 36.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Parvovirus B19 test negative, SARS-CoV-2 test negative, Tachycardia
Clinical narrative: Developed severe chills/sweating 48 hours after vaccine. Afebrile. Was seen in urgent care, found to be tachycardic and sent to ER for further eval. Blood work showed pancytopenia. Negative for COVID, paro, and flu. No other cause for pancytopenia identified. Patient remain pregnant and was told baby is doing fine.
Age: 36.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Asthenia, Chills, Exposure during pregnancy, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Developed severe chills/sweating 48 hours after vaccine. Afebrile. Was seen in urgent care, found to be tachycardic and sent to ER for further eval. Blood work showed pancytopenia. Negative for COVID, paro, and flu. No other cause for pancytopenia identified. Patient remain pregnant and was told baby is doing fine.
Age: 36.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Hyperhidrosis, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Lymphocyte count
Clinical narrative: Developed severe chills/sweating 48 hours after vaccine. Afebrile. Was seen in urgent care, found to be tachycardic and sent to ER for further eval. Blood work showed pancytopenia. Negative for COVID, paro, and flu. No other cause for pancytopenia identified. Patient remain pregnant and was told baby is doing fine.
Age: 36.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Mean platelet volume normal, Neutrophil count, Pain, Pancytopenia, Platelet count decreased
Clinical narrative: Developed severe chills/sweating 48 hours after vaccine. Afebrile. Was seen in urgent care, found to be tachycardic and sent to ER for further eval. Blood work showed pancytopenia. Negative for COVID, paro, and flu. No other cause for pancytopenia identified. Patient remain pregnant and was told baby is doing fine.
Age: 36.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Red blood cell count decreased, SARS-CoV-2 test negative, White blood cell count decreased
Clinical narrative: Developed severe chills/sweating 48 hours after vaccine. Afebrile. Was seen in urgent care, found to be tachycardic and sent to ER for further eval. Blood work showed pancytopenia. Negative for COVID, paro, and flu. No other cause for pancytopenia identified. Patient remain pregnant and was told baby is doing fine.
Age: 36.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Chills, Exposure during pregnancy, Hyperhidrosis, Influenza virus test negative, Pancytopenia
Clinical narrative: 16 weeks pregnant at time of vaccination. 48 hours after vaccination started experiencing severe chills followed by profuse sweating, extreme weakness and body aches. No fever. Flu, covid and Parvo virus tests returned negative.  Referred to emergency room 72 hours after vaccination with resting heart rate of 115. While chill/sweating symptoms had disappeared after 72 hours, bloodwork from ER visit showed acute pancytopenia. Bloodwork performed 5 days after vaccination showed all levels returned to normal and all other symptoms had resolved. Fetal ultrasound at 18 weeks (2 weeks after vaccination) appeared normal.
Age: 36.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Parvovirus B19 test negative, SARS-CoV-2 test negative, Tachycardia
Clinical narrative: 16 weeks pregnant at time of vaccination. 48 hours after vaccination started experiencing severe chills followed by profuse sweating, extreme weakness and body aches. No fever. Flu, covid and Parvo virus tests returned negative.  Referred to emergency room 72 hours after vaccination with resting heart rate of 115. While chill/sweating symptoms had disappeared after 72 hours, bloodwork from ER visit showed acute pancytopenia. Bloodwork performed 5 days after vaccination showed all levels returned to normal and all other symptoms had resolved. Fetal ultrasound at 18 weeks (2 weeks after vaccination) appeared normal.
Age: 36.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Asthenia, Chills, Exposure during pregnancy, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: 16 weeks pregnant at time of vaccination. 48 hours after vaccination started experiencing severe chills followed by profuse sweating, extreme weakness and body aches. No fever. Flu, covid and Parvo virus tests returned negative.  Referred to emergency room 72 hours after vaccination with resting heart rate of 115. While chill/sweating symptoms had disappeared after 72 hours, bloodwork from ER visit showed acute pancytopenia. Bloodwork performed 5 days after vaccination showed all levels returned to normal and all other symptoms had resolved. Fetal ultrasound at 18 weeks (2 weeks after vaccination) appeared normal.
Age: 36.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Hyperhidrosis, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Lymphocyte count
Clinical narrative: 16 weeks pregnant at time of vaccination. 48 hours after vaccination started experiencing severe chills followed by profuse sweating, extreme weakness and body aches. No fever. Flu, covid and Parvo virus tests returned negative.  Referred to emergency room 72 hours after vaccination with resting heart rate of 115. While chill/sweating symptoms had disappeared after 72 hours, bloodwork from ER visit showed acute pancytopenia. Bloodwork performed 5 days after vaccination showed all levels returned to normal and all other symptoms had resolved. Fetal ultrasound at 18 weeks (2 weeks after vaccination) appeared normal.
Age: 36.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Mean platelet volume normal, Neutrophil count, Pain, Pancytopenia, Platelet count decreased
Clinical narrative: 16 weeks pregnant at time of vaccination. 48 hours after vaccination started experiencing severe chills followed by profuse sweating, extreme weakness and body aches. No fever. Flu, covid and Parvo virus tests returned negative.  Referred to emergency room 72 hours after vaccination with resting heart rate of 115. While chill/sweating symptoms had disappeared after 72 hours, bloodwork from ER visit showed acute pancytopenia. Bloodwork performed 5 days after vaccination showed all levels returned to normal and all other symptoms had resolved. Fetal ultrasound at 18 weeks (2 weeks after vaccination) appeared normal.
Age: 36.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Red blood cell count decreased, SARS-CoV-2 test negative, White blood cell count decreased
Clinical narrative: 16 weeks pregnant at time of vaccination. 48 hours after vaccination started experiencing severe chills followed by profuse sweating, extreme weakness and body aches. No fever. Flu, covid and Parvo virus tests returned negative.  Referred to emergency room 72 hours after vaccination with resting heart rate of 115. While chill/sweating symptoms had disappeared after 72 hours, bloodwork from ER visit showed acute pancytopenia. Bloodwork performed 5 days after vaccination showed all levels returned to normal and all other symptoms had resolved. Fetal ultrasound at 18 weeks (2 weeks after vaccination) appeared normal.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Muscular weakness
Clinical narrative: pt complained of muscle weakness in legs and balance issues due to that and possible falling
Age: 1.33
Sex: M
Vaccine: DTAP, FLU4, HIBV, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever to 104 by temporal thermometer. Down to 102.7 by removing extra blankets. Gave Tylenol. No redness, streaking or swelling. Area of immunization is not painful.
Age: 14.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Pain, Pyrexia, Syncope, Vomiting
Clinical narrative: seasonal flu shot  in left shoulder.  Reaction: chills @ 6 hours. Fever, vomiting and body aches @15 hours.  Fainted in shower @ 15 hours and began having chills again.  Resolution by 36 hours
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: Headache chills body aches
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site
Clinical narrative: pt states that vaccine was given too high on left arm, hurt, later was not able to use/lift arm, going to dr today 10/15/20 to assess
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Shoulder injury related to vaccine administration
Clinical narrative: Immediate severe pain in left shoulder, pain became increasingly worse. Unable to lift arm, bend shoulder, unable to groom properly not able to use left arm at it's full capacity due to significant pain.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th September 2020, the patient received Shingrix. On 9th October 2020, 10 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but was selected as adult as per vaccine indication. The patient had a case of shingles that broke out 2 days ago from the day of reporting.
Sex: F
Vaccine: FLUX
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: Patient got SIRVA (Shoulder injury Related vaccine administration); This case was reported by a consumer via interactive digital media and described the occurrence of shoulder injury related to vaccine administration in a adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced shoulder injury related to vaccine administration. The patient was treated with non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the shoulder injury related to vaccine administration was not recovered/not resolved.   It was unknown if the reporter considered the shoulder injury related to vaccine administration to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient's parent who stated that the patient got shoulder injury related to vaccine administration (SIRVA) and was then under going physical therapy.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: received mi first Shingrix vaccine / ended up with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received the vaccine at the end of May 2020 and ended up with shingles on his or her left hand and was treated with antiviral medication on 5th July 2020.  The reporter stated that he or she might had to wait longer than the typical 2 to 6 months for his or her second shot.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Incorrect dose administered, Product preparation issue
Clinical narrative: Mild headache; Mild fatigue; Didn't mix the vaccine properly / thinks I didn't get the proper vaccine; Didn't mix the vaccine properly; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced headache, fatigue, inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the headache and fatigue were recovered/resolved and the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   It was unknown if the reporter considered the headache and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The reporter stated that, next day after vaccination, the patient experienced mild headache and mild fatigue. The reporter stated that, the pharmacist did not mix the vaccine properly and thought that did not the proper vaccine, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: bad local reaction / injection site hurt; bad local reaction / injection site / was swollen; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than a year after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were reported as follows: The patient received the 1st dose of Shingrix and developed a bad local reaction. She mentioned that she received the dose along with flu shot (could not specify which one) and the injection site hurt and was swollen. The reporter consented to follow up. For toleranace of 2nd dose, refer case US2020AMR201322.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR201322:same patient (2nd dose)
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash papular
Clinical narrative: rash on her side/rash on her trunk area on both sides/erupting on her trunk/little breakouts; itching / is still experiencing come itching/itchy; Bumps; This case was reported by a consumer via call center representative and described the occurrence of rash in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, between 1 and 2 months after receiving Shingrix, the patient experienced rash, pruritus and rash papular. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the rash and rash papular were unknown and the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the rash, pruritus and rash papular to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the vaccine in her left arm and developed a rash on her trunk area on both sides.  It was currently erupting on her trunk and started 3-4 weeks ago and was itchy and it had bumps.  The physician provided 10 day Anti-Viral medication. Itching was not resolved and patient notified physician again on 10th August 2020 and wanted to know if this was common after receiving the Shingrix vaccine. She had completed the antiviral but still had little breakouts at the time of reporting. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site paraesthesia
Clinical narrative: Swelling from the injection site (right arm) which radiates all the way to the customer's forearm and wrist; Redness from the injection site (right arm) which radiates all the way to the customer's forearm and wrist; Pain from the injection site (right arm) which radiates all the way to the customer's forearm and wrist; Tingling from the injection site (right arm) which radiates all the way to the customer's forearm and wrist; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number JP427, expiry date 13th May 2022) for prophylaxis.   On 7th October 2020, the patient received the 1st dose of Shingrix. On 10th October 2020, 3 days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, erythema of extremities, pain in arm and tingling of extremity. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema of extremities, pain in arm and tingling of extremity were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema of extremities, pain in arm and tingling of extremity to be related to Shingrix.  Additional details were provided as follows: The patient had received vaccine at right deltoid and around 10th October 2020, the patient had reported swelling, redness, pain, tingling from the injection site (right arm) which radiated all the way to the patient's forearm and wrist. The swelling was more at the upper arm upto the elbow and only slight swelling was there below the elbow. The patient had also reported that she was in lot of pain a day before the reporting date, but  the pain had improved on the reporting date. The reporter consented to follow-up and fax details were provided.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain in extremity, Paraesthesia
Clinical narrative: Swelling from the injection site (right arm) which radiates all the way to the customer's forearm and wrist; Redness from the injection site (right arm) which radiates all the way to the customer's forearm and wrist; Pain from the injection site (right arm) which radiates all the way to the customer's forearm and wrist; Tingling from the injection site (right arm) which radiates all the way to the customer's forearm and wrist; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number JP427, expiry date 13th May 2022) for prophylaxis.   On 7th October 2020, the patient received the 1st dose of Shingrix. On 10th October 2020, 3 days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, erythema of extremities, pain in arm and tingling of extremity. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema of extremities, pain in arm and tingling of extremity were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema of extremities, pain in arm and tingling of extremity to be related to Shingrix.  Additional details were provided as follows: The patient had received vaccine at right deltoid and around 10th October 2020, the patient had reported swelling, redness, pain, tingling from the injection site (right arm) which radiated all the way to the patient's forearm and wrist. The swelling was more at the upper arm upto the elbow and only slight swelling was there below the elbow. The patient had also reported that she was in lot of pain a day before the reporting date, but  the pain had improved on the reporting date. The reporter consented to follow-up and fax details were provided.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Nausea, Pain in extremity, Pruritus
Clinical narrative: Shingles-like pain and itching/Itching beginning behind the knee/then down to the ankle/then to the top of thigh/ moving to the lower back; Pain moving to the lower back; Pain beginning behind the knee/then down to the ankles; Nausea; Arm pain/Pain to the top of thigh; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included valley fever and shingles.   On 30th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 31st August 2020, 1 days after receiving Shingrix, the patient experienced pain in arm. On 11th September 2020, the patient experienced pruritus, low back pain, knee pain and nausea. On an unknown date, the outcome of the pruritus, low back pain, knee pain, nausea and pain in arm were recovered/resolved.   It was unknown if the reporter considered the pruritus, low back pain, knee pain, nausea and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient had received the first dose and twelve days later, the patient experienced shingles-like pain and itching beginning behind the knee, then down to the ankles, then to the top of thigh, then moving to the lower back and the symptoms had resolved. The patient had also experienced nausea and arm pain, which had also resolved. The reporter did not consent to follow-up.
Age: 2.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Glassy eyes, Musculoskeletal stiffness, Tremor, Unresponsive to stimuli
Clinical narrative: PT was eating lunch today, jello, and began having an episode of shaking, upper body with more tremor movements, eyes glazed over not deviated, left leg stiffened somewhat, episode last for approx 60 seconds, no coughing or choking during episode, no incontinence, did not respond for episode but was reaching for his milk during that time, after episode did not walk immediately but did not have any postictal period, began running around, has since eaten some more , playing, acting normally, episode happened about 1 hr prior to visit, did have 2 yr WCC today, influenza and Hep A vaccines given
Sex: M
Vaccine: FLUC4
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: I am afraid that the patient may not have received the full dose 0.5 ml of flu vaccination because upon admistration (IM left deltoid) some medication escaped from the needle cap.  Some vaccination was injected, some vaccination escaped.  I have no way of confirming the amount injected & the amount escaped.  The patient reported feeling some vaccine on his arm.  I observed some come out of the needle cap.  So I know the full amount injected was not 0.5 ml.  I check with the CDC; they informed the best practise is to reinject the dose in any event that the full dose is not administered. I will readminister the vaccination.
Age: 54.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Swelling face, Tachycardia, Throat irritation
Clinical narrative: 10 mins after administration of influenza and Shingrix vaccine patient experienced facial swelling, scratchy throat, and tachycardia.  Patient self treated with Benadryl 50 mg PO and Pepcid 20 mg PO.  Outcome: adverse reaction symptoms resolved.
Age: 39.0
Sex: F
Vaccine: FLUR4
Symptoms: Burning sensation, Muscular weakness, Paraesthesia
Clinical narrative: Tingling from elbow radiating to hands and burning both feet. Weakness in upper extremities.  Possible Guillian Barre Syndrome.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall, Loss of consciousness, Syncope
Clinical narrative: After patient received vaccine moved to chair so sibling could get their flu shot. Moved without difficulty. While sitting in chair and sister receiving her injection, pt states became light headed and fainted landing on the floor next to the chair. Came around within in few seconds. Alert and oriented. Dad states had a history with fainting during a stress test prior, but not with vaccinations. Remained seated on the floor for few minutes and able to sit up without assitance. Denies any pain. Can move neck and arm/shoulders without difficulty. Answers questions appropriately. Stood and moved back into chair without difficulty. Again no pain when questioned. Did inform patient and dad to make sure to notifity healthcare that she has fainted in the past with injections. To make sure she stays seated for longer period of time or laying down when receives the injection.
Age: 74.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Balance disorder, Decreased appetite, Feeling abnormal, Vertigo, Weight decreased
Clinical narrative: I received the two above mentioned shots at the same time.  In the middle of the night after receiving the shots, I got up to use the bathroom and had severe vertigo (had to walk along the wall, head spinning and feeling of being pulled to the right),  got to the bathroom but had to crawl back to bed.  The vertigo lasted until early Monday, 9/18, 19, 20 and part of 9/21.  As long as I was laying down, I was okay.  Barely ate.  Lost weight.  Did not feel normal for several weeks.    I am hesitant to get the second Shingrix shot.  I do not know if the vertigo will just happen again.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: A red rash down the injected left arm, while also traveling up to neck line on left side. Benadryl 400 mg and rest at 06:30 PM
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Fall, Gaze palsy, Headache, Hypoaesthesia, Seizure
Clinical narrative: Pt was standing and attempting to place her jacket on. Pt fell down on the floor and MOP seemed to think that pt had a small seizure as her eyes rolled back and she was shaking. Ice pack given and vitals taken.  Pt reported 8/10 pain on the back of her head. No blood or swelling of head. No dizziness or nausea. Pt reported feeling numbness in hands that lasted for about 10 mins.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Tremor
Clinical narrative: Pt was standing and attempting to place her jacket on. Pt fell down on the floor and MOP seemed to think that pt had a small seizure as her eyes rolled back and she was shaking. Ice pack given and vitals taken.  Pt reported 8/10 pain on the back of her head. No blood or swelling of head. No dizziness or nausea. Pt reported feeling numbness in hands that lasted for about 10 mins.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Anaemia, Blood smear test abnormal, Cold type haemolytic anaemia, Dyspnoea, Endotracheal intubation
Clinical narrative: Hospital admission 9/13/2020 to 10/8/2020 On date of receipt of vaccine, 9/11/2020 parents noted mild fussiness. On 09/12/2020 he was more tired and did not drink as much as usual. On 9/13/2020 noted to be lethargic, poor color , not drinking and difficulty breathing.  Admitted to Hospital 9/13/2020, 2 days after receiving routine 2 month immunizations of Pentacel, Rotavirus, and PCV with severe anemia (Hgb 2.5), respiratory failure, shock , hypothermia and metabolic acidosis. Intubated and admitted directly to PICU.  Received massive transfusion protocol as well as respiratory and hemodynamic support.  Initial blood smear suspicious for Donath Landsteiner hemolytic anemia.  Able to be extubated within 48 hours, but required sequential multiple transfusions as hemolysis was ongoing.  Further evaluation did not confirm Donath Landsteiner but diagnosis of cold agglutin anemia, unknown etiology. During hospitalization noted to have high pitched cry, with increased right upper extremity tone - Neurology consulted and will follow for possible watershed infarct or ischemic encephalopathy.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Fatigue, Fluid intake reduced, Haemoglobin decreased, Haemolysis, Haemolytic anaemia
Clinical narrative: Hospital admission 9/13/2020 to 10/8/2020 On date of receipt of vaccine, 9/11/2020 parents noted mild fussiness. On 09/12/2020 he was more tired and did not drink as much as usual. On 9/13/2020 noted to be lethargic, poor color , not drinking and difficulty breathing.  Admitted to Hospital 9/13/2020, 2 days after receiving routine 2 month immunizations of Pentacel, Rotavirus, and PCV with severe anemia (Hgb 2.5), respiratory failure, shock , hypothermia and metabolic acidosis. Intubated and admitted directly to PICU.  Received massive transfusion protocol as well as respiratory and hemodynamic support.  Initial blood smear suspicious for Donath Landsteiner hemolytic anemia.  Able to be extubated within 48 hours, but required sequential multiple transfusions as hemolysis was ongoing.  Further evaluation did not confirm Donath Landsteiner but diagnosis of cold agglutin anemia, unknown etiology. During hospitalization noted to have high pitched cry, with increased right upper extremity tone - Neurology consulted and will follow for possible watershed infarct or ischemic encephalopathy.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: High-pitched crying, Hypertonia, Hypothermia, Intensive care, Irritability
Clinical narrative: Hospital admission 9/13/2020 to 10/8/2020 On date of receipt of vaccine, 9/11/2020 parents noted mild fussiness. On 09/12/2020 he was more tired and did not drink as much as usual. On 9/13/2020 noted to be lethargic, poor color , not drinking and difficulty breathing.  Admitted to Hospital 9/13/2020, 2 days after receiving routine 2 month immunizations of Pentacel, Rotavirus, and PCV with severe anemia (Hgb 2.5), respiratory failure, shock , hypothermia and metabolic acidosis. Intubated and admitted directly to PICU.  Received massive transfusion protocol as well as respiratory and hemodynamic support.  Initial blood smear suspicious for Donath Landsteiner hemolytic anemia.  Able to be extubated within 48 hours, but required sequential multiple transfusions as hemolysis was ongoing.  Further evaluation did not confirm Donath Landsteiner but diagnosis of cold agglutin anemia, unknown etiology. During hospitalization noted to have high pitched cry, with increased right upper extremity tone - Neurology consulted and will follow for possible watershed infarct or ischemic encephalopathy.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Lethargy, Metabolic acidosis, Pallor, Respiratory failure, Septic screen
Clinical narrative: Hospital admission 9/13/2020 to 10/8/2020 On date of receipt of vaccine, 9/11/2020 parents noted mild fussiness. On 09/12/2020 he was more tired and did not drink as much as usual. On 9/13/2020 noted to be lethargic, poor color , not drinking and difficulty breathing.  Admitted to Hospital 9/13/2020, 2 days after receiving routine 2 month immunizations of Pentacel, Rotavirus, and PCV with severe anemia (Hgb 2.5), respiratory failure, shock , hypothermia and metabolic acidosis. Intubated and admitted directly to PICU.  Received massive transfusion protocol as well as respiratory and hemodynamic support.  Initial blood smear suspicious for Donath Landsteiner hemolytic anemia.  Able to be extubated within 48 hours, but required sequential multiple transfusions as hemolysis was ongoing.  Further evaluation did not confirm Donath Landsteiner but diagnosis of cold agglutin anemia, unknown etiology. During hospitalization noted to have high pitched cry, with increased right upper extremity tone - Neurology consulted and will follow for possible watershed infarct or ischemic encephalopathy.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Shock, Transfusion
Clinical narrative: Hospital admission 9/13/2020 to 10/8/2020 On date of receipt of vaccine, 9/11/2020 parents noted mild fussiness. On 09/12/2020 he was more tired and did not drink as much as usual. On 9/13/2020 noted to be lethargic, poor color , not drinking and difficulty breathing.  Admitted to Hospital 9/13/2020, 2 days after receiving routine 2 month immunizations of Pentacel, Rotavirus, and PCV with severe anemia (Hgb 2.5), respiratory failure, shock , hypothermia and metabolic acidosis. Intubated and admitted directly to PICU.  Received massive transfusion protocol as well as respiratory and hemodynamic support.  Initial blood smear suspicious for Donath Landsteiner hemolytic anemia.  Able to be extubated within 48 hours, but required sequential multiple transfusions as hemolysis was ongoing.  Further evaluation did not confirm Donath Landsteiner but diagnosis of cold agglutin anemia, unknown etiology. During hospitalization noted to have high pitched cry, with increased right upper extremity tone - Neurology consulted and will follow for possible watershed infarct or ischemic encephalopathy.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Rash papular, Urticaria, Vaccination site reaction
Clinical narrative: urticarial rash at the site of vaccination and at other sites including all extremities and trunk, followed by papular rash in clusters diffusely over body
Age: 1.08
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Death, Influenza virus test negative, SARS-CoV-2 test negative
Clinical narrative: Child found deceased in bed.
Age: 1.08
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Death
Clinical narrative: Child found deceased in bed.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine administered.  Vaccine expiration date was 6/30/2020., vaccine administered on 10/14/2020. Patient denied negative reaction after administration, no signs/symptoms of a reaction.  Per  recommendation of  a website, repeat vaccine should be administered.  Based on that recommendation the visit provider will contact the patient to disuss/ arrange repeat clinic visit for a second vaccine..   What should we do if a dose of expired vaccine is given to a patient?  The dose should be repeated. If the expired dose is a live virus vaccine, you should wait at least 4 weeks after the previous (expired) dose was given before repeating it. If the expired dose is not a live vaccine, the dose should be repeated as soon as possible. If you prefer, you can perform serologic testing to check for immunity for certain vaccinations (e.g., measles, mumps, rubella, varicella, and hepatitis A).
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Diarrhoea, Dyspnoea, Pyrexia, Sinus disorder
Clinical narrative: Same day: fever, cough, shortness of breath, "sinus" - still continuing through today 10/15/20-diarrhea
Age: 22.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness, Vaccine positive rechallenge
Clinical narrative: Patient passed out after injection. Patient replied "no" to previous reaction to vaccine on intake form, but upon questioning stated that this happens every time he gets a flu shot.
Age: 38.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Chills, Dizziness, Fatigue, Headache, Injection site erythema
Clinical narrative: - headache began at 10 pm on 10/12/20 - 10/13  developed 102.3 f fever, chills, dizziness, left deltoid redness, swelling, warmth, pain, headache - 10/15 continues to have headache and fatigue and left arm pain/redness/swelling but no fever. no history of prior vaccine reaction