chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: TDAP
Symptoms: Throat tightness
Clinical narrative: allergic reaction to vaccination; flu like symptoms; swelling face; throat closing; miserable; elevated temperature; crying; feeling unwell; cold symptons; congested; couldn't breathe; couldn't swallow; refused food and water/really needy; refused food and water/really needy; Inappropriate age at vaccine administration; accidental underdose; This case was reported by a consumer via call center representative and described the occurrence of allergy to vaccine in a 3-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   In May 2019, the patient received the 3rd dose of Boostrix. In May 2019, several hours after receiving Boostrix, the patient experienced allergy to vaccine, influenza-like symptoms, facial swelling, throat constriction, feeling miserable, body temperature increased, crying, feeling unwell, cold symptoms, nasal congestion, difficulty breathing, unable to swallow, fluid intake reduced, appetite absent, inappropriate age at vaccine administration and accidental underdose. The patient was treated with antihistamine. On an unknown date, the outcome of the allergy to vaccine, influenza-like symptoms, facial swelling, throat constriction, feeling miserable, body temperature increased, crying, feeling unwell, cold symptoms, nasal congestion, difficulty breathing and unable to swallow were recovered/resolved and the outcome of the fluid intake reduced, appetite absent, inappropriate age at vaccine administration and accidental underdose were unknown.   It was unknown if the reporter considered the allergy to vaccine, influenza-like symptoms, facial swelling, throat constriction, feeling miserable, body temperature increased, crying, feeling unwell, cold symptoms, nasal congestion, difficulty breathing, unable to swallow, fluid intake reduced and appetite absent to be related to Boostrix.  Additional details were provided as follows:  In May 2019, the patient had the Boostrix vaccine and reported that the patient experienced an allergic reaction to the vaccination. Within a couple of hours, after receiving the vaccine, the patient experienced flu like symptoms. And felt miserable and had an elevated temperature and wasn't feeling well and refusing food and water and was really needy.   Five hours later, her whole face started to swell and her throat started closing up. The patient was crying that the patient couldn't swallow.  The patient was describing her symptoms as cold symptoms with a temperature and the patient was congested which got worse with face swelling and the patient couldn't breathe. The patient was taken to the emergency room and stayed for a few hours until the reaction resolved. They gave her an antihistamine and monitored her condition for a few hours before released.  The mother of the patient claims that her daughter's pediatrician already reported the information. The Mother believed that the Boostrix vaccine was her 3rd DTap dose but she couldn't be certain, which led to inappropriate age at vaccine administration and underdose were unknown. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: fever; joint pain; injections site pain; injection site redness; injection site swelling; nausea; shivers; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2019, less than a week after receiving Shingrix, the patient experienced nausea and shivers. On 22nd June 2019, the patient experienced injection site pain, injection site erythema and injection site swelling. On 23rd June 2019, the patient experienced fever and joint pain. The patient was treated with non-drug therapy, non-drug therapy (Ice Pack (No Medication)). On 23rd June 2019, the outcome of the fever was recovered/resolved. On 24th June 2019, the outcome of the nausea was recovered/resolved. On 25th June 2019, the outcome of the shivers was recovered/resolved. On 26th June 2019, the outcome of the injection site pain, injection site swelling and joint pain were recovered/resolved. On an unknown date, the outcome of the injection site erythema was recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, nausea, shivers, fever and joint pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm. Less than a day after receiving his 1st dose, the patient developed injection site pain, swelling and redness. On 22nd June 2019, the patient applied an ice bag at night.  The patient also developed nausea, shivers, fever and joint pain.  All symptoms had resolved except for the site redness, which persisted but had improved daily. The patient did not have vaccine information for this adverse event and did not consent to follow up. There is a discrepancy with respect to the onset date of the events nausea and shivers. In source document, the onset date is reported as 27th June 2019 (future date)and outcome date as 25th and 26 June 2019 respectively. The onset date for nausea and shivers was kept as unknown June 2019 conservatively. Also, the outcome of the events injection site pain, injection site swelling, joint pain, nausea and shivers was reported as recovered/ resolved with sequel but in narrative it was recovered/ resolved. Outcome of all these events is retained as per narrative.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: fever; joint pain; injections site pain; injection site redness; injection site swelling; nausea; shivers; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2019, less than a week after receiving Shingrix, the patient experienced nausea and shivers. On 22nd June 2019, the patient experienced injection site pain, injection site erythema and injection site swelling. On 23rd June 2019, the patient experienced fever and joint pain. The patient was treated with non-drug therapy, non-drug therapy (Ice Pack (No Medication)). On 23rd June 2019, the outcome of the fever was recovered/resolved. On 24th June 2019, the outcome of the nausea was recovered/resolved. On 25th June 2019, the outcome of the shivers was recovered/resolved. On 26th June 2019, the outcome of the injection site pain, injection site swelling and joint pain were recovered/resolved. On an unknown date, the outcome of the injection site erythema was recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, nausea, shivers, fever and joint pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm. Less than a day after receiving his 1st dose, the patient developed injection site pain, swelling and redness. On 22nd June 2019, the patient applied an ice bag at night.  The patient also developed nausea, shivers, fever and joint pain.  All symptoms had resolved except for the site redness, which persisted but had improved daily. The patient did not have vaccine information for this adverse event and did not consent to follow up. There is a discrepancy with respect to the onset date of the events nausea and shivers. In source document, the onset date is reported as 27th June 2019 (future date)and outcome date as 25th and 26 June 2019 respectively. The onset date for nausea and shivers was kept as unknown June 2019 conservatively. Also, the outcome of the events injection site pain, injection site swelling, joint pain, nausea and shivers was reported as recovered/ resolved with sequel but in narrative it was recovered/ resolved. Outcome of all these events is retained as per narrative.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis
Clinical narrative: sweating; This case was reported by a pharmacist via call center representative and described the occurrence of excess sweating in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number XC972, expiry date 29th August 2021) for prophylaxis.   On 26th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 26th June 2019, immediately after receiving Shingrix, the patient experienced excess sweating. On 26th June 2019, the outcome of the excess sweating was recovered/resolved.   It was unknown if the reporter considered the excess sweating to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. The pharmacist just administered the Shingrix vaccine, to a patient and patient was experiencing excessive sweating.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Somnolence
Clinical narrative: drowsiness; extra dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of drowsiness in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) (batch number 9LG54, expiry date 25th September 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 27th March 2019, the patient received the 2nd dose of Shingrix. On 26th June 2019, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, less than a year after receiving Shingrix and less than a day after receiving Shingrix, the patient experienced drowsiness and extra dose administered. On an unknown date, the outcome of the drowsiness and extra dose administered were unknown.   It was unknown if the reporter considered the drowsiness to be related to Shingrix, Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination for 1st dose was not reported. The patient was potentially given a 3rd dose of Shingrix.  The reporter stated that they were not sure if the patient received 3 doses. They could only verify 2 given at their location. No additional information was given. It was not clear after which dose drowsiness was occurred hence all 3 doses of Shingrix were considered as suspects. The vaccination date of the 3rd dose was reported as 26th June 2016 but, it seems to be typhographical error so we have changed it to 26th June 2019.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site pain, Malaise, Myalgia
Clinical narrative: chills; muscle aches; joint aches; arm pain at injection site; felt like crud/crummy; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (received 1st dose in 2019, refer case US2019AMR117378).   On 25th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). In June 2019, 6 hrs after receiving Shingrix, the patient experienced injection site pain and feeling unwell. On 26th June 2019, the patient experienced chills, muscle pain and joint pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, feeling unwell, chills, muscle pain and joint pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, feeling unwell, chills, muscle pain and joint pain to be related to Shingrix.  Additional details were provided as follows: The caller was calling about herself. She mentioned that she was a nurse.  The patient received Shingrix in the deltoid intramuscularly.She said she felt like crud and crummy after receiving Shingrix. Around 3 am woke up with arm pain at the injection site. She says when she woke up later and felt fine but then later developed chills and muscle and joint aches and then slept for 10 hours and felt much better. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: chills; muscle aches; joint aches; arm pain at injection site; felt like crud/crummy; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (received 1st dose in 2019, refer case US2019AMR117378).   On 25th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). In June 2019, 6 hrs after receiving Shingrix, the patient experienced injection site pain and feeling unwell. On 26th June 2019, the patient experienced chills, muscle pain and joint pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, feeling unwell, chills, muscle pain and joint pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, feeling unwell, chills, muscle pain and joint pain to be related to Shingrix.  Additional details were provided as follows: The caller was calling about herself. She mentioned that she was a nurse.  The patient received Shingrix in the deltoid intramuscularly.She said she felt like crud and crummy after receiving Shingrix. Around 3 am woke up with arm pain at the injection site. She says when she woke up later and felt fine but then later developed chills and muscle and joint aches and then slept for 10 hours and felt much better. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Headache, Pain
Clinical narrative: dizziness; headache; body aches; This case was reported by a physician via sales rep and described the occurrence of dizziness in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 23rd May 2019, the patient received the 1st dose of Bexsero. On 23rd May 2019, 2 hrs after receiving Bexsero, the patient experienced dizziness, headache and general body pain. The patient was treated with intravenous fluid (nos) (Intravenous Fluids) and ketorolac trometamol, ketorolac trometamol (Toradol). On 24th May 2019, the outcome of the dizziness, headache and general body pain were recovered/resolved.   The reporter considered the dizziness, headache and general body pain to be related to Bexsero.  Additional information received were as follows: The patient experienced extreme dizziness and body aches. The patient experienced headache followed the center of her head line a mohawk pattern would be. The patient went to the local emergency room where she was given IV fluids and Tordal. The symptoms resolved the next morning. The physician does believe the issues were related to the vaccine. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site pain, Limb discomfort
Clinical narrative: soreness at injection site; discomfort on left side of body; felt the solution going doing the left side of her body; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 3L794, expiry date 21st September 2021) for prophylaxis.   On 31st May 2019, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain, arm discomfort and feeling abnormal. On an unknown date, the outcome of the injection site pain, arm discomfort and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the injection site pain, arm discomfort and feeling abnormal to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. The patient experienced soreness at the injection site on her left arm, she felt the solution going doing the left side of her body and some discomfort on that side, which went away after 1 day.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: muscle aches/ Myalgia; Serum reaction; possible post herpetic neuralgia; Headache; skin discomfort; skin sensation; fatigue; injection site soreness; injection site redness; This case was reported by a other health professional via call center representative and described the occurrence of muscle pain in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date, no adverse event to the 1st dose).   On 5th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 6th June 2019, 1 days after receiving Shingrix, the patient experienced muscle pain, serum reaction, post herpetic neuralgia, headache, skin discomfort, sensitive skin, fatigue, injection site pain and injection site erythema. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the muscle pain, post herpetic neuralgia, headache, skin discomfort, sensitive skin and fatigue were not recovered/not resolved and the outcome of the serum reaction, injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the muscle pain, serum reaction, post herpetic neuralgia, headache, skin discomfort, sensitive skin, fatigue, injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. The health care professional stated that the patient reported skin sensation/discomfort possible post herpetic neuralgia but no rash, muscle aches, headache, mild fatigue following 2nd dose of Shingrix.  The patient took Tylenol which helped to lessen the symptoms but the symptoms still had not resolved. The patient also experienced injection site soreness and redness. The physician's diagnosis was myalgia and other serum reaction due to vaccination initial encounter. The reporter had consented to follow up. There was a discrepancy in outcome of the events, in the source document outcome of the events were reported as recovering/ resolving, but it was reported as not recovered/ resolved. The outcome kept as reported.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Sensitive skin, Serum sickness, Skin discomfort
Clinical narrative: muscle aches/ Myalgia; Serum reaction; possible post herpetic neuralgia; Headache; skin discomfort; skin sensation; fatigue; injection site soreness; injection site redness; This case was reported by a other health professional via call center representative and described the occurrence of muscle pain in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date, no adverse event to the 1st dose).   On 5th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 6th June 2019, 1 days after receiving Shingrix, the patient experienced muscle pain, serum reaction, post herpetic neuralgia, headache, skin discomfort, sensitive skin, fatigue, injection site pain and injection site erythema. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the muscle pain, post herpetic neuralgia, headache, skin discomfort, sensitive skin and fatigue were not recovered/not resolved and the outcome of the serum reaction, injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the muscle pain, serum reaction, post herpetic neuralgia, headache, skin discomfort, sensitive skin, fatigue, injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. The health care professional stated that the patient reported skin sensation/discomfort possible post herpetic neuralgia but no rash, muscle aches, headache, mild fatigue following 2nd dose of Shingrix.  The patient took Tylenol which helped to lessen the symptoms but the symptoms still had not resolved. The patient also experienced injection site soreness and redness. The physician's diagnosis was myalgia and other serum reaction due to vaccination initial encounter. The reporter had consented to follow up. There was a discrepancy in outcome of the events, in the source document outcome of the events were reported as recovering/ resolving, but it was reported as not recovered/ resolved. The outcome kept as reported.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: Low Titers; This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a male patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B at an unknown dose. On an unknown date, unknown after receiving Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Engerix B.  Additional information received were as follows: The lot number of Engerix B was not provided. The caller did not thought it was related to lot numbers but that the product has too many variations. The patient received 3 series of Engerix B and did not developed Hepattis B antibody, which led the patient to be therapy non responder. The physician reported that there was one patient got one dose and had more than a million antibodies and another that only had 45-100 antibodies. The caller stated with follow up he could provide more data. No further information provided. This case has been linked with US2019AMR117506, reported by the same reporter.      Lab Comments: On an unknown date, the patient's had test for Hepatitis B antibody which was found to be low titer
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Injection site pain, Pain in extremity
Clinical narrative: severe shooting leg pain; injection site soreness; condition aggravated; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included leg paralysis (partial) and nephropathy (peripheral).   On 25th June 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 26th June 2019, 1 days after receiving Shingrix, the patient experienced injection site pain, condition aggravated and leg pain. On 27th June 2019, the outcome of the injection site pain, condition aggravated and leg pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, condition aggravated and leg pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The patient experienced injection site soreness and severe shooting leg pain in her right leg.  The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Nausea, Pain in extremity
Clinical narrative: nauseous; tired; feeling unwell/ Felt badly; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th April 2019, the patient received the 1st dose of Shingrix. On 19th April 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and feeling unwell. On 20th April 2019, the patient experienced nausea and tiredness. On 21st April 2019, the outcome of the nausea, tiredness and feeling unwell were recovered/resolved. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm, nausea, tiredness and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on an unknown arm. The patient felt badly after receiving Shingrix. The patient's arm became sore on the day of receiving Shingrix and the next one day after vaccination she experienced nauseous and tiredness. This case was linked with case US2019116892 reported by the same reporter. There is a discrepancy between the outcome reported in the structured field "resolved with sequelae" and the outcome reported in the sender's comment "recovered/resolved" for all events.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Paraesthesia, Pruritus
Clinical narrative: Tingling; Linear Unilateral Erythema; Itching in L2 distribution; This case was reported by a physician via call center representative and described the occurrence of erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th May 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a month after receiving Shingrix, the patient experienced tingling. On 19th June 2019, the patient experienced erythema and pruritus. On an unknown date, the outcome of the erythema and pruritus were recovered/resolved and the outcome of the tingling was not recovered/not resolved.   It was unknown if the reporter considered the erythema, pruritus and tingling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced  linear unilateral erythema and itching in L2 distribution.  It took a week to disappear and he never had any blisters.  Late it was clarified as the erythema was almost gone, but there was some tingling. It was reported that,  the patient had just finished a few days earlier on a trip, sleeping in mosquito netting in a hut. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: induration; erythema; localized pain; This case was reported by a physician via call center representative and described the occurrence of injection site induration in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site induration, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site induration, injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site induration, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient.  The age at vaccination was not reported but it could be 67 years or 68 years. The patient received Shingrix 1st dose 5 to 6 months ago. Afterwards, he experienced a large induration, localized pain and redness which scattered 3 to 4 inch from injection site.  The patient did not state when the symptoms were occurred, how long they lasted and if they subsided. The patient asked that, was this a contraindication to receive the 2nd dose of Shingrix.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Gastric disorder
Clinical narrative: stomach distress; pain in her stomach; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of gastric disorder in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th January 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced gastric disorder, stomach pain and upset stomach. On an unknown date, the outcome of the gastric disorder, stomach pain and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the gastric disorder, stomach pain and upset stomach to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's husband. The patient received Shingrix and she experienced stomach distress, pain in her stomach and upset stomach.  The patient said that she was a tiny person and might be the Shingrix dose was too strong for her.  The reporter consented to follow up. The caller put the patient directly on the phone. For the tolerances of 2nd dose, refer case US2019116952.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Blister, Drug hypersensitivity, Rash vesicular, Skin discolouration, Swelling
Clinical narrative: welts; swelling; purple; blisters; antibiotic allergies; blistering across the ends of nerves; This case was reported by a consumer via call center representative and described the occurrence of welts in a female patient who received Flu unspecified (Influenza vaccine) for an unknown indication.   Previously administered products included Flu vaccine with an associated reaction of anaphylactic reaction. Concurrent medical conditions included allergy to antibiotic.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, 1 day after receiving Influenza vaccine, the patient experienced welts, swelling, skin discoloration, blister, allergy to antibiotic and blistery rash. On an unknown date, the outcome of the welts, swelling, skin discoloration, blister, allergy to antibiotic and blistery rash were recovered/resolved.   The reporter considered the welts, swelling, skin discoloration, blister, allergy to antibiotic and blistery rash to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had gone into anaphylaxis from a previous flu shot, for no reason other than possible antibiotic use. The patient received a flu vaccine at least 15 years.  It was reported that the morning after she got the vaccine she woke up with huge solid welts from head to toe and she was swollen and purple.  Several months later the patient had blisters that looked almost like a tree across her back, apparently she was blistering across the ends of nerves.  The physician said this was also a reaction to the flu vaccine. She has severe antibiotic allergies, so it is thought the reaction was due to trace amounts of antibiotics in the vaccine. The reporter did not consent to follow-up. The reporter declined to provide additional information since it was reported to the Health Department at the time it occurred. A clarification has been requested to create an additional case for the same patient who received flu vaccine and had anaphylaxis reaction.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Urticaria
Clinical narrative: welts; swelling; purple; blisters; antibiotic allergies; blistering across the ends of nerves; This case was reported by a consumer via call center representative and described the occurrence of welts in a female patient who received Flu unspecified (Influenza vaccine) for an unknown indication.   Previously administered products included Flu vaccine with an associated reaction of anaphylactic reaction. Concurrent medical conditions included allergy to antibiotic.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, 1 day after receiving Influenza vaccine, the patient experienced welts, swelling, skin discoloration, blister, allergy to antibiotic and blistery rash. On an unknown date, the outcome of the welts, swelling, skin discoloration, blister, allergy to antibiotic and blistery rash were recovered/resolved.   The reporter considered the welts, swelling, skin discoloration, blister, allergy to antibiotic and blistery rash to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had gone into anaphylaxis from a previous flu shot, for no reason other than possible antibiotic use. The patient received a flu vaccine at least 15 years.  It was reported that the morning after she got the vaccine she woke up with huge solid welts from head to toe and she was swollen and purple.  Several months later the patient had blisters that looked almost like a tree across her back, apparently she was blistering across the ends of nerves.  The physician said this was also a reaction to the flu vaccine. She has severe antibiotic allergies, so it is thought the reaction was due to trace amounts of antibiotics in the vaccine. The reporter did not consent to follow-up. The reporter declined to provide additional information since it was reported to the Health Department at the time it occurred. A clarification has been requested to create an additional case for the same patient who received flu vaccine and had anaphylaxis reaction.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: welts; swelling; purple; blisters; antibiotic allergies; blistering across the ends of nerves; This case was reported by a consumer via call center representative and described the occurrence of welts in a female patient who received Flu unspecified (Influenza vaccine) for an unknown indication.   Previously administered products included Flu vaccine with an associated reaction of anaphylactic reaction. Concurrent medical conditions included allergy to antibiotic.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, 1 day after receiving Influenza vaccine, the patient experienced welts, swelling, skin discoloration, blister, allergy to antibiotic and blistery rash. On an unknown date, the outcome of the welts, swelling, skin discoloration, blister, allergy to antibiotic and blistery rash were recovered/resolved.   The reporter considered the welts, swelling, skin discoloration, blister, allergy to antibiotic and blistery rash to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had gone into anaphylaxis from a previous flu shot, for no reason other than possible antibiotic use. The patient received a flu vaccine at least 15 years.  It was reported that the morning after she got the vaccine she woke up with huge solid welts from head to toe and she was swollen and purple.  Several months later the patient had blisters that looked almost like a tree across her back, apparently she was blistering across the ends of nerves.  The physician said this was also a reaction to the flu vaccine. She has severe antibiotic allergies, so it is thought the reaction was due to trace amounts of antibiotics in the vaccine. The reporter did not consent to follow-up. The reporter declined to provide additional information since it was reported to the Health Department at the time it occurred. A clarification has been requested to create an additional case for the same patient who received flu vaccine and had anaphylaxis reaction.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Loss of consciousness
Clinical narrative: loss of conciousness
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pallor, Pulse abnormal, Tremor
Clinical narrative: The patient appeared pale, shaking, with a weak pulse and a BP of 90/60 approximately five minutes after the administration of the vaccines.  The patient was moved to the exam table, her legs were elevated, she was able to sip water and to respond verbally.   911 was called and the paramedics arrived quickly.  They measured her O2 level of saturation and it was 97%.  The patient was transported via ambulance to the hospital for further observation.
Age: 49.0
Sex: F
Vaccine: DT
Symptoms: Cellulitis, Hypersensitivity, Local reaction, Wrong product administered
Clinical narrative: On July 1, 2019 a Nurse Practitioner student gave the wrong medication. The patient was to receive Tubersol 0.1m intradermal to the left arm, volar surface. Instead she gave Tetanus and Diptheria Toxoids Adsorbed, unknown if 0.5 ml or 0.1 ml given and unknown if given subcutaneous or intradermal. Pt developed localized allergic reaction, sought treatment the same day at urgent care and was Rx'd prednisone 50 mg po qd x 5 days. she reported back to clinic on July 3rd, was to continue Prednisone which she had not started until that day. returned on July 5th and noted to have a cellulits starting. Started on Keflex 500 mg po tid and she is following w her PCP.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram head normal, Fall, Head injury, Loss of consciousness, Posturing
Clinical narrative: pt passed out about a few mins after HPV injection was given. Fell off the exam table, hit her head on the floor, and started posturing. Returned to consciousness a few secs after the fall. EMS called and pt sent to the ER to be examined.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Cough, Nausea, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: Arm pain for 5 days. Fever, cough, sore throat and nausea
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Erythema, Rash, Rash erythematous
Clinical narrative: Redness around the eyes and a couple of raised red bumps on the face.  The symptoms started 10 minutes after vaccines were administered. I checked her throat and mouth for swelling, but it looked normal. Advised mother to keep her in clinic for another 10 minutes. Client redness and bumps got better. But advised mother to taker her to the urgent care if symptoms got worse.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Gait disturbance, Hyperhidrosis, Influenza, Malaise
Clinical narrative: 6/29/19 Woke up at 11 PM perspiring profusely,  low grade temperature 100 degrees,  very weak, painful muscle aches all over body including fingers and toes, had difficulty walking,  in general he felt very ill as if he had flu symptoms. Lasted 48 to 72 hours. Took tylenol for pains. Still feels mild symptoms are persisting. Did not go to doctors because he was told these symptoms are common after the second Shringrix shot.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: 6/29/19 Woke up at 11 PM perspiring profusely,  low grade temperature 100 degrees,  very weak, painful muscle aches all over body including fingers and toes, had difficulty walking,  in general he felt very ill as if he had flu symptoms. Lasted 48 to 72 hours. Took tylenol for pains. Still feels mild symptoms are persisting. Did not go to doctors because he was told these symptoms are common after the second Shringrix shot.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on back of thigh pt is to get steroids from md
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Local reaction
Clinical narrative: LOCALIZED SWELLING AND REDNESS, HARD BUMP AT SITE.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: LOCALIZED REACTION: SWELLING AND REDNESS AT SITE. SMALL RED BUMP AT INJECTION SITE.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Woke up the following day with rash/red bumps covering arms and legs. They're not itchy, nor appear to be filled with anything, but there are hundreds of them.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Decreased appetite, Fatigue
Clinical narrative: POOR APPETITE, FATIGUE
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site cellulitis, Vaccination site erythema, Vaccination site pain
Clinical narrative: Development of a small circle of erythema on day of vaccination, but then increased to 10x8cm area of erythema surrounding the vaccine site by day #4. Tender to palpation, but no fluctuance. Started on doxycycline for presumed cellulitis.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Nodule, Pain, Pain in extremity
Clinical narrative: ACHY FEELING IN THE BEGINING, NOW SORENESS AND KNOT ON THE ARM
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Immunisation, Product preparation error
Clinical narrative: ActHIB lypholized powder was mixed with Sterile Water Diluent  from Merck Sharp and Dohme and administered to the patient. The mistake was discovered approx 90 minutes after the event. The patient's primary care physician  was immediately notified. The event happened late on a Friday afternoon so the  Public Health vaccine nurse was notified the next Monday  7/1/2019. Upon the advice of the immunization nurse who  utilized the website information site, the dose needed to be repeated. Pt was  re-vaccinated on 7/5/19.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Pain in extremity, Pruritus, Urticaria
Clinical narrative: Patient experienced a large welt on upper arm that itched and hurt for several days.  There is still a big mark on deltoid of arm from where patient received vaccine over 1 week ago.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse effects reported; one-year old patient was administered PROQUAD instead of VARIVAX; This spontaneous report was received from a medical assistant and refers to a 1 year old patient of unknown gender. The patient's historical condition, and drug reactions or allergies were not provided.  Concomitant therapies included sterile diluent.   On 01-JUL-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S002496 and expiration date 23-JUL-2020, for prophylaxis (dosage schedule, route, anatomical location were not reported) instead of varicella virus vaccine live (Oka/Merck) (VARIVAX)(wrong product administered). No adverse effects reported.     The outcome of wrong product administered and no adverse event was unknown.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles out break/ shingles under her; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included myelodysplasia, decreased immune responsiveness, myelofibrosis and herpes simplex type i.   On 18th March 2019, the patient received the 1st dose of Shingrix. On 14th May 2019, 57 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose in the left arm. The patient had a history of a decreased immune system, myelofibrosis, mylodysplacia and HSV1 (herpes simplex type I).  The patient experienced a shingles out break under her breast and on her back. The patient did not receive dose 1 at the reporter's facilities and therefore, the reporter could not provide lot number or expiration date for dose 1. However, the patient planned to continue follow-up with her physician on an unknown date and she consented to follow up. The case US2019116923 was found to be duplicate of case US2019118478. Hence case US2019118478 would be deleted and all the information of this case will be added in case US2019116923 which is case of record for this patient.
Sex: F
Vaccine: TD, TDAP
Symptoms: Wrong product administered
Clinical narrative: given a dose of Tenivac in error due to the consumer not knowing she was to receive the Adacel; Initial information received on 24-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 22 years old female patient who DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and reported that given a dose of Tenivac in error due to the consumer not knowing she was to receive the Adacel.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 19-Jun-2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U6014AB and expiry date: 20-Jul-2020 via intramuscular route.  It was a case of actual medication error due to wrong vaccine administered.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Antibody test negative
Clinical narrative: low immunity to type C and W; Initial information received on 28-Jun-2019 regarding an unsolicited valid non serious case received from a nurse.  This case involves a 21 years old male patient who experienced low immunity to type c and w, while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past vaccination(s), concomitant medication(s) and family history were not provided.   He is on immunosuppressant for Crohn's disease  On 07-May-2009, the patient received a first dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot via unknown route in unknown administration site. On 30-Apr-2014 he also received second dose of the same vaccine lot U4610BA and expiry date: 14-Jan-2015 via intramuscular route in the right arm.  On an unknown date, following the vaccination the patients antibody levels drawn and they were immune to a lot of things. A patient had low immunity to type C and W.  (Other relevant tests included no lab data.)  Final diagnosis was antibody test negative.  It was not reported if the patient received a corrective treatment.  The outcome of the event was not applicable at the time of reporting.  List of documents held by sender: none.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: was given only the liquid portion of the Pentacel vaccination; Initial information received on 01-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a five months old male patient who was vaccinated with a 0.5 ml dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot C5447AB, Exp. Date 15-Nov-2019) via intramuscular route in unknown administration site on 01-Jul-2019.  The patient's medical history were not reported.  Concomitant medication included- Prevenar and Rotavirus vaccine administered on 01-Jul-2019.  It was an actual medication error case due to inappropriate reconstitution technique as only liquid component of the Pentacel vaccine was administered to the patient.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.