chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Malaise, Nausea, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of chills in a 31-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On 19th September 2018 11:00, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 20th September 2018 11:00, 1 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced chills, nausea, feeling unwell and fever. On an unknown date, the outcome of the chills, nausea, feeling unwell and fever were not recovered/not resolved. It was unknown if the reporter considered the chills, nausea, feeling unwell and fever to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The healthcare professional (HCP) reported her own experience. The patient started to experience chills, feeling sick feverish and nausea which were on-going at the time of reporting and felt worse as the day progressed. The HCP did not have the vaccine lot number or expiry date for this adverse event (AE). The HCP stated no intervention was taken but she called her primary care doctor and left a message. The HCP stated that, she never felt like this with a flu vaccine in the past.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Scab
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shingles in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles and scab. On an unknown date, the outcome of the shingles and scab were unknown. It was unknown if the reporter considered the shingles and scab to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient presented with shingles within 3 days of receiving the vaccine. The patient came in with scabs on her ankles that were already crusted. It was not clear that which patient out of 3 has not received vaccine in reported pharmacy, the pharmacy name is not coded. This case has been linked with US2018GSK173217 and US2018GSK173216, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shingles in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week 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 patient presented with shingles within 3 days of receiving the vaccine. It was not clear that which patient out of 3 has not received vaccine in reported pharmacy, the pharmacy name is not coded. This case has been linked with US2018GSK173217 and US2018GSK173211, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of shingles in a adult female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 21 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. The reporter considered the shingles to be unrelated to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient developed Shingles 3 weeks later diagnosed by MD. The reporting HCP did not believe it to be related to the Shingrix.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in a 59-year-old male patient who received 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 pain. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to Shingrix. Additional information received as follows: For tolerance to next dose, refer case US2018170158.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old male patient who received Shingrix for prophylaxis. In May 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. 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 to be related to Shingrix. Additional details were provided as follows: In 2018, the patient experienced a sore arm after the vaccination. This case has linked to case US2018171852, reported by the same reporter for same patient.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 79-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (on 20th March 2018, vaccinated with the 1st dose). Concurrent medical conditions included rheumatoid arthritis, prostate cancer, brachytherapy (prostate cancer radioactive seed implantation therapy) and radiotherapy (for treating prostate cancer for 28 days, ending on 3rd August 2018). On 14th September 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced itchy rash. The patient was treated with cortisone acetate, prednisone and BENADRYL. On an unknown date, the outcome of the itchy rash was not recovered/not resolved. It was unknown if the reporter considered the itchy rash to be related to SHINGRIX. Additional information was reported as follows: On Friday, the patient was vaccinated with the 2nd dose of SHINGRIX in the right deltoid. The patient did not experience any symptoms within the first 24 hours after vaccination with SHINGRIX. The patient stated that he felt normal till Saturday night, however after Saturday midnight the patient experienced rash on his lower back which spread to his groan, neck and under his arm and it itched badly. On 16th September 2018, the patient went to the urgent care and was given a cortisone, a prednisone shot and BENADRYL. On Monday, 17th September 2018, the rash experienced by the patient was still the same and existed up to the back of his neck till the time of reporting. The patient's wife might take him to his primary doctor on the day of reporting. The physician contact details were provided.
Age: 49.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Rash pruritic
Clinical narrative: Received Influenza and MMR vaccines on 9/20/18 at 0739 and 0738 and states on Saturday 9/22 started having a pinpoint rash on her left anticubital space. States on Sunday when she woke up had rash to both arms, thighs and hips. Rash itches. Today starting  to go up  her neck also. Started using Benadryl Cream Sunday night and then has used daily. Started Benadryl 50 mg PO at bedtime last night 9/27. Today the rash is going up her neck, on both arms, thighs and stomach.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Associate experienced intense red itchy non raised rash, covering the upper arm and post shoulder and some areas of chest.
Age: 52.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Flu vaccine given Wed 9/26/18 around 1:30pm. Pt states she woke up 9/28/18 around 1:30am and her arm was very itchy. She is prone to hives and when she checked her arm the area around the injection site was swollen, red and itchy. No treatment done at time. States if the itchiness worsens she will apply the medication given to her by dermatology.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site paraesthesia
Clinical narrative: Patient has been experiencing tingling and pain at different times of the day in the upper arm (the same arm she received her vaccination) since the day of the injection. Its been two months and she experiences them at different time of the day in that location.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling of body temperature change, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Significant pain at injection site. Significant muscle aches. Feverish. Alternating hot and cold.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Child is over 3 yrs old, however he was given the pediatric dose of 0.25. We informed parent, and they returned for an additional pediatric dose.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an adult patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with M-M-R II (lot # N002337; expiry date: 20-JAN-2019) by intramuscular injection rather than subcutaneous (inappropriate route of vaccination). No adverse effects reported. The outcome of the events was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX. On 13th September 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site itching, sleeplessness, headache, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site itching, sleeplessness, headache, injection site swelling and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site itching, sleeplessness, headache, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine in the left arm. The patient did mention that was not sure if the vaccine caused the severe headache or if it could have come from the lack of sleep. The patient said that the itching lasted about a week and the soreness slowly tapered off. In September 2018, all of issues had resolved. The patient did not provide any further information, especially demographics.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week 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 patient presented with shingles within 3 days of receiving the vaccine. It was not clear that which patient out of 3 has not received vaccine in reported pharmacy, the pharmacy name is not coded. This case has been linked with US2018GSK173211 and US2018GSK173216, reported by the same reporter.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Health Department placed BEXSERO vaccine in right arm and GARDASIL vaccine in left arm on 9/26/18 at 4:45 pm, The High School nurse called Health Department on 9/28/18 and stated, "Patient's right arm is mildly swollen and sore. She said it started hurting yesterday, 9/27/18, but did not come to my office until today 9/28/18 around 10:00am. I just wanted to let you know that this happened. I am going to put some warm packs on it and keep an eye on it."
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: At orginal time of vaccination (08/28/2018) patient had come asking for HIB vaccination (Haemophilus influenzae) as directed by his MD. From a miscommunication with the patient, it was assumed he was requesting the hep B vaccine. At the administration of the second dose, the error was discovered.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation, Pain, Skin discolouration
Clinical narrative: PATIENT HAVE A RANDOM ENCOUNTER WITH A PHARMACIST OF OUR PHARMACY AND SHOW HER ARM TO HER. ARM WAS REPORTED WITH A EXTENDED RED AREA, WITH INFLAMMATION AND DARK SKIN. PATIENT INFORM TO HAVE APPLY DICLOFENAC GEL TO THE AREA BECAUSE IT HURTS. SHE ALSO REPORTED INTOLERANCE TO ASPIRIN. PATIENT WAS ORIENTED AT THE TIME OF VACCINATION AND WAS RECOMMENDED TO ADMINISTER THE VACCINES IN DIFFERENTS ARMS. PATIENT DENIED BECAUSE SHE HAS A STROKE AND SHE HAVE RIGHT ARM DEBILITATED IN CONSEQUENCE. SHE REPORTED THAT SHE ALWAYS HAD HER VACCINES IN THE SAME ARM AND THAT HER DOCTOR RECOMMENDED HER TO ADMINISTER BOTH, FLU AND PNEUMONIA VACCINE. THE TWO VACCINES WAS ADMINISTERED SEPARATED BUT IN THE LEFT ARM. TODAY I CALLED HER TO FOLLOW UP, AND KEEP RECOMMENDING TO SEEK MEDICAL CARE IMMEDIATELY. HER DOCTOR TOLD HER TO STAY APPLYING COLD AND TO KEEP IN OBSERVATION. SHE REPORTED TO HAVE IMPROVE TODAY AND NO RED AREA WAS OBSERVED.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth, Local reaction, Pruritus, Rash erythematous
Clinical narrative: Within 30 minutes of receiving the influenza vaccination, the associate experienced intense itching followed by a progressive non raised red rash resembling a drug reaction. This involved the upper right arm, posterior shoulder and right chest. The injection site was swollen and warm to touch as well. The associate was seen in the Occ Health clinic and treated with Benadryl. This was diagnosed as a local reaction. There was no breathing difficulties or other reactions involved.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Vesicular rash.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Headache, Nasal congestion, Nausea, Pain
Clinical narrative: Swelling and extreme soreness in entire right upper arm, much greater than any previous injection. On day of injection and day after. Today, day 3, extreme fatigue and full body aches, headache, nausea, nasal congestion, and low grade fever. TYLENOL taken right after injection as done with every previous flu vaccination in the past.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Swelling and extreme soreness in entire right upper arm, much greater than any previous injection. On day of injection and day after. Today, day 3, extreme fatigue and full body aches, headache, nausea, nasal congestion, and low grade fever. TYLENOL taken right after injection as done with every previous flu vaccination in the past.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: PATIENT RECEIVED HIS FIRST SHINGRIX ON 7/28/2018 AT HIS LOCAL PHARMACY. HE SAID THAT ABOUT 1 WEEK AFTER THE INJECTION HE STARTED HAVING ITCHING ALL OVER HIS BODY. HE DENIES ANY RASH OR REDNESS. PATIENT CALLED HIS PCP TO REPORT THE SYMPTOMS ON 9/26/2018 AT WHICH TIME HE WAS ADVISED TO GO TO AN URGENT CARE FACILITY. HE WAS PRESCRIBED HYDROYXINE 25 MG BY THE URGENT CARE PROVIDER.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pruritus
Clinical narrative: Erythema and pruritis.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Dizziness, Hyperhidrosis, Pharyngeal oedema
Clinical narrative: Throat swelling, sweating, dizziness, increased blood pressure.
Age: 96.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, Immunodeficiency
Clinical narrative: This is a spontaneous report from a contactable consumer. A 96-years-old female patient (grandmother) received the second dose of PREVNAR 13, via an unspecified route of administration at single dose for pneumococcal immunization, on 13Sep2018, 30 days after the administration of the first dose. The patient medical history and concomitant medications were not reported. The patient received the first dose of pneumococcal 13-val conj vac (dipht crm197 protein) on 14Aug2018, 30 days before the second. On unknown date in 2018 the patient experienced immune system compromised with outcome of unknown. The event was serious due to hospitalization. Consumer reported her grandmother was given 2 injections of PREVNAR 13, 30 days apart. She received the first one on 14Aug2018 because it was mandatory before going into a nursing home. Consumer told the facility that her grandmother had received a pneumonia shot. Her records did not show that she had received the first one and she was given the second one. Consumer stated her grandmothers immune system was compromised. Whether someone is 52, 92 or 10 this shouldn't have happened. Consumer adds that this was potent and her grandmother was hospitalized. Consumer confirms she previously reported this to the safety department. Information on the batch number has been requested.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Within hour of administration patient hd vomiting. Later the same day the patient developed fever, body aches and continue dot have intermittent nausea and vomiting. Symptoms persisted for two days and then resolved. The patient was kept at home. She was provided rehydration fluids and fever reducing medications.
Age: 61.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Dizziness, Feeling abnormal, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Patient received FLUCELVAX and PREVNAR 13 at the same time, and about 5 minutes after the second vaccine the patient experienced extreme sweating, paleness, nausea, light-headedness, dizziness and feeling "yucky" as she described it.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The right upper arm was very painful when I barely moved it during the first night. The pain went  into the area of my chest that's near the arm. In the morning I noticed the area about 3" below the injection site to about 3" above the crease of my elbow was red, warm and swollen. The site of the injection was fine. It stayed like that for 2 days. It slowly got better and today (9/28)  it's just a little pink.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: The right upper arm was very painful when I barely moved it during the first night. The pain went  into the area of my chest that's near the arm. In the morning I noticed the area about 3" below the injection site to about 3" above the crease of my elbow was red, warm and swollen. The site of the injection was fine. It stayed like that for 2 days. It slowly got better and today (9/28)  it's just a little pink.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fall, Loss of consciousness, Migraine
Clinical narrative: Patient got a migraine hours after getting the SHINGRIX immunization, the patient went to sleep and within 12 hours after immunization when she woke up she felt dizzy and lightheaded, she called out for help to her husband while trying to walk to the bathroom, but she passed out as she made her way. He husband caught her when she fell down.
Age: 39.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Fatigue, Skin warm
Clinical narrative: Patient complained about tiredness the remaining day after the vaccination. Next day, didn't get a time, she noticed redness and heat coming from an area below the injection sites. She came to the pharmacy on 9/26/18 and I could see the redness and feel the heat myself. I called to check on her today (9/28/18) and she said it is not as red or warm, but is moving around her to the backside. She did call her dr and they just advised her to use benedryl cream and ice on the area. I told her if it continues to move around or down her arm, she needs to call the dr back.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Erythema, edema, induration and tenderness at area of DTaP injection at 24hrs after vaccine - 2.5 x 3.5 inches. Started on hydroxyzine plus ice pack. At 48 hrs worsening symptoms - given ROCEPHIN IM.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Skin warm
Clinical narrative: Pt. called 9/27/18 and spoke with RPh saying she had reaction to flu shot. Came to pharmacy and she said she had a rash on cheek/nose that was hot to touch. Used cold compress and went away. RPh said there was no sign of rash when she came in. Patient reported it all went away within 24 hours. No fever/SOB/etc. MD notified 9/2/18 via RN. She is going to follow up with patient and said nothing else was needed from us at this time.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 6 x 4 cm area of induration, erythema and warmth, left deltoid. Possible subcutaneous infiltration.
Age: 1.0
Sex: M
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Child was given 1 yr vaccines. Hep B, MMR, Varicella, and Hep A, after the vaccines were given child developed hives on both cheeks upper out at sternal area upper extremities and, both thigh, where the vaccines were given. There was no fever, sneezing, cough, vomiting, chest tightness respiratory difficulty, drooling, nausea, any discomfort, severe diarrhea or pale color. BENADRYL (12.5 mg/5 ml was given by mouth. Dr called the ER spoke to the charge nurse. Complete report was given, mom was advised to take child to ER right away will report case to VAERS.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash, Rash pustular, Rash vesicular, Scab
Clinical narrative: About two and half hours after receiving the shot, patient got itchy on his chest. By three hours after the shot, he noticed a rash on his upper chest. By three and a half hours after the shot, I (his mom) saw him and looked at his chest: it had chicken-pox like rash with additional bumps around the sides of his abdomen and a few bumps on his mid and upper back. Also, there were some bumps on his thighs. He saw the doctor the following day to determine if he had a rash-reaction, chicken pox, or something else. The doctor said her findings were inconclusive. She said it could be a reaction, it could be chicken pox (which she had only seen two cases so she was not sure if it would present this way), or it could be atopic dermatitis (we had used another detergent two weeks prior... with no skin reactions). The chicken pox like rash continued to spread down his abdomen and back, and up the back of his neck towards behind the ears. He has also had one or two clear pox (scabs) on his leg bumps.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Body temperature increased, Erythema, Injection site pain, Skin warm
Clinical narrative: Vaccine - 11 AM - Fri. 9/7/18 arthroplasty. Temp. 99 - hot - aching (L) knee. 4 PM Fri - aching - heat - red over knee - increased 9 PM. (2) ES - Acetaminophen 500 mg - 10 PM and 6 AM Sat. 9/8. 9/9 - Sun. - 8 AM - all symptoms resolved. Nothing happened on (R) knee arthroplasty, minimal soreness at injection site (L) arm. I do not have a computer. All (3) medical providers said "Not a known reaction". But complete VAERS form from CDC. My question remains why did the left knee replacement side become red, hot, and painful within hours of vaccine and (R) knee replacement side did not?? Can I get the vaccine next year?
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Influenza like illness, Pain, Pruritus
Clinical narrative: Patient developed shingles rash on entire left upper back - pt reported painful, itchy, burning - worsened since onset. Treated with 2 courses of VALTREX and NEURONTIN. Patient rash worsened after initial visit in office. Patient required to complete second course of VALTREX. Patient seen in office 3x 9/5/18, 9/11/18, 9/19/18 rash - not typical shingles - followed multiple dermatomes. All patient symptoms still not resolved after 2 weeks of treatment. Patient also developed achiness, soreness, "flu like symptoms" after vaccination - which resolved after 2 days.
Age: 60.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Blood test normal, Chest pain, Dehydration, Electrocardiogram normal, Hyperhidrosis
Clinical narrative: At 6:30 PM on 8-8-18 started to vomit for 4 hrs. Bad sweating, chest pain. I didn't plan on taking part 2, of shingles shot. Was sick for almost 2 weeks. Seen at clinic, and urgent care. I spent more money in Co-Pays to get checked out and to have ZOFRAN. For almost 2 wks. could only drink a little, and eat very little. Had to take ZOFRAN 3 x day to be able to do that.
Age: 60.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Hypophagia, Vomiting
Clinical narrative: At 6:30 PM on 8-8-18 started to vomit for 4 hrs. Bad sweating, chest pain. I didn't plan on taking part 2, of shingles shot. Was sick for almost 2 weeks. Seen at clinic, and urgent care. I spent more money in Co-Pays to get checked out and to have ZOFRAN. For almost 2 wks. could only drink a little, and eat very little. Had to take ZOFRAN 3 x day to be able to do that.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Musculoskeletal chest pain, Pain, Vaccination complication
Clinical narrative: Severe extremity pain around rib cage received post, TYLENOL and eventually hydrocortisone and LYRICA. Also VALIUM and TYLENOL before cortisone LYRICA (not together). I paid over $400.00 for 1st and (around $200 for this second vaccine which had adverse reaction and suffered so much pain, weakness - loss of appetite therefore I believe vaccine company should reimburse me for these constant pain was suffering.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspepsia, Dyspnoea, Pruritus generalised, Rash, Urticaria
Clinical narrative: Severe heartburn, followed by itchy from head to toe, followed by severe hives and rash neck to toe, followed by trouble breathing.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and pain around injection site.
Age: 50.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Extra dose administered, Pyrexia
Clinical narrative: PATIENT EXPERIENCES HIGH FEVER AFTER GETTING THE VACCINES ON THE SAME DAY. ACCORDING TO THE NURSE FROM FAMILY RESIDENCE AND ESSENTIAL ENTERPRISE, PATIENT ALREADY GOT A FLU SHOT WITH HIS PRIMARY CARE PHYSICIAN ON 09/11/2018.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth, Pruritus, Rash
Clinical narrative: The patient had a prominent injection site reaction with swelling and heat around the injection site. The following day she developed a rash under her right arm and down the right side of her torso. The rash then spread the next day following to the left side of her body where it was accompanied by itchiness. I encouraged her to follow up with her primary care physician or other provider to have it evaluated further.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm, Vomiting
Clinical narrative: Right arm at 530am bright red 2 spots hot to touch swelling spots getting larger. Reported to me agreed yes to use ice watch for itching or not going away. At 1110am school nurse called to say patient vomited once but had three spells of vomiting. School nurse suggested reporting to md and to report to vaccine info personnel this info since he received these 3 shots at once. Left message at md and received message back unknown if from shots can bring patient in if we want. I opted to let him rest. He has not thrust up again.
Age: 35.0
Sex: F
Vaccine: FLUC4, MMR, VARCEL
Symptoms: Chills, Cold sweat, Hypoaesthesia, Peripheral swelling, Pruritus
Clinical narrative: Chills, cold sweat that evening. Non vesicular rash in AM on (R) arm (varicella) swelled, itchy, hot, arm numb. Rash on (L) arm (MMR) (R) arm influenza. Then appeared after Tx with corticosteroids and antihistamines.
Age: 35.0
Sex: F
Vaccine: FLUC4, MMR, VARCEL
Symptoms: Rash, Skin warm
Clinical narrative: Chills, cold sweat that evening. Non vesicular rash in AM on (R) arm (varicella) swelled, itchy, hot, arm numb. Rash on (L) arm (MMR) (R) arm influenza. Then appeared after Tx with corticosteroids and antihistamines.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Yellow skin
Clinical narrative: Yellow patch on left side of chest on next day after vaccination. Painful but pain subsided after 1 day. Has not resolved since.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Hypoaesthesia, Injection site swelling, Vaccination complication
Clinical narrative: Child developed swelling from L deltoid to elbow the morning of 9/26/18 with feeling of skin numbness and development of tiny wate blisters. She was seen in ER that night and Dx with vaccine reaction. Seen for follow up in our office on 9/27/18 and swelling had improved but was still present.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Patient left voicemail reporting she had a low grade fever and ached all over. Patient reports she just wanted to let us know. LPN called and checked on patient 09/28/18. Patient reported she also had swelling on her arm, redness in the shape of a tear drop about 2-3 days after the vaccine. Patient reports she took Benadryl and she is better now. Patient reports she might get a scar from the reaction on her arm.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Lethargy, Pyrexia, Vomiting
Clinical narrative: Patient reports decreased appetite, extreme lethargy, vomiting and low grade fever.
Age: 43.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Infection, Pain in extremity, Peripheral swelling, Pyrexia, Vaccination complication
Clinical narrative: Pt was seen by Dr. for a physical on 9/17/2018. Dr. ordered a Tdap and PNEUMOVAX 23. Prior to administration the patient and daughter were counseled by Dr. and were also given copies of each VIS (vaccine information sheet) to review and take home. Per pt request both vaccines were administered in the L deltoid. Pt called office the following day Tuesday 9/18/18 stating that she was experiencing pain and swelling on her L arm. Pt denied rash, difficulty breathing, and fever. Advised pt to apply ice and take ibuprofen to help with pain and swelling and if she developed any additional symptoms she should be seen. Pt expressed understanding. Several days later Friday 9/28/18. Patients daughter stopped into office to inform me that her mom (the patient) was in the hospital due to a "reaction or infection" from the vaccine. Daughter confirmed that pt never developed a rash or difficulty breathing but swelling was worsening and when temperature was checked at hospital she did have an fever.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient had swelling and redness in the injection site. She still has a red mark at the injection site 2 months later that is painful and will also itch.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Dizziness, Malaise, Nausea
Clinical narrative: Patient got the vaccination for flu and SHINGRIX on 09/24/2018. She was ok that day but woke up in the middle of the night with fever and chills. The next day morning she had shivering, diarrhea, body ache and rash on the right arm. Was feeling very sick and dizzy and was in the same state for 2 days. On 9/27/2018, she called the pharmacy to report and pharmacist advised her to consult md. The md gave her the nausea medication and prednisone  and said he could not do anything else. She called pharmacy on 09/28/2018 and I advised the patient to take mulitsympton Tylenol and an allergy pill as well we keep herself well hydrated. She was also advised to take Imodium for diarrhea. Will check with patient on Monday.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Patient got the vaccination for flu and SHINGRIX on 09/24/2018. She was ok that day but woke up in the middle of the night with fever and chills. The next day morning she had shivering, diarrhea, body ache and rash on the right arm. Was feeling very sick and dizzy and was in the same state for 2 days. On 9/27/2018, she called the pharmacy to report and pharmacist advised her to consult md. The md gave her the nausea medication and prednisone  and said he could not do anything else. She called pharmacy on 09/28/2018 and I advised the patient to take mulitsympton Tylenol and an allergy pill as well we keep herself well hydrated. She was also advised to take Imodium for diarrhea. Will check with patient on Monday.
Age: 54.0
Sex: F
Vaccine: IPV, YF
Symptoms: Dyspnoea, Erythema, Lip swelling, Pruritus, Tachycardia
Clinical narrative: Also received STAMARIL (Adverse Report form submitted per protocol)-swollen lips, diff breathing, tachycardia, redness and itching of face-seen in ER with BENADRYL IV. Better today. Leaving on trip in AM.
Age: 54.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Fatigue, Inflammation, Injection site hypoaesthesia, Injection site reaction
Clinical narrative: Right Arm (Shingles vaccine): Very sore and painful, red, inflamed, sore, top part of arm feels cold and numb. Skin very red. Feel tired.
Age: 54.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain in extremity, Peripheral coldness
Clinical narrative: Right Arm (Shingles vaccine): Very sore and painful, red, inflamed, sore, top part of arm feels cold and numb. Skin very red. Feel tired.
Age: 19.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Injected limb mobility decreased, Injection site pain, Rotator cuff syndrome
Clinical narrative: Not certain if HPV or meningococcal vacc in the R deltoid. One of them was. Documentation error indicated both in L deltoid. Developed pain in right shoulder with limited active ROM within 14 hours of vaccination. Over 2 weeks, ROM improved. On exam today, symptoms consistent with impingement of the R shoulder.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Erythema, Injection site erythema, Injection site urticaria, Pruritus
Clinical narrative: Patient received vaccine and within 10-15 minutes started complaining that his right arm was itching. His arm was red above and below the bandaid so I had him wait awhile longer to make sure it was not the Band-Aid causing a skin reaction. After giving another patient his shot I came back to the patient and his arm was more red above and below the Band-Aid than it had been before. I instructed the nurse to give him 25mg of Benadryl at that time. After stating he was not having any scratchy throat, or shortness of breath, he was allowed to go to group. I checked on him again in an hour, right before I left facility and at that time the redness looked more like hives but still just around the injection site and no other symptoms reported. I informed the nurse to give 25 mg every 4 hours for the next 24 hours and I would call and check on him later that day and again in the morning. Any signs of airway compromise he will need to see his dr. Nurse understood orders given. I called facility back at 3 pm and he had received his next dose of Benadryl and when he did his arm was not near as red and the hives were starting to go away. I called the next day and the nurse had seen him at lunch and he did not have any hives at all, no redness, itching subsided, and no other complaints.
Age: 71.0
Sex: M
Vaccine: FLUR4, VARZOS
Symptoms: Eye pain, Limb discomfort
Clinical narrative: Patient's eyes were sore the night of the shots. That soreness lasted until midday the following day. Also, developed heavy foot in my left leg. That too has also subsided.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Impaired driving ability, Pain
Clinical narrative: 9/25/18 Pt called reporting pain and was couseling that pain may occur and to take an otc such as tylenol. She reported no redness no swelling no heat. She stated that she could not take any otc meds as she had maxed out her prescription med for the day. 9/26/18 She picked up her prescriptions at thr drive up window. One hour later she called to complain that the pain was so bad she was unable to drive for the past two days. She was not receptive to advise nor counseling per protochol.
Age: 75.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient reports waking this morning with redness and swelling at injection site. No pain reported.  On examination patient would found to gave 6X6cm area of erythema with swelling. No fever.  Denies pain to site. Advised to monitor and report any increased pain, swelling, redness to area.  Apply ice for comfort and Acetaminophen. Patient will be seen back in the office on Monday for follow up evaluation. Patient advised to contact on call provider for any increase in symptoms.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Culture negative, Injection site reaction, Joint fluid drainage, Nuclear magnetic resonance imaging normal, Pain in extremity
Clinical narrative: Within three hours of administration, patient noted swelling in pain in injection arm. Patient went to the ER for evaluation and was then hospitalized for four days. Fluid was surgically removed from injection shoulder and was treated with antibiotics, but cultures and MRI were negative.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Within three hours of administration, patient noted swelling in pain in injection arm. Patient went to the ER for evaluation and was then hospitalized for four days. Fluid was surgically removed from injection shoulder and was treated with antibiotics, but cultures and MRI were negative.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Mononucleosis heterophile test negative, Nausea, Pain, Pyrexia
Clinical narrative: Within 12 hours of vaccine, developed body aches, nausea, fatigue, fever of 101.0. Fever for 48 hours and nausea and body aches for total of 4 days.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Injection site rash, Pain, Pyrexia
Clinical narrative: Feverish, aches and pains, rash at injection site, stomach pain.
Age: 76.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Acne, Chills, Paraesthesia, Pyrexia, Rash
Clinical narrative: PATIENT RETURNED FROM TRIP ON 9/4. PATIENT GOT VACCINATED ON 9/5. ON 9/6 PATIENT STARTED EXPERIENCING FEVER/CHILLS/TINGLY SKIN AND ABOUT A DOZEN "SPOTS" ON HIS HEAD, CHEST, BACK, LEGS AND SHOULDERS. SPOTS WERE NOT PAINFUL OR ITCHY. SOME LOOKED HIVE-ISH, OTHERS LOOKED LIKE PIMPLES WITH A HEAD. THE PERSON HE WENT ON TRIP WITH GOT A RASH AROUND HIS ANKLE. PATIENT DID NOT TAKE ANYTHING. FEVER/CHILLS RESOLVED AFTER A COUPLE OF DAYS AND RASH RESOLVED BY THE END OF THE MONTH.
Age: 76.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Urticaria
Clinical narrative: PATIENT RETURNED FROM TRIP ON 9/4. PATIENT GOT VACCINATED ON 9/5. ON 9/6 PATIENT STARTED EXPERIENCING FEVER/CHILLS/TINGLY SKIN AND ABOUT A DOZEN "SPOTS" ON HIS HEAD, CHEST, BACK, LEGS AND SHOULDERS. SPOTS WERE NOT PAINFUL OR ITCHY. SOME LOOKED HIVE-ISH, OTHERS LOOKED LIKE PIMPLES WITH A HEAD. THE PERSON HE WENT ON TRIP WITH GOT A RASH AROUND HIS ANKLE. PATIENT DID NOT TAKE ANYTHING. FEVER/CHILLS RESOLVED AFTER A COUPLE OF DAYS AND RASH RESOLVED BY THE END OF THE MONTH.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Blood pressure increased, Chest discomfort, Electrocardiogram normal, Nausea, Pain in extremity
Clinical narrative: Pt C/O tightness in center of chest, nausea, pain in L arm. Chest tightness and nausea occurred within minutes of receiving vaccine, resolved after 2-3 minutes. L arm pain began after chest tightness and nausea subsided, lasted 10-15 minutes. Pt had vitals checked, initially BP elevated at 152/87, rechecked after 7 minutes down to 124/78. All other vitals normal (84 BPM, 98.2 degrees, 14 RPM, 99% O2). ECG performed and reported "Normal ECG". Pt noted symptoms resolved before leaving office.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Concomitant therapies included sterile diluent. On 27-SEP-2018, the patient was vaccinated with improperly stored dose of VARIVAX (strength, dose, route of administration were unknown) with lot # R002507 and expiration date of 25-JAN-2020 for prophylaxis which was stored from 6 Fahrenheit degrees (°F) to 14 °F for 30 minutes and was determined due to a data logger. There was no previous temperature excursions. No adverse effects were reported. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1809USA013613.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 83-years-old female patient. The patient had no historical conditions, concurrent conditions, concomitant therapies, historical drugs or allergies. On 25-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 injection, in her right upper arm, reported lot number R006465, expiry date 24-OCT-2019 (strength, dose, route and frequency were not reported) for prophylaxis. On the same date, also reported as later that day, the patient stated that her arm became red, hot, and swollen at and around the injection site (she went to the pharmacy and reported it on 26-SEP-2018). On 26-SEP-2018, also reported as on the evening, the patient called the pharmacy and stated that the symptoms had gotten worse (unspecified). Therefore, she was recommended to use ice and diphenhydramine (BENADRYL) as treatment. No lab diagnostics-studies were performed to the patient due to the events. At the time of the report, the pharmacist stated that he had not heard from the patient since 26-SEP-2018, and that he assumed her symptoms had improved or resolved, but he did not know. The causality assessment between PNEUMOVAX 23 and the events arm became red, hot, and swollen at and around the injection site was not provided.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Hyperaesthesia, Injection site pain, Rash
Clinical narrative: Pain at injection site, then the next day, a 6? long rash developed that was very sensitive to the touch. It lasted 7 days, and then settled into a bruise at the lower part of the rash.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Injection area became red and sore almost immediately after injection. By the next day, 24 hours later, the area had increased in size and became hard and painful. Patient noted her face was flushed and she felt as though she had a fever, but did not. 48 hours after the injection, the injection site was approx. a golf ball size, hard, red, warm to the touch lump that was burning painful and becoming pruritic. Patient, self, decided to seek medical attention when itching began to affect truck of body, face, and both arms. Patient was seen in the clinic where she works, and was prescribed a 7 day course of Prednisone and advised to continue to take Benedryl until improved. Swollen lump began to improved approx. 48 hrs after starting prednisone and benedryl. It took 1 week before area was completely back to normal and no longer visible.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site warmth, Pyrexia
Clinical narrative: Injection area became red and sore almost immediately after injection. By the next day, 24 hours later, the area had increased in size and became hard and painful. Patient noted her face was flushed and she felt as though she had a fever, but did not. 48 hours after the injection, the injection site was approx. a golf ball size, hard, red, warm to the touch lump that was burning painful and becoming pruritic. Patient, self, decided to seek medical attention when itching began to affect truck of body, face, and both arms. Patient was seen in the clinic where she works, and was prescribed a 7 day course of Prednisone and advised to continue to take Benedryl until improved. Swollen lump began to improved approx. 48 hrs after starting prednisone and benedryl. It took 1 week before area was completely back to normal and no longer visible.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient reported pain when moving arm and swollen from shoulder to elbow. Patient called Dr's office and was told to ice and heat and continue to take Ibuprofen.
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthma, Dyspnoea, Pyrexia, Throat tightness
Clinical narrative: Patient said that within 2 hours of the shot he experienced shortness of breath and his throat tightened up. He does have asthma but said the this was nothing like any of his asthma flare ups in the past. He also experienced a low grade fever for 2 days and felt like he has the flu. He did not seek medical attention and is fully recovered.
Age: 52.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Erythema, Pain
Clinical narrative: Intense redness and pain with erythema 24 hours afterward, chills and no fevers. Extreme pain and redniess that lasted 5 days, gradually resolved over the week.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Feeding disorder, Hallucination, Nausea, Pain, Poor quality sleep
Clinical narrative: PATIENT REPORTED PAIN, HALLUCINATIONS, COULD NOT EAT, OR SLEEP WELL NIGHT OF INJECTION, NAUSEA.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness, Headache, Nausea
Clinical narrative: Patient is complaining of dizziness, headache, cold sweats and nausea 3 days following vaccination.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Patient reported pain in shoulder 2 weeks following injection.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Abdominal pain upper, Dyspepsia, Vomiting
Clinical narrative: Moderate stomach cramping the evening following my injection. Significant vomiting spells at approx 9:30 AM and approx 6:00 PM the day after receiving the flu vaccine. Significant stomach ache and indigestion between vomiting spells. Felt much better following second vomiting spell.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site erythema, Rash
Clinical narrative: Within one hour of receiving the FIRST SHINGRIX injection, I had a red ring around my arm at the injection site. Three weeks later I started breaking out in red rashes on my upper torso, shoulders, neck, arm, buttocks and around my waist. This has continued on a daily basis ever since. I have been back to Dr, who prescribed Steroids for 4 days and then Claritin. I also saw my Dermatologist, Dr. who prescribed Allegra and Benadryl, both of which I am still taking. I have NOT had the SECOND SHINGRIX injections! These red rashes start as a burning sensation before they develop into the actual rash.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Eyelid rash, Inflammation, Pruritus, Rash
Clinical narrative: itching, inflammation, redness, rash mainly at underwear borders but also in eyes/eyelids.