chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Cellulitis, Erythema, Injection site erythema
Clinical narrative: Patient reported redness at injection site with it traveling down arm. Went to Emergency room and cellulitis was confirmed. Patient will be following up with primary MD 11/11/16.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous, Rash pruritic
Clinical narrative: 11/2/16 Client presents with rash, red and pruritic stated it started right on her upper (L) chest close to her shoulder no rash noted on 12 site. She claimed itching started after receiving the flu shot-high dose. Rash still present and had spread to her trunk area.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: (L) upper arm with generalized erythema, warmth, firmness and tenderness extending entire length of upper arm and cirmferentially - worsened over 24 hours; TX'd w/Clinda (PCN allergy). R/O cellulitis.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Rash
Clinical narrative: Right arm 5 days after vaccine administration, patient developed rash on same arm in which she received shot (not at injection site). Rash did not itch and was not painful.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Continuous pain at injection site and start of unbearable pain in left shoulder blade on the same side as the injection site.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Feeling hot, Throat irritation
Clinical narrative: After flu shot was administered, patient waited with me for 10 minutes in treatment said he felt warm but otherwise ok. He got up and went back to work. Patient had never previously received flu shot. I walked with him down the hall and he said he was having trouble breathing. We went back to the treatment room. He said his throat started to "feel funny". Per protocol, I administered .5ml of epinephrine IM into his left leg. Also called the house supervisor who came down with our CNO and the hospital Nurse Practitioner. 25mg of po Benadryl given after patient stated he was having an easier time breathing. VSS. patient waited with me (vaccine administrator) until his wife came to pick him up an hour later.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Chills, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Extreme pain at injection site, chills, headache, muscle aches, fever over 101.2 lasting approximately 42 hours.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Pruritus, Urticaria
Clinical narrative: Hives, dizziness, itch, weakness. Went to ER. Received prednisone 60mg.
Age: 70.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness, swelling, itching.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Eyelid oedema, Lip swelling, Swelling face, Urticaria
Clinical narrative: Puffy feeling in face, lips, eyes. Hives to hands, feet, neck, underarms, abdomen. Patchy, not itchy. No dyspnea. Noticed symptoms about 24 hours after vaccine given. Tried small amt Benadryl, but she is allergic to antihistamines, and it didn't help. Denies nausea/vomiting. No other symptoms. States she will contact PCP.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test normal, Computerised tomogram head normal, Confusional state, Dizziness, Feeling hot
Clinical narrative: Yes, within minutes before leaving the Dr office I experienced confusion and numbness followed by numbness on the left side of my face. I was told to go back to the exam room then became dizzy and the numbness ran through the rest of my face and whole body. My face felt warm and I had severe pain in my left arm (when lifting) where the injection was given. I was unable to drive and my speech was impaired. The Dr dismissed it as vasovagal. These symptoms subsided for a day and then returned on the 10th upon waking. My Dr concluded it had lasted too long to be vasovagal and sent me to the ER to be checked for a mini stroke. The CT scan reveled no signs of a stroke and blood work came out fine. The ER said it was a reaction to the Flu shot. I am continuing to have these symptoms as of today the 11th.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Impaired driving ability, Injection site pain, Pain, Speech disorder
Clinical narrative: Yes, within minutes before leaving the Dr office I experienced confusion and numbness followed by numbness on the left side of my face. I was told to go back to the exam room then became dizzy and the numbness ran through the rest of my face and whole body. My face felt warm and I had severe pain in my left arm (when lifting) where the injection was given. I was unable to drive and my speech was impaired. The Dr dismissed it as vasovagal. These symptoms subsided for a day and then returned on the 10th upon waking. My Dr concluded it had lasted too long to be vasovagal and sent me to the ER to be checked for a mini stroke. The CT scan reveled no signs of a stroke and blood work came out fine. The ER said it was a reaction to the Flu shot. I am continuing to have these symptoms as of today the 11th.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: Yes, within minutes before leaving the Dr office I experienced confusion and numbness followed by numbness on the left side of my face. I was told to go back to the exam room then became dizzy and the numbness ran through the rest of my face and whole body. My face felt warm and I had severe pain in my left arm (when lifting) where the injection was given. I was unable to drive and my speech was impaired. The Dr dismissed it as vasovagal. These symptoms subsided for a day and then returned on the 10th upon waking. My Dr concluded it had lasted too long to be vasovagal and sent me to the ER to be checked for a mini stroke. The CT scan reveled no signs of a stroke and blood work came out fine. The ER said it was a reaction to the Flu shot. I am continuing to have these symptoms as of today the 11th.
Age: 88.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Rash erythematous, Rash pruritic, Vaccination site reaction
Clinical narrative: After receiving both PREVNAR 13 and FLUZONE HIGH DOSE the patient developed a raised, red, rash on her left arm in the spot where the vaccines were given. The rash is localized to the injection site. The patient describes the rash as itchy but not painful. The rash appeared to be 3.5in in diameter.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Patient felt dizzy and light headed, had patient lay down flat on the bench, gave her some water and blood pressure checked bp at the time is 99/55. No other medications were given. BP rechecked after 10 mins was 109/56. Observed for addition 10 mins, patient stated she feel much better, walked around and left.  Follow up call 2 days later patient stated that she was fine.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: GENERAL WARM RED SWOLLEN AREA (INSIDE OF LEFT UPPER ANTERIOR ARM). WARM, RED SWOLLEN AREA LEFT UPPER POSTERIOR ARM (BELOW INJECTION SITE). NOT AFFECTING SHOULDER AREA. NOT AFFECTING ELBOW AREA.
Age: 45.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient received Yellow Fever Vaccine on 11/04/2016 (Lot: UI293AA and Exp: 04/20/2018 Reconstituted with Sodium Chloride Diluent Lot: UI564AA and Exp: 11/2019 Administered by RN.  Patient developed an oval, red and raised area to the left arm due to the injection or the vaccine itself.  Dr. was made aware and she saw the patient.  She stated she wants the patient to come back on Monday and see me regarding the swelling and soreness.  She also prescribed the patient medication to take. A Stars report and a Vaer's report will be entered regarding this adverse reaction. Thank you.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Reddened, raised area at injection site, warm to the touch, measured 40 mm x 40 mm.  Plans to use over-the-counter medications and ICE as needed.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable consumer by way of Claim Letter and Medical Records. This 69-year-old, female patient of an unknown race was injected PREVNAR 13 vaccine 0.5 ml on 25Oct2016 in the left arm through intramuscular route for pneumonia. The lot number was reported as N47827, expiration date was Nov2017 and NDC number was 00005-1971-02. The frequency was unknown. The relevant medical history, concomitant medication and past drug history were unknown. On 25Oct2016, the patient developed allergic reaction. The relevant lab data was unknown. The action taken with pneumococcal 13-val conj vac (dipht crm197 protein) in response to the event was unknown. The therapeutic measures taken were unknown. As of 09Nov2016, the clinical outcome of the event allergic reaction was unknown.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A more than 70-year-old female patient of an unspecified age and ethnicity received PREVNAR 13 at single dose in the right arm and INFLUENZA VACCINE at an unspecified dose in the left arm, both via an unspecified route of administration on an unspecified date for immunisation. The patient medical history included dementia. Concomitant medications were not reported. On an unspecified date the patient experienced Prevnar 13 in the right arm, flu shot in the left arm with outcome of unknown, redness (about 3-4 inches in diameter) and swelling around the injection site with outcome of recovering, redness and swelling were experienced around the injection site with outcome of recovering. The redness and swelling was visible several days after vaccination but seemed to be improving with each day. It was unknown if the patient has shown similar reactions to other vaccines.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Discomfort, Limb discomfort, Myalgia
Clinical narrative: This is a spontaneous report from a contactable nurse reported for herself. A 79-year-old female patient received PREVNAR 13, (lot L99271) for immunization on 13Nov2015 at single dose. No medical history was reported. Concomitant medications were none. On 14Nov2015 the patient experienced big discomfort in her arm for a week and it also went down the body and muscle aches and pain. The outcome of the events was reported as recovered on 21Nov2015.
Sex: U
Vaccine: PNC13
Symptoms: Adverse reaction
Clinical narrative: This is a spontaneous report from a non-contactable consumer who reported for him/her self. A patient of unspecified age race and gender received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported.  The patient had a reaction from the vaccine on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program, from a contactable pharmacist. A 65 year-old female patient of an unspecified race and ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration on 24Oct2016 for immunization.  The patient medical history and concomitant medications were not reported.  After a couple of days, on 26Oct2016, not at the injection site but a couple of inches below the injection site, the patient got a big rash of about a 6 inches bigger. Outcome was unknown. The reporting pharmacist wanted to know if that was normal and if it was something related to the vaccine. She further added that she knew that there could be a skin reaction but that she thought that it would be at the same region (injection site) where the injection was given however this (big rash) was off the injection site a couple of inches.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Rash erythematous
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program, from a contactable pharmacist. A 65 year-old female patient of an unspecified race and ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration on 24Oct2016 for immunization.  The patient medical history and concomitant medications were not reported.  After a couple of days, on 26Oct2016, not at the injection site but a couple of inches below the injection site, the patient got a big rash of about a 6 inches bigger. Outcome was unknown. The reporting pharmacist wanted to know if that was normal and if it was something related to the vaccine. She further added that she knew that there could be a skin reaction but that she thought that it would be at the same region (injection site) where the injection was given however this (big rash) was off the injection site a couple of inches.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Dysgeusia, Feeding disorder
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 75-year-old female patient received PREVNAR 13 (Lot# N47827, Exp date Nov2017, NDC# 00005197102, UPC# 30005197102), via an unspecified route of administration, on 27Oct2016, at single dose, for immunisation. The patient was vaccinated at the pharmacy. Medical history included hypercholesterolaemia. There were no concomitant medications. The patient experienced whenever she had anything to eat, she had a bad taste in her mouth on 28Oct2016 with outcome of unknown and not able to eat on 28Oct2016 with outcome of unknown. No therapeutic measures were taken in response to the adverse events.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Received Flu Shot on 10/12/16.  On 10/14/16 when she woke up noticed arm was hurting a little but as the day went on, noticed it was itching alot.  Arm had erythema, warm to the touch, and measured 65 mm wide x 37 mm tall.  Plans to use over-the-counter medications and ICE as needed.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Influenza like illness, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: PATIENT HAD PAINFUL ARM FROM SHOULDER TO ELBOW.  ARM WAS SWOLLEN, RED, HOT AND PAINFUL. PATIENT FELT LIKE SHE HAD FLU LIKE SYMPTOMS ALSO.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Tender lump under skin at injection site.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Blood test, Herpes zoster, Injection site induration, Injection site mass
Clinical narrative: Injection site formed a hard lump and was itchy and hot the their day after the injection and lasted for a week.  Severe abdominal pain started on 10/19/16 and shingles rash appeared on 10/21/16 on back near T11 vertebrate.  Rash is resolving but abdominal pain continues.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site warmth, Ultrasound abdomen
Clinical narrative: Injection site formed a hard lump and was itchy and hot the their day after the injection and lasted for a week.  Severe abdominal pain started on 10/19/16 and shingles rash appeared on 10/21/16 on back near T11 vertebrate.  Rash is resolving but abdominal pain continues.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: ARM SORENESS CONTINUING.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site urticaria, Urticaria
Clinical narrative: Pt states she woke up with a rash/hive over her entire injection site deltoid, as well as hive on stomach and scalp. She is taking Benadryl at night and cetirizine during day.
Age: 11.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Product reconstitution issue
Clinical narrative: Gave liquid portion of MENVEO immunization.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Oxygen saturation decreased, Vaccination complication
Clinical narrative: OXYGEN SATURATION IN 70'S, "EVERY INTERACTION LISTED FOR THE VACCINE".
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Arm became swollen, red and warm at injection site.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Blister, Pyrexia, Rash papular, Scab, Varicella
Clinical narrative: Patient received vaccines (MMR, VZV, Prevnar 13) on Monday 11/07/2016. Pt began having fever on Tuesday 11/8/16 and then rash on Wednesday 11/9/16. Pt seen at PCP 11/11/16- erythematous papules, blisters, scabs noted on arms, legs, trunk primarily. Diagnosed with vaccine induced varicella.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Swelling and redness right upper arm. Hot to touch. Pain in right arm. Headache. Flu-like symptoms. Steroid prescription given along with Zyrtec.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Swelling and redness right upper arm. Hot to touch. Pain in right arm. Headache. Flu-like symptoms. Steroid prescription given along with Zyrtec.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient's husband stated that nite of 11-2 her arm was sore and red, next day she had soreness all down her arm.
Age: 37.0
Sex: M
Vaccine: FLU4, HEP, MMR, TDAP, VARCEL
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient was seen at 1:00 pm for 6 injections, including TB skin test. Patient fainted after 4th injection; nurse was present and stood in front of patient (who was seated) so he would not slide out of chair. Another nurse applied cold packs and wet paper towels. When patient regained consciousness he took one sip of cold water, then requested to lie on floor. Nurses assisted patient to floor where he laid on his back with his feet elevated on the chair while nurses continued to apply wet towels and cold packs. Patient was given lollipop and licked on it. Patient eventually requested to receive the other 2 vaccinations. One was administered sitting up in chair while patient sipped the rest of the cup of cold water, then patient requested to lie on floor again for the last injection. Patient remained on floor until he insisted that he felt ok and wanted to get up against advice of both nurses. Patient insisted that "this always happens" and refused to remain at the clinic for observation or to be assisted out to his car. Patient left treatment room on his own at 1:30 pm, and Nurse observed through window that patient walked successfully to his car, got in, and drove off. At no time did the patient fall or strike any part of his body on anything.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Anxiety, Chest pain, Dyspnoea, Hypoaesthesia
Clinical narrative: At time that vaccine was given, numbness and tingling to left hand and would switch back and forth between right and left feet and left side of head. Symptoms became more severe the next day and went to ED for evaluation, was told it was probably nerve inflammation. The next day she reported chest pain, shortness of breath, abdominal pain and a feeling of impending doom.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Neuritis, Paraesthesia
Clinical narrative: At time that vaccine was given, numbness and tingling to left hand and would switch back and forth between right and left feet and left side of head. Symptoms became more severe the next day and went to ED for evaluation, was told it was probably nerve inflammation. The next day she reported chest pain, shortness of breath, abdominal pain and a feeling of impending doom.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Dizziness, Flushing, Malaise, Nausea, Pruritus
Clinical narrative: Nausea, dizziness, light headed, flushed, hives, intense itching, swelling of face/skin, skin feels hot, feeling ill.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Skin warm, Swelling face, Urticaria
Clinical narrative: Nausea, dizziness, light headed, flushed, hives, intense itching, swelling of face/skin, skin feels hot, feeling ill.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Abdominal pain upper, Dizziness, Hypersensitivity, Local swelling, Nausea
Clinical narrative: Nausea, dizziness, light headed, flushed, hives, intense itching, swelling of face/skin, skin feels hot, feeling ill.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Pruritus, Rhinorrhoea, Skin warm, Urticaria
Clinical narrative: Nausea, dizziness, light headed, flushed, hives, intense itching, swelling of face/skin, skin feels hot, feeling ill.
Age: 0.58
Sex: M
Vaccine: FLU4
Symptoms: Insomnia, Pyrexia, Respiratory tract congestion, Vomiting projectile
Clinical narrative: Very congested, projectile vomiting, fever max 103, would not lay down in bed to sleep.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Paraesthesia oral, Vaccination complication
Clinical narrative: Patient returned to the pharmacy the next day complaining of soreness in the arm in which she received the vaccination. She was recommended to take OTC acetaminophen. Her doctor treated her with prednisone for lingering symptoms in late October. The patient also came by the pharmacy at this time with tingling in her lips and asked for a recommendation on a lip balm. She was tested for neuropathy at her doctor's office and was told the lip tingling was a reaction to the flu shot and an "extreme immune response".
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Rash generalised
Clinical narrative: PATINET HUSBAND REPORTED TO PHARMACIST THAT SHE HAD ALLERGIC REACTION/RASH TO ALL OVER THE BODY.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Pt stated on 11/10/16 that arm of injection site was red, warm, and hard below the injection site area. On 11/11/16 patient came in to show pharmacist and arm was red and warm. Patient was sent to the MD. Patient reported that MD said it was a localized reaction without infection and instructed patient to take Benadryl and a cold compress.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site nodule, Injection site pain
Clinical narrative: Per pt report, she experience a knots at injection after administration which she rubs to prevent it from getting worse. Pt contacted me on 11/10 to let me know that her arms was hurting and she experienced tender at injection site 7 days later, per pt knots disappear but her arm is still tender and difficult for her to freely move her arm.
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: Very sore arm where flu shot was given. Spread up to neck and down arm. Took ALEVE 2 x 220mg with minimal relief. Painful to move.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Feeling hot, Hyperhidrosis, Pyrexia
Clinical narrative: Patient felt heated, was sweating profusely, had a high fever, and had chills.
Age: 25.0
Sex: F
Vaccine: FLU3, TYP, YF
Symptoms: Loss of consciousness, Nausea
Clinical narrative: Patient reported feeling a little nauseous and was mid conversation after receiving the first vaccine and passed out for just a few seconds.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness around left deltoid muscle where vaccine was administered for approximately 3 days. Patient advised to take oral diphenhydramine on the third day following vaccination (when she presented to the pharmacy) and follow-up with primary care doctor if unresolved.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Arm pain evolving into what patient described as not being able to move his arm.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dysgeusia, Flushing, Nausea, Paraesthesia oral
Clinical narrative: Lightheaded, nausea, flushing, metallic taste, tingling on upper lip area, seeing white spots, pt sat down and took deep breaths and felt better within 5 to 7 minutes.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Visual impairment
Clinical narrative: Lightheaded, nausea, flushing, metallic taste, tingling on upper lip area, seeing white spots, pt sat down and took deep breaths and felt better within 5 to 7 minutes.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient said a week after the immunization her arm started with a dull throbbing pain. She still has the pain the majority of the day and she can't lift it all the way up.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: Sharp, throbbing pain in the muscle, hurt really bad, and the pain spreading down to the elbow/arm. Patient put on ice pack, take ibuprofen to help with the pain. She said it helps a little bit.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Erythema, Pain
Clinical narrative: Patient reports severe body aches/joint pain which she states have gotten better but still has large red area (extended hand size) on arm of injection even after a week has past since injection given. Has been instructed to watch area and come in to her primary care doctor on Monday if redness has not resolved.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal distension, Diarrhoea, Flatulence, Weight decreased
Clinical narrative: Diarrhea, gassy, bloating.  Lasted on and off for over a week.  Used several Immodium and finally got severe diarrhea under control. Lost 10 pounds.
Age: 1.08
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Feeling abnormal, Lethargy, Tension
Clinical narrative: Patients mother observed her being dazed, lethargic, tensing her body and staring into space.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site swelling and redness.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Pain in extremity
Clinical narrative: Pt stated that her left arm began to ache throughout the day and continue to worsen over the next few days.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PPV
Symptoms: Muscular weakness, Pain
Clinical narrative: Extreme Pain, Shaky Legs.
Sex: F
Vaccine: HPVX
Symptoms: Cervix carcinoma
Clinical narrative: This spontaneous report was received from a consumer, through social media, concerning a 14 year old girl. No pertinent medical history, concurrent conditions, or drug reactions/allergies of this patient were provided. No concomitant medications were reported. On an unspecified date, the patient had been vaccinated with an unspecified Human Papillomavirus Infection (HPV) vaccine (manufacturer unknown) (Dose, Lot # and expiry date were not provided). On an unspecified date, after the shot, the patient developed cervical cancer. The consumer stated that they had researched this vaccine extensively and spoken to those who have gotten. It was unknown if the patient received any treatment, sought medical attention or about the outcome of the event. The causality between Human Papillomavirus Infection (HPV) vaccine (manufacturer unknown) and cervical cancer was unknown. A PQC was not involved. Upon internal review, the cervical cancer was considered medically significant. Additional information is not expected because the primary reporter cannot be contacted privately.
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Blood test, Cellulitis, Chest X-ray, Dysphonia, Dyspnoea
Clinical narrative: This spontaneous report was received from a 65 year old female patient regarding herself. medical history included thyroid disease. The patient was allergic to TYLENOL with Codeine. On 20-APR-2016, the patient was vaccinated with one shot of ZOSTAVAX and PNEUMOVAX 23 each in the same left arm. The ZOSTAVAX was given in the fatty back part in the arm by the elbow and the PNEUMOVAX 23 was administered in the left arm up by the shoulder area. On an unknown date in 2016 a few days after receiving the two vaccines, the patient experienced cellulitis. The symptoms started with swelling on her left arm into her chest area up to her face which also got swollen and the swelling continued more, especially if she felt warm. Patient said she felt pains and aches when she would stand up and her body in general felt swollen. Patient also mentioned that she got an eruption which was a red rash that developed around her lower legs into her calves and the rash would look like it was healing and then the rash would suddenly flare up again around her lower legs. The patient also felt exhausted and fatigued. The patient stated that when she got the PNEUMOVAX 23, the clinic where she got both vaccines told her apparently the PNEUMOVAX 23 had touched her bone or nerve possibly and a few days later, she experienced a fever and cellulitis as well, which she was given an unknown antibiotic as treatment however the antibiotic made her very light sensitive in her eyes and face to the extent that she couldn't see in the light very well and after 3 days she had to stop taking the antibiotic. On an unknown date in 2016, her throat became hoarse and she felt breathlessness. The patient was prescribed an unknown anti-histamine to help treat some of her side effects. Lab data included blood tests, pulmonary test, lung X-ray. The patient went to see several Internist doctors and an immune disorder specialist but none of them could diagnose exactly why she was having numerous side effects or what specifically was causing her adverse reaction. The outcome of cellulitis, photophobia, dyspnoea and dysphonia was reported as not resolved. Causality was not reported. Upon internal review cellulitis was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Fatigue, Feeling abnormal, Feeling hot, Pain, Peripheral swelling
Clinical narrative: This spontaneous report was received from a 65 year old female patient regarding herself. medical history included thyroid disease. The patient was allergic to TYLENOL with Codeine. On 20-APR-2016, the patient was vaccinated with one shot of ZOSTAVAX and PNEUMOVAX 23 each in the same left arm. The ZOSTAVAX was given in the fatty back part in the arm by the elbow and the PNEUMOVAX 23 was administered in the left arm up by the shoulder area. On an unknown date in 2016 a few days after receiving the two vaccines, the patient experienced cellulitis. The symptoms started with swelling on her left arm into her chest area up to her face which also got swollen and the swelling continued more, especially if she felt warm. Patient said she felt pains and aches when she would stand up and her body in general felt swollen. Patient also mentioned that she got an eruption which was a red rash that developed around her lower legs into her calves and the rash would look like it was healing and then the rash would suddenly flare up again around her lower legs. The patient also felt exhausted and fatigued. The patient stated that when she got the PNEUMOVAX 23, the clinic where she got both vaccines told her apparently the PNEUMOVAX 23 had touched her bone or nerve possibly and a few days later, she experienced a fever and cellulitis as well, which she was given an unknown antibiotic as treatment however the antibiotic made her very light sensitive in her eyes and face to the extent that she couldn't see in the light very well and after 3 days she had to stop taking the antibiotic. On an unknown date in 2016, her throat became hoarse and she felt breathlessness. The patient was prescribed an unknown anti-histamine to help treat some of her side effects. Lab data included blood tests, pulmonary test, lung X-ray. The patient went to see several Internist doctors and an immune disorder specialist but none of them could diagnose exactly why she was having numerous side effects or what specifically was causing her adverse reaction. The outcome of cellulitis, photophobia, dyspnoea and dysphonia was reported as not resolved. Causality was not reported. Upon internal review cellulitis was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Photophobia, Pulmonary function test, Pyrexia, Rash, Rash erythematous
Clinical narrative: This spontaneous report was received from a 65 year old female patient regarding herself. medical history included thyroid disease. The patient was allergic to TYLENOL with Codeine. On 20-APR-2016, the patient was vaccinated with one shot of ZOSTAVAX and PNEUMOVAX 23 each in the same left arm. The ZOSTAVAX was given in the fatty back part in the arm by the elbow and the PNEUMOVAX 23 was administered in the left arm up by the shoulder area. On an unknown date in 2016 a few days after receiving the two vaccines, the patient experienced cellulitis. The symptoms started with swelling on her left arm into her chest area up to her face which also got swollen and the swelling continued more, especially if she felt warm. Patient said she felt pains and aches when she would stand up and her body in general felt swollen. Patient also mentioned that she got an eruption which was a red rash that developed around her lower legs into her calves and the rash would look like it was healing and then the rash would suddenly flare up again around her lower legs. The patient also felt exhausted and fatigued. The patient stated that when she got the PNEUMOVAX 23, the clinic where she got both vaccines told her apparently the PNEUMOVAX 23 had touched her bone or nerve possibly and a few days later, she experienced a fever and cellulitis as well, which she was given an unknown antibiotic as treatment however the antibiotic made her very light sensitive in her eyes and face to the extent that she couldn't see in the light very well and after 3 days she had to stop taking the antibiotic. On an unknown date in 2016, her throat became hoarse and she felt breathlessness. The patient was prescribed an unknown anti-histamine to help treat some of her side effects. Lab data included blood tests, pulmonary test, lung X-ray. The patient went to see several Internist doctors and an immune disorder specialist but none of them could diagnose exactly why she was having numerous side effects or what specifically was causing her adverse reaction. The outcome of cellulitis, photophobia, dyspnoea and dysphonia was reported as not resolved. Causality was not reported. Upon internal review cellulitis was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Swelling, Swelling face
Clinical narrative: This spontaneous report was received from a 65 year old female patient regarding herself. medical history included thyroid disease. The patient was allergic to TYLENOL with Codeine. On 20-APR-2016, the patient was vaccinated with one shot of ZOSTAVAX and PNEUMOVAX 23 each in the same left arm. The ZOSTAVAX was given in the fatty back part in the arm by the elbow and the PNEUMOVAX 23 was administered in the left arm up by the shoulder area. On an unknown date in 2016 a few days after receiving the two vaccines, the patient experienced cellulitis. The symptoms started with swelling on her left arm into her chest area up to her face which also got swollen and the swelling continued more, especially if she felt warm. Patient said she felt pains and aches when she would stand up and her body in general felt swollen. Patient also mentioned that she got an eruption which was a red rash that developed around her lower legs into her calves and the rash would look like it was healing and then the rash would suddenly flare up again around her lower legs. The patient also felt exhausted and fatigued. The patient stated that when she got the PNEUMOVAX 23, the clinic where she got both vaccines told her apparently the PNEUMOVAX 23 had touched her bone or nerve possibly and a few days later, she experienced a fever and cellulitis as well, which she was given an unknown antibiotic as treatment however the antibiotic made her very light sensitive in her eyes and face to the extent that she couldn't see in the light very well and after 3 days she had to stop taking the antibiotic. On an unknown date in 2016, her throat became hoarse and she felt breathlessness. The patient was prescribed an unknown anti-histamine to help treat some of her side effects. Lab data included blood tests, pulmonary test, lung X-ray. The patient went to see several Internist doctors and an immune disorder specialist but none of them could diagnose exactly why she was having numerous side effects or what specifically was causing her adverse reaction. The outcome of cellulitis, photophobia, dyspnoea and dysphonia was reported as not resolved. Causality was not reported. Upon internal review cellulitis was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Antibody test, Blood creatine phosphokinase, C-reactive protein, Erythema, Joint stiffness
Clinical narrative: This spontaneous report was received from a 65 year old female patient regarding herself. medical history included thyroid disease. The patient was allergic to TYLENOL with Codeine. On 20-APR-2016, the patient was vaccinated with one shot of ZOSTAVAX and PNEUMOVAX 23 each in the same left arm. The ZOSTAVAX was given in the fatty back part in the arm by the elbow and the PNEUMOVAX 23 was administered in the left arm up by the shoulder area. On an unknown date in 2016 a few days after receiving the two vaccines, the patient experienced cellulitis. The symptoms started with swelling on her left arm into her chest area up to her face which also got swollen and the swelling continued more, especially if she felt warm. Patient said she felt pains and aches when she would stand up and her body in general felt swollen. Patient also mentioned that she got an eruption which was a red rash that developed around her lower legs into her calves and the rash would look like it was healing and then the rash would suddenly flare up again around her lower legs. The patient also felt exhausted and fatigued. The patient stated that when she got the PNEUMOVAX 23, the clinic where she got both vaccines told her apparently the PNEUMOVAX 23 had touched her bone or nerve possibly and a few days later, she experienced a fever and cellulitis as well, which she was given an unknown antibiotic as treatment however the antibiotic made her very light sensitive in her eyes and face to the extent that she couldn't see in the light very well and after 3 days she had to stop taking the antibiotic. On an unknown date in 2016, her throat became hoarse and she felt breathlessness. The patient was prescribed an unknown anti-histamine to help treat some of her side effects. Lab data included blood tests, pulmonary test, lung X-ray. The patient went to see several Internist doctors and an immune disorder specialist but none of them could diagnose exactly why she was having numerous side effects or what specifically was causing her adverse reaction. The outcome of cellulitis, photophobia, dyspnoea and dysphonia was reported as not resolved. Causality was not reported. Upon internal review cellulitis was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Pain, Paraesthesia, Peripheral swelling, Pyrexia, Rash
Clinical narrative: This spontaneous report was received from a 65 year old female patient regarding herself. medical history included thyroid disease. The patient was allergic to TYLENOL with Codeine. On 20-APR-2016, the patient was vaccinated with one shot of ZOSTAVAX and PNEUMOVAX 23 each in the same left arm. The ZOSTAVAX was given in the fatty back part in the arm by the elbow and the PNEUMOVAX 23 was administered in the left arm up by the shoulder area. On an unknown date in 2016 a few days after receiving the two vaccines, the patient experienced cellulitis. The symptoms started with swelling on her left arm into her chest area up to her face which also got swollen and the swelling continued more, especially if she felt warm. Patient said she felt pains and aches when she would stand up and her body in general felt swollen. Patient also mentioned that she got an eruption which was a red rash that developed around her lower legs into her calves and the rash would look like it was healing and then the rash would suddenly flare up again around her lower legs. The patient also felt exhausted and fatigued. The patient stated that when she got the PNEUMOVAX 23, the clinic where she got both vaccines told her apparently the PNEUMOVAX 23 had touched her bone or nerve possibly and a few days later, she experienced a fever and cellulitis as well, which she was given an unknown antibiotic as treatment however the antibiotic made her very light sensitive in her eyes and face to the extent that she couldn't see in the light very well and after 3 days she had to stop taking the antibiotic. On an unknown date in 2016, her throat became hoarse and she felt breathlessness. The patient was prescribed an unknown anti-histamine to help treat some of her side effects. Lab data included blood tests, pulmonary test, lung X-ray. The patient went to see several Internist doctors and an immune disorder specialist but none of them could diagnose exactly why she was having numerous side effects or what specifically was causing her adverse reaction. The outcome of cellulitis, photophobia, dyspnoea and dysphonia was reported as not resolved. Causality was not reported. Upon internal review cellulitis was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Red blood cell sedimentation rate decreased, Skin warm
Clinical narrative: This spontaneous report was received from a 65 year old female patient regarding herself. medical history included thyroid disease. The patient was allergic to TYLENOL with Codeine. On 20-APR-2016, the patient was vaccinated with one shot of ZOSTAVAX and PNEUMOVAX 23 each in the same left arm. The ZOSTAVAX was given in the fatty back part in the arm by the elbow and the PNEUMOVAX 23 was administered in the left arm up by the shoulder area. On an unknown date in 2016 a few days after receiving the two vaccines, the patient experienced cellulitis. The symptoms started with swelling on her left arm into her chest area up to her face which also got swollen and the swelling continued more, especially if she felt warm. Patient said she felt pains and aches when she would stand up and her body in general felt swollen. Patient also mentioned that she got an eruption which was a red rash that developed around her lower legs into her calves and the rash would look like it was healing and then the rash would suddenly flare up again around her lower legs. The patient also felt exhausted and fatigued. The patient stated that when she got the PNEUMOVAX 23, the clinic where she got both vaccines told her apparently the PNEUMOVAX 23 had touched her bone or nerve possibly and a few days later, she experienced a fever and cellulitis as well, which she was given an unknown antibiotic as treatment however the antibiotic made her very light sensitive in her eyes and face to the extent that she couldn't see in the light very well and after 3 days she had to stop taking the antibiotic. On an unknown date in 2016, her throat became hoarse and she felt breathlessness. The patient was prescribed an unknown anti-histamine to help treat some of her side effects. Lab data included blood tests, pulmonary test, lung X-ray. The patient went to see several Internist doctors and an immune disorder specialist but none of them could diagnose exactly why she was having numerous side effects or what specifically was causing her adverse reaction. The outcome of cellulitis, photophobia, dyspnoea and dysphonia was reported as not resolved. Causality was not reported. Upon internal review cellulitis was determined to be medically significant. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Rash, Tremor
Clinical narrative: Patient had developed rash band around arm (about 6 inches below where vaccine injection site was). Rash band was approximately 3 in wide. Patient reported rash appeared 24 hrs after vaccine administered. Also reported general headache and a brief period of shaking.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 5-year-old female patient who received FLUARIX QUADRIVALENT (batch number 9J4B7, expiry date 30th June 2017). On 31st October 2016 less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced extensive swelling of vaccinated limb and injection site redness. The patient was treated with BENADRYL and ibuprofen. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site redness were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site redness to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT in her left deltoid and within 24 hours the patient experienced swelling and redness which spread from the injection site to the patient's shoulder, elbow and inner part of her arm. On 2nd November 2016, the patient was seen for a follow up and was prescribed BENADRYL and Ibuprofen as treatment. The reporter has given permission to contact again. This is one of the 5 cases reported by the same reporter.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: LF Deltoid region red, hyperemic, tender to touch, size 4.5"x3" (margins non elevated). Ice, MOTRIN, BENADRYL-Call update (x3 dy)
Sex: F
Vaccine: FLU3
Symptoms: Face and mouth X-ray abnormal, Pyrexia, Respiratory tract congestion, Sinus congestion
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of sinus congestion in a 89-year-old female patient who received Flu Seasonal TIV Dresden. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, less than a week after receiving Seasonal Influenza vaccine, the patient experienced sinus congestion, respiratory tract congestion and fever. On an unknown date, the outcome of the sinus congestion, respiratory tract congestion and fever were unknown. It was unknown if the reporter considered the sinus congestion, respiratory tract congestion and fever to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that the patient presented to her clinic with congestion in her sinuses and chest 2 days after receiving flu vaccine. X-rays showed some cloudiness in her sinuses and she had a slight fever. The patient had required an emergency room visit. This case had been  linked with case US2016159850 and US2016159851, reported by the same reporter.
Age: 51.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Pruritus generalised, Pyrexia, Rash
Clinical narrative: Patient developed a rash with itching all over his body and fever for 2 days after immunizations. No treatment. Patient reported symptoms to primary doctor one month after event.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site pain
Clinical narrative: Patient has had pain in her deltoid muscle since injection (4 weeks)- pain has not improved and is interfering with her activities.