chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Influenza like illness, Injection site pain, Nausea, Pain
Clinical narrative: immediately during getting the injection i was told it would "burn" . instead of burning it felt like i was being punched with knife in my arm.  i kinda screamed a bit in fact.  in the car after that i kept moving my arm around as i was told that would help disperse the vaccine faster in my body, but 30 minutes later i felt queezy, tired and was in EXTREME pain.  i took tylenol about 4 hours later and when i got home that night the pain was SO SEVERE that i went to bed at 8:30 without dinner.  i took another tylenol and thru the night i kept waking up with SO MUCH PAIN at the site of the injection i took more tylenol (about 4 times) . today it is only slightly, every to slightly better but i am experiencing flu like symptoms. tired, body aches, etc.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Screaming, Sleep disorder
Clinical narrative: immediately during getting the injection i was told it would "burn" . instead of burning it felt like i was being punched with knife in my arm.  i kinda screamed a bit in fact.  in the car after that i kept moving my arm around as i was told that would help disperse the vaccine faster in my body, but 30 minutes later i felt queezy, tired and was in EXTREME pain.  i took tylenol about 4 hours later and when i got home that night the pain was SO SEVERE that i went to bed at 8:30 without dinner.  i took another tylenol and thru the night i kept waking up with SO MUCH PAIN at the site of the injection i took more tylenol (about 4 times) . today it is only slightly, every to slightly better but i am experiencing flu like symptoms. tired, body aches, etc.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Body temperature increased, Erythema, Flushing, Peripheral swelling, Tachycardia
Clinical narrative: patient given Vaqta 0.5 ml in left Vastus Lateralis this was #2 in series. upon waiting 15 minutes after vaccine I went to release patient to go and mom stated "I think she's having a reaction" brought patient to room she had bilateral redness and mild swelling to back of both arm, mild facial flushing and some redness to hands, temp went up  to 99.8. Provider alerted, ice packs applied to bilateral arm, Benadryl given. vital signs monitored Provider noted some tachycardia, patient stable and transported via ambulance to Hospital.
Sex: F
Vaccine: MMR, UNK, VARCEL
Symptoms: Incorrect route of product administration, Pain in extremity
Clinical narrative: her left arm just hurts; vaccines should have been administerd subcutaneously but one was administered intramuscularly/the patient was told it was MMR vaccine; The spontaneous report was received from a 27-year-old female patient who reported on herself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-APR-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # N023956, expiration date: 01-SEP-2019 in the left arm (formulation, strength, dose were not reported), measles, mumps, rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) albumin status of recombinant human albumin (rHA), lot number R019391 (verified as valid) or RO19391 (RO19391 verified as non-valid), expiration date 05-JUL-2020, in the left arm (formulation, strength, dose, route of administration were not reported) and reconstituted with sterile diluent (STERILE DILUENT) as a requirement for work. On 10-APR-2019, the patient realized when she got home that both vaccines should be administered subcutaneously but one was administered intramuscularly. When she called to the pharmacy, to ask about routes of administration, she was told that measles, mumps, rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) had been given intravenously, however the person she spoke did not seem too sure about it. The patient reported, that she was fine, but her left arm just hurt (start date: 10-APR-2019). The outcome of pain in extremity was unknown. The relatedness between measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (Oka/Merck)(VARIVAX), sterile diluent and pain in the extremity was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: sore arm since injection; This spontaneous report was received from a physician via company representative refers to a 35-year-old female patient. Information on patient's historical condition and concurrent condition was not provided.   On an unknown date in March 2019, (also reported as about a month and half ago) the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis.   On an unknown date in March 2019, (also reported as since the injection) the patient had a sore arm (injection site pain). None of the lab tests were performed. The patient sought medical attention. The patient received treatment with unspecified analgesic. At the time of this report, outcome of injection site pain was unknown. The causality of the event for the suspect therapy hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: muscle pain; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was unknown.   It was unknown if the reporter considered the injection site muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination may be 73 or 74 years. The patient had muscle pain in the location where he got first Shingrix shot which was two month ago. It was now time for patients second shot and patient was afraid to get that fearing more muscle pain.
Sex: U
Vaccine: MENB
Symptoms: Influenza like illness, Pain, Swelling
Clinical narrative: Pain; Swelling; flu-like symptom; This case was reported by a physician via sales rep and described the occurrence of pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced pain, swelling and influenza-like symptoms. On an unknown date, the outcome of the pain, swelling and influenza-like symptoms were not reported.   It was unknown if the reporter considered the pain, swelling and influenza-like symptoms to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. After receiving the Bexsero, the patient experienced pain, swelling and flu-like symptoms. The reporter consented to follow up from GSK.
Age: 53.0
Sex: M
Vaccine: MMR
Symptoms: Headache, Pain, Rash, Respiratory tract congestion
Clinical narrative: Pt received MMR vaccine Wednesday morning (5/1/19). Congestion and headache developed by that afternoon. Headache relieved with Extra Strength Tylenol. Patient took Theraflu for symptoms. Started having body aches Thursday. Took another Theraflu. Friday morning noticed a flat rash to torso and arms. Came to clinic Friday late morning. Allergy medication given and instructed patient to go to ER if headache returns or symptoms worsen. Rash was not painful and did not itch. No fever, No eye redness.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient seen 05/03/19 for right arm swelling, redness and warmth. Dx with cellulitis and given amoxicillin.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: After administering varicella and Influenza on 4-25-19 @ 4P in (L) thigh, noted immediate redness, swelling and hives surrounding the site where varicella was given. Benadryl given within 5 min and ice pack applied
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: leg swelling hot to touch Redness  low grade fever.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: This report was customer retrospective self report. The batch number and expiry date for Shingrix was not reported. The patient received both the doses of Shingrix in the first quarter of 2019. The patient experienced very sore arm and that exercise helped her to resolve some of the pain that was associated with Shingrix. This case was linked with the case US2019AMR071496 reported by the same reporter.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness; Vertigo; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date).   On 3rd March 2019, the patient received the 2nd dose of Shingrix. On 5th March 2019, 2 days after receiving Shingrix, the patient experienced dizziness and vertigo. The patient was treated with dramamine (nos), dramamine (nos) (Dramamine) and Benadryl. On an unknown date, the outcome of the dizziness and vertigo were not recovered/not resolved.   It was unknown if the reporter considered the dizziness and vertigo to be related to Shingrix.  Additional details were provided as follows: The reporter was patient. The lot number was not known at time of report. The patient received 2nd dose of Shingrix in the right arm. The patient experienced dizziness and vertigo that will not go away. The vertigo was right side dominant. The patient had seen her physician and was prescribed Dramamine and Benadryl.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Nasopharyngitis, Pain in extremity, Product storage error
Clinical narrative: product storage error; flu-like symptoms; head cold; chills; sore arm; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. On 22nd April 2019, the patient experienced influenza-like symptoms, head cold and chills. On an unknown date, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the influenza-like symptoms, head cold, chills and pain in arm were not recovered/not resolved and the outcome of the incorrect storage of drug was unknown.   It was unknown if the reporter considered the influenza-like symptoms, head cold, chills and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient reported that she overheard the pharmacy personnel state that the vaccine was not placed into refrigeration upon receipt of the shipment. The patient felt that she received Shingrix that was out of temperature range, which led to incorrect storage of vaccine. Later that evening, the patient reported flu-like symptoms consisting of a head cold and chills. The patient also reported a sore arm. At the time of reporting, the symptoms were not resolved. The reporter did not consent to follow up.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site cellulitis, Injection site erythema, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable Nurse. A 65-year-old female patient received first dose of PREVNAR 13, (Lot Number: X62324, Expiry date: 30Nov2020), intramuscularly at left deltoid on 19Apr2019 at 0.5 ml, single for immunization. Medical history included ongoing diabetes. Concomitant medication included metformin and AMARYL, both for diabetes. The patient also had other concomitant products for diabetes. The nurse was calling on behalf of a patient who received the vaccine and soon after developed cellulitis at the site of injection on 19Apr2019. Nurse stated that the MD thought it may have been administered subcutaneously. Nurse stated, "pneumococcal 13-val conj vac (dipht crm197 protein), cellulitis about a week after the administration, the patient came in with cellulitis at the site of injection. The provider after seeing the patient and completed an event report stating that the arm was sore after the injection and then it progressed over the last week. She said that she had pain immediately after the injection and it progressed and she was seen again on 26Apr2019 with increased pain and redness." Treatment taken in response to adverse events included the patient was prescribed KEFLEX 500 mg. The patient did not do any blood work. The patient's investigations was none. The outcome of cellulitis and redness at the site of injection was unknown, the outcome of arm was sore after the injection was not recovered. Sender's Comments: Based on the information currently available, it cannot be fully excluded that wrong technique in administration with PREVNAR 13 might have played a contributory role in triggering the occurrence of vaccination site cellulitis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: PPV
Symptoms: Death, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable consumer (who reported for the mother) via Pfizer sponsored program. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (unknown manufacturer) on an unspecified date at single dose for pneumococcal immunisation. The patient medical history and concomitant medications were not reported. The patient died of pneumonia on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Pfizer is the Marketing Authorization holder of pneumococcal 13-val conj vaccine (dipht crm197 protein) in reporter's country. This may be a duplicate report in situations where another Marketing Authorization holder of pneumococcal 13-val conj vaccine (dipht crm197 protein) has submitted the same report to the regulatory authorities. No follow-up attempts are possible, information about batch number cannot be obtained. Reported Cause(s) of Death: died of pneumonia; died of pneumonia.
Sex: F
Vaccine: PNC13
Symptoms: Guillain-Barre syndrome
Clinical narrative: This is a spontaneous report from contactable Nurse via Pfizer Sales Representative. A 66-year-old female patient received PREVNAR 13 (lot # X47910) via an unspecified route of administration at single dose on 04Apr of an unspecified year for immunisation. No other vaccines were given. The patient medical history was not reported. The concomitant medications were none. The patient experienced Guillain-Barre syndrome on an unspecified date after vaccination, for which she returned to clinic on 22Apr (year unspecified). The outcome of unknown. No follow-up attempts are possible. No further information is expected. Sender's Comments: There is no plausible mechanism to implicate PREVENAR 13 to the occurrence of the serious event "Guillain-Barre syndrome" due to the information currently available. More information such as medical history and concomitant medications are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There was no event that was an adverse reaction, patient received a pediatric dose of Hep B instead of adult dose.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Folliculitis, Generalised vaccinia, Rash pustular, Tenderness
Clinical narrative: 4 days after administration of smallpox vaccine patient left axilla became tender and he noted an "outbreak". On exam multiple 2-3mm pustular lesions on an erythematous base noted. DDx includes generalized vaccinia vs folliculitis. Patient advised to keep area covered and treat lesions as infectious.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Patient had fever several days after receiving the vaccine then started with a rash on her back that quickly spread to  other parts of her body (Chest, arms, legs)
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Patient received Prevnar vaccine 5/1/19.  She began experiencing symptoms the next day - redness, swelling, soreness, and warm to touch.  Symptoms did not improve despite arm elevation.  Erythema extends from shoulder to elbow.  Dr. prescribed prednisone 40mg x 5 days today (5/6/19).  Cannot give Benadryl as patient has an allergy to it.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: Flu like symptoms  - very tired and very achey for five whole days
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Given wrong immunization should of been Tdap.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Chills, Headache, Myalgia, Nausea
Clinical narrative: Pt reported a headache, abdominal pain, nausea, muscle aches and shivering lasting 12 to 24 hours.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Chills, Headache, Nausea
Clinical narrative: Pt reported a headache, abdominal pain, nausea, muscle aches and shivering lasting 12 to 24 hours.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Rash, red, swollen , warm to touch on left thigh only
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: arm is very red and hot to the touch below injection site. pt reports it has been getting better since time of injection
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: The patient recieved and expired dose of M-M-R II; No known adverse effects; This spontaneous report was received from a other healthcare professional regarding and anonymized patient. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant therapies were not reported.   On 02-MAY-2019, the patient received an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M- R II) (expired product administered), subcutaneous, lot number N024696, expiration date 07-APR-2019, for prophylaxis. No known adverse effects reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; A patient was inadvertently administered an expired dose of M-M-R II.; This spontaneous report was received from a health professional and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.    On 02-MAY-2019, the patient was inadvertently administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA), lot # N013296 and expiration date 28-APR-2019 (expired product administered) for prophylaxis (dose and route of administration were not reported). The vaccine was reconstituted with diluent MRK, lot # N027783 and expiration date 17-NOV-2019. No adverse effect reported. The outcome of the event expired product administered was not reported.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient reported that several hours after getting the vaccine she developed hives.  The hives have spread over the weekend and itch.  Patient denies any shortness of breath.   Patient advised to take Benedryl 25-50mg every 6 hours and Zantac 150 mg twice daily until hives are gone.  Patient advised to go to ER if she has any difficulty breathing.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: patient developed redness and swelling and warmth at the site.  Dr. prescribed patient Acetaminophen and Benadryl.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersomnia, Malaise, Somnolence
Clinical narrative: Shingrix shot on Friday. Extreme malaise, daytime sleepiness for one day  (Saturday) after Shingrix shot. I slept for twelve hours the next night (Saturday/Sunday). I woke on Sunday feeling very well.    One day of malaise is a small price to pay to reduce the chances of Shingles!
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site swelling, Injection site warmth, Pain
Clinical narrative: PT received Kinrix, Proquad 4/25/19, that night patient c\o pain and mother noticed warmth and swelling  on right arm where vaccines where administered. Pt was taken to Urgent care, was prescribed benadryl and ibuprofen
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Crying, Injection site pain, Pain
Clinical narrative: Pt seen 5/6/19 for c/o left shoulder pain at rest and worse with any movement.  Pain is severe with movement- Pt is crying with physical exam/range of motion.  No skin abnormalities, erythema, swelling, or fever.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Pyrexia
Clinical narrative: severe diarrhea lasting for 4 days, fever, pain in joints of hands
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Ear pain, Headache, Limb discomfort, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: On 3/28/19 I woke up and had pain on my left arm, it felt heavy and when I tried to lift my head my neck felt stiff and I could hardly lift my head off the pillow.  I applied heat, took tylenol arthritis and applied icy hot but the pain continued.  I called my doctor's office and spoke to the girl in the office I expected her to tell the doctor but she did not.  Later when I called again she said I should have gone to the office.  I mentioned I could not lift my head off the pillow.  Today 5/6/19 I feel better but I still have headache and ear ache (right side).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chest pain, Injection site pain, Myalgia, Pain
Clinical narrative: Pt received the 2nd dose of the Shingrix vaccine in our office on 1/21/19. After the injection the area was sore, but over the next 2 weeks the pain spread from her deltoid to the surrounding muscles and shoulder joints and progressively got worse. One month later she started to get pain in her L thorax that felt like shingles pain (no vesicles) that lasted for approximately 2 weeks. The pain in her left arm and shoulder still persist. She has throbbing at the injection site that spreads throughout her arm in waves. She has extreme pain when she reaches for anything or elevates her arm that significantly impairs her quality of life. She took some Aleve sparingly which helped and is currently using topical Voltaren gel which provides relief in addition to heat, stretching and massage, but can tell when the medication wears off. She has not felt like the pain has improved as of yet. She denied any redness or swelling and no f/c with the injection. When she received the first injection in 10/2018 she had pain at injection site for 1 month then it resolved.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Quality of life decreased
Clinical narrative: Pt received the 2nd dose of the Shingrix vaccine in our office on 1/21/19. After the injection the area was sore, but over the next 2 weeks the pain spread from her deltoid to the surrounding muscles and shoulder joints and progressively got worse. One month later she started to get pain in her L thorax that felt like shingles pain (no vesicles) that lasted for approximately 2 weeks. The pain in her left arm and shoulder still persist. She has throbbing at the injection site that spreads throughout her arm in waves. She has extreme pain when she reaches for anything or elevates her arm that significantly impairs her quality of life. She took some Aleve sparingly which helped and is currently using topical Voltaren gel which provides relief in addition to heat, stretching and massage, but can tell when the medication wears off. She has not felt like the pain has improved as of yet. She denied any redness or swelling and no f/c with the injection. When she received the first injection in 10/2018 she had pain at injection site for 1 month then it resolved.
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: L arm soreness, swelling, redness
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Pain, Pain in extremity, Pruritus
Clinical narrative: arm became very red, warm, sore, itchy, stared about four hours after shot and was still sore six days later. Also had a fever of 100.9 at night for 3 nights ands was tired and felt achy, have never had a vaccine do this before and not sure I want the second one.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: arm became very red, warm, sore, itchy, stared about four hours after shot and was still sore six days later. Also had a fever of 100.9 at night for 3 nights ands was tired and felt achy, have never had a vaccine do this before and not sure I want the second one.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain
Clinical narrative: patient reports that her injections site became red and discolored and sore
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: PATIENT HAS AN ITCHY, SORE, RASHY ARM. SHE NOTICED IT THIS MORNING. SHE WILL APPLY ICE FOR 10-15 MINS AT A TIME AS NEEDED AND WILL APPPLY CORTISONE 1% IF NEEDED FOR THE ITCHING.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Mobility decreased, Pain, Pyrexia
Clinical narrative: Pt returned to pharmacy today complaining of intense pain around the area of the injection.  She is experiencing redness and swelling approximately 5 inch diameter.  She also experience fever and body aches.  She feels the pain has not lessened 3 days later and has limited mobility in her arm.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Pt returned to pharmacy today complaining of intense pain around the area of the injection.  She is experiencing redness and swelling approximately 5 inch diameter.  She also experience fever and body aches.  She feels the pain has not lessened 3 days later and has limited mobility in her arm.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Injection site pain, Pyrexia
Clinical narrative: Fever, chills, sweating beginning 7 hours after vaccination and lasting >24 hours.  Tenderness at injection site.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Aphonia, Blood glucose increased, Blood test abnormal, Injection site rash, Lethargy
Clinical narrative: AFTER 5 DAYS ,LETHARGIC, LOST MY VOICE. ON 7TH DAY BROKE OUT IN SORES IN THROAT, BEHIND EARS, IN HAIR. 9TH DAY BROKE OUT IN RASH ON SHOULDERS, 12TH DAY RASH SPREAD COMPLETELY COVERED BACK, CHEST. 15TH DAY THROAT AND EARS BETTER, BUT BACK STILL SPREADING DOWN TO LOWER BACK, FRONT OF STOMACH AND AROUND GENITALS. 17TH DAY FEELING BETTER BUT STILL LETHARGIC, SORES ALL OVER BACK, CHEST, THROAT STILL SCRATCHY. DR. PUT ME ON VALACYLOVIR FOR ANOTHER 7 DAYS. STARTED ON 4/29/2019. USING A CREAM FOR SORES. BLOOD SUGAR HAS INCREASED TO 200- 300 DAILY. BLOOD WORK NUMBERS HAVE ALL INCREASED TO POOR LEVELS ACCORDING TO DR.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pharyngeal ulceration, Rash, Skin ulcer, Throat irritation
Clinical narrative: AFTER 5 DAYS ,LETHARGIC, LOST MY VOICE. ON 7TH DAY BROKE OUT IN SORES IN THROAT, BEHIND EARS, IN HAIR. 9TH DAY BROKE OUT IN RASH ON SHOULDERS, 12TH DAY RASH SPREAD COMPLETELY COVERED BACK, CHEST. 15TH DAY THROAT AND EARS BETTER, BUT BACK STILL SPREADING DOWN TO LOWER BACK, FRONT OF STOMACH AND AROUND GENITALS. 17TH DAY FEELING BETTER BUT STILL LETHARGIC, SORES ALL OVER BACK, CHEST, THROAT STILL SCRATCHY. DR. PUT ME ON VALACYLOVIR FOR ANOTHER 7 DAYS. STARTED ON 4/29/2019. USING A CREAM FOR SORES. BLOOD SUGAR HAS INCREASED TO 200- 300 DAILY. BLOOD WORK NUMBERS HAVE ALL INCREASED TO POOR LEVELS ACCORDING TO DR.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: continued pain in the area of the arm where shot was given when the arm is moved, or when lifting
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Chills, Fatigue, Myalgia, Pain
Clinical narrative: continued pain in the area of the arm where shot was given when the arm is moved, or when lifting
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: continued pain in the area of the arm where shot was given when the arm is moved, or when lifting
Age: 88.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthritis, Musculoskeletal pain
Clinical narrative: Daughter called and said she had just been to doctor complaining of pain in shoulder. Doctor stated that he thought it was arthritis. Daughter called and stated that she thought it was due to shot and that pain started soon after shot but did not go to doctor until May 2019.
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Stridor
Clinical narrative: after rotateq. developed inspiratory stridor  pulse ox. always 100%; was given saline  nebulizer and resolved. Episode of stridor  intermittent lasted approximately 30!
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: (R) thigh had some itching & swelling some erythema that seems to be spreading from under the band aid that still remains. Child had a fever day after vaccine given, no fever today. put on cephalexin told to return 5/9/19 for recheck.
Age: 80.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Hip arthroplasty, Myalgia
Clinical narrative: I had a total hip replacement on Thursday, Feb. 27th 2019. The pain was at my new hip joint and the muscules surrounding the area. This continued for (3) three days. Resulting in having to take Aleve during that time
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: He developed shingles in left T4 distribution 4 days after his vaccine. No sick relatives or contacts. Wife had same vaccine and had no rash. Hx of varicella in his youth.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Body temperature increased, Chills, Erythema, Feeling abnormal
Clinical narrative: Stabbing pains in top of left foot and joint of left thumb. Back aching bad headache, feeling weired, T 100.6. face bright red and patient was chilling.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: Stabbing pains in top of left foot and joint of left thumb. Back aching bad headache, feeling weired, T 100.6. face bright red and patient was chilling.
Age: 28.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: 4/10/19 received vaccine. 4/17/19 woke up with soreness at injection site 5/6/19 still sore at the injection site when touched or layed on at night.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Decreased appetite, Myalgia, Pain
Clinical narrative: MUSCLE/ JOINT PAIN BODY ACHES LOW GRADE FEVER (100.3) UPSET STOMACH (MILD) NO APPETITE
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: MUSCLE/ JOINT PAIN BODY ACHES LOW GRADE FEVER (100.3) UPSET STOMACH (MILD) NO APPETITE
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Pain, Skin warm
Clinical narrative: redness to (R) thigh x 1 day. She was painful & warm yesterday 05/02/18, no  pain today. Denies fatigue or fever.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Pyrexia, Rash, Skin warm, Swelling
Clinical narrative: Vaccine reaction, got Dtap on lt arm on 4/23/19 on 4/24/19 present with redness, swelling, hot to touch, c/o fever & rash.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Vaccination complication
Clinical narrative: Vaccine reaction, got Dtap on lt arm on 4/23/19 on 4/24/19 present with redness, swelling, hot to touch, c/o fever & rash.
Age: 66.0
Sex: F
Vaccine: DTAP
Symptoms: Pain, Peripheral swelling, Pyrexia
Clinical narrative: Terrile pain all over Body. Fever  Was in Bed For 3 Days. Swelling in arm  Feel Fine now
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm swelling, redness, tenderness and warmth. Seen 2 days after vaccine administration. Given Cephalexin for Cellulitis.
Age: 33.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Myalgia, Fever & injection site redness/tenderness  IBUPROFEN
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Blood culture negative, Body temperature increased, C-reactive protein increased, Chest X-ray normal, Febrile convulsion
Clinical narrative: 4/28/19 3 pm Febrile seizure, temp 104°F rectal      seen in ER; rapid flu (-), UA normal, CXR normal  Initially had fever after Imms 4/12 - 4/14/19. Then new fever started      4/27/19 to 104°F. No other symptoms.   4/29/19 Clinic visit for ongoing fever to 104°F, labs drawn,      ceftriaxone 50mg/kg IM given x2 (24hrs apart)
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Haematocrit normal, Haemoglobin normal, Influenza virus test negative, Lymphocyte count increased, Monocyte count increased
Clinical narrative: 4/28/19 3 pm Febrile seizure, temp 104°F rectal      seen in ER; rapid flu (-), UA normal, CXR normal  Initially had fever after Imms 4/12 - 4/14/19. Then new fever started      4/27/19 to 104°F. No other symptoms.   4/29/19 Clinic visit for ongoing fever to 104°F, labs drawn,      ceftriaxone 50mg/kg IM given x2 (24hrs apart)
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Neutrophil count increased, Platelet count normal, Pyrexia, Streptococcus test negative, Urine analysis normal
Clinical narrative: 4/28/19 3 pm Febrile seizure, temp 104°F rectal      seen in ER; rapid flu (-), UA normal, CXR normal  Initially had fever after Imms 4/12 - 4/14/19. Then new fever started      4/27/19 to 104°F. No other symptoms.   4/29/19 Clinic visit for ongoing fever to 104°F, labs drawn,      ceftriaxone 50mg/kg IM given x2 (24hrs apart)
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: White blood cell count increased
Clinical narrative: 4/28/19 3 pm Febrile seizure, temp 104°F rectal      seen in ER; rapid flu (-), UA normal, CXR normal  Initially had fever after Imms 4/12 - 4/14/19. Then new fever started      4/27/19 to 104°F. No other symptoms.   4/29/19 Clinic visit for ongoing fever to 104°F, labs drawn,      ceftriaxone 50mg/kg IM given x2 (24hrs apart)
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: gave shot in upper back sitting face to face  Has been experiencing pain since 4/16/19  Has progressively gotten worse  going down whole arm
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: low fever. Very sore arm - raised, swollen, very red, hot, hard as well - next day very painful  On 5/3 = 2 days after = looked like cellulitis   went to Dr on 5/4/19.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin infection, Skin warm
Clinical narrative: low fever. Very sore arm - raised, swollen, very red, hot, hard as well - next day very painful  On 5/3 = 2 days after = looked like cellulitis   went to Dr on 5/4/19.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Pain, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report was received from a physician referring to a 13 year-old male patient with history of previous drug reactions as penicillin caused rash, and AUGMENTIN caused vomiting. The patient's concomitant medications and concurrent conditions were not reported. On 02-APR-2018, the patient was vaccinated with GARDASIL 9 dose 1, in the left arm, for prophylaxis (route of administration was not provided); Lot No. N023828 has been verified to be a valid lot number for GARDASIL 9, expiration date not reported, but upon internal validation established as 25-JUN-2020. On that same day, the patient experienced headache, vomiting and pain; which caused a visit to the emergency room. There was no laboratory data provided, and the current illnesses at the time of the vaccination were reported as none. The outcome of headache, vomiting and pain was reported as recovered/resolved. At the time of this report, the causality assessment between GARDASIL 9 and the aforementioned events, was not disclosed. Follow-up information was received from the physician on 15-APR-2019, who confirmed that the patient required a physician's office visit due to the events, instead of an emergency room visit. The patient was vaccinated with GARDASIL 9 on 02-APR-2018 at 17:34. There was no previous administration of other vaccines. Follow-up information was received from the physician, on 29-APR-2019. The patient's demographics were updated. His concomitant medications included CLARITIN for rhinitis. The physician reported that the headaches last an unspecified amount of days, and vomiting lasted 1-2 days. No prescribed drug treatment was required for headaches and vomiting. The reporter considered the events vomiting and headaches to be medically significant.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Migraine with aura
Clinical narrative: ocular migraine; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic migraine in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced ophthalmic migraine. On an unknown date, the outcome of the ophthalmic migraine was unknown.   It was unknown if the reporter considered the ophthalmic migraine to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient asked how common was optic neuritis with the Shingirx shot and said did not experienced it. But shortly after the patient experienced ocular migraine. The patient did not give consent to contact the physician.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Migraine with aura, Photopsia
Clinical narrative: ocular migraine; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic migraine in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced ophthalmic migraine. On an unknown date, the outcome of the ophthalmic migraine was unknown.   It was unknown if the reporter considered the ophthalmic migraine to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient asked how common was optic neuritis with the Shingirx shot and said did not experienced it. But shortly after the patient experienced ocular migraine. The patient did not give consent to contact the physician.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Patient stated there was no pain when receiving the injection.  About 2 hours later she experienced pain in her left arm from her shoulder to her elbow.  It was painful to lift her arm at that time.  She took 2 doses of Ibuprofen 800 mg which did help.  The pain began to lessen on 5/5/19.  On Monday when she reported this the pain was a little less.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient stated there was no pain when receiving the injection.  About 2 hours later she experienced pain in her left arm from her shoulder to her elbow.  It was painful to lift her arm at that time.  She took 2 doses of Ibuprofen 800 mg which did help.  The pain began to lessen on 5/5/19.  On Monday when she reported this the pain was a little less.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site reaction, Lymphadenopathy, Muscle swelling
Clinical narrative: swelling in lymph node left arm deltoid muscle swollen usually larger than usual
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: no adverse effect reported; one dose of improperly stored VARIVAX was administered; Information has been received from a medical assistant referring to a patient with unknown age and gender. The patient's concomitant drug included sterile diluent. The patient's pertinent medical history, drug reactions or allergies were not reported.  On 05-APR-2019, the patient received one dose of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number: R018980; expiration date: 01-JUL-2020; strength was not reported), subcutaneously for prophylaxis. No adverse effect reported. The temperature of storage was 6 degrees Fahrenheit to 14 degrees Fahrenheit (9.7F) for 1 hour and 17 minutes; 6 degrees Fahrenheit to 14 degrees Fahrenheit (6.6 F) for 35 minutes. There was no previous temperature excursion. Data logger was involved.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse effects were reported; received a fourth dose of GARDASIL-9; Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not reported.  On 01-OCT-2018, the patient received a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number: N035032; expiration date 24-SEP-2020; strength was not reported), intramuscularly for prophylaxis (extra dose administered). No adverse effects were reported. The outcome of the event was unknown.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from an attorney and refers to currently 62 years old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided. On an unknown date in April 2016, the patient was vaccinated by the pharmacist with ZOSTAVAX injection (dose, route of administration, anatomical location, lot# and expiration date were not reported) for long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced herpes zoster, which was treated by a healthcare provider. The patient claimed damages as a result of: injury to themselves; loss of consortium, loss of services and economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; punitive damages. The outcome of the events was unknown. The reporter considered herpes zoster to be related to ZOSTAVAX. The relatedness between the product quality issue and ZOSTAVAX was not provided.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported; the patient, with birth date of 11/30/2018; received first dose of ROTATEQ/Initial Dose Received At A Later Than Recommended Age; This spontaneous report was received from a nurse and refers to a 4-month-old patient. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or past medical history provided.    On 15-APR-2019, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, orally, lot # R028191, expiration date 07-JUL-2020 for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 84 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or around 27-AUG-2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose detail and route were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. The patient was treated by a physician for herpes zoster on an unknown date. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse affects reported; patients received doses of improperly stored Varivax; This spontaneous report was received from a health professional and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not reported.   On an unknown date in April 2019 (reported as 25-APR-2019 or 26-APR-2019), the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously, lot # R034396, expiration date 27-NOV-2020, (dose was not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 72 hours. Sterile diluent was stored properly. There were no previous excursions reported. Data logger was not involved. No adverse effects were reported.  This is one of eleven reports from the same reporter.; Sender's Comments:  US-009507513-1904USA013210: US-009507513-1904USA013268: US-009507513-1904USA013276: US-009507513-1904USA013272: US-009507513-1904USA013270: US-009507513-1904USA013275: US-009507513-1904USA013265: US-009507513-1904USA013269: US-009507513-1904USA000191: US-009507513-1904USA013278: