chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Resuscitation, Vomiting, Withdrawal of life support
Clinical narrative: Child developed fussiness and vomiting within 24 hours of vaccine. Arrested en route to the ED for evaluation of listlessness on 7/26/19.  Child had CPR for 14 minutes with return of heart rate, however due to prolonged arrest had severe  hypoxic injury to the brain and developed autonomic instability. Support was withdrawn on 7/28 and patient died 7/28/19.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Lethargy
Clinical narrative: After receiving the injection mid-afternoon on 6/23/2019, I woke up on the morning of 6/24/2019, at about 8:00, with an aching back and feeling lethargic.  Later in the morning, I took ibuprofen, which made my back stop aching, however the feeling of lethargy remained all day. I felt fine when I woke up the second day, 6/25/2019.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Limb injury, Skin lesion, Wound
Clinical narrative: Single raised .5 cm lesion with dark center to proximal dorsal phalanx of right 3rd digit 9 days after receiving smallpox vaccination and 7 days after injuring hand (breaking skin) while working on his car.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Urticaria
Clinical narrative: breakout/ looks like pox; hives; This case was reported by a consumer via call center representative and described the occurrence of varicella-like rash in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th July 2019, the patient received Shingrix (intramuscular). On 19th July 2019, 3 days after receiving Shingrix, the patient experienced varicella-like rash and hives. On an unknown date, the outcome of the varicella-like rash and hives were not recovered/not resolved.   It was unknown if the reporter considered the varicella-like rash and hives to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and brokeout all over her body. The patient thought it looks like pox, but it might be hives. The reporter had consented to follow up. There was discrepancy in outcome reported in source document (recovering/ resolving) and (not recovered/not resolved). The outcome kept as reported.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Injection site erythema
Clinical narrative: Redness at injection site; Stomach Cramping; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th July 2019, the patient received Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and stomach cramps. On an unknown date, the outcome of the injection site erythema and stomach cramps were recovering/resolving.   It was unknown if the reporter considered the injection site erythema and stomach cramps to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and experienced redness at the injection site that was beginning to fade 3 days following vaccination. The patient also reports stomach cramping. The reporter did not consent to follow-up. The reporter provided limited information and did not want to proceed with providing further details including date of birth, consent, pharmacy information, or details about side effects.  The reporter mentioned she may contact back if desired. The reporter enquired how long redness and stomach cramping would last.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site pain, Injection site swelling, Rash
Clinical narrative: Rash; Discoloration; Pain at injection site; Swelling; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   On 16th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced rash, injection site discoloration, injection site pain and swelling. On an unknown date, the outcome of the rash, injection site discoloration and injection site pain were unknown and the outcome of the swelling was recovering/resolving.   It was unknown if the reporter considered the rash, injection site discoloration, injection site pain and swelling to be related to Shingrix.  Additional information received were as follows: The pharmacist stated that the patient experienced rash, discoloration at injection site about 2 to 3 inches in size, pain and swelling. The swell had decreased. No further details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Low grade fever; body aches; flu like symptoms; This case was reported by a other health professional via call center representative and described the occurrence of low grade fever in a male patient who received Herpes zoster (Shingrix) (batch number H7JY4, expiry date 1st July 2021) for prophylaxis.   On 13th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 14th March 2019, 1 days after receiving Shingrix, the patient experienced low grade fever, general body pain and influenza-like symptoms. The patient was treated with paracetamol (Tylenol). On 16th March 2019, the outcome of the low grade fever, general body pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the low grade fever, general body pain and influenza-like symptoms to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient received Shingrix on left deltoid. The patient experienced flu-like symptoms with a low grade fever and body aches. The patient self medicated with over the counter Tylenol.  The reporter did not consent to follow-up. The outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovered/resolved with sequel).
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Fatigue, Feeling abnormal, Headache, Neck pain, Odynophagia
Clinical narrative: Son reported fever, headache, painful swallow, neck pain, feeling of being out of his mind, intense fatigue.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Son reported fever, headache, painful swallow, neck pain, feeling of being out of his mind, intense fatigue.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Muscle spasms, Pyrexia
Clinical narrative: Low grade temp, Chills, Cramps, feeling tired and week. Took 3 Advil liquid gel and went to bed. No reaction the next day (back to normal).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Headache, Nausea, Pain
Clinical narrative: Fever, fatigue, aches and pains, headache, slight nausea/loss of appetite for approximately 36 hours
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, fatigue, aches and pains, headache, slight nausea/loss of appetite for approximately 36 hours
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Muscle fatigue
Clinical narrative: Patient husband called and said she is experiencing Muscle fatigue, joint pain and some dizziness.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient received a diagnosis of Shingles following vaccination. Patient has 9 shingles lesions located on his right  thigh.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injected limb mobility decreased, Injection site mass, Injection site pain, Injection site rash
Clinical narrative: The evening of the vaccination the patient developed a rash on left deltoid described as the size of the hand, tried naproxen and heating pad with no alleviation. The next morning the patient said the rash was very tender to the touch and the arm was very sore described as could not lift her arm. As well as the patient had a lump under the skin at the site of injection.  Currently recommending antihistamines for allergic reaction as well as continuing naproxen for pain relief.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Anxiety, Dizziness, Fall, Nervousness
Clinical narrative: Patient stated that he was very anxious and nervous about receiving his vaccines today. Patient was given his vaccines and stated he felt ok, but we had his sit for about 10 minutes just to keep an eye on him. After about 10 minutes he was asked how he was feeling, he stated he was fine and so he was told he could leave. Upon leaving the room, he became a little lightheaded and fell on the floor. He did not loses consciousness and did not have any pain. He was examined by the provider who saw him and determined that he could leave. (Unsure if vaccine or anxiety related)
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Feeling abnormal, Headache
Clinical narrative: Severe reaction : huge knot at injection site of right  arm, hot reddish& purple rash 5" x 5" -bruising  soreness, itching , site raised and swollen. I ran fever, chills, nausea , stomach cramping, lethargic no energy, headache. Received the shot on 7/23/19 and still have symptoms. Friday 7/26/19 was sick and went to bed and slept until 7pm on Saturday night 7/27/2019. I still do not feel good and  still have hurtful warm raised rash on arm with swelling and bruising one week later . I have been applying topical steroid cream, benadryl gel and using ice pack. I may see doctor tomorrow 7/30/19  if not better.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: Severe reaction : huge knot at injection site of right  arm, hot reddish& purple rash 5" x 5" -bruising  soreness, itching , site raised and swollen. I ran fever, chills, nausea , stomach cramping, lethargic no energy, headache. Received the shot on 7/23/19 and still have symptoms. Friday 7/26/19 was sick and went to bed and slept until 7pm on Saturday night 7/27/2019. I still do not feel good and  still have hurtful warm raised rash on arm with swelling and bruising one week later . I have been applying topical steroid cream, benadryl gel and using ice pack. I may see doctor tomorrow 7/30/19  if not better.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Lethargy, Malaise
Clinical narrative: Severe reaction : huge knot at injection site of right  arm, hot reddish& purple rash 5" x 5" -bruising  soreness, itching , site raised and swollen. I ran fever, chills, nausea , stomach cramping, lethargic no energy, headache. Received the shot on 7/23/19 and still have symptoms. Friday 7/26/19 was sick and went to bed and slept until 7pm on Saturday night 7/27/2019. I still do not feel good and  still have hurtful warm raised rash on arm with swelling and bruising one week later . I have been applying topical steroid cream, benadryl gel and using ice pack. I may see doctor tomorrow 7/30/19  if not better.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Severe reaction : huge knot at injection site of right  arm, hot reddish& purple rash 5" x 5" -bruising  soreness, itching , site raised and swollen. I ran fever, chills, nausea , stomach cramping, lethargic no energy, headache. Received the shot on 7/23/19 and still have symptoms. Friday 7/26/19 was sick and went to bed and slept until 7pm on Saturday night 7/27/2019. I still do not feel good and  still have hurtful warm raised rash on arm with swelling and bruising one week later . I have been applying topical steroid cream, benadryl gel and using ice pack. I may see doctor tomorrow 7/30/19  if not better.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: The morning after the injection, I did not feel well, but was able to do regular activities. As the day progressed, symptoms did as well and it became a chore to do anything.  By 24 hrs after injection, I had a fever of 101.2, a severe headache, was shivering and extremely fatigued. I took 600mg ibuprofen, went to bed, and woke up without symptoms. I was warned this could happen, but I am reporting these adverse events because the literature I was given stated that this happens to 1 in 6 individuals, and were more common in younger people. Perhaps that ratio needs to be revised, and the definition of "younger people" needs definition (I am only 3 weeks shy of turning 60).
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Blood magnesium, Blood thyroid stimulating hormone, Echocardiogram, Electrocardiogram ambulatory
Clinical narrative: Patient had immunization at outside Pharmacy, his second dose shingrix, and subsequently 2 days later he went into his first ever episode of Atrial Fibrillation w/ RVR
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Full blood count, Metabolic function test, Troponin
Clinical narrative: Patient had immunization at outside Pharmacy, his second dose shingrix, and subsequently 2 days later he went into his first ever episode of Atrial Fibrillation w/ RVR
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Right deltoid, spreading to right arm, erythema and edematous, consistent with vaccine site reaction. Edu to apply cold compress, give tylenol for pain, warning signs of cellulits to ER/RTC.
Age: 53.0
Sex: F
Vaccine: MNQ, TDAP, TDAP, MNQ, TDAP
Symptoms: Altered state of consciousness, Dizziness, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Pt. stated she had fever, extreme dizziness and felt like she is going to pass out after the administration of vaccines. Had to lie down to feel better. Presented today, 07/29/2019  redness, swelling, warmness, pain 8 cm to the L arm and same symptoms but smaller size of 3.3 cm to the R arm.
Age: 53.0
Sex: F
Vaccine: MNQ, TDAP, TDAP, MNQ, TDAP
Symptoms: Pyrexia, Skin warm
Clinical narrative: Pt. stated she had fever, extreme dizziness and felt like she is going to pass out after the administration of vaccines. Had to lie down to feel better. Presented today, 07/29/2019  redness, swelling, warmness, pain 8 cm to the L arm and same symptoms but smaller size of 3.3 cm to the R arm.
Age: 53.0
Sex: F
Vaccine: MNQ, TDAP, TDAP, MNQ, TDAP
Symptoms: Depressed level of consciousness, Dizziness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt. stated she had fever, extreme dizziness and felt like she is going to pass out after the administration of vaccines. Had to lie down to feel better. Presented today, 07/29/2019  redness, swelling, warmness, pain 8 cm to the L arm and same symptoms but smaller size of 3.3 cm to the R arm.
Age: 53.0
Sex: F
Vaccine: MNQ, TDAP, TDAP, MNQ, TDAP
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Pt. stated she had fever, extreme dizziness and felt like she is going to pass out after the administration of vaccines. Had to lie down to feel better. Presented today, 07/29/2019  redness, swelling, warmness, pain 8 cm to the L arm and same symptoms but smaller size of 3.3 cm to the R arm.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Peripheral swelling, Pyrexia, Rash pustular, Secretion discharge
Clinical narrative: On the afternoon of July 14,   2019; the adverse effects began.  My normal temp which runs 97.8 was up to 101.6   My arm was very swollen and extremely red.  I took a picture which even shows a couple of very small pustules out of which issued a white discharge.  I took a Tylenol and the fever dropped; it reoccurred for 3 more days.  I went to my primary doctor and she prescribed an antibiotic for 7 days.  It is now two weeks since the injection and the swelling and redness are not yet totally gone,
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Pyrexia, Vaccination site vesicles
Clinical narrative: On the afternoon of July 14,   2019; the adverse effects began.  My normal temp which runs 97.8 was up to 101.6   My arm was very swollen and extremely red.  I took a picture which even shows a couple of very small pustules out of which issued a white discharge.  I took a Tylenol and the fever dropped; it reoccurred for 3 more days.  I went to my primary doctor and she prescribed an antibiotic for 7 days.  It is now two weeks since the injection and the swelling and redness are not yet totally gone,
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Balance disorder, Chills, Fatigue, Headache
Clinical narrative: flu like systems: chills, mild fever, body ache, head ache, sore arm, off balance, upset stomach
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Influenza like illness, Pain, Pain in extremity, Pyrexia
Clinical narrative: flu like systems: chills, mild fever, body ache, head ache, sore arm, off balance, upset stomach
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test abnormal, Loss of consciousness, Pain, Pain in extremity
Clinical narrative: She got her 1st shingrix 4/17/19 and she had no issues. She got her 2nd dose 7/20/19 at around 10 am and said later in the day she had arm soreness and an overall achy feeling. I told the patient that is fairly common with the shingles vaccine. She then said she woke up the next morning and felt better until she was out to lunch with friends and passed out. They ended up taking her to ER where they ran tests and saw signs that she may have had a small seizure. She said she had never had a seizure before. She did say several years ago she had a brain bleed but never had a seizure from that. She was taken to ER on 7/20/19 and is following up with neurologist. She wanted to let us know about the incident and she wasn't sure if getting the shingles shot had anything to do with it but wanted to inform us.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis contact, Injection site reaction
Clinical narrative: Contact  Dermatitis at site of injection and anterior part of abdomen (as alleged by PA)
Age: 0.67
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; 2 improperly stored doses of ROTATEQ were administered to unspecified patients on unspecified dates; This non-valid spontaneous report was received from a registered nurse and refers to unspecified patients of unknown demographics. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with 2 improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R012954 with expiration date: 04-DEC-2019 and lot # R033256 with expiration date: 23-JUN-2020, orally (exact doses were not reported) for prophylaxis. The vaccines underwent temperature excursion of the highest temperature above 47 degrees Fahrenheit (48.7 degrees Fahrenheit  for 18 minutes There was no previous temperature excursion. The digital data logger was involved in recording excursion details. No adverse effects were reported.  Follow up information has been received from nurse on 23-JUL-2019.  Upon receipt of follow-up information, it was determined that this case is now valid because the patient identifier was received.   The nurse reported that only two patients were vaccinated. The patient initial and date of birth has been updated. Currently the patient was 8-month-old. On 03-JUL-2019, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot # R012954, expiry date: 04-DEC-2019) that had been involved in a temperature excursion but did not experience any adverse event.  This is one of two reports received from the same reporter (1907USA015441).
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The injection site was red painful and swelling had spread to elbow; The injection site was red painful and swelling had spread to elbow; The injection site was red painful and swelling had spread to elbow; Information has been received from a medical assistant, concerning a 69-year-old female patient. The patient had no medical history, concurrent conditions or concomitant medications. The patient was allergic to "sulfa" and levofloxacin (LEVAQUIN).  On 11-JUL-2019, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) intramuscular, lot number: S004548 with expiration date: 12-AUG-2020 (anatomical location was not provided) as prophylactic precaution.  On the same date, the patient called to the office, and reported that the injection site was red, painful and swelling had spread to elbow(injection site erythema/ injection site pain/ injection site joint swelling). The reporter stated that there was no lab diagnostics or studies performed. An unspecified nurse practitioner prescribed an unspecified dose of cephalexin (KEFLEX) and prednisone for 5 days. The swelling resolved on an unknown date. The outcome of the injection site redness and injection site pain was unknown at the time of this report.  The causal relationship between the injection site joint redness,  injection site pain and injection site joint swelling with the therapy with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not provided.  The reporter considered the injection site erythema, injection site pain and injection site joint swelling as medically significant events.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; 2 improperly stored doses of ROTATEQ were administered to unspecified patients on unspecified dates; This spontaneous report was received from a registered nurse refers to a 6-month-old patient.  There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 10-JUL-2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R012954, expiry date: 04-DEC-2019), via oral route for prophylaxis. Lot # R033256 with expiration date: 23-JUN-2020 was also reported in previous report.        The vaccines underwent temperature excursion of the highest temperature above 47 degrees Fahrenheit (48.7 degrees Fahrenheit) for 18 minutes (product storage error). There was no previous temperature excursion. The digital data logger was involved in recording excursion details. No adverse effects were reported. The outcome of product storage error and no adverse event was unknown.     This is one of two reports received from the same reporter (1907USA010818).
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Suspected vaccination failure; flu; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patients had stated they got the flu after receiving a flu shot (unknown brand). No additional details were available regarding patient or vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
Sex: M
Vaccine: MENB
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: sore arm; extra dose administered; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced pain in arm and extra dose administered. On an unknown date, the outcome of the pain in arm and extra dose administered were unknown.   It was unknown if the reporter considered the pain in arm to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The reporter shared that his son was given a 3rd dose of Bexsero and experienced a sore arm. The reporter stated that mistake probably occurred due to transition from a pediatric to adult practice and the original 2 dose series may not have been documented in the immunization registry.
Sex: F
Vaccine: MENB
Symptoms: Chills, Headache, Nausea
Clinical narrative: Chills; Headache; Nausea; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced chills, headache and nausea. On an unknown date, the outcome of the chills, headache and nausea were unknown.   It was unknown if the reporter considered the chills, headache and nausea to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine before going to college. The patient had side effects like chills, headache and nausea. The reporter stated, it was scary.
Sex: M
Vaccine: MENB
Symptoms: Musculoskeletal stiffness, Neck pain, Pain, Pain in extremity
Clinical narrative: sore arm; neck stiffness; neck stiffness and aches; aches/ Pain; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced pain in arm, stiff neck, neck pain and pain. On an unknown date, the outcome of the pain in arm, stiff neck, neck pain and pain were unknown.   It was unknown if the reporter considered the pain in arm, stiff neck, neck pain and pain to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The office manager stated that her son had gotten the 2nd dose of Bexsero and experienced a sore arm, neck stiffness, and aches and pains but mentioned he did not have fever.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: swelling on arm; warmth on arm; itching on arm; Redness; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) (batch number 4H9G2, expiry date 25th September 2021) for prophylaxis.   On 11th July 2019, the patient received Shingrix (intramuscular). On 13th July 2019, 2 days after receiving Shingrix, the patient experienced swelling arm, skin warm and itchy upper limbs. In July 2019, the patient experienced erythema. On an unknown date, the outcome of the swelling arm, skin warm, itchy upper limbs and erythema were unknown.   It was unknown if the reporter considered the swelling arm, skin warm, itchy upper limbs and erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient experienced warmth, itching, and swelling on the arm below the injection site of the left deltoid and above the elbow. The pharmacist also reported redness below the injection site, near the elbow, appeared to be spreading.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus, Skin warm
Clinical narrative: swelling on arm; warmth on arm; itching on arm; Redness; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) (batch number 4H9G2, expiry date 25th September 2021) for prophylaxis.   On 11th July 2019, the patient received Shingrix (intramuscular). On 13th July 2019, 2 days after receiving Shingrix, the patient experienced swelling arm, skin warm and itchy upper limbs. In July 2019, the patient experienced erythema. On an unknown date, the outcome of the swelling arm, skin warm, itchy upper limbs and erythema were unknown.   It was unknown if the reporter considered the swelling arm, skin warm, itchy upper limbs and erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient experienced warmth, itching, and swelling on the arm below the injection site of the left deltoid and above the elbow. The pharmacist also reported redness below the injection site, near the elbow, appeared to be spreading.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered, Injection site erythema, Injection site pain
Clinical narrative: redness at the injection site; Soreness of the right arm; Expired vaccine administered; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 5-year-old female patient who received DTPa-IPV (Kinrix) (batch number 7492S, expiry date 25th May 2019) for prophylaxis.   On 18th July 2019, the patient received Kinrix. On 18th July 2019, less than a day after receiving Kinrix, the patient experienced injection site erythema, injection site pain and expired vaccine used. On an unknown date, the outcome of the injection site erythema, injection site pain and expired vaccine used were unknown.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Kinrix.  Additional details were provided as follows: The case was reported by the patient's grandmother. The patient received a dose of Kinrix in right arm which was already expired on 25th May 2019. The patient was also experiencing right arm soreness and redness at the injection site. The reporter consented to follow up.
Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Low birth weight baby, Premature baby
Clinical narrative: Low birth weight/Birth weight: 2466g; Fetal exposure during pregnancy; This is a serious spontaneous case initially received from other health-professional on 25-Jul-2019, concerning a male neonate patient.   The patient's mother was a 23-year-old, female who had one preterm live birth. The patient's mother had no history of offspring with major congenital malformation and no maternal/paternal history with major congenital malformation. The patient's mother did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The concomitant medication of the mother included Prenatal vitamins (minerals NOS, vitamins NOS) for pregnancy. The mother's last menstrual period (LMP) date was 16-Oct-2018 and type of pregnancy was singleton.   On 09-Jan-2019, at approximately 12 weeks of gestation, the patient was exposed to Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture-derived, route of administration: transplacental, batch number: 252675, dose, parent's route of administration, expiry date and anatomical location: not reported] (explicitly coded as foetal exposure during pregnancy) for an unknown indication. On the same day, the patient's mother underwent panorama prenatal screening test and no major congenital malformation was noted.  On 05-Jul-2019, at gestational age of 37.4 weeks, the mother gave live birth to a male neonate by caesarean section. The characteristics of neonate included birth weight: 2466 grams (reported as low birth weight) and appearance, pulse, grimace, activity and respiration (APGAR) scores at one minute was 8 and at five minutes was 9. The neonate had no major congenital malformations identified at birth.  The estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) of patient's mother was reported as 23-Jul-2019.  This case is linked to the case 201904228 (the corresponding maternal pregnancy report).; Reporter's Comments: A male neonate delivered at gestational age of 37.4 weeks was considered to have low birth weight baby, after receipt of Flucelvax QIV vaccine administered to mother at approximately 12 weeks of gestation. Considering the timeframe of event with respect to vaccine administration, risk factor (one preterm live birth) and no evidence suggestive of  biological mechanism that could cause the event, the event was assessed as not related to the suspect vaccine. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of foetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).
Sex: M
Vaccine: UNK
Symptoms: Premature labour
Clinical narrative: Low birth weight/Birth weight: 2466g; Fetal exposure during pregnancy; This is a serious spontaneous case initially received from other health-professional on 25-Jul-2019, concerning a male neonate patient.   The patient's mother was a 23-year-old, female who had one preterm live birth. The patient's mother had no history of offspring with major congenital malformation and no maternal/paternal history with major congenital malformation. The patient's mother did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The concomitant medication of the mother included Prenatal vitamins (minerals NOS, vitamins NOS) for pregnancy. The mother's last menstrual period (LMP) date was 16-Oct-2018 and type of pregnancy was singleton.   On 09-Jan-2019, at approximately 12 weeks of gestation, the patient was exposed to Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture-derived, route of administration: transplacental, batch number: 252675, dose, parent's route of administration, expiry date and anatomical location: not reported] (explicitly coded as foetal exposure during pregnancy) for an unknown indication. On the same day, the patient's mother underwent panorama prenatal screening test and no major congenital malformation was noted.  On 05-Jul-2019, at gestational age of 37.4 weeks, the mother gave live birth to a male neonate by caesarean section. The characteristics of neonate included birth weight: 2466 grams (reported as low birth weight) and appearance, pulse, grimace, activity and respiration (APGAR) scores at one minute was 8 and at five minutes was 9. The neonate had no major congenital malformations identified at birth.  The estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) of patient's mother was reported as 23-Jul-2019.  This case is linked to the case 201904228 (the corresponding maternal pregnancy report).; Reporter's Comments: A male neonate delivered at gestational age of 37.4 weeks was considered to have low birth weight baby, after receipt of Flucelvax QIV vaccine administered to mother at approximately 12 weeks of gestation. Considering the timeframe of event with respect to vaccine administration, risk factor (one preterm live birth) and no evidence suggestive of  biological mechanism that could cause the event, the event was assessed as not related to the suspect vaccine. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of foetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).
Age: 6.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: 12 hours after receiving the first Shingrex shot, next to the vaccination site in my upper left arm, I developed redness the size of a golf ball, the next day, it grew to the size of a tennis ball, slightly swollen and itchy. There was barely any soreness in the needle site, only tenderness upon touch. The accompanying post instructions indicated that any redness would be subside in 2-3 days; however, the redness did not dissipate until two weeks later. I returned to the Pharmacy to show them and was told this was normal. My reason for submitting this report is to suggest that future accompanying instructions for Shingrex indicated that the redness could last longer than 2-3 days to prevent any anxiety.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Malaise, Nausea
Clinical narrative: - malaise - didn't want to eat - only lasted a day - no rxn @ site vaccine - nausea
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: redness & swelling. itching.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pt started having intense pain at the site of injection starting the day after injection. He said the pain was unbearable for 2 to 3 days, even after taking aleve. it is 20 days post-vaccination and he still says his pain at site of injection is still a 2 out of 10. He has not consulted a doctor regarding This.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Patient reported that when she removed bandaid from site the next morning, it was red , warm with hardened area.  Today 7/29/2019, RN looked at area.  Now pink, slight warm to touch and small hardened area.  Patient reports tenderness.  Patient reports improvement in area
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: L arm started to get swollen and sore 3.5 hours after injection.  Redness and swelling progressed over the next few days. Swelling was rom the top of the shoulder extending down to the elbow. Arm was painful and hot to touch.  On 7/18/2019 went to rapid care, nurse practitioner stated that it was not cellulitis. Patient was prescribed Ranitidine, she was unsure why.  By 7/20/2019 the swelling started to subside.  7/29/19 swelling gone, no longer painful, only a little itchy.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: L arm started to get swollen and sore 3.5 hours after injection.  Redness and swelling progressed over the next few days. Swelling was rom the top of the shoulder extending down to the elbow. Arm was painful and hot to touch.  On 7/18/2019 went to rapid care, nurse practitioner stated that it was not cellulitis. Patient was prescribed Ranitidine, she was unsure why.  By 7/20/2019 the swelling started to subside.  7/29/19 swelling gone, no longer painful, only a little itchy.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented with swollen red, hot, itchy left upper arm (front and back, shoulder to elbow) on 7/29/2019 Advised her to go to doctor. I notified doctor. She wanted to wait and "watch it". I will follow up daily with her until it resolves
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Limb discomfort, Mass, Swelling
Clinical narrative: Pt reports swelling, redness and lumps appeared and lasted the weekend. States arm is feeling much better now
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Myalgia, Pain
Clinical narrative: Very painful shoulder muscle, unable to raise arm above shoulder level without pain
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Injection site erythema, Nausea, Pain
Clinical narrative: Left arm became extremely sore with redness all over deltoid.  I became weak nauseated with all over aches and pains and a fever and headache.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Left arm became extremely sore with redness all over deltoid.  I became weak nauseated with all over aches and pains and a fever and headache.
Age: 28.0
Sex: M
Vaccine: HEP, PPV, TDAP
Symptoms: Cellulitis, Headache, Inflammation, Injection site erythema, Injection site warmth
Clinical narrative: Patient tolerated vaccines well, appropriately spaced on arm, arm wiped with alcohol pad prior to administration. Next day he woke up with a HA, was lethargic, had a fever of 101 by the afternoon, and his arm was sore. Noticed the back of his arm (where PPSV23 was given) was red and warm to the touch. Next day, felt more lethargic and erythema spread to almost the entire underside of his arm. He saw a nurse at his recovery center who marked the outline of the inflamed area. 3 days after administration, area continued to increase in size and patient went to ED where he was told he had cellulitis and given a prescription for SMX/TMP 800/160mg po BID for 5 days. Patient reports arm was completely back to normal within 3-4 days after ED visit. Doing well 14 days later.
Age: 28.0
Sex: M
Vaccine: HEP, PPV, TDAP
Symptoms: Lethargy, Pain in extremity, Pyrexia
Clinical narrative: Patient tolerated vaccines well, appropriately spaced on arm, arm wiped with alcohol pad prior to administration. Next day he woke up with a HA, was lethargic, had a fever of 101 by the afternoon, and his arm was sore. Noticed the back of his arm (where PPSV23 was given) was red and warm to the touch. Next day, felt more lethargic and erythema spread to almost the entire underside of his arm. He saw a nurse at his recovery center who marked the outline of the inflamed area. 3 days after administration, area continued to increase in size and patient went to ED where he was told he had cellulitis and given a prescription for SMX/TMP 800/160mg po BID for 5 days. Patient reports arm was completely back to normal within 3-4 days after ED visit. Doing well 14 days later.
Age: 13.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: about 5-10 minutes after administration, pt complained of tingling and weakness in the arm vaccination was given.  after monitoring the pt, she stated that the feeling was going away.  By the time of leaving the pharmacy about 20 minutes after initial complaint, pt stated that she was better.
Age: 13.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypotonia, Muscular weakness, Paraesthesia
Clinical narrative: about 5-10 minutes after administration, pt complained of tingling and weakness in the arm vaccination was given.  after monitoring the pt, she stated that the feeling was going away.  By the time of leaving the pharmacy about 20 minutes after initial complaint, pt stated that she was better.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient started having swelling and redness at site of immunization on 07/29/19, 3 days after injection. The area measures 5 cm x 9 cm and is tender to touch and painful when she walks. Patient and mom advised to use MOTRIN for pain, ice pack for swelling and BENADRYL if itching begins.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB
Symptoms: Chest pain, Dyspnoea, Pruritus, Rash, Wheezing
Clinical narrative: Within approximately 3 minutes of receiving Menactra and Trumenba vaccines patient started complaining of difficulty breathing. Pulse ox was 97%. Wheezing was noted and patient started breathing treatment of Albuteral 2.5mg immediately . Patient then developed a rash with itiching . Benadryl 25mg and Dexamethasone 8mg was given IM at 9:43 AM. Wheezing, rash and itiching then resolved but patient was complaining of chest pain. Patient was transported by EMS to ER
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Within approximately 3 minutes of receiving Menactra and Trumenba vaccines patient started complaining of difficulty breathing. Pulse ox was 97%. Wheezing was noted and patient started breathing treatment of Albuteral 2.5mg immediately . Patient then developed a rash with itiching . Benadryl 25mg and Dexamethasone 8mg was given IM at 9:43 AM. Wheezing, rash and itiching then resolved but patient was complaining of chest pain. Patient was transported by EMS to ER
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Prevnar 13 administered on 7/22/2019.   Patient presented back at pharmacy on 7/29/2019 whith redness and warmth around injection site on right shoulder.   Patient reported no pain or discomfort just wondering if there was anything she could do.  Advised patient they could use tylenol/ibuprofen, benadryl, ice packs, and if doesn't get better or worsens to see their primary care physician.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Continuous positive airway pressure, Infantile apnoea
Clinical narrative: Apneic requiring moderate stimulation and CPAP
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC13, VARCEL
Symptoms: Abnormal faeces, Asthenia, Decreased appetite, Diarrhoea, Faeces discoloured
Clinical narrative: --7/18 -- Immunizations received approx. 12pm --7/19  -- Fever started approx. 7-8 am; T 99; Tm 102 that evening; fever lasted 3 days; took Tylenol/Children's Motrin --7/19  -- Also with decreased energy/appetite; increased fussiness, runny nose and nasal congestion - slowly resolving --7/19 -- Also with looser stools -- fouls smell;  not going more often; nonbloody; darker green stools --7/27 -- Erythematous rash started with few spots on face and abdomen; increased fussiness --7/28 -- Rash spread to more of trunk --7/29 -- Rash spread to more of body; more concentrated on trunk, also scattered on limbs and more on face; no new fevers; still having loose stools.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC13, VARCEL
Symptoms: Irritability, Nasal congestion, Pyrexia, Rash, Rash erythematous
Clinical narrative: --7/18 -- Immunizations received approx. 12pm --7/19  -- Fever started approx. 7-8 am; T 99; Tm 102 that evening; fever lasted 3 days; took Tylenol/Children's Motrin --7/19  -- Also with decreased energy/appetite; increased fussiness, runny nose and nasal congestion - slowly resolving --7/19 -- Also with looser stools -- fouls smell;  not going more often; nonbloody; darker green stools --7/27 -- Erythematous rash started with few spots on face and abdomen; increased fussiness --7/28 -- Rash spread to more of trunk --7/29 -- Rash spread to more of body; more concentrated on trunk, also scattered on limbs and more on face; no new fevers; still having loose stools.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC13, VARCEL
Symptoms: Rhinorrhoea
Clinical narrative: --7/18 -- Immunizations received approx. 12pm --7/19  -- Fever started approx. 7-8 am; T 99; Tm 102 that evening; fever lasted 3 days; took Tylenol/Children's Motrin --7/19  -- Also with decreased energy/appetite; increased fussiness, runny nose and nasal congestion - slowly resolving --7/19 -- Also with looser stools -- fouls smell;  not going more often; nonbloody; darker green stools --7/27 -- Erythematous rash started with few spots on face and abdomen; increased fussiness --7/28 -- Rash spread to more of trunk --7/29 -- Rash spread to more of body; more concentrated on trunk, also scattered on limbs and more on face; no new fevers; still having loose stools.