chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Joint effusion, Nuclear magnetic resonance imaging abnormal, Osteoarthritis, Rotator cuff syndrome
Clinical narrative: Vaccine was given as per usual protocol in the left deltoid. We received a phone call ~1 month later stating that since the time of the vaccine, he had ongoing left shoulder pain for which he had been treating with OTC remedies without improvement, and the pain was starting to affect his sleep. He was then seen in the office the following day, 10/25/18, and diagnosed with deltoid tendinitis and biceps tendinitis of the left shoulder. He was sent to physical therapy without resolution of his symptoms. He was seen by orthopedics, diagnosed with impingement syndrome of the left shoulder and received a cortisone injection. His sx improved somewhat, but didn't resolve. An MRI was performed 3/1/19 showing a "Massive rotator cuff tear, severe long head biceps tendinopathy with low-grade interstitial tear of the intra-articular portion, diffuse labral degeneration and near circumferential tear, and advanced acromioclavicular joint osteoarthritis, moderate volume glenohumeral joint effusion, decompressing into the subacromial/subdeltoid bursa via the full-thickness rotator cuff tear defect."
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Sleep disorder, Tendon disorder
Clinical narrative: Vaccine was given as per usual protocol in the left deltoid. We received a phone call ~1 month later stating that since the time of the vaccine, he had ongoing left shoulder pain for which he had been treating with OTC remedies without improvement, and the pain was starting to affect his sleep. He was then seen in the office the following day, 10/25/18, and diagnosed with deltoid tendinitis and biceps tendinitis of the left shoulder. He was sent to physical therapy without resolution of his symptoms. He was seen by orthopedics, diagnosed with impingement syndrome of the left shoulder and received a cortisone injection. His sx improved somewhat, but didn't resolve. An MRI was performed 3/1/19 showing a "Massive rotator cuff tear, severe long head biceps tendinopathy with low-grade interstitial tear of the intra-articular portion, diffuse labral degeneration and near circumferential tear, and advanced acromioclavicular joint osteoarthritis, moderate volume glenohumeral joint effusion, decompressing into the subacromial/subdeltoid bursa via the full-thickness rotator cuff tear defect."
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Injection site pain, Injection site swelling, Paraesthesia oral
Clinical narrative: First sigh of a reaction to this immunization as tingling of my lips along with very red palms and itching of fingers. Pain at the injection site with swelling. Swelling and redness to the left of the injection site and lower that extended close to and  under arm area. Joint aches the next two days.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Swelling
Clinical narrative: First sigh of a reaction to this immunization as tingling of my lips along with very red palms and itching of fingers. Pain at the injection site with swelling. Swelling and redness to the left of the injection site and lower that extended close to and  under arm area. Joint aches the next two days.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Dizziness, Feeling abnormal, Middle insomnia, Nausea
Clinical narrative: About 12 hours after taking the injection, I woke up about 3 am feeling dizzy and nauseous. About 7 am I asked my wife to help me to the bathroom as I was unsteady on my feet and was feeling nauseous. I stayed in bed until 9 am and was then able to get up and move slowly without too much dizziness and feelings of being nauseous. By 6 pm I was almost back to normal but still felt somewhat unusual. By the next morning I was feeling normal.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin discolouration, Swelling
Clinical narrative: Red area of upper right deltoid of arm. Some areas raised some area very red/purple color.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Psoriasis, Skin exfoliation
Clinical narrative: 8/15/18 - Scalp psoriasis appeared (itching and scaling). Examined by MD/Dermatologist 9/26/18. Psoriasis had spread to other parts of body. Rx: topicals. 12/18/19 ACITREN Rx'd.
Age: 79.0
Sex: U
Vaccine: TDAP
Symptoms: Erythema, Fungal infection, Pain in extremity, Swelling
Clinical narrative: Pt received shot on 2/12/19. Three to four days later, on inside of armpit, opposite side of arm pain and redness radiated to shoulder and face from armpit, skin and shoulder joint. Pt went to Dr. The Dr. diagnosed the redness as a fungal infection and prescribed "a cream", which the pt did not use. Pt reports that the pain and swelling is going down, using only ALEVE. As of today, 3/4/19, the pain is "tolerable" with ALEVE.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Rash erythematous, Scab
Clinical narrative: Symptoms started yesterday (03/10/2019) day 11 after having vaccines. Per Parent face, ears, belly back, feet started off as red dots change to blister and now some are scabbed over. Do not seem to be very itchy. Advised mom can give BENADRYL if the do get itchy, or some CALADRYL lotion. TYLENOL for a fever.
Age: 1.33
Sex: U
Vaccine: MMRV
Symptoms: Culture negative, Parotid gland enlargement, Pyrexia, Streptococcus test negative, Swelling face
Clinical narrative: 5 days after patient given MMRV (PROQUAD). She developed swelling left side of face (mumps like swelling of left parotid gland 5 x 6 cm in size). Had fever 2-3 days prior.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site warmth
Clinical narrative: CHILLS, SHIVERING FOR 3 TO 4 HOURS. REDNESS AND WARMNESS AT INJECTION FOR 4 - 5 DAYS.
Age: 61.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Immunoglobulin therapy, Vaccination complication
Clinical narrative: Went through 6 months of hospital and rehab after taking pneumonia and flu vaccines which gave me CIDP and will be affected by the rest of my life. I am still taking medicine and getting IVIG infusions monthly.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Vaccine received 03/01/19. 3/7/2019 rash appears. On 3/8/19 went to dermatologist with full blown case of shingles. Took antiviral valacyclovir.
Age: 33.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Chills, Lip swelling, Pyrexia, Swelling face
Clinical narrative: Facial swelling, fever, chills, swollen lips.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, X-ray
Clinical narrative: 2 days after vaccine I could not move my left arm. Severe pain.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Injection site pain, Rash erythematous
Clinical narrative: In the evening after the vaccine patient started to  experience the typical injection site pain experienced by most patients after they receive a vaccine. On the morning AFTER SHE DEVELOPED A BRIGHT RED RASH with no appetite. Diarrhea ensued in the evening along with fatigue.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Headache, Pain, Rash, Rash erythematous
Clinical narrative: Pt. reports body aches and headache the day after the vaccine. She developed a rash on the anterior surface of her LFA. The area was round and approximately 4 cm. in radius. Pt. reports that the rash was pink and itched. No spread of the rash from the time it was first noticed. She was seen in the office again on 3/12/19. At that time the rash was observable. The skin looked dry and the area was no longer pink. The rash area was more of an opaque color and the skin was flaky.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Skin exfoliation
Clinical narrative: Pt. reports body aches and headache the day after the vaccine. She developed a rash on the anterior surface of her LFA. The area was round and approximately 4 cm. in radius. Pt. reports that the rash was pink and itched. No spread of the rash from the time it was first noticed. She was seen in the office again on 3/12/19. At that time the rash was observable. The skin looked dry and the area was no longer pink. The rash area was more of an opaque color and the skin was flaky.
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative, referring to a female patient of an unknown age. Information about her historical conditions, drug reactions or allergies and concomitant medications were not provided. On an unspecified date in 2019 (reported as early February), the patient was vaccinated with GARDASIL 9 for prophylaxis (anatomical location, route of administration, lot number and expiration date were not provided). On an unknown date, the patient experienced hives (urticaria). By the time of the report, the outcome of the event was not provided. The causality assessment between GARDASIL 9 and urticaria was not provided.
Sex: U
Vaccine: PPV
Symptoms: Drug hypersensitivity
Clinical narrative: This spontaneous report was received from a physician via Pfizer regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medication were unknown. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, route, lot # and expiry date not reported) for prophylaxis. On an unknown date, the patient experienced drug allergies with PNEUMOVAX 23. The outcome of drug hypersensitivity was unknown. Causality assessment for the event was not provided by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received Shingles vaccine for prophylaxis. On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved. It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient received the shingles vaccine and felt ill for 8 hrs.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Bone pain, Chills, Feeling cold
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 59-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included Flu vaccine with an associated reaction of pain (In 2012 or 2013 the patient received flu vaccine and was laying on the floor all day, no energy and motionless, refer case US2019GSK042498). On 4th March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 4th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site tenderness, injection site erythema and injection site swelling. On 5th March 2019, the patient experienced weakness and pain. In March 2019, the patient experienced shivering, coldness local, cold feet, pain in hip, bone pain and pain in extremity. On an unknown date, the outcome of the injection site tenderness, injection site erythema and injection site swelling were recovered/resolved and the outcome of the shivering, coldness local, cold feet, pain in hip, weakness, bone pain and pain in extremity were not recovered/not resolved and the outcome of the pain was unknown. It was unknown if the reporter considered the injection site tenderness, injection site erythema, injection site swelling, shivering, coldness local, cold feet, pain in hip, weakness, bone pain, pain in extremity and pain to be related to SHINGRIX. Additional details were reported as follows: On 4th March 2019 at 9:00 am, the patient received SHINGRIX on the left arm. On 5th March 2019 at 2:00 am, 17 hours after receiving SHINGRIX,the patient awoke with shivering, her nose was super cold, freezing feet, achiness in her hips, bones, thighs and calves. The patient put on extra layers of clothes and fell asleep and awoke today (5th March 2019) with achiness and she was still experiencing weakness. One day after vaccination, the patient experienced weakness, no energy and achiness. The patient had been laying on the couch today with no energy. The patient also experienced a reaction at the injection site and the injection site was tender, red, and swollen earlier but at the time of reporting, it had resolved. The reporter gave consent to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 59-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included Flu vaccine with an associated reaction of pain (In 2012 or 2013 the patient received flu vaccine and was laying on the floor all day, no energy and motionless, refer case US2019GSK042498). On 4th March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 4th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site tenderness, injection site erythema and injection site swelling. On 5th March 2019, the patient experienced weakness and pain. In March 2019, the patient experienced shivering, coldness local, cold feet, pain in hip, bone pain and pain in extremity. On an unknown date, the outcome of the injection site tenderness, injection site erythema and injection site swelling were recovered/resolved and the outcome of the shivering, coldness local, cold feet, pain in hip, weakness, bone pain and pain in extremity were not recovered/not resolved and the outcome of the pain was unknown. It was unknown if the reporter considered the injection site tenderness, injection site erythema, injection site swelling, shivering, coldness local, cold feet, pain in hip, weakness, bone pain, pain in extremity and pain to be related to SHINGRIX. Additional details were reported as follows: On 4th March 2019 at 9:00 am, the patient received SHINGRIX on the left arm. On 5th March 2019 at 2:00 am, 17 hours after receiving SHINGRIX,the patient awoke with shivering, her nose was super cold, freezing feet, achiness in her hips, bones, thighs and calves. The patient put on extra layers of clothes and fell asleep and awoke today (5th March 2019) with achiness and she was still experiencing weakness. One day after vaccination, the patient experienced weakness, no energy and achiness. The patient had been laying on the couch today with no energy. The patient also experienced a reaction at the injection site and the injection site was tender, red, and swollen earlier but at the time of reporting, it had resolved. The reporter gave consent to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral coldness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 59-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included Flu vaccine with an associated reaction of pain (In 2012 or 2013 the patient received flu vaccine and was laying on the floor all day, no energy and motionless, refer case US2019GSK042498). On 4th March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 4th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site tenderness, injection site erythema and injection site swelling. On 5th March 2019, the patient experienced weakness and pain. In March 2019, the patient experienced shivering, coldness local, cold feet, pain in hip, bone pain and pain in extremity. On an unknown date, the outcome of the injection site tenderness, injection site erythema and injection site swelling were recovered/resolved and the outcome of the shivering, coldness local, cold feet, pain in hip, weakness, bone pain and pain in extremity were not recovered/not resolved and the outcome of the pain was unknown. It was unknown if the reporter considered the injection site tenderness, injection site erythema, injection site swelling, shivering, coldness local, cold feet, pain in hip, weakness, bone pain, pain in extremity and pain to be related to SHINGRIX. Additional details were reported as follows: On 4th March 2019 at 9:00 am, the patient received SHINGRIX on the left arm. On 5th March 2019 at 2:00 am, 17 hours after receiving SHINGRIX,the patient awoke with shivering, her nose was super cold, freezing feet, achiness in her hips, bones, thighs and calves. The patient put on extra layers of clothes and fell asleep and awoke today (5th March 2019) with achiness and she was still experiencing weakness. One day after vaccination, the patient experienced weakness, no energy and achiness. The patient had been laying on the couch today with no energy. The patient also experienced a reaction at the injection site and the injection site was tender, red, and swollen earlier but at the time of reporting, it had resolved. The reporter gave consent to follow up.
Age: 0.5
Sex: M
Vaccine: HIBV, IPV, PNC13
Symptoms: Incorrect route of product administration
Clinical narrative: Initial information received on 07-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional by phone. This case involves a 6 months old male patient who was vaccinated with a 0.5 ml dose of ACT-HIB (Batch number: UI987AAA and expiry date: 01-Apr-2020) via subcutaneous route in the left thigh on 04-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVENAR and POLIO VACCINE on the same day of vaccination. It was a case of actual medication error due to inappropriate route of vaccination. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Age: 12.0
Sex: F
Vaccine: HPVX, MNQ, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 07-Mar-2019 regarding an unsolicited valid non-serious case received from an other health professional by phone. This case involves a 12 years old female patient who was vaccinated with two doses (first and second dose) of MENACTRA and ADACEL on 28-Nov-2017 and 21-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included patient was vaccinated with HPV vaccine on 21-Jan-2019. On 21-Jan-2019, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6143AA, expiry date: 22-Feb-2019) via intramuscular route in the left arm. On 28-Nov-2017 she also received a 0.5 ml dose of the same vaccine (lot number: U5823AB and expiry date: 22-Feb-2019) via intramuscular route in the left arm. On 21-Jan-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6104AA, expiry date: 02-Nov-2020) via intramuscular route in the left arm. On 28-Nov-2017 she also received a 0.5 ml dose of the same vaccine (lot number: C5228AA and expiry date: 26-Jun-2019) via intramuscular route in the right arm. It was also a case of actual medication error due to extra dose administered. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Sex: M
Vaccine: FLUC4
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Low birth weight baby
Clinical narrative: This is a serious spontaneous case, initially received from other health professional on 25-Feb-2019, concerning a male neonate patient. The patient's mother was 21-year-old mother with obstetrical history of one previous pregnancy reported with a full-term live birth. The mother's historical condition included bacterical vaginosis (from 09-Jul-2018 to 16-Jul-2018), chlamydial infection (from 15-Jul-2018 to 04-Oct-2018) and anemia (16-Jul-2018 to 10-Sep-2018). The mother's current condition included nausea and constipation (since 05-Jul-2018). The concomitant medications included Metrogel for bacterical vaginosis, ferrous sulfate for anemia, prenatal vitamins (minerals NOS, vitamins NOS) for pregnancy, promethazine for nausea, azithromycin for chlamydia and Colace for constipation. The mother's last menstrual period (LMP) date was 15-March-2018. On 04-Oct-2018, at gestational age of 31-weeks and 5 days, the foetus was exposed to FLUCELVAX QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture-derived, route of administration: transplacental, batch number: 252664, dose, anatomical location and expiry date: not reported) (explicitly coded as foetal exposure during pregnancy) for an unknown indication. On 18-Oct-2018, 08-Nov-2018 and on 16-Nov-2018 mother's ultrasound test was performed, and no major congenital malformation was noted. 1 month and 26 days after vaccination, the mother delivered a male neonate at 37.6 weeks gestation, vaginally. At the time of delivery, no pregnancy complications were reported. The neonate's birth weight was 2066 grams (coded as low birth weight), head circumference was 33 cm and body length was 47 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 9 (at one minute and five minutes) and there was no data for 10 minutes. There was no major congenital malformation noted. The outcome of the events was unknown. The mother's estimated delivery date (EDD) was reported as 06-Dec-2018 and corrected EDD was reported as 17-Dec-2018. This case is linked to (201902219), the corresponding maternal pregnancy report.; Reporter's Comments: A male neonate patient delivered at 37.6 weeks gestation experienced low birth weight, 1 month and 26 days after administration of Flucelvax QIVc to mother (coded to fetal exposure during pregnancy). Despite the plausible temporal relationship, there is no evidence for a biological mechanism that could cause the event and underlying risk factors (bacterial vaginosis, chlamydial infection, nausea and anemia) and co-administered drugs (metrogel, ferrous sulfate, promethazine and azithromycin) to mother are risk factors for the reported event. Therefore, the event of low birth weight was assessed as not related to the suspect vaccine. The event of fetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine during pregnancy.The company assessed the event 'low birth weight' as serious (medically significant).
Age: 68.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Cellulitis of left upper limb. Redness, pain, swelling. Tender red induration at site of injection 2x4cm.
Age: 68.0
Sex: F
Vaccine: TD
Symptoms: Pain, Swelling
Clinical narrative: Cellulitis of left upper limb. Redness, pain, swelling. Tender red induration at site of injection 2x4cm.
Age: 1.5
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Mom reports left thigh site where pt received Hep A and MMR was red when she check the site on arrival to home. this was on 3/4/19. Mom then reports that on 3/9/19 site was raised and reddened. Today site remains red and raised. Feels like a little knot. Was prescribed AUGMENTIN 4cc by mouth BID for 10 days today.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Pain, redness, swelling, itching.
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Rash generalised, Varicella post vaccine
Clinical narrative: Development of full body rash consistent with varicella.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Pyrexia, Rash erythematous, Scab
Clinical narrative: Symptoms started yesterday day 11 after having vaccines. Face, ears, belly, back, started off as red dots, changed to blister and now some are scabbed over. Do not seem to be very itchy. Advised mom can give BENADRYL if they do get itchy, or some CALADRYL LOTION. TYLENOL for a fever. Patient is still consider contagious until all of the lesions are scabbed over. He doesn't need to come in unless mother is concerned and he is not well or having any complications other than the rash (i.e. high fever, hydration concerns, etc).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Incomplete course of vaccination, Pruritus, Rash
Clinical narrative: Rash on back with blisters, itching, Dr. diagnosed as shingles. MD - Dr. consulted. Will not take second shot-taking VALTREX.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness, Mechanical ventilation, Pneumonia
Clinical narrative: Flu-like, then pneumonia, currently on respirator. Informed by his son.
Age: 10.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Dyspepsia, Neck pain, Rash, Regurgitation
Clinical narrative: The first reaction was a pain in her neck, to the left of and at the base of her head. That went away within a day. She had a strange rash on the elbows and arms of both arms. These were minor problems. The issue that worried me and I spoke with her doctor about is her now constant diarrhea and indigestion. She has always been on the slightly constipated side. Now she is having a burning diarrhea that goes back and forth from being watery and a soft-serve consistency. Her indigestion is probably bothering her the most. Every time she eats, she has stomach acid regurgitate. She says it tastes like she's vomiting bits of her food into her mouth and it burns.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: The patient noticed pain, redness and swelling localized to the site of injection at 3am the morning after receiving the injection. The redness was about 2 inches in diameter and the patient had no systemic symptoms. Rash has improved per patient.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Differential white blood cell count normal, Full blood count normal, Haemoglobin normal, Rash, Skin warm
Clinical narrative: She received the SHINGRIX shot at 11 am on 3/8/19. Prior to receiving the shot, she had watched a patient educational video explaining expected adverse effects. She woke up on Sunday morning , 3/10/19, feeling "hot" under her left arm. It hurt as something touched it. It then had a "bug bite" like area on her shoulder blade that looked like a mosquito bite. She noticed the rash on her back today, 3/12/19, and called our office. She sent a photo, but she was unable to come in because of work and distance from our office. She is going to try to see a dermatologist today or tomorrow closer to home. Although Valtrex was called in for her, she was hesitant to take it because she "does not like medications".
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness, White blood cell count normal
Clinical narrative: She received the SHINGRIX shot at 11 am on 3/8/19. Prior to receiving the shot, she had watched a patient educational video explaining expected adverse effects. She woke up on Sunday morning , 3/10/19, feeling "hot" under her left arm. It hurt as something touched it. It then had a "bug bite" like area on her shoulder blade that looked like a mosquito bite. She noticed the rash on her back today, 3/12/19, and called our office. She sent a photo, but she was unable to come in because of work and distance from our office. She is going to try to see a dermatologist today or tomorrow closer to home. Although Valtrex was called in for her, she was hesitant to take it because she "does not like medications".
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site was very warm to touch, swollen, and was painful.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Lip swelling, Rash, Urticaria
Clinical narrative: Patient developed an urticarial rash of the upper and lower extremities one day following vaccination. Family denies new medications or new topical agents at that time. Patient treated himself with a dose of Benadryl for which rash resolved initially, but the next day patient had a similar eruption (this time including the back) on the skin with lip swelling requiring a second dose of Benadryl. Family reports that patient had a waxing and awaiting urticarial rash over the next 5 days following administration of meningitis B vaccine. Symptoms were treated with 25-50 mg of Benadryl each time.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site became painful, red, swelled up and patient had fever of 103, headache and chills.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Site became painful, red, swelled up and patient had fever of 103, headache and chills.
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Irritability, Malaise, Pyrexia, Sleep disorder
Clinical narrative: Off and on fever till next day. Sleeping patterns were light and was very fussy, just seemed like he did not feel well. Per Dr office we let it run it's course.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Erythema, Limb discomfort, Nausea, Oedema peripheral
Clinical narrative: Dizziness since receiving vaccine-as of today-4 days of dizziness. L arm with redness, edema and warmth. L arm tender and "feels heavy". Nausea. No treatment recommended.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Skin warm, Tenderness
Clinical narrative: Dizziness since receiving vaccine-as of today-4 days of dizziness. L arm with redness, edema and warmth. L arm tender and "feels heavy". Nausea. No treatment recommended.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Impaired driving ability, Impaired work ability, Mental impairment
Clinical narrative: Soreness in arm, slight fever, chills, body aches, severe dizziness (required pt to lie down, unable to work or drive), diminished mental capacity lasting 7 days (pt reported she was not at full capacity to complete her daily tasks at work which include counting money).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Soreness in arm, slight fever, chills, body aches, severe dizziness (required pt to lie down, unable to work or drive), diminished mental capacity lasting 7 days (pt reported she was not at full capacity to complete her daily tasks at work which include counting money).
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Headache, Pain
Clinical narrative: Cold, shivering, teeth chattering, body aches, slight headache.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Headache
Clinical narrative: Patient reported mild chills, headache, and temp of 101 overnight. Patient went to ER for evaluation.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Rash
Clinical narrative: After vaccine was administered 4 days after, I noticed little bumps on her forehead and over her legs. This is not the first time she's gotten these bumps after vaccination.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Pruritus, Rash
Clinical narrative: Patient developed rash and itching that spread from the injection site to middle of chest and down abdomen to waist. She experienced itching that was relieved with Benadryl. The rash also improved after administration of Benadryl.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Injection site erythema, Pain, Pruritus
Clinical narrative: Patient reported that on 3.6.18 her whole upper arm became very red and she felt achy, tired and slightly feverish. By March 10th her arm was itchy and covered in a bad rash she treated with hydrocortisone. Patient was encouraged via telephone on 3.12.19 to make an appointment to be checked by her provider, but declined, stating now her arm just has a red ring around the area where the injection was given. Injection given by CMA at Health Center. Patient agreeable to seeking care tomorrow if the problem is not resolved.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Patient reported that on 3.6.18 her whole upper arm became very red and she felt achy, tired and slightly feverish. By March 10th her arm was itchy and covered in a bad rash she treated with hydrocortisone. Patient was encouraged via telephone on 3.12.19 to make an appointment to be checked by her provider, but declined, stating now her arm just has a red ring around the area where the injection was given. Injection given by CMA at Health Center. Patient agreeable to seeking care tomorrow if the problem is not resolved.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided). The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about November 2016, a pharmacist administered the ZOSTAVAX (lot# and route unknown) vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about December 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles  and zoster-related injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Chest X-ray abnormal, Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, by a contactable other HCP. A 72-year-old male patient received at the age of 71 years PREVNAR 13 (lot number R75238, expiration date 01May2017), intramuscular at 0.5 ml single in left deltoid on 02Aug2017 for immunisation. Medical history included cough. There were no concomitant medications. The patient previously took TESSALON for cough. The patient experienced pneumonia (medically significant) on an unspecified date with outcome of recovering. The patient underwent lab tests and procedures which included on 28Jan2019 chest X-ray, result: pneumonia. The patient received also PREVNAR 13 (lot number: X47910, Expiry Date 01Sep2020) on 26Feb2019 at 0.5 ml single intramuscular injection in right deltoid and he is 72 years. Sender's Comments: Based on the information currently available, the known adverse event profile of the suspect product PREVNAR 13 and the pathophysiology of the event pneumonia, the Company cannot completely exclude that the suspect vaccine contributed to the development of the reported event.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Crying, Skin warm, Vomiting
Clinical narrative: Returned call to mother. Mom stated that child had Dtap earlier in the day at health department and was suffering from a "reaction". Mom reports child vomited x 1 in car after leaving Health Department, felt hot to touch, and cried for 20 minutes. Mother denies any seizures, pain, shortness of breath, additional vomiting, or swelling at site. Mother could not take temperature due to not having a thermometer. She states that child has stopped crying, and not vomited since. Instructed mom to take child to ER or call 911 if any seizure like activity, swelling of face or trouble breathing occurs. Mom agreed in instruction. Educated on mild to moderate reactions to INFANRIX Vaccine. Also educated to take child to primary care doctor for additional vaccines for further monitoring of reactions. Mom stated that she was making child an appointment with doctor's office. This was the first vaccine child has ever received.
Age: 62.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Shivering, Fever, Headache, Muscle Pain, Tiredness - Shivering and Fever lasted 1.5 days, tiredness lasted 3 days.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Headache, Herpes zoster, Injection site pain, Rash
Clinical narrative: Pain at the injection site then swelling and bruising lasted for ~3 weeks then she experienced facial rashes with severe headache, diagnosed shingles attack and treated with valtrex tablets completely resolved now.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Pain at the injection site then swelling and bruising lasted for ~3 weeks then she experienced facial rashes with severe headache, diagnosed shingles attack and treated with valtrex tablets completely resolved now.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Severe arm pain in the first few days. Pain has continued from 1/14/2019 to present 3/12/2019 but intensity has decreased.
Age: 41.0
Sex: M
Vaccine: DTAP
Symptoms: Deafness, Eczema
Clinical narrative: Eczema 3 days later. Increased in severity as time went on. After 2 years it has gone down. Hearing loss the evening of vaccine. Hearing loss has not improved and has continued to get worse.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Blood glucose increased, Feeling hot, Formication, Hallucination, Ketoacidosis
Clinical narrative: First of all, pt was given shots in both arms, yet the person who filled out the paper work took a short cut and said she only got her shots in the left arm. Pt got her shots and then went to school, when i picked her up at 2:15 pm on 4/12/16 from school she said she wasn't feeling well and felt warm. I took her home and took her temp, she was at 102. I did not treat the fever. At 4pm she told me there were snakes crawling on her stomach, she was having hallucinations and had a fever of 104.6; at this point I gave her ibuprofin for her size. Her fever would only drop to 101. She had fever for 3 days. On the night of 4/12/16 pt also was complaining of weak arms and legs and that they were hurting. To this very day she has severe leg pains. On June 12, 2016 pt was displaying symptoms to Type 1 Diabetes. She was extremely thirsty, urinating freqently, had a ketone smell on her breath and was losing weight. We tested her blood sugar and she was 436, she was diagnosed with Type 1 Diabetes later that week.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Laboratory test, Malaise, Muscular weakness, Pain in extremity, Pollakiuria
Clinical narrative: First of all, pt was given shots in both arms, yet the person who filled out the paper work took a short cut and said she only got her shots in the left arm. Pt got her shots and then went to school, when i picked her up at 2:15 pm on 4/12/16 from school she said she wasn't feeling well and felt warm. I took her home and took her temp, she was at 102. I did not treat the fever. At 4pm she told me there were snakes crawling on her stomach, she was having hallucinations and had a fever of 104.6; at this point I gave her ibuprofin for her size. Her fever would only drop to 101. She had fever for 3 days. On the night of 4/12/16 pt also was complaining of weak arms and legs and that they were hurting. To this very day she has severe leg pains. On June 12, 2016 pt was displaying symptoms to Type 1 Diabetes. She was extremely thirsty, urinating freqently, had a ketone smell on her breath and was losing weight. We tested her blood sugar and she was 436, she was diagnosed with Type 1 Diabetes later that week.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Pyrexia, Thirst, Type 1 diabetes mellitus, Weight decreased
Clinical narrative: First of all, pt was given shots in both arms, yet the person who filled out the paper work took a short cut and said she only got her shots in the left arm. Pt got her shots and then went to school, when i picked her up at 2:15 pm on 4/12/16 from school she said she wasn't feeling well and felt warm. I took her home and took her temp, she was at 102. I did not treat the fever. At 4pm she told me there were snakes crawling on her stomach, she was having hallucinations and had a fever of 104.6; at this point I gave her ibuprofin for her size. Her fever would only drop to 101. She had fever for 3 days. On the night of 4/12/16 pt also was complaining of weak arms and legs and that they were hurting. To this very day she has severe leg pains. On June 12, 2016 pt was displaying symptoms to Type 1 Diabetes. She was extremely thirsty, urinating freqently, had a ketone smell on her breath and was losing weight. We tested her blood sugar and she was 436, she was diagnosed with Type 1 Diabetes later that week.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: PALM-SIZED RASH, RED, HOT RAISED PAINFUL AT INJECTION SITE. 12 DAYS TO RESOLVE.
Age: 36.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Rash
Clinical narrative: Rash developed on legs then arms about 36 hours post injection.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Patient had a rash localized to the lower back in 2018. After getting the first dose of the SHINGRIX, that rash was spread from head to toe per patient.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever of 100.5, chills, body aches. Symptoms lasted until next morning.
Age: 32.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Patient was feeling lightheaded immediately following the HAVRIX vaccine. I instructed him to remain seated, a few moments later, he lost conciousness and passed out in the chair. My technician and I sat him upright and checked for breathing and no obstruction. 911 was immediately called and the paramedics arrived in under 5 minutes. EMT's took patient's vital signs and were within normal range. EMT's asked if he had used any drugs or alcohol today, patient responded that "he had a pint after work" EMS recommended and offered to take him to the emergency room, the patient declined treatment against medical advice. Patient remained in the pharmacy waiting area for approximately 30 minutes before leaving with his wife/girlfriend.
Age: 66.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: The patient called the pharmacy 3/12/19 and said she had a fever above 100 degrees (she could not tell me the exact temp), chills, and a rash on her breasts and stomach. She said she took TYLENOL for the fever and it was worse for the first 2 days. I told her to monitor symptoms and try BENADRYL for the rash, and to call her PCP if there is any worsening of the reaction.
Age: 0.17
Sex: F
Vaccine: HIBV, IPV, PPV, RVX
Symptoms: Electroencephalogram normal, Laboratory test normal, Respiratory arrest, Resuscitation
Clinical narrative: Stopped breathing twice. Needed rescue breathing.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Food allergy, Furuncle, Rash, Urticaria
Clinical narrative: Patient presented to the pharmacy today 3/12/19 and stated that post immunization she has developed an allergy to garlic and make-up she has been using. Pre-immunization no allergy to garlic or make up. Patient states she developed hives and rash and boils when she eats garlic or when she applies her makeup.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Nausea, Pain, Pain in extremity
Clinical narrative: Patient stated they after receiving vaccine she started feeling lethargic, nauseous, having body aches, and her arm was very sore. She called her doctor and they told her to call pharmacy. As of time of filing this report patient is still experiencing adverse effects.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Hyperacusis, Loss of personal independence in daily activities, Photophobia
Clinical narrative: The patient developed a headache the evening after her second HPV immunization. The headache has persisted since then (over one month). The headache is exacerbated intermittently, especially when around bright lights or loud noises, but is gradually improving. The patient missed four days of school the first week, and one day of school the second week. She has attended school since then, but still complains of headache, and is not able to participate in some activities such as cheer. The patient's mother notes that the patient developed similar headaches two days after her first HPV vaccine (given on 2/8/18) and now suspects that they were triggered by the HPV vaccines. Last year the patient was admitted to the hospital for unremitting headaches 3/14/2018, and was followed closely by neurology.  Those headaches lasted a total of three to four months, and eventually resolved.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Lethargy, Pain, Peripheral swelling, Pyrexia, Skin infection
Clinical narrative: PT RECEIVED VACCINE ON 03-05-19 AT 6PM, 2 DAYS AFTER VACCINE ARM BECAME WARM, TENDER, SWOLLEN AND SPREAD THROUGH ENTIRE AREA OF UPPER ARM. PT ALSO DEVELOPED HIGH FEVER OF 102 AND FELT LETHARGIC WITH BODY ACHES AND PAINS LAST OVER THE NEXT 3-4 DAYS. WAS SEEN AT URGENT CARE BY DR. WHO DIAGNOSED PT WITH SKIN INFECTION, CLAIMED THE VACCINE ADMINISTRATOR DID NOT CLEAN AREA PROPERLY BEFORE INJECTING AND GAVE PT PRESCRIPTION ANTIBIOTICS (SEPTRA DS AND CEPHALEXIN).
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Tenderness
Clinical narrative: PT RECEIVED VACCINE ON 03-05-19 AT 6PM, 2 DAYS AFTER VACCINE ARM BECAME WARM, TENDER, SWOLLEN AND SPREAD THROUGH ENTIRE AREA OF UPPER ARM. PT ALSO DEVELOPED HIGH FEVER OF 102 AND FELT LETHARGIC WITH BODY ACHES AND PAINS LAST OVER THE NEXT 3-4 DAYS. WAS SEEN AT URGENT CARE BY DR. WHO DIAGNOSED PT WITH SKIN INFECTION, CLAIMED THE VACCINE ADMINISTRATOR DID NOT CLEAN AREA PROPERLY BEFORE INJECTING AND GAVE PT PRESCRIPTION ANTIBIOTICS (SEPTRA DS AND CEPHALEXIN).