chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Drooling, Emotional distress, Eyelid ptosis, Facial paralysis, Fatigue
Clinical narrative: Patient had left sided Bell's palsy symptoms (slurred speech, droopy of face, saliva coming out of mouth) on 5/6/18. Patient went to Hospital and underwent evaluations by a neurologist who ruled out everything and speculated that it may have been caused by SHINGRIX vaccine.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Hemiplegia, Hypoacusis, Hypoaesthesia, Malaise, Nuclear magnetic resonance imaging normal
Clinical narrative: Patient had left sided Bell's palsy symptoms (slurred speech, droopy of face, saliva coming out of mouth) on 5/6/18. Patient went to Hospital and underwent evaluations by a neurologist who ruled out everything and speculated that it may have been caused by SHINGRIX vaccine.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Patient had left sided Bell's palsy symptoms (slurred speech, droopy of face, saliva coming out of mouth) on 5/6/18. Patient went to Hospital and underwent evaluations by a neurologist who ruled out everything and speculated that it may have been caused by SHINGRIX vaccine.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Angiogram normal, Blood test normal, Computerised tomogram normal, Discomfort, Drooling
Clinical narrative: Patient had left sided Bell's palsy symptoms (slurred speech, droopy of face, saliva coming out of mouth) on 5/6/18. Patient went to Hospital and underwent evaluations by a neurologist who ruled out everything and speculated that it may have been caused by SHINGRIX vaccine.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Dysarthria, Emotional distress, Eyelid ptosis, Facial paralysis, Fatigue
Clinical narrative: Patient had left sided Bell's palsy symptoms (slurred speech, droopy of face, saliva coming out of mouth) on 5/6/18. Patient went to Hospital and underwent evaluations by a neurologist who ruled out everything and speculated that it may have been caused by SHINGRIX vaccine.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Hypoacusis, Hypoaesthesia, Malaise, Nuclear magnetic resonance imaging normal, Vision blurred
Clinical narrative: Patient had left sided Bell's palsy symptoms (slurred speech, droopy of face, saliva coming out of mouth) on 5/6/18. Patient went to Hospital and underwent evaluations by a neurologist who ruled out everything and speculated that it may have been caused by SHINGRIX vaccine.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Visual impairment
Clinical narrative: Patient had left sided Bell's palsy symptoms (slurred speech, droopy of face, saliva coming out of mouth) on 5/6/18. Patient went to Hospital and underwent evaluations by a neurologist who ruled out everything and speculated that it may have been caused by SHINGRIX vaccine.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incomplete course of vaccination, Peripheral swelling, Pruritus
Clinical narrative: Pt received the vaccine here on 04/26/2018. She stopped by the pharmacy May 9 and told us that her left arm was red, itchy and swollen all the way down to her wrist. She went to her primary doctor the day following the vaccine and he told her not to get the 2nd vaccine shot in the series for fear of an allergy.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Soreness, red bulls eye at injection site, about the size of a baseball circumference. Thursday and Friday after the shot patient had a headache that kept her in bed most the day sleeping. Thursday after receiving the shot she felt like there was a tight band around her arm. She had diarrhea twice Friday after receiving the shot. The injection site is warm to touch. Saturday after receiving the shot her underarm on her right side was tender to touch.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin tightness, Somnolence, Tenderness
Clinical narrative: Soreness, red bulls eye at injection site, about the size of a baseball circumference. Thursday and Friday after the shot patient had a headache that kept her in bed most the day sleeping. Thursday after receiving the shot she felt like there was a tight band around her arm. She had diarrhea twice Friday after receiving the shot. The injection site is warm to touch. Saturday after receiving the shot her underarm on her right side was tender to touch.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient received Tdap vaccine, no immediate reaction. Patient was paying for vaccine about 15 minutes later, when he asked if dizziness is normal after this vaccine. Less than 30 seconds later, he lost consciousness and slumped down to the floor. I layed him on his side, and called for help on the floor and for 911 call to be placed. Less than 1 minute later, he regained consciousness. He slowly sat up and remained sitting while propped up for about 30 minutes. A sales floor attendant gave him a carbonated drink and cool towel. He asked for the 911 call to be cancelled and did not want any medical attention. The patient walked out of the store without assistance. I checked up on the patient the following morning; no further adverse symptoms.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: Severe pain, swelling and itching lasting for 7 days.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: C-reactive protein increased, C-reactive protein normal, Rash, Rash papular, Rash pruritic
Clinical narrative: Pruritus vesiculopapular rash in underarm, chest, groin, and shaft of penis.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site papule, Injection site rash
Clinical narrative: Localized red rash around the injection site. Bumps similar to hives.
Age: 71.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Contusion, Headache, Nausea, Swelling
Clinical narrative: Swollen, bruising, headache, nausea.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Impaired work ability, Injected limb mobility decreased, Joint swelling, Musculoskeletal pain, Pain
Clinical narrative: Patient had extreme pain and swelling in shoulder within 3 hours. The pain was bad enough all the way down the arm to where patient had to go to the ER. Patient describes the pain as shooting pains that went all the way down to her hands and could not move arm at all that evening. She also had swelling that went down to her elbow. She was given pain meds and BENADRYL at the hospital but was out of work for a week. She says the pain didn't totally alleviate until 7 days later.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient had extreme pain and swelling in shoulder within 3 hours. The pain was bad enough all the way down the arm to where patient had to go to the ER. Patient describes the pain as shooting pains that went all the way down to her hands and could not move arm at all that evening. She also had swelling that went down to her elbow. She was given pain meds and BENADRYL at the hospital but was out of work for a week. She says the pain didn't totally alleviate until 7 days later.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Patient received vaccine in left arm, she then noticed the arm had become red at injection site. 2 days later below injection site a rash developed and began to spread over whole upper arm that was hot to touch, but the patient did not experience fever. She waited a couple days to see if the rash would resolve on its own but it did not so she went to her PCP and a dermatologist who diagnosed a likely cellulitis. Patient was given doxycycline hyclate 100mg tabs PO BID x 7days. Patient had picture of rash on phone which I saw.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Malaise, Mobility decreased, Pyrexia
Clinical narrative: Fever, headache, chills, malaise, pt couldn't get out of bed for a day.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Limb discomfort
Clinical narrative: 3 hrs after injection, my left arm became very sore. I was unable to lift my above mid-chest. Felt as though there was a cord in my upper arm between shoulder and elbow and it was being pulled tighter and tighter. Had lack of strength - unable to use arm when driving my SUV.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Headache, Influenza like illness
Clinical narrative: Severe flu like symptoms: running nose, sore throat, headaches, body aches. Chills, very  weak. Dizzy.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: Severe flu like symptoms: running nose, sore throat, headaches, body aches. Chills, very  weak. Dizzy.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Injection given in L tricep area with no unusual symptoms at time of administration. But the next day, a noticably firm, reddened, oval shaped lump about 2.5 inches in diameter was noticed. It was slightly painful, which progressed to mild, intermittent itching. At the second day, there was a reduction in lump size but a substantial increase in the affected area, about 6 inches running between the shoulder and elbow. Itching intensity increased substantially. Application of topical BENADRYL, lidocaine, betamethasone and oral BENADRYL were mostly ineffective, with the aerosolized BENADRYL giving the most relief, partly due to its cooling effect. On the third day, itching was reduced, but the redness spread to almost the entire back of the upper arm, to an area about 8 inches by five inches. It would appear the adverse event has begun to diminish, and there are no other sequelae to report.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Malaise, Pyrexia
Clinical narrative: Pain, redness at injection site - the redness spread distally (as opposed to proximally) on the arm and was blotchy; also felt ill and reported low grade fever. I ran into her at the pharmacy two days after the injection (she was seeing the NP at the clinic who she says told her that she had not seen this type of reaction) and then at my office on May 8. The reaction had improved compared to what she showed me in the pharmacy.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: Pain, redness at injection site - the redness spread distally (as opposed to proximally) on the arm and was blotchy; also felt ill and reported low grade fever. I ran into her at the pharmacy two days after the injection (she was seeing the NP at the clinic who she says told her that she had not seen this type of reaction) and then at my office on May 8. The reaction had improved compared to what she showed me in the pharmacy.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Urticaria
Clinical narrative: Patient came back with a pink welt on her arm where the injection was given. It hurt a little bit.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Influenza like illness, Lip blister, Pain
Clinical narrative: Swelling of arm - double deltoid size. Redness that extended to elbow. Pain. Itching. Diarrhea. Lips blistered. Body wide flu, aches, pain. Taking BENADRYL, TYLENOL, applying ice packs.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Swelling of arm - double deltoid size. Redness that extended to elbow. Pain. Itching. Diarrhea. Lips blistered. Body wide flu, aches, pain. Taking BENADRYL, TYLENOL, applying ice packs.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Complaining of Redness, warm to touch area about size of fist around injection site.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Swollen glands in armpit, cervical area, neck. Low grade fever using ibuprofen.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Biopsy, Erythema, Facial pain, Herpes zoster, Pruritus
Clinical narrative: Patient developed itching and a rash on the face about 2 days after receiving the SHINGRIX vaccine. She later went to the dermatologist and was diagnosed with Shingles.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Swelling face
Clinical narrative: Patient developed itching and a rash on the face about 2 days after receiving the SHINGRIX vaccine. She later went to the dermatologist and was diagnosed with Shingles.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: Patient developed itching and a rash on the face about 2 days after receiving the SHINGRIX vaccine. She later went to the dermatologist and was diagnosed with Shingles.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient developed itching and a rash on the face about 2 days after receiving the SHINGRIX vaccine. She later went to the dermatologist and was diagnosed with Shingles.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Facial pain, Herpes zoster, Hyperaesthesia, Irritability, Pruritus
Clinical narrative: Patient developed itching and a rash on the face about 2 days after receiving the SHINGRIX vaccine. She later went to the dermatologist and was diagnosed with Shingles.
Age: 48.0
Sex: F
Vaccine: YF
Symptoms: Pain, Pyrexia, Rash, Swelling
Clinical narrative: THE PT EXPERIENCED FEVER SWELLING RASH AND PAINFUL TO THE TOUCH.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a registered nurse referring to an approximately 73 years old female patient. The patient had no pertinent medical history, no drug reactions/allergies. Concomitant medication was reported as none. On 16-APR-2018, the patient was vaccinated with PNEUMOVAX 23 (strength and dose were not reported) (lot # N019838 and expiry date: 16-FEB-2019) subcutaneously in the left arm to prevent pneumonia. On 16-APR-2018 (2 hours after receiving the vaccine), the patient developed Patient developed redness, warmth, tenderness, pain (pain in extremity), intense itching, and swelling from the elbow and half way up the injection site arm. It was reported that the patient was in the office on 18-APR-2018 for an unspecified reason unrelated to the PNEUMOVAX 23 and reported the symptoms. No treatment was provided for the adverse events. No lab diagnostics/studies performed. At this visit, the patient stated that she had the same reaction to PREVNAR 13 (Wyeth) "1 year ago." No further clarifying information was provided. The outcome of the events was reported as not recovered/not resolved. Causality was not reported for the adverse events redness, warmth, tenderness, pain (pain in extremity), intense itching, and swelling with PNEUMOVAX 23 vaccination. Additionally, the reporter stated that the adverse event not specified was not related to PNEUMOVAX 23 vaccination. No product quality complaint (PQC) was involved.
Age: 73.0
Sex: U
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report was received from a nurse and refers to a 73 year old patient. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 26-APR-2018, the patient was vaccinated with a dose of  PNEUMOVAX 23 for prophylaxis, intramuscularly, 0.5ml, lot # R000692, and expiration date 09-SEP-2019. The patient had previously been vaccinated on 2017 with PNEUMOVAX 23 for prophylaxis; dose, route of administration, strength, frequency, lot# and expiration date unknown. On 27-APR-2018, the patient reported a cellulitis like reaction. The outcome of injection site cellulitis was unknown. Causal relationship between PNEUMOVAX 23 and the event injection site cellulitis was unknown.
Age: 73.0
Sex: U
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a nurse and refers to a 73 year old patient. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 26-APR-2018, the patient was vaccinated with a dose of  PNEUMOVAX 23 for prophylaxis, intramuscularly, 0.5ml, lot # R000692, and expiration date 09-SEP-2019. The patient had previously been vaccinated on 2017 with PNEUMOVAX 23 for prophylaxis; dose, route of administration, strength, frequency, lot# and expiration date unknown. On 27-APR-2018, the patient reported a cellulitis like reaction. The outcome of injection site cellulitis was unknown. Causal relationship between PNEUMOVAX 23 and the event injection site cellulitis was unknown.
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of LIQUID PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse on 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to a female patient vaccinated with improperly stored RECOMBIVAX HB(lot# N011851 with expiration date 19-DEC-2019 ) on 27-SEP-2017. No adverse event was reported. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter(link reports: 1710USA004069, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004591, 1805USA004592, 1805USA004593,  1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
Sex: M
Vaccine: MMR
Symptoms: Type 1 diabetes mellitus
Clinical narrative: This spontaneous report was received from a physician via company representative, referring to a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions and concomitant medications. In May 2014 (reported as 4 years ago), the patient was vaccinated with M-M-R II, subcutaneously (SC) for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported). Other suspect therapies included sterile diluent (manufacturer unknown), (SC) for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported). On an unknown date in May 2014 (reported as one week after administration of M-M-R II, the patient experienced type 1 diabetes mellitus. The patient sought medical attention (unknown type). No further information was provided. At the time of the report, the outcome and the causality assessment between type 1 diabetes mellitus and the suspect therapies was unknown. Upon internal review the event type 1 diabetes mellitus was considered to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an adult patient of an unknown gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On 03-MAY-2018, the patient was inadvertently administered a dose of expired PROQUAD recombinant human albumin (rHA), lot # M039447 with an expiration date 20-MAR-2018, subcutaneously for prophylaxis (anatomical location were not reported). The sterile diluent used to reconstitute the Oka-Merck PROQUAD was not expired and there was no temperature excursion. No adverse effects were reported.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report was received from a nurse practitioner via Poison and Drug Center (PDC) regarding a 13-year-old male patient. The patient's medical history included that his hand was smashed in a door on an unknown date and experienced a skin reaction on his hand. The patient's concomitant medications included KEFLEX for several days to treat the skin reaction on his hand. The patient's concurrent conditions was not reported. On 03-MAY-2018, the patient was vaccinated with VAQTA 50U/1mL, 1 mL dose, once, intramuscularly in the left arm (lot# M028743, expiration date: 23-NOV-2018) for Hepatitis A outbreak. The patient was mistakenly provided the adult 1mL dose instead of the pediatric 0.5mL dose (drug administered to patient of inappropriate age) (incorrect dose administered). The patient had no relevant laboratory data. At the time of the call, it was unknown if the patient had experienced any untoward effects. It was unknown if the patient continued on VAQTA. Lot number [M028743] is an invalid lot number for VAQTA.
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster disseminated
Clinical narrative: This spontaneous report was received from a consumer and refers to an approximately 73 years old male patient reporting on himself. The patient had no medical history, concurrent conditions, drug reactions or allergies. However, he stated that prior to receiving ZOSTAVAX, he was always healthy and rarely sick. On an unknown date in 2016, the patient was vaccinated with one dose of ZOSTAVAX, in his shoulder, (dose, route, lot number and expiration date were not reported), to prevent shingles. The vaccine was diluted with Merck sterile diluent. On an unknown date in 2016, the day after the patient received the ZOSTAVAX, the patient developed shingles on his shins, stomach area, and from his ear lobes down to his Adam's apple. Since the patient developed herpes zoster disseminated, he had been getting "flare ups" of the shingles, primarily on the right side. On an unknown date, the patient visited the physician's office, and underwent an unspecified blood work without results reported. The herpes zoster disseminated was not treated. At the time of reporting, the outcome of herpes zoster disseminated was not recovered. The reporter did not assess the causal relationship between the herpes zoster disseminated and the therapy with ZOSTAVAX or Merck sterile diluent. Upon internal review the event of herpes zoster disseminated was determined to be a medically significant event.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician via Poison and Drug Center (PDC) regarding a baby unknown age and gender. The patient's medical history, current condition and concomitant medication were not reported. On an unknown date, the staff inadvertently vaccinated an expired (wistar ra 27-3) M-M-R II (strength, dose, frequency, lot number and expiry date were not reported) (expired product administered) for prophylaxis. The patient's relevant lab data was unknown. At the time of report (04-MAY-2018), it was unknown if the baby would continue to receive (wistar ra 27-3) M-M-R II. It was reported that the baby was okay.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding the medical history, drug reactions/allergies and concurrent conditions was not reported. On 11-APR-2018, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX subcutaneously, lot # N013277, expiration date: 28-APR-2019 (dose and site of administration were not reported) for prophylaxis. It was stored in temperature of 6 Fahrenheit degrees (F) to 14 F (7.9 F) for 19 minutes. There was no previous temperature excursion. The call was a result of a reading from a Digital Data Logger. The nurse reported that the diluent (lot number and expiration date were unknown) used to reconstitute the Oka/Merck VARIVAX was properly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA003480: US-009507513-1805USA003481: US-009507513-1805USA003482: US-009507513-1805USA003483: US-009507513-1805USA002990.
Sex: F
Vaccine: HPV9
Symptoms: Allergic respiratory symptom, Nasopharyngitis, Respiratory disorder
Clinical narrative: This spontaneous report was received from a nurse referring to a 15 year old female patient. No concurrent conditions, pertinent medical history, drug reactions / allergies nor concomitant medications were reported. On 05-MAR-2018, the patient was vaccinated with the first dose of GARDASIL 9 (Lot # N001533, expiration date 16-OCT-2019, dosage, route of administration and anatomical location were not reported) as routine vaccination. On approximately May 2018 (reported as within the last week) the patient experienced "being sick with a cold", clarified as "respiratory issue, most likely allergies" (Allergic respiratory symptom). No treatment was given for the adverse event, no lab diagnostic/ studies were performed, the patient did not seek for medical attention. At the time of reporting, the outcome of Allergic respiratory symptom was reported as not recovered/not resolved. The reporter did not assess the causal relationship between the adverse event and the vaccination with GARDASIL 9.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency, expiry date and route of administration were not reported) (lot # N000508) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency, expiry date and route of administration were not reported) (lot # N000508) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency and route of administration were not reported) (lot # N003997, expiry date: 20-OCT-2018) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency and route of administration were not reported) (lot # N003997, expiry date: 20-OCT-2018) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency and route of administration were not reported) (lot # N010106, expiry date: 15-NOV-2018) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency and route of administration were not reported) (lot # N010106, expiry date: 15-NOV-2018) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency and route of administration were not reported) (lot # N010106, expiry date: 15-NOV-2018) for prophylaxis. The pneumococcal PNEUMOVAX 23 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency and route of administration were not reported) (lot # N020502, expiry date: 08-FEB-2019) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, frequency and route of administration were not reported) (lot # M035486, expiry date: 05-JUN-2019) for prophylaxis. The GARDASIL 9 was exposed to a total time in the range at or above 0 degrees C to 1 degrees C for 8.25 hours. It was reported the exact temperature and time below 0 degrees C was: -1.9 degrees C for 15 minutes, -1.2 degrees C for 15 minutes, -1.0 degrees C for 15 minutes, -0.8 degrees C for 15 minutes, -0.4 degrees C for 15 minutes and -0.2 degrees C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Drug dose omission
Clinical narrative: This spontaneous report has been received from a healthcare professional via a company representative referring to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with M-M-R II (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient missed a dose of M-M-R II (drug dose omission) for an unknown reason.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions, as well as concomitant medications, were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (strength, dose, route and frequency were not reported) lot # N003536, expiration date 02-NOV-2019 for prophylaxis, which has a temperature excursion of 33°F for 18 hours. The reported stated that the temperature excursion was detected by a data logger. The vaccine had no previous temperature excursion. No adverse symptoms were reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant regarding 26-year-old patient of unknown gender. There was no information about the patient's concurrent conditions or medical history. The patient's concomitant medication included sterile diluent. On an unknown date, the patient was administered inadvertently a dose of ZOSTAVAX subcutaneous, lot # N013274 and expiration date 04-JUL-2018 (strength, dose and anatomical location were not reported) instead of varicella virus vaccine live (manufacturer unknown) for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: HEP, HEPA, HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of LIQUID PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to a male patient vaccinated with improperly stored ROTATEQ (oral; lot# N000175 with expiration date 20-SEP-2018) on 22-SEP-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter (link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618, 1805USA004591, 1805USA004592, 1805USA004593, 1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patient s' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to two male patients vaccinated with improperly stored VAQTA (lot# N019924 with expiration date 02-SEP-2018) on 21-SEP-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter(link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004592, 1805USA004593, 1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of LIQUID PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to a male patient vaccinated with improperly stored RECOMBIVAX HB(lot# N011851 with expiration date 19-DEC-2019 ) on 28-SEP-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received from the same reporter(link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004591, 1805USA004593,  1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).