chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Eye swelling, Flushing, Hyporesponsive to stimuli, Lip swelling, Nasal congestion
Clinical narrative: 5-10 minutes after vaccines, pt became flushed and less responsive; never unconscious. HR 120, BP 100/60. L eye & upper lip swelled and nose - began to un and become blocked. Benadryl given, observed for 1 hour. Became playful, alert, eye swelling resolved, nose remained congested. Pt d/c'd to home. Time in office from vaccine administration to d/c: 11:50a - 1:30p
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rhinorrhoea
Clinical narrative: 5-10 minutes after vaccines, pt became flushed and less responsive; never unconscious. HR 120, BP 100/60. L eye & upper lip swelled and nose - began to un and become blocked. Benadryl given, observed for 1 hour. Became playful, alert, eye swelling resolved, nose remained congested. Pt d/c'd to home. Time in office from vaccine administration to d/c: 11:50a - 1:30p
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Feeding disorder, Feeling abnormal, Gait disturbance
Clinical narrative: On March 25, 2019 I got my first shingles shot. It is the most painful injection I have ever had. Other than hurting for two days I did not have any other reactions to it. On June 5, 2019 I returned for the second injection in the series. It hurt just as bad. Day one it was sore but only had a small red spot at the site probably 1 1/2 -2 inches in diameter. Day 2 at about 12:30 I met my husband for lunch I was unable to eat because I had a headache. When I stood up my legs had pains (muscle/joint) it was a little difficult to commence walking. When I got home I went straight to bed. I got chills, a high fever 102.5, profuse sweating and a headache. I took several doses of Tylenol & Aleve through the night. Day 3 Friday June 7, I no longer had the chills but continued with low grade fevers & feeling bad. The redness at the injection site got bigger, redder & hot. It was about 4 inches all the way around. One large circle. I may have slept 30 minutes at the most. I had leg muscle and joint pains throughout the night. On Day 4 Saturday June 8 I returned to pharmacy to have the pharmacist take a look at it. She hesitantly advised that I may be able to wait a day. She cleaned it up with alcohol swabs & covered it with a bandaid. At that point I decided I better go to the Urgent Care Clinic. Because today the injection site was even redder, more swollen & more inflamed and hot. While I waiting to be seen the pharmacist called. She had done some research & felt I sho see I went to urgent care and was seen by Dr. His diagnosis is I have staph/cellulitis of my left arm on injection site. His prescriptions were doxcycline hyclate 100 mg & mupirocin cream. He administered an injection of cetriaxone sodium per. Day 5 Sunday June 9, still red & swollen but slowly getting better. Day 6 - Monday June 10 still recovering the site slowly fading
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Injection site cellulitis, Injection site erythema, Injection site inflammation
Clinical narrative: On March 25, 2019 I got my first shingles shot. It is the most painful injection I have ever had. Other than hurting for two days I did not have any other reactions to it. On June 5, 2019 I returned for the second injection in the series. It hurt just as bad. Day one it was sore but only had a small red spot at the site probably 1 1/2 -2 inches in diameter. Day 2 at about 12:30 I met my husband for lunch I was unable to eat because I had a headache. When I stood up my legs had pains (muscle/joint) it was a little difficult to commence walking. When I got home I went straight to bed. I got chills, a high fever 102.5, profuse sweating and a headache. I took several doses of Tylenol & Aleve through the night. Day 3 Friday June 7, I no longer had the chills but continued with low grade fevers & feeling bad. The redness at the injection site got bigger, redder & hot. It was about 4 inches all the way around. One large circle. I may have slept 30 minutes at the most. I had leg muscle and joint pains throughout the night. On Day 4 Saturday June 8 I returned to pharmacy to have the pharmacist take a look at it. She hesitantly advised that I may be able to wait a day. She cleaned it up with alcohol swabs & covered it with a bandaid. At that point I decided I better go to the Urgent Care Clinic. Because today the injection site was even redder, more swollen & more inflamed and hot. While I waiting to be seen the pharmacist called. She had done some research & felt I sho see I went to urgent care and was seen by Dr. His diagnosis is I have staph/cellulitis of my left arm on injection site. His prescriptions were doxcycline hyclate 100 mg & mupirocin cream. He administered an injection of cetriaxone sodium per. Day 5 Sunday June 9, still red & swollen but slowly getting better. Day 6 - Monday June 10 still recovering the site slowly fading
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: On March 25, 2019 I got my first shingles shot. It is the most painful injection I have ever had. Other than hurting for two days I did not have any other reactions to it. On June 5, 2019 I returned for the second injection in the series. It hurt just as bad. Day one it was sore but only had a small red spot at the site probably 1 1/2 -2 inches in diameter. Day 2 at about 12:30 I met my husband for lunch I was unable to eat because I had a headache. When I stood up my legs had pains (muscle/joint) it was a little difficult to commence walking. When I got home I went straight to bed. I got chills, a high fever 102.5, profuse sweating and a headache. I took several doses of Tylenol & Aleve through the night. Day 3 Friday June 7, I no longer had the chills but continued with low grade fevers & feeling bad. The redness at the injection site got bigger, redder & hot. It was about 4 inches all the way around. One large circle. I may have slept 30 minutes at the most. I had leg muscle and joint pains throughout the night. On Day 4 Saturday June 8 I returned to pharmacy to have the pharmacist take a look at it. She hesitantly advised that I may be able to wait a day. She cleaned it up with alcohol swabs & covered it with a bandaid. At that point I decided I better go to the Urgent Care Clinic. Because today the injection site was even redder, more swollen & more inflamed and hot. While I waiting to be seen the pharmacist called. She had done some research & felt I sho see I went to urgent care and was seen by Dr. His diagnosis is I have staph/cellulitis of my left arm on injection site. His prescriptions were doxcycline hyclate 100 mg & mupirocin cream. He administered an injection of cetriaxone sodium per. Day 5 Sunday June 9, still red & swollen but slowly getting better. Day 6 - Monday June 10 still recovering the site slowly fading
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Staphylococcal infection
Clinical narrative: On March 25, 2019 I got my first shingles shot. It is the most painful injection I have ever had. Other than hurting for two days I did not have any other reactions to it. On June 5, 2019 I returned for the second injection in the series. It hurt just as bad. Day one it was sore but only had a small red spot at the site probably 1 1/2 -2 inches in diameter. Day 2 at about 12:30 I met my husband for lunch I was unable to eat because I had a headache. When I stood up my legs had pains (muscle/joint) it was a little difficult to commence walking. When I got home I went straight to bed. I got chills, a high fever 102.5, profuse sweating and a headache. I took several doses of Tylenol & Aleve through the night. Day 3 Friday June 7, I no longer had the chills but continued with low grade fevers & feeling bad. The redness at the injection site got bigger, redder & hot. It was about 4 inches all the way around. One large circle. I may have slept 30 minutes at the most. I had leg muscle and joint pains throughout the night. On Day 4 Saturday June 8 I returned to pharmacy to have the pharmacist take a look at it. She hesitantly advised that I may be able to wait a day. She cleaned it up with alcohol swabs & covered it with a bandaid. At that point I decided I better go to the Urgent Care Clinic. Because today the injection site was even redder, more swollen & more inflamed and hot. While I waiting to be seen the pharmacist called. She had done some research & felt I sho see I went to urgent care and was seen by Dr. His diagnosis is I have staph/cellulitis of my left arm on injection site. His prescriptions were doxcycline hyclate 100 mg & mupirocin cream. He administered an injection of cetriaxone sodium per. Day 5 Sunday June 9, still red & swollen but slowly getting better. Day 6 - Monday June 10 still recovering the site slowly fading
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Furuncle, Injection site erythema, Injection site urticaria, Injection site warmth, Rash
Clinical narrative: Redness at site of injection, 4 inch round wheal, warm, light rash on the back of neck developed 4-5 days later. Rash did go away but boil like welt developed near lymph node on back of neck? Boil and irritation reported 6/10/19
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin irritation
Clinical narrative: Redness at site of injection, 4 inch round wheal, warm, light rash on the back of neck developed 4-5 days later. Rash did go away but boil like welt developed near lymph node on back of neck? Boil and irritation reported 6/10/19
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: The patient reports that she had a lot of pain, itchiness on the arm at the vaccination site with swelling and redness (almost the size of a small hand). She also reported that she had a headache. She took acetaminophen for the pain and used ice and Vicks on the arm. We encouraged her to visit the doctor but she specified that she feels better and for the time being she won't go.
Age: 3.0
Sex: F
Vaccine: TYP
Symptoms: Pruritus, Rash
Clinical narrative: Rash on forehead and cheeks. Itching
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Area of redness & warmth just below Kinrix injection site. It got bigger over the course of the day on 6/9. Mom went to the ER that night & patient was given benadryl, which helped.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site urticaria
Clinical narrative: 9:28AM Developed local urticaria at varicella imm sight right away. Cold compresses and 3.4mL Benadryl given. No generalized rash, cough or wheezing. Lungs clear and pulse ox 100%. Observed in MD office. 9:57AM: Pt playing/walking. Hive at site smaller in size. 10:15AM: site of IM minimally erthematous appx 1 cm. No other SX. No other reactions.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: fever 102 degrees Chills Body aches
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt. Returned 2 days after with baseball size Allergic Reaction to INj complained of Itching/Redness/Swelling At Site, PT was seen same day at Doctor given lorAtidine, ZANtAC, Advised to plAce ice oN site
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Genital herpes, Herpes simplex test positive, Influenza like illness, Pain in extremity
Clinical narrative: AFTER 2 DAYS OF RECIEVING THE 1ST DOSE OF THE  VACCINE, PT REPORTED FLU LIKE SYMPTOMS AND A SORE ARM.  3 WEEKS LATER, SHE HAD AN OUTBREAK OF HERPES AND REPORTED LESIONS ON HER GENITALS. SHE HAD NO HISTORY OF HSV-1 OR HSV-2 AND HAS BEEN WITH THE SAME PARTNER FOR 12 YEARS.  AFTER THE FIRST INCIDENT, SHE TOOK L-LYSINE AND LEMON BALM AS A FORM OF TREATMENT.  PATIENT CAME BACK ON 9/11/2018 FOR THE SECOND DOSE OF HER SHINGRIX VACCINE AND 9 MONTHS LATER ON 6/01/2019 REPORTED ANOTHER EPISODE OF GENITAL HERPES.  SHE GOT CULTURES DONE ON 6/01/2019 AND HER LAB RESULTS CAME BACK ON 06/11/2019 AND WAS CONFIRMED AS A TYPE 2 OUTBREAK OF HSV-2. AFTER THIS SECOND INCIDENT, SHE RECIEVED VALTREX 1GRAM AND LIDOCAINE HCl 2% SOLUTION AS TREATMENT.
Age: 50.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Burning sensation, Chills, Dizziness
Clinical narrative: flu like side effects; feeling miserable; This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a 50-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms and feeling miserable. On an unknown date, the outcome of the influenza-like symptoms and feeling miserable were unknown.   It was unknown if the reporter considered the influenza-like symptoms and feeling miserable to be related to Shingrix.  Additional details were provided as follows: The patient received a Shingrix vaccine this past Wednesday and experienced horrible flu like side effects. The patient just turned 50 years old and paid for this vaccine full price out of pocket. The patient was very upset with how miserable it made them feel. The patient asked that did a single vaccine provide any protection because the patient did not want to go through this again and would have to pay again for a second shot to feel horribly sick that was truly awful.
Age: 50.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Eye irritation, Eye pain, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: flu like side effects; feeling miserable; This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a 50-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms and feeling miserable. On an unknown date, the outcome of the influenza-like symptoms and feeling miserable were unknown.   It was unknown if the reporter considered the influenza-like symptoms and feeling miserable to be related to Shingrix.  Additional details were provided as follows: The patient received a Shingrix vaccine this past Wednesday and experienced horrible flu like side effects. The patient just turned 50 years old and paid for this vaccine full price out of pocket. The patient was very upset with how miserable it made them feel. The patient asked that did a single vaccine provide any protection because the patient did not want to go through this again and would have to pay again for a second shot to feel horribly sick that was truly awful.
Age: 50.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pruritus, Insomnia, Myalgia
Clinical narrative: flu like side effects; feeling miserable; This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a 50-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms and feeling miserable. On an unknown date, the outcome of the influenza-like symptoms and feeling miserable were unknown.   It was unknown if the reporter considered the influenza-like symptoms and feeling miserable to be related to Shingrix.  Additional details were provided as follows: The patient received a Shingrix vaccine this past Wednesday and experienced horrible flu like side effects. The patient just turned 50 years old and paid for this vaccine full price out of pocket. The patient was very upset with how miserable it made them feel. The patient asked that did a single vaccine provide any protection because the patient did not want to go through this again and would have to pay again for a second shot to feel horribly sick that was truly awful.
Age: 50.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Neck pain, Pain in extremity, Palpitations, Pyrexia, Throat irritation
Clinical narrative: flu like side effects; feeling miserable; This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a 50-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms and feeling miserable. On an unknown date, the outcome of the influenza-like symptoms and feeling miserable were unknown.   It was unknown if the reporter considered the influenza-like symptoms and feeling miserable to be related to Shingrix.  Additional details were provided as follows: The patient received a Shingrix vaccine this past Wednesday and experienced horrible flu like side effects. The patient just turned 50 years old and paid for this vaccine full price out of pocket. The patient was very upset with how miserable it made them feel. The patient asked that did a single vaccine provide any protection because the patient did not want to go through this again and would have to pay again for a second shot to feel horribly sick that was truly awful.
Age: 50.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Emotional distress, Feeling abnormal, Influenza like illness
Clinical narrative: flu like side effects; feeling miserable; This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a 50-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms and feeling miserable. On an unknown date, the outcome of the influenza-like symptoms and feeling miserable were unknown.   It was unknown if the reporter considered the influenza-like symptoms and feeling miserable to be related to Shingrix.  Additional details were provided as follows: The patient received a Shingrix vaccine this past Wednesday and experienced horrible flu like side effects. The patient just turned 50 years old and paid for this vaccine full price out of pocket. The patient was very upset with how miserable it made them feel. The patient asked that did a single vaccine provide any protection because the patient did not want to go through this again and would have to pay again for a second shot to feel horribly sick that was truly awful.
Age: 1.0
Sex: M
Vaccine: VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site reaction, Rash macular
Clinical narrative: Seen at urgent care on 6/1/19 for rash, fever, fussy and runny nose. Prescribed cefdinir 125mg/5ml-give 3ml BID x 10 days and mupirocin 2% topical TID for dx otitis media of both ears. Seen on 6/4/19 for recurrent otitis media and continued rash to left leg. Referral made to ENT.  Seen again on 6/6/19 for continued rash on left leg. No fever, local reaction. otitis media resolving.
Age: 1.0
Sex: M
Vaccine: VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Irritability, Otitis media, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Seen at urgent care on 6/1/19 for rash, fever, fussy and runny nose. Prescribed cefdinir 125mg/5ml-give 3ml BID x 10 days and mupirocin 2% topical TID for dx otitis media of both ears. Seen on 6/4/19 for recurrent otitis media and continued rash to left leg. Referral made to ENT.  Seen again on 6/6/19 for continued rash on left leg. No fever, local reaction. otitis media resolving.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Photosensitivity reaction, Skin burning sensation, Sunburn
Clinical narrative: I got a sunburn while out on the beach.  I don't normally get sun burns.  I used sunscreen but my skin felt supper sensitive to the sun.  The burn was not severe as it did not peel or act like a regular sunburn.  My skin felt like it was on fire while I was exposed to the sun.  The "burn" or sensitivity lasted for days.  Two weeks later I still could not stand to be out in the sun.  My skin felt like it was on fire.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient inadvertently received both of the above-mentioned vaccines concurrently as a result of an physician-ordering miscommunication.  The mother of the patient was notified by phone by the ordering physician, and there have been no reported adverse reactions or side effects.
Age: 1.0
Sex: M
Vaccine: MMRV, UNK, VARCEL
Symptoms: Extra dose administered
Clinical narrative: patient received doses of ProQuad and Varivax on the same day; both vaccines administered "intramuscular"; This spontaneous report was received from a registered nurse referring to a 12 month old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     On 23-MAY-2019, around 11:45, the patient received 0.5 ml doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S000620, expiry date on 06-JUL-2020, therapy type rHA and varicella virus vaccine live (oka/merck) (VARIVAX) lot #R010469, expiry date on 10-APR-2020; both by intramuscular route, for prophylaxis and reconstituted with sterile diluent (STERILE DILUENT).   The nurse realize that both vaccines were administered on the same day until the end of the day, they had not reached out to the mother and the mother had not called to report any adverse event.  As of reporting date, it was unknown if the patient was experiencing any adverse event from receiving measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) at 12 months old.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored dose of MMR II was administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concomitant medications or drug reactions/allergies.     On 08-MAY-2019, the patient was vaccinated with one dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose and route were not reported, lot # was R027999, expiration date was 01-OCT-2020) for prophylaxis (product storage error). There was no previous temperature excursion. The highest temperature was above 9 Celsius for 3 hours and 45 minutes. No adverse effects were reported.
Age: 18.0
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: May or may not have received a second dose of Gardasil or Gardasil 9; May or may not have received a second dose of Gardasil or Gardasil 9; No adverse effect reported; This spontaneous report was received from a physician and refers to currently 22 year old patient of unknown gender.  On an unknown date, the patient was vaccinated with the first dose of either quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, frequency, route of administration, lot# and expiration date were not reported).    It was reported that the patient was 18 years old when the first dose of the vaccine was received, and a second dose may or may not have been administered in an unknown date. No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic reaction
Clinical narrative: Experienced anaphylaxis after receiving the Pneumovax23; This spontaneous report was received from a pharmacist, via a company representative, referring to a female patient of unknown age. The patient's relevant medical history, drug reactions/allergies and concomitant medication were unknown by the reporter.   In May 2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported).         On an unknown date in 2019, the patient experienced anaphylaxis and she visited the physician. It was unknown by the reporter whether the patient received treatment, or if any laboratory tests were carried out.  The outcome of anaphylactic reaction was unknown. Causality assessment was not provided.  Upon internal review, anaphylactic reaction was considered to be a medically significant event.
Sex: U
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Prolonged vaccine-acquired rotavirus infection//Vaccine strain virus identified in 9 (8 SCID, 1 IPEX); This literature report as received from the authors of published article as stated below refers to 30 infants of unknown age and gender with immunocompromising conditions (IC). Historical conditions and concomitant medications were not reported.  On an unknown dates, the patients were vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent(manufacturer unknown), orally for prophylaxis.  The authors characterize adverse events (AE) after rotavirus vaccine (RV) in infants with IC reported to the Vaccine Adverse Event Reporting System (VAERS). They search for RV reports received from February 2006 to December 2015 in infants with IC. On an unknown date, the patients experienced prolonged vaccine-acquired rotavirus infection. Diarrhea was the most common primary AE reported, others AEs included pneumonia, failure to thrive, rotavirus viremia, eczema, hemophagocytic syndrome, bronchiolitis. 27 Patients required hospitalization. Stool tested for rotavirus 19 (13 SCID, 6 non-SCID); 11 positive. Vaccine strain virus identified in 9 (8 SCID, 1 IPEX).  The outcome of rotavirus infection and vaccinia virus infection was unknown.    The reporter considered the events to be related to Rotavirus Vaccine, Live, Oral, Pentavalent(manufacturer unknown).  Upon internal review rotavirus infection and vaccinia virus infection were considered as medically significant events.     A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received a dose of VARIVAX following a temperature excursion; no adverse event; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.      On an unknown date, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX), lot # R035222  and expiration date 04-DEC-2020, subcutaneously, for prophylaxis (dosage schedule, anatomical location, were not reported) . The administered dose of the vaccine experienced a temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 29 minutes, as recorded by a data logger. There was previous temperature excursion that was 6 degrees Fahrenheit  to 14 degrees Fahrenheit (multiple excursions)  for 25 minutes. No adverse effect reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The patient developed swelling, redness and pain at injection site-inner biceps of the left arm; The patient developed swelling, redness and pain at injection site-inner biceps of the left arm; The patient developed swelling, redness and pain at injection site-inner biceps of the left arm; This spontaneous report was received form a nurse and referring to a 69-year-old female patient. The information about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or medical history provided was unknown by the reporter.  On 29-MAY-2019, the patient was vaccinated with 1 dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, intramuscularly in the left deltoid, lot # R025296, expiration date 08-JUN-2020 (strength was not reported) for prophylaxis.        On 30-MAY-2019 in the afternoon, the patient experienced swelling, redness and pain at the injection site, also reported as the inner biceps of the left arm.   On 31-MAY-2019, the patient sought for medical attention in order to report the adverse events.   The outcome of the aforementioned events was recovered at the reporting time.   Furthermore, it was unknown by the reporter if any laboratory diagnostics or studies were performed.   The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was unknown.
Sex: F
Vaccine: HPV9
Symptoms: Influenza
Clinical narrative: unspecified patient received one dose of GARDASIL 9 "2 months ago" and developed the flu on an unspecified date.; This spontaneous report was received from a pharmacist concerning a 26-year-old female patient. The patient's historical conditions, concurrent condition, and drug reactions/ allergies were not reported.  On approximately 07-APR-2019 (reported as 2 months ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, number of doses, route of administration, lot number and expiration date were not reported) for prophylaxis.         On an unknown date, the patient developed the flu (influenza).      The outcome and the causality assessment of influenza with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) were not reported.
Sex: U
Vaccine: MMR, UNK, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No adverse effects reported; The dose of VARIVAX was inadvertently administered too early; This spontaneous report was received from a pharmacist referring to a referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 23-APR-2019, the patient was vaccinated Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) diluted with sterile diluent (dose, frequency, route, lot# and expiration date not reported) for prophylaxis. On 13-MAY-2019, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot #R007688 and expiration date 14-MAR-2020) that was reconstituted with sterile diluent (lot# S002624 has been verified to be a valid lot number for sterile diluent, expiration date reported as May 2021, but upon internal validation established as 05-NOV-2021) (dose, frequency and route not reported) for prophylaxis. The reporter stated that the dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) was inadvertently administered too early (inappropriate schedule of product administration).
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: developed swelling, redness and pain at injection site - inner biceps of the left arm; developed swelling, redness and pain at injection site - inner biceps of the left arm; developed swelling, redness and pain at injection site - inner biceps of the left arm; This spontaneous report was received from a licensed practical nurse and refers to a 69 years old male patient of unknown race. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.   On 04-JUN-2019, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) 0.5 mL, intramuscular in left deltoid, lot number R025296 with expiration date on 08-JUN-2020 (frequency was not reported) for prophylaxis.   On 05-JUN-2019, the patient developed swelling, redness and pain at the injection site-inner biceps of the left arm. That was stated by the patient on 06-JUN-2019, in a visit to the office to sought medical attention for the adverse event. The patient also received treatment for the adverse event, but it was unknown if laboratory diagnostics or other studies were performed for the even. At the moment of this report the patient was recovering from swelling, redness and pain at the injection site (reported as swelling on the site was reduce).     The relatedness between the events occurrence and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) administration was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse affects reported; reported a expired dose of VAQTA was administered to patient; This spontaneous report was received from a Medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions, allergies, and concomitant therapies were not reported.     On 07-JUN-2019, the patient was vaccinated with one expired dose of hepatitis a vaccine, inactivated (VAQTA) vial 50 by intramuscular route (strength and dose and were not reported; lot # R013515 with expiration date 30-MAY-2019) for prophylaxis. No adverse effects reported.   Lot number and expiration date were reported in the source document. But, when entering the lot number in the system automatically auto-populated the correct expiration date, which sometimes may differs from the expiration date reported by the source.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Delivery, Exposure during pregnancy, Incorrect route of product administration
Clinical narrative: patient received the varivax vaccine in february 2009 while pregnant with her daughter in her first trimester; Varivax was administered via intramuscular route; patient received varivax vaccine while pregnant; This spontaneous retrospective pregnancy report was received from a currently 31-year-old adult female patient regarding herself.  The patient did not have any pertinent medical history, drug reactions or allergies, and there were no concomitant medications. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. On an unknown date, sometime in February 2009 (during first trimester of her pregnancy) the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), one shot intramuscularly in the arm for chickenpox (prophylaxis) (dose, lot # and expiry date were not reported) (maternal exposure during pregnancy, Incorrect route of product administration, Product use issue). The patient delivered a female baby. The pregnancy outcome was live birth. The product quality complaint was not involved.  This case is linked to the case 1906USA003555 (child case) (parent-child link).
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Abdominal pain upper, Ankle deformity, Foetal exposure during pregnancy, Foot deformity, Herpes simplex
Clinical narrative: patient received the varivax vaccine in february 2009 while pregnant with her daughter in her first trimester; Varivax was administered via intramuscular route; patient received varivax vaccine while pregnant; This spontaneous retrospective pregnancy report was received from a currently 31-year-old adult female patient regarding herself.  The patient did not have any pertinent medical history, drug reactions or allergies, and there were no concomitant medications. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. On an unknown date, sometime in February 2009 (during first trimester of her pregnancy) the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), one shot intramuscularly in the arm for chickenpox (prophylaxis) (dose, lot # and expiry date were not reported) (maternal exposure during pregnancy, Incorrect route of product administration, Product use issue). The patient delivered a female baby. The pregnancy outcome was live birth. The product quality complaint was not involved.  This case is linked to the case 1906USA003555 (child case) (parent-child link).
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Migraine, Weight decreased
Clinical narrative: patient received the varivax vaccine in february 2009 while pregnant with her daughter in her first trimester; Varivax was administered via intramuscular route; patient received varivax vaccine while pregnant; This spontaneous retrospective pregnancy report was received from a currently 31-year-old adult female patient regarding herself.  The patient did not have any pertinent medical history, drug reactions or allergies, and there were no concomitant medications. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. On an unknown date, sometime in February 2009 (during first trimester of her pregnancy) the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), one shot intramuscularly in the arm for chickenpox (prophylaxis) (dose, lot # and expiry date were not reported) (maternal exposure during pregnancy, Incorrect route of product administration, Product use issue). The patient delivered a female baby. The pregnancy outcome was live birth. The product quality complaint was not involved.  This case is linked to the case 1906USA003555 (child case) (parent-child link).
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Delivery, Exposure during pregnancy, Incorrect route of product administration
Clinical narrative: herpes simplex virus (HSV 1); migraines; lost a lot of weight as a result of developing blister in her mouth; ankles are turned inward and was duck footed; ankles are turned inward and was duck footed; stomach aches; Fetal exposure during pregnancy, first trimester; This spontaneous report as received from a consumer refers to a female patient of unknown age.    On FEB-2009 the patient was exposed to varicella virus vaccine live (oka/merck)(VARIVAX), transplacental.       On an unknown date the patient experienced herpes simplex, foot deformity, ankle deformity, weight decreased, foetal exposure during pregnancy, migraine and abdominal pain upper.    The outcome of herpes simplex, ankle deformity, foot deformity, abdominal pain upper, weight decreased and migraine is unknown. The outcome of foetal exposure during pregnancy was reported as recovered/resolved.     This case is linked to the case 1906USA003475 (parent case) (parent-child link).
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Abdominal pain upper, Ankle deformity, Foetal exposure during pregnancy, Foot deformity, Herpes simplex
Clinical narrative: herpes simplex virus (HSV 1); migraines; lost a lot of weight as a result of developing blister in her mouth; ankles are turned inward and was duck footed; ankles are turned inward and was duck footed; stomach aches; Fetal exposure during pregnancy, first trimester; This spontaneous report as received from a consumer refers to a female patient of unknown age.    On FEB-2009 the patient was exposed to varicella virus vaccine live (oka/merck)(VARIVAX), transplacental.       On an unknown date the patient experienced herpes simplex, foot deformity, ankle deformity, weight decreased, foetal exposure during pregnancy, migraine and abdominal pain upper.    The outcome of herpes simplex, ankle deformity, foot deformity, abdominal pain upper, weight decreased and migraine is unknown. The outcome of foetal exposure during pregnancy was reported as recovered/resolved.     This case is linked to the case 1906USA003475 (parent case) (parent-child link).
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Migraine, Weight decreased
Clinical narrative: herpes simplex virus (HSV 1); migraines; lost a lot of weight as a result of developing blister in her mouth; ankles are turned inward and was duck footed; ankles are turned inward and was duck footed; stomach aches; Fetal exposure during pregnancy, first trimester; This spontaneous report as received from a consumer refers to a female patient of unknown age.    On FEB-2009 the patient was exposed to varicella virus vaccine live (oka/merck)(VARIVAX), transplacental.       On an unknown date the patient experienced herpes simplex, foot deformity, ankle deformity, weight decreased, foetal exposure during pregnancy, migraine and abdominal pain upper.    The outcome of herpes simplex, ankle deformity, foot deformity, abdominal pain upper, weight decreased and migraine is unknown. The outcome of foetal exposure during pregnancy was reported as recovered/resolved.     This case is linked to the case 1906USA003475 (parent case) (parent-child link).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect; inadvertently administered expired dose of VAQTA; This spontaneous report as received from a other health professional refers to a patient of unknown age.    On 07-JUN-2019 patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # R012988 for prophylaxis.       On 07-JUN-2019 the patient experienced expired product administered.  On an unknown date the patient experienced no adverse event.    The outcome of expired product administered and no adverse event is unknown.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; Patient received improperly stored dose of PEDVAXHIB; This spontaneous report was received from a nurse referring to a patient of unknown age and unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided.   On 07-JUN-2019, the patient was vaccinated with a dose of improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # R027326, expiration date 10-JUL-2021, therapy type digital data logger; strength, dose and route were not reported) for prophylaxis (product storage error). The vaccine experienced temperature excursion at highest temperature above 47 Fahrenheit degrees/9 degree Celsius (46.9 Fahrenheit degrees) for 40 minutes. There was no previous temperature excursion. A data logger was involved. No adverse effects were reported.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th May 2019, the patient received the 1st dose of Shingrix. On 16th May 2019, less than a day after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: In the evening after receiving a dose of Shingrix the patient saw the first signs of what he find out 5 days later was a case of shingles. This seemed like a very unlikely series of events. The patient visited the physician. The patient inquired whether it was possible to get shingles from the Shingrix.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Skin exfoliation
Clinical narrative: Shingles; bumps; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th May 2019, the patient received the 1st dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The patient experienced slight case of shingles after the 1st Shingrix shot. The patient also experienced three bumps with circles and and area of about 1 to 2 inches scaling. None of the crazy itching.
Age: 52.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: chills; headache; This case was reported by a consumer via call center representative and described the occurrence of chills in a 52-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th May 2019, the patient received the 2nd dose of Shingrix. On 28th May 2019, 4 days after receiving Shingrix, the patient experienced chills and headache. On an unknown date, the outcome of the chills and headache were unknown.   It was unknown if the reporter considered the chills and headache to be related to Shingrix.  Additional details were provided as follows: On Friday, from the date of reporting, the patient received a dose of Shingrix. On the day of reporting, the patient experienced chills and headache and inquired whether it was normal to have chills and headache. The patient called and spoke with their pharmacist regarding to this situation. And the pharmacist replied that he felt better knowing that and inquired that whether the patient heard it from other people.
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a consumer via other manufacturer and described the occurrence of influenza-like symptoms in a 27-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra) for prophylaxis.   On an unknown date, the patient received Fluarix Tetra. On an unknown date, unknown after receiving Fluarix Tetra, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Fluarix Tetra.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu like symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Injected limb mobility decreased, Pain in extremity
Clinical narrative: arm pain; barely lift the affected arm.; unable to turn in bed; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date and did not have problems with it).   On 27th May 2019, the patient received the 2nd dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced injected limb mobility decreased and bedridden. On 27th May 2019, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, injected limb mobility decreased and bedridden were unknown.   It was unknown if the reporter considered the pain in arm, injected limb mobility decreased and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Less than a day after receiving Shingrix, the patient developed severe pain in the arm and running the length of the arm, though there was no redness or evidence of a local reaction. Consequently, the patient could barely lift the affected arm. She was unable to turn in bed, lift or move the arm.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not provided. The patient received a dose of Shingrix approximately 2 months before the date of reporting. The patient developed pain and soreness at the injection site. The reporter did not consent to follow-up. The reporter did not wish to provide any additional details or contact information