chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Rash, Scab, Skin swelling
Clinical narrative: For both vaccine 1&2, within 3 hours, I had redness, swelling and immobility of my left arm. This extreme discomfort prevented me from lying on my arm or on my side for 3- 4 days each vaccine.  Each time I also developed within 24 hours (Day 2), body aches, fatigue, loss of appetite,  fevers of 100.3 (v1) and 101.7 (v2), body chills and night sweating when fevers broke the next day Day 3)..  For vaccine 2, on Day 3 morning, after a Fever broke after  of sweats,  I noticed an itching in my back by lower neck between shoulder blades. I thought it was a mosquito bite and scratched it. As I did, I felt my skin was raised and felt that it wasn?t a one bite, but was multiple  bites that covered about an 1.5? area. Finding it difficult to see, I took a photo of my back in the reflection of the mirror. And there was quite a swollen area about 2-3? trapezoid shaped raised bumps and skin area with what looked like bug bites, plus a trail of them from one corner. I still thought it was mosquitos, but the raised red skin concerned me. I sent photo to my DR and she quickly replied that it?s a shingles rash. She said to put calamine lotion on it daily and take a Zyrtec at night. She said it?s from dead virus, so I?m not contagious, and to look for more outbreaks, which there were none. She  relieved the rash should crust over within days and  take 7-14 days to resolve. She did say I should contact the pharmacy. I did and they told me to report via  this link.  On days 4&5, no other bumps or rashes noted, no other symptoms, arm is no longer swollen and can be raised and will though issue. Bumps are now crusted  over,  area still raised.  Visible to anyone looking.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: 13 hours after receiving the Shingles/Recombiant Zoster vaccine, I developed chills, fever, headache and a temperature of 100.8 degrees. I telephoned a 24 hour pharmacy at 3:25 a.m. on 7/14, to ask if I could take an NSAID so I could get some relief of my headache. After speaking with two pharmacists, I elected to take one (1) Advil pill. My headache, chills and fever disappeared by 6:30 a.m. I continue to have a < slight > headache and took one (1) Advil at 1:00 p.m.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Dyspnoea, Hypersensitivity, Lip swelling, Ocular hyperaemia, Urticaria
Clinical narrative: ON 7-7-19 PATIENT EXPERIENCED WHELPS ON TORSO AND RIGHT ARM. PATIENT WAS TREATED AT AN URGENT CARE FOR ALLERGIC REACTION. ON 7-8-19 PATIENT EXPERIENCED WHELPS ON LEFT ARM,SWOLLEN LIPS,DIFFICULTY BREATHING AND BLOOD SHOT EYES. PATIENT WAS TREATED IN THE ER FOR ALLERGIC REATION. ON 7-8-19 MOTHER REPORTED ADVERSE REACTION AND SAID SHE WAS DOING BETTER.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Dyspnoea, Erythema, Extra dose administered, Hypersensitivity, Lip swelling
Clinical narrative: ON 7-7-19 PATIENT EXPERIENCED WHELPS ON TORSO AND RIGHT ARM. PATIENT WAS TREATED AT AN URGENT CARE FOR ALLERGIC REACTION. ON 7-8-19 PATIENT EXPERIENCED WHELPS ON LEFT ARM,SWOLLEN LIPS,DIFFICULTY BREATHING AND BLOOD SHOT EYES. PATIENT WAS TREATED IN THE ER FOR ALLERGIC REATION. ON 7-8-19 MOTHER REPORTED ADVERSE REACTION AND SAID SHE WAS DOING BETTER.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Ocular hyperaemia, Urticaria
Clinical narrative: ON 7-7-19 PATIENT EXPERIENCED WHELPS ON TORSO AND RIGHT ARM. PATIENT WAS TREATED AT AN URGENT CARE FOR ALLERGIC REACTION. ON 7-8-19 PATIENT EXPERIENCED WHELPS ON LEFT ARM,SWOLLEN LIPS,DIFFICULTY BREATHING AND BLOOD SHOT EYES. PATIENT WAS TREATED IN THE ER FOR ALLERGIC REATION. ON 7-8-19 MOTHER REPORTED ADVERSE REACTION AND SAID SHE WAS DOING BETTER.
Age: 44.0
Sex: F
Vaccine: HEP, MMR, TDAP, UNK, VARCEL
Symptoms: Erythema, Hypersensitivity, Pain, Swelling
Clinical narrative: Patient reported pain, redness, swelling.  Was seen by PA who diagnosed an allergic reaction and prescribed Hydroxyzine 10 mg and Triamcinolone 0.025% ointment. Drew line around the area and told her to return if redness spread.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Hyperhidrosis, Injection site reaction, Lethargy, Myalgia
Clinical narrative: Patient had a large sized red patchy rash around injection site after receiving the vaccine.  Came in to report to me the day after receiving.  Also stated his nose was running non-stop, he felt weak, muscles ached, and was extremely sweaty.  He stated he felt feverish.  I contacted the patient today 07/14/19 at 3:00 PM and was still feeling lethargic and still has runny nose.  The rash on his arm around the injection site is still slightly red (slightly less in color from day before )and has not gotten worse or spread.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Rash erythematous, Rhinorrhoea
Clinical narrative: Patient had a large sized red patchy rash around injection site after receiving the vaccine.  Came in to report to me the day after receiving.  Also stated his nose was running non-stop, he felt weak, muscles ached, and was extremely sweaty.  He stated he felt feverish.  I contacted the patient today 07/14/19 at 3:00 PM and was still feeling lethargic and still has runny nose.  The rash on his arm around the injection site is still slightly red (slightly less in color from day before )and has not gotten worse or spread.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Back pain, Cough, Dry throat, Fatigue
Clinical narrative: swollen glands on left side of neck, one gland hurt the others didn't. burning/aching pain sensation in both hips down legs, lower neck and lower back areas. Both eye pressure/tired feeling, head pressure/pain when coughing, throat feeling dry. Entire body rash with some raised bumps and some itch randomly. Reactions noticed eight days after injection and continuing with new reactions every few days and currently almost 14 days in on 7/15/2019. Hoping will end soon! Have gone to clinic: benadryl
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Head discomfort, Lymph node pain, Lymphadenopathy, Neck pain, Ocular discomfort
Clinical narrative: swollen glands on left side of neck, one gland hurt the others didn't. burning/aching pain sensation in both hips down legs, lower neck and lower back areas. Both eye pressure/tired feeling, head pressure/pain when coughing, throat feeling dry. Entire body rash with some raised bumps and some itch randomly. Reactions noticed eight days after injection and continuing with new reactions every few days and currently almost 14 days in on 7/15/2019. Hoping will end soon! Have gone to clinic: benadryl
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Pain in extremity, Rash generalised, Rash pruritic
Clinical narrative: swollen glands on left side of neck, one gland hurt the others didn't. burning/aching pain sensation in both hips down legs, lower neck and lower back areas. Both eye pressure/tired feeling, head pressure/pain when coughing, throat feeling dry. Entire body rash with some raised bumps and some itch randomly. Reactions noticed eight days after injection and continuing with new reactions every few days and currently almost 14 days in on 7/15/2019. Hoping will end soon! Have gone to clinic: benadryl
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Computerised tomogram, Dizziness, Nausea, Rash, Rash erythematous
Clinical narrative: patient felt dizzy and nauseated. when for cat scan and had projectal vomiting.  9 days later arm still has a red rash and warm to touch.  she is going  to see md this week.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm, Vomiting projectile
Clinical narrative: patient felt dizzy and nauseated. when for cat scan and had projectal vomiting.  9 days later arm still has a red rash and warm to touch.  she is going  to see md this week.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Redness, Swelling, fever
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling below injection site
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Computerised tomogram head, Headache, Lumbar puncture
Clinical narrative: Severe headache, chills and lower back muscle pain began 2 AM after shot at 2 PM afternoon prior.  Emergency room visit after severe headache for 12 hours.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Malaise, Pain
Clinical narrative: Patient experienced malaise, achiness, and had a rash around the injection site extending down to her elbow.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash
Clinical narrative: Patient went to the Urgent Care two days  after receiving the Shingrix vaccine with shingles like symptoms.  She was diagnosed with shingles presenting with a painful, burning rash.  She was given rx for Valtrex 500mg
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The following day most of patient's left leg puffed up noticeably and much of the left thigh was red, the area of the injection was also very warm.  No treatment was given as he didn?t seem to be in any discomfort.  The issues resolved themselves in approximately one week.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Injection site bruising, Injection site reaction, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: extreme swelling at injection site, hot skin for a week.  Nausea, intestinal distress for 7 days.  Still have a baseball size 'bruise' at the injection site with stiffness at the needle mark.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Skin warm
Clinical narrative: extreme swelling at injection site, hot skin for a week.  Nausea, intestinal distress for 7 days.  Still have a baseball size 'bruise' at the injection site with stiffness at the needle mark.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: I developed a rash/hives on the right side of my stomach, about belt-line.
Age: 66.0
Sex: M
Vaccine: PPV, TD
Symptoms: Asthenia, Chills, Headache, Injection site pain, Insomnia
Clinical narrative: Although I thought the left arm (Td vaccine) might get sore, by 10:30 PM, the right upper arm was getting very sore,; by 11:30 (when I went to bed), I was shaking with sever chills, which last for next 2+ hours.  Got little sleep all night. My arm was so tender (& slightly swollen) I couldn't lay on it. No fever, but the next day I still felt groggy, with a headache & weak all day, napping for hours. Only today do I feel much better (although arm is still tender).
Age: 66.0
Sex: M
Vaccine: PPV, TD
Symptoms: Peripheral swelling, Somnolence, Tenderness, Tremor, White blood cell count abnormal
Clinical narrative: Although I thought the left arm (Td vaccine) might get sore, by 10:30 PM, the right upper arm was getting very sore,; by 11:30 (when I went to bed), I was shaking with sever chills, which last for next 2+ hours.  Got little sleep all night. My arm was so tender (& slightly swollen) I couldn't lay on it. No fever, but the next day I still felt groggy, with a headache & weak all day, napping for hours. Only today do I feel much better (although arm is still tender).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Headache; nausea; abdominal pain; fever; body ache; swelling, redness, fever, pain at injection site
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Headache; nausea; abdominal pain; fever; body ache; swelling, redness, fever, pain at injection site
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Limb discomfort, Weight bearing difficulty
Clinical narrative: initially: sharp pain at injection site for several weeks. transitioning to more general ache over larger area of left arm.  currently: ache in upper arm near injection site, inability to put weight on shoulder for more than a few minutes due to increasing pain, occasional discomfort (perhaps numbness) extending to lower arm and wrist.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Electroencephalogram abnormal, Epilepsy, Generalised tonic-clonic seizure, Petit mal epilepsy
Clinical narrative: Started with absent seizures within one week of shots.  Then 4/16/19 first Grand Mal, resulting in Epilepsy diagnosis.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: Strong Flu type symptoms, sweating, headache, stomach pain.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: Redness and pain at injection site.  Fever, chills, fatigue , muscle aches
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Redness and pain at injection site.  Fever, chills, fatigue , muscle aches
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness swelling pain at injection site.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Bronchitis, Conjunctivitis, Deafness, Neuralgia, Oropharyngeal pain
Clinical narrative: Patient experienced viral like symptoms beginning 5 days after immunization. They included: bronchitis, conjuctivitis, and temporary hearing loss which resolved. He continues to have a sore throat and nerve pain in his neck. He is currently taking prednisone (Taper) and thinks he is improving.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Viral infection
Clinical narrative: Patient experienced viral like symptoms beginning 5 days after immunization. They included: bronchitis, conjuctivitis, and temporary hearing loss which resolved. He continues to have a sore throat and nerve pain in his neck. He is currently taking prednisone (Taper) and thinks he is improving.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antinuclear antibody, Arthralgia, Blood creatinine, Blood thyroid stimulating hormone, Differential white blood cell count
Clinical narrative: Severe pain in all joints especially back & could not stand up straight, severe fatigue, blurred vision. - Was told to take Ibuprofen which helps -after 3 months still sleeping about 10 hrs & was sleeping 6  - nap most days.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Full blood count, Metabolic function test, Mobility decreased, Pain
Clinical narrative: Severe pain in all joints especially back & could not stand up straight, severe fatigue, blurred vision. - Was told to take Ibuprofen which helps -after 3 months still sleeping about 10 hrs & was sleeping 6  - nap most days.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: Severe pain in all joints especially back & could not stand up straight, severe fatigue, blurred vision. - Was told to take Ibuprofen which helps -after 3 months still sleeping about 10 hrs & was sleeping 6  - nap most days.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Dysstasia, Fatigue, Hypersomnia, Laboratory test
Clinical narrative: Severe pain in all joints especially back & could not stand up straight, severe fatigue, blurred vision. - Was told to take Ibuprofen which helps -after 3 months still sleeping about 10 hrs & was sleeping 6  - nap most days.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vision blurred
Clinical narrative: Severe pain in all joints especially back & could not stand up straight, severe fatigue, blurred vision. - Was told to take Ibuprofen which helps -after 3 months still sleeping about 10 hrs & was sleeping 6  - nap most days.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain, Injection site discolouration, Loss of personal independence in daily activities, Mobility decreased, Musculoskeletal pain
Clinical narrative: Pharmaceutical product complaint; bad reaction; out of commission; immobilized; This case was reported by a consumer via other manufacturer and described the occurrence of adverse reaction in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis (diagnosed about 16 to 17 years before, from the date of reporting), fibromyalgia (diagnosed before rheumatoid arthritis) and ankylosing spondylitis (diagnosed within the last 4 years, from the date of reporting).   On 8th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 8th June 2019, less than a day after receiving Shingrix, the patient experienced adverse reaction, inability to work and mobility decreased. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the adverse reaction, inability to work and mobility decreased were recovered/resolved and the outcome of the pharmaceutical product complaint was unknown.   It was unknown if the reporter considered the adverse reaction, inability to work and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and was totally out of commission for 15 days and was immobilized. The patient was unable to provide the NDC, lot or expiry for the vaccine or confirm the manufacturer or dose provided. The patient did not received any treatments after the vaccination. There was also product complaint reported and the patient had really a bad reaction. The reporter consented for follow-up.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia, Tenderness
Clinical narrative: Pharmaceutical product complaint; bad reaction; out of commission; immobilized; This case was reported by a consumer via other manufacturer and described the occurrence of adverse reaction in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis (diagnosed about 16 to 17 years before, from the date of reporting), fibromyalgia (diagnosed before rheumatoid arthritis) and ankylosing spondylitis (diagnosed within the last 4 years, from the date of reporting).   On 8th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 8th June 2019, less than a day after receiving Shingrix, the patient experienced adverse reaction, inability to work and mobility decreased. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the adverse reaction, inability to work and mobility decreased were recovered/resolved and the outcome of the pharmaceutical product complaint was unknown.   It was unknown if the reporter considered the adverse reaction, inability to work and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and was totally out of commission for 15 days and was immobilized. The patient was unable to provide the NDC, lot or expiry for the vaccine or confirm the manufacturer or dose provided. The patient did not received any treatments after the vaccination. There was also product complaint reported and the patient had really a bad reaction. The reporter consented for follow-up.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse reaction, Impaired work ability, Mobility decreased, Product complaint
Clinical narrative: Pharmaceutical product complaint; bad reaction; out of commission; immobilized; This case was reported by a consumer via other manufacturer and described the occurrence of adverse reaction in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis (diagnosed about 16 to 17 years before, from the date of reporting), fibromyalgia (diagnosed before rheumatoid arthritis) and ankylosing spondylitis (diagnosed within the last 4 years, from the date of reporting).   On 8th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 8th June 2019, less than a day after receiving Shingrix, the patient experienced adverse reaction, inability to work and mobility decreased. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the adverse reaction, inability to work and mobility decreased were recovered/resolved and the outcome of the pharmaceutical product complaint was unknown.   It was unknown if the reporter considered the adverse reaction, inability to work and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and was totally out of commission for 15 days and was immobilized. The patient was unable to provide the NDC, lot or expiry for the vaccine or confirm the manufacturer or dose provided. The patient did not received any treatments after the vaccination. There was also product complaint reported and the patient had really a bad reaction. The reporter consented for follow-up.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Dyspnoea, Hypersensitivity, Lip swelling, Ocular hyperaemia, Urticaria
Clinical narrative: severe allergic reaction; lips were swollen; difficulty breathing; eyes bloodshot; received her second dose of Menactra; woke up with red, raised areas, welts on her torso and under her right arm and woke up with welts on her left arm; Initial information received on 08-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 18 years old female patient who experienced eyes bloodshot and severe allergic reaction, while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no other vaccines   On 05-Jul-2019, the patient received a second dose of .5 ml  MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6365AA via intramuscular route in the arm nos. The patient had received first dose of same vaccine (dosing details not reported)  On an unknown date, (latency unknown) after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, the patient developed a non-serious severe allergic reaction (hypersensitivity). On 07-Jul-2019, two days after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, the patient developed a non-serious red, raised areas, welts on her torso and under her right arm  and then welts on her left arm (urticaria). On an unknown date, (unknown latency) after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, the patient developed a non-serious eyes bloodshot (ocular hyperaemia), lips were swollen (lip swelling), difficulty breathing (dyspnoea).  The was a case of actual medication error due to extra dose administered (as the subject received two doses of Menactra).  Lab data was not reported.  Final diagnosis was red, raised areas, welts on her torso and under her right arm, extra dose, welts on her left arm, difficulty breathing, severe allergic reaction, lips were swollen and eyes bloodshot.   The patient went to the ER for treatment. The patient was given medications (unspecified)  The events were resolving at the time of reporting as she was doing better now.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by the sender: None.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Dyspnoea, Erythema, Extra dose administered, Hypersensitivity, Lip swelling
Clinical narrative: severe allergic reaction; lips were swollen; difficulty breathing; eyes bloodshot; received her second dose of Menactra; woke up with red, raised areas, welts on her torso and under her right arm and woke up with welts on her left arm; Initial information received on 08-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 18 years old female patient who experienced eyes bloodshot and severe allergic reaction, while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no other vaccines   On 05-Jul-2019, the patient received a second dose of .5 ml  MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6365AA via intramuscular route in the arm nos. The patient had received first dose of same vaccine (dosing details not reported)  On an unknown date, (latency unknown) after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, the patient developed a non-serious severe allergic reaction (hypersensitivity). On 07-Jul-2019, two days after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, the patient developed a non-serious red, raised areas, welts on her torso and under her right arm  and then welts on her left arm (urticaria). On an unknown date, (unknown latency) after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, the patient developed a non-serious eyes bloodshot (ocular hyperaemia), lips were swollen (lip swelling), difficulty breathing (dyspnoea).  The was a case of actual medication error due to extra dose administered (as the subject received two doses of Menactra).  Lab data was not reported.  Final diagnosis was red, raised areas, welts on her torso and under her right arm, extra dose, welts on her left arm, difficulty breathing, severe allergic reaction, lips were swollen and eyes bloodshot.   The patient went to the ER for treatment. The patient was given medications (unspecified)  The events were resolving at the time of reporting as she was doing better now.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by the sender: None.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Ocular hyperaemia, Urticaria
Clinical narrative: severe allergic reaction; lips were swollen; difficulty breathing; eyes bloodshot; received her second dose of Menactra; woke up with red, raised areas, welts on her torso and under her right arm and woke up with welts on her left arm; Initial information received on 08-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 18 years old female patient who experienced eyes bloodshot and severe allergic reaction, while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no other vaccines   On 05-Jul-2019, the patient received a second dose of .5 ml  MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6365AA via intramuscular route in the arm nos. The patient had received first dose of same vaccine (dosing details not reported)  On an unknown date, (latency unknown) after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, the patient developed a non-serious severe allergic reaction (hypersensitivity). On 07-Jul-2019, two days after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, the patient developed a non-serious red, raised areas, welts on her torso and under her right arm  and then welts on her left arm (urticaria). On an unknown date, (unknown latency) after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, the patient developed a non-serious eyes bloodshot (ocular hyperaemia), lips were swollen (lip swelling), difficulty breathing (dyspnoea).  The was a case of actual medication error due to extra dose administered (as the subject received two doses of Menactra).  Lab data was not reported.  Final diagnosis was red, raised areas, welts on her torso and under her right arm, extra dose, welts on her left arm, difficulty breathing, severe allergic reaction, lips were swollen and eyes bloodshot.   The patient went to the ER for treatment. The patient was given medications (unspecified)  The events were resolving at the time of reporting as she was doing better now.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by the sender: None.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Myalgia, Pain in extremity
Clinical narrative: Severe pain left deltoid, which eventually radiated down into arm and into left upper back
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Chills, Dizziness, Headache, Presyncope
Clinical narrative: Headache began the evening of trhe day of vaccine, Followed the next day by fever up to 101.7 degrees F and chills. Had Presycopal episode got weak and collapsed. Called 911 but improved and not taken to ER. On the next day ( 2 days after vaccine) still weak and woozy.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia, Syncope
Clinical narrative: Headache began the evening of trhe day of vaccine, Followed the next day by fever up to 101.7 degrees F and chills. Had Presycopal episode got weak and collapsed. Called 911 but improved and not taken to ER. On the next day ( 2 days after vaccine) still weak and woozy.
Age: 41.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Gave pediatric dose to an adult .
Age: 41.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: given a pediatric dose of Hep A. No adverse effects.
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: She was given a pediatric dose of Hep A. No adverse effects.
Age: 35.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Patient was given a pediatric dose of Hep A.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No adverse effects reported; patient was administered MMR II after it was reconstituted for more than 72 hour; Information has been received from a HBP referring to a patient of unknown age and gerder. The patient's concomitant medications, pertinent medical history and drug/allergies reactions were not provided.  On 17-JUN-2019, the patient was administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot number R030806, expiration date 24-OCY-2020; strength and route of administration were not reported) for prophylaxis after it was reconstituted for more than 72 hours (wrong technique in product usage process). No adverse effects were reported. The patient did not seek medical attention. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  In February 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a certified physician assistant for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 21-NOV-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a certified physician assistant for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 74 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effect reported; patient was inadvertently administered M-M-R II intramuscularly; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history or drug/ allergies reactions were not provided.   On 21-JUN-2019, the patient was inadvertently administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Lot number N027779, expiration date 08-AUG-2019; formulation and dose were not reported) intramuscularly for prophylaxis (incorrect route of product administration) and sterile diluent (DILUENT MRK INJ) (Lot number N006324, expiration date 24-JUL-2019;. No adverse effect reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was administered an improperly stored VARIVAX; Information has been received from an office manager who was in charge of vaccine storage, referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug/allergies reactions were not provided.  On 25-JUN-2019 the patient was administered an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number S000132, expiration date 02-JAN-2021; strength, dose number and route were not reported) for prophylaxis (product storage error). No adverse effects.   Temperature and Time frame: 6 degrees Fahrenheit to 14 degree Fahrenheit (8.2 F) for 1 hour and 25 minutes; 15 degrees Fahrenheit to 46 degrees Fahrenheit (16 F) for 5 minutes. No data logger.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product container seal issue, Product storage error
Clinical narrative: manufacturer-filled syringe on which the seal was broken and a needle attached 2 days prior was administered to patient; manufacturer-filled syringe on which the seal was broken and a needle attached 2 days prior was administered to patient; No adverse effects was reported; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication, drug reactions/allergies and medical history was not provided.  The reporter reported hepatitis a vaccine, inactivated (VAQTA) (lot# R034340, expiration date was 23-NOV-2019, indication: prophylaxis; strength, dose and route were not reported) manufacturer-filled syringe on which the seal was broken (Product container seal issue) and a needle attached 2 days prior was administered to patient on an unknown date (reported as 23-NOV-2019, which is a future date and did not being captured) (Product storage error). No adverse effects was reported.   The outcome of the product container seal issue was unknown. The causality between the product container seal issue and hepatitis a vaccine, inactivated (VAQTA) was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patient was admnistered improperly stored doses of PROQUAD; Information has been received from a nurse referring to a 5 years old patient of unknown gender.There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided.   On 21-MAR-2019, the patient were vaccinated with improperly stored stored doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot number R020676, expiration date 15-JAN-2020 (dose and route of administration were not reported). The sterile diluent, lot number S003325, expiration date 03-NOV-2019, was properly stored. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 6 to 14 (10.4) Fahrenheit for 18 minutes. Data logger was involved. There were no previous excursions reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA001029:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; one dose of improperly stored PROQUAD (S002926 7/28/2020) was administered to one patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information of pertinent medical history and drug reactions/allergies was not reported. Concomitant therapies included sterile diluent, which was stored properly.  On 01-JUL-2019, the patient was vaccinated with one dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)(lot # S002926,  expiration date: 28-JUL-2020, therapy type: rHA, strength and frequency were unknown) subcutaneously for prophylaxis (Incorrect product storage). No adverse effects were reported.   The stored temperature was -14 to -10 degree Celsius (-12.98 degree Celsius). The time frame was 4 hours and 30 minutes. There was no previous temperature excursion. The temperature excursion was detected by a data logger.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: on 30-MAR-2017 at age of 12 years, patient received GARDASIL 9/the patient received the second dose in the HPV vaccination series, GARDASIL 9, on 02-JUL-2019.; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, previous drug reactions, allergies and concomitant medications were not provided.  It was reported that on 30-MAR-2017, at age of 12-years-old, a patient was vaccinated with first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dosage schedule and route of administration were not provided). Subsequently, on 02-JUL-2019, the patient received the second dose in the Human Papilloma Virus (HPV) vaccination series, HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration).  Lot number R032766 has been verified to be a valid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), expiration date reported as 03-AUG-2021 but upon internal validation established as 31-AUG-2021.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: herpes zoster; post-herpetic neuralgia; This spontaneous report was received from a lawyer regarding a case in litigation and referring to a currently 83 years old male patient. No information regarding medical history, concurrent conditions, or concomitant medications was provided.  On or about 16-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.  On unspecified dates, the patient experienced herpes zoster and post herpetic neuralgia respectively. On unspecified dates, the patient was treated by physicians for herpes zoster and post herpetic neuralgia. The outcome of herpes zoster and post herpetic neuralgia was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation and referring to a currently 78 years old female patient. No information regarding medical history, concurrent conditions, or concomitant medications was provided.  On or about 08-FEB-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced herpes zoster. On an unknown date, the patient was treated by physician for herpes zoster. The outcome of herpes zoster was not reported.  The reporter considered the herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).     Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Meningitis viral, Occipital neuralgia
Clinical narrative: herpes zoster; This initial spontaneous report has been received from a lawyer regarding a case in litigation and refers to a currently 65 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or around 20-OCT-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for occipital neuralgia and varicella meningitis. The outcome of the events occipital neuralgia and varicella meningitis was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 59 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 01-MAR-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 49 year old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date in 2017, the patient was prescribed and vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not provided) for long term prevention of shingles and zoster-related conditions by a healthcare provider. On an unknown date, the patient was treated by a healthcare provider from the following injuries resulting from use of with zoster vaccine live (ZOSTAVAX): shingles. The outcome of shinlges was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 27.0
Sex: F
Vaccine: MMR, UNK
Symptoms: Dysphagia, Lymphadenopathy, Upper-airway cough syndrome
Clinical narrative: swollen glands with difficulty swallowing and post nasal drip; swollen glands with difficulty swallowing and post nasal drip; swollen glands with difficulty swallowing and post nasal drip; This spontaneous report was received from a pharmacy technician who then put the pharmacist on the phone, the pharmacist refers to a 27 year old female patient with attention deficit hyperactivity disorder (ADHD) for which she was under an unspecified medication. No information was provided regarding the patient's medical history, previous drug reactions or allergies.  On 21-JUN-2019 (reported as "two weeks ago"), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R031629 with expiration date on 01-NOV-2020, subcutaneously in the right arm for prophylaxis (strength, dose and frequency were not reported). Other suspect therapies included sterile diluent (MERCK STERILE DILUENT) subcutaneously in the right arm for an unknown indication (strength, dose, frequency, lot number and expiration date were not reported).    On 28-JUN-2019 (reported as "one week ago"), the patient called the pharmacist with symptoms of swollen glands (lymphadenopathy) with difficulty swallowing (dysphagia) and post nasal drip (upper-airway cough syndrome). No treatment was provided for the events.   At the reporting time, the patient had not recovered from her upper-airway cough syndrome, lymphadenopathy and dysphagia.  The reporter did not assess the causal relationship between therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and sterile diluent (MERCK STERILE DILUENT) and the aforementioned events, however, the patient wanted to know if this was related to receiving the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and/or because she was on an unspecified ADHD medication.