chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: On 11/29/12 I was cold most of the day, the morning of 11/130/12 when I woke up I noticed what I thought might be bug bits on my right side torso under my breast and going around to my back on right side. I took Benadryl to see if it would go away but it didn't. I decided to go to the Dr. 12/4/12 and was told I have shingles and was put on Valacyclovir for 7 days.
Age: 9.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Haemorrhage, Infection, Pruritus, Scar
Clinical narrative: The scar seems to be infected.  Started out same size of original scar, but through the years has grown to about 3" x 4".  Keep bandaged to prevent bleeding on shirt. Itches. Reported to several doctors, but none would address the issue.
Age: 9.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Scar, Skin infection
Clinical narrative: The scar seems to be infected.  Started out same size of original scar, but through the years has grown to about 3" x 4".  Keep bandaged to prevent bleeding on shirt. Itches. Reported to several doctors, but none would address the issue.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Musculoskeletal stiffness
Clinical narrative: Lower back ache pain and stiffness.
Age: 67.0
Sex: F
Vaccine: MEA
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Soreness redness at site.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Feeling hot, Headache, Memory impairment, Nausea
Clinical narrative: Dizzy, heat radiating, nausea, memory & speech problems, tingling, headache. This lasted till after 8PM 12/05/2012. Went to hospital and got a shot of Benadryl & a steroid shot.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia, Speech disorder
Clinical narrative: Dizzy, heat radiating, nausea, memory & speech problems, tingling, headache. This lasted till after 8PM 12/05/2012. Went to hospital and got a shot of Benadryl & a steroid shot.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Pain, Tenderness
Clinical narrative: Redness, tenderness, firmness, pain.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Rash on chest and neck.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: PATIENT HAD ITCHINESS IN SCALP AND A RASH IN AREAS. CAME INTO THE PHARMACY ON THURSDAY 12/6. SHE WENT TO THE PHYSICIAN ON 12/7 AND WAS DIAGNOSED WITH SHINGLES AND PRESCRIBED VALACYCLOVIR.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Intense itching, redness 1-2cm surrounding injection site, pain at site.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Acute onset of intense itching, erythema and pain surrounding injection site.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Emotional distress, Irritability, Pyrexia
Clinical narrative: Fever, extreme irritability, unconsolable for 6 hours.
Age: 43.0
Sex: M
Vaccine: DTAP
Symptoms: Chills, Hyperhidrosis, Injection site pain, Nausea, Pyrexia
Clinical narrative: Approx 8 hours after receiving injection, had onset of high fever, complete body sweating, nausea, violent chills and uncontrolled shakes lasting approx 3 hours.  Had pain in injection site for next 3 weeks.
Age: 43.0
Sex: M
Vaccine: DTAP
Symptoms: Tremor
Clinical narrative: Approx 8 hours after receiving injection, had onset of high fever, complete body sweating, nausea, violent chills and uncontrolled shakes lasting approx 3 hours.  Had pain in injection site for next 3 weeks.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Hyperaesthesia, Limb discomfort, Pain in extremity, Skin warm
Clinical narrative: Significant pain in arm and under area of injection. Continuous pain that interferes with daily activities and sleep. Feels like a bee sting. Arm feels swollen. Arm is warm with increased pain to touch. Pain has continued for more than 12 hours.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder
Clinical narrative: Significant pain in arm and under area of injection. Continuous pain that interferes with daily activities and sleep. Feels like a bee sting. Arm feels swollen. Arm is warm with increased pain to touch. Pain has continued for more than 12 hours.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: Patient returned to Immunization clinic after going to the lab complaining of fore arm redness, pain, and itching in the same arm a TDap was given. The arm was inspected, no swelling was noted but it appeared slightly more red than the unaffected arm. She stated it was slightly itchy, and somewhat painful. The site of the injection had no symptoms. I contacted my officer in charge, a physician, and he stated it did not sound like an adverse event but to continue with a VAERS report. I noitified the patient of these procedures and instructed her to return if she felt any difficulty breathing, if she noticed the pain/redness spreading, or felt itching anywhere else in her body. The patient verbalized her understanding of these instructions.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Acute onset of intense itching and erythma (area 2cm surrounding injection site) with pain onset 5 minutes after injection.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injection site anaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Sore arm at injection site on left arm. Tingling and numbest to left fingers. Then, up to left shoulder. Went to urgent care as require by hosptial on 11/7/2012 to be elevated of condition.
Age: 7.0
Sex: F
Vaccine: YF
Symptoms: Abdominal discomfort, Fatigue, Hallucinations, mixed, Nightmare, Pyrexia
Clinical narrative: Fever 100.1, tired, GI upset, significant nightmares. Recurrent nightmares 11/30/12. On 12/6/12 mother contacted our office to report above and additionally child called from school reporting "hearing voices" and seeing visions from her nightmares.
Age: 57.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Feeling hot, Muscular weakness, Nausea, Pain in extremity, Sensation of heaviness
Clinical narrative: Received both flu and Tdap into the Left upper arm at patient request. Next day he felt wrm and nausea. Lasted for two days. Still has soreness and arm feels weak, heavy and achy. No redness or swelling. Has not been to a doctor. Taking Aleve for a few days with ice and heat.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Pain at the injection site in muscle that radiates down the arm just above the elbow. Hurts when I raise my arm.
Age: 18.0
Sex: M
Vaccine: ADEN_4_7, FLUN3, HEPAB, MNQ, TDAP
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: Patient developed 2009 H1N1 several weeks after being vaccinated with FLUMIST. Confirmed by Lab test.
Age: 21.0
Sex: M
Vaccine: ADEN_4_7, FLUN3, HEPAB, MNQ, TDAP
Symptoms: Blood immunoglobulin G increased, Influenza, Influenza A virus test positive, Mycoplasma test positive
Clinical narrative: Patient developed 2009 H1N1 post immunization with FLUMIST.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Arms were sore and swollen by the time he got home from vaccinations.  Both arms were involved.  Swelling continued and mom sought medical treatment on 11/16/2012 from primary doctor.  Reports both arms were swollen and red from shoulder to elbows.  Was given oral predisone and completely resolved.
Age: 18.0
Sex: M
Vaccine: ADEN_4_7, FLUN3, HEPAB, MNQ, TDAP
Symptoms: Influenza A virus test positive, Influenza like illness
Clinical narrative: Patient presented with ILI symptoms and tested positive for 2009 H1N1 post immunization with FLUMIST.
Age: 67.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Patient states that he had swelling at injection site, fever, chills, fatigue, joint pain, headache and dizziness.
Age: 67.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Patient states that he had swelling at injection site, fever, chills, fatigue, joint pain, headache and dizziness.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site urticaria
Clinical narrative: WELT AT INJECTION SITE, WIDTH OF A LEMON (2 1/2 BY 1 INCH).
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Conjunctivitis, Cough, Fatigue, Malaise, Nausea
Clinical narrative: Extreme fatigue, malaise, nausea as well as minor sinus congestion starting at 7:45pm. Symptoms got progressively worse through the evening and night. Woke up on 11/20/2012, with sore throat, significant sinus congestion, conjuctivitis and mild cough, as well as continued malaise, fatigue and mild nausea. Symptoms began to slowly improve on 11/21/2012, with largely complete resolution by 11/22/2012.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Sinus congestion
Clinical narrative: Extreme fatigue, malaise, nausea as well as minor sinus congestion starting at 7:45pm. Symptoms got progressively worse through the evening and night. Woke up on 11/20/2012, with sore throat, significant sinus congestion, conjuctivitis and mild cough, as well as continued malaise, fatigue and mild nausea. Symptoms began to slowly improve on 11/21/2012, with largely complete resolution by 11/22/2012.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bacterial infection, Injection site erythema
Clinical narrative: Went to doctor on Nov 1 to get a pneumonia shot from her doctor and doctor saw that her arm was red running down to her elbow from the flu shot. Said she had a bacterial infection from the shot. Started on antibiotics.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Fatigue, Glossodynia, Headache, Influenza like illness
Clinical narrative: Extreme thirst and dry tongue on 11/22/2012. Sore throat on 11/26/12. Flu-like symptoms on 11/29/12 including fatigue, headache, body aches, fever (102 degrees), night sweats, coughing, and congestion.  Also developed a very sore tongue and a thick, white coating on my tongue that will not go away after brushing my tongue.  All flu-like symptoms were gone by 12/5/2012, but white coating on tongue still remains as of today 12/07/12.  The white coating on my tongue is the symptom which is most concerning to me.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Night sweats, Pain, Pyrexia, Respiratory tract congestion, Thirst
Clinical narrative: Extreme thirst and dry tongue on 11/22/2012. Sore throat on 11/26/12. Flu-like symptoms on 11/29/12 including fatigue, headache, body aches, fever (102 degrees), night sweats, coughing, and congestion.  Also developed a very sore tongue and a thick, white coating on my tongue that will not go away after brushing my tongue.  All flu-like symptoms were gone by 12/5/2012, but white coating on tongue still remains as of today 12/07/12.  The white coating on my tongue is the symptom which is most concerning to me.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Tongue coated, Tongue disorder, Tongue dry
Clinical narrative: Extreme thirst and dry tongue on 11/22/2012. Sore throat on 11/26/12. Flu-like symptoms on 11/29/12 including fatigue, headache, body aches, fever (102 degrees), night sweats, coughing, and congestion.  Also developed a very sore tongue and a thick, white coating on my tongue that will not go away after brushing my tongue.  All flu-like symptoms were gone by 12/5/2012, but white coating on tongue still remains as of today 12/07/12.  The white coating on my tongue is the symptom which is most concerning to me.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Patient received Gardasil while on Bactrim Ds on Dec fifth. On Dec. 6 at approx. 6 pm developed a sudden rash covering his entire trunk and extremities. He has a history of allergy to Cipro with similar reaction to the Cipro.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Burning sensation, Pain, Rash
Clinical narrative: Patient got burning painful rash, went to ER and was told she was having an anaphylaxis reaction.
Age: 14.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Paraesthesia, Swelling
Clinical narrative: Softball-size swelling; tingly hand.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Diplegia, Dyspnoea, Hypoaesthesia, Muscular weakness, Neck pain
Clinical narrative: Numbness and partial paralysis in both arms, severe pain in left arm and neck, muscle weakness in both legs, difficulty catching breath.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Numbness and partial paralysis in both arms, severe pain in left arm and neck, muscle weakness in both legs, difficulty catching breath.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: HOT, RED AREA AT THE INJECTION SITE SPREADING TO THE BACK OF THE ARM DOWN TOWARD THE ELBOW AND ALMOST TO THE SHOULDER BLADE..ABOUT THE SIZE AND LENGTH OF HER HAND.
Age: 51.0
Sex: F
Vaccine: DTAP
Symptoms: Hypoaesthesia
Clinical narrative: Vaccinated arm went numb and I lost control of it for several hours post vaccination.
Age: 1.06
Sex: F
Vaccine: MMR
Symptoms: Blindness, Death, Immune system disorder, Pyrexia, Surgery
Clinical narrative: This spontaneous report was received from the patient's brother refers to a 13 months old female patient with no pertinent Medical History or Drug reactions/allergies who on unspecified date in approximately November 1994 (when the patient was 13 months of age) was vaccinated with MMR II (dose, lot number and route no reported). No other co-suspects were reported. No concomitant medications were reported. The night the patient received the vaccine, the patient developed a high fever (107-108 F) and was sent to an unspecified hospital where she was admitted and treated for an unspecified period of time. On unknown date, the patient had multiple unspecified surgeries, became blind and her "immune system failed." The patient was two years of age when she died (approximately in 1995). The outcome of the events patient developed a high fever (107-108 F), became blind and her "immune system failed" was unknown. The relatedness for the event and MMR II was unknown. Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Convulsion, Excessive eye blinking, Gait disturbance, Grand mal convulsion
Clinical narrative: Seizure activity described as "rapid eye blinking and dragging her right foot" was seen approx 3 hours post administration of Tdap. Family stated she had generalized tonic-clonic seizures with previous (>10 yrs ago) administration of DPT.
Age: 60.0
Sex: F
Vaccine: DTP, FLU3, PPV
Symptoms: Chills, Erythema, Headache, Oedema peripheral, Pain
Clinical narrative: PM - severe headache/pressure, chills, body aches. Fever spiked 101.6 next day severe head pressure, chills/body ache fever. Went to drs - fever 101.6 - Lt arm raised and redness developed - slight itch - bright red - (took pictures). Headaches continued - fever subsided along w/chills & aches after - 4 days - mostly severe head pressure & pain for 4 days. 1st time for Pneumonia shot & whooping cough. Tetanus injection was already given within the last 10 yrs.
Age: 60.0
Sex: F
Vaccine: DTP, FLU3, PPV
Symptoms: Pruritus, Pyrexia
Clinical narrative: PM - severe headache/pressure, chills, body aches. Fever spiked 101.6 next day severe head pressure, chills/body ache fever. Went to drs - fever 101.6 - Lt arm raised and redness developed - slight itch - bright red - (took pictures). Headaches continued - fever subsided along w/chills & aches after - 4 days - mostly severe head pressure & pain for 4 days. 1st time for Pneumonia shot & whooping cough. Tetanus injection was already given within the last 10 yrs.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 85.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Skin exfoliation
Clinical narrative: Patient received pneumonia from us on 11/29/12. He received the PNEUMOVAX in his right deltoid. As of today 12/1/12 his arm looked very swollen and some of his skin looked like it was peeling. He was evaluated by a physician and then prescribed some cefadroxil and SILVADENE cream.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Left upper arm started to get warm, red, and tender just below injection site. Pt given KEFLEX and BENADRYL.
Age: 36.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: Fever x 2 days cold symptoms x 2 days. No treatment.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Ache in upper arm when raised above shoulder level. This started a week after flu shot. No other symptoms. Continues to date.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Bronchitis
Clinical narrative: Bronchitis acute Emergency Dept 10/27/12.
Age: 74.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Pruritus, Pyrexia, Swelling
Clinical narrative: Patient received her ZOSTAVAX and FLUVIRIN immunizations around 12 pm 11/26/12. That evening at 4-5 pm, the arm that had ZOSTAVAX started to turn red and started to itch. She also had a fever of 99 degrees. Swelling and redness continued until 11/30/12 and then subsided.
Age: 12.0
Sex: F
Vaccine: FLUN3, HEP, IPV, MMR, TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Client received 5 vaccines. Immediately follow injection of last vaccine client passed out & started to slide from chair to floor. Slide client to floor when she regained consciousness B/P taken 122/82. Move client to exam table & 1st moving her to wheelchair. Placed in supine position after several minutes client felt better allowed to sit B/P 122/82 color good. Client stated she felt better allowed to leave with mother.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Swollen tongue, Throat irritation
Clinical narrative: After flu vaccination: throat itching, tongue swelling, lip swelling.
Age: 39.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Local swelling, Pain
Clinical narrative: Pt reported acute flu like sx 1D after rcvg flu vaccine. Same thing happened after rcvg vaccine 2 y ago. Body aches, fever, etc. Pt also reported local swelling, redness, pain at injection site.
Age: 39.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pyrexia
Clinical narrative: Pt reported acute flu like sx 1D after rcvg flu vaccine. Same thing happened after rcvg vaccine 2 y ago. Body aches, fever, etc. Pt also reported local swelling, redness, pain at injection site.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash generalised, Rash vesicular
Clinical narrative: Approximately 5 days after vaccine, patient started itching on left shoulder and collar bone area. Rash proceeded to spread covering most areas of body except face. Rash has chicken pox like appearance. Patient saw physician & was prescribed Acyclovir as well as topical CALAMINE lotion.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Flank pain, Headache, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Pt states received vaccine 11/12/2012/ Developed erythematous lesion "large" around vaccine site 11/13/12. Was "hard" & "itchy". On 11/28/12 developed HA & nausea in morning followed by stabbing pain on left flank 4 hrs later. Noted 3 "spots" (vesicular rash) on flank then 11/29 more "spots" occurred - painful. T9 or T10 dermatome. 11/30 zoster-like rash noted by me.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Nausea, Pain, Rash vesicular, Skin lesion
Clinical narrative: Pt states received vaccine 11/12/2012/ Developed erythematous lesion "large" around vaccine site 11/13/12. Was "hard" & "itchy". On 11/28/12 developed HA & nausea in morning followed by stabbing pain on left flank 4 hrs later. Noted 3 "spots" (vesicular rash) on flank then 11/29 more "spots" occurred - painful. T9 or T10 dermatome. 11/30 zoster-like rash noted by me.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye swelling, Skin test negative, Swelling face, Urticaria
Clinical narrative: Enclosed letter. Solid body hives (mouth, head, feet, hands). On October 19, 2012 I took the shingles shot. I was fine until the next day. When I got up I had hives my faces was swollen and my body same. I called pharmacy he said take BENADRYL. (I did that for 3 days) I was fine for about 3 weeks). I swelled up with hives worse than before Saturday November 10, 2012 4:30 A.M. I went to emergency room in hospital. Told me to take BENADRYL gave it to me there. I had to wait to make sure it took effect. Took it until following Monday. Went to dr on Monday November 12, 2012. He put me on prednisone and hydroxyzine. I took it for 2 days and went back to him again as I wasn't a lot better. He upped the amount of both the prescriptions. I took them for about 10 days. This did help me. This is now, Dec. 4th 2012. I still get swelling in my face (eyes) some still come & go in my mouth Carrying an Epipen prescribed by my doctor. Went to allergy doctor on Nov 29th 2012. Did 100 patch test that all came negative she said reaction was proof from the shingles shot. I was fine prior to all of this. Going for more testing in January.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oedema mouth, Pharyngeal oedema, Polymenorrhoea, Pruritus, Rash pruritic
Clinical narrative: Enclosed letter. Solid body hives (mouth, head, feet, hands). On October 19, 2012 I took the shingles shot. I was fine until the next day. When I got up I had hives my faces was swollen and my body same. I called pharmacy he said take BENADRYL. (I did that for 3 days) I was fine for about 3 weeks). I swelled up with hives worse than before Saturday November 10, 2012 4:30 A.M. I went to emergency room in hospital. Told me to take BENADRYL gave it to me there. I had to wait to make sure it took effect. Took it until following Monday. Went to dr on Monday November 12, 2012. He put me on prednisone and hydroxyzine. I took it for 2 days and went back to him again as I wasn't a lot better. He upped the amount of both the prescriptions. I took them for about 10 days. This did help me. This is now, Dec. 4th 2012. I still get swelling in my face (eyes) some still come & go in my mouth Carrying an Epipen prescribed by my doctor. Went to allergy doctor on Nov 29th 2012. Did 100 patch test that all came negative she said reaction was proof from the shingles shot. I was fine prior to all of this. Going for more testing in January.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin test negative, Swelling face, Urticaria
Clinical narrative: Enclosed letter. Solid body hives (mouth, head, feet, hands). On October 19, 2012 I took the shingles shot. I was fine until the next day. When I got up I had hives my faces was swollen and my body same. I called pharmacy he said take BENADRYL. (I did that for 3 days) I was fine for about 3 weeks). I swelled up with hives worse than before Saturday November 10, 2012 4:30 A.M. I went to emergency room in hospital. Told me to take BENADRYL gave it to me there. I had to wait to make sure it took effect. Took it until following Monday. Went to dr on Monday November 12, 2012. He put me on prednisone and hydroxyzine. I took it for 2 days and went back to him again as I wasn't a lot better. He upped the amount of both the prescriptions. I took them for about 10 days. This did help me. This is now, Dec. 4th 2012. I still get swelling in my face (eyes) some still come & go in my mouth Carrying an Epipen prescribed by my doctor. Went to allergy doctor on Nov 29th 2012. Did 100 patch test that all came negative she said reaction was proof from the shingles shot. I was fine prior to all of this. Going for more testing in January.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Pruritus
Clinical narrative: 11/29/12 Approx. 9 pm pt noted (L) arm itching. Pt saw 3 circles - 1 at injection site, 2 toward inner aspect of arm. 12-1-12 8:30AM contacted office - 3 circles, warm, red & itches. Treatment: LIDEX cream to site, ZYRTEC PO.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Lymph node pain, Lymphadenopathy, Swelling
Clinical narrative: Warm, erythematous, swelling deltoid, s/p PNEUMOVAX. Axillary nodes swollen & tender.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Oedema mouth
Clinical narrative: 5 mins follow injection, swelling of mouth and lips, given BENADRYL and ZANTAC.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Urticaria
Clinical narrative: Pt. received Tdap booster during well ck on 12/04/12. It was the only vaccine given. Pt. reported to parent evening of 12/06/12 of "welt, size of softball on left arm". Dx with cellulitis on 12-7-12 - treated with Clindamycin HCl 300mg and instructed to return to clinic in 24 hrs for f/u./
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient is complaining her arm still hurts one month post vaccination. Does not hurt all of the time but has soreness intermittently & sporadically.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Oedema peripheral
Clinical narrative: Arm started swelling and turning red below injection site several hours after injection given. By following day arm is red in approx 3 x 5 inch area below injection site, warm to touch.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Abasia, Dysstasia, Mobility decreased, Muscular weakness, Sluggishness
Clinical narrative: 6 weeks after receiving FLUMIST, child was unable to stand or walk because weakness in legs, could not bend chin to chest. Went to MD, MD sent him to the hospital. Hospital ruled out meningitis and said it was a viral illness. Hospital kept him for several hours and then released him. Mother told MD about FLUMIST, but not hospital but mother states he noticeably sluggish during day usually morning and evening.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Viral infection
Clinical narrative: 6 weeks after receiving FLUMIST, child was unable to stand or walk because weakness in legs, could not bend chin to chest. Went to MD, MD sent him to the hospital. Hospital ruled out meningitis and said it was a viral illness. Hospital kept him for several hours and then released him. Mother told MD about FLUMIST, but not hospital but mother states he noticeably sluggish during day usually morning and evening.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: General muscle pain.
Age: 1.58
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Swelling
Clinical narrative: Approx. 1 inch area of redness, itching & tiny bumps around varicella injection site. Swelling started at day 7 following vaccine. Mom called to report on day 11 & site still getting larger.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUN3, IPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: DTAP given at (R) thigh at the village clinic by PHN on 12/4, & then child developed fever 101.4 degrees F & red, swollen (R) leg -> was seen at clinic 12/6 1030 pm & released to home.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Pain, Pain in extremity
Clinical narrative: Patient reports a hot pain that lasted almost 2 weeks. Arm still sensitive, not swollen.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Pt tolerated well. TVC FP purchased.
Age: 10.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema, Skin warm
Clinical narrative: Pt. had DTAP, Hep A (L) deltoid 12/05/2012. 12/06/2012, Mom states he had a small redness in the area. 12/07/2012 the work area that had grown to 5 cm area that was hot to touch. Ice was applied to area. Patient started on Prednisone 5mg/5ml 2 tsp. once a day for 3 days.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Skin discolouration
Clinical narrative: Pain radiating from arm to fingers. Black/blue marks on hand. Pt follow up with PCP recommended.
Age: 51.0
Sex: F
Vaccine: HEP, HEPA, PPV
Symptoms: Erythema, Fatigue, Local reaction, Nausea, Oedema peripheral
Clinical narrative: Immunization update secondary DM. Hep A #1, PNEUMOVAX administered (L) arm Hep B #1 (R) arm at appt. 12/5/12. PM sx of local rxn left arm red swelling & nausea & fatigue 12/6/12. Tx Amox.
Age: 1.72
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Red in thigh - area shot given (L) thigh. 4 vesicles on red base.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site vesicles
Clinical narrative: 2 scattered vesicles on (L) arm.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Chest pain, Dyspnoea, Palpitations, Tachycardia
Clinical narrative: As per pt.'s mother he experienced chest pain, shortness of breath, and palpitations. Pt. was hospitalized overnight for 1 day due to tachycardic event. Mom was informed that pt. shouldn't receive Flu vaccine again.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from an office manager via company representative refers to 40 patients of unknown age (gender unspecified). On an unknown date, the patients were vaccinated with PROQUAD (merck), (lot number, expiration date and route not reported). No concomitant medications were reported. On an unknown date, the office manager informed the company representative that the clinic had experienced a power failure and there supply of PROQUAD was stored outside of the required temperature range but 40 patients had already been received the medication before it was discovered. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a Nurse refers to an 11 years old female patient with vaccination. The patient was vaccinated with, .5 ml GARDASIL on 01-DEC-2012. No other co-suspects were reported. Concomitant medications included: BENADRYL. On 01-DEC-2012 the patient experienced urticaria, 1 day after onset of therapy. The patient was treated with BENADRYL was reported. The outcome of urticaria was reported as recovered/resolved. The relatedness for urticaria is unknown for GARDASIL. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure during pregnancy
Clinical narrative: This spontaneous report as received from a consumer refers to a 24 years old female patient. The patient was vaccinated with GARDASIL. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced become pregnant. No treatment information was reported. The outcome of become pregnant is unknown. The relatedness for becoming pregnant is unknown for GARDASIL. She indicated through the language line translator that she received the GARDASIL vaccination and has become pregnant. No further information is available. No further information is expected.
Age: 0.8
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 9 months old patient. The patient was vaccinated with GARDASIL. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced a 9 month old patient received GARDASIL on an unspecified date. No treatment information was reported. The outcome of a 9 month old patient received GARDASIL on an unspecified date is unknown. The relatedness for a 9 month old patient received GARDASIL on an unspecified date in unknown for GARDASIL. No adverse symptoms was reported. No further information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injury associated with device, Neuralgia
Clinical narrative: This spontaneous report as received from a company representative refers to a male patient HCP of unknown age.  ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced numbness and nerve pain on his hand, nerve pain on his hand and accidently got "needle stick". No treatment information was reported. The outcome of numbness and nerve pain on his hand, nerve pain on his hand and accidently got "needle stick" was reported as not recovered/not resolved. The relatedness for numbness and nerve pain on his hand, nerve pain on his hand and accidently got "needle stick" is unknown for ZOSTAVAX. No other information is available. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. On 15-NOV-2012, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number reported as 0614AA), that had expired on 27-SEP-2012. Concomitant medications were not reported. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Chills, Pallor, Pyrexia
Clinical narrative: This spontaneous report was received from a registered nurse refers to patients of unknown age (gender unspecified). On an unknown in 1991, the patients were vaccinated with (Merck) VARIVAX, (lot number, expiration date and route not reported). No concomitant medications were reported. On an unknown in 1991, the reporter stated that she had seem many pediatric patients; mostly severely handicapped, nursing home pediatric patients where she worked had reactions to (Merck) VARIVAX with chills, spike in temperature and turning pale. The outcome of the events were unknown. This is one of the several report received from the same reporter. Additional information is not expected.
Age: 0.3
Sex: U
Vaccine: PPV
Symptoms: Accidental exposure, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical nurse refers to a 4 months old child (gender unspecified). On 27-NOV-2012. The patient was inadvertently administered with a dose of PNEUMOVAX23 (lot number, expiry date and dose were not reported) intramuscularly. No concomitant medications were reported. No adverse effect reported. No treatment information was reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to unspecified number of patients of unknown age (gender unspecified). The nurse stated that her office had improperly stored PEDVAXHIB. On an unknown date, the patients were vaccinated with PEDVAXHIB(lot number, expiration and route not reported). No concomitant medications were reported. The reporter stated it was possible that an unspecified number of patients might have been administered with the improperly stored vaccine. No symptoms were reported. This is one of several report received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative, Blood immunoglobulin G decreased, Immunoglobulin therapy, Infection
Clinical narrative: This literature marketed report refers to a case of a novel mutation associated with an immunodeficiency. A 20 years old female patient with trisomy 10p and monosomy 4q, developmental delay, type 1 diabetes, hypothyroidism and deafness. She had no history of pneumonia, bacteremia, or skin infections. She did have an episode of mucocutaneous candidiasis requiring two months of antifungal medications to treat. The patient was vaccinated with PNEUMOVAX 23. She had a poor antibody response to Streptococcal pneumoniae after PNEUMOVAX 23. Her antibody titer was protective to tetanus. Her IgG (666 mg/dL), IgG2 (97 mg/dL), and IgG4 (2.8 mg/dL) were low with normal IgG1 and IgG3. IgA was low (41 mg/dL) and IgM was normal. Lymphocyte subpopulations were normal. Her lymphocyte mitogen proliferation was diminished to pokeweed, Candida albicans, and tetanus. Repeat lymphocyte antigen and mitogen proliferation were normal. Despite prophylactic antibiotics, she continued to have infections and was placed on intravenous immunoglobulin replacement. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a patient's mother refers to her daughter of unknown age, who on an unknown date was vaccinated with a dose of M-M-R II (lot#, dose and route not reported). On an unknown date the patient experienced fever of 105. The outcome of patient was not reported. The relatedness for fever of 105 was not reported for M-M-R II. This is one of several reports received from the same source. Additional information has been requested.
Age: 26.0
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 26 years old patient with vaccination. The patient was vaccinated with M-M-R II. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced had a negative titer following vaccination with M-M-R II on 11/30/2012. No treatment information was reported. The outcome of had a negative titer following vaccination with M-M-R II is unknown. No other information to report. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Faeces discoloured, Irritability
Clinical narrative: This spontaneous report as received from a pharmacist refers to (her daughter) a 8 weeks old female patient with immunization. The patient was vaccinated with ROTATEQ on 27-NOV-2012. No other co-suspects were reported. Concomitant medications included: DTaP (unspecified), tetanus toxoid. On 27-NOV-2012 the patient experienced developed green, mucousy diarrhea, 1 day after onset of therapy and fussy and irritable. No treatment information was reported. The outcome of developed green, mucousy diarrhea and fussy and irritable is unknown. The relatedness for developed green, mucousy diarrhea and fussy and irritable is unknown for ROTATEQ. Additional information has been requested.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, HEP, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 17 weeks old female infant. On 29-NOV-2012, the patient (reported as preterm infant) was vaccinated with dose 1 ROTATEQ (lot number was reported as 0208AE, expiry date, dose and route were not reported) at the age of 17 weeks. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Burning sensation, Muscle spasms, Musculoskeletal pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a consumer refers to a 78 years old female patient with skin cancer, penicillin allergy and "blue dye" allergy. The patient was vaccinated with ZOSTAVAX subcutaneous injection on 25-OCT-2012. No other co-suspects were reported. Concomitant medications included digoxin, LOSARTAN and tizanidine. Three days after the vaccination the patient experienced arm and shoulder pain. She was also experiencing severe leg cramps, and "recently"itching in her legs and burning in her legs. Her blood pressure also became elevated to 161/100. On 16-NOV-2012 the patient went to see her physician and she was diagnosed with shingles. Treatment medication included VALTREX and MEXICAM. The patient also visited her cardiologist due to the elevated blood pressure. No outcome was reported and no causality assessment was provided. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report as received from a consumer refers to a 78 years old female patient with skin cancer, penicillin allergy and "blue dye" allergy. The patient was vaccinated with ZOSTAVAX subcutaneous injection on 25-OCT-2012. No other co-suspects were reported. Concomitant medications included digoxin, LOSARTAN and tizanidine. Three days after the vaccination the patient experienced arm and shoulder pain. She was also experiencing severe leg cramps, and "recently"itching in her legs and burning in her legs. Her blood pressure also became elevated to 161/100. On 16-NOV-2012 the patient went to see her physician and she was diagnosed with shingles. Treatment medication included VALTREX and MEXICAM. The patient also visited her cardiologist due to the elevated blood pressure. No outcome was reported and no causality assessment was provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown demographics. The nurse reported that her office had improperly stored M-M-R II. It was possible that on an unspecified date, an unspecified number of patients might have been administered with this improperly stored M-M-R II (lot number, expiry date, route and dose were not reported). No concomitant medications were reported. No symptoms reported. It was unspecified if the patients had sought medical attention. This is one of the several reports received from the same reporter (MARRS# 1211USA012711, 1211USA012714, 1211USA012716 and 1211USA012717). Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Drug administered at inappropriate site, Muscle spasms
Clinical narrative: This spontaneous report as received from a 62 years old female consumer refers to herself. The patient did not have drug reactions or allergies. The patient was vaccinated with a dose of ZOSTAVAX (lot number not provided) in November 2009. No other co-suspects were reported. Concomitant medications included "muscle relaxers". In November 2009 the patient got the shot injection on the joint of the left shoulder. She felt the shot going towards her neck and it was followed by cramping and burning ever since then. Treatment (unspecified) was given for adverse event. The outcome of adverse events was unknown. It was unspecified if the patient had sought unspecified medical attention. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, PPV
Symptoms: Accidental exposure, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 4 months old female patient. The patient was vaccinated with, .5 ml PNEUMOVAX on 04-DEC-2012. No other co-suspects were reported. Concomitant medications included ACTHIB and DTaP (unspecified), tetanus toxoid. On an unknown date the patient experienced inadvertently vaccinated with PNEUMOVAX 23. No treatment information was reported. The outcome of inadvertently vaccinated with PNEUMOVAX 23 is unknown. The relatedness for inadvertently vaccinated PNEUMOVAX 23 is unknown for PNEUMOVAX 23. No adverse effects was reported at this time. No other information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Liver function test
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced having a liver function test done. No treatment information was reported. The outcome of having a liver function test done is unknown. The relatedness for having a liver function test done is unknown for ZOSTAVAX. The pharmacist did not have any patient specific information. No further information is available.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient was vaccinated with dose 1 VARIVAX (merck) (lot#, expiration date and route not reported) on unknown date in 1999. The patient did not receive his second dose of vaccine. No concomitant medications were reported. On an unknown date in 2010 the patient experienced shingles. The patient sought unspecified medical attention and unspecified treatment was given for adverse event. The outcome of shingles was unknown. The relatedness for shingles was unknown for VARIVAX (Merck). Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Initial information has been received from a pharmacist refers to a female patient with unspecified age with nonsteroidal anti-inflammatory drug (NSAIDS) allergy, sulfa allergy and cephalosporin allergy, who, on 23-NOV-2012 ("6 days ago") was vaccinated with ZOSTAVAX (dose, route and lot # were not reported). No other co-suspects were reported. Concomitant medications included DIOVAN, letrozole, simvastatin (manufacturer unknown), tramadol hydrochloride, fluticasone, ipratropium bromide, PRILOSEC, hydrochlorothiazide (+) triamterene and cetirizine hydrochloride. In November 2012, the patient experienced swelling, redness and itching around injection site after receiving ZOSTAVAX. The patient was treated with a moisturizer to affected area. The patient's outcome was unknown. The patient sought medical attention by speaking to the pharmacist. Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Ocular hyperaemia, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 77 years old female patient with some allergies but unspecified, who on 23-NOV-2012, was vaccinated with 0.65 ml dose of ZOSTAVAX (lot H018091, 04-JAN-2014), subcutaneously on her left arm. No other co-suspects were reported. No concomitant medications were reported. In November 2012, the patient developed a blood red eye, unspecified which eye and also a rash that the pharmacist might be on the both sides of the patient's face but the pharmacist was insure. The patient's husband went to the pharmacy over the weekend to get VALTREX prescription filled for his wife. The pharmacist stated that the patient was seen by an eye specialist and was being treated with erythromycin ophthalmic ointment. It was reported that the cause of the red eye was unknown at the time of report. The pharmacist stated she called the patient and she was feeling okay but the symptoms remain the same. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Dry eye, Eye inflammation, Keratitis, Neurotrophic keratopathy
Clinical narrative: Information has been received from an other health care professional author. PURPOSE: In this study, the case of a patient who presented with reactivation of herpes zoster (HZ) keratitis and worsening of neurotrophic keratopathy, keratouveitis, and keratoconjunctivitis sicca after vaccination with live attenuated ZOSTAVAX is described. METHOD: This is a retrospective case review. RESULTS: A 63-year-old man, with a history of HZ and neurotrophic keratopathy that had been quiescent for 3.5 years off medication, presented with keratouveitis 2 weeks after ZOSTAVAX administration. Oral acyclovir and topical prednisolone acetate and cyclopentolate hydrochloride were started, with subsequent improvement in inflammation and visual acuity. However, the patient was unable to be tapered completely off the steroids. CONCLUSIONS: HZ keratouveitis was the result of cell-mediated immunity (CMI) directed toward viral antigens within the eye. The live attenuated ZOSTAVAX, boosts the recipient's CMI to prevent reactivation of HZ. However, patients with a history of HZ keratitis may have persistent viral antigens in their corneas and can develop recurrence of keratouveitis because of the vaccine-induced increase in CMI. Vaccination should be undertaken with caution in patients with a history of HZ ophthalmicus. Additional information is not expected.