chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Walking aid user
Clinical narrative: Lower back pain first appeared on bending over, in the morning, 40 hours after vaccination. No other apparent cause.  Condition worsened throughout the day. Could remain sitting and standing without discomfort, but difficulty getting up, sitting down, walking and negotiating steps. Sitting on rolling chair at a short distance from desk and grasping edge of desk, could not pull myself back to the desk. By end of work day, could not walk without support. Next day, had chiropractic treatment and began a 30-day course of daily meloxicam 7.5 mg. Condition resolved fully within a week.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Influenza like illness, Injection site reaction, Injection site scab, Malaise
Clinical narrative: severe flu like symptoms for 2 weeks and scabbing at injection sites(5 inch radius). if remove would ooze and rescab. no tingling or neuropathy. Had diarrhea, fever, nausea,malaise, no vomiting,
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Skin weeping
Clinical narrative: severe flu like symptoms for 2 weeks and scabbing at injection sites(5 inch radius). if remove would ooze and rescab. no tingling or neuropathy. Had diarrhea, fever, nausea,malaise, no vomiting,
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Injection site pain, Nausea
Clinical narrative: Severe muscular injection site pain, nausea and chills.
Age: 72.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site pain, Injection site paraesthesia
Clinical narrative: Patient describes a tingling starting the day of the vaccine at the injection site in a circle about 4 inches in diameter. Tingling sensation moved downward over the next few days until it reached his elbow. Grew to be painful in his whole upper arm, but primarily near his elbow. The tingling and pain has continued until today (no better or worse). His arm has not lost any of its mobility but he has pain with everyday tasks.  Patient saw his chiropractor who massaged the injection area but did not produce any relief. Chiro referred patient back to pharmacy.  Pain improves but does not go away with advil. Patient does not describe his arm as swollen or red since vaccination.  I recommended the patient call his PCP
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: PATIENT CAME IN ON 12/28/2019 WITH A RASH ON ARM WHERE THE INJECTION SITE WAS. PATIENT WAS ADVISED TO GET CHECKED OUT FROM A PHYSICIAN.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chapped lips, Cheilitis, Lip dry, Oral herpes
Clinical narrative: 3 days after receiving her 2nd dose of Shingrix, the patient broke out with spots all over her face, on her lip, and on her buttocks. She states that the spots burn. No spots located on her scalp. The area on her lip looks like a dry cracked cold sore without swelling. She did not think this was a big deal and just wanted to mention it to us. She has been trying to keep the spots covered with make-up. No treatment sought. She states that the spots are improving but are still uncomfortable.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: 3 days after receiving her 2nd dose of Shingrix, the patient broke out with spots all over her face, on her lip, and on her buttocks. She states that the spots burn. No spots located on her scalp. The area on her lip looks like a dry cracked cold sore without swelling. She did not think this was a big deal and just wanted to mention it to us. She has been trying to keep the spots covered with make-up. No treatment sought. She states that the spots are improving but are still uncomfortable.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Limb discomfort, Paraesthesia
Clinical narrative: Patient complains of a "buzzing" feeling in arm/tingling. He states it started immediately after the shot
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Influenza like illness, Myalgia, Pain
Clinical narrative: Patient called on 12/27/19 around 7 PM and stated that he has had flu-like symptoms all week. He had extreme muscle pain to the point that it hurt to even bend over, and he stated that he had diarrhea all week as well. He stated this was the first day that he was starting to feel some relief all week.
Age: 14.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Chest discomfort, Dizziness, Palpitations
Clinical narrative: dizziness, chest heaviness, heart palpitations, racing heart rate, weakness
Age: 53.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Eyelid rash, Ocular hyperaemia, Ophthalmic herpes zoster, Rash
Clinical narrative: I broke out a few days later with my right eye herpes zoster,  then a week later it hit my left eye. Red eye little bumps coming down eye into the face are.  It took 4 days to heal each eye. Using acyclovir pills and eye drops. I have not had this happen since I was a little girl, maybe 10 yrs of age.
Age: 11.0
Sex: M
Vaccine: FLUC4
Symptoms: Fatigue, Feeling abnormal, Headache, Loss of consciousness, Neck pain
Clinical narrative: Patient was showing no symptoms and was in good mood until right before he went unconscious. After the incident the patient reported "feeling weird", but did not share information with his father or me. After his syncopal episode his father moved him into a chair in the immunization room. The ASM immediately called 911 and I talked to the patient and asked how he felt and whether he was having difficulty breathing. There were no signs of SOB or anaphylactic reaction. I check pupil dilation and asked what other symptoms the patient had. His only complaints were "being tired, and mild head and neck pain". I stayed with him until EMS arrived and turned over the lead to them. At that point 4 minutes had passed
Age: 11.0
Sex: M
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: Patient was showing no symptoms and was in good mood until right before he went unconscious. After the incident the patient reported "feeling weird", but did not share information with his father or me. After his syncopal episode his father moved him into a chair in the immunization room. The ASM immediately called 911 and I talked to the patient and asked how he felt and whether he was having difficulty breathing. There were no signs of SOB or anaphylactic reaction. I check pupil dilation and asked what other symptoms the patient had. His only complaints were "being tired, and mild head and neck pain". I stayed with him until EMS arrived and turned over the lead to them. At that point 4 minutes had passed
Age: 62.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient has had severe radiating arm pain, especially when lying down. Has continued for the last three weeks Described as almost a muscle cramping feeling of severe pain. Has not been relieved by Muscle relaxers or heat. Somewhat relieved by Ibuprofen. Recommended patient try Lidocaine based OTC cream and Apply Sparingly at night Went to Orthopedic Doctor and may get MRI if unrelieved.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Rash
Clinical narrative: Patient reported constant headache and rash on and around ear. Patient went to doctor on 12/27/19 and doctor prescribed valacyclovir 1gm 1 tablet twice daily for 7 days. Doctor thought that vaccine may have caused shingles.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Headache, Pain, Pruritus, Wheezing
Clinical narrative: temperature 102 for 3 days body aches/pains headache for 3 days itchy skin 1 day wheezing 1 day no treatment symptoms disappeared by 12/09/2019
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Loss of consciousness, Nausea, Nervousness
Clinical narrative: PATIENT FELT FAINT, SHAKY AND NAUSEOUS.  BP 81/38 PULSE 99. PT LOST CONCIOUSNESS, (OVER 5 TO 10 MINUTE TIME)
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Hypotension, Tachycardia
Clinical narrative: Patient developed dizziness and tachycardia 1 minute after receiving vaccination. Blood pressure was low. Full recovery after 10 minutes.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Fatigue, Feeling cold, Headache, Hypersomnia
Clinical narrative: Body aches, headache, abdominal pain, fever, extreme fatigue,  unable to get warm, thirst. I did not go to urgent care.  Took naproxen sodium for pain, slept for 24 hours.   Symptoms completely resolved by the next day.  I feel great now.  Thank you.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Thirst
Clinical narrative: Body aches, headache, abdominal pain, fever, extreme fatigue,  unable to get warm, thirst. I did not go to urgent care.  Took naproxen sodium for pain, slept for 24 hours.   Symptoms completely resolved by the next day.  I feel great now.  Thank you.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Decreased appetite, Fatigue, Injection site pain, Myalgia
Clinical narrative: Sore arm at injection site. Sore muscles, aching joints, fatigue, decreased appetite
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Nausea, Rash erythematous, Rash macular
Clinical narrative: 12 hours post vaccination patient experienced severe chills and nausea that resolved at 24 hours post vaccination. Patient also noticed several days later a small rash near axilla that appeared like small, red dots. it was approximately 2 inches in diameter and was not raised, blistering  or causing any discomfort.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: Upper lip swelling on right side of mouth
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Protrusion tongue, Tremor
Clinical narrative: Patient felt dizzy a few seconds after getting the immunization. Stood up and after a few steps sat down. According to Father she had a possible seizure: was shaking her head back and forth few times and then she had her tongue sticked out and then 911 was called.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Magnetic resonance imaging
Clinical narrative: Patient reported pain at injection site that started immediately. Since the vaccination her arm pain has worsened and she has noticed decreased range of motion. Has seen her PCP multiple times and received an MRI. Doctor beleives there may be nerve damage. No signs of improper injection site, and no signs of swelling or redness at injection site at time of vaccination, just pain that progressively got worse.
Age: 68.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Chiropractic, Discomfort, Disorientation, Loss of consciousness, Malaise
Clinical narrative: 5 hours after receiving the shots I felt sick: disoriented feeling and didn't know if I'd vomit or have diarrhea - but neither happened.   From the waist up every nerve felt like it was being stabbed by a thousand knives - VERY uncomfortable!  12 hours after the shots (about 4 a.m.)  I felt I would pass out, got to the bathroom, then woke up later (I don't know how long) on the floor with my head jammed against the door frame.  I couldn't turn my head from the impact and laying in an unnatural position for some time.    I got back to bed around 6 a.m. and slept 3 hours.  I've had 8 chiropracter treatments for my neck, which turns a little better now, but not fully.  I will seek physical therapy since my neck is still in pain.
Age: 68.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Mobility decreased, Nausea, Neck pain, Neuralgia
Clinical narrative: 5 hours after receiving the shots I felt sick: disoriented feeling and didn't know if I'd vomit or have diarrhea - but neither happened.   From the waist up every nerve felt like it was being stabbed by a thousand knives - VERY uncomfortable!  12 hours after the shots (about 4 a.m.)  I felt I would pass out, got to the bathroom, then woke up later (I don't know how long) on the floor with my head jammed against the door frame.  I couldn't turn my head from the impact and laying in an unnatural position for some time.    I got back to bed around 6 a.m. and slept 3 hours.  I've had 8 chiropracter treatments for my neck, which turns a little better now, but not fully.  I will seek physical therapy since my neck is still in pain.
Sex: M
Vaccine: FLUR4
Symptoms: Cough, Dyspnoea, Nasopharyngitis, Pyrexia
Clinical narrative: Cold, coughing, trouble breathing, fever,
Age: 60.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Asthenia, Headache, Nausea, Pain
Clinical narrative: Patient felt  weakness, Headache and nausea.  Patient was asked to stay hydrated, take rest, tylenol for headache/body ache, meclizine for nausea.  Patient has been instructed to go to see a dr. if symptomps worsens.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue
Clinical narrative: EMPLOYEE STATES FEELS FATIGUED FROM VACCINATION
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Cough, Fatigue, Injection site pain, Malaise
Clinical narrative: Slight fever Cough Sore throat Stuffy nose Extensive muscle aches Soreness at vaccination site Fatigue and malaise All occurred within about 18 hours and then abated; they were severe enough that if I hadn't known I had gotten a shot, I would have gone to the ER I continue to have soreness at the injection site and significant knee pain
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: Slight fever Cough Sore throat Stuffy nose Extensive muscle aches Soreness at vaccination site Fatigue and malaise All occurred within about 18 hours and then abated; they were severe enough that if I hadn't known I had gotten a shot, I would have gone to the ER I continue to have soreness at the injection site and significant knee pain
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient received second Shingrix vaccine on 11/19/19 and by 11/28/19 he and his wife needed to go to an urgent care for treatment for an active shingles outbreak. Patient previously had shingles on his head (many years prior to this incident) and after receiving the second Shingrix dose had shingles reactivate in the same location on his head.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient received the second dose in the Shingrix series on 11/19/19 and on 11/28/19 noticed a spider-bite like rash in a cluster on her upper torso. On 11/30/19, she and her husband (who also has a VAERS submitted because a similar occurrence happened to him) felt symptoms were bad enough to make a trip to an urgent care. They went to a walk in clinic and both received prescriptions for antiviral medication as they were both diagnosed with shingles.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Asthenia, Chills, Cough, Decreased appetite, Disturbance in attention
Clinical narrative: 11.25-28??? dtap, hep b, polio ?i feel sick? - runny nose, low energy, irritable, not much appetite  ?i don?t care if i die from getting shots.?   11.30/12.1 sick - sneeze, mucous production, difficulty breathing. complaining of neck pain.   12.03.19 cough, complain of injection site pain in left arm.   12.09 tics worsening, constant fidgeting. trouble falling asleep, unable to relax - scratching face, picking finger nails. pulling out eyebrow hair. complaining of neck pain.   swinging arms around and hitting chest.   12.11.19 excessive mucous production. extreme difficulty breathing during sleep.   12.17.19 increased repetition of words and phrases.  continued increase in repetitive body movements - hitting himself.  difficulty maintaining concentration.  rapid mood swings.   ?i?m an idiot. i wish i was never born. i want to kill myself.?   NOT IN MY CARE FOR 4 DAYS and NIGHTS  SICK - constant runny nose, sneezing, coughing, unable to breathe at night!   12.24.19 i put an anti-congestion rub on him - coconut oil, peppermint, tea tree, and eucalyptus EOs. and he said, ?that doesn?t even help anything.? i asked, ?says who?? and he says, ?me. and my dad - he?s a doctor.?   12.25.19 all signs and symptoms worsening. constant snot. face is red and painful from wiping nose every 30 seconds.  started complaining of pain in his right ear around 5pm.  no interest in dinner. asked to go to bed at 6:30pm.  probable fever - chills and tears. thermometer not registering higher than 97.6  12.26.19 asked to take a nap midday   12.27.19 ALL signs and symptoms still present when dropped off with father.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Dyspnoea, Erythema, Facial pain, Initial insomnia, Injection site pain
Clinical narrative: 11.25-28??? dtap, hep b, polio ?i feel sick? - runny nose, low energy, irritable, not much appetite  ?i don?t care if i die from getting shots.?   11.30/12.1 sick - sneeze, mucous production, difficulty breathing. complaining of neck pain.   12.03.19 cough, complain of injection site pain in left arm.   12.09 tics worsening, constant fidgeting. trouble falling asleep, unable to relax - scratching face, picking finger nails. pulling out eyebrow hair. complaining of neck pain.   swinging arms around and hitting chest.   12.11.19 excessive mucous production. extreme difficulty breathing during sleep.   12.17.19 increased repetition of words and phrases.  continued increase in repetitive body movements - hitting himself.  difficulty maintaining concentration.  rapid mood swings.   ?i?m an idiot. i wish i was never born. i want to kill myself.?   NOT IN MY CARE FOR 4 DAYS and NIGHTS  SICK - constant runny nose, sneezing, coughing, unable to breathe at night!   12.24.19 i put an anti-congestion rub on him - coconut oil, peppermint, tea tree, and eucalyptus EOs. and he said, ?that doesn?t even help anything.? i asked, ?says who?? and he says, ?me. and my dad - he?s a doctor.?   12.25.19 all signs and symptoms worsening. constant snot. face is red and painful from wiping nose every 30 seconds.  started complaining of pain in his right ear around 5pm.  no interest in dinner. asked to go to bed at 6:30pm.  probable fever - chills and tears. thermometer not registering higher than 97.6  12.26.19 asked to take a nap midday   12.27.19 ALL signs and symptoms still present when dropped off with father.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Intentional self-injury, Irritability, Malaise, Mood swings, Neck pain
Clinical narrative: 11.25-28??? dtap, hep b, polio ?i feel sick? - runny nose, low energy, irritable, not much appetite  ?i don?t care if i die from getting shots.?   11.30/12.1 sick - sneeze, mucous production, difficulty breathing. complaining of neck pain.   12.03.19 cough, complain of injection site pain in left arm.   12.09 tics worsening, constant fidgeting. trouble falling asleep, unable to relax - scratching face, picking finger nails. pulling out eyebrow hair. complaining of neck pain.   swinging arms around and hitting chest.   12.11.19 excessive mucous production. extreme difficulty breathing during sleep.   12.17.19 increased repetition of words and phrases.  continued increase in repetitive body movements - hitting himself.  difficulty maintaining concentration.  rapid mood swings.   ?i?m an idiot. i wish i was never born. i want to kill myself.?   NOT IN MY CARE FOR 4 DAYS and NIGHTS  SICK - constant runny nose, sneezing, coughing, unable to breathe at night!   12.24.19 i put an anti-congestion rub on him - coconut oil, peppermint, tea tree, and eucalyptus EOs. and he said, ?that doesn?t even help anything.? i asked, ?says who?? and he says, ?me. and my dad - he?s a doctor.?   12.25.19 all signs and symptoms worsening. constant snot. face is red and painful from wiping nose every 30 seconds.  started complaining of pain in his right ear around 5pm.  no interest in dinner. asked to go to bed at 6:30pm.  probable fever - chills and tears. thermometer not registering higher than 97.6  12.26.19 asked to take a nap midday   12.27.19 ALL signs and symptoms still present when dropped off with father.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Pyrexia, Repetitive speech, Restlessness, Rhinorrhoea, Secretion discharge
Clinical narrative: 11.25-28??? dtap, hep b, polio ?i feel sick? - runny nose, low energy, irritable, not much appetite  ?i don?t care if i die from getting shots.?   11.30/12.1 sick - sneeze, mucous production, difficulty breathing. complaining of neck pain.   12.03.19 cough, complain of injection site pain in left arm.   12.09 tics worsening, constant fidgeting. trouble falling asleep, unable to relax - scratching face, picking finger nails. pulling out eyebrow hair. complaining of neck pain.   swinging arms around and hitting chest.   12.11.19 excessive mucous production. extreme difficulty breathing during sleep.   12.17.19 increased repetition of words and phrases.  continued increase in repetitive body movements - hitting himself.  difficulty maintaining concentration.  rapid mood swings.   ?i?m an idiot. i wish i was never born. i want to kill myself.?   NOT IN MY CARE FOR 4 DAYS and NIGHTS  SICK - constant runny nose, sneezing, coughing, unable to breathe at night!   12.24.19 i put an anti-congestion rub on him - coconut oil, peppermint, tea tree, and eucalyptus EOs. and he said, ?that doesn?t even help anything.? i asked, ?says who?? and he says, ?me. and my dad - he?s a doctor.?   12.25.19 all signs and symptoms worsening. constant snot. face is red and painful from wiping nose every 30 seconds.  started complaining of pain in his right ear around 5pm.  no interest in dinner. asked to go to bed at 6:30pm.  probable fever - chills and tears. thermometer not registering higher than 97.6  12.26.19 asked to take a nap midday   12.27.19 ALL signs and symptoms still present when dropped off with father.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Sneezing, Stereotypy, Suicidal ideation, Tearfulness, Tension
Clinical narrative: 11.25-28??? dtap, hep b, polio ?i feel sick? - runny nose, low energy, irritable, not much appetite  ?i don?t care if i die from getting shots.?   11.30/12.1 sick - sneeze, mucous production, difficulty breathing. complaining of neck pain.   12.03.19 cough, complain of injection site pain in left arm.   12.09 tics worsening, constant fidgeting. trouble falling asleep, unable to relax - scratching face, picking finger nails. pulling out eyebrow hair. complaining of neck pain.   swinging arms around and hitting chest.   12.11.19 excessive mucous production. extreme difficulty breathing during sleep.   12.17.19 increased repetition of words and phrases.  continued increase in repetitive body movements - hitting himself.  difficulty maintaining concentration.  rapid mood swings.   ?i?m an idiot. i wish i was never born. i want to kill myself.?   NOT IN MY CARE FOR 4 DAYS and NIGHTS  SICK - constant runny nose, sneezing, coughing, unable to breathe at night!   12.24.19 i put an anti-congestion rub on him - coconut oil, peppermint, tea tree, and eucalyptus EOs. and he said, ?that doesn?t even help anything.? i asked, ?says who?? and he says, ?me. and my dad - he?s a doctor.?   12.25.19 all signs and symptoms worsening. constant snot. face is red and painful from wiping nose every 30 seconds.  started complaining of pain in his right ear around 5pm.  no interest in dinner. asked to go to bed at 6:30pm.  probable fever - chills and tears. thermometer not registering higher than 97.6  12.26.19 asked to take a nap midday   12.27.19 ALL signs and symptoms still present when dropped off with father.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Tic
Clinical narrative: 11.25-28??? dtap, hep b, polio ?i feel sick? - runny nose, low energy, irritable, not much appetite  ?i don?t care if i die from getting shots.?   11.30/12.1 sick - sneeze, mucous production, difficulty breathing. complaining of neck pain.   12.03.19 cough, complain of injection site pain in left arm.   12.09 tics worsening, constant fidgeting. trouble falling asleep, unable to relax - scratching face, picking finger nails. pulling out eyebrow hair. complaining of neck pain.   swinging arms around and hitting chest.   12.11.19 excessive mucous production. extreme difficulty breathing during sleep.   12.17.19 increased repetition of words and phrases.  continued increase in repetitive body movements - hitting himself.  difficulty maintaining concentration.  rapid mood swings.   ?i?m an idiot. i wish i was never born. i want to kill myself.?   NOT IN MY CARE FOR 4 DAYS and NIGHTS  SICK - constant runny nose, sneezing, coughing, unable to breathe at night!   12.24.19 i put an anti-congestion rub on him - coconut oil, peppermint, tea tree, and eucalyptus EOs. and he said, ?that doesn?t even help anything.? i asked, ?says who?? and he says, ?me. and my dad - he?s a doctor.?   12.25.19 all signs and symptoms worsening. constant snot. face is red and painful from wiping nose every 30 seconds.  started complaining of pain in his right ear around 5pm.  no interest in dinner. asked to go to bed at 6:30pm.  probable fever - chills and tears. thermometer not registering higher than 97.6  12.26.19 asked to take a nap midday   12.27.19 ALL signs and symptoms still present when dropped off with father.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: patient experienced moderate rash on trunk, arms, thighs. Rash comes and goes. Patient has tried benadryl and calamine with no relief. Patient has follow up with provider on 12/30.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Expected sore arm. Extreme swelling, redness that extended way out from site and fever of shot site, headache, nausea. The headache and flu type symptoms lasted 4 days. The fever and swelling lasted another several. The redness (extended outward from shot site) lasted for 6-8 weeks. Felt awful and made me question if I even wanted to follow through with second vaccine. Took pics of arm and showed to nurse when receiving the second shot. She was amazed at the size and brightness of the redness. Second shot: sore arm as expected with much smaller area of redness around shot site with slight fever, slight headache for one day.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea
Clinical narrative: Expected sore arm. Extreme swelling, redness that extended way out from site and fever of shot site, headache, nausea. The headache and flu type symptoms lasted 4 days. The fever and swelling lasted another several. The redness (extended outward from shot site) lasted for 6-8 weeks. Felt awful and made me question if I even wanted to follow through with second vaccine. Took pics of arm and showed to nurse when receiving the second shot. She was amazed at the size and brightness of the redness. Second shot: sore arm as expected with much smaller area of redness around shot site with slight fever, slight headache for one day.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling cold, Malaise, Pain, Pyrexia
Clinical narrative: Patient was very sick after vaccine administration. Patient's wife reported chills, fever,malaise, and severe pain. Patient went to the ER and received care then was discharged the same day.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported swelling in both of her eyes and extreme pain and swelling in her hands approximately 2 days after receiving the Shingrix vaccine. The swelling went down after a couple of days, but the pain in her hands is severe and has persisted for 2 months.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Pruritus, Pyrexia, Rash
Clinical narrative: started with rash on left arm, moved to  jaw and face and scalp.  fever, weakness itchiness for 10 days now.   Using otc Benadryl with some improvement but still not recovered
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood creatine phosphokinase normal, Muscular weakness, Myalgia, Red blood cell sedimentation rate increased
Clinical narrative: Muscle aches and weakness over entire body, began with major muscles and gradually getting more severe and spreading to smaller muscles (hands).  I spoke to the pharmacist and she said she was not aware of any such reactions.  I have no insurance so finances are limited as far as tests go.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: Patient received 2nd shingrix shot on 12-14-19 and went to Doctor's office and they reported it seems to be shingles that she broke out on the left side of her body. Patient describes it as upper left torso, 10-11 blisters, occuring 1 week after she shot. Stated she first had internal pain then 4 days later blisters appeared.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: BODY ACHES
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Headache, Hyperhidrosis
Clinical narrative: Intense headache, alternating chills and sweating, nausea, vomiting, muscle pain in both shoulders, along spine, and between ribs. These symptoms occurred primarily between 9 p.m. on day of vaccination and 9 a.m. the following day.  Headache diminished, but continued for about 12 hours until about 9 p.m. on the 20th.  Vomiting stopped by 9 a.m. on 12/20, but appetite did not return for approximately 48 hours.   Felt weak and lethargic for about 48 hours.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Musculoskeletal pain, Myalgia, Nausea, Spinal pain
Clinical narrative: Intense headache, alternating chills and sweating, nausea, vomiting, muscle pain in both shoulders, along spine, and between ribs. These symptoms occurred primarily between 9 p.m. on day of vaccination and 9 a.m. the following day.  Headache diminished, but continued for about 12 hours until about 9 p.m. on the 20th.  Vomiting stopped by 9 a.m. on 12/20, but appetite did not return for approximately 48 hours.   Felt weak and lethargic for about 48 hours.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Intense headache, alternating chills and sweating, nausea, vomiting, muscle pain in both shoulders, along spine, and between ribs. These symptoms occurred primarily between 9 p.m. on day of vaccination and 9 a.m. the following day.  Headache diminished, but continued for about 12 hours until about 9 p.m. on the 20th.  Vomiting stopped by 9 a.m. on 12/20, but appetite did not return for approximately 48 hours.   Felt weak and lethargic for about 48 hours.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Patient returned to the pharmacy 12/28/2019 and showed me his left arm complaining of itching and redness. I took a look at his arm and it there was a large area which was pink and very warm to the touch. The patient said it was not painful at all, just very thcing and he has noticed the pink area has spread in the last 2 days is worsening. He did not do anything to treat it, but asked for an over the counter remedy before he goes into his doctor  I recommended Benadryl for the possible allergic reacton and hydrocortisone cream topically. I recommended he go to his MD since it is spreading and warm to touch and there may be an infection beginning.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin abnormal, Eczema, Erythema, Fungal test negative, Melanocytic naevus
Clinical narrative: Eczema; This case was reported by a consumer via call center representative and described the occurrence of eczema in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced eczema. On an unknown date, the outcome of the eczema was unknown.   It was unknown if the reporter considered the eczema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got eczema after receiving the first shingles shot. It was reported that the at least two other people this had happened.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Microscopy, Periodic acid Schiff stain, Phototherapy, Pityriasis rosea, Rash
Clinical narrative: Eczema; This case was reported by a consumer via call center representative and described the occurrence of eczema in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced eczema. On an unknown date, the outcome of the eczema was unknown.   It was unknown if the reporter considered the eczema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got eczema after receiving the first shingles shot. It was reported that the at least two other people this had happened.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Skin papilloma
Clinical narrative: Eczema; This case was reported by a consumer via call center representative and described the occurrence of eczema in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced eczema. On an unknown date, the outcome of the eczema was unknown.   It was unknown if the reporter considered the eczema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got eczema after receiving the first shingles shot. It was reported that the at least two other people this had happened.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Eczema
Clinical narrative: Eczema; This case was reported by a consumer via call center representative and described the occurrence of eczema in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced eczema. On an unknown date, the outcome of the eczema was unknown.   It was unknown if the reporter considered the eczema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got eczema after receiving the first shingles shot. It was reported that the at least two other people this had happened.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Injection site erythema, Injection site induration
Clinical narrative: I had shot in upper left arm. And after I got home later. Pain in my left side of upper chest. And pain in my left upper arm. My top upper arm got swollen. Pain did travel down my arm to risk. And did not remain long. Stayed all night the pain in my arm till next morning. A little over 12 hours. Before the pain went away.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: I had shot in upper left arm. And after I got home later. Pain in my left side of upper chest. And pain in my left upper arm. My top upper arm got swollen. Pain did travel down my arm to risk. And did not remain long. Stayed all night the pain in my arm till next morning. A little over 12 hours. Before the pain went away.
Age: 69.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Pain
Clinical narrative: Site effects; This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was recovered/resolved.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and experienced site effects that lasted for 24 hours. The patient asked, it could take 2nd dose of Shingrix vaccine.
Age: 69.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: Site effects; This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was recovered/resolved.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and experienced site effects that lasted for 24 hours. The patient asked, it could take 2nd dose of Shingrix vaccine.
Age: 69.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction
Clinical narrative: Site effects; This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was recovered/resolved.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and experienced site effects that lasted for 24 hours. The patient asked, it could take 2nd dose of Shingrix vaccine.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature increased, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Temperature over 102, myalgia, weakness, swollen and hot pink injection site, with effects including temperature over 100 lasting more than 48 hours.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: I had the flu vaccination for the first time in my life and have had ongoing upper shoulder muscle pain ever since. It?s at the exact site of the vaccination. I have trouble lifting with that arm and trouble sleeping because of the pain.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional adverse effects; four pediatric patients received the adult formulation of VAQTA; This spontaneous report was received from the office manager and refers to an unspecified pediatric patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 13-NOV-2019, the patient was vaccinated with the adult formulation of hepatitis a vaccine, inactivated (VAQTA) 1 milliliter, once,  lot # S012250 expiration date on 07-JUL-2020, for prophylaxis. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1912USA011816: US-009507513-1912USA011814: US-009507513-1912USA011815:
Age: 1.08
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse effect reported; vaccine was administered on 28-OCT-2014 and vaccine expired on 18-OCT-2014; This spontaneous report was received from a nurse referring to a 13-month-old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported.   On 28-OCT-2014, the patient was vaccinated with a dose of expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: rHA) for prophylaxis (lot # H018948 with expiration date: 18-OCT-2014; strength, route and anatomical location were not reported) (expired product administered). No adverse effect was reported. No product quality complaint (PQC) was involved.   This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-1912USA006771:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms reported.; A nurse states that on 12/17/2019 a patient was administered an expired dose of VAQTA; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 17-DEC-2019, the patient was administered an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # R032910, expiration date of 18-NOV-2019 (route of administration and frequency were not reported).  No adverse symptoms were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms were reported; One patient was administered a dose of improperly stored ROTATEQ; This spontaneous report was received from a nurse, concerning a 9 week old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions or concomitant medications.  On 13-DEC-2019, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) per oral route lot # R035673 with expiration date of 19-SEP-2020, for prophylaxis (dose, frequency, route of administration and anatomical location were not provided. The storage temperature of the vaccines was reported as above 9 Celsius degrees (12 Celsius degrees) for a time frame of 12 hours and 14 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse symptoms were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Herpes zoster, Ophthalmic herpes zoster, Pain, Pain in extremity
Clinical narrative: Periferal vascular disease; shingles on her eyes/vision problems; painful and debilitating shingles on her eyes, face scalp, hands and fingers; PHN; Information was received from a lawyer regarding a case in litigation concerning a female patient(pt) of unspecified age.  It was claimed the pt was inoculated with Zoster Vaccine Live (ZOSTAVAX) on 11-DEC-2014, at pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. Shortly after vaccination with Zoster Vaccine Live (ZOSTAVAX), On unspecified date in October 2015, pt suffered debilitating injuries including painful, debilitating shingles on her eyes and vision problems (herpes ophthalmic), significant scarring, throbbing pain, face scalp, hands and fingers (herpes zoster), as well as post herpetic neuralgia (PHN), peripheral vascular disease.  It was claimed that as a direct and proximate result of defective Zoster Vaccine Live (ZOSTAVAX) vaccine, pt's symptoms had resulted in physical limitations not present prior to using Zoster Vaccine Live (ZOSTAVAX) product. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and has suffered economic losses due to her inability to work. On unspecified date in 2018, the patient recovered from the herpes ophthalmic, herpes zoster, PHN, peripheral vascular disease. The reporter considered herpes ophthalmic, peripheral vascular disorder, post herpetic neuralgia and herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).  Upon internal review, herpes ophthalmic was considered to be medical significant.  Additional information was requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Peripheral vascular disorder, Post herpetic neuralgia, Scar, Visual impairment
Clinical narrative: Periferal vascular disease; shingles on her eyes/vision problems; painful and debilitating shingles on her eyes, face scalp, hands and fingers; PHN; Information was received from a lawyer regarding a case in litigation concerning a female patient(pt) of unspecified age.  It was claimed the pt was inoculated with Zoster Vaccine Live (ZOSTAVAX) on 11-DEC-2014, at pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. Shortly after vaccination with Zoster Vaccine Live (ZOSTAVAX), On unspecified date in October 2015, pt suffered debilitating injuries including painful, debilitating shingles on her eyes and vision problems (herpes ophthalmic), significant scarring, throbbing pain, face scalp, hands and fingers (herpes zoster), as well as post herpetic neuralgia (PHN), peripheral vascular disease.  It was claimed that as a direct and proximate result of defective Zoster Vaccine Live (ZOSTAVAX) vaccine, pt's symptoms had resulted in physical limitations not present prior to using Zoster Vaccine Live (ZOSTAVAX) product. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and has suffered economic losses due to her inability to work. On unspecified date in 2018, the patient recovered from the herpes ophthalmic, herpes zoster, PHN, peripheral vascular disease. The reporter considered herpes ophthalmic, peripheral vascular disorder, post herpetic neuralgia and herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).  Upon internal review, herpes ophthalmic was considered to be medical significant.  Additional information was requested.
Sex: F
Vaccine: MMR, UNK
Symptoms: Rash
Clinical narrative: patint developed a rash on her body from head to toe; This spontaneous report was received from a nurse referring to a 58 year old female patient. The patient's historical drug included mycolog- II. The patient's concurrent conditions included moderate Intellectual development disorder (IDD), down syndrome, high cholesterol, hypothyroid, cardiomegaly, pulmonary regurgitation, bilateral axially lymphadenopathy grad3 3/ 4 sem, fibrocystic breast disease, glaucoma, gastro esophageal reflux disease (GERD), severe C spine disease, dementia, drug hypersensitivity and hypersensitivity (bubble bath). Concomitant therapies included donepezil, memantine, simvastatin, levothyroxine sodium (SYNTHYROID) and timolol maleate. On 05-DEC-2019, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II), lot # S018593 and expiry date 17-JUN-20121, via subcutaneous route in the left deltoid for prophylaxis (reported as "did a rubella titer and patient was not immune so the patient received MMR II") (strength and dose not reported) that was reconstituted with sterile diluent (dose, lot number and expiry date were not reported). On 20-DEC-2019, the patient developed a rash on her body from head to toe after receiving measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II). On 21-DEC-2019, the rash got worse. The patient did not seek medical attention and it was reported that "the patient is seeing physician today". No product quality complaint (PQC) was reported. Action taken with the suspect therapy sterile diluent was unknown. The outcome of rash was reported as not recovered. The causality assessment was not provided.
Sex: F
Vaccine: FLUN4
Symptoms: Nausea
Clinical narrative: NAUSEA; A spontaneous report has been received from a consumer. The report concerns a female patient of Unknown ethnic origin.    No medical history was reported.     Concomitant medication included omeprazole for celiac disease.     The patient received nasal Flumist Quadrivalent (influenza vaccine (live, attenuated)) 0.2 ml, on an unknown date.     On an unknown date, the patient experienced nausea (preferred term: Nausea).     The outcome of the nausea was unknown.    The company Physician assessed the nausea as non-serious.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: On the visit of 12/23/2019 Dr. ordered Pneumovax for the patient. Patient was given PCV 13 instead of Pneumovax. patient had received PCV 13 in the past dated 11/16/2017 ( PCV 13 lot # S 51635 NDC # 00005-1971-01