chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical histories and drug reactions or allergies were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II human serum albumin (HSA) injection, lot # M032485, expiration date 06-JUL-2018 (dose, route and site of administration were not reported), which were reconstituted with properly stored sterile diluent (MERCK). No adverse effects were reported. Product quality complaint was not involved. The administered doses of M-M-R II were stored in the temperature between 47 degrees Fahrenheit and 77 degrees Fahrenheit, for 1 hour and subsequently for 30 minutes. Data logger was involved. No further information was provided.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: This spontaneous report as received from a other refers to an unspecified number of female patients of unknown age. On an unknown date the patients were vaccinated with GARDASIL, intramuscular for prophylaxis. On an unknown date the patients experienced human papilloma virus test positive. The outcome of human papilloma virus test positive was unknown.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: This spontaneous report was received from a physician concerning a 20 years old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9, for prevention of human papillomavirus (HPV) related cancer (dose number, route of administration, lot # and expiration date were unknown). Concomitant medications were not reported. On 06-SEP-2017 (also reported as "an unknown amount of time after receiving GARDASIL 9"), the patient experienced dizziness, was sent to an unspecified emergency room and was possibly admitted after her emergency room visit. At the time of reporting, the patient had recovered from the dizziness. The causality assessment between the dizziness and GARDASIL 9 was not provided.
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain, Nausea, Pancreatic enzymes increased, Pancreatitis acute
Clinical narrative: Information has been received from an unspecified reporter on an article, via a company representative, referring to a 20 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (strength, administration route, anatomical location, lot number and expiration date were not reported) for prophylaxis (also reported as "vaccine for human papillomavirus (HPV)"). On an unspecified date one week after receiving the first dose, the patient developed severe abdominal pain. It was reported that the patient also experienced nausea. On an unknown date, the patient continued to receive the second dose of GARDASIL (strength, administration route, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unspecified date ten days after receiving the second dose, the patient had unspecified lab done which results revealed significantly elevated pancreatic enzymes (values and units not provided), then he was diagnosed with acute pancreatitis. The outcome of the severe abdominal pain, the nausea and the acute pancreatitis was unknown and the causality between the vaccination with GARDASIL and the aforementioned events was not reported. Upon internal review, the acute pancreatitis was considered as a medically significant event.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Red rash itching.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Arm ached evening of shot, followed by throbbing over the weekend with fever noted below shot area Sunday eve followed by swelling and redness and hot to touch Monday morning.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: Arm ached evening of shot, followed by throbbing over the weekend with fever noted below shot area Sunday eve followed by swelling and redness and hot to touch Monday morning.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Pain in extremity
Clinical narrative: Patient says her arm hurts and has  pain in her back that runs down her leg.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dysphagia, Dysphonia, Pharyngeal oedema
Clinical narrative: Pt was given flu vaccine at approximately 11:20 am on 9/11/17. Within 30 minutes, pt developed voice hoarseness, difficulty swallowing, coughing, and feeling of throat swelling. Pt sent to Emergency Room. ER administered benadryl injection (25 mg, IV push), epinephrine injection (.3 ml, subQ), ipratropium-albuterol (3ml, raindrop nebulizer), pepcid intravenous (20 mg, IV med infusion), sodium chloride 0.9% intravenous (1000 ml/hr, IV Med Infusion), and Solu-Medrol Injection (125 mg, IV Push). Pt was discharged to home at approximately 14:30 pm. Pt reports benadryl taken PO on 9/12/17 due to continued feeling of throat swelling.
Age: 51.0
Sex: F
Vaccine: HEPAB
Symptoms: Facial pain, Pyrexia, Swelling face
Clinical narrative: Fever & left side of face swollen.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Flushing, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Per patient: "I experienced ~5-7 days of site reaction, with localized heat, and pain like from tetanus shot. Then cold like symthoms, with sore throat beginng 9/6.  9/8, 9 days after shot broke out in rash, under chin, ie lymph nodes. Today, 9/9 my whole face is flushed, beet red.  I'm going on 3 benadryl until it resolves. I know I have a very long history of drug reactions, but this seems to be over the top". Per Doctor: I will report your reaction. Also, continue with benadryl every 6 hours if not completely resolved. If this is making you drowsy, consider zyrtec, claritin, or allegra as a non-drowsy antihistamine. We won't give flu vaccines to you anymore if you're having such reactions. "
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Nasopharyngitis, Oropharyngeal pain, Rash
Clinical narrative: Per patient: "I experienced ~5-7 days of site reaction, with localized heat, and pain like from tetanus shot. Then cold like symthoms, with sore throat beginng 9/6.  9/8, 9 days after shot broke out in rash, under chin, ie lymph nodes. Today, 9/9 my whole face is flushed, beet red.  I'm going on 3 benadryl until it resolves. I know I have a very long history of drug reactions, but this seems to be over the top". Per Doctor: I will report your reaction. Also, continue with benadryl every 6 hours if not completely resolved. If this is making you drowsy, consider zyrtec, claritin, or allegra as a non-drowsy antihistamine. We won't give flu vaccines to you anymore if you're having such reactions. "
Age: 19.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pharyngeal oedema, Pruritus, Swelling, Throat irritation
Clinical narrative: Pt. was seen for immunization update. Per record previous doses of varicella was given on 10/23/1999 and 10/21/1999. Per ACIP recommendation pt. received 2nd dose early. Provider recommended repeating dose. The third dose of varicella was administered on 09/05/2017. Shortly after administration patient began experiencing local itching, 2 cm of erythema. Pt. states symptoms increased on 0/08/2017 pt school nurse suggested he schedule appt. with PCP. Pt. seen in our office by Dr. on 09/08/2017 at 10:00am. At time of visit patient had local swelling and erythema. Pt. stated he felt his throat was swollen and itched. Provider administered 2 tabs of diphenhydramine 25 mg in office and prescribed prednisone 20mg, epinephrine 0.3mg and BENADRYL 25mg. Pt. was given ED precautions and advised to never get the varicella immunization again.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. Since 14-JUN-2017, the patients were vaccinated with RECOMBIVAX HB lot # N002202 with expiration date on 11-APR-2019 and lot # N002913 with expiration date on 23-FEB-2019, 0.5 ml, intramuscularly for prophylaxis. The doses of RECOMBIVAX HB were exposed to a temperature excursion of 32 degrees Fahrenheit (°F) during a time frame of 2 minutes which was detected by the data logger. Previous temperature excursion was reported as of 30 °F for 6 minutes and no adverse events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Herpes zoster
Clinical narrative: This spontaneous report was received from a female patient of unknown age reporting on herself. The patient's concurrent conditions included familial risk factor. The patient did not have medical history. The patient did not take concomitant medications. On unspecified date in 2007 (reported as: "about 10 years ago"), the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (strength, dose number, route of administration, lot number and expiration date were not provided) for herpes zoster. The reporter stated that "she gets shingles every year" (In 2007) since receiving ZOSTAVAX, it was stated that she "gets shingles roughly around every November" (last episode was In November 2016); additionally, the patient presented "a small rash in the same spot, on her upper hip" (unspecified right or left hip). The patient "self-medicates" (unspecified treatment). At the time of the report, the patient recovered on unspecified date in November 2016 from the herpes zoster. The reporter did not assess the relatedness between herpes zoster and ZOSTAVAX.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse (LPN), referring to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not provided. On multiple unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot number M023380, expiration date 11-MAY-2018, for prophylaxis (dose, frequency and administration route were not provided). Concomitant therapies included a properly stored sterile diluent (lot number M011786, expiration date 22-SEP-2018). The data logger registered a temperature range of minus (-) 14°Celsius (C) to -10°C during a time frame of 3 hours. There was not a previous temperature excursion. No adverse effects were reported. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1709USA004385.
Age: 0.08
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a physician via a company representative, referring to a 1 month old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with the first dose of VAQTA, 0.5 ml (strength, route of administration, lot# and expiration date were not provided) for prophylaxis by mistake. The reporter stated that the mistake was due to an human error and not due to product confusion. No adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse (LPN), referring to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not provided. On multiple unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot number M044719, expiration date 07-MAY-2018, for prophylaxis (dose, frequency and administration route were not provided). Concomitant therapies included a properly stored sterile diluent (lot number M011786, expiration date 22-SEP-2018). The data logger registered a temperature range of minus (-) 14°Celsius(C) to -10°C during a time frame of 3 hours. There was not a previous temperature excursion. No adverse effects were reported. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1709USA004056.
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Skin redness, swelling and pain.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient returned to pharmacy a couple days later complaining of slight swollen at site of injection, with fevered area and redness. By the time the patient came in the symptoms were dissipating per patient.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient returned to pharmacy a couple days later complaining of slight swollen at site of injection, with fevered area and redness. By the time the patient came in the symptoms were dissipating per patient.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Pain
Clinical narrative: Immunization was administered too high and patient presented with severe pain. Patient stated she was unable to move her arm and went to see her physician. Doctor stated vaccine was administered too high.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Fainted for 1 or 2 sec. Call paramedics and Div help.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site irritation, Injection site pain, Malaise
Clinical narrative: Pt stated that he local pain and irritation at injection site on 9/9/17 along with fatigue and malaise. On 9/10/17 he noticed that the right arm began to swell and had turned red from shoulder to elbow. He contacted his physician who suggested he start prednisone 5 mg daily and monitor progress. I looked at his arm today (9/12/17) and saw that it is still red and swollen but he states that it has decreased in severity over the past couple of days.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Pt stated that he local pain and irritation at injection site on 9/9/17 along with fatigue and malaise. On 9/10/17 he noticed that the right arm began to swell and had turned red from shoulder to elbow. He contacted his physician who suggested he start prednisone 5 mg daily and monitor progress. I looked at his arm today (9/12/17) and saw that it is still red and swollen but he states that it has decreased in severity over the past couple of days.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: The HIB part of the vaccine was not administered to the patient, just the DTaP and IPV. It was not re Parent was notified and there was no adverse reaction at the time of the phone call.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Posture abnormal, Seizure like phenomena, Syncope
Clinical narrative: Patient slumped over shortly after receiving her vaccines, fainted and sustained seizure like movement for approx. 3-5 seconds. Patient awakened immediately and was monitored for an hour afterwards by the school nurse. Patient felt better and went back to her classroom.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Dizziness, Fatigue, Injected limb mobility decreased, Injection site pain
Clinical narrative: After 2 hours had severe shooting pain at site. Also had feelings of fatigue and lightheaded. Difficult to move left arm. Had short period of sharp chest pain which resolved. Still feels fatigued and achy.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: After 2 hours had severe shooting pain at site. Also had feelings of fatigue and lightheaded. Difficult to move left arm. Had short period of sharp chest pain which resolved. Still feels fatigued and achy.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Blood glucose normal, Dizziness, Flushing, Immediate post-injection reaction
Clinical narrative: Per NP, right after receiving Tdap Vaccine patient stated she is feeling flushed and lightheaded. She asked patient if had eaten today and she stated no, NP stated vital signs were taken and blood pressure was 114/74, P-86, R-20, O2 Sat 100% on RA, blood sugar was 78. NP gave patient orange juice and crackers and patient felt better stated she had no more flushing or lightheadedness.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Nervousness
Clinical narrative: Patient wasn't sure if she was overreacting or not but thought her face may have felt funny, perhaps a little numb. She also thought her tongue was swelling but that she could also be imagining that because she wasn't really having trouble breathing. She got nervous and so thought maybe that was why she felt like her heart was beating fast. Patient did not seem to be in need of the EPIPEN because she was functioning at full capacity and breathing was fine. She did not have a rash.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Arthropathy, Diarrhoea, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: "Onset 3 days ago. Location is arm, foot and leg. The describes it as erythematous. It occurs continuously. The problem is with no change. Associated factors include urticaria. Pertinent negatives include diarrhea, fatigue, fever, headache, joint symptoms, kerion(s) in scalp, pain, sore throat and vomiting. Additional information: Rash developed one day after receiving PNEUMOVAX vaccine. Rash is not pruritic. She denies angioedema, difficulty breathing, GI symptoms and presyncope. Denies reactions to vaccines in the past." Patient Plan Continue BENADRYL ALLERGY. Advised no pneumonia vaccines in the future. RTC if swelling in toes does not resolve within 1 week.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, Rash, Skin disorder, Urticaria
Clinical narrative: "Onset 3 days ago. Location is arm, foot and leg. The describes it as erythematous. It occurs continuously. The problem is with no change. Associated factors include urticaria. Pertinent negatives include diarrhea, fatigue, fever, headache, joint symptoms, kerion(s) in scalp, pain, sore throat and vomiting. Additional information: Rash developed one day after receiving PNEUMOVAX vaccine. Rash is not pruritic. She denies angioedema, difficulty breathing, GI symptoms and presyncope. Denies reactions to vaccines in the past." Patient Plan Continue BENADRYL ALLERGY. Advised no pneumonia vaccines in the future. RTC if swelling in toes does not resolve within 1 week.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: "Onset 3 days ago. Location is arm, foot and leg. The describes it as erythematous. It occurs continuously. The problem is with no change. Associated factors include urticaria. Pertinent negatives include diarrhea, fatigue, fever, headache, joint symptoms, kerion(s) in scalp, pain, sore throat and vomiting. Additional information: Rash developed one day after receiving PNEUMOVAX vaccine. Rash is not pruritic. She denies angioedema, difficulty breathing, GI symptoms and presyncope. Denies reactions to vaccines in the past." Patient Plan Continue BENADRYL ALLERGY. Advised no pneumonia vaccines in the future. RTC if swelling in toes does not resolve within 1 week.
Age: 74.0
Sex: F
Vaccine: FLUA3, PPV, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reactions- Pain, warmth, soreness, redness, swelling down to elbow, hardening at injection site.
Age: 74.0
Sex: F
Vaccine: FLUA3, PPV, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reactions- Pain, warmth, soreness, redness, swelling down to elbow, hardening at injection site.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Asthma, Chest discomfort, Chills, Condition aggravated
Clinical narrative: Received flu vaccine 9/11 ~2:30pm. ~7pm began having sensation of rapid HR- recorded by Fitbit 107 BPM. Was sitting calmly studying w/o stress or anxiety that could explain the tachy. Also had chest tightness/diff breathing which I would assoc with asthma, but not comfortable using albuterol inhaler to exacerbate uncomfortable rapid HR. ~8pm myalgias and general malaise, took 1/2 dose acetaminophen. Aches made it uncomfortable to study, vague HA, headed for bed. Myalgias progressed to cramping and weakness with assoc. nausea. 9pm chills and fever of 100.5, second 1/2 dose of acetaminophen. Severe pain/cramping/weakness in cervical, thoracic, lumbar regions, unable to relieve with position changes in bed. Nausea continued, no vom. Alternating chills/diaphoresis. Continued until 12a. Mostly resolved by 5a, able to work 9/12.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Dyspnoea, Headache, Heart rate increased, Hyperhidrosis
Clinical narrative: Received flu vaccine 9/11 ~2:30pm. ~7pm began having sensation of rapid HR- recorded by Fitbit 107 BPM. Was sitting calmly studying w/o stress or anxiety that could explain the tachy. Also had chest tightness/diff breathing which I would assoc with asthma, but not comfortable using albuterol inhaler to exacerbate uncomfortable rapid HR. ~8pm myalgias and general malaise, took 1/2 dose acetaminophen. Aches made it uncomfortable to study, vague HA, headed for bed. Myalgias progressed to cramping and weakness with assoc. nausea. 9pm chills and fever of 100.5, second 1/2 dose of acetaminophen. Severe pain/cramping/weakness in cervical, thoracic, lumbar regions, unable to relieve with position changes in bed. Nausea continued, no vom. Alternating chills/diaphoresis. Continued until 12a. Mostly resolved by 5a, able to work 9/12.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Muscle spasms, Myalgia, Nausea, Pain
Clinical narrative: Received flu vaccine 9/11 ~2:30pm. ~7pm began having sensation of rapid HR- recorded by Fitbit 107 BPM. Was sitting calmly studying w/o stress or anxiety that could explain the tachy. Also had chest tightness/diff breathing which I would assoc with asthma, but not comfortable using albuterol inhaler to exacerbate uncomfortable rapid HR. ~8pm myalgias and general malaise, took 1/2 dose acetaminophen. Aches made it uncomfortable to study, vague HA, headed for bed. Myalgias progressed to cramping and weakness with assoc. nausea. 9pm chills and fever of 100.5, second 1/2 dose of acetaminophen. Severe pain/cramping/weakness in cervical, thoracic, lumbar regions, unable to relieve with position changes in bed. Nausea continued, no vom. Alternating chills/diaphoresis. Continued until 12a. Mostly resolved by 5a, able to work 9/12.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Received flu vaccine 9/11 ~2:30pm. ~7pm began having sensation of rapid HR- recorded by Fitbit 107 BPM. Was sitting calmly studying w/o stress or anxiety that could explain the tachy. Also had chest tightness/diff breathing which I would assoc with asthma, but not comfortable using albuterol inhaler to exacerbate uncomfortable rapid HR. ~8pm myalgias and general malaise, took 1/2 dose acetaminophen. Aches made it uncomfortable to study, vague HA, headed for bed. Myalgias progressed to cramping and weakness with assoc. nausea. 9pm chills and fever of 100.5, second 1/2 dose of acetaminophen. Severe pain/cramping/weakness in cervical, thoracic, lumbar regions, unable to relieve with position changes in bed. Nausea continued, no vom. Alternating chills/diaphoresis. Continued until 12a. Mostly resolved by 5a, able to work 9/12.
Age: 49.0
Sex: F
Vaccine: FLU4, TTOX
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swollen, hot to the touch. Approximately the size of a silver dollar.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmness, swelling at the injection site. Symptoms occurred approximately 3 hours post-vaccination and continuing at time of report (28 hours later). Advised patient to ice the area to reduce swelling and warmness.
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Confusional state, Crying, Dizziness, Injection site haemorrhage, Loss of consciousness
Clinical narrative: After administring the vaccine to the patient i pulled the needel and there was a blood droplet showing on the site of injection. I applied a bandadge and some pressure for the bandadge to stik to the patients' (her) skin while the patient was looking at it. The patient said that she is feeling light headed and leaned on the counter and lost conciousness. I tried to lay her on  the ground and asked if she is ok in a loud voice then called the pharmacy tech to call 911. The patient regained back her conciousness and was confused for few seconds then she asked to cancell the 911 call so we did. I asked if she can sit on a chair so she did and asked if she is ok. She was crying a little bit and said that she was under a lot of stress and had a long day and wants to go home. I insisted on calling 911 agian to make sure that she is ok. i was chatting to the patietn while waiting for the emergency responders to come. In few minutes the emergency responders showed up and asked if she is ok and if she wants them to check on her. the patient said that she do not mind but she is really feeling ok and there no need for it and that she wants to go home. The emergency responders offered to walk her to her car she said ok. they all walked away from the pharmacy toward the the main entrance\.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site rash
Clinical narrative: Patient experienced a skin rash on the biceps region of her left arm and also reported a headache that was relieved when she took TYLENOL.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction to the right arm. Red, hot, swollen, and painful. PCP does not think this is more than an injection site reaction with no infection and no fever.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Patient developed severe pain in shoulder that has persisted. Vaccine site indicated by patient was into the deltoid ligament and not in the muscle. Continues to have limited range of motion and pain.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Nodule, Peripheral swelling, Pruritus, Scar, Urticaria
Clinical narrative: Pt. stated that his arm started swelling within the hour, felt like he had been stung by a bee, then hand swelled, left his hand and calf swelled and pt says there was a knot at his knee, then his buttocks got welts that were extremely itchy and pt scratched them and he still has marks from that. Afterwards  went back to legs and arm swelled quite severely like he had been stung by a wasp. This lasted about two weeks. Pt did not seek treatment and reported to me today on 9/12/2017.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Patient told us that she had gone to urgent care over the weekend to have her injection site looked at. she said it became red and inflamed and hot for about 3 inches all around the site. She was given a steroid shot at urgent care and then told to take Benadryl when she got home.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient said on the anterior surface of her right arm from shoulder 1/2 way down to elbow was red and hot to touch. It is much better today she has been using BENADRYL and cold packs.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient's arm became swollen the next day (9/10). On 9/11 the patient went to urgent care where doctor prescribed prednisone. Patient states she is much better today and swelling is almost all gone (today 9/12).
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site within minutes after administration. Redness spread to large area of tricep but receded by 50% within minutes.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Rash erythematous, Skin warm, Swelling
Clinical narrative: Red rash and hot to the touch, swelled to the size of a small egg within 3 hours of administration. On the third day, pt went urgent care and the md there determined cellulitis from the PNEUMOVAX. Prescribed mupiricin oint and clindamycin capsules.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Vaccination site cellulitis
Clinical narrative: Red rash and hot to the touch, swelled to the size of a small egg within 3 hours of administration. On the third day, pt went urgent care and the md there determined cellulitis from the PNEUMOVAX. Prescribed mupiricin oint and clindamycin capsules.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Death
Clinical narrative: She passed away.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had redness in the area that was administered. The redness has spread since that date of administration and area is swollen.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: L deltoid swelled up, extremely painful, hot to touch, bright red. Migrated to underside of arm (spreading down toward elbow).
Age: 58.0
Sex: M
Vaccine: PNC13
Symptoms: Peripheral swelling, Swelling face
Clinical narrative: Swelling of face arm and legs.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Blister, Dry skin, Rash erythematous, Rash pruritic
Clinical narrative: Beginning 1 day after receiving 3 vaccines, patient developed a rash on face, neck and chest that has progressively gotten worse. Very red, dry, itchy with blisters that are oozing with a clear, sticky liquid Possibly like shingles.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13, PPV
Symptoms: Infection, Injection site erythema, Injection site swelling, Sepsis
Clinical narrative: Patient developed infection after receiving PREVNAR 13 vaccine. Area around injection became red and swollen.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13, PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Patient developed infection after receiving PREVNAR 13 vaccine. Area around injection became red and swollen.
Age: 8.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Hypoaesthesia, Somnolence
Clinical narrative: Pt when given the vaccine felt he was going to faint. His hands went numb. He felt he could not keep his eyes open. Pt was made to sit at Pharmacy under observation for sometime. Pt felt perfectly fine in few minutes.
Age: 11.0
Sex: M
Vaccine: FLUC4
Symptoms: Dysstasia, Fall, Vision blurred
Clinical narrative: Pt. got vaccine and in 5-7 mins. he fell on the ground but was conscious. He complained that he had blurred vision and could not stand. he was made to sit in the chair in the vaccination area under observation and he was ok in few mins.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV
Symptoms: Pyrexia, Vaccination site bruising, Vaccination site swelling
Clinical narrative: Pt got PROQUAD vaccine on 25 August and got fever with local swelling with bruise RT at the site of vaccination (after a wk on 9/6/17). Local ice and MOTRIN were given by mom.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large amount of swelling/redness around injection site within approximately 1 day of injection, lasted several days, did prednisone to treat.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Skin exfoliation, Skin warm
Clinical narrative: Patient came to office five day after reaction started. When seen area was 5x4cm area red, still a little warm to touch. Skin is peeling, size of quarter knot. Complaining of itching-Parents did not call office prior to coming-and had not really done anything. Let it run its course.
Age: 66.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Hyperhidrosis, Insomnia, Listless, Pain, Pain in extremity
Clinical narrative: Pt received this vaccine in his right arm and he has been sore in this arm, no redness no swelling, can't see where the injection was given; pt is sweating, he feels listless, he has body aches and is concerned that he has never had this kind of reaction from a a vaccine before-pt feeling better today (6/23) than the night of the vaccine (6/20). States he is not sleeping and feels that is why he feels the way he does.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness,warmth and swelling at the site.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Abscess limb, Cellulitis, Discomfort, Swelling, Ultrasound scan normal
Clinical narrative: Pt received Flu shot 8/30/17. Patient experienced discomfort swelling the next day. Went to ER 9/1 and had ultrasound. Nothing showed up. Went back on 9/5 due to increased swelling. Pt was hospitalized 9/5-9/11. Diagnosis: Right arm abscess and cellulitis.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 24 hours post-injection Pt C/O red, raised, itchy area where injection site located - warm to touch, tender. No fever.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: (L) upper arm/shoulder swollen, red, warm to touch. Local reaction to influenza vaccine. Treatment - continue analgesics, antihistamines and cool compresses.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Ear discomfort, Haematoma, Headache, Hypoaesthesia
Clinical narrative: Complained about clogged ears (felt like she was under water), night vaccine was administered; hematoma (swollen); severe headache; thumb of the arm where shot was administered numb whenever patient bends her fingers (only happens) on left and right thumb, mostly left.
Age: 2.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Asthenia, Dizziness, Dyspnoea, Hyperventilation
Clinical narrative: Hyperventilation, weakness, lightheadedness, shortness of breath.
Age: 28.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, swelling, warmth, itchy began within 24hrs of injection. Treated with ice. Presents 4 days later with improvement.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Headache, Injection site pain, Injection site warmth
Clinical narrative: Area at inj. site sore. Feels warm. No temp taken. C/o slight ha.
Age: 1.0
Sex: F
Vaccine: HEPAB, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: The patient developed fever for 48 hours post vaccination with MMR, HepA, Varicella, and PCVB. Subsequently, on day 5 developed a maculopapular rash-diffuse. No fever at that time.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Injection site mass, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Burning sensation, itching, blisters around injection site, swelling, soreness, fever, injection site hot with large lump, swelling.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pruritus, Pyrexia, Swelling
Clinical narrative: Burning sensation, itching, blisters around injection site, swelling, soreness, fever, injection site hot with large lump, swelling.
Age: 1.58
Sex: F
Vaccine: FLUX, HEP
Symptoms: Cough, Croup infectious, Stridor
Clinical narrative: Patient received both influenza and HepB vaccines around 0930 on morning of 9/12/2017. No prodromal illness or upper respiratory symptoms. Patient woke at 2230 on night of 9/12/2017 with barky cough and inspiratory stridor, ultimately presenting to Pediatric ED where she required racemic epinephrine nebulizer treatment and oral DECADRON for croup symptoms with stridor.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Body temperature increased, Chills, Headache, Injection site pain
Clinical narrative: I did NOT keep the paper which specified flu vaccine details! Pharmacist did. 5:00 pm 9/12 pain @ injection site similar to bursitis. 12:30 am 9/13, chills, shivering, teeth chattering despite warm bed wear, bedclothes, room temp. 3:30 am 9/13 stabbing pain in joints (both shoulders, both knees, neck both sides near mastoid, both hips, uncontrollable shivering, teeth chattering. Got up to take temp 101.1 (patient basal temp is 97.9). Forehead headache across brow temple to temple.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Injection site erythema, Injection site warmth, Malaise
Clinical narrative: Redness and hot to the touch around the site, HA, and feeling of malaise off/on X 4 days.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 17-AUG-2017, the patient was vaccinated with VARIVAX (lot # N002204, expiration date 19-JAN-2019) (route, dosage and frequency were not reported) which was improperly stored. The sterile diluent used to reconstitute the VARIVAX was properly stored. No symptoms reported. The vaccine was stored at -1.6 degree centigrade for 15 hours. The vaccine had previous temperature excursion which was stored at a temperature from -9 degree centigrade to 8 degree centigrade for 30 hours and 15 minutes. Data logger was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010756: US-009507513-1708USA010757: US-009507513-1708USA010758: US-009507513-1708USA010759: US-009507513-1708USA010760: US-009507513-1708USA010761: US-009507513-1708USA010762.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 18-AUG-2017, the patient was vaccinated with VARIVAX (lot # N002204, expiration date 19-JAN-2019) (route, dosage and frequency were not reported) which was improperly stored. The sterile diluent used to reconstitute the VARIVAX was properly stored. No symptoms reported. The vaccine was stored at -1.6 degree centigrade for 15 hours. The vaccine had previous temperature excursion which was stored at a temperature from -9 degree centigrade to 8 degree centigrade for 30 hours and 15 minutes. Data logger was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010758: US-009507513-1708USA010754: US-009507513-1708USA010757: US-009507513-1708USA010762: US-009507513-1708USA010759: US-009507513-1708USA010761: US-009507513-1708USA010760.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 18-AUG-2017, the patient was vaccinated with VARIVAX (lot # N002204, expiration date 19-JAN-2019) (route, dosage and frequency were not reported) which was improperly stored. The sterile diluent used to reconstitute the VARIVAX was properly stored. No symptoms reported. The vaccine was stored at -1.6 degree centigrade for 15 hours. The vaccine had previous temperature excursion which was stored at a temperature from -9 degree centigrade to 8 degree centigrade for 30 hours and 15 minutes. Data logger was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010758: US-009507513-1708USA010756: US-009507513-1708USA010754: US-009507513-1708USA010762: US-009507513-1708USA010759: US-009507513-1708USA010760: US-009507513-1708USA010761.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 22-AUG-2017, the patient was vaccinated with VARIVAX (lot # N002204, expiration date 19-JAN-2019) (route, dosage and frequency were not reported) which was improperly stored. The sterile diluent used to reconstitute the VARIVAX was properly stored. No symptoms reported. The vaccine was stored at -1.6 degree centigrade for 15 hours. The vaccine had previous temperature excursion which was stored at a temperature from -9 degree centigrade to 8 degree centigrade for 30 hours and 15 minutes. Data logger was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010754: US-009507513-1708USA010756: US-009507513-1708USA010757: US-009507513-1708USA010762: US-009507513-1708USA010759: US-009507513-1708USA010760: US-009507513-1708USA010761.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 23-AUG-2017, the patient was vaccinated with VARIVAX (lot # N002204, expiration date 19-JAN-2019) (route, dosage and frequency were not reported) which was improperly stored. The sterile diluent used to reconstitute the VARIVAX was properly stored. No symptoms reported. The vaccine was stored at -1.6 degree centigrade for 15 hours. The vaccine had previous temperature excursion which was stored at a temperature from -9 degree centigrade to 8 degree centigrade for 30 hours and 15 minutes. Data logger was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010758: US-009507513-1708USA010756: US-009507513-1708USA010757: US-009507513-1708USA010762: US-009507513-1708USA010754: US-009507513-1708USA010760: US-009507513-1708USA010761.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 21-AUG-2017, the patient was vaccinated with VARIVAX (lot # N002204, expiration date 19-JAN-2019) (route, dosage and frequency were not reported) which was improperly stored. The sterile diluent used to reconstitute the VARIVAX was properly stored. No symptoms reported. The vaccine was stored at -1.6 degree centigrade for 15 hours. The vaccine had previous temperature excursion which was stored at a temperature from -9 degree centigrade to 8 degree centigrade for 30 hours and 15 minutes. Data logger was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010758: US-009507513-1708USA010756: US-009507513-1708USA010757: US-009507513-1708USA010762: US-009507513-1708USA010759: US-009507513-1708USA010754: US-009507513-1708USA010761.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 21-AUG-2017, the patient was vaccinated with VARIVAX (lot # N002204, expiration date 19-JAN-2019) (route, dosage and frequency were not reported) which was improperly stored. The sterile diluent used to reconstitute the VARIVAX was properly stored. No symptoms reported. The vaccine was stored at -1.6 degree centigrade for 15 hours. The vaccine had previous temperature excursion which was stored at a temperature from -9 degree centigrade to 8 degree centigrade for 30 hours and 15 minutes. Data logger was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010758: US-009507513-1708USA010756: US-009507513-1708USA010757: US-009507513-1708USA010762: US-009507513-1708USA010759: US-009507513-1708USA010760: US-009507513-1708USA010754.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 15-AUG-2017, the patient was vaccinated with VARIVAX (lot # N002204, expiration date 19-JAN-2019) (route, dosage and frequency were not reported) which was improperly stored. The sterile diluent used to reconstitute the VARIVAX was properly stored. No symptoms reported. The vaccine was stored at -1.6 degree Centigrade for 15 hours. The vaccine had previous temperature excursion which was stored at a temperature from -9 degree Centigrade to 8 degree Centigrade for 30 hours and 15 minutes. Data logger was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010758: US-009507513-1708USA010756: US-009507513-1708USA010757: US-009507513-1708USA010754: US-009507513-1708USA010759: US-009507513-1708USA010760: US-009507513-1708USA010761.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a other refers to a 58 year old male patient. The patient's medical history included transfusion. On 06-OCT-2009 the patient was vaccinated with ZOSTAVAX lot # M041086, .65 ml, subcutaneous in the right arm for prophylaxis. Concomitant therapies included sterile diluent (MERCK). On 06-OCT-2009, 1 day after onset of therapy the patient experienced inappropriate schedule of drug administration. The outcome of inappropriate schedule of drug administration is unknown. The reporter considered inappropriate schedule of drug administration to be not related to ZOSTAVAX.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concurrent condition and medical history were not reported. The concomitant therapy included sterile diluent (manufacturer unknown). Since 22-MAY-2017 to 23-AUG-2017, the patients administered improperly stored doses of GARDASIL 9 (dose, frequency and route unknown, lot #M023169, lot#M028323, expiration date: 26-SEP-2018, lot# M037770,) for prophylaxis. The temperature excursion was at 9 Celsius Degree to 25 Celsius Degree for 4.5 hours. There was no previous temperature excursion. Data logger involved. No adverse effects were reported in any patients. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA006063: US-009507513-1709USA006065: US-009507513-1709USA006062: US-009507513-1709USA006064.