chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical student refers to a patient of unknown age and gender. Patient's pertinent medical history, drug reactions and allergies were not reported. On an unknown date in 2011, the patient was vaccinated with the first dose of GARDASIL (lot number and expiry date unspecified). No concomitant medications were reported. On an unknown date in 2012 (reported as a year later), the patient was vaccinated with the second dose of GARDASIL (inappropriate schedule of drug administration). The reporter confirmed that the patient did not receive the third dose of the three dose vaccine series (drug dose omission). No adverse effects were reported. The action taken with the suspect therapy and outcome of the events was unknown. There was not product quality complaint (PQC) reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (15 hours in 34F) doses of GARDASIL 9 (lot # reported as L020190 with expiration date 13-APR-2017; dose and route of administration were not reported). No previous excursion and no adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD injection, lot # M006104, expiration date 01-AUG-2017 or lot # reported as M023931, expiration date 09-NOV-2017 (doses, routes and sites of administration were not reported). It was unknown if the patients experienced any adverse events as the call was disconnected prior to providing this information. Product quality complaint was not involved. The administered doses of vaccine were stored in the temperature of 7.3 degrees Fahrenheit for 18 minutes. The data logger was involved. There were no previous excursions reported. No further information was provided. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Vaccine administered 10/19. Patient developed red swollen painful arm. 10/26 came to pharmacy. Redness spread to elbow suggested medical attention.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm was red and warm to the touch slightly swollen. I told her to watch over next 24 hours if does not get better or symptoms get worse seek MD treatment.
Age: 82.0
Sex: U
Vaccine: PPV
Symptoms: Bacterial infection, Erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 2 days after administration of PNEUMOVAX 23, pt. went to Urgent Care w/complaints of redness, swelling, hot to touch skin from left side of neck down through the left hand. Pt. experienced twinges in arm, tingling in fingers as well as blotches.
Age: 82.0
Sex: U
Vaccine: PPV
Symptoms: Local swelling, Paraesthesia, Peripheral swelling, Rash macular, Skin warm
Clinical narrative: 2 days after administration of PNEUMOVAX 23, pt. went to Urgent Care w/complaints of redness, swelling, hot to touch skin from left side of neck down through the left hand. Pt. experienced twinges in arm, tingling in fingers as well as blotches.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Apnoea, Blood glucose normal, Musculoskeletal stiffness, Unresponsive to stimuli
Clinical narrative: Patient became unresponsive, stiffened up, and stopped breathing. After a minute patient came to. Called 911. Blood pressure, HR, and blood glucose was checked everything normal.
Age: 1.08
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Erythema, Induration, Swelling
Clinical narrative: She had redness and swelling starting the day of the injection no fever, limp or difficulty with squatting down and standing back up. Seen in our office 10/27, 1x1.5cm area of induration with mild erythema. No sign of pain with palpation of the area. No fluctuance or purulence. Mom said the redness had decreased since 10/26.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Reaction to PREVNAR 13 vaccination raised approximately 10x10 cm area with redness, swelling and itching Not anaphylaxis.
Age: 53.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt. went to hospital. Injection site was red, hot and painful. According to MD. pt. might have had serum reaction which develop into infection and to cellulitis. Pt. given clindamycin and MEDROL pack.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Lipoatrophy
Clinical narrative: Lipoatrophy.
Age: 80.0
Sex: U
Vaccine: FLU3, PPV, FLU4, PPV, FLU4
Symptoms: Injection site pain
Clinical narrative: Initial unsolicited report received from a pharmacist on 19 Oct 2016. This case is linked with 2016SA193104 (same vaccine, same reporter). This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE (batch number: L038522, expiration date: 11 Aug 2017, dose not reported) via intramuscular route on 06 Oct 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not provided. The patient received thyroid medication and glaucoma drops as corrective treatment. On an unspecififed date, post vaccination; the patient experienced excessive soreness and inability to lift arm. On 09 Oct 2016, the patient was followed up and the patient was better but still had sore and cannot lift arm without use of other arm and there was still extreme soreness. Lab data was reported as none. Corrective treatment received was ibuprofen for pain (upto 800 mg). The patient was not recovered from the events. List of documents held by sender: none.
Age: 80.0
Sex: U
Vaccine: FLU3, PPV, FLU4, PPV, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a pharmacist on 19 Oct 2016. This case is linked with 2016SA193104 (same vaccine, same reporter). This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE (batch number: L038522, expiration date: 11 Aug 2017, dose not reported) via intramuscular route on 06 Oct 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not provided. The patient received thyroid medication and glaucoma drops as corrective treatment. On an unspecififed date, post vaccination; the patient experienced excessive soreness and inability to lift arm. On 09 Oct 2016, the patient was followed up and the patient was better but still had sore and cannot lift arm without use of other arm and there was still extreme soreness. Lab data was reported as none. Corrective treatment received was ibuprofen for pain (upto 800 mg). The patient was not recovered from the events. List of documents held by sender: none.
Age: 80.0
Sex: U
Vaccine: FLU3, PPV, FLU4, PPV, FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a pharmacist on 19 Oct 2016. This case is linked with 2016SA193104 (same vaccine, same reporter). This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE (batch number: L038522, expiration date: 11 Aug 2017, dose not reported) via intramuscular route on 06 Oct 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not provided. The patient received thyroid medication and glaucoma drops as corrective treatment. On an unspecififed date, post vaccination; the patient experienced excessive soreness and inability to lift arm. On 09 Oct 2016, the patient was followed up and the patient was better but still had sore and cannot lift arm without use of other arm and there was still extreme soreness. Lab data was reported as none. Corrective treatment received was ibuprofen for pain (upto 800 mg). The patient was not recovered from the events. List of documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Pyrexia, Tremor
Clinical narrative: This is a spontaneous report received from a contactable physician from FDA. Temporary VAERS E-Report Number was E-109774. A 17-year-old female patient received a second single dose of TRUMENBA; (Lot Number: N11903), intramuscular in right arm on 17Oct2016 at 16:30 for immunisation. No Illnesses at the time of vaccination or pre-existing conditions reported. There were no concomitant medications. On  17Oct2016 at 19:30 the patient experienced Fever at 102 F and shakiness. Events not recovered.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: This is a spontaneous report obtained from a contactable nurse. A 65-year-old female patient received, on 14Oct2016, between 1-2 PM, PREVNAR 13, (Lot. M67951, Expiration date: 01Aug2017) intramuscularly, in the left arm, at 0.5 ml, single dose, for immunization. On the day of vaccination, the patient complained of joint aches but nothing else. She had come in to see the PCP for joint pain in her shoulder and pain in her hands and right hip; arthritis, status post right hip replacement. Concomitant medications included oral naproxen 500 mg, twice daily, from 21Jun2016 (ongoing); macrogol 3350 (PEG 3350) from 06Jun2016 (ongoing); oral gabapentin 300 mg, daily, at night from 06Jun2016 (ongoing); PREMARIN; MIRALAX and influenza vaccine (Lot. U1634AB, Expiration date: 22Sep2017) on an unspecified date, in Sep2016, in the right arm, for immunization. On an unspecified date, the patient experienced pain at the injection site and on 19Oct2016 cellulitis. The patient came to the office on 19Oct2016 because of the adverse event. She was started on an antibiotic sulfamethazole 160 mg 1 tablet every 12 hours for 14 days. She returned to the office because it was not resolving on 21Oct2016 and was advised to go to the ER after the primary care physician saw her.  The patient did place a Lidoderm patch on her injection site because of the pain. Clinical outcome of the events was unknown at time of this report. Sender's Comments: A causal relationship between the administration of PREVNAR 13 and the occurrence of the reported events cannot be excluded based on the known adverse event profile and on the temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Cellulitis, Injection site pain
Clinical narrative: This is a spontaneous report obtained from a contactable nurse. A 65-year-old female patient received, on 14Oct2016, between 1-2 PM, PREVNAR 13, (Lot. M67951, Expiration date: 01Aug2017) intramuscularly, in the left arm, at 0.5 ml, single dose, for immunization. On the day of vaccination, the patient complained of joint aches but nothing else. She had come in to see the PCP for joint pain in her shoulder and pain in her hands and right hip; arthritis, status post right hip replacement. Concomitant medications included oral naproxen 500 mg, twice daily, from 21Jun2016 (ongoing); macrogol 3350 (PEG 3350) from 06Jun2016 (ongoing); oral gabapentin 300 mg, daily, at night from 06Jun2016 (ongoing); PREMARIN; MIRALAX and influenza vaccine (Lot. U1634AB, Expiration date: 22Sep2017) on an unspecified date, in Sep2016, in the right arm, for immunization. On an unspecified date, the patient experienced pain at the injection site and on 19Oct2016 cellulitis. The patient came to the office on 19Oct2016 because of the adverse event. She was started on an antibiotic sulfamethazole 160 mg 1 tablet every 12 hours for 14 days. She returned to the office because it was not resolving on 21Oct2016 and was advised to go to the ER after the primary care physician saw her.  The patient did place a Lidoderm patch on her injection site because of the pain. Clinical outcome of the events was unknown at time of this report. Sender's Comments: A causal relationship between the administration of PREVNAR 13 and the occurrence of the reported events cannot be excluded based on the known adverse event profile and on the temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 70.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Injection site erythema
Clinical narrative: Initial unsolicited report received from a pharmacist on 17 October 2016. This case involves a 70-year-old male patient who was vaccinated with FLUZONE (lot number, expiration date, route of administration, dose and dose in series were not reported) and PNEUMOVAX 23 (lot number: M013156, expiration date of product:15 October 2017, route of administration, dose and dose in series were not reported) in the arm on 24 September 2016. The medical history was as unknown and concomitant medications was reported as none. On 24 September 2016, same day of the vaccination, the patients developed redness in the arm which continued to spread out from the injection site for about 3 days. No laboratory test was performed and the corrective treatment were reported as none. The outcome of the events was reported as recovered on an unspecified date. List of the documents held by sender: none.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Tenderness
Clinical narrative: Localized erythema, itching and tenderness to touch.
Age: 46.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site pain
Clinical narrative: Severe pain in the muscle of the injection sight.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for herself. This 22 year-old female patient received the first dose of TRUMENBA intramuscular in the left arm on 27Sep2016 at 0.5 ml single for immunisation.  Medical history included polycystic ovarian syndrome from Feb2016, Hashimoto's disease from Feb2016, low immunity, headache, fever, sore throat and cold. Concomitant medications included ethinyl estradiol, ORSYTHIA, tablet for polycystic ovarian syndrome, ROBITUSSIN for sore throat, FLONASE, TYLENOL for headache and fever, levothyroxine (100mcg on the weekend and during the weekdays 88 mcg) intramuscular for Hashimoto's disease. The patient experienced bump on arm, red and hard on 27Sep2016. Therapeutic measures were taken as a result of events and included menthol ointment and hot compress, but it did not go away. The patient was recovering at the time of this report. The patient said that she had been having a cold lately so she did not know if having a low immunity was causing the bumps on her left arm.
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a non-contactable female Pharmacist via a Company representative reporting for herself. An adult female patient of an unspecified age (in her mid to upper 50s) and ethnicity  received PREVNAR 13, via an unspecified route of administration on an unspecified date 0.5ml, single for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced swelling in arm and pain in arm on an unspecified date with outcome of unknown.  The pain and swelling lasted about 4 to 5 days. Reporter pointed to her right arm when reporting the event, but caller is not sure if the injection was administered in her right arm. No follow up attempts possible. No further information expected.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray normal, Chest discomfort, Computerised tomogram normal, Cough, Dysphonia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 73-year-old female patient received PREVNAR 13, intramuscular in the left arm, on 20Aug2016 at 02:40 PM, at 0.5 ml single, for immunisation. Relevant medical history included osteoporosis from 2010 (she has shrunk 2 1/2 inches from osteoporosis), osteopenia from 2005, fractures (history of three fractures), allergy multiple (to Penicillin, Clarithromycin, egg whites, cats, horses, dust mites), high cholesterol, hypoactive thyroid, sickness from 1995, pneumonia from 1995, flu from 1995, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities, diabetes, obesity. Past drug history included tetanus diphtheria (unspecified trade name) in 2011 for immunisation and the patient experienced vaccination site reaction, swelling, redness and soreness; Levaquin (unspecified trade name) and experienced tendon disorder. Concomitant medications included simvastatin (unspecified trade name) from 2004 and ongoing, for high cholesterol and SYNTHROID from an unspecified date and ongoing, for hypoactive thyroid. The patient previously took tetanus diphtheria for immunisation and experienced skin reaction, swelling, erythema and pain. The patient experienced hoarseness of voice on 27Aug2016 with outcome of recovered, wheezing on 29Aug2016 with outcome of recovering, coughing on 29Aug2016 with outcome of recovering, tightness in chest on 29Aug2016 with outcome of recovering, difficulty breathing added to PREVNAR 13 on 29Aug2016 with outcome of recovered, got sick with the PREVNAR 13 on an unspecified date with outcome of unknown. Events wheezing, cough and tightness in chest were evaluated at physician office. The patient underwent lab tests and procedures which included: chest x-ray, no pneumonia scarring from previous pneumonias on Aug2016; computerised tomogram, negative on 22Sep2016; echocardiogram, everything was ok on 07Oct2016. Therapeutic measures were taken as a result of wheezing, coughing, tightness in chest and difficulty breathing added to PREVNAR 13.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Echocardiogram normal, Malaise, Wheezing
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 73-year-old female patient received PREVNAR 13, intramuscular in the left arm, on 20Aug2016 at 02:40 PM, at 0.5 ml single, for immunisation. Relevant medical history included osteoporosis from 2010 (she has shrunk 2 1/2 inches from osteoporosis), osteopenia from 2005, fractures (history of three fractures), allergy multiple (to Penicillin, Clarithromycin, egg whites, cats, horses, dust mites), high cholesterol, hypoactive thyroid, sickness from 1995, pneumonia from 1995, flu from 1995, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities, diabetes, obesity. Past drug history included tetanus diphtheria (unspecified trade name) in 2011 for immunisation and the patient experienced vaccination site reaction, swelling, redness and soreness; Levaquin (unspecified trade name) and experienced tendon disorder. Concomitant medications included simvastatin (unspecified trade name) from 2004 and ongoing, for high cholesterol and SYNTHROID from an unspecified date and ongoing, for hypoactive thyroid. The patient previously took tetanus diphtheria for immunisation and experienced skin reaction, swelling, erythema and pain. The patient experienced hoarseness of voice on 27Aug2016 with outcome of recovered, wheezing on 29Aug2016 with outcome of recovering, coughing on 29Aug2016 with outcome of recovering, tightness in chest on 29Aug2016 with outcome of recovering, difficulty breathing added to PREVNAR 13 on 29Aug2016 with outcome of recovered, got sick with the PREVNAR 13 on an unspecified date with outcome of unknown. Events wheezing, cough and tightness in chest were evaluated at physician office. The patient underwent lab tests and procedures which included: chest x-ray, no pneumonia scarring from previous pneumonias on Aug2016; computerised tomogram, negative on 22Sep2016; echocardiogram, everything was ok on 07Oct2016. Therapeutic measures were taken as a result of wheezing, coughing, tightness in chest and difficulty breathing added to PREVNAR 13.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from a consumer via social media on 10 Oct 2016. This case is linked with 2016SA188144, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851, 2016SA191730, 2016SA191735, 2016SA191739, 2016SA191741, 2016SA191743, 2016SA191744 (same source and same vaccine). This case involves a male patient (age unknown) who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, dose, route and site of administration were not reported) on unspecified date. Medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient had got flu. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. The reporter assessed the events as minor. List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness, Multiple sclerosis relapse
Clinical narrative: Initial information for this unsolicited case was received from a patient on 12-Oct-2016. This case concerns a 67-year-old female patient who experienced MS to flare up and flu-like symptoms unknown duration after administration of Aubagio and influenza vaccine. Concomitant medications included simvastatin, ampyra, ramipril, Vitamin B12, Vitamin C3, calcium/Vitamin D. no relevant medical history or past drugs were reported. On an unknown date, the patient started therapy with influenza vaccine (dosing details, lot number and expiry date; unknown) and with oral teriflunomide tablet (strength; 14 mg) at a dose of 14 mg once daily for multiple sclerosis (lot number and expiry date; unknown). The patient had a flu shot was had flu like symptoms (onset and latency; unknown) which was causing her multiple sclerosis to flare up (onset and latency; unknown) but she felt like she was getting better since the flu like symptoms were getting better. Action taken; unknown Corrective treatment; not reported. Outcome; resolving. Reporter causality; not reported. Sender's Comments: Sanofi company comment dated 21-10-16- This case concerns a 67-year-old female patient who experienced multiple sclerosis flare while on influenza vaccine. Although the causal role of the vaccine with the event cannot be assessed due to lack of adequate information about patient's past medical history, concomitant medications and underlying medical conditions.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Initial unsolicited report received from a pharmacist on 17 Oct 2016. This case involves a female patient (age and date of birth not reported) who was vaccinated with a dose of Fluzone high dose (batch number: UI666AB, expiration date: 13 Apr 2017, route, dose not reported) and dose of Pneumovax 23 (batch number: L035686, expiration date: 16 Feb 2017, route, dose not reported) in the arm on 07 Oct 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and concomitant medications were not provided. On 07 Oct 2016, same day post vaccination; the patient experienced soreness and a red area on upper arm in the area of the injections. It was reported that the red area was increased in size (until 10 Oct 2016) and extending from the injection sites down to elbow. Lab data and corrective treatment was not reported. On an unspecified date, the patient was recovered from the event soreness. Outcome of other events was not reported. List of documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Initial unsolicited report received from a nurse on 18 October 2016. This case involves a 17-year-old female patient, who was vaccinated with dose of FLUZONE QIV MDV (batch number: UI669AA, expiry date, route and site of administration were not reported) on 13 September 2016. Patient's medical history and concomitant medications were not reported. On 03 October 2016, 20 days following vaccination patient was seen again by office complaining of muscle weakness and diagnosed with Guillain-Barre syndrome. On 03 October 2016, patient was hospitalized. Laboratory data and corrective treatment were not reported. The outcome of the events was not reported. Documents held by sender: none. Sender's Comments: This case concerns 18 year old female patient who received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and 20 days later developed Guillain-Barre syndrome. However in this particular case very limited information has been provided. Further information regarding etiological work up, concurrent condition at the time of vaccination, concomitant medication and investigation results to rule out the alternative cause are needed for complete assessment of the case.
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Rash
Clinical narrative: Initial unsolicited report received from a consumer on 17 October 2016. This case involves a female patient (age not reported) who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration was not reported) on September 2016. Patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination patient experienced injection site pain and a rash on arm. Laboratory data was not reported. On an unspecified date patient was treated with antibiotics as corrective treatment. Outcome of the events was not reported. Documents held by sender: none.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: Initial unsolicited report received from a pharmacist in the United States on 19 Oct 2016. This case involves a 76 year old female patient who was vaccinated with a dose of FLUZONE HD (Batch number: UI712AA, expiration date- 25 May 2017) intramuscularly in right deltoid on 14 Oct 2016. The patient illness at the time of vaccination was reported as none. And preexisting physician diagnosed allergies include allergy to erythromycin, the patient birth defects, medical conditions and Any other vaccinations within four weeks of vaccinations was not reported. The patient concomitant medications were not reported. On 14 Oct 2016, same day after the vaccination, the patient reported that she have red bumps on both arms (Rash papular). The patient Laboratory investigations and corrective treatment were not reported. The outcome of event was reported as not recovered. List of documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pleurisy
Clinical narrative: Initial unsolicited report received from a pharmacist on 19 Oct 2016. This case involves a 65 year old female patient who was vaccinated with a dose of FLUZONE HD (Batch number, expiry date, dose in series, route and site of administration was not reported) on 04 Oct 2016. The patient illness at the time of vaccination, preexisting physician diagnosed allergies, birth defects, medical conditions was reported as not provided and any other vaccinations within four weeks of vaccinations was not reported. The patient concomitant medications were not reported. On 12 Oct 2016, eight days following the vaccination, the patient developed pleurisy. The patient Laboratory investigations and corrective treatment were not reported. The outcome of event was reported as unknown. List of documents held by sender: none.
Age: 1.08
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea
Clinical narrative: Initial unsolicited report received from a non- healthcare professional (Medical Assistant) on 20 October 2016. This case involves a 13-month-old female patient who was vaccinated with a second dose Fluzone Qiv 0.25ml (batch number: UT5583UA, expiration date: 30 June 2017, dose and route of administration were not reported), in the left thigh on 18 October 2016. It was reported that patient had diarrhea after first dose (previous) of flu vaccine vaccinated on 07 March 2016. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none. Any other vaccinations within 4 weeks of vaccinations were reported as none. On 18 October 2016, same day following the vaccination, the patient had diarrhea. Relevant diagnostic tests or laboratory data was reported as none. Patient's corrective treatment was not reported. On an unknown date patient recovered from the event. List of documents held by sender: none.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from other non-healthcare professional on 20 October 2016. This case involves a 71-year-old male patient who was vaccinated with dose of FLUZONE QIV (batch number: UT5673KA, expiry date: 30 June 2017) intramuscularly in left deltoid on 04 October 2016. Patient's Illness at time of vaccination: none as per reporter and pre-existing physician diagnosed allergies, birth defects, medical conditions includes: Allergies: no known drug allergies as per reporter. Concomitant medication was reported as none. On 04 October 2016, same day following vaccination patient experienced shoulder pain radiating to shoulder blade since received vaccination that continued till (20 October 2016) and it was painful upon movement of the arm. Laboratory data and corrective treatment were not reported. Patient was not recovered from the events. Documents held by sender: none.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site rash
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 20 October 2016. This case involves 38 years old female patient who was vaccinated intramuscularly with a dose of FLUZONE QIV (batch number: UT5673KA, expiry date: 30 June 2017, dose in series was not reported) in an unknown site on 06 October 2016. The patient had not reported any medical history. Patient illness at time of vaccination were reports as none, pre-existing physician diagnosed allergies, and birth defects included NKDA (no known drug allergies) and medical conditions not reported. Allergies was reported as none. The patient had not reported any concomitant medications. On 06 October 2016, same day following the vaccination, the patient developed vaccination site rash. The patient had not reported any lab data and the patient had not received any corrective treatment. On 11 Oct 2016, patient recovered from the event. List of documents held by sender: none.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling, Urticaria
Clinical narrative: REDNESS/SWELLING/WARMTH INTO FOREARM. SEEN IN ED-PO ANIBIOTIC, IN ED AGAIN-IV ANTIBIOTIC--REACTION, D/C'D. HIVES, WHELPS, ARM CLEARED BY 10/7 ALL CLEAR.
Age: 94.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Diarrhoea
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 94 year old female patient. The patient's pertinent medical histories, drug reactions/allergies and concomitant medications were not reported. On 19-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # L033707 and expiry date 18-MAY-2017) intramuscular in the left deltoid. On an unknown date in October 2016, she experienced cellulitis. She was also admitted to hospital for diarrhea. It was not known whether the patient experienced diarrhea before or after. She was discharged from the hospital on 23-OCT-2016. Unspecified treatment was given for the events. The outcome of the event was unknown. The reporter did not provide the relatedness of the events with the vaccine. Upon internal review "cellulitis" was determined to be medically significant. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: HAD PAIN WHEN RECEIVED. PAIN, 35X57 MM BORDER OF REDNESS, SWELLING, HOT TO TOUCH.
Age: 50.0
Sex: F
Vaccine: FLUX, PPV, TTOX, FLU4, PPV, TDAP
Symptoms: Erythema, Fatigue, Headache, Mobility decreased, Nausea
Clinical narrative: Red, swollen, hot to touch, arm immobile, extremely painful, headache, nausea, fatigue.
Age: 50.0
Sex: F
Vaccine: FLUX, PPV, TTOX, FLU4, PPV, TDAP
Symptoms: Pain in extremity, Skin warm, Swelling
Clinical narrative: Red, swollen, hot to touch, arm immobile, extremely painful, headache, nausea, fatigue.
Age: 50.0
Sex: F
Vaccine: FLUX, PPV, TTOX, FLU4, PPV, TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site warmth
Clinical narrative: Red, swollen, hot to touch, arm immobile, extremely painful, headache, nausea, fatigue.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness and induration at site of shot, which spread.
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: PATIENT INDICATES PAIN IN THE LEFT ARM AND SWOLLEN AREA. SHE WENT TO THE DOCTOR AND WAS DIAGNOSED WITH CELLULITIS. SHE IS CURRENTLY TAKING CIPROFLOXACIN 750MG.
Age: 60.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Muscle spasms
Clinical narrative: Patient states she has been experiencing spasms in her left and right arms.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Haemorrhage, Skin discolouration
Clinical narrative: Bleeding, Black and Blue, it is 10 days later and I'm still black and blue.
Age: 61.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Malaise
Clinical narrative: Pt reported redness after injection 10/20/16. On 10/25/16 pt reports start of severe itching and redness spreading down arm. Redness observed with raised darkened border around it's edge from around injection site of left deltoid extending down towards elbow and inside of left upper arm on 10/27/16 when pt returned to health department.  Denies swelling or pain.  Heat at site of redness felt.  Denies fever or chills.  Reports c/o malaise for first 2 days after injection with flu vaccine given in right deltoid.  Denies any c/o with right deltoid site.  Pt. saw primary care provider on 10/27/16 with report of steroid shot given and instructions for benadryl use.  Phone call 10/28/16 with report of improvement after provider treatment.
Age: 60.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to a 60 year old female patient. The patient had breast cancer on an unspecified date 3-4 years ago. She had no drug reactions/allergies. Concomitant therapies included ARIMIDEX and unspecified flu shot on 22-OCT-2016. On 22-OCT-2016, the patient was vaccinated with ZOSTAVAX 19400 PFU (lot # M019646 with expiration date 18-JUL-2017, dose not reported, subcutaneous). On 26-OCT-2016, the patient called the pharmacist back to report that after receiving the vaccine, she developed warmth, itching and redness about 4 inches in diameter at the injection site  (unspecified date in October 2016). No treatment was given for the events and no lab diagnostics studies were performed. The patient reported to the pharmacist that the size of the affected area had "now" decreased to a 3-inch area as of 26-OCT-2016. The outcome of the events was reported as not recovered. The causality was not reported. Additional information has been requested.
Age: 63.0
Sex: U
Vaccine: FLU4, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient called me approximately 20 hours after his FLUARIX shot and reported limited mobility + pain in his arm. He did report he had surgery on this shoulder approx. 6 years ago.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling, Skin reaction
Clinical narrative: Bicep red, swollen painful no hives or fever.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Paraesthesia, Rash macular, Wheezing
Clinical narrative: Tingling in fingers, SOB/wheeze, blotchiness of skin, went to ER treated with IV, kept overnight to monitor. She sound fine on the phone.
Age: 1.0
Sex: M
Vaccine: FLUX, MMR
Symptoms: Rash, Scab, Varicella
Clinical narrative: Began getting spots on face and head. Spread through Thursday morning and began to look crusty. Dr. Confirmed chicken pox on 10/27 around noon.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: Arm Where injection very sore.  Low grade fever and muscle aches.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Patient reports swelling and redness in arm accompanied by fever of approximately 104 in night of vaccination. Visited primary care physician for follow up to symptoms who patient says diagnosed her with cellulitis.
Age: 60.0
Sex: M
Vaccine: FLU4, HEPAB
Symptoms: Cough, Dyspnoea, Hyperhidrosis
Clinical narrative: Patient received TWINRIX #1 and Influenza vaccines approximately 1535. At 1545, I was notified that patient was having SOB, cough, and was slightly diaphoretic. His cough and SOB persisted; at 1555 epinephrine 1:1000 0.3 mg given SQ RT upper arm. B/P 210/110, pulse 110. Patient remained alert and oriented. SOB decreased, but cough remained. Ambulance called to transport patient to ER for further evaluation and treatment. B/P was 200/100 at 1600, then 198/100 at 1605. Ambulance arrived around 1610 to transport patient. Patient remained alert and oriented throughout episode.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Aphasia, Asthenia, Bone pain, Decreased appetite, Hepatitis
Clinical narrative: Injection site reaction, bone aches, weakness, loss of appetite, high fever, inability to talk and liver inflammed and wbc count high according to pcp.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site reaction, Pyrexia, White blood cell count increased
Clinical narrative: Injection site reaction, bone aches, weakness, loss of appetite, high fever, inability to talk and liver inflammed and wbc count high according to pcp.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Rash generalised, Rash macular
Clinical narrative: Mom states that child woke up this morning at 4:30 AM with a "blotchy" rash on his face, back and all over his body.  He did not have a fever or any difficulty breathing.  No previous illness.  Itchy, but manageable, went to school today.  The injection site was also a bit reddened as well, no complaints of arm pain or discomfort.  He has had FLUMIST in 2013 and 2014 without any problems.  This is the first flu injection that he has had.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Upper-airway cough syndrome
Clinical narrative: Headaches, postnasal gtt, chills, no fever.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: n/a documentation error
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pain in extremity
Clinical narrative: My arm that received the vaccine had a severe ache all day, the same ache that I experienced for the two days following the vaccine administration.  I could barely move the arm due to the pain.  Ibuprofen reduced the pain marginally.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Maternal drugs affecting foetus, Mechanical ventilation, Respiratory distress, Resuscitation
Clinical narrative: 2 days after getting vaccines PENTACEL, PREVNAR, ROTATEQ, the baby came to the office in distress, was resuscitated and sent to the hospital.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Short of breath, audible wheezing. 0.3 cc Epinephrine SC, sent to E.D.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster cutaneous disseminated, Pain of skin, Skin burning sensation
Clinical narrative: Information has been received from a physician concerning a female patient of unknown age. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. In 2013, the patient was vaccinated with an unspecified dose of ZOSTAVAX 19400 PFU (strength, dosage schedule, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant medications were not provided. The physician reported that the patient was seeking medical attention by contacting the physician and described the following symptoms "burning and pain in a dermatome fashion and this could possibly be Herpes Zoster" (herpes zoster cutaneous disseminated) that started on an unknown date. The physician reported that the patient had not been examined and did not have rash at the time of the call. It was unknown if the patient received treatment for the adverse event. No product quality complain was involved. At the time of reporting, the patient was not recovered from the herpes zoster cutaneous disseminated. The relatedness between the event and therapy with ZOSTAVAX was not reported. Upon internal review, herpes zoster cutaneous disseminated was determined to be medically significant. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash on both arms and legs--started evening of 10/26/2016-----rash gone on 10/28/2016----medical attention was not sought---NDC# 49281-625-78.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: Patient experienced lymphadenopathy in her arm.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Large swollen knot at injection site with redness, and warmth.
Age: 5.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered
Clinical narrative: Patient was given vaccination that expired on 09/23/2016.
Age: 5.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given vaccination that expired on 09/23/2016.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Blood thyroid stimulating hormone, Dyskinesia, Dystonia, Full blood count, Metabolic function test
Clinical narrative: Dystonic Reaction- tremors of extremities and head/neck. Abnormal movements of the trunk.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain, Tremor
Clinical narrative: Dystonic Reaction- tremors of extremities and head/neck. Abnormal movements of the trunk.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: CLIENT EXPERIENCED REDNESS AND TENDERNESS AT INJECTION SITE WHICH HAS DEVELOPED INTO A NODULE IN THE LEFT VASTUS LATERALIS WHERE THE VACCINE WAS ADMINISTERED.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Local redness where injection was along with 2 yellow raised spots, warm and painful to touch.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Patient developed a red rash that started on the back of her upper right arm and migrated lower and to the inside. Rash was raised/swollen and warm to the touch.
Age: 70.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Seizure
Clinical narrative: 2 Seizures back to back.
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Feeling cold, Pyrexia, Vomiting
Clinical narrative: Chills, severe fever (104.6) Vomiting.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling cold, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Head and body aches, chills, fever, nausea.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Syncope
Clinical narrative: Feeling of flushing, lightheadedness, dizziness, 3 minutes after vaccine given. She had to lie down and close her eyes. Was able to sit up about 5 minutes later. Consistent with a vasovagal syncope.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Fatigue, Influenza like illness, Local reaction, Local swelling
Clinical narrative: Approx. 6-7 post injection, pt experienced flu-like sx (fever, fatigue, nausea) which lasted about 3 days, pt took Tylenol to treat sx. After 3 days, a local reaction appeared (swelling, redness, hot to touch, and rash). Pt reported to PCP via phone and was instructed to take Benadryl and ice site. Sx were completely relieved after 3 days.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pyrexia, Rash, Skin warm
Clinical narrative: Approx. 6-7 post injection, pt experienced flu-like sx (fever, fatigue, nausea) which lasted about 3 days, pt took Tylenol to treat sx. After 3 days, a local reaction appeared (swelling, redness, hot to touch, and rash). Pt reported to PCP via phone and was instructed to take Benadryl and ice site. Sx were completely relieved after 3 days.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Pruritus, Vulvovaginal pruritus
Clinical narrative: Vaginal itching, vaccine site redness, left side of neck itching.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Initial itching at injection site within first hour followed within hours by redness, swelling and pain from top of shoulder to lateral elbow. Took Benadryl in evening and Ibuprofen. 10/26/16 evaluation at Clinic: symptoms resolving, some persisent redness measuring 10x6cm, slight warmth and tenderness.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site erythema, Mobility decreased, Myalgia
Clinical narrative: Injection site redness/bruising. Muscle pain. Limitation of arm movement.
Age: 1.17
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Decreased appetite, Irritability, Middle insomnia, Screaming
Clinical narrative: Waking up screaming every hour maybe more. Extremely fussy and not really able to make feel better. Loss of appetite.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Dizziness, Injection site erythema, Injection site induration
Clinical narrative: Upper left arm started hurting; hurt to move arm; upper arm swollen and felt hard to the touch; used ice on arm first night; morning of the 27th I felt very weak, dizzy, and nauseous, with chills. Morning of the 28th the swelling of the upper arm was now in the tricep and red.