chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PNC13
Symptoms: Injection site cellulitis
Clinical narrative: This is a spontaneous report by a contactable nurse via Pfizer Sales Representative. A female nurse reported for a patient who received PREVNAR 13 at single dose on arm on 21Jul2014. Relevant medical history and concomitant medications were unknown. Vaccines given on the same day or within the last four weeks were unknown. On 23Jul2014 the patient had cellulitis at the injection site. Relevant lab data and sibling information were unknown. The patient was placed on an unspecified antibiotic as therapeutic intervention for the above mentioned event in Jul2014. At the time of report clinical outcome of the above mentioned event was unknown. The causality of the event in relation to the product was unknown.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Immunization TDAP 7/25/14. Reaction noted at 7/29/14. Diagnosis: Cellulitis Tx: KEFLEX.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding a patient of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. On 06-AUG-2014, patient was vaccinated with M-M-R II, lot # H014648, Expiry date: 03-AUG-2014, dose. 5 ml (millilitre) subcutaneously. No concomitant therapy reported. The patient was vaccinated with expired dose of M-M-R II. No adverse effect was reported. There was no product quality complaint involved. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The reporter stated that a patient was administered a dose of VARIVAX (Merck) (dose, units, route of administration, anatomical location were not reported) that was improperly stored. No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Malaise, Pyrexia
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 17 year old male patient. On 09-JUN-2014 the patient was vaccinated with a first dose of GARDASIL (dose, route, lot # and expiration date were not reported). The reporter stated that mother of GARDASIL patient told her that son developed a fever for three days and felt sick immediately after receiving first dose of GARDASIL on 09-JUN-2014. The patient did not take any medication for the treatment. The therapy with GARDASIL was continued. The outcome of the events was unknown. The patient did not seek any medical attention. The relatedness between the events and GARDASIL was not reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site erythema, Oropharyngeal pain, Pruritus generalised
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age with no pertinent medical history and no drug reactions or allergies. On 04-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX strength reported as plaque-forming units (PFU) (dose, route and lot number were not reported). There were no concomitant medications. On 04-AUG-2014, the patient developed redness at the injection site which responded to unspecified treatment recommendations prescribed by the physician. On 07-AUG-2014, reported as today, the patient notified the physician that she had the following symptoms (started in August 2014, exact date not specified): itching all over her body, diarrhea and sore throat. The patient sought medical attention. The outcome of itching all over her body, redness at the injection site, diarrhea and sore throat was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates, reported as since December 2013, the patients were possibly administered doses of ROTATEQ suspension 2 (units not provided), orally (dose and lot number were not reported) which were not stored properly. No adverse effects were noted. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Heart rate decreased, Syncope
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a 12 year old female patient. The patient's medical history included abdominal pain. Drug reactions or allergies were unspecified by the reporter. The patient was a think girl who was in the 9th percentile in weight and hadn't eaten anything all day on 14-JUL-2014, when the patient was vaccinated with a dose of GARDASIL injection as a routine vaccine (dose, lot number and route were not reported). The reporter believed it was the patient's first dose. Concomitantly the patient was administered three unspecified vaccines in addition to GARDASIL. On 14-JUL-2014, after the administration of GARDASIL, the patient fainted. The patient was given water and sat in the office for 15 minutes after recovering from fainting, but never lot consciousness. Her heart rate might have gone low, but went up again after those 15 minutes of sitting down. There were not lab diagnostics studies performed. The patient did not seek medical attention. The outcome of the events was reported as recovered on 14-JUL-2014. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates, reported as since December 2013, the patients were possibly administered doses of (Oka/Merck) PROQUAD injection (dose, route and lot number were not reported) which were not stored properly. No adverse effects were noted. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site plaque, Injection site swelling, Injection site urticaria, Local swelling
Clinical narrative: This spontaneous report was received from a 66 year old female patient who is also a physician, regarding herself. Patient's pertinent medical history included arthritis, mild asthma, psoriasis and irritable bowel. Drug reactions or allergies were reported as none. She stated she has had anaphylactic like reactions to other unspecified medications in the past. She reported that when she received an unspecified tetanus vaccine on an unspecified date, an unspecified arm of hers swelled 2 to 3 times its previous size. She also reported that after she received an unspecified influenza vaccine on an unspecified date, she developed what she called a hill at the injection site. On 04-AUG-2014, the patient received PNEUMOVAX 23 Lot# J009827, expiration date: 10-AUG-2014, 0.5 ml in the arm. Concomitant therapies included Metoprolol and vitamin D. Patient reported that she developed tenderness and swelling in her armpit on the evening when she received PNEUMOVAX 23. She also reported that she noted plaques that were about 2-3 inches in diameter around the injection site the next day on 05-AUG-2014. She stated that the plaques looked like hives. She also stated that she had one plaque that developed the next day on her inner arm that was slightly elevated and very red and tender. She reported that the plaque on her inner arm recovered on 06-AUG-2014 (stop date reported as gone down today, the date of this report). She stated that an unspecified pneumonia vaccine is the harder of the vaccines to administer to children due to adverse reactions that can develop. Patient did not provide any further information about children. No treatment was given for the events. Laboratory diagnostic studies were reported as none. Outcome of events were reported as recovering. No product quality complaint was reported. Causality assessment was not provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Skin plaque, Tenderness
Clinical narrative: This spontaneous report was received from a 66 year old female patient who is also a physician, regarding herself. Patient's pertinent medical history included arthritis, mild asthma, psoriasis and irritable bowel. Drug reactions or allergies were reported as none. She stated she has had anaphylactic like reactions to other unspecified medications in the past. She reported that when she received an unspecified tetanus vaccine on an unspecified date, an unspecified arm of hers swelled 2 to 3 times its previous size. She also reported that after she received an unspecified influenza vaccine on an unspecified date, she developed what she called a hill at the injection site. On 04-AUG-2014, the patient received PNEUMOVAX 23 Lot# J009827, expiration date: 10-AUG-2014, 0.5 ml in the arm. Concomitant therapies included Metoprolol and vitamin D. Patient reported that she developed tenderness and swelling in her armpit on the evening when she received PNEUMOVAX 23. She also reported that she noted plaques that were about 2-3 inches in diameter around the injection site the next day on 05-AUG-2014. She stated that the plaques looked like hives. She also stated that she had one plaque that developed the next day on her inner arm that was slightly elevated and very red and tender. She reported that the plaque on her inner arm recovered on 06-AUG-2014 (stop date reported as gone down today, the date of this report). She stated that an unspecified pneumonia vaccine is the harder of the vaccines to administer to children due to adverse reactions that can develop. Patient did not provide any further information about children. No treatment was given for the events. Laboratory diagnostic studies were reported as none. Outcome of events were reported as recovering. No product quality complaint was reported. Causality assessment was not provided. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea, Rotavirus test negative
Clinical narrative: Pt had diarrhea stools up to several per hour.  Diarrhea resolved on 08/07/2014.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Respiratory disorder
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 88 year old female patient. The patient had no pertinent medical history, no drug reactions or allergies. In 2006 (reported as about eight years ago), the patient was vaccinated with the dose of PNEUMOVAX23 (dose and lot number were not reported)(indication reported as vaccination). The patient did not use any concomitant medications. On an unknown date in July 2014 (reported as recently) the patient experienced unspecified respiratory issues. No treatment was given for the event. Lab diagnostics studies were not preformed. The outcome of unspecified respiratory issues was reported as not recovered/not resolved. The relatedness between the event between the event and the PNEUMOVAX23 was not reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HIBV, HPV4, TDAP
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 11 year old female patient. No information on her medical history, concurrent conditions or concomitant drugs was provided. On 20-JUN-2014 the patient was vaccinated with a dose of GARDASIL dose number 1; site and route of administration, lot# and expiration date not reported. Other suspect therapies included BOOSTRIX and meningococcal protein conjugate (manufacturer unknown). On 20-JUN-2014, after receiving GARDASIL and two other vaccines concomitantly, the patient developed hives. The patient sought medical attention and was treated with BENADRYL and prednisone. On an unknown date in 2014 the patient recovered from the adverse event. Relatedness between use of GARDASIL and the adverse effect was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, strength, dose, frequency and route unspecified). On an unknown date the patient experienced rash and pain after receiving the vaccine. The patient sought medical attention via office visit on unspecified date and no treatment was given for the events. The outcome of pain and rash was reported as recovering. Additional information is not expected as the physician did not want to be contacted.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a certificated medical assistant refers to a 14 year old female patient with no pertinent medical history and drug reactions/allergies. On 06-AUG-2014 the patient was vaccinated with the third dose of GARDASIL lot # H021861, Exp date: 09-OCT-2015, 0.5 ml, subcutaneous. No concomitant medication was taken. It was unknown when the patient received the first and second dose of GARDASIL. On 06-AUG-2014 the patient experienced tenderness, at the injection site after receiving the third dose of GARDASIL. No treatment was given for the event. No lab diagnostics studies were performed. The outcome of the event was unknown. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 31 year old female patient. The patient had no pertinent medical history. On an unspecified date in 2007 (reported as "about 7 years ago"), the patient was vaccinated with series of GARDASIL injection (dose, frequency, route and lot # unknown). On 28-JUL-2014 the patient had a pap test completed. Results of papanicolaou (pap) test exhibited "abnormal, atypical cells that are positive for HPV". The patient was scheduled to receive a colposcopy on an unspecified date in the near future. There was no treatment was given for the event. The outcome of results of the event was reported as not recovered/not resolved. The relationship between event and GARDASIL was not reported. Addiitonal informatino has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates, reported as since December 2013, the patients were possibly administered doses of VAQTA injection 25/0.5 (units not reported)(dose, route and lot number were not reported) which were not stored properly. No adverse effects were noted. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates, reported as since December 2013, the patients were possibly administered doses of PEDVAXHIB injection (dose and lot number were not reported) which were not stored properly. No adverse effects were noted. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates, reported as since December 2013, the patients were possibly administered doses of RECOMBIVAX HB injection 10 "Y" (dose, route and lot number were not reported) which were not stored properly. No adverse effects were noted. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates, reported as since December 2013, the patients were possibly administered doses of GARDASIL injection (dose, route and lot number were not reported) which were not stored properly. No adverse effects were noted. Concomitant medications were not specified. This is one of several reports received from the same reproter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates, reported as since December 2013, the patient were possibly administered doses of VARIVAX (Merck) injection (dose, route and lot number were not reported) which were not stored properly. No adverse effects were noted. Concomitant medications were not specified. This is one of several reports received from the same reproter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 2 patients of unknown age and gender. The reporter stated that those two patients were administered a dose of PROQUAD (Merck) (dose, units, route of administration, anatomical location were not reported) that was improperly stored. No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLUC3, PPV
Symptoms: Ultrasound scan normal, Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The reporter stated that on 01-AUG-2014 the patient was administered an expired dose of PNEUMOVAX 23 (lot # H021941, expiration date: 11-JUL-2014, dose, units, route of administration, anatomical location were not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and drug reactions or allergies were not specified. On 08-AUG-2014, the patient received an expired dose of PNEUMOVAX 23 injection, lot number J006242, expiration date 03-AUG-2014 (dose, dose number and route were not reported). No adverse effects were reported. Concomitant medications were not specified. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored ROTATEQ orally (dose and lot # were not reported). Patients were also vaccinated with improperly stored TD. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored RECOMBIVAX HB (dose, lot # and route of administration were not reported). Patients were also vaccinated with improperly stored TD. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored PNEUMOVAX 23 (dose, lot # and route of administration were not reported). Patients were also vaccinated with improperly stored Tetanus-Diphtheria vaccine (TD). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improeprly stored GARDASIL (dose, lot # and route of administration were not reported). Patients were also vaccinated with improperly stored Tetanus-Diphtheria vaccine (TD). No adverse effects were reported. This is one of several reprots received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored PEDVAXHIB (dose, lot # and route of administration were not reported). Patients were also vaccinated with improperly stored Tetanus-Diphtheria vaccine (TD). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Left thigh with a 3mm erythematous area of induration, a light 2cm circumferential area as well, slightly tender; immune reaction vs. cellulitis. Treated with KEFLEX.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration
Clinical narrative: Left thigh with a 8cm red, indurated area shot reaction vs. cellulitis. Treatment- KEFLEX.
Sex: M
Vaccine: FLUX, HEP, HEPA
Symptoms: Adverse drug reaction, Amnesia, Convulsion, Disability, Dyslexia
Clinical narrative: Information was received on 06-AUG-2014 via the Freedom of Information Act. A male consumer reported the following in a letter to the Health Department: About one and a half years ago, he received Hepatitis A and B series (manufacturer not specified) and a shot for the flu "that we are supposedly required being over 55 years old". He had flu like symptoms for five weeks. Then he lost feeling in his toes and tops of the feet that worked slowly up through his whole body and had numbness in his hand. The consumer also reported breathing problems and that he lost 46 pounds in four and half months. He had a seizure and was taken to the hospital but he had a bad reaction to every med they gave him. He lost his short term memory and has a constant buzzy in his ears and a rash for which he takes "tons" of lotion. He stated he is handicapped and has dyslexia. Upon internal review, seizure was considered medically significant. Additional information is not expected.
Sex: M
Vaccine: FLUX, HEP, HEPA
Symptoms: Dyspnoea, Hypoaesthesia, Influenza like illness, Rash, Sensory loss
Clinical narrative: Information was received on 06-AUG-2014 via the Freedom of Information Act. A male consumer reported the following in a letter to the Health Department: About one and a half years ago, he received Hepatitis A and B series (manufacturer not specified) and a shot for the flu "that we are supposedly required being over 55 years old". He had flu like symptoms for five weeks. Then he lost feeling in his toes and tops of the feet that worked slowly up through his whole body and had numbness in his hand. The consumer also reported breathing problems and that he lost 46 pounds in four and half months. He had a seizure and was taken to the hospital but he had a bad reaction to every med they gave him. He lost his short term memory and has a constant buzzy in his ears and a rash for which he takes "tons" of lotion. He stated he is handicapped and has dyslexia. Upon internal review, seizure was considered medically significant. Additional information is not expected.
Sex: M
Vaccine: FLUX, HEP, HEPA
Symptoms: Tinnitus, Weight decreased
Clinical narrative: Information was received on 06-AUG-2014 via the Freedom of Information Act. A male consumer reported the following in a letter to the Health Department: About one and a half years ago, he received Hepatitis A and B series (manufacturer not specified) and a shot for the flu "that we are supposedly required being over 55 years old". He had flu like symptoms for five weeks. Then he lost feeling in his toes and tops of the feet that worked slowly up through his whole body and had numbness in his hand. The consumer also reported breathing problems and that he lost 46 pounds in four and half months. He had a seizure and was taken to the hospital but he had a bad reaction to every med they gave him. He lost his short term memory and has a constant buzzy in his ears and a rash for which he takes "tons" of lotion. He stated he is handicapped and has dyslexia. Upon internal review, seizure was considered medically significant. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Oral shaped erythematous and slightly warm, firm patch on upper lateral leg. No fluctuance vaccine site reaction.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Electrocardiogram, Erythema, Heart rate increased, Malaise, Respiratory rate increased
Clinical narrative: Mom brought child back stating she didn't feel well and her face was red. Child walked back AAOx3 and laid on exam table elevated legs and check vitals. 144/88 O2 100%, RR 26, Temp 98.6, pulse 112 asked child to take nice slow deep breaths color returned to normal and rechecked vitals, 130/84, pulse 103, RR 16 O2 99%. No visible swelling or bleeding lungs clear to auscultation. When child sat up mom started to say her face still looks red and child again began breathing fast and heart rate increase. Paramedics called arrived at 12:06pm and did EKG and vitals mom refused transport to ER, child after approximately 20 min of monitoring was able to sit up, stand and walk around store and stated she felt fine, Mom signed refusal for further eval and transportation and took child stated will follow up in ER if needed.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Gaze palsy, Pain, Pallor, Tremor
Clinical narrative: HPV given, pt. c/o hurt, really hurt, then she started shaking, eyes rolling around, lip color faded to pale, pale. I immediately laid pt back on exam table, ask her if she was ok, and she answered ok.  Shaking stopped within 20sec of laying down.  I gave her a peppermint and ask her to chew it up and swallow it.  Color to lips then returned within 1-2 mins.  5-7 mins after episode started pt is upright and walking to check out unassisted, color good, coherent.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Right lateral leg with 4x5 erythematous, indurated, warm patch. No influence, No tender. Immunization reaction vs cellulitis. Treated with KEFLEX.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Incorrect storage of drug, Product name confusion
Clinical narrative: This spontaneous report as received from a registered nurse refers to patients of unknown demographics. It was reported that (Oka/Merck) PROQUAD was placed in the refrigerator when it was received at her facility, and she believes that someone placed it in the refrigerator because it was mistaken as M-M-R II. She stated that the cartons of both products look similar, in that the cartons both have blue on them and the name MMRV is on the (Oka/Merck) PROQUAD carton. No patients received any doses of (Oka/Merck) PROQUAD in error, and no patients were involved in this product confusion. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Local swelling, Musculoskeletal pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. In 2013 (last year) the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, lot number and exp date were unknown). She reported that she had gotten an allergic reaction to a pneumonia vaccine she received last year (in approximately 2013). She got a bump on her arm and then started experiencing pain on her shoulder and her arm in approximately 2013 ("last year"). The outcome of events was unknown. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Erythema, Injection site pain, Skin warm
Clinical narrative: Left arm has dull pain at injection site, now 2 but this morning 3. It is red, warm to touch, 9 mm in diameter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia
Clinical narrative: Patient having short term memory loss and feels it has been since receiving injection.
Age: 0.16
Sex: F
Vaccine: RV5
Symptoms: Gastrointestinal sounds abnormal, Haematochezia, Hypophagia, Irritability, Mucous stools
Clinical narrative: This spontaneous report was received from a pediatrician refers to a 1 month old female patient (also reported as 2 months) with milk protein allergy required a change in formula to Elecare which she was doing fine on, she had blood in her stools in the past with the protein allergy, which resolved, and successive hemoccult tests were all negative. On 27-JUL-2014 a stool had faint amount of blood and on 03-JUL-2014 and 10-JUL-2014 both stool samples were negative for blood, she also had Gastrooesophageal reflux disease (GERD). Her relevant past drug history was unknown. On 25-JUL-2014 the patient was vaccinated with ROTATEQ, oral, once, lot number: K001935, expiration date: 12-AUG-2015, (dosage was not reported) for vaccination. Concomitant therapies included ranitidine. On 26-JUL-2014 about 24 hours after receiving ROTATEQ, the patient did not want to eat as much formula and became fussy. On 27-JUL-2014 her mother noted mucous in her stools. On 28-JUL-2014, the mother spoke with the pediatrician about the events and on 29-JUL-2014 she was seen in the office and the mother brought in 2 of her stools samples, which did not have overwhelming amounts of mucous did not have some estringinessa to it. One of the stools samples, which had been collected last night on 28-JUL-2014 was negative for blood. The other spots sample, which had been collected that morning on 29-JUL-2014 was slightly positive for blood, but nothing like she had in the past. This pediatrician reports that the blood was seen microscopically and was not visible in the stool. On 29-JUL-2014 she had increased bowel sounds. As of 29-JUL-2014 at the time of the call, it was unknown if she will receive another ROTATEQ. She was still not eating as much formula, and the outcome of her fussiness, mucous blood and blood in her stools and increased bowel sound were unknown. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: RV5
Symptoms: Occult blood positive, Stool analysis abnormal
Clinical narrative: This spontaneous report was received from a pediatrician refers to a 1 month old female patient (also reported as 2 months) with milk protein allergy required a change in formula to Elecare which she was doing fine on, she had blood in her stools in the past with the protein allergy, which resolved, and successive hemoccult tests were all negative. On 27-JUL-2014 a stool had faint amount of blood and on 03-JUL-2014 and 10-JUL-2014 both stool samples were negative for blood, she also had Gastrooesophageal reflux disease (GERD). Her relevant past drug history was unknown. On 25-JUL-2014 the patient was vaccinated with ROTATEQ, oral, once, lot number: K001935, expiration date: 12-AUG-2015, (dosage was not reported) for vaccination. Concomitant therapies included ranitidine. On 26-JUL-2014 about 24 hours after receiving ROTATEQ, the patient did not want to eat as much formula and became fussy. On 27-JUL-2014 her mother noted mucous in her stools. On 28-JUL-2014, the mother spoke with the pediatrician about the events and on 29-JUL-2014 she was seen in the office and the mother brought in 2 of her stools samples, which did not have overwhelming amounts of mucous did not have some estringinessa to it. One of the stools samples, which had been collected last night on 28-JUL-2014 was negative for blood. The other spots sample, which had been collected that morning on 29-JUL-2014 was slightly positive for blood, but nothing like she had in the past. This pediatrician reports that the blood was seen microscopically and was not visible in the stool. On 29-JUL-2014 she had increased bowel sounds. As of 29-JUL-2014 at the time of the call, it was unknown if she will receive another ROTATEQ. She was still not eating as much formula, and the outcome of her fussiness, mucous blood and blood in her stools and increased bowel sound were unknown. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Erythema, Local swelling, Pain in extremity, Pruritus
Clinical narrative: C/O swelling, itching, pain and redness to (R) arm. Massaged with ice and given acetaminophen.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Rash, Rash pruritic
Clinical narrative: 2 hrs after inj. pt had pain in entire arm. States itchy rash along hairline and (L) wrist area. Took BENADRYL 2 days and rash cleared. Tramadol taken for pain. Came to office 4 days later to report, and states improving.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Chest pain, Crying, Dizziness, Loss of consciousness, Vomiting
Clinical narrative: Doing well kp. after given the immunizations pt pass out c/o dizziness, upper chest pain BP 123/83 110 given him cold compress move pt to room #1 wait x 5 min vital signs: BP 116/60 83 after 10 min pt start craying for upper chest pain around shoulders. Also vomiting 2 times. HCP call 911 pt reflused to go to the ER said feeling ok after vomit.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: Patient said made her arm swell and red. Hospitalized for 9 days. Waited here for 15 min after shot. Must've been a delayed rxn.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pt has a 10cm x 10cm erythematous, warm, pruritic area surrounding the injection sites. Slightly tender, but itchy. No secondary infection. No treatment at this time. (L) Deltoid
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Guttate psoriasis
Clinical narrative: Pt has baseline psoriasis but has had flares of diffuse guttate psoriasis since his shingles vaccine (given 2/18/2014).
Age: 63.0
Sex: F
Vaccine: HEPAB, TYP, YF
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Allergic reaction to Yellow fever, TWINRIX, Typhoid swelling at the site of injections. Pain, redness, itching.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis in vaccine arm.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count, Headache, Local swelling, Pyrexia, Swelling
Clinical narrative: Patient presented to follow up appointment with provider 8-4-14. Left arm very swollen. Swelling extends from clavicle to her mid forearm. States has had fever and headaches. States this started 8-2-14. She states that her left arm was so swollen she couldn't get her sleeve on. Patient states has improved. Patient took BENADRYL at home. MEDROL dose pack order, 8/4/14.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: White blood cell count normal
Clinical narrative: Patient presented to follow up appointment with provider 8-4-14. Left arm very swollen. Swelling extends from clavicle to her mid forearm. States has had fever and headaches. States this started 8-2-14. She states that her left arm was so swollen she couldn't get her sleeve on. Patient states has improved. Patient took BENADRYL at home. MEDROL dose pack order, 8/4/14.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Vasovagal syncope post HPV injection. Supportive care only. Patient recovered and was stable upon leaving office.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Erythema, Induration, Local reaction, Skin discolouration
Clinical narrative: Large local reaction - red - purplish color - hard lump - no fever only local discomfort - vaccine on 7/28/14 - reported 7/31/14 - 8/5/14 much better no redness now.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Breast tenderness, Burning sensation, Chills, Fatigue, Hyperaesthesia
Clinical narrative: Breast area tender - arm at site of injection very tender and on fire - began as round hard spot, now large hard spot. Rxn has spread to armpit areas. Feel tired and sluggish. Skin sensitive to touch around injx area. Pt. report chills.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site induration, Injection site pain, Sluggishness, Tenderness
Clinical narrative: Breast area tender - arm at site of injection very tender and on fire - began as round hard spot, now large hard spot. Rxn has spread to armpit areas. Feel tired and sluggish. Skin sensitive to touch around injx area. Pt. report chills.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood pressure decreased, Cold sweat, Heart rate increased, Pallor
Clinical narrative: -Symptoms 1) Sudden, 2) extreme pallor 3) Skin cold/clammy 4) increased pulse/decreased Blood pressure, Reaction 10:18, Left ambulatory 11:00am, no treatment.
Age: 22.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Feeling hot, Injection site erythema, Local swelling, Pain in extremity
Clinical narrative: Patient states she noticed redness and swelling on left arm and pain to touch 1 day after receiving Varicella vaccine. It has doubled in size and feels hot.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous was received by a Healthcare Worker. The report refers to a patient of unknown age. On 14-OCT-2013, patient was vaccinated with GARDASIL. On 14-OCT-2013, patient was vaccinated with GARDASIL. 03-JAN-2014, patient was vaccinated with GARDASIL. On an Unknown date, the patient came into the office to receive a third dose. No further information was provided. Outcome of inappropriate dose schedule unknown. Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Large red blisters at admin site 3 days after admin. Worsened to day 7. Patient had to go to Md for prednisone and VALTREX rx. Day 7 still unresolved.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash and urticaria pruritus.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 01-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose number was not reported), 0.65 ml, subcutaneous. Co-suspect and concomitant therapies were not reported. The pharmacist reports that on 01-AUG-2014 a dose of ZOSTAVAX that underwent a temperature excursion was administered to five patients. (MARRS 1408USA006489, 1408USA006490, 1408USA006491, 1408USA006492 and 1408USA001809). This case is one (1) of five (5) reports from the same source. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash pruritic
Clinical narrative: Rash that was itchy on upper back with vesicles.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Erythema, Pain, Pyrexia, Skin warm
Clinical narrative: Pt states on the evening of 8/8 developed a fever 101.5 and had shaking chills. On 8/9 developed redness, warmth, soreness and site felt "hardened" at vacine site @ 3" band. Left deltoid area. Pt stated he would follow up with his own doctor today.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Tremor, Vaccination site induration
Clinical narrative: Pt states on the evening of 8/8 developed a fever 101.5 and had shaking chills. On 8/9 developed redness, warmth, soreness and site felt "hardened" at vacine site @ 3" band. Left deltoid area. Pt stated he would follow up with his own doctor today.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash generalised, Urticaria
Clinical narrative: Rash/hives, all over body, lasting over a week, despite treatment with Benadryl.
Age: 11.0
Sex: M
Vaccine: RAB
Symptoms: Cough, Dyspnoea, Fatigue, Headache, Myalgia
Clinical narrative: Fever, muscle aches, headache, coughing, dyspnea, fatigue, and paresthesias.
Age: 11.0
Sex: M
Vaccine: RAB
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Fever, muscle aches, headache, coughing, dyspnea, fatigue, and paresthesias.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Hot flush, Pyrexia, Respiratory tract congestion, Throat tightness
Clinical narrative: Fever, chills, congestion, throat felt closed, hot flashes.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Feeling of body temperature change, Hyperhidrosis, Nausea
Clinical narrative: SICK TO HIS STOMACH, FELT LIGHT HEADED, HOT AND SWEATY AND THEN FREEZING ALL AT THE SAME TIME.
Age: 65.0
Sex: F
Vaccine: DTAP, HEP
Symptoms: Injection site bruising, Periarthritis, X-ray
Clinical narrative: Bruise x 2 1/2 weeks from LD to shoulder.  Pts private provider did xrays a couple of weeks post injections, dx frozen shoulder, pt currently receiving PT.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Face and mouth X-ray normal, Full blood count normal, Headache, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: Beginning a few hours after vaccine, developed low grade fever.  Continued for 3 days, then increased to 102 and began with mild headache.  Went to vaccine provider's office and given azithromycin for possible otitis media (very questionable diagnosis).  The following day developed severe, debilitating headache, which lasted for 5 days and resolved once he was off the azithromycin.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture, CSF culture, Convulsion, Culture urine, Electrocardiogram
Clinical narrative: Seizure activity.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Computerised tomogram head normal, Convulsion, Electroencephalogram normal, Laboratory test normal, Resuscitation
Clinical narrative: Seizure activity.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Laboratory test, Sleep disorder
Clinical narrative: Pt complain of pain at injection site since date of injection (9/24/13). She claims pain interrupts her sleep. Also claims that her doctor has done various tests to find out reason for pain.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pain in extremity
Clinical narrative: Achiness in bil legs and pain in bil legs 7/30/14 in PM worsened 8/1/14 contacted drs. office and took Ibuprofen resolved by 8/3/14.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Syncope after administration of vaccine lasted only a few seconds. Resolved on its own.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Asthenia, Loss of consciousness, Syncope
Clinical narrative: At approx 10-15 minutes post injection patient was with his mother at our counter when he became faint. His mother eased him to the floor. He came to quickly but remained weak for a few minutes. at 4:30pm BP 118/72 P 57, alert. 4:40 - 145/80 P 68, 4:50 12272 P 62. Left the office at 4:55 fully alert and no c/o's.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Dysphagia, Headache, Lymphadenopathy, Mobility decreased, Pain in extremity
Clinical narrative: The patient called 8/1/14 and said she had a reaction and went to the ER. Her symptoms she stated were a really sore arm she can't move easily, fever, headache, swollen lymph node, trouble swallowing. She was also being treated for other conditions also.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: The patient called 8/1/14 and said she had a reaction and went to the ER. Her symptoms she stated were a really sore arm she can't move easily, fever, headache, swollen lymph node, trouble swallowing. She was also being treated for other conditions also.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Pt. experienced vomiting after HPV immunization. Cleared and all sx resolved  in approx. 10 min. No PH vasovagal sx or immuniz rxn.
Age: 16.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Per mom pt developed swelling and redness on right deltoid area where (Hep-B) was given. Mom described redness looked like a welt the size of a silver dollar. Mom reports by Saturday morning sxs became worse welt increasing to what mom described the size of the bottom of a coffee mug. Doing better after BENADRYL administering.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Aggression, Tic, Vaccine positive rechallenge
Clinical narrative: 8 days after MMR vaccine on 7/16/14, sudden increase in aggressive behavior (hitting people while laughing) and motor tics. Waxing and waning since also happened 10 days after 1st MMR on 1/4/10. Took 6 month to resolve.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash
Clinical narrative: Local rash at the site of both injections. 3in x 3in rash on (Rt) vastus lateralis. 1in x 1in rash on (Lt) outer vastus lateralis.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection, Injection site inflammation, Product contamination
Clinical narrative: Administration: technician uncapped syringe needle with her teeth, laid exposed needle by computer keyboard while typing and continuing to talk with needle cap in mouth. Drew up vaccine with contaminated needle, then changed needle prior to injection. Inflamed, infected injection site.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Vaccination site rash
Clinical narrative: Mom noticed rash Sunday morning at site of vacc adm.
Age: 23.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema multiforme, Skin lesion
Clinical narrative: Pt presented in ER on 7 and 18 Aug'14 for spreading skin lesions that she developed after her primary SPV given 30 Jul'14. Pictures sent and was determined to have erythema multiforme minor. Given oral steroids and medical exemption to SPV.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Skin warm
Clinical narrative: Warm, sore, 12cm x 8cm.