chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4
Symptoms: Lethargy, Rash erythematous
Clinical narrative: Rash is red; Rash is [red,] raised; Rash of red spots diffusely all over her body; Lethargic; This non-serious spontaneous case, initially received from other health professional on 02-Oct-2018, concerns a female patient of an unspecified age.  On 28-Sep-2018 (reported as Friday), the patient was administered Afluria Quadrivalent (influenza vaccine, dose, route of administration, anatomical location, batch number and expiry date: not reported) for an unknown indication.  Within 24 hours after receiving the vaccination, the patient developed a rash of red spots diffusely all over her body. The rash was red, raised, and in some area rows of 4 or 5 in the shape of a crescent and some of the spots had a white circle around the outside of them. The rash spots were not pustular or vesicular. The patient reported feeling somewhat generally lethargic. The patient sought treatment at an urgent care facility and was given Benadryl injection and a prescription for steroid cream. No other reported systemic reaction was reported.  At the time of this report, the outcome of the events was not reported.; Reporter's Comments: A female patient of unspecified age developed rash all over which was red and raised within 24 hours after vaccination and felt lethargic on an unspecified day after the administration of Afluria Quadrivalent. The company assessed the causality as related due to plausible temporal relationship between the events and suspect vaccine.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Local reactions at the site of injections/5 inch area erythema; This is a spontaneous case, initially received on 11-Oct-2018, reported by other healthcare professional (nurse) concerning a patient of unspecified gender and age.  On an unspecified date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 00844621A (reported as 02844621A), expiry date: 25-Jun-2019] for an unknown indication.   On an unspecified date after vaccination, the patient developed erythema of 5 inches in area at the site of injection.  At the time of this report, the outcome of the event was not reported.  The reporter assessed this case as non-serious.  Non-significant case amendment (11-Oct-2018): The verbiage in the narrative was updated from On an unspecified date after vaccination, the patient developed erythema of 5 inches in area, which was considered as a local reaction' to on an unspecified date after vaccination, the patient developed erythema of 5 inches in area at the site of injection'. The narrative was amended accordingly.; Reporter's Comments: A patient of unspecified gender and age developed injection site erythema after vaccination with Afluria Quadrivalent. The company assessed the causality of the event as related to the suspect vaccine due to site-specific occurrence of the event.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Local reactions at the site of injections/3 inch area erythema; This spontaneous case, initially received from other healthcare professional (nurse) on 11-Oct-2018, concerning a patient of unspecified gender and age.  On an unspecified date, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 00844621A (reported as 02844621A) and expiry date: 25-Jun-2019] for an unknown indication.   On an unspecified date after vaccination, the patient developed erythema of 3 inches in area at the site of injection, which was considered as a local reaction.  The outcome of the event was not reported.  The reporter assessed this case as non-serious.  This case: 201804406 was cross-linked to case 201804405 owing to the same reporter.  Non-significant case amendment (11-Oct-2018): In the narrative, "On an unspecified date after vaccination, the patient developed erythema of 3 inches in area" was changed to "On an unspecified date after vaccination, the patient developed erythema of 3 inches in area at the site of injection".; Reporter's Comments: A patient of unspecified gender and age developed injection site erythema after vaccination with Afluria Quadrivalent. The company assessed the causality of the event as related to the suspect vaccine due to anatomical site specific reaction.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site nodule
Clinical narrative: Tremendous knot to come up right at the site injection/ hard knot of about 1-1.5 inch; This is a spontaneous case, initially received from a pharmacist on 30-Oct-2018, concerns a 38-year-old, adult male patient.  The patient's current condition included high cholesterol. The patient's concomitant medications included Lipitor (atorvastatin calcium) and Xanax (alprazolam) for unknown indications.  On 30-Oct-2018, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YF36905 and expiry date: 16-May-2019) for active immunization against influenza.  On the same day, immediately after vaccination, when the pharmacist went to put plaster on it, a tremendous hard knot of about 1-1.5 inches came up at the injection site (injection site lump). The patient had no other symptoms like redness or rash or inflammation. The patient had not taken any treatment measures for the event. On the same day evening, the patient reported that he felt fine and knot started to go quite a bit (as reported). Approximately 6 hours after vaccination, the knot had resolved. It was reported that, the knot was not noticeable anymore.  At the time of this report, the patient had recovered from the event.  The reporter assessed this case as non-serious.  Follow-up report received from reporter on 19-Nov-2018: The reporter confirmed that the patient had recovered from the event approximately 6 hours after vaccination. The outcome of the event (injection site lump) was changed from not recovered' to recovered'. Added concomitant medication (Xanax) but the information regarding its indication was not available. The narrative was amended accordingly.; Reporter's Comments: A 38-year-old, male patient developed an injection site lump, immediately after vaccination with Afluria Quadrivalent. The company assessed the causality of the event as related to the suspect vaccine due to localized nature of the event and plausible temporal relationship between the event and suspect vaccine.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Loss of personal independence in daily activities, Mobility decreased, Musculoskeletal pain
Clinical narrative: Shoulder has become progressively more sore; Could not lift the arm all the way up/ almost impossible to flex in some directions; Shoulder [was getting progressively the soreness and a ] weakness; Could not take a tshirt off; This is a spontaneous case initially received from the other non-health professional (consumer) on 31-Oct-2018, concerning a 63-year-old, adult male patient.  The patient's current condition included glaucoma. The patient's concomitant medication included unspecified eye drops for glaucoma.   On 11-Oct-2018, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid (left shoulder), batch number: 02144621A and expiry date: 30-Jun-2018) for active immunization against influenza.  On 13-Oct-2018, two days after the vaccination, the patient experienced progressive soreness and weakness in shoulder. The patient neither could lift the arm up nor flex in some directions. It was reported that the patient could not take a t-shirt off (explicitly coded as activities of daily living impaired).  As of 01-Nov-2018, the patient felt better. The events had not completely subsided but was not hurting all the time. The outcome was recovering.  The reporter assessed this case as non-serious.; Reporter's Comments: A 63-year-old, female patient experienced progressive soreness and weakness in shoulder has become progressively sorer and weaker, injected limb mobility decreased and activities of daily living impaired, two days after administration of Afluria Quadrivalent. The company assessed the causality of the events (soreness and weakness in shoulder has become progressively sorer and weaker, injected limb mobility decreased) as related to the suspect vaccine due to the plausible temporal relationship between the event and suspect vaccine. The company assessed the causality of the event activities of daily living impaired as not related to the suspect vaccine as it can be alternatively explained by pain and weakness in shoulder.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal pain, Tenderness
Clinical narrative: Shoulder pain; Tenderness under the biceps; This is a spontaneous case, initially received from other health professional on 20-Nov-2018, concerning a 54-year-old, adult, female patient.  The patient had no medical history. The patient did not receive any concomitant medications.  On 09-Oct-2018, the patient was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252663 and expiry date: 31-May-2019] for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.  On an unspecified date in 2018, few days later after vaccination, the patient experienced shoulder pain and tenderness under the biceps. The patient had no redness and swelling. It was reported that, the patient felt better.  At the time of this report, the patient was recovering from the events.  This case is linked to case 201805709 (same reporter).  The reporter assessed the case as non-serious.; Reporter's Comments: A 54-year-old, female patient developed shoulder pain and tenderness on an unspecified in 2018, after administration of Flucelvax QIVc vaccine. The causality of the events was unassessable due to lack of information regarding the onset latency of the events. The case will be further assessed upon receipt of follow up information.
Age: 73.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal pain, Tenderness
Clinical narrative: Shoulder pain; Tenderness under the biceps; This is a spontaneous case, initially received from other health professional on 20-Nov-2018, concerning a 73-year-old, elderly, female patient.  The patient had no medical history and did not receive any concomitant medications.  On 16-Oct-2018, the patient was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252663 and expiry date: 31-May-2019] for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.  On an unspecified date in 2018, reported as few days later after vaccination, the patient experienced tenderness under the biceps and pain in the shoulder. The patient had no redness and swelling.   At the time of this report, the patient was recovering from the events (reported as feeling better now).   This case is linked to 201805709, due to same reporter.  The reporter assessed the case as non-serious.; Reporter's Comments: A 73-year-old, female patient developed shoulder pain and tenderness on an unspecified date (reported as few days later) after administration of Flucelvax QIVc. The company assessed the causality of the events as unassessable due to lack of information regarding the onset latency. The case will be further assessed upon receipt of follow up information.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: first shot of GARDASIL in March 2016/second and third dose she received GARDASIL 9; the first dose was "painful"; arm was sore; This spontaneous report was received from a consumer who refers to herself, a female patient of an unknown age. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On an unknown date in March 2016, the patient was vaccinated with 1 dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (exact dose, route of administration, lot number and expiration date were not provided). The first dose was painful. The patient explained that her arm was sore with the first dose.   The patient reported that for the second and third dose she received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, lot number and expiration date were not provided) vaccine in May 2016 and October 2016. The patient stated that she cannot remember if the second or third dose was painful.  The outcome of the event was unknown. The causality assessment was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; received improperly stored dose of VARIVAX; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies, and reactions were not reported.    On 24-MAR-2020, the patient was vaccinated with a first dose of an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S025609 with an expiration date on 18-AUG-2021 (strength, dose, anatomical location, and route of administration were not reported) for prophylaxis, which was reconstituted with a sterile diluent (MERCK STERILE DILUENT) properly stored.      The dose of varicella virus vaccine live (Oka/Merck)(VARIVAX) was exposed to a total time in the range of 15 Fahrenheit (°F) to 46°F (-9 Celsius degrees (°C) to 8°C): -5.48°C for 7 hours, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: she is experiencing redness, warmth and tenderness; she is experiencing redness, warmth and tenderness; she is experiencing redness  1/4 x 1 inch on her left deltoid; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) (batch number 7L27G, expiry date 27th February 2022) for prophylaxis.   On 20th April 2020, the patient received the 1st dose of Shingrix (intramuscular). In April 2020, less than a week after receiving Shingrix, the patient experienced pain in arm, skin warm and erythema of extremities. The patient was treated with benadryl (nos) (Benadryl) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the pain in arm, skin warm and erythema of extremities were unknown.   It was unknown if the reporter considered the pain in arm, skin warm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: Medical assistant reported that a patient notified their office the day before reporting, that she was experiencing redness, warmth and tenderness that measures 1 1 divided by 4 by 1 inch on her left deltoid.   They advised the patient to use topical Benadryl and ice for pain. The reporter consented to follow. This case has been linked with US2020048480, reported by same reporter.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: 7 months old received DTap/IPV of the Pentacel without reconstitution of the HIB/no AE; Initial information received on 27-Apr-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 7 months old female patient who received DTAP/IPV of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without reconstitution of the HIB (product preparation issue) via intramuscularly at the left upper thigh on 27-Apr-2020 for prophylactic vaccination [batch number UJ195AAA; expiry date 12-Mar-2021; dosing details - third dose 0.5 ml of the partial Pentacel]. Batch number and expiry date of HIB was reported as UJ195AA and 12-Mar-2021 respectively.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE).  It was an actual medication error case due to inappropriate reconstitution technique.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site mass
Clinical narrative: Small lump at the injection site; This spontaneous case reported by a pharmacist and initially received on 20-Sep-2018, concerns a 54-year-old, adult, female patient.  The patient's medical history and concomitant medications were unknown.   On 20-Sep-2018, the patient was administered Afluria Quadrivalent [Influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: YF37606 (as reported), expiry date: 11-Jun-2019] for protection against seasonal influenza. The reported batch number (YF37606), does not match Seqirus batch numbers, however, because the reporter named Seqirus product YF37606' as the suspect vaccine, this report has been conservatively entered as a Seqirus case. However, the query regarding the batch number has been raised.   On the same day right after administration of the vaccine, the patient developed a small lump at the injection site. Patient did not undergo any treatment for the event.  At the time of this report, the patient was recovering from the event.  The reporter assessed this case as non-serious.; Reporter's Comments: A 54-year-old female patient developed an injection site lump on the same day after vaccination with suspect vaccine Afluria Quadrivalent. The company assessed the causality of the event as related considering site-specific reaction (injection site) and due to plausible temporal relationship between event and suspect vaccine.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Shaking; This spontaneous case, initially received from a pharmacist on 07-Nov-2018, concerns a 60-year-old, adult, female patient.  On 06-Nov-2018, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YF39007 and expiry date: 30-Jun-2019] for influenza prophylaxis.  On the same day, three hours after vaccination, the patient experienced shaking.  At the time of the report, the outcome of the event was not reported.   This reporter considered the case as non-serious.; Reporter's Comments: A 60-year-old, female patient experienced shaking, three hours after vaccination with Afluria Quadrivalent. The company assessed the causality as related considering the plausible temporal relationship between the event and suspect vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Day after vaccines (4/25/20) mom noticed redness and swelling of left thigh erythema covering about half of left thigh around the area of injection, mild erythema on right.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Dizziness, Pain, Pyrexia
Clinical narrative: Approximately 4 hours following the injection I began to experience abdominal pain. After 12 hours, in addition to abdominal pain, I was experiencing low grade fever, chills, dizziness, and body aches. After 24 hours, I was experiencing the previously stated effects with the addition of vomiting that lasted until 34 hours after the injection.  Effects began to ease at approximately 48 hours  flowing the injection. At 60 hours following the injection, all adverse effects were gone.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Approximately 4 hours following the injection I began to experience abdominal pain. After 12 hours, in addition to abdominal pain, I was experiencing low grade fever, chills, dizziness, and body aches. After 24 hours, I was experiencing the previously stated effects with the addition of vomiting that lasted until 34 hours after the injection.  Effects began to ease at approximately 48 hours  flowing the injection. At 60 hours following the injection, all adverse effects were gone.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling at site of injection on right thigh
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Swelling
Clinical narrative: RED AND SWELLING
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Anxiety, Asthenia, Chest discomfort, Chills, Hyperhidrosis
Clinical narrative: Pt in clinic with mom for 2nd Hep A. Pt tolerated well to left deltoid, but then a few minutes later started to feel like seeing white spots and white film over eyes, then feeling weak This turned into other symptoms, diaphoresis, pale complexion, white lips then tingling to legs VS: 100% , HR 98, BP 58/48 (difficult to read, manual) similar bilat, pulse equal and full bilat EMS notified, pt layed on floor in trendelenburg, legs elevated, 15L O2 with non-rebreather placed on face Pt with other symptoms, now more so chest tightness, hyperventilating, chills (anxiety attack) Once on the floor, BP immediatiately raising, BP: 90/68, color coming back to face, 02 dropped for a moment to 88-90%, but quickly came back up and stabilized at 96-97% EMS arrived, but felt patient was stable and did not even assess. Mom signed waiver stating did not want ride to hospital. Monitored for another 5-10 min in triage room floor and then slowly transitioned and walked patient to the exam room. Continued O2 and kept laying on bed for 15-20 min. Then fully re-assessed. Suspect possible adverse reaction to HepA Other factors:  no breakfast this morning, only a couple sips water this morning no symptoms prior to coming Pt does admit to anxiety
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Hyperventilation, Lip discolouration, Pallor, Paraesthesia, Visual impairment
Clinical narrative: Pt in clinic with mom for 2nd Hep A. Pt tolerated well to left deltoid, but then a few minutes later started to feel like seeing white spots and white film over eyes, then feeling weak This turned into other symptoms, diaphoresis, pale complexion, white lips then tingling to legs VS: 100% , HR 98, BP 58/48 (difficult to read, manual) similar bilat, pulse equal and full bilat EMS notified, pt layed on floor in trendelenburg, legs elevated, 15L O2 with non-rebreather placed on face Pt with other symptoms, now more so chest tightness, hyperventilating, chills (anxiety attack) Once on the floor, BP immediatiately raising, BP: 90/68, color coming back to face, 02 dropped for a moment to 88-90%, but quickly came back up and stabilized at 96-97% EMS arrived, but felt patient was stable and did not even assess. Mom signed waiver stating did not want ride to hospital. Monitored for another 5-10 min in triage room floor and then slowly transitioned and walked patient to the exam room. Continued O2 and kept laying on bed for 15-20 min. Then fully re-assessed. Suspect possible adverse reaction to HepA Other factors:  no breakfast this morning, only a couple sips water this morning no symptoms prior to coming Pt does admit to anxiety
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Erythema, Swelling
Clinical narrative: REDNESS AND SWELLING
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Electroencephalogram abnormal, Magnetic resonance imaging normal, Seizure
Clinical narrative: Seizures started 03/28. Have progressively became more frequent. Meds are being give at this time.
Age: 37.0
Sex: F
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Client reported and I observed her upper left arm with redness and swelling in the same area Varicella vaccine was administered on 4/27/2020.  Client will continue to monitor.  I advised client this needed to be reported.    Client also had a PPD placement on lower left forearm, PPD read on 4/30/2020 before 2:37 pm.
Age: 56.0
Sex: F
Vaccine: MENB, MNQ, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Musculoskeletal stiffness, Pain
Clinical narrative: Patient started to have stiffness, swelling and redness in the left upper arm the first night after the vaccines were administered. No shortness of breath or lip swelling was reported. Patient arm after coming a couple days later (4/29/20) was red in the area and swollen. Patient reported that she could barely move her arm and was in a lot of pain.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The vaccine was given on AM of 4/27 at the left thigh and mom noticed redness/ swelling at the left thigh on the AM of 4/28 (no associated itching). The swelling/ erythema worsened on 4/29 and, given suspicion for cellulitis, pt was started on Keflex on 4/29. Pt seen on 4/30 for follow up and infection is responding well to Keflex, ie swelling/ erythema are markedly decreased. Pt has been afebrile  and otherwise well appearing during this time.   Note: on 4/27, pt also received Hep A vaccine at the right thigh (which is normally appearing)
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Crying, Neck pain
Clinical narrative: MOP made appointment to see our pediatrician after pt complained of extreme neck pain and would not stop crying for about an hour.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling hot, Irritability, Nausea, Pain in extremity, Screaming
Clinical narrative: irritability (woke up screaming), legs aching, felt that she was very hot (no thermometer at home), nausea
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Flushing, Pain
Clinical narrative: Woke this morning at 6 am with temp of 99.9,  chills, fatigue, flushed face,  body aches all over and cold hands and goose bumps. Took two Tylenol but symptoms returned after 3 hours.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral coldness, Piloerection
Clinical narrative: Woke this morning at 6 am with temp of 99.9,  chills, fatigue, flushed face,  body aches all over and cold hands and goose bumps. Took two Tylenol but symptoms returned after 3 hours.
Age: 43.0
Sex: F
Vaccine: DTAP
Symptoms: Pain in extremity, Peripheral swelling, Skin warm, Ultrasound Doppler
Clinical narrative: Left arms swelled , was hot to touch and painful
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient reported to clinic 2 days after receiving vaccine to report redness and firmness the size of a hand located at the site of injection. Area was warm to the touch. Patient was seen by experienced AI technician and was told to come back if symptoms worsen, because the reaction was unfortunate but common and WNL.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Lethargy, Vomiting
Clinical narrative: Vomiting, lethargic
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Patient developed Lump, Redness, warm to Touch, itching to Right Deltoid area next day after Tdap vaccine. Patient was seen by MD and instructed to use Zyrtec & Benadryl. Pt was instructed to call or RTC if Sx's worse
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: left upper arm redness, tenderness, swelling and warmth after vaccines on yesterday 04-29-2020. Tylenol given on last night. Benadryl and Tylenol given in office today 04-30-2020, along with cold pack. 7cmx8cm of induration no streaking
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Patient stated she has had severe pain for over a year in the arm that had was immunized.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Patients were administered a dose of improperly stored vaccine; No adverse symptoms were reported; This spontaneous report was received from a registered nurse regarding multiple unspecified number of patients (age or gender not reported).   Concurrent conditions and medical history were not reported for the unspecified number of patients. Concomitant medication reported was sterile diluent (also reported as DILUENT MRK) (lot # not reported).   On unknown dates, doses of varicella virus vaccine live (Oka/Merck) (VARIVAX)(lot # R017635, expiration date 20-JUN-2020) which was improperly stored in a temperature between 6°F to 14°F (7F)) in a time frame of 1 hour were administered to multiple unspecified patients. It was reported that the call was made due to data logger and no previous temperature excursion occurred.  No adverse symptoms were reported for the unspecified multiple patients.   This case was considered non valid due to lack of patient identifiers.
Sex: U
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; the patient was inadvertently administered a dose of VAQTAthat had been improperly stored; This spontaneous report as received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.      On 20-APR-2020, the patient was inadvertently vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe (strength, dosage regimen, route of administration, and anatomical location were not reported; lot number S032056 has been verified to be valid, expiration date reported and validated as 09-NOV-2020) as prophylaxis (product storage error). No additional adverse event.  The temperature reported was of 47.7 degrees Fahrenheit (F) for 12 minutes, with a previous temperature excursion of 58.3 F for 14 hours. A data logger was used. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress:  manufacturercity: ; manufacturerstate: ; manufacturercountry:; devicelotnumber: S032056; expirationdate: 09-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event.; the patient was inadvertently administered a dose of ROTATEQ on 3/3/2020 that had been improperly stored.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 03-MAR-2020, the patient was inadvertently administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # S006050 with expiration date of 12-DEC-2020, for prophylaxis.        No adverse effects were reported.  It was stated that the vaccines underwent a temperature excursion in  08-FEB-2020, of above 47F (degrees Fahrenheit) (50.9F) for 30 minutes; on 25-FEB-2020, of above 47F (52.7F) for 15 minutes; on 03-MAR-2020, of above 47F (50.7F) for 25 minutes.  No previous temperature excursion was done. The call was because of a "data logger".
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK VIVOTIF ON CONSECUTIVE DAYS; This spontaneous case report was received from a pharmacist (PVX2019-184) on 18-Jan-2019. The report describes a 64-year-old adult male consumer who "took Vivotif on consecutive days". The consumer was receiving Vivotif (one dose every other day) for typhoid prevention.  It was reported that the consumer took Vivotif two days in a row and did not skip a day. He picked up the doses on 15-Jan-2019. She was unsure and believed the doses were taken on 16-Jan-2019 and 17-Jan-2019.  The action taken with Vivotif with respect to the event "took Vivotif on consecutive days" was not applicable.  The clinical outcome of the event "took Vivotif on consecutive days" was unknown.  Company's Comment: The causality of the event "took Vivotif on consecutive days" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif on consecutive days" was considered as not applicable.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: I have all of the usual side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a 71-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21st April 2020, the patient received the 2nd dose of Shingles vaccine. In April 2020, less than a week after receiving Shingles vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingles vaccine.  Additional details were reported as follows:  The patient got second shingles shot the day before reporting.  The patient had all of the usual side effects.  The patient asked how long should the patient expect the side effects to last.
Age: 17.0
Sex: F
Vaccine: MMRV
Symptoms: Asthenia, Dizziness, Eye pain, Head discomfort, Headache
Clinical narrative: Severe eye pain and our daughter could not look from side to side without pain.  Especially in the left eye.  Headache.  Vision was ok. She could hardly  move for two days, very sore right arm where the shot was administered, swollen and painful glands, sore throat, nausea, faintness, weakness all over, pox on chest, rough small bumps under eyes, an increase in head pressure in the days following, feelings of pressure around her brain, back of head, forehead, generally the whole head felt like "a shrinking cap was being pulled over it".
Age: 17.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site pain, Laboratory test normal, Lymph node pain, Lymphadenopathy, Mobility decreased
Clinical narrative: Severe eye pain and our daughter could not look from side to side without pain.  Especially in the left eye.  Headache.  Vision was ok. She could hardly  move for two days, very sore right arm where the shot was administered, swollen and painful glands, sore throat, nausea, faintness, weakness all over, pox on chest, rough small bumps under eyes, an increase in head pressure in the days following, feelings of pressure around her brain, back of head, forehead, generally the whole head felt like "a shrinking cap was being pulled over it".
Age: 17.0
Sex: F
Vaccine: MMRV
Symptoms: Nausea, Oropharyngeal pain, Pustule, Rash
Clinical narrative: Severe eye pain and our daughter could not look from side to side without pain.  Especially in the left eye.  Headache.  Vision was ok. She could hardly  move for two days, very sore right arm where the shot was administered, swollen and painful glands, sore throat, nausea, faintness, weakness all over, pox on chest, rough small bumps under eyes, an increase in head pressure in the days following, feelings of pressure around her brain, back of head, forehead, generally the whole head felt like "a shrinking cap was being pulled over it".
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Autism spectrum disorder, Extra dose administered
Clinical narrative: My daughter (6months at the time) got a double dose of DTap/IPV/Hib. I space out her shots, so On 3/14/18 she had her DTap/IPV/Hib shot and the next week on 3/23/18 she went in for another shot and they gave her the DTap/IPV/Hib again. The nurse told me what happened and assured me that it was okay so of course  I trust them with my child's safety. Just this past week, my daughter who is almost 26 months was diagnosed with Autism (4/20/2020). (I do know that vaccines have NEVER been proven to cause autism). We did notice some autism like symptoms after that incident. I do have screen shot proof of the double dose vaccine.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Approximately 3 hours after the injection, her right upper arm started turning red, was swollen, warm to the touch, itched, and was painful.  Approximately 18 hours after injection, she was swollen from her shoulder to her elbow, had blisters all around the site of the injection, arm was warm to the touch and painful.  When she removed the bandaid that covered injection site, the skin around injection site came off with bandaid.  She started taking Levaquin 500 mg daily.  This morning is 7 days from injection and she still has a slight amount of swelling in upper right arm and site has not healed completely from where skin came off with bandaid.  The blisters that were around the site have resolved.  She has site covered with bio-occlusive dressing.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site vesicles, Injection site warmth, Skin exfoliation
Clinical narrative: Approximately 3 hours after the injection, her right upper arm started turning red, was swollen, warm to the touch, itched, and was painful.  Approximately 18 hours after injection, she was swollen from her shoulder to her elbow, had blisters all around the site of the injection, arm was warm to the touch and painful.  When she removed the bandaid that covered injection site, the skin around injection site came off with bandaid.  She started taking Levaquin 500 mg daily.  This morning is 7 days from injection and she still has a slight amount of swelling in upper right arm and site has not healed completely from where skin came off with bandaid.  The blisters that were around the site have resolved.  She has site covered with bio-occlusive dressing.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis, Incorrect route of product administration, Pain of skin, Skin warm
Clinical narrative: hot, tender, large inflamed area 10 inches below the injection site; hot, tender, large inflamed area 10 inches below the injection site; hot, tender, large inflamed area 10 inches below the injection site; The doctor believes the injection may have been given Subcutaneously; This case was reported by a physician via call center representative and described the occurrence of skin warm in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 16th March 2020, the patient received the 2nd dose of Shingrix (subcutaneous). On 16th March 2020, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On 17th March 2020, the patient experienced skin warm, skin tenderness and skin inflammation. On an unknown date, the outcome of the skin warm, skin tenderness, skin inflammation and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the skin warm, skin tenderness and skin inflammation to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of vaccine and next day developed a hot, tender, large inflamed area 10 inches below the injection site. The doctor believed that the injection might have been given Subcutaneously which led to Intramuscular formulation administered by other route. The vaccine was given at an unspecified pharmacy. The reporter consented to follow up.   Follow up information received from nurse on 23rd April 2020: The patient's demographic details were updated. VAERS details were updated. The reporter considered the skin warm, skin tenderness and skin inflammation to be related to Shingrix
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Clinic gave 9 doses of flu shipment that had spent too long in transit, no advese event; Based on information previously received on 04-Oct-2019, the following information updated: case validity has been amended due to number of patients involved specified.  Initial information received on 04-Oct-2019 regarding an unsolicited non-valid non-serious case received from a consumer.  This case involves nine patients who were vaccinated with a dose each of vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot number and Exp. Date not reported) via unknown route in unknown administration site on an unknown date and for this vaccine shipment had spent too long in transit.   The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to incorrect product storage.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder' s compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was not obtained despite contact attempts with the reporter.  Follow up information received on 07-Nov-2019 regarding an unsolicited non-valid non-serious case received from a consumer.  Report contain no new information.  Addendum: Based on information previously received on 04-Oct-2019, the following information updated: case validity has been amended due to number of patients involved specified.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: first dose of Pentacel at 2 months and then the second at 5 months/no AE; Initial information received on 23-Apr-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient(unknown demographics) who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] first dose at 2 months of age and then the second at 5 months (inappropriate schedule of product administration) on an unknown date for prophylactic vaccination [batch number, expiry date, dosing details, route and site of administration not reported].  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate schedule of vaccine administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Sex: M
Vaccine: FLU3
Symptoms: Headache, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: extreme muscle weakness, weakness in legs; fever; severe muscle aches throughout the body; headache; Initial information received on 24-Apr-2020 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case is linked to case 2020SA109892 (same reporter).  This case involves male patient (age unknown) who experienced extreme muscle weakness, weakness in legs (muscular weakness), fever (pyrexia), severe muscle aches throughout the body (myalgia) and headache, while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 13-Sep-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On 13-Sep-2019 (same night), the patient developed a non-serious extreme muscle weakness, weakness in legs (muscular weakness), fever (pyrexia), severe muscle aches throughout the body (myalgia) and headache following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  No laboratory data reported.  Final diagnosis was headache, pyrexia, muscular weakness and myalgia.   An unknown corrective treatment was received the patient except tyenolol.  Case details: patient stated that the headache, muscles aches, and muscle weakness come and go over about a 2-day interval; he will get better, then 2 days later the symptoms come back again, and this has been going on since September 2019. Patient stated that the one symptom he has not experienced since that first night, 13 Sep 2019, is fever. Patient stated that he was previously very healthy, and he has worked in a cardiology laboratory for many years.  The patient recovered from fever after one and a half day while was recovering other reported events..  There will be no information on the batch number for this case.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Contusion, Erythema, Induration
Clinical narrative: Mother reports her right arm became hardened around deltoid area, red, she applied ice to area and on 5/1/20 it was not hard anymore but can still see redness. Mild around area, bruise, no fever, pain
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reaction - patient was given the incorrect vaccines. Once discovered it happened the patient/parent was notified to get correct vaccine. F/u call 04-29-20 no additional symptoms. Doing well
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Decreased appetite, Haematochezia
Clinical narrative: bloody stools x2 with decreased appetite
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient states that her arm is very very sore, warm to touch, and has some  swelling  at the injection site.  The pain started in the evening about 9:30pm on 4/30/20 after vaccination administration on 4/30/20 at 2:30pm. Patient did take acetaminophen and that did help her pain.  Patient is going to ice her arm and take more tylenol to help control her pain and inflammation.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia, Tremor
Clinical narrative: body aches.  Headache, sharp pain in head.  Fever of 100.4.   Chills.  Shaking.