chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Adacel was inadvertently given to patient/ no AE; Initial information received on 13-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is related to case- 2019SA133619 same reporter.  This case involves a 52 years old male patient received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patients past medical history and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]) on unknown date.   On 04-May-2019, the patient received a Booster dose 0.5ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5656AA, expiry date 02-May-2019 via intramuscular route in the right deltoid.  It was an actual medication error due to expired vaccine used.  It was reported that expired dose of Adacel was inadvertently given to patient.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender- none.
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Adacel injection that had been frozen in a prior temperature excursion reached 27 fahrenheit making the doses not suitable for use which was administered to a female patient /No AE; Initial information received on 15-May-2019 regarding an unsolicited valid non-serious case received from a consumer.   This case is linked to case 2019SA135518 (male patient).   This case involves a 37 years old female patient who was injection a 0.5ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot C5602AA via unknown route in the left deltoid on 10-May-2019 that had been frozen in a prior temperature excursion reached 27 Fahrenheit making the doses not suitable for use.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to product storage error.  No side effects reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: ten year old who was inadvertently given Quadracel/ no adverse event; Initial information received on 16-May-2019 regarding an unsolicited valid non-serious case received from other health care professional.  This case involves a 10 years old male patient who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past vaccination(s) included DTAP in 2009 and IPV in 2009 (last dose of each was in 2009).  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications were none.  On 13-May-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5532AA and expiry date 09-Oct-2020 via intramuscular route in left arm.  It was a case of actual medication error due to inappropriate age at vaccine administration. It was also reported that the child needed his 4th dose of Dtap and IPV.  No adverse event reported (symptoms-none).  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.  List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 2 month old patient was given Quadracel by mistake; the wrong product had been given, intended product was Pentacel; Initial information received on 16-May-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 2 months old female patient who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number not reported via unknown route in the left thigh.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered. It was reported that 2 month old patient was given Quadracel by mistake and the wrong product had been given as intended product was Pentacel.  It was unknown if the patient had any adverse event.  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 requested.  List of documents held by sender: none.
Sex: U
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: MDV Polio (Ipol) was exposed to temperature excursion for 16 hours 54 minutes; Initial and additional (live-follow-up) information received on 16-May-2019 and 17-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves three patients who may have received vaccine IPV (VERO) [IPOL] (formulation: unknown, lot number not reported via unknown route in unknown administration site) on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage (It was reported that the opened MDV Polio (IPOL) was exposed to temperature excursion for 16 hours 54 minutes)  It was unknown whether the patient had any adverse event.  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.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 40.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a 40 year old woman received Fluzone Highdose and another flu vaccine/ no adverse event; a 40 year old woman receiving 2 Flu shots in one day/ no adverse event; a 40 year old woman received Fluzone Highdose and another flu vaccine/ no adverse event; Initial information received on 16-May-2019 regarding an unsolicited valid non-serious case received from a physician by phone.  This case involves a 40 years old female patient who received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and a dose of Influenza vaccine on same day (vaccination date not reported.(Batch number, expiry date, dose, dose in series and route of administration were not reported), site of administration was reported as left and right arm for both vaccines).  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  It was a case of actual medication error due to extra dose administered, overdose and inappropriate age at vaccine administered.  No Lab data was reported.  No adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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 requested.  Documents held by the sender: none.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Pentacel vaccine components should not be used separately/ the Hib lyophilized component administered separately will count as a valid dose only if it was reconstituted with the proper diluent, i.e. 0.4% NaCl saline solution/ no AE; Initial information received on 16-May-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves a 2 months old male patient who was vaccinated with 0.5 ml first dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Batch number: UJ032AA and expiry date: 04-Jul-2020) via intramuscular route in the right thigh on 16-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) on an unknown date.  It was a case of actual medication error due to wrong solution used in drug reconstitution.  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 holders 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.   Documents held by the sender: none.
Sex: M
Vaccine: HIBV, IPV
Symptoms: Wrong product administered
Clinical narrative: IPOL vaccine was administered to a patient who was suppossed to get an ActHIB; Initial information received on 16-May-2019 regarding an unsolicited valid non-serious case received from other health care professional.  This case involves a 5 months old male patient who received vaccines HIB (PRP/T) VACCINE [ACT-HIB] and IPV (VERO) [IPOL] and Ipol vaccine was administered to a patient who was suppossed to get an ActHib.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and HEPATITIS B VACCINE (HEPATITIS B VACCINE).  On 14-May-2019, the patient received a dose of suspect IPV (VERO) lot P1A242M and expiry date: 26-Apr-2020 via unknown route in unknown administration site.  It was a case of actual medication error due to wrong vaccine administered.  It was unknown if the patient had any adverse event.  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.  List of documents held by sender: none.
Sex: F
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: received an expired Day 0 Imovax vaccine on 15May2019, the expiration date was 26Feb2019; Initial information received on 16-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 59 years old female patient who received an expired dose of vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patients past medical history and family history were not provided.  Concomitant medications included IMMUNOGLOBULIN HUMAN ANTI-RABIES (RIG) on 15-May-2019.  On 15-May-2019, the patient received a 0.5ml dose post exposure vaccination of suspect RABIES (HDC) VACCINE lot N1B05, expiry date 26-Feb-2019 via intramuscular route in the right deltoid.  It was an actual medication error due to expired vaccine used.  It was reported that patient received an expired Day 0 Imovax vaccine on 15May2019, the expiration date was 26Feb2019.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender- none.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Chills, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Pt reported arm pain late friday night. Chills & fever friday into saturday. The arm pain got better saturday & sunday but moved into the patient's axilla area & still reports pain there today. Patient stated the deltoid muscle is pain-free, but the pain is just in the axilla area now. Patient reported no rash, no redness, no itching, no red, warm skin.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Continuing sporadic pain at injection site, becoming much more frequent.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Accidental exposure to product, Device malfunction
Clinical narrative: When administering the TDAP vaccine, the vaccine fluid shot out at nurse. Device malfunction - that is, the device did not do what it was supposed to do.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Second dose of Shingrix vaccine has caused persistent muscle pain at the injection site for 3 weeks
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Pain
Clinical narrative: Shingles vaccine given evening of 5-16-19 - one day later I experienced a bad headache, all over body aches, extreme fatigue, nausea and diarrhea for 48 hours or more.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Malaise, Pain, Pain in extremity
Clinical narrative: I received the second dose of Shingrix and became ill. I expected a sore arm but not the headache, fever and body ache that I experienced. I did not have any reaction to the first one. I felt terrible and was basically ill for 1.5 days. I felt like I should tell someone in case there was a bad lot.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I received the second dose of Shingrix and became ill. I expected a sore arm but not the headache, fever and body ache that I experienced. I did not have any reaction to the first one. I felt terrible and was basically ill for 1.5 days. I felt like I should tell someone in case there was a bad lot.
Age: 9.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMRV, TD
Symptoms: Syncope
Clinical narrative: Patient fainted after receiving vaccines. He was treated immediately with placing in position to increase blood flow to head and given Apple juice to drink. Ice pack applied to bump on forehead.  Patient recovered quickly and was stable, ok to go home after approximately 15 minutes.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain in extremity
Clinical narrative: Patient had "extremely" sore arm for several days, and flu-like fatigue for 24 hours
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: States reports to MD that she broke out in a red spotted itchy rash on Head, torso and upper legs.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Tenderness
Clinical narrative: Patient reported multiple red, tender, dime-sized areas on right arm which she noticed the morning after the injection. No accompanying sypmtoms.
Age: 1.08
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received MMRV as well as Varicella- so 2 doses of Varicella received on 5/21/19. Patients Mother notified that evening and currently no adverse reactions seen in patient. Per IIS  ? Immunization Information System on call epidemiologist to watch for an increased localized reaction, Patients mother aware to watch for any reaction and to call with questions or concerns.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Mobility decreased, Muscular weakness, Myalgia
Clinical narrative: Extreme muscle pain and weakness in the RIGHT arm and shoulder- the arm opposite of the injection site arm.  Painful and difficult/weak to lift fist of this arm above head level.  The injection site arm pain and rash improved since the day injection but the opposite arm and shoulder became worse and does not seem to have diminished in pain in the days after the injection.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Extreme muscle pain and weakness in the RIGHT arm and shoulder- the arm opposite of the injection site arm.  Painful and difficult/weak to lift fist of this arm above head level.  The injection site arm pain and rash improved since the day injection but the opposite arm and shoulder became worse and does not seem to have diminished in pain in the days after the injection.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Eye oedema, Pyrexia, Rash
Clinical narrative: Pt got 15 mth old vaccines yesterday. This morning, child presented to office with BILATERAL eye edema and fever. Some rash noted. Referral made to Allergy specialist.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cold sweat, Disturbance in attention, Pyrexia
Clinical narrative: Fever and Chills; wasn?t sure if I was having a stroke.  All of a sudden nothing would focus and I saw total ?stars?.  My whole body went clammy. I actually thought I should call 911. Then everything started to refocus again.
Age: 60.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Aphonia, Chills, Cough, Ear pain, Fatigue
Clinical narrative: chills, achy, tired, sore throat, ear ache, cough, loss of voice.
Age: 60.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: chills, achy, tired, sore throat, ear ache, cough, loss of voice.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Malaise, Pain
Clinical narrative: Patient developed some soreness and redness at the site that she describes as being about a quarter size.  She reports that night after getting the vaccine she felt somewhat generalized illness with mild headache and body aches.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Cough, Cystitis, Decreased appetite, Diarrhoea
Clinical narrative: Last Fall I had a first shingles attack so in December I started the Shingrex two shot series, completed near the end of March.  I should note that although I am 80 years old, I had not had the flu or even a cold for years.  After the second shot I got the usual sore arm, worse the next day and that evening endless attacks of diarrhea, trouble breathing, coughing, a sleepless night.  I slept most of the next day, had little energy or appetite the rest of the week, and then came down with a Staphylococcus aureus bladder infection, cause unknown.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Insomnia, Pain in extremity, Staphylococcal infection, Staphylococcus test positive
Clinical narrative: Last Fall I had a first shingles attack so in December I started the Shingrex two shot series, completed near the end of March.  I should note that although I am 80 years old, I had not had the flu or even a cold for years.  After the second shot I got the usual sore arm, worse the next day and that evening endless attacks of diarrhea, trouble breathing, coughing, a sleepless night.  I slept most of the next day, had little energy or appetite the rest of the week, and then came down with a Staphylococcus aureus bladder infection, cause unknown.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site haemorrhage, Injection site pain
Clinical narrative: patient called stating that she had an unusual amount of pain in the injection site. She stated that it looked as though there was a "pool of blood" underneath the injection site. She visited an urgent care, and according to the patient they told her they believe it might be that the vaccine didn't spread out from the injection site. She was instructed to ice it. As of yesterday, Tuesday 5/21, patient stated that it had improved considerably.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Muscular weakness
Clinical narrative: The evening of the vaccination, Pt reported tingling down both arms, weakness in knees and lower back, calves.  This weakness worsens when going down the steps.  Pt also reported a headache for two days following vaccine.  Currently (12 days post vaccination) pt describes arm soreness (both arms) as in "lifting lots of weights," generalized weakeness/fatigue and continued soreness in knees.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: The evening of the vaccination, Pt reported tingling down both arms, weakness in knees and lower back, calves.  This weakness worsens when going down the steps.  Pt also reported a headache for two days following vaccine.  Currently (12 days post vaccination) pt describes arm soreness (both arms) as in "lifting lots of weights," generalized weakeness/fatigue and continued soreness in knees.
Age: 12.0
Sex: M
Vaccine: HPV9, PPV
Symptoms: Body temperature increased, Headache, Injection site erythema, Injection site induration
Clinical narrative: Started with headache at 1200 on 5/21/19.  Went to school nurse.  Had temp of 100.6 and slight redness around site of pneumococcal 23 injection on right deltoid.  Early am of 5/22/19 pt had temp of 101.   Saw in office at 1200.  Induration on right deltoid was 6 x 8.5 cm.  Temp was 101.2
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Fever 102.2
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Hypersomnia, Muscle discomfort, Muscle spasms, Muscle tightness
Clinical narrative: The next morning, patient was fatigued to the point that he could not do much and slept most of the day. Saturday afternoon, mild discomfort in shoulder muscles started. Sunday morning spams in left shoulder were severe.  It was like a Charley horse because the pain and muscle tightness was incredible. Used cold/warm compresses and massaged area to release the muscle tightness; also took Aleve. The muscles occurred if moved head/neck in a certain way.   On Monday could not handle normal activities and could not even get to sleep.  Called doctor on Tuesday afternoon and he prescribed Flexeril along with Aleve. Diagnosed with Torticolis and Cervical Dystonia. The medicine along with hot/cold compresses and massages relieved some of the pain and loosened up muscle tissue.  Today, spams not as frequent but still cannot move head up or turn left since certain movements trigger the spams again. Doctor provided referral for physical therapy and patient will start this afternoon.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Torticollis
Clinical narrative: The next morning, patient was fatigued to the point that he could not do much and slept most of the day. Saturday afternoon, mild discomfort in shoulder muscles started. Sunday morning spams in left shoulder were severe.  It was like a Charley horse because the pain and muscle tightness was incredible. Used cold/warm compresses and massaged area to release the muscle tightness; also took Aleve. The muscles occurred if moved head/neck in a certain way.   On Monday could not handle normal activities and could not even get to sleep.  Called doctor on Tuesday afternoon and he prescribed Flexeril along with Aleve. Diagnosed with Torticolis and Cervical Dystonia. The medicine along with hot/cold compresses and massages relieved some of the pain and loosened up muscle tissue.  Today, spams not as frequent but still cannot move head up or turn left since certain movements trigger the spams again. Doctor provided referral for physical therapy and patient will start this afternoon.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: patient stated the injection site had unusual hardness, redness, itching, and a greater than 2 inch circumference at the injection site. the reaction started one day after the injection and lasted for approximately 7 days.  after 7 days the area was still hard but no longer red or sore
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Later that evening arm was very sore.  Next day was aching all over; stayed in bed and had joint pain. Patient did not take medications, nor contacted doctor or pharmacist.  Patient felt better by 5/5 but soreness in arm lasted for 1 week.  As of today, patient has recovered completely.   First dose of vaccine was in January 2019; same pharmacy and sore arm lasted for 3 days.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Chest pain, Chills, Fatigue, Headache, Malaise
Clinical narrative: Mom called office on 5/22/2019 and reported that on Monday evening 5/20/19 patient started to not feel well, arm pain, fatigue, shivers, headache, and chest pain. Fever started 5/21/2019 of 101.  Motrin was given and patient was told to call if not better in two days or if worse to call sooner to be seen
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Mom called office on 5/22/2019 and reported that on Monday evening 5/20/19 patient started to not feel well, arm pain, fatigue, shivers, headache, and chest pain. Fever started 5/21/2019 of 101.  Motrin was given and patient was told to call if not better in two days or if worse to call sooner to be seen
Sex: M
Vaccine: HPV9
Symptoms: Pain
Clinical narrative: some painful side effects afer getting the first dose of the GARDASIL 9 series; This spontaneous report was received from a consumer, a 27-year-old male patient, reporting on himself. No details regarding the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were provided. On an unknown date, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, strength, route of administration, lot # and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced some painful side effects. The outcome of the event was not provided. The causality assessment between the suspect therapy and the event was not provided.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Dizziness, Electrocardiogram, Injection site erythema, Pain in extremity, Palpitations
Clinical narrative: erythema 4x6 centimeters in the arm that received ZOSTAVAX; Sore in the arm that received PNEUMOVAX 23; Palpitations; light-headedness; This spontaneous report was received from a Nurse prescriber refers to a 66 year old female patient. The patient's historical medication included carisoprodol (SOMA) with which patient developed drug reaction/allergy. The patient's concurrent condition included drug allergy. The patient's concomitant medications and pertinent medical history were unknown. On 15-MAY-2019, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) on one arm along with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) on another arm at unspecified locations for prophylaxis (dosing details, lot # and expiration date not reported). On 16-MAY-2019 (reported as in 24 hours'), the patient developed erythema of 4 x 6 centimeters in the arm that received zoster vaccine live (ZOSTAVAX) (vaccination site erythema) and developed sore in the arm that received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (vaccination site pain). On an unknown date in May 2019, the patient developed palpitations and light headedness (dizziness). On an unknown date in May 2019, the patient underwent electrocardiogram (EKG). The patient sought medical attention and received treatment for the events. On 17-MAY-2019, the patient visited a clinic complaining of injection site reactions, palpitations and light-headedness. Outcome of the events was unknown. The reporter's causality assessment was not provided.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Anaphylactic reaction, Blood pressure decreased, Dyspnoea
Clinical narrative: This spontaneous report was received from a physician refers to a 10-year-old male patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were reported as "none". On 10-SEP-2012, the patient was administered a dose of VARIVAX via subcutaneous route for routine vaccinations (prophylaxis). Other suspect therapies included a dose of M-M-R II via subcutaneous route for prophylaxis and sterile diluent (dosage schedule was not reported). The physician reported that within few minutes of being administered these vaccines the patient had experienced anaphylactic reaction including blood pressure dropping and shortness of breath. The patient's mother reported to the physician that they had spent 6 hours in the doctor's office and then the patient was transported to an emergency room. The patient did not undergo any laboratory investigations. The patient sought medical attention. The patient was treated with Epinephrine (unknown dose/ manufacturer), steroids (unknown dose/ manufacturer) and antihistamines (unknown dose/ manufacturer). The patient was recovered on the same day. Causality of the event was not reported. The reporter considered the event anaphylactic reaction to be life threatening. Upon internal review the event anaphylactic reaction was considered as medically significant.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Erythema, Fatigue, Hyperaesthesia, Injection site erythema
Clinical narrative: Body aches; itchy and redness at injection site; itchy and redness at injection site; Redness on entire upper arm; Hot to touch; Sensitive to touch; Lump at injection site; Tiredness/extreme exhaustion; Bruising; Initial pain at injection site; Limited arm movement; This is a spontaneous report from a contactable physician via Pfizer sales representative. A 73-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13; lot number: X93809), via an unspecified route of administration on 06May2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On 06May2019, the patient experienced initial pain at injection site, limited arm movement. On 08May2019 to 10May2019, bruising developed. By 11May2019, redness on entire upper arm, hot to touch, sensitive to touch, lump at injection site, and tiredness. On 14May2019, patient continued with extreme exhaustion, hot to touch, sensitive to touch, body aches, itchy and redness at injection site. The outcome of the events tiredness/ extreme exhaustion, hot to touch, sensitive to touch, body aches, itchy and redness at injection site was not recovered, bruising recovered on 10May2019, while the outcome of the events initial pain at injection site, limited arm movement, redness on entire upper arm, and lump at injection site was unknown.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site mass, Injection site pain, Injection site pruritus, Mobility decreased, Pain
Clinical narrative: Body aches; itchy and redness at injection site; itchy and redness at injection site; Redness on entire upper arm; Hot to touch; Sensitive to touch; Lump at injection site; Tiredness/extreme exhaustion; Bruising; Initial pain at injection site; Limited arm movement; This is a spontaneous report from a contactable physician via Pfizer sales representative. A 73-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13; lot number: X93809), via an unspecified route of administration on 06May2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On 06May2019, the patient experienced initial pain at injection site, limited arm movement. On 08May2019 to 10May2019, bruising developed. By 11May2019, redness on entire upper arm, hot to touch, sensitive to touch, lump at injection site, and tiredness. On 14May2019, patient continued with extreme exhaustion, hot to touch, sensitive to touch, body aches, itchy and redness at injection site. The outcome of the events tiredness/ extreme exhaustion, hot to touch, sensitive to touch, body aches, itchy and redness at injection site was not recovered, bruising recovered on 10May2019, while the outcome of the events initial pain at injection site, limited arm movement, redness on entire upper arm, and lump at injection site was unknown.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Body aches; itchy and redness at injection site; itchy and redness at injection site; Redness on entire upper arm; Hot to touch; Sensitive to touch; Lump at injection site; Tiredness/extreme exhaustion; Bruising; Initial pain at injection site; Limited arm movement; This is a spontaneous report from a contactable physician via Pfizer sales representative. A 73-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13; lot number: X93809), via an unspecified route of administration on 06May2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On 06May2019, the patient experienced initial pain at injection site, limited arm movement. On 08May2019 to 10May2019, bruising developed. By 11May2019, redness on entire upper arm, hot to touch, sensitive to touch, lump at injection site, and tiredness. On 14May2019, patient continued with extreme exhaustion, hot to touch, sensitive to touch, body aches, itchy and redness at injection site. The outcome of the events tiredness/ extreme exhaustion, hot to touch, sensitive to touch, body aches, itchy and redness at injection site was not recovered, bruising recovered on 10May2019, while the outcome of the events initial pain at injection site, limited arm movement, redness on entire upper arm, and lump at injection site was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Injection site rash, Injection site swelling, Rash generalised
Clinical narrative: Generalized rash; Rash at site of administration; Swelling at site of administration; This is a spontaneous report from a contactable physician. A patient of unknown age and gender received a single dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) for immunization. Medical history and concomitant medications were not reported. The patient developed a generalized rash, as well as a rash and swelling at the site of administration. Outcome was unknown.
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Syncope was observed; This is a spontaneous report from contactable physician. This report was received via a sales representative. This physician reported similar events for 3 patients. This is 1st of three reports.  A female patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced syncope was observed on an unspecified date between 6 months and 12 months ago. Event took place after use of product. The outcome was unknown.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine meningococcal group b rlp2086 contributed to the development of the reported event syncope.,Linked Report(s) : US-PFIZER INC-2019217421 Same reporter/drug/event, different patient;US-PFIZER INC-2019217420 Same reporter/drug/event, different patient
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Syncope was observed; This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for 3 patients. This is the second of the 3 patients.  A female patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced syncope was observed on an unspecified date between 6 months and 12 months ago. Event took place after use of product. The outcome was unknown.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine meningococcal group b rlp2086 contributed to the development of the reported event syncope.,Linked Report(s) : US-PFIZER INC-2019217296 Same reporter/drug/event, different patient;US-PFIZER INC-2019217421 Same reporter/drug/event, different patient
Sex: M
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Syncope was observed; This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported similar events for 3 patients. This is third of 3 reports.  A male patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced syncope was observed on an unspecified date between 6 months and 12 months ago. Event took place after use of product. The outcome was unknown.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine meningococcal group b rlp2086 contributed to the development of the reported event syncope.,Linked Report(s) : US-PFIZER INC-2019217296 Same reporter/drug/event, different patient;US-PFIZER INC-2019217420 Same reporter/drug/event, different patient
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site rash, Peripheral swelling
Clinical narrative: Redness and swelling from shoulder to elbow within 24 hours of immunization; resolved around 72 hours later. Localized rash developed around and below injection site within 24 hours of injection, per parent "looked like a bunch of broken blood vessels" that have since faded.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling from shoulder to elbow within 24 hours of immunization; resolved around 72 hours later.
Age: 35.0
Sex: F
Vaccine: FLU4, HEP
Symptoms: Gait inability, Impaired work ability, Paraesthesia, Sensory loss
Clinical narrative: Employee reports not being able to feel legs/walk, or know when she was using the bathroom 5/11/2019. She was hospitalized 5/11-5/18. Currently has to do therapy and has tingling all over her body. Unable to work.
Age: 21.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Worsening arm pain to include all over body aches, fever chills and headache
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram, Impaired driving ability, Injected limb mobility decreased, Nerve injury, Pain in extremity
Clinical narrative: right arm started hurting shortly after vaccine. Thought it would go away but got progressively worse. Talked to MD in Nov or Dec and was referred to an orthopedic MD who gave her a cortisone shot. Shot was ineffective. MD thought vaccine must have hit a nerve which has been causing the problems. She has been receiving therapy for a few months to help movement of arm since she is now needing assistance to move arm and has since been having problems driving due to the pain and lack of being able to move it.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: On 5/15/2019 after immunization around 9pm, patient experienced side effects of body aches. Next day 5/16/2019 around 3pm, patient experienced fever, nausea, more body ache. Patient went to urgent care that day due to symptoms. Patient said urgent care physician mentioned symptoms could be related to Shingrix immunization. On 5/17/2019, patient noticed some symptoms are subsiding, but still feeling very tired. On 5/22/2019, patient revisited urgent care, this time she was diagnosed with bronchitis.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, Papilloma viral infection
Clinical narrative: She ended up contracting the human papillomavirus (HPV) so she "got HPV."; She received the third dose much later than the second dose, approximately "6 years later"; This spontaneous report was received from a 21 year old female patient, referring herself. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.      In 2010, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL); then, approximately in 2010, (reported as approximately "one month later" after getting the first dose), she received the second shot; the patient finally completed the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) series; however, she received the third dose much later than the second dose, she said approximately in 2016 (reported as "6 years later" after getting the second dose) (inappropriate schedule of product administration), all the three doses were administered for prophylaxis (dose, route of administration, lot number and expiration date were not reported).         On an unknown date, sometime afterwards, the patient ended up contracting the human papillomavirus (HPV) (papilloma viral infection).      The outcome of papilloma viral infection and was unknown. The causality assessment between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and the event was not reported.
Sex: U
Vaccine: MMR
Symptoms: Autism spectrum disorder
Clinical narrative: This spontaneous report was received from a physician regarding patients of child age group. The patient's concurrent condition, medical history and concomitant medication was not reported. On an unknown date, the patient was vaccinated with M-M-R II for prophylaxis (dose, route, strength, lot, batch number and expiry date were not reported). Other suspect therapies included sterile diluent (dose, route, strength, lot, batch number and expiry date were not reported) for unknown indication. On an unknown date, the patient's experienced formation of autism and autism spectrum disorders such as Asperger's Syndrome (autism spectrum disorder). The outcome of the event was unknown. The causality assessment of the event was not reported. Upon internal review, the event autism spectrum disorder was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: pain in all the areas where I had shingles; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles two and one half years ago). Concomitant products included Herpes zoster (Shingrix).   In April 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm and pain. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the pain in arm and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got the first Shingrix vaccine in mid January 2019 and the second one in mid April 2019. After the second dose the patient had a sore arm for one day.  Now, the patient experienced pain in all the areas where the patient had shingles previously. The patient was not happy and was not told about reactions and saw very few listed on GSK site. There were lot of comments on side effects. The patient was not happy and wish that never had either of the Shringrix shots. The patient had a lot of shingle pain for over two years and now going through it again.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: chills; aches; headache; This case was reported by a consumer via call center representative and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, pain and headache. On an unknown date, the outcome of the chills, pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the chills, pain and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group selected as Adult as per vaccine indication. The patient experienced chilling, aches, headache. The reporter inquired how long does the side effects last. The patient had denied permission to contact their physician, and told that he would contact him.