chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Injection site pruritus, Nausea
Clinical narrative: On Wednesday, after immunization, ached at vaccination site through the night even if was not laying on it. As soon as got home vaccination site started itching and was red; it was a 3x3 area and used Cortisone 10. On Thursday, woke up with a headache, nausea and lightheadedness; resolved by mid- afternoon. Put moisture on arm and took Advil but medicine did not seem to really help. On Friday woke up with chills so put blankets on. Chills lasted for about 30 minutes--could not get warm. The pain eased by the weekend but it did not disappeared. It has been 6 weeks and patient still is in pain and has mild itch. Arm periodically gets painful, sometimes nothing triggers the pain or sometimes movement causes it. For example, when patient picks up something she gets a short pain that does not last long.  On 9/28 notified doctor by mail but he did not have any suggestions. On 10/20 called doctor and next day got a call back from NP that prescribed Prednisone. Took first Prednisone on 10/22 and a few hours later got immense headache so stopped taking it. Patient also contacted neurologist on Friday and got a call back on Tuesday called and was asked to come in to the office; by then pain had dissipated. Today patient still has pain at vaccination site. Patient has called doctor and has appointment with PCP for follow-up. Patient recently recalled some symptoms she experienced out of norm after the vaccination that were out of norm. About 4 hours after vaccination patient go pain in heart that lasted for a couple of seconds. On Friday and Saturday, pain recurred 2-3 times for 10 seconds episodes. On Sunday, the pain lasted about 2-3 minutes then it was gone. Patient has never had a pain like that before even when she got her heart attack and has not had it since. Patient did not notice any other symptoms along with the heart pain.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Zoster within 1-2 days after vaccination/herpes zoster; This case was reported by a physician via sales rep and described the occurrence of herpes zoster in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced herpes zoster. The patient was treated with antivirals nos. On an unknown date, the outcome of the herpes zoster was recovered/resolved.   It was unknown if the reporter considered the herpes zoster to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but the patient was in their 70s. The patient was vaccinated and then developed zoster within 1-2 days after vaccination.  The health care professional did not have patient information available and also did not know the vaccine lot number, expiration or which arm the vaccine was administered in (unknown arm).  The patient had come to health care professional following vaccine administration and was diagnosed with herpes zoster which had resolved later. The health care professional made visual diagnosis but did not confirm with PCR testing.  The patient was treated with antiviral therapy and the herpes zoster episodes resolved without complications. As per health care professional, patient did not have a medical history significant to herpes zoster other than age-patient was in the 70s with hypertension.  Patient was currently not receiving therapy for herpes zoster episode. The reporter consented to follow-up. This case has been linked to US2020AMR214315, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR214315:same reporter,same suspect, same event, different patient
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Hot to touch; Lump at the injection site; Redness at injection site; Rash on neck, chest and shoulder; Lw grade fever; Flamed arm; Feels the area is flamed/pain at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site burning in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site mass (1st dose received on 30th October 2019, refer linked case US2020213909).   On 6th March 2020, the patient received the 2nd dose of Shingrix. In 2020, less than 9 months after receiving Shingrix, the patient experienced injection site burning. On an unknown date, the patient experienced injection site warmth, injection site lump, injection site erythema, rash, low grade fever and burning sensation. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site burning and injection site erythema were not recovered/not resolved and the outcome of the injection site warmth, injection site lump, rash, low grade fever and burning sensation were unknown.   It was unknown if the reporter considered the injection site burning, injection site warmth, injection site lump, injection site erythema, rash, low grade fever and burning sensation to be related to Shingrix.  Additional details were provided as follows: The patient experienced adverse reactions after receiving 2nd dose of Shingrix. Health care professional explained that both 1st and 2nd dose were administered on the same arm (not sure which arm as patient had received the vaccinations on different facility). Less than 9 months after vaccination, the patient felt the area was flamed, hot to touch, lump at the injection site, rash on neck, chest and shoulder and low grade fever and flamed arm. Pharmacist also reported that patient experienced redness and pain at injection site. The patient was still experiencing these symptoms, coming and going till the time of reporting. No batch number or expiration date was known as the patient had received the shots on different facility. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020213909:1st dose, same patient
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Hot to touch; Lump at the injection site; Redness at injection site; Rash on neck, chest and shoulder; Lw grade fever; Flamed arm; Feels the area is flamed/pain at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site burning in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site mass (1st dose received on 30th October 2019, refer linked case US2020213909).   On 6th March 2020, the patient received the 2nd dose of Shingrix. In 2020, less than 9 months after receiving Shingrix, the patient experienced injection site burning. On an unknown date, the patient experienced injection site warmth, injection site lump, injection site erythema, rash, low grade fever and burning sensation. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site burning and injection site erythema were not recovered/not resolved and the outcome of the injection site warmth, injection site lump, rash, low grade fever and burning sensation were unknown.   It was unknown if the reporter considered the injection site burning, injection site warmth, injection site lump, injection site erythema, rash, low grade fever and burning sensation to be related to Shingrix.  Additional details were provided as follows: The patient experienced adverse reactions after receiving 2nd dose of Shingrix. Health care professional explained that both 1st and 2nd dose were administered on the same arm (not sure which arm as patient had received the vaccinations on different facility). Less than 9 months after vaccination, the patient felt the area was flamed, hot to touch, lump at the injection site, rash on neck, chest and shoulder and low grade fever and flamed arm. Pharmacist also reported that patient experienced redness and pain at injection site. The patient was still experiencing these symptoms, coming and going till the time of reporting. No batch number or expiration date was known as the patient had received the shots on different facility. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020213909:1st dose, same patient
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event, Injected limb mobility decreased, Injection site pain
Clinical narrative: Injection site muscle pain; Difficult for me to lift my arm; Adverse event; This case was reported by a consumer via interactive digital media and described the occurrence of injection site muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than 3 weeks after receiving Shingrix, the patient experienced injection site muscle pain, injected limb mobility decreased and adverse event. On an unknown date, the outcome of the injection site muscle pain was not recovered/not resolved and the outcome of the injected limb mobility decreased and adverse event were unknown.   It was unknown if the reporter considered the injection site muscle pain, injected limb mobility decreased and adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st Shingrix dose almost 3 weeks ago. The patient had many of the side effects for about 47 hours. The they went away. However the patient still have injection site muscle pain that makes it difficult for me to lift my arm.  The reporter asked was this a normal reaction
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Arm pain; couldn't lift my Shingles shot arm; This case was reported by a consumer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were unknown.   The reporter considered the pain in arm and mobility decreased to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and flu vaccine and had pain in arm and mobility decreased. The reporter stated it was administered at the same time as the flu vaccine. The patient took shot together with flu vaccine and had pain and latest for about a week. The Shingles arm pain lasted for a week and then suddenly it was better and was so relieved because arm felt normal again. The patient had to get a 2nd booster shot.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR216227:same reporter
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: bump that is warm and red; is a bump that is warm and red; is a bump that is warm and red; was injected into under the skin (subcutaneously) instead of intramuscularly; This case was reported by a consumer via call center representative and described the occurrence of injection site lump in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 73T27, expiry date 9th September 2022) for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season).   On 21st October 2020, the patient received the 1st dose of Shingrix (subcutaneous). In October 2020, less than a week after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site lump, injection site erythema, injection site warmth and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site lump, injection site erythema, injection site warmth and intramuscular formulation administered by other route were unknown.   The reporter considered the injection site lump, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right deltoid. The patient received flu shot in the left arm. The reporter stated that, after vaccination, the patient experienced injection site reaction which was bump that was warm and red and is about 3 inches in diameter. The reporter stated that, the patient received Shingrix vaccine into under the skin (subcutaneously) instead of intramuscularly, which led to intramuscular formulation administered by other route. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020212048:FU1 deleted
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot
Clinical narrative: Warm feeling; This case was reported by a other health professional via call center representative and described the occurrence of feeling of warmth in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th October 2020 03:00, the patient received the 1st dose of Shingrix. On 28th October 2020, several hours after receiving Shingrix, the patient experienced feeling of warmth. On an unknown date, the outcome of the feeling of warmth was recovered/resolved.   It was unknown if the reporter considered the feeling of warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was a medical science lisaon. The patient had received first dose of Shingrix day before the reporting date at around 3; and within a couple hours began to develop a warm feeling. The warm feeling reportedly resolved approximately 12 hours later. The batch number was not known. The reporter consented to follow up via phone. No health care professional consent was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain, Rash
Clinical narrative: Pain at injection site; Aching; Chills; Rash; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, pain, chills and rash. On an unknown date, the outcome of the injection site pain, pain, chills and rash were unknown.   It was unknown if the reporter considered the injection site pain, pain, chills and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the father of the patient and reported that his daughter received the first dose day before reporting date and had aching, chills, pain at the injection site, and a rash. The reporter did not consent to follow-up and did not wanted to provide any additional information regarding these events.
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: get a strain of pneumonia; get a strain of pneumonia; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable consumer (patient).    A 79 years old male patient reported that he received both types of vaccines, pneumococcal vaccine polysacch 23v (PNEUMOVAX) in 2010, and pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) in 2015, both at single dose, for immunization. He did not need to have either again per his primary care physician. Relevant medical history and concomitant medications were not reported. On an unspecified date, he did get a strain of pneumonia. Clinical outcome of the adverse event was unknown at time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Wrong product administered
Clinical narrative: nurse gave the patient a shot of trumenba on 28Oct2020, when she intended to give menactra; occasional dizziness in the mornings; This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 11-year-old male patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on 28Oct2020 at single dose for immunization, meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), via an unspecified route of administration on an unspecified date at unspecified dose for immunization. The patient's medical history and concomitant medications were not reported. The nurse gave the patient a shot of trumenba on 28Oct2020, when she intended to give menactra. Patient experienced occasional dizziness in the morning on unspecified date in Oct2020 with outcome of not recovered. After appointment, mother took child to ER since he was still dizzy.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Urticaria
Clinical narrative: urticaria type of rash; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 27Oct2020 at single dose for immunization. Medical history was none. There were no concomitant medications. The patient experienced urticaria type of rash on 29Oct2020 with outcome of unknown. Additional information: no other symptoms, took allegra to relieve rash symptoms.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: PNC13
Symptoms: Feeling abnormal, Malaise, Pain in extremity
Clinical narrative: I am hurting so bad in my arm, below my arm, up to my shoulder; I am hurting so bad in my arm, below my arm, up to my shoulder; I really feel sick tonight; I am not feeling too good; I am not feeling well at all; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had a Pneumonia shot, the patient believe it was Prevnar 13 and the patient was hurting so bad in arm, below the arm, up to the shoulder and the patient really feel sick tonight. Consumer was informed about Medical Information department and was also informed to contact the Physician regarding for the concern. The patient was not feeling too good and was not feeling well at all on an unspecified date. The outcome of events was unknown.  No follow up attempts are possible. Information about the lot/batch number cannot be requested.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: ill; flu; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a male patient (age unspecified) who felt ill (malaise) and had flu (influenza), while he received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was ill (malaise) and had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  The reporter's dad got very ill after getting the flu shot 3 years in a row. He came close to dieing the 3rd year. Family begged him not to get a flu shot the following year, he did not and he did not get the flu either. He never did get another flu shot after that and he never did get the flu again.   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: 12 months old patient received expired dose of Pentacel vaccine/no AE; Initial information was received on 30-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer or other non-professional.  This case involves a 12 month old female patient who received 0.5 mL expired dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [injection, lot UJ097AAA, expiry date: 19-Sep-2020] via an intramuscular route at the left thigh, on 30-Sep-2020 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date patient received PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and FAIRVAX as concomitant medications.  It was a case of actual medication due to expired vaccine used. (Latency: at the same time of vaccination)  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.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Patient inadvertently received an expired Quadracel dose,  no adverse event; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious case from the other health care professional via phone.  This case involves a four year and ten month old male patient who was vaccinated with a 0.5 ml final dose (in series) of an expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (single-dose vial , lot C5532AA  and expiration date 09-Oct-2020) via an intramuscular route in the right thigh on 13-Oct-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient had concomitantly vaccinated with a dose of HEPATITIS A VACCINE on 13-Oct-2020 for prophylactic vaccination.  This was an actual medication error case due to expired vaccine used (latency was same day).  At the time of reporting, no adverse event was reported to the patient.  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.
Age: 0.17
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 2 months old son was given the Fluzone Quadrivalent by accident, no AE; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious case from a non-health care professional (Reference number- 00315804).  This case involves a two-month-old male patient who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number and other dosing details were not reported) on an unknown date for prophylactic vaccination (inappropriate age at vaccine administration).  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.   This was an actual medication error case due to inappropriate age at vaccine administration (latency was same day).  At the time of reporting, 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 the batch number for this case.
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: the patient was given an expired dose of Quadracel , no adverse event; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious case from the other health care professional via phone.  This case involves an unknown demographic patient who was vaccinated with a 0.5 ml one dose of expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5532AB and expiration date 09-Oct-2020) via an unknown route at an unknown administration site for prophylactic vaccination on 14-Oct-2020.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.   This was an actual medication error case due to expired vaccine used (latency was same day).  It was reported that someone at the facility had put a mark on the product at the location of the expiration date on the box. The facility's mark made someone think the expiration was 19-Oct-2020 instead of the actual 09-Oct-2020.  At the time of reporting, no adverse event was reported to the patient.  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.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Her arm at the site of injection became red, swollen and minimally painful a few hours after her injection. Daughter described about a 3 inch diameter are of mild pinkness that feels slightly rubbery to her.  Patient stopped by the doctors office the following day to have it looked at. The injection site was looked at by the provider and described it as less swollen and less painful than yesterday. No temperature. Patient was advised to continue to monitor and it the redness expands or becomes firmer or more tender she was to let us know.
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Herpes zoster, Rash
Clinical narrative: developed rash consistent with shingles
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Skin warm, Tenderness
Clinical narrative: The patient says yesterday went into a pharmacy, got second set of her Shingles shot. Arm is sore, red, feels warm to touch, tender. Redness has gotten redness. Not sure if should be concerned but she is, has gotten larger. No subjective fever. No nausea/vomiting. No dyspnea. No tongue swelling/throat swelling/trouble swallowing. +PCN allergy noted - got bad hives. Has tolerated cephalexin in past when had sinusitis and has tolerated bactrim in past for UTI's.
Age: 63.0
Sex: F
Vaccine: FLUR4
Symptoms: Arthralgia, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Patient reported experiencing the following starting on 10/31/2020 after lunch: -nausea/vomiting -low grade fever (~99F) -body aches, headache -hip pain exacerbation
Age: 63.0
Sex: F
Vaccine: FLUR4
Symptoms: Vomiting
Clinical narrative: Patient reported experiencing the following starting on 10/31/2020 after lunch: -nausea/vomiting -low grade fever (~99F) -body aches, headache -hip pain exacerbation
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: 5 hours after vaccine administration patient has experienced a very sore and painful arm. She felt as though she could barely lift it for 7 days after straight. Tylenol didn't help the pain at all and she is not able to take ibuprofen because of her xarelto. Pharmacist recommended lidocaine topical cream to help numb it.
Age: 12.0
Sex: F
Vaccine: FLUA4, HPV9, MNQ, TDAP
Symptoms: Blood glucose increased, Laboratory test normal, Syncope
Clinical narrative: Syncopal episode and a second episode of possible seizure Treatment is ongoing - did not receive medications for possible seizure activity
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site scar
Clinical narrative: MIld scar in center deltoid with tenderness at site and movement of arm.  No numbness of tingling, grip strength wnl.  Bursa not inflammed.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Influenza like illness, Pain
Clinical narrative: This was my 2nd Shingrix vaccine so I was prepared, because the same thing happened on my 1st dose. After 4 hours, the 1st day, I started to feel achy.  That got to be so bad it was like I had the flu. That got worse through the 1st night. By the 2nd day I checked my temperature and it was 99.4. It fluctuated between 97 and 99.4. I was sweating a lot and trying to just keep as comfortable as possible, taking Ibuprofen. The 3rd day I began to feel better with less aches, and no fever. By the 4th day, good as new!
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient states she had pain immediately at site of injection. Pain, soreness, arm difficult to lift - started soon after injection and is still present on 11/2/2020 (approx 2 weeks later). States no redness, swelling or raised areas
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Influenza like illness, Pyrexia
Clinical narrative: I gradually had an increasing fever of 101.  Felt like flu symptoms.  Aches and pain in joints.  Chills, and thirsty. After 8 hours, fever subsided, and then a headache for about 2 hours.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Thirst
Clinical narrative: I gradually had an increasing fever of 101.  Felt like flu symptoms.  Aches and pain in joints.  Chills, and thirsty. After 8 hours, fever subsided, and then a headache for about 2 hours.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Dyskinesia, Hypoaesthesia, Injection site induration, Injection site mass
Clinical narrative: 10/30/2020 Hard lump, swelling, and aches/pain at the injection site (right shoulder).  Also, experienced unusual weakness, loss of control, and numbness of right arm, hand and wrist, causing me to think I was having a stroke.  Currently, 11/02/2020, side effects are improving (at about 80% of normalcy).  However, my normal writing strokes (penmanship) and right hand and wrist strength have not improved.  Currently, I am wearing a "Drop sky" support to help restore hand and wrist control.  I am making appointment with my doctor.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: 10/30/2020 Hard lump, swelling, and aches/pain at the injection site (right shoulder).  Also, experienced unusual weakness, loss of control, and numbness of right arm, hand and wrist, causing me to think I was having a stroke.  Currently, 11/02/2020, side effects are improving (at about 80% of normalcy).  However, my normal writing strokes (penmanship) and right hand and wrist strength have not improved.  Currently, I am wearing a "Drop sky" support to help restore hand and wrist control.  I am making appointment with my doctor.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Heart rate decreased, Presyncope
Clinical narrative: Vasovagal reaction, pulse dropped to 29, ambulance called
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Feeling hot, Headache, Pain, Throat irritation
Clinical narrative: Initially scratchy throat, followed by very hot spells but no increase in temperature.  Later severe body aches and mild headache.  I took zinc (5mg) twice daily as well as Vitamin C..  Also Paracetamol for pain.  Symptoms persisted mildly for just under one week after which my energy returned.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Flu Like symptoms   achy, sweating, headache, redness and swelling at injection site.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Flu Like symptoms   achy, sweating, headache, redness and swelling at injection site.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling
Clinical narrative: lip swelling
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Fatigue, Hyperhidrosis, Mobility decreased
Clinical narrative: Patient started experiencing side effects around 3-4pm. Arm pain was severe to the point she felt she was unable to move her arm without severe pain. During the night she experienced chills/sweats and fatigue, when she took her temperature it was 103F. Denies redness, rash, or bump  at the site. Reports arm tenderness. Took Tylenol for the fever. Symptoms completely resolved by  Sunday 11/1.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Patient started experiencing side effects around 3-4pm. Arm pain was severe to the point she felt she was unable to move her arm without severe pain. During the night she experienced chills/sweats and fatigue, when she took her temperature it was 103F. Denies redness, rash, or bump  at the site. Reports arm tenderness. Took Tylenol for the fever. Symptoms completely resolved by  Sunday 11/1.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Lip swelling, Periorbital swelling
Clinical narrative: Mom called day after vaccine administered to report child had rash at injection site along with swelling of lip and around eyes.  No difficulty breathing.  Residual rash at time of her call.
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Vaccination error
Clinical narrative: Vaccine given in error. Parent had declined
Age: 18.0
Sex: F
Vaccine: FLUX
Symptoms: Eye pain, Immediate post-injection reaction, Periorbital swelling
Clinical narrative: Immediately (within 10-30 Min) started with puffy eye Lids. Next day with increased puffiness and eyes hurt. Benadryl helped alleviate symptoms Improved 60%. today (2 days post vaccination).
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Limb discomfort, Neuralgia
Clinical narrative: Patient experienced pain went to MD where they said (virtual visit) pt is experiencing nerve pain at the site of injection. Pt reports pain going down the arm with discomfort like neurologic. They suspect shot was given to high. Pt was prescribed Medrodosepack.
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Palpitations, Rash
Clinical narrative: PATIENT IMMEDIATELY DEVELOPED RASH,  STATED HEART WAS RACING AND NUMBNESS DOWN LEGS.  CALLED EMS AND PATIENT WAS EVALUATED BY EMS. EMS CLEARED PATIENT TO GO HOME AND FOLLOW UP WITH PROVIDER AS SHE WAS 'STABLE' AND HAD NO DIFFICULTY BREATHING OR WORSENING SYMPTOMS.  PT WILL FOLLOW UP WITH PCP.
Age: 87.0
Sex: F
Vaccine: FLUA3
Symptoms: Vomiting
Clinical narrative: Vomiting one hour after vaccine administration for a long time. Resolved.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Swelling of eyelid
Clinical narrative: eyelid swelling
Age: 66.0
Sex: F
Vaccine: FLUR4
Symptoms: Chills, Extra dose administered, Fatigue, Malaise, Wrong product administered
Clinical narrative: Patient requested Pneumovax23 and accidentally received Flublok vaccine. Patient previsouly received Fluad Quad vaccine on 9/29/20 so this was her second flu vaccine for 2020/2021 season. Patient called the following day stating she felt ill after receiving a second flu vaccine, including chills/fatigue. Patient's doctor was contacted and made aware of the situation.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: Loss of use of left arm/shoulder.  Able to bend at the elbow but severe pain throughout arm.  Unable to lift arm away from body, up in air in front of body or behind body. As the day progressed it got worse, and I have since had tingling and numbness in my hand and fingers.   I went to my primary doctor on Friday, have done 3 days of prednisone. Have gotten some mobility back.  Still unable to lift arm more than 12? away from body. Cannot lift any weight using the shoulder muscles and still have pain.  Shot was administered far up on arm. Did contact CVS shortly after onset of symptoms to see if they were normal or to see what I should do. They said they would document my symptoms, and suggested I maybe seek advice from a walk-in or er as they hadn't heard of it before.
Age: 77.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness unilateral
Clinical narrative: 62 YOM who had his first shingrix vaccine 2 months ago (8/13/2020). The following day developed hearing loss in his right ear which recovered after 3 days. He has normal hearing now.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Pt. was administered Afluria and left the pharmacy, pt fainted leaving the pharmacy. Pt got back up on her own will
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR
Symptoms: Rash maculo-papular, Scab
Clinical narrative: patient presented with a maculopapular rash to trunk and extremities with a few scattered vesicles to posterior left thigh and crusting to right cheek.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV, VARZOS
Symptoms: Limb discomfort, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient states both her arms were swollen (the size of an orange on both arms), painful, hot to touch; both arms felt heavy.  Patient states she was seen by her chiropractor the following day, whom she states released the vaccine through chiropractic manipulation, as well taking prescribed pain medication (Dilaudid).  She states she felt better today, but her arms remain sore.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Rash, Scar
Clinical narrative: Firm raised red lump at injection site. Rash developed over the next 2 weeks as a cluster of bumps with surrounding redness.  At 1 month after shot, there is still a remaining scar.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling abnormal, Hyperhidrosis, Pain in extremity, Pyrexia
Clinical narrative: About 5.30pm arm was sore.  By 8pm started to get chills and temperature started to rise--highest was 102.3. Patient was not sure if took medicine for fever. Patient had to pile up with blankets.  Next day, called doctor and nurse called back and told patient to take Tylenol and Benadryl.  Patient still did not feel good and had some fever.    On Thursday, patient woke up in soaking in bed.  Patient was fine by Saturday and has had no problems since.
Age: 53.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Injection site rash, Injection site reaction, Pyrexia, Rash erythematous
Clinical narrative: 10-27-2020    fever (101) & chills 10-28-2020    red rash at site of injection (right deltoid)
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Vaccination site pain
Clinical narrative: Immediately after receiving the vaccine, pain at the vaccination site on left arm. Pain got worse overtime but did not do any treatment or take any medicine. Pain was worse when moving the arm or raising it. Sometime in August patient received shingles vaccine at same vaccination facility on the other arm. Patient went to pharmacist and let him know he could not use his arm and was encouraged to go to the doctor. In September patient went to doctor to get a physical and received a Flu shot also on the other arm. Upon examination of the left arm patient referred to physical therapy. Patient has had 5 sessions already and has not seen that much improvement. Patient went back to pharmacy last week and was encouraged to file a report. Pharmacist recommended  use of Asper cream but has not helped much.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Chills, Ear swelling, Erythema, Feeling hot
Clinical narrative: Patient received Fluzone high dose on 10/27/20. By the time patient returned home (approx. 20minutes) pt. felt fever and chills and stomach ache. Patient went to bed early due to symptoms and woke up later that night feeling stiffness in face. When he looked in mirror, he saw face was very swollen and red hot. Both eyes were swollen shut. He called doctor on Thursday 10/29/20 and was prescribed Medrol dosepak. Sunday 11/1/20 patient call pharmacy to say dosepak was slow in taking effect and he was starting to itch and face  was scaly. I recommended he talk to doctor and buy Benadryl. Today, Monday 11/2/20 patient states skin around eyes is scaly and peels easily. Scalp is painful to the touch and left ear is swollen like cauliflower and very hot. Vision is good and breathing not affected. Patient is waitng for MD to return his call.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Pain of skin, Pruritus, Pyrexia, Skin exfoliation
Clinical narrative: Patient received Fluzone high dose on 10/27/20. By the time patient returned home (approx. 20minutes) pt. felt fever and chills and stomach ache. Patient went to bed early due to symptoms and woke up later that night feeling stiffness in face. When he looked in mirror, he saw face was very swollen and red hot. Both eyes were swollen shut. He called doctor on Thursday 10/29/20 and was prescribed Medrol dosepak. Sunday 11/1/20 patient call pharmacy to say dosepak was slow in taking effect and he was starting to itch and face  was scaly. I recommended he talk to doctor and buy Benadryl. Today, Monday 11/2/20 patient states skin around eyes is scaly and peels easily. Scalp is painful to the touch and left ear is swollen like cauliflower and very hot. Vision is good and breathing not affected. Patient is waitng for MD to return his call.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Skin warm, Swelling face, Swelling of eyelid
Clinical narrative: Patient received Fluzone high dose on 10/27/20. By the time patient returned home (approx. 20minutes) pt. felt fever and chills and stomach ache. Patient went to bed early due to symptoms and woke up later that night feeling stiffness in face. When he looked in mirror, he saw face was very swollen and red hot. Both eyes were swollen shut. He called doctor on Thursday 10/29/20 and was prescribed Medrol dosepak. Sunday 11/1/20 patient call pharmacy to say dosepak was slow in taking effect and he was starting to itch and face  was scaly. I recommended he talk to doctor and buy Benadryl. Today, Monday 11/2/20 patient states skin around eyes is scaly and peels easily. Scalp is painful to the touch and left ear is swollen like cauliflower and very hot. Vision is good and breathing not affected. Patient is waitng for MD to return his call.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Pain of skin, Pruritus, Rash
Clinical narrative: rash = itchy and stingy on skin
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Asthenia, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: Patient experienced pain, redness, tenderness, slight swelling around injection site.  Evening of October 30, middle of night, pain approximately 2 inches below breast in stomach area only began and continued for 2 days.  Patient had loose stools during that time also.  Patient not hungry and laid in bed due to feeling tired or weak.  When patient woke up on 10/31/20, had body rash but it quickly disappeared - no itching, pain.  After 2 days, patient feels better.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: Patient experienced pain, redness, tenderness, slight swelling around injection site.  Evening of October 30, middle of night, pain approximately 2 inches below breast in stomach area only began and continued for 2 days.  Patient had loose stools during that time also.  Patient not hungry and laid in bed due to feeling tired or weak.  When patient woke up on 10/31/20, had body rash but it quickly disappeared - no itching, pain.  After 2 days, patient feels better.
Age: 77.0
Sex: M
Vaccine: FLUA4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: The patient stated that he has had a sore left arm since he got the vaccine over 2 weeks ago. He demonstrated that it was hard to lift his left arm above shoulder height.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling, Skin burning sensation, Swelling, Tenderness
Clinical narrative: patient stated her arm started burning , swelling and turned red and swollen from shoulder to elbow over a period of 2 days. she took benadryl with little relief since she thought it was an allergic reaction. presented monday with large area from shoulder to elbow still swollen and tender to touch.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Conjunctivitis, Ear infection, Illness, Pyrexia
Clinical narrative: High fever > 103.6 Double ear infections within 1 week Double pink eye within 1 week  Child has not had sickness like this before and no one in his daycare nor home had any illness at the time
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Culture stool negative, Haematochezia, Rotavirus test positive, Salmonella test positive
Clinical narrative: bloody stool multiple episodes.
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Back pain, Pain in extremity
Clinical narrative: Extreme Pain in back, hip, and leg
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: Pt was given flu vaccine for her first time, as she reports.  While giving her the flu vaccine, and for a minute or two afterward, she was jovial and conversational.  She even expressed interest in the tetanus vaccine after getting the flu vaccine.  But while filling out the paperwork for the tetanus vaccine, she began feeling lightheaded, wanted to get the tetanus vaccine later in the week, and went to sit down.  Just after seating herself, she fell out of the chair and bumped the part of her forehead two inches above her left eye.  She was non-responsive for approximately 15 seconds, but regained consciousness thereafter.  EMS was summoned and pt was provided water to drink and ice pack for forehead.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Four days after receiving the shot, I started to break out with a massive cold sore on my top lip and a second one on my lower lip. Luckily I had Valtrex which I started taking Monday morning when I realized that it was a cold sore.  It didn?t start the way it usually does (tingling, blisters).  I took Valtrex 1