chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site discharge, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Redness, lump at site of Pvax 23. Gave prednisone  and suggested Tylenol, motrin and ice on 9/2/2020. Sent picture of site on 9/10/2020. Much worse, dark spot in center with pain. Sent in RX for Keflex, pt to come in 9/11/2020. Came to office, redness spreading, mild discharge from site. Concerned about necrotic tissue, made immediate appt at surgeon for same day. 9/11/2020
Age: 67.0
Sex: F
Vaccine: FLUA4
Symptoms: Dysstasia, Gait disturbance, Joint stiffness, Joint swelling, Loss of personal independence in daily activities
Clinical narrative: My left arm was very sore within an hour of the vaccinator.  Stiffness in my right knee began two days later on Sept. 10th in the evening.  The day of Sept. 11th I awoke with severe stiffness in both knees and my wrists and shoulders.  The stiffness and pain became so intense I needed assistance to get up after sitting.  Walking was reduced to short distances at a very slow pace.  The extreme stiffness and swelling progressed to my elbows, both hands (knuckles initially and then thumbs), and shoulders.  The knees proved to be most debilitating.  I visited my Primary Care physician on Monday afternoon and was prescribed Ibuprofen, 800mg tablets; previously I had been taking over the counter Tylenol and Ibuprofen.  I took these until Wednesday when I again contacted my Primary Care physician and requested steroids as the Ibuprofen wasn't having much effect.  I am presently on the third day of the Methylprednisolone 4mg DosPak 21s and am improving.
Age: 67.0
Sex: F
Vaccine: FLUA4
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: My left arm was very sore within an hour of the vaccinator.  Stiffness in my right knee began two days later on Sept. 10th in the evening.  The day of Sept. 11th I awoke with severe stiffness in both knees and my wrists and shoulders.  The stiffness and pain became so intense I needed assistance to get up after sitting.  Walking was reduced to short distances at a very slow pace.  The extreme stiffness and swelling progressed to my elbows, both hands (knuckles initially and then thumbs), and shoulders.  The knees proved to be most debilitating.  I visited my Primary Care physician on Monday afternoon and was prescribed Ibuprofen, 800mg tablets; previously I had been taking over the counter Tylenol and Ibuprofen.  I took these until Wednesday when I again contacted my Primary Care physician and requested steroids as the Ibuprofen wasn't having much effect.  I am presently on the third day of the Methylprednisolone 4mg DosPak 21s and am improving.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain in site of injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number XG52X, expiry date 28th November 2021) for prophylaxis.   On 20th August 2020, the patient received the 2nd dose of Shingrix. In September 2020, 3 weeks after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported pain in site of injection after administration of Shingrix, 2nd dose. The reporter did not consent to follow up. The batch number was changed from X652X to XG52X.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Menactra was administered to a 12 year old female, no AE; Initial information received on 03-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12-year-old female patient who was vaccinated with an expired 0.5 mL once dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6346AA and expiry date: 30-Aug-2020) via an intramuscular route in the left deltoid for prophylactic vaccination on 02-Sep-2020.  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation.  It was an actual medication error case due to expired vaccine used (latency same day).   At the time of this report, no adverse event symptoms 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: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Area of redness, mild swelling, tenderness and warmth extending halfway down upper arm. Resolved 09/18/2020.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: About 10 hours after vaccine, severe headache (lasted 10 hours) (On a scale of 1-10, headache was a 9) About 12 hours after vaccine, severe nausea (lasted 6 hours) (On a scale of 1-10, nausea was a 9) About 12 hours after vaccine, fever (99.5) and chills, lasted about 4 hours About 14 hours after vaccine, body aches (On a scale of 1-10, aches were a 5), lasted about 4 hours About 16 hours after vaccine, unusual thirst (On a scale of 1-10, thirst was an 8), lasted about 2 hours
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Thirst
Clinical narrative: About 10 hours after vaccine, severe headache (lasted 10 hours) (On a scale of 1-10, headache was a 9) About 12 hours after vaccine, severe nausea (lasted 6 hours) (On a scale of 1-10, nausea was a 9) About 12 hours after vaccine, fever (99.5) and chills, lasted about 4 hours About 14 hours after vaccine, body aches (On a scale of 1-10, aches were a 5), lasted about 4 hours About 16 hours after vaccine, unusual thirst (On a scale of 1-10, thirst was an 8), lasted about 2 hours
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Haematochezia
Clinical narrative: Approximately 8 hours after receiving vaccines my daughter had blood in her stool.
Age: 70.0
Sex: U
Vaccine: FLU4
Symptoms: Dyspnoea, Erythema, Injection site erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Manufacturer-Sanofi Pasteur Patient is a 70 year old female here today acutely because of having: Patient presents with:Adverse Reaction Patient was seen yesterday and received an influenza vaccine in her left deltoid. She states that last night she noticed her arm became very sore, red, warm to the touch and swollen. Patient states that she became short of breath last night and almost went to the ER. Patient had an influenza vaccine last year and had this same issue. Left deltoid 9 cm x 12 cm erythema, faint, with irregular borders. BP 116/74  | Pulse 60  | Temp (97 °F) (Temporal)  | Resp 18
Age: 70.0
Sex: U
Vaccine: FLU4
Symptoms: Skin warm, Vaccine positive rechallenge
Clinical narrative: Manufacturer-Sanofi Pasteur Patient is a 70 year old female here today acutely because of having: Patient presents with:Adverse Reaction Patient was seen yesterday and received an influenza vaccine in her left deltoid. She states that last night she noticed her arm became very sore, red, warm to the touch and swollen. Patient states that she became short of breath last night and almost went to the ER. Patient had an influenza vaccine last year and had this same issue. Left deltoid 9 cm x 12 cm erythema, faint, with irregular borders. BP 116/74  | Pulse 60  | Temp (97 °F) (Temporal)  | Resp 18
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Hypoaesthesia, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Patient called and said that the day after she received the flu shot she developed a stiff neck & headache. She also experienced numbness in fingers. She said she was shivering so she probably had a fever- she did not take her temperature to confirm this.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Nausea, Pain, Pyrexia
Clinical narrative: Sweats, nausea, headache, body aches, low grade fever
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Fall, Feeling hot, Loss of consciousness, Retching
Clinical narrative: Patient was sitting and was injected with the vaccine. Mother was in the room with her. Prior to the injection the mother was asked if the patient has had vaccines in the past and if there were any problems such as anaphylaxis, seizures, passing out etc. The mother stated that she got vaccines all the time at the pediatricians office with no issue. When the  injection was complete the band aid was placed and when I do this I feel for any bumps and observe the skin. She was normal, no rise in fever either. The patient said that was a "painless" vaccine and rotated with her mom where I gave her mom the vaccine as well. With the history of having received and no issues I sent the patients to check out to receive the prescription during which the patient seemed okay. Roughly 15-20 minutes went by and then I see the mom hurrying towards me with the patient running with her as well. I instruct them to reenter the room where the patient was sat down and the mother said the patient complained of feeling dizzy and hot then fell over in the isle. I observed patient for any signs of anaphylaxis, there was none. Then the patient started to gag so I gave her the trash can to throw up in which she did. Then I asked my technician to get me a blood pressure cuff and an soaked paper tower with an ice brick along with the thermometer because the patient was burning up.  After the patient threw up she quickly felt better and we continued to monitor. I checked her blood pressure and it was 88/66. The heat was dissipated and the patient said she no longer felt dizzy and could see. We monitored for a few minutes. At this point the scare seemed to have pass. I explained to the mother that what likely occurred is that she passed out which can occur post injections. After roughly 15 minutes the patient felt better and  the mother asked if they could walk around. I said yes just stay close to make sure she is okay. The patient had energy again and when she stood up and walked around felt fine. After a few more minutes the patient said she was okay again and the mother took her home.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Vomiting
Clinical narrative: Patient was sitting and was injected with the vaccine. Mother was in the room with her. Prior to the injection the mother was asked if the patient has had vaccines in the past and if there were any problems such as anaphylaxis, seizures, passing out etc. The mother stated that she got vaccines all the time at the pediatricians office with no issue. When the  injection was complete the band aid was placed and when I do this I feel for any bumps and observe the skin. She was normal, no rise in fever either. The patient said that was a "painless" vaccine and rotated with her mom where I gave her mom the vaccine as well. With the history of having received and no issues I sent the patients to check out to receive the prescription during which the patient seemed okay. Roughly 15-20 minutes went by and then I see the mom hurrying towards me with the patient running with her as well. I instruct them to reenter the room where the patient was sat down and the mother said the patient complained of feeling dizzy and hot then fell over in the isle. I observed patient for any signs of anaphylaxis, there was none. Then the patient started to gag so I gave her the trash can to throw up in which she did. Then I asked my technician to get me a blood pressure cuff and an soaked paper tower with an ice brick along with the thermometer because the patient was burning up.  After the patient threw up she quickly felt better and we continued to monitor. I checked her blood pressure and it was 88/66. The heat was dissipated and the patient said she no longer felt dizzy and could see. We monitored for a few minutes. At this point the scare seemed to have pass. I explained to the mother that what likely occurred is that she passed out which can occur post injections. After roughly 15 minutes the patient felt better and  the mother asked if they could walk around. I said yes just stay close to make sure she is okay. The patient had energy again and when she stood up and walked around felt fine. After a few more minutes the patient said she was okay again and the mother took her home.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Blister, Eye swelling, Eyelids pruritus
Clinical narrative: The client has been felt itching on his left eyelid since yesterday afternoon, then , through the night , his left eye becomes swollen and getting blisters. This morning, the blisters were diminished but the client feels itching sensation on his left eyelid and remains swollen around on left eye.
Age: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash, Pain in extremity
Clinical narrative: Patient called the pharmacy on 9/18/2020 stating they had received a flu shot on 9/15/2020 and their arm was still sore from it. Upon further questioning  the patient stated they had a rash from the site of the injection down to their elbow. It had started the next morning after the shot on 9/17/2020.
Age: 18.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MENB, MNQ
Symptoms: Dizziness, Dyskinesia, Loss of consciousness, Pallor
Clinical narrative: Client became light-headed, dizzy, and pale after vaccination. Client lost consciousness for a few seconds and jerked but came too and knew where he was. Crackers and water given. Talked to father on the phone. Color returned and he stated he felt much better. Father came to health dept and client left with father.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Patient called on 9/14/20 experiencing injection site reaction including redness and swelling at injection site.  On 9/16 she called and stated she was still feeling unwell--reported lethargy, a knot at the injection site and it felt a little itchy.  She stated she had "hives" for 2 hours around the injection site. On 9/18/20, she called back to let us know that she was still experiencing side effects including lethargy, knot at the injection site and general pain and "twinges".   Instructed patient to call doctor to be evaluated
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Malaise, Pain
Clinical narrative: Patient called on 9/14/20 experiencing injection site reaction including redness and swelling at injection site.  On 9/16 she called and stated she was still feeling unwell--reported lethargy, a knot at the injection site and it felt a little itchy.  She stated she had "hives" for 2 hours around the injection site. On 9/18/20, she called back to let us know that she was still experiencing side effects including lethargy, knot at the injection site and general pain and "twinges".   Instructed patient to call doctor to be evaluated
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain upper, Dizziness, Loss of consciousness
Clinical narrative: patient "passed out"; woozy; faint; stomach pain; This spontaneous report was received from a physician via company representative and refers to a male 'possibly adolescent' patient of unknown age. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug allergies and reactions was provided.  On an unknown date in 2020 (reported as 'couple of weeks ago'), the patient was vaccinated with unknown series of dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exact dose, route of administration, lot # and expiry date were not provided) for prophylaxis.  After vaccination, the patient 'passed out', was 'woozy' and faint. The physician watched the patient for an hour and the patient was sent to the emergency room (ER) as he was still faint. The patient received fluids (unspecified) in the hospital. He was discharged from the hospital on an unknown date in 2020, but had complained of stomach pain. It was reported that at the time of the report the patient was doing okay.  The causality assessment between the events and the suspect vaccine was not provided.  Upon internal review, loss of consciousness was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Rash, Skin warm
Clinical narrative: headache; hot spot inche below injection site; hot spot 1 inch below injection site; This case was reported by a consumer via call center representative and described the occurrence of headache in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced headache, skin warm and rash. On an unknown date, the outcome of the headache, skin warm and rash were recovered/resolved.   It was unknown if the reporter considered the headache, skin warm and rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported.  The patient enquired about the difference between the first and second dose of Shingrix. It was confirmed that there was no difference between the 2 doses. Patient pharmacy mistakenly thought that it was second dose and not the first. The patient had reaction that lasted for 4 days. The patient got headache first then about 24 hours later there was a hot spot 1 inch below the injection site. The patient would talk to physician about getting the second one.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Hypoaesthesia, Pruritus, Rash papular
Clinical narrative: a giant bump on her right arm, near the site of injection/bump as full of liquid; spot on her arm that were not there before; Hot to the touch/Numbness localized; but numb on the inside; Spots on arm; This case was reported by a pharmacist via call center representative and described the occurrence of papular rash in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 4RR52, expiry date 7th December 2021) for prophylaxis.   On 2nd September 2020, the patient received Shingrix (intramuscular). On 8th September 2020, 6 days after receiving Shingrix, the patient experienced papular rash, localized erythema, pruritus, numbness localized and skin discoloration. On an unknown date, the outcome of the papular rash, localized erythema and pruritus were not recovered/not resolved and the outcome of the numbness localized and skin discoloration were unknown.   It was unknown if the reporter considered the papular rash, localized erythema, pruritus, numbness localized and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The dose was given intramuscular at the right deltoid. The patient that presented giant bump on her right arm, near the site of injection. The patient was given the dose of Shingrix and before the morning of the call report patient did not have that lump. The patient describes the bump as full of liquid, hot to the touch, itchy on the outside but numb on the inside.  The patient also mentions the presence of spot on her arm that were not there before. The reporter consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration, Skin warm, Swelling
Clinical narrative: a giant bump on her right arm, near the site of injection/bump as full of liquid; spot on her arm that were not there before; Hot to the touch/Numbness localized; but numb on the inside; Spots on arm; This case was reported by a pharmacist via call center representative and described the occurrence of papular rash in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 4RR52, expiry date 7th December 2021) for prophylaxis.   On 2nd September 2020, the patient received Shingrix (intramuscular). On 8th September 2020, 6 days after receiving Shingrix, the patient experienced papular rash, localized erythema, pruritus, numbness localized and skin discoloration. On an unknown date, the outcome of the papular rash, localized erythema and pruritus were not recovered/not resolved and the outcome of the numbness localized and skin discoloration were unknown.   It was unknown if the reporter considered the papular rash, localized erythema, pruritus, numbness localized and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The dose was given intramuscular at the right deltoid. The patient that presented giant bump on her right arm, near the site of injection. The patient was given the dose of Shingrix and before the morning of the call report patient did not have that lump. The patient describes the bump as full of liquid, hot to the touch, itchy on the outside but numb on the inside.  The patient also mentions the presence of spot on her arm that were not there before. The reporter consent to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction to the bovine content on an unspecified Tdap; This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Tdap Vaccine.  Additional details were provided as follows: The age at vaccination was not reported. A nurse reported that a patient experienced an allergic reaction due to the bovine content on an unspecified Tdap vaccine. The reporter consented to follow up. The nurse stated that the patient had the reaction decades ago and that she not specific report information.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling of body temperature change, Laboratory test
Clinical narrative: Chills; Hot-cold flashes; This case was reported by a physician via call center representative and described the occurrence of chills in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st received on October 2019).   In January 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced chills and feeling hot and cold. On an unknown date, the outcome of the chills and feeling hot and cold were not recovered/not resolved.   The reporter considered the chills and feeling hot and cold to be related to Shingrix.  Additional details were provided as follows: A physician reported that a patient completed the series of Shingrix with 2 doses: October 2019 and January 2020.  The patient had complained of chills/hot-cold flashes and believes the symptoms are attributable to the vaccine.  The patient had seen an endocrinologist, lab-work was performed, no specific cause had been identified.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 12 year patient was today by mistake given a Menactra dose and one year apart, no AE; Initial information received on 14-Sep-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 12 year old female patient who received two doses MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] one year apart [extra dose administered].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation; HPV VACCINE (HPV VACCINE) for Immunisation; and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  On an unknown date (today), the patient received a0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6455CA and expiry date: 15-Nov-2020) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered (same day latency).  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.; Sender's Comments:  US-SA-2020SA250172:same patient
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient recieved adacel today and had also received it on Sep 29, 2019, no AE; Initial information received on 14-Sep-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 12 years old female patient who recieved DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and had also received it previously the same vaccine (inappropriate schedule of product administration).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 29-Sep-2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiration date not reported) via unknown route in unknown administration site and again on an unknown date she also received a 0.5 ml dose of the same vaccine  (lot U6638AA and expiration date 12-Apr-2022) via intramuscular route in the right deltoid as prophylactic vaccination.  It was an actual medication error case due to drug dose administration interval too short.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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.; Sender's Comments:  US-SA-2020SA251424:same patient
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: patient had joint pain in most joints (large and small) and had limited movement
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Hypopnoea, Loss of consciousness, Nervousness, Syncope, Tremor
Clinical narrative: Patient was extremely nervous prior to receiving vaccine. She was visibly shaking her knees and shallow breathing. After receiving the immunization she stood up to leave and then collapsed onto the shelf. She regained consciousness immediately
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient reported a mild fever, tenderness at the injection site and redness with swelling that involved the bicep.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives fevers about 4 weeks from when immunization was administered
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chest pain, Dizziness, Hyperhidrosis
Clinical narrative: on 9/2-9/3/20 patient experiencing short shocking intermittent pain in his stomach and chest.  He said he was dizzy last night.  He stated he and his wife were sweaty for a short time this morning.  Symptoms have not changed in 12 hours.  Office reached out to patient on 9/4/20 by phone and patient portal without response
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Patient stated that they had a bad headache 45 minutes after getting and had fever and chills.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: 9/2-9/3/20 patient has been experiencing short intermittent shock pains in her arms, legs stomach and chest.  She otherwise has no symptoms  patient contacted via phone but no response
Age: 69.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: RIGHT ARM SWELLED UP (VERY HOT). SUGGESTED GOING TO URGENT CARE FOR FURTHER EVALUATION
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Pyrexia
Clinical narrative: Joint pain, fatigue, fever, brain fog.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Confusional state, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: This vaccine was given on 9/16/20 at approx 130pm.  Patient was asymptomatic at time of vaccine and had been screened for covid per usual protocols--no symptoms and no temperature.  Within 15-20 minutes of receiving the vaccine, patient was extremely weak and confused, severe headache and tunnel vision in both eyes.  within 30 minutes developed a fever of 100.4.  Employee went home after picking up her child at school and then called the Employee Health RN who gave her the vaccine.  The RN told her to go to the hospital emergency department (ED) or see her provider asap.  Employee was confused, did not see a provider or go to the ED.  Employee Health called her the next morning, 9/17, to check on her and told her again she must go have a family member drive her to the ED, though temperature was back to normal, vision was normal, she still had headache.  Was seen in hospital Emergency Room, tested for Covid-19 and a urinalysis done.  Employee discharged from ED with education of if symptoms get worse/return to return to the ED.  Symptoms are resolved morning of 9/18/20.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Tunnel vision, Urine analysis
Clinical narrative: This vaccine was given on 9/16/20 at approx 130pm.  Patient was asymptomatic at time of vaccine and had been screened for covid per usual protocols--no symptoms and no temperature.  Within 15-20 minutes of receiving the vaccine, patient was extremely weak and confused, severe headache and tunnel vision in both eyes.  within 30 minutes developed a fever of 100.4.  Employee went home after picking up her child at school and then called the Employee Health RN who gave her the vaccine.  The RN told her to go to the hospital emergency department (ED) or see her provider asap.  Employee was confused, did not see a provider or go to the ED.  Employee Health called her the next morning, 9/17, to check on her and told her again she must go have a family member drive her to the ED, though temperature was back to normal, vision was normal, she still had headache.  Was seen in hospital Emergency Room, tested for Covid-19 and a urinalysis done.  Employee discharged from ED with education of if symptoms get worse/return to return to the ED.  Symptoms are resolved morning of 9/18/20.
Age: 67.0
Sex: F
Vaccine: FLUA4
Symptoms: Dizziness, Injection site erythema
Clinical narrative: Redness at an around injection site. Dizziness
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Dyskinesia, Loss of consciousness, Pallor, Syncope
Clinical narrative: a 13  y.o. 4  m.o. patient here to receive the vaccine(s) as ordered today. The VIS(s) were given to the caregiver and contraindications screened.  Education was provided to the patient/consenting adult and all questions answered.   Patient has been screened for eligibility for the Vaccines for Program at this office visit.  She is eligible for vaccine due to the following criterion: no health insurance.   The patient is instructed to wait for 15-20 minutes after the injection to watch for any side effects or syncopal symptoms.   The patient did not tolerate the procedure well.  The patient had the following syncopal symptoms: paleness, dizziness, brief loss of consciousness, and jerking movement.  The patient was sitting in the back seat of her mother's car when the incident occurred after receiving Tdap, MCV4, and HPV.  The patient regained consciousness immediately following the incident.  She was awake, alert, and oriented X 3.  At 11:20 am the vital signs were the following:  99%,B/P: 89/51, P: 62.  According to the patient, she had not eaten or drunken anything since last night. The patient was given a juice and asked to drink it slowly.  She was laid down in the car with her feet elevated above her heart level.  The patient's color returned and her vital signs at 11:42 am were the following: B/P 108/61 and P 70.  The patient denied feeling dizzy, faint, or light headed.  Mother instructed to notify future providers about the episode so they can give her vaccines lying down.  Also instructed the mother and patient to always eat and drink before receiving vaccines.  They verbalized understanding of the same.       PPE used during this procedure: Face Shield / Goggles, Procedural Mask, Gown, Gloves.
Age: 37.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event
Clinical narrative: patient denies any adverse symptoms.  Patient was to get Hepatitis B vaccine
Age: 80.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Severe arm pain and limited mobility. recommended otc tylenol at onset og symptoms.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: Patient had very little arm pain or muscle soreness on the day of the vaccination.  On 9/17/2020, 1 week after vaccination, patient developed left arm pain that he described as muscle pain, with shooting pain when raising his left arm in a wing motion.  Patient took 800mg if ibuprofen that relieved the pain.  The arm is still painful to move as of 9/18/2020.
Age: 45.0
Sex: M
Vaccine: SMALL
Symptoms: Headache, Pain, Pyrexia, Robust take following exposure to vaccinia virus, SARS-CoV-2 test
Clinical narrative: FEVER, BODY ACHES, HEADACHES, AND ROBUST TAKE AT VACCINATION SITE. PRESENT FOR 2 DAYS PRIOR TO EXAM. SYMPTOMATIC TREATMENT WITH OTC PAIN RELIEVERS AND PERFORMED COVID-19 PCR TEST TO CONFIRM RULE OUT.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site joint pain, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Day 1 after vaccination, left arm sore, red at vaccination site.  Starting day 2,  pain started in left shoulder joint...increasing each day.  Today is day 7, and I cannot lift my arm without terrible pain in shoulder.  Pain radiates even when not having any motion of shoulder.  My personal physician highly recommended I get this vaccination....but with the pain I am experiencing, I will not be getting the 2nd vaccination.  Tylenol does not have any impact at relieving pain.  Using ice and heat alternately, but only get short, minimal relief.  Unable to sleep if I should roll over on arm.  Will be reporting to my physician, on Monday, 9/21/20.
Age: 72.0
Sex: M
Vaccine: UNK
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Continuing pain in left arm and left shoulder towards back and behind the arm pit region. This began on 9/6/2020, the day after the first dose of the vaccination (first dose) and remaining up to now 9/19/2020. Next dose is 11/4/2020.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Nausea, Presyncope, Urticaria, Vomiting
Clinical narrative: Patient stated just stated the following occured.  She described welts at the site of injection the following day that lasted 2 days. Additionally,  she had nausea/vomiting and almost passed out. These items resolved within 48 hours after start of symptoms.
Sex: F
Vaccine: HPV9
Symptoms: Adverse reaction, Bedridden
Clinical narrative: had an unidentified adverse reaction/She is now bed ridden; This spontaneous report was received from the patient's husband and refers to a female patient of an unknown age. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On an unknown date in 2019 (reported as over a year ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (exact dose, route of administration, lot number and expiration date were not provided). On an unknown date, the patient experienced unidentified adverse reaction. She was now bed ridden.   The outcome of the event was unknown. The causality assessment was not provided.
Sex: F
Vaccine: FLUN3
Symptoms: Discomfort, Malaise
Clinical narrative: DISCOMFORT; I FELL JUST AS SICK THE FOLLOWING DAYS.; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided) of Unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent: Sex: Unknown. No concomitant products were reported.    The patient started treatment with Flumist (influenza virus vaccine live, intranasal), nasal, on an unknown date.     On an unknown date, the patient experienced discomfort (preferred term: Discomfort). On an unknown date, the patient experienced i fell just as sick the following days. (preferred term: Malaise).     The outcome of the event(s) of discomfort and i fell just as sick the following days. was unknown.     The events were considered non-serious.
Sex: M
Vaccine: MEN
Symptoms: Fatigue, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Fainted; Nauseous; feeling a lot of pain at area; redness and hard at injection site; hard at injection site; Fatigue/feeling tired; Headache; This case was reported by a consumer via call center representative and described the occurrence of fainting in a 17-year-old male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On 10th September 2020, the patient received Meningococcal B vaccine. On 10th September 2020, less than a day after receiving Meningococcal B vaccine, the patient experienced fainting (serious criteria GSK medically significant), nausea and injection site pain. In September 2020, the patient experienced injection site erythema, injection site induration, tiredness and headache. On an unknown date, the outcome of the fainting, headache, nausea and injection site pain were unknown and the outcome of the injection site erythema, injection site induration and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the fainting, injection site erythema, injection site induration, tiredness, headache, nausea and injection site pain to be related to Meningococcal B vaccine.  Additional details were provided as follows: The reporter was patient's mother. The age at vaccination was not reported. After receiving meningococcal B vaccine, the patient fainted at the doctor's office. The patient was nauseous, then feeling a lot of pain at area. At the time of reporting, the patient still had redness and hard at injection site, feeling tired, fatigue and headache. No further details were provided.  The reporter was consented to follow up.
Sex: M
Vaccine: MEN
Symptoms: Nausea, Syncope
Clinical narrative: Fainted; Nauseous; feeling a lot of pain at area; redness and hard at injection site; hard at injection site; Fatigue/feeling tired; Headache; This case was reported by a consumer via call center representative and described the occurrence of fainting in a 17-year-old male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On 10th September 2020, the patient received Meningococcal B vaccine. On 10th September 2020, less than a day after receiving Meningococcal B vaccine, the patient experienced fainting (serious criteria GSK medically significant), nausea and injection site pain. In September 2020, the patient experienced injection site erythema, injection site induration, tiredness and headache. On an unknown date, the outcome of the fainting, headache, nausea and injection site pain were unknown and the outcome of the injection site erythema, injection site induration and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the fainting, injection site erythema, injection site induration, tiredness, headache, nausea and injection site pain to be related to Meningococcal B vaccine.  Additional details were provided as follows: The reporter was patient's mother. The age at vaccination was not reported. After receiving meningococcal B vaccine, the patient fainted at the doctor's office. The patient was nauseous, then feeling a lot of pain at area. At the time of reporting, the patient still had redness and hard at injection site, feeling tired, fatigue and headache. No further details were provided.  The reporter was consented to follow up.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: The patient was given IPOL after 28 days, no AE; Initial information was received on 01-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a patient (gender and age unspecified) who was administered IPV (VERO) [IPOL] after 28 days (poor quality product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 31-Jul-2020, the patient received a dose of suspect IPV (VERO) (lot number not reported, expiry date: 11-Sep-2020) via unknown route in unknown administration site for prophylactic vaccination.  The vial was opened on 02-Jul-2020 and was given to the patient on 31-Jul-2020.  It was reported that it follows a 28 day rule.  It was a case of an actual medication error due to deteriorated drug administered (latency: same day)  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on lot number.
Age: 66.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Blood test normal, Chest discomfort, Cough, Fatigue, Headache
Clinical narrative: Pt called 9/17/20 to report after Hep A on 8/27. Pt began with flu-like symtoms on 8/28. (fatigue, low grade fever 100, cough, chest pressure, headache, some hives on chest.) Fevers range from 100 - 102.5 9/8/20 went to see PCP & had Blookwork & Covid test which was neg. pt presently still has symptoms.
Age: 66.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Influenza like illness, Pyrexia, SARS-CoV-2 test negative, Urticaria
Clinical narrative: Pt called 9/17/20 to report after Hep A on 8/27. Pt began with flu-like symtoms on 8/28. (fatigue, low grade fever 100, cough, chest pressure, headache, some hives on chest.) Fevers range from 100 - 102.5 9/8/20 went to see PCP & had Blookwork & Covid test which was neg. pt presently still has symptoms.
Age: 66.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Chest discomfort, Chest pain, Chills, Cough, Fatigue
Clinical narrative: Pt called 9/17/20 to report after Hep A on 8/27. Pt began with flu-like symtoms on 8/28. (fatigue, low grade fever 100, cough, chest pressure, headache, some hives on chest.) Fevers range from 100 - 102.5 9/8/20 went to see PCP & had Blookwork & Covid test which was neg. pt presently still has symptoms.
Age: 66.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Headache, Influenza like illness, Insomnia, Malaise, Pyrexia
Clinical narrative: Pt called 9/17/20 to report after Hep A on 8/27. Pt began with flu-like symtoms on 8/28. (fatigue, low grade fever 100, cough, chest pressure, headache, some hives on chest.) Fevers range from 100 - 102.5 9/8/20 went to see PCP & had Blookwork & Covid test which was neg. pt presently still has symptoms.
Age: 66.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Rhinorrhoea, SARS-CoV-2 test negative, Tremor, Urticaria
Clinical narrative: Pt called 9/17/20 to report after Hep A on 8/27. Pt began with flu-like symtoms on 8/28. (fatigue, low grade fever 100, cough, chest pressure, headache, some hives on chest.) Fevers range from 100 - 102.5 9/8/20 went to see PCP & had Blookwork & Covid test which was neg. pt presently still has symptoms.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Acute onset of pain and limitation of range of motion in left arm and shoulder. Started 4 hours after administration of vaccine. No injection site erythema or induration. Pain worsening overnight. During clinical exam on following day, significant loss of glenohumeral range of motion (both active and passive) without erythema or swelling.
Age: 80.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Erythema, Injection site erythema, Injection site swelling, Malaise, Peripheral swelling
Clinical narrative: Redness and swelling at injection site and down arm to mid forearm. Patient had malaise and suspected fever although temp was not taken or recorded. At time of reporting, redness and swelling had receded to just past elbow. Patient reported feeling better.
Age: 80.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Pyrexia
Clinical narrative: Redness and swelling at injection site and down arm to mid forearm. Patient had malaise and suspected fever although temp was not taken or recorded. At time of reporting, redness and swelling had receded to just past elbow. Patient reported feeling better.
Age: 58.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Patient said he  started having chills and all-over body aches on the evening of the day he got the vaccines. He said the injection site of the Pneumovax23 was swollen and red. He put a thermometer on the site at the reading was 102 degrees. He stated he took his temperature orally and it was 101.6. He took Tylenol and his body temperature returned to normal but the injection site remained inflammed and hot to the touch. On 9/17/20 he was not feeling any better and sought care at Urgent Care. He was given Diphenhydramine 50mg, 2 adult Tylenol tablets and a prescription for Clindamycin 300mg. I spoke with him today (9/18/20) and he said his arm was still red but "not as puffy and swollen." He said he was instructed to continue to take Benadryl and to seek medical attention at the emergency room if the redness expanded outside the line drawn on his arm. He said the redness was outside the line but he is feeling much better and the swelling was subsiding.