chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Pain in extremity, Pyrexia
Clinical narrative: Gave her chills; Gave her / fever; Made her weak; This case was reported by a consumer via other manufacturer and described the occurrence of chills in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, refer case US2021AMR064841).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, fever and weakness. On an unknown date, the outcome of the chills, fever and weakness were unknown.   It was unknown if the reporter considered the chills, fever and weakness to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported The patient received 2nd dose of Shingrix and experienced chills, fever and made her weak For tolerance for Flu Shot refer US2021AMR064858. The reporter and healthcare professional consents to follow up was reported as not applicable.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR064841:Same reporter. US-GLAXOSMITHKLINE-US2021AMR064858:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination site pain
Clinical narrative: Painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was captured as adult as per vaccine indication. The age at vaccination was not reported. The patient had received shingles vaccine and stated it was painful. The follow-up would not possible as no contact details were available.  This case had been linked with US2021AMR066116 and US2021AMR066117, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR066116:Father's case US-GLAXOSMITHKLINE-US2021AMR066117:Sister's case
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient's child. The age at vaccination was not reported. The patient had received shingles vaccine and experienced pain. The follow-up would not possible as no contact details were available.  This case had been linked with US2021AMR066108 and US2021AMR066117, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR066108:Reporter's case US-GLAXOSMITHKLINE-US2021AMR066117:Sister's case
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient's sibling. The age at vaccination was not reported. The patient had received shingles vaccine and experienced pain. The follow-up would not possible as no contact details were available.  This case had been linked with US2021AMR066108 and US2021AMR066116 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR066116:Father's case US-GLAXOSMITHKLINE-US2021AMR066108:Reporter's case
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: terrible headache / brutal headache; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th March 2021, the patient received Shingrix. On 18th March 2021, 1 days after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received a vaccine a day before reporting, expereinced a terrible and brutal headache on the day of reporting. The patient wanted to know if he/she could take acetaminophen.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: Suspected Vaccination failure / get shingles pimples; shingles; shingles pimples on my forehead; vaccinated with Shingrix for both doses in March 2019; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In March 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pimples. On an unknown date, the outcome of the vaccination failure, shingles and pimples were not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pimples to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient received Shingrix both doses and had shingles pimples on forehead. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthma, Chills, Condition aggravated, Dyspnoea, Headache
Clinical narrative: trouble breathing / used asthma inhaler to help with the breathing; chills; body aches; headache; sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of difficulty breathing in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 394KF, expiry date 23rd September 2022) for prophylaxis.   Concurrent medical conditions included asthma.   On 28th January 2021, the patient received the 1st dose of Shingrix. On 28th January 2021, less than a day after receiving Shingrix, the patient experienced difficulty breathing, chills, general body pain, headache and pain in arm. The patient was treated with other anti-asthmatics, inhalants (Asthma Inhaler (Nos)). On an unknown date, the outcome of the difficulty breathing, chills, general body pain, headache and pain in arm were recovered/resolved.   It was unknown if the reporter considered the difficulty breathing, chills, general body pain, headache and pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient had trouble breathing, chills, body aches, headache and sore arm that lasted for 24 hours.  the patient used asthma inhaler to help with the breathing.  The reporter did not consent to follow-up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: trouble breathing / used asthma inhaler to help with the breathing; chills; body aches; headache; sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of difficulty breathing in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 394KF, expiry date 23rd September 2022) for prophylaxis.   Concurrent medical conditions included asthma.   On 28th January 2021, the patient received the 1st dose of Shingrix. On 28th January 2021, less than a day after receiving Shingrix, the patient experienced difficulty breathing, chills, general body pain, headache and pain in arm. The patient was treated with other anti-asthmatics, inhalants (Asthma Inhaler (Nos)). On an unknown date, the outcome of the difficulty breathing, chills, general body pain, headache and pain in arm were recovered/resolved.   It was unknown if the reporter considered the difficulty breathing, chills, general body pain, headache and pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient had trouble breathing, chills, body aches, headache and sore arm that lasted for 24 hours.  the patient used asthma inhaler to help with the breathing.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Facial discomfort, Facial pain, Headache, Injection site erythema, Injection site pain
Clinical narrative: Redness / in the injection side; Painful in the injection side; Headache; Fever; Painful on the right side of patient face; Still with some discomfort on your face; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th December 2020, the patient received the 1st dose of Shingrix. On 25th December 2020, 7 days after receiving Shingrix, the patient experienced injection site erythema, injection site pain, headache, fever, facial pain and facial discomfort. On an unknown date, the outcome of the injection site erythema, injection site pain, headache, fever and facial pain were unknown and the outcome of the facial discomfort was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, headache, fever, facial pain and facial discomfort to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported bit could be 66 or 67 years. The patient was not immunocompromised.  No information about lot number as it was given in a pharmacy and not in doctor´s office.  The patient went to Emergency room but there was no diagnosis.  The patient still had some discomfort on her face at the time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Redness / in the injection side; Painful in the injection side; Headache; Fever; Painful on the right side of patient face; Still with some discomfort on your face; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th December 2020, the patient received the 1st dose of Shingrix. On 25th December 2020, 7 days after receiving Shingrix, the patient experienced injection site erythema, injection site pain, headache, fever, facial pain and facial discomfort. On an unknown date, the outcome of the injection site erythema, injection site pain, headache, fever and facial pain were unknown and the outcome of the facial discomfort was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, headache, fever, facial pain and facial discomfort to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported bit could be 66 or 67 years. The patient was not immunocompromised.  No information about lot number as it was given in a pharmacy and not in doctor´s office.  The patient went to Emergency room but there was no diagnosis.  The patient still had some discomfort on her face at the time of reporting. The reporter consented to follow up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash, Rash erythematous
Clinical narrative: rash presented in his left arm pit / smaller rash in the right arm /  Just a rash/ helped it turn from red to light pink; felt stinging; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on an unknown date).   In November 2020, the patient received the 2nd dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced red rash and stinging. The patient was treated with liquid paraffin (Vaselin). On an unknown date, the outcome of the red rash was not recovered/not resolved and the outcome of the stinging was unknown.   It was unknown if the reporter considered the red rash and stinging to be related to Shingrix.  Additional details were reported as follows : The case was reported by patient himself. The patient had his second dose and few days following this vaccination, a rash presented in his left arm pit. The patient did not pay much attention to it until a week later when he felt stinging in the area when applying deodorant. The rash area was 2 by 2 and there was also a smaller rash in the right arm. It was 1 by 3 or 1 by 4 of the size of the area in the left arm pit. The patient reported that there was no pain or irritation and just a rash. A dermatologist recommended treating the areas with vaseline. That has helped it turn from red to light pink. The reporter did not consent to follow up.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Eyelid ptosis, Headache, Herpes zoster, Hypoaesthesia
Clinical narrative: little numb; left eye droops; lesions appeared on the left side of her face, scalp and left eye; lesions appeared on the left side of her face, scalp and left eye; severe headache/ head tenderness; burning presented on the left side of her head; area was tender and stretched from the face to the back of her head / tenderness on the base of her head; couldn't lay on her back; stretched from the face to the back; itchy; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included zostavax.   On 22nd October 2020, the patient received the 1st dose of Shingrix. On 1st November 2020, 10 days after receiving Shingrix, the patient experienced headache, burning sensation, pain localized, mobility decreased and tenderness. On 6th November 2020, the patient experienced shingles and skin lesion. In November 2020, the patient experienced itchy skin. On an unknown date, the patient experienced numbness and eye discomfort. On an unknown date, the outcome of the shingles and skin lesion were unknown and the outcome of the itchy skin was recovering/resolving and the outcome of the numbness, eye discomfort, pain localized, mobility decreased and tenderness were not recovered/not resolved and the outcome of the headache and burning sensation were recovered/resolved.   It was unknown if the reporter considered the shingles, skin lesion, itchy skin, numbness, headache, burning sensation, eye discomfort, pain localized, mobility decreased and tenderness to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. In the evening of 1st November 2020, the patient had severe headache and burning presented on the left side of her head. By 6th November 2020, lesions appeared on the left side of her face, scalp and left eye, the reporter stated that, the lesions were shingles lesions.The area was tender and stretched from the face to the back of her head. The patient could not lay on her back because of the tenderness on the base of her head. The area where the lesions presented was still a little numb and itchy. The patient's left eye droops a bit. The reporter consented to follow up.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Ocular discomfort, Pain, Pruritus, Skin lesion
Clinical narrative: little numb; left eye droops; lesions appeared on the left side of her face, scalp and left eye; lesions appeared on the left side of her face, scalp and left eye; severe headache/ head tenderness; burning presented on the left side of her head; area was tender and stretched from the face to the back of her head / tenderness on the base of her head; couldn't lay on her back; stretched from the face to the back; itchy; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included zostavax.   On 22nd October 2020, the patient received the 1st dose of Shingrix. On 1st November 2020, 10 days after receiving Shingrix, the patient experienced headache, burning sensation, pain localized, mobility decreased and tenderness. On 6th November 2020, the patient experienced shingles and skin lesion. In November 2020, the patient experienced itchy skin. On an unknown date, the patient experienced numbness and eye discomfort. On an unknown date, the outcome of the shingles and skin lesion were unknown and the outcome of the itchy skin was recovering/resolving and the outcome of the numbness, eye discomfort, pain localized, mobility decreased and tenderness were not recovered/not resolved and the outcome of the headache and burning sensation were recovered/resolved.   It was unknown if the reporter considered the shingles, skin lesion, itchy skin, numbness, headache, burning sensation, eye discomfort, pain localized, mobility decreased and tenderness to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. In the evening of 1st November 2020, the patient had severe headache and burning presented on the left side of her head. By 6th November 2020, lesions appeared on the left side of her face, scalp and left eye, the reporter stated that, the lesions were shingles lesions.The area was tender and stretched from the face to the back of her head. The patient could not lay on her back because of the tenderness on the base of her head. The area where the lesions presented was still a little numb and itchy. The patient's left eye droops a bit. The reporter consented to follow up.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: little numb; left eye droops; lesions appeared on the left side of her face, scalp and left eye; lesions appeared on the left side of her face, scalp and left eye; severe headache/ head tenderness; burning presented on the left side of her head; area was tender and stretched from the face to the back of her head / tenderness on the base of her head; couldn't lay on her back; stretched from the face to the back; itchy; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included zostavax.   On 22nd October 2020, the patient received the 1st dose of Shingrix. On 1st November 2020, 10 days after receiving Shingrix, the patient experienced headache, burning sensation, pain localized, mobility decreased and tenderness. On 6th November 2020, the patient experienced shingles and skin lesion. In November 2020, the patient experienced itchy skin. On an unknown date, the patient experienced numbness and eye discomfort. On an unknown date, the outcome of the shingles and skin lesion were unknown and the outcome of the itchy skin was recovering/resolving and the outcome of the numbness, eye discomfort, pain localized, mobility decreased and tenderness were not recovered/not resolved and the outcome of the headache and burning sensation were recovered/resolved.   It was unknown if the reporter considered the shingles, skin lesion, itchy skin, numbness, headache, burning sensation, eye discomfort, pain localized, mobility decreased and tenderness to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. In the evening of 1st November 2020, the patient had severe headache and burning presented on the left side of her head. By 6th November 2020, lesions appeared on the left side of her face, scalp and left eye, the reporter stated that, the lesions were shingles lesions.The area was tender and stretched from the face to the back of her head. The patient could not lay on her back because of the tenderness on the base of her head. The area where the lesions presented was still a little numb and itchy. The patient's left eye droops a bit. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Left (injected) arm was swollen; Left (injected) arm / red; Left (injected) arm / warm to the touch; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced swelling arm, erythema of extremities and skin warm. On an unknown date, the outcome of the swelling arm, erythema of extremities and skin warm were recovered/resolved.   It was unknown if the reporter considered the swelling arm, erythema of extremities and skin warm to be related to Shingrix.  Additional details provided as follows: The patient reported case for herself. The age at vaccination was not reported. The reporter did not provided lot no. and expiry date of vaccine. The patient got her first Shingrix shot in August or September 2019. The patient reported that her left (injected) arm was swollen, red and warm to the touch for a few days post vaccination. All the events were resolved. This case has been linked with case US2021054993, reported by same reporter for same patient. The patient did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021054993:Same reporter, same patient, 2nd dose
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test abnormal, Herpes simplex, Herpes simplex test positive, Sexually transmitted disease test
Clinical narrative: positive for HSV 2; This case was reported by a consumer via call center representative and described the occurrence of herpes simplex type ii in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th February 2021, the patient received the 1st dose of Shingrix (intramuscular). In March 2021, less than 3 weeks after receiving Shingrix, the patient experienced herpes simplex type ii. On an unknown date, the outcome of the herpes simplex type ii was unknown.   It was unknown if the reporter considered the herpes simplex type ii to be related to Shingrix.  Additional information was provided as follows: The patient received dose one of Shingrix, formulation unknown, on 28th February 2021. The patient had routine bloodwork done and requested an STD (sexually transmitted diseases) test. The test came back positive for HSV 2 (herpes simplex virus type II). The reporter did not consent to follow-up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Pyrexia
Clinical narrative: Fever; Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of fever in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix. In March 2020, 12 hrs after receiving Shingrix, the patient experienced fever and upset stomach. On an unknown date, the outcome of the fever and upset stomach were recovered/resolved.   It was unknown if the reporter considered the fever and upset stomach to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix. The patient experienced upset stomach and fever. The adverse events were resolved 4 days later. The reporter did not share which arm the vaccine was administered. The reporter did not consent to follow-up. For tolerance of a 2nd dose of Shingrix refer case US2021AMR063193.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063193:Same reporter.
Age: 88.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Asthenia, Back pain, Decreased appetite, Fatigue, Malaise
Clinical narrative: did not feel like eating; low energy; fatigue; feeling sick; Overdose; This case was reported by a consumer via call center representative and described the occurrence of appetite absent in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Concurrent medical conditions included drug allergy (allergy to isoflurane).   On 10th December 2020, the patient received the 1st dose of Shingrix (intramuscular) and the 1st dose of Influenza vaccine Quadrivalent 2020-2021 season (intramuscular). On 10th December 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced appetite absent, energy decreased, fatigue, feeling unwell and overdose. On an unknown date, the outcome of the appetite absent, energy decreased, fatigue and feeling unwell were recovered/resolved and the outcome of the overdose was unknown.   It was unknown if the reporter considered the appetite absent, energy decreased, fatigue and feeling unwell to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The case was reported by patient herself. The patient received a dose of Shingrix and High Dose Infulenza vaccine on the same day, manufacturer not known and one injection of each in each arm., which led to overdose for Influenza vaccine. The patient reported that later in the day after the injection experienced feeling sick, defined as fatigue, low energy, and did not feel like eating.   All symptoms have resolved.   The patient had not had dose 2 yet. The reporter consented to follow up. This case was 1 of the 3 cases, reported by the same reporter. Note- even though description about overdose was not given (dosing amount) but since the statement is provided as high dose of influenza vaccine, overdose is conservatively coded.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021063955:same reporter US-GLAXOSMITHKLINE-US2021063953:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Fatigue
Clinical narrative: did not feel like eating; low energy; fatigue; This case was reported by a consumer via call center representative and described the occurrence of appetite absent in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced appetite absent, energy decreased and fatigue. On an unknown date, the outcome of the appetite absent, energy decreased and fatigue were unknown.   It was unknown if the reporter considered the appetite absent, energy decreased and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported for reporter's son in law. The patient received Shingrix and experienced fatigue, low energy, and did not feel like eating. The dates and timing of onset unknow by the reporter. The reporter consented to follow up. This case was 3 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021063953:same reporter US-GLAXOSMITHKLINE-US2021063952:same reporter
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Skin lesion
Clinical narrative: Cellulitis; Four redness with purplish lesions to the upper arm almost to antecubital; This is a spontaneous report from a contactable nurse. An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6202), dose 1 via an unspecified route of administration on 26Feb2021 as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed on day four (unknown date in 2021) redness with purplish lesions to the upper arm almost to antecubital. He was put on Levaquin by primary physician, the evaluation in his case was a cellulitis (unknown date in 2021). The reporter asked if the patient should get the second dose. The outcome of the events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported cellulitis cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fall, Loss of consciousness, Pain in extremity
Clinical narrative: Lost consciousness; fell face first onto floor; Arm pain; Chills shivering; This is a spontaneous report from a contactable other health professional (patient). A 46-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6202), via an unspecified route of administration, administered in right arm on 05Mar2021 08:45 as single dose for COVID-19 immunization at a hospital. The patient has no medical history. Concomitant medications were not reported. Patient has no known allergies. The patient previously received the first dose of bnt162b2 (lot number: EL9264) on 12Feb2021 14:30 (2:30 pm) for COVID-19 immunization. The patient did not received other vaccines in four weeks. No COVID-19 test post vaccination was done. On 06Mar2021 at 13:45 (1:45 pm), the patient lost consciousness and fell face first onto floor. The patient also experienced arm pain and chills shivering. No treatment was received. The event required doctor's office visit. The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Gastric disorder, Gastrointestinal disorder
Clinical narrative: Joint pain; lower back pain; bowel issues; stomach issues; chills; severe neuropathy attack/both feet were on fire when with proper medication, he has been under control for years; This is a spontaneous report from a contactable consumer. A 57-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: unknown), via an unspecified route of administration in the left arm on 05Mar2021 at 15:45 at a single dose for COVID-19 immunization. Medical history included gout, neuropathy, high cholesterol and heart disease with 4 heart 'stints' and known allergies to dairy. Concomitant medications included colchicine (COLCHICINE), gabapentin (GABAPENTIN), acetylsalicylic acid (ASPRIN). The patient had no other vaccine in four weeks. The patient previously took and had allergies with Cipro [ciprofloxacin] and Erythromycin. It was reported that 20 hours plus after the shot, on 06Mar2021 at 13:15, the patient experienced the most severe neuropathy attack of his life - both feet were on fire when with proper medication, he has been under control for years. The patient also reported joint pain, lower back pain, bowel and stomach issues and chills on 06Mar2021 at 21:15. The patient had no COVID prior to the vaccination and had not tested post vaccination. No treatment administered for the events. The events had not resolved.   Information on the lot/batch number has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Joint pain; lower back pain; bowel issues; stomach issues; chills; severe neuropathy attack/both feet were on fire when with proper medication, he has been under control for years; This is a spontaneous report from a contactable consumer. A 57-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: unknown), via an unspecified route of administration in the left arm on 05Mar2021 at 15:45 at a single dose for COVID-19 immunization. Medical history included gout, neuropathy, high cholesterol and heart disease with 4 heart 'stints' and known allergies to dairy. Concomitant medications included colchicine (COLCHICINE), gabapentin (GABAPENTIN), acetylsalicylic acid (ASPRIN). The patient had no other vaccine in four weeks. The patient previously took and had allergies with Cipro [ciprofloxacin] and Erythromycin. It was reported that 20 hours plus after the shot, on 06Mar2021 at 13:15, the patient experienced the most severe neuropathy attack of his life - both feet were on fire when with proper medication, he has been under control for years. The patient also reported joint pain, lower back pain, bowel and stomach issues and chills on 06Mar2021 at 21:15. The patient had no COVID prior to the vaccination and had not tested post vaccination. No treatment administered for the events. The events had not resolved.   Information on the lot/batch number has been requested.
Age: 3.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Act-HIB given, stated that on the component or powder it say 29-May-2021 and the dilute stated 01-Mar-2021 with no reported adverse event; Initial information received on 04-Mar-2021 regarding an unsolicited valid non-serious case received from a physician and consumer/ non health care professional.  This case involves a 3 year-old female patient who was vaccinated with expired dose of HIB (PRP/T) VACCINE [ACT-HIB], stated that on the component or powder would expired on 29-may-2021 and the dilute expired on 01-Mar-2021 (Expired Product administered).   The patient's past 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 (DAPTACEL) for prophylactic vaccination.  On 03-Mar-2021, the patient received 0.5 mL (once) dose of suspect HIB (PRP/T) VACCINE (strength- standard) [lot UJ165AAA and expiry date 01-Mar-2021) via intramuscular/right vastuslaterallus route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, Product preparation issue
Clinical narrative: 5-month patient was given diluent portion of the Pentacel and not the vaccine/ NO AE; Initial information received on 11-Mar-2021 regarding an unsolicited valid non-serious case received from a other health professional via call-center.  This case involves a 5-months-old male patient who received only diluent portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] not the vaccine (frequency: once and strength: standard batch number: UJ226AAA and expiry date 04-Apr-2021) via an unknown route at an unknown administration site (product preparation issue) on 02-Mar-2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, and family history were not provided.  List of concomitant was unknown and no other vaccines were reported.  It was an actual medication error case due to inappropriate reconstitution technique (latency: same day)  Dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin (TB) skin test.  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.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Syringe issue, Underdose
Clinical narrative: Vaccinator attempted to give vaccine using vanish point needle. Needle misfired and retracted when vaccinator attempted to administer. Some vaccine was injected, but some also squirted on the arm of the pt. Per CDC guidance, another vaccine of standard dose was administered in the patient's other arm.
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Breakout of a rash on my right, arms, shoulder and back area.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, C-reactive protein increased, Hepatic enzyme increased
Clinical narrative: Muscle pain and weakness beginning 2/28/2021, hospitalized 3/2/2021-3/8/2021 for rhabdomyolysis (peak CK = 112,000) and severe transaminitis (ALT and AST in the 2000's).  No preceding injury or trauma, no drug or excessive alcohol use.  By 3/19/2021 patient still unable to  get out of chair without using arms, significant proximal mm weakness.  Inflammatory markers elevated and CK and liver enzymes still surprisingly high.  Re-hospitalized  3/22/2021.  Still in hospital, improving, on date of report (3/23/2021).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammatory marker increased, International normalised ratio normal, Mobility decreased, Muscular weakness, Myalgia
Clinical narrative: Muscle pain and weakness beginning 2/28/2021, hospitalized 3/2/2021-3/8/2021 for rhabdomyolysis (peak CK = 112,000) and severe transaminitis (ALT and AST in the 2000's).  No preceding injury or trauma, no drug or excessive alcohol use.  By 3/19/2021 patient still unable to  get out of chair without using arms, significant proximal mm weakness.  Inflammatory markers elevated and CK and liver enzymes still surprisingly high.  Re-hospitalized  3/22/2021.  Still in hospital, improving, on date of report (3/23/2021).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate increased, Rhabdomyolysis, Transaminases increased
Clinical narrative: Muscle pain and weakness beginning 2/28/2021, hospitalized 3/2/2021-3/8/2021 for rhabdomyolysis (peak CK = 112,000) and severe transaminitis (ALT and AST in the 2000's).  No preceding injury or trauma, no drug or excessive alcohol use.  By 3/19/2021 patient still unable to  get out of chair without using arms, significant proximal mm weakness.  Inflammatory markers elevated and CK and liver enzymes still surprisingly high.  Re-hospitalized  3/22/2021.  Still in hospital, improving, on date of report (3/23/2021).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Nasal congestion, Nausea, Pain, SARS-CoV-2 test positive
Clinical narrative: Patient received dose 1 of COVID vaccine on 1/4/2021.  On 1/18/2021 developed body aches, nasal congestion, and nasuea/vomiting.  Tested positive for COVID.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Patient received dose 1 of COVID vaccine on 1/4/2021.  On 1/18/2021 developed body aches, nasal congestion, and nasuea/vomiting.  Tested positive for COVID.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Diarrhoea, SARS-CoV-2 test negative
Clinical narrative: I have terrible colitis now. Around day 6 I started with diarrhea, I have been eating bananas and rice for about 3 days. Today the 23rd I have moved to broth, jello and coconut water.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Heart rate increased, Hot flush, Nausea, Pruritus
Clinical narrative: Extreme heat of head flushed , itching of chest and arms, rapid heart beat,, extreme nausea, coughing
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Bradycardia, Electrocardiogram normal, Hypoaesthesia, Lip swelling
Clinical narrative: Roof of mouth swelling, soft pallet swelling (@10 minutes),right side of upper scalp went numb (@20 mins) spreading to brow ridge -right side then spreading to left  upper lip swelling (@30 mins). tongue and throat @40mins.  Epipen given, swelling improved within a minute observed for 4 hours then released
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Palatal disorder, Palatal swelling, Pharyngeal swelling, Swollen tongue
Clinical narrative: Roof of mouth swelling, soft pallet swelling (@10 minutes),right side of upper scalp went numb (@20 mins) spreading to brow ridge -right side then spreading to left  upper lip swelling (@30 mins). tongue and throat @40mins.  Epipen given, swelling improved within a minute observed for 4 hours then released
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dysphagia, Speech disorder
Clinical narrative: After receiving the COVID immunization client complained of tightness in chest.  She had a hard time swallowing and speaking.  RN asked if she could swallow Zyrtec and client shook head no.  RN asked if she was OK having epinephrine injection and client shook head yes.  Three minutes after epinephrine 0.3 injection in left thigh client was able to answer questions appropriately and stated she could breathe better.  Vital signs were taken at beginning of client complaints and continued throughout event.  EMS called and client was transported to hospital.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Pyrexia
Clinical narrative: fever, chills, sick to stomach
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Diarrhoea, Dyspnoea
Clinical narrative: Diarrhea for 24 hrs, followed by shortness of breath and chest pain continuing for weeks.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Chest pain, Computerised tomogram thorax, Dyspnoea
Clinical narrative: Diarrhea for 24 hrs, followed by shortness of breath and chest pain continuing for weeks.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Loss of consciousness, Nausea, Pain in extremity
Clinical narrative: 03/05/2021 A 42 years old female received Janssen vaccine. Lot #1805018 Exp 05/25/2021 to left deltoid. Immediately after vaccines patient C/O left arm pain. 10:15 am patient continue to C/O left arm pain radiating up and down arm. C/O dizziness and nausea. Patient fading in and out of conscientiousness. V/S 97 BP 136/86 Left arm. O2 sats 100 %. room air. 10:30 am patient still experiencing dizziness and fading in and out of conscientiousness. Emergency services notified. Patient offered ice chips unable to consume. 10:45 am EMS arrived and resumed care for patient. Patient left facility by ambulance Lupon departure. Patient still experiencing dizziness and fading in and out of conscientiousness.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, Atrial fibrillation, Dyspnoea, Pneumonia
Clinical narrative: Shortness of breath sepsis AKI (acute kidney injury) (CMS/HCC) Atrial fibrillation with rapid ventricular response (CMS/HCC) Acute respiratory failure with hypoxia (CMS/HCC) Pneumonia of both lower lobes due to infectious organism
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sepsis
Clinical narrative: Shortness of breath sepsis AKI (acute kidney injury) (CMS/HCC) Atrial fibrillation with rapid ventricular response (CMS/HCC) Acute respiratory failure with hypoxia (CMS/HCC) Pneumonia of both lower lobes due to infectious organism
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Throat irritation
Clinical narrative: After receiving his vaccine client stated his throat felt "Itchy" and he was "light headed".   Reclined in car seat and seen by EMS and Dr on site.  Client reports he does carry and Epi Pen for a shell fish allergy that causes anaphylaxis.  Blood pressure 132/88 Pulse 80 and oxygen saturation 100%.  Released by Dr  once feeling better,  Advised to seek medical attention later if needed. Client verbalized understanding
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Feverish, extremely bad headache and sore body
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Large red swollen area around injection site with a small dark red spots too
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Night sweats
Clinical narrative: Symptoms began around 9am the next morning and progressively worsened over the day (lower body muscle aches, chills, headache, fatigue, overnight sweats. Symptoms worsened in the evening. Took Tylenol PM, showered and went to bed early. Felt better next day.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: I experienced a red, itchy rash/hives on my stomach about 1-week after receiving my first dose of vaccine. Over the next 2-3 days, the systemic rash and itchiness was present on my hands, legs, and face. I took 1 dose of 10mg Zyrtec and the rash subsided, but 2-3 days later the systemic rash and itchiness would reappear anywhere on the body. I took a dose of Zyrtec and the rash subsided. On the day before my scheduled second dose shot (apprx 3-weeks) systemic rashes on my stomach, hands, and face appeared, but were less red, itchy, not as large. I received my second dose on March 22, 20201. I did not experience any allergic symptoms immediately after the shot, however, in the evening (approx 7 hours) after receiving the shot, I experienced a red, itchy, large rash on my stomach. I took 1 dose of Zyrtec, and the rash subsided for 24hours. I am planning to continue to take Zyrtec for the next few days and monitor the rash and itchiness.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Headache, fatigue, body aches and flu like symptoms lasting about 24 hours. Chills and shakes for about 20 minutes, 10 hours after injection.