chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Phantom limb syndrome, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: suspected vaccination failure; Shingles; Phantom Pain on head at night; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included colorectal cancer (survivor with missing 36 lymph nodes) and shingles (experienced in February 2020). Previously administered products included Shingrix with an associated reaction of herpes zoster (1st dose received on unknown date in 2020, refer case US2021AMR019382). Concomitant products included gabapentin.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and phantom pain. The patient was treated with valaciclovir hydrochloride (Valtrex). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and phantom pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the phantom pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the spouse of the patient. The age at vaccination was not reported, however could be 58 or 59 years. The patient had shingles approximately every week since his second Shingrix vaccine. He also had phantom pain on his head at night. Valtrex was used as a treatment for shingles. This case was considered as suspected vaccination failure as laboratory test confirmation and time to onset for the event was unknown at the time of reporting. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR019382:same patient, 1st dose
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Herpes zoster, Nausea, Nerve injury, Neuralgia
Clinical narrative: received the second dose / shingles appeared; shingles / on her upper right thigh and wrapped around her back; nerve damage from shingles; severe pain / burning pain; nerve pain; dizziness; nausea; pins and needles feeling; wake her up in the middle of the night; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, nerve damage, pain, nerve pain, dizziness, nausea, pins and needles and wakefulness. On an unknown date, the outcome of the vaccination failure, shingles, nerve damage, pain, nerve pain, dizziness, nausea, pins and needles and wakefulness were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, nerve damage, pain, nerve pain, dizziness, nausea, pins and needles and wakefulness to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, in the evening of vaccination the patient experienced dizziness and nausea. In the following day, the patient had some sever pain. The patient had shingles on right upper thigh and wrapped around back. The patient was woke up in the middle of the night with nerve pain sometimes. The patient still had nerve damage from shingles with the pins and needles feeling but there is no more burning pain anymore and the shingles outbreak has resolved. The patient received Tylenol, Ibuprofen and pain killer from the physician as a treatment medication. The reporter consented to follo wup.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Paraesthesia, Poor quality sleep, Vaccination failure
Clinical narrative: received the second dose / shingles appeared; shingles / on her upper right thigh and wrapped around her back; nerve damage from shingles; severe pain / burning pain; nerve pain; dizziness; nausea; pins and needles feeling; wake her up in the middle of the night; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, nerve damage, pain, nerve pain, dizziness, nausea, pins and needles and wakefulness. On an unknown date, the outcome of the vaccination failure, shingles, nerve damage, pain, nerve pain, dizziness, nausea, pins and needles and wakefulness were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, nerve damage, pain, nerve pain, dizziness, nausea, pins and needles and wakefulness to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, in the evening of vaccination the patient experienced dizziness and nausea. In the following day, the patient had some sever pain. The patient had shingles on right upper thigh and wrapped around back. The patient was woke up in the middle of the night with nerve pain sometimes. The patient still had nerve damage from shingles with the pins and needles feeling but there is no more burning pain anymore and the shingles outbreak has resolved. The patient received Tylenol, Ibuprofen and pain killer from the physician as a treatment medication. The reporter consented to follo wup.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain, Post herpetic neuralgia, Vaccination failure
Clinical narrative: second dose of Shingrix in November /  january 2021 patient presented shingles; shingles / shingles lesions in face; postherpetic neuralgia; pain in site of injection; This case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) (batch number 3GK5K ?, expiry date 17th September 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cancer.   In November 2020, the patient received the 2nd dose of Shingrix. On 17th September 2020, the patient received the 1st dose of Shingrix. In January 2021, between 1 and 3 months after receiving Shingrix and between 3 and 5 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, post herpetic neuralgia and injection site pain. On an unknown date, the outcome of the vaccination failure, shingles, post herpetic neuralgia and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and injection site pain to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. After the administration of second dose, starting in january 2021 patient presented shingles (pain in site of injection, post herpetic neuralgia, shingles lesions in face). The reporter consented to follow up. The batch number of the suspect vaccine had multiple possibilities hence updated with 3GK5K ? as per sales data sheet.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: experienced 6 episodes of shingles outbreaks; experienced 6 episodes of shingles outbreaks/Shingles rash; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 5DH34, expiry date 10th December 2021) for prophylaxis.   On 22nd April 2020, the patient received the 2nd dose of Shingrix. On 28th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 28th July 2020, 97 days after receiving Shingrix and 182 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The patient experienced 6 episodes of shingles outbreaks. The onset dates were as follows 28th July 2020, 3rd Sep 2020, 7th December 2020, 15th December 2020, 5th January 2021 and 22nd January 2021. The reporter stated that a little shingles rash presents in the middle of her buttocks on the left side every time. The lot number was provided but it was not clear that it was of which dose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Off label use, Product administered to patient of inappropriate age, Vaccination failure
Clinical narrative: Patient received both doses / have shingles/Suspected vaccination failure; Patient did have shingles; Patient is a 45 year old female and received Shingrix; The patient actively had shingles and HCP prescribe Shingrix to 45 year old patient; This case was reported by a other health professional and described the occurrence of suspected vaccination failure in a 45-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix and not applicable after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, inappropriate age at vaccine administration and off label use. On an unknown date, the outcome of the vaccination failure, inappropriate age at vaccine administration and off label use were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st 2 doses. The health care professional reported that Patient was a 45 year old at the time of reporting and patient received both doses of shingrix from a different HCP, administration time was unknown of the 2 doses or when the last one was given which led to inappropriate age at vaccine administration. The HCP wanted to give the patient an additional dose even though she had already received both because she actively had shingles, which led to off label use (off label use in unapproved age group and indication) .  The patient did have shingles, health care professional forgot to put it in the description. 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. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Developed shingles, but could not specify the dates of both injections/suspected vaccination failure; Developed shingles, but could not specify the dates of both injections; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient had reported the case for himself. The age at vaccination was not reported. The patient received both doses of Shingrix. The patient developed shingles, but could not specify the dates of both injections, or the date of experiencing shingles. This case was considered as suspected vaccination failure, as information about laboratory test confirmation for shingles infection and time to event onset were unknown. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Shingrix vaccine both doses 2 years ago and still got Shingles/ suspected vaccination failure; shingles; Rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure and rash were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2 doses of Shingrix and experienced shingles. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The reporter did not consent to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Illness, Injected limb mobility decreased
Clinical narrative: first Shingrix shot in September / first week of September 2020 / second Shingrix shot in November 2020 around Thanksgiving / (starting around Feb 6 2021) she has a big shingles outbreak; severe shingles outbreak; ribs are hurting; red line around her belly / 2 red lines moving toward the front of her belly; there's a huge blister; very sick; left (injected) arm was painful; could not move it for 3 days; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 2nd dose of Shingrix (intramuscular). In September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 6th February 2021, between 2 and 3 months after receiving Shingrix and between 4 and 6 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rib pain, erythema and blister. On an unknown date, the patient experienced injection site pain, injected limb mobility decreased and sickness. On an unknown date, the outcome of the vaccination failure, shingles, erythema and blister were unknown and the outcome of the injection site pain, injected limb mobility decreased and sickness were recovered/resolved and the outcome of the rib pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, injection site pain, injected limb mobility decreased, rib pain, erythema, sickness and blister to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, rib pain, erythema, sickness and blister to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. In November 2020 around Thanksgiving, the patient received 2nd dose of Shingrix and less than 3 months after the 2nd dose, her left (injected) arm was painful and she could not move it for 3 days and less than 6 months after the 1st dose and less than 3 months after the 2nd dose, the patient was also very sick for 3 days. On 6th Feb 2021 (approximately), the patient had a big shingles outbreak, it's on her back right behind the ribcage and her ribs were hurting and there was a red line around her belly, there are 2 red lines moving toward the front of her belly and there was a huge blister and was unable to lay on her right side. The patient was sick, and she could not touch her ribs for 3 days now was shocked that this shingles outbreak was far worse than anything she was experienced before. The reporter did not consent to follow-up.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Musculoskeletal chest pain, Pain in extremity, Vaccination failure
Clinical narrative: first Shingrix shot in September / first week of September 2020 / second Shingrix shot in November 2020 around Thanksgiving / (starting around Feb 6 2021) she has a big shingles outbreak; severe shingles outbreak; ribs are hurting; red line around her belly / 2 red lines moving toward the front of her belly; there's a huge blister; very sick; left (injected) arm was painful; could not move it for 3 days; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 2nd dose of Shingrix (intramuscular). In September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 6th February 2021, between 2 and 3 months after receiving Shingrix and between 4 and 6 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rib pain, erythema and blister. On an unknown date, the patient experienced injection site pain, injected limb mobility decreased and sickness. On an unknown date, the outcome of the vaccination failure, shingles, erythema and blister were unknown and the outcome of the injection site pain, injected limb mobility decreased and sickness were recovered/resolved and the outcome of the rib pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, injection site pain, injected limb mobility decreased, rib pain, erythema, sickness and blister to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, rib pain, erythema, sickness and blister to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. In November 2020 around Thanksgiving, the patient received 2nd dose of Shingrix and less than 3 months after the 2nd dose, her left (injected) arm was painful and she could not move it for 3 days and less than 6 months after the 1st dose and less than 3 months after the 2nd dose, the patient was also very sick for 3 days. On 6th Feb 2021 (approximately), the patient had a big shingles outbreak, it's on her back right behind the ribcage and her ribs were hurting and there was a red line around her belly, there are 2 red lines moving toward the front of her belly and there was a huge blister and was unable to lay on her right side. The patient was sick, and she could not touch her ribs for 3 days now was shocked that this shingles outbreak was far worse than anything she was experienced before. The reporter did not consent to follow-up.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Discomfort, Herpes zoster, Pain, Pruritus
Clinical narrative: Suspected vaccination failure; till breaking out with Shingles / still breaking out on left shoulder / shingles all over patient shoulder; but painful / very painful no lesions though / still hurts; burning sensations; and some itching; a lot of discomfort.; This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number ZP3P9, expiry date 12th February 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 455KD, expiry date 4th May 2021) for prophylaxis.   On 12th April 2019, the patient received the 2nd dose of Shingrix. On 5th February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, burning sensation, pruritus and discomfort. On an unknown date, the outcome of the vaccination failure, pain, burning sensation, pruritus and discomfort were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, burning sensation, pruritus and discomfort to be related to Shingrix and Shingrix.  Additional details were provided as follows: Patient received two doses of Shingrix and one month before reporting patient broke out with shingles across left upper shoulder and back area,no lesions but painful / burning sensations and some itching but a lot of discomfort. Patient asked about how to get rid of shingles. This case was considered as suspected vaccination failure since the details regarding, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up. The reported batch number 2P3P9 was not found in sales data sheet sheet so updated as ZP3P9
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Suspected vaccination failure; till breaking out with Shingles / still breaking out on left shoulder / shingles all over patient shoulder; but painful / very painful no lesions though / still hurts; burning sensations; and some itching; a lot of discomfort.; This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number ZP3P9, expiry date 12th February 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 455KD, expiry date 4th May 2021) for prophylaxis.   On 12th April 2019, the patient received the 2nd dose of Shingrix. On 5th February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, burning sensation, pruritus and discomfort. On an unknown date, the outcome of the vaccination failure, pain, burning sensation, pruritus and discomfort were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, burning sensation, pruritus and discomfort to be related to Shingrix and Shingrix.  Additional details were provided as follows: Patient received two doses of Shingrix and one month before reporting patient broke out with shingles across left upper shoulder and back area,no lesions but painful / burning sensations and some itching but a lot of discomfort. Patient asked about how to get rid of shingles. This case was considered as suspected vaccination failure since the details regarding, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up. The reported batch number 2P3P9 was not found in sales data sheet sheet so updated as ZP3P9
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Initial insomnia, Sleep disorder, Vaccination failure
Clinical narrative: Feels that he is experiencing symptoms of self diagnosed ZSH; Self diagnosed ZSH; Abdominal pain where his shirt rubs against his belly; Hard for him to sleep; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included gas (has been seen by the Gastrointestinal specialist). Concomitant products included pregabalin (Lyrica).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster, abdominal pain and trouble falling asleep. On an unknown date, the outcome of the vaccination failure, herpes zoster, abdominal pain and trouble falling asleep were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster, abdominal pain and trouble falling asleep to be related to Shingrix. It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received both the Shingrix shots 3 years prior to the report but 6 weeks ago sought medical care for abdominal pain where his shirt rubs against his belly. This made it hard for him to sleep. The patient has also been seen by the neurologist who prescribed Lyrica 75 mg Bid. The patient felt that he was experiencing symptoms of self diagnosed ZSH (zoster sine herpete). The reporter did not consent to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time normal, Anisocytosis, Computerised tomogram, Contusion, Haematocrit
Clinical narrative: Thrombocytopenia (diffuse petechiae, easy bruising, bleeding gums); Polychromasia; Petechiae; Easy bruising; Mild headache; Anisocytosis; A spontaneous report was received from a literature article concerning a 36, year old, female patient who experienced thrombocytopenia, headache, polychromasia, anisocytosis, petechiae and easy bruising.    The patient's medical history included thrombocytopenia and allergy to acetaminophen. Products known to have been used by the patient, within one week prior to the event, included ibuprofen and sumatriptan. A vaginal ring containing etonogestrel-ethinyl estradiol,  was place one week prior to hospitalization    Approximately one week prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on unknown date, intramuscularly in the for prophylaxis of COVID-19 infection.    The patient presented to the hospital on unknown date with diffuse petechiae, easy bruising, bleeding gums and mild headache. Vital signs were within normal limits upon arrival at hospital. Physical exam was notable for diffuse petechiae of the extremities and trunk along with oral ecchymosis of 1-2 cm: no focal neurological deficits were observed, and no hepatic or splenic enlargement was noted. Blood work was significant for white blood count of 13.1 L/uL, hemoglobin 13.6 g/dL, heamatocrit of 42.1%, and platelet count of 3000/uL.  Prothrombin time and activated partial thromboplastin time were within normal limits. SARS-CoV2 swab was negative but the SARS-CoV2 IgG antibodies were reactive. Peripheral smear showed thrombocytopenia without clumping along with polychromasia and anisocytosis appreciated with some mature neutrophils.  A CT scan of the head did not show acute infarction or hemorrhage.   Treatment for the event included, dexamethasone 40 mg intravenously daily for four days, intravenous immunoglobulin (IVIG) 1 mg/Kg for three days and was place on the Health Stroke Scale monitoring. Platelet count improved to 28000/uL within 3 days and oral lesions disappeared through some petechiae remained. The patient's contraception ring was not removed. The patient was discharged with outpatient hematology follow up.  Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the event(s) was not reported.  According to the abstract, the temporal sequence of the events suggests an exacerbation of the patient's chronic thrombocytopenia related to the receipt of the mRNA-1273 Covid-19 vaccine. The abstract also stated that it is possible based on reviews of reported side effects unlikely, that the patient's headache medications and contraception were triggers for this event.    Follow up: No follow up provided.; Reporter's Comments: Very limited information regarding the events has been provided at this time.
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin, Headache, Petechiae, Platelet count, Polychromasia
Clinical narrative: Thrombocytopenia (diffuse petechiae, easy bruising, bleeding gums); Polychromasia; Petechiae; Easy bruising; Mild headache; Anisocytosis; A spontaneous report was received from a literature article concerning a 36, year old, female patient who experienced thrombocytopenia, headache, polychromasia, anisocytosis, petechiae and easy bruising.    The patient's medical history included thrombocytopenia and allergy to acetaminophen. Products known to have been used by the patient, within one week prior to the event, included ibuprofen and sumatriptan. A vaginal ring containing etonogestrel-ethinyl estradiol,  was place one week prior to hospitalization    Approximately one week prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on unknown date, intramuscularly in the for prophylaxis of COVID-19 infection.    The patient presented to the hospital on unknown date with diffuse petechiae, easy bruising, bleeding gums and mild headache. Vital signs were within normal limits upon arrival at hospital. Physical exam was notable for diffuse petechiae of the extremities and trunk along with oral ecchymosis of 1-2 cm: no focal neurological deficits were observed, and no hepatic or splenic enlargement was noted. Blood work was significant for white blood count of 13.1 L/uL, hemoglobin 13.6 g/dL, heamatocrit of 42.1%, and platelet count of 3000/uL.  Prothrombin time and activated partial thromboplastin time were within normal limits. SARS-CoV2 swab was negative but the SARS-CoV2 IgG antibodies were reactive. Peripheral smear showed thrombocytopenia without clumping along with polychromasia and anisocytosis appreciated with some mature neutrophils.  A CT scan of the head did not show acute infarction or hemorrhage.   Treatment for the event included, dexamethasone 40 mg intravenously daily for four days, intravenous immunoglobulin (IVIG) 1 mg/Kg for three days and was place on the Health Stroke Scale monitoring. Platelet count improved to 28000/uL within 3 days and oral lesions disappeared through some petechiae remained. The patient's contraception ring was not removed. The patient was discharged with outpatient hematology follow up.  Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the event(s) was not reported.  According to the abstract, the temporal sequence of the events suggests an exacerbation of the patient's chronic thrombocytopenia related to the receipt of the mRNA-1273 Covid-19 vaccine. The abstract also stated that it is possible based on reviews of reported side effects unlikely, that the patient's headache medications and contraception were triggers for this event.    Follow up: No follow up provided.; Reporter's Comments: Very limited information regarding the events has been provided at this time.
Sex: F
Vaccine: COVID19
Symptoms: Prothrombin level, Prothrombin time, Thrombocytopenia, White blood cell count increased
Clinical narrative: Thrombocytopenia (diffuse petechiae, easy bruising, bleeding gums); Polychromasia; Petechiae; Easy bruising; Mild headache; Anisocytosis; A spontaneous report was received from a literature article concerning a 36, year old, female patient who experienced thrombocytopenia, headache, polychromasia, anisocytosis, petechiae and easy bruising.    The patient's medical history included thrombocytopenia and allergy to acetaminophen. Products known to have been used by the patient, within one week prior to the event, included ibuprofen and sumatriptan. A vaginal ring containing etonogestrel-ethinyl estradiol,  was place one week prior to hospitalization    Approximately one week prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on unknown date, intramuscularly in the for prophylaxis of COVID-19 infection.    The patient presented to the hospital on unknown date with diffuse petechiae, easy bruising, bleeding gums and mild headache. Vital signs were within normal limits upon arrival at hospital. Physical exam was notable for diffuse petechiae of the extremities and trunk along with oral ecchymosis of 1-2 cm: no focal neurological deficits were observed, and no hepatic or splenic enlargement was noted. Blood work was significant for white blood count of 13.1 L/uL, hemoglobin 13.6 g/dL, heamatocrit of 42.1%, and platelet count of 3000/uL.  Prothrombin time and activated partial thromboplastin time were within normal limits. SARS-CoV2 swab was negative but the SARS-CoV2 IgG antibodies were reactive. Peripheral smear showed thrombocytopenia without clumping along with polychromasia and anisocytosis appreciated with some mature neutrophils.  A CT scan of the head did not show acute infarction or hemorrhage.   Treatment for the event included, dexamethasone 40 mg intravenously daily for four days, intravenous immunoglobulin (IVIG) 1 mg/Kg for three days and was place on the Health Stroke Scale monitoring. Platelet count improved to 28000/uL within 3 days and oral lesions disappeared through some petechiae remained. The patient's contraception ring was not removed. The patient was discharged with outpatient hematology follow up.  Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the event(s) was not reported.  According to the abstract, the temporal sequence of the events suggests an exacerbation of the patient's chronic thrombocytopenia related to the receipt of the mRNA-1273 Covid-19 vaccine. The abstract also stated that it is possible based on reviews of reported side effects unlikely, that the patient's headache medications and contraception were triggers for this event.    Follow up: No follow up provided.; Reporter's Comments: Very limited information regarding the events has been provided at this time.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Paranasal sinus discomfort, Pyrexia
Clinical narrative: Fever up to 100.9 F; Sinus pressure; Body aches; Tiredness; Pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration in the left arm on 27Jan2021 at 16:30 at the age of 43 years old at a single dose for COVID-19 Immunization at health clinic/ administration facility. The patient's medical history included mild asthma, CT contrast agent allergy from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) at the age of 43 years old on 07Jan2021 at 12:30 pm in the left arm for COVID-19 Immunization. The patient's concomitant medication included montelukast, albuterol (Salbutamol) and beclomethasone. The patient experienced fever up to 100.9 F, sinus pressure, body aches, tiredness, pain at injection site on 28Jan2021 at 6:00 AM. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fever up to 100.9 F; Sinus pressure; Body aches; Tiredness; Pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration in the left arm on 27Jan2021 at 16:30 at the age of 43 years old at a single dose for COVID-19 Immunization at health clinic/ administration facility. The patient's medical history included mild asthma, CT contrast agent allergy from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) at the age of 43 years old on 07Jan2021 at 12:30 pm in the left arm for COVID-19 Immunization. The patient's concomitant medication included montelukast, albuterol (Salbutamol) and beclomethasone. The patient experienced fever up to 100.9 F, sinus pressure, body aches, tiredness, pain at injection site on 28Jan2021 at 6:00 AM. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: early, heavy period; early, heavy period; This is a spontaneous report from a contactable other health care professional (patient). A 31-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EV0142, expiry date was not provided) via Intramuscular route, at Left arm, on 06Jan2021 17:30 as single dose for COVID-19 immunization, at hospital. Patient's medical history included congenital adrenal hyperplasia, late, light periods and COVID-19 (Prior to vaccination, patient was diagnosed with COVID-19). Concomitant medications included methylprednisolone, colecalciferol (VITAMIN D) and cetirizine hydrochloride (ZYRTEC); all these medications received within 2 weeks of vaccination. Patient had no Allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19. It was reported that, Prompted an early, heavy period on 11Jan2021. No none other stressors. Patient had history of late, light periods. This one came 2 weeks early and was significantly heavier than usual. Facility the most recent COVID-19 vaccine was administered to hospital. No treatment was received for these events. Seriousness of the events was reported as non-serious. Outcome of the events was recovered in Jan2021.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: site sore; tiredness; headache; chills; nausea; feeling unwell; dizziness; weakness; This is a spontaneous report from a contactable consumer (reporting for himself). A 73-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiration date: unknown), via an unspecified route of administration in his left arm from an unspecified date at single dose for covid-19 immunization. The patient's medical history included post-traumatic stress disorder (PTSD). Concomitant medications were not reported. The patient previously took codeine and sertraline and experienced allergy. On 22Jan2021 at 16:00, the patient experienced site sore, tiredness, headache, chills, nausea, generally feeling unwell, dizziness and weakness. The outcome of the events was recovered on an unspecified date. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Malaise, Nausea
Clinical narrative: site sore; tiredness; headache; chills; nausea; feeling unwell; dizziness; weakness; This is a spontaneous report from a contactable consumer (reporting for himself). A 73-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiration date: unknown), via an unspecified route of administration in his left arm from an unspecified date at single dose for covid-19 immunization. The patient's medical history included post-traumatic stress disorder (PTSD). Concomitant medications were not reported. The patient previously took codeine and sertraline and experienced allergy. On 22Jan2021 at 16:00, the patient experienced site sore, tiredness, headache, chills, nausea, generally feeling unwell, dizziness and weakness. The outcome of the events was recovered on an unspecified date. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities, Shoulder injury related to vaccine administration, Vaccination site movement impairment
Clinical narrative: severe shoulder pain; shoulder injury related to vaccine administration; limited range of motion; limitations with activity of daily living; This is a spontaneous report received from a contactable Pharmacist via Medical Information Team. A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot/Batch number: Unknown), on an unspecified date via an unspecified route of administration at single dose for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient had concern about shoulder injury related to vaccine administration. On an unknown date the patient had severe shoulder pain, limited range of motion, and limitations with activity of daily living. The outcome of the events was reported as unknown.  Information about lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vertigo
Clinical narrative: Woke up the following day (1/29/2021) with extreme vertigo. I have a history of vertigo, last episode 4 or 5 years ago. This episode lasted 5 hours; Exhaustion and slept for 4 hours; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EZ9264), via an unspecified route of administration on right arm on 28Jan2021 at 15:45 at the age of 69 year old at a single dose for COVID-19 immunisation at the hospital. Medical history included coronary artery disease, vertigo (I have a history of vertigo, last episode 4 or 5 years ago). Allergies to medications, food, or other products was dilantin, streptokinase. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Concomitant medications were not reported. The patient previously took dilantin, streptokinase and experienced allergies. It was reported that patient woke up the following day (29Jan2021, 09:00 AM) with extreme vertigo. This episode lasted 5 hours. Following that, about an hour after she arose, she had exhaustion and slept for 4 hours. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient recovered from the event vertigo aggravated on 29Jan2021 14:00 and recovered from exhaustion on an unspecified date in Jan2021.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Malaise
Clinical narrative: Headache; profound fatigue/tired; not feeling well; sick; This is a spontaneous report from a contactable consumer. A 72-Year-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID VACCINE, lot number unknown, expiration date unknown), via intramuscular on the left upper arm, on 21Jan2021 at 16:30 at the age of 72 years old at a single dose for COVID-19 immunisation at senior residence. The patient medical history was none. Concomitant medications were not reported. The patient previously took Shingrix for shingles vaccine (immunisation) and both times she took it she was in bed for 3 days and then she was fine. Patient was calling about the Pfizer BioNtech covid vaccine. Since she had the vaccine and this is the 8th day since she had it. On 21Jan2021, patient had a headache and profound fatigue, she was not feeling well since she got the vaccine. She was still sick on an unspecified date in 2021. Her headache started about 30 minute s after getting the vaccine. That same night she felt really tired and when she woke up she was really fatigued. The patient occasionally takes Advil as treatment. The patient did not visit emergency room and physician office. No additional vaccines administered on same date of the Pfizer suspect. The patient was not recovered from the event sick, while patient was recovering from all other events.  Information on lot/batch number has been requested.