chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pneumococal vaccine used in a less than 2 year child;   Information has been received from the authors in a published literature article, entitled as stated above, referring to a 12 month old, adopted, female patient with  family history not available.  At 4 months of age, she developed persistent wheezing poorly responsive to bronchodilators. At 6 and 9 months of age, she had two chest X-rayconfirmed pneumonias treated in the hospital with IV antibiotics and O2 supplementation.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) for prophylaxis.     At 12 months of age, the infant was enrolled in a study approved by the Hospital. Immunological evaluations revealed a combined immunodeficiency with normal absolute CD3+ T cell numbers, CD4+ Tcell lymphopenia (627 cells/µl) with a reduced proportion of naive T cells and T regulatory cells, increased frequency of memory CD4+,CD8+ cells, and CD45RA+CCR7- CD8+ Tcells (TEMRA). High-throughput sequencing of TCR Vß (TRB) repertoire in sorted CD4+ T cells, CD8+ T cells, and T regulatory cells in the patient demonstrated a polyclonal repertoire with reduced diversity and prominent clonotypic expansions, associated with a higher proportion of unique clonotypes containing cysteines at the apex of the CDR3, consistent with a T cell repertoire enriched for self-reactive specificities likely due to defective thymic selection.  Reduced numbers of switched and unswitched memory B cells, hypogammaglobulinemia (IgG 338 mg/dL), and impaired vaccination response to Haemophilus influenzae type B and Pneumococcus were also present.  A copy of the published article is attached as further documentation of the patient's experience.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Nausea, Vomiting
Clinical narrative: Asthenia; Nausea; Vomiting; A spontaneous report was received from a Pharmaceutical Company concerning a 90 Years-old male patient who received Moderna' s COVID-19 vaccine (mRNA-1273) and experienced nausea, vomiting, generalized weakness with a fatal outcome.  The patient's medical history is aortic aneurysm, aortic stenosis, coronary artery disease, hypertension, cardiac heart failure,  atrial fibrillation, HLD, ischemic heart failure, pacemaker, ventricular fibrillation, peripheral vascular shunt, palpitations, hypotension, and small bowel obstruction. No concomitant medications were provided.  On 06 FEB 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection.  On 11 FEB 2021, the patient experienced the events, nausea, vomiting, generalized weakness. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 12 FEB  2021. The cause of death was unknown.  Plans for an autopsy were unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Nausea
Clinical narrative: Nausea; Muscle soreness; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea, muscle soreness and fatigue. On an unknown date, the outcome of the nausea, muscle soreness and fatigue were unknown.   It was unknown if the reporter considered the nausea, muscle soreness and fatigue to be related to Shingrix.  Additional details provided as follow: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received shingrix and experienced nausea, muscle soreness and fatigue. The patient reported that there was no allergic reactions after vaccination. The reporter wanted to know if nausea can be a side effect of the vaccine. No further information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Immediate post-injection reaction
Clinical narrative: Felt a burning sensation during vaccine administration; Administered outside of the muscle, near to the shoulder joint,Patient concern that her / dose was given / into the skin rather than the muscle; This case was reported by a nurse via call center representative and described the occurrence of burning sensation in a female patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date 2nd February 2022) for prophylaxis.   On 12th February 2021, the patient received Shingrix. On 12th February 2021, immediately after receiving Shingrix, the patient experienced burning sensation and intramuscular formulation administered by other route. On an unknown date, the outcome of the burning sensation and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the burning sensation to be related to Shingrix.  Additional details was reported as follows: The patient believed that vaccine was administered outside the muscle, into the skin near shoulder joint, which led to Intramuscular formulation administered by other route. The patient felt a burning sensation during vaccine administration but no other side effects. The reporter did not consented to follow up. No further was provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021055000:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus
Clinical narrative: Itching in the arm of the injection site; Redness at the injection that spread to to her elbow/ big red ring; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site itching and erythema of extremities. On an unknown date, the outcome of the injection site itching and erythema of extremities were recovered/resolved.   The reporter considered the injection site itching and erythema of extremities 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 1st dose of Shingrix in left arm and experienced redness at injection site that spread to the elbow and she described it as big red ring and itching in the arm of injection site, which lasted for about 3 weeks. The reporter did not consent to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: fatigue; slight fever; had itching on her chest and face area; hives on her chest and face area; swelling at the injection site; pain at the injection site; had redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in left arm on 28th August 2020).   On 16th January 2021, the patient received the 2nd dose of Shingrix. On 16th January 2021, 1 hr after receiving Shingrix, the patient experienced itching and hives. On 17th January 2021, the patient experienced fatigue and fever. On an unknown date, the patient experienced injection site swelling, injection site pain and injection site erythema. The patient was treated with diphenhydramine hydrochloride (Benadryl). On 18th January 2021, the outcome of the fatigue and fever were recovered/resolved. On an unknown date, the outcome of the injection site swelling, injection site pain, injection site erythema, itching and hives were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, injection site erythema, itching, hives, fatigue and fever to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The patient received 2nd dose of Shingrix in her left arm and less than 2 months after receiving Shingrix, the patient had redness, pain and swelling at the injection site which lasted for a week and then resolved. The patient after about one hour of vaccination had itching and hives on her chest and face area, which resolved as soon as she took Benadryl. The patient had slight fever and fatigue the day after the 2nd dose of the Shingrix and was resolved the next day. The reporter consented to follow-up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Urticaria
Clinical narrative: fatigue; slight fever; had itching on her chest and face area; hives on her chest and face area; swelling at the injection site; pain at the injection site; had redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in left arm on 28th August 2020).   On 16th January 2021, the patient received the 2nd dose of Shingrix. On 16th January 2021, 1 hr after receiving Shingrix, the patient experienced itching and hives. On 17th January 2021, the patient experienced fatigue and fever. On an unknown date, the patient experienced injection site swelling, injection site pain and injection site erythema. The patient was treated with diphenhydramine hydrochloride (Benadryl). On 18th January 2021, the outcome of the fatigue and fever were recovered/resolved. On an unknown date, the outcome of the injection site swelling, injection site pain, injection site erythema, itching and hives were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, injection site erythema, itching, hives, fatigue and fever to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The patient received 2nd dose of Shingrix in her left arm and less than 2 months after receiving Shingrix, the patient had redness, pain and swelling at the injection site which lasted for a week and then resolved. The patient after about one hour of vaccination had itching and hives on her chest and face area, which resolved as soon as she took Benadryl. The patient had slight fever and fatigue the day after the 2nd dose of the Shingrix and was resolved the next day. The reporter consented to follow-up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on right rib cage; This case was reported by a consumer via call center representative and described the occurrence of rash in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th February 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th February 2021, 1 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. The patient had rash on right rib cage that lasted two weeks appearing the day after her 1st Shingrix shot about 1 month ago. It was not painful and there was no fever.  The reporter consent to follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Agitation, Back pain, Chills, Headache
Clinical narrative: Stomachache; Agitated; Shaking; Upper back pain; Neck pain; Chills; Achy muscles; Headache; Tachycardia; A spontaneous report was received from a consumer, concerning a 58 year-old female who developed tachycardia, chills, achy muscles, headache, neck pain, upper back pain, shaking, stomachache, and agitation. The patient's medical history and concomitant medication lists were not provided.  On 22Jan2021, the patient received her first dose of mRNA-1273 (batch number: 01362019) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 22Jan2021, post vaccination, the patient experienced chills, achy muscles, headache, neck and upper back pain. On 22Feb2021, the patient experienced tachycardia and shaking in the morning and subsequently the patient went to the emergency room (ER) and was later released. The patient underwent unspecified series of tests.   Treatment included administration of acetaminophen, lansoprazole, and diazepam.  The outcome of the events, tachycardia, chills, achy muscles, headache, neck pain, upper back pain, shaking, stomachache, and agitated were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Tachycardia, Tremor
Clinical narrative: Stomachache; Agitated; Shaking; Upper back pain; Neck pain; Chills; Achy muscles; Headache; Tachycardia; A spontaneous report was received from a consumer, concerning a 58 year-old female who developed tachycardia, chills, achy muscles, headache, neck pain, upper back pain, shaking, stomachache, and agitation. The patient's medical history and concomitant medication lists were not provided.  On 22Jan2021, the patient received her first dose of mRNA-1273 (batch number: 01362019) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 22Jan2021, post vaccination, the patient experienced chills, achy muscles, headache, neck and upper back pain. On 22Feb2021, the patient experienced tachycardia and shaking in the morning and subsequently the patient went to the emergency room (ER) and was later released. The patient underwent unspecified series of tests.   Treatment included administration of acetaminophen, lansoprazole, and diazepam.  The outcome of the events, tachycardia, chills, achy muscles, headache, neck pain, upper back pain, shaking, stomachache, and agitated were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Nephrolithiasis, Pneumonia
Clinical narrative: Possible pneumonia; Kidney stone; A spontaneous report was received from a consumer concerning a 81-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced kidney stone and possible pneumonia.  The patient's medical history included coronary artery disease, prostate cancer and skin disease - itching and eczema. No relevant concomitant medications were reported.  On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date, the patient developed kidney stone and was hospitalized on 19 Feb 2021. Patient's status of kidney stone was unknown. On an unspecified date, the patient experienced pneumonia. Second vaccine date was outside dosing interval.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events kidney stone and pneumonia was not reported.  The outcome of the events kidney stone and pneumonia was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Cerebrovascular accident, Memory impairment
Clinical narrative: Stroke; recall/memory problems; could no longer speak; A spontaneous report was received from consumer (patient's husband) for a 90-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke and could no longer speak, stroke and recall/memory problems  The patient's medical history was not provided. Concomitant product use included enalapril maleate, hydrochlorothiazide, furosemide, potassium chloride extended release, clopidogrel and apixaban.  On 04-Feb- 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 020M20A) intramuscularly on left non dominant deltoid for prophylaxis of COVID-19 infection. After receiving the vaccine on an unspecified date in 2021 in the middle of the night, the patient woke up and could no longer speak. The patient was taken to the hospital and had a stroke. The patient was admitted for 2 days and 2 nights. The patient was not able to recall and have memory problems at the time of this report.  Treatment information was not provided.  Action taken with mRNA-1273 was unknown.  The outcome of the events, could no longer speak and stroke were  unknown and outcome for recall/memory problems was not recovered.; Reporter's Comments: Although a temporal association exist, based on the lack of critical details such as the patient's medical history and other relevnt information for accurate assessment is lacking.  Concomitant medications is suggestive of underlying cardiac disease.  Additional information have been requested.
Sex: U
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Thrombocytopenia
Clinical narrative: Thrombocytopenia; Vaccinators are vaccinating very high up on the shoulder; A spontaneous report was received from a nurse concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Vaccinators are vaccinating very high up on the shoulder, thrombocytopenia.  The patient's medical history, was not provided by the reporter.No Concomitant medications were  reported.  On an unknown date, the patient received their planned dose of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   The reporter stated that Vaccinators are vaccinating very high up on the shoulder. They need to go down on the deltoid. She also reported the event of thrombocytopenia of which one involved a doctor who died.  Action taken with mRNA-1273 in response to the events was not applicable.   The  outcome of the event, vaccinators are vaccinating very high up on the shoulder was resolved . The outcome of the events thrombocytopenia is fatal.; Reporter's Comments: This report refers to a patient who experienced non-serious of vaccinating very high up on the shoulder, (Vaccine administered at inappropriate site). There were no reported AEs associated with this case of vaccine administered at inappropriate site.; Reported Cause(s) of Death: Thrombocytopenia
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage, Pain, Sleep disorder
Clinical narrative: broken blood vessel in the right eye; not getting sleep; Achy; A spontaneous report ) was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was achy, not getting sleep and broken blood vessel in her right eye.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 02 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 036A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 2 Mar 2021, the patient was achy and was not getting sleep. On 05 Mar 2021, she had a broken blood vessel in her right eye. She stated that she was better but her right eye was still red. No treatment information was provided.  Action taken with mRNA-1273 in response to the events achy, not getting sleep and broken blood vessel in her right eye was unknown.  The seriousness criterion for the event broken blood vessel in her right eye was medically significant.  The outcome of the event, broken blood vessel in the right eye was not resolved, while the outcome of the events not getting sleep and achy was resolving.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: one side of his face was paralyzed/ had bell's palsy; A spontaneous report was received from a consumer concerning an 85-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and one side of his face was paralyzed (Bell's palsy).   The patient's medical history as not reported. Concomitant use was not reported.   On 08-Feb-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On 11-Feb -2021, three days after receiving vaccine, one side of his face was paralyzed. They called the nurse line and was unsure if he was having a stroke. They were instructed that he needed to go the emergency room and to call 911. After several hours in emergency department, the healthcare professionals said he had Bell's Palsy. He was given antiviral medication, prednisone, and eye drops as a treatment.   Action taken with mrna-1273 in response to the event was not reported.    The outcome of event was not reported.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, and excluding any other etiology, a causal relationship with the event cannot be excluded.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination
Clinical narrative: Started having hallucination; A spontaneous report was received from a consumer concerning a 94-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  Medical history included unknown pre existing medical condition. Concomitant medications were not provided.  On 05 Feb 2021, approximately nine days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 28 Feb 2021, 2 weeks after first  vaccination dose (on 14 Feb 2021) the patient had hallucination and was hospitalized, she had history of recent hospitalization on 26 Jan 2021 prior to vaccine administration but the details were unknown. The reporter was also concerned about her mother receiving the second dose of vaccine. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, hallucination was not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Eyelid sensory disorder, Hypoaesthesia, Tachycardia
Clinical narrative: Bells palsy effect; Rapid heartbeat; Numb nose, nasal cavity, cheeks; Numb eyelids; A spontaneous report was received from a consumer, concerning a 65 year-old, female who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a rapid heartbeat/tachycardia, her nose, nasal cavity, cheeks and eyelids were numb/hypoaesthesia, Bell's palsy effect/facial paralysis.  The patient's medical history included were overweight and pre diabetic. The patient was allergic to latex and was dairy sensitive was not provided. Concomitant product included was vitamins.  On 16 Feb2021, few minutes prior to the onset of symptoms, the patient received her first of two planned doses of mRNA-1273 (batch number: 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient, while she was staying for 15 minutes in the facility, she felt a rapid heartbeat. It was not alarming, but it was faster than normal. Five minutes after leaving the facility, which was 20 minutes after she received the vaccine, her nose, nasal cavity, cheeks and eyelids were numb. This numbness stayed for two hours and the disappeared. The numb sensation on the nose stayed for 3 whole days after the vaccine was administered. The patient consulted the primary doctor, who stated that it was a Bells Palsy effect. Treatment information was not provided.  The outcome of the events of rapid heartbeat, nose, nasal cavity, cheeks and eyelids were numb were considered recovered and the outcome for Bells palsy effect was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Emotional distress, Sleep talking, Somnambulism, Stent placement
Clinical narrative: walking and talking in my sleep; walking and talking in my sleep; mental things, something would run through my mind that happened years ago; two stents put in her arteries; blood pressure went up to 200-something; A spontaneous report was received from a consumer concerning a 77-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood pressure went up to 200-something/blood pressure increased, walking and talking in her sleep/somnambulism/sleep talking, two stents put in her arteries/stent placement, mental things, something would run through my mind that happened years ago/emotional distress.  The patient's medical history included hasimoto's. No concomitant product use was reported.  On 04-FEB-2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 06-FEB-2021, post vaccination, the patient's blood pressure increased up to 200 and taken to emergency room and hospitalized. During her hospitalization, the patient reported on either the second or third night, she experienced walking and talking in her sleep with no memory. Per the patient, she had never done this before. On the third day of her hospitalization, she reported she had two stents placed in unspecified arteries and that evening had bad anesthetic and sleep walking. Thoughts of things that happened years prior would run through her mind, this happened twice. The patient stated she was prescribed clopidogrel 75 milligrams and acetylsalicyclic acid/dipyridamole 25-200 micrograms.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, blood pressure went up to 200-something/blood pressure increased, walking and talking in her sleep/somnambulism/sleep talking, two stents put in her arteries/stent placement, mental things, something would run through my mind that happened years ago/emotional distress, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Somnolence
Clinical narrative: Chills; fever; soreness; sleepy; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date unknown), via an unspecified route of administration in the left arm, on 28Jan2021 08:00, as single dose, for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medication included vitamins. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient experienced chills, fever, soreness, and was sleepy on 28Jan2021 (reported as 03:30 AM, pending clarification). No treatment was given for the events. The outcome of the events was not resolved. The reporter assessed the events as non-serious.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles on her eye and forehead, it has persisted and is painful; This is a spontaneous report from a contactable consumer (patient). A 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL0140, Expiration Date: 31Mar2021) via an unspecified route of administration, administered in right arm on 13Jan2021 11:10 am at 0.3 ml (SINGLE DOSE) for covid-19 immunisation. Medical history included shingles (Family history) as sister had shingles 10 years ago, grandson on back a couple years ago. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was provided as N/A. Additional Administered Vaccines was administered on same date with the vaccine considered as suspect was none. Vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none. AE(s) following prior vaccinations was none. There were no concomitant medications. The patient experienced shingles on her eye and forehead, it has persisted and is painful (herpes zoster) (non-serious) on 21Jan2021. Caller mentioned that she received the 1st shot on 13Jan2021 and developed Shingles 10 days after (date mentioned was 21Jan2021). She is scheduled to take the 2nd dose on 03Feb2021 and is asking if she should hold off for a week or so for her 2nd shot because of the shingles being still there. If so, she is also asking whether she should she restart the vaccine if she goes over the 21 days. Caller is a consumer, states she had her first Covid vaccine on 13Jan2021, states ten days later developed shingles on her eye and forehead. States she is supposed to take second shot on 03Feb2021, next Wednesday, caller states she is concerned if she does not take it, wants to know if can she put it off for a week or two and if she needs to will she have to restart with the first dose again. Caller asks if there is any kind of special diet along with the shingles that we know of. Caller states she actually developed the shingles on 21Jan2021, states it has persisted and is painful, states she is treating the shingles with an antiviral medication. Caller states the ophthalmologist says she has no blisters on eye or anything. Vaccination Facility Type included Other. Vaccine was not Administered at Facility. The outcome of event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Drug ineffective
Clinical narrative: Resident tested herself for antibodies and the test came back negative.; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EJ1686) via an unspecified route of administration on an unspecified date at single dose (dose number 1) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EJ1686) via an unspecified route of administration on an unspecified date at single dose (dose number 2) for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller stated a resident at the hospital has had both doses of the pfizer covid 19 vaccine. Resident tested herself for antibodies and the test came back negative. Resident used the (name) home test kit. Caller wanted to know if the batch should be recalled. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative, SARS-CoV-2 test
Clinical narrative: undergone second COVID-19 PCR nasal swab test and tested positive; undergone second COVID-19 PCR nasal swab test and tested positive; COVID-19 virus antibody test negative; This is a spontaneous report from by a contactable consumer (patient). A 24-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the left arm on 16Jan2021, (age at vaccination: 24-year-old) as a single dose for COVID-19 immunisation. The patient medical history including any illness at time of vaccination was none. The concomitant medication was not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was none. It was reported that the patient undergone laboratory test COVID-19 PCR nasal swab test was negative on 21Jan2021, COVID-19 virus antibody test was negative on 27Jan2021, She said she had undergone second COVID-19 PCR nasal swab test and tested positive on 29Jan2021. She said her state's health department was unsure if she would be able to get the second COVID-19 vaccine dose, and her doctor was unsure if she should get the second COVID-19 Vaccine dose. The caller asked once she was done with her quarantine period, is it ok for her to get the second COVID-19 vaccine dose. The patient received Zicam (Z101124, Expiration Date: Nov2022) as a therapeutic measure for the event undergone second COVID-19 PCR nasal swab test and tested positive. Additional vaccines administered on same date of the Pfizer suspect was none. The patient didn't receive any vaccine within 4 weeks prior vaccination. The patient didn't visit emergency room and physician office. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: Patient also reports having a sore arm after receiving the vaccine; This is a spontaneous report from a contactable physician. A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had both doses of the Pfizer covid vaccine. 19 days since second dose. Had blood drawn yesterday and came back negative- Quest Sars Cov 2 serology IGG antibody test with NEG result with no numerical result. Then took finger stick rapid IGm and IGG test that was negative for both as well. The patient experienced patient also reports having a sore arm after receiving the vaccine on an unspecified date. The Outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Has Shingles; This is a spontaneous report from Pfizer sponsored program received from a contactable female consumer(patient).A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unspecified route of administration on an unknown date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date the patient stated has shingles and scheduled for 1st dose tomorrow (Precautionary AE) (As reported). The outcome of the event was unknown.  Information about batch/lot number has been requested
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular, Urinary incontinence
Clinical narrative: LOSS OFBLADDER CONTROL; IRREGULAR HEARTBEAT; This is a spontaneous report from a contactable 56-year-old female healthcare professional reported for herself that she received bnt162b2 (BNT162B2, Solution for injection), dose 1 intramuscula, administered in Arm Right on 07Jan2021 (Batch/Lot Number: EJ 1686) as SINGLE DOSE for covid-19 immunisation. Medical history was not reported. The patient's concomitant medications were not reported. The patient experienced loss of bladder control and irregular heartbeat on Jan2021 with outcome of not recovered. The patient underwent lab tests and procedures which included heart rate: irregular on 2021.  The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was reported as not recovered.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain
Clinical narrative: Burning pain in left buttocks area, researched and thought it was a sciatica issue/Could not lay down, bend over or put weight on that leg/Pain lasted over 48 hours; Burning pain in left buttocks area, researched and thought it was a sciatica issue/Could not lay down, bend over or put weight on that leg/Pain lasted over 48 hours; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot number: El3247), via an unspecified route of administration, administered in Gluteus Medius Right on 31Jan2021 as single dose for an unspecified indication. Medical history included AFib, sleep apnoea, high cholesterol and drug allergy to Sulfa. Concomitant medications included apixaban (ELIQUIS), diltiazem (trade name not reported), atorvastatin (trade name not reported), paracetamol (TYLENOL) and melatonin (trade name not reported). The patient previously took atropine and experienced drug hypersensitivity. The patient experienced burning pain in left buttocks area, researched and thought it was a sciatica issue. Could not lay down, bend over or put weight on that leg. Used alternately ice and heat. No fever. Pain lasted over 48 hours on 31Jan2021 16:00. The outcome of the event was recovering.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Blood pressure measurement, Blood test, Chest discomfort, Chills
Clinical narrative: heart started pounding out of chest; blood pressure was high; Cough; ended up in ER with tachycardia; Anemic; lightheaded, foggy, kind of disconnected; lightheaded, foggy, kind of disconnected; chest got tight; hard time of breathing; chills and body aches; chills and body aches; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL8982), via an unspecified route of administration on Left arm on 21Jan2021 at single dose for covid-19 immunisation. Medical history was not reported. The patient's concomitant medications were not reported. It was reported that she was sick in October, she was exposed to COVID, but tested negative, she got sick. She got the vaccine on 21Jan2021, she started having about 4 hours after, chills and body aches, which is normal, then her heart started pounding out of chest, her chest got tight and she had a hard time of breathing. It lasted a couple minutes, the pounding of her heart, but it slowed down, it was fast but not as bad, and she took some Benadryl and after a half hour things settled down, her breathing went back to normal. She contacted her doctor who said to let him know if it happened again, and the next day (22Jan2021) she was kind of out of it, lightheaded, foggy, kind of disconnected, almost like a hangover feeling, just yucky and ran down, Saturday she was feeling a little better, then had 2 more episodes of heart pounding and continued shortness of breath. She ended up in the ER with tachycardia on23Jan2021. She is still having problems. In ER, they found out she was anemic on 23Jan2021.On 23Jan2021 they did bloodwork that day, she had an X-ray and EKG. EKG showed fast rate, normal rhythm, appeared to be no damage to heart. Her blood pressure was high and X-ray of lungs was clear, she had another X-ray this morning, since she developed a cough on 30Jan2021, a barky cough, is coughing up phlegm, Cough started on Saturday, this past Saturday, and is ongoing and worsening, it turned into a cough with a whistle into a barky cough, they are thinking it is connected to asthma response. She is supposed to have pulmonary function tests on the 19th and on the 15th, and endoscope and colonoscope due to anemia to ensure no bleed anywhere. They did another X-ray (on 04Feb2021) this morning and it was clear. They only thing they found is she is anemic, and her doctor is wondering if it is underlying asthma or long haul COVID or a combination of anemia and the shot kicked up stuff. It was reported that she had some asthma like symptoms, which were fully resolving, but kicked back up again since the shot. The events were considered as non-serious. The outcome of the event was chills and body aches was recovered, outcome of the event cough was not recovered and outcome of other events was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Dyspnoea, Electrocardiogram, Feeling abnormal
Clinical narrative: heart started pounding out of chest; blood pressure was high; Cough; ended up in ER with tachycardia; Anemic; lightheaded, foggy, kind of disconnected; lightheaded, foggy, kind of disconnected; chest got tight; hard time of breathing; chills and body aches; chills and body aches; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL8982), via an unspecified route of administration on Left arm on 21Jan2021 at single dose for covid-19 immunisation. Medical history was not reported. The patient's concomitant medications were not reported. It was reported that she was sick in October, she was exposed to COVID, but tested negative, she got sick. She got the vaccine on 21Jan2021, she started having about 4 hours after, chills and body aches, which is normal, then her heart started pounding out of chest, her chest got tight and she had a hard time of breathing. It lasted a couple minutes, the pounding of her heart, but it slowed down, it was fast but not as bad, and she took some Benadryl and after a half hour things settled down, her breathing went back to normal. She contacted her doctor who said to let him know if it happened again, and the next day (22Jan2021) she was kind of out of it, lightheaded, foggy, kind of disconnected, almost like a hangover feeling, just yucky and ran down, Saturday she was feeling a little better, then had 2 more episodes of heart pounding and continued shortness of breath. She ended up in the ER with tachycardia on23Jan2021. She is still having problems. In ER, they found out she was anemic on 23Jan2021.On 23Jan2021 they did bloodwork that day, she had an X-ray and EKG. EKG showed fast rate, normal rhythm, appeared to be no damage to heart. Her blood pressure was high and X-ray of lungs was clear, she had another X-ray this morning, since she developed a cough on 30Jan2021, a barky cough, is coughing up phlegm, Cough started on Saturday, this past Saturday, and is ongoing and worsening, it turned into a cough with a whistle into a barky cough, they are thinking it is connected to asthma response. She is supposed to have pulmonary function tests on the 19th and on the 15th, and endoscope and colonoscope due to anemia to ensure no bleed anywhere. They did another X-ray (on 04Feb2021) this morning and it was clear. They only thing they found is she is anemic, and her doctor is wondering if it is underlying asthma or long haul COVID or a combination of anemia and the shot kicked up stuff. It was reported that she had some asthma like symptoms, which were fully resolving, but kicked back up again since the shot. The events were considered as non-serious. The outcome of the event was chills and body aches was recovered, outcome of the event cough was not recovered and outcome of other events was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hypertension, Pain, SARS-CoV-2 test
Clinical narrative: heart started pounding out of chest; blood pressure was high; Cough; ended up in ER with tachycardia; Anemic; lightheaded, foggy, kind of disconnected; lightheaded, foggy, kind of disconnected; chest got tight; hard time of breathing; chills and body aches; chills and body aches; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL8982), via an unspecified route of administration on Left arm on 21Jan2021 at single dose for covid-19 immunisation. Medical history was not reported. The patient's concomitant medications were not reported. It was reported that she was sick in October, she was exposed to COVID, but tested negative, she got sick. She got the vaccine on 21Jan2021, she started having about 4 hours after, chills and body aches, which is normal, then her heart started pounding out of chest, her chest got tight and she had a hard time of breathing. It lasted a couple minutes, the pounding of her heart, but it slowed down, it was fast but not as bad, and she took some Benadryl and after a half hour things settled down, her breathing went back to normal. She contacted her doctor who said to let him know if it happened again, and the next day (22Jan2021) she was kind of out of it, lightheaded, foggy, kind of disconnected, almost like a hangover feeling, just yucky and ran down, Saturday she was feeling a little better, then had 2 more episodes of heart pounding and continued shortness of breath. She ended up in the ER with tachycardia on23Jan2021. She is still having problems. In ER, they found out she was anemic on 23Jan2021.On 23Jan2021 they did bloodwork that day, she had an X-ray and EKG. EKG showed fast rate, normal rhythm, appeared to be no damage to heart. Her blood pressure was high and X-ray of lungs was clear, she had another X-ray this morning, since she developed a cough on 30Jan2021, a barky cough, is coughing up phlegm, Cough started on Saturday, this past Saturday, and is ongoing and worsening, it turned into a cough with a whistle into a barky cough, they are thinking it is connected to asthma response. She is supposed to have pulmonary function tests on the 19th and on the 15th, and endoscope and colonoscope due to anemia to ensure no bleed anywhere. They did another X-ray (on 04Feb2021) this morning and it was clear. They only thing they found is she is anemic, and her doctor is wondering if it is underlying asthma or long haul COVID or a combination of anemia and the shot kicked up stuff. It was reported that she had some asthma like symptoms, which were fully resolving, but kicked back up again since the shot. The events were considered as non-serious. The outcome of the event was chills and body aches was recovered, outcome of the event cough was not recovered and outcome of other events was unknown.