chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Pain, Pityriasis rosea
Clinical narrative: soreness / achiness; lethargy; This case was reported by a consumer and described the occurrence of pain in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pityriasis rosea (1st dose received on 2nd September 2020 Intramuscularly in left arm, batch number T7S73, expiry date 30th June 2021, refer case US2020215496.).   On 10th December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain and lethargy. On an unknown date, the outcome of the pain and lethargy were unknown.   It was unknown if the reporter considered the pain and lethargy to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in left arm. After receiving 2nd dose of Shingrix, the patient experienced soreness, lethargy and achiness. The reporter consent to follow up. This is 1 of the 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020248584:same reporter US-GLAXOSMITHKLINE-US2020AMR249123:same reporter US-GLAXOSMITHKLINE-US2020215496:same patient (2nd dose)
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: body aches; nausea; This case was reported by a other health professional and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 17th December 2020, less than a day after receiving Shingrix, the patient experienced general body pain and nausea. On 19th December 2020, the outcome of the general body pain and nausea were recovered/resolved.   It was unknown if the reporter considered the general body pain and nausea to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. On 17th December 2020, the patient received 2nd dose of Shingrix on left arm. The patient experienced nausea and body aches which lasted for about 2 days. The patient did not have lot number or expiration date. The reporter consented to follow up.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration
Clinical narrative: Discoloration of skin at the injection site; This case was reported by a pharmacist and described the occurrence of injection site discoloration in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number ZR979, expiry date 28th March 2022) for prophylaxis.   On 30th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site discoloration. On an unknown date, the outcome of the injection site discoloration was not recovered/not resolved.   It was unknown if the reporter considered the injection site discoloration to be related to Shingrix.  Additional information was provided as follows: The patient received 1st dose of Shingrix and experienced discoloration of skin at the injection site. The patient wasn't sure when the discoloration started. The reporter wanted to know if it was ok to give the 2nd dose to the patient. The reporter did not consent to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Pyrexia, Vaccination site induration, Vaccination site warmth
Clinical narrative: Not injected in the deltoid muscle/ injected subcutaneously; Giant hard spot 3-4 inches; It is also hot; Fever; A spontaneous report  was received on 03 FEB 2021 from a nurse (50-year-old female), who was administered 2nd dose of Moderna's COVID-19 vaccine was not injected in the deltoid muscle but was injected subcutaneously. She had giant hard spot 3-4 inches, it is also hot, and had fever.  The patient's medical history includes high blood pressure and allergies to penicillin, codeine and raw shellfish. No relevant concomitant medications were reported.  On 02-FEB-2021, the patient received her 2nd dose of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection on left arm. She stated that, it was not given intramuscularly, but given subcutaneously (inappropriate route of vaccination). She had a giant hard spot 3-4 inches and it was hot. She also had fever. The treatment she took was Tylenol and ice.  Action taken with mRNA-1273 was not applicable as the patient received two doses of vaccine already.  The event, vaccine was not injected in the deltoid muscle but was injected subcutaneously was considered resolved on 02-FEB-2021 and outcome of the events giant hard spot 3-4 inches, hot spot, and fever were not provided at the time of report.; Reporter's Comments: This case concerns a 50-year-old female patient with medical history of allergies to penicillin, codeine and raw shellfish, who reported Incorrect route of product administration and experienced non-serious events of Vaccination site induration, Vaccination site warmth, and Pyrexia. The events occurred on the same date after 2nd dose of two planned doses of mRNA-1273, lot # unknown. Treatment details included Tylenol and ice. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Incomplete dose of a vaccine because some dropped down his arm; A spontaneous report was received on 03 FEB 2021 from a healthcare professional concerning a patient, unknown age, unknown gender, who was administered Moderna's COVID-19 vaccine (mRNA-1273) incomplete dose because some dropped down on arm.   The patient's medical history was not provided.  No relevant concomitant medications were reported.  On an unknown date, patient received their first of two planned doses of mRNA-1273(Lot number: unknown) intramuscularly for the prophylaxis of COVID-19 infection.  On an unknown date, patient received incomplete dose  of the vaccine because some dropped down on arm,   Action taken with the events was not reported.  The event, Moderna's COVID-19 vaccine incomplete dose administered because some dropped down on arm, was considered resolved.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of Incorrect dose administered.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient had two dose of the vaccine 15 days apart; A spontaneous report  was received from a pharmacist concerning a 39-year-old, female patient who received two doses of the Moderna's mRNA-1273 vaccine 15 days apart.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     The patient received two doses of mRNA-1273 (1st Batch number:011J20A) on 21 Jan 2021 intramuscularly in the left arm and (2nd Batch number: 028L20A) on 02 Feb 2021 intramuscularly in the right arm for prophylaxis of COVID-19 infection.    It was reported that patient received two doses of the mRN-1273 vaccine 15 days apart. No symptoms reported yet. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.   The event, "patient received two doses of the mRN-1273 vaccine 15 days apart" was considered resolved on 02 Feb 2021.; Reporter's Comments: This case concerns a 39 year old female patient who received two doses of mRNA-1273 (1st Batch number:011J20A) on 21 Jan 2021 intramuscularly in the left arm and (2nd Batch number: 028L20A) on 02 Feb 2021 intramuscularly in the right arm for prophylaxis of COVID-19 infection 15 days apart. There were no reported adverse events after the vaccines were administered in this case of inappropriate schedule of product administration
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old received the 1st dose of the Moderna COVID-19 vaccine; A spontaneous report was received from a healthcare professional, concerning a 16-years-old patient of unknown gender, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown), intramuscularly for the prophylaxis of COVID-19 infection.  On an unknown date, a 16 years old patient who received the first dose of Moderna COVID-19 vaccine and now present for the second dose. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event "COVID-19 vaccine given to a 16-year-old patient", was considered as resolved on an unknown date.; Reporter's Comments: This case concerns a 16-year old of unknown age who received her first of two planned doses of mRNA-1273 (Bach/Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of product administered to patient of inappropriate age.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first and second doses 8 days apart; A spontaneous report  was received from a health care professional concerning a 42-year-old male patient who receive his first dose of Moderna Covid-19 on 27jan2021. He had an appointment for another clinic and was mistakenly given his second Moderna Covid-19 vaccination, 8 days from the first dose.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     The patient received his first of two planned doses of mRNA-1273 (batch number:unknown) on 27Jan 2021. The soldier had an appointment for another clinic and was mistakenly given his second Moderna Covid-19 vaccination, 8 days from the first dose. On 03 Feb 2021 the patient received his second of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not reported.  The event "first and second doses 8 days apart" was considered as resolved on 03 Feb 2021.; Reporter's Comments: This case concerns a 42 year old male patient who received his two doses of Moderna Covid-19 vaccinations 8 days apart. There were no reported adverse events after the vaccines were administered in this case of inappropriate schedule of product administration
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: was not fully vaccinated this morning; A spontaneous report was received from a consumer concerning a male patient, of unknown age, who was administered Moderna's COVID-19 vaccine, but he was not fully vaccinated.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03 Feb2021, prior to the onset of the event, the patient received his first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of Covid-19 infection.  The patient reported that he was not fully vaccinated. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The event "not fully vaccinated", was considered as resolved on 03 Feb 2021.; Reporter's Comments: This case concerns a male patient of unknown age who received his first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of Covid-19 infection and reported that he was not fully vaccinated. There were no reported events in this case of incorrect dose administered
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered
Clinical narrative: Patient got half of a dose; liquid came out between needle and syringe; A spontaneous report was received from a nurse concerning a patient of unknown age, gender, race and ethnicity who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced "patient got half of a dose" and "liquid came out between needle and syringe". The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. On an unknown date, patient received half of a dose of the mRNA vaccine because liquid came out between needle and syringe. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not reported. The event, "patient got half of a dose" and "liquid came out between needle and syringe" was considered resolved on an unknown date.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered and Device connection issue.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Chills, Cluster headache, Headache, Nausea
Clinical narrative: Debilitating headache; body ache; vomiting; nausea; chills; This is a spontaneous report from a contactable consumer (patient) and the consumer's spouse. A 38-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EZ3246) via an unspecified route of administration on 20Jan2021 (at the age of 38-years-old) as a single dose for COVID-19 vaccination. Medical history was reported as "no" and concomitant medications ("other products") were reported as "no". The patient experienced "debilitating headache", "body ache", "vomiting", "nausea" and "chills", all on unspecified dates. It was reported that the patient went to the emergency room for the adverse events and was hospitalized on 26Jan2021 for the events "debilitating headache", "body ache" and "vomiting". The consumer called to report "a debilitating headache afterward (after the first dose of the vaccine) that persisted for 3 days and was still present, but diminished, for a total of 3.5 days. He also reported nausea, vomiting, chills, body ache, no fever.  He went to the ER (emergency room) and was treated with fluids and other meds." The patient wanted to know whether the symptoms would be worse with the second shot and if they were more commonly reported after the second shot? The patient's spouse also called and reported that her husband "received the COVID Pfizer Vaccination (COVID-19 Vaccine) last Wednesday and had a really bad experience with that afterwards." She stated that he received the vaccine at a hospital. When asked about the start date of the adverse reaction the reporter stated "Saturday 23rd." When clarification was requested regarding the adverse reaction, the reporter stated, "He had an extremely bad reaction to it. His head was hurting so bad that it was more than a migraine and he was vomiting, body ache but way worse than anyone that he has ever talked to, that has had it. He had to go to the hospital for it, it was bad." The reporter stated that the date of hospitalization was "yesterday 26Jan2021." The reason for hospitalization was not confirmed further. When asked about the outcome of the events the reporter stated, "A little bit better but not much". The reporter wanted to know whether "this was a common thing, are you seeing this happening?" The clinical outcome of the events "debilitating headache", "body ache", "vomiting", "nausea" and "chills" were all not recovered/not resolved.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: Debilitating headache; body ache; vomiting; nausea; chills; This is a spontaneous report from a contactable consumer (patient) and the consumer's spouse. A 38-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EZ3246) via an unspecified route of administration on 20Jan2021 (at the age of 38-years-old) as a single dose for COVID-19 vaccination. Medical history was reported as "no" and concomitant medications ("other products") were reported as "no". The patient experienced "debilitating headache", "body ache", "vomiting", "nausea" and "chills", all on unspecified dates. It was reported that the patient went to the emergency room for the adverse events and was hospitalized on 26Jan2021 for the events "debilitating headache", "body ache" and "vomiting". The consumer called to report "a debilitating headache afterward (after the first dose of the vaccine) that persisted for 3 days and was still present, but diminished, for a total of 3.5 days. He also reported nausea, vomiting, chills, body ache, no fever.  He went to the ER (emergency room) and was treated with fluids and other meds." The patient wanted to know whether the symptoms would be worse with the second shot and if they were more commonly reported after the second shot? The patient's spouse also called and reported that her husband "received the COVID Pfizer Vaccination (COVID-19 Vaccine) last Wednesday and had a really bad experience with that afterwards." She stated that he received the vaccine at a hospital. When asked about the start date of the adverse reaction the reporter stated "Saturday 23rd." When clarification was requested regarding the adverse reaction, the reporter stated, "He had an extremely bad reaction to it. His head was hurting so bad that it was more than a migraine and he was vomiting, body ache but way worse than anyone that he has ever talked to, that has had it. He had to go to the hospital for it, it was bad." The reporter stated that the date of hospitalization was "yesterday 26Jan2021." The reason for hospitalization was not confirmed further. When asked about the outcome of the events the reporter stated, "A little bit better but not much". The reporter wanted to know whether "this was a common thing, are you seeing this happening?" The clinical outcome of the events "debilitating headache", "body ache", "vomiting", "nausea" and "chills" were all not recovered/not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abdomen abnormal, Condition aggravated, Imaging procedure abnormal, Splenomegaly
Clinical narrative: Spleen enlarged (worsening splenomegaly); Spleen enlarged (worsening splenomegaly); This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. Medical history included ongoing Hodgkin's Lymphoma, ongoing splenomegaly (at baseline). Concomitant medications were not reported. The patient experienced spleen enlarged (worsening splenomegaly) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included imaging procedure: increased significantly in size on unknown date. Her oncologist was not overly convinced that her splenomegaly was related to her Hodgkin's Lymphoma, though was going to send her for splenectomy (not jet scheduled). The case was reported as non-serious.  The information on the lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blister, Eye swelling, Induration, Injected limb mobility decreased
Clinical narrative: anxiety attack; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; in the evening arm swelled/swelling went down to size of pin hole; there was a welt at the vaccination site / there was still a little knot on arm; fever; night sweats; body rash/ rash beneath eyes; blister sores; swelling of eyes; arm was painful and is still; This is a spontaneous report from a contactable consumer. A 29-years-old female patient, a registered nurse, received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number BK9231, in Hospital, via an unspecified route of administration in left arm on 04Jan2021 at 14:00 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of the vaccination. Concomitant medications included ibuprofen and cetirizine hydrochloride (ZYRTEC). The patient reported that 2 mins after the shot, her left arm felt heavy and was hard to move and, on 04Jan2021 at 14:15 she had tingling/dead feeling; in the evening arm swelled and there was a welt at the vaccination site. On an unknown date in Jan2021 she had fever at 102 °F for 48 hours and swelling went down to size of pin hole; her arm was painful and was still sore, there was still a little knot on arm. On 07Jan2021 she experienced an anxiety attack; 20 days after, in Jan2021 the patient experienced night sweats. She also experienced body rash and little blister sores on her body and both arms, swelling of eyes and rash beneath eyes. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was administered to the patients for the events. On 25Jan2021 the patient underwent COVID-19 test via Nasal Swab which showed negative results. The event "Fever" resolved after 48 hours, whereas the outcome of all the reported events was unknown at time of the report.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Limb discomfort, Mobility decreased, Night sweats, Pain in extremity
Clinical narrative: anxiety attack; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; in the evening arm swelled/swelling went down to size of pin hole; there was a welt at the vaccination site / there was still a little knot on arm; fever; night sweats; body rash/ rash beneath eyes; blister sores; swelling of eyes; arm was painful and is still; This is a spontaneous report from a contactable consumer. A 29-years-old female patient, a registered nurse, received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number BK9231, in Hospital, via an unspecified route of administration in left arm on 04Jan2021 at 14:00 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of the vaccination. Concomitant medications included ibuprofen and cetirizine hydrochloride (ZYRTEC). The patient reported that 2 mins after the shot, her left arm felt heavy and was hard to move and, on 04Jan2021 at 14:15 she had tingling/dead feeling; in the evening arm swelled and there was a welt at the vaccination site. On an unknown date in Jan2021 she had fever at 102 °F for 48 hours and swelling went down to size of pin hole; her arm was painful and was still sore, there was still a little knot on arm. On 07Jan2021 she experienced an anxiety attack; 20 days after, in Jan2021 the patient experienced night sweats. She also experienced body rash and little blister sores on her body and both arms, swelling of eyes and rash beneath eyes. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was administered to the patients for the events. On 25Jan2021 the patient underwent COVID-19 test via Nasal Swab which showed negative results. The event "Fever" resolved after 48 hours, whereas the outcome of all the reported events was unknown at time of the report.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling, Pyrexia, Rash, SARS-CoV-2 test negative
Clinical narrative: anxiety attack; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; in the evening arm swelled/swelling went down to size of pin hole; there was a welt at the vaccination site / there was still a little knot on arm; fever; night sweats; body rash/ rash beneath eyes; blister sores; swelling of eyes; arm was painful and is still; This is a spontaneous report from a contactable consumer. A 29-years-old female patient, a registered nurse, received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number BK9231, in Hospital, via an unspecified route of administration in left arm on 04Jan2021 at 14:00 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of the vaccination. Concomitant medications included ibuprofen and cetirizine hydrochloride (ZYRTEC). The patient reported that 2 mins after the shot, her left arm felt heavy and was hard to move and, on 04Jan2021 at 14:15 she had tingling/dead feeling; in the evening arm swelled and there was a welt at the vaccination site. On an unknown date in Jan2021 she had fever at 102 °F for 48 hours and swelling went down to size of pin hole; her arm was painful and was still sore, there was still a little knot on arm. On 07Jan2021 she experienced an anxiety attack; 20 days after, in Jan2021 the patient experienced night sweats. She also experienced body rash and little blister sores on her body and both arms, swelling of eyes and rash beneath eyes. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was administered to the patients for the events. On 25Jan2021 the patient underwent COVID-19 test via Nasal Swab which showed negative results. The event "Fever" resolved after 48 hours, whereas the outcome of all the reported events was unknown at time of the report.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site reaction
Clinical narrative: anxiety attack; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; in the evening arm swelled/swelling went down to size of pin hole; there was a welt at the vaccination site / there was still a little knot on arm; fever; night sweats; body rash/ rash beneath eyes; blister sores; swelling of eyes; arm was painful and is still; This is a spontaneous report from a contactable consumer. A 29-years-old female patient, a registered nurse, received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number BK9231, in Hospital, via an unspecified route of administration in left arm on 04Jan2021 at 14:00 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of the vaccination. Concomitant medications included ibuprofen and cetirizine hydrochloride (ZYRTEC). The patient reported that 2 mins after the shot, her left arm felt heavy and was hard to move and, on 04Jan2021 at 14:15 she had tingling/dead feeling; in the evening arm swelled and there was a welt at the vaccination site. On an unknown date in Jan2021 she had fever at 102 °F for 48 hours and swelling went down to size of pin hole; her arm was painful and was still sore, there was still a little knot on arm. On 07Jan2021 she experienced an anxiety attack; 20 days after, in Jan2021 the patient experienced night sweats. She also experienced body rash and little blister sores on her body and both arms, swelling of eyes and rash beneath eyes. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was administered to the patients for the events. On 25Jan2021 the patient underwent COVID-19 test via Nasal Swab which showed negative results. The event "Fever" resolved after 48 hours, whereas the outcome of all the reported events was unknown at time of the report.
Sex: F
Vaccine: PNC13
Symptoms: Anaphylactic reaction, Aspiration joint, Swelling face
Clinical narrative: anaphylaxis (states her face blew up) to another medication when her knee was aspirated for fluid; face blew up; aspirated her knee and removed fluid from it; This is a report from a contactable consumer (patient). A female patient of unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13) received in 2015 (reported as 6 years from the time of the report) via an unspecified route of administration at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) and had a bad reaction 6 years ago (2015). It was  an anaphylaxis (states her face blew up), they even aspirated her knee and removed fluid from it. She ended spending overnight in the hospital because of the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein). The outcome of the events was unknown.   Information on the Lot/Batch has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Eye swelling, Lip swelling, Nausea
Clinical narrative: On 2/5/21- Patient reported getting her 1st moderna COVID vaccine.  1 hour after the vaccine she developed "tingling throughout" her body.  3 hours later developed fever, nausea, dizziness, tachycardia.    On 2/6/21- She woke up reporting facial swelling and swelling to her eyes and lips.  C/o chest tightness, soreness, and rash on her chest and shoulders.   Her symptoms resolved during the day on its own without any intervention.   Pt. did not need to seek care at the hospital or with a provider.  Reaction was self-reported on 2/10/21.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Pyrexia, Rash, SARS-CoV-2 test negative
Clinical narrative: On 2/5/21- Patient reported getting her 1st moderna COVID vaccine.  1 hour after the vaccine she developed "tingling throughout" her body.  3 hours later developed fever, nausea, dizziness, tachycardia.    On 2/6/21- She woke up reporting facial swelling and swelling to her eyes and lips.  C/o chest tightness, soreness, and rash on her chest and shoulders.   Her symptoms resolved during the day on its own without any intervention.   Pt. did not need to seek care at the hospital or with a provider.  Reaction was self-reported on 2/10/21.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Tachycardia
Clinical narrative: On 2/5/21- Patient reported getting her 1st moderna COVID vaccine.  1 hour after the vaccine she developed "tingling throughout" her body.  3 hours later developed fever, nausea, dizziness, tachycardia.    On 2/6/21- She woke up reporting facial swelling and swelling to her eyes and lips.  C/o chest tightness, soreness, and rash on her chest and shoulders.   Her symptoms resolved during the day on its own without any intervention.   Pt. did not need to seek care at the hospital or with a provider.  Reaction was self-reported on 2/10/21.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Administration site rash, Injection site pruritus, Skin warm
Clinical narrative: The Lot # was 007M20A On the 7th February I noticed a small rash around the site of administration. It was hot to the touch and a little itchy. On the 8th February, it had grown progressively bigger. I could feel the heat of the rash through my sweat-shirt. It was still itchy. On the 8th, I took 10mg of loratadine to help with the itching/heat. I have been taking it every day (today is the 11th) since then. The rash has become even bigger still. The edges of the rash are somewhat darker than the rest of it. I have pictures of rash which can be made available upon request.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Impaired work ability, Pyrexia
Clinical narrative: FEVER AND CHILLS RESULTING IN 24 HOURS OF LOST WORK TIME.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Hypoaesthesia, Muscle spasms, Pain, Paraesthesia
Clinical narrative: She developed worsening localized left shoulder pain, she had numbness /tinging of the shoulder radiating to the neck and down to  the left middle and 4th fingers. She had difficulty moving the left arm due to  pain.  Warm compress and Naprosyn with transient help. She refuses to  take Gabapentin and Naprosyn due to  fear of side effects. She was  sent for X-rays of the Cervical spine, left shoulder and left wrist and has not found bony  abnormalities, has signs of spasm of the neck. She was referred to a neurologist who planned to do shoulder MRI and EMG and are  still pending
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Spinal X-ray normal, X-ray limb normal
Clinical narrative: She developed worsening localized left shoulder pain, she had numbness /tinging of the shoulder radiating to the neck and down to  the left middle and 4th fingers. She had difficulty moving the left arm due to  pain.  Warm compress and Naprosyn with transient help. She refuses to  take Gabapentin and Naprosyn due to  fear of side effects. She was  sent for X-rays of the Cervical spine, left shoulder and left wrist and has not found bony  abnormalities, has signs of spasm of the neck. She was referred to a neurologist who planned to do shoulder MRI and EMG and are  still pending
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Immediately after No effect or symptoms noted
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: patient developed red itchy rash around vaccination site.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever of 101.7, chills. Took Tylenol for fever which was effective. Advised to let them know if symptoms continue for more than two days.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Rapid Heart Rate.  Client did not take her medication in the morning.  Also, she did not eat anything at breakfast.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Systemic: Nausea, Systemic: Vomiting
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Feeling abnormal, Hypersensitivity
Clinical narrative: I  lost my taste and smell and experienced brain fog the following days after receiving the shot. 8 days after receiving the vaccine, my arm broke out in an itchy rash, and I experienced chills and nausea days following the rash. These symptoms have subsided, but I have noticed my allergic reactions to wine have become more reactive and sensitive.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rash pruritic
Clinical narrative: I  lost my taste and smell and experienced brain fog the following days after receiving the shot. 8 days after receiving the vaccine, my arm broke out in an itchy rash, and I experienced chills and nausea days following the rash. These symptoms have subsided, but I have noticed my allergic reactions to wine have become more reactive and sensitive.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Member reported "itching" to bilateral hands and feet.  Per observer RN; "couple bumps" to hand with itching to hand and legs. Member contacted 02/11/21; states all resolved.  States "took Benadryl" at home and "is fine."
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Facial neuralgia, Herpes zoster, Hypothyroidism, Neuralgic amyotrophy
Clinical narrative: 2 weeks after injection I developed multiple hermetic lesions on my lips.  3 weeks after developed shingles on left neck with neuralgia of face and shoulder  Also increased hypothyroidism.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: 2 weeks after injection I developed multiple hermetic lesions on my lips.  3 weeks after developed shingles on left neck with neuralgia of face and shoulder  Also increased hypothyroidism.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Welt about 2.5 inches in diameter at injection site, raised about .5 inches high; welt is red/pink, warm, and very tender. Soreness started that night of the injection but assumed it was just sore from injection, when I woke up in the morning there was that big welt. The following day I had some fatigue and just felt run-down?nothing real remarkable there. Took some ibuprofen and have iced the area a couple of times. Today (2 days post-vax) it is less tender and seems to have shrunk a little bit but still very present.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Welt about 2.5 inches in diameter at injection site, raised about .5 inches high; welt is red/pink, warm, and very tender. Soreness started that night of the injection but assumed it was just sore from injection, when I woke up in the morning there was that big welt. The following day I had some fatigue and just felt run-down?nothing real remarkable there. Took some ibuprofen and have iced the area a couple of times. Today (2 days post-vax) it is less tender and seems to have shrunk a little bit but still very present.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Headache
Clinical narrative: 2600 hrs aftr injection,  light headache,  100.3 temp. 6 hours after that  all symptoms resolved.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatine abnormal, Blood urea abnormal, Cardiac failure congestive, Cardiomegaly, Chest X-ray abnormal
Clinical narrative: Resident complained of feeling "hot" at supper time.  Had emesis an hour or so later.  Became hypoxic and was transferred to the hospital emergency room.  Her evaluation in the ED revealed continued presence of UTI, leukocytosis (19.8), and renal insufficiency (BUN 22 Cr. 1.3) BP 99/63; P 74; Temp 98.1; RR 16; and O2 sat of 95% with 2 LPNC (she is typically on RA). CXR reported changes most consistent with CHF with cardiomegaly and bilateral pulmonary vascular prominence. Bibasilar pleural effusions greater on the right than left with pulmonary edema. Large hiatal hernia and likely old chronic wedge defromities involving the mid thoracic vertebral body. She was admitted for IV antibiotics.  She expired 2/6/2021
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Feeling hot, Hiatus hernia, Hypoxia, Leukocytosis
Clinical narrative: Resident complained of feeling "hot" at supper time.  Had emesis an hour or so later.  Became hypoxic and was transferred to the hospital emergency room.  Her evaluation in the ED revealed continued presence of UTI, leukocytosis (19.8), and renal insufficiency (BUN 22 Cr. 1.3) BP 99/63; P 74; Temp 98.1; RR 16; and O2 sat of 95% with 2 LPNC (she is typically on RA). CXR reported changes most consistent with CHF with cardiomegaly and bilateral pulmonary vascular prominence. Bibasilar pleural effusions greater on the right than left with pulmonary edema. Large hiatal hernia and likely old chronic wedge defromities involving the mid thoracic vertebral body. She was admitted for IV antibiotics.  She expired 2/6/2021
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Pleural effusion, Pulmonary oedema, Pulmonary vascular disorder, Renal failure, Spinal fracture
Clinical narrative: Resident complained of feeling "hot" at supper time.  Had emesis an hour or so later.  Became hypoxic and was transferred to the hospital emergency room.  Her evaluation in the ED revealed continued presence of UTI, leukocytosis (19.8), and renal insufficiency (BUN 22 Cr. 1.3) BP 99/63; P 74; Temp 98.1; RR 16; and O2 sat of 95% with 2 LPNC (she is typically on RA). CXR reported changes most consistent with CHF with cardiomegaly and bilateral pulmonary vascular prominence. Bibasilar pleural effusions greater on the right than left with pulmonary edema. Large hiatal hernia and likely old chronic wedge defromities involving the mid thoracic vertebral body. She was admitted for IV antibiotics.  She expired 2/6/2021
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection, Vomiting, White blood cell disorder
Clinical narrative: Resident complained of feeling "hot" at supper time.  Had emesis an hour or so later.  Became hypoxic and was transferred to the hospital emergency room.  Her evaluation in the ED revealed continued presence of UTI, leukocytosis (19.8), and renal insufficiency (BUN 22 Cr. 1.3) BP 99/63; P 74; Temp 98.1; RR 16; and O2 sat of 95% with 2 LPNC (she is typically on RA). CXR reported changes most consistent with CHF with cardiomegaly and bilateral pulmonary vascular prominence. Bibasilar pleural effusions greater on the right than left with pulmonary edema. Large hiatal hernia and likely old chronic wedge defromities involving the mid thoracic vertebral body. She was admitted for IV antibiotics.  She expired 2/6/2021
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Paraesthesia oral, Pharyngeal paraesthesia, Pharyngeal swelling, Pruritus
Clinical narrative: Client received Pfizer covid vaccine, and during her observed wait time, she became hot and felt a flush through her body. She also reported tingling in her tongue and throat. She reported itching of her chest, cheeks, and ears. Client was brought back to emergency area, and was assess by nurses. Client did have a prior history of allergy to Iodine and shellfish- but never anaphylaxis. 10:20am, pulse 68, bp 142/83, 98% O2. 10:25am, bp 140/85, still complaining of throat swelling and itching, pulse ox stil 98%. Once client was in a private area, she reported that the flushing and feeling of being hot, had gotten much better. Per Client , her tongue and throat, were not getting worse. Our Medical Director was contacted, and the decision was made to give Benadryl IM.  10:39 pulse 70, O2 95%, . 10:41 am 1ml (50 mg) Benadryl given IM in the right deltoid (lot # 080014, exp. 8/2022). Within a few minutes patient reported that signs and symptoms were better but had not completely gone away. 10:44, respirations 14/minute, O2 94%, patient sat up at this time to help clear some phlem. 10:46 client states tongue feels better. 10:53 am 96% O2, pulse 93.  Nurses continued to monitor client, and asked if she felt any worsening of her symptoms to warrant more medication. Client stated she felt a little better and would like to go home. 11:15 am, spoke to Docter again, per his instruction, client was allowed to go home with her sister. Instructed to take more Benadryl in 4 hours if symptoms return. Client was told if anything gets worse than her original symptoms, regarding her airway, tongue, lips, swallowing, she should call 911.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Lymphadenopathy
Clinical narrative: Left axilla- Swollen painful lymph nodes  x5 days, started 6 days after vaccine administration Left arm around injection site- Red circle 3 inch diameter, itching, sensitive to touch, palpable 2cm bump at injection site x5 days, started 6 days after vaccine administration
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia, Rash, Rash pruritic, Skin weeping
Clinical narrative: A very itchy, burning (pins and needles) rash formed in-between my breasts that spread to my upper chest. They did ooze and crystalize when I did itch but tried over the counter itching cream and Benadryl to help with symptoms. Ended up going to the doctor after 7-10 days of the rash but by that time they could not get a culture of the rash.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Head discomfort, Syncope
Clinical narrative: s/p first injection c/o feeling faint, dizzy, and pressure above eyes
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Pt reported feeling dizziness 10 minutes after vaccination. Laying down his blood pressure was 110/70 P 74; sitting was 118/74 and standing 120/76. Patient was sent home he denied feeling any dizziness at time of discharge and reports that he was feeling well.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Encephalopathy
Clinical narrative: Systemic: Other- encephalopathy
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Pt reported Heart palpitations apprx 3 days following 1st dose.  Pt reports  the episode last for apprx 2hrs
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Red, firm, itchy, warm rash about 3" in diameter at injection site
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: possibly received 2 vaccines, wasn't sure if anything was in the first vaccine
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Rash below injection site on same arm
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Hyperhidrosis, Nasal congestion, Pyrexia
Clinical narrative: Woke up with body chills, soaked in sweat, febrile, nasal congestion, and dry cough
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injected limb mobility decreased, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, chills, achy, entire left arm sore to the point i could not lift my arm without assistance of my other arm
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Lip swelling, Swelling face, Vaccination complication
Clinical narrative: Patient presented to clinic for 2nd Pfizer covid vaccine. Vaccine administered @ 1520 and patient waited for 15 min with no reaction and discharged @ 1540. Patient called the next day (2/11/21) @ 0927 and reported swelling on left side of face and lips and denied any SOB or difficulty swallowing.  Patient came into office to be assessed by Doctor; Assessment and Plan angioedema-adverese reaction to 2nd Pfizer covid vaccine, mild and should subside spontaneously. Recommend Benadryl OTC for swelling. Regarding future covid vaccines not enough information for specific advice, however would presume she would never take this particular vaccine again, not sure about a different type/brand.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Dizziness, Dizziness postural, Electrocardiogram
Clinical narrative: I received the shot at 12 p.m.   At 3:30 I began to experience rapid heart beat - dizziness when I stood up, feeling I needed to faint.  It has never happened before.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Magnetic resonance imaging
Clinical narrative: I received the shot at 12 p.m.   At 3:30 I began to experience rapid heart beat - dizziness when I stood up, feeling I needed to faint.  It has never happened before.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Heart rate increased, Injection site induration
Clinical narrative: Fatigue, congestion, short of breath, rattling, wheezing, high heart rate (100), 180/130BP. he was admitted to the hospital for 24 hours and diagnosed with viral pneumonia and sent home with an oxygen generator that he only used at night.  after the second dose of the vaccine his symptoms were the same but escalated. he now has headache and nausea and fever and uses the oxygen generator daily. he had a swollen cigarette box shaped hard spot on the injection site.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Nausea, Pneumonia viral, Pulmonary congestion, Pyrexia
Clinical narrative: Fatigue, congestion, short of breath, rattling, wheezing, high heart rate (100), 180/130BP. he was admitted to the hospital for 24 hours and diagnosed with viral pneumonia and sent home with an oxygen generator that he only used at night.  after the second dose of the vaccine his symptoms were the same but escalated. he now has headache and nausea and fever and uses the oxygen generator daily. he had a swollen cigarette box shaped hard spot on the injection site.