chrisvoncsefalvay/vaers-outcomes huggingface dataset:
High blood pressure; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2, solution for injection), administration date 07Oct2021 (Batch/Lot number: unknown) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 Immunization; Bnt162b2 (2nd dose), for Covid-19 Immunization. The following information was reported: HYPERTENSION (non-serious) with onset 10Oct2021, outcome "unknown", described as "High blood pressure"; HEADACHE (non-serious) with onset 10Oct2021, outcome "unknown", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller is a 66 year-old female who received the booster dose of the Pfizer Covid-19 vaccine on 07Oct2021 and had complaints of headache and hypertension on 10 Oct 2021. states that her blood pressure reading was 130/84 and that the systolic number is usually 120 and the diastolic number usually runs lower. she got her booster shot last Thursday, and she started to experience a headache, and had high blood pressure by last Sunday. states she normally has high blood pressure which is controlled with medications, but as of Sunday night, she was experiencing a headache and high blood pressure. she does not specifically report her medication. Side effects that she experience throughout the rest of the body were first observed 1 to 2 days after vaccination and resolved shortly thereafter. Caller is asking if anyone else has reported hypertension after receiving the Pfizer Covid-19 vaccine?  Caller is asking if is common that a person doesn't get a side effect from the Pfizer Covid-19 vaccine until a few dose after the dose?  Follow-up attempts are completed. No further information is expected.
Severe muscle aches and joint pain; shakes and chills; intense night sweats; and large mass under left arm (injection arm). All started the morning after the second dose, and lasted until the following morning. The mass in my armpit is still present and is slightly sore to the touch.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gener. On 27-DEC-2013 the patient was vaccinated with less than a full dose of ZOSTAVAX (lot #, expiration date, dose, indication, route not reported). No adverse effects reported. Follow up information was received from an other pharmacist. The pharmacist reported that on 18-DEC-2013 (previously reported as 27-DEC-2013) the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route were not reported). The pharmacist also reported that "half the dose leaked out of the syringe and ran down the patients arm during administration". Additional information has been requested.
Patient stated that she experienced welts. Patient called her primary care doctor and they told her to take benadryl, famotidine and zyrtec. patient stated that those treaments are successful.
Case number PHEH2014US025354, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to an 80 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 27 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error (incorrect storage of drug).
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On an unknown date the patient was vaccinated with VAQTA (strength, dose, route and lot number unspecified), which underwent a supported temperature excursion. No adverse effects were reported. This is one of the 23 reports received from the same reporter. Additional information has been requested.
Breakthrough case after four vaccines Moderna 1/26/21 Lot# 029L20A;  Moderna 2/23/21 Lot# 015M20A;  Moderna 12/15/21 Lot# 060H21A;  Moderna 6/14/22 Lot# 037A22B
after second dose of moderna Covid-19 vaccine person got very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (after second dose of moderna Covid-19 vaccine person got very sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (after second dose of moderna Covid-19 vaccine person got very sick). At the time of the report, ILLNESS (after second dose of moderna Covid-19 vaccine person got very sick) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
11:15 am headache started- mild 11:45 tingling sensation down left arm from injection site 12:00 pm itching on arms and face resolved after couple hours 4:30 pm headache moderate  resolved by next day 7:00pm body aches moderate 3:00pm next day resolved 10:00 mild fever- 12:00am resolved
pt recv vax & devel fever by 4:30 redness by evening later swelling to knee cap on Friday-no more fever by 5/24/99 swelling going down, area is soft, less redness;
2 weeks after injection, itchy raised rashes that come and go on various areas of the body. These seemed to be triggered especially after eating a meal, this is not due to a food allergy. This reaction happens irregardless of what is eaten.   This same thing happened to me 2 to 3 weeks after my second booster as well. At the time, I didn't attribute it to the vaccine. But now that I can see the pattern after the same thing has happened again after the 3rd shot, I now believe both times are an adverse reaction to the vaccine.   Since my second dose, I have also developed gallbladder disfunction problems. Before the vaccine, I had no problem with my gallbladder in anyway. This issue has persisted untill present day.
She thinks the vaccine provider may not have pushed the plunger after she stuck the needle in; A spontaneous report was received from a female consumer of unknown age who received Moderna COVID-19 vaccine on 16-JAN-2021 thought that the vaccine provider may not have pushed the plunger after she stuck the needle in.  The patient's medical history was not provided. The concomitant product use was not provided by the reporter.   On 16 JAN 2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) through intramuscular route in her left arm for prophylaxis of COVID-19 infection. The patient thought that the vaccine provider may not have pushed the plunger after she stuck the needle in her left arm because the nurse was abruptly distracted. The provider told the patient that after two weeks she could get an antibody test to see if she actually got the vaccine. The patient reported that the establishment where she got her original vaccine was shut down. The patient asked about time frame for receiving the Moderna vaccine. The patient has been advised to reach out to her Healthcare Professional for any concerns which she may had. Treatment information was not provided.  The Action taken with the second dose of mRNA-1273 in response to the event was not provided.  The outcome of the event, she thought the vaccine provider may not have pushed the plunger after she stuck the needle in was resolved.; Reporter's Comments: This report refers to a case of Product administration error - wrong technique in device usage process ,for mRNA-1273 , COVID-19 vaccine. There were no reported AEs associated with this case of Product administration error wrong technique in device usage process .
Patient began feeling ill the evening after receiving the 2nd dose of the Pfizer COVID vaccine on 3/3/21.  He woke the next morning with AMS and was admitted to the ED with a fever of 103F. He was initially unresponsive to stimulus but no other symptoms. After arrival, given tylenol and ice packs placed. Awoke upon examination. Admitted for management of UTI with acute metabolic encephalopathy and need for cardiopulmonary monitoring. Discharged to SNF with no complaints on 3/8 for continued PT.
Did not get the second dose of the primary series; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Did not get the second dose of the primary series) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Did not get the second dose of the primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Did not get the second dose of the primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Did not get the second dose of the primary series).    The concomitant medication was not reported by reporter. It was reported that patient came for a booster and all they had was a Bivalent booster now. Caller knew you must have the first entire series to get the Bivalent booster. Caller enquired that do we have information on anyone getting the bivalent booster if they just got the first dose of Moderna. HCP reported a patient got the first dose in 2021 and did not get the second dose of the primary series but needed to have a booster to be able to start a job on Friday.  HCP was unsure why the patient did not get the second dose of the primary series. The treatment medication was not reported by reporter.
1 hour after vaccination pt expierenced swelling (the size of 1/2 of a pingpong ball) at injection site. Hours later redness surrounding site (the size of a hand) & hot- pt attributes this to possibly having a sleeve that was tight above the injection site at time of administration.  That night she experienced a low grade fever (not more than 100) and hallucinations at bedtime along with being nauseous. These symptoms continued until Tuesday 12/08/15. Wednesday she was symptom free.
Client had numbness and tingling at the roof of her mouth 15 minutes after receiving the vaccine.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo any temperature excursions. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non significant live follow-up: Additional reporter added.
Raised bump 2" in diameter, thick in texture and red in color in the area of injection. The area is warmer in temp than surrounding skin.
Facial swelling; This case was reported by a consumer and described the occurrence of facial swelling in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced facial swelling. Shingrix was discontinued. On an unknown date, the outcome of the facial swelling was recovered/resolved.   It was unknown if the reporter considered the facial swelling to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient received Shingrix around June of 2019 (reporter was uncertain of exact timeframe).  The patient experienced facial swelling approximately 2-3 days after receiving first dose of Shingrix and it was resolved approximately two days after it began. The patient's doctor and pharmacist advised not to receive the second dose of Shingrix. The reporter did not consent to follow-up.
Patient was having shortness of breath, Heart rate was 111, respirations were 44, suctioned multiple times MD notified and sent to Emergency room for evaluation
Muscle pain in shoulder of injection site that often radiates to the elbow. Continued through the month wait between injections, and continues to linger after shot #2 (4/22/21).
arm  which was hurting; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (arm  which was hurting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lymphoedema.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm  which was hurting). At the time of the report, PAIN IN EXTREMITY (arm  which was hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.
12/16/09: c/o fever, itching and pain at site of injection. Four inch radius of redness around injection site. 12/17/09: patient was seen by PA-C who states that patient has a vesicular, very erythemic; 4cm macule with surrounding erythmatous pink area over most of the upper arm post-aspect.
Redness & swelling on R arm noted greater or equal to ab 24 hours after vaccination. Symptoms resolved after 48 hours.
sore throat; Difficulty breathing; Fever; feeling sooo sick; This spontaneous report has been received from a 65-year-old patient of unknown gender reporting on him/herself.   The patient's concurrent conditions included asthma and allergies. The patient's medical history and concomitant medications were not reported.   On 20-JAN-2022,  the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency, lot #, and route of administration were not provided) for an unknown indication.  On the same date (reported as since the vaccine), the patient have been so sick, with fever, sore throat, and difficulty breathing.  The outcome for the events was unknown.   Causal relationship with the suspect vaccine and the events was unknown.
covid-19; Lost taste & smell; Lost taste & smell; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (covid-19), AGEUSIA (Lost taste & smell) and ANOSMIA (Lost taste & smell) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced COVID-19 (covid-19), AGEUSIA (Lost taste & smell) and ANOSMIA (Lost taste & smell). At the time of the report, COVID-19 (covid-19), AGEUSIA (Lost taste & smell) and ANOSMIA (Lost taste & smell) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Fever, chills, joint paint, muscle pain for 48 hours after...   A few weeks later - back muscle spasms, intense back pain, shooting pain down legs ... I haven't had any issues with my back since my spinal fusion (in June 2013), and I called my surgeon who thought it was related to vaccine.
received vaccine that underwent a temperature excursion in the Freezer; No adverse event; received vaccine that underwent a temperature excursion in the Freezer; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (received vaccine that underwent a temperature excursion in the Freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (received vaccine that underwent a temperature excursion in the Freezer) and NO ADVERSE EVENT (No adverse event) in a 34-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (received vaccine that underwent a temperature excursion in the Freezer). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (received vaccine that underwent a temperature excursion in the Freezer) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (received vaccine that underwent a temperature excursion in the Freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (received vaccine that underwent a temperature excursion in the Freezer) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (received vaccine that underwent a temperature excursion in the Freezer) and PRODUCT TEMPERATURE EXCURSION ISSUE (received vaccine that underwent a temperature excursion in the Freezer).    No Concomitant medications were provided.  Reporter reported that a temperature excursion that occurred several days ago in the Freezer.   Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.   Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.  Patient did not reported any adverse event.  No treatment medications were provided.
Moderna vaccine was administered outside of clinic- reported by patient ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------  PULMONARY EMBOLISM, UNSPECIFIED. 7/7/2021 ABDOMINAL PAIN  ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 7/2/2021 ABDOMINAL PAIN  PULMONARY EMBOLISM, UNSPECIFIED. 7/7/2021 LEUKOCYTOSIS  ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 7/2/2021 LEUKOCYTOSIS
Patient mother stated that patient was 12 by filling out date of birth on consent with wrong year and signed consent after reviewing information.  When vaccine was processed a rejection was received "wrong date of birth".  Pharmacy called insurance and confirmed year of birth.  Mother then called and confirmed birth year.  Patient will be 12 in 10 days, doctor told her ok to get vaccine
2 days p/vax pt exp sz & was taken to ER;a UA performed @ ER was positive for tricyclics;pt was transferred to a tertiary care ctr;the reporting hlth care professional suspects abuse;
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-JUN-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time of the first time was 212 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree. The total cumulative excursion time of the third time was 828 hours with the lowest recorded temperature of 29 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Redness, swelling to 5 x 2 size. Warm to touch, painful to touch, nausea.
Patient developed acute thoracic transverse myelitis with flaccid paralysis of bladder and legs and loss of sensation below T10. Treated as inpatient with SOLU MEDROL 1g IV daily x 5 days with partial recovery.
Received Boostrix instead of DTap dose; Boostrix administered to a 17 months-old; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 17-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 345R4, expiry date 9th February 2023) for prophylaxis.   On 9th February 2023, the patient received Boostrix. On 9th February 2023, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 9-Feb-2023 Reporter's comment: A registered nurse called in to report that a patient was accidentally administered a dose of Boostrix instead of a dose of DTap.  The reporter called in to receive information about how to proceed and to know if there would be other adverse effects.  The reporter provided adverse event report information and details about the patient.  The reporter was then escalated to second line. During the call, a myriad of audio issues were present. The vaccine administration facility was the same as primary reporter. Additional supportive information: The patient received Bostrix instead of DTap at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.