chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; Stomach does not feel rigth; Could not raise her arm up and down the rest of the day and the next day; Feeling weak; Headache; Arm was sore; Arm was red; Arm was swollen half way around and red; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2019, the patient received Shingrix. On 21st October 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, erythema of extremities and swelling arm. On 22nd October 2019, the patient experienced mobility decreased, weakness and headache. On 24th October 2019, the patient experienced diarrhea and stomach upset. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the pain in arm, erythema of extremities, swelling arm, mobility decreased, weakness, headache, diarrhea and stomach upset were unknown.   It was unknown if the reporter considered the pain in arm, erythema of extremities, swelling arm, mobility decreased, weakness, headache, diarrhea and stomach upset to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix vaccine approximately 12:00pm. She reports her arm was sore before she went to bed that night.When she was taking a shower the next morning she noted that her arm was swollen half way around and red.  She could not raise her arm up and down the rest of the day and the next day. At the time of reporting, she reports that her arm was not as sore and red and she can now move it around. The next morning after receiving the vaccine she noted that she was feeling weak.  She had headaches on October and she took Advil to help treat them. At the time of reporting she has not had any headaches so far and not as weak as she was.   She did not that she was having stomach issues. Her stomach does not feel right and she has had some diarrhea. The reporter did not consent to follow up. The reporter unable to obtain additional information.
Chills; Headache; Fatigue like stiffing congested; I am not feeling well; Fatigue like stiffing congested; This is a spontaneous report from a contactable consumer (Patient reported for self). A patient of unspecified age and gender received unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, LOT#:Not reported/ Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. On an unspecified date the patient experienced Chills, Headache, Fatigue like stiffing congested, patient stated "I am not feeling well". Reason for no lot number: of Covid Vaccine: Other: Patient stated, "I don't have it. I have to call back with because I am not feeling well." As Patient was not willing to proceed the call. Limited information available over the call. The outcome of the events was unknown.  Batch/lot number not available for vaccine [BNT162B2]. Follow-up attempts are completed and no further information is expected
It was like a bad flu. I had pain, fever, loose stools, no appetite, lost my taste, headache. I can't remember if my throat was sore. I went to Urgent care, they did a COVID test and it was negative. They gave me Zithromax and an antibiotic shot. I had a fever of 102 and above.
This case was reported by a nurse via sales rep and described the occurrence of nausea in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced nausea and vomiting. On an unknown date, the outcome of the nausea and vomiting were unknown. It was unknown if the reporter considered the nausea and vomiting to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient ate shrimp after receiving a dose of SHINGRIX and experienced nausea and vomiting. The reporter agreed to be followed up. This case was linked with US2018GSK138896, reported by the same reporter.
Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: pt vomited 2 or 3 times but felt better after resting in chair. left after about 30min. tried to call at 8pm that night and no answer-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: tried to call parents after and no answer but pt seemed fine after he threw up. he might have been a little nervous or scared from the shot
Prior to Imm mom reported with last 2 sets of shots and recent venous lead draw, child got red bumps around sites beyond bandaid and used non - alcohol wipe. About 5 minutes after shots MMR - VAR sites; red rash at site and bandaid partly applied BENADRYL topically, rash decreased and resolved 15 minutes. Given po BENADRYL before left.
not moving arm well, painful & swollen in area of shot, just occurred this AM;DPH ordered;
Red swelling  and itching around injection site that didn't appear until a week after the 1st dose of the vaccine.  Swollen spot is about the size of the palm of my hand.
Nov 2, 2009 Raised lg hive like rash noted over entire body. Slight pruritis noted. MD Rx: BENADRYL 12.5 mg q 6 hours.
Patient received vaccine on 10/20/21 and negative symptoms started 10/22/21. Adverse effects include: sore swollen arm, headache, chills, exhaustion and dizziness. Injection site (left arm) was red, very warm, swollen and raised  itchy rash.
PNEUMOVAX on 20-FEB-2002 and on 15-FEB-2007; This spontaneous report has been received from a lawyer, via a Plaintiff from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2103USA004021), concerning a 60-year-old female patient. The patient's medical history, concurrent condition and concomitant medication was not provided.  On 20-FEB-2002, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # 640578/0996L has been verified to be valid, expiration date not reported, but upon internal validation established as 11-APR-2003; strength and route were unknown) for prophylaxis.  On 15-FEB-2007, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # 655289/0958F has been verified to be valid, expiration date not reported, but upon internal validation established as 21-OCT-2008; strength and route were unknown) for prophylaxis (inappropriate schedule of product administration).  On 05-FEB-2014, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # J004332 has been verified to be valid, expiration date not reported, but upon internal validation established as 26-SEP-2014; strength and route were unknown) for prophylaxis.; Sender's Comments:  US-009507513-2103USA004021:
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of OVERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced OVERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, OVERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) 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 assessment was provided for OVERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received contains age group added and narrative updated.
Approximately 40 hours after second Pfizer vaccine, patient complained of pain in lower right leg, and a cold foot, lethargy, weakness, feeling unwell.  3 days later, shortness of breath, difficulty breathing, rapid heartbeat, and confusion began.  Went to  Medical center on 4/20/21, diagnosed with DVT, PE and clots in and around the heart and passed away on 4/21/21 of cardiac shock in the setting of pulmonary and arterial thrombosis.
administered the second dose to a patient 14 days after the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered the second dose to a patient 14 days after the first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered the second dose to a patient 14 days after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered the second dose to a patient 14 days after the first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
tired after first vaccine; nauseous after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired after first vaccine) and NAUSEA (nauseous after vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    In April 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 FATIGUE (tired after first vaccine) and NAUSEA (nauseous after vaccine). At the time of the report, FATIGUE (tired after first vaccine) and NAUSEA (nauseous after vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided by the reporter. No treatment information provided.   This case was linked to MOD-2022-455736, MOD-2022-455739 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2022: Significant Follow-Up Appended. Reporter's Demographics updated.Dosage information updated for 1st Dose.
Felt fine for first 30 minutes. Then face started to burn and tingle. 10-15 minutes later felt heart racing, slightly short of breath. Felt like I was going to faint. This only lasted 20 seconds or so. Base of the tongue felt strange. Took Benadryl 50 mg and prednisone 20 mg. Paramedics came. Hr was 68, O2 sat 99, bp176/126. Lungs clear. No trouble breathing. I felt better and they left. All symptoms improved except my face is still burning and tingling at 2 pm on same day (today). Face is mildly red but no hives. Bp is now normal 126/76, hr  50.
Tenderness, warm , achy sore on the inside of my left arm near elbow, not at injection site- but on the same arm. Feels like I banged it, but didn?t.
Patient was given 0.5 ml of  0.9 Sodium chorine instead of the J&J Vaccine.
FELT LIKE RUN OVER BY A TRUCK; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: crohn's disease, and coronary artery disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced felt like run over by a truck, and low grade fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) low grade. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like run over by a truck, and low grade fever on APR-2021. This report was non-serious.
m/p rash over lt thigh 5cm x 8cc;1 red, indurated lesion of 1cm diameter;
Internal chills, shivering but not cold, arm soreness. Still shivering on 02/26/2021, but seems improved.
Mild - moderate pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 83 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jan2021 19:30 (Batch/Lot number: unknown) at the age of 83 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "BP" (unspecified if ongoing), notes: BP; "mild prediabetic" (unspecified if ongoing), notes: mild prediabetic; "artritis of knee" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN (non-serious) with onset 12Jan2021, outcome "unknown", described as "Mild - moderate pain". It was unknown if therapeutic measures were taken as a result of pain.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID19. No allergies to medications, food, or other products. Patient did not require a visit to Emergency room/Physician office. No antipyretic use (around date(s) of Vaccination).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shingrix - Less than recommended dose/during the administration of Shingrix due to a leakage, the total volume of the dose was not administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: Shingrix - Less than recommended dose/during the administration of Shingrix due to a leakage, the total volume of the dose was not administered). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 22-Jun-2023 An pharmacist called on behalf of a friend of hers to ask for guidance on the situation. The reporter did not provide patient information nor vaccine data (lot number, expiry date, date of administration) since the person involved in this situation was not her patient. During the administration of Shingrix due to a leakage, the total volume of the dose was not administered, which led to incomplete dose administered.
T-dap vaccine, 2010, all over body/joint pain, pain level 9/10, arm swelling/ redness, chest pain, diarrhea, headache, severe abdominal pain.  COVID VACCINE 2021/2022 duplicate symptoms, all over body/joint pain, pain level 9/10, arm swelling/ redness, chest pain, diarrhea, headache, severe abdominal pain. Third trimester pregnancy, due date 5/5/22
Pain on my arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for prophylaxis.   On an unknown date, the patient received RSV vaccine and PREVNAR 20. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: Pain on my arm). The outcome of the pain in arm was resolved (duration 1 day).   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 28-SEP-2023 This case was reported by a patient via (social media) interactive digital media. The patient reported that he or she received RSV vaccine along with the new Prevenar20 and experienced pain on his or her arm for one day and had no other side effects. It was unknown if the reporter considered the pain in arm to be related to Prevenar20. Follow-up would not possible as no contact details were available.
Pt had swelling & tenderness at the site the day after the shot was administered. She stated that she could hardly move her arm.
Fever 103.0 for 18 hours; This is a spontaneous report from a contactable other Health Care Professional (patient reported for herself).  A 49-year-old female (Non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6199), dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 at 11:00 (at the age of 49 years old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included allergy to penicillin, environmental and hives from an unknown date and unknown if ongoing. Concomitant medication(s) included hydrochlorothiazide, losartan potassium (LOSARTAN/ HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported. Previously patient received bnt162b2 (Batch/Lot Number: EL9261), dose 1 via an unspecified route of administration, administered in Arm Left on 10Feb2021 at 15:30 h (at the age of 49 years old) as DOSE 1, SINGLE for covid-19 immunisation and had experienced generalized pruritus with skin rash. Exactly like a chicken pox rash. Each patch resolved over 7-8 days, 14-15 days until completely of cured. So itchy rash went before crusting over. Bilateral - rash erupted in both sides of body at the same time. Face, lower legs never got a rash (nor hands/feet). Patient did not receive any recent vaccines for any other conditions prior to the event being reported. Patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNtech COVID-19 Vaccine prior to the event reported. Patient had not received any other vaccines around the time of Pfizer-BioNtech COVID-19 Vaccination. After second dose, the patient experienced fever 103.0 for 18 hours on an unspecified date. Saw a doctor. Doctor was puzzled. Vitals normal, no fever. Patient did not require the Emergency department or Intensive Care Unit. The patient was not hospitalized. Multi organ involvement was reported as, dermatological/mucosal, checked. Event did not require the initiation of new medication or other treatment or procedure. laboratory tests or diagnostic studies performed were None. Outcome of the event was recovered.
Client presented to the clinic today to receive second dose of covid vaccine and we noticed that she was vaccinated on 9/24/2021 with Moderna. Client was informed to complete series of Moderna which second dose was given today. Client stated that she did not have any adverse reaction from the first dose.
Swollen lymph node that is extremely painful in the groin area going on 3 weeks.
10 days after vaccine, patient broke out w/full blown measles rash, from head to toe. Fever ranging from 101.0-104.3 non-stop crying, lethargic, refused to walk, eyes irritated him severely. Lasted 5 days. Prescribed Benadryl and Motrin. 3/21/06 Received medical records from PCP which revealed patient experienced rash, fever & swollen lymph glands/ss
REDNESS AND SWELLING AT SITE OF VARCELLA VACCINE, LEFT THIGH THAT DEVELOPED > 1 WEEK AFTER THE VACCINE WAS ADMINISTERED.
Swelling was painful, in arm pit extending from torso (not from arm); Swelling under the arm, same arm shot received; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the right arm on 16Apr2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took prochlorperazine (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 26Mar2021 at 12:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. On 18Apr2021 at 15:00 the patient experienced swelling under the arm-same arm shot received, swelling was painful, in armpit extending from torso (not from arm). Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events  swelling under the arm-same arm shot received(swelling), swelling was painful, in armpit (armpit pain) were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient diagnosed with COVID 09May2022; Patient diagnosed with COVID 09May2022; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adolescent male patient received BNT162b2 (BNT162B2), on 05May2021 as dose 1, single (Batch/Lot number: unknown) and on 10Jun2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "recovered" (May2022) and all described as "Patient diagnosed with COVID 09May2022". The event "patient diagnosed with covid 09may2022" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course of the events: Facility type vaccine: Unknown. If other vaccine in four weeks: Unknown. Patient diagnosed with COVID 09May2022. Ae resulted in: Doctor or other healthcare professional office/clinic visit. If covid prior vaccination: Unknown. If covid tested post vaccination: Yes  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.