chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea; severe pain; swollen gland; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), PAIN (severe pain) and LYMPHADENOPATHY (swollen gland) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced NAUSEA (nausea), PAIN (severe pain) and LYMPHADENOPATHY (swollen gland). On 20-Feb-2021, NAUSEA (nausea) and PAIN (severe pain) had resolved. At the time of the report, LYMPHADENOPATHY (swollen gland) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD21-086694 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: contact info updated; Sender's Comments:  MOD21-086694:
Reddened, swollen area noted L deltoid area 8/27/02 am.
Soreness in arm, nauseated, hot/cold flashes, headache.  General body aches for days following vaccine.
sore; tender; upset stomach; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore), TENDERNESS (tender), ABDOMINAL DISCOMFORT (upset stomach) and DIARRHOEA (diarrhea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN (sore), TENDERNESS (tender), ABDOMINAL DISCOMFORT (upset stomach) and DIARRHOEA (diarrhea). At the time of the report, PAIN (sore), TENDERNESS (tender), ABDOMINAL DISCOMFORT (upset stomach) and DIARRHOEA (diarrhea) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-060494 (Patient Link).
Redness, warmth, painful, facial redness. (R) Deltoid. 4 in x 4 1/2 in diameter.
Reaction to shingles vaccine; This spontaneous report was received from a consumer regarding an elderly female patient of unknown age. The patient's medical history and concomitant medications were not reported. Her concurrent conditions included moderate to severe rheumatoid arthritis.      On an unknown date, the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) as prophylaxis (Strength, dose, route of administration, lot # and expirationd ate were not reported). Other suspect therapies included adalimumab(HUMIRA) citrate free, administered via subcutaneous for moderate to severe rheumatoid arthritis (Strength, dose, frequency, lot # and expiration date were not reported).    On an unknown date, the patient experienced a reaction to shingles vaccine (vaccination complication). The action takwen with suspect therapies was not reported. The outcome of vaccination complication was reported as recovered on an unspecified date.   The reporter considered vaccination complication to be related to Zoster Vaccine Live(ZOSTAVAX) and to be reasonable possible related to adalimumab(HUMIRA).
Rheumatoid arthritis flare up; Booster; Headache; Generalized aching; Diarrhea; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not Available). The reporter is the patient. Other Case identifier(s): 21K-163-4072856-00 (AbbVie).  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 27Dec2021 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single, intramuscular, administration date 04Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 08Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; RHEUMATOID ARTHRITIS (medically significant) with onset 06Jan2022, outcome "recovering", described as "Rheumatoid arthritis flare up"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Headache"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Generalized aching"; DIARRHOEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Diarrhea". The action taken for upadacitinib was unknown. It was unknown if patient was enrolled in a covid-19 vaccine trial.   Causality for Rinvoq (Upadacitinib): The reporter's causality for the event(s) of rheumatoid arthritis flare up, headaches, body aches and diarrhea was not provided.   The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, a causal association between reported events rheumatoid arthritis, headache, pain, diarrhoea, and the suspect BNT162B2 cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a registered pharmacist concerning a 66 year old female patient with chronic obstructive pulmonary disease, sulfa, iodine and codeine reaction/allergy who on 19-NOV-2009 was intramuscularly vaccinated with a 0.5 mL dose of PNEUMOVAX 23 (Lot#662661/0978X). Concomitant therapy included H1N1. The pharmacist reported that after received the PNEUMOVAX 23, on 21-NOV-2009, the patient experienced red and swollen at the injection site. No lab tests were performed. The patient called to the pharmacist for medical attention. "3-4 days after the start of the reaction", the patient had recovered. Follow up information has been received from the pharmacist that reported that the patient did not need to saw her doctor and that the symptoms resolved. No further information is expected.
some mild soreness in the arm/a tender, sore spot in my right underarm/it is still mildly sore; some mild soreness in the arm/a tender, sore spot in my right underarm/it is still mildly sore; I had my Covid vaccine booster shot; A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Dec2021 14:30 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021 14:30, outcome "unknown", described as "I had my Covid vaccine booster shot"; PAIN IN EXTREMITY (non-serious), TENDERNESS (non-serious) all with onset 04Dec2021, outcome "not recovered" and all described as "some mild soreness in the arm/a tender, sore spot in my right underarm/it is still mildly sore". Therapeutic measures were taken as a result of pain in extremity, tenderness.  Additional Information: Patient took two Aleve for mild soreness in the arm.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Information has been received from a physician concerning a 17 year old female with lyme disease who on 12-JUL-2010 was vaccinated with the first dose of GARDASIL (therapy dose, site and route unknown). Concomitant therapy included hormonal contraceptives (unspecified) and ZANTAC. On 12-JUL-2010 after receiving the first dose the patient experienced headaches, fainting, dizziness and abdominal pain. The patient sought medical attention, complete blood count, "CMT", lipase and urine analysis were done (results unknown). At the time of this report, the patient's headache and fainting and dizziness and abdominal pain persisted. Additional information has been requested.
Pt c/o fever 102 degrees, H/A, cough, sinus pressure (R) arm sore, red warm to touch over area of injection site- came to office on Monday morning 11/3/08. Evaluated by Doctor - started on course of KEFLEX. Diagnosed with cellulitis.
Information has been received from a pharmacist referring to a patient of unknown age and gender. On 17-FEB-2016 the patient was inadvertently administered an expired dose of ZOSTAVAX (lot # K018172 with expiration date of 12-DEC-2015, dose, strength and route unknown). No adverse effects were reported. Additional information has been requested.
Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case involves a 68 years old female patient and reports that patient received a second FLUZONE HIGH-DOSE vaccine injection approximately 30 minutes from the first injection, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history included Dementia. The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 26-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: U1985AB) (expiry date, dose in series was not reported) via intramuscular route in the left deltoid. On 26-Sep-2018 she also received a 0.5 ml dose of the same vaccine (lot number: U1985AB) via intramuscular route in the right deltoid. It was a case of actual medication error due to extra dose administered. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Pt devel bruising, swelling (quarter size), hard lump lasting 2 months;
pt recv vax & started crying shortly p/vax & did not stop until next day;pt devel high pitch crying lasting few min;mom reported did not sleep much;pt seen by MD 22NOV96;pt nose nl & chest congestion;
17MAY93 cried x 3 1/2 hrs w/o stopping & had severe local reaction p/1st DTP;
pain spreading through his body, arm, should, elbow, it gets worse when he uses more force like when lifting.; minimum pain at inject site of Left arm; had fever blisters all over on my lower lip; I tried moving the couch and both arms went numb gave out on me; felt like I had internal fever until they showed up; as severe muscle and joint pain; as severe muscle and joint pain; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 25Jun2021 (at the age of 34-year-old) as dose 1, single for COVID-19 immunization. No medical history and concomitant medications were not reported. It was reported that side effects started the same day as vaccine stated it was normal at injection site went on for 2 to 3 days minimum pain at inject site of Left arm. By the 4th day till today it has gotten worse, pain spreading through his body, arm, should, elbow, it got worse when he used more force like when lifting. 2 or 3 days ago (as reported), he started experiencing internal fever, although no temperature had fever blisters all over on his lower lip. they are still there and started 3 days ago, when his joint pain got worse, felt like had internal fever until they showed up. Right now, few hours ago, tried moving the couch and both arms went numb gave out on him. It was also reported that he did not want to go to the emergency room (ER) until he spoke. He wanted to know if this was a severe reaction. The patient explained that he was experiencing severe muscle and joint pain. The outcome of the events was not resolved.   Follow-up attempts are possible. Information on lot/batch number can be obtained.
Breakthrough COVID infection in fully vaccinated patient. Positive date 07/26/2021.
after vaccination noticed small amount of vaccine on arm at injection site possilble due to malfunction of intregra syringe, needle detached from syringe while deploying retraction of needle before placing sharps container.  amount of vaccine present on outside of arm was deemed to be less than 1/2 dose of vaccine.  and no re-vaccination necessary as per cdc guidelines.   patient has been notified of incident.
FEELING BAD; FEVER; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced feeling bad, and fever. Treatment medications (dates unspecified) included: amoxicillin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and the outcome of feeling bad was not reported. This report was non-serious.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: 911 was called when patient fainted. She was conscious when they arrived. They evaluated her at the store and did not take her to the ER
A few minutes after receiving the shot, heart rate seemed faster than normal. Stayed a few minutes longer due to this just in case. On the way home, heart rate seemed faster, lips/ cheeks/ tongue felt numb/ slightly swollen and started to get lightheaded/ dizzy/ faint feeling. At home, stayed low to ground and head in between knees and tried concentrating on deep breathing. Contacted a couple people who stayed in contact with me--if I did not respond, they were to call emergency # in case I passed out. I then decided to try the Children's benadryl my daughter takes for her tree nut allergy--took 15 mL. Helped reduce some swelling / numbness and other symptoms so that I felt well enough to lie down. Fatigued for next few days. 4 days later, heart rate suddenly increased again w/ lightheaded/ faint feeling --had to go home immediately and rest. About 3 weeks after vaccination while driving my kids, bottom lip, cheeks, tongue went numb/ swelled some/ heart rate increased/ lightheaded/ faint feeling---had to pull over and called a neighbor to come get us and drive us home. Swelling and fatigue still present now a couple days after this event.
Since the second vaccine dose, she has felt periodically fatigue (minor to intense), dizzy, chills, headaches, pain in left arm (where vaccine was administered), and brain fog. These effects were felt minimally at first, then more intensely after several days. During the past three months, she has gone up to 9-10 days without experiencing symptoms, but these eventually return, frequently more intensely than before, for periods of up to 10 days. She is able to function and complete tasks, but the impact of these side effects is overall debilitating, both physically and, increasingly, psychologically. She is increasingly concerned that these symptoms will never go away. In April she contacted Pfizer regarding her side effects, but was referred to her general practitioner.
Dizziness followed by worsening headache starting approximately 30 minutes after Anthrax ,Typhoid and smallpox immunizations. Pt presented back to the clinic with the above complaints. Pt had normal vitals and photophobia was noted on initial exam. Pt had worsening headache 10/10  pain and dizziness to the point in which he needed help ambulating. No local site erythema or reaction. Patient was given Totadol 60 mg IM and his symptoms improved over the next 30 minutes. Dizziness and headache resolved over 45 minutes.
Pt received MMR, PCV, IPV and Hib vaccines on 11/23/2002. Hair started falling out in patches in January 2003. Completely bald by March 2003.
Thrombocytopenic purpura, large bruises, about 10 days later.       Win Rho dose 6-24-99
Patient had swollen left neck all the way down the whole left arm for a day and redness and itching in the injection site for few days. Symptoms resolve by itself without taking any medications or treatment.
sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (sore arm at the injection site) outcome was unknown.            No concomitant medications was provided by the reporter. No treatment was provided by the reporter.   This case was linked to MOD-2021-303933 (Patient Link).
24 hours after vaccines - temp 104-105 with seizure to ER; ROCEPHIN - 6-18-08 - in ER.
almost felt like hit by a truck, shooting pain inner part of the body; Body is full of pain / lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (almost felt like hit by a truck, shooting pain inner part of the body) and MYALGIA (Body is full of pain / lot of pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, OMEPRAZOLE, TIZANIDINE and HYDROCODONE for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (almost felt like hit by a truck, shooting pain inner part of the body) and MYALGIA (Body is full of pain / lot of pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (almost felt like hit by a truck, shooting pain inner part of the body) and MYALGIA (Body is full of pain / lot of pain) outcome was unknown.
Received Prevnar booster (#4) in left thigh on 10/25/04. Developed redness, swelling and pain the following day in same area.
Moderna COVID-19 Vaccine EUA Started getting a tingly/numb face and tongue at 7:10 pm on my way home from the vaccination clinic.  Call PCP and was told to call 911 since the tingly feeling was mostly on the left side of face and that is a sign of a stroke.  Emergency personnel did not notice any other signs of stroke but recommended visit to ER.  Went to ER where the doctor on site performed some physical tests to check for stroke and other issues.  Nothing else was found, I was sent home with instructions to follow up with PCP.  Met with doctor from PCP office on 6/3/21.  No change in face numbness since the previous day.  Instructed to drink lots of water and take motrin.  Still have numbness in face.
No Adverse event; Extra dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Dec-2022, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Extra dose administered) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Extra dose administered).    This case contains the information of 6th out of 13 elderly patient who received the vaccine as described by the reporter. No concomitant medications were reported. Pharmacist called to report that the patient received a 2nd Bivalent booster on 16-Dec-2022, 2 months after the first Bivalent booster. All vials thawed on 16-Dec-2022.  No treatment drugs were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-688372 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-688372:Master case
I was exposed and started to feel symptoms after ten days. I lost my sense of taste and smell and it lasted for two weeks. I did not have a fever and my Oxygen levels were good. I had chills for a few days, and I had a mild cough. I was given an infusion of antibodies on the second day. I quarantined for two weeks, and I was very tired. I got better very slowly and after that I started to get headaches and nausea. Now it has been four weeks and I still have Sinus congestion and some fatigue. I had to go to the doctor this week and I was diagnosed with Long COVID-19 Respiratory infection. I still have some loss of taste.
Generalized mocular-papular rash appeared on trunk.  Mild congestion, low grade fever for 1 week.  Treatment: Calamine lotion, Tylenol, Benadryl.