chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse (RN) concerning a 20 week old white male who on 22-Jun-2005 was vaccinated in the right thigh with a second dose of Hib conj vaccine (OMPC) (Lot #650357/0083R). The RN reported that on 11-Jul-2005, the patient developed reactive nodule and abscess on his right thigh. The patient's abscess was lanced at the physician's office. The patient's reactive nodule and abscess were considered to be resolved. No further information is available.
At 9pm of the day of the vaccination (Monday August 16) I came down with a fever, body aches, chills, headache, extreme fatigue, pain, shortness of breath, and pressure in my chest/heart/lungs/upper back area. On Thursday the symptoms resolved EXCEPT for a continued headache, shortness of breath, unproductive cough, and pressure in my chest/heart/lungs/upper back area and they continue even today, August 26. I started my menstral cycle a week early, The Thursday after vaccination instead of the following week. I bled for 6 days instead of 3 days and before this, my periods have been consistent to the exact day for a solid 12+ years, since after my last pregancy, every 28 days. Every day since the vaccination, multiple times a day, I break into a sweat as if I have a fever for no apparent reason and then it passes. The pressure in my chest is still present as I am typing now, it has not subsided.
t104-105, swollen lymph nodes, h/a, arm hurting prescribed ATB & pt improving;
Swelling of elbow and shoulder. Rash on neck. Pustule of shingles on cheek.
72-year-old white male with a past medical history of CAD, CHF, COPD, hypertension, cholesterol and prior strokes.  Patient had just received a second Pfizer dose and had waited appropriate 15 minutes without issue.  He was then wheeling his wife in her wheelchair out to their car.  When he was halfway there he started developing a pounding sensation in his midsternal chest without radiation.  When he got in the car it was associated with significant diaphoresis.  Rapid response was called and the patient was brought to the ED immediately.  Initial EKG does show an acute lateral MI.  Patient additionally had 2 episodes of vomiting.  He denies any recent fever, chills, cough, runny nose, sore throat.  He denies any abdominal pain or urinary symptoms.  He has been compliant with his medications but his medical record states that he has a history of noncompliance.  He additionally was just seen by cardiology and was advised that everything was stable in the neck follow-up with me in 6 months.  He rates his pain as a 10 out of 10.
Dizzy, chills, headache, fatigue....for the first 2 days then nausea and lightheadedness for added for next three.
Symptoms were noticed by patient on 7/31/2021 and were visible by pharmacist on 8/5/2021 at 6:45pm.  She states she has a 3 inch red area at injection site and it is hard in the middle.  It is warm to the touch.  On 8/5/21 she noticed burning, hardness  and itching at vein in fold of left arm.  She has not seen any physicial.    I recommended to take Benadryl tablets or capsules orally for the itch, take acetaminophen for the pain, and apply a cold pack to the area.
7-6 admit: 5-6 day h/o headache, dizziness, nausea, has h/o migraines. Occ blurry vision and scotomata. Thrombotic thrombocytopenia purpura requiring 5 days of plasmapheresis. Pt vaccinated on 6-25 for Tdap, MMR, varicella.
pt had chickenpox vax 12DEC97 & chickenpox on 16MAY98;
Cheeks started flushing, became hot, and irritated; Cheeks started flushing, became hot, and irritated; This spontaneous case was received on 07-Oct-2022 from other non-healthcare professional (consumer) via Communications (reference number: SEQW22-04164), with additional information received on 11-Oct-2022 (reference number SEQW22-04340) (being processed together) and concerned a female patient of an unreported age.  The patient's medical history and concomitant medication were not reported.  On 06-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, anatomical location: not reported) for influenza virus vaccine indicated for active immunization against influenza caused by influenza virus subtypes A and B contained in the vaccine. The batch number reported was 348368 and expiry date 30-Jun-2023.   On the same date, at 11 am, about an hour after receiving Flucelvax Quadrivalent, the patient's cheeks started flushing, became hot, and irritated. The patient reported it to the nurse.  The outcome of the events was unknown.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A patient of an unreported age was vaccinated with Flucelvax Quadrivalent. About an hour after receiving Flucelvax Quadrivalent, the patient's cheeks started flushing, became hot, and irritated. Causal role of the suspect vaccine is assessed as probably related, due to suggestive time relationship and no alternative aetiology provided.; Sender's Comments: A patient of an unreported age was vaccinated with Flucelvax Quadrivalent. About an hour after receiving Flucelvax Quadrivalent, the patient's cheeks started flushing, became hot, and irritated. Causal role of the suspect vaccine is assessed as probably related, due to suggestive time relationship and no alternative aetiology provided.
About 15 hours after my second dose of the Pfizer vaccine, around 3:15AM on 2/18/21, I woke up with chills, nausea, aches in my neck, back, head, and at injection site. Took my temperature twice and it was 100.3 each time. I then proceeded to dry heave for about ten minutes.      Around 8AM I spoke with Employee Health. She asked about other symptoms and I informed her that I noticed small, tender bumps near my groin when she asked about swollen lymph nodes. Shortly after this phone call I vomited and my temperature had gone to 100.6. I took Tylenol every 6 hours the rest of this day and slept.     The next day, 2/19/21, upper arm where the shot was administered was sore to the point where I could not move it. I continued taking Tylenol every 6 hours although most other symptoms had subsided.     By 2/20/21 I was still feeling lethargic and sore but stopped taking Tylenol to get a true temperature; fever has not returned since.     As of today, 2/22/21, I would say I am at 95%. Still have a minimal amount of lethargy and swollen lymphs but other than that I am fine.
Information has been received from a nurse concerning a 25 year old female patient with no drug reactions/allergies who on 11-SEP-2009 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL. On 02-NOV-2009, the patient was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot # 665547/1318Y) at 15:00. Later that evening, the patient developed an injection site reaction. She developed a 1 inch band of red petechiae that extended from injection site to elbow. The arm was swollen and the patient had a slight fever. She was treating with ice. The patient sought medical attention at the physician's office. There were no lab diagnostics studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
COVID-19 case.  I've had a cough for 2 weeks. I had fever, congestion. I didn't need to go to the hospital but I was pretty sick. I felt awful. I took Paxlovid for 5 days and was put on an inhaler.
Extreme arm pain at injection site, muscle weakness in arm, inability to use arm fully, weakness lasted ~2 months and pain ~9 months.
Grey dots on legs; This case was reported by a pharmacist and described the occurrence of skin discoloration in a infant patient who received Hib (Hiberix) for prophylaxis.   Concomitant products included HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (HIBERIX).   On 17th August 2022, the patient received the 2nd dose of Hiberix. On an unknown date, less than 3 months after receiving Hiberix, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Hiberix.     Linked case(s) involving the same patient:  US2022AMR171044, US2022AMR171048, US2022AMR171052   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced the gray dots on right thigh that have been noted on patient's legs after receiving Hiberix. The reporter consented to follow up. Additional supportive information: This case has been linked to the case US2022AMR171048. This was 1 of 19 linked cases, reported by same reporter; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171062:Same reporter
Approx 6 mos after shot #6 (24Sep95) a raised rash formed on left upper interior side of arm. Rash red, itchy. It also was some type of rash for right arm same spot. Rash on right arm resolved, left is not. Pt saw provider on 24May and was given a hydrocortisone type cream to apply shortly after and seemed rash appeared in proximity to left axilla area. This rash was on part of the arm. Pt has refilled cream x1 and rash is still present. However rash does not always itch. Pt also states possible spread to inner thigh area, but not as severe.
Fever, redness at injection site, body aches, pain at injection site, malaise.
This case was reported by a healthcare professional via a sales representative and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with BOOSTRIX. On an unspecified date the subject received unspecified dose of BOOSTRIX. At an unspecified time after vaccination with BOOSTRIX, the subject experienced injection site redness and raised area injection site. At the time of reporting the outcome of the events was unspecified. Per the sales representative, there were two reports of injection site redness and raised area injection site. Please see A0865132A for an additional report of injection site redness and raised area injection site.
Fatigue and muscle aches that interfered with normal daily activities, stayed in bed for about 2 days. Sore arm.  No fever or other symptoms.  Pregnant 30 weeks and 5 days at time of second dose administration.  Estimated date of delivery  2021.
started with "lump in throat" (feeling of swollen throat) about 5pm; progressed over course of evening to swollen eyes, fatigue, "I don't feel right,"  "I feel weak;" able to sleep only in spurts "my head feels swollen;" following morning continued with subjective swollen throat (but able to swallow), noticeably swollen eyes, fatigue, weakness
Patient began to develop pain 2 hours after vaccine administration. Approximately 4 hours after administration was unable to move arm due to pain. Injection area and down elbow of vaccinated arm was swollen and red and hot to touch. Follow up with patient and stated arm no longer swollen and was without pain and completely normal by 9/27. Patient was later admitted to the hospital for elevated glucose but vaccine arm was OK.
feeling dizzies; Pt can't drive and is dropping things with their hands; vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feeling dizzies), MOTOR DYSFUNCTION (Pt can't drive and is dropping things with their hands) and VERTIGO (vertigo) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced DIZZINESS (feeling dizzies), MOTOR DYSFUNCTION (Pt can't drive and is dropping things with their hands) and VERTIGO (vertigo). At the time of the report, DIZZINESS (feeling dizzies), MOTOR DYSFUNCTION (Pt can't drive and is dropping things with their hands) and VERTIGO (vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
getting a reaction from the vaccine; getting the chills; itchy all over; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (getting a reaction from the vaccine), CHILLS (getting the chills) and PRURITUS (itchy all over) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     The patient's past medical history included ADHD since an unknown date. Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) for ADHD, FEXOFENADINE HYDROCHLORIDE (ALLEGRA ALLERGY) for Allergy.   On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced ADVERSE REACTION (getting a reaction from the vaccine), CHILLS (getting the chills) and PRURITUS (itchy all over). At the time of the report, ADVERSE REACTION (getting a reaction from the vaccine), CHILLS (getting the chills) and PRURITUS (itchy all over) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Histamine level: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include Birth Control pills. Patient took an H2-blocker and anti-histamines to treat the symptoms. She stated that she took Allegra regularly during the day and that she added Benadryl every night to boost the dose of her anti-histamine, and Pepcid 40mg which she did not take on a regular basis.   This case was linked to MOD-2021-104392, MOD-2021-104392.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 9:04 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 9:04 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 76.64 Years.   Concomitant products were not provided.   On 17-Feb-2021, Excursion time was 09.04 AM, temperature was 22, total doses given for the day was 62, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 11-Feb-2021, vial was moved to clinic on 17-Feb-2021. 5 vials were sent to clinic. Vaccine BUD date was 13-Mar-2021.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.   Temperature recordings were taken using a traceable temperature monitor at every hour.   After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.   It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.   Treatment medications were not reported.
I had an angry red patch at the injection site; Mark appeared that's 2 inches in diameter and is getting larger; Arm was swollen; Sore arm; Itching all throughout the body; Nausea; Achiness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (I had an angry red patch at the injection site), NAUSEA (Nausea), MYALGIA (Achiness), HEADACHE (Headache) and RASH (Mark appeared that's 2 inches in diameter and is getting larger) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cholesterol (Takes a cholesterol medicine.). Concurrent medical conditions included Allergy (allergic to mosquito bites). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced NAUSEA (Nausea), MYALGIA (Achiness), HEADACHE (Headache), PRURITUS (Itching all throughout the body) and PAIN (Sore arm). On 07-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (I had an angry red patch at the injection site), RASH (Mark appeared that's 2 inches in diameter and is getting larger) and PERIPHERAL SWELLING (Arm was swollen). At the time of the report, VACCINATION SITE ERYTHEMA (I had an angry red patch at the injection site), NAUSEA (Nausea), MYALGIA (Achiness), HEADACHE (Headache), RASH (Mark appeared that's 2 inches in diameter and is getting larger), PRURITUS (Itching all throughout the body), PERIPHERAL SWELLING (Arm was swollen) and PAIN (Sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treated with clobetasol cream 0.5mg applied for infected area.   This case was linked to MOD-2021-038402 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up on 21 Apr 2021 12.50 Pm: added medical history- allergic to mosquito bites and cholesterol , updated products tab- 2nd dose information, added concomitant drugs- Synthroid & a cholesterol medicine, the generic for Crestor as daily maintenance medications and added events of  07Feb2021: Her arm was swollen, & she had an angry red patch at the injection site. On 21-Apr-2021: Follow up on 21 Apr 2021 2.15pm: Events are still ongoing On 30-Apr-2021: Non-Significant follow up
Patient received FLUVIRIN vaccination on 11/22/13. She is complaining of shoulder pain after receiving vaccination. According to patient, has not taken any pain med. to help but still in pain (shoulder).
bilateral forearm hives; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6202 and expiry date: 30Jun2021), via an unspecified route of administration, administered in left upper arm, on 05Mar2021 12:25 (at the age of 62-year-old), as dose 1, single, for COVID-19 immunisation in Department of Health. Medical history included Hashimoto's, heart arrhythmias, allergy to sulfa drugs, asthma, allergy to shellfish, blood pressure, thyroid, inhalation therapy. Concomitant medications included amlodipine taken for blood pressure; levothyroxine taken for thyroid disorder; albuterol sulfate taken for inhalation therapy; mometasone furoate (ASMANEX HFA) taken for an unspecified indication. The patient gets allergy shots for 30 years and would get puffy at the injection site. The patient gets the flu shot every year with no reaction. She doesn't have lot or expiry for any of the products she has received. The patient took bactrim and experienced hives all over and was reported that she might not be allergic anymore. Patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. On 05Mar2021 evening, the patient noticed bilateral forearm hives. She had a long-sleeved shirt and didn't notice it until that evening. One was on the right arm and the rest were on the left arm. She got the injection in left arm. She was not sure if there was something in the vaccine causing the hives. Two of the hives went right way. The others lasted two days. It was reported that, the patient gets heart arrhythmia from Benadryl, so the doctor told her to get Zyrtec without the D. The reporter doesn't have the lot and expiry for the Benadryl that gave her heart arrhythmias. The patient called her primary care doctor and talked to the PA. The PA said to call the number, take antihistamine, and if she started to wheeze go to the hospital. The patient wants to know if she should get the second dose after this reaction. The patient took Zyrtec: expiry: Sep2022, lot: BDC033 due to the event. The outcome for the event was recovered in Mar2021.  No follow-up attempts are possible. No further information is expected.
Caught the flu no matter what; Initial information received on 11-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via social media  This case involves an unknown age and gender patient who experienced caught the flu no matter what ,while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (unknown dose, formulation, via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient reported Like never any more the only time I caught the flu no matter what (influenza) (unknown latency) you think. Four years now without flu shot and 4 years now without flu.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Caught the flu no matter what).  At time of reporting, the outcome was Unknown for the event caught the flu no matter what.