chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 17 year old female who on 05-MAR-2007 was vaccinated IM with the first dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). On 05-MAR-2007, two hours post-vaccination, the patient developed swollen eyes and face and went to an emergency room. The patient underwent sinus films, which were noted to be negative, and was administered BENADRYL and unspecified antibiotics for a possible eye infection. The patient was released that same evening. On 07-MAR-2007, the physician contacted the patient and reported that there was "not much improvement." The patient's swollen eyes and face persisted. Eye and face swelling were reported as other important medical events. Additional information has been requested.
uncontrollable spasms in her left arm; arm became weak/  weaker than her right arm; left arm was numb up to her shoulder; Left arm was tingling; Patients left arm was sore; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (uncontrollable spasms in her left arm), MUSCULAR WEAKNESS (arm became weak/  weaker than her right arm), VACCINATION SITE ANAESTHESIA (left arm was numb up to her shoulder), VACCINATION SITE PARAESTHESIA (Left arm was tingling) and VACCINATION SITE PAIN (Patients left arm was sore) in a 20-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (first booster dose.) and Pfizer doses (primary series). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer doses.    On 04-Nov-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 09-Nov-2022, the patient experienced MUSCLE SPASMS (uncontrollable spasms in her left arm), MUSCULAR WEAKNESS (arm became weak/  weaker than her right arm), VACCINATION SITE ANAESTHESIA (left arm was numb up to her shoulder), VACCINATION SITE PARAESTHESIA (Left arm was tingling) and VACCINATION SITE PAIN (Patients left arm was sore). At the time of the report, MUSCLE SPASMS (uncontrollable spasms in her left arm), MUSCULAR WEAKNESS (arm became weak/  weaker than her right arm), VACCINATION SITE ANAESTHESIA (left arm was numb up to her shoulder), VACCINATION SITE PARAESTHESIA (Left arm was tingling) and VACCINATION SITE PAIN (Patients left arm was sore) was resolving.            No concomitant information provided On 10-NOV-2022 the patient's arm felt better however was still sore, tingling, and weaker than her right arm. No treatment information provided
Large (3x6" oval) red area; some edema in same area; sore & itchy at injection site; persisted several days then started to diminish in size.  Day after injection: generalized muscle weakness and aches (resolved next day). Did not seek treatment.
reddish macular lesion, well circumscribed, 10 inches by 4 inches on  ventral aspect of left arm. No tenderness or warmth, no induration of skin.  Blanches with pressure. No axillary LN.
Patient had body aches, felt ill for a couple days.  Then on 6/30 his right arm became reddened and warm to the touch from elbow to shoulder.  Injection site was swollen and he noted swollen axillary lymph nodes.  Contacted us on 7/10 and was advised to see his physician.  Was diagnosed with cellulitis and being treated with antibiotic.
Per the individual.  He recevied the booster of Janssen at the pharmacy on 10/25/21.  Approximately two days later he had lab work completed at the local office.  He was weak and fatiqued.  He has also been having a work up due to indigestion and "stomach pain".  He stated his Neutrophil level dropped from the "normal range to 42.9 which is a low level in just two days from my booster shot."  Advised individual to follow up with PCP for another blood level if necessary
Covid positive after 1st shot; If patient takes 2nd dose, interval will be more than 42 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Covid positive after 1st shot) in an 85-year-old male patient who received mRNA-1273 for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced COVID-19 (Covid positive after 1st shot) (seriousness criterion hospitalization). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (If patient takes 2nd dose, interval will be more than 42 days). At the time of the report, INCOMPLETE COURSE OF VACCINATION (If patient takes 2nd dose, interval will be more than 42 days) had resolved and COVID-19 (Covid positive after 1st shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Intramuscular) was unknown.       Concomitant medications not reported. Patient had COVID-19 one week after taking vaccine. Treatment medications not reported.; Sender's Comments: This report refers to a case of incomplete course of vaccination for mRNA-1273, lot # unknown  with associated AE COVID-19 positive result. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
migraine; Initial information was received on 02-Nov-2021 regarding an unsolicited valid non-serious case received from other health professional under reference number - US-SA-SAC20211110001044.  This case involves an unknown age and unknown gender patient who experienced migraine, after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included IBUPROFEN (ADVIL [IBUPROFEN]) for Migraine.  On an unknown date, the patient received dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious migraine (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "I realized that my latest migraine coincided with my Oct 28 fluzone hd vaccine. Before that time, I had not made a mental connection on the coincidental timing because I get migraines all of the time at any time of year. I took Advil and zomitriptan and the migraine completely resolved."  No additional laboratory data was reported.  It is unknown if the patient experienced any additional symptoms/events  It was not reported if the patient received a corrective treatment for the event (migraine).  At time of reporting, the outcome was recovered for the event migraine.  There will be no information available on batch number for this case.
This spontaneous case, initially received on 01-Jun-2017, was reported by other health professional (registered nurse) and concerns students in an academic campus, who received flu vaccine. This case deals with seventeenth of 23 reports. From 03-Oct-2016 to 04-Oct-2016, 176 students were vaccinated with FLUCELVAX in the total of 258 students in the campus. In the spring of 2017, an outbreak of the flu occurred and lasted for approximately 10 days. The reporter stated that, from 13-Apr-2017 to 18-Apr-2017, they treated 22 students with flu and among them 5 students had the vaccine on campus. In the beginning of 18-Apr-2017, they treated another 23 students with flu symptoms and only 3 of those had not received the flu vaccine. The students were tested positive for influenza A via rapid flu test with nasopharyngeal swab. This case concerns an  18-years-old patient of unspecified gender. On 03-Oct-2016, the patient received FLUCELVAX QIV (dose, route of administration and anatomical location: not reported, batch number: 185888, expiration date: 31-May-2017). On 23-Apr-2017, the patient was tested positive for influenza A via rapid flu test with nasopharyngeal swab (characterized as vaccination failure). Based on the investigation performed, it can be concluded that FLUCELVAX 185888 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE complaint was the result of the Fill Finish or Bulk manufacturing process and no trends were identified for the batch number 185888, or any other FLUCELVAX QIV batches from the 2016-2017 FLUCELVAX Commercial season. Therefore no internal root cause could be confirmed. Outcome of influenza A virus infection and vaccination failure was not reported. The reporter did not assess the seriousness and did not provide the causality between events and suspect vaccine. The reporter stated that, the students received flu vaccine had less severe symptoms than those who had not received the flu vaccine. Batch review report (QAIR number 1022277) received from quality assurance department on 29-Jul-2017: QA investigation results were updated. Narrative amended accordingly. Non-significant case correction received on 10-Aug-2017: The narrative and case comment were corrected.
pt recvd MMR/HIBTITER vax on 22AUG91; on 28AUG91 inject site was red, swollen, painful & had purulent drainage; also pt devel t101; pt dx cellulitis w/an abscess was made; culture staphylococcus aureus;
Pfizer-BioNTec COVID-19 vaccine Patient received vaccine on 12/22/2020 and on 12/29/20, she emailed us saying that she was feeling sleepy, tired, was having night sweats, and had headaches.  Her head felt like someone had put a heavy stone on it. She can still function.
At night headaches started and lasted all night and they were all over my head, just like I was wearing a helmet. I also had 2 days of beinf lethargic and sleepy. Still feel tired.  I recovered from everything except the trembling and the fatigue.
Information has been received from a physician concerning a 17 year old female who on 25-JUN-2007 at 11:00 A.M. was vaccinated in the right deltoid with the first dose of Gardasil (lot # 658094/0524U) which was tolerated well. After two to three minutes, the patient stated that she felt dizzy and then lasted approximately 30-45 seconds. Additional information has been requested.
her doctor reported to her that another female patient also had neuropathy in the feet; "hemochromatosis" 2 weeks after she received her 2nd moderna dose; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (her doctor reported to her that another female patient also had neuropathy in the feet) and HAEMOCHROMATOSIS ("hemochromatosis" 2 weeks after she received her 2nd moderna dose) in a female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (her doctor reported to her that another female patient also had neuropathy in the feet) and HAEMOCHROMATOSIS ("hemochromatosis" 2 weeks after she received her 2nd moderna dose). At the time of the report, NEUROPATHY PERIPHERAL (her doctor reported to her that another female patient also had neuropathy in the feet) and HAEMOCHROMATOSIS ("hemochromatosis" 2 weeks after she received her 2nd moderna dose) outcome was unknown.            Company Comment- This is a spontaneous case concerning a female patient  of unknown age and unknown medical history, who experienced the unexpected  non serious event of Neuropathy peripheral and hemochromatosis. The event occurred after the second dose of mRNA 1273 vaccine. Event neuropathy peripheral was automatically upgraded as a serious event as per IME list. However, based on the information available and as per medical judgment it is classified as Non-serious.   The Benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.  No concomitant medication details provided. No treatment medication details provided.  The reporter stated that her doctor reported to her that another female patient also had neuropathy in the feet and hemochromatosis 2 weeks after she received her 2nd moderna dose as she stated that same thing happened to the other patient.; Sender's Comments: This is a spontaneous case concerning a female patient  of unknown age and unknown medical history, who experienced the unexpected  non serious event of Neuropathy peripheral and hemochromatosis. The event occurred after the second dose of mRNA 1273 vaccine. Event neuropathy peripheral was automatically upgraded as a serious event as per list. However, based on the information available and as per medical judgment it is classified as Non-serious.   The Benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
behind my ear I feel like it's like the gland is swollen; behind my ear I feel like it's like the gland is swollen/saw the swelling and it's painful, pain a little bit, painful; This is a spontaneous report from a contactable consumer (reported for herself). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration in the left arm on 12Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she had the first dose of vaccine and it was on Tuesday afternoon (12Jan2021) and this morning (16Jan2021), she woke up and felt behind her ear, she felt like it's like the gland was swollen, so she wanted to know if anything to concern about it or she should wait few days or asked if is this normal for the gland could be swollen from an infection but. The further stated she didn't take anything as treatment but stated, its just this morning she woke up and she saw the swelling and its painful, pain a little bit, painful. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Information has been received from a certificated medical assistant referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 03-AUG-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K006117, expiration date 14-JAN-2017, dose and route were not reported). Concomitant drug was not reported. This is one of several reports from the same reporter. Additional information has been requested.
HEADACHE; DIFFICULTY SPEAKING; WEAKNESS ON THE RIGHT ARM; This spontaneous report received from a patient 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, intramuscular, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 08-MAR-2021, the patient experienced headache. On 08-MAR-2021, the patient experienced difficulty speaking. On 08-MAR-2021, the patient experienced weakness on the right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness on the right arm, and the outcome of headache and difficulty speaking was not reported. This report was non-serious.
1st - severe  body aches, severe headaches, lethargic, congestion, coughing  and couldn?t sleep much.  - medicine given was a z-pak, cough medicine and an inhaler.  2nd - severe body aches,  vomiting, diarrhea, severe migraines, severe headaches, blood clots coming out of my nose without nose bleeds. Stomach pains behind my chest. So incredibly tired, - medicine given anti nausea Med, cough Med and pain Med.   Went to Urgent Care then ER.
Patient received ZOSTAVAX on Tuesday May 25th at approximately 6pm and reports that she had developed an itchy rash that became hot, red and swollen. At this point, patient has presented to her physician and the pharmacy as it has been over two weeks and has gradually improved.
Pt arrives with weakness, fatigue, cough, and worsening shortness of breath on exertion. He has a PMH of OSA and is on CPAP at night with 4L of oxygen. Pt admitted for COVID-19 and acute on chronic hypoxia requiring 4L NC during the day.
Moderna COVID-19 Vaccine EUA. Rather moderate joint soreness, Chills, body aches, slight fever.It all started the night of the vaccine with the soreness at the injection site (1/5/21). Then the next morning I was riding in my car (1/6/21 around 9:45am) and a weird virtigo feeling settled in. After that was when the chills started with the body aches. I checked my temperature before I went in to the shower and it was running 99.7. Then when I was showering I had that uncomfortable feeling when the water hits you right before you get sick. Kind of a werid feeling to describe if you've never experienced it before. I have just been monitoring my symptoms and staying home, and hydrating.
On my drive home, I began to feel queasy,  A few minutes later, I felt a rush of heat on my back, concentrated on my right side, but traveled out across my back.  It lasted only a few seconds.  My skin was not sweaty, but I felt like I was really sweating on my back and forehead.  About 3 minutes later, I vomited.   I was sipping water on my drive home.  When I got home, I ate food though I still felt a bit nauseous.  About an hour later, my stomach got more upset , I had a loose bowel movement, but no more vomiting.  Within 3 hours, I was feeling fine. I do NOT have a history of panic attacks or an anxiety disorder.
Developed flat red hive around R arm injection site within 30 minutes- ? end hives across upper back - no respiratory symptoms, vitals stable, monitored in clinic for 1 hr. hives mostly resolved. BP 120/70 HR 80. Discharged 130/80 HR 72. Follow-up call 90 minutes later no change no increased hives. 10/25/05   follow-up call hives have resolved.
fever 103, rash diarrhea, weakness, chills, malaise, hives, h/a, muscle aches;
After H1N1 Clinic @ preschool, it was discovered that vaccine was given to 3yr. old children was for 4yr. old and older. No immediate reaction noted.
Right arm at site is inflamed and sore to the touch.  It is also itchy, burning and warm.  Area of approximately 3" x 3".  This did not start until a week after injection.
Exactly a week after the vaccine I have a red, itchy, hot to touch rash, right over the injection site. Raised bumps.
patient was positive for Covid-19 in October 2020, received Pfizer vaccine on 01/06/2021 and 01/27/2021. Patient admitted to hospital on 05/19/2021 and tested positive per PCR
Full rash from waist up to her body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Full rash from waist up to her body) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy and Shellfish allergy. Concomitant products included BETAHISTINE HYDROCHLORIDE (VERTEX [BETAHISTINE HYDROCHLORIDE]) for Allergy, TAMOXIFEN for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Full rash from waist up to her body). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (Full rash from waist up to her body) was resolving.            This case was linked to MOD-2021-041535 (Patient Link).
Pfizer 1st dose- Not even five minutes after receiving the vaccine I started sweating, dizziness, headache, nausea and getting hives on both arms. They made my crew take me to the ER. When they took my vitals my O2 was 88% and they put me on 4lpm, HR was upper 110s and my BP was 160s/100s... The next day I couldn?t walk, keep my eyes open, had a headache, my whole body was aching and sore. I ended up sleeping for over 20 hours that day, couldn?t eat my husband had to actually help me walk to the shower and bathe me because I kept almost passing out.
Lethargy unable to stand or walk. Extremely fussy and hurting when moved or picked up. Call emergency line and was told to continue giving Advil, apply cold compresses to the site and massage if he would permit.
Rash all over his body; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH (Rash all over his body) 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) (Intramuscular) 1 dosage form. In February 2021, the patient experienced RASH (Rash all over his body). In February 2021, RASH (Rash all over his body) had resolved.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  The concomitant medications and treatment details were not provided.
Information has been received from a registered nurse concerning an 11 year old female with allergic rhinitis and asthma on 14-SEP-1996 was vaccinated SC on right thigh with first dose of varicella vaccine live (Oka/Merck) (Lot# 617690/0568D). Concomitant therapy included a SC first dose on left thigh with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 619015/0471D). At the time of vaccination, the patient did not have any illness. It was reported that on 17-MAY-2007 the patient  developed less than 50 lesions on her torso and legs after returning from camp. The lesions were reported to be very itchy. On 18-MAY-2007, the patient recovered. No medical attention was sought and no diagnostic laboratory tests were undertaken. It was also noted that the patient did not have any adverse events following prior vaccination. No further information is expected. This is one of the several reports received from the same source. It was also reported that the patient's sibling had a similar experience after therapy with varicella virus vaccine live (Oka/Merck) (WAES # 0705USA03993).
@ 1208, Pt. c/o burning/numbing sensation to Rt. arm. I asked if she wanted me to assess her, and she stated that she will be fine. @1230, the Pt was ready to leave. I informed her that if her symptoms worsened, to call her PCP. Pt signed paperwork that indicated she did not want to receive further tx.