chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed Guillan-Barre; This is a spontaneous report received from non-contactable reporter(s) (Physician).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but unknown manufacturer.), for covid-19 immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "developed Guillan-Barre".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully 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.,Linked Report(s) : US-PFIZER INC-202201348518 same reporter/product/AE, different patient;
Patient received a dose of Janssen vaccine today despite a previous completed Moderna vaccine. Moderna was not received here, so there was no knowledge of that previous vaccination.
about 5, I sat down to eat supper and I had a sensation in my arm of tightness. Shortly after i experienced a stiffness from the shoulder to the elbow with pain as I tried to use that arm, upward, or outward.  for the headache I took 2 ibuprofen but did not notice any change. I stood in the hot shower for a bit with some difficulty in using the towel to dry.  I used a "Cool & Heat" on the shoulder and this gave some relief . The stiffness made sleep difficult. It is much less this morning.
muscle spasm by the injection site; its like twitching sensation under the muscle / Twitching is all over her body; Feels like she has a bug on her legs, but she doesn't; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (muscle spasm by the injection site), MUSCLE TWITCHING (its like twitching sensation under the muscle / Twitching is all over her body) and FEELING ABNORMAL (Feels like she has a bug on her legs, but she doesn't) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (muscle spasm by the injection site), MUSCLE TWITCHING (its like twitching sensation under the muscle / Twitching is all over her body) and FEELING ABNORMAL (Feels like she has a bug on her legs, but she doesn't). At the time of the report, MUSCLE SPASMS (muscle spasm by the injection site), MUSCLE TWITCHING (its like twitching sensation under the muscle / Twitching is all over her body) and FEELING ABNORMAL (Feels like she has a bug on her legs, but she doesn't) outcome was unknown. Not Provided          Concomitant medications were not provided by reporter. Treatment medications were not provided.   This case was linked to MOD-2021-231175 (Patient Link).
Got a huge reaction to the Pneumovax starting Wednesday afternoon with soreness in left shoulder and 3 really tender spots and red spots with pain lifting arm and swollen LN.
Nausea; Vomiting; Looks flush; Face slightly swollen; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomiting), FLUSHING (Looks flush) and SWELLING FACE (Face slightly swollen) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced SWELLING FACE (Face slightly swollen). On 26-Feb-2021, the patient experienced NAUSEA (Nausea), VOMITING (Vomiting) and FLUSHING (Looks flush). At the time of the report, NAUSEA (Nausea), VOMITING (Vomiting), FLUSHING (Looks flush) and SWELLING FACE (Face slightly swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported Treatment information were not provided
Approximately 7 hours after vaccination, chills, fatigue, and body aches began. Two hours later, nausea and vomiting  and a fever started and continued off and on for eight hours. Fever broke the following morning and vomiting ceased. Back to feeling healthy approx. 24 hours after vaccination. Did not use any medicine, drank adult Pedialyte to replenish fluids.
Temp of 101. 1/20/2010- Saw Dr. Strep test neg. Amoxicillin 400 mg. BID for 10 days prescribed. Gave Ibuprophen at 4:30 p.m. Approx. 6:30 p.m. on 01/20/2010 child awoke having seizure(lasted 3-4mins.).  Went to ER. Temp was 104. Gave Tylenol. Gave Rocephin IV.  Temp. down to 101 on discharge.  Maintained temp of 100 for 1 week (relieved with fever med) then spiked  back up. Temp normal 1/8-2/1.  On 2/2 temp back up to 100 and also today - 2/3/10.
1st dose 24Oct2022, 2nd dose 08May2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 80-year-old female patient who received HAB (Twinrix) (batch number 2PG39) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 24th October 2022).   On 08-MAY-2023, the patient received the 2nd dose of Twinrix. On 08-MAY-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 24Oct2022, 2nd dose 08May2023). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 08-May-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal mail. The patient received 2nd dose of Twinrix later than recommended interval, which led to lengthening of vaccine schedule.
Patient is 62 years old. He was given fluad quad, which is for those people 65 years and up. I spoke with the patient and he described no adverse reaction.
the day after pt received vaccine, she became very tired and started not to feel well. site became red and swollen and warm to the touch. not as red today, but still warm to the touch. i called dr to inform them
Patient presents to the ED with chief complaint of swollen lymph nodes in the area of the left clavicle with pain radiating down his left arm.
Breakthrough case after two vaccines Moderna 6/20/21 Lot3 022B21A;  Moderna 7/18/21 Lot# 002B21A;
Patient fainted and fell on floor after flu shot. She woke up a minute later, but when she tried to sit up, she fainted again. So when she woke up again, I had her lie down on the floor with pillow under her head until the paramedics came. As we were waiting for the paramedics, she said her head and stomach hurt.
37 year old who said that starting an hour after receiving her initial dose of the Pfizer vaccine (she received lot number FF2587 on 9 Sept 2021), she started experiencing dyspnea.  She did not endorse wheezing or coughing, and did not endorse fever, but she said over the next 2 days the dyspnea began getting worse, and she started to experience difficulty with activities such as climbing stairs.  She recalls at one point (about 2-3 days post vaccination) she felt like she was going to black out (she did not actually experience syncope).  The patient saw her PCP on the 10th and had mentioned this, as well as other concerns regarding fatigue (she has a history of hypothyroidism and Hashimoto?s disease), but the dyspnea was not addressed.  The patient says that as of today, she still endorses minor dyspnea.  She denies a history of asthma or other atopic conditions.  No other systemic symptoms.
Dizzy - BP 124/87, pulse 81, 99% O2 sat.
Janssen (J&J) COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 04/01/2021. Patient presented to ED with complaints of shortness of breath x 3 days. On arrival he was placed on high flow nasal cannula. Patient was mechanically ventilated on 8/5/2021 due to worsening hypoxia. Patient received dexamethasone & remdesivir. Patient was transferred to hospital on 8/5/2021. Patient received methylprednisolone, cefepime, meropenem, metronidazole, & vancomycin IV and PO. Hospital course progressed without meaningful recovery of lung function.  On 8/24/2021, family decided to move to comfort care. Patient expired on 8/24/2021.
a "funny" feeling in my mouth/A sore sensation; a "funny" feeling in my mouth/A sore sensation; It felt as if it had been burned; slurred speech; loss of taste; This is a spontaneous report from a contactable consumer.  A 32-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 17Dec2020 09:30 for immunization, administered at hospital.  Medical history included asthma, allergies: aluminum, pet dander, trees/weeds/grass, seasonal allergy. She had not Covid prior vaccination. Concomitant medication included montelukast sodium (SINGULAIR), colecalciferol (VITAMIN D [COLECALCIFEROL]), received within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine.  On 17Dec2020 14:30, the patient experienced a funny feeling in my mouth/a sore sensation, it felt as if it had been burned, slurred speech, loss of taste. Course of events: Within 5 hours of injection she started noticing a "funny" feeling in her mouth. A sore sensation. By 19:30 her tongue was very sore. It felt as if it had been burned. she had nothing hot to eat that day and nothing new to eat. The soreness increased. She also had some slurred speech and loss of taste. The patient underwent lab tests: Sars-cov-2 test (Rapid nasopharyngeal, nasal swab): negative on 18Dec2020. She received no treatment. The symptoms have stayed steady and have not gotten better. The outcome of events was not recovered. The case was assessed as non-serious.   Information on the lot/ batch number has been requested.
Itching; chills; Protruding chest pain; Left breast is hurting and has noticeable lymph nodes that actually feels like it wraps around to the back; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Protruding chest pain), BREAST PAIN (Left breast is hurting and has noticeable lymph nodes that actually feels like it wraps around to the back), PAIN IN EXTREMITY (Sore arm), PRURITUS (Itching) and CHILLS (chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced CHEST PAIN (Protruding chest pain), BREAST PAIN (Left breast is hurting and has noticeable lymph nodes that actually feels like it wraps around to the back) and PAIN IN EXTREMITY (Sore arm). On 24-Apr-2021, the patient experienced PRURITUS (Itching) and CHILLS (chills). The patient was treated with HYDROCORTISONE at a dose of UNK dosage form; VALACICLOVIR HYDROCHLORIDE (VALTREX) at a dose of UNK dosage form; MOMETASONE at a dose of UNK dosage form and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at a dose of UNK dosage form. At the time of the report, CHEST PAIN (Protruding chest pain), BREAST PAIN (Left breast is hurting and has noticeable lymph nodes that actually feels like it wraps around to the back), PRURITUS (Itching) and CHILLS (chills) had not resolved and PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No concomitant product reported.  Action taken with m-RNA1273(moderna COVID-19 Vaccine) in response to events was not applicable. After receiving the first dose of moderna vaccine patient had protruding chest pain and 3 bumps on her back on 13-Apr-2021 were still present but was  lighter in color on 30-May-2021, the bumps were still itchy. After receiving  second dose of vaccine patient got chills, heat bump and itchy and it was ongoing.
Patient had general  malaise unknown cause. Onsite EMS was called vitals BP135/92   99% O2 room air  HR 82 . Patient refused evaluation/care  and released agianst medical advice.
Information has been received from a physician concerning a retired 63 year old white male who on 11/5/02 was vaccinated with a 0.5ml dose of pneumococcal vaccine 23 polyvalent (lot 642750/0210M). Concomitant therapy with oral medications included Claritin 10mg, Prozac 20mg, Wellbutrin Sr 150mg, Lipitor 20mg and viagra 50mg. On 11/5/02 the pt's left arm became swollen, and he developed a rash. On 11/6/02 the pt's left arm was red, had marked inflammation/edema, and was tender. The pt was treated with Clarinex 1 by mouth daily and Keflex 500mg TID. As of the report on 11/19/02, the pt had not recovered and was still being treated. It was reported that the pt had no prior exposure to this or a related drug. Left arm swelling, left arm redness, left arm with marked inflammation/edema and left arm tenderness were considered to be disabling. Additional info has been requested.
Vertigo, nausea, vomiting, diarrhea, complete uselessness of (no control over) but unfortunately not numbness of my right arm (Tdap). It just hung there.
After each Rotateq, no stool for 48 hours then hard pebble stool for 2-3 days. Otherwise fine.
Flu-like symptoms within 18 hrs of vaccination.  Moderate/Severe body aches, fever, chills.  Lasted for about 36 hrs after onset.
As patient was receiving second vaccine (PREVNAR) he said, "I can feel it coming on". The wife then stated that he has had similar reactions in the past. Patient lost conscientiousness for approximately 15 seconds after receiving the PREVNAR. His breathing was labored and his eyes rolled into the back of his head. His wife and the pharmacy intern laid him on  the ground and he regained consciousness and began to breathe more regularly. He  started throwing up approximately 2 minutes later. He remained on the ground with his head down until EMS arrived. EMS said that he was stable and just nauseous in the ambulance. I overheard the wife tell the EMS that he gets "vasovagal" during surgeries and vaccines and that this incident was worse than normal. The patient did answer "no" to the "Has the person ever had a reaction, fainted, or felt dizzy after receiving a vaccine.
I developed diarrhea on March 5th, and still have it today on march 7th.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 10-DEC-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) injection (lot # L029466, expiration date 06-AUG-2017, exact dose and route of administration were not reported). No adverse effects were reported. The nurse also reported that the temperature excursion was secondary to human error. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a caller concerning a 14 year old female patient who on 21-FEB-2011 was vaccinated with the first dose of PNEUMOVAX 23 (Lot #, expire date and route not reported). Suspect therapy administered also on 21-FEB-2011 included AFLURIA. Caller stated that on 21-FEB-2011 within minutes of receiving the first dose of PNEUMOVAX 23 and a dose of AFLURIA, the patient's face became purple and she had difficulty breathing. Caller mentioned that the patient was taken to an emergency room at an unspecified hospital. That same day the patient had been to her physician's office for evaluation of an unspecified illness. The caller reported that the patient had had a flu vaccine in the past, but she believed that this was the patient's first dose of PNEUMOVAX 23. At the time of the report, patient's outcome was unknown. No further information is available. It has been determined that WAES # 1102USA03540 was mistakenly created from WAES# 1102USA03129. Therefore, WAES # 1102USA03540 is being deleted from our files and the reports consolidated into WAES # 1102USA03129.
FEVER; This spontaneous report received from a patient concerned a 37 year old male. 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: 1805025, and  expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Dizziness, double vision and headache about 25 minutes after injection. Vision changes resolved within minutes, headache gone after 24 hours. Dizziness persisted but improving.
Adverse event was the tingling and pain of my skin from my neck to my toes.  I did not develop a rash, but the pain of my skin was a surprise.  Felt like I had the shingles.  Depending on activities it would seem to dissipate, but at night it seems to get worse.  I did take an antihistamine (24 hr.) generic which did seem to help a little.   I did not go to a Dr. or ER to be examined.
Pain at injection site after 2 months. Stinging when injection was given. Visible scarring at injection site. Pain that radiates from arm to neck and shoulder blade. Patient reported to multiple pharmacists at this location, but pharmacy manager assessed arm and vaccination site today.
loss of vision in left eye; herpes zoster; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 05-JUL-2011 at the age of approximately 60 years old, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by a health care provider (reported as provider) for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster and loss of vision in left eye. The outcome of the events was not reported.   Upon internal review, loss of vision in left eye was determined to be medically significant.
1st Moderna shot given on 5/16/2021 left arm Lot number 036C21A and 2nd Moderna shot given 6/13/2021 in left arm Lot 023C21A;  August 10, 2021 I woke up with left leg swelling.  I saw my PCP on 8/25/2021 sent for Doppler to rule out blood out. Results were negative for blood clot.  I saw my PCP again on 9/24/2021 in follow up orders given for X-ray left Knee & prescribed Methyiprednisolone 4 mg 21 tablets to be taken over 6 day period to reduce leg swelling and pain.
Imbalance; Muscle issues; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Imbalance) and MUSCLE DISORDER (Muscle issues) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BALANCE DISORDER (Imbalance) and MUSCLE DISORDER (Muscle issues). At the time of the report, BALANCE DISORDER (Imbalance) and MUSCLE DISORDER (Muscle issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.
pt w/hematoma 2cm size lt thigh;no fever;screaming & crying 4hrs constant p/vax per mom
History of a fever of 106.4F, 6 days after vaccine administered. History of thrush and URI.
Pain at the injection site, muscle pain, tiredness, fever, headache, fatigue, shivering, nausea. Second dose on 12/6/18 at the same pharmacy and I had a worse reaction! I felt dizzy when I received the vaccine. My whole body hurts. I thought I would die.
Patient experienced brief loss of consciousness and seizure 1/2 hr after GARDASIL in car on way home. Episode lasted less than 1 minute. Waited in medical office 20 minutes after injection before driving home without incident.
I have had a swollen thyroid gland (goiter) for about 2 weeks.  Even though I do have both hypo and hyper thyroidism, I have never had a goiter before, so my doctor thought it might be because of the vaccine.
Information has been received from a physician concerning a 13 year old female patient who on unspecified date was vaccinated with the second dose of GARDASIL (lot number not provided). On an unspecified date, "after receiving her second GARDASIL dose ", the patient developed shooting pain, nausea and dizziness a few days after getting the GARDASIL. At the time of this report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Covid postive; admitted to hospital; treated with remdesivir, oxygen and dexamethasone
Multiple incidents of leg weakness, unsteady gait, falls and memory problems, which started about 6 weeks after the second dose.  After speaking with MD believe these incidents were TIAs. On October 14 my husband suffered a STROKE.  unable to enter information under 21. Hospital stay from oOt 14, 2021 with plans for discharge to a rehab hospital on October 23, 2021.  My husband was very rarely sick,  HTN, well controlled with supplements and one HTN med before the stroke.   when needed he saw a PA.
He premedicated with Tylenol and took a 2nd dose later in the day. About 10 hours after the injection he had a mild headache and fatigue. Later that evening he developed body aches, fatigue, severe headache, chills and low grade fever. Symptoms lasted for 24 hours. He also took motrin.