chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pronounced weight loss began within two weeks of the first dose. Patient lost 30 pounds in 3 months. She was diagnosed as a Type 1 diabetic July 12, 2021.  Her symptoms during those three months included weight loss, dizziness, fatigue, sensitivity to heat, racing heart, easily out of breath, nausea and vomiting.
Some of it is coming back out; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE EXTRAVASATION (Some of it is coming back out) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025S202A) 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 INJECTION SITE EXTRAVASATION (Some of it is coming back out). At the time of the report, INJECTION SITE EXTRAVASATION (Some of it is coming back out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. No treatment information was provided.
Had the classic fever, headache and body aches, but 5 week later still have extreme lower back pain and knee joint pain, way more than is normal for me.  I did have back surgery in early December but had a follow-up a week after vaccination and X-ray showed everything in back was looking good, yet pain persists and did not have it the two months leading up to the vaccination.
14 minutes post vaccination i began to have a rapid heart, trembling hands, feeling like I?m about to pass out. I informed The nurse  and she had me lay down. I had Tachycardia, systolic BP in the 170 range, and 98% O2. I was Transferred to the ER and during transfer my chest began feeling mildly tight. An EKG was done and it came back clean. I was observed and monitored for several hours and eventually the symptoms subsided. This all occurred for roughly 2 hours.
Lack of efficacy - COVID-19 2nd booster; Lack of efficacy - COVID-19 2nd booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Lack of efficacy - COVID-19 2nd booster". Event took place after use of product. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
allergic reaction to the Pfizer shot; paralyzed; This is a spontaneous report received from a contactable reporter (Consumer or other non- HCP). This consumer reported for a male patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as single dose for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (medically significant) with onset Nov2021, outcome "unknown", described as "allergic reaction to the Pfizer shot"; PARALYSIS (medically significant) with onset Nov2021, outcome "unknown", described as "paralyzed". Clinical course: The caller was calling regarding a report she had previously filed regarding her reaction to the Pfizer Covid shot. During the call, she stated that she went for a test one day and she told the nurse that she had an allergic reaction to the Pfizer shot and the nurse told her that so did her husband and now he was paralyzed.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Pfizer-BioNTech COVID- 19 Vaccine EUA: Vaccine recipient experience vasovagal syncope post vaccination
Itchy, blotchy, bright red medium sized patch that is painful to touch & very itchy. Has been nearly 3 weeks since I got the injection.
On 03/14/01 pt noticed a growing area of swelling, inflammation and pain at injection site. Pt noticed the area growing for 3 days and then sought medical attention. Cellulitis was dx by a MD on 03//9/01. Pt completed a 10 day po antibiotic regimen ,
Information has been received from a physician concerning an 11 year old female who in 2001 was vaccinated with varicella virus vaccine live (Oka/Merck). On 03-NOV-2007, the patient developed zoster. The physician did not provide any additional information. The patient sought unspecified medical treatment. At the time of the report, the patient has not recovered. Additional information has been requested.
Starting about 11pm the day of receiving the 2nd SHINGRIX vaccine, began to experience excessive urination that continued for 8 hours overnight. Could not sleep, partly due to the expected muscle aches & chills, but also the need to get up & urinate. On Oct 3, was excessively dehydrated with dizziness & low blood pressure - 86/50 -- and normal is at least 125/75. Realizing the problem - drank large amounts of fluid to rehydrate -- and found did not have a return to normal urinary patterns until about 6pm Oct 3 -- meaning did not urinate much during that day, but have been normal for about 12 hrs at this time. Muscle aches & fever has subsided. My main reason for reporting this side effect is that I have found no mention of excessive urination on any of the websites I consult for side effects from medications.
Information has been received from a medical assistant concerning a female patient (age not reported) who in November (reported as "Noember") 2013 was vaccinated with dose one of GARDASIL (route and site not reported) for disease prevention. On 13-MAR-2014 the patient received the second dose of GARDASIL. No adverse effects noted to patient. The patient did not seek for medical attention. Additional information has been requested.
Please see ER physician note below. Patient later expired at 1337 on June 12th.  One day after receiving the COVID vaccine.   ER physician note:  Patient presents completely unresponsive, CPR in progress Patient's wife reports that this afternoon, they were lying in bed and he leaned over to her and said "help me".  He then became unresponsive.  She reports that she believed he may have aspirated because he has an issue with his esophagus where he is unable to adequately swallow food sometimes.  The family began CPR at home, and reports that EMS arrived approximately 10 minutes later. Patient arrived here at the ED around 1250.  CPR continued.  Patient given multiple rounds of epi and bicarb.  Patient intubated with an 8 at 21 cm with some cold liquid around the tube.  He was intubated at arrival.
I started feeling like I was getting my period even before I got my second shot. On the one hand, maybe I was and it was just a coincidence. I had the typical brain fog, muscle and overall body fatigue. Nothing horrible, but it was there. The second shot itself was no big deal and I went about my day no problem afterward. I was just surprised when I started menstruating given that I haven't actually bled in more than a year because I am on the Mirena IUD (inserted in 2018). Period symptoms like tender breasts and being foggy heads or tired for a day is one thing, an actual period is another. I haven't even had spotting in at least a year, probably two. I had active (light) bleeding for 2 or 3 days. I am now two and a half weeks post my second shot and my breasts are as tender as if I am getting my period imminently, which doesn't make sense at all given the timing. I had the most painful mammogram I have ever experienced in my life on Friday (April 23) though the results were clear. Other than that, and since the moment I got my shot,  I have felt perfectly fine. Maybe a little tired and hungover feeling the day immediately after the shot, but nothing more.
26MAY98 pt recv vax & reported fine body rash which started on 28MAY98 still has pruritus & rash on 5JUN98;has body rash;
On day two began to have hot sweats and chills, muscle aches, fatigue, headache. Day three was worse, and then the symptoms subsided - except that I continued to have hot sweats episodes, especially at night. It has been two weeks now and I am still having hot sweats. It is a mild symptom, but ongoing
Shingles in eye, 3rd visit to ER/The patient was diagnosed with shingles (in the eye and back of the head); The patient was diagnosed with shingles (in the eye and back of the head); First ER visit, was treated for a Urinary tract infection (UTI); Not eating, 4th time in ER; Not sleeping, 4th time in ER; Dehydration, sent to a rehab facility; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included eye dryness (The patient had picked up a prescription for dry eye at the time he was vaccinated for Shingrix).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles, urinary tract infection, appetite absent, insomnia and dehydration. The patient was treated with antibiotics nos (Antibiotics Therapy (Unknown)). On an unknown date, the outcome of the ophthalmic herpes zoster, shingles, urinary tract infection, appetite absent, insomnia and dehydration were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster, shingles, urinary tract infection, appetite absent, insomnia and dehydration to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: The reporter was the daughter of the patient. The patient was diagnosed with shingles in the eye and back of the head shortly after receiving the first dose of Shingrix. The patient had picked up a prescription for dry eye at the time he was vaccinated for Shingrix. The daughter was not sure of the date of vaccination, but it was prior to 11 September, 2022. Following the vaccination with Shingrix, the patient was seen in the Emergency Room (ER) no. 4 times within 7 days. The first ER visit was on 11 September, 2022, the patient was treated for a Urinary tract infection (UTI), had given antibiotics, and was sent home. The patient had went back to the ER on 12 September, 2022 and sent home. The third visit to the ER on 14 September, 2022, the patient was diagnosed with shingles and was sent home. Because the patient was not sleeping, or eating the patient ended up in the Emergency Room again on either 17 September or 18, 2022. He was treated for dehydration. He was subsequently sent to a rehab facility. The reporter and patient live in different states. The reporter had believed that the pharmacy below was where the patient had received the Shingrix vaccine. The reporter had consented to follow-up. Additional supportive information: The vaccination date was not reported and from the narrative it was not clear when the event was started the time to onset was captured as unknown for events. The case has been linked with case US2022157209 reported by same reporter.; Sender's Comments:  US-GSK-US2022157209:Same reporter.
slight site pain; chills; sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "slight site pain"; CHILLS (non-serious), outcome "unknown", described as "chills"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: Reporter was asking for information on the covid vaccine trials the booster trials". "Patient received both shots from Pfizer. Her 2nd dose (Pfizer covid vaccine) was on 26Jan2021. She knew a booster trial was going on. She thought she would be a good candidate for the trial. She had the normal side effects with the 2nd dose. After the first dose Patient had slight site pain but it was because she slept on that arm. She stated "You have a good product". She want to participate for the booster trials. She also stated that she had received both doses and had the normal standard side effects like chills and a sore arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a health professional concerning 3 pts who in approx. 9/00 were vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent (lot 635893/0690K). Subsequently, the pts experienced cellulitis and malaise. The reporter expressed a concern with the lot number. Unspecified medical attention was sought. Additional information has been requested.
pt was seen @ hosp on 25APR94 approx 1PM w/t102 & shaking; mom states pt had sx @ 18mon of age & was seen @ hosp;
Information has been received from a nurse practitioner concerning an approximately 66-year-old female who on 26-OCT-2007 at 12:08 pm was vaccinated subcutaneously in the right deltoid with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot# 652722/1127R). No previous dose had been given. There was no illness at the time of vaccination. On 26-OCT-2007, the patient was inadvertently administered a dose of varicella virus vaccine live (Oka/Merck) instead of a dose of zoster vaccine live (Oka/Merck). It was unspecified if medical attention was sought and the nurse practitioner confirmed that this was not a case of product confusion, but rather human error. Subsequently, no problems were reported. No product quality complaint was involved. Additional information is not expected.
suspected vaccination failure; shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The reporter stated that he/she had the shingles shot experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Discovered on 10.12.17 that vaccine was expired. Called pt to schedule re-vaccination time.
Immunizations administered 2-26-20. She developed a fever up to 103 degrees the morning of 2-28-20. She had an episode of perioral cyanosis. and tremors. Evaluated in ER. Dx with febrile seizure.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Concomitant medication was not provided. Treatment medication was not provided
At 10 pm I started getting uncontrollably shaky.  I could not calm down - teeth chattering - full body shaking.  My husband covered me with an extra blanket until I could stop... which did happen within 20 minutes and I was able to sleep. ... until around 2 am.  I looked because I did not want to get out of bed because I felt weak...but I thought I had to vomit... so I tried to get up to make it to the bathroom.  I stood up and fell on the ground.  My legs could not support me.  I started moaning.  I told my husband I had to vomit and he encouraged me to crawl to the bathroom on scoot and fall at a time.  When what seemed like forever I got to the tile floor, I laid my head on the tile and it felt so good that I crawled the rest of my unclothed body on the tile.  And stayed there sweating profusely for what my hubby said was 40 minutes.  I can't recall that much time.  But when I woke up I was in a puddle of liquid.  My chest was dripping wet and my back was in a puddle.  My husband thinks I peed, but it's unknown if I could actually sweat that much or if I had an involuntary pee that I can't recall.   But when I got up I made it back to the bed without vomiting (the urge passed) and slept until morning.  In morning I felt weak but ok.  Able to eat and function, etc.  I felt good enough by afternoon to strip bed and wash towels that hubby used to dry floor.  It was a huge scare.  In retrospect maybe I had a 24 hour covid?  I had gone to jury duty that morning with 400 other masked people in a big room....    In the weeks that followed I had more heart palpitations than usual.   I call them heart murmurs but not sure what they are.  I got a checkup and went to cardiologist but by the time I got in to see him, the heartbeat went back to normal so I didn't do all the tests.
Left leg reddened, swollen, warm to touch 3cm x 5cm, rash around injection site left upper thigh.
We both got the Pfizer vaccines and now we are both taking Paxlovid; We both got the Pfizer vaccines and now we are both taking Paxlovid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (172086).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LORAZEPAM; ROBITUSSIN [DEXTROMETHORPHAN HYDROBROMIDE]; ALKA-SELTZER FLU; TUMS [CALCIUM CARBONATE]; MOTRIN [IBUPROFEN]; CLARITIN [LORATADINE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "We both got the Pfizer vaccines and now we are both taking Paxlovid".  Clinical course included Reporter states that he is on his 2nd day of taking Paxlovid. Reporter states that his doctor told him to stop taking Lipitor while taking Paxlovid. Reporter states that his doctor told him to continue taking his blood pressure medicine Lisinopril and Hydrochlorathiazide. it was reported that Referred Reporter to follow up with his doctor for clarification and informed Reporter not to stop taking any medications before first consulting with his doctor.Reporter is a male consumer who is calling on behalf of his wife, withheld (female), who was prescribed Paxlovid today and just picked up her prescription from the pharmacy. Reporter states that both he and his wife have both been vaccinated with Pfizer Covid19 vaccines. Reporter states "it is 3pm here now and my wife would like to know if she should take her 1st dose of Paxlovid now or wait until this evening" Reporter also states "Reporter started my Paxlovid yesterday at 9:00 and then took my evening dose at 9pm and then my morning dose this morning at 9:30.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200726753 same reporter/drug/event, diff patients
First dose caused him a lot of pain; Pain generally all over his body but mostly joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN (non-serious), outcome "unknown", described as "First dose caused him a lot of pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "Pain generally all over his body but mostly joint pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
allergy; Initial information received on 30-Apr-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves adult female patient who experienced allergy (hypersensitivity) when received vaccine TETANUS TOXOID.  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious (pertussis) allergy (hypersensitivity) (unknown latency) following the administration of TETANUS TOXOID.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event (allergy).  The event outcome was unknown for allergy.  There will be no information available on the batch number for this case.
Pt recv vax on 2/2/99; on 2/3/99 pt exp erythema, induration, warm area of arm