chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got sore in my arm, I got the second shot so it was little bit at the injection site; I got sore in my arm, I got the second shot so it was little bit at the injection site; Little bit of nausea; Headache; I don't wanna eat anything thing because I don't have a good stomach; I don't wanna eat anything thing because I don't have a good stomach; I don't feel good; This is a spontaneous report from a contactable consumer (patient). A 77-years-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration, administered in Arm on 24Aug2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization.  In Aug 2021, the patient had experienced sore in arm and got the second shot so, it was little bit at the injection site but then started getting headache and if the patient took some Aspirin (Further clarification Unknown), it doesn't really doing any and now the patient still had the headache but the patient also have like a little bit of nausea like and didn't wanted to eat anything thing because the patient don't have a good stomach. The patient just wondered how long something like that would last and the patient inquired if the symptoms the patient had are common. The patient needed somebody right now that could tell a simple answer, yes the patient was going to have it for couple days, it should go away, it won't go away.Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever (103 degrees), headache, body aches, dizziness, fatigue.
Information has been received from a female consumer in her 60's, who is an administrator for her physician's medical group but at a different office.  On an unspecified date she was vaccinated in the arm (laterality not specified) with a dose of Zostavax.  There was no concomitant medication.  Subsequently, 2 days post vaccination, the patient developed a fist sized large, swollen, red area at the injection site which lasted one 1 week.  A nurse at the office reported that she thinks the patient had an allergic type reaction.  Unspecified medical attention was sought.  On an unspecified date the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Pt recvd 2nd dose of vax & 12 hr p/vax pt devel severe vertigo, nausea & malaise which persisted up to 3 days later;
CHILLS,  FEVER, SWEATS, WEAKNESS , HEADACHE LASTED 24 HOURS - 10:30 PM FRI. TO 10:30 PM SAT, SOME REMAINING EFFECTS INTO MONDAY (WEAKNESS)
Redness at injection site, slight swelling and itchiness; a little sore and achy (injection site only). This lasted about 5 days.
Felt really bad; Strange tingling in fingertips and hands; Her hand goes numb. It is like a tingling feeling; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: UNKNOWN), via an unspecified route of administration on 01May2021, as 2nd dose, single dose, for COVID-19 immunization and co-suspect drug included celecoxib (CELEBREX; Capsule, hard; Lot Number: Unknown) for arthritis. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: UNKNOWN), via an unspecified route of administration on 02Apr2021, as single dose for COVID-19 immunization. On 01May2021 at night, after the second shot, the patient experienced a strange tingling in her fingertips and hands, which continued. Patient wondered if it was a side effect and does not know if it improved, persisted or worsened. Patient had no prescribing doctor and she went to pharmacy. Patient felt really bad and had not moved around a lot. It started off with her fingers, and then her hand gone numb. It was like a tingling feeling, as if she laid on it , or slept on it. The clinical outcome of the event strange tingling in fingertips and hands was not resolved. The clinical outcome of all other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I woke up at dawn with a feeling of having a concrete slab on top that took my breath away. I did not feel my body and I did not feel that I was breathing, I could not speak .. I managed to get up and get to the bathroom and my body woke up and I had a very strong pain in my arms and legs and cramps. I went back to bed because I was having a brutal dream and I lay in a fetal position on the pillows. I fell asleep and I don't know how much time passed and I woke up again on my back with the sensation of having a cement board on me that would not let me breathe and I did not feel my body, again I could not breathe or speak and I returned to the bathroom with great fear and when my body woke up my arms and legs hurt too much. Despite the dream I had I couldn't sleep, now the pain was incredible. And I was about 10 days without being able to sleep well because I was afraid of falling asleep and not being able to wake up. I am still very tired and have trouble sleeping.
Approx. 2 weeks after 3rd shot (Booster), my legs became heavy and weak. I could not walk normally and experienced loss of balance. THIS IS ONGOING. I am also experiencing stabbing pains at the top and bottoms of my feet and in my calfs, along with reddish toes. Both thigh muscles pain to the touch. Stabbing pain occurs randomly. No fever at any time.   As stated, condition has not gotten better even though I use a stationary bike daily to strengthen muscles.
8/11 - rash and itchiness on the left arm where the shot was given, dull pain in my left underarm and a lump under the left armpit 8/17 - swelling of the area under my right jaw near the throat.  It was blocking part of my airway on the right side.  The left side felt normal.  It started around 6am and lasted about 20 minutes. 8/18 - 20 - Same area under my right jaw near the throat swelled up and went after 15- 20 minutes 8/24 - same swelling occurred again and went away after 20 minutes  8/28 & 8/30 - sensation of a bug crawling on my left leg
The patient reports that when he looked in the mirror he noticed that his right eye was red. He stated that it feels mildly scratchy and "gamey", but his vision is unaffected. He denies discharge and pain.
Within 3 hours of receiving 2nd dose a very swollen red welt began to appear at the site of injection.  The welt itched, as well as burned, and continued to spread in length and width to the point where it reached my elbow.  As of 5/5/21 the welt remains.
My left arm grew increasingly sore and painful. My left lymph nodes in my arm pit grew increasingly swollen 24 hours after my shot. My left lymph nodes in my arm pit were visibly large and swollen and extremely painful the night of the seventeenth, around 32 hours after my shot. I have a high pain tolerance and I considered going to urgent care that night if the pain continued. When I woke up the morning of the 18th the pain had reduced but was still noticeable, swelling had subsided. The night of the 19th, 48 hours after symptoms started, swelling has gone away but left arm pit lymph nodes are still painful to touch.  I would say right under arm lymph nodes were slightly swollen the night of the 17th, but not painful. Occasional nausea up to 48 hours after shot.  I took no pain medication or anti-inflammatories.
FATIGUE, NAUSEA, DIARRHEA, NONPRODUCTIVE COUGH
Welts on head, hives left side, hypersensitivity, eye pain & dryness, inside mouth hurts.
Received Moderna Bivalent Booster on 9/3/2022.   Symptoms began on 9/19/2022 (fever, weakness, sore throat, dry cough).  Treated initially with Amoxicillin.  Symptoms did not improve on Amoxicillin.  Daily fevers as high as 101.7.   Diagnosed with thyroiditis on 10/4/2022.  Currently treated with Prednisone, methimazole and atenolol.   I reported event to Moderna and this is the number we received "Private".
Vomited; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional.    A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 02Mar2021 (at the age of 74-year-old), in arm left as dose 2, single for COVID-19 immunization. And co-suspect reported as zinc, oral from an unspecified date (Batch/Lot Number: DBTE820N6009; Expiration Date: Aug2022) to an unspecified date, at 50 mg, 1x/day for an unspecified indication. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269), via an unspecified route of administration, on 06Feb2021 (at the age of 74-year-old), as dose 1, single for COVID-19 immunization. Patient received first and second dose of Pfizer covid-19 vaccine. Patient said that she only vomited once which was 3-4 days later after getting the second dose of the vaccine. Patient reported that it was on 04Mar2021, which was two days later that she vomited. Patient said that she had been taking a lot of vitamins, she studied vitamins to take once the pandemic started and had been taking a lot more. Patient reported that the Zinc she had taken is 50mg, and it once a day by mouth. Patient clarified that the Zinc wasuj made by store, she bought two bottles and they both have the same numbers. Patient said that she found out she should did not take the Zinc on an empty stomach. Patient had already went to get her second dose they could not find her in the system. Patient said after the first dose they gave her, her birth date was incorrect and she needs to correct that, they did not correct it because it was wrong on her second dose. Patient said that she did have a comment in regards to her dose of the second vaccine. Patient reported that she did vomit but that could had been because she drank her Zinc vitamin without eating breakfast, so on an empty stomach. Patient said this happened shortly after she got the vaccine, but she did not think it could be attributed to COVID vaccine, but maybe a lot of people are thinking from COVID vaccine or Zinc. Patient looked it up on Google, and regarding Zinc it said that the product needed to be drank with food, a full stomach, not on an empty. Patient never had vomited, it was very seldom, and it was listed as one of symptoms of COVID, clarified to COVID vaccine, hopefully not that. Patient clarified that she would like to know if others had commented that vomiting after second dose of the COVID vaccine, though that could have been the Zinc that she took on an empty stomach. Patient said that her vaccine card information and they made many mistakes. Treatment was not received as a result of AE. The clinical outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Hospitalized with CHF likely due to cocaine use, potentially long-standing hypertension. Could be myocarditis. IV Lasix. Did not require oxygen.
Pt received Tdap and Moderna bivalent vaccine at approx 4:20 pm. Pt reports SOB, 8/10 HA, sudden fatigue minutes after Tdap and Moderna bivalent vaccine. Pt has GDM, last ate local sandwich shop at 1:50 pm. BS at 4:28 141 mg/dl. BP 136/84 HR 92 O2 100% Temp 98.6. Pt denies CP, dizziness. Asked about swelling, pt reports pressure in throat, can speak and breathe but feels difficult. Thinks anxiety related, has not had reaction like this before. Reports latex allergy. Reports last Tdap in childhood, no documentation.  Dr. notified and assessed pt. Pt came via bus, advised to have family member pick her up and observe, any worsening s/s proceed to hospital. Pt verbalized understanding. No one able to pick her up at this time, 40 minutes since vaccine, pt feels OK to take bus home, will be with family. ER preCx given for worsening s/s. Pt verbalized understanding.
felt dizzy and a little weak; felt dizzy and a little weak; profuse vomiting; being cold with chills; a little stomach pain; had a severe headache; decreased appetite; swollen lymph nodes; light headed; Dates for doesn't feel like he normally does; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Jan2022 04:30 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single and administered in arm left, administration date 28Dec2021 04:45 (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: DIZZINESS (non-serious), ASTHENIA (non-serious), outcome "unknown" and all described as "felt dizzy and a little weak"; VOMITING (non-serious), outcome "unknown", described as "profuse vomiting"; CHILLS (non-serious), outcome "unknown", described as "being cold with chills"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "a little stomach pain"; HEADACHE (non-serious), outcome "unknown", described as "had a severe headache"; DECREASED APPETITE (non-serious), outcome "unknown", described as "decreased appetite"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes"; DIZZINESS (non-serious), outcome "unknown", described as "light headed"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Dates for doesn't feel like he normally does". Relevant laboratory tests and procedures are available in the appropriate section. The caller was a consumer who received his second dose of the Pfizer COVID 19 Vaccine on Tuesday. He received the vaccine early Tuesday afternoon and woke up at 1AM with side effects. After receiving the vaccine the caller reported having felt dizzy and a little weak, profuse vomiting, being cold with chills, and then a little stomach pain. He also notes having had a severe headache with decreased appetite and swollen lymph nodes. The caller does also note that he has not had any joint pain or diarrhea as well as no rash. State that when he went home and started to eat dinner he wasn't feeling well and he went to bed and woke up throwing up profusely, he was cold and had chills. Caller states it was 3-4 times from 1am-6am. Caller states he had a little bit of stomach pain, a really severe headache, and all day just stayed in bed on Wednesday. Caller states that yesterday he got up and felt fine and is a little better today, he is a little light headed and has a little weakness. States he has been taking his blood pressure and it is basically normal, 130/77 and his pulse was 93 beats per minutes. Caller states that is an average of 3 times.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hepatitis A and VARIVAX given Rt thigh 10/11/2016. 10/18 developed papular induration and discoloration tenderness at injection site. Seen 10/24-
Immediate mildly sore arm persisting for 3 months, then progressing to increasing pain, especially at night, and reduced ROM until Frozen Shoulder (April 2012); say primary care physican, Orthopaedic specialist, 6 weeks Physical Therapy for Frozen Shoulder (adhesive capsulitis). Improved after 7 months.
fever/mild side effect of fever; This is a spontaneous report from a contactable other healthcare professional (HCP, patient himself) via Medical information team. A 24-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; NDC/batch/lot number and expiration date were unknown), via an unspecified route of administration on the left shoulder on 17Dec2020 at 13:30 at a  single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient previously received a flu shot [influenza vaccine (INFLUENZA)] for immunization when he was a kid (a long time ago) and experienced the same reaction, fever. The patient was having a fever/mild side effect of fever on 18Dec2020. He said he just called the number on the packet they gave him at the site, where he got the vaccine and he was wondering if it was okay to take ibuprofen. He did not think they provided him with an NDC, lot, and expiration as it was not on the packet he got; he said they might have put the information on the little card they gave him, but he did not have it with him at the time of the report. He did not know the dose that he was administered.  This was the first injection with this COVID 19 vaccine. He further stated that fever started on 18Dec2020; when he woke up, it was like that, but he woke up at 9AM. The event did not require a visit to an emergency room or physician office. The patient had no prior vaccinations (within 4 weeks). The patient had no investigation assessment. Therapeutic measures were taken as a result of fever/mild side effect of fever. The patient was not recovered from the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
first night after fever, chills, aching muscles, etc. second night after extreme pain in lower right back, position sensitive, some pain with deep breaths third day and night developed cough, still aching muscles, still some pain with deep breaths, lower right back pain improving. having sharp central chest pain when trying to sleep on left side, can't lay on left side. present 7th day, still have productive cough, still feel weak and achy, still can not lay down on left side with out causing sharp pain in central chest area.
having surgery on the "24th" and he was discharged on the "25th; Initial information received on 23-Mar-2022 regarding an unsolicited valid serious case was received from a patient.  This case involves an unknown age male patient who had surgery on the "24th" and he was discharged on the "25th after 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 an unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number: UI684AE or UT5570BA, expiry date: 30-Jun-2017) via unknown route in unknown administration site as prophylactic vaccination. Information on batch number was requested.  Patient stated that health care provider may not have recorded accurately the flu vaccine that he received. His health care provider stated that they did not give him an intradermal shot, but he thinks he may have been given an intradermal shot, because it was different from any shot he had received before. At one place in material, he had about what may be his case, it mentions a quadrivalent flu shot and then elsewhere it mentions a trivalent flu shot. Patient stated that the trivalent vaccine may have been expired. The healthcare provider gave him one lot number UI684AE, but he thinks a different lot number may be involved, lot UT5570BA. Patient mentioned having surgery on the 24th (month and year not specified) and he was discharged on the 25th (month and year not specified) (surgery, latency: unknown) but unable to clarify further details. At one point he mentioned going to the emergency room.   Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the events (having surgery on the "24th" and he was discharged on the "25th).  At time of reporting, the outcome was Unknown for the event having surgery on the "24th" and he was discharged on the "25th.  Seriousness criteria: hospitalization for the event of surgery.; Sender's Comments: Sanofi company comment dated 25-Mar-2022: This case concerns an unknown age male patient who had surgery on the "24th" and he was discharged on the "25th after receiving vaccine influenza vaccine. A significant temporal relationship cannot be established due to lack of information on event onset date and product start date and hence, causal role of suspect vaccine cannot be excluded in occurrence of the event. Further information such as condition at the time of vaccination, medical history, concomitants, would be needed to rule out alternative etiologies. Based on the reported information, the role of an individual vaccine cannot be assessed.
Pt stated on 2/18/21 he had muscle pain, swelling at injection site, headache, nausea, and a rash.  And this has lasted since injection on 2/18/21. Pt contacted today to verify information and he stated he went to the clinic on 3/8/21.
The student became lightheaded about 5 minutes post injection.  No acute breathing distress or hives @ 1040.
Administered on 02/19/2023. The BUD for this vial was 02/18/2023
This spontaneous report as received from a certified medical assistant refers to an unknown number of patients of unknown ages and gender. On an unknown dates the patients were vaccinated with a dose of ROTATEQ (lot #, expiration date, dose, route unspecified) stored as high as 53F and as low as 26F for unknown periods of time. No adverse effect was reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. She reported that a pediatric patient was administered an expired dose of RECOMBIVAX HB (lot # 668558/0894AA, expiry date 17-MAY-2013, intramuscular, dose was unknown). No adverse effects were reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2021 as dose 1, single (Lot number: EW0167) and on 14May2021 as dose 2, single (Lot number: EW0161) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing). There were no concomitant medications. The patient had no known allergies. There was no other medication in 2weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received oral paxlovid for COVID 19 Treatment from 25Jun2022 to 30Jun2022. COVID symptoms rebound/recurred on 07Jul2022.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.
Pt began w/fever in early afternoon 2PM; APAP given all day & night; fever 104.6; Pt was brought to Hosp 6AM w/convuls lasting 45min; IV valium was given; MD plans to do EEG;