chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Awoke with alternating chills; Severe arthralgia; Myalgias; General weakness; an intense vise grip like headache began, behind both eyes; Squeezing, not throbbing; Appetite reduced; This is a spontaneous report from a contactable physician, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 08Apr2021 at 13:30 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, osteoporosis and arthritis. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (UNITHROID), calcium (MANUFACTURER UNKNOWN) and ergocalciferol (VIT D); all for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 18Mar2021 at 14:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 09Apr2021, the patient was asymptomatic for first 14 hours, awoke with alternating chills, severe arthralgia, myalgias and general weakness. At approximately 24 hours post, other symptoms continued and an intense vise grip like headache began, behind both eyes, squeezing, not throbbing. No photophobia, nausea, vomiting or fever. The patient had appetite reduced. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of chills, arthralgia, myalgia, weakness, headache, pain and decreased appetite and included treatment with paracetamol (TYLENOL), (3 doses total), intermittently. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe arthralgia was recovered on 10Apr2021. The clinical outcome of the events awoke with alternating chills, myalgia, general weakness, vise grip like headache began, behind both eyes, squeezing and appetite reduced were recovered on 11Apr2021 at 13:30, completely back to normal by 72 hours post.  No follow-up attempts are needed. No further information is expected.
Client presented to the vaccine site for 2nd dose Pfizer vaccine on 1/20/2022. Client received 1st dose COVID Pfizer vaccine on 12/30/2021 and reported that she experienced "sharp chest pain" rated 9/10 3 days after receiving the vaccine. Client described the pain as "sharp and heavy" and explained that she continues to experience this intermittently, approximately 2-3 times per week lasting for 2 minutes at a time. Client reported to Lead RN that she had not followed up with her PCP. Client disclosed that she had an IUD inserted on 12/29/21. Client reported NKDA and no chronic health conditions. Lead RN submitted medical consult for guidance on administration of 2nd dose COVID Pfizer vaccine. Vaccine Operations Lead forwarded guidance from MD with approval for Pfizer 2nd dose and recommendation for "f/u with provider re other health issues". Lead RN advised the client to follow up with PCP regarding chest pain. At 1348 client received the 2nd dose Pfizer vaccine (lot #FJ6369) in the L deltoid. No adverse reaction was reported by client during her 15 minute observation. Client left vaccine site with a steady and symmetrical gait at 1405.
Right deltoid area red, induiated, warm and tender. Mothers state began 3 hours after administration.
Patient started to feel fatigued and run down the evening of the shot. By the next day she can hardly lift her head off her pillow. Also experiencing chills.
Breakthrough case of Covid 19; Breakthrough case of Covid 19; breakthrough case as booster dose of Pfizer vaccine; 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 (BNT162B2), administration date 09Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for covid 19 immunization; Bnt162b2 (Dose 2), for covid 19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 09Dec2021, outcome "unknown", described as "breakthrough case as booster dose of Pfizer vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Dec2021, outcome "unknown" and all described as "Breakthrough case of Covid 19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Dec2021) positive. Symptoms included: cough and mild nasal congestion.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101842425 Same reporter/drug, different patient
Mopey, droopy, no energy. Covid Vaccine 11/2021 at the Hospital within one week had Covid and he went to the ER for an infusion. He had attitude issues and memory issues. Flu Vaccine 10/5/2022 at the local Hospital Covid Booster Vaccine at local Drug Pharmacy on 10/12/2022 ended up in the ER 10/21/2022 and was diagnosed with congestive heart failure.  between 10/12 and 10/21 he demonstrated that he "couldnt think", had memory issues, stated "i am going to the airport to check on their construction on their bushes" and in reality it was the neighbor who was replacing their bushes.  Ended up in the emergency room again on 2/18/2023 and was referred to his heart doctors for heart issues.  Heart Hospital 3/20/2023 medication increase. Talk about a CPAP machine.  Meantime he has upped his anemia pill, and with the congestive heart failure he is taking water pills.  He is still droopy and mopey and very much not like himself.
VIAL FROM PREVIOUS DAY WAS USED TO DILUTE THAWED VIAL ON 8/11/2021. PATIENT WAS ADMINISTERED 0.3 ML. PATIENT IMMEDIATELY NOTIFIED WHILE STILL IN PHARMACY OBSERVATION. COUNSELED ON EXPECTED SIDE EFFECTS. PATIENT WAS ANXIOUS WITH A BP OF 191/75, 193/80. PATIENT WAS ESCORTED TO HER PRIMARY CARE OFFICE FOR NURSE TO TAKE BLOOD PRESSURE. BP READING WAS 145/85 AND SATISFACTORY WITH NURSE. FOLLOWED UP WITH PATIENT WHO MENTIONED DIARRHEA DUE TO NERVES. PATIENT WAS DIGANOSED WITH COVID ON 2/16/2021 AND STATED AWARE OF POSSIBLE SYMPTOMS.
Itching and rashes started to appear on initial date.  This happened for three days and then huge bumps appeared and rash turned in hives.  Given Prednisone to take and Benadryl every four hours.
I would say that the 28th of April was when the adverse event began. So I got a HEP B vaccine booster on April the 20th and I am not sure if the adverse event was from the Pfizer 2nd dose or the HEP B or a combination of the two. I had severe leg cramping for two to three days, no fever, but experienced shortness of breath and severe fatigue. I contacted my Dr on the 30th of April and I did not go in but had blood work a few days later. The Dr did not prescribe me anything for the adverse event. I am still having those symptoms though, the Dr's are not certain that it is coming from these two vaccinations or not.
soreness; This is a spontaneous report from a non-contactable consumer. A 28-year-old female patient received first dose of bnt162b2 (BNT162B2 lot number and expiry date not reported) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced soreness on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021148908 same patient/drug, different dose/event
Information has been received from a medical assistant referring to a 16 months old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported)(Incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Nausea; upset stomach; chills; headache; dizziness; trouble sleeping; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07May2021 at 08:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included post-traumatic stress disorder (PTSD) with anxiety panic attacks and migraines. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications taken within two weeks of vaccination included melatonin (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), venlafaxine (MANUFACTURER UNKNOWN), alprazolam (XANAX) and cetirizine hydrochloride (ZYRTEC); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously took gabapentin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and experienced drug allergy. On 08May2021 at 02:30, the patient experienced nausea, upset stomach, chills, headache, dizziness and had trouble sleeping. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nausea, upset stomach, chills, headache, dizziness and trouble sleeping was resolved on an unknown date in May2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
No fever per mother. Mother called public health nurse stating 2 month old son is waking from deep sleep screeching with high pitched crying. Called private MD told to give Tylenol. By 10:00pm patient feeling better. Patient given immunization approximately 930am.
suspected vaccination failure; shingles very bad; This case was reported by a consumer via interactive digital media 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 patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got very bad shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Moderate to severe left arm pain. for 12 days now post first covid vaccine shot.  Mild neck stiffness also noted. The worse pain on left arm felt on first day, then slowly got better after. However still with Limited mobility (my left arm movement very guarded  due to feeling of soreness on the affected arm), stiffness on left arm.  Ice pack, advil and tylenol, and sometime with cyclobenzaprine, which I thought would help, but did not help.
Covid arm-arm was all red, slightly raised, painful, warm to the touch and some bruising that started the following day around 3:30 pm. The area that looked like bruising started to look like a sunburn and is currently peeling.  Nausea and insomnia for about a week after
PATIENT PRESENTED TO PHARMACY FOR BIVALENT BOOSTER/ THEY DID NOT HAVE THEIR VACCINE CARD BUT INDICATED THAT THE LAST VACCINE THEY RECEIVED WAS OVER 8 MONTHS AGO AND HAD NOT RECEIVED THE BIVALENT VACCINE YET.  AFTER ADMINISTRATION OF THE BIVALENT BOOSTER WE PROCESSED THE VACCINE AND NOTICED THAT THE PATIENT HAD ALREADY RECEIVED THE BIVALENT BOOSTER 6 MONTHS EARLIER.  PATIENT WAS CALLED.  THERE WERE NO SIDE EFFECTS FROM ADDITIONAL SHOT.
neurological ticks like back spasm; This is a spontaneous report from a contactable consumer (the patient who is a private citizen and had a pretty good knowledge of how virus works since she worked with wildlife and rehab them. She is familiar with domestic wildlife virus. She is basically a naturalist and catches wild animals). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER2613) via an unspecified route of administration in right arm on 19Mar2021 14:00 at age of 71-year-old at single dose for COVID-19 immunisation. Medical history included old injuries sustained years and years ago on her C2, T7, T8, L4, and L5, got COVID on 22Dec2020 and when she took the dog to Pharmacy she got another test 06Jan2021 that came back negative. Caller stated because when she had COVID and had a headache that lasted 10 days and she did not want to get the International version. The patient's concomitant medications were not reported. Past drug information was as follows: Caller stated after Prednisone she was at 139 and before was down to 126 and she wanted to be back down to 110, she stated she is quiet chunky. Unknown drug code, lot number, expiry for the prednisone. Caller stated the only thing she sees is the ER. Caller also stated she gained a bunch of weight when she had COVID prior to the shot and got it two days before on 22Dec2020 from neighbor but she was wearing a paper mask like a surgical mask. No prior vaccinations within 4 weeks. No family medical history relevant to AE. Caller stated after the vaccine she is experiencing neurological ticks like back spasm stuff like that from injuries in the past and she has never had this problem. Caller asked if it was a symptom of the vaccine. She got the vaccine on 19Mar2021 and this symptom started on 03Apr2021.The event require a visit to physician office. Caller stated she wanted to try a vitamin B12 shot and she did not want to go to the neurologist or orthopedic because they would say oh we can do surgery. Caller stated she wanted to try a Vitamin B12 and was going for acupuncture to see if that would help because the muscle relaxants did not. Caller also stated she had taken muscle relaxants which did not help. She was unsure of the name, drug code, expiry date as she borrowed them from her neighbor on Sunday. Treatment for the event included Vitamin B12 yesterday to see if it would help, acupuncture, and 3 muscle relaxants she got from her neighbor. The outcome of the event neurological ticks like back spasm was not recovered.  No follow-up attempts are needed. No further information is expected.
Information has been received from a medical assistant concerning an 8 week old male with no allergies and medical history, who on 22-APR-2208, was vaccinated PO with the third 2.0 ml dose of ROTATEQ (lot # 660376/0019X). Suspect vaccine therapy included PEDVAXHIB. TRIPEDIA, (CRM197) PREVNAR. The medical assistant reported that on 22-APR-2008, 25 minutes after receiving the ROTATEQ, the patient vomited. Medical attention was sought by calling the office. The outcome was reported as recovered (date unspecified). A product quality complaint was not involved. Additional information has been requested.
About 30 seconds after receiving the vaccine (which I did not even feel), I developed full body tingling and my heart started to pound very quickly. This did go away on its own after a few minutes, but following this once I was back at work, I had extreme hot flashes and drenched myself in sweat, again with elevated heart rate. This all resolved itself after a couple hours.  I never did have any of the expected immune response symptoms over the weekend.
Pain down fingertips, stabbing pain under armpits, redness on arm, swollen arm, fatigue, fever, naseau
Fatigue, nausea, loss of appetite, tenderness at injection site - started ay of injection, soreness/tenderness and swelling under the (R) arm and outside of (R) breast started 3 days later, resolved 7 days after shot.
Vaccine induced thrombotic thrombocytopenia, submassive PE, DVT, intubated
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 30-DEC-2008, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2014, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Felt fine after the shot, woke up at 1:30am with severe abdominal cramps. Thought I might have a sick belly and used the bathroom, while I was using it I had diarrhea and started feeling lightheaded. Walked back to my bedroom still feeling vertigo/nauseous. I had a feeling of uneasiness and told my partner I didn?t feel right. I laid halfway in the bed on my stomach and broke out in a cold sweat that was dripping down my face and back. Told my partner I thought I was going to pass out, about a minute later I semi lost consciousness. The way I?d describe it was I felt like I was stuck in the undercurrent of a wave and couldn?t come to surface. I could hear my partner saying my name. I was able to come to and I waited an hour before falling asleep. When I woke up in the morning I felt fine, just had a sore arm.
Approximately 16 hours following vaccine (L) arm - ROM decreased. Hard to grip with hand next 24 hours extreme joint pain - hard to ambulate left joints and pain moved to muscles - 5-2-2012 DECADRON IM given. 5-3-2012 slight improvement - Rx ASA. 5-4-2012 - still sore - all over but improving. No Temp. Red non-raised rash to shoulder area above injection site.
Exactly 1 week after receiving the vaccine my arm started getting warm and itchy developing a rash and lumps under my skin at the vaccine injection site.
The first time she had COVID, had a headache and it felt like her head was about to explode; The first time she had COVID, had a headache and it felt like her head was about to explode; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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), COVID-19 (medically significant), outcome "unknown" and all described as "The first time she had COVID, had a headache and it felt like her head was about to explode". Clinical course: Caller stated that during her initial call, she was talking about a home COVID test. The COVID home test had dates on it and she noticed it had expired. Then someone told her it was still good. When she used that home test, the liquid in it was like a slime, so she knew it wasn't good, knew she could just throw that away. She received a bio bottle with papers inside to return the vaccine injectable. She got a card recently saying to return it back. It was clarified it was not any vaccine injectable, she was referring to a COVID home test. She was testing because she had COVID. Then the COVID test was bad so she went to one of the walk in clinics and they tested her, and she found out she did have COVID. She had mild symptoms because of it. She was started on Paxlovid. She never had COVID before. She had 2 COVID-19 Vaccines. The nurse was sick and think it was the nurse who brought COVID. She stated they are the only 3 there and nobody else and the nurse had pneumonia but probably had COVID too. The first time she had COVID, had a headache and it felt like her head was about to explode. Then she had taken another COVID-19 booster, but not right after she had COVID. It was a while after her first time having COVID. When she caught COVID second time, the side effects were better. Had a little cough, nagging cough at night, but they gave her something for that. Because it was 3 days of her symptoms, clarifies that is when they started on her Paxlovid. She stated the Paxlovid did good, she had nothing.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported events Drug ineffective , COVID-19 cannot be excluded,Linked Report(s) : US-PFIZER INC-202300307923 same patient, different drug/event;US-PFIZER INC-202300308269 same patient/drug, different dose/event;
A 2' long deep red rash appeared on the pt's arm about an inch below the injection site. She then developed a rash that spread from her arm to her chest and neck area. Her arm was extremely sore for over a weekand therefore she had difficulty in mobilization.
inconsolable crying for about 20hr beginning about 3hr p/vax;fever 012 controlled w/APAP & Ibuprofen;
Describe the adverse events, treatment, and outcomes?: enter: ?Patient received vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer to freezer on 6/17/21. According to guidance from Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the patient will need to be re-vaccinated.?
Hypoxic respiratory failure requiring oxygen, Pneumonia, Atypical chest pain with troponin elevation, uncontrolled hypertension.
While taking out Expired inventory. I noticed that Layla Randel received a vaccine 1/17/23 one day after the expiration date 1/16/2023. Pulled records which showed vaccine dose without asterisk. Notified local health dept to verify the status of vaccine.  Local Health Dept response. (Notified Staff to contact provider and parent of child regarding non valid vaccine given.) Any expired vaccine needs to repeated even if it was only expired by 1 day.  Since Proquad (MMRV) is a live vaccine, it should be repeated atleast four weeks (28 days) after expired dose was given. I will mark the expired dose as invalid in records. Please let me know if you have any questions. Have a great week!