chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2022 at 16:30 as dose 4 (booster), single (Lot number: FK9893) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID; VALACYCLOVIR [VALACICLOVIR]; MITOCOR. Past drug history included: Known allergies: sulfa drugs, reaction(s): "Allergies". Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Negative, notes: Felt better 24 hours after taking Paxlovid. Tested negative 3 days later; (01May2022) Positive, notes: About 5 days later felt worse and tested positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. On 27Apr2022, the patient started Paxlovid for the treatment of covid-19 and stopped on 01May2022. Felt better 24 hours after taking Paxlovid. Tested negative 3 days later. About 5 days later felt worse and tested positive. Other concomitant medications in two weeks included: Probono and Orthomolecular.
suspected vaccination failure; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In November 2019, less than 2 years after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 73 or 74 years. The batch number and expiry date of Shingrix were not provided. It was reported that, an year before the date of reporting, the patient received two doses of Shingrix. At the time of reporting, the patient experienced shingles. The reporter consented to follow up. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset for the event and laboratory test confirmation were unknown.
Severe L. arm pain and swelling, L. neck, L. face and head  severe pain w/headache;  chest pain  w/malaise and felt sick.  Incapacitated for 5-6 days .  Symptoms lasted for over a week
Patient had swollen throat and could hardly swallow, sore arm where shot was given, aches all over, and neck and back would hardly let me sit or get up from chair.
This spontaneous report was received from a Registered Nurse referring to a patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 15-MAY-2018, the patient inadvertently received an expired dose of VAQTA (route, dose, frequency, and anatomical location were unknown) with lot # N005605 and expiration date 08-APR-2018 for prophylaxis. No adverse effects were reported.
This patient received a bivalent Pfizer dose on 10/4/2022.  The MA on 1/10/23 gave another bivalent Pfizer dose which was incorrect.  This patient should NOT have received the 1/10/23 dose.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 14-OCT-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021936, expiration date 10-NOV-2016, dose and route not provided). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Rash all over body. I looked up the rash on line, she had never had a rash. I matched it to an HPV rash, and called doctor immediately. I had never seen it and suspected it was a side effect of the HPV vaccination. The doctor examined, said it had nothing to do with the Gardasil, and said it would clear up. It did clear up - but she has never had another rash since and had never had one before. I feel very lucky given the other much more serious side effects but it was still very scary to see a rash like this appear out of the blue. I did not appreciate the refusal to attach it to the recent vaccination as to me, it was obvious that it was an HPV rash.
Like I said previously, it initially started that night, I got the fever and chills, which I was told to expect along with the extreme body aches and tiredness. Most of it (the fever, chills, body aches) went away Sunday and I was just tired with pain in my left arm where the shot was. All of these things didn?t worry me so much, however, Sunday night, the mouth area of my face along with my chin started breaking out into hives. My boyfriend gets hives often so he gave me some Triamcinolone Acetonide Cream that I left on overnight. Today the apparently went down a bit, but they?re still present and I?m unsure what to make of it. I applied more of the cream hoping for the best. Nothing I ate is out of the ordinary from what I usually eat, so it couldn?t be food related and I don?t have a history of hives, so I?m not sure. I still have them and am kind of waiting it out, I?m unsure if mask wearing is gonna help this situation.
appendicitis; This is a spontaneous report from a contactable consumer reported for self. This 42-Year-old male received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunisation. No Covid prior vaccination. No known allergies. No other vaccine in four weeks. Facility type Vaccine: Hospital. He developed appendicitis after the vaccine on 11Jan2021. First symptoms appeared three days after first dose. Checked into hospital for an appendectomy the following day. Treatment was appendectomy. Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 2 days. Lab data included Nasal Swab on 15Jan2021: Negative. Outcome of the event was recovering.  Information on Lot/batch number has been requested.
She received her 1st dose of the Pfizer COVID vaccine. 30 minutes later, she started developing redness of her skin, hives, and itching.  Given Zyrtec, Benadryl IV, IV fluids, and famotidine IV.   Observed for 2 hours. Patient redness of arms and legs improved. Still has redness of anterior chest. She is still itchy and has developed itchiness of the throat. I assessed her throat there was no evidence of swelling or irritation. She wishes to hold off on epi if possible. I will reassess at 1230. 1230: She is feeling much better.  She was observed from 1045-1245 and never required steroids or epi. I will send her home with a prescription for Zyrtec and an epi pen
sore arm; A spontaneous report was received from a consumer concerning a 72-years-old male patient who received Moderna's COVID-19 1556210(mRNA-1273) and experienced events sore arm/pain in extremity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unavailable) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced the event(s) sore arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event sore arm was unknown at the time of reporting.
developed Covid after receiving the first dose; developed Covid after receiving the first dose; This is a spontaneous report from a contactable 71 year old male consumer (patient) who reported that:  Dates for developed Covid after receiving the first dose: (From: Unspecified To: Unspecified) Reporter seriousness for developed Covid after receiving the first dose: Hospitalization Dates when patient was in hospital for developed Covid after receiving the first dose: Unspecified to Unspecified  Additional Context: Caller received the first dose of the Covid-19 vaccine on 17Mar2021. He was supposed to have received the second dose on 02Apr2021. After receiving the first dose he developed Covid and was in the hospital. He is now negative. He is asking when can he get the second dose?  Declines to provide email address. Declines to provide further details. initially provided date of birth but then requested that his birthdate be eliminated.   Communication: PC filed.   Is there a Product Complaint: Yes Description of Product Complaint: Description of complaint: developed Covid after receiving the first dose Product strength and count size dispensed: Covid 19 vaccine
After receiving the injection, I was directed by an RN to sit in a chair for 15min in the same room. Five minutes after the injection I felt my upper back  muscles, ribcage area, contract.  The contraction continued around to the front of my chest with next 3 minutes.  I felt tightness with each breath.  The RN who gave me the injection came to see if I felt alright. She informed the charge nurse that my chest felt tight and the charge nurse came to ask me questions.  The charge nurse called the hospital pharmacist to come to see me.  The pharmacist arrived with various medications and talked to me.  He instructed me to do breathing exercises and meditate.  I told him that I was familiar with these techniques and using them.  I also informed the pharmacist that I had a heart attack in 2018 and had atrial tachycardia but I wasn't feeling any problems with my heart, that it was beating normally.  I also informed the pharmacist of my severe allergies to certain items but I wasn't experiencing any anaphylaxis that I've experienced in past allergic episodes.  The pharmacist left and told the charge nurse to keep me a half hour longer under observation and to call him if I felt worse.  During that half hour, the muscle contractions stopped and I was able to breathe normally.  The charge nurse asked me if I was ready to leave after the half hour was up, I told her I was feeling odd so she said to stay another 20min.   I began to experience intestinal cramping and asked to leave to go to the bathroom.  In the bathroom I had a bout of diarreah that lasted 10minutes.  After that I drove home but was experiencing a headache that started.   The headache lasted for 20hrs. It felt like I was wearing tight hat, squeezing.  Iv'e not had that type of headache before.  My right arm site of injection feels a little warm and is pink but isn't painful.
Date of start of drug 23May2021 06Jun2021; Dolor en el brazo donde fue aplicada la vacuna (Pain in the arm where the vaccine was given).; Dolor en el brazo donde fue aplicada la vacuna (Pain in the arm where the vaccine was given).; This is a spontaneous report from a contactable consumer, the patient.   A 40-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, (Batch/Lot Number: EW0187), via unspecified route, in left arm on 23May2021 at 12:00 (at 40-years age) as 1st dose, single for covid-19 immunization at pharmacy or drug store. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The concomitant drugs were not reported. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, (Batch/Lot Number: EW0196), via unspecified route, in left arm on 06Jun2021 at 01:45 PM as 2nd dose, single for covid-19 immunization. On 23May2021 at 19:00 the patient had experienced Dolor en el brazo donde fue aplicada la vacuna (Pain in the arm where the vaccine was given). The device date was reported as 16Jun2021. The patient had not received the treatment. No other medications were taken by the patient within 2 weeks of vaccination. The patient was not hospitalized. The outcome of the events was recovered in 2021.
hypotension; Initial information received on 31-Jul-2023 regarding an unsolicited valid non-serious case received from an other health professional. This was a courtesy case received from Pfizer.  This case involves an unknown age and unknown gender patient who experienced hypotension after receiving vaccine Tetanus toxoid.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included palbociclib (Ibrance) for Malignant breast neoplasm and Bone neoplasm malignant.  On an unknown date, the patient received a dose of suspect tetanus toxoid produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, formulation, strength, lot/batch number and expiration date: not provided) for Immunisation.  On an unknown date the patient developed hypotension (unknown latency) following the administration of tetanus toxoid.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Day 2 fatigue, nausea, diarrhea, malaise Sore arm from elbow to shoulder from day 1 to day 32 following 2nd dose
within 24 hours my right shoulder and right knee became inflamed,  my lower back also left me unable to bend.  The back, then the shoulder subsided over a period of two weeks.  My knee remained enflamed for four months.   I have also experienced heart palpations since the vaccination.
Information has been received from a physician concerning a female who on 17-JAN-2007 was vaccinated with a 0.5 ml first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 17-JAN-2007 the patient experienced flu-like symptoms described as malaise and myalgia.  Unspecified medical attention was sought.  At the time of the report, the patient was recovering.  Additional information is not expected.
Prolonged secondary amenorrhea for ~90 days with return of spontaneous menstrual cycle on 04/12/2021. Typical cycle length is about 23-28 days. Continuing to monitor for return of regular menses.
soreness in arm, no feeling well, swollen lymph glands for 2-3 days following injection; bad nausea and dizziness when tying to move on Day 8 - can not get out of bed due to the nausea.
Very sore arm , more than any other vaccine I have ever received. It has been improving less than 24 hour later. I woke with a fever (my feet were especially warm) Body aches, especially my joints. Mild cough I have taken ibuprofen and acetaminophen, which help. This was my second Pfizer dose. Other than a mildly sore arm, I had no issues with the first dose
"I" received "my" first dose. On the 2nd day "I" started to feel fatigue; then "my" back, upper hips, calves of both legs and the left arm of the injection site all muscles was very painful.; "My" back, upper hips, calves of both legs and the left arm of the injection site all muscles was very painful anytime "I" used these areas "I" could feel the muscles tighten to the point "I" just had to lay still..; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EWO151) via an unspecified route of administration in the left arm on 20Apr2021 at 11:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, thyroid and depression. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks of vaccination. On 22Apr2021 at 06:15, on the second day after receiving the first dose, the patient started to feel fatigue, then her back, upper hips, calves of both legs and the left arm of the injection site all muscles were very painful anytime she used these areas she could feel the muscles tighten to the point that she just had to lay still. The events did not result in doctor or other health care professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were taken as a result of the reported events and included treatment with TYNELOL. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events started to feel fatigue, back, upper hips, calves of both legs and the left arm of the injection site all muscles was very painful anytime she used these areas she could feel the muscles tighten to the point she just had to lay still were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pt called stating that starting about  6 hours after her second dose of Moderna vaccine, she began feeling ill with fever, chills, nausea, and aches. As of the time she contacted our pharmacy, 5 days later, she states her symptoms are gradually improving but she felt too sick to even make the phone call on days 2-3 following the vaccine. Advised pt to take OTC pain/fever relievers as needed and contact physician if symptoms worsen within 24 hrs.
pt recvd 2nd dose of vax & delivered a premature nl baby; the baby weighed 3 pounds & the estimated gestational age was approx 7 months; This resulted in a prolonged hospitalization;
he had a significant reduction in stiffness; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Num-ber: EL9265; Expiration Date: 31May2021), via intramuscular, administered in Deltoid Right on 04Feb2021 08:18 (at the age of 66-year-old) as unknown, 0.3ml, single for covid-19 immunisation. Medical history included ongoing mild case of diabetes diagnosed two years ago, he has been stiff for many years and when he woke up he had a significant reduction in stiffness. There were no concomitant medications. On 05Feb2021, the patient reported that he has been stiff for many years and when he woke up this morning he had a significant reduction in stiffness. The patient underwent lab tests and procedures which included blood serum was slightly off on an unknown date. The outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
covid positive; covid positive; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2022 (Batch/Lot number: unknown) as dose 4 (booster), single, (Batch/Lot number: unknown) as dose 1, single, (Batch/Lot number: unknown) as dose 2, single and administration date Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "heart condition" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Mar2022, outcome "unknown" and all described as "covid positive". The event "covid positive" and "covid positive" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Mar2022) positive. The patient reported that as of this morning (28Mar2022) she is covid positive and is currently in the ER to be examined for potential monoclonal infusion.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from a nurse practitioner concerning a 19 year old female with no pertinent medical history or drug reactions/allergies who on 12-DEC-2007, 13-FEB-2008 was vaccinated IM with the first and second dose of GARDASIL (lot # not reported), respectively. On 30-JUN-2008 the patient was vaccinated with the third dose of GARDASIL (lot # 660553/0070X, expiration date October 2010). Concomitant therapy included loratadine and TRI-LEVLEN. In MAY 2009 the patient had Papanicolaou (PAP) smear done. The PAP was normal but the human papillomavirus (HPV) reflux did not meet the criteria and was not performed. On 29-DEC-2010 another PAP smear was done which was abnormal and the patient's HPV DNA was positive for high risk HPV. The patient sought unspecified medical attention. The patient did not recover at the time of reporting. Additional information has been requested.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 19-JUL-2016 a dose of improperly stored M-M-R II (lot# L032044, rHA, expiration date 24-AUG-2017) was given to the patient. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reports received from the same source. Additional information is not expected as there is no consent to contact the physician.
PATIENT STATES INJECTION WAS VERY PAINFUL AND IT WAS GIVEN HIGH IN DELTOID; NOTICED IMMEDIATELY HER ARM HURT AND NOTICED AT HOME THAT IT WAS DIFFICULT TO LIFT HER ARM & WAS PAINFUL. THE PATIENT STATED SHE WENT TO SLEEP AND IT WAS IMPROVED THE NEXT DAY, WE CONTACTED HER AS SOON AS WE WERE AWARE OF THE ISSUE AND SHE WAS INSTRUCTED TO ICE THE AREA AND REPORT TO DOCTOR IF ANY SWELLING, WARMTH TO TOUCH, OR INCREASED PAIN. SHE WAS INSTRUCTED TO ICE THE AREA AND TAKE ANTI-INFLAMMATORIES IF WARRANTED AND SHE WILL RECEIVE A FOLLOW UP IN 3 DAYS.
Patient presented 2 days after SHINGRIX Vaccine and had redness of right arm where vaccine was given. There is a 5cm x 3 cm erythemic, warm to touch, raised area to right deltoid area, as well as a satellite type area to about 1cm x 1cm to right. Two weeks after vaccine was given, May 8, 2018, patient reported 2 chicken pox forming.
Posterior Vitreous Detachment of the left eye. Treated by Eye Hospital Physicians. Thorough eye exam. Return to visit scheduled December 13,2022.
general swelling, induration of approx. 50mm, pain with movement and painful to touch. Informed by MD as well as Medical Assistant who administered the vaccine that it would be painful .   With that said, yes it was that and a WHOLE lot more.  There should be some other additive  or solution that should be used to prevent such a reaction and pain.  This vaccine is set out for the elderly and with reduced muscle mass and increased tenderness , it will be no wonder if people do not get the second one.  Some may not even get it at all if they take the advice of someone who did get it.
C/O dizzy, nausea. VS remained stable. P between 76-80, BP 132/76 to 148/72. After D/C from clinic, went to ER. Given BENADRYL, Prednisone, PEPCID.
Pt recv vax on 9/22/98; on 10/3/98 pt exp lacy macular rash over body &bilateral otitis media; tx=Suprax 10mg-5mL daily.