chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nauseous; severe stomach cramps; shortness of breath; chest tightness; diaphoretic; chilled; cold to the touch, ashen; cold to the touch, ashen; patient was treated as if a heart attack; This is a spontaneous report from a contactable healthcare professional (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 29Jan2021 15:30 at a single dose for Covid-19 immunization. Medical history included high BP, and cholesterol. Patient had no known allergies. Concomitant medications included amlodipine and simvastatin. The patient experienced nauseous, severe stomach cramps, shortness of breath, chest tightness, diaphoretic, chilled, cold to the touch, ashen on 01Feb2021 at 15:30. Ambulance was called, patient was brought to the ER and was hospitalized on an unknown date for 2 days. Treatment of events: patient was treated as if a heart attack, nitro, baby aspirin. Patient was not diagnosed with Covid-19 prior to vaccination. Patient has not tested positive for Covid-19 after vaccination. Outcome of the events was recovered.   Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completely excluded based on a compatible temporal relation. Case will be re-assess once additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
I WASN'T GOING TO BOTHER WITH THIS, BUT THEN A DOCTOR OF MINE TOLD ME TO REPORT IT JUST IN CASE.  ON THE 1ST SHOT (AND I HAD THE 2ND SHOT YESTERDAY), I HAD MANY OF THE COVID SYMPTOMS I HAD IN THE PAST, BUT JUST SPED UP TO ONLLY 5 DAYS - THE ONE THING THAT HAPPENED THAT I HAVE NOT SEEN REPORTED BEFORE IS THAT I LOST MY SENSE OF SMELL FOR A DAY - IT WAS VERY OBVIOUS BECAUSE I COULD NOT EVEN SMELL VICKS VAPOR RUB
Quality: itches. The pain is mild (no pain at rest, but movement can trigger mild pain). Associated symptoms include a limited range of motion (some pain with abduction).
I26.99 ACUTE PULMONARY EMBOLISM 10/15/2021 AORTIC VALVE STENOSIS I95.9 HYPOTENSION 10/29/2021 AORTIC VALVE STENOSIS
painful injection site arm; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE PAIN (painful injection site arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, 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 PAIN (painful injection site arm). At the time of the report, INJECTION SITE PAIN (painful injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported. It was reported that patient did not have lot number and expiration date of the dose, and also did not remember which arm the patient received the vaccination.   This case was linked to MOD-2021-348585 (Patient Link).
Starting on Wed afternoon my left arm at the injection site became rock hard, flaming hot and extremely swollen. Upon consultation with my doctor she suggested topical Benadryl oral Benadryl and Tylenol. As well as cool compresses on the injection site. Beginning on Friday evening  the pain began to subside and has gradually gotten better over today Saturday.
Fever for 3.5 days of up to 103F. Also developed a rash on his torso and back, also some parts of his legs and arms. Rash still present 1.5 weeks later. MD checked for strep b/c of mildly red throat, but negative.
Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 63 years old female patient for whom they have a patient under 65 yr old a FLUZONDE HD yesterday was reported, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no other vaccines. On 16-Oct-2018, the patient received a 0.5 ml  once dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI977AC via intramuscular route in the right deltoid. The patient developed a non-serious they have a patient under 65 yr old a FLUZONE HD yesterday (drug administered to patient of inappropriate age) unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient had not reported any side effects. Lab data was not reported. Final diagnosis was they have a patient under 65 yr old a FLUZONE HD yesterday.  This case is actual medication error due to inappropriate age at vaccine administration. Outcome of the event was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none
Pt reports headache, sore arm, and fatigue 1 day after vaccination. Pt reports symptoms resolved in 1-2 days.  Upon receiving the shipment of Pfizer in March, it was entered with the incorrect expiration date of 11/15/2021. It was discovered on October 25 , 2021 after looking for expiration extension dates for Moderna, 044A21A, that the lot number was in fact expired on 08/31/2021. Moderna manufacturer was contacted regarding incident. Moderna manufacturer gave estimated of 8-10 days before final decision regarding expiration date and if dose was valid. Patient was notified on 11/02/2021 and made aware of the situation. Pt desires to wait until final decision before coming in for possible repeat dose.
16 year old patient received MMRV instead of MMR and Varicella vaccines. MMRV is only approved for 12mon-12yrs according to FDA and CDC. 13 and over should received MMR and Varicella individual vaccines.
Information was received from a nurse who reported that on unknown dates, multiple unspecified patients were vaccinated with improperly stored VAQTA (lot numbers, expiration dates, dosages, and routes of administration unknown). No adverse effects reported. Excursion information: Temperature: 32 degrees Fahrenheit to 35 degrees Fahrenheit Time frame: 1 hour 40 minutes Previous temperature excursion: No Involved "data logger"? Yes No further information provided. This a one of several reports received from the same source. Telephone call attempt on 22-MAY-2017 to obtain follow-up information was unsuccessful. Follow up information has been received from the reporting nurse (also reported as a certified medical assistant (CMA)) on 12-JUN-2017. It was reported that the temperature on the refrigerator was too cold for 5 days. The minimum temperature was ranging from 34 degrees Fahrenheit to 35 degrees Fahrenheit between these days. The maximum temperature was 42 degrees Fahrenheit. And the temperature when discovered on 25-APR-2017 at 12:45 pm was 40 degrees Fahrenheit. The dating was never notified by an alarm going off as the reporter was assuming the average time the temperature was cold was no longer the 20 min for each occasion (due to delay limit on "Tempguard" system (20 min delay), it was received from the system, all excursions were 20 minutes). Refrigerator was taped that no one was allowed to use any vaccines until each manufacturer was called to make sure. The reporter called the manufacturers seeking information about use the vaccines in the refrigerator. All companies stated vaccines were okay to still be used, with exception of opened vials, which were discarded.; Sender's Comments: US-009507513-1704USA013562: US-009507513-1707USA000474: US-009507513-1707USA000472:
Low-grade temperature ranging from 99.8-100.3; chills; body aches; fatigue; This is a spontaneous report from a non-contactable nurse (patient). An adult female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), intramuscular on the right arm on 16Dec2020 18:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Dec2020 05:00, the patient experienced low-grade temperature ranging from 99.8-100.3, chills, body aches, and fatigue. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovering. The events were considered non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Had shot 2 around 1:30pm on 5/20 - shortly after midnight around 12:30am 5/21 I woke up with severe stomach cramps which led to  diarrhea and throwing up for about 20 minutes then began itching all over my body and broke out in hives everywhere and started  having trouble breathing - I immediately took several Benadryl and waited to see if it would help.  I ended up falling back asleep and didn?t have to seek medical help.  Fast forward to Tuesday, 5/25 I woke up around 11:30 with severe stomach cramps and had diarrhea again. I didn?t throw up this time.  Within 10-15 after the diarrhea finished I broke out in severe hives all over my body and the itching was way worse than the first episode. I was having difficulty breathing so had someone drive me to the Emergency Room.  I was immediately taken back to a room and administered an epi-pen and given Benadryl and dexamethasone in iv then given iv fluids. Around 4am they decided they needed to keep me for observation because my blood pressure was so low. At that time it was 85/49.  They decided to release me around 1:00 and at that time my boss was 94/57?.however when I went to unhook from the machine it had fallen to 89/54.  They still release me and told me to follow up with my doctor on 5/27.
pt woke up @ 2AM w/t104.1; mom gave APAP; t101.2 @ 8AM; mom called this morning & will call PMD;
Burning pain in arm at time of injection, then burning pain off and on for about 8 hours after the injection.  Sore muscle in the arm of injection for 4 days.  Extreme hot flashes and sweating starting 22 hours after injection, and ongoing  off and on for 24 hours.  Menstrual cycle started 8 hours after injection, which wasn't due for 12 days.  Stomach cramping (not menstrual cramping-actual stomach cramps) started 10 hours after injection, and continued off and on for 28 hours.
This spontaneous report as received from a pharmacy intern refers to a 80 years old female patient with no drug reactions or allergies. The patient was vaccinated subcutaneously with lot # (671786/0254AE; expiration 08-MAR-2013), 0.65 ml dose of ZOSTAVAX on 05-AUG-2012. No other co-suspects were reported. Concomitant medications included verapamil (manufacturer unknown) and lovastatin (manufacturer unknown). On 06-AUG-2012 the patient developed redness, a warm sensation and burning pain at the injection site. The patient went to the pharmacy on 08-AUG-2012, no treatment was given and no lab diagnostic tests were performed. The outcome of the events was reported as not recovered. The relatedness for the reported events was not provided for ZOSTAVAX. Additional information has been requested.
Urticaria on feet and lower extremities approximately 10 minutes after immunization. Given Benadryl and observed for 30 minutes.
Per patient, "Friday night I began having a fever, headache and nausea. Fever has come and gone, but currently do not have a fever."
CV recieved an IM Hepatitis B Vaccination in the shoulder. 1.5 hours later, patient developed pain in her arm. It began to swell up and become hard. She was unable to move her arm. She recieved Bactrim and Vicodin as treatment. The reaction dissapated over 1 week
body aches at the beginning which was followed by joint pain.  Both of these symptoms progressively became worst throughout the day.  I experienced nausea and loose stool.  Around 2pm I had a headache.  At this point, the joint pain was so severe it was painful to rub lotion on my hands and sitting in a chair was very uncomfortable due to the body aches and joint pain.  When I got home I took my temperature and I had a low grade fever of 100.5.  Friday morning I woke with all of the same symptoms and my fever was now 102.3.  I took some ibuprofen which helped with the pain and fever.  These symptoms continued through Saturday minus the loose stool.  The nausea wasn't as bad on Saturday.  Friday and Saturday my upper left jaw was hurting.  By that evening it had progressed to my lower left jaw.  Sunday, my left side jaw no longer hurt but high in my upper right jaw especially when I opened my mouth.  It's Monday morning and if I cough my head feels like its going to explode and the swelling in my right arm covers a 5"x 6"area and my muscles surrounding that area are sore.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 23-OCT-2015, the patient was vaccinated with the first dose in the series of three GARDASIL (dose, route, lot # and expiration date were not reported). It was reported that the second dose was administered of GARDASIL 9 (dose, route, lot # and expiration date were not reported) on 01-FEB-2016, and the third dose in the three doses series was administered of GARDASIL 9 on 06-APR-2016. No adverse effects were reported. Additional information has been requested.
brown urine; 'brown ear end'; received the Pfizer Covid 19 Vaccine Booster on Wednesday 01Dec2021; General Measles; muscle weakness; tiredness; achy joint/achiness in knees; temperature 101.3/Fever; Chills; Achiness in back; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 35-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), administered in arm left, administration date 01Dec2021 (Lot number: FD0809) at the age of 35 years as dose number unknown (booster), single for COVID-19 immunisation. Relevant medical history included: "Chronic migraine" (unspecified if ongoing). Concomitant medication included: EMGALITY [GALCANEZUMAB]. Vaccination history included: COVID-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 01Dec2021, outcome "unknown", described as "received the Pfizer Covid 19 Vaccine Booster on Wednesday 01Dec2021"; MEASLES (medically significant) with onset Dec2021, outcome "recovering", described as "General Measles"; MUSCULAR WEAKNESS (non-serious) with onset Dec2021, outcome "recovering", described as "muscle weakness"; FATIGUE (non-serious) with onset Dec2021, outcome "recovering", described as "tiredness"; ARTHRALGIA (non-serious) with onset Dec2021, outcome "recovering", described as "achy joint/achiness in knees"; PYREXIA (non-serious) with onset Dec2021, outcome "recovering", described as "temperature 101.3/Fever"; CHROMATURIA (non-serious) with onset 03Dec2021, outcome "unknown", described as "brown urine"; CHILLS (non-serious) with onset Dec2021, outcome "recovering", described as "Chills"; BACK PAIN (non-serious) with onset Dec2021, outcome "recovering", described as "Achiness in back"; OTORRHOEA (non-serious) with onset 03Dec2021, outcome "unknown", described as "'brown ear end'". The patient underwent the following laboratory tests and procedures: body temperature: (Dec2021) 101.3. Clinical course: Per caller she received the Pfizer COVID-19 Vaccine Booster on 01Dec2021. Per caller, she experienced the common side effects muscle weakness, tiredness, achy joint, temperature 101.3. She felt much better today. She started voiding brown urine on 03Dec2021. Patient stated that she is well hydrated. Patient also reported having fever, chills, general measles, achiness in her knees and back especially. But on 03Dec2021, she was presented with like a 'brown ear end' (further not clarified) all day and she had not seen that as common side effect, so was not sure if it could be something more serious.  Follow-up attempts are completed. No further information is expected.
The 3rd day, 60 hrs post vaccination, started developing racing heart at rest.  I am very active and my resting heart rate is always around 70.  The 3rd day to now the 14th day, I develop racing heart rate at rest, especially at night.  I saw my physician on 31st and HR was 117 at that time.  It has been in the mid 100"s daily off and on.  She said it was a normal process of immunity.  My EKG on the 31st was normal.  She prescribed Xanax to help sleep.  My condition has not improved at all and I am concerned with getting my second vaccine on 4/16.
sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient got Shingles vaccine and made him/her sick. The patient bucked up to, however he/she had issues on how vaccine was given, between the restrooms at pharmacy. The patient asked that could he/she not get the shingles vaccine at the doctor's office and found that disgusting. The follow up would not be possible as no contact details were available.
Myalgia, Fever, NauseaVomiting, Pain at injection site Narrative:
Pt receiving COVID booster dose.  There was concern after 2nd dose (and 1st?) that she had an anaphylactic reaction requiring administration of IM Epinephrine.  Both previous doses were Pfizer as well. Her PCP recommended she receive a 3rd dose d/t high risk status from use of RA medications. Was given 3rd dose in monitored setting. Within 10 min.  of administration of 3rd dose 10/22/2021 had urticarial rash, which progressed to nausea, tachycardia and subjective throat swelling with mild uvular edema. Received a single dose of IM epinephrine, IV diphenhydramine, saline bolus. Responded well to initial medical therapy, no hypotension occurred, and was discharged from ED following observation  for 3 hours and was back to baseline with normal vital signs.
This solicited report was received from a pharmacist concerning five unspecified female patients of unknown age enrolled in a market research program. The patients' concurrent condition, medical history and concomitant therapy were not provided. On an unknown date in 2015 (reported as last year), the patients were vaccinated with unspecified doses of PNEUMOVAX 23 intramuscularly (dosage schedule, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant medications were not provided. After received the PNEUMOVAX 23 vaccine, the patients experienced injection site pain and a red swelling arm. The outcome of the injection site pain, injection site swelling and injection site erythema was reported as recovered with sequelae on an unspecified date. The reporter considered the events to be related to PNEUMOVAX 23 and considered the events to be medically significant. Additional information has been requested. This case was created in order to correct the aware date of 1611USA010878 which was entered incorrectly as 22-NOV-2016 instead of 21-NOV-2016.
Knot/rash/mild soreness at injection site-Patient monitoring site at present. She will take non drowsy allergy medication as she will go to work today. She will return to clinic/ER as needed for worsening symptoms.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The indiviudal was vaccinated with the Moderna product on 01/29/2021, 02/26/2021, and 11/05/2021. They became symptomatic for COVID-19 disease on approx 12/28/2021 and tested positive for COVID-19 via antigen test on 12/29/2021. They were also seen in Emergency Dept on 12/29/2021 but were not admitted to hospital at that time. About a  month later,  on 01/19/2022, the individual fell and had rib pain after this fall. On 01/21/2022, they fell again and then presented to Emergency Dept on the same day; they had fractured multiple ribs. The clinic notes from this emergency dept encounter describe that the individual had "essentially recovered" from the COVID-19 illness but was still experiencing an ongoing cough. The individual was admitted to hospital on 01/21/2022 due to multiple factors contributing to overall poor health. They were discharged to hospice care at a Skilled Nursing Facility on 01/24/2022. They died on 01/26/2022. Death Certificate does have COVID-19 as a contributing factor in this death.
Around 04/01/2021, that is when it reached a point when it was extremely noticeable. It began by creating discomfort from my lower back into my upper thighs. It was in my shoulders to my lower arms. And at 1st I thought it was related to bursitis, I have bursitis in my right hip but as it got worse it became much more limiting. Through blood work and different test, there are inflammatory marker they were looking for and that is how it was diagnosed and being treated.  It was diagnosed as polymyalgia rheumatica-PMR. It is being treated with prednisone. I started 15 mg, 3 to 5 times a day. and now I am being weaned off of it, it's like 1 mg per week. Today as we speak I am down to 10 mg. So far my symptoms have not come back. I would say I am recovered when I am not on this medication. The medication has side effects: weight gain, bloating, it can contribute to cataracts. It's murder on osteoporosis. I have osteoporosis, so I have to take another drug to treat the osteoporosis. The goal is to take me off the prednisone as quickly as possible without having a flare up of this condition and that is why it has to be done very slowly.
After 30 min slight tickle in throat a little heavy in chest and pulse increased slightly - feel a little weird all over functioning began with slight blotchy rash then became red flushed urticaria over entire body 1215 total body - 50mg BENADRYL. Needed BENADRYL x 3 over next 48 hours. Very drained x 4 days.
11/10/2022 was making dinner and began feeling like I had an upset stomach. Thought it could be gas and took gas meds with no relief. Vomited on the way to the car when I went to ER. Went to walk-in clinic and was transported by EMS to ER. ER started an IV and pain meds. Did CT with contrast and it was determined that it was acute appendicitis and was admitted for an emergency appendectomy. Appendix and everything surrounding it was inflamed. Was discharged on Sunday 11/13/2022.