chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got the shot - got the flu anyway; Initial information received on 23-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a patient unknown age and gender who experienced got the shot - got the flu anyway  after receiving vaccine INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect of INFLUENZA VACCINE produced by unknown manufacturer (lot number, formulation, dose, expiry date, strength: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.   It was unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
This is a spontaneous report from a contactable consumer reporting for himself. This 93 year-old male patient of an unspecified ethnicity received PREVNAR 13 (NDC number 00005-1971-02) at single dose and FLUZONE QUADRIVALENT VACCINE (lot 02517-18IN, NDC number 492810417-50)  at 1 dosage form, both on 19Jan2018 for vaccination. The patient medical history was none. Concomitant medication included hydrochlorothiazide, triamterene (TRIAMTERENE 37.5 mg AND HYDROCHLOROTHIAZID 25 mg)  once a day to keep his feet from swelling. The patient lost the hearing out of one of his ears on 20Jan2018. No relevant tests were done.The patient was not recovered. He wanted to know if this could be a possible adverse event of pneumococcal 13-val conj vac (dipht crm197 protein). The information on the lot number has been requested.
Skin Inspection:  R lateral thigh:  faint 5 mm gray colored bruise (presumed to be vaccine injection site).  Surrounding bruise, w/majority of affected area being lateral/posterior to injection site, is erythematous, maculopapular rash in circular shape, ~ 7x8 cm diameter.  Mild warmth and swelling of affected area stated above.  See pictures attached to this note.  Borders outlined w/marker for parental monitoring of rash for enlargement.  2-3 mm erythematous, papular lesions on waistline (#8-10), upper back, chest and few on arms (total of approx 8-10 different lesions scattered on other named locations).  No vesicular or pustular heads. Palpation:  nonfluctuant.
Patient stood up, was noticing discomfort in arms where he received two vaccines today- MenACWY in the right arm and Men B in the left arm.  The left arm hurt badly as her raised it above the shoulder level and he fainted.  Came to within seconds of hitting carpeted floor.  No injury.
1pm approx. 10 min post  vax given, some tingly tongue. Some anxiety 1:10 Gave Zyrtec 10mg  1:13 pulseox 98, bp 138/71, pulse 98, some anxiety noted; Gave Benadryl 25mg per patient request 1:23 Tongue tingly gone,  1:40, she felt fine and she went back to work ;  Discussed calling MD prior to next vaccine and consider an allergist
Flu shot administered on 11/13/03, woke up on 11/14/03 approx. 7 a.m. could not get any air into lungs. gasping for air. Husband call 911, went to hospital in ambulance.  ER administered shot, and breathing treatments. Gave me two prescriptions: Prednisone 20mg 1,3x's a day (Q-15) and Doxycycl 100 mg 1, 2x's a day (Q-20).  If symptons persist follow up with Dr.
rash on my upper thighs; left more inflamed than the right. Eventually went away. Ittchy.
Patient reports extremely swollen, red, itchy arm at site of injection beginning 9 days after vaccination.
Pt went to sit down to wait 15 minutes after his Pfizer/BioNTech COVID-19 shot at about 7 pm on March 22, 2021.  Approximately five minutes later he mentioned to his female colleague who was with him that he felt feverish and sweaty and when he reached over to get a drink from his water bottle he fell over and passed out for a few seconds.  By the time I ran out to check on him he was already getting up and I had him sit in the chair while my technician called 9-1-1.  The paramedics soon came out (I think it was about 10 minutes) and checked him out.  Both theirs and my IR thermometers showed a normal temperature.  His BP was normal according to the paramedics.  They asked some more questions and ultimately let him go home under his own power with his female cohort.
Initially started as wandering abdominal discomfort, and anxiety, followed by peripheral numbness/tingling left arm, bilateral calves. Most debilitating was brain fog and severe lightheadedness. First e.r. visit I had cat scan of abdomen. Insignificant findings. 2 days later, a second e.r. visit cat scan of head. Negative Insignificant findings. Lightheadedness and calve tingling dissipated 01/13/2021. Current slight c-spine discomfort, left distal arm tingling.
Mother states pt turned pale and eyes rolled back in his head and fell asleep. This reaction was not observed by Dr or nurse.
Extreme pain suddenly, thought I had possibly eaten something bad night before. Toughed it out for 2.5 days before going to ER. Diagnosed with ruptured appendix.
Extremely blurred vision secondary to a central retinal vein occlusion in the right eye.
8 hours after vaccine, fever, aches, chills, flu-like symptoms. 36 hours later, hives on underarms and top of shoulders, shingles-like rash from left hip to left breast area. Flushed face, fast heart rate.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated with GARDASIL (dose, route and lot number were not reported), vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines' stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Follow up information was received with patient identifiers. This case reported that GARDASIL (dose and route not reported, lot # J013277, expired date: 08-JUN-2015) was administered to a 17 year old patient on 26-FEB-2014. This case was linked to 1405USA001665, 1405USA001164, 1405USA001163, 1405USA001161, 1405UA001166 and 1403USA007265. Additional information has been requested.
Extreme nausea; vomiting; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 30Mar2021 at 12:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have a history of allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 30Mar2021, the patient experienced extreme nausea and vomiting for 04 days. The patient did not receive treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extreme nausea and vomiting was resolving at the time of report.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
The pain switched to the right arm today; it got to where on the 2nd day, he was unable to sleep as the pain was strong; patient experienced pain from shoulder down to the hand/there is a separate pain in the wrist of the left arm; arm was hurting; patient experienced pain at injection site; slept whole day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was hurting), PAIN (The pain switched to the right arm today), SOMNOLENCE (slept whole day), INSOMNIA (it got to where on the 2nd day, he was unable to sleep as the pain was strong) and VACCINATION SITE PAIN (patient experienced pain at injection site) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was hurting), SOMNOLENCE (slept whole day) and VACCINATION SITE PAIN (patient experienced pain at injection site). On 06-Apr-2021, the patient experienced INSOMNIA (it got to where on the 2nd day, he was unable to sleep as the pain was strong) and ARTHRALGIA (patient experienced pain from shoulder down to the hand/there is a separate pain in the wrist of the left arm). On 08-Apr-2021, the patient experienced PAIN (The pain switched to the right arm today). At the time of the report, PAIN IN EXTREMITY (arm was hurting), PAIN (The pain switched to the right arm today), SOMNOLENCE (slept whole day), INSOMNIA (it got to where on the 2nd day, he was unable to sleep as the pain was strong), VACCINATION SITE PAIN (patient experienced pain at injection site) and ARTHRALGIA (patient experienced pain from shoulder down to the hand/there is a separate pain in the wrist of the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Followup received on 2-JUL-2021 contain No New Information
This spontaneous report as received from a health care student refers to a 6 patients of unknown ages and genders. In 2012 the patients were vaccinated intramuscular with PNEUMOVAX 23 (dose and lot # not reported). No concomitant medications were reported. The Pharmacy intern reported that in the past 2 weeks, 6 patients have developed cellulitis at the injection site and fever after receiving PNEUMOVAX 23. The outcome for the patients of cellulitis at injection site and fever after receiving PNEUMOVAX 23 was unknown. The relatedness for all adverse events was unknown for PNEUMOVAX 23. Additional information has been requested.
Some chills, temperature; Some chills, temperature; Soreness in the administration site; This is a spontaneous report from a contactable nurse reported for himself. This 51-year old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. On 21Dec2020, the patient experienced some chills, temperature, and soreness in the administration site. The patient was vaccinated at 51 years old. The patient wanted to know if he should isolate himself again, and if he will get Covid again after receiving the vaccine. Outcome of the events was unknown.   Information about lot/batch number has been requested.
At about 45 minutes of having the vaccine I had an instant feeling of lethargicness, muscle weakness,  little bit of coughing, just exhausted, I had to go lie down. The first week of May I went to the doctor, they did all kinds of blood work and everything was normal, except one thing, the  EGFR level 51 which is incredibly low and dangerous, and 3 years ago my level was 78. I got it retested yesterday and the levels came back to 73-78.  The blood work mentioned that race matters with this number. 2 weeks ago when I went back for my results the muscles in my back were hurting so the doctor gave me some mild muscle relaxers. They also did a bilateral kidney ultrasound with doppler. I have never had any sort of knee problems and I had to go to the doctor yesterday because suddenly this past weekend my knee swelled up on the joint and I have not been able to walk. They did some x-rays and blood work and I am going back on Monday to get the results.
Cold-like congestion, followed by fever (102F) and severe aches for four days; missed one day work on third day (Mon.)
3rd dose administered; Rotarix administered to a 6-month-old; 1st dose 24 Jun 2022, 2nd dose on 30 Aug 2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, Rota (Rotarix lyophilized formulation) for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   Previously administered products included Rotarix (received 1st dose on 24th June 2022).   On 1st November 2022, the patient received the 3rd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 30th August 2022, the patient received the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 30th August 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced drug dose administration interval too long. On 1st November 2022, the patient experienced extra dose administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the drug dose administration interval too long, extra dose administered and inappropriate age at vaccine administration were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Nov-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received 2nd dose of Rotarix later than the recommended interval, which led to lengthening of vaccine schedule. The patient received 3rd dose of Rotarix at inappropriate age, which led to extra dose administered and inappropriate age at vaccine administration.
58 Y male with h/o ischemic cardiomyopathy with prior STEMI/NSTEMI, stents to LM/LAD/Lcx, last intervention was LAD IST in 12/2019, s/p HVAD implantation on 7/6/20. Post op course c/w takeback for clot evacuation 7/9/20, ischemic bowel requiring ex lap and colostomy placement 7/18/20, thrombectomy of R external iliac artery and fasciotomy 7/23/20, and PNA.  Post LVAD complications: GIB, DL infection, enterococcus bacteremia on chronic amox.  TIA/CVA, pump thrombosis 7/2021.  Numerous hospital admissions in 2022. 1/2/22-1/6/22 pulmonary edema discharged after diuresis and optimization. 1/12-1/13/22 after +Covid exposure and illness with hypoxemia. Received 2 doses of remdesivir and decadron and during the hospital stay noted hypotension and hypovolemia, antihypertensives were adjusted.  1/19/22-1/22/22 for ongoing SOB, hypoxemia and post Covid symptoms, completed 5 days of remdesivir and decadron. Hypertensive during hospital stay, increase BP meds   Now presented on 1/23/22 with numerous low flow alarms.  High Pis.  Hypertensive. Lactate 2.1  Admitted for hypertensive emergency, nitroglycerin gtt transitioned to nipride gtt.  BP better controlled, uptitrating oral antihypertensives increase amlodipine from 2.5 to 5.  Increase hydral to 75 TID to 100 TID.  Increase isordil to 40 TID and hydral 100TID. Added coreg 3.125mg BID.   COVID+ with hypoxemia dx on 1/12: continue isolation received a total of 5 doses of remdesivir and decadron
No additional AE reported; A dose of PNEUMOVAX 23 expired on 8/23/2021 and was administered on 10/14/2021; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 14-OCT-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 (units not provided), with lot number T007383 (verified to be a valid for vial formulation), expiration date on 23-AUG-2021, for prophylaxis (route of administration, vaccination scheme frequency, and anatomical location were not reported) (expired product administered). No adverse events were reported.
No additional AE details provided; Improperly stored PROQUAD admnistered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with an improperly stored of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (lot # T021301 has been verified to be a valid lot number measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and establish as 19-DEC-2021) (strength, dose, route of administration and anatomical location were not provided). The temperature of storage and time frame of the excursion were 9° Celsius (C) for 80 minutes respectively.  If a digital data logger was involved was not reported; measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) did not experience a previous temperature excursion.  No adverse event reported.
p/vax pt exp red; blotchy rash at inj site; swell lips; benadryl for TX
Vaccine administered in Employee Health on 8/20/07.  Patient reports that her right arm hurt the rest of that day and the entire next day.  Following work on 8/21/07, Patient applied ice (which she states made her arm hurt worse) and then heat to her right arm. She then states on 8/22/07, her legs felt "crampy" and although she felt like going back to bed, she did work that day.  Her arm was warm, but no redness noted.  She was instructed to take Tylenol for discomfort.  That night, Patient reports her temperature increased to 102 degrees, she hurt "everywhere," and had a bad headache.  She did not come into work on 8/23/07 and contacted Employee Health regarding her symptoms.  When seen in EH on that day, Patient reports that she is feeling better, her arm is less swollen and hurting less.  She does report still being very tired.  "Pinkness" was noted in her right upper arm around injection site and it remained warm to touch.  She no longer had any temperature.  On 8/24/07, Dr. was notified of "reaction."  Today (8/28/07), Patient reports that she is "pretty much back to normal."  States that the pink on her arm is pretty much gone and that even rubbing it vigorously she is not having any pain.  Also states the swelling is gone and she is back to doing all normal activities.
Couple weeks later after 3rd dose, severe gastric reflex, burning in chest and into the back of my throat and sometimes it feels like chest pain. Pain in my jaw area and left arm had pains just like a heart attack. Protonix didn't work. To make sure it wasn't in my heart, I went to doctor on 15Oct2021. He changed the meds to another medicine.
3rd dose administered to non-immunocompromised individual; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (3rd dose administered to non-immunocompromised individual) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced OFF LABEL USE (3rd dose administered to non-immunocompromised individual). On 05-Oct-2021, OFF LABEL USE (3rd dose administered to non-immunocompromised individual) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Caller was not willing to report adverse event. Caller stated a 3rd dose was administered to an non-eligible consumer.  Concomitant medication use was unknown Treatment information was unknown
No adverse event; On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 12-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to .25 milliliter. On 12-May-2023, the patient experienced PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml).    No concomitant medications were reported. Patient's age was reported as >65 years. Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and or at the time of adverse vent were unknown. It was unknown whether patient had Chronic or long-standing health conditions and Acute illnesses at the time of vaccination and up to one month before. The batch number was reported as 067H22A.  The vaccine was administered in the deltoid site.  On 11-May-2023, 26 patient's were contacted, and on 12-May-2023 18 patient's received an additional 0.25ml. No treatment medications were reported.  This case contains information for the 4th of 27 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:Master case