chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Later on after getting the shot I noticed that my arm was starting to feel sore, and I got real tired so I went to bed at around 11, and I woke up a few times because I couldn't get comfortable on that sore arm. When i woke up this morning I just felt yucky and I took my temperature and I was running a fever, 101.4
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Additional Details: Called EMS after patient was identified having adverse effects. Moved patient to ground to lay down.  Could not find a pulse.  After a few seconds patient regained consciousness, but was still very confused and disoriented.  Instructed patient to ramain supine until EMS arrived. No s/s of allergic rxn. Hypotensive. Patient was taken out of store via stretcher & ambulance.  I am unsure of outcome.
Case number PHEH2014US025133, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 57-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 27 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperatures was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
Both siblings also had vaccine failure cases of Varicella (medical doctor-confirmed) 2 weeks ago.
Patient said about 2 hours after injection pt said she noticed swelling, redness and increased temperature at site of injection. Swelling progressed down and up her arm.
The next day had headache and right axillary swelling and tender right axillary lymph nodes.
- Pain in jaw, teeth, chin, gums, neck& tongue (severe). - Swollen lymph nodes, neck, chin, gums, lower jaw. - Stiffness in jaw, chin, neck, - Hard to breath (tight in neck).
Phone call from mom, reported rash on torso and neck.  Instructed see physician for assessment.  Mom reports child developed "whelts" over most of body and eyes very red and swollen.  Mom took child to ER and areas treated with Benadryl and steriod.  Will 1/4 see MD.
Patient started to feel pain in area of shot and was not able to lift arm completely. Pt noticed some swelling over right deltoid. Ice tried and helped. tried heat but not as good for relief. Pt eventually had to go to urgent care who gave narcotic, muscle relaxant. Since that time it has gradually improved but as of today(3/2/2020) arm is still stiff and movement of shoulder up hurts.
Received T/C ct c/o fever, numbness of arm, unable to walk, nosebleed and not feeling the same since receiving vaccines on 6/4/14. Ct reports still having symtoms this date.
Sleepiness, sore arm on second day; stiff neck 3rd day relieved by heating pad and NSAIDs, soreness lasted until 5th day
male patient was given the GARDASIL Quadrivalent vaccine on an unspecified date and subsequently developed lymphoma; This spontaneous report was received from a physician via company representative and refers to an unspecified male patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date over ten years ago, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, site, route of administration, lot # and expiration date were not reported) for prophylaxis, and subsequently developed lymphoma on an unspecified date. The physician reported the patient had unspecified treatment for the lymphoma and was doing fine since an unspecified date. He sought for medical attention, but it was unknown by the reporter if any laboratory diagnostic studies were performed. The outcome of lymphoma was reported as recovered. The relatedness between the lymphoma and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported.  Upon internal review, lymphoma was determined to be medically significant.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA006586:
fever; He was shivering/shaking; He was shivering/shaking; He was shivering/shaking and was cold; This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever, shivering, tremor and cold. Shingrix was discontinued. On an unknown date, the outcome of the fever, shivering, tremor and cold were recovered/resolved.   The reporter considered the fever to be related to Shingrix. It was unknown if the reporter considered the shivering, tremor and cold to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the wife. The reporter would not provide an email address and did not have a personal fax number.  The patient received Shingrix about 2 years ago. The reporter would not give his exact date of birth.  The patient received Shingrix and woke up in the middle of that night with a fever.  The patient was shivering, shaking and was cold. The reporter did not know the exact temperature because it was so long ago but thinks it might had been 102-103 degrees.  The reporter stated that due to this side effect he never went back for the second shot of the series and does not plan to.  No further information was collected due to reporter reluctance and the fact that the first shot was 2 years ago. The reporter did not consent to follow up. The reporter did not want to share MD contact information. This case linked with US2020159657, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159657:Same reporter
More than 35 days after the first dose without receiving the second dose; feet started hurting,they hurt so much; She feels her feet very tight since she received the vaccine,like if she has her feet tied; felt dizzy; had high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (feet started hurting,they hurt so much), LIMB DISCOMFORT (She feels her feet very tight since she received the vaccine,like if she has her feet tied), DIZZINESS (felt dizzy), BLOOD PRESSURE INCREASED (had high blood pressure) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     Concurrent medical conditions included Varicose vein (it is too thick). Concomitant products included CARVEDILOL for Blood pressure increased, LISINOPRIL and SPIRONOLACTONE for an unknown indication.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced PAIN IN EXTREMITY (feet started hurting,they hurt so much), LIMB DISCOMFORT (She feels her feet very tight since she received the vaccine,like if she has her feet tied), DIZZINESS (felt dizzy) and BLOOD PRESSURE INCREASED (had high blood pressure). On 24-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose). On 27-Jul-2021, DIZZINESS (felt dizzy) and BLOOD PRESSURE INCREASED (had high blood pressure) had resolved. On 24-Aug-2021, PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved. At the time of the report, PAIN IN EXTREMITY (feet started hurting,they hurt so much) and LIMB DISCOMFORT (She feels her feet very tight since she received the vaccine,like if she has her feet tied) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2021, Blood pressure measurement: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
my arm was sore, really sored, when I lift it, it sored; knuckle cracking/her arm was cracking/with the left arm, the crack in the knuckle; my body is still aching; it was not her whole body, but from her shoulder and down.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), administration date: Aug2022, for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), administration date: Sep2022, for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset Dec2022, outcome "unknown", described as "it was not her whole body, but from her shoulder and down."; JOINT NOISE (non-serious) with onset Dec2022, outcome "unknown", described as "knuckle cracking/her arm was cracking/with the left arm, the crack in the knuckle"; PAIN IN EXTREMITY (non-serious) with onset Dec2022, outcome "recovered" (2022), described as "my arm was sore, really sored, when I lift it, it sored"; PAIN (non-serious) with onset Dec2022, outcome "not recovered", described as "my body is still aching".  Additional information: Patient reported that from 02Dec "unintelligible" then her arm was sore, really sored, when she lifted it, it sored. Patient also had knuckle cracking and stated she never had this problem before. She then mentioned the soreness remained for two weeks. Patient confirmed she was vaccinated on 02Dec, she mentioned she noticed that the main thing was that her arm was cracking, she mentioned she was not going through pain on her body, but that this all began after she received her booster bivalent dose for adults from Pfizer. She mentioned her previous vaccines were also Pfizer's in August and September. She mentioned that it was not her whole body, but from her shoulder and down. After the information was provided, patient then stated she would not recommend for people to take it, the way she feel. She wished she would not have it because with the left arm, the crack in the knuckle, she did not have that issue. She was not doing anything, and the knuckle was cracking, and her body was still aching.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
when he has sex with his girlfriend his penis stays erect; This is a spontaneous report from a contactable consumer. A 30-Year-old male consumer (patient) reported for himself that:  A 30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 30Aug2021 as DOSE 2, SINGLE for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced when he has sex with his girlfriend his penis stays erect. The clinical outcome of event was unknown.   The caller declines to file a safety report. No further information is provided or obtained.   The lot number for the vaccine, [BNT162B2], was not provided and will be re-quested during follow up.
Shortness of breath, extremely tired, chills. nausea, feeling unwell, lymph nodes, allergic reaction such as rash, extreme itching, swelling of face, loss of taste and smell, severe congestion upon awakening.   PCP is out of town entire month of June.  Sick of being sick.  Must be remedy to all of this!  Am not recommending to my friends.  I should have never had second vaccination.
HOSPITALIZATION RELATED TO COVID-19 FOLLOWING COMPLETION OF PRIMARY COVID-19 VACCINE SERIES
approximately 20 hours after vaccination, I started experiencing chills and a fever of 102.4.  Body and joint pain.  About 30 hours after vaccination I started diarrhea and continued with these symptoms for 3 days.  I also have a twitch on the ride side of my face and my lips are buzzing  from the inside (only way to describe it)  My concern is that I had the Covid virus beginning with a positive test on December 26 and had the exact same symptoms for  7-10 days.  My senses of taste and smell finally returned somewhat skewed in late January.    I did not lose my taste or smell after this first vaccination.    Please advise if I should get the second dose of the Moderna vaccine as I do not want these symptoms again and do I need a third dose of Covid since I had the disease in December?  I have a yearly appointment with my doctor on March 2, 2021, and I will discuss with him before making a  decision on whether to get the second dose.
In the morning of Dec 30: Red urine - blood (bright red) - (Lower urinary tract) - didn't have pain. One episode. I did a Urine Dip Stick at my office (I'm a doctor) - positive for blood;  Went to lab - He Took LAB -blood in the urine (microscopic) -Dec 31 days -MicroAlbumin - checked that, too, and it was negative for that. No proteins in the urine. I dip sticked my urine in the office this Monday (18th) or Tuesday - no blood - negative. I think it's resolved now.
administration of improperly stored vaccines; This spontaneous report was received from a medical assistant referring to a 16-month-old patient of unknown gender. The patient's concurrent condition, medical history and allergic histories were not reported.  On 27-AUG-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 0.5ml (lot number was T002845, expiration date: 23-JAN-2022, dose strength and route were not applicable) for prophylaxis (Incorrect product storage)The vaccine was reconstituted with sterile diluent (lot# and expiration date were unknown by the reporter). The vaccine underwent temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (10.56 degrees Fahrenheit) for 50 minutes. There was previous temperature excursions of  6 degrees Fahrenheit to 14 degrees Fahrenheit (8.47 degrees Fahrenheit) for 30 minutes. The digital data logger was involved in recording excursion details. The outcome of incorrect product storage error was unknown.; Sender's Comments:  US-009507513-2009USA000777: US-009507513-2009USA000747:
Pt received vaccine on 11/23/98 and on this date 8/23/04 with a mild case of chicken pox.
I got the second dose at 1:30 pm on March 8th. At around 1:30 AM on March 9th I began feeling very cold and shaking uncontrollably. I had a sharp and persistent headache that lasted most of the night. I felt a little pain in my chest, and even when I took deep breaths it never felt like I had enough air. I'm wondering in the breathing difficulties might have been due to heartburn/indigestion. I had to stop taking my heartburn medicine because it's not good for my kidneys (I also have kidney disease). On rare occasions I have had symptoms from heartburn that feel almost like asthma. The fever-symptoms and chills subsided a few hours later after I took a Tylenol, but I continue to feel fatigued and I have a bad headache.
Swelling-tenderness-muscle pain-headache I was shivering-very Lethargic-No appetite For days The Injection area was very red It was the size of a 1/2 Tennis Ball by the end of the week. It was much better a little Black & Blue on Injection area. (The only thing I didn't Get was the Fever.)
Approximately 8 hours after receiving the vaccine, I experienced chills, body aches, flu-like symptoms for the next 36 hours, fatigue for 48 hours. I did not take any medications to mitigate the symptoms.
Information has been received from a pharmacist concerning a 75 year old patient who on 05-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot# 659410/0412X) 0.65ml SQ. On 09-JUN-2008 the patient blacked out for a short period of time and then had difficulty speaking. The patient was recovering. The patient sought medical attention. Additional information has been requested.
Rcv'd Td in left arm 11/17. Quarter sized knot appeared next day; fever varied from 99F-100F continuously taking taking Tylenol every 6 hrs. Knot still present today, slight redness & warm to touch. Pt. states painful & arm goes numb.
This spontaneous report was received from an office manager refers to a patient of unknown age who on 15-OCT-2012 was vaccinated with a dose of RECOMBIVAX HB (lot number 671326/1522AA) (dose and route not reported) that was improperly stored. No symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Pt. sitting with mother and sister in observation area.  Mother signed for assistance.  Pt reported feeling hot and having blurred vision.  Able to state name throughout event.  Pupils dilated, skin hot.  Pt instructed to remove mask and breath deeply, cool pack applied to back of neck.  After several minutes patient reported vision retuning to normal.  Patient incontinent during episode.  Pt transferred to private room.  Water, peanuts, and fruit snacks provided.  Sister very tearful and anxious.  Water and snacks provided.  Family remained 30 minutes. Verbalized feeling okay, reported slight headache.  Mother made appointment for patient to see pcp today, family left clinic.
edema of feet & legs;1st notice this in evening @ supper;only sl swelling the following morning;no other sx;
3 year old received a dose of Pediarix and IPOL at the same visit extra doses of IPOL being administered with no adverse event; Initial information received on 18-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 years old male patient who was administered an extra dose of IPV (vero) [IPOL] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (yeast), pertussis vaccine acellular 3-component, polio vaccine INACT 3V (vero), tetanus vaccine toxoid (Pediarix) for Prophylactic vaccination.  On 24-Jun-2022, the patient received 0.5 mL dose of suspect IPV (vero) (lot Z1A121M; formulation and strength not reported) via subcutaneous route in the right thigh for immunization.  On 24-Jun-2022, the patient received a dose of pediarix and ipol at the same visit extra doses of ipol being administered with no adverse event (extra dose administered) following the administration of IPV (vero).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the Directive 2001/83/EC 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.
ED to Hosp-Admission Current  5/20/2021 - present (6 days)   Last attending ? Treatment team Syncope and collapse Principal problem   History of Present Illness     a 66 y.o. yo male presenting to the ED with syncope.  Patient is diagnosed with COVID-19.  He has passed out twice today.  He feels lightheaded and nauseous prior to passing out.  He wakes up feeling diaphoretic.  Denies chest pain.  Admits to shortness of breath and the feeling of difficulty getting a deep breath in.  Patient denies history of blood clots, recent unilateral leg swelling or edema, hemoptysis.
Initial and follow up information has been received from a pharmacist, concerning a 36 year old male patient with pneumonia, and no allergies, who on 25-JUL-2007, at 11:30am, was vaccinated IM in the left arm, with a dose of PNEUMOVAX 23 (Lot #657039/0698U). On 26-JUL-2007 (previously reported as 25-JUL-2007), the patient developed swelling and warmth in his left upper arm. The pharmacist requested a vaccine lot check. Follow up information from the pharmacist indicated that the patient also developed a fever, and visited the emergency room where he underwent a magnetic resonance imaging (MRI) test. He also had an infectious disease consultation, and was diagnosed with cellulitis and myositis; the pharmacist noted that there was no abscess or osteomyelitis. The patient was not hospitalized, and was discharged on unspecified antibiotic therapy. At the time of this report, he had recovered from the events (date and duration not specified). The pharmacist felt that the events were caused "as a result of PNEUMOVAX 23 administration." The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research, and was released. No further information is expected.
Increase sweetness in taste receptors for approximately 48 hours. Occurred about 7 hours after injection, lasting two days. Everything I ate and drank tasted very sweet, ie, coffee (no sugar), meat (no added sugar), plain vegetables. After 48 hours taste returned to normal.
Mom noticed 4/13/10 at breakfast time vaccine given approx. 1:30 pm 4/12/10. Left thigh red area 11 cm x 6 cm warm to touch.
This spontaneous report was received from a Certified Medical Assistant, referring to an unspecified number of patients of unknown age and gender. Neither medical history nor concurrent conditions were reported. On 17-JUL-2015, 20-JUL-2015 and 21-JUL-2015, the unspecified number of patients were vaccinated with improperly stored PROQUAD (Merck) (route unknown, lot # L008356, expiration date 11-SEP-2016 and lot # K023363, expiration date 20-MAY-2015). No adverse effects were reported. No product quality complaints were reported. No further information provided. This is one of two reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 27-APR-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been requested.
C/o dull ache in L/deltoid area, off & on since receiving vax. Soreness started on 10/15. Denies swelling, redness in area at any time. Soreness goes away & reappears w/movement of arm, like when cleaning around home.
Fever (100.7 F),  fatigue, joint pain, muscle aches, chills, headache, nausea