chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness/redness in her arm; swelling/swelling in her arm; hardness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness/redness in her arm), VACCINATION SITE SWELLING (swelling/swelling in her arm) and INJECTION SITE INDURATION (hardness at injection site) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness/redness in her arm), VACCINATION SITE SWELLING (swelling/swelling in her arm) and INJECTION SITE INDURATION (hardness at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness/redness in her arm), VACCINATION SITE SWELLING (swelling/swelling in her arm) and INJECTION SITE INDURATION (hardness at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient wanted to know can she take 2nd dose of Moderna vaccine after these side effects?   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: event verbatim updated, recoded and DOB added.
Initial unsolicited report received from a pharmacist on 30 Sep 2016. This case involves a 69 year old male patient who was vaccinated with a second dose of FLUZONE HD (batch number-UI664AA expiry date: 06 Apr 2017 and route was not reported) in left deltoid on 30 Sept 2016. The patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions and any other vaccinations within 4 weeks of vaccinations were reported as none. The patient previously vaccinated with FLUZONE HD last year (2015) on an unspecified date. The patients Concomitant medications were not reported. On 30 September 2016, right after administration of vaccine, the patient had developed a large lump approximately the size of a nickel under the skin at the site of injection. The patient denies pain at site. The patient laboratory data was reported as none. The patient Corrective treatment was not reported. The outcome of the event was reported as unknown. List of documents held by sender: none.
This spontaneous report was received from a pharmacist via manufacturer (manufacturer control # 2015339993) concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, lot/batch#, ,expiration date, route and anatomical location were not reported). Co-suspect therapies or concomitant medications were not provided. On an unknown date, the patient was allergic to PNEUMOVAX23 (allergy to vaccine). The outcome of allergy to vaccine was unknown. The reporter considered allergy to vaccine to be related to PNEUMOVAX23. Additional information has been requested.
1620: CHILD WAS SEEN FOR 5 YEAR WELL CHILD VISIT.  AFTER VISIT ON THE WAY TO CAR PT LOOKED PUFFY, RED, FEET HURT AND COMPLAINED OF DIFFICULTY BREATHING.  1640: PT RETURNED TO OFFICE ABOUT 30 MINUTES POST VACCINATION C/O COUGH,DIFFICULTY BREATHING AND GENERALIZED ITCHING.  1645: PT ADMINISTERED ORAL DOSE OF BENADRYL 9 ML (12 MG/4ML), BUT SUBSEQUENTLY VOMITED.  PERIPHERAL IV CATHETER PLACED.  GIVEN 20 MG IV BOLUS BENADRYL, 40 MG SOLU-MEDROL (125 GM/2ML) IV, IV SALINE, ALBUTEROL NEB.  1700: URTICARIA RESOLVED, AND NO TROUBLE BREATHING.  1730: EDEMA RESOLVED. ABOUT 1800 ON 4/4/06, PATIENT TRANSFERRED BY AMBULANCE TO HOSPITAL FOR OBSERVATION WTIH A CHIEF COMPLAINT OF ANALPHYLACTIC RXN TO VACCINES.  PT MARKEDLY IMPROVED SINCE TRANSFER.  ARRANGEMENTS TO SEE ALLERGIST RECHECK.  2200: DISCHARGED FROM THE HOSPITAL WITH PREDNISOLONE 2 MG/KG/DAY X 2 DOSES (1 DOSE IN PM, AND 1 DOSE IN AM, BENADRYL X 4 DAYS, ZANTAC AND EPI PEN.  PT HAS HAD SIMILAR RXNS TO TRAIL NUTS, ALTHOUGH SKIN TESTS NEGATIVE.  ALSO HAD RXN TO GUMMY WORMS.  HAS RECEIVED ALL CHILDHOOD IMMUNIZATIONS IN PAST WITHOUT REACTION.
Severe burning in feet sensation Bone pain in lower legs Fever Sweat Injection site swelling to 1/2 baseball size Shakes and tremors Extreme fatigue Lower back pain Confusion Joint pain entire body Severe headache Numbness and tingling left side of face Severe back pain
Flu vaccine given in right arm.  EE left burning pain in arm as vaccine was being given.  By 10:00pm EE could not move arm and had intense pain of 8/10.  EE had no improvement for 3 day and went to MD 10/25/21.  EE received steroid shot to right shoulder for rotator cuff tendonitis due to Flu vaccine given in joint.
dramatic increase in Rheumatoid Arthritis symptoms; This is a spontaneous report received from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, in Feb2021 (reported as "last month"), as single dose, for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. The patient previously took tofacitinib (XELJANZ XR) for rheumatoid arthritis. The patient reported that she missed two weeks of XELJANZ XR last month (Feb2021) due to receiving COVID-19 vaccine. She said she experienced a dramatic increase in rheumatoid arthritis symptoms (unspecified date) as a result of this but she feels like overall Xeljanz XR is managing her rheumatoid arthritis well. The outcome of the event was unknown.  No follow-up attempts are possible. Information on lot/number cannot be obtained. No further information is expected.
patient had swelling at the injection site. patient was given ice pack. The patient swelling went down. Patient  left smiling. Patient wanted second covid vaccination.
Fever, severe headache, body aches, upset stomach, swelling and redness at injection site.
On Tuesday 12/28 I started to have severe leg pain in my right leg.  The next morning the pain was still in the right leg and had moved up through my right side in my joints to my knee, hip then went to the with shoulder down that arm.  My forearm became very painful on 12/30 and started to swell then radiated into my wrist joint and finger joints.  12/31 the pain continued in all those areas and had moved to my left side of my body starting with the left arm following the same course as the right side.  On 1/1 the pain has persisted and I am unable to perform any ADL's.  I saw an urgent care physician who told me to take ibuprofen.  I have been taking ibuprofen and Tylenol with no relief. Now all my joints are swelling in bilateral hands, wrist.  On 1/2 my bilateral ankle joints and feet started to have similar pain.  Know all my extremities are difficult to use and it is hard to walk due to the pain.  Because of the pain in my hands things feel heavier than what they should.  I am a medical provider and this almost seems like polyarthralgia rheumatica, I am going to go see a physician on Monday
After I received the shot, I was told to wait 15 minutes to be monitored.  A short time later, everything was getting dark.  I blacked out for a unknow amount of time.  I just remember waking up to the pharmacist and a technician asking me if I was ok and rubbing my arm.  I was given a bottle of water and a mint.  I was weak, dark vision, and sweaty.  I was walked to a recliner chair where I was monitored again.  I stayed there until my weakness left and my vision was normal, maybe 10-15 minutes longer.  My heart rate seemed to be elevated and beating harder, even 6 hours after the shot.
Suspected vaccination failure.; I got the shot and got the shingles.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-APR-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient got the shot and got the shingles. It had been 2 years and patient was fighting them. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
This spontaneous report as received from a nurser refers to a patient of unknown age and gender. On 26-AUG-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23, 0.5ml, intramuscular (lot number and expiration date not reported). No adverse effects reported. Additional information is not expected because the reporter refused additional contact.
Pt developed a rash all over his body which grew worse over the course of 2 days, until he was completely covered. The doctor prescribed steroids and rash cleared in about 2 weeks.
All over muscle twitching; Headache; generalized body aches/pain; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Aug2021 as dose 1, single (Lot number: FA7485) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "COVID-19", start date: 09Oct2020 (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; SLYND; XYZAL. Past drug history included: Sulfa, percocet, reaction(s): "Drug Allergy". The following information was reported: MUSCLE TWITCHING (non-serious) with onset 11Aug2021, outcome "not recovered", described as "All over muscle twitching"; HEADACHE (non-serious) with onset 11Aug2021, outcome "not recovered"; PAIN (non-serious) with onset 11Aug2021, outcome "not recovered", described as "generalized body aches/pain". The events "all over muscle twitching", "headache" and "generalized body aches/pain" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of muscle twitching, headache, pain.  Additional information: It was also reported that there was no other vaccine in four weeks. Patient had all over muscle twitching. Headache for 3 months, generalized body aches/pain on 11Aug2021 at 12:00 am. Patient had taken every medicine possible. Patient had Covid prior to vaccination.
Sore arm both shots.  Fever 24 hours after 2nd shot lasting 24 hours
Information has been received from a physician concerning an 11 year old female who was vaccinated with GARDASIL (dose, therapy route, lot number not reported). The patient received GARDASIL and experienced dizziness and a profuse/painful menstruation. The patient reported feeling dizzy the day following vaccination with GARDASIL. It was unknown which dose of GARDASIL was administered. The patient also reported a profuse and painful menstruation following the dose of GARDASIL. The patient normally did not have profuse and painful menstruation and felt it was related to the dose of GARDASIL. On 11-AUG-2008 the patient sought medical attention by an office visit. Subsequently the patient recovered from the dizziness and a profuse/painful menstruation. No further information is available.
Date:3/18 Problem: Dizziness Notes: Patient received vaccine at approx. 12:45. At 12:50 patient c/o dizziness I took VS and gave patient water and crackers. VS were 91/43, 59HR,18R and 100 SPO2. Told patient to sit an extra 15 minutes and she will be evaluated. Patient later came back and said she was ok just hungry and ready to go. I asked patient if she was sure she felt fine, patient stated she did and left.
Pt was hospitalized for possible bursitis after receiving the Shingrix shot on 09/03/2018
This spontaneous report received from a nurse refers to a patient of unknown age. Information on pertinent medical history and concurrent condition was not provided. Information on pertinent medical history and concurrent condition was not provided. On an unknown date, the patient was vaccinated with VARIVAX lot # M005971 for prophylaxis. The Nurse reported that the vaccine administered was improperly stored. No adverse event reported. The outcome of incorrect product storage and no adverse event was unknown. Lot M005971 was stored at 12°C for 63 hours, and in the range of -14°C to-10°C for 487.5 hours. No previous temperature excursion. The call was not because of a "data logger". Additional information has been requested.
"Subject was walking out to leave when he suddenly got lightheaded, dizzy and had a near syncopal episode (falling to the ground). He was not injured. He was treated and released by EMS. Patient accepted assessment/refused transport to hospital." per site supervisor report.
Two swollen anterior cervical lymph nodes one 5 mm, one 2-3 mm. No itching. No hives. No distress. Talking no distress. Discharged to home at 12 pm.
Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In June 2015, a healthcare provider at a clinic administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In June 2015, the patient was treated by a healthcare provider at a clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
PAIN IN GROIN AREA; SWOLLEN LYMPH NODES/STOMACH SWELLING IN GROIN AREA (THINNER BUMP LIKE A LINE); This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211021A expiry: UNKNOWN) dose was not reported, administered on 27-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On DEC-2021, the patient experienced pain in groin area, and swollen lymph nodes/stomach swelling in groin area (thinner bump like a line). On 30-DEC-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) swollen lymph node in groin area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in groin area on DEC-2021, and the outcome of swollen lymph nodes/stomach swelling in groin area (thinner bump like a line) was not reported. This report was non-serious.
Hands are periodically turning blue; This is a spontaneous report from a contactable consumer. A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date (at the age of 52-years-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Patient was not pregnant. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. It was reported that patient's hands were periodically turning blue on an unspecified date. They are normal temperature when this happens. The patient had seen her health care provider and could not find any cardiac or other issues that may contribute to this symptom. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment was given for the event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
On 3/14/21 pt got up from bed to use BR and didn't know where she was, fell into wall and to floor.  She had fatigue, headache, and generalize pain, her BP was low 100/44. All she could do was sleep and had no appetite, on the 20th she felt well enough to go for a car ride, her husband drove.  She did see her PCP on the 18th who thought she was depressed, seemed unconcerned that she fell to the floor, her Bp was low this day as well, all labs were normal. This was her 2nd Covid-19 Moderna vaccine, she had no symptoms with the first injection. She has never before experienced disorientation, that she did on 3/14/21 @ 3 am.
As a diabetic, my blood sugar is very controlled.  Prior to getting the injection it was 99.  Thirty minutes after the injection it was 227.  My blood sugar has been hovering between 200-225 since getting the vaccination.  Nothing is working to bring it down (my doctor is aware and I?ll be fine, but there should be a warning for others).
Tested positive after vaccination; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Tested positive after vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced COVID-19 (Tested positive after vaccination). At the time of the report, COVID-19 (Tested positive after vaccination) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.  Company comment:The event of COVID-19 is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection resulting in producing a positive test.; Sender's Comments: The event of COVID-19 is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection resulting in producing a positive test.
Chills; fatigue; fever; headache; joint pain; muscle pain and pain at injection site.
Of course arm pain (it was in my left (non-dominant) arm in which I sometimes have discomfort from nerve impingement at my neck & for which I take gabapentin. The pharmacist helpfully instructed me to gently move arm to avoid stiffening. Also I took some Advil before the shot, and that helped, too. The movement and the Advil  helped, and everyone taking this vaccine should be instructed to do so.  The more alarming symptoms were a kind of labored breathing. It's true I have some emphysema and continue to smoke! but this was different. I did feel increased weakness. I have had dizziness sporadically for a year, maybe two  years, and I'm not sure if this vaccine increased or exacerbated that. I felt some general chest  pressure as well as some panic, both of which I sometimes do anyway, and again, I feel the vaccine may have worsened these. I felt a little bit of sweating & chills. My heart beat is usually pretty slow (49, 62 - it varies) but these first several hours after the vaccine it was up to about 72 bpm and not worrisome to me. After about 6 hours or so these symptoms lessened, and I calmed down more as well. I want to mention them because some of my symptoms were on the "Call 911 if this happens" list and I didn't quite know what to do.  (I had an "innocent murmur" at one time in my life and I'm not sure if this is gone, or turned into a calcified aortic vale.)
Approximately twelve hours after receiving my second vaccination (2:45 AM 4/23), I was not able to sleep because of extreme chills. I figured it was mild fever, but quickly began to shake in uncontrollable tremors. I thought I might break my teeth it was terrible. I suffered through this for maybe an hour, and this triggered my IBS. So I had bowel pain and a small bowel movement. Feeling a little better, but still having tremors, I took my temperature.  At approximately 4:00 AM , 4/23, the temperature in my left armpit read 106 degrees. The temperature in my right armpit was 103. My forehead was 97.  I then took Ibubrofin-800mg, and acetaminophen-500mg. I sat on the couch with a cold compress on my left wrist for about an hour.  The tremors did subside and I took my temperature again at 7:00AM. My left armpit was still 106, and right armpit was 102 and forehead was 96. I pointed the meter at my open mouth and it read 103.  I did not feel like it was a medical emergency, but I was feeling very ill with fever.  At 10:00AM the temperature in my left armpit dropped to 102. I did take more tylenol and rested uncomfortably.  It is now 8:00PM 4/23, and i have been ill all day, and my temperature is down.
Red rash with swelling at site, warm to touch, headache, temp to 104, joint pain beginning morning after vaccination. Returned to MD, 48 hrs after shot. Erythematous, speckled rash continues on left upper arm - swollen bicep and tricep. MOTRIN and TYLENOL - 3 doses of prednisone.