chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Few little bumpy places; Itchy; Swelling up around the site goes to her elbow; Warm; Round solid area, large and hard; Redness; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Few little bumpy places), ERYTHEMA (Redness), PAIN IN EXTREMITY (Arm soreness), PRURITUS (Itchy) and VACCINATION SITE INDURATION (Round solid area, large and hard) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Drug allergy (Tinasil). Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), CETIRIZINE for Allergy, APIXABAN for Anticoagulant therapy, AMIODARONE for Atrial fibrillation, ATORVASTATIN and COLESTIPOL for Cholesterol, LISINOPRIL for Hypertension, LEVOTHYROXINE SODIUM (L THYROXINE) for Hypothyroidism, ALENDRONATE SODIUM (FOSAMAX) for Osteoporosis, METHOTREXATE SODIUM (METOTREXATE), FOLIC ACID and INFLIXIMAB (REMICADE) for Rheumatoid arthritis.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ERYTHEMA (Redness), PAIN IN EXTREMITY (Arm soreness) and VACCINATION SITE INDURATION (Round solid area, large and hard). On 04-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm). On 05-Mar-2021, the patient experienced VACCINATION SITE MASS (Few little bumpy places), PRURITUS (Itchy) and VACCINATION SITE SWELLING (Swelling up around the site goes to her elbow). At the time of the report, VACCINATION SITE MASS (Few little bumpy places), ERYTHEMA (Redness), PAIN IN EXTREMITY (Arm soreness), PRURITUS (Itchy), VACCINATION SITE INDURATION (Round solid area, large and hard), VACCINATION SITE WARMTH (Warm) and VACCINATION SITE SWELLING (Swelling up around the site goes to her elbow) outcome was unknown.            Concomitant medications were not provided. Treatment details include cortisone cream.
Swollen , hives, itchness all over body. Hives all over. Has retained over 40 lbs of water since shot was given on 30 Oct 01. ER visit 3 Nov 01
Intense itching in upper arms within 24 hours of vaccine. Welts on arms and legs.
I felt ill with slight headache and tired within hours after the vaccine. The next two days I felt better. On Thursday, 3/18/21, I went to bed and awoke with severe vertigo. On 3/19/21, I went to the ER, and even though I reported I had vertigo, was treated for dehydration and a migraine--I suffer from migraines, and this was NOT a migraine. I returned to the ER via ambulance on 3/21/21, and was treated for vertigo and diagnosed with BPPV, and was referred to an audiologist/balance specialist. I was prescribed several medications for the nausea and dizziness. They helped tremendously. I saw a chiropractor on 3/22 and 3/23, believing I had crystals in my ears which needed manipulating. Treatment was unsuccessful. I saw Dr. on 3/24/21. By this time, the vertigo has subsided some, but I had constant dizziness and no balance; the world spun with great force to the right constantly. Dr. performed approximately 2.5 hours of tests that morning. It was his conclusion I had severe right inner ear nerve damage which very likely resulted from a dormant virus awakened by the Covid vaccine. I was diagnosed with vestibular neuritis.  Over the next two weeks, I was to go home and ween myself off the medications for nausea and dizziness. I was completely unable to walk or do anything without assistance. I was unable to read or watch TV without getting nauseas or dizzy.I saw Dr. again on April 7, 2021. He performed a follow up exam. I was still unable to walk without assistance at this appointment, and I was completely off work. I started Vestibular Rehabilitation Therapy from home daily. This initially exacerbated my symptoms, but I eventually found a good balance. I saw Dr. again on May 6, 2021. I had only progressed to week two of VRT. I was finally able to walk without assistance; however, my balance was not good and I walked very gingerly with great concentration. I was not driving, nor was I leaving my house, or working. I was having trouble processing all the sensory input. I was dealing with fatigue and cognitive issues from an overloaded brain that was simply working hard to keep me upright and compensate without an inner ear nerve. Dr. wrote me off work for another 4 weeks, however, I started working from home an hour a day.  On June 22, 2021, I saw an audiologist Dr. referred me to for pulsatile tinnitus. This seemed to be lessening in June, but has been back in full force since August.  Currently, I am 5 months out from the vaccine, and at about 65% better. Most days I don't wake up dizzy, and can progress through a "typical work from home day" without getting dizzy or off-balance until the evening. I can go to the grocery store now. But I am not able to do what I was a year ago.  I am unable to move quickly without loosing my balance. I can not bend over or exercise without feeling dizzy or disconnected from my body. I still suffer from the fatigue and cognitive issues that seem to creep in mid day.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 17-JUL-2015, the patient was vaccinated with an improperly stored M-M-R II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
After I got the shot you can see the shot moving though my body it was turning red and then purple and it started cutting off my circulation, it started to close off my throat as it started flowing through my body I started to get hot from the inside out from by bones to my outer body, from there they gave me an antihistamine blocker and I was still burning up inside, they took me to the ER and they hooked me up the some machines and gave me steroids and acid and protein blockers, I was nearly passed out, I came two twice both times my heart rate was either too high or too low and my blood pressure was at stroke level. I don't remember much after that. I got released to go back to work they gave me two bottles of steroids 4 and 5 times a day as I was leaving. Afterwards I get real bad headaches, my body still gets inflamed on the inside, my breathing gets a bit shaking and the only thing that helps is either the medicine they gave me. I am fatigued and tired all the time now since the vaccine. I get confused a lot and I am starting to lose my memory a lot since then. I also got COVID in Jan 2022.
Day 1 - Day Seven - only sore arm.  January 10th arm itched at injection site.  On January 12th noticed continued itching but redness and some swelling.
incorrect product storage; This spontaneous report was received from a medical assistant and refers 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 23-SEP-2020, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, 1 dose, lot # S020961, expiration date: 07-JUL-2021 (also reported as 24-MAR-2022) and varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1dose, lot # T010310, expiration date: 24-MAR-2022 (also reported as 07-JUL-2021) (injection sites and routes of administration were not provided) both for prophylaxis.  The administered doses experienced the temperature excursion of 19.32 degrees Celsius (C) for 7 hours and 45 minutes. No previous temperature excursion had occurred.
Initial report received from a nurse practitioner on 17 September 2010. A 31-year-old female patient had received a left arm dose of FLUZONE SV 2010-2011 (lot number U3652AA) on 17 September 2010 and 2 minutes post-vaccination experienced numbness of the tongue and lips; and her throat felt different. The patient was administered epinephrine and emergency medical team was called for transport to the hospital emergency department. It was not reported whether the patient was hospitalized or not, or if further treatment was required. At the time of vaccination, the patient had no concurrent illnesses; was not using any other medications; and had no known allergies. The patient had received flu vaccines in the past, but it was not reported whether any adverse events were noted with these vaccinations. At the time of this report, the patients recovery status was unknown. Documents held by sender: None
On 01/03/2001 the patient experienced 3 lesions on her face, 1 on her ankle and 1 on her arm. She was seen in employee health on 01/08/2001 for evaluation. The patient had no fever and the lesions were dry, scabbed and very small. The lesions were not filled with fluid. The patient recovered on 01/09/2001. Additional information is not expected.
Receive flu injection on 10-29-13. Starting Wed. morning burning and itching of skin. Also "some trouble breathing". Went to ER Thursday night and Friday morning. Has hives/whelps "all over" "plaque-like", swelling eyes. Currently on BENADRYL, Prednisone, PEPCID. SOLUMEDROL given at ER. To try to see allergist.
Death - pt had co-morbities at the time, poss pneumonia, pneumothorax.  Death occurred on a subsequent admission not the same as Prevnar 13 administration.
4 days after the injection of the COV-PFR 10 into the upper left arm patient had an itchy red rash around the injection site. It was a mild rash that eventually went away. The oddity was it started days after the injection. I googled it and read articles on a website and the CDC website that said this was normal and to use a warm compress and OTC pain reliever. I used a warm wash cloth, applied calamine lotion and gave her 2 children's ibuprofen for swelling. This helped and she was able to sleep.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 19-NOV-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L010595, expiry date: 12-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Hearing loss in her left ear; Tinnitus; Losing her mind because of the ringing in her ears; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the parent.  A 14-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEAFNESS UNILATERAL (medically significant), outcome "unknown", described as "Hearing loss in her left ear"; TINNITUS (non-serious), outcome "unknown"; MENTAL DISORDER (non-serious), outcome "unknown", described as "Losing her mind because of the ringing in her ears". The events "hearing loss in her left ear", "tinnitus" and "losing her mind because of the ringing in her ears" required physician office visit. Therapeutic measures were taken as a result of deafness unilateral, tinnitus, mental disorder.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax & 3 hrs following vax exp a severe h/a; sx resolved p/24 hrs;
Body pain; Joint pain; This is a spontaneous report from a contactable consumer (patient) via the Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose 1, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, after first dose, the patient experienced body pain and joint pain. She was scheduled for the second dose today however she's was still experiencing the body pain. She then asked if she needs time or if she needs to consult a dose for today. Outcome of the event body pain was not recovered, while for joint pain was unknown.  No follow-up attempts are possible; information on lot/batch number cannot be obtained. No further information is expected.
Severe myalgia to the left arm; This case was reported by a pharmacist via other manufacturer and described the occurrence of myalgia upper extremities in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced myalgia upper extremities. On an unknown date, the outcome of the myalgia upper extremities was unknown.   It was unknown if the reporter considered the myalgia upper extremities to be related to Shingrix.     Additional Information: GSK receipt date: 12 Sep 2022 Reporters comment: The caller is the reporter and he reported that the patients received the shingrix vaccine and experienced severe myalgia to the left arm. The reporter did not provide the lot number OR expiry date or any additional information for this report, no additional information provided.  No additional adverse event reported.  No PQC reported. .
Case description: This 44 year old female took Vivotif Berna Vaccine (Typhoid Vaccine Live Oral Ty21a) on 24 FEB 2003 and two days later on 16 FEB 2003 she developed generalized rash with redness and itching. The patient recovered completely.
My reaction to the second primary Covid vaccine, which was Moderna, as well as to my 2 Moderna boosters and my recent pfizer omicron variant booster were all quite similar:  About 12 hrs after my vaccine/booster, close to midnight, I begin having tremors.  Not chills, not sweating, but uncontrollable body shaking, accompanied by full body aches, some lymph node pain.  The tremor -like shaking  lasts about 45 minutes. I also feel nauseated after the shaking stops, but don't vomit.  The next morning I am somewhat drained of energy and awaken with a headache and a fever of 101 degrees.  I then take 2 Tylenol & by noon that next day, I feel pretty good except some brain fog.
Fairly moderate side effects; Malaise; Chills; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Fairly moderate side effects), MALAISE (Malaise), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Fairly moderate side effects), MALAISE (Malaise), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, VACCINATION COMPLICATION (Fairly moderate side effects), MALAISE (Malaise), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was provided.  Treatment information was not provided.   Reporter did not allow further contact
11-8-22 - headache, achy, flu-like, tightness across back from injection site across to other shoulder. 11-9 - tightness spread throughout body! Heavy feeling all over, headache, feeling flu-like. 11-10 - itchiness across top of back (same area where I felt tightness) 11-11- not feeling well, 100.9 temp, nauseous, itchy, rash. 11-12 - stomach feels weird, shaky, headache, very itchy! Rash everywhere I felt the tightness (arm to arm), spreading across arms, back, chest, neck up into hairline. 11-13 -itchy!!! Rash same as previous day. Appointment with Dr. - "Covid Arm" - advised to take heavy dose zyrtec and Hydroxyzine,  also ointment for Rash.  (Rash for a few more days, very tired from heavy doses of antihistamines, arms/chest/back very itchy for a couple more weeks, hard to wear certain types of shirts over the itchy parts)  *** Dr. did not administer the shot - I went to Facility  for that. ***
Information has been received from a consumer concerning her 18 month old son "generally sensitive to different ingredients" and with no pertinent medical history, who in approximately 2002 was vaccinated with one dose of MMR II. Concomitant suspect therapy included DTaP (manufacturer unknown). After getting his vaccines, the patient experienced some fever. In the next couple of months, he started having other problems. "One day he pooped and there were blisters on his butt that looked like burn and it was infected". Later he started having diarrhea and his speech regressed, the reporter "thought it was mercury poisoning". The consumer stated that her son was diagnosed with pervasive developmental disorder NOS. At the time of reporting, the patient had not recovered. Upon internal review, pervasive developmental disorder NOS was considered to be an other important medical event. No further information is available.
Vaccine administered on a Thursday, all day and Friday he seemed fine. Saturday morning he would not wake and was approaching 14-15 hours of straight sleep. I expected my son to be a little drowsy but this was concerning, I called his pediatrician and she said he should not be sleeping like that, to wake him and get fluids in him. Upon waking him he shook uncontrollably and screamed a high pitch scream I have never heard him make before.  His fever peaked at 104 degrees. His lethargy continued for next few days, and fever was controlled via tylenol but remained around 101-102 until Sunday. Each time he woke he would scream that same high pitch scream we initially heard Saturday morning. I brought him back to office Monday and saw PA. She said he seemed to have had a reaction to the vaccine but he was no longer running a fever. When I spoke to pediatrician (6/19) about reporting, she said she did not report it because she considered it a "side effect" and not a reaction.  Therefore, as his parent, I am reporting this event.
Swollen arm too painful to touch, head ache and neck ache, fever and flu like symptoms for a full 8 days.
Patient presented 03/30/18 with site reaction: approximately 3 inches in diameter, irregular, sensitive, with redness, and warm to the touch; patient reported pain post administration in right side of back and described pain as feeling like she was hit by a 2 x 4 or punched; pain resolved within 24 hours after taking naproxen.
Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (mild immunocompromise.).    On 16-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) was resolving.            No concomitant treatment was provided. No treatment medication was provided. Patient had experienced hives after 48 hours of getting her third dose and still experiencing them, but patient said that hives presently are not as bad as before. Patient had stated that she was mild immunocompromised, and so she got her third dose of Moderna Covid-19 Vaccine.   This case was linked to MOD-2021-211489, MOD-2021-293610 (Patient Link).
elevation in blood pressure/hypertension has persisted; This is a spontaneous report from a contactable Physician (patient himself). An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9266, expiry date: not reported) via unspecified route of administration in left deltoid, on 17Feb2021 13:00 (age at vaccination: 86-year-old) as DOSE 2, SINGLE for Covid-19 immunisation. Patient took first dose of vaccination (Lot: EN5318 or it could be ENS318, expiration date: not reported), via unspecified route of administration in left shoulder in the deltoid on 27Jan2021 13: 00 (age at vaccination: 86) as DOSE 1, SINGLE for Covid-19 immunisation. The patient medical history t and concomitant medication were not reported. He was taking a very modest dose of Lisinopril 2.5mg daily, now taking 10mg lisinopril daily. Information was reported regarding Lisinopril 5mg, expiration was filled 25Nov2019 says discard 24Nov2020. It was reported that his blood pressure has gone up after receiving the second dose Pfizer Covid 19 Vaccine, he doesn't know if his blood pressuring going up is a coincidence or if this is being seen by other people. Blood pressure has gone up: states 29Apr2021 was when the caller first noticed the hypertension, the blood pressure going up is ongoing and it is the same, states he has increased his anti hypertensive medication so in a sense. Before 29Apr2021 the caller's blood pressure systolic was below 120, and now the caller is getting ratings like 135, was taking a very modest dose of Lisinopril 2.5mg daily and is now taking 10mg Lisinopril daily. It was also reported that because this spike in protein reacts with the ACE2, the molecule on the surface of the cell spikes protein reactions, which has to do with blood pressure. Patient stated that on 29Apr2021 he noticed an elevation in blood pressure and this hypertension has persisted. He would like to know if this event is a coincidence or if this is a side effect that has been reported with the Pfizer COVID-19 vaccine. Patient was inquiring about the length of time the spike protein remains in the body and circulates after receiving the Pfizer COVID-19 vaccine. He escalated to secondline for further research. He asked if Pfizer would be interested in obtaining a blood sample from him to see if he still has spike proteins circulating in his system from the Pfizer COVID-19 vaccine after his second dose in Feb. Treatment was given for the adverse events includes Lisinopril 2.5mg daily and is now taking 10mg Lisinopril daily. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021651524 same reporter/SD, different patient/AE
Swollen (R) deltoid, redness, warm to the touch 1/19/2017.
First, this form is WAY to cumbersome to expect many lay people to fill out before getting to the point.  After getting the second of the three COVID vaccines I am one of the people who developed TINNITUS. It is ONGOING. I hear it more in the left ear than my right.
Tingling on entire right side of body from top of head to bottom of foot. Brought to doctor who ordered MRI. 2 brain lesions discovered of a demyelinating nature.
Headache started next day, 11/22/2021.  Headache has been lingering since 11/22/2021 turning into migraines at least 3 times since the 21st, but never fully going away.