chrisvoncsefalvay/vaers-outcomes huggingface dataset:
small little raised area; welts surrounding the injection site site; covid arm; bright red; warm; sore arm; painful feeling; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (small little raised area), VACCINATION SITE WARMTH (warm), PAIN IN EXTREMITY (sore arm), PAIN (painful feeling) and VACCINATION SITE URTICARIA (welts surrounding the injection site site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm), PAIN IN EXTREMITY (sore arm), PAIN (painful feeling), VACCINATION SITE REACTION (covid arm) and VACCINATION SITE ERYTHEMA (bright red). On 25-Mar-2021, the patient experienced SWELLING (small little raised area) and VACCINATION SITE URTICARIA (welts surrounding the injection site site). At the time of the report, SWELLING (small little raised area), VACCINATION SITE WARMTH (warm), PAIN IN EXTREMITY (sore arm), PAIN (painful feeling), VACCINATION SITE URTICARIA (welts surrounding the injection site site), VACCINATION SITE REACTION (covid arm) and VACCINATION SITE ERYTHEMA (bright red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: No specific follow-up information recorded.
Expired vaccine was given. Vaccine expired on 02/04/2022. We contacted Pfizer, they stated that there is a shelf life of 2 weeks after the expiration so no need for repeated dose. The patient reported no adverse effects.
committed suicide; ringing in his ears; This spontaneous case was reported by a consumer and describes the occurrence of COMPLETED SUICIDE (committed suicide) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COMPLETED SUICIDE (committed suicide) (seriousness criterion death) and TINNITUS (ringing in his ears). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, TINNITUS (ringing in his ears) outcome was unknown.        Concomitant medications were not reported; Reported Cause(s) of Death: Unknown cause of death
Within @ 1 minute I had a tingling on the tip of my tongue, then slightly burning sensation. I felt almost like I was going to pass out, but did not. I also had a feeling of swelling in my upper lip. No obvious visual swelling, just sensation of fullness. I have a history of angioedema, but this has been a long time ago. I just stayed at site for @ 30 minutes. Sensations stayed for more than 1 hour. I took a antihistamine when I got home. This helped and it dissipated. Tongue "felt funny" for a few hours No other symptoms
c/o red and swollen at (L) arm right after immunization. Decreased swelling today. no pain
feeling unwell; headaches; small rashes on the left shoulder area, just in front of her chest; she experienced a racing heart rate for a short time; This is a spontaneous report from a non-contactable consumer (patient). This 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received the Covid-19 Vaccine last 18Dec2020 and was due to have the 2nd dose on an unspecified date (reported as tomorrow). However, she said she was feeling unwell. She said she was experiencing headaches, and small rashes on the left shoulder area, just in front of her chest. Patient mentioned that the rashes appeared 15 days after she received her 1st dose in Jan2020. She also mentioned that she experienced a racing heart rate for a short time and said it happened within 24 hours after receiving the 1st dose, but not immediately. Patient wanted to know if receiving the 2nd dose of the Covid-19 Vaccine later than 21 days would affect the efficacy of the vaccine. Outcome of the events was unknown.  No follow-up attempts are possible; Information about Lot/Batch could not be obtained.
Fussy, restless, no sleep after vaccines. After 28 hours of vaccine administration, weird involuntary movements of extremities, starting right upper limb, moving to Rt leg - Lt leg - Lt upper limb; dystonic movements described. Tics on face also with eye involvement. At 36 hrs, acute life threatening event while in mom's arm, arching, slowed breathing, tongue rolling back. Needed mom's intervention to open airway. Lasted 20 seconds. Baby dazed. Taken to ER. Similar episode at 40 hrs. Hospitalized to date. Continued twitches, dystonic movement in Hosp. Somewhat better. Had Sats initially. Neck stiffness, buckling knees episodic. Reflexes intact. No fever. No LOC even though dazed off and on. No obvious seizures. No resp symptoms. Feeding mostly well. IV BENADRYL helps.
don't sound very well; upper neck was hurting; full blown head cold/head cold on right side of face, nose, throat and progressed to chest; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (don't sound very well), NECK PAIN (upper neck was hurting) and NASOPHARYNGITIS (full blown head cold/head cold on right side of face, nose, throat and progressed to chest) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced MALAISE (don't sound very well), NECK PAIN (upper neck was hurting) and NASOPHARYNGITIS (full blown head cold/head cold on right side of face, nose, throat and progressed to chest). At the time of the report, MALAISE (don't sound very well), NECK PAIN (upper neck was hurting) and NASOPHARYNGITIS (full blown head cold/head cold on right side of face, nose, throat and progressed to chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported.
pt recvd Hep B vax on 14SEP90 & exp hypertension; 28MAY91 pt delivered a healthy full-term baby; mom exp anemia @ delivery;
pt recv vax 30OCT95 & 14SEP97 pt exp rash of approx 100 scabbing pox & a pap rash;no fever was noted;
Gas; Aches and pains; Passed out; Fell; did get hurt when he fell; Hit his head on the counter and cut open his head; Dizzy; Nausea; Weakness/He is very weak; This is a spontaneous report from a contactable consumer (caregiver). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jan2021 as a single dose for COVID-19 immunisation, lot number: unknown. Medical history included Blood pressure high. Concomitant medications included some blood pressure medicine (no names reported). It was reported that patient got up in the morning the following day (on 16Jan2021), so dizzy, weak, nauseous, and he fell (did get hurt when he fell), passed out. On the way down, he hit his head on the counter and cut open his head, not a pretty sight when he got up. On unknown date patient experienced gas, aches and pains. Patient was very weak. Patient was not going to pass out, but he was very weak, and reporter thought some of it was from fall, he fell. When you pass out, you fall like a ton of bricks. He fell on a tile floor. So, he had gas, he had some aches and pains now too. Patient was going to take him to the doctor because he did get hurt when he fell. No treatment received for the events, patient had not seen a doctor yet, he will be seeing one the day of the report. Patient had not recovered from weakness, while outcome of the other reported events was unknown. Information about Batch/Lot number has been requested.
About 10 hours after injection, started experiencing headache, body aches, chills and fatigue; took acetaminophen then and every 6 hours for 24 hours; worst of symptoms eased off after about 8 hours, with slight headache and fatigue lasting another 12 hours.
Skin eruptions, pain body and headaches, burning, itching, tingling, nausea.
administered covid orange top monovalent as booster. MOP notified pt will need to return to clinic for booster dose.
Initially minor soreness at injection site (no problem), the afternoon of the injection. That evening, I had slight headache, tiredness, and chills. Next morning, "pinching feeling" in left underarm. After continuing to feel this, I finally went and looked and found a "red spot" at the point of the greatest soreness and also noted swelling of the general area. This soreness has continued on through to today (3/29/2021).
Developed tinnitus in both ears and ear pain 24 hours after vaccine. Worse in right ear. Mostly gone after 18 hours of symptom onset but still occasionally mild tinnitus in right ear.
1/22/22 pt had a positive COVID test; 1/28/22 pt to ED with AMS (previous dx of delirium, hyperthyroidism and UTI; currently unable to take much by mouth including medications; pt remained in ED until 2/2/22 due to COVID surge; transferred to ICU; dx with UTI, anemia with signs of bleeding; on O2 via NC without respiratory sx; sepsis, delirium, acute renal failure; ABX; DNR; pt became unresponsive, asystole, pt expired in the hospital
Immediate fatigue and muscle pain the following few days.  Progressed to whole body pain, paresthesias.  She has seen multiple providers without a clear diagnosis.  Also has fatigue, bruising, and bleeding issues now.
Telephone memo has been received from a physician confirming that a specimen has been collected and submitted to the Varicella Zoster Virus Identification Program (VZVIP) program: "the female patient (age and ethnicity were unknown) enrolled in the VZVIP to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain". The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with VARIVAX (dose, frequency, route and lot# not specified) as prophylaxis. On an unknown date, the patient had juvenile idiopathic arthritis (JIA), and was receiving the "newest biologics" (product name not specified). And whenever she got the biologics, she developed a rash reported as VZV on whatever side she received the biologic. A sample was obtained with this occurrence and was found to be polymerase chain reaction (PCR) positive for VZV in the hospital lab. The patient was hospitalized. The lab was not open over the weekend and was asked to hold the sample for shipment until Monday (18-SEP-2017). On that day, the physician was contacted. The physician confirmed that she would not be sending the sample on that day. The site would speak with the physician regarding the paperwork and submitting the sample. The outcome of all the events was not reported. The causality between all the events and VARIVAX was not reported. Upon internal review, the event of juvenile idiopathic arthritis (JIA) was considered to be medically significant. Follow up information was received on 21-SEP-2017. It was confirmed that the sample sent on 20-SEP-2017 from the VZVIP Laboratory was received on 21-SEP-2017. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the VARIVAX vaccine and the reported events of varicella zoster virus infection and juvenile idiopathic arthritis cannot be established. The report doesn't include medical history, concurrent conditions, exposure to someone with varicella, concomitant medications. Additionally the report also does not provide time to onset (No dates of Vaccine administration, neither start date of the event). Company Comment- No changes to the product safety information are warranted at this time. Merck and Co., Inc., also known as MSD, continues to monitor the safety profile of the product.
Lost dose. The luer lock on the syringe was cross threaded and the vaccine leaked from the syringe at the time of administration.
Swollen and tender lymph nodes on above left collarbone at the base of neck. Felt swollen when I woke up the morning of 12/08/21.
5 days after vaccine developed hives. Day 6 and 7 was really really bad hives. Did a tele appt. List of meds: Pepcid - 20 mg 2 x/day; Satirazine - 10 mg 1 day per day; benydryl 25 mg - several times a day - took over the weekend (over the counter). On 28th they prescribed Prednisone: 20 mg two times/day for five days. There was a fever with the hives so I wasn't allowed to work; off work for six days (three scheduled and three were scheduled off). Resolved after prednisone.  Still a bit itchy but no hives.
One week after receiving the COVID19 Moderna shot my arm started itching at the injection spot.  I have some bumps that are itchy there.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Blue lips, white face, blurry vision-Severe, Systemic: Hypotension-Severe
Dizziness, Headache, Myalgia, fatigue, chills Narrative:
Rash with vesicles, myalgias, arthralgias and mild cough (mild chickenpox).
Patient developed shortness of breath with bilateral pulmonary emboli. He was hospitalized on 6/3/21 to 6/4/21 and was discharged home on blood-thinning medication.
On 03/31/02 mom noticed few spots on neck. On 04/02/2002, mom noticed face very red and rash all over body. On 04/03/2002 mom took the pt to a physician. He diagnosed hives and prescribed Allegra. Rash gone within 24 hrs.
Mild to moderate chest pain, shortness of breath, tingling sensation.   Did a video visit with a doctor one week after the vaccine when they told me to take ibuprofen, they said come back if it doesn't get better to get an EKG and treatment.  After I went into the doctor they prescribed me prednisone. I've yet to start the prescription (20mg). If I don't get better in 5 days after taking it see a cardiologist.
Back Pain; This case was reported by a other health professional via call center representative and described the occurrence of back pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2019, the patient received the 2nd dose of Shingrix. On 13th August 2019, 1 days after receiving Shingrix, the patient experienced back pain. The patient was treated with ambiguous medication nos (Cortisone (Nos)) and prednisone (Prednisone (Oral)). On an unknown date, the outcome of the back pain was unknown.   It was unknown if the reporter considered the back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient. The patient made an appointment with primary care physician after experiencing bad back pain. The patient received cortisone and oral prednisone taper.
This spontaneous report was received from a physician via company representative and refers to a currently 18 years old patient of unknown gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 06-APR-2015, 03-AUG-2015 and 29-SEP-2015, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route of administration were not provided) for prophylaxis. The patient was 13 years old at the moment of vaccination. The administered schedule was not congruent with the recommended one. The patient did not experience any adverse event.
Fever, chills for 48 hours. Induration at injection site 6cm in diameter.
pt stated that she felt like someone was choking her.  gave benadryl 50 mg, epinephrine 0.3 mg, solumedrol 125 mg, and famotidine 40 mg and then another 0.3 mg of epinephrine in that order at 3:50 pm after reaction began.  NP was notified.  pt was observed and felt better after about 30 minutes and pt was then released to her family and taken home with the instruction of taking benadryl every 4 hours to continue through the evening.
Injection site and surrounding 4 inches are hot to the touch, swollen, red, skin/muscles are hardened and sensitive to the touch. Symptoms are still persisting 5 days later but are decreasing. Severe exhaustion, mild nausea and persistent diarrhea. Advil and other pain relievers did nothing to help.
Rash of anterior neck and low back; pruritic: Began after COVID-19 vaccine. Present for 3-4 weeks. Questionable for acute urticaria, no sign of angioedema or pulmonary involvement.  Attempted treatment with calamine, betamethasone without relief.
This is a spontaneous report from a contactable consumer (patient). A 57-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0158), at the age of 57, via an unspecified route of administration, left arm, on Apr 14, 2021, at 13:15, single dose, for COVID-19 immunisation. Medical history included high blood pressure from an unknown date. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Concomitant medication included amlodipine besylate for an unknown indication; from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EN6207) at the age of 57, via an unspecified route of administration, left arm, on Mar 24, 2021, at 13:15, single dose, for COVID-19 immunisation. The patient previously received doxycycline, Ceftin (cefuroxime axetil), hydrochlorothiazide, Augmentin (amoxicillin/clavulanic acid) and Lotrel (amlodipine besylate/benazepril hydrochloride); and experienced drug allergy. On Apr 15, 2021, at 02:00, patient experienced swollen lymph node at collar bone area on the left-side (same side as injection). It was very large and slightly sore. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of swollen lymph node at collar bone area on the left-side and very large lymph node and slightly sore: unknown (at the time of this report). No follow-up attempts needed. No further information expected.
Patient received first injection of Pfizer's COVID-19 vaccine on March 27, 2021. Approximately a week or so after the injection, the patient stated that she had headaches, back aches, and occasional cough. On April 17, 2021, patient received second dose of the Pfizer COVID-19 vaccine (ER8735).  Within a couple of days of the injection, patient complained that the back pain was worse.  By Wednesday, April 21, 2021, patient indicated that back pain was "excruciating" and cough had increased.  She contacted her Primary Care Provider's office to set up an appointment.  An appointment was scheduled for Friday, April 23, 2021.  In the interim, the back pain continued, the coughing increased and she developed chest pain. During the Dr. Visit on April 23, 2021, the Physician ordered a Chest X-ray which showed "bibasilar pleural effusions with associated atelectasis".  The patient was advised to take Aleve for the pain and was also prescribed a muscle relaxant (Flexeril).  (Please Note: Patient has never had any lung problems.  Previous Xrays and CT indicated clear lungs). The Physician also ordered a CT Scan of the Chest. The CT Scan of the Chest was completed on May 12, 2021.  Chest CT Findings: multiple areas of lympadenopathy in chest and lungs; Possible pulmonary metastases. Mild upper abdominal lymphadenopathy was also present. Most recently (week of 05/09/2021), patient developed pain in left calf.  Ultrasound negative. Additional Note: Patient is post left mastectomy for breast cancer (Sept. 2020)- with negative margins and negative lymph nodes. Patient had remained healthy up until the onset of the headaches, back pain and chest pain, as described above. As stated, these symptoms appear to have started after the first dose of Pfizer COVID-19 vaccine.
mom reports temp of 103-104 x 3 days despite alternating APAP/Ibuprofen every 3hr;reports vomiting x 3-5 days w/crying/screaming;all s/s started evening p/vax;mom denies adverse rxn w/1st set of vax but exp temp & crying w/2nd vax;
10OCT91 435 TC from mom states pt has generalized hive rxn on entire body & is fussy; no signs of breath holding or sz like activity noted in clinic or home; facial swelling-feet to head welts;
8/21/09 Received phone call from pt reporting red, warm area on (L) deltoid. States started about 3-4 hrs after receiving the vaccine on 8/19/09. Instructed to call PCP, cool compress to area, Tylenol or Motrin to seek medical evaluation if needed.
Headache, fever, nausea, chills, tinnitus, lightheaded all within 24 hours of vaccinations. Tinnitus first symptom and only symptom that hasn?t cleared up.
Pt called around 2100 on 5/2/09; spoke with one RH to report that her (L) arm where they injected Pneumococcal vaccine started to get swollen. Pt was instructed to schedule appointment with primary MD the next morning to be checked. Pharmacy notified about incident.
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. Concurrent or medical conditions were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route and lot number were not reported). Secondary suspects and concomitant therapies were not reported. The physician reported that on an unknown date, the patient experienced syncope past the 15 minute observation time and a tightening in her throat while on therapy with GARDASIL 9. On an unknown date, the patient recovered from syncope and tightening in her throat. The patient did not sought medical attention. No treatment was given for the events. The events did not required intervention to prevent serious criteria, did not produce significant disability or incapacity, did not required hospitalization and there were not life threatening for the patient. No product quality complaint was reported. Additional information is not expected as the reporter did not wish further contact.
Right arm swollen, fever - not taken (11:00 AM 3/27/03).
Have report from remote community - Did not see child, After receiving PCV-& IM w/ Binjection in upper right thigh, he developed hard, welted "blister" area, warm to touch like a scab but scab prevent no pus or drainage. "Lump' on muscle under the affected area. No reacting  at any other immunization site. Treated with compresses for comfort & Tylenol. Resolved in 1.5 weeks
Narrative: Patient received one dose of the covid vaccine. PMH of HTN, PVD, Dementia, Patient appears to have been declining before vaccine ie weight loss, multiple falls. Patient has recent CVA and was transferred to hospice. no other details of death. reporting per facility.
pt recv vax later that day pt devel SOB & cough, malaise, fever, body ache;OK next day;