chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hand was tingling; Hand was numb; Felt deep in arm, radiating down to hand; Pain in his arm was excruciating; Arm was sore to touch; Distraught; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Hand was tingling), HYPOAESTHESIA (Hand was numb), PAIN (Felt deep in arm, radiating down to hand), ANXIETY (Distraught) and PAIN IN EXTREMITY (Pain in his arm was excruciating) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided.  Concomitant products included OXYCODONE for an unknown indication.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced ANXIETY (Distraught). On 20-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (Arm was sore to touch). On 21-May-2021, the patient experienced PARAESTHESIA (Hand was tingling), HYPOAESTHESIA (Hand was numb), PAIN (Felt deep in arm, radiating down to hand) and PAIN IN EXTREMITY (Pain in his arm was excruciating). The patient was treated with LIDOCAINE at a dose of UNK dosage form and OXYCODONE at a dose of 1 UNK. At the time of the report, PARAESTHESIA (Hand was tingling), HYPOAESTHESIA (Hand was numb), PAIN (Felt deep in arm, radiating down to hand), ANXIETY (Distraught), PAIN IN EXTREMITY (Pain in his arm was excruciating) and MYALGIA (Arm was sore to touch) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2021, Computerised tomogram: unknown (Inconclusive) results not provided. On 15-May-2021, X-ray: unknown (Inconclusive) results not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications included steroids, both injections and oral and muscle relaxers.   This case was linked to MOD-2021-225680 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received on 25-JUN-2021 contains no new information.
EXTREME WEAKNESS, unsafe waking, BP  90/60    heart rate 50. Lasting from 3/28/21 to date and more
Lcalized vaccine reaction, redness, swelling R thigh at injection site, low grade fever, transient.
day 1 : extreme tiredness night 1: restless and could not sleep day 2: so tired again - i needed to take multiple naps to get through my day ,  also had a fever through the day  day 5: bad headache started  - i had this same reaction to the first shot as well
Received HPV, Tdap on 6/20/12. Returned 6/25/12 complains of pain and swelling in left upper arm. Pt advised to take ALEVE or ADVIL OTC CLARITIN. ATARAX Rx as PRN. Instructed to report if sx worsen or no improvement.
arm was sore where it had been injected; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore where it had been injected) 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) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm was sore where it had been injected). At the time of the report, VACCINATION SITE PAIN (arm was sore where it had been injected) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported No treatment medications were reported    This case was linked to US-MODERNATX, INC.-MOD-2021-098594 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098594:
On 1/10/10 (two days after vaccines), stated myoclonic jerking of arms - up to few times per hour. Gradually decreased frequency over following 2 wks. EEG ?? diagnosed by neurologist with myoclonus.
swelling in the injection arm; arm reaction; Pain in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in the injection arm), VACCINATION SITE REACTION (arm reaction) and VACCINATION SITE PAIN (Pain in the injection arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling in the injection arm), VACCINATION SITE REACTION (arm reaction) and VACCINATION SITE PAIN (Pain in the injection arm). At the time of the report, PERIPHERAL SWELLING (swelling in the injection arm), VACCINATION SITE REACTION (arm reaction) and VACCINATION SITE PAIN (Pain in the injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter   This case was linked to MOD-2021-237309 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (Poor sleep) and PYREXIA (Fever) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L00A) for COVID-19 vaccination. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced POOR QUALITY SLEEP (Poor sleep) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, qid. On 28-Jan-2021, PYREXIA (Fever) had resolved. At the time of the report, POOR QUALITY SLEEP (Poor sleep) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
One day p/Td shot, pt devel t100, red, hot area from site down to elbow;
This spontaneous report as received from a physician regarding a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 30-JUN-2015, the patient received improperly stored PROQUAD (Merck) (lot# L002419, expiry date: 23-JUL-2016, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was no concomitant medication reported. No adverse effects was reported and no product quality complaint involved. This is one of several reprots received from the same reporter. Additional information has been requested.
Lethargic, apathetic, Weakness, fatigue the morning after vaccination. 4 inch diameter erythema around vaccine site, tender to the touch and firm to pressure.
Chest pain, light headed, SOB. 3:45 became unresponsive for approx 1 hour-ambulance to ER-response then unresponsive again for 1/2 hour-responsive for 20 mins then unresponsive for 10 mins-heard everything but could not move any part of my body-I had some eye movement. 11/18/09 Medical records received for DOS 11/12/09. Chest pain and LOC s/p flu vaccine. Went floppy. Could not speak but knee what was going on. Responded to pain.  Back to baseline but gait unsteady. Using walker. Follow-up: When I wrote a description of my adverse reaction I should have said "total body paralysis" and not "unresponsive" since I did respond to painful stimuli and was aware of my surroundings. So of my 8 symptoms listed-"unresponsive to stimuli" and "hypokinesis" are wrong-it should be "paralysis". I'm so sorry-but I have been out of work for 3 weeks and still have high b/p, dizziness and headache. I guess I was hoping if this "motor paralysis" is happening to other people I could figure out what is wrong with me.
24 Hours after nausea, fever, chills, diarrhea, arm pain lasting 48 hours. At time of visit no nausea, fever, chills. 4 days after arm pain, heat in affected area, red welt , hands red.
Patient stated that he came down with shingles a couple days (about 2 days) after receiving the Shingrix Vaccine. He went to the doctor's office to get it looked at and was told he had shingles. He stated a rash appearing on one side of his back (left side) that later expanded down around to his mid back (left side). His physician gave him a 7 day course of oral valacyclovir and lidocaine ointment to be applied to the affected area.
Breakthrough COVID-19. Sore throat, runny nose, cough and malaise started on 7/16. Tested negative on LFT on evening of 7/16. Symptoms worsened on waking in the morning of 7/17. Performed LFT; was positive. Notified medical center, who performed PCR; returned positive.  99.5 fever. Bussed to quarantine on 7/18. Received molnupiravir prescription on 7/19. Isolated and quarantined until 7/26. Returned home. No fever after 3 days. Significant reduction of runny nose after 5 days, and significant reduction (although still nagging) cough after 7 days. Not completely symptom-free until 7/14.  Still some fatigue.
Sever pain at injection site. Numbness and tingling in right arm. Shooting pain in arm when arm lifted over head.
severe rash.; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller received her second dose of the vaccine on an unknown data (Saturday) and started to develop a severe rash on an unknown date. The outcome of the event was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial unsolicited report received from a consumer on 14 October 2015. This case involves a 61-Year-Old female patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (batch number, route and site of administration, dose in series were not reported) on unspecified date on Sunday. Patient had medical history of feeling ill which were flu like symptoms after taking Avonex. The patient was also taking TERIFLUNOMIDE (Aubagio) 14 mg orally daily since 24 September 2015 as concomitant medication for multiple sclerosis. On an unspecified date after vaccination on Monday, the patient was feeling ill. The patient's laboratory data was not reported. The patient received corrective treatment with Ibuprofen. The patient was recovered from the event on an unspecified date. List of documents held by sender: none.
Information has been received from a nurse practitioner via a company representative concerning a 65 year old female with egg allergy who on Oct 14 2004 was vaccinated IM in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (manufacture unknown). Subsequently the patient experienced site reaction with a 6cm in diameter red area around the injection site. It was unknown when the first dose was given. Follow up information indicated that the local reaction was treated, and there was no further problem. The outcome was reported as recovered. No additional information is expected.
Rash around injections site, anterior upper chest wall rash, tachycardia (HR 120-150), numbness in hands, SOB, dizziness, nausea. Treated with Xyzal and prednisone
No adverse event; Bivalent doses administered after the BUD to the patient 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to the patient 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 43-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to the patient 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to the patient 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to the patient 12 and up.).    Concomitant medication was not reported. Patient ID was reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Reportedly, in this report the patient was not Eligible. Breakdown of doses were reported as 51 doses from batch numberAS7140C and 60 doses from Batch number AS7148B.  Treatment medication was not reported.
Fatigue. Moving slowly. Feeling like trying to ?walk through water?. Slight headache (front of head above eyes) that wasn?t resolved with ibuprofen.
Day of shot and following 2 days: Tingling in arm of injection site for about 15 minutes directly after vaccine, followed by slightly soar arm, and fleeting auto-immune response "cruddiness" the following day. Overall not bad though. Week after shot: Stomach issues and bad cramps one week after the vaccine. Three weeks after shot: Developed skin tenderness around my left rib cage and late area. Followed by a rash with with fluid filled blisters. Ribs are now very tender and skin is raw to the touch. "Diagnosis is SHINGLES!"
Erythema, induration, warmth, tenderness of injection site, measuring 7 cm. Pain in arm and shoulder of R upper extremity where injection given.
Left upper arm pain up shoulder, Back + Down arm since the shot. Aleve relieves pain temporarily.
Pharmacist drew up 0.3 mL of Pfizer monovalent vaccine and vaccinator administered instead of the intended 0.3 mL Pfizer bivalent vaccine. No adverse reactions or symptoms were observed.
Dizziness, BP at 5:10pm 74/35, at 5:12 76/38, 5:14 120/57, 5:16 110/69, 5:19 11064, 5:22 134/67, 5:25 112/66, and standing 5:31 123/74.  Heart rate 45 at 5:10, 66 at 5:31.
On 8/3/01, pt's left arm became red and swollen about 15:00 today. Advised to use cold compresses today and warm compresses tomorrow and Tylenol for pain.
I been spotting even though I am on birth control for 4 months. It has stop now. I went to my doctor about this. They did blood work and ultra sound, all came back normal.
Shingles after receiving two doses of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 3rd September 2019, the patient received the 2nd dose of Shingrix. On 17th September 2019, 14 days after receiving Shingrix and 81 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The batch number was not reported. The patient developed Shingles two weeks after receiving Shingrix. The reporter did not have lot numbers or expiration dates of Shingrix at time of call. The reporter consented to follow up.
2 wks after injection-child developed chicken pox, approx 50-249 lesions.
pt awoke this AM 8:00 & had reddish blotch on legs & raised red areas on face & arms;mom states grandma gave pt smashed baked beans 19NOV97 in evening;mom advised to call MD & let MD know;
Breakthrough COVID infection. Potential COVID exposure on 6/10/2022. Tested positive for COVID after complaining of scratchy throat and runny nose on 6/13/2022.
Pt.'s Grandmother states that after receiving the 1st dose of Phizer 12/07/2021, started experiencing symptoms 12/08/2021 of possible fever and hives throughout the body (redness in both ears). Scheduled appt. with Primary 12/10/2021 for follow-up. Previously received Influenza Vaccine 11/23/2021 (no adverse reactions noted).
1/7 - Got vaccine, minor soreness in arm at injection site. 1/8 - Soreness in arm at injection site, no discoloration nor lump. Sore back and abdominal muscles. 1/9 - Some minor soreness remaining, resolved by end of day. 1/10-1/15 - No soreness, discoloration, lump, nor other symptoms of any kind. 1/16 - Suddenly noticed a hard lump at injection site, apx. 2" diameter. Lump was minorly itchy and sore to touch, and area was red and hot.  1/16-1/20 - Lump gradually reduced in size, itch and pain resolved. Redness remains.  1/20 - Redness at inj. site has progressed to a bullseye pattern. There's a center red spot apx. 1" diameter, surrounded first by a ring of normal skin, then by a ring of redness. Diameter of outer red ring apx. 2".
Had these symptoms that night such as sleeplessness, pain at injection site, upset stomach, diarrhea in the morning and felt lousy all next day, Oct 29.  Symptoms were much improved by evening but noticed that blotches were starting on my face and being my ears.They became redder, raised and itchy as the day went by.  Called the tech at the Pharmacy who gave me the shots.  He told me he had not seen the red raised splotches  as a complication but I should call my family  Dr to report this. I did so on Wednesday, Oct 30th and have not heard back. Not using anything different on my face or eating anything different. Took a benadryl last night and splotches look muchbetter this morning.
Syncopal episode with LOC for approx. 10 seconds, diaphoretic, pale, with HR at 92 BP 140/80, pt. was on table and placed in lying position, no injury sustained during fainting spell. Kept supine for 20 min, gradually placed in upright position but then felt dizzy,placed back into reclining position for another 10-15 min, VS stable, oriented X3, skin color returned to normal after about 30 min with no more clamminess of skin, tearful and upset, Vs rechecked at 110/70 HR 66, Resp.14, denied SOB or signs of allergic reaction, area of injection appears without signs of reaction. Pt. was able to stand and was taken out of clinic with assistance to family car. Appeared stable upon getting into car.
Rash, Hives 20 minutes after vaccine. Treated with Benadryl.
After the vaccination I have had severe and almost progressive hand and arm pain,  hand numbness,  muscle fatigue.  I can't explain how weak my arms feel. Most problems have been on the left,  my vaccine site.  I can't rule out diabetic complications but I can tell you I have had normal EMG testing and no known cause at this time.  Diagnosis has been a provisional carpal tunnel but the issues are not typical of carpal or cubital tunnel.  Sometimes my hands and arms are so weak they shake with little use.
Patient was administered Moderna monovalent 1st dose for the primary series on X/XX/2023 with lot# 015b22a. Patient was administered in the left arm 0.5 ml IM. The lot expired on XX/XX/2023 and hadn't been removed from inventory and was administered to the patient. This was discovered on XX/XX/2023 and follow up with patient reported only normal injection site reactions such as sore arm and fatigue for a few days. There were no major adverse events related to the vaccine administration. There were no major adverse events related to the vaccine administration. This was discovered on XX/XX/2023 and follow up with patient reported only normal injection site reactions such a sore arm and fatigue for a few days.
pt recvd vax 10OCT94 (lt thigh) that evening devel urticarial rash all over body;no fever;seen by MD on 11OCT;in addition to rash,pt had purple discoloration to both legs;(lt worse than rt) & fever 100.5;no resp distress;no irritability
After receiving  vaccine, patient starting feeling  dizzy. Pt was instructed to lay down and elevate her legs. Patient HR was elevated and stated she started feeling like she did when she had her seizure (tingly all over and tongue tingly). No rash identified on back, neck, face, chest, belly. No tongue swelling. EMS was called due to hx of seizure and pt was transported to hospital for further evaluation.
fever, chills, pain between shoulders, nauseau, tremor in hands, exhaustion Fever and pain lasted for 6 days, exhaustion and tremor lasted for 2 weeks Gabepentin, Melosixam, Ondansetron
Approx 1 hr after injection had bronchospasms, developed generalized body aches, headache. At approx 1300 became nauseous, diaphoretic, pale. BP: 90s/40s, weak thread pulse - near syncope. Temp 100.8. Next morning symptoms resolved.
L axillary lymph node swelling and pain ( shot was in L deltoid injection site_)
no symptoms were reported by  the patient after administration; VARlVAX was administered to patient since the excursion; This spontaneous report was received from a certified medical assistant referring to a patient (age and gender unspecified). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 21-JUL-2021, the temperature exurcion ocurred.  On 26-JUL-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), dose reported as 1 (units not provided),  lot # T032319, expiration date:22-SEP-2022 for prophylaxis (dose number and  route of administration were not reported) during the excursion. The administered dose of the vaccine experienced a temperature excursion was 10.2 degrees Fahrenheit~for 1 hour 15 minutes, as recorded by a data logger. No previous excursions were reported. No symptoms were reported by the patients after administration. No product quality complaint reported.  This is one of several reports received from the same reporter; Sender's Comments:  US-009507513-2108USA001788: US-009507513-2108USA001787: US-009507513-2108USA001789: US-009507513-2108USA001786:
Next morning felt pain tenderness and swelling on left arm and left side of nose (skin) diarrhea mild and fast heart rate 110 bpm.