chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soft tissue swelling upper (proximal) half (R) arm. (R) arm 1cm > diam than left - A 4cm area of erythema & tenderness, 7cm below injection site - Entire injection site itself free of redness, swelling or tenderness. Rx Ice/ Ibuprofen or heat.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID 19 Treatment with paxlovid from 21Jan2023 to 25Jan2023, received other medication in 2weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 30-45 minutes after the injection, my lips and front/top tongue started to tingle.  Since then, my lips /tongue have a prickly, tingly, sometimes burning sensation.    This has been constant. Additionally, the following day (Saturday) I started experiencing palpitations.   Every day since then, I experience palpitations at some point during the day, and even in the middle of the night.  During those times, my heart is not racing.  My heartbeat remains in the 70-72 range, but beats hard at those times.
Pt admitted on 11/21/2021 Tested Positive for Covid -19. Pt presented with Body aches, Decreased appetite, Nausea and vomiting. Pt treated with lasix
Information has been received from a registered nurse concerning a 61 year old male with hypertension and hypercholesterolaemia and no known drug allergies who on 23-OCT-2007 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot# 658083/0885U) in the left arm.  Concomitant drug therapy included aspirin daily, NIASPAN ("NIASTAN"), simvastatin (MSD), INDERAL ("INDEROL"), lisinopril and hydrochlorothiazide.  On approximately 12-NOV-2007 the patient developed shingles on right posterior scalp and the neck at hairline.  Medical attention was sought in the physician's office on 12-NOV-2007.  A viral culture test was performed.  The patient was treated with VALTREX and prednisone.  The patient was not recovered at the time of this report.  There was no product quality complaint.  Additional information has been requested. 03/26/2008 Follow-up information received from the reporting registered nurse indicated that a 61 year old male developed shingles on 09-NOV-2007 characterized by a rash with 8-13 lesions to the right posterior scalp/upper neck extending behind the ear lasting 2 weeks. No other systemic symptoms were noted. There was no recent exposure to chickenpox or herpes zoster. A viral culture test was performed, but no photos, PCR or DFA were done. Additional follow-up information from a physician and medical records indicated there was no illness at the time of vaccination. The final result of the virus culture test collected on 12-NOV-2007 froma rash on the posterior scalp showed no virus isolated on 29-NOV-2007. On 30-NOV-2007 the patient recovered. Additional information has been requested.
Site: Pain at Injection Site-Mild, Systemic: patient reports changes in taste after his first shot on 4/13/21, presented today 5/4/21 with hesitancy about second shot-Severe, Additional Details: Patient reports that after the first covid vaccine he started experiencing changes in taste. His first shot was 4/13/21, and presented today for his second dose on 5/4/21 with some hesitancy about getting the second shot. Patient says that he had covid before, and had mild changes to taste because of COVID infection. He says that after his first shot, his sense of taste changed and worsened, and was unsure about getting the second shot today.
BODY ACHE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and company unable to perform follow-up. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body ache and fever was not reported. This report was non-serious.
hives and rash all over body that has not gone away in 2 days since it began
Never got his 2nd shot; Tested positive for Covid; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Never got his 2nd shot) and COVID-19 (Tested positive for Covid) in a male 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, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never got his 2nd shot) and COVID-19 (Tested positive for Covid). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Never got his 2nd shot) had resolved and COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive positive (Positive) Tested positive for COVID..     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.   No concomitant and treatment medications were reported.
Fatigue, dizziness, agitation, groggy "foggy" feeling with loss of appetite for 3 days after MENACTRA vaccine. No dyspnea, rashes or Guillain Barre.
Low grade fever 100.5 Sunday night and Monday morning.  Diarrhea started Monday evening and still continues today 1/20/11.
Patient reported tingly face within 3 minutes of vaccine. Gave pt 50mg diphenhydramine and monitored for 30 minutes. No worsening symptoms/signs. Patient left to return to work. Contacted patient at 1:30 to check up. She face was still tingly but less than before. She was tired.
No adverse event; Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    No concomitant medications were reported. 27 adult patients received pediatric dose of Bivalent COVID-19 vaccine 0.25 ml instead of 0.5 ml. No treatment information was provided by the reporter.  This case contains information for the 17 of 27 adult patients described by the reporter.
My arm hurt like mad that night; I couldn't even sleep when I went to bed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My arm hurt like mad that night"; INSOMNIA (non-serious), outcome "unknown", described as "I couldn't even sleep when I went to bed".  Additional information: She received her first dose of the Pfizer vaccine on 09Mar2021 at and she took Benadryl allergy relief, gas x and aspirin a day. Today was the first day she took the aspirin. Her next one on the 30Mar2021. She was at the doctor's office that day. She doesn't like taking medications. She has taken some that she was allergic too. Patient stated, "She didn't take anything NSAID. Her arm hurt like mad that night and she couldn't even sleep when she went to bed. She didn't take medication for her pain. Her first dose was on 09Mar2021 a week tomorrow.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Administered vaccine with on incidents. Suddenly with in 2-3 mins. became faint, sweaty, pale layed pt down on exam table. Responded immediately BP 98/56 AP 68. Observation, cool drink rest no further incidence-discharged with mom (did not drug herself).
Within few hours of administration distal to injection site to elbow, red. Swollen. Not able to move shoulder. No fever, discharge. (+) pruritis. Tx - OTC BENADRYL and CLARITIN (allergic to steroids). Improved after 2 days.
Fever Fatigue, Injection site pain, Swelling at injection site Narrative:  Other Relevant History:
Patient arrived for COVID vaccine prior to working shift. He stated upon questioning having an anaphylactic reaction to seafood. We requested him to stay in observation for 30 minutes after vaccine administration. He agreed and vaccine was administered. After working  approximately 3 hours later he returned to the pharmacy stating he felt out of breath. He didn't know if it was because of vaccine or CHF. Questioning him further, he said he felt a little swollen around neck. He was responsive. Administered 50mg of Benadryl. Instructed him to sit. He had a portable fan. After sitting down, he started to feel better. He remained at the pharmacy and called for transportation home, leaving approximately 1 hour later
PERIODIC PANIC; ANXIETY; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 32 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 25-MAY-2021) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced flu like symptoms. On 21-MAR-2021, the subject experienced periodic panic. On 21-MAR-2021, the subject experienced anxiety. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 19-MAR-2021, and had not recovered from anxiety, and periodic panic. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Left arm pain and swelling, no fever started TYLENOL/MOTRIN, BENADRYL for next 72 hours, start AUGMENTIN. Call office or return if needed.
Rash on body (arms chest) following a low grade fever> I always get a skin rash following a break  in a fever
Seizure within 2-3 minutes after given vaccine, observed here for 60 minutes the sent to E.R.
Information has been received a 61 year old female nurse with diabetes mellitus non insulin dependent who on an unknown date in approximately 1999 received her first dose of pneumococcal 23v polysaccharide vaccine and on 17-NOV-2005 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (Lot#651322/1044P).  Concomitant therapy included metformin HCl (GLUCOPHAGE), hydrochlothiazide (+) telmisartan (MICARDIS HCT), estrogens, conjugated (PREMARIN) and atorvastatin calcium (LIPITOR).  On 17-NOV-2005 approximately 2-3 hours after receiving the vaccination the patient experienced sharp pain in shoulder and reported that she "could not move her arm".  She reported that on 18-NOV-2005 the pain and aching spread all over the body.  She reported that her arm became red and hot about two inches below the injection site.  She reported that the affected area was about 5 inches in length and wrapped around her arm.  The area was raised slightly with purple spots in it.  Unspecified medical attention was sought.  Subsequently, the patient reported that by 21-NOV-2005 there was little to no pain and the redness turned a brownish color.  She reported that she had recovered from the event.  Additional information has been requested.
Information has been received from a physician concerning a 13 year old female who on 16-SEP-2008 was vaccinated intramuscularly with the 0.5 ml third dose of GARDASIL. Three hours after the vaccination, the patient fainted and possibly had a seizure. At the time of the report, the patient was recovering from the symptoms. The patient was seen by the physician. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Report A0370536A describes mercury poisoning in a male child of unspecified age who received hep B vaccine recombinant. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not provided. The child received injections of Engerix-B on 03/08/96, 04/23/96 and 10/27/97. He also received combination Tetramune 04/23/96; diphtheria and tetanus toxiods and pertussis vaccine adsorbed 06/18/96 and 08/20/96; Tripedia 10/27/97; ActHIB 06/18/96, 08/20/96 and 10/27/97; IPOL 04/23/96, 06/18/96 and 10/27/97; Orimune 08/20/96; measles vaccine 08/20/96; and MMR II 05/03/97. The vaccinee's attorney alleged that the vaccinee experienced mercury poisoning due to vaccines administered "from March 1996 through at least October 1997." Time to onset from immunization and treatment were not provided. This report of mercury poisoning is considered medically serious.
Temp noted of 100.4 degrees F.  Right leg very tender with large baseball size red lump.  Patient unwilling to walk (per mom).
Pta developed erythema, induration and mild tenderness around site of injection. Will observe now. Cool soaks. Recheck day to day if worsening.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a female patient who received SHINGRIX (batch number G47M2, expiry date 11th October 2020) and (batch number 5NY3B, expiry date 13th July 2020). On 27th April 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 29th April 2018, 2 days after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was not recovered/not resolved. The reporter considered the injection site rash to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Pharmacist reported that they had a SHINGRIX clinic on Friday (27th April 2018). Three of her patients returned to her pharmacy on reporting date with the same symptoms. All three patients were female. The reporter did not have additional details to differentiate one patient from the other. They used two different lot numbers of SHINGRIX. This case has been linked with case US2018GSK080994 and US2018075831, reported by the same reporter.
Itchiness at injection site developed the next day (1/23/19) and still itches today (2/12/19). No other signs or symptoms.
he experienced burning, red, itchy rash, blisters, peeling skin/  itchy rash on his back, arms, and legs; he experienced burning, red, itchy rash, blisters, peeling skin; he experienced burning, red, itchy rash, blisters, peeling skin; he experienced burning, red, itchy rash, blisters, peeling skin; he experienced burning, red, itchy rash, blisters, peeling skin; Initial information received on 07-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 89 years old male patient who experienced burning, red, itchy rash, blisters, peeling skin (skin exfoliation), (rash erythematous), (burning sensation), (blister) itchy rash on his back, arms, and legs (rash pruritic) , while he received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On 07-Oct-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot 2J501AB and expiration date 30-6-2021] via unknown route in the left deltoid for prophylactic vaccination.  On 07-Oct-2020, the patient experienced burning, red, itchy rash, blisters, peeling skin (skin exfoliation), (rash erythematous), (burning sensation), (blister) itchy rash on his back, arms, and legs (rash pruritic) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Relevant laboratory data was not reported.  The patient was treated with triamcinolone, avena sativa (aveeno eczema therapy) and gramicidin, neomycin sulfate, polymyxin b sulfate (neosporine).  The outcome was reported as Not Resolved for all events.
Intercranial hemorrhage/brain bleed; Chills; Fatigue; Really bad shortness of breath; A spontaneous report was received from a pharmacist regarding a 64-year-old female consumer, unknown race, and ethnicity, who experienced intracranial hemorrhage, chills, fatigue, and dyspnoea.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 22 Feb 2021, prior to the onset of symptoms, the patient received one of her two planned doses of mRNA-1273  vaccine intramuscularly for the prophylaxis of Covid-19 infection (Batch# 023M20A).   On 22 Feb 2021, 7 hours post-vaccination, the patient developed symptoms of chills, fatigue, and a "really bad" shortness of breath with a pulse oximetry reading of 81% on room air.   On 23 Feb 2021, the patient was hospitalzed and subsequently transferred to a sister hospital for an intracranial hemorrhage/brain bleed. Lab investigations and treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, intracranial hemorrhage/brain bleed, chills, fatigue, and shortness of breath, was unknown at the time of the report.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Patient experienced a raised welt at injection site, headache, body pain, stiffness, sharp pain at injection site when touched, and a blood-shot red eye on the right side (opposite side of injection). Body pain, stiffness were very significant for 48 hours post- injection, to the point that the patient wasn't able to get out of bed. Patient took Aleve on day of injection due to significant pain. The blood red eye started on day 2, after taking the Aleve. Patient presented on day3 post injection to pharmacy and still has a significant welt with bruising on arm at injection site, sharp pain when touched and stiffness still present.
the next morning (Thursday) I had a fever of 101F. I had a headache. My whole body was fatigued. I mostly spent the day sleeping because every time I got up I felt like I might pass out. By 8pm I was shaking with chills. By 4am the Friday morning I was sweating profusely. Friday my temperature was 100, still headache and fatigue. Saturday my temperature was 99.4 with fatigue.
This is a non-serious spontaneous case initially received from other non-health professional on 13-Dec-2018, concerning a 63-year-old, adult male patient. On 02-Oct-2018, the suspect vaccine was frozen. On the same day, the patient was administered FLUCELVAX QUADRIVALENT (QIV) which was frozen, (dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252660, expiry date: 31-May-2019) for influenza prophylaxis. The patient did not experience any adverse events after vaccination. Follow up received from the reporter on 28-Jan-2019: The reporter stated that the vaccine was frozen on 02-Oct-2018 (added in event tab). The reporter county was updated in the general tab and the patient details were updated in the patient tab. Narrative was amended accordingly. Reporter's Comments: A 63-year-old, male patient administered FLUCELVAX QUADRIVALENT vaccine which was frozen. The company assessed the causality of the event incorrect product storage as not related to the suspect vaccine due to incidental nature of the event and event drug administration error as not related to the suspect vaccine due to accidental nature of the event.
Extremely sore heavy arm. Dizziness for 24 hours. Apparent ?load? to nervous system which seemed to settle in uterus.
Gastrointestinal hemorrhage - He was transfused 1 units PRBCs and hemoglobin remained stable around 8.5. He was made NPO, gastroenterology was consulted. He required 10L of Golytely prep and he went for EGD/Colonoscopy that showed two 2-4mm non-bleeding polyps in descending colon and transverse colon, but was otherwise normal throughout entire colon. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Severe watery diarrhea that reoccured during day 3, 4, 5.  2 episodes of vomiting. Arm was red and swollen. Otherwise, felt well during those days.  Initial low grade fever and malaise was gone.
Dizziness; Headaches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (Headaches) and CHILLS (Chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unkown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), HEADACHE (Headaches) and CHILLS (Chills). At the time of the report, DIZZINESS (Dizziness), HEADACHE (Headaches) and CHILLS (Chills) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.
Headache, sore arm, vomiting, diarrhea, chills  Took injection @ approx. 10:45 am on 1/4/21; symptoms started about 3:30pm and lasted from 6-8 hrs.  Headache & sore arm lingering on 1/6/21.