chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Presented to the ED on 1/21/22 for weakness, wife tested positive 5 days prior.  Denies pain, chest pain, SOB, nausea, v/d.  In the emergency room his WBCs were 15.3, hemoglobin 8.8, hematocrit 29, platelets 289, sodium 132, potassium 4, chloride 92, bicarb 30, anion gap 10, blood sugar 165, BUN 48 and creatinine 2.04.  His troponin is 59, AST 55 an ALT is 55, and ammonia level is 11.  His TSH is 5.43, Tylenol and salicylate levels are negative.  His urinalysis shows 30 WBCs and he is COVID positive.  Lactic acid is 1.1.  In the emergency room he was given a L of IV fluids and started on Rocephin.  He is not hypoxic.  Pt D/C to home 1/24/22.  Had received Moderna 7/27/21 & 8/23/21
Fever highest at 102. Chills. Body aches. Muscle aches. Severe migraine. Weakness.
Patient was administered 3 vaccines. She was told that she might be woozy and to sit for a minute after she had the vaccines. Nurse administered vaccines then left the room. Patient sat for about 5 minutes and decided she was able to walk. So, we walked down the hall. As I was going to pay the bill, she collapsed behind me. A few nurses went to her and one sent for a doctor. She was face down. When I lifted her head, her eyes were open but unresponsive. She came to in about 1 or 2 minutes. She laid there for about another 2 minutes before the nurses helped her walk to the trauma room where they placed her on a bed and put a wet paper towel on her forehead. They also gave her a little bottle of water and some ibuprofen. We sat there for about 20 minutes when the doctor came to check on her. She examined her rib and asked if she had headaches. She told us that fainting is not uncommon after vaccines are given and that if patient felt dizzy the next day or anything happened to contact her. She also instructed to give her plenty of fluids. We left. She felt dizzy off and on with headaches off and on for the remainder of the day.
Child seen in clinic on 04/06/04.  Received immunizations with biojector.  Received one immunization right thigh MMR.  Received DTAP/IPV in left thigh.  Seen in ER 04/08/04.  Diagnosed with Cellulitis after ultrasound left thigh. Treatment with IV antibiotics.  Follow up on 04/09/04.  Prescription given Penicillin for 10 days.
The hep b vaccine was administered first, followed by the prevnar. Within minutes of the prevnar vaccine, the patient started to experience visual disturbances. tachycardia, and his face was pale. I asked if the patient was having trouble breathing and he said yes. I called EMS and they arrived shortly after. While in transit to the pharmacy, the patient started to feel better. When EMS arrived they offered oxygen but the patient said he didn't need it. EMS medically cleared the patient . Epinephrine was not administered.
Mother called and stated pt was having an allergic reaction (rash and temperautre), "I need to know what you gave him so I can tell the ER."
This case was reported by a healthcare professional via a sales representative and described the occurrence of swelling in a 5-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). On 23 May 2011 the subject received unspecified dose of KINRIX at 0.5 ml in the left arm. On 26 May 2011, 3 days after vaccination with KINRIX, the subject experienced swelling, erythema and fever. The events were indicated to be local injections site reactions. At the time of reporting the events were unresolved. In the reporter's opinion, the events were probably related to treatment with KINRIX. Follow-up information was received on 14 June 2011. It was reported that the subject experienced a local reaction at the injection site the day following administration of KINRIX, on 24 May 2011. The reaction included swelling, erythema and fever. The events resolved by 30 May 2011. In the reporter's opinion, the events were probably related to treatment with KINRIX.
LEFT ARM REDNESS, WARM TO TOUCH AND SLIGHT SWELLING APPROXIMATELY 1.5 INCH BELOW THE INJECTION SITE
Patient received SHINGRIX vaccine and was hospitalized the next day for cellulitis which she attributes to the injection she received.
2 days following the vaccine I experienced increased/excessive heart beat rate of 140 to 144 beats per minute consistently for a period of 2 days (3/7/21/thru 3/8/21).  Normal heart beat  rate returned on 3/9/21.
TONGUE SWELLING,  JAW NUMBING, HIVES IN MOUTH. TOOK BENEDRYL
After receiving injections of Tdap, varicella & meningitis client was asked if he was ok by R.N. client responded "he was". Mother present they went to leave facility (satellite clinic) Client appeared to have fainted, as he fell he struck tooth on door as he was leaving, chipping front tooth. Cold compress given client (ice pack) along with feet elevated, chipped tooth placed in baggie of H2O first aid care given x2 nurses.
At 11:30 AM, after vaccination, the patient complained of nausea and slight headache. She then went to sit down and felt flushed and hot. Her fingers on her right hand felt numb and her lips were tingling and numb. She declined to call paramedics or go to the emergency room. At 11:45, her BP was 160/72, HR 78, 02 was 78. She was alert and oriented. Her S1 and S2 were noted, heart sounds were normal, lung sounds were normal. She did not faint. She was observed for 45 minutes. At 12:30, her BP was 158/60, HR 74, 02 100%. Patient ambulated normally, alert and oriented x 4, denied dizziness or numbness or rash.
Next day: Significant arm pain at site of injection; headache, joint pain, slight nausea,  myalgia. Two days after: Red rash on arm near site of injection.
Significant changes to menstrual cycle (two separate and distinct mentsruations in a 3 week time period following 6 months with no menstruation)
Cellulitis in left thigh, area 4" X 4". Pt came to office on 5/19/00.
Anxiety, caused dizziness, nausea, vomiting, and fainting. She was taken to the nearest hospital.
arm pain after the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain after the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    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, the patient experienced PAIN IN EXTREMITY (arm pain after the second dose). At the time of the report, PAIN IN EXTREMITY (arm pain after the second dose) outcome was unknown. Not Provided          No concomitant and treatment medications were provided.   This case was linked to MOD-2021-035864 (Patient Link).
I started to experience body tremors. It was prominent to my left arm and hand. I am still experiencing the tremors almost two years later. I have received 4 doses of Pfizer and they have all been in my left shoulder. I went to see a neurologist, she told me to follow up with her a year after my exam on 04/01/2021, since the tremors were small. I followed up with her 03/2022, and that was at the time where it seemed to have gotten a little worse. She recommended a DAT scan to see if there was anything abnormal or to rule out muscle fatigue. We went over the results. There was an abnormality found in my scan. I do not have family history of tremors. Parkinson's has been ruled in, but it could be something else. She said that only time will tell if it is definitely Parkinson's because everyone reacts differently to the disease. There are options for medications, but I don't feel there is a hinderance at this time to take any. I will be following up with the neurologist every six months.
Developed a staph infection/staph infection was on leg and butt had spots all over body; This spontaneous case was reported by a consumer and describes the occurrence of STAPHYLOCOCCAL INFECTION (Developed a staph infection/staph infection was on leg and butt had spots all over body) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination. a    No Medical History information was reported.    On 21-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced STAPHYLOCOCCAL INFECTION (Developed a staph infection/staph infection was on leg and butt had spots all over body) (seriousness criterion medically significant). The patient was treated with CEFAZOLINE [CEFAZOLIN] for Staphylococcal infection, at an unspecified dose and frequency. At the time of the report, STAPHYLOCOCCAL INFECTION (Developed a staph infection/staph infection was on leg and butt had spots all over body) outcome was unknown.            Patient stated that she was taking some concomitant medications but did not provide further details. She had photos of the same for proof if needed.  Patient was unsure on the onset date for the event post dose 1 and mentioned it as 03-Jun-2021 or 04-Jun-2021.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  More information has been requested.   This case was linked to MOD-2021-265886 (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 event, a causal relationship cannot be excluded.  More information has been requested.
10/8/22 -Pain at injection site & also achy pain under arm 10/21/22-pain in left chest up to neck, bad chest pain on inhaling (worse on any exertion & after laying down), shortness of breath, high BP, fast pulse
Pt called on 9/14/17 w/ complaining of weakness and fatigue as well as nausea and generalized myalgias was seen in Urgent Care on 9/18/17 with continued c/o's and again on 9/27/17 with off and on sx's slowly resolving.
Red bumps on upper left chest and back.  Few other similar bumps located on lower arms and right shoulder.
Pt seen ER 3/12/2021  Dr for vaccine reaction, initial encounter, evaluation for possible vaccine reaction, pt received first dose COVID vaccine today in clinic, episode where became lightheaded, possibly near syncopal.  On arrival to ER back to baseline, monitored on heart monitor with out changed, initially hypertensive but came down, discharged home. Follow up in 1 week with PCP Dr to discuss whether he should receive second dose or not,   pt felt just got hot and anxious about the shot, history of CVA which required crainiotomy and led to seizure disorder, wife thought he might be having a seizure, blanking out. No other s/s noted.
pt had no adverse rxn to vax reported ever;report being submitted only because child died on 17MAR96;case sensitive d/t death mom not contacted regarding cause;death certificate states COD SIDS;
Trigeminal neuralgia began 9/7, shingles diagnosis 9/10
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On unspecified day in 2013, the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot #, expiration date were not reported). On an unknown date, few days after administration of ZOSTAVAX, the patient developed pain and itching at the injection site. The outcome of the events was not provided. The relatedness between the event and the vaccination with ZOSTAVAX was not provided. Additional information is not expected, as the reporting pharmacist declined to provided any additional information.
Headache, Myalgia, UrticariaPruritus, NauseaVomiting, chills and fatigue , hives Narrative:
Tinnitus in both ears 5 minutes after administration of 2nd Moderna injection. Lasted from 1:50 pm 'tll bed time. Woke up with no tinnitus.
Received Flu vaccine around 930am and has been itchy on and off. Recently developed a facial hive and chest "not feeling right". Received BENADRYL with relief in ED.
Seizure-like episode. Patient was seated when his body went rigid and he lost postural control and started to slide sideways. His body was shaking slightly and his eyes were open but there was no cognitive awareness. This lasted no more than 90 seconds and then patient came to abruptly and reoriented himself on the chair before I had the opportunity to get him to the floor. Patient then stated that he was lightheaded, warm and sweaty. EMT had been called and upon assessment of the patient transported him to the ER.
on-going tinnitus, no treatment- I have not yet reported to my physician, onset in December 2022
Joint pain; Aches; Mild fever; Fatigue; Dose received: 3 / dose number = 3; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 38-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 02Dec2021 at 13:45 (Lot number: FJ1620) at the age of 38 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: Migraines and "Acid Reflux (osophageal)" (unspecified if ongoing), notes: Reflux. Concomitant medications included: FAMOTIDINE and VITAMIN D. Past drug history included: Ciprofloxacin, reactions: "Drug allergy", notes: Known allergy: Ciprofloxacin and Bactrim, reactions: "Drug allergy", notes: Known allergy: Bactrim. Vaccination history included: bnt162b2 (BNT162B2), DOSE 2, SINGLE; Lot number: EP6955; Anatomical location: Left arm; Vaccine Administration Time: 11:00, administration date: 12Apr2021, when the patient was 37 years old, for COVID-19 immunisation; and bnt162b2 (BNT162B2), DOSE 1, SINGLE Lot number: EP6955; Anatomical location: Left arm; Vaccine Administration Time: 10:45, administration date: 22Mar2021, when the patient was 37 years old, for COVID-19 immunisation.   The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 at 13:45, outcome "unknown", described as "Dose received: 3 / dose number = 3"; ARTHRALGIA (non-serious), described as "Joint pain"; PAIN (non-serious), described as "aches"; PYREXIA (non-serious), described as "mild fever"; FATIGUE (non-serious), described as "fatigue"; all with onset 02Dec2021 at 22:00, outcome "recovering", Therapeutic measures were not taken as a result of arthralgia, pain, pyrexia and fatigue.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to COVID-19 vaccine. It was reported that symptoms were most severe 12 hours after vaccination. Symptoms mostly resolved 30 hours post dose. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a medical assistant referring to multiple unknown patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was reported. On unknown dates, the patients' were vaccinated with improperly stored doses PNEUMOVAX23 which had lot # L012042, expiry date: 18-NOV-2016, (route and dose not reported). The vaccines were exposed to temperature of 9 degree Celsius for 3 hours (also reported as 50 degree Fahrenheit for 4 hours). No previous temperature excursion was reported. The temperature excursion was detected by a data logger. Additionally, no adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
pt recvd v 21MAY93 c/o small knot size of small acorn or dime @ inject site; there was localized tenderness to touch & pain upon movement exp when lifts arm; no redness or swelling noted; pt was advised to use warm moist compresses;
On the day of dose 1 it was 45 mins after I had moderate dizziness. Lasted for 2 weeks . It is possible that I have lost some hearing in my left ear.
21 y/o male here with brother whom he witnessed having an adverse reaction.  Male moved into treatment area with brother and started to have a panic attack/vasovagal response.  Became lightheaded, dizzy and diaphoretic.  Placed on EKG per EMS, stable normal sinus rhythm, heart rate 71, BP 120/73.   Placed in supine position, AAOx4 neurologically intact.  Waited about 30 minutes, stable.  No complaints or any other issues at this time.  Able to walk out with brother.
Mid-upper arm pain, pain during ROM. Tried Ibuprofen, icy/heating pad, ROM exercises, and icy hot with no resolution.
Bumps On Back Of Tongue & Throat Chest Pain Dizziness  Nauseous  Diarrhea  Fever Headache  Exhaustion  Pain At Injection Site
Pt arrived lane 6A. After confirming right pt, vaccine was attempted on R Upper arm and when med was pushed needle and Syringe fell apart and all medications fell out. After confirming with PA stated to give a full vaccine to pt.
The patient was seen 4 weeks after receiving his vaccine. Per the MD note on 6/22/09. The patient is a 68-year-old who comes in with a complaint of a pruritic rash and erythema all over his arms and torso since 2 days after getting his ZOSTAVAX vaccine on June 1st. The patient already has chronic pruritis and takes hydroxyzine for this. He said that nothing else changed in his regimen except for the ZOSTAVAX vaccination. He has never had any problems with vaccinations before. He said that he first developed redness and rash on his left arm and that it spread to his torso and right arm. He tried hydrocortisone cream and calamine lotion and they have not worked. He has been on the hydroxyzine chronically anyway. He has had no short of breath or wheezing. He has has no swelling in the face. 6/25/09 still having problems with itching and rash, just took last PREDNISONE. 7/1/09 wife calls back stating Pt. still has rash at the front of his chest and itching a lot and he could not sleep at night after he took PREDNISONE.
No adverse effects reported; patient received improperly stored doses of VARIVAX and M-M-R II; Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and current conditions was not provided.   On 28-MAY-2019, the patient received improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number R018142 and expiration date 28-NOV-2019 defaulted as 25-JUN-2020; frequency, route of administration and anatomical location were unknown) for prophylaxis and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot number R000552 and expiration date 08-JAN-2020; frequency, route of administration and anatomical location were unknown) for prophylaxis (product storage error). It was unknown the sterile diluent (DILUENT MRK INJ) (lot number R001254 and expiration date 20-SEP-2020) was improperly stored. No adverse effects were reported.  The time frame was varicella virus vaccine live (Oka/Merck) (VARIVAX) 15 Fahrenheit scale to 46 Fahrenheit scale (26.7 Fahrenheit scale) for 3 hours and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) highest temperature above 47 Fahrenheit scale (59.3 Fahrenheit scale) for 3 hours. There was no previous temperature excursion. Data logger was not involved.
Client received his first dose of the Pfizer Covid-19 vaccine (Lot # EW0185 Exp. 08/2021) on 5/27/21 at 1036 AM. At approximately 1045 the client walked up to the EMT asking for water and stating that he felt lightheaded. " Client was a 22-year-old male alert and tracking with his eyes and beginning to stumble. The client had a chief complaint of syncope. EMT managed to assist the client to the observation bed while an additional EMT and RN arrived for further assistance. The client was positioned supine on the cot and proceeded to lose consciousness. The client did not fall or injure himself in any way. He regained consciousness after approximately 15 seconds. He was alert and oriented to person, place, time, and situation immediately upon regaining consciousness. Client stated that he did not have anything to eat or drink before arriving at the vaccination site. The client had no known allergies and denied any medical history. The client was negative for hives, swelling, discoloration, signs or symptoms of shortness of breath, or other signs of anaphylaxis. The client's airway, breathing, and circulation were intact. The first set of vital signs were taken at 1045 and are as follows: blood pressure 110/76, pulse 52, O2 saturation 96%, skin pale, sweaty and hot. The client consented to stay an additional 30 minutes after his initial vitals were taken and his vitals were reassessed every five minutes until his symptoms resolved. After approximately 10 minutes, the client was fully pink in his face and denied any further lightheadedness. At 1051 the second set of vital signs were: bp 122/82, p 56, O2 96%, skins pink, normal, and warm. Client was assisted to an upright seated position and was given Pringles and juice. At 1059 clients vitals were - 124/84 BP, 74HR O2 99%, Resp 16.  At 1109 vitals: bp 122/82, p 68, O2 97%, skins pink, normal and warm. At the completion of his additional 30-minute observation, the client stated that he was feeling better. All pertinent information was given to client by EMT and RN and he was encouraged to follow up with his primary before his next dose. The client was also instructed to call 911 if a severe allergic reaction occurred later in the evening and was reminded to eat before his next vaccination. RN educated client about the possible signs and symptoms of an allergic reaction. The client at 1115 in positive disposition with his mother.
swollen eyes; a rash on her forehead , around her eyes and both cheeks; very itchy eyes; This is a spontaneous report from a contactable Nurse (patient's mother).  A 22-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on 06Jan2021 17:30 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Nurse stated her daughter received her first Pfizer vaccine on 06Jan2021 around 5:30 pm. The patient's signs and symptoms began shortly after receiving the shot. That evening at 19:00, she had very itchy eyes, the next morning (07Jan2021) she woke up with swollen eyes, a rash on her forehead, around her eyes and both cheeks. She took benedryl and zyrtec on 07Jan2021. The symptoms clear up by 10Jan2021, following a visit to her HCP, on 08Jan2021. She received a steroid shot, a prednisone dose pack her HCP. Her HCP recommended she not take dose 2 and instructed her mother to call Pfizer for recommendations. The outcome of the events was recovered on 10Jan2021.  The  reporting nurse considered the case as non-serious.  Information on the lot/batch number has been requested.; Sender's Comments: The reported events of swollen eyes, itching eyes and rash on face were likely related to first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), due to plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Nausea, Gagging reflex, injection site pain, heart palpitations,  anxiety, aggravated, chest heaviness,  trouble breathing