chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SHORTNESS OF BREATH WHEN SITTING; HEART RACING; BLURRY VISION; DIFFICULTY SLEEPY; BODY ACHES; FELT LIKE FEVER BUT WASN'T; TIRED; SWEATING; This spontaneous report received from a patient concerned a female 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: 1802068, and batch number: 1802068 expiry: unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the patient experienced heart racing, blurry vision, difficulty sleepy, body aches, felt like fever but was not, tired, sweating. Laboratory data included: Heart rate abnormal (NR: not provided) 130. On 18-MAR-2021, the patient experienced shortness of breath when sitting. It was reported that around 03:00 am heart racing, shortness of breath, body aches, tried to take blood pressure unable to obtain reading, reported that when able to take blood pressure, pulse around 130, being sweaty, thought had a fever but did not after checking her temperature felt like she was going into a-fib, reported blurry vision reports still having some of that but a little better. It was reported that her heart was not racing as much. At the time of reporting patient had slight shortness of breath and given herself a breathing treatment and doing breathing exercises felt better but when sitting or walking around and not doing treatments the shortness of breath returned. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the difficulty sleepy, shortness of breath when sitting, tired, heart racing, body aches, felt like fever but was not, blurry vision and sweating was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210340845-Covid-19 vaccine ad26.cov2.s-Shortness of breath. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
10MAR pt had fever to 103.4-rash-similar to "braille" noted next day; raised bumps; see by MD 11MAr; dx virus;
3/24 - first Pfizer shot (days 1-7 no symptoms). 4/1 ? (day 8) severe headache woke me at 4am (pain 10), achy, dizzy, hurt to move, hot/chills. 4/2 - 4am headache, malaise, 99.3 fever. 2pm COVID PCR test (negative), 99.3 fever. 4/3 - 98.9 fever; little energy, headache (pain 6). 4/4 ? 4:30am ? woke from headache (pain 9.5), back of neck (pain 4), fever 99.9, right cheek redder than left cheek, 1pm to 5pm - headache increasing to bad (pain 9), intermittent sharp pain above left ear (pain 10 for 2 seconds) and tender scalp above left ear. 6pm - headache (pain 8), 99.8 fever, intermittent sharp pain at back of head where spine and skull meet (pain 10 for 2 seconds) and above left ear. 4/5 - 6am - headache (pain 6) and intermittent pain above left ear (pain 10 for 2 seconds), 10am - right cheek normal, left cheek deep red (gone by bedtime), 1:30 bright red cheeks, (left more). Energy all day. Intermittent sharp pain above left ear, scalp hurts above ear and top of head, one time pain shot down left side of neck. 11pm - pain worse, achy, back of neck hurts (can tilt forward, can't tilt much side to side), 98.3 temperature. COVID pharyngeal test (negative), blood work (no sign of infection), CT scan without contrast (normal, no sign of bleed). 4/6 - 8:15am - headache mostly top of head (pain 7), intermittent pain above left ear, very tender scalp (most top of head). 97.8 temperature. 8:30pm - headache (pain 7), bad intermittent pain above ear (pain 9, 2 sec), very sore tender scalp all day. 98.5 temperature, achy. 4/7 - 98.2 temp, headache (pain 6), intermittent sharp pain over left ear all day (pain 8, 1 second), painful scalp top of head. 4/8 ? AM - left cheek red (stayed all day), right cheek normal, headache (pain 3); PM ? sharp intermittent pain over left ear (pain 6, 2 seconds). 4/9 - headache (pain 1), temp 98.6, flushed cheeks.
12/09/2022 my symptoms came on pretty fast I started feeling fatigued, severe headache and body aches. 12/10/2023 tested positive for COVID-19. I contacted the Telemed service at a clinic and was prescribed a 5-day course. My symptoms lasted about 15 days and I did not test negative until 12/26/2022.
Site of shot was very painful more than just sore I couldn?t even put a sheet on me at night, I had a fever from 99 on Monday night the day of the shot to 102 up and until Wednesday morning, chills and aches
lt arm, site of vax hives red raised & itching;lt arm sore mildly then hives cont to spread down lt arm & both shoulder & thighs;DPH PO helpful;
breakthrough bleeding; sweats without fever; bad headache,migraine did not respond to benadryl; Cramping; hot flash; Body aches; chills; it feels like I am about to have a period.; This is a spontaneous report from a contactable consumer (patient).  A 48-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 13Apr2021 11:00 AM (Batch/Lot Number: ER8727) (at the age of 48-years-old) as single dose for covid-19 immunisation. Medical history included eczema, beef allergy, allergies: Sulfa, on birth control pills from an unknown date. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for birth control, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included BNT162B2, dose 1, administered in arm left on 23Mar2021 10:30 AM (Batch/Lot Number: EW0151) (at the age of 48-years-old) for covid-19 immunisation and experienced first shot just a sore arm like tetanus shot. The patient did not receive other vaccine in four weeks. The patient did not get Covid prior vaccination and did not receive Covid tested post vaccination. The patient stated after second shot, bad headache starting about 12 hours after shot on 13Apr2021 23:00. On 13Apr2021 10:00 PM, body aches, chills/sweats without fever. Similar to having flu on 13Apr2021 10:00 PM. Migraine did not respond to benadryl (usually benadryl or phenergan helps). Headache took about 36 hours to go away. Cramping and breakthrough bleeding the day after shot on 13Apr2021 10:00 PM and continuing today, two days after. She was on birth control pills (for hormones) and was on active row of pills. It's like she forgot to take a pill - hot flash, bleeding, even headache were all things that happen if she was missing progesterone. Headache and most aches gone except it felt like she was about to have a period. Treatment received for event Migraine included Benadryl and no treatment received for the other events. The outcome of the events breakthrough bleeding and Cramping was not resolved, of the event headache was resolved in Apr2021, of the event it feels like I am about to have a period was unknown and of the other events was resolving.
Pt was given the influenza vaccine on Nov. 30, 2018 at 4 pm or so. Not sure which one, but not nasal spray. At about 24 hours, he began to experience heavy and difficulty breathing, almost gasping, dizziness, numbness in hands feet and entire body at times. He began to feel very hot and cold, but experienced no fever. He was listless and seemed like he would pass out and speech became mumbling. After several hours he got a bit better in terms of the numbness and breathing. Still experienced headaches for a few days and general weakness for several days.
Second Dose should have been Modena.   Staff administered Pfizer.   No reaction.
Papular erythematous rash primarily on trunk, spread to proximal upper extremities and forehead. No fever. Rash is not pruritic or otherwise bothersome to patient.
Got my shot 2 weeks ago, the amount of pain, needle much easier; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In JUN-2023, the patient received Shingles vaccine. In JUN-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Got my shot 2 weeks ago, the amount of pain, needle much easier). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-JUN-2023 This case was reported by a patient via interactive digital media. The patient got his/her shingles shot 2 weeks ago from the day of reporting and the amount of pain and needle was much easier.
no additional AEs; Caller reports that MMR II lot expired on 10/08/22 and was administered on 10/11/22; This spontaneous report was received from an administrator and refers to a 19-year-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant therapies, allergies and drug reactions were not provided.  On 11-OCT-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin  (M-M-R II) subcutaneous injection, 0.5 milliliter, lot #T034391, expiration date: 08-OCT-2022, (strength, dose number, route and site of vaccination were not provided) for prophylaxis (expired product administered). No additional adverse event (AE) was reported (no adverse event).  .
The Dr. called another Dr. on 3/29/2021 to report that he is having neurologic problems with onset two days after receipt of his first dose of COVID vaccine on 1/6/2021. Department of health confirmed that  second dose of Moderna was administered  on 2/3/2021. The RN called the Dr. who stated that on January 8 he started having severe pain from the right side across his scalp to the other side of his ear.  Slurred speech.  Tongue deviation to the right.  Saw internist on 1/9.  CT, MRI x2 Negative.  R/o stoke.  Per neurologist: R cranial Nerve 4, 6, 9, 19, 11, 12 shows dysfunction, but there is no structural reason.  Seeing speech pathologist now.  Wanted to ensure this is reported as he thinks his problems might be related to COVID vaccine. RN left message @ vaers for staff regarding this report, as Dr. wants to know if this has been seen in other instances.
Large hives started in the evening of 6/22/10 on small of back, torso and legs. Treatment: BENADRYL and ORAPRED.
Redness, pain, extreme swelling & bruising at injection site. Headache, fatigue, chills & sweats on 8/30/09. By that evening and into 8/31/09, fast heart rate, difficulty breathing & paleness. Symptoms kept worsening so attempted to call on 8/31/09 around 10 am, ER where vaccine was administered and Charge Nurse was not helpful and very dismissive of symptoms.In fact he contradicted the literature that was given to me at the time of the injection. Either the staff is not versed on these vaccines or just don't care. Called my primary care doctor for treatment. Symptoms finally subsided on their own. Arm continues to be bruised, red and painful on 9/7/09. Hoping this goes away eventually. Seems there is no one who knows of the reactions to these vaccines so they are very unhelpful to patients. I am lucky the worst of these symptoms went away and did not require another ER visit. I will NEVER take another vaccine again!
Headache, Arthralgia, Fever, NauseaVomiting, lethargy, chills, Narrative:  Other Relevant History:
Throwing up; Colds; Bowel movement was not going anywhere; A spontaneous report was received from a consumer concerning an 80-year-old female patient who received Moderna's COVID-19 (mRNA-1273) vaccine and experienced cold/nasopharyngitis, throwing up/vomiting and bowel movement was not going anywhere/constipation.  The patient's medical history was not provided. No Relevant concomitant medications were reported.  On 23 Feb 2021, approximately two weeks prior to the onset of symptoms, the patient received their first of the two planned vaccine doses of mRNA-1273 (Lot number: 010T00A21A), on an unspecified arm with unknown dose and route of administration, for prophylaxis of COVID-19 infection.   On 9 March 2021, the patient was hospitalized for colds.   On 12 Mar 2021, the patient was discharged.   On 13 Mar 2021, the patient was throwing up and was again brought back to the hospital. The patient was told that their "bowel movement was not going anywhere."   On 17 Mar 2021, Diagnostic procedure, Endoscopy was performed on the patient and the result was normal.  No Treatment information was provided.  Action taken with mRNA-1273 in response to the event(s) was unknown.  On 12 March 2021, the outcome of the event, cold was considered resolved.  On an unknown date, the outcome of the events, throwing up and bowel movement was not going anywhere were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, Constipation and vomiting, a causal relationship cannot be excluded.  The event of Nasopharyngitis was assessed as Unlikely Related to study drug, as this could be due to spread of virus droplets.
BODY ACHES; CHILLS; FEVERING; This spontaneous report received from a patient concerned a 35 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: UNKNOWN) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, Laboratory data included: COVID-19 virus test (NR: not provided) virus detected. On 01-DEC-2021, the patient experienced body aches. On 01-DEC-2021, the patient experienced chills. On 01-DEC-2021, the patient experienced fevering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fevering, chills, and body aches. This report was non-serious.
Swelling, itching at local area of injection, muscle feels warm and hard. Occurred 6 days after injection.
Chronic Spontaneous Urticaria started on 12/25/2021. Symptoms have continued but are under control now with medication. Taking 2 Xyzal in 2x's a day, 20 mg Pepcid AC 2x's a day, Montelukast 1x a day.  Still getting some hives occassionally, especially if I take medication a little late or miss one pill.
pt presented to facility on 12APR97;c/o pain in joints, ankles, knees & wrist joints x several days & MMR on 24MAR97;dx it as arthralgia;pt given med;
Head feels like a bad hangover; Very bad headache; Headache not allowing him to sleep; This spontaneous case was reported by a consumer and describes the occurrence of HANGOVER (Head feels like a bad hangover), INSOMNIA (Headache not allowing him to sleep) and HEADACHE (Very bad headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Back pain. Concomitant products included OXYCODONE for Back pain.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced INSOMNIA (Headache not allowing him to sleep). On 20-Feb-2021, the patient experienced HANGOVER (Head feels like a bad hangover) and HEADACHE (Very bad headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Hangover, at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Headache, at an unspecified dose and frequency. At the time of the report, HANGOVER (Head feels like a bad hangover), INSOMNIA (Headache not allowing him to sleep) and HEADACHE (Very bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. The reporter mentioned that the pain comes back as Tylenol wears off.
Orthostatic hypotension, postural orthostatic tachycardia, lightheadedness on standing. Began approximately one month after second dose of Pfizer/BioNTech  Covid 19 vaccine and lasted 2 months.
Area on left leg where vaccine was given became very red with splotches. Area had fever in it. Approx 12 inches in a circular diameter became very swollen for 3 days without any change. On 4th day the area is still red/splotchy and gone down half way with the swelling. Child is very ill and cranky as well as not as much energy.
3 hrs after inj. sweat, chills, HA, pt said body felt hot but didn't take temp.
Headache, Myalgia, sore arm  Narrative: day of vaccine had sore arm, body ache, second day had sore arm and mild headache, third day had sore arm
Date of Admission: 10/12/2022   Date of Discharge: 10/17/2022   Admission Diagnosis: COVID-19     Hospital Principal Problem (Discharge Diagnoses): COVID-19
A report was received from a health care professional on 10/21/02 concerning a 46 year old female vaccinee who developed a welt over the deltoid region of her arm on 10/16/02,  which was described as red, swollen, painful and warm after receiving 0.5 ml Fluvirin on 10/15/02. The vaccinee was reported as recovered since 10/18/2002. There was insufficient information to determine the reporter's causality assessment. Ref: PJP200200596, PJP200200601, PJP200200602 and PJP200200597.
Fever 103 w/in 24 hrs pain, redness lt knee to thigh; also arthralgia;
PATIENT RECEIVED PNUEMOVAX VACCINE ON 7/27/07 AT 1425 ON RIGHT UPPER ARM. AT 7/28 2330 PATIENT WAS NOTED TO HAVE SORENESS,REDNESS AND SWELLING, HOT TO TOUCH- AT INJECTION SITE. TEMP 100.9. REDNESS CONTINUED DOWN THE ARM TO THE ELBOW. CELLULITIS WAS DIAGNOSED. KEFLEX WAS STARTED FOR A 10 DAY COURSE. ELEVATION OF EXTREMITY AND HEAT WERE UTILIZED. BY 7/29 THE ERYTHEMA WAS RESOLVING AND HAD RESOLVED BY 7/31 PER MD NOTE.  PATIENT'S HISTORY WITH OTHER IMMUNIZATIONS UNKNOWN. MANUFACTURER OF THE VACCINE WAS MERCK
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L013206, expiration date 29-JAN-2017, dose and route were unknown). The vaccines were stored under 34.5 F (Min) and 37.9 F (Max) for 24 hours. There was no previous temperature excursions. It was called because of a "data logger". No adverse effects were reported. Additional information has been requested.
developed and retained diplopia; This is a spontaneous report received from a contactable consumer (patient) via Regulatory Authority. This non-pregnant 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an unspecified route of administration in the right arm on 07Feb2021 (at 42-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had not received any other vaccines in the four weeks prior to the COVID vaccine. The patient took unspecified concomitant medications within 2 weeks of the COVID-19 vaccine. The patient previously received sulfamethoxazole, trimethoprim (BACTRIM) from an unknown date for an unknown indication and experienced allergy. On 08Feb2021 the patient developed and retained diplopia; further reporting increased intensity after the second shot. The patient reported it had been going on for 14, almost 15, weeks. The event required an ophthalmology doctor's office visit and was treated. Lab tests included a computerised tomogram (CAT scan); ear, nose, and throat (ENT) scope, and A1C blood tests, all of which were completed on unknown dates with unknown results. The patient received the second dose of BNT162B2 on 28Feb2021. The clinical outcome of diplopia was not recovered. Since vaccination the patient was tested for COVID-19 on 05May2021 via nasal swab which was negative.
Information has been received from a registered nurse concerning an approximate 70-year-old female with allergies to BENGAY and opsite topical dressing who on 18-OCT-2007 was vaccinates subcutaneous with a dose of ZOSTAVAX (lot # 657559/0462U). Concomitant therapy included IMODIUM, omeprazole (MSD), TRIAMTEREN COMP), atenolol (MSD) and influenza virus vaccine (unspecified) administered on 23-OCT-2997. On an unspecified date (after administration of vaccine) the patient experienced injection site erythema and swelling. The patient sought medical attention via a telephone call. On an unspecified date a hemogram diagnostic lab was performed. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested.
Beginning DEC 10, 2021. Nausea & sore arm. DEC 11: fever 101.2, nausea, body chills, muscle aches, severe headache. DEC 12: Continuing fever, severe nausea, vomiting, red arm, sore arm, fatigue, severe headache  DEC 13: extreme fatigue & weak, nausea & vomiting, SEVERE headache, odd stabbing sensations in head felt as if bugs crawling in brain but extremely PAINFUL!! Been using flexible ice packs on neck, top of head & sides of head. Since Dec 11 been taking Rx Naproxen every 12 hours & extra strength Tylenol as often as I can (at least 3 hrs after Naproxen & 6 hrs between Tylenols)  DEC 14:  same issues continue .. again, nausea & vomiting, EXCRUCIATING headache (nothing like my migraines I've experienced for 36 years.  Couldn't cope any longer so husband drove me 20+ miles to the Emergency Room at a hospital.  As I was taken in my husband was required to remain outside in 20 degree weather in the parking lot at 1am.  I spoke to 4 different entry points & at each location I said I was having an adverse reaction to my 3rd Moderna vaccine.  I had my booster on December 9th and I was extremely sick from it.  After about an hour I saw a doctor & an RN.  The doctor was very dismissive of my reporting of my experience and instead treated me for a 'virus' and possibly a 'migraine'.  They tested me for Covid, RSV, and flu.  I had none of those.  Those tests all came back negative.  They ran some blood tests and said I was 'fine'.  They gave me an injection of compazine to help with the nausea, an injection of toradol for inflammation, and they gave me an injection of magnesium to help relax the muscles.  They also gave me a Rx when I left for the generic of compazine.  I showed the Doctor a report about how they have seen some people having inflammation of the brain as a side effect from the boosters.  She was extremely angry at me for even doing any reseach on this.  My sister-in-law is a primary care physician but she doesn't live here and I had no one else to talk to about this.  I didn't want to call her at 3am her time.  I just needed to be seen and see if that was what was happening to me.  She completely ignored the possiblity.   DEC 15: Nothing has changed.  Still sick with SEVERE headache, nausea, fatigue, weak, and arm still red the size of a baseball.  DEC 16:  Same as Dec 15    DEC 17:  Still horrible night headaches.  Still feel as if I have bugs crawling inside my brain.  Stabbing headaches.  Headaches SEVERE!   DEC 18:  Still have headaches but seem to be subsiding a bit.  Headaches seem to last about 12 to 16 hours a day now   DEC 19:  my fatigue is still an issue.  I can barely walk anywhere or do anything.  I walk from the bedroom to the living room and must rest.  Can't do much of anything.  Skip ahead now to JANUARY 1, 2022:  Still have daily headaches from the booster.  These are completely different from migraines or other headaches.  They are every single day now.  I am scared to death to try another booster!!  I would say I'm *mostly* recovered after 3 weeks and 2 days but headaches remain, and I still have fatigue and weakness.