chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sinus headache; Cough; Allergies; 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), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "COVID-19"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "COVID-19"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: MULTIPLE ALLERGIES (non-serious) with onset 2022, outcome "unknown", described as "Allergies"; COUGH (non-serious) with onset 2022, outcome "unknown"; SINUS HEADACHE (non-serious) with onset 2022, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Product was Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent. Reporter was asking if it was okay to get the Bivalent vaccine since she has had a sinus headache for about 3 months now and did home test twice but tested negative. Reporter stated she and her husband both had COVID-19 at the end Jun2022. She stated they have both had the Pfizer-BioNTech COVID-19 Vaccine, (monovalent) vaccines, have had the primary series and the booster doses 2. The reporter and her husband both received their last booster dose in May2022. Referred her to her HCP for treatment recommendations. Other Condition, Investigations and other products were not provided. Patient and her husband both got COVID in Jun2022. NDC number and Expiry Date of COVID-19 vaccine was not provided. Reason for no lot number of COVID-19 vaccine was Complainant hung up abruptly/transfer incomplete. Packaging sealed and intact was not provided. Patient stated that she started with a cough but no fever. Patient mentioned she had allergies so the cough was most likely associated with that but she just wanted to confirm.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Could walk. Crippled hands. Totally Dependent on others. Water from shower burned as needles.  Brain Tumor found.
Started period off-cycle on 5th day after receiving vaccine, 13 days early; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 15Sep2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included unspecified hormonal birth control pills (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing. On 20Sep2021, the patient's period started off-cycle on the 5th day after receiving the vaccine which was 13 days early. It was reported that the period was normally on a regular schedule. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 20Sep2021, the patient underwent nasal swab test for COVID-19 and the result was negative. The clinical outcome of the event started period off-cycle on 5th day after receiving vaccine, 13 days early was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Fever, chills, hot flashes, throwing up, diarrhea, slowed armpit lymph nodes
Burst blood vessel in right big toe the day following booster vaccine. Bruising spread to second toe. Doctor described the event as a paroxysmal hematoma.
Freezing, chills, fever of 101.5, sweats, and whole body aches. Most of the symptoms lasted 24 hrs except the body aches which lasted for 48 hrs.
Day after vaccine she had pain from area of inmunization down to elbow and 2 days ago it became red to a diameter size of about 3 1/2 to 4/12 inches and it has an erythethous macule
she has had serious problems with her feet and legs ever since; both of her feet and legs swelled up; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (she has had serious problems with her feet and legs ever since) and PERIPHERAL SWELLING (both of her feet and legs swelled up) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (she has had serious problems with her feet and legs ever since) and PERIPHERAL SWELLING (both of her feet and legs swelled up). At the time of the report, LIMB DISCOMFORT (she has had serious problems with her feet and legs ever since) and PERIPHERAL SWELLING (both of her feet and legs swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was reported.        Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Correspondence email letter - TCR received where Patient identifier (gender) and event has been reported.
Within 30 minutes of injection, headache occurred that lasted approx 6 hours reported that was similar to first injection. Approx 2 hours after administration mild nausea that lasted approx 3 hours. At approx 16 hours after injection, headache again reported with elevated HR (approx 20 bpm above normal resting average), nausea, and muscle aches that lasted approx 3 hours. 24 hours after injection, low grade fever with muscle aches, chills, headache, and nasal congestion that lasted approx 5 hrs.
immediate sx were: chills, fatigue, myalgias/arthragias, headache; after ~5 d,  return of fatigue, headaches, same quality as all prior fatigue, headaches s/p Moderna shots (I never thought to check BP with those headaches, as expected with vax).  Note my first booster, 8/18/21, was full dose given prior to EUA, and the booster antecedent to these sx was EUA half dose.  continued into week 11th April so i checked my BP and had SBP 155-165 and DBP 85-95.  prior to that i had rare intermittent labile BP not sustained and not with headaches.  Saw my oncologist 18Apr for routine check up and shared this and BPs and on 19APR started amlodipine 5 mg qhs with regulation of BP by d3 (today). I am a practicing oncologist; follicular lymphoma x 17 yr, active disease returned Aug21 on watch and wait, no immediate concern by my doctor that these sx related to the lymphoma
Fever, high pitched scream, excessive crying for 5 days, measles type rash over trunk, face x 3 days, swollen lymph nodes neck slowly resolving Tylenol and cool baths.
pt given shots & exp lt knee pain, joints, fingers & elbows & wheal/flare rxn on abdo;
After receiving these vaccinations patient had all over joint pain. Once patient received second SHINGRIX shot in February patient's left side has been numb and tingly, the left side of her mouth under her tongue was numb. Her dentist told her that since she had the SHINGRIX shot normal anesthesia would not work for her.
I started experiences perimenopausal systems again, such as severe sweating.  I had not had "the sweats" in years before getting the vaccine.
5 minutes after shot felt weak -> brief syncope with pulse 48 pulse, clammy, twitches a few times, slumped in chair (we have all new patients wait 15 minutes before going home). Taken back to room, lied down, later some fluid given. BP ok. Went home about 30-40 min later and doing well exam WNL.
Client of a group home requested to be vaccinated with the Johnson and Johnson (J&J) vaccine. Client was asked if he had ever had an adverse reaction the the Covid-19 vaccine, Client stated no. The J&J vaccine was administered in the client's left deltoid. Client went into observation area and was observed for 15 minutes without incident. When the Community Health Worker was entering the administration of the J&J into the system, the client had previously received 2 doses of Pfizer on dates 3/28 and 4/18. Client was requested to come back to observation. Client was observed for an additional 15 minutes. Client was instructed not to get any more Covid-19 vaccines. Group home administrator was notified of the event.
A report was received from a regulatory authority on 3/6/02, concerning a 25 year old male pt who had been enrolled in a (non-company clinical trial) who experienced vertigo, which was considered disabling after receiving a Fluvirin vaccine on 10/20/95 which (was not part of the clinical trial). The pt (a helicopter pilot) had received adsorbed tetanus-diphtheria vaccine (reduced dose) and a poliomyelitis booster on 9/26/95. Since 2/01, the pt had experienced paroxymal vertigo approx. once a week, lasting between 30 seconds and a minute. A full exam was performed which was normal, including ENT/neurological and psychiatric assessment and MRI evoked potentials. Further investigations are planned to rule out migraine. At the time of reporting, the pt had not yet recovered. There was insufficient information to determine the reporter's causality assessment.
Patient presented to pharmacy on 5/8/21 after receiving 1st dose covid -19 moderna vaccine on 4/10/21 (without any effects) and right arm began feeling exceedingly painful, deep muscular pain limiting arm motion to an extreme degree, along with severe wide spread itching across the entire upper shoulder area radiating out from the area of the injection. Symptoms still present without abating on 5-10-2021 in spite of application of ice packs for 24 hours, followed by moderate heat from electric heating pad.
41 year old female received Moderna vaccine on 1/8/2021 (lot 011J20A) and 2/4/2021(lot 011 L20A) .  About 2 days post vaccination noted small red spots on her tongue, arms and legs. On 6 days post vaccination she noticed a red mark on her neck and had prolonged epistaxis. She had a normal hemocue in the clinic and normal vital signs with no further bleeding. She was sent to the Emergency Department via chartered flight. In the ED she was noted to have a petechial rash of mucous membranes, upper and lower extremities and multiple ecchymosis. Her platelet count was 2. Hemoglobin 13.3, hematocrit 40.2%, WBC 7.86. Metabolic panel unremarkable, coagulation studies unremarkable. Vital signs normal.  After consultation with hematology, Dr., she was given high dose steroids and tranexamic acid and sent via medevac to MC for possible IV Ig and platelet transfusion. She arrived there sometime early this morning. Platelets were 4 upon arrival at Medical Center.
Patient had no side effects initially but developed a quarter-sized red spot at the injection site 7 days afterward.
WARMTH, SWELLING, PAIN BEGAN ON 12/26/20 AND WORSENING SINCE THAT TIME. 8x8cm ERYTHEMATOUS, INDURATED, CALORIC AREA NOTED UPON ASSESSMENT 12/30/20.
Acute on chronic diastolic heart failure- She was initiated on IV diuretic on admission. During hospitalization she was quickly diuresed with 40 mg IV lasix, which was ultimately held the day prior to discharge d/t decreasing weight and slight increase in kidney function.  She was ultimately weaned onto room air and resumed her regular diuretic dosing.  ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Friday 5pm- upon vaccine, I felt a tingling and slight numbness in my lips, which went away within an hour. Later that night (around 8pm) I felt a slight tingling, numbness in my lower left calf and foot. Saturday- my lower left calf and foot had more of a tingling/numbness, which improved as the day went on, Sunday Day- still slight tingling in left and now right calf, feet, upper arms. Sunday night- numbness in both legs and feet, Monday- woke up with numbness in both shins, tingling in upper left leg.
14 days after vaccine - High Fever (100) for 4 hrs, dehydration, diarrhea (toke acetominaphin) Next day no fever, but tired, shortness of breath, and some loss of taste and appetite, but not extreme, 16 days days after vaccine - Low Fever (99),  chills and sweating for about 2 hrs. (Took acetominaphin) Next day, tired, some chills and sinus and upper resp. congestion. 17 days after vaccine - High Fever (102) for 10 hrs and full body rash which started as flush redness and then became almost like blisters on inner fore and upper arms, thighs, and abdomen. TO NOTE: The day after taking the MOD vaccine I resumed taking supplements B, Calium and Alpha Lipoic Acid daily. I took maybe one of two Zyrtec in those two weeks. WHAT POSSIBLY TRIGGERED THE RASH: I changed the B-Complex Brand since I ran out. 15 minutes after taking it I got the flush and then 1 hour later the high fever. I thougt it was high Niacin related reaction.
When woke up the next morning, felt feverish took temperature and it was 100.7F, felt extreme fatigue could not get out of bed, legs were very weak, could not move out of bed. Called ER and they told me to take some aspirin (2). I tried to walk around the house and eat but decided to go back to bed and slept it off. ER also told me to drink electrolytes, I could not even open the bottle, I had to call my daughter to come and open it for me. I broke up in a  sweat last night around midnight, this morning I took my temp it was 98F and I still feel weak. I also woke up with a headache and my nose is stuffed up, I have some mucus. Feels like a head cold.
22 hrs post injection acute dizziness and nausea. Acute dizziness lessoned after rest.  I've continued experiencing dizziness upon standing and sometimes lying down since 3/16/2021
A non-serious spontaneous report of fever has been received from a physician concerning a 74 month old female subsequent to FLUMIST. Medical history and concomitant medications were not reported. The patient received a single dose of FLUMIST on 03-Oct-2009. The same day, at night, the patient ran a fever of 102. On 05-Oct-2009, the fever had decreased to 99.9. The event was resolving.
Patient reported that they noticed redness and tenderness in left arm the day after immunization. Patient reported that this reaction got progressively worse over the next 2 days post vaccination and he visited an urgent care because the redness spread along his arm to elbow, and was warm and tender to the touch and swollen. He was prescribed Keflex 500mg to be taken twice daily for a period of 10 days. The symptoms resolved within 4 days after medication was started.
This spontaneous report ws received from a pharmacist concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 19-JUN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX for prophylaxis Lot number M001746 and expiration date 07-APR-2017 (dose and route of administration, were not reported) . Concomitant therapies included sterile diluent(STERILE DILUENT).   No adverse effects were reported.
cold sweats at night, heavy breathing, severe nausea, dizziness, and weakness. This happens randomly and last for about 5 hours
Received FLUZONE 9/11. Cranky on 9/12 and started seizing at 5AM on 9/12. Was given DIASTAT 5 mg rectal. Seized for one hour - partial/complex. During that time he also was talking but not making sense. No problem since then. No fever.
Patient returned to site 30 mins after observation as he felt short of breath, difficulty swallowing and dry throat. Patient was evaluated by RN and EMS. No swelling noted. Vital signs obtained. Patient hydrated and was closely monitored. Patient was also evaluated by PA and PA. Patient was then had some complaints of left arm tingling. Patient provided with water to hydrate. Patient felt better after 30 mins.  Patient instructed to contact PCP  if any worsens Symptoms or if any medical emergency to call 911 or to ER. Patient also advised to report any symptoms  using the VAERs online on card.
Vaccine given 10:00 am on 10/21/2005 began with pain in left elbow about 4 hours after injection. Took Tylenol deltoid area became hot, hard and painful at some time as the elbow started hurting waited 4 hours took Motrin. Next day pain continued. On Sunday used compresses went to ER on Sunday did EKG, lab test, all test were normal. Given antiinflammatory (Motrin) and Percocet.
Vaccinated roughly around 4pm on 5/19/21. a few hours later had painful cramp that made his arm draw in for about 30 minutes. that relaxed and since then he has had numbnes and weakness in the right hand. I believe brachial neuritis.
It was the second 0.25mL dose that they've had in 4 weeks; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (It was the second 0.25mL dose that they've had in 4 weeks) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (It was the second 0.25mL dose that they've had in 4 weeks). At the time of the report, ACCIDENTAL OVERDOSE (It was the second 0.25mL dose that they've had in 4 weeks) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  No treatment medications were reported.  The couple really wanted to get the Flu shot but got booster second 0.25ml dose within 4 weeks.
No treatment needed at this time. Received 2nd dose of PREVNAR pt stated no previous pneumonia vaccine. Administered vaccine. Realized afterwards that she had already received but did not remember. No treatment needed. Seemed to be fine when spoke to pt.
1st 24 hour: Extreme pain at left arm injection site, fatigue, overall body pain (muscles & joints), sore/swollen breasts, and brain fog. 10/9/2021-Present: Fatigue, sore breasts, menstrual issues (unusual bleeding: random spotting when not menstruating, heavier than usual bleeding during menstruation, longer & shorter menstrual bleeding), one short 17 day cycle with no ovulation, abdominal pains in reproductive area (lower abdomen)
ONE OF 2 OR 3 PTS WHO RECEIVED IMMUN DEVELOPED SWOLLEN, RED ARM.
Extreme pain surrounding injection site. Unable to use my arm fully. The following day pain continued and flu like symptoms ensued.
petechiae noticed on 3/27. Thrombocytopenia (2x10(9)/L) noted 3/30.
While I can't be definitive of the cause, within 12 hours of the shot, Patient was limping due to pain in her leg.   Within 24 hours, she was acting lethargic at school and felt warm.   She was sent home due to elevated temp of 99.6 and saying she needed to vomit.  She threw up at 3:00pm.   She said she had a headache and a sore throat. Temperature up to 100.    Called nurse, they suggested she be seen next day if not improved.    Vomited again that evening.  The next morning, she vomited 3 times, and 3 more in the afternoon. Though fever resolved. She was unable to eat or drink without vomit. She also complained of sore throat.   Called for appointment.   We were allowed to give her Zofran.  Doctor said it could be a tummy bug, but her symptoms were the same as her recent covid illness (sore throat, vomit, fever, and headache).   So it was possibly a response to the vaccine.   She said to be prepared for the possibility of it happening again at her 2nd dose, and suggested to have our Zofran ready to hopefully mitigate these effects.  The appointment occurred around the 48 hour mark from the vaccine.   Overnight, Patient vomited 7 times.   The next day, she kept attempting to vomit, but did not.  We contined to give Zofran at the prescribed times.  She was still fatigued and did not attempt to get up and play.  We gave pedialyte pops and ice chips.  She did not want to eat food.   Around 74 hours from vaccine, she ate a cracker, and started to improve, no longer wanting to attempt to vomit.
Patient requests no demographic data be entered.  She developed 3 pustular lesions on her left chest 13 days after her husband received his primary Smallpox Vaccination.  Vaccinia PCR positive. Symptomatic treatment with Allegra, Patient education on care of site and methods to prevent further transfer of vaccinia virus.
Received ZOSTAVAX vaccine 5/19/10. Slight tingling on right side of mouth 6/5/10. Zoster-like lesion visible at site 6/6/10. Returned to physician for diagnosis. Prescribed valacyclovir - 20 tablets 6/9/10.
pt recv vax 9OCT96 & devel dysquesia;lip palsy then 8hr later VII nerve palsy peripheral;steady recovery w/Pred;
11/14/2002 Flu shot given. 11/18/2002 Jr stooped at CPHS Toreport that 11/15 at 10:30 while laying in bed felt dizzy for a few seconds and then passed, reported drank glass of colna but that didn't make the dizzy before. On 11/17 reports she got up at 6:30 and fell back in bed with c/o feeling dizzy, stated she did get up fast 11/18 at 01:00 am states to have gotten up at HS and again felt dizzy, no dizziness in am but reports to have gotten up slowly. No c/o dizziness now or at other times on the weekend. Discussing c/o dizziness from others in the community that had not gotten flu shot, questioned others S+S. c/o hand hurting when riping out some parts also c/o a thickness in voice when talking but no one else noticed this. 11/20/02 TC to JR no home or work. 11/20/2002 TC to manufact reported above, TC message left with manufact to return call. 11/21/2002 TC to JR no c/o dizziness now. Reports by 11/18 felt better after work. Reports hands felt like she had too much salt over weekend had taken  ASA qd on Sat- Sun no relief. Did not expand on thickness in speech except felt funny in hand. Again denied any S+S of thick tongue, swollen lips. Encouraged her to call her MD and report everything. She had to me and discuss recommendations for getting that flu shot in the future.
feeling a little hot sometimes, but claims "that's just me."; arm was a light colored red; arm swelled up a little bit; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled up a little bit), ERYTHEMA (arm was a light colored red) and FEELING HOT (feeling a little hot sometimes, but claims "that's just me.") in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included THYROID and PARACETAMOL (TYLENOL) for an unknown indication.    On 21-Jul-2021 at 4:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced PERIPHERAL SWELLING (arm swelled up a little bit). On 29-Jul-2021, the patient experienced ERYTHEMA (arm was a light colored red). On an unknown date, the patient experienced FEELING HOT (feeling a little hot sometimes, but claims "that's just me."). On 24-Jul-2021, PERIPHERAL SWELLING (arm swelled up a little bit) had resolved. At the time of the report, ERYTHEMA (arm was a light colored red) and FEELING HOT (feeling a little hot sometimes, but claims "that's just me.") outcome was unknown.        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.