chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had Pfizer covid-19 vaccine and flu shot to left arm and complained of left arm pain; Initial information received on 01-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 65 years old male patient (101.587 kg) who had pfizer covid-19 vaccine and flu shot (INFLUENZA VACCINE ) to left arm and complained of left arm pain while also being treated with with TREPROSTINIL SODIUM [TYVASO].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  On 13-Jul-2022, the patient started taking TREPROSTINIL SODIUM (formulation: unknown, strength: 0.6 mg/ml) 54 ug QID inhalational (lot - 2102217, expiration date:31-Dec-2024) for Secondary pulmonary arterial hypertension.  On 28-Sep-2022, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer, and PFIZER BIONTECH COVID-19 VACCINE not produced by Sanofi Pasteur (formulation, strength: unknown) lot number not reported via intramuscular route in the left arm.  On 28-SEP-2022 the patient had pfizer covid-19 vaccine and flu shot to left arm and complained of left arm pain (pain in extremity) 2 months 15 days following the first dose intake of TREPROSTINIL SODIUM and same day latency following the other suspect vaccines.  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local Marketing authorization.  Action taken with TREPROSTINIL SODIUM was unknown. Action taken was not applicable for other vaccines.  Corrective treatment: PARACETAMOL (TYLENOL) for Pain.  At time of reporting, the outcome was Unknown for the event
The pt received his 2nd Moderna covid vaccine on 6/13/21 at 10:45 am (approximately).  Starting at 5pm he c/o pain, redness and tenderness  in the injection site, chills, and lethargy .  The next day he did not go to work b/o he felt tired and he stayed home with his 7 y/o daughter while his wife went to work.  His wife spoke with him in the am and he reports he was making breakfast for their daughter and he was going to lie down and sleep afterward.  He made lunch for daughter about 1 pm and he went to lie down in his chair.  His brother called his wife at about 4:30 pm stating he was blue.  911 was called and they were unable to revive him.
No adverse effects; improperly stored dose administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-JUN-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin)(PROQUAD) injection, lot # R020678, expiration date: 15-JAN-2020 (exact dose, injection site and route of administration were not reported) for prophylaxis. The vaccine experienced a temperature excursion from -14 degrees Celsius to -10 degrees Celsius (-12.09 degrees Celsius) for 5 hours 30 minutes. The digital data logger was involved in recording the temperature excursion details. Previous temperature excursion had occurred with total time in the range from -14 degrees Celsius to -10 degrees Celsius (-13.61 degrees Celsius) for 2 hours 20 minutes. No adverse effects were reported.
This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (He couldn't swallow anything), BLADDER PAIN (His bladder was hurting), URTICARIA (Developed hives all over his body/ hives started on his scalp, thighs and just went everywhere/ hives were getting worse) and MYALGIA (Muscles also started hurting) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination. No Medical History information was reported. On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced DYSPHAGIA (He couldn't swallow anything), URTICARIA (Developed hives all over his body/ hives started on his scalp, thighs and just went everywhere/ hives were getting worse) and MYALGIA (Muscles also started hurting). On 01-Jan-2022, the patient experienced BLADDER PAIN (His bladder was hurting). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 29-Dec-2021 for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 29-Dec-2021 for Adverse event, at an unspecified dose and frequency and LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) on 01-Jan-2022 for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPHAGIA (He couldn't swallow anything), BLADDER PAIN (His bladder was hurting) and MYALGIA (Muscles also started hurting) outcome was unknown and URTICARIA (Developed hives all over his body/ hives started on his scalp, thighs and just went everywhere/ hives were getting worse) was resolving. No concomitant medications were provided. Treatment medications also included Steroid injection in his butt. On 29-DEC-2021 the patient went to Urgent Care. He conveyed that the hives were getting worse and his bladder was hurting so he went to the Emergency on 01-JAN-2022. The patient stated that Xyzal helped him more and the hives are improving.
100ISH FEVER FOR ABOUT 24 HOURS; This spontaneous report received from a patient concerned a patient of unspecified age and 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: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced 100ish fever for about 24 hours. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 100ish fever for about 24 hours on 2021. This report was non-serious.
This spontaneous report as received from a physician refers to a 19 years old female patient. The patient was vaccinated intramuscularly with 0.5 ml GARDASIL on an unknown date in July 2011. No other co-suspects were reported. No concomitant medications were reported. On an unknown date in August 2011 the patient experienced debilitating muscle weakness and pain (hospitalization and disability). The events were treated with KEPPRA, fentanyl and PAXIL. MRI, CT Scan, Blood Labs and Bone scans were performed, but no results were reported. The outcome of debilitating muscle weakness and pain was reported as not recovered/not resolved. The relatedness for debilitating muscle weakness and pain was not reported for GARDASIL. Additional information has been requested.
Patient received both  Spikevax covid booster and flu HD in left arm. she states the injection site was sore and below the injection site her arm was red and swollen for couple days.
Pt had DTaP, IPOL, MMR on 07/15/02. Back to office 07/22/02-broke out in pustules. 07/23/02 dx. chicken pox-vesicular red papules. Rt leg around injection site-other similar lesions on body. 07/22/02 parent called and reported local reaction to DTaP site right thigh-parent reports multiple lesions itch lasting at injection site spread to generalized.
Patient got a rash on her arm at the vaccination site. It started 5/3/2021 and has been the same since it appeared. She has not been treating it but will contact PCP if the rash worsens. She described it as red, itchy, and warm.
There was no adverse reaction. Patient was given a vaccine that was left in the freezer too long and was expired.
I just had COVID-19, I took a home test and it was positive. I had COVID-19 on Feb 9th. On Dec 2022 I was diagnosed with Breast Cancer. I had body ache, fever, congestion, running nose, but it was a mild case of COVID-19. I called my doctor on the phone and he gave me the PAXLOVID, I took it and cough syrup too.
The patient had facial paralysis on one side of their face.  And has went to the emergency room to have tests done.
Swollen lymph node in right arm noticed on 12/26. I saw my PCP and she said it was likely from the vaccine. Has not gone away. Also nasal congestion started from date of vaccine.
Rash on body, placed in warm bath 11/5 vomiting and diarhea lasted 12 hours, feaver (101.5) better bu 11-7.  More severe rash on 11-8 with facial (nose and mouth blistering.
Redness, swelling and heat at injection site of right deltoid. Instructed to take Tylenol or Motrin and apply cool cloth. If increased redness or worsens, return to clinic or ER.
Dev temp to 105 degrees with chills, cellulitis left deltoid area after vac.
pt recv vax & coughed & vomited small amount;clear mucous then left w/mom;mom states 1-2hr later @ home struggling to breathe;resp approx 80x/min;called MD office & started pt on prelone, DPH & breathing tx;pt slept 14hr;has sinus infect
This case was reported by a consumer via call center representative and described the occurrence of erythema in a 82-year-old female patient who received SHINGRIX for prophylaxis. On 12th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th March 2019, 1 days after receiving SHINGRIX, the patient experienced erythema, rash, pruritus, injection site warmth, upset stomach, tiredness, shivering and fever. On an unknown date, the outcome of the erythema, rash, upset stomach, shivering and fever were recovered/resolved and the outcome of the pruritus, injection site warmth and tiredness were not recovered/not resolved. It was unknown if the reporter considered the erythema, rash, pruritus, injection site warmth, upset stomach, tiredness, shivering and fever to be related to SHINGRIX. Additional details were provided as follows: The next day post vaccination, the patient had redness, rash, itching and heat at the injection site. She also had fever, upset stomach, tiredness and shivering. The patient was mostly feeling better at the time of reporting, but she was still a tired and has some itching and warmth at the injection site. The reporter did not consent to follow-up.
Hours after receiving vaccination became real dizzy, vomiting, fatigue, abdominal pain, and no appetite.
Severe headache (migraine), nausea, extremely high blood pressure. Treated at ER, admitted on 5/8/22. Given meds to reduce blood pressure, treat nausea and headache. CT scan of head showed no CVT. Discharged on  5/10/22. Convalescence at home, in bed due to continued headache and nausea. Blood pressure still elevated over patient's normal but not in danger zone. Needed assistance to walk for another week. Up about 3 AM on 5/15/22  walking without assistance, fell and struck head on floor. Severe bruise to forehead, contusions on bridge of nose, forehead and left hand. Vision changes persist: double vision and blurred vision. Under care of internist and has been seen by eye specialist. Still has mild headache and mild nausea from time to time.
Another Provider (FNP) used the wrong diluent. She used sterile water instead of 0.9% sodium chloride and gave the vaccine to the child.
Mother of child believes the patient received an adult dose (0.3mL) instead of a child dose (0.2mL). Nurse who administered says the correct dose was given. IF patient received 0.3 mL of the correct product (Pfizer for 5-11yrs) then the patient only received 15 mcg and not the full adult dose of 30 mcg. If the incorrect syringe was picked up and it was indeed the Adult Pfizer (ages =12yrs) (30mcg/0.3mL), then the patient potentially received 30 mcg.
Pt had vasovagal reaction to vaccine for less than 20 seconds. Had pt lay down on exam table, was given a cool pack for the back of neck and given water. Pt was asked to wait an additional 15 minutes to assure no other reaction took place. Pt was instructed to notify if any light headedness or dizziness occured again. After 15 minutes pt stated he felt fine and left.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 07Jan2021 at 12:00 as dose 1, single (Lot number: EL1284), in left arm, on 28Jan2021 at 14:30 as dose 2, single (Lot number: EL9262), in left arm, on 13Nov2021 at 12:30 as dose 3 (booster), single (Lot number: 3203BD), in right arm and on 11Aug2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Atopic dermatitis" (unspecified if ongoing), notes: Other medical history: Atopic dermatitis. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had no known allergies. Other medication in 2 weeks reported as no. Therapeutic measures included Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, treatment started on 13Dec2022 and stopped on 18Dec2022, Lot number: 1923795A, indication: Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, the reported serious event Vaccination failure and Covid-19 cannot be excluded for the suspect product BNT162b2.
Pt received inj. PREVNAR 13 - 06/17/16 states hurt a lot and afterward - swelling and pain size of tennis ball - red and warm to touch - resolved without treatment called in info 6/22/16.
An allergic reaction/ an anaphylactic reaction; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "An allergic reaction/ an anaphylactic reaction". The event "an allergic reaction/ an anaphylactic reaction" required emergency room visit.  Clinical course: Doctor said she personally experienced an allergic reaction to Pfizer's COVID vaccine that led her to visit a local hospital ER. She believed it to be an anaphylactic reaction. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Initial report received from a healthcare professional on 09 October 2012. A 34-year-old female patient, whose illness at the time of vaccination was none and had allergy to sulfa drugs with no medical conditions, had received second dose of FLUZONE intradermal (Lot number: UT4473AA) in left deltoid on 02 October 2012. The patient had received one dose of FLUZONE ID in past. It was reported that on 02 October 2012 after receiving vaccine i.e. within 15 minutes, the patient experienced metallic taste in mouth, headache and itch at injection site. Laboratory details were none. Corrective measures were not reported. On 04 October 2012, 48 hours later, the patient recovered from the events. Documents held by sender: none.
Pain in lower leg, used ultrasound to locate blood clot and was treated for Superficial Thrombophlebitis and is currently prescribed Enoxaparin (blood thinner) for 45 days.
10/12/20 had some discomfort (R) deltoid  after shot.  10/13/20 couldn't move right arm, weakness.  Went to ED  states arm feels "numb" today 10/14/20
Allergic reactions:arm swelling rush from shoulder to elbow, skin  rush  on both legs, lower lip was cracked for about 1 week right on the middle,most scary was throat was swelling for 3 days, chills and headache .
Narrative: Symptoms: Dizziness, Myalgia, Fever & CoughWheeze Treatment: REMDESIVIR 200 MG ONCE 200mg on day 1 then 100mg on days 2-5 ,DEXAMETHASONE 6 MG EVERY DAY for a total of 6 days
Received pneumococcal vaccine at 5:12 pm on 1/2/13 at (R) deltoid on 1/3/13 at about 8:30 pm has redness, warmth and swelling same upper arm.
Fever; Injection site hurts; Headache; A spontaneous report  was received from a (Consumer) concerning a  72 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (fever, injection site hurts, headache) list.      The patient's medical history was not provided. No relevant concomitant medications were reported.      On 25-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the Left Upper Arm for prophylaxis of COVID-19 infection.    On 26-JAN-2021, The patient experienced the events list (fever, injection site hurts, headache).    Laboratory details was not provided.    No treatment information was provided.     Action taken with mRNA-1273 in response to the events was not reported.     At the time of this report, the outcome of the event(s) (fever, injection site hurts, headache) was <unknown>.    The reporter assessed the event(s), [fever, injection site hurts, headache], as related to study drug.
Massive blood clot in right lung terrible pain fever/chills fluid around lun  1/2 liter withdrawn with procedure in hospital headaches extreme fatigue trouble breathing
PATIENT CALLED 11/10/2021 AT ABOUT 11AM  - SHE SAID THE INJECTION SITE IS  SWOLLEN, RED AND CHING THAT PREVENTS  DRIVING. SHE ALSO SAID SHE IS WEAK TO THE POINT OF USING WALKING CANE AND ALL THESE STARTED 11/08/2021 AFTER THE VACCINATION. SHE SAID SHE HAS CALLED HER PRIMARY CARE PHYSICIAN ON 11/09/2021 AND HAS AN APPOINTMENT FOR 11/12/2021. SHE SAID SHE IS FEELING MUCH BETTER TODAY 11/10/2021
Sinus infection; Nose running wild; Running a slight fever between 99°F and 100°F; Vomiting; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), SINUSITIS (Sinus infection), RHINORRHOEA (Nose running wild), PYREXIA (Running a slight fever between 99°F and 100°F) and VOMITING (Vomiting) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) and VOMITING (Vomiting). On an unknown date, the patient experienced SINUSITIS (Sinus infection), RHINORRHOEA (Nose running wild) and PYREXIA (Running a slight fever between 99°F and 100°F). The patient was treated with AZITHROMYCIN for Sinus infection, at an unspecified dose and frequency. On 08-Mar-2021, VOMITING (Vomiting) had resolved. At the time of the report, DIARRHOEA (Diarrhea), SINUSITIS (Sinus infection), RHINORRHOEA (Nose running wild) and PYREXIA (Running a slight fever between 99°F and 100°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, SARS-CoV-2 test positive: Positive. On an unknown date, Oxygen saturation: 97 Inconclusive. On an unknown date, Pyrexia: 99°f (Low) slight fever between 99°F and 100°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information included Tussan, Advil and Azithromycin tabet.
Fatigue and headache, body aches occurred the day after vaccination, but resolved the next day. The left arm became very irritating on the 25th with flaking skin and very itchy. Saturday the arm became inflamed which has remained through today. Redness, swelling, and hot to touch today.
Vaccines administered 11:44 am, MMR in (L) vastus lateralis, PCV 13 upper (R) vastus lateralis, Hep A bottom (R) vastus. Premedicated with 3/4 tsp BENADRYL, 3/4 tsp ADVIL at 11:35 am. At 11:53 am, significant swelling and redness to (R) vastus worse around upper site. 3" diameter. Circular induration. Gone at 12:05p after 1/4 tsp BENADRYL given at 12:00p.
Patient developed a red circular area around the part of the arm that she had received a small pox vaccine in as a child.
This spontaneous report was received from a 23 year old female consumer referring to herself. The patient did not have any medical history or concurrent condition. On an unspecified date in October 2014, the patient was vaccinated with a dose of GARDASIL (lot #, expiration date and route of administration were not reported) dose 1, one vaccine only, one time. Concomitant therapies included unspecified birth control medication. Suspect drugs were not reported. On that same date, in October 2014, immediately after vaccination, the patient experienced what her physician called a "medically induced seizure" (no further specifics were given about this event in the office which were considered as related by the patient's physician to GARDASIL; she stated that she felt dizzy for a month after receiving the vaccine, she also reported that she had experienced fainting at work and that she had been "experiencing syncope off and on, just about all the time since getting the vaccine". It was stated that on an unspecified date, the patient was taken to an unspecified emergency facility. On an unknown date, her physician told her to drink fluids with a lot of electrolytes and wear compression socks. On unknown dates, Tilt table test, Stress test, EKG (electrocardiogram) and 24 hour heart monitor were performed, but the results were not provided. At the time of the report, it was stated that the therapy with GARDASIL was discontinued; and the outcome of seizure, syncope and dizziness was reported as not recovered. Upon internal review, seizure was considered as medically significant. Additional information has been requested.
15:30-17:30: Itching, whole body hives, prescribed Benadryl, called PMD, started complaining of breathing, ER visit, continue benadryl, arm swollen.
Prolonged muscular pain.  My existing low back pain has worsened and remains worse with increased amounts of inflammation for an extended period of time.  I am currently 13 days from my vaccination date and still experiencing inflammation  and pain.  I had pain at the injection site the day after the injection which went away but returned again - 1 week later and it lasted for 2 days.