chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FLUBLOK that was administered to a 6 month old with no reported adverse event; Initial information received on 14-Jun-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 6 month old female patient to whom  influenza quadrivalent recombinant vaccine [Flublok Qiv] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Immunisation; HIB VACCINE CONJ (OMPC) (PEDVAXHIB) for Immunisation; PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation; and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for Immunisation.  On 28-Mar-2022, the patient received 0.5ml  dose of suspect  influenza quadrivalent recombinant vaccine (strength, formulation not reported)(lot QFAA2137; expiry date: 30-Jun-2022) via intramuscular route in the right thigh for Immunisation.  On 28-Mar-2022 the flublok that was administered to a 6 month old with no reported adverse event (off label use).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event flublok that was administered to a 6 month old with no reported adverse event.
Sore arm for 24hrs, chills and low grade fever (99.1). 28 hrs
Nausea, vomiting,  dizziness during night.  The next day, I was very weak,and it took about 4 days to get back to feeling  normal.   I didn't fill in Dr info because my Dr is aware of this. I just learned about this site.  Can I do something so my 2nd shot doesn't make me so ill?
Pt had immunization on Monday/ was ill with nausea and muscle aches & pains on Tuesday & arm red, swollen & tender to touch (RUE)/came to clinic on Wednesday
One hour after ADPT and IPV given in left deltoid swelling occurred with itchiness. Induration centered around ADPT site.
Pt recvd vax 12AUG92 & approx 2 wks following vax pt exp swollen lt upper arm; swollen tender lymph node w/some redness & warmth in the area; red streak running from elbow to wrist; MD dx lymphangitis;
patient reported a high fever of up to 105 degrees F. on both Sunday and Monday. patient did not go to see a doctor . Patient reported still a fever on Tuesday but better than Monday and still did not want to go to see a doctor
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 05-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 05-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 05-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 05-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 05-Jul-2022).    Concomitant product was not provided. Treatment information was not provided.  Patient received half dose.  On 04-Jun-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age with high blood pressure, thyroid disorder, high cholesterol. Patient did not have any allergy. On 13-JAN-2014 the patient was vaccinated with ZOSTAVAX lot # J007211, .65 ml, subcutaneous. No concomitant medications were there. On 15-JAN-2014, 3 days after onset of therapy the patient experienced bumps, redness, itching and swelling at the ZOSTAVAX. The outcome of bumps, redness, itching and swelling at the ZOSTAVAX and injection site is unknown. No laboratory tests were done. Medical attention was sought by consulting pharmacist. The pharmacist advised the patients to stop scratching the area and to apply a cold compress to the area. This case is linked to 1401USA008040 due to same reporter link. Additional information has been requested.
Big area in arm hurts/ arm hurst so bad/ most painful shot ever; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-Sep-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient needed the shot and had got his/her first one most painful shot which he/she ever had for which the patient arm hurts so bad. There was a big area in arm hurts. Additional supportive information: The follow-up would not possible, as no contact details were available.
Bloody nose bleed; Elevated BP; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Bloody nose bleed) and HYPERTENSION (Elevated BP) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced EPISTAXIS (Bloody nose bleed) and HYPERTENSION (Elevated BP). At the time of the report, EPISTAXIS (Bloody nose bleed) and HYPERTENSION (Elevated BP) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment details were provided.
patient called public health for advise on what to do for the side effects she is experiencing. Side effects, per patient, include shortness of breath, nausea, and back & abdominal pain.
Patient is a 51 yo white woman with PMH of ILD followed by (pulmonology) Doctor as well as an ILD specialist.. Her husband tested positive for COVID on 1/17/22. She started having cough and rhinorrhea on 1/19/22. She tells me she normally uses 6L O2 at home, but she has turned her O2 up to 10L as she has become progressively more short of breath and fatigued just moving from room to room in her home. She was prescribed OFEV for her ILD, but she has been off of OFEV for over 3 weeks because she was unable to tolerate the side effects. She had her first doses of the Pfizer COVID vaccine in April/May 2021 and a booster in August 2021. She was using Dayquil at home and did reduce her cough. She is is currently requiring 10 L O2. Her labs are WNL. Her chest imaging showed no PE, but reticular changes are seen throughout with bullous changes most suggestive of emphysematous change due to her ILD. Review of Systems: 10 point review of system was done and was negative except what was mentioned in subjective. PT REMAINS INPATIENT AT THIS TIME.
Approx 10 minutes after receiving vaccine, pt called out for help from his car in the waiting area. Was monitoring the area and went to assess patient. He stated he felt faint. O2 sat 94%, pt diaphoretic, pale, drooling, tongue protruding from mouth, eyes open, but difficult to arouse, unable to respond. Epi administered and EMS contacted. Pt then lost consciousness. Grossly diaphoretic, clammy to touch, in and out of consciousness, pupils small but reactive, BP 84/48, R16, pulse 68. Unable to obtain O2 sat as monitor wouldn't register values. Lost consciousness again. Not responding to sternal rub. Gave 2nd dose of epi and maintained airway with jaw thrust. Pt regained consciousness
14NOV95 began w/redness & swelling;15NOV redness & swelling inc;16NOV hot w/blisters, painful swelling 5-6" of upper arm w/bruising put on Pred
Client tested positive for COVID on 5/10/2021 after being fully vaccinated. States he started having a cough on 4/24, no other symptoms reported except for one episode of SOB on 5/13 while in the hospital (not for COVID).
Shingles skin rash developed on right leg. Itching, burning, redness and blisters presented over approximately 6 cm area. No treatment, currently remains active.
Pt received vaccine on 10/01/03 in the left superior posterior deltoid and developed pain, less ROM, induration at site that resulted in an MD visit on 10/06/03 and treatment with analgesic and antiinflammatory prescription medication.
Walked up to toilet in bathroom, blacked out/fainted & fell bkwds into tub. Wife helped me out, and then I had nausea, extreme lightheadedness, ringing in ears, and chills/sweating for about 15 mins. Better today, as far as I can tell, except for dull headache. I jog several times per week, am pretty physically fit, so this was very unusual for me.
Hot lump at vaccine cite with large rash and mild itchiness.  Taking antihistamine and applying cortisone cream.
congestion; coughing; low grade temperature fever; chills; body aches; soreness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on her arm), PYREXIA (low grade temperature fever), CHILLS (chills), MYALGIA (body aches) and COUGH (coughing) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history report provided by the reporter.  Concomitant products included LORAZEPAM, ESTROGENS CONJUGATED (PREMARIN) and SIMVASTATIN for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness on her arm). On 22-Jan-2021, the patient experienced PYREXIA (low grade temperature fever), CHILLS (chills), MYALGIA (body aches), COUGH (coughing) and NASAL CONGESTION (congestion). At the time of the report, PAIN IN EXTREMITY (soreness on her arm), PYREXIA (low grade temperature fever), CHILLS (chills), MYALGIA (body aches), COUGH (coughing) and NASAL CONGESTION (congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications and concomitant medications were reported.
Quite ill for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Quite ill for 24 hours) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Quite ill for 24 hours). At the time of the report, ILLNESS (Quite ill for 24 hours) had resolved.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. This case was linked to MOD-2021-599534, MOD-2021-599535 (Patient Link). Reporter did not allow further contact
burning sensation of her mouth, tongue; numbness in her face; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 04Mar2021 as 2nd dose, single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose, single dose for COVID-19 immunization. Any unaddressed medical questions were not referred or forwarded to Medical Information. Patient got the second dose of the vaccine on 04Mar2021. On an unspecified date in Mar2021, she was experiencing the burning sensation of her mouth, tongue, and numbness in her face, wants to know if these are side effects of the vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
5/8/2022: Chills, Muscle aches, Lightheaded, Fatigue, Night sweats 5/9/2022: Chills, Muscle aches, Sore throat, Congestion, Runny nose, Fatigue, Night sweats 5/10/2022: Sore throat, chills, congestion, runny nose, Fatigue, Anxiety, Night sweats 5/11/2022: Sore throat, chills, congestion, runny nose, coughing, Anxiety, Night sweats 5/12/2022: Sore throat, 101 fever, congestion, runny nose, coughing, Anxiety 5/13/2022: Sore throat, runny nose, coughing, Weight loss (5 pounds)
Information has been received from a nurse concerning a male patient who on 09-AUG-2011 was vaccinated with the first dose of ROTATEQ (lot# 669833/0196AA, exp unknown). On 04-OCT-2011 the patient was diagnosed with intussusception. Patient sought unspecified medical attention. The outcome of adverse effect was unknown at the time of the report. Upon internal review, intussusception was determined to be an other important medical event. Additional information has been requested.
Noticed tingling in hand, ring finger and pinky finger. Elbow and wrist feel some pain. Feels kind of weak in hand. Pain in arm at injection site.
The COVID  vaccine (Lot number FH8028 with expiration of 2/28/22) was given after it's beyond use date of 1/15/2022. Outcomes of giving the vaccine after the Beyond Use Date unknown.
I prepared the vaccine without diluent, by mistake.  I had prepared gray top Pfizer vaccine and a Moderna vaccine prior to the Pedi Pfizer and  didn't remember to dilute these two doses.  I normally place the diluent with the vaccine; however, today the diluent was not in plain view and I overlooked that step.  It was not  intentional.
Following shot pain in neck extending up to the face. That night muffled hearing in one ear with pain. Pain on one side of the throat and swallowing. Following morning rash and hives on neck, chest, face. By the end of the second day blisters on hands and thighs.
Client received IPV after 1pm. When arrived at home started to cry, fuss and was completely and utterly inconsolable. She did nurse , and had periodic small naps of 10 minutes, would jerk awake cry very shrill cries. That continued up to 7pm when she finally went to sleep. after thsi no more episodes of crying. No fever or other symptoms displayed. Presently well.
Left arm localized urticaria, erythematous 5"x4" swollen area.
Got a large rash on upper left leg.; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the right arm on 02Feb2021 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, diabetes and heart disease. The patient had no known allergies to medications, food, or other products. The patient did take unspecified other medications within two weeks of vaccination. 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 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on 11Jan2021 (at the age of 70-years-old) as a single dose for COVID-19 immunization and experienced rash on my upper arms (both). On an unknown date in 2021, after second dose, the patient experienced a large rash on upper left leg and it was still on his leg on 12May2021, he would have it for about a week or two then go away and come back in about a week. It has been that way since the second dose. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event got a large rash on upper left leg was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
2 Pentacel vaccines that were broken and nurse was trying to draw out the vaccine for a patient and realized her hand was wet /No AE; Two Pentacel vaccines were broken and other vial had a crack in it as well/ No AE; Initial information was received on 02-Aug-2021 regarding an unsolicited valid non-serious case received from an other health care professional via phone (under Global Information Number Inquiry Number: 00706640).  This case involves an unknown age female patient (nurse).  This case involves two DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was broken and nurse was trying to draw out the vaccine for a patient and realized her hand was wet and other vial had a crack in it as well (occupational exposure to product and product physical issue) lot number: UJ542AAA and expiry date: 10-JUL-2022, indication: prophylactic vaccination.  The patient's medical history, past medical treatments, concomitant medications vaccinations and family history were not provided.  It was a case of occupational exposure via skin contact with product and cracked product (latency: same day).  It was reported "Caller stated receiving two PENTACEL vaccines that were broken. Caller stated a nurse was trying to draw out the vaccine for a patient and realized her hand was wet. Caller stated the nurse noticed the bottom of the bottle was in the box and not attached to the vial. Caller stated the other vial had a crack in it as well. Caller reported she receives her shipments via FEDEX. Caller was requesting for a replacement of two PENTACEL vaccines. Resent due to possible Adverse Event (AE) vaccine got on a hand. Product used: Not Used, Still using product: No. Was Device Used: No, Product Technique Complain assessment medical/ Physical: Physical."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
child found on the floor due to fainting. she stated she was dizzy and the floor was spinning. She did not eat breakfast. Approx 1/2" in length and 1/4" deep cut noted on chin. no bleeding observed.  This RN gave her grape juice and donut holes.  walked out on her own.,
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Oct2021 at 16:00 as dose 3 (booster), single (Lot number: FF2589) at the age of 39 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Spontaneous pneumomedia stinums" (unspecified if ongoing), notes: Two spontaneous pneumomedia, stinums at age 17. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE]; LOESTRIN; ZYRTEC DAIICHI. Past drug history included: No, reaction(s): "Allergy".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: If vaccine received Yes. Other medication in 2weeks Yes. Anti-viral details: Product=COVID 19 Treatment, Brand=Paxlovid, Treatment start date=11Jul2022, Treatment stop date=15Jul2022, Indication=Treatment of COVID-19.Adverse event. I took my last dose of Paxlovid on Friday evening 15Jul2022. By Sunday morning 17Jul2022 I had a small rebound. My sore throat and swollen glands came back (had previously subsided since Wednesday or day 3 of Paxlovid). Rebound lasted 2 days. Symptoms were not as bad as the firsttime. I also experienced bad nausea on Paxlovid and was prescribed Zofran. Adverse event country. Adverse event start date 17Jul2022. Adverse event start time 12:00 AM. Ae resulted in [None of the above]. If patient recovered: Recovered. If treatment ae Yes. Ae treatment Zofran. Known allergies No. Other medical history Two spontaneous pneumomedia stinums at age 17.
severe react lost 2 wks work-could not breathe; exp onset of stroke like weakness 8MAR90; dx CFS-dx EBV;
But she developed a painful rash on her forehead on Friday night.  She did get the Shingrix immunization about 1.5 weeks ago.  Her one eye feels a little puffy too.  Does appear she has vesicular rash across her forehead, like a shingles rash.  Started her on Valtrex and told her to make appt to see eye doctor today or tomorrow.   This should be reported to VAERS, that she developed a painful rash on forehead after her Shingrix injection
palpitations/tachycardia sent to ER by MD who ordered DPH @ office;ER MD examined-pt OK (p/ 1 1/2hr);
I think this is the lot number hard to read the handwriting on the card.  Swollen ankles for weeks , extreme fatigue, diarrhea,  headache, tingling, needles and pins sporadic throughout my body , sharp sporadic pains in arms and legs , muscle cramps in arms and legs ; legs stiff at times; extreme cramps in both upper arms, but I only received one shot in the left arm.  No menstrual cycle  since the vaccine.   I called Pfizer reported the events and Pfizer stated that happened during clinical trials I should see a doctor. The muscle cramps worse in the second week called Pfizer on advice for the second dose. My employer requires us to be fully vaccinated.  The agency should stand up for our rights with side effects and public in general.  Not everyone can get a second shot.  So now I have to deal with these side effects, possibly lose my job , lose health insurance , medical bills I will be responsible for, because companies think they are so smart and everyone's body is the same.