chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sick; Sleepy; Weak; Throwing up; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), SOMNOLENCE (Sleepy), ASTHENIA (Weak), VOMITING (Throwing up) and FATIGUE (Very tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick), SOMNOLENCE (Sleepy), ASTHENIA (Weak), VOMITING (Throwing up) and FATIGUE (Very tired). At the time of the report, ILLNESS (Sick), SOMNOLENCE (Sleepy), ASTHENIA (Weak), VOMITING (Throwing up) and FATIGUE (Very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Additional immunizations given - (duplicated) - Patient had 2 accounts in the Grits - same name.
TOOK AN UNREFRIGERATED DOSE; A spontaneous case report was received from a caregiver on 25-Feb-2019 for two consumers.  Based on the information obtained from the caregiver, two individual case safety reports PVX201902-000152 (PVX2019-513; female child) and PVX201902-000153 (PVX2019-514, male child) were created and cross-linked in the database.  This case report describes a 13-year-old male consumer who "took an unrefrigerated dose". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer picked Vivotif on 20-Feb-2019 and left it outside of the refrigerator since then. She took her unrefrigerated first dose on 25-Feb-2019.  The action taken with Vivotif with respect to event "took an unrefrigerated dose" was not applicable.  The clinical outcome of the event "took an unrefrigerated dose" was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable. US-PaxVax Berna GmbH-PVX201902-000152:
Mild lymphadenopathy at right arm for two days starting on the second day after the injection
27 year old female complained of chest pain. Onsite EMS responded. Vitals BP 122/76 HR 58 100% O2, she was tranported to the local Hospital
Nasal congestion;face red blotchy and swollen from nose up and during the course of talking, the redness spread below nose and around mouth.  Pt called the following day and stated that 30 min. after taking benadryl she was back to normal.
20min p/vax severe h/a devel began sweating-palms were red & sweaty had metal taste in mouth-took ASA for h/a;h/a lasted 5 days-OK now;
HEADACHE; 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, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious.
This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient inadvertently given dose from different age group.) and NO ADVERSE EVENT (No adverse event) in an 18-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. AR4504B and 056M21A) for COVID-19 vaccination. Patient had no known allergies. It was unknown if patient ever had COVID positive test or diagnosis.  On 06-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 05-Aug-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 05-Aug-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INCORRECT DOSE ADMINISTERED (Patient inadvertently given dose from different age group.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient inadvertently given dose from different age group.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Patient inadvertently given dose from different age group.). No concomitant medications were reported. It was unknown if other vaccines given within 1 month prior to Moderna vaccine. It was reported that 18yr old patient was inadvertently given 0.5mL dose from a purple vial Lot number AR4504B, which was slated for 6-11 year old age group and 18 plus booster dose. No treatment medications were reported.
PFIZER vaccine that was stored in pharmacy refrigerator given outside of 31 day expiration. Vaccine received at hospital on 11/19/2021. Expiration date on vial 02/2022. NDC# 59267100001
Information has been received from a 61 year old female consumer with codeine, bee stings, and "spring" allergies who on 09-MAY-2008 was vaccinated IM with zoster vaccine live (Oka/Merck). Concomitant therapy included amtriptyline hydrochloride (MSD), calcium (unspecified) and IMITREX. Subsequently, on the 09-MAY-2008 the patient developed swelling in her left arm. It was noted that the patient had redness which seemed to appear on 13-MAY-2008. It was also noted that the patient's arm was sore down to her elbow. Medical attention was not sought and there were no lab studies performed. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information is available.
total body flushing, joint aches, pedal edema, nausea started on 19OCT approx 48hr p/still prominent 1wk later;took advil, cold showers used cortaid ointment;also had total body itching-no hives, no diarrhea;
Reported pain & decreased mobility the evening of the injection.  By the next morning a raised red "line" developed from the injection site into the left armpit.  The line was very tender.  All symptoms gone by 4th day post injection.  No treatment sought.
Headache; Sore throat; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. The patient had a vaccine received this afternoon on 30Dec2020, 4 to 5 hours after, she was having a headache and had sore throat as well. The patient wanted to know if it was okay to take Tylenol. The outcome of events was unknown.  No follow-up attempts are possible; Information on Lot/Batch Number cannot be obtained.
Heaviness came over body; Blood pressure shot up; Very nervous and over; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW1070) via an unspecified route of administration on 12Aug2021 at 09:30 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure abnormal (B/P), blood cholesterol abnormal and shellfish allergy. 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. Concomitant medications were not reported. On 12Aug2021 at 09:45, the patient had heaviness which came over body and blood pressure shot up. This made her very nervous and over. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included additional time watch after blood pressure taken by registered nurse. The clinical outcome of the event heaviness came over body, blood pressure shot up and very nervous and over were resolved on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
throat pain; chills; fever; This is a spontaneous report from a non-contactable consumer (patient). This consumer reported events for two patients (himself and partner). This is the first of two reports.   A male patient of unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient reported that 24 hours after the application, patient felt throat pain, chills, and fever in the subsequent 18 hours. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021406357 same reporter/drug, different patient/event.
Patient received third dose of Shingrix; The patient received 1st and 2nd dose on same day; This non-serious case was reported by a physician via call center representative and described the occurrence of overdose in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 7cx23) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number fd47f) for prophylaxis and Herpes zoster (Shingrix) (batch number 7ta92) for prophylaxis.   On 08-NOV-2023, the patient received the 3rd dose of Shingrix. On 01-JAN-2023, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 01-JAN-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix and Shingrix, the patient experienced overdose (Verbatim: The patient received 1st and 2nd dose on same day). On 08-NOV-2023, the patient experienced extra dose administered (Verbatim: Patient received third dose of Shingrix). The outcome of the overdose and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 08-Nov-2023 The reporter reported that the patient received first and second dose on same day, which led to overdose. The patient received third dose of Shingrix vaccine, which led to extra dose administered. The reporter asked information was available about the administration of a third dose of Shingrix in a patient. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Began itching along right upper forehead and hairline and had some red splotchiness in that area and just above right eyebrow about 20 minutes after administration of vaccine.
Muscle twitching diffuse starting 15 days post vaccine, continuing to current (6 wks later). Sibling also had FLUMIST same day. had onset of twitching 12 days post vaccine.  12/02/09 PCP notes on 09/28/09. DX: Post vaccination myoclonic reaction.  Pt c/o being tired, having muscle twitching, nystagmus, nausea; tx: Vit. D, Nordic naturals, B vitamin, Ca magnesium, Iron, Culturelle.  Pt is scheduled for F/U in 4wks.
Cold chills severe, 24 hour cough, flu-like symptoms x 1 wk.
Initial report received from a patient on 29 May 2007. A 32 year old female patient (with a history of no known allergies and was 6 weeks post partum) developed a large red welt around the injection site, 24 hours after she received Adacel (lot number unknown) intramuscularly in the left deltoid on 23 May 2007. She also had muscle aches and repetitive - nonproductive cough that began 5 days post immunization. She did not have any illness at the time of vaccination. At the time of the report, she states the cough subsides during the days and she has the same coughing as her infant. She has not recovered. Follow-up information received on 02 July 2007. Adacel lot number C2734AA was provided. Additional information was not provided.
extreme nausea, burning sensation down throat and into stomach, throat tightening, loss of voice, headache, lethargy, fatigue, paleness.
Pt has patchy, red vesicular eruption on anterior right thigh. Dr from ER described.
Dry heaves; vomiting; pain in the arm; Bruise at vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), VACCINATION SITE BRUISING (Bruise at vaccination site), RETCHING (Dry heaves) and VOMITING (vomiting) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm) and VACCINATION SITE BRUISING (Bruise at vaccination site). On an unknown date, the patient experienced RETCHING (Dry heaves) and VOMITING (vomiting). On 08-Apr-2021, PAIN IN EXTREMITY (pain in the arm) had resolved. At the time of the report, VACCINATION SITE BRUISING (Bruise at vaccination site), RETCHING (Dry heaves) and VOMITING (vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-080186 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Added events (Dry heaves, vomiting ).; Sender's Comments:  MOD21-080186:Husband's case
received booster dose of Moderna Covid vaccine on 11/19. She woke up at 3 am on 11/20 with fever 101.6, bad muscle aches, migraine headache, dizziness and tinnitus. She used Advil and lidocaine patches to manage pain. She reports that she tried to workout as normal, but noticed while in pilates class, she had ?no balance?. On 11/23 she c/o tinnitus, headache and vertigo symptoms, her head feels like it is swimming when she looks down and then look up.
Infant's mother telephoned 2-13-02 stating infant became ill Monday night and she took her to the doctor on 2-12-02. "She has ear infection again-7th time since October. The doctor didn't think it had to do with her shots." She had just had a "little bit of a temperature and a little rash on her leg after the shots"
Axillary lymph node swelling, rash on left arm which has migrated from injection site. Painful when pressure is applied, intermittently itchy, and feels tight.  Injection site pain has been present since the day after the dose, but I only feel it when applying pressure on it (e.g., when lying in bed). Feeling of tightness began a few days ago near underarm crease. Rash on left arm (near armpit and also on shoulder) began today. Today was also the first day I noticed the lump in my underarm (which I assume is a swollen lymph node).
Patient noted discomfort, redness and warmth of his left arm (site of injection) about an hour after vaccine administration.  When awoke this am on 9/12/2014, complained of further discomfort and father noted arm to be swollen, warm and red extending near area from deltoid to forearm.  No treatment given at home prior to evaluation.  Patient seen on 9/12/14 at clinic visit for evaluation.
6/8-Saw doctor. Diagnosis-possible vaccine reaction. Red spot (4-5 inches diameter, warm) on left arm, neck discomfort, feverish (104 degrees). Diagnosis arm cellulitis, Treatment with Augmentin twice a day for 10 days, Tylenol.
Initial information received on 31-Aug-2018 regarding an unsolicited valid non-serious case received from a health professional. This case involves a 15 months old male patient who was vaccinated with an expired dose of PENTACEL (Lot number: C5390AA; expiry date:17-Jul-2018) in the left thigh on 30-Aug-2018. The patients medical history, previous medications were not reported. The patients concomitant medications included a dose of FLUZONE QUADRIVALENT. It was a case of actual medication error due to expired vaccine used. It was not reported whether the patient experienced any adverse events or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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. Documents held by sender: none.
as soon as the injection was given patient c/o nausea and bent forward in the chair, then slipped forward onto floor and had LOC approximately 5 seconds. Assisted onto the bed, cold packs applied legs elevated, water given. Felt better after approximately 10 minutes and was ok to leave.
Initially I had a sore arm (of injection site) the next day. It lasted about  a day and about a week it came back again (the sore arm). I think it lasted about two days. I had second vaccine on February 5th. I felt really tired and I slept for two days. My arm was sore again for about two days.  Currently, I feel my neck and lower back is very painful - it's in the middle of neck and middle of back. I needed to see a doctor. I saw the physical therapist doctor for a few times. I am not sure if it's helping.  I needed to see an acupuncture doctor and I still need to get treatments. I am still having some of that pain in neck and lower back.  No medication.
Extreme sleepiness, vision blurry, sensitive to noise, fever, joint pain, headache lasting 4-5 days. Light-headed, unable to drive for 2 days. Moving objects (such as cars) seemed to be in "slow motion." Doctor visit on 10/31/03.
Patient developed urticarial within 12 hours of the vaccine and a sore throat. Was screened for strep which was negative. History eliminated other new suspected triggers for allergic reaction other than vaccine.
Injection site swelling, Tenderness, warm to touch, red, 3?x3 ? induration.  Has consulted a provider and was prescribed Keflex.
A non-serious report of expired dose of vaccine administered has been received from a health care professional concerning a 12-year-old patient of unknown gender.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 28-Jan-2008.  The FluMist had expired on 14-Jan-2008.  The reporter indicated that no adverse events have occurred since the time of the report.  Rechallenge is not applicable to this adverse event.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Patient was given 2nd Pfizer vaccine 7 days before the recommended time between the 1st and 2nd dose.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 29Mar2021 as dose 2, single (Lot number: ER8732), in left arm and on 23Nov2021 as dose 3 (booster), single (Lot number: FH8030), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Naproxen sodium, reaction(s): "Known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took Paxlovid on 07Nov2022 to 11Nov2022 for treatment of COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201308884 same patient and drug, different dose number and event;
Patient received her second dose Pfizer vaccine at 10 am. Stayed for 15 mins without any discomfort. She then went to the store and came back because she feels dizzy. Didn't have any breakfast. RN offered water, juice and crackers. BP 138/98 HR 90 SP02 98% RA. Patient denies SOB, difficulty breathing. Per patient, just doesn't feel right. Still lightheaded.  Called physician clinic and spoke with Dr.  RN provided information and per Dr, send patient to 3rd floor and will monitor patient in trauma room.
I began menstruating twice a month. Not just spotting, they are full and heavy periods. My periods, prior to the vaccine, were typically every four weeks with light to moderate flow. I?ve never had complaints of irregular or heavy periods, or ever had to see a medical provider for treatment concerning my periods until after the vaccine. My periods changed to moderate to heavy flow, twice a month.
pt recvd vax & exp black & blue marks, red stripes, & an indentation @ the inject site on the buttock; pt also exp pain @ the inject site described as a pinching & pulling feeling; area of atrophy @ the inject site measures 4cm in length;
Vaccine administered @ 11AM.  Approximately 8 - 10 hrs later, patient had fever 102 degree. Parents administered Motrin.  Within 24 hrs of administration patient afebrile no other signs and symptoms of side effects.
Felt Cruddy; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31-JUL-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: Felt Cruddy). The outcome of the feeling unwell was not reported.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.     It was unknown if the company considered the feeling unwell to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR154098   Additional Information: GSK Receipt Date: 07-NOV-2023 The patient reported that after dose 1 he felt cruddy but no stomach issues like with dose 2. For tolerance of dose 2, refer case US2023AMR154098.; Sender's Comments:  US-GSK-US2023AMR154098:Same Patient Same reporter Different Dose
Strange scratch marks suddenly appear on skin whether sleep or awake. Marks are around 1-5 inches in length.  They  itch and are red with a little blood and leaves permanent scars. They appear on my back, arms, chest, abdomen, thighs, knees and legs.