chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient felt extreme dizziness as soon as Pfizer 0.3ml vaccine was administered. He said he felt that he was going to pass out and was in an out of consciousness. We called 911 immediately and was cleared to leave by EMS.
having hot flash things; she started her period little bit, and it didn't stop since then. It's been still going on and on 08Oct2021 she started bleeding a lot; maybe on 04Sep2021, she started her period little bit, and it didn't stop since then. It's been still going on and on 08Oct2021 she started bleeding a lot; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 3 via an unspecified route of administration, administered in Arm Left on Aug2021 (Lot Number: FC3181) as dose 3 (booster), single (at age of 40-years-old) for covid-19 immunisation. Medical history included Lupus; pain associated with severe back spine issues, immune compromised. Concomitant medications included hydroxychloroquine taken for Lupus; duloxetine hydrochloride (CYMBALTA) taken for pain associated with severe back spine issues. Historical Vaccine included the first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation on an unspecified date. The patient got the booster vaccine (Covid-19 Vaccine) probably 6 weeks ago and after a week, maybe on 04Sep2021, she started her period little bit, and it didn't stop since then. It's been still going on and on 08Oct2021 she started bleeding a lot, she was having hot flash things. The patient will call her OB-GYN (further not clarified) on Monday. She was assuring if it was all brought on by booster vaccine. Which happened about 5 weeks ago, maybe 04Sep2021. The event was not worsening. When probed if any doctor prescribed the vaccine, the patient stated doctor didn't prescribe her. She got vaccine because she was immune compromised (further not clarified the word). No treatment received. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Excruishiating pain in the right arm, center deltoid from the elbow to the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Excruishiating pain in the right arm, center deltoid from the elbow to the shoulder) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SIMVASTATIN, ARIPIPRAZOLE (ABILIFY), SERTRALINE and METFORMIN for an unknown indication.    On 05-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 PAIN IN EXTREMITY (Excruishiating pain in the right arm, center deltoid from the elbow to the shoulder). The patient was treated with HYDROMORPHONE at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Excruishiating pain in the right arm, center deltoid from the elbow to the shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  On 05-Mar-2021, the patient received their first dose of vaccine and experienced excruciating pain in the right arm and center deltoid from the elbow to the shoulder.  Treatment information provided by the reporter also included heating pad.
GOT PFIZER COVID VACCINE THEN FOUND OUT ALREADY RECEIVED THE JANSSEN COVID VACCINE; This spontaneous report received from a pharmacist concerned a 71 year old male. The patient's weight was 78.93 kilograms, and height was 173 centimeters. The patient's concurrent conditions included: schizophrenia, and hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.   Concomitant medications included amlodipine for hypertension, lisinopril for hypertension, bnt 162 for prophylactic vaccination, and haloperidol. On 27-OCT-2021, the patient experienced got pfizer covid vaccine then found out already received the janssen covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got pfizer covid vaccine then found out already received the janssen covid vaccine was not reported. This report was non-serious.
Headache; Itchy arm; Swelling underneath skin; Swelling; Soreness; Redness; A spontaneous report  was received from a consumer concerning a 44-year-old female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced swelling, soreness and redness in her arm, itchy arm, redness, swelling underneath and on the skin and headache.  The patient's medical history included migraines. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Lot number: was not provided) on 28 Dec 2020 in the left arm for prophylaxis of COVID-19 infection.   She experienced swelling, soreness and redness in the left arm in which she received her injection that lasted three days. On 04 Jan 2021, she reported experiencing an itchy arm, redness and swelling underneath and on the skin.   On 06 Jan 2021, she reported having a headache that resolved the same day. She stated she went to urgent care for her symptoms.  Treatment for the event included a steroid and antibiotic.  Action taken with mRNA-1273 in response to the events was not provided.   The events swelling, soreness and redness in the arm were considered resolved on 31 Dec 2021.   The itchy arm, redness and swelling underneath and on the skin was considered unknown. The headache, was considered resolved on 07 Jan 2021.; Reporter's Comments: This case concerns a 44-year-old female who experienced NS events of unexpected erythema, pruritus, pain, swelling, skin swelling and expected headache.  Event onset Day 1 after the first dose of mRNA-1273, followed by skin swelling and pruritus on Day 8. Treated with steroid and antibiotic. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Headache, Fever, Fatigue, injection site pain and swelling. 2.22.2021 Nausea and diarrhea x 48 hrs. 2.23.2021 resolved. Narrative:
Patient reports itching, warmth and redness for a few hours after vaccine administration and next day.  Also, next day reports of extreme body aches all over. High dose was given - Sanofi consulted for recommendations with none provided.
Pt recvd 3 doses of Engerix-B 13NOV90, 17DEC90, & 09MAY91 & p/3rd Engerix-B vax given antibody titer was 2.3; A 4th dose was given 11JUN91 & titers were inc to 4.2;
This is a spontaneous report from a contactable nurse (patient). A 79-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN6207), at the vaccination age of 79, via an unspecified route of administration, in left arm (reported as left upper arm), on Mar 16, 2021, at 13:30, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications: none. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. On Mar 18, 2021, patient experienced rash on her upper left arm, chest, back and neck (just the left-side). The outcome of the event: recovering. No follow-up attempts possible. No further information expected.
Child received vaccines on 9/14/12. Parent reported found child unresponsive on 9/15/12. Taken by ambulance to ER and pronounced.
Sick as dogs; Severe Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Sick as dogs), CHILLS (Severe Chills) and MYALGIA (Body aches) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included OMEPRAZOLE from 10-May-1995 to an unknown date for an unknown indication.   On 12-Feb-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced MALAISE (Sick as dogs), CHILLS (Severe Chills) and MYALGIA (Body aches). On 15-Mar-2021, CHILLS (Severe Chills) and MYALGIA (Body aches) had resolved. At the time of the report, MALAISE (Sick as dogs) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable No treatment for the events was reported.   This case was linked to MOD-2021-116538 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: event were updated On 07-Jul-2021: No new information was provided.
feel like total crap; Symptoms just like the flu; Can't get warm; joint pain; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 7th December 2022, the patient received the 1st dose of Shingles vaccine. In December 2022, less than a week after receiving Shingles vaccine, the patient experienced feeling unwell, influenza-like symptoms, coldness and joint pain. On an unknown date, the outcome of the feeling unwell, influenza-like symptoms, coldness and joint pain were unknown.   It was unknown if the reporter considered the feeling unwell, influenza-like symptoms, coldness and joint pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 09-DEC-2022 Reporters comment: This case was reported by a consumer interactive digital media via . The patient received dose of Shingle vaccine 2 days ago (2 day before the day of reporting) and felt like total crap, symptoms just like the flu, can't get warm and the joint pain. Additional Supportive information: As per narrative can't get warm , conservatively the event was coded as feeling cold.
11/6/14 Gave PEDIARIX - Hib - PCV-13 - ROTATEQ at 10:35 AM. Noted pt have red spot rash - all over her - right after she received vaccines. No SOB noted. Dad took her to ER. ER noted at transfer at 10:36 AM.
Mild muscle spasms and intermittent numbness in arm, leg and hip muscles on same side as injection site; Mild muscle spasms and intermittent numbness in arm, leg and hip muscles on same side as injection site; This is a spontaneous report from a contactable consumer (patient). A 16-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 19Aug2021 16:15 (at the age of 16-years-old) as dose 1, single for covid-19 immunisation. Medical history included Benign Pineal gland brain tumor and known allergies Adhesive. Concomitant medication included birth control, received medication in two weeks. The patient was not pregnant at Time of Vaccination. No other vaccine in four weeks. The patient had no covid prior vaccination and no covid tested post vaccination. On 19Aug2021 18:00, the patient had Mild muscle spasms and intermittent numbness in arm, leg and hip muscles on same side as injection site, still continues and not present prior to injection. No treatment was received for the events. The outcome of the events was not recovered.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
After 24 hrs pt. states area got large red and hard, everyday it kept getting bigger came in on 10-5-15 PM the area was 2 x 7" red and warm and raised.
positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient's wife) Pfizer Sponsored Program.   A 65-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in upper left arm on 20Mar2021 14:00 (Lot Number: EN6205), at age 65-years at vaccination, as SINGLE DOSE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid Virus on 27Mar2021 after receiving first dose Pfizer Covid Vaccine 20Mar2021. The reporter took husband to the Emergency Room.  It was technically 0100 Tuesday morning on 30Mar2021.  The patient was taken the emergency room because of Covid, caller's husband had a fever of 103-104, never would go below 103.  The reporter stated everything was fine with her husband, his vitals, EKG, everything look good. They are asking, should the reporter and her husband get their second dose Pfizer Covid Vaccine on this coming Saturday,10Apr2021 as scheduled or wait a longer period of time until they have no symptoms. The patient had nasal swab left and right at two different CVS pharmacies. After testing positive for Covid both the patient used Tylenol and Ibuprofen pills. The Tylenol was extra strength 250 or 200 each pill. Both the caller and her husband took Ibuprofen 200 sometimes 2 pills, sometimes 3 pills, sometimes 4 pills, depending on the level of the fever. The outcome of the events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021387474 same reporter/drug/event, different patients
ER reported lump at the injection site and red lines going from it. Also reported rash, fever, chills, immunization reaction, and cellulitis of R arm.
Sore chest and butt muscles. Then sore feet and ribs; hurt to turn in bed. Then swollen foot with rash at 2 weeks; could not walk. Something in my tailbone or nerves? Now it is in the hands, feet, and left knee. Per annual report- Still have swelling on my left hip (per MRI), 3 fingers and right foot.  I'm using crutches.  Soreness moves around in my right shoulder and neck, knees.  This past week I can feel it will be leaving.  I was told by my doctor this will be a slow recovery in August 2005. The pain is not as severe anymore. Medical record sttes arthralgia. msv
Patient is a 77 y.o. female patient of DO with history of small cell lung cancer on chemotherapy, hyperlipidemia, COPD, hypertension, hypothyroidism, neuropathy and Afib presented to Hospital with generalized weakness and cough.   Generalized weakness S/p Fall  Multifactorial from ongoing cancer chemotherapy (last tx 3 weeks ago) and COVID-19 infection. Having some falls at home Doubt bacterial PNA, but continue antibiotics for now  Had a fall OOB 12/3; no LOC or significant injuries sustained and exam non focal.  Treated with mIVF; encourage adequate PO intake  Consulted PT/OT Doing well 12/6-7 AM   Covid-19 Virus Infection Abnormal CXR, possible CAP Respiratory insufficiency  Date of onset of symptoms: unclear; baseline chronic cough, generalized weakness for 1-2 weeks Symptoms present on admission: Weakness, chronic cough w/ clear phlegm Date of covid positive test: 12/3/22 Vaccination status: vaccinated Imaging: CXR w/ left lung base patchy infiltrate possible pneumonia vs atelectasis  Oxygen requirements on admission: None-- >2L Current oxygen requirements: stable on room air Medical therapy: dexamethasone given 12/3; unclear onset of symptoms, holding remdesivir; continue ceftriaxone/azithromycin for now  Consultants following: e-consult ID to eval for Paxlovid - not a candidate Anticipated special isolation end date: 12/13/2022 U Ag negative; S Cx negative  Wean O2 goal 88-92% Encourage IS/PEP, mucolytics PRN   SCLC w/ mets to adrenals and brain SCLC diagnosed in 12/2021, treated with chemoradiation (carboplatin/etoposide) S/p whole brain radiation in September, currently on lubrinectedin every 3 weeks, due for cycle 3 on 12/5/22 Follows w/ Dr - consulted    COPD Tobacco use Not in acute exacerbation. Recently quit smoking Resume home Spiriva, BD PRN NRT offered, patient declined   Chemotherapy induced peripheral neuropathy Continue gabapentin and B12    Supratherapeutic INR - resolved Hold warfarin, check INR daily INR currently 1.9;   Atrial fibrillation INR 1.9, can resume warfarin per pharmacy Continue metoprolol Elevated BNP likely secondary to Afib than CHF (clinically hypo or euvolemic) Pharmacy to dose warfarin, daily INR  Coumadin managed by PMC AC clinic   HLD Cont statin   Hypothyroidism Cont Synthroid   HTN Resume clonidine and metoprolol   Anemia  Thrombocytopenia Chronic, stable, due to chemotherapy Stable iron and B12 studies in the past Will trend lab   Severe malnutrition poa Nutrition consulted
Pt stated that she began her period soon after dose and has bleed continuously up to today.   Pt states that she is feeling  joint pain that is new onset.  Pt states an overall malaise.  Advised pt to seek medical care immediately regarding  adverse events from COVID-Pfizer vaccination.
Lump that looks like a local reaction at the site of injection. Numbness and pain for 3 days and just pain thereafter.
Had malaise and fever for a few days after vaccination. He then began to notice palpiations approximately 2-3 days after immunization. Within 24 hours they were frequent and associated with swallowing. No chest pain, no shortness of breath. Vaccinee is an adult ID physician and did not see another MD nor had any tests, EKG etc. They became more sporadic and then stopped.
My arms were tired, weak, heavy. I went to urgent care they thought it was Guiganne barre, but it wasn't. I was told follow up with my PCP. No treatments were done. I did feel better with time.  I feel like it was possibly  happening this way due to me having had Covid.
pt recvd vax on 6Jun95 & on 27JUN95 exp papular rash & pruritus;in f/u pt stated was asthmatic & had an extensive allergic hx;exp myalgia;24JUN & 25JUN95 exp flu-like synd;rash described as fine, confluent, maculopapular
Patient with J+J vaccine on 12/07/21 who admitted to hospital for COVID complications and subsequently died.  Provider discharge summary below:  "48 YO with PMH of OSA/OHS, chronic hypercapnic respiratory failure, HTN, HFrEF, CKD4, T2DM, bipolar disorder, BPH. Presented to the ED 1/14 for a 3 day history of progressive SOB, orthopnea, PND and lower extremity edema; found to be COVID positive. Admitted for acute on chronic hypercapnic respiratory failure and decompensated heart failure. Initially started on a few L of oxygen and escalated to BiPAP. Since admission he has been very agitated, ripping off his BiPAP and eventually started on precedex. At that time was evaluated by ICU team. Significant agitation with concomitant respiratory failure led to intubation on 1/16/2022. He was placed on propofol and fentanyl drips and admitted to critical care.   Please see chart for entire ICU care.     On 2/2 after discussion with palliative care team, the family decided to extubate him to BiPap with the intention of not to re-intubate the patient if he failed BiPap.  Please see chart for full discussions.   Despite pt being on BiPap his saturations started to decrease around 11 PM on 2/2.  He was then made comfort measures. Family was at bedside throughout the night. Time of death 12:20 AM with family at beside."
HALF DOSE ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 12-APR-2021, the subject experienced half dose administered.   The outcome of half dose administered was not reported. This report was non-serious.
Initial report received on 13 September 2010 from a consumer who is the patient's spouse. A 72-year-old male patient had received a dose of FLUZONE High-Dose (lot number unknown) at 12:00 pm on 07 September 2010. Two hours post-vaccination, the patient had a cough and chills. He experienced hot and cold feelings all night. At the time of this report, the cough was still persisting. The patient had no concurrent illnesses, no known allergies and was taking blood pressure medication, and medication for his cholesterol. The reporter for this case is the same as for case 2010-04954. Documents held by sender: None.
Initial misuse report received from a healthcare professional on 12 July 2013. It was reported that a patient (No information was provided regarding the patient) was administered a dose of ADACEL instead of administering Varicella vaccine. The patient had received first dose of ADACEL vaccine before 18 months. No adverse event was reported. List of documents held by sender: none.
Severe pain and redness on my left upper arm from the shoulder to my elbow. A rash on my chest. Muscle pain, headache, fever, chills. Constipation. It had been 10 days and the arm is still sore the redness is finally gone.
Fever (max of 101.8), chills, headache, fatigue, injection site reaction (swelling, redness, skin sensitivity)
Body aches, fever, headache, elevated ESR and CRP, also took NSAIDs for symptoms and developed UGI bleed.
Pt called at about 12:10pm today stating he has mid-back pain. He denied any SOB or any other problems at this time. Pt stated he had this pain when inhaling. Pt states he didn't have this with 1st Hep B.
Headache, body aches, sharp pains along lower ribs/diaphragm into chest, numbness of left lateral lower and upper lip
Pt had possible reaction to Pfizer COVID19 immunization on 10/01/21. Followup with Parent on Monday following she said that daughter was doing fine and that they had gone to an urgent clinic and had been given benadryl which seemed to help.
assistant was out of the office for three to four days after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (assistant was out of the office for three to four days after the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced VACCINATION COMPLICATION (assistant was out of the office for three to four days after the vaccine). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (assistant was out of the office for three to four days after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       From the first dose she just had a sore arm later in the evening
Development if severe and consistent tinnitus, primarily in right ear with milder but consistent tinnitus in left ear
Cramps in the ribs, diarrhea, watery eyes, nausea, headache, chest pain.
The pharmacist on duty gave a 2nd booster (4th vaccine) to a 27 year old with no immunocompromising conditions. Per CDC recommendations the vaccine is only indicated at the time of the vaccination for his age if he had a immunocompromising condition. The patient did not have any adverse reaction to the vaccination. The report is being conducted because this would fall under a vaccine administration error.
Noted headache just over an hour after receiving vaccine. No fever and subsided after about an hour. Awakened 12/19 with a headache that was relieved by Advil.