chrisvoncsefalvay/vaers-outcomes huggingface dataset:
WITHIN 4 HOURS HIVES AND HEADACHE,IN 24 HOURS HIVES ON ARM AND CHEST, PATIENT WAS TIRED AND WEAKNESS . DAY 4/21/21 SHE SAID WAS THE WORST HIVES ALL OVER BODY, TIRED,DIZZINESS,WEAK AND COULD NOT STAND, RAPID PULSE OR HEART .
large, warm, red area around injection site, remained this way for 11 days post vaccination, referred to pcp for possible infection
felt sick after her second Pfizer COVID-19 shot; This is a spontaneous report from a non-contactable consumer (family member). A 34-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date (on either Friday 05Mar2021 or Friday 12Mar2021) single for covid-19 immunisation. On an unknown date the patient felt sick after her second pfizer covid-19 shot. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
viral meningitis with encephalitis secondary to Flu shot,  symptoms: chills, high grade fever, lethargy, loss of appetite, malaise, nausea, vomiting. confusion, aphasia, loss of alertness.  outcome of symptoms: 9 days in ICU followed by recommended 20 sessions of physical and occupational therapy plus Brain injury rehab
Report 20020015431 describes cellulitis in a 5 year old female who received Infanrix. Medical history, concurrent conditions, and concurrent medications were not specified. She had an unspecified reaction to Infanrix and MMR vaccine at the age of 15 months. On 01/21/2002, the vaccinee received her fifth injection of Infanrix and her second injection of MMR. On 01/23/2002, the child's mother noted a "bruise" on the right deltoid. On 01/24/2002, the child was seen by the physician. The physician noted a 2cm x 4cm "dark purple" area on the right deltoid. A firm erythematous area was observed next to the ecchymotic area. The physician made a diagnosis of cellulitis and prescribed amoxicillin clavulanate. The most recent info received on 02/15/2002, indicated the ecchymotic area resolved on 02/01/2002; the outcome of the cellulitis and erythema were not specified.
Woke up at 6:30 am on 5/29/03-was very sleepy acting so I put her back to bed, thought she was extra tired due to having vaccines. Went in at 10:30 am and she could not move, had no muscle control, could not even open her eyes, when picked up she was very limp and floppy, very lethargic until late afternoon 5/29/03 wen to PP at 11:15 am.
patient guessed patient missed the mark. But patient's arm did hurt; Initial information was received on 09-Dec-2020 regarding an unsolicited non-valid non-serious case from a non-health care professional/consumer (patient) via social media.  This case involves a patient of unknown age who guessed patient missed the mark. But patient's arm did hurt (pain in extremity), while patient was treated with influenza vaccine.  Medical history, medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient guessed patient missed the mark. But patient's arm did hurt (pain in extremity).  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Information has been received from a 24 year old female with no known drug allergies who on 03/28/2001 was vaccinated with one dose of hep b vaccine recombinant. On 03/29/2001 the pt broke out in small bumps all over her body. The caller states the symptoms have continued to the present. The pt sought unspecified medical attention. Additional info has been requested.
Patient called  the emergency services line at home after experiencing difficulty breathing, being not able to move or walk on her feet, and  having high temperature.  She was subsequently treated at the Regional hospital where she hospitalized as at the time of this reporting.
Rash on the right side of shoulder blade; Itching at the injection site; Swelling of the injection site to the size of a knot; Fine rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on the right side of shoulder blade), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE SWELLING (Swelling of the injection site to the size of a knot) and VACCINATION SITE RASH (Fine rash at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced RASH (Rash on the right side of shoulder blade), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE SWELLING (Swelling of the injection site to the size of a knot) and VACCINATION SITE RASH (Fine rash at the injection site). At the time of the report, RASH (Rash on the right side of shoulder blade), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE SWELLING (Swelling of the injection site to the size of a knot) and VACCINATION SITE RASH (Fine rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was reported
Case number PHEH2014US025068, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to an 11 year old male patient. Medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose on 18 Nov 2014. Nurse reported that patient received FLUVIRIN that was at 49 degree F 12 times over a period of 34 days. The temperature excursions began around 16 Oct 14. 12 separate temperature excursions lasting 30 minutes each in which the temperature was 46-49 degree F during each of those excursions. No adverse event was reported following this maladministration. No further information was provided.
vaccine given and the next day noted to have significant swelling of the right arm from shoulder to mid forearm. Tender, tight and red and hot to touch., Small hives on cheek and forehead and under right axilla that come and go. Given oral Benadryl q 6 hrs and no change today so prescription given for oral steroids Orapred bid x 5 days. breathing ok a referred to allergist, child has had flu vaccine 2021 without issue. still swollen today no change but has not started steroids yet.
Large red, slightly swollen area around administration site. Measuring about 5'x4'. No reportable fever, malaise, weakness, nausea or anything else other than the site reaction.
red numbness; tingling on little toe; red; swelling of breast; lots of discomfort; swelling of hands; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red), BREAST SWELLING (swelling of breast), DISCOMFORT (lots of discomfort), PERIPHERAL SWELLING (swelling of hands) and HYPOAESTHESIA (red numbness) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Breast cancer.   On 05-Mar-2021 at 6:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced ERYTHEMA (red), BREAST SWELLING (swelling of breast), DISCOMFORT (lots of discomfort) and PERIPHERAL SWELLING (swelling of hands). On 07-Mar-2021, the patient experienced HYPOAESTHESIA (red numbness) and PARAESTHESIA (tingling on little toe). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, ERYTHEMA (red), BREAST SWELLING (swelling of breast), DISCOMFORT (lots of discomfort), PERIPHERAL SWELLING (swelling of hands), HYPOAESTHESIA (red numbness) and PARAESTHESIA (tingling on little toe) outcome was unknown.            It was reported that patient had immune issue . No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Added facility information.Updated patient demographics, batch number and re-challenge field.
Information has been received via Pfizer (MFR #US-WYE-H02045408) on 27-APR-2015, from an investigator concerning a 4 month old male subject enrolled in a study. The subject's concurrent conditions and medical history were not reported. There were no known allergies. On 02-JAN-2008, the subject received the second dose of ROTATEQ, 1 dose form (DF) per day orally. Other suspect therapies included the second dose of pneumococcal 13-valent conjugate vaccine, 1 DF per day intramuscularly, the second dose of PEDIARIX 1 DF per day intramuscularly and the second dose of ACTHIB 1 DF per day intramuscularly, all on 02-JAN-2008. Concomitant therapies were not reported. On the night of 02-JAN-2008, the subject's mother noticed a rash/allergic reaction, which proceeded to spread over the entire body. Treatment for the event included BENADRYL (0.4 cc) on 05-JAN-2008, which was administered by the subject's mom. The subject presented to the clinic on 06-JAN-2008 (also reported as 2007) and rash was characterized by red, blanchable petechiae on entire body, excluding the face. On that day, body temperature was 36.7 centigrade. Further treatment included topical hydrocortisone (0.5%). The subject recovered on 09-JAN-2008 and was withdrawn from the study. Action taken with ROTATEQ, PEDIARIX and ACTHIB was not reported. Action taken with pneumococcal 13-valent conjugate vaccine was withdrawn. The investigator and medical monitor considered hypersensitivity possibly related to ROTATEQ as well as other suspect therapies. The event hypersensitivity was considered to be medically significant. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Eczema" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive; (20Nov2022) Negative, notes: testing negative for the past 4 days; (21Nov2022) Negative, notes: testing negative for the past 4 days; (22Nov2022) Negative, notes: testing negative for the past 4 days; (23Nov2022) Negative, notes: testing negative for the past 4 days; (24Nov2022) Positive, notes: today i tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No, the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Patient had COVID-19 Treatment with brand=Paxlovid from 15Nov2022 to 19Nov2022. It was stated as Today she woke up with a sore throat and sinus congestion. She took Paxlovid for 5 days last week and after testing negative for the past 4 days today she tested positive again.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient stated he was feeling clammy, sweaty with mild nausea. He was feeling fine after 0920am; patient was seen and cleared by EMS
Patient felt dizzy, cool, nauseated and had ringing of the ears.  We had him lay down with feet elevated and began to feel better within 5 mins.
Client called yesterday in regards to symptoms after having 2nd covid vaccine.  Client's 2nd Moderna Covid vaccine admin. on 04/17/2021.
2 hours after the vaccine patient has sharp pain on outside of right half on/off. Standing up helps the pain, sitting down makes it worse. Continues to experience side effects today.
This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 61-year-old female patient who received SHINGRIX (batch number ZG47A, expiry date 28th February 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date and did not had any reaction). On 9th October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced erythema of extremities and pain in arm. On an unknown date, the outcome of the erythema of extremities and pain in arm were unknown. It was unknown if the reporter considered the erythema of extremities and pain in arm to be related to SHINGRIX. Additional details were provided a follows: The health care professional reported an adverse event via click to chat. The reporter was reporting an adverse drug reaction for the first time. The patient received a dose of SHINGRIX on Tuesday of reporting week and had a reaction about a 3 inch red band around her arm and it was painful. The patient did not have any reaction like this with the first dose. The patient liked to report it as a adverse drug reaction. But also wanted to know if the patient do anything specific.
Redness at injection site that went away in 2 weeks after administration after adding ice pack to the redness site.
Information has been received from a health professional concerning a 20 year old female with a history of syncope vasovagal, "patient has passed out seven times in her life", who on 17-OCT-2007 was vaccinated with the first dose of Gardasil vaccine. Shortly after the vaccination the patient passed out. The patient remained unconscious for approximately one minute. The same day the patient felt light-headed and she had a decreased in her blood pressure. Unknown medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a health professional concerning a 21 year old female with a history of syncope vasovagal who on 17-OCT-2007 was vaccinated with the first dose of GARDASIL. Shortly after the vaccination the patient became lightheaded and passed out in the mid sentence. Hit her head, became very pale. Started jerking movements as if it was a seizure. She was sweating. Blood pressure went low and very hard to sit and back up again without being dizzy. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Vaginal bleeding/spotting since day after covid vaccine to present, also the day of to a week after, I had bloating and gas.
Facial flushing, slight chest tightness. BPs 155/103 (pulse 90), 98-99% O2 sat; 156/97 (pulse 79), 99% O2 sat.
Per pt, she developed severe erythema around the injection site accompanied by itching on 04/22/2012. Over the next couple of days, the redness worsened. Pt went to see Dr. on 04/24/2012 and was diagnosed with cellulitis, for which she was given a 10 day course of clindamycin (she is currently on day 7 of treatment). Symptoms started resolving within 24 hours of initiation of clindamycin therapy, and are now greatly improved.
Information has been received from a vaccine coordinator referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not applicable. On unspecified dates, the patients were vaccinated with improperly stored doses of MMR II (lot # L035674, expiration date 17-SEP-2017, dose and route not provided). The vaccines were stored at minus 13.21 degree C for 12 hours. No adverse effects were reported. There was no product quality issue (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Transient global amnesia - had 24 hours of short and long term memory loss,  admitted to hospital, symptoms resolved without intervention
pharmacist administered 1.0 ml dose instead of U&C 0.5 ml dose.  pt  & clinic notified immediately upon discovery of error.  pt reported no pain at injection site or other issues at the time (about 2 hrs after immunization).   CDC guidance document says pt may experience more pronounced post-immunization s/sx and the 2nd dose may be skipped unless the pt & dr feel it is in the pts best interest to administer.
On 27JAN90 pt devel rash started on face & by 30JAN90 progressed to entire body but dec on face; Also adenitis, fever, malaise, nasal congest, coughing, typical coryza & OM; tympanic membranes red & bulging; MD felt rash immun assoc measles
Caller stated 2 days after the vaccine, patient had a cycle that was short. She spotted for a week after that. Patient has not had a cycle for July. Patient is not sexual active. Patient is six days late as of July 28th. Patient first started having a cycle December 2019. Patient has kept track of cycle since the beginning and has not been late or missed any cycles.
Bruise like rash broke out on back and arms with spots with several dozen spots up to 1 inch in diameter.
Head rushing sensation with extreme nausea and motion sickness for about 2 weeks after vaccination. Tremors on the right side of my body that started in my face and then moved to the rest of my body only on my right side. My right foot went numb as well and this went on for a while. I got feeling back in my foot but I am still having small Tremors on the right side of my body.
hives down shoulder blades and left arm; itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives down shoulder blades and left arm) and PRURITUS (itching) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives down shoulder blades and left arm) and PRURITUS (itching). At the time of the report, URTICARIA (hives down shoulder blades and left arm) and PRURITUS (itching) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
This spontaneous report as received from a nurse practitioner refers to a 10 month old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 09-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 2 month old patient with no medical history who was vaccinated with the first oral dose of Rotateq. Subsequently the patient developed diarrhea within 5 days of receiving Rotateq. It was reported that the patient had 3 bowel movements for 3 weeks. Unspecified medical attention was sought. No labs were performed. Subsequently, the patient recovered. No product quality complaint reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2007.  Information has been received from a physician concerning a 2 month old patient with no medical history who was vaccinated with the first oral dose of ROTATEQ.  Subsequently the patient developed diarrhea within 5 days of receiving ROTATEQ.  It was reported that the patient had 3 bowel movements a day for 3 weeks.  Unspecified medical attention was sought.  No labs were performed.  Subsequently, the patient recovered.  There were no product quality complaint reported.  Additional information has been requested.
Received Moderna vaccines on 2/5, 3/5, 9/19/21 COVID-19 positive by PCR on  1/11/22 admitted to hospital  s/p fall w/ polytrauma; incidental finding of COVID on admission.
Call came to Immunization Program on-call staff.  Situation: On 5/18/05, Nurse at a family practice clinic was administering varicella vaccine. The boy receiving the vaccine squirmed, the needle came out, and some varicella vaccine got into the administering nurse's eye. She rinsed the eye thoroughly two times, then called the State Immunization Program for guidance. Spoke to nurse on the morning of 5/20, she reported no adverse events to the eye.
Ear pain, swelling in right face 5/21/06 seen by ER, TX with Keflex and Ultram.
hives devel evening of 20APR93; mom called hlth line @ local hosp; was told to give DPH then hives resolved;
He is now having coughs and flem; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for male patient (reporter's father) of an unspecified age received BNT162B2(BNT1PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date at single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient was now having coughs and flem on an unspecified date with outcome of unknown.  Information about Lot/Batch has been requested.
Dose 1 - sore arm Dose 2 - sore arm Dose - 3 - bad headaches, slurring speech, nausea, dizziness, diarrhea - generally very sick for 4 days
Moderna vaccine was administered outside the recommended time outside refrigeration conditions. Called Moderna and asked what was to be expected. They said series was still complete and patient was still fully vaccinated. Called and left message with patient to return call to me so that we can following up with side effects and the patient's general condition over the next several days.