chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number B23EA, expiry date 15th May 2022) for prophylaxis.   On 9th August 2022, the patient received Havrix. On 9th August 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 26-AUG-2022 Reporter's Comment: The reporter reported that, a patient was administered a expired dose of Havrix. The reporter declined to provide information about the patient. At the time of reporting, the dose had not been repeated. The reporter gave permission for follow-up but declined to provide any patient information. The reporter consented to follow up. Additional Supportive Information: The patient was administered with expired dose of Havrix, which led to expired vaccine used.
large 17 cm x 11 cm erythemia & induration; 10 days p/inject-has inc over period of 6-7 days;
Information has been received from a licensed visiting nurse concerning a 10 week old male who on 24MAR2004 was vaccinated with a dose of hepatitis B virus vaccine +Hib conj vaccine. On 24MAR2004, "that evening", the patient developed knots in his leg in the area on the injection. It was noted that treatment was required and the nurse told the mother to put ice on the knots, which resolved the next day on 25MAR2004. The outcome was recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information was received from the reporter and revealed that this was not from hepatitis B virus vaccine +Hibocnj vaccine . No further information has been requested. Follow up 03/03/05: WAES number 604USA00276 does not exist.
Second dose of Pfizer vaccine resulted in an outbreak of genital HSV-1 about 4 days after the injection. Also had fever, body aches, and fatigue for about 8 hours starting 12 hours after the injection.
This is a spontaneous report from a contactable pharmacist reporting for his wife via a Pfizer Sales Representative.  A female patient of unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration, in 2017 (2 months before report), at 0.5 ml single, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced arm hurts at the injection site in 2017 with outcome of recovering. Therapeutic measures were not taken as a result of the event. The reporter assessed the event as related to pneumococcal 13-val conj vac (dipht crm197 protein).
Itching; rash; trouble breathe; This is a spontaneous report from a contactable consumer (patient reported for self). A 55-years-old (non-pregnant) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration, administered in left arm on 11Aug2021 11:00 (at the age of 55-years-old) as dose number unknown, single for COVID-19 immunisation (Reason why batch/lot is Unknown: Unable to locate or read the details). Medical history included sulfa allergy. The patient's concomitant medications were not reported. The patient previously received Shingles vaccine (Lot Number: not reported). 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 COVID vaccine. On 13Aug2021 22:30, patient experienced itching, rash and trouble breathe. 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 adverse events, treatment: Benadryl. Outcome of the events was reported as not recovered.  Device Date: 14Aug2021   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I have  intense burning sensation in my left buttock cheek and thigh but no rash. I went to my gynecologist , first thinking I may have a yeast infection but she did not see a rash and couldn't diagnose me. She told me that my pain was probably neurological. She took my blood and sent it to a lab for possible yeast infection and STDs. She prescribed me Clotrimazole and Betamethasone Diporopionate 1%. I went to my PCP on Wednesday because the burning intensified and I thought that I may have shingles. I have a stuffy nose and my sense of smell isn't very good right now. My PCP gave me a Covid test and told me that she can not test me for shingles because I do not have a rash. She did prescribed me Gabapentin 100mg . I am awaiting Covid test and Lab results
April 4th started Headache, dizziness, lightheaded and fatigue and since then have improved, but still experiencing headache and fatigue.  Platelet count is very low 102, based on blood work on 4/7/21.  To treat symptoms taking Tylenol and doctor has recommeded aspirin 81mg for 2 weeks.
11x8mm swelling, erythema at shot site, red streaks, sharp pain, itching. Pt seen in urgent care and released.
Vaccine was administered before the date reccomended by CDC. Pt has completed the series with ppsv23 on 12/18/2020 (previous doses of PCV13 on 12/17/2019). the next dose was supposed to be administered on 2025.
Administered with expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032N20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). On 08-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   There were 9 patients instead of 10 as initially reported of which this case is for the 7th patient. No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-314567, MOD-2021-314573, MOD-2021-314468, MOD-2021-314517, MOD-2021-314545, MOD-2021-314555, MOD-2021-314793, MOD-2021-314805, MOD-2021-314810 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow-up information included no new information
I started itching within about 10 minutes of receiving the vaccine/The itching started around my torso. It moved to both arms, but more predominantly on my left arm; a rash or hives; a rash or hives; This is a spontaneous report from a contactable consumer (Patient). A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: FC3183 and expiration date was not reported), via an unspecified route of administration, administered in Right Arm on 20Aug2021 18:00 (at the age of 44-years-old) as dose 1, single for COVID-19 immunization. Patient had no know allergies and medical history were none. There were no concomitant medications. Patient have not received any other medications in two weeks and have not received any other vaccine in four weeks. Patient did not have COVID prior vaccination. Not tested COVID post vaccination. On 20Aug2021 at 18:15 the patient was started itching within about 10 minutes of receiving the vaccine, the itching started around his torso. It moved to both arms, but more predominantly on his left arm, patient thought he would see a rash or hives when he got home, but there was nothing. The itching subsided within about 30 minutes. The treatment was not received. The outcome of all the events was recovered in Aug2021.     Information on the lot/batch number has been requested.
stomach problems; acid indigestion; anxiety; heart pounding; bloating/tight all around that area of the stomach; queasy; This is a spontaneous report from a contactable consumer (Patient). A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3302), dose 1 via an unspecified route of administration, administered in left arm on 01Feb2021 13:35 as (at the age of 69-years) 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Patient Medical History including any illness at time of vaccination: anxiety, and drug sensitivity. It was reported that patient mother and sister and herself all have drug sensitivity, No further information provided. There were no concomitant medications. Patient did not receive any Prior Vaccinations within 4 weeks. No Other Products and Investigation Assessment were reported. Patient did not had history of any previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. On 01Feb2021 patient experienced queasy, bloating, upset stomach, tight all around that area of the stomach and heart pounding. Patient already had some stomach problems due to the anxiety before receiving the vaccine but started feeling queasy within an hour after receiving the vaccine. Her stomach problems got worse after with some bloating, tightness around the stomach area, and acid indigestion. Patient heart would start pounding a little bit off and on starting the first day through the evening. It was reported that she had the first dose on Monday and within an hour she felt queasy, bloating, upset stomach, tight all around that area of the stomach; and her heart was pounding. The heart was off and on the first and second day. This morning she started to feel a little queasy but yesterday she was fine. Patient clarified she received the first dose of the Pfizer COVID 19 vaccine on 01Feb2021 1335PM in the left arm. Patient was scheduled for the second dose on 23Feb2021 and plans to receive it depending on the answer to her question. Patient asked was stomach problems, acid indigestion, and heart pounding a common side effect. Events did not require visit to physician office or ER. No Relevant test ware reported. The outcome of event stomach problems, bloating/tight all around that are of stomach and queasy was recovering, outcome of event heart pounding recovered on 03Feb2021 and outcome of acid indigestion and anxiety was unknown.  Follow-up attempts are completed. No further information is expected.
1st IZ, transient, unilateral upper arm numbness, pain and tenderness in shoulder to finger distribution. 2nd IZ; milder transient, unilateral arm pain, numbness, tenderness followed by over a week of back and neck pain and stiffness.
unable to breath; Anxiety; invalid dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (invalid dose), DYSPNOEA (unable to breath) and ANXIETY (Anxiety) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 027C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy and Drug allergy. Concomitant products included TRIAMTERENE, CARVEDILOL, SIMVASTATIN, ALLOPURINOL and LAMOTRIGINE for an unknown indication.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (invalid dose) and ANXIETY (Anxiety). On an unknown date, the patient experienced DYSPNOEA (unable to breath). On 25-Jun-2021, ANXIETY (Anxiety) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (invalid dose) had resolved and DYSPNOEA (unable to breath) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received on 19-JUL-2021 contains: Added Patient demographics- Height, weight; Added medical history- Allergies; Added dose 2 information- Route of administration, Anatomical location; Added Concomitant medications; Added event- Anxiety, Dyspnea;
Minor chest pains were felt; Shortness of breath; This is a spontaneous report from a from a contactable physician and from contactable consumer (patient reported for himself). A 36-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via intramuscular route of administration, administered in Arm Left on 12Jun2021 at 10:30 am (Batch/Lot Number: EW0179) as dose 1, single for covid-19 immunization (at the age of 36-years-old). Medical history included ongoing slightly elevated high blood pressure and anxiety from an unknown date. Concomitant medication(s) included bisoprolol fumarate (BISOPROLOL FUMARATE, 5 mg) taken for slightly elevated high blood pressure from 29May2021 and ongoing. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient had no known allergies. It was reported by the patient that within hours of receiving first dose of vaccine on 12Jun2021 at 16:30 pm the minor chest pains were felt and these continued sporadically, about twice a day, for several days, along with occasional shortness of breath. One week after receiving the first dose, the chest pains became more frequent, five to six times a day. this increased frequency continues through the date this report was being filed 23Jun2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. After that the physician reported the laboratory test results and physician considered that the Pfizer product had a causal effect to the adverse event. Therapeutic measures were taken as a result of adverse events. The patient underwent lab tests and procedures which included TSH (blood thyroid stimulating hormone) which result showed units 2.8, normal on 26Jun2021, CXR (chest x-ray) which showed RBBB, normal in ER (emergency room) on 21Jun2021, Echo (echocardiogram) which was normal on 08Jul2021, EKG (electrocardiogram) had unknown results on an unspecified date in 2021 and showed NSR incomplete on 20Jun2021 in emergency room, Troponin level test (troponin) and X-ray which had unknown results on an unspecified date in 2021. The outcome of the events was unknown.   The Physician considered that the Pfizer product had a related causal effect to the adverse event.  Follow-up attempts are completed. No further information is expected.
12/22/20- day of vaccine- sore arm several hours after vaccine x 2 days. Took Tylenol (3 doses total in 2 days)   12/28/20- sore arm again and felt a little itchy, noted to be warm, slightly red and indurated. No fever. Slightly worse as day went on. Appx 3x4 inch area.  12/29/20- still appeared the same, but felt more itchy and maybe a little more sore. Took Motrin 400 mg.  12/30/29- redness and induration resolved. Still with mild soreness 12/31/20- no symptoms.
Redness, swelling, warmth at vaccination site (L)FA (BEXSERO) 16 h after given, decreased 2d later - but minimal warmth and nodule persist - 4 D after vaccination.
giving low doses of Moderna injections; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (giving low doses of Moderna injections) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 UNDERDOSE (giving low doses of Moderna injections). At the time of the report, UNDERDOSE (giving low doses of Moderna injections) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication details was provided. No treatment medication details was provided.
Acute stomach pain beginning at 3 am, lasting 8 hours. Severe pain all over body, chills, and low fever entire next day. Acute tiredness. Stomach pain still present 1/21, but recovering and able to have soup and bread. No vomiting.
Patient presented to PCP on Thursday and received GARDASIL around 1700. Mother reports that patient woke up around 0200 Friday morning complaining with itching and hives on trunk. Patient presented to ED on Saturday with worsening hives. Mother reported that other students at patient's school had similar outbreaks. No signs of scabies were noted. Mother did not mention the recent vaccination at that time. Patient was discharged on DECADRON, BENADRYL, and an EPIPEN. Patient presented again on Sunday with worsening itching and rash head to toe with swelling in lips and face with shortness of breath. Mother reported at this visit patient received the GARDASIL on Thursday, but this is the second series. Patient denies any pain or swelling at injection site. Denies any swelling in throat, nausea, or vomiting. Patient received BENADRYL x2, PEPCID x2, DECARDON, MOTRIN, DUONEBS, and Epi 0.3 with some improvement. Patient is being transferred to Hospital for observation.
Swollen red hot lump that itches, lump developed day after the injection and has not gotten better
burning urination frequency, bladder infl/trouble sitting; tests urine C&S/upr G.I./ sigmoidocopy/bone scan;cystscopy/ct scan;
Slight dizziness when tying shoes getting out of bed for four days though Alpine skiing each of those days then fifth day dizzy almost staggering all day; Slight dizziness when tying shoes getting out of bed for four days though Alpine skiing each of those days then fifth day dizzy almost staggering all day; high blood pressure; This is a spontaneous report from a non-contactable consumer (Patient). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number not reported), via an unspecified route of administration, administered in left arm on 20Jan2021 at 15:30 (at the age of 76-years-old) as an unknown, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no other vaccine within four weeks prior vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 21Jan2021 at 07:00 (next day after vaccination), patient experienced slight dizziness when tying shoes getting out of bed for four days though alpine skiing each of those days then fifth day dizzy almost staggering all day and high blood pressure. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of all the events was recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Fever going on two days even with Tylenol.  But Tylenol she's help.  Passed out briefly a half hour ago
Pt recv vax on 4/28/99; immediately post vax pt exp syncope x 1 min, pale skin color; tx=ammonia whiffs, pt to urgent care for observation
61 y/o female received Janssen vaccine @ 2:08 pm, while in the recovery area, @ 2:15 began to c/o feeling flushed and rapid heart rate.  2:15 pm vitals: 128/87, 115, O2 Sats 99% on RA, expressed feeling very anxious stating, "I have a hx of panic attacks".  Patient instructed on deep breathing, and posturing to relax from very tensed positioning.  2:20 vitals: 120/103, 130, sats unchanged. Recovery Nurse worked w/patient to continue relaxed breathing, began to calm , HR down to 99 @ 2:25.  Remained in recovery until 2:45 pm, last vital check, 112/84, 80 sats 99% RA, feeling more at ease, no further c/o rapid heart rate or feeling flushed, dc from recovery w/Son In Law who drive patient to appoint.
I began having sinus issues in May of 2022. My symptoms were headache, feeling a loss of energy, and sinus pressure that would come and go. I continued to have my sinus issues and received an antibiotic in November of 2022 and my sinus issues got better. In August of 2022, in the middle of all of my sinus issues, I had a stuffy nose and tested positive for COVID-19. I did not have any other symptoms. I tested positive for 12 days.
10 hours post-injection  experienced 20 hours of fever, shaking chills, near syncope, severe myalgia,.  2-3 weeks later 1 week of pitting edema .  chronic fatigue for 10 months, dyspnea on exertion, for 3 months
Has an infection in her tooth, in the bone of her teeth; This spontaneous case was reported by a nurse and describes the occurrence of TOOTH INFECTION (Has an infection in her tooth, in the bone of her teeth) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TOOTH INFECTION (Has an infection in her tooth, in the bone of her teeth). The patient was treated with AMOXICILLIN for Tooth infection, at a dose of 500 mg. At the time of the report, TOOTH INFECTION (Has an infection in her tooth, in the bone of her teeth) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter stated that they had a patient who wanted to get a Moderna booster. The patient received both doses of the Moderna Covid-19 vaccine and had an infection in their tooth, in the bone of their teeth, and had completed a round of antibiotics Amoxicillin 500mg for 5 days for that, a month and a half ago. It was also reported that the patient hasn't had another X-ray, so they don't know whether it was still active or not. Reportedly, the patient was not having their teeth out until January, when they would have them removed.   No Concomitant product use was reported.
Patient reports swollen large (about 4 inches in diameter) circular raised rash on left arm at injection site. Very warm, as reported by patient. No chills or fever. patient was concerned she had eaten crawfish, but has eaten crawfish in the past with no problems/allergic reactions. Instructed patient to contact provider as soon as possible, and to go to urgent care with any fever or chills or worsening rash. Advised Tylenol and ice packs for now until provider can make sure it is not infected.
PMH:  HTN, hypothyroid; to ED with worsening SOB; 8 dys prior to coming to ED diagnosed COVID positive; in ED pt was hypoxic and febrile, mild hyponatremia, leukocytosis, elevated D-dimer; started on remdesivir and decadron; waxed and waned; unable to get off non-invasive ventilator unit; opted for comfort measures and inpatient hospice; pt died in the hosp before could be transferred to hospice
Beginning around 9:30 pm - fever, chills, body aches, tiredness, and racing heartbeat.
Systemic: Fainting / Unresponsive-Mild, Additional Details: pt was still conscious  just felt faint
I have all the information reported on a document.  Please send an email for me to add additional information so I can upload the document.
pt recv vax & @ home exp 3 episodes of high pitch cry (scream), vomited x 1 became limp & less alert