chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hey am or shaking can't sign anything lymph nodes under the arms are all swollen; hey am or shaking can't sign anything lymph nodes under the arms are all swollen; This is a spontaneous report from a non-contactable consumer (patient). A 77-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: hfc3182), via an unspecified route of administration on 03Sep2021 (at the age of 77 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunisation. On 03Sep2021 patient experienced shaking can't sign anything lymph nodes under the arms are all swollen. The outcome of events was unknown.  No follow-up attempts are Possible. No further information is expected.
A non-serious spontaneous report of received expired vaccine was received from a health professional concerning a seven-year-old male. Neither past medical history nor concomitant medications were reported for this patient. The FLUMIST expired on 29-Nov-2010. On 12-Dec-2010, the patient received the expired FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Pt recv vax on 10/29/98; post vax pt exp headache & aches all over x 12-16 hr; tx=aspirin
Right eye was swollen shut approximately 28hrs after the second dose was given. Primary care doctor said to take 50mg of Benadryl every four hours and use a cold compress. The swelling lasted about 16 hours and then subsided.
About 15 minutes after the injection I began to feel some tightness and pain in my chest.  About 30 minutes to an hour after the injection I started having really bad chest pains in the center to right portions of my chest, especially when taking a deep breath, which the tightness was making me feel like I needed to take in a some deeper breaths.  About 2 hours after the injection I went to the ER because the pain in my chest was becoming more severe, and when I stood up from my desk I began to feel light headed.
PAIN IN MOUTH WENT AWAY AND AFTER 2 WEEKS HAS STILL NOT COME BACK; This spontaneous report received from a patient via a company representative concerned a male 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, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced pain in mouth went away and after 2 weeks has still not come back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain in mouth went away and after 2 weeks has still not come back was not reported. This report was non-serious.
brown in color injection site; red in color injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (brown in color injection site) and VACCINATION SITE ERYTHEMA (red in color injection site) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MORNIFLUMATE (FLOMAX [MORNIFLUMATE]) and FINASTERIDE (PROSCAR) for Urinary tract disorder.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE DISCOLOURATION (brown in color injection site) and VACCINATION SITE ERYTHEMA (red in color injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (brown in color injection site) and VACCINATION SITE ERYTHEMA (red in color injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications Flomax, Proscar. Treatment information was not provided.
Fever 102 F next day, lymph node on left arm pit (same arm as shot was given) swelled up about the size of a golf ball and lasted a week.
pt recv vax & devel lumps @ the inj site 2 to 3 wk p/vax;the lumps needed to be drained several times;the resulting fluid was clear in color;
Sore arm day after; ached all over; Shivers (cold and hot) felt like a fever; This is a spontaneous report from a contactable consumer (patient). A 87-year-old non pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch /Lot Number: EL3249), via an unspecified route of administration, administered in Arm Right on 02Feb2021(at the age of 87-years-old) as dose 2 single for covid-19 immunization. Medical history included myocardial infarction, lung neoplasm malignant, hypersensitivity from an un-known date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot Number: EL3249) via an unspecified route of administration, administered in Arm left on 19Jan2021 as single dose for covid-19 immunization. On 10Feb2021, the patient experienced sore arm day after, ached all over, shivers (cold and hot) felt like a fever. The patient did not receive any treatment for the events. The outcome of sore arm day after, ached all over, shivers (cold and hot) felt like a fever was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Information has been received from a physician concerning a 2 month old male who was vaccinated although "it may be a charting error." Subsequently, at 5 months of age, a titer revealed a lack of seroconversion to MMR. The pt sought unspecified medical treatment. Additional information has been requested.
bowels have been acting differently and  are off.; some stomach irregularities/his bowels have been acting differently; This spontaneous case was reported by a consumer and describes the occurrence of INTESTINAL OBSTRUCTION (bowels have been acting differently and  are off.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTESTINAL OBSTRUCTION (bowels have been acting differently and  are off.) (seriousness criterion medically significant) and ABDOMINAL DISCOMFORT (some stomach irregularities/his bowels have been acting differently). At the time of the report, INTESTINAL OBSTRUCTION (bowels have been acting differently and  are off.) and ABDOMINAL DISCOMFORT (some stomach irregularities/his bowels have been acting differently) outcome was unknown.            No concomitant medication was mentioned.  Reporter stated that patient received the 3rd full Moderna covid-19 dose three weeks ago and since receiving the injection her husband has been experiencing some stomach irregularities and stated his bowels have been acting differently and were off.  No treatment medication was mentioned.  Company comment- This case concerns a unknown age male patient with no medical history provided, who experienced the unexpected  serious adverse event of Intestinal obstruction (seriousness criterion medically significant) and the non serious event of Abdominal discomfort. The patient received the third dose of mRNA-1273 (Moderna COVID-19 Vaccine) on an uknown date. According to her husband, three weeks later he started to experienced Intestinal obstruction and Abdominal discomfort.The rechallenge was unknown as there's no information available about the first or second dose. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a unknown age male patient with no medical history provided, who experienced the unexpected  serious adverse event of Intestinal obstruction (seriousness criterion medically significant) and the non serious event of Abdominal discomfort. The patient received the third dose of mRNA-1273 (Moderna COVID-19 Vaccine) on an uknown date. According to her husband, three weeks later he started to experienced Intestinal obstruction and Abdominal discomfort.The rechallenge was unknown as there's no information available about the first or second dose. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Expired Bexsero administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB28AA, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th July 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 4th July 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:13-JUL-2022 Reporter's Comments:  The Registered Nurse (RN) reported that, the patient administered expired dose of Bexsero. The reporter consented to follow up. Additional Supportive Information: The patient received expired dose of Bexsero, which led to expired vaccine used. The case had been linked with US2022106151 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022106151:same reporter, patient 1
30 minutes post vaccine, pt started experiencing tongue and throat  feeling "thick", after a couple more minutes pt was having difficulty speaking and reporting difficulty breathing. Epi Pen (0.3) was administered, 911 called. EMTs arrived within 5 minutes and additional epinephrine was administered along with Benadryl. Pt was transported to ER and released about 4 hours later in stable condition.
Severe immune system reaction, starting slow and continuing to get worse, requiring Prednisone treatment. 01/21/2019: Shingrix vaccination #1. Lot # N79Z5 01/22/2019 ? 01/23/2019: Significant fatigue and body aches for 2 days. Feb/March/April 2019: Low energy & fatigue continuing to get worse. 05/08/2019: Shingrix vaccination #2: Lot # F3D7H 05/09/2019 ? 5/10/19: Severe fatigue, body aches, fever, chills and sweats for 2 days 05/13/2019: Colitis symptoms, blood in stool, fatigue. May/June/July 2019: Colitis symptoms continuing to worsen, blood in stool, pain, fatigue. 08/06/19: Begin Prednisone treatment. 09/15/2019: Pulmonary embolisms - due to Colitis inflammation.
expired dose of Menactra was inadvertently administered to a patient, no adverse event; Initial information was received on 19-May-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves an 18 year old male patient who was administered an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] inadvertently (Expired product administered)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 19-May-2020, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6204AA, expiry date 08-May-2020) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.
Information has been received from the nurse referring to a 15 year old male patient with asthma and none drug allergies. The patient's medical history included acne. The reporter reported the patient was inadvertently administered a total of 5 doses of GARDASIL. The first dose (lot and expiration unspecified) was administered on 01-AUG-2011. The second and third doses (lot and expiration unspecified) were administered on unspecified dates. The fourth dose (lot/expiration unspecified) was administered on 21-OCT-2014. The fifth dose (lot K006960, expiration 19-FEB-2017) was administered on 24-FEB-2015. There was no concomitant medications. On an unspecified date between the fourth and fifth dose, patient developed scalp itching, which was ongoing at the reporting time. The patient did not seek medical attention. None lab was performed and no treatment was given. The outcome of the scalp itching was reported as not recovered. Additional information has been requested.
pt recv vax;17dec95 devel a morbilliform rash which was generalized & most pronounced on cheeks & rt anterior thigh; nurse felt that rash related to vax;
This spontaneous report as received from a pharmacy technician concerning a currently 25 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 25-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J005416; expiration date: 02-MAY-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
The patient,  who was a pharmacist, developed fatigue and shortness of breath hours after receiving vaccine.  Two days later, on 01/28/2021, the patient went to local urgent care for worsening shortness of breath and was referred to Hospital for worsening dyspnea and hypoxia.  The patient was admitted to the hospital   We was found to have bilateral pulmonary infiltrates and treated for pneumonia with Rocephin and azithromycin.  He was tested for COVID-19 multiple times, but each of the results were negative.  Despite the negative results, there was high clinical suspicion for COVID-19 and the patient was started on Remdesivir and Decadron.  The  patient's oxygen requirements continued to worsen and the patient was transferred to another facility for higher level of care.  There  his hypoxia worsened and he required mechanical ventilation.  Patient then developed hypotension and required vasopressors for blood pressure support.  Furthermore, patient developed acute renal failure requiring hemodialysis.  Despite mechanical ventilation with FiO2 100%, and for vasopressors, patient clinically deteriorated and family decided to palliatively extubate on 02/05/2021.
PT WAS ON SCHEDULE TO RECEIVE THE PFIZER BIVALENT INJECTION TODAY;  NOT KNOW THAT THE AGE GROUP OF 5-11 ARE ONLY SUPPOSED TO RECEIVE 3SHOTS, STAFF GAVE HER A 4TH COVID INJECTION. STAFF MONITORED PT FOR 30MINS TO MAKE SURE SHE HAD NO ADVERSE REACTIONS OR SIDE EFFECTS.
Hands Feeling Numb; Itching all over body; Feet Feeling Numb; Hands would Tingle; Initial Report Received on 31-Mar-2021  A 38-year old female certified pharmacy technician (race and ethnicity not provided) reported that she received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and developed itching all over her body, but mostly in her hands and feet, feeling numbness in her hands and feet, and tingling in her hands.  No relevant medical history or drug allergies were reported.    No relevant concomitant medications were reported.    On 23-Feb-2021, the patient received the first dose of HEPLISAV-B (Lot # 033093, expiration date 11-Apr-2021 and NDC # not reported) to the left deltoid. The patient reported no adverse reactions to this dose.   On 30-Mar-2021 at around 1100, 36 days after having been vaccinated with HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot # 934600, expiration date 28-Feb-2022, NDC # not reported and serial number 334287615870) to left deltoid. At about 1930 the same night, the patient started having itching all over her body. While she was sleeping, she woke up about three times with her hands and feet feeling numb and reported that her hands would tingle. The patient reported that she does not have a rash, and while she stated that the itching was all over her body, it was mostly in her hands and feet.   At the time of the report, she had no further complaints of numbness since waking up that day. Her doctor advised her to take Claritin (loratadine) 10 mg and Benadryl (diphenhydramine) 25 mg three times daily as needed for itching.   No additional information was reported.   Company Comment:  The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Pain in the armpit; This spontaneous case was received on 22-Oct-2021 from other healthcare professional (nurse) via the Regulatory Authority (reference number: SEQW21-04427) and concerned a 29-year-old, female patient.  The patient's medical history was not reported, and she had no allergies. The patient was not taking any concomitant medications.  On 20-Oct-2021, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was P100354286 and expiry date was 15-Jun-2022.  On the same day, after receiving Afluria Quadrivalent, the patient experienced pain in the armpit. The corrective treatment included ibuprofen.  At the time of initial reporting on 22-Oct-2021, the patient had not recovered from the event as armpit continued to become sorer.  The reporter did not provide a causality assessment.  The reporter assessed the event as non-serious.  Company comment: A 29-year-old patient was vaccinated with Afluria Quadrivalent. On the same day, after receiving Afluria Quadrivalent, the patient experienced pain in the armpit. Causal role of the suspect vaccine is assessed as possibly related, considering plausible time relationship.; Sender's Comments: A 29-year-old patient was vaccinated with Afluria Quadrivalent. On the same day, after receiving Afluria Quadrivalent, the patient experienced pain in the armpit. Causal role of the suspect vaccine is assessed as possibly related, considering plausible time relationship.
Patient received IPOL in office on 5/12/2020 and the vaccine that was given had expired on 4/26/2020.  This was the patient's 2nd of three dose series of IPOL ( Alternative schedule ).  Patient had no negative symptoms after receiving the vaccine.  Mom was contacted to let her child received expired vaccine.  When mom returns for 6 month booster, Dr would like to do a titer to assure that child is protected.
11pm that evening I woke up with nausea, fever and aches all over. I took Tylenol and fever did not go down. Didn't sleep well that night and next day very nauseas, with fever of over 101 and could not keep Tylenol down due to nausea. Slept all day on 2/4/21 and woke up around 6pm feeling a little better. Still with fever, took Tylenol and fluid. Fever finally broke late that evening. Felt exhausted next two days due to dehydration. Blood pressure low due to dehydration for next two days.
On 9-20-2012 at about 5:20pm, I received a ZOSTAVAX (shingles) vaccine at pharmacy by the pharmacist. Within 5 minutes, I felt like my heart was beating fast and I felt my bronchial tubes get tickly (asthma like). Also I had a rash at site of shot. The next day it was big as a fist. I still have a red mark and I had to go to the doctor on 9-25-12 for persistent rash (red mark) and asthma symptoms.
Vaccines (polio, haemophilus influenzae B, and hepatitis B) given at 1515 on 04/02/05. According to nursing notes, the patient became "very upset" and held his breath.  The patient was stimulated by mom and received O2 by blow-by.  SpO2 was in the 50s and heart rate was in the 80s.  The patient's vital signs returned to normal after about 20-30 seconds of O2 blow-by.
Large local reaction, including 3cm area of induration with mild surrounding erythema.  Tender to palpatation.
Chills, low-grade fever, swelling and redness at site.  Aching feeling all-over body.
Since 6 hours after the j&j vaccine, I have had a low grade headache every day that turns into a full blown headache/migraine every couple days. It feels like a constant pressure/squeezing in my head and I can feel my heart beat in my head at all times. It feels worse sitting/sitting up and better lying down on my side. When I get up in the morning it is a bit better and gradually gets worse as the day goes on. I have tried taking allergy/sinus medicine in case it was related to allergies (which i have never had) or a sinus infection but that doesn?t seem to work. I have also tried Maxalt when the headache turns bad but that doesn?t seem to work much, if at all. The only thing that seems to work is advil however I can?t take that forever since it could lead to stomach issues, etc. I am good at hydrating so that is not the issue and I eat and exercise regularly. Nothing has changed in my health/health routine since receiving the vaccine.
pt recv vax 18FEB97 & devel swollen joints, flu like sx, aches & pains, nausea & vomiting, severe abd cramps, erythema mult rash;seen in allergists to determine whether cont w/course of vax;
Received PNEUMOVAX-noticed redness next day edema with redness increased to 5 inches induration acquired cellulitis.
UNABLE TO FEEL LEFT SIDE OF BODY; SEVERE HEADACHE; SEVERE NAUSEA; This spontaneous report received from a patient via social media 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 on an unspecified anatomical site for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, in APR-2021, the patient was unable to feel the left side of her body and had severe headaches and nausea and the patient was hospitalized for 5 days within a period of 3 weeks post receiving vaccine. It was also reported that the events had not gone away at the time of the report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unable to feel left side of body, severe headache, and severe nausea. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:-Covid-19 vaccine ad26.cov2.s-Unable to feel the left side of body . This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. -Covid-19 vaccine ad26.cov2.s-Severe headache, Severe nausea. These events are labeled per RSI and is therefore considered potentially related.