chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an office staff worker at a doctor's office via a field employee concerning unknown amount of patients who were vaccinated with improperly stored ZOSTAVAX (dose, route and lot number not provided). No adverse effect was reported at this time. Additional information has been requested.
Abnormal pregnancy. Chromosome abnormalities, fetal Hydrops and cystic hygroma
EXTREMELY HIGH FEVER. HIGHEST WAS 104.8. VERY LETHARGIC.
About 3 weeks after the vaccine I started having lower intestinal issues. I have elimination several times a day of unformed, fairly undigested food and mucus with some foul odor. I usually experience this within an hour of eating and have to eliminate several times to resolve. It has continued every day for 3-4 weeks now. I do not have an upset stomach, just spontaneous need to eliminate and some lower intestinal cramping and rumbling.
Severe full body rash including palms of hands and feet.  Extreme itching.  Some swelling around rash site.
This is a spontaneous report from a contactable consumer or other non hcp, Report 29 of 37. A 52-years-old male patient received second dose of bnt162b2 (BNT162B2) PFIZER-BIONTECH COVID-19 VACCINE, (Lot Number: EN5318 Expiration Date: 31May2021) via an unspecified route of administration on 05Feb2021 as Dose 2, single for covid-19 immunisation. Medical history included covid-19 from 28Nov2020 to an unknown date, History of Covid. The patient's concomitant medications were not reported. Historical vaccine included dose 1 (Lot: EL3249 expiration: unknown) via unspecified route of administration on 15Jan2021 as a single dose for COVID-19 immunisation. Reporter stated they are monitoring and tracking the vaccine breakthrough cases in their area and she had some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. The reporter at the time, did not have the NDC or expiration date, however, was going to work on pulling patient information so that she would be able to have this information available to provide upon transfer. Reporter stated that Covid positive is defined as having both vaccines and testing positive for Covid longer than two weeks after both doses. Testing positive for Covid virus, after both vaccines. On 06Aug2021, tested positive for Covid. Description of complaint: Caller reporting on the Pfizer Covid 19 vaccine. Outcome of the events was unknown.  The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN5318 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN5318, fill lot EN5317, and the formulated drug product lot EN5316. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root causes were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Sender's Comments: Linked Report(s): US-PFIZER INC-202101075254 Same reporter, drug, AE, different patients.
No adverse event. Patient received Tdap on 2/13/23 and again on 4/3/23 in error.
Low grade Malt B-cell lymphoma; Arm soreness; This spontaneous case was reported by a patient and describes the occurrence of EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE) (Low grade Malt B-cell lymphoma) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044321A and 0311321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety and Cholesterol. Concomitant products included SERTRALINE for Anxiety, ATORVASTATIN for Cholesterol.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). In June 2021, the patient experienced EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE) (Low grade Malt B-cell lymphoma) (seriousness criterion medically significant). On 04-May-2021, PAIN IN EXTREMITY (Arm soreness) had resolved. At the time of the report, EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE) (Low grade Malt B-cell lymphoma) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-2021, Mammogram: abnormal (abnormal) low grade Malt B-cell lymphoma. On 09-Jul-2021, Biopsy: abnormal (abnormal) low grade Malt B-cell lymphoma. On 28-Jul-2021, Positron emission tomogram: abnormal (abnormal) Abnormal.         The patient stated not experiencing any side effects after the first dose. The patient has not taken anything to help with the symptoms of arm soreness. The first week of June the patient found a lump just above the left breast. The patient went in the last week of June to see their health care provider for the lump. On 14-Jul-2021, the results of laboratory came back as low grade Malt B-cell lymphoma.   Action taken with mRNA-1273 in response to the event was Not Applicable  Company's comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  There is a short time between the administration of vaccine and the development of breast tumor. Unlikely, that the events are related to the vaccine. Very limited information has been provided at this time.  Further information is expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  There is a short time between the administration of vaccine and the development of breast tumor. Unlikely, that the events are related to the vaccine.Very limited information has been provided at this time.  Further information is expected.
Tinnitus  within 8 hrs of vaccination. No treatment. Too early for an outcome
She is like lost, she doesn't know anything, she don't, her memory is still lost; Headache; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (She is like lost, she doesn't know anything, she don't, her memory is still lost) and HEADACHE (Headache) in a 59-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AMNESIA (She is like lost, she doesn't know anything, she don't, her memory is still lost) and HEADACHE (Headache). At the time of the report, AMNESIA (She is like lost, she doesn't know anything, she don't, her memory is still lost) had not resolved and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medication was not provided.
Pt. was administered Tdap during routine PE 3/7. States he went home and arm was sore, red, and hot at injection site. Pt reports pain this morning in (L) arm only, is not able to work. Site feels hot to touch today, afebrile. Pt took TYLENOL last night and applied ice to site. Improvement in symptoms today.
As described by patient in DPH report: "On 12/2/12 I went to Pharmacy for a shingles injection (Zostavax), on 12/4/12 my right (injection site) had turned red and in pain. I went to my doctor that day and the doctor said I had an infection. He gave me an antibiotic (cephalexin) told me to take it for a week, if not healed to come back on 12/11/12. Today is 12/10/12 and I plan to go back to him tomorrow.  The infection has gotten better, but not gone."  PHYSICIAN UNABLE TO PROVIDE ME WITH ADDITIONAL INFORMATION.
soreness @ site of inj;nauseousness, lightheaded, numbness in lt arm, t101 & chills;pt went to bed, took advil for pain & fever;next day stiffness in lt arm;
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: patient confirmed didnt eat today and was dehydrated-Severe, Systemic: Hypotension-Severe, Additional Details: patient was up in front store by cash register and collapsed, employee notified another employee who notified another employee. got patient into a chair gave water, patient declined all help except almonds and water. patient refused medical treatment, refused to have emt or medics  called. will follow up with patinet in am
Temperature 103F (ax); measles type rash covering whole body; coryza and cough.
Mom noted rash on 12/27/02. Was seen on 12/28/02 and diagnosed with varicella. Zovirax prescribed.
Underneath my eyebrow is real puffy and the corner is puffy; Eyelids itching; Bottom of the eyelid itching and is progressed to swelling and it feels like sand paper in my eye; Bottom of the eyelid itching and is progressed to swelling and it feels like sand paper in my eye; it just started to run just a little bit; This spontaneous case was reported by a non-health professional and describes the occurrence of PERIORBITAL SWELLING (Underneath my eyebrow is real puffy and the corner is puffy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EW0158) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Acid reflux (esophageal) and Anxiety attack. Concurrent medical conditions included Blood pressure high and Acquired hypothyroidism. Concomitant products included CLONAZEPAM for Anxiety attack, METOPROLOL, AMLODIPINE and OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PERIORBITAL SWELLING (Underneath my eyebrow is real puffy and the corner is puffy) (seriousness criterion medically significant), EYELIDS PRURITUS (Eyelids itching), SWELLING OF EYELID (Bottom of the eyelid itching and is progressed to swelling and it feels like sand paper in my eye), OCULAR DISCOMFORT (Bottom of the eyelid itching and is progressed to swelling and it feels like sand paper in my eye) and LACRIMATION INCREASED (it just started to run just a little bit). At the time of the report, PERIORBITAL SWELLING (Underneath my eyebrow is real puffy and the corner is puffy), EYELIDS PRURITUS (Eyelids itching), SWELLING OF EYELID (Bottom of the eyelid itching and is progressed to swelling and it feels like sand paper in my eye), OCULAR DISCOMFORT (Bottom of the eyelid itching and is progressed to swelling and it feels like sand paper in my eye) and LACRIMATION INCREASED (it just started to run just a little bit) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received treatment with Biotrue eye drops.
Moderna COVID-19 Vaccine EUA. Chills for several hours, headache, fever, sweating, fatigue, swelling at the injection site, rash at the injection site, joint and muscle pain.
breasts started swelling and getting warm; nipples started itching; arm sore for days, hurt like the daylights; breasts uncomfortable heavy and sore; breasts uncomfortable heavy and sore; Fatigue; felt feverish but no actual; headache; Nausea/ experienced nausea early but it didn't last long; dry cough; Sore throat/ Sore throat stayed till weekend; pain radiated to shoulder ridge; had diarrhea off and on for two weeks; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (dry cough), OROPHARYNGEAL PAIN (Sore throat/ Sore throat stayed till weekend), PAIN (pain radiated to shoulder ridge), DIARRHOEA (had diarrhea off and on for two weeks) and BREAST SWELLING (breasts started swelling and getting warm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (dry cough), OROPHARYNGEAL PAIN (Sore throat/ Sore throat stayed till weekend), PAIN (pain radiated to shoulder ridge), DIARRHOEA (had diarrhea off and on for two weeks), BREAST SWELLING (breasts started swelling and getting warm), PRURITUS (nipples started itching), PAIN IN EXTREMITY (arm sore for days, hurt like the daylights), BREAST DISCOMFORT (breasts uncomfortable heavy and sore), BREAST PAIN (breasts uncomfortable heavy and sore), FATIGUE (Fatigue), PYREXIA (felt feverish but no actual), HEADACHE (headache) and NAUSEA (Nausea/ experienced nausea early but it didn't last long). At the time of the report, COUGH (dry cough), BREAST SWELLING (breasts started swelling and getting warm), PRURITUS (nipples started itching), PAIN IN EXTREMITY (arm sore for days, hurt like the daylights), BREAST DISCOMFORT (breasts uncomfortable heavy and sore), BREAST PAIN (breasts uncomfortable heavy and sore), FATIGUE (Fatigue), PYREXIA (felt feverish but no actual) and HEADACHE (headache) outcome was unknown and OROPHARYNGEAL PAIN (Sore throat/ Sore throat stayed till weekend), PAIN (pain radiated to shoulder ridge), DIARRHOEA (had diarrhea off and on for two weeks) and NAUSEA (Nausea/ experienced nausea early but it didn't last long) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were reported. No treatment details were reported.
Patient had redness and swelling at injection site when she was home. She also had symptoms of diarrhea, chills, fever, runny nose and still has that several days later.
On Wednesday January 6th, I started to have itching, swelling, and redness at the injection site. The injection site continued to swell and was warm/hard to the touch, with mild pain. I took Benadryl that night (Jan 6th). On the morning of January 7th, the swelling had gone down but redness and warmth at injection site was still present. I took Benadryl that night (Jan 7th) as well. Today, January 8th, the redness and warmth is still present.
mother began noticing a few welts a few hours post vaccination. Mom also noted local reaction in injection site. 4 hours post vaccination, pt was noted to have significant unilateral eyelid swelling. No coughing, SOB, emesis, diarrhea, or diffuse hives.  Benadryl subsequently alleviated pt's symptoms.
Patient felt dizzness and giddiness . Onsite EMS was called vitals were taken BP 140/96  92% O2 room air HR 90. Patient refused evaluation/care. Left aginst medical advice.
maybe or maybe not related: Elevated Blood Sugar 3 hrs post IM influenza pt reports "I felt like I was crashing". Pt had breakfast and 10 units of humalog earlier. She started to experience blurred vision and shakiness. Pt took blood glucose Reading and it was 275. She reports never has blood glucose that high so she repeated and was 276. Pt took 10 more units of Humalin and ate lunch. Symptoms resolved that evening and got a blood sugar of 94. The only thing different from her normal routine was the vaccination. She believes that it is somehow related to this event.
Approximately 7 minutes after vaccine administration, client was standing and his eyes started to roll and started to fall to his left. Mom of client was able to catch client, before he hit anything on the ground. Client was unconscious for about 1 minute. 911 was called for EMS. When he came to, he was slightly disoriented. Clients color was pale and he was sweaty and complained of being hot. Client began to improve. Clients breathing was stable to the entire time. Client was laying in mothers lap and began to become disoriented again, and started to loose color in his face and sweat again. At this time Epi Autoinjector was given. EMS arrived approximately 2 minutes after Epi given. Clients breathing remained stable.
Patient experienced hypotension, dizziness, and was diaphoretic. Staff on site provided hydration, checked vitals and blood sugar, elevated patient's legs and called EMS. EMS arrived on site, patient's blood pressure stabilized, and patient was not transported to the ER.
30mins past vaccination-patient c/o itchy throat able to swallow, but cleaning throat felt getting worse-same sxs with previous  anaphylaxislofish (dietary)
Information has been received from a consumer, a 25 year old female patient with high blood pressure, who on 30-MAR-2007 was vaccinated orally with the first dose, 0.5ml, of Gardasil. There was no concomitant medication. On 31-MAR-2007 the patient reported that she had experienced tingling in her hands and feet after the vaccine was administered. At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.  6/25/07 Received office note from reporter which reveals patient called office on 4/16 to report having been seen in ER for complaints of body aches.  Tx w/anti inflammatory meds & felling well now.  Refused further HPV vaccine. FINAL DX: Adverse reaction to HPV vaccine.
Tight chest on the way home from the Pharmacy. I did NOT wheeze though. I gave myself a Nebulizer Tx  with Albuterol Solution after I got home. The Nebulizer Tx was effective.
Tenderness at injection site. loss of energy in legs ,shaking chills Took an antihistamine pill
Initial report was received from a nurse on 23 Dec 2009: This patient had received a S-OIV FLUVIRIN intramuscular and a dose of intranasal H1N1 vaccine on 22 Dec 2009. No adverse events were reported.
Patient pregnancy unbeknownst to provider when vaccine administered. Patient didn't divulge pregnancy test at home. Was positive one month prior.
headache, shortness of breath, back pain, nausea, vomiting, hair loss, myalgia
Case number PHHY2011US55142 is an initial spontaneous report received from a consumer on 21 Jun 2011 with a follow up report from consumer received on 12 Jul 2011. This report refers to an 18 years old male patient. His medical history included unspecified allergies. He was given only the Men A lyophilized conjugate component of MENVEO (batch number A10031) 0.5 ml, intramuscularly in the left deltoid on 16 Jun 2011 which was reconstituted with sterile water instead of Men CYW-135 liquid conjugate component. No adverse reaction was reported following this drug administration error. Follow up information received on 12 Jul 2011: Patient demographics, medical history and vaccination details were updated.
This spontaneous report as received from a physician refers to a child of unknown age and gender. No medical history was provided. On an unknown date the patient was vaccinated with ROTATEQ 9oral). No concomitant medications were provided. In 1988 ("25 years ago") the child patient developed intussusception. The physician considered this a "bad experience" with ROTATEQ and did not want his statement to become an adverse event report. The outcome of intussusception is unknown. Additional information is not expected.
patient hadn't received the 2nd dose of Shingrix on time; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th Oct 2020).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 04-JAN-2022 Reporters comment: The pharmacist reported that patient did received the 2nd dose of Shingrix on time. First dose was received on 4th October 2020, and since then the scheme was not completed  The reporter consent to follow up  Details reported for 1st dose. Additional Supportive information: The patient received the first dose on 04th OCT 2020 and did not receive the second dose which led to incomplete course of vaccination; Sender's Comments:  US-GSK-US2023000767:Same reporter
other zoster-related conditions; shingles; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to a currently 77-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In or about 2017, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the patient was treated by the physician for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster-related conditions. The outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
is depression/anxiety reported as a side effect post vaccine?; is depression/anxiety reported as a side effect post vaccine?; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (is depression/anxiety reported as a side effect post vaccine?) and ANXIETY (is depression/anxiety reported as a side effect post vaccine?) 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 DEPRESSION (is depression/anxiety reported as a side effect post vaccine?) and ANXIETY (is depression/anxiety reported as a side effect post vaccine?). At the time of the report, DEPRESSION (is depression/anxiety reported as a side effect post vaccine?) and ANXIETY (is depression/anxiety reported as a side effect post vaccine?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and  treatment medications were provided.
Patient reported not feeling well immediatley post-vaccine and proceeded to slide off chair to floor and have seizure like activity for approximately 30-60 seconds.  Post-ictal confusion.  Vitals stable post seizure.
A red sploch appeared.about 3 days after on my neck and has yet to go away
This case was reported by a physician via call center representative and described the occurrence of throat swelling in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced throat swelling. On an unknown date, the outcome of the throat swelling was unknown. It was unknown if the reporter considered the throat swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient had a delayed reaction after receipt of the 1st dose of SHINGRIX which was characterized by throat swelling. The information collected via chat, only got gender from the healthcare professional he would not provide anything else and his office did not administer the first dose of SHINGRIX so had no vaccine information.