chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed practical nurse concerning a 65 year old female patient with hypertension, who on 31-JUL-2012 was vaccinated with PNUEMOVAX 23, intramuscular, (lot number reported as 1947AA, expiration date 20-OCT-2013). No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient experienced erythema and warmth from her neckline onto her chest and 3/4 the way down the arm that received the vaccination and the site got black. The nurse stated that on 03-AUG-2012, the patient was seen in the office and the patient was 75% better. The erythema was not as high up in the patient's arm anymore and there was a slight discoloration in the inner arm, but redness was disappearing. The patient was given BENADRYL and CLARITIN as treatment for the events. At the time of the report, the patient was recovering from the events. Additional information had been requested.
Started developing tongue numbness and tingling 48 hours after the immunizations which then progressed to a slight right facial droop consistent with Bell's palsy. She was started on Prednisone and Valtrex
Expired 3rd dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-370951 (Patient Link).
swelling; redness; Initial information was received on 10-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 5 years old male patient who experienced swelling and redness while receiving vaccine diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 08-Nov-2022, the patient received a dose 4 of suspect standard diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection once (lot C5969AD, expiry date - 17-Feb-2024) via unknown route at arm not otherwise specified for Immunization.  On an unknown date the patient developed non-serious event of swelling (vaccination site swelling), redness (vaccination site erythema) (unknown latency) following the administration of vaccine.  It was reported He has had swelling and redness on a large portion of his arm. he had no other vaccines that day. He has had no nausea or vomiting.   Action taken was not applicable.  The patient was treated with diphenhydramine hydrochloride (Benadryl [diphenhydramine hydrochloride]) for Vaccination site swelling and Vaccination site erythema.  At time of reporting, the outcome was Unknown for the events.
After the First vacine i take the COVID; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST POSITIVE (After the First vacine i take the COVID) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST POSITIVE (After the First vacine i take the COVID). At the time of the report, SARS-COV-2 ANTIBODY TEST POSITIVE (After the First vacine i take the COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
within 12 hrs all joints ache, took 2  extra strength tylenol, within 18 hrs sinus congestion, tinnitus severe to deafness in right ear, 24 hrs soar throat and sinus discharge of green mucus, tinnitus and deafness resolved.
Narrative:  He reports having developed 2-3 hours of nausea/diarrhea after the first vaccination. These adverse effects began about 2-3 hours after the vaccination. Both spontaneously resolved with rest. He denied other common adverse effects such as headache, fatigue, vomiting, abdominal cramping, and rash.
Patient received an expired dose of peds Pfizer vaccine. The vaccine had been drawn up on 11/18/21 at approximately 1554. It was administered on 11/19/21 at 1521.  Pfizer was contacted on 11/22/21 for recommendations but they were unable to provide any additional stability data outside of the 12 hrs. CDC guidance recommends revaccination as soon as possible. Patient's PCP was consulted and she also recommended revaccination as soon as possible. Patient's guardian was notified that the vaccine received on 11/19/21 is considered invalid and options were reviewed. Guardian decides to bring patient back in to restart the series on 12/3/21.
COLON INFLAMMATION; FEELING ABNORMAL/FEELS BLAH; FLU/FLU LIKE SYMPTOMS; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient via other manufacturer (AbbVie) concerned a 27 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease. The patient received 2 doses of covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 in total administered on 01-APR-2021, and dose was not reported, 1 in total administered on 01-SEP-2021 for prophylactic vaccination which was an off label use, and inappropriate schedule of vaccine administered. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  The patient received non-company suspect drug included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) (citrate free) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease. Concomitant medications included elasomeran (Moderna covid-19 vaccine) for prophylactic vaccination. On an unspecified date, the patient experienced entire colon was inflamed. The patient was in the hospital for four days and went to the emergency room. She found that her entire colon was inflamed. She had both COVID-19 vaccination. Second day felt like she had flu, and the third day feeling abnormal/felt blah. Flu shot caused flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s, and adalimumab was not reported. The outcome of the colon inflammation, feeling abnormal/feels blah, flu/flu like symptoms, off label use and inappropriate schedule of vaccine administered was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220362454. covid-19 vaccine ad26.cov2.s - colon inflammation. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE. (CROHN'S). Therefore, this event(s) is considered not related.
pt recv vax 17MAY96 & 20DEC96 pt devel more than 25 chicken pox lesions on chest, back & face, & a fever;presented to MD;tx w/DPH, APAP & Aveeno;reporter described the exp as a good case of chickenpox;
Immediate malaise - Headache-Eyes aches-Joints-Very ill-Pain-Red-swelling-Injection site  Next day-Rash below injection site-Gradually moved almost-to elbow-Bone in site injection-very sore-aching & painful
12 hours post vaccine, HA Fever Chills body aches , continued with symptoms into the next day
On day 8 post-vaccine, I developed lymphadenopathy (right axillae). It was very painful and I felt a big lump. On day 9 (post-vaccine) I developed nausea, general malaise, fatigue, general weakness, body aches, and other lymph nodes started to hurt (neck and right arm). These symptoms lasted for 1 month.
Redness at Injection SIte With Firmess and Heat; Redness at Injection SIte With Firmess and Heat; Does not have appetite; Drinking much water; Redness at Injection SIte With Firmess and Heat; Initial Report Received on 11-Jul-2019  A male patient (age not disclosed, race not provided), was administered with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and developed redness at injection site with firmness and heat; he also "does not have appetite and is drinking much water."  Relevant medical history was not provided (not disclosed). Allergies included horse serum and Lipitor (atorvastatin).  Concomitant medications included pioglitazone, vitamin C (ascorbic acid), Wellbutrin (bupropion), Crestor (rosuvastatin), glipizide, multivitamin, and Aspirin (acetylsalicylic acid).  On 09-Jul-2019, the patient received a dose of HEPLISAV-B in the left shoulder (lot #, expiration date, and NDC # not provided) and Pneumovax (pneumococcal vaccine) in the left shoulder (lot #, expiration date, and NDC # not provided).   On 11-Jul-2019, the patient reported that he developed a three-inch redness at the injection site with firmness and heat. He also stated that he does not have an appetite and was drinking much water. He also reported that these were new symptoms since Tuesday (09-Jul-2019). The patient had telephoned his health care provider (HCP) twice to inform them of his condition but with no return call.  On 11-Jul-2019, the patient was contacted to obtain further information after receiving the initial report from him earlier in the day and he sounded short of breath and weak. The patient stated he had heard back from his HCP but could not travel to their office due to the long distance and his wife had the car. The patient also stated he could not afford to go to the doctor. He was instructed to seek medical help if his condition worsened. The patient stated he had been sleeping, his condition sounded improved, and he verified that he was okay.   At the time of report, the outcome of redness at injection site with firmness and heat, and "does not have appetite and is drinking much water" was unknown.  The reporter did not provide a seriousness assessment for the events.   Company comment:  The company assessed the events of injection site induration, injection site warmth, injection site redness, decreased appetite, and polydipsia as non-serious. The events of injection site induration, injection site warmth, decreased appetite and polydipsia are unlisted and the event of injection site redness is listed per HEPLISAV-B.; Sender's Comments: The company assessed the events of injection site induration, injection site warmth, injection site redness, decreased appetite, and polydipsia as non-serious. The events of injection site induration, injection site warmth, decreased appetite and polydipsia are unlisted and the event of injection site redness is listed per HEPLISAV-B.
urticarial rash over bilateral upper and lower extremities, waistline, back and bilateral ears
doses administered after excursion; No adverse event; Prior to knowing that the vaccines underwent a temperature excursion in the freezer, patient received doses of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines underwent a temperature excursion in the freezer, patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 39-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines underwent a temperature excursion in the freezer, patient received doses of the vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines underwent a temperature excursion in the freezer, patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines underwent a temperature excursion in the freezer, patient received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    Concomitant medications details were not reported by the reporter.  Reportedly, Pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. the excursion was found out in an audit and all the vaccines were viable.  Treatment details were not reported by the reporter.
symptoms I had when I first got the first shot on 8/13/2021 felt pain in my arm and felt a little bit tired the next day I was very tired and fatigue. I was very anxious throughout the time I gotten getting it. Now today on 8/21/2021 I am getting a red itchy and swallon arm which under my skin not on the outside of it and suffering with anxiety along with it as well. I called up the Phamacry to see what they thought of it and they told me its normal.
very bad rash, I had it on all my torso, my arms and my thighs; hives/ welts; Itchy; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0202), intramuscular, administered in right arm on 16Jul2021 (at the age of 69 years old) as dose 1, single for COVID-19 immunisation. Medical history included pacemaker and right hip prosthesis. Concomitant medication included vitamins. On 27Jul2021, the patient woke up with hives, very bad rash. He had it on all of his torso, his arms and his thighs. He waited to see if it will go away and it did not go away and it was extremely itchy. So, he walked as he does not have a car, to a pharmacy and bought some Benadryl antihistamine and brought that back and took at part of the instruction and after about an hour, he had his rash finally started going away, while about 6 to 7 hours or so later, the rash came back and so, he took more Benadryl and then another 7 to 8 hours, the rash came back again. So, he took more Benadryl so this kept on about a day and a half with coming back over and over again and then he ran out of Benadryl. So, he walked back to the pharmacy and bought another big bottle and the rash continued. So, it was continuing for about one week gradually it had become not quite so bad but it still require the Benadryl and at that point, he considered going to the hospital that was in the area. The hospital said unless it was a true medical emergency, he should not come over and he had to be very very sick or they would not even look at him. So, he call a few hospital and they said no, do not go, if the Benadryl makes it go away, then just keep taking the Benadryl. He did not have the rash today. Since the last time he had it, he did not need to take the additional Benadryl and rash continued coming back and it was very bad, it was huge welts, "huge ostium" and everything. He said that he became eligible for 2nd dose on Friday (unspecified date). He further added that if the agent understand why he was nervous about getting the 2nd shot. He stated he does not have lab test, in fact, he has not seen a doctor in the last 6-7 months. The outcome of the event rash was not recovered while the outcome of the other events was unknown.   Follow-up attempts are completed. No further information is expected.
sore all over; Feeling tired; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore all over), FATIGUE (Feeling tired), CHILLS (chills) and HEADACHE (headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN (sore all over), FATIGUE (Feeling tired), CHILLS (chills) and HEADACHE (headache). On 16-Jan-2021, PAIN (sore all over), FATIGUE (Feeling tired), CHILLS (chills) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient mentioned she's wondering if that's ( reaction to the shot ) because she just got over having the virus about 8 days. She also mentioned My last quarantine day was 06Jan2021 and I had the shot on 14Jan2021. I read that you have to wait 90 days, but it's too late for me. Patient reported taking ibuprofen on 15Jan2021 and laid around to rest all day.
Pt seen for well visit 6/17/03, AM. Asymptomatic. Vaccines given. In afternoon developed fever and vomiting. One dose Tylenol given and fever resolved. Continued vomiting all day, that night, and still vomiting at follow-up 6/20/03. No diarrhea.
The usual listed on the paper given to me: redness on the arm, swelling at the injection site, muscle pain, tiredness, headache, shivering AND, one not listed was blurred vision for about 20 minutes upon waking in the a.m. as I was sweating at the time.
About a week later I had a pounding on my chest of heart palpitations and the same thing again with the second does vaccine on 3/17/2021 about a week later.  Lot # EP7534 Also, COVID Pfizer vaccine.
This spontaneous report was received from a pharmacist referring to a 18 year old male patient who on 04-APR-2014 and on 22-MAY-2014, was vaccinated with adult doses of RECOMBIVAX HB (lot #s not reported). No adverse effect had been observed or reported. Additional information has been requested.
Pt presented to walk-in COVID clinic to receive vaccine accompanied by her father. The provider administering the vaccine took the patient and her father back to the treatment room to administer the vaccine. Provider confirmed date of birth but did not identify that the patient was only 17 years old and did not meet the the requirement of 18 years old for the vaccine administered. Patient had no adverse events as a result of receiving this vaccination. The vaccination program contacted us and requested that we submit this event.
Chills, body aches, joint aches, headache. Treated extra strength Tylenol. Resolved within 24hrs
Pt reports that initially, immediately after the injection she had dizziness and hypotension.  She reports history of allergic reactions to injections and had her Epi Pen ready, but did not need to use it. They gave her water and a Tylenol at the vaccination site as well as a Claritin.  Pt denies rash , tongue swelling, or difficulty breathing.   Does not know what her BP was when they told her she had hypotension, but did not require ED treatment.    She recovered and was able to return home after an hour.
Appearance of small red spots began, continued into the following day, spreading to most of patient's body. Most spots looked like chicken pox, but some spread and became a larger contiguous rash. Determined to be viral exanthem on March 7th.
Vomiting of blood, treatment was rehydration and supportive.  Patient doesn't recall other treatment.  Time course was 1 week from start.  Patient has recovered.
Pt describes onset of edema (3") within 3 hours of vaccine administration. Also notes, pain and warmth at site. Took Benadryl and Tylenol, used compresses and ace wrap prn for 2 days, post vax. Edema is resolving; has bruising appearance with slow resolution of edema.
pt recvd vax; exp fever w/in 2 hrs of vax;acetaminophen given,generalized clonic activity noted by fam mbr w/in 1 hr from onset of fever w/ postictal somnolence afterwards;
Pale, felt faint, vomited. Lay down: 82/34 b/p with pulse 48, O2sat 98%,  after a few minutes, felt better, stood w/ bp of 97/60, pulse 91, left feeling well per pt.
shortness of breath; congestion; shooting pain in left leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (shooting pain in left leg), DYSPNOEA (shortness of breath) and NASAL CONGESTION (congestion) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (shooting pain in left leg), DYSPNOEA (shortness of breath) and NASAL CONGESTION (congestion). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (shooting pain in left leg), DYSPNOEA (shortness of breath) and NASAL CONGESTION (congestion) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) for Covid.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided
Severe intestinal irritability with U/S documented small bowel intussusception. 11/26/2007 MR received for several OV with ped surgeon and ped gastroenterology beginning 10/03/2007 to 11/08/07 operative report for ventral hernia repair.  Child presented to ped surgeon on 10/03/2007 with c/o significant diarrhea as well as blood in stool. Seen again 10/5/07 for irritability and abdominal pain. DX:  irritable bowel 2' disrupted bowel flora.  GI visit 10/18/07 with assessment: Constipation.  Milk Allergy.  Diarrhea.  Abdominal pain.  Ventral hernia. Ventral hernia repair on 11/08/07. 12/10/2007 Vaqx record received from PCP.  Corresponds with VAERS report.
Aggressive CIDP (Chronic Inflammatory Demyelinating Polyneuropathy)   This began late February 2021/Early March 2021.  Patient's condition deteriorated rapidly over a few months.
Fever, fatigue, and arm soreness next day. Cold sores on day 3.
Within 2-3 minutes of receiving injection, I became very hot, sweaty, and red and the blood was rushing through my veins. I asked one of the providers and she told me where the epi-pen was located but I didn't feel the need to use it. This continued for several minutes, then as we were moved to the observation area, I was lightheaded. For first 15 min of observation, the blood rushing lessened but I was still hot, red and sweaty. After second 15 min of observation, I had mostly cooled off. But over an hour after the injection my face was still somewhat flushed.