chrisvoncsefalvay/vaers-outcomes huggingface dataset:
THE DAY OF I WAS OKAY THE NEXT DAY I WAS TIRED AND THE NEXT COUPLE OF DAYS I WAS REALLY TIRED AND HAD HEADACHES AND THEN ON 10/02 I WENT TO THE CLINIC AND THEY GAVE ME STEROIDS AND COUPLE OF OTHER MEDICATION FOR MY PAIN. I TOOK THE MEDCICINES AND IT DID NOT GOT BETTER AND THEN I WENT TO THE ENT AND THEY ORDERED A MRI FOR MY BRAIN AND GAVE MY MTRIX FOR MY HEADACHE AND THEN THE NEXT DAY I WANT TO THE EMERGENCY ROOM AND THEY GAVE ME A COUPLE OF MEDICINES.
Patient listed above presented with II classic varicella lesions 10 days after being in house with cousin.  Cousin had 20-30 varicelle lesions plus low grade temp 7 days after he received varivax.  This is reportedly a quite rare event post-varicella vaccination.
Has had initial J&J vax plus J&J booster, tested positive for covid on binax rapid antigen test 1/21/2022.
severe flu symtoms,sore arm, fever ,headache,body aches, fever and sweating at night and  now coughing
This 6 month old alert, active playful male was referred on 21 February 2006 for reported hives/urticaria following childhood vaccinations on 20 January 2006. Mom reported her son had been being treated for an ear infection with amoxicillin for 10 days prior to receiving his 4 month immunizations of Prevnar #2, Pediarix #2, and Pedvax #2 on 20 Jan 2006 @ 1400. She denies any adverse events with inital vaccinations on 12 Oct 2005. On 21 Jan 2006 approximately 18-20 hours post vaccination she noted a circular red patch to the top of her son's right leg (vaccine site for unknown vac) with a second patch behind his left ear. Each approximately 1/2 dollar size with a white center. His fever was 103.8. She contacted clinic and they could not see until 1800.  By 10:30am the rash was gone and his fever was down with use of Tylenol. By 12:00 noon, his face was swollen, red, with his eyes swollen shut. There were multiple "hives" to his face. Mom stated there was NO respiratory distress, dietary problems, and was easily consolable.  He was taken to (ER). Following evaluation by MD and normal lab values he was diagnosed with a probable viral illness and the hives were "not from the immunizations".  She followed up with her pediatrician Monday 1/23/06 and was advised the urticaria was a vaccine reaction. She continued to administer tylenol for fevers and benadryl for hives for 3-4 days noting when the Benadryl wore off the hives returned.The child was given a referral to Allergy and Immunology for 2/21/06 where he no longer experiences hives. Mother requests to know which vaccine caused the reaction.      PMH: - Diet: he was 100% breast feed but was being weaned to formula and solids since 2/10/2006.  Each food group change was done individually and for 3-4 days before introducing another change in diet. He had not begun changes in diet when hives/urticaria developed post vaccination.  -Birth: C-section delivery full term healthy child (past c-sections). No complications. -Treated prophylatically in December 2005 for RAD with albuterol unit dose inhaler for 4 weeks as strong maternal/paternal/2 brothers and one sister w/asthma and allergic to penicillin. No family or personal hx of skin disorders. Allergies: none known Medications: none Environmental: no cats/dog/animals, carpets in 2 rooms, not in bedroom, no smoking.
Information has been received from a female consumer who was vaccinated with GARDASIL vaccine (yeast). Subsequently the patient reported she experienced a reaction (not specified). No further details were provided. Additional  information has been requested.
Client received Moderna Covid vaccine at 21:30. Reported and noted with twitching of LUE at 21:45. Placed in enhanced supervision with clinical team. VS 140/80, HR 88, 98% RA. At 21:55 client began to have seizures. EMS called. Oxygen at 4L nasal cannula placed on patient. Positioned on floor for safety. Client left with EMS at 10:19pm. Alert/oriented x 4. Blood glucose 132. In stable condition.
peripheral neuropathy after the shot; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (peripheral neuropathy after the shot) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced NEUROPATHY PERIPHERAL (peripheral neuropathy after the shot) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (peripheral neuropathy after the shot) had not resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected serious (medically significant) event of neuropathy peripheral. The event occurred after a dose of mRNA-1273.222 vaccine. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, event was not resolved. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.    Reporter did not allow further contact; Reporter's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected serious (medically significant) event of neuropathy peripheral. The event occurred after a dose of mRNA-1273.222 vaccine. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, event was not resolved. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.
pt reports that on the noc of 24OCT96 when laid on rt side that shoulder hurt;then the next day rt elbow was red & swollen;went to MD who prescribed ATB & ice packs;by the next day arm did not hurt & red & swelling resolved;
18JAN2023 I could not stop coughing and I was feeling achy and flu like symptoms, I had no temperature or fever. I had head congestion, chest pains when I would cough, coughing became worse especially when laying down. I went to the local clinic and was tested for COVID-19 an influenza both were negative. I was wheezing so the nurse prescribed cough medicine and to follow up with my PCP, with the stormy weather it was February 2023 before I saw my PCP. I was still coughing, wheezing and I was diagnosed with sinus and ear infections once I saw my PCP. I was tested for COVID-19 and bronchitis both were negative. This lasted for three or four weeks total.
have shingles, but have the 2 shots already/suspected vaccination failure; shingles; nerves damage on my legs/pain, most painful thing; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 23-May-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient self-reported this case. The patient had already received 2 shots and had shingles a year ago and felt some nerves damage on his/her leg.  The patient stated that this pain was the most painful thing that he/she have had ever. The patient stated that every one 50 and older such have that. Additional Supportive Information: This case was considered as suspected vaccination failure, since the details regarding the time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available. Note: As it was reported that patient already received 2 shots therefore 2 suspect was coded.
3" x 2" red sl. swollen area approx. 2 1/1 below injection site.
Patient developed lymphadenopathy in left axillary lymph node; administered flu shot at the same time as the COVID-19 bivalent booster vaccine; administered flu shot at the same time as the COVID-19 bivalent booster vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but unknown manufacturer.), for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Patient developed lymphadenopathy in left axillary lymph node"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "administered flu shot at the same time as the COVID-19 bivalent booster vaccine".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
pain in the body; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in the body), PYREXIA (fever) and CHILLS (chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MYALGIA (pain in the body), PYREXIA (fever) and CHILLS (chills). At the time of the report, MYALGIA (pain in the body), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
PATIENT BEGAN TO EXPERIENCE A SENSATION OF THROAT TIGTHNESS AND WARM FEELING. SHE DENIES CHEST PAIN OR SHORTNESS OF BREATH INTIALLY, BUT ABOUT 10 MINUTES LATER FELT A SLIGHT STERNAL CHEST PRESSURE. PATIENT WAS ASSISTED TO LAY DOWN IN THE FACILITY CLINIC ROOM AND ASSISTED BY THIS WRITER TO EXAM TABLE. B/P; 132/82. HR;78. R-22. O2 SAT; 98%. PATIENT IN NO ACUTE DISTRESS. 911 WAS CALLED DUE TO UNRESOLVED SYMPTOMS. SHE WAS TRANSFERRED TO LOCAL HOSPITAL VIA AMBULANCE.
within 48hr of second moderna vaccine, patient developed large supraclavicular swelling on right side of neck (same side as vaccine). is mildly tender to touch. no redness, erythema
Rash covering from neck; Rash covering neck to buttocks; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 15:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient had no medical and past drug history. Concomitant medications included rosuvastatin calcium (CRESTOR) 40mg.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 21Apr2021 at 09:00 the patient experienced rash covering from neck to buttocks. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse event and included treatment with steroids(MANUFACTURER UNKNOWN) . On 03May2021, the patient underwent PCR test (nasal swab) and the result was negative. The clinical outcome of the event rash covering from neck to buttocks was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
(L) upper arm: some edema, erythematous measuring approx. 8x10 cm. No c/o itching. Tx applied ice pack.
04 NOV 05: Patient presented 3 weeks s/p smallpox immunization with c/o generalized rash over face/trunk/extremeties; positive odynophagia; no fevers/chills/nausea/vomiting/diarrhea/photophobia.  No history of excema/seborrhea. Diagnosed with generalized smallpox vaccination reaction (self-limited).  Prescribed Prednisone.
Ate 30 minutes after the administration of Vaxchora; Spontaneous report received on 12NOV2020.  A physician reported that a female consumer "ate 30 minutes after the administration of Vaxchora" (PT: Product administration error). She was receiving Vaxchora for immunisation. It was reported that the consumer ate 30 minutes after the administration of Vaxchora. Action taken with Vaxchora with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: It was  reported that a consumer has eaten 30 minutes after the administration of Vaxchora (product administration error). Consumer should avoid eating or drinking for 60 minutes before and after oral ingestion of Vaxchora, and the causality of product administration error is assessed as not applicable with Vaxchora.; Sender's Comments: It was  reported that a consumer has eaten 30 minutes after the administration of Vaxchora (product administration error). Consumer should avoid eating or drinking for 60 minutes before and after oral ingestion of Vaxchora, and the causality of product administration error is assessed as not applicable with Vaxchora.
ITT low grade; A spontaneous report  was received from a consumer, concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Immune Thrombocytopenic Purpura (ITP) low grade wherein her platelet count was 81.  The patient's medical history was not provided. concomitant product use was not provided by the reporter.  On 16 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route for the prophylaxis of COVID-19 infection.  Over a month later the patient reported to have ITT low grade (Immune thrombocytopenic) where in her platelet count was 81. No treatment medication was reported. This event considered medically significant.  Action taken with the mRNA-1273 in response to the event was not applicable.  The outcome of the event was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
gave a booster dose from a vile that had been started the previous day; 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 EXPIRED PRODUCT ADMINISTERED (gave a booster dose from a vile that had been started the previous day) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave a booster dose from a vile that had been started the previous day). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave a booster dose from a vile that had been started the previous day) had resolved. Concomitant medications was not provided by the reporter.The previous day, vial had been refrigerated the whole time. Treatment information was not provided.
tested positive for Covid 19; tested positive for Covid 19; This is a spontaneous report from a contactable nurse via the sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the 1st dose of the Pfizer Covid vaccine in Jan2021, tested positive for Covid 19 on an unspecified date, and subsequently received convalescent therapy. It was mentioned that the patient received the first dose of the Covid-19 Vaccine in Jan2021 and shortly after tested positive for Covid and also had a antibody test done as well. It has been over 90 days since the first dose and they are wondering if the patient can get the second dose now. The reporting nurse clarified that she wanted to know if the patient can either get the second dose or if they need to restart the vaccine series. The patient was only 3 weeks past the 90 days and was really anxious to get the vaccine. The outcome of the events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 59 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Dry Eyes" (unspecified if ongoing); "Pork allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300146024 Same patient, different drug, different event;
Site: Itching at Injection Site-Mild, Systemic: Lymph Node Swelling-Mild, Additional Details: experienced change in bowel movement, getting diarrhea
Patient was given Varicella vaccine on 08/02/2010 in right arm SQ. Same day a few house later started having swelling, redness, warm to touch and pain around injection site. Swelling from 1.5 to 2.5 inches, complaining very itchy, muscle aches, and blister like area over top of skin. Plan of treatment to area was Keflex 500 mg take by mouth tid x 10 days.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mild
Patient developed itching on his back 3 days after receiving the vaccine;  1 day later, he developed swelling + 3 lesions on his right jaw;  1 day later he developed swelling in the left face + eye + ear- all now resolving.
injection site pain; was able to tell if full dose was received or a partial dose / received an under dose; liquid from Shingrix dose in syringe ran down arm; liquid from Shingrix dose in syringe ran down arm; This case was reported by a consumer and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received on 25th September 2020, 0.5 ml Intramuscularly in left deltoid and the patient experienced injection site pain, nausea, feeling of warmth and fever, for the tolerability of 1st dose, refer case US2020238719 reported for same patient.).   On 1st December 2020, the patient received the 2nd dose of Shingrix. On 1st December 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: After receiving 2nd dose of Shingrix, the patient experienced injection site pain. The consumer reports the liquid from Shingrix dose in syringe ran down arm and the pharmacist or consumer was able to tell if full dose was received or a partial dose, which led to accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. The reporter reported that due to a faulty needle or loose syringe that caused a vaccination error. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020238719:Same reporter
pt recv vax & c/o feeling funny & exp very warm & hot feeling, shakiness, lethargy & nausea; BP 190/88, pulse was 80 & resp pattern was 12; pt was observed for over 2 hr, by which time exp resolved;
seen in office on 11MAY98 for ?cellulitis rt arm treated w/keflex;seen again on 14MAY98-arm much better keflex discount;
pt was brought to house on 7/30;MMR had been given on 7/27;papular vesicular rash 5-6 lesion on & cheek were noted;
Severe sinus pain and associated migraine headache: onset 11/09/21 @ 11AM. Chills, muscle twitches, lethargy, muscle  & joint pain as well
Breakthrough case admission after 3 vaccines Pfizer 3/2/21 lot# EN6202;  Pfizer 3/23/21 lot# ER2613;  Pfizer 9/29/21 Lot# FE3592;
Onset within an hour or so of administration of excruciating pain at the site of the injection, fever to 103, severe headache, but no erythema or swelling at the injection site.
1400 HR lt arm & finger dusky, hand grip weak, c/o puffy fingers-rings removed from hand; ice pack applies to arm; 1530 HR pt observed & released to class-arm feeling better & released to home;
SM got dyspnea with significant chest pain.  Still having ongoing sx's at this time.  Has been to ER.  ER did not perform D-dimer or rule out PE but did perform and report normal EKG.  SM still having  shortness of breath that increases with activity and is still being evaluated.
Right arm redness, swelling, firmness, raised area 1/2 inch below injection site