chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Moderna bivalent booster administered instead of monovalent primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna bivalent booster administered instead of monovalent primary series) and NO ADVERSE EVENT (No adverse event) in a 14-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna bivalent booster administered instead of monovalent primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna bivalent booster administered instead of monovalent primary series) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna bivalent booster administered instead of monovalent primary series).    Concomitant medication was not provided.  A pediatric patient inadvertently received Moderna COVID-19 bivalent booster shot prior to receiving any of primary series doses. Patient has not reported any adverse reactions to this dose.  Treatment information was not provided.
right middle cerebral artery stroke; Information has been received from a lawyer, regarding a case in litigation, and refers to a female patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions and concomitant therapies was provided. On or around 18-OCT-2010, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On approximately 28-OCT-2010, reported as approximately 10 days after receiving zoster vaccine live (ZOSTAVAX), the pt suffered a right middle cerebral artery stroke. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of right middle cerebral artery stroke was considered to be disabling.  Upon internal review, the event of right middle cerebral artery stroke was determined to be medically significant.
Pt to ED 9/4 unresponsive.  9/28 Pt noted to have productive cough, crackles noted, unable to expectorate phlegm, suctioning done as needed. Pt COVID+ 9/28, no anti-COVID rx needed. 9/29 Pt is on 4L NC; no respiratory difficulties noted. 10/2 pt lethergic, no sign of respiratory distress. 10/3 PT has copious secretions, extensive oral care and suctioning, patient has gag cough withdraws to pain. 10/5 Pt aox0, non verbal unresponsive, on 2L 02 NC , not in distress, no s/sx of pain noted. 10/6 RRT called due to low SpO2, Increased HR and RR. 10/7 pt discharged.
Left lower lid eye edema,itching and hives on body. Slight wheeze. Took  a 25mg Benadryl p.o. Used my Proventyl  inhaler. Relief within 30-45 minutes. NOTE; I had been to my beauty salon to have highlight treatments to my hair that day also. (2/02/21.)I have had this  reaction in the past after my salon treatment but not the hives before. I strongly feel this was related to the chemicals used on my hair but felt I needed to report it.
pt recv vax 15JUL97 & 16JUL97 pt devel a rash consisting of 3-4 vesicles on leg & arm &  a temp of 100;An ER or MD visit was required;pt recovered;
Patient had a sore left arm; injection site swollen; injection site itchy; injection site hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Patient had a sore left arm), VACCINATION SITE SWELLING (injection site swollen), VACCINATION SITE PRURITUS (injection site itchy) and VACCINATION SITE WARMTH (injection site hot to the touch) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Patient had a sore left arm), VACCINATION SITE SWELLING (injection site swollen), VACCINATION SITE PRURITUS (injection site itchy) and VACCINATION SITE WARMTH (injection site hot to the touch). At the time of the report, VACCINATION SITE PAIN (Patient had a sore left arm), VACCINATION SITE SWELLING (injection site swollen), VACCINATION SITE PRURITUS (injection site itchy) and VACCINATION SITE WARMTH (injection site hot to the touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-375119 (Patient Link).
Left arm  extreme deep bone pain.; Diarrhea; vomiting; Fatigue; Exhausation; This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old patient of an unspecified gender received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6207) via an unspecified route of administration in Arm Left on 03Apr2021(age at vaccination: 49 Years) as DOSE,2 SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination. Patient received other medications within 2 weeks of vaccination. Medical history included hyperthyroidism from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing. Patient had allergies. Patient didn't had covid-19 to post vaccination. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number EN6207) via unspecified route of administration in Arm left on unspecified date (age at vaccination: 49 Years) as DOSE 1, SINGLE for covid-19 immunisation. On Apr2021 the patient experienced left arm extreme deep bone pain, diarrhoea, vomiting, fatigue, exhaustion. No Therapeutic measures were taken for the events. Patient was not tested for covid to post vaccination. The outcome of the events bone pain, diarrhoea, vomiting, fatigue was recovered.  No follow-up attempts are possible. No further information is expected.
p/vax pt devel chickenpox which was dx by MD;pt devel approx 30 lesions all over body which were mildly itchy & did not sleep;
female with past medical history significant for multiple medication allergies presents to the emergency department for evaluation of possible medication reaction.  Patient was getting her 1st COVID vaccine and states she became nauseous, diaphoretic and had chills.  Patient denies facial or throat swelling, no shortness of breath and without any hives.  Patient was instructed to come to the ED for further evaluation.  Upon evaluation in the emergency department patient feeling better and without physical complaints.
Large red itchy rash at the injection site at the top of my arm.  2 1/2 inches wide, 4 inches long.  Started a week after injection. Ongoing, itchy as of today (1-28-21)
48 hours post vaccine c/o achy bones, achy muscles, temp 101.6 diarrhea 10/11/12. Refer to PCP.
Red blotches, slight tenderness at injection site on arm when awaking on day 9 following the vaccination.
pt recvd vax 20DEC95 & 26DEC95 pt c/o gen erythema on rt buttock, pruritic on 27DEC95 erythema spread down outer aspect of rt leg & c/o bruising @ inj site;pt dx w/cellulitis & placed on ATB
At the time of vax, the infant's father had a cold sore and the infant was breast fed by his mother, who had herpes simplex virus. On 05/17/99, the pt received vaxs. Later that same day, he developed papules ranging form 'eraser-head' size to 'pinpoint' over the trunk, neck and bilateral, proximal upper extremities. Physician attributed the rash to exposure to herpes simplex-1. The most recent information , received on 09/29/99 report the condition of pt is resolved.
Information has been received form a registered pharmacist that reported hearing second hand of a patient with undiagnosed leukemia who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Lot #, expire date and route not reported). Registered pharmacist stated that on unspecified date after being administered ZOSTAVAX, the patient developed shingles. Registered pharmacist mentioned that it was subsequently discovered that "this patient had diagnosed leukemia". It was unknown if the patient sought medical attention. At the time of the report, patient's outcome was unknown. Attempts are being made to verify the existence of an identifiable patient and reporter. Additional information has been requested.
Information has been received from a physician concerning a female child (age not provided) with asthma who was initially vaccinated (date not provided) with a dose of pneumococcal 23v polysaccharide vaccine (lot 651318/1006).  Subsequently the patient developed marked, painful redness and swelling at the site of injection.  The patient's outcome was not reported.  There was no product quality complaint involved.  The physician also provided information regarding another patient's experiences with pneumococcal 23v polysaccharide vaccine.  The lot check has been requested.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.  Additional information has been requested.
had swelling, erythema & warmth to lt thigh from knee to hip;no fever;no change in walking, does not bother pt;tx keflex & DPH;
Recently diagnosed with thrombocytopenia; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOCYTOPENIA (Recently diagnosed with thrombocytopenia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thrombocytosis (he had a history of elevated platelets).   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOCYTOPENIA (Recently diagnosed with thrombocytopenia) (seriousness criterion medically significant). The patient was treated with HYDROXYUREA ongoing since an unknown date for Thrombocytopenia, at an unspecified dose and frequency. At the time of the report, THROMBOCYTOPENIA (Recently diagnosed with thrombocytopenia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: normal (normal) blood counts are all normal.         Patient was recently diagnosed with thrombocytopenia, which he stated is not related to the vaccine because he had a history of elevated platelets. his physician had been advising him to go see a hematologist for about a year.  Concomitant medications were not provided by the reporter.  Company 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. Patient was recently diagnosed with thrombocytopenia which he stated is not related to the vaccine because he had a history of elevated platelets. Myelosuppression is a common side effects of the drug "HYDROXYUREA"  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. Patient was recently diagnosed with thrombocytopenia which he stated is not related to the vaccine because he had a history of elevated platelets.Myelosuppression is a common side effects of the drug "HYDROXYUREA"  Further information is expected..
At about 1 pm the following day of my  Moderma vaccine I had severe chest pain along with severe intestinal pain!! Almost went to the ER but I just curled up in a ball and they subsided in about 1/2 hour!! Never felt so sick! Also had chills and Diarrhea all day with a slight fever 100.4
Spike in BP, feeling of a lump in throat, pt feels hot and nauseous, 50 mg of generic Benadryl orally administered with water,  pt went by ambulance to the hospital
pt exp achiness in deltoid region & groin & had no energy p/vax (date unclear);10 days p/onset pt saw MD who dx polymyalgia rheumatica & prescribed pred;approx 1mo later seen by rheumatologist who slowly took pt off med;swollen hands, tired Annual follow-up received on 10/2/00 provided no additional data.
Severe flu-like symptoms; Kept having a lot of mucus/lot of mucus from their nostrils; Her husband and her both got sick; Arm was sore; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (Severe flu-like symptoms), RHINORRHOEA (Kept having a lot of mucus/lot of mucus from their nostrils), ILLNESS (Her husband and her both got sick) and VACCINATION SITE PAIN (Arm was sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 INFLUENZA LIKE ILLNESS (Severe flu-like symptoms), RHINORRHOEA (Kept having a lot of mucus/lot of mucus from their nostrils), ILLNESS (Her husband and her both got sick) and VACCINATION SITE PAIN (Arm was sore). At the time of the report, INFLUENZA LIKE ILLNESS (Severe flu-like symptoms), RHINORRHOEA (Kept having a lot of mucus/lot of mucus from their nostrils), ILLNESS (Her husband and her both got sick) and VACCINATION SITE PAIN (Arm was sore) outcome was unknown. Not Provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Reporter reported about the Pfizer COVID-19 vaccine booster shot which she said she had received. She said her arm was sore the first day but a few days after that she had severe flu-like symptoms and kept having a lot of mucus. Reporter said her husband and her both got sick, her husband had received Moderna. She said they both were getting a lot of mucus from their nostrils and can't figure out what was going on. Reporter said she doesn't know if that was one of the side effects or if the booster dose was more stronger. Reporter said her husband's symptoms were the same as hers.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Went to get something to eat after visit at Health dept. Received Dtap, IPV, MMR-2 shortly before. Developed rash and sensation of throat closing. Went directly to ER.
blood clots in upper thigh down to foot; swelling of the foot; tingling; clot was burning and hot; A spontaneous report was received from a consumer concerning a 62-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events blood clots in upper thigh down to foot, swelling of the foot, tingling, and clot was burning and hot.  The patient's medical history included insertion of a blood clot filter. Concomitant medications reported were Xarelto for drug use for unknown indication. She is also taking 17 other medications (not provided) and has other medical issues (not provided). She also has a blood clot filter inside her body (location not provided). She also wears compression and diabetic socks.  On 25 Feb 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: L014M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) blood clots in upper thigh down to foot, swelling of the foot, tingling, clot was burning and hot.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event(s), blood clots in upper thigh down to foot, swelling of the foot, tingling, clot was burning and hot was unknown.; 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.
I have gotten seasonal influenza vaccines before, and had a prior adverse reaction in 1999, stopped getting them for a couple years, and then started getting them again in 2002 during pregnancy at the urge of my doctor with no side effect. This shot was the seasonal influenza with H1N1 for the 2010 flu year. Initially, significant swelling and bruising at vaccine site. Within hours was extremely sleepy, felt weak. Slept almost constantly for 3 days following the vaccine, other then getting up to eat. Felt weak, tired, drained, abnormal. This led to back pain which I believe was due to being bedridden in sleep for days because of vaccine. This acute back pain caused me to miss work for two weeks. There was a painful knot at vaccine site for weeks.
Immediate "pop" feeling when needle inserted into Left Deltoid (I believe that it was injected too high). After 2 days of soreness, sharp constant pain in left shoulder. Decreased ROM and weakness.
Patient received ZOSTAVAX on 7-12-16 after having shingles 3 weeks ago. Patient was complaining of swelling, redness and pain at site of injection, diarrhea, no fever.
Patient has fainted with previous vaccinations and blood draws. Patient was anxious before vaccination. Immediately after vaccination, patient's eyes rolled back, her body tensed and she passed out. She woke up a short time later, she asked where she was. She aided to the floor to lie down. Her feet were elevated and a cold pack was placed on the back of her neck. Called 911 as a precaution. When she was ready to sit up, we helped her back up to the chair and she drank some water. EMS arrived and evaluated her. She refused further treatment and did not want to go to the hospital.
patient woke up sweating and vomited liquid but did not have upset stomach or nausea
w/in about 1hr T101-104.6, rash all over body, fever x 6 days;still has rash as of 23MAR99-irritable, appetite decreased;crying a lot, clumsy, decreased motor skills not walking @ before;
Received first dose Pfizer/BioNTech vaccine 4/14. One day after vaccination began feeling abdominal pain, associated with nausea.  Described as starting near the umbilicus, then to bilateral sides.  Presented to medical attention on 4/16 (2 days after vaccination.)  Initial concern was for appendicitis.  Stat CT was ordered, which demonstrated jejunal-jejunal intussuception without evidence of obstruction. Pt advised to adhere to clear liquid diet.  Pt re-evaluated 4/19.  Upper GI series that day demonstrated unrelated gastroesophageal reflux but was otherwise unremarkable. Further follow-up scheduled for 4/26.
after i got the 2nd Covid booster [moderna Bivalent] I was getting extremely hot. Couldn't sleep at night coz of night sweats.  On the 12 day i started getting Hives all over my body, including face & head.  Red rash appears & horrible itching  occurs soon.  Its wk 3 now since the hives started.
Patient received COVID vaccine booster dose #2 on 05/25/22.Patient woke the next day with hip pain and "I couldn't open my eyes for 1-1/2 days".  Left side felt paralyzed and she felt that her heart felt sore".  F/u with cardiology .labs and EKG done. Waiting for ECHO to be done.
Suspected Vaccination failure; got Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided. This case had been linked with case US2021AMR178176, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178176:same reporter