chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 44-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 01 December 2010, 05 January 2011 and 07 June 2011 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (1 ml, unknown route, unknown deltoid). On 21 July 2011, 44 days after the 3rd vaccination with ENGERIX B, 6 months after the 2nd vaccination with ENGERIX B, and 8 months after the 1st vaccination with ENGERIX B, the subject experienced not responding to therapy. The subjects titers were drawn on 21 July 2011 and were less than 0.1 (units not provided). At the time of reporting the subject had not been restarted on vaccination series for hepatitis B. This case involves a pharmaceutical product complaint. The healthcare professional reported that she had seen an increase in non-responders to vaccination with ENGERIX B and was concerned about the vaccine. It was noted that all the vaccines are monitored by several methods for temperature excursions. The healthcare professional reported 7 cases of not responding to therapy following hepatitis B vaccination. This is case 2 of 7 (see case IDs A0947199A, A0947240A-A0947244A for details of the other reports). Follow-up received from the reporting healthcare professional on 18 October 2011: All doses of ENGERIX B were administered intramuscularly. Dose 1 was given in the right deltoid, and doses 2 and 3 were given in the left deltoid. On 20 July 2011, the subject's hepatitis B surface antibody was less than 0.1 mIU/mL (immunity was noted by the healthcare professional as greater than 0.99). The healthcare professional reported that the ENGERIX B series would be repeated and the 1st dose of the 2nd series was administered on 30 September 2011.
Received Janssen vaccine on 3/4/21. Tested positive for COVID-19 by PCR on 4/21/21. Onset date 4/18/21 w/ cough.  Known exposure to COVID-19.
Missed 2nd dose; Possibly pregnant during 1st shot; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Possibly pregnant during 1st shot) and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 14-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Possibly pregnant during 1st shot). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose). On 14-Apr-2021, EXPOSURE DURING PREGNANCY (Possibly pregnant during 1st shot) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter. No treatment was reported by the reporter.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
This spontaneous report was received from a physician via Pfizer regarding a female patient of unknown age. The patients' concurrent conditions, concomitant therapy and medical history were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX subcutaneously (strength, dose, frequency, lot # and expiry date were not reported) for prophylaxis. Other suspect therapies included XELJANZ 11 mg oral tablet extended release once a day. On an unknown date, the reporter stated that "problems-zoster without complications, back under axilla to the breast left T-2 dermatome (herpes zoster). The outcome of herpes zoster was unknown. The reporter's causality assessment was not provided.
Fever 102 1st day itching from scalp to toes 1st  day - (1/2 of the day) fever 99 and next 2 days no energy for 1st 4 days after vaccine. Felt like she couldn't get a good breath.
Imm site warm to touch, slightly tender. Step sibling with same reaction to same imm today.
Patient started having tingling feelings in hands and legs a couple hours after vaccination and still is persistent as of today 8/9/21
Autoimmune problems; Joints pain swelling; Joints pain/ wrists are very sore; Walking is hard; my hand have lost most grip strength; This is a spontaneous report from a contactable consumer, the patient. This 70-year-old male patient reported that he received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route in the left arm on 05Mar2021 at 16:00 (at the age of 70-years-old) as a single dose for COVID-19 immunization. Medical history included gout (one every 18 months or so). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications the patient received within 2 weeks of vaccination included vitamin (unspecified product) and Tamsulosin hcl (FLOMAX). On 08Mar2021, 2 to 7 days after shot (as reported), the patient experienced autoimmune problems in most joints pain swelling. Patient reported that most symptoms are still with him more than 2.5 months. He reported walking is hard and his hand has lost most grip strength wrists are very sore. There was no treatment received for the events. The clinical outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
elliptical eight inch area reaching from the elbow to the shoulder/ area is increasing in redness, still warm to touch, with slight swelling; Three and one-half inch diameter circular area around elbow that was slightly swollen; Warm to the touch; Red; Hurting; This spontaneous case was reported by a non-health professional and describes the occurrence of CONDITION AGGRAVATED (elliptical eight inch area reaching from the elbow to the shoulder/ area is increasing in redness, still warm to touch, with slight swelling), PERIPHERAL SWELLING (Three and one-half inch diameter circular area around elbow that was slightly swollen), VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE PAIN (Hurting) and VACCINATION SITE ERYTHEMA (Red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (Hurting). On 29-Mar-2021, the patient experienced PERIPHERAL SWELLING (Three and one-half inch diameter circular area around elbow that was slightly swollen), VACCINATION SITE WARMTH (Warm to the touch) and VACCINATION SITE ERYTHEMA (Red). On 02-Apr-2021, the patient experienced CONDITION AGGRAVATED (elliptical eight inch area reaching from the elbow to the shoulder/ area is increasing in redness, still warm to touch, with slight swelling). At the time of the report, CONDITION AGGRAVATED (elliptical eight inch area reaching from the elbow to the shoulder/ area is increasing in redness, still warm to touch, with slight swelling), PERIPHERAL SWELLING (Three and one-half inch diameter circular area around elbow that was slightly swollen), VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE PAIN (Hurting) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.            No relevant concomitant medications were reported. Treatment information included ice pack. Action taken with mRNA-1273 in response to the events was not applicable.
Received the flu shot around 4:30-5:00 on 9/15/09. Around 9-9:30 that night, I started experiencing adverse symptoms that included: coughing, wheezing, throat swelling closed, inability to swallow without severe pain, extreme salivation (making the swallowing part even more difficult), also felt like I had drainage in the back of my throat but couldn't clear my throat, fever (not low grade but didn't get an actual), severe joint pain (every joint felt like it was being torn in half), severe pain in the shot arm including being unable to move the arm. I should have went to the ER, but didn't because of the cost. Where I live, we have a great 911 system/service so I knew I could receive help within minutes. Had I lived somewhere that didn't have a great 911 system, I would definitely have went to ER when my throat swelled closed. So I checked "required er/dr visit" in the next section. Upon waking this morning, I was only slightly feverish, throat is slightly irritated, very tired, headache, shot arm is only tender now, but my face is very swollen (specifically lips & eyes) and my eyes are crusted over.
huge lump on her left arm where she got the shot; golf ball size; whole arm is completely numb; tingles; pregnant; arm hurt really bad; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (huge lump on her left arm where she got the shot; golf ball size), HYPOAESTHESIA (whole arm is completely numb), PARAESTHESIA (tingles), MATERNAL EXPOSURE DURING PREGNANCY (pregnant) and VACCINATION SITE PAIN (arm hurt really bad) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy (No medical history reported.).   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 06-Oct-2021. On 03-Feb-2021, the patient experienced VACCINATION SITE MASS (huge lump on her left arm where she got the shot; golf ball size), HYPOAESTHESIA (whole arm is completely numb), PARAESTHESIA (tingles), MATERNAL EXPOSURE DURING PREGNANCY (pregnant) and VACCINATION SITE PAIN (arm hurt really bad). On 03-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved. At the time of the report, VACCINATION SITE MASS (huge lump on her left arm where she got the shot; golf ball size), HYPOAESTHESIA (whole arm is completely numb), PARAESTHESIA (tingles) and VACCINATION SITE PAIN (arm hurt really bad) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Symptoms experienced within 3-5 minutes of vaccine administration: rapid heart rate of 130=140 bpm, regular rate, palpated right radial pulse. Chest heaviness, lightheaded, feeling warm.  The above symptoms were experienced with the 1st dose, too.
suspected vaccination failure; had my last shot on March 18 / Shingles / my back / only one blister; Started hurting on April 17.; my daughter look at my back / sees only one blister; have not been to sleep for the pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On 18th March 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. On 17th April 2021, 30 days after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, blister and difficulty sleeping. On an unknown date, the outcome of the vaccination failure, shingles, pain, blister and difficulty sleeping were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain, blister and difficulty sleeping to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure, shingles, pain and blister to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  On 18th March 2021, the patient received the last dose of shingles vaccine and on 17th April 2021 started hurting. The patient stated that shingles did not cross his/her mind untill the morning of day of reporting, till the patient's daughter looked at back of patient and she saw only one blister. It was reported that patient was not able to sleep for the pain. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles was unknown at the time of reporting
Vial was initially stored in the refrigerator 29Apr2022 & 04May2022; 25 doses of expired Moderna Covid-19 vaccine were administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 29Apr2022 & 04May2022) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 29Apr2022 & 04May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 29Apr2022 & 04May2022) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant drug was reported. The vial was initially stored in the refrigerator on 29-Apr-2022. The vial did not undergo any temperature excursions. The patient received third full dose. No treatment drug was reported.
pt recv vax 18AUG95 itchy rash bumps noted on rt arm on 20AUG95 & face & groin 21AUG95; also c/o laryngoedema treated w/DPH & Epi;
Six hours after receiving the vaccination I went to bed.  Each time I would be right on the verge of falling asleep, one of my arms, legs, shoulder or head would suddenly jerk and wake me up.  This went on all night.  I have NEVER had this happen before.  I was awakened several times by the jerking motions which literally raised my arms off the bed at times and caused my head to suddenly and uncontrollably turn up to 45 degrees.  The next morning I had no problems with it as long as I was awake.  However, I have had them every night after going to bed.  They never occur until I am on the realm of falling asleep when my muscles are completely relaxed.  Although I have had them every night since the day of the vaccination, they have not been strong enough to keep me awake.
The patient received her 1st Pfizer vaccine on 1/4/21. She then tested positive for COVID-19 on 1/18/21; The patient received her 1st Pfizer vaccine on 1/4/21. She then tested positive for COVID-19 on 1/18/21; This is a Spontaneous report from Pfizer sponsored program from a contactable pharmacist.  A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04Jan2021 at the age of 40-years-old (Batch/Lot Number: EL0142) as 1ST DOSE,SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient received her 1st Pfizer vaccine on 04Jan2021. She then tested positive for COVID-19 on 18Jan2021. The patient was hospitalized for the event. She then received a "plasma transfusion" on 28Jan2021. She was now returning for her 2nd vaccine dose today 06May2021. The reporter asked if  this was ok since it had been 90 days and if her first dose need to be repeated. The outcome of the events was resolved on an unspecified date in 2021. The reporter considered Pfizer Covid-19 Vaccine with event tested positive for Covid-19 after first dose was unrelated.  Follow-up attempts are needed. Further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 test positive and drug ineffective due to temporal relationship.  Case will be re-assessed upon the additional information provided.
felt crummy; sniffles; chills; head felt dull; sleep like log/didn't sleep well; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (head felt dull), SLEEP DISORDER (sleep like log/didn't sleep well), FEELING ABNORMAL (felt crummy), RHINORRHOEA (sniffles) and CHILLS (chills) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Post-traumatic stress disorder.    On 10-Mar-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced FEELING ABNORMAL (felt crummy). In March 2021, the patient experienced HEAD DISCOMFORT (head felt dull), SLEEP DISORDER (sleep like log/didn't sleep well), RHINORRHOEA (sniffles) and CHILLS (chills). At the time of the report, HEAD DISCOMFORT (head felt dull), SLEEP DISORDER (sleep like log/didn't sleep well), FEELING ABNORMAL (felt crummy), RHINORRHOEA (sniffles) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had not slept well because of PTSD on Thursday night, 11-March-2021.  Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
This spontaneous report as received from a pharmacy technician refers to unspecified number of patients. On 04-JUN-2014, the patients were vaccinated with PNEUMOVAX 23 (dose, route and lot # not provided) that was improperly stored. The product was supported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, since the reporter does not want to be contacted.
This spontaneous report as received from a medical assistant, refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2016, the patients were vaccinated with oral ROTATEQ (lot # L013203, expiration date 28-JAN-2017; lot# L013204, expiration date 28-JAN-2017). The vaccines were improperly stored during the months of January 2016 and February 2016. No symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
Headache; nausea; vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 17:15 (Lot number: Fk5127) at the age of 8 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "if Covid prior vaccination: Yes" (unspecified if ongoing), notes: if Covid prior vaccination: Yes. Concomitant medication(s) included: MELATONIN AND MULTIVITAMIN. The following information was reported: HEADACHE (non-serious) with onset 24Nov2021 20:30, outcome "recovering", described as "Headache"; NAUSEA (non-serious) with onset 24Nov2021 20:30, outcome "recovering", described as "nausea"; VOMITING (non-serious) with onset 24Nov2021 20:30, outcome "recovering", described as "vomiting". Therapeutic measures were not taken as a result of headache, nausea, vomiting.  Additional information: The vaccine was facilitated in Doctor's office/urgent care. It was unknown, if other vaccine in four weeks. Patient did Not experienced Covid test post vaccination. Patient did not have any known allergy.  No follow-up attempts are possible. No further information is expected.
Some redness at the injection site after the 2nd dose; A spontaneous report  was received from a consumer concerning a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events some redness at the injection site after the 2nd dose/ vaccination site erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: not have the card) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event some redness at the injection site after the 2nd dose.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.  The outcome of event, some redness at the injection site after the 2nd dose was unknown.
Disorientation, Agitated, Hyperthermia 105*. Encephalopathy continued for 2 weeks. 10/16/2009 MD records for visits spanning a period from 4/1999 to 6/21/2009. Patient seen for sx of short attention span, poor social skills, behavioral problems. PE noted subtle dysmorphism, high arched palate, rt simian crease, pes planus and extra nipples. TX: OT, speech therapy, audiological exam, administer Childhood Autism rating scale. Patient later dx'd with Simpson-Gloabi-Behmel  syndrome, dx'd with Autism 2007 with OCD. Last meds noted Accai and Gastrocom Other tx: hyperbaric tx's and speical diet with supplements.