chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 08-FEB-2010, the patient was inoculated with ZOSTAVAX at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 09-MAY-2013, the patient was treated by a Medical Specialists center for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
Was feeling unwell (possibly stomach issues); Was feeling unwell (possibly stomach issues); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), GASTRIC DISORDER (non-serious) all with onset 25Nov2021, outcome "recovered" (26Nov2021) and all described as "Was feeling unwell (possibly stomach issues)".  Additional Information: I do not think I have further information for this one  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.is expected.
Difficult time with full range of motion, difficult to lift items over 10 LBS, Feels like a nerve is affected. Unable to do curtain exercises at local gym. It has not gone away since 07/14/2021. Will be seeking advise from a Primary Care provider.
patient is still having muscle achiness and joint pain and he is getting tingling down his legs.  Told patient to consult his physician.
Approximately 15 min after Fluzone was given, pt started experiencing itching and maybe little bumps all over her body, not just at the site of injection. Per her mom, she has received the vaccine yearly and no reaction in the past or egg allergy. No new other meds were given to the pt. Lot # is UI433AA Flu vaccine qs 2015-16. Benadryl 25 mg iv x 1 was given and symptoms improved. Plan is to discharge pt today.
Reports arm pain two days after vaccination. Pain with lifting right arm in bicep region started two days after vaccine. Has seen PT and an MD and got a steroid injection. The MD reports he think the pain is muscular in nature but client does have arthritis in the right shoulder. Also has a history of carpal tunnel surgery in the right wrist.
Patient states arm became painful after immunization and was unable to move his arm. Patient states he had to make a visit to ER and has missed work due to the pain. Patient states he visited his primary care doctor also.
Loss of taste Metallic taste The morning after I received the first dose, I woke up with a strong metallic taste in my mouth. It lasted for a couple of hours. Then it became a total loss of taste (unable to taste any food) that lasted about 8 hours. I also experienced a partial and minor loss of smell, which also resolved in about 8 hours.
Patient states "am I supposed to feel funny?" Patient states she is lightheaded. Patient brought to cot; denies nausea or other symptoms. Patient was provided water.
fever 4 days 104-102;rash day 4 nonspecific small papular rash trunk-external face,arms,legs;was poss roseola;
All types of digestive problems; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (All types of digestive problems) in a male patient of an unknown age 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 DYSPEPSIA (All types of digestive problems). At the time of the report, DYSPEPSIA (All types of digestive problems) 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
Adverse reaction to J&J booster: Severe chills; shaking for 11 hours; no sleep; aches; fever; fatigue for 2 days. I had no reaction to the J&J vaccine, only reaction to booster.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Medical history and concurrent condition was not reported. On unknown dates the patients were vaccinated with GARDASIL (lot # K011562 with expiration date of 08-APR-2017; strength, dosage, frequency and route unspecified), which were exposed to temperatures outside of the recommended range. No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
5 x 3 inch red , hot area on top of right arm, lasted for 2 weeks. Look dark and bruised some days.
On 6/19 the pt complained of a 4x4cm area of redness at injection site. No itching, no pain and no other symptoms.
All information was provided to me by the patient's spouse.  The patient awoke for the day at 6am (took fiber pill and daily aspirin) and by 6:05am had tripped and landed in a seated position on a living room recliner.  His eyes were rolled back and he was unresponsive.  Wife called 911.  Meanwhile, he remained unresponsive for 4 minutes but still breathing.  When he came to, he vomited and continued to vomit 6 times while waiting for EMS.  It took 25 minutes for EMS to arrive due to a train.  When EMS evaluated the patient they checked his blood pressure and heart rate (73) which were normal.  Wife noted that his heart rate was elevated compared to his normal range.  EMS offered to take the patient to the hospital for evaluation but he has no insurance and declined.  His wife checked his blood fasting blood sugar which was 100 (normal).  After the event, Wife contacted me at 9:48am to let me know what happened.  She said at that time he was resting.
This was a vaccine error where I mistakenly gave the patient a pfizer second dose instead of moderna. At this time there are no reported side effects from the patient.
Pt recvd pneumo inject 6NOV91 c/o rt arm onset 11NOV91 of pain radiating to shoulder rt  & neck; sl swelling rt arm; performed arm exercise using 3lb;
Stiff and Severe lower back and left hip pain, unable to stand up without significant difficulty. I am a runner and since the injection, have barely been able to get out of bed or chair or to walk.  Today is Sunday and have started being able to move somewhat,
Nausea, vomiting x 1, light-headedness/wooziness.
topical reaction at injection site (red, swollen, minor pain, warm to the touch).  Ice pack & warm compress alternating
I had my past menstrual period starting 1/18/2021 and received the vaccine the next day 1/19/2021. Now, as today 2/3/2021 I started to have my menstrual period again (just 2 weeks after the previous menstrual period) I always have my menstrua periods regularly every 26 to 28 days. There was only one time in 2012 when I had Dengue virus that my menstrual period came very early as well, at that point I had a CBC done showing thrombocytopenia with Platelets at 110.  I am planning to have a CBC test done. I suspect that my platelets are low again. I want to make sure the vaccine is not causing me thrombocytopenia and to report this event for future data collection.
This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received from a registered nurse RN, through a manufacturer pregnancy registry, concerning a 24 year old female who on 20NOV2003 was vaccinated with a dose of varicella virus vaccine live (lot #640726/0221N). Concomitant vaccinations on that same day included diptheria toxoid + tetanus toxoid. The RN reported that on 20NOV2003, the pt experienced abdominal pain. On that same day, the pt was seen by a physician in the Emergency Room ER. A pregnancy test was positive (LMP-15-Oct-2003, EDD + 21-Jul-2004). At the time of this report, the outcome of the abdominal pain was unknown and the patient was noted to be lost to follow-up. Additional information is not expected.
It started that day with a few hours of dizziness and RUQ pain. I'm still having pain that has progressed into my back and also have aching legs. More so on the right. I have been to the ER and my Primary.
This spontaneous care, initially received on 26-Oct-2016, was reported by a health professional and concerns 60-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received ALFURIA from 26-OCT-2016 to 26-OCT-2016. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54607. No additional suspect drugs. Adverse event description: On 26-Oct-2016, the patient received a dose of AFLURIA that had experienced a temperature excursion (outcome: unknown, special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). The PFS (pre-filled syringe) reached 68-72 Fahrenheit for a maximum of 40 hours. Reporter's comments: The healthcare professional considered the event non-serious and classified the report as misuse.
This spontaneous report was received from a physician via a company representative and refers to a 65 year old female patient. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On an unknown date reported as "couple years ago", the patient was vaccinated with 0.65 ml one time shot ZOSTAVAX (route and site of administration, lot# and expiry date were not reported) for prevention of shingles. On an unknown date in approximately May 2016, reported as "within the last week", the patient experienced shingles. The patient's symptoms consisted of "pain and a rash" which resulted in the patient going to the Emergency Room for an unspecified duration. The outcome of the event was reported as recovering/resolving. On 05-MAY-2016, the patient did see the physician for a follow-up visit. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Information has been received from a physician concerning a female (age unknown), who in 2007 was vaccinated with a dose of Gardasil. Concomitant suspect vaccination included Varivax. Subsequently, the patient was pregnant. It was reported that "a couple days" post vaccination the patient had a miscarriage. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Upon internal review miscarriage was determined to be an other important medical event. Additional information has been requested.
Within 2 hours of getting the vaccine, my arm was sore. It got more and more tender as the hours went by. Approximately 8 hours after the injection, I started to feel very tired and achy. I remained achy all night and couldn't sleep or get comfortable. It's now 24 hours since getting the vaccine and I feel a bit better, but still achy and my arm is extremely sore and tender.
28MAR PM child felt warm to mom, went limp for several seconds, w/? of perioral cyanosis was taken to Hosp;
Child showed some withdrawal following vaccination, mother attributed to 'feeling puny' from shots.  Child lost all words (including 'Mommy' and 'Daddy') except for two, and autistic behaviors were noted by parents as early as six weeks following vaccination.  Child began early intervention at age 2 and was formally diagnosed with Autism at age 3.  1/12/2009 MR received from PCP dated 12/11/2002- 3/2006.  WCCs 5/2003 and 9/18/2003 with Assess: WCC-6 words lots of babble, social, variety of food at 9/18/03 exam. OV 4/5/04 with concern for decreased social and verbal expression and recognition. Not responding to spoken language. DX: Autism by 4/19/2004. Labs and Diagnostics:  Speech and Language Eval 4/6 and 5/4/2004 (+) for significant deficits in language, social communication and play skills.
Patient reported having a fever of 104, lightheadiness (fainted), blood pressure 90/55
Information has been received from a physician and a nurse or office manager concerning a few adult patients who were vaccinated with pediatric version of RECOMBIVAX HB by doubling up on the dose. Subsequently the patients experienced not reaching sufficient titer levels. At the time of reporting, the outcome was unknown. The patient's sought unspecified medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
pt recv vax 23JUN95 11AM & devel reddened & became hardened w/raised area approx dime size; immed applied ice & bathed w/alcohol; spoke w/MD on premises;examined leg felt was local rxn
1. Migraine; Gabapentin, tylenol, and Fioricet : 2 hours after for 5 days. 2. Syncope/near Syncope; Cardiologist & neurologist: From 6/11/2021 to current
rash/hives on arms and upper chest - warm to touch - itching occurred within 10 minutes of receiving vaccine
On the same evening of the vax 8/23/00, the infant developed a seizure. Seizures are considered "Medically Important" The infant developed a seizure following receipt of Prevnar, DTaP, HIB and IPV vaccines on 6/24/00. Information from follow-up report states: A company representative reported that a 4 month old received his second immunizations with Prevnar, Acel-Imune, Hib (manufacturer unknown), and IPV vaccines on 23-Aug-2000. That evening, the infant developed a seizure. Seizures are considered medically important. This infant developed a seizure following receipt of first immunizations with Prevnar, DTaP, Hib, and IPV vaccines on 24-Jun-2000. A copy of this report has been forward to the manufactuer of IPV vaccine. Follow-up information recevied from the physician on 25-Sep-2000 identified the patient and the manufacturer and lot number of concomitant vaccines. On 24-Aug-2000, she was seen by a pediatric neurologist who performed a "work-up." She recovered. OMIC
This case was reported by a pharmacist and described the occurrence of fainting in a teenager male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of BOOSTRIX (unknown). The subject fainted 15 minutes after vaccination with BOOSTRIX. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. The reporting pharmacist was questioning a possible bad batch of BOOSTRIX, product complaint. No other events noted.
received vaccine pfizer 4/18 reports cramping to forearms and calves; soreness to neck, shoulders, chest. Used no  meds to Tx.  Denies SOB, flutters, palpitations. States his chest discomfort feels like muscle pain  after lifting or a rigorous workout rather than cardiac in nature. Referred to ER
Itching on chest began around midnight on 10/7/22.  On that morning noticed a rash about 6-7 inches wide and 4 inches high on the chest, like hives, slightly raised, but no blistering.  On 10/8, noticed facial swelling on left side of face, puffy L eye and additional facial swelling on 10/9, mostly on left side but some on right side of face.  Is taking generic claritin with some relief.  At the time of call 10/10 at 1630, rash on chest continues to itch and feel on fire, and still has some left sided facial swelling but it seems to be better. As of 10/12/22 at 1230, rash is getting better but is moving towards her neck and facial swelling continues to come and go. Has not reported to PCP yet, but plans to go to Urgent Care this afternoon (10/12/22).
17 patients administered expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (17 patients administered expired Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (17 patients administered expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (17 patients administered expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.  The vial was initially stored in the refrigerator on 14 Sep 2021.The vial did not undergo any temperature excursions. The patient did not report any other adverse events.  No treatment medication was provided by reporter.
Pt reported mild stiffness and swelling in finger joints after first MMR; states symptoms worsened after second MMR on 2/6/2020. Reports swelling, stiffness and pain in finger joints bilaterally since receiving MMR vaccines in January and February 2020. Symptoms have persisted for over 3 months.
had a temperature of almost 102F which is similar to what happened after the other doses; breastfeeding when she got her 1st dose & stopped 2 or 3 weeks later; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (had a temperature of almost 102F which is similar to what happened after the other doses) and MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding when she got her 1st dose & stopped 2 or 3 weeks later) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding when she got her 1st dose & stopped 2 or 3 weeks later). On an unknown date, the patient experienced PYREXIA (had a temperature of almost 102F which is similar to what happened after the other doses). At the time of the report, PYREXIA (had a temperature of almost 102F which is similar to what happened after the other doses) and MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding when she got her 1st dose & stopped 2 or 3 weeks later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were provided Company Comment : This case concerns a 34 year old female with no reported medical history , who experienced Non-serious event of Maternal exposure during breastfeeding when vaccination with the 1st dose of mRNA-1273 vaccine (Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the outcome of the events is unknown  The benefit -risk relationship of mRNA -1273 (Moderna Covid 19 vaccine ) is not affected by this report.   This case was linked to MOD-2021-373021, MOD-2021-373022 (Patient Link).; Sender's Comments: This case concerns a 34 year old female with no reported medical history , who experienced Non-serious event of Maternal exposure during breastfeeding when vaccination with the 1st dose of mRNA-1273 vaccine (Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the outcome of the events is unknown  The benefit -risk relationship of mRNA -1273 (Moderna Covid 19 vaccine ) is not affected by this report.
Lasting 36 hours; Fever 103*  Rigors with Chills  Fatigue  Body aches  Sweating through multiple sets of clothing Headache  Brain fog  Loss of appetite  Took Tylenol and ibuprofen and hydrated  After ~ 36 hours feel relatively normal with occasional hot flashes
Information has been received from a medical assistant concerning her daughter, about 6 years old who had been sick with a cold, who in late August 2006, was vaccinated with "one dose" of varicella virus vaccine live (Oka/Merck). On 02-NOV-2006 the child broke out in "pocs" on her back and trunk, but "not so much" on her extremities. The mother reported her daughter had greater than 50 "pocs". At the time of this report the child was reportedly recovering and "crusting over". Unspecified medical attention was sought. There was no product quality compliant. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2007. Additional information has been received from the child's physician who reports that the vaccine was not administered at the office and there is no record of a report of adverse reaction at the office. No further information is avilable.
Erythematous lesions in face, neck, epistaxis, gingival, hemorrhage via vaginal. Rash over the face with itching and anterior upper thorax. Bilateral inflammatory to both knee. Numbness sensation to bilateral hands. Above mentioned symptoms for 3 or 4 days. Currently is taking ZYRTEC by mouth once a day.
Approximately 12 hours after the injection - started feeling that the L side of her face was numb and tingling.  Also started with nausea (no vomiting); headache (located in the back of her head) and fever (102.2).  She noted head felt very heavy and she had difficulty walking by herself (son was at her home to assist).  Facial numb ness resolved in ~3 hours.  She tried taking 800 mg ibuprofen but didn't have any relief so took Tylenol (this was  still on 12/24) and then took another dose of each at around 5:00am 12/25.  Fever was still coming/going (responded to the medicine but towards the end of that timeframe her temperature went up again).   Last fever was on 12/26 - no fever since (reporting this on 12/28).  Headache resolved on 12/27/2020.  She also noted that her injection site had small vessicles and was red/tender to touch - as of 12/28 vessicles have resolved and injection area appears back to normal.
Severe physiological anxiety attack within 3 hours of dose administration.  Shaking, uncontrollabe crying. Completely disabling, had to seek medical attention. Physician on staff had me lie down for about two hours until it passed. Fatigue, exhaustion afterward/
No Adverse reaction but patient was outside of the age range for vaccine. I called mom and informed as soon as I was informed that I gave the wrong vaccine.
Patient broke out in a generalized non erythematous papular rash over face, trunk, extremities. Few looked vesicular, few wheal like lesions.