chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 11-month-old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) 0.5 ml, intramuscular (lot # J006695, expiry 30-MAY-2015) that was stored inappropriately. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Popping and crackling of ears going for more than 2 weeks after the shot. Ears feel clogged.
The patient experienced swelling at the Tdap injection site on right lower deltoid developed 3-5 days after vaccination given 3/1/13. The swelling created a mass under the skin the size of a quarter initially. It was very painful and tender to the touch or with use of her arm. The site of the Tdap vaccination on right arm on 3/14/13 still had a solid lump under the skin the size of a grape, it was no longer painful at this time. On 3/21/13 the solid lump under the skin remains the size of a dime. Other vaccinations administered on 3/1/13 included Ipol  IM right upper delt & Twinrix IM left deltoid, which resulted in no adverse events.
Patient called pharmacy on 11/16/21 and spoke to a 'unbearable' amount of pain in arm that recieved the injection, as well as states his arm is 'immobile'. At the time of the call, patient had not sought any treatment. The patient was advised and planning on seeking evaluation of symptoms.
The patient states she was administered the Johnson & Johnson vaccine in March 2021 and was tested COVID-19 positive on 8/1/2021.
Next two days my testicles ached.   Sleep was not great the first 2-3 days. Four days in I was sneezing as though I had a head cold.  Energy felt really low for the first 6 days. 6-7 days in I have a hive or something on my left temple that is super sensitive and sore to the touch.
Dizziness; This is a spontaneous report from a Non-Contactable Physician. This Physician reported for a 22-Year-old female patient. A 22-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown, via unspecified route, on 20Jan2021 as unknown, single dose for covid-19 immunisation. The Patient's medical history included was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced dizziness yesterday and lasted for a day. Today she is fine with no dizziness. The outcome of the event was recovered in 2021.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021173043 Same Drug/Reporter/Event and Different Patient
Administered patient vaccines as MCV4, TDaP, and then HPV last. After administering the HPV vaccine pt. immediately said "Oh wow, I feel dizzy" and proceeded to lose consciousness. Seconds after losing consciousness he appeared to have Tonic-Clonic seizure-like activity and his pupils fully dilated. This episode lasted around 60 seconds. Minutes after the seizure-like activity, pt. had BP of 118/78 R arm and 8 mins post-ictal BP 110/72 R arm P:78 Patient's mother stated that this patient has no history of seizures.
After the shot a couple of hours later I was vomiting. I felt fever and pain like menstrual cycle with cramp. I was taken to the Hospital. At the hospital they gave me x-ray. They said we have no more time we have to do this right now. They took out my appendix. I was at the hospital over night.
Extreme fatigue on first day. On the second day I experienced dizziness and vertigo. I have not felt safe to drive although the symptoms are becoming less severe the last 24 hours.
Needle might have leaked out; Believed that she gave 0.3mL or 0.4mL of the dose instead of the full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (Needle might have leaked out) and UNDERDOSE (Believed that she gave 0.3mL or 0.4mL of the dose instead of the full dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient experienced DEVICE CONNECTION ISSUE (Needle might have leaked out) and UNDERDOSE (Believed that she gave 0.3mL or 0.4mL of the dose instead of the full dose). On 22-Jun-2021, DEVICE CONNECTION ISSUE (Needle might have leaked out) and UNDERDOSE (Believed that she gave 0.3mL or 0.4mL of the dose instead of the full dose) had resolved.        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.   Concomitant product use was not provided. Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: No new information
got them, got the shot/suspected vaccination failure; got them; hurt; 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient got a shot and got shingles about five days ago. The patient stated it hurt. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact detail were available.
Developed and was diagnosed with Erythema multiforme minor by his doctor. Today is day 6 and the "rash" continues to reappear and fade throughout the day. Doctor said to use Ibuprofen and Benadryl to help with any discomfort from the "rash" or the joint pain. No other illness present.
pt recv vax & devel fever & chills 48hr p/vax these resolved;3mo post vax pt devel weakness in the jaw & face w/diff talking & swallowing;dx w/myasthenia gravis & tx w/med;dx changed to ALS then to dystonia;diff w/speech & swallowing;
Patient recieved Covid vaccine, waited 15 minutes No reaction. Patient left and husband was joking. He took off his band aid w/ Blood and she became nausea.
Site of injection swelled up to size of tennis ball with extreme pain.  Treatment was wearing arm in sling for one week and taking daily prescription pain medication.
Patient had vaccine administered on 9/16/10 (TDAP). (L) shoulder/arm swollen & unable to move. Extremely painful.
Fatigue; Upset stomach; Low grade fever; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 31Mar2021 at 11:30 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA), COVID-19 and NSAIDS drug allergy. Concomitant medications included duloxetine hydrochloride (CYMBALTA) and hydroxychloroquine phosphate (PLAQUENIL) for unknown indication on unknown dates within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. On 25Feb2021, the patient underwent COVID-19 virus teat (nasal swab) and the result was negative. Since the vaccination, the patient had been tested for COVID-19 with result unknown. On 31Mar2021 at 12:00 the patient experienced upset stomach and low-grade fever. On day 2, 01-Apr-2021, the patient experienced fatigue. Therapeutic treatment received for the reported event low-grade fever was TYLENOL but the event was continuing. The patient did not receive any treatment for the events upset stomach and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events upset stomach, low-grade fever and fatigue were not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Pt completed initial Pfizer COVID 19 Vaccination (on 3/23/2021 and 4/13/2021 respectively), plus the Pfizer booster on 10/19/2021.  COVID test was positive 10/26/2021 and he was transferred from a smaller hospital to this hospital for higher level of care.  Pt eventually needed ICU level care here, but has since improved enough to be cared for in our ICU department.
Information has been received from a healthcare worker concerning a patient who on an unspecified date was vaccinated with a dose of MMR II. The patient did not "show immunity" for rubella. No other adverse experiences reported. Additional information has been requested.
Cold sores; This case was reported by a pharmacist via call center representative and described the occurrence of cold sores in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 3R774, expiry date 8th March 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced cold sores. On an unknown date, the outcome of the cold sores was unknown.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced cold sores. The reporter consented to follow up.
This nurse noticed that the patient was coughing and clearing his throat around 11:10 am. This nurse asked if he needed some water and the patient replied he thought he may be having an allergic reaction to the shot. This nurse went to get a bottle of water and gave two Benadryl capsules at 11:15 am. 911 was called. This nurse notice the patient's eyes were looking swollen and red and that his face and neck were turning red around 11:20 am/ 11:25 am.  Patient also stated his throat felt like it was getting tighter. This nurse then gave 0.3 mL of Epinephrine in right thigh at 11:30am. Almost immediately patient stated he was starting to feel better. EMS arrived, checked him over, asked questions, and offered to transport to the hospital. Patient refused the hospital and signed their paperwork. This nurse asked patient to stay an additional 30 minutes and patient complied. No other complications occurred. Patient's eyes still looked slightly red, but was no longer swollen. Stated he felt a little jittery. Gave patient a snack. Patient left around 12 noon/ 12:15pm. Patient drove self and walked without assist.
Initial report received from a healthcare professional on 06 November 2013.  An unknown age and gender patient received dose of FLUZONE at unknown site and on an unknown date. Reporter mentioned that they had 3 year and 3 month old baby they gave it to but gave the baby the dose for 6/month to 35 month.   As of 06-NOV-2013, no adverse event reported. Documents held by sender: none.
Pregnant patient receiving vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient receiving vaccine) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 06-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient receiving vaccine). On 06-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient receiving vaccine) had resolved.            Treatment medications information was not provided.   This case was linked to MOD-2021-303333 (Parent-Child Link).   See case MOD-2021-303333 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: follow up received: reporter contact details were updated, coding of event pregnant patient receiving vaccine updated to maternal exposure during pregnancy, outcome of the event maternal exposure during pregnancy updated to recovered and stop date was updated.; Sender's Comments: This is a case of maternal exposure during pregnancy with no associated AEs for this 20-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in right 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure (treated)" (unspecified if ongoing), notes: other medical history: High blood pressure (treated); "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (Jun2022) Negative, notes: tested negative over 3 days; (Jun2022) Positive, notes: tested positive with a resumption of Covid symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
Booster dose; Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint fever; Nausea; Feeling unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 immunization; Bnt162b2 (Dose 2, single), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster dose"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site pain"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; CHILLS (non-serious), outcome "unknown", described as "Chills"; ARTHROPATHY (non-serious), outcome "unknown", described as "Joint fever"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; MALAISE (non-serious), outcome "unknown", described as "Feeling unwell".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  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 completed. No further information is expected.
On 8/13/22 - fatigue began.  On 8/15/22 - sob began.  Was diagnosed with pulmonary emboli on 8/17/22 at local Health Care.
Inappropriate schedule of vaccine; Headache; fever; Joint stiffness; This case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 8 months ago from the reporting date).   On 2nd May 2019, the patient received the 2nd dose of Shingrix. On 2nd May 2019, 12 hrs after receiving Shingrix, the patient experienced headache, fever and stiff joint. On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the headache, fever, stiff joint and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the headache, fever and stiff joint to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient asked do the two Shingrix vaccine shots had to be separated by 2 to 6 months in order to be effective, which led to lengthening of the vaccination schedule. The clinic scheduled the shots 8 months apart and the patient wonder if I am adequately vaccinated. Also, the patient had side effects headaches, fever and joint stiffness. The patient had the 2nd shot at 10 this morning, so 12 hours before the reporting date.
double vision; right posterior cerebral artery stroke; vertigo; loss of balance; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a male patient of unknown age. His concurrent conditions, medical history and concomitant medications were not reported. On or around 20-JAN-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered sudden onset of double vision, vertigo and loss of balance. The patient was hospitalized and diagnosed with right posterior cerebral artery stroke. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to vaccination. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), he sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient 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, he suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   The events were determined to be disabling.  Upon internal review, the event of right posterior cerebral artery stroke was considered to be medically significant.
This child received the Varicella vaccine on 01/05/01. The mother noticed redness at the injection site beginning 01/10/01. The reddened area has increased and is now 5 cm in diameter. The child became fussy, and irritable, low grade fever, area of redness, is slightly firm with macular rash covering reddened area, also non tender. On 01/19/01, the patient is improving.
Muscle and joint aches Extreme fatigue  Recovered by 2/7/21 at 7 AM
Staff waited the full 30 minutes with no issues.  At the 15 minute mark, her injection site was assessed by RN and was found to be without edema or erythema.  At the 30 minute mark, the staff proceeded to her office.  Upon arrival, she began to feel light-headed, and a co-worker noted that she had red areas on her chest and arms.  The staff immediately returned to staff development for assessment,  presenting with pronounced erythematous areas on her chest and upper arms, none noted on the stomach.  The staff denied any problems breathing or swallowing.  Throat appeared wnl upon inspection.  Lung sounds were clear upon auscultation.  Physician contacted, and 100ml Benadryl IM administered.  Staff monitored until EMS arrived. 1343   T: 9.6 P: 132 R: 24 BP: 152/93 O2: 99%   1351   T: 97.6 P: 127 R: 21 BP: 148/96 O2: 99%   1400   T: 97.2 P: 121 R: 20 BP: 149/103 O2: 98%   1402   BP: 142/98   1417   T: 97.4 P: 157 R: 20 BP: 150/90 O2: 99%
Information has been received from a physician concerning a patient who on an unspecified date "a long time ago" was vaccinated with a dose of MMR II (LOT# not reported). Recently, the patient came into the office and had blood work that showed no titers to two of the components of MMR II, but did have titers for one component. No additional information was available at the time of this report. This is one of the reports from the same source. Additional information has been requested.
30JUL97 pt broke out w/few bumps on arms;no illness, no temp;itching only;cont breaking out numerous pustules face, neck, arms, legs;
Slight persistent pain in my right lower back beginning 5/17/21 at around 3:30 Am. Also noticed I'm producing a fair amount of clumpy mucus than before I had the vaccine.
How long are the Moderna side effects likely to last for; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (How long are the Moderna side effects likely to last for) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (How long are the Moderna side effects likely to last for). At the time of the report, VACCINATION COMPLICATION (How long are the Moderna side effects likely to last for) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       for mRNA-1273 (Moderna COVID-19 Vaccine) (intramuscular), the reporter did not provide any causality assessment.  Concomitant drug was not reported. Treatment medication was not reported.