chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age and gender. Initially reported as RECOMBIVAX HB (lot # J009374; expiration: 11-JUN-2016) and GARDASIL vial wet SD (lot # K005083; expiration: 04-NOV-2016) were improperly exposed to 31 Fahrenheit (F) for 48 hours on an unspecified date, and to several other unspecified temperature excursions on unspecified dates. An unspecified number of patients received at least one of these vaccines on unspecified dates. Further it was reported that RECOMBIVAX HB (lot # J009374; expiration: 11-JUN-2016) and GARDASIL (lot # K005083; expiration: 04-NOV-2016) were exposed to 31F for 15 days (360 hours). However later it was confirmed that GARDASIL was not administered to anyone. On 06-SEP-2014, the patients were vaccinated with improperly exposed RECOMBIVAX HB vial SD, intramuscularly, lot # J009374, expiry date 11-JUN-2016, for unknown indication. Later it was confirmed with the reporter that RECOMBIVAX HB were improperly exposed to 33F for 96 hours from 04-SEP-2014 to 08-SEP-2014. No adverse effects reported. Outcome of events was unknown. No product quality complaint (PQC) was involved. No further information reported. This is one of several reports received from the same reporter. Additional information has been requested.
6/21/21 Vertigo - lightheaded, dizziness that lasted 36 hours and continued with milder symptoms coming and going until 7/5/2021.  7/11/21 deep cough, 7/12/21 severe headache and fatigue and muscle aches...diagnosed Covid-19 on 7/13/21 at ER.
Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching). At the time of the report, PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. Treatment medication not provided.   This case was linked to MOD-2021-071350 (E2B Linked Report).; Sender's Comments:  MOD-2021-071350:2nd dose case
a second dose of PNEUMOVAX 23 to a patient 4 years and 5 months after the 1st dose; no adverse event; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies details were not reported.  On an unknown date, the patient was vaccinated with a first dose pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On an unknown date, reported as after 4 years and 5 months, the patient was vaccinated with second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (inappropriate schedule of vaccine administration). No further information was provided. No additional adverse event or product quality complaint was reported.
Missed second dose, 6 months after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose, 6 months after first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose, 6 months after first dose). On 25-Aug-2021, PRODUCT DOSE OMISSION ISSUE (Missed second dose, 6 months after first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received the first dose of Moderna COVID-19 vaccine 6 months ago. Relevant concomitant medications were not provided by the reporter. Treatment medication was not reported.
This is a spontaneous report by a contactable nurse. A 4-year-old male patient received a dose of PREVNAR 13 0.5 ml intramuscular injection at 11 AM on right deltoid of the arm as a recommended vaccination on 21Jun2011. Relevant medical history and concomitant medication was none. Relevant vaccine history included the first three doses of PREVNAR. This constituted a therapy regimen change. On 22Jun2011 the patient experienced an extremely swollen right arm. Outcome was unknown at time of report. Follow up (30Jun2011): New information reported from the contactable nurse includes: outcome changed to unknown and clinical details.
1 wk p/vax pt woke up crying @ 530AM; seen by MD @ 1PM given Ceclor; t102.4 settled down & was back to nl w/in 24 hrs; screamed for 8 hrs;
Pt received PNEUMOVAX 05/03/10 - started to develop swelling by end of day at injection site. Which came on 05/04/10 for us to see, it had swollen up from injection site to mid arm - red, some warmth.
Client (DOB:08/14/1960) received the 2nd dose of Pfizer COVID vaccine lot # EW0179 and expiration date 5/1/21 at 12:36pm.  Client received first dose of Pfizer on 3/31/21 and had no reaction. Vaccinator noticed client had some trouble with balance as he was walking in so right after vaccine vaccinator was there as support to help client walk to observation area and then he seemed more off balance so she got him a chair.  Vaccinator alerted RN who walked over to observation area to get EMT.  PHN overheard client saying his "throat is closing up" and alerted PHN about emergency and then ran to get Ekit.  PHN got ekit from observation area and returned to client and other RN stayed to assist in observation area.  PHN called 911 at 12:40PM. Client reports having a diagnosis of lymphoma 4 months ago and being treated for fungal pneumonia 3 months ago to PHN who started to take notes.  Client was in a chair when PHN  arrived and opened ekit to give epinephrine, which client declined. First set of vitals taken at 12:42pm: blood pressure:130/50 , pulse:83, and oxygen:96%. At 12:44PM FIRE Department arrived and assumed care. Client was transported by paramedics out of the building at 12:53PM.
Severe body aches, chills, fever 103, fatigue dizziness, headache - symptoms lasted 2days,  the third day I had diarrhea and nausea.
fever 25SEP97 104-105 @ home;MD dx poss viral synd or poss rxn to pertussis portion of vax;
Pt was given Shingrix in error.  Then given correct vaccine MMR  No side effects Reportely
This spontaneous case was reported by a patient and describes the occurrence of PAIN (body aches) and PYREXIA (fever (100.5 °F)) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN (body aches) and PYREXIA (fever (100.5 °F)). At the time of the report, PAIN (body aches) and PYREXIA (fever (100.5 °F)) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 100.5 degree farenheit High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. The patient had not taken any treatments yet, but plans to take Tylenol to mitigate the symptoms.
sleeping all the time; fatigued; This spontaneous case was reported by a nurse and describes the occurrence of HYPERSOMNIA (sleeping all the time) and FATIGUE (fatigued) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced HYPERSOMNIA (sleeping all the time) and FATIGUE (fatigued). At the time of the report, HYPERSOMNIA (sleeping all the time) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    relevant concomitant products usage were not reported by the reporter. Treatment details included ibuprofen.   Reporter did not allow further contact
PENTACEL and MMR vaccines were ordered by dr. However patient received PREVNAR 13 and MMR instead. Vaccines were ordered on 08-20-11 and discovery was made on 08-07-12 by dr.
When I had my last shot I had some anticipated reactions including fatigue which lasted about 24 hours; When I had my last shot I had some anticipated reactions including headache which lasted about 24 hours; I had a positive reaction that was not expected; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 25Apr2021 at 10:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and cholesterol. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified multivitamins, metoprolol tartrate (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and sertraline hydrochloride (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 04Apr2021 at 10:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021, the patient had a positive reaction that was not expected. For the last 18 months or, he had muscle pain and difficulty getting up and down from sitting, bending over, picking things up, walking down steps sideways because he did not have the leg strength. When he had his last shot, he had some anticipated reactions including headache and fatigue which lasted about 24 hours. His shot was on 25Apr2021. By 27Apr2021, those side effects dissipated. However, so did his normal muscle pain to the extent he can much more easily move and traverse steps. It was quite remarkable. He was not sure if it was related to the vaccine but the timing was very coincidental. There were no changes in his daily routine other than the vaccine and thereafter a very positive improvement in his ability to move. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event when he had his last shot he had some anticipated reactions including headache and fatigue which lasted about 24 hours was recovered on 27Apr2021; while that of the event had a positive reaction that was not expected was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient is 17 years old at the time of  moderna vaccination which is approved in ages 18+.
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Overdue 2nd dose of Moderna COVID-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Overdue 2nd dose of Moderna COVID-19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Overdue 2nd dose of Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs and treatment medications were reported.
pt exp soreness @ inj site, numbness radiating down the arm, & hip pain p/vax in arm;
she was 235 pounds, but since getting COVID, she is now 224 pounds; sore arm; feeling her chest tighten, and congestion; back was hurting; she had lost her taste and smell; she had lost her taste and smell; feeling her chest tighten, and congestion; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; allergy symptoms; This is a spontaneous report from a Pfizer Sponsored program. A contactable consumer (patient) reported that a 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration on 29Dec2020 at a single dose on left arm for COVID-19 immunization as COVID-19 prevention. Medical history included ongoing asthma diagnosed more than three years ago. The patient's concomitant medications were not reported. She had no other vaccines on the same day as her COVID vaccine. The patient had the first dose of the Pfizer COVID vaccine on 29Dec2020, and since then she has contracted COVID, and tested positive for it on 07Jan2021 with symptoms. She asked if she still can get the second shot on the 21st day following her first dose. When she got the vaccine, she was fine, just had a sore arm. A couple days before 07Jan2021, she developed allergy symptoms, and so on the 7th (07Jan2021), she went to get tested, and it was positive. She was 235 pounds, but since getting COVID on Jan2021, she is now 224 pounds. She reported that she started to have allergy like symptoms on maybe 05Jan2021, and on the 7th she went to get tested for COVID, because she had started feeling her chest tighten, and congestion, and her back was hurting, and she has a history of asthma, so she wanted to be seen. She confirmed that on 07Jan2021, she had a Rapid test for COVID, and the results came back the same day, as Positive. She was told that she should also have a 48-hour test, so she had that performed as well, and that one also came back positive, but she knew it would, because by then she had lost her taste and smell. The patient is scheduled for her 2nd dose 19Jan2021. She was wanting to know if she can still get the 2nd dose. She was told she needed to wait 30 days from her positive diagnosis before she could get the 2nd dose. She added that she will still be in isolation when her 2nd dose is due. Outcome of the events was unknown.
Patient presented to emergency department on 1/5/2022 with shortness of breath and cough. She was admitted for spontaneous pneumothorax and was found to be COVID-19 positive. Patient was discharged home on 1/21/2022.
Patient passed out & hit head after IZs given.  Awoke oriented, no laceration.
General malaise, alternating chills and fever, body aches and pain that lasted for just over a day. After the start of symptoms late morning, I rested and slept until the following day. I was able to work as normal the next day, but didn't feel close to 100% normal until later that evening.
Pt 1 of 9,from total of 191 pts who completed series of 3 Hep B vax and failed to achieve immunity.Pt did not seroconvert.
extremely swollen axilla nodes that have remained consistently swollen and painful.   US shows benign cysts in L axillary nodes
Myalgia, Fever, NauseaVomiting, Fatigue Narrative:  Other Relevant History:
After receiving the vaccine at 9:30pm, I was awoken at approximately 4:30am that night/the next morning with an extremely high heart rate. After about thirty minutes, I was able to calm down and my pulse/heart rate dropped down to a level that still seemed elevated, but no longer caused a great deal of concern. This event was followed by nausea for the remainder of the day.
This spontaneous report was received from a consumer refers on behalf of himself as a 42 year old male patient. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose, route, lot # were not reported). Concomitant therapy was not reported. On an unknown date, the patient experienced malaise. Action taken was not applicable. The outcome of malaise was unknown. Causality was not assessed by the reporter. Additional information has been requested.
3/28/00, woke up in AM to find chest, neck, face and back, broken out in red, raised rash. Reports she had a low-grade fever and mild sore throat for past 3 days.
The patient developed headache approximately 2 weeks after receiving her vaccine and was found to have intraparenchymal hemorrhage (i.e. hemorrhagic stroke) and intraventricular hemorrhage in the setting of thrombocytopenia with a platelet count of 47 thousand. She was intubated and mechanically ventilated. Platelet count normalized 9 days after admission.  She underwent ventriculoperitoneal shunt placement 11 days after admission and was extubated 4 days later, then transferred out of the ICU 2 days after that.  Course complicated by pulmonary embolism diagnosed 4 days after she left the ICU which is being treated with apixiban.  She has a right hemiparesis and continues to have dysphagia and dysarthria.  She is dependent on NG feeds for nutrition.  Anticipate discharge to long-term acute care within the next 2-3 days.
I started to lose weight without trying. I made an appointment with my doctor who ordered bloodwork that showed my PSA blood count was high. I also had a prostate exam that showed I had an enlarged prostate. I was scheduled for a biopsy, that came back showing cancer. I am currently undergoing radiation therapy.
Patient developed Gallium Barre Syndrome. Needs to receive IVIG therapy to reduce symptoms and cure.
Arm became red,itchy,hot, raised at injection site. Patient treated with hydrocortisone cream and irritation resolved.
Extreme fatigue - slept from 11 hours Tuesday night and slept another 10 hours Wednesday night.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/23/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/23/2023 ALTERED MENTAL STATUS, UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/23/2023 LUNG CANCER RIGHT LUNG, UNSPECIFIED PART J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/23/2023 HTN (HYPERTENSION)
no symptoms being reported; patient probably received 90% of the vaccine; This spontaneous report was received from a medical assistant referring to a 12 month old patient of unknown gender. The patient's pertinent medical history, concurrent conditions and drug reactions/ allergies were not provided. Concomitant therapies included sterile diluent, hepatitis a vaccine, inactivated (VAQTA) and pneumococcal 13v conj vaccine (crm197) (PREVNAR 13). On 09-JAN-2020, the patient was vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis, lot number S017244 and expiry date 01-DEC-2020, (exact dose, route of administration and anatomical location were not reported). It was reported that as the medical assistant was about to finish vaccination, the patient pulled away and some vaccine was sprayed (incorrect dose administered) and the patient probably would have received 90% of the vaccine. No adverse events were reported. No product quality complaint (PQC) was reported.  This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-2001USA003805:
Headache, NauseaVomiting, LOWER BACK PAIN Narrative:
Itching and rash on face, right arm within 15 minutes of vaccination. Resolved within an hour. Fever >100F, myalgia, severe headache, nausea started evening of vaccination, 3 day duration. On 02/04/2021, injection site redness, pain, swelling and heat, which lasted 5 days.
8/2/03 7AM muscle spasm right thigh. 8/3/03 muscle spasm at back of right thigh 10wav extremity for approx 5-10 minutes, more intense than 8/2/03 symptoms, denies fever. 8/4/03 visit B/P 136/88, p 73, no symptoms.
Information has been received from a 33 yr old white female licensed practical nurse with a relevant medical history of past pneumothorax who on 11Nov02 at 0930 was vaccinated with a fourth 0.5ml dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 642497/0344M). It was noted that she received the measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) as a child at 15 months of age, then received another dose at approx 5 yrs of age and another dose as a teenager. On 25Aug04 an antibody test was negative for rubeola. She stated she had no untoward effects from the vaccinations. Unspecified medical attention was sought. It was also reported that on 14Oct02 at 1000 the pt was vaccinated with a dose of measles virus vaccine (lot638832/1722K). There was no product quality complaint complaint involved. No further information is expected.
On August 12, 2009, 11:39 AM, infant had four-month checkup and was found to be well.  At 12:00 PM, he was given five immunizations (DTaP/DT, IPV, Hib, PCV7, Rotovirus).  The following morning at 8:00 AM (20 hours later), he was found unconscious by his parents.  Cardiopulmonary resuscitation was initiated.  Emergency medical services found the infant in full code.  He was transported to the hospital where he was essentially dead on arrival.  12/10/09 Autopsy report received. Cause of Death: Undetermined. Manner of Death: Undetermined. Additional infomation abstracted: Pathological Diagnosis - Well baby by clinical history. Overlay cannot be excluded.   12/3/09 PCP, cardiology consultation, and hospital records received. Service dates 4/1/09 to 8/13/09. Assessment: Not breathing. Child was sleeping with parents, not breathing this AM. EMS called.
Initial report was received on 12 September 2012 from a consumer from an unverified internet source. An unidentified male patient (reported as older man) had received the Influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later "became blind". No further information was available at the time of the report. The patient's outcome was not reported. The reporter for this case is the same as for case 2012-08539.
16 min after administration pressure between ears about 20-25 min after administration slight nausea about 30 min after administration and continuing until 1 hr 45 min after administration periodic trouble swallowing and sensation that throat was constricting  about 1 hour after administration chills took 50mg Benadryl at 1 hr 45 min after administration and trouble swallowing and sensation that throat was constricting stopped  normal chills, body aches, fatigue continued for 3 days
"Felt hot", grand mal seizure X 10 min. Given valium per rectum and IV (on ambulance). Phenobarbital q 12 h IV. Is recovering.
2 in x 2.5 in swelling at injection site, pain, itch.  Returned to clinic on 9/26, seen by Dr. Prescribed hydrocortisone cream and antihistamine.