chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 36-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Spontaneous abortion on 03-May-2020 and Pregnancy on 02-Jan-2020. Concurrent medical conditions included Anxiety. Concomitant products included SERTRALINE for Anxiety, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 03-Jan-2021 and the estimated date of delivery was 18-Oct-2021. On 06-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 06-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, Pregnancy test: positive (Positive) Positive.     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 treatment medications were reported.
I95.9 HYPOTENSION 9/26/2022 SEVERE PROTEIN CALORIE MALNUTRITION I95.9 HYPOTENSION 9/26/2022 DYSPHAGIA I95.9 HYPOTENSION 9/26/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I95.9 HYPOTENSION 9/26/2022 ATRIAL FIBRILLATION, UNSPECIFIED I95.9 HYPOTENSION 9/26/2022 ATHEROSCLEROSIS OF AORTA I95.9 HYPOTENSION 9/26/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I95.9 HYPOTENSION 9/26/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
1800 59 years old female with a history of hypertension, obesity received in post vaccination observation with complaint of mild SOB and dizziness. Patient took of mask for a few seconds and felt better. Symptoms resolved in less than five minutes. 1830 Patient denies any further symptoms. Able to ambulate with no problems.    V/S BP 159/99 HR 75 RR16
My dad (78 year old male) received the second Pfizer Covid19 vaccine shot on Wednesday, Jan 27 that night he started experiencing trouble breathing, Fatigue, chills, night sweats, etc. He was admitted to the hospital on Wed, Feb 3. CT scan showed he has an infection and inflammation of the lungs. Today is day 6 of hospitalization, and he has not improved despite many antibiotics, steroids, IVIG and oxygen. He is also in year two of remission from Multiple Myeloma so he is immunocompromised.
Tingling paresthesias up contralateral SCM to ear & lips. Hx bad left sided  Zoster in V3. Fatigue Narrative:  . Fine for a while today. Not even arm pain. Now left SCM has tingling as if numb. Neck and teeth and lips. Sensations similar to dental anesthesia. Adverse rxn to multiple medications. No prior reaction to vaccinations.
An 18 yr old male patient came in today (11/30/2021) around 1:25 pm  for flu and pfizer booster. Both flu and pfizer booster vaccine was given and did not catch that the 2nd pfizer dose was given on 09/04/2021, which was too soon as it was not separated by 6 months apart from 2nd dose stated in CDC guideline
no additional AE details available; improperly stored vaccine administered; This spontaneous report was received from an other reporter and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, drugs reactions or allergies were not provided.  On 09-SEP-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella virus vaccine live(PROQUAD) (lot # T013537, expiration date: 17-OCT-2021)(dose, route of administration were not provided) for prophylaxis.  The vaccine was stored from  15 Fahrenheit degrees (F) to 46 Fahrenheit degrees (36.5 Fahrenheit degrees) for a time frame of 3 hours and 15 minutes. There was no previous temperature excursions. Digital data logger was involved.  The outcome of product storage error was unknown. There was no additional adverse events (AE) details available.
Information has been received as part of a class action suit concerning a pregnant female who was vaccinated with hepatitis B immune globulin. Subsequently, her son experienced toxic neurological effects of mercury poisoning. Outcome is unknown. Toxic neurological effects and mercury poisoning were considered other important medical events (OMIC). No further information was provided. This report was received from the manufacturer's legal department on 12/13/04.
SWELLING,SHORTNESS OF BREATH,TENDNESS,PAIN,LYMPH NODES SWELLING,HARDNESS,FAST HEARTBEAT
Red and swollen at injection site. Hot and painful so patient took TYLENOL and iced it initially. Did not help so she took BENADRYL and LORTAB which still did not help.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 02-DEC-2013 the patient was vaccinated with ZOSTAVAX vial of lot # J001729 expiry date 02-DEC-2013 single dose of 0.65 milliliters, via subcutaneous route. An expired dose was administered to the patient on that day. No adverse effect was reported. Additional information has been requested.
Patient was diagnosed with Plasmacytoma and then tested for Multiple Myeloma, which came back positive.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patient was vaccinated with an unspecified dose of GARDASIL 9 (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date the patient was inadvertently administered a dose of GARDASIL (lot number and expiry date unknown) (dosing regimen and frequency unknown) (wrong drug administered) (interchange of vaccine products). No adverse effects were reported. The action taken with GARDASIL and GARDASIL 9 was unknown. The outcome of the events was unknown. There was no product confusion reported. There was no product quality complaint reported. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 08-DEC-2014 the patient was vaccinated with the second dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
24JUL96 mom called & stated pt crying about an hr, leg red, sore & swollen;pt feels warm;25JUL96 mom states pt cried most of the noc & only slept about an hr;swelling & redness in leg dec;APAP given & cool compresses;
Severe left leg, hip, joint/muscle pain, can barely walk, leg gives way. Taking Tylenol every 4 hours, is not helping very much! Have not called doctor yet. 4/6/2021.
THE NURSE VACCINATING PATIENT STATED THAT WHEN PATIENT WAS VACCINATED AT LEAST A 70% OF THE DOSE WAS LOST DUE TO MALFUNCTION OF THE RETRACTABLE NEEDLE, AS A RESULT, BASED ON THE MEDICAL TEAM DECISION AND BASED ON CDC GUIDELINES, PATIENT WAS PROVIDED WITH A FULL DOSE OF THE VACCINE IN THE OPPOSITE DELTOID.  THE FIRST DOSE ADMINISTERED 08/14/2021 WAS ON LEFT DELTOID AT 1:15PM PFIZER LOT# FD8448. SECOND DOSE ADMINISTERED 08/14/2021 WAS ON RIGHT DELTOID AT 1:25 PM PFIZER LOT # FD8448.
Redness/swelling from 7/10/15-7/11/15 went to walk in. BENADRYL 12.5mg Q 6 hours PRN et ORAPRED 15mg/5ml 1 tsp dly x 5 days.
Pfizer booster administered 20 days early  No negative effects observed during the administration of the vaccine nor during the 15 minutes observation period after
I also have had symptoms of swollen armpits since my booster vaccine on Nov 2 2021. My armpits are still swollen , (but not as bad  as after my booster),and very smelly to the point I have to wash my underarms a few times a day and change my clothes frequently. I normally don?t need to wear deodorant and don?t smell when I?m warm.  I tried soaking my armpits twice a day with warm water for 5 minutes & for 2 weeks.  The smell is not as bad now, 02/08/2022, as it was in November 2021 and I only have to wash my underarms once a day. If I take a bath the night before, I still have to wash my smelly wet underarms in the morning again. Now the smell only happens in the morning. I am going to see my physician for the swollen armpits to make sure something  else is not going on.  Please add this also to the possible Covid vaccine reaction list.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Information regarding the patients's medical history, concurrent condition and concomitant medication was not reported. On unknown dates in 2016 (reported as since 01-JAN-2016), the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 prefilled syringes (dose and route were not reported, lot# reported as L040181, expiration date 08-AUG-2017). No adverse effects had been reported. The PNEUMOVAX 23 vaccines underwent the temperature excursion of -3 Celsius degrees for 19 hours. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from the registered nurse regarding 1 day old female patient who on 28-JUN-2014 at 02:38 AM was vaccinated with improperly stored first dose of RECOMBIVAX HB (Thimerosal Free) (lot # J012520, expiration date 30-JAN-2016) dose not reported, intramuscularly. The reporting nurse stated that there were no adverse events (reported as zero) after the vaccination. The reporter stated that, on unspecified dates (between May 14 and July 21), vaccine storage temperature dropped to 0-1 degree in 18  different episodes, and that according to minimum and maximum, all recorded temperatures were supposed to be between 2-8 degrees. This is one of several reports from the same source. Additional information is not expected because all follow up information was received.
Got shots on 10/15. Rash started on 10/17. Patient seen 10/21 and had erythema multiforme. Other than rash she was fine so we did not treat or give steroids. As of 10/23 rash slowly ending based on phone call to mom.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 29-MAY-2014 the patient was vaccinated with VARIVAX (lot# and expiration date not provided) of dose 0.5 ml (milliliters) subcutaneously. It was reported that VARIVAX was exposed to an improper temperature for the third time on 29-MAY-2014 in which it reached a high temperature of 25 Farenheit (F) for 20.5 hours. No adverse effect was reported. No product Quality complaint involved. Outcome of medication error was not reported. This is one of several reports from the same reporter (Same Reporter Link: MARRS#1405USA015420, MARRS#1405USA015421, MARRS#1405USA015422, MARRS#1405USA015423, MARRS#1406USA005107, MARRS#1406USA005108, MARRS#1405USA014687). Additional information has been requested.
Patient complained of immediate pain near shoulder joint after vaccination. There was a note on the Allergic Reaction record to call patient "about injection." Patient called 2/9/21 at 11:13 am to inquire about injection by Nurse. Patient states her arm started hurting within 3 minutes after injection and was focal. Per patient, her shoulder has been hurting since the day of injection, but it is much improved currently. She reports pain with palpation and upward movement, but again significantly improved. Reports taking Tylenol once to alleviate pain but has not taken any more pain medication so as not to interfere with antibody response to vaccine. Instructed to report symptoms to PHP for follow-up
Pt recv vax on unknown day; on 1/19/99 pt exp varicella lesions
This vaccine is the updated Pfizer version.  I have had the standard vaccine, boosters, and the bivalent prior to this vaccine.   I was tired on September 24 and heart palpitations started Monday September 25 and have continued through September 26.  I have dizziness and some shortness of breath, although the shortness of breath is not constant.  The heart palpitations are frequent (very).  There is no pain whatsoever.
DIED OF COVID; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age and unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, it was reported that "My Brother took your vaccine, he died of covid soon thereafter!" (Suspected vaccination failure). It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of covid on an unspecified date, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0- 20211248611-Covid-19 vaccine ad26.CoV-2.s- Died of COVID. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. :20211248611-Covid-19 vaccine ad26.CoV-2.s- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: COVID-19
Bumpy, itchy rash on both thighs, both calf?s and arm of injection n site.  Moderna booster 12/13  4pm and rash later in day 12/14. Telehealth appointment 12/16. Have been taking Zyrtec and Benadryl, with only periodic relief. Will begin course of steroid 12/19.
pt recv vax 12JAN98 & on 16JAN97 pt started having neck pain then should discomfort (bilat) & now arm discomfort (bilat);
Metallic taste in mouth immediately after. Loss of smell and taste hours later.  Arm soreness
a cough; chest tightness; drug rash; a red ring around the injection site; patient believed there was a drug interaction with the PNEUMOVAX 23 and her TRESIBA; This spontaneous report as received from a physician via field employee refers to a 76-year-old female patient. The patient's concurrent condition included diabetes mellitus. No information regarding the patient's medical history or allergies was provided.  On 08-JAN-2020 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S033516, expiration date 29-JUN-2021 (dose, frequency, and route of administration were not reported) for prophylaxis. Other suspect therapies included insulin degludec (TRESIBA) (dose, frequency, route of administration and indication were not reported). On 16-JAN-2020, the patient experienced a drug rash, a red ring around the injection site for the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), a cough and chest tightness. On 24-JAN-2020, the patient was seen in the office and all symptoms had resolved. Physician informed field employee that the patient believed there was a drug interaction with the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and her insulin degludec (TRESIBA). No treatment was given for the adverse events.  The outcome of a drug rash, a red ring around the injection site, a cough, chest tightness and drug interaction was reported as recovered/resolved. The causality assessment between the events and the suspect therapy was not provided.
pt recv vax & MD noticed lt arm DTAP site red, swollen (about 2 1/2 x 2 1/2") soft, no pain, no fever & child appeared well;mom reported that sweling started noc of vax;APAP given;
Information has been received from a health professional concerning a 22 year old female who was vaccinated on an unspecified date with her first dose of GARDASIL (lot# not reported). Subsequently the patient experienced a rash on her neck and chest the same day as the vaccination. Subsequently, the patient recovered from rash on neck and rash on chest. The patient sought unspecified medical attention. Additional information has been requested.
Pt reports numbness and tingling in the right arm since 4/24/2021 when he received the vaccine. The vaccine was administered at school
Pt recvd vax 29JUN92 & exp lt deltoid pain ot lt elbow until 13JUL92; 13JUl92 exp new onset lt 4th & 5th digit & unlnar hand numbness (pins & needles); 13JUl92 was seen the ER dx as having paresthesia lt ulnar nerve dermatome;
Significant stomach ache; Could not eat, could not drink; napped most of the day. Thought she was going to vomit, felt Nauseated; significant headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Significant stomach ache), FEEDING DISORDER (Could not eat, could not drink), SOMNOLENCE (napped most of the day.), NAUSEA (thought she was going to vomit, felt Nauseated) and HEADACHE (significant headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2022 at 10:00 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2022, the patient experienced ABDOMINAL PAIN UPPER (Significant stomach ache), FEEDING DISORDER (Could not eat, could not drink), SOMNOLENCE (napped most of the day.), NAUSEA (thought she was going to vomit, felt Nauseated) and HEADACHE (significant headache). On 16-Apr-2022, ABDOMINAL PAIN UPPER (Significant stomach ache), FEEDING DISORDER (Could not eat, could not drink), SOMNOLENCE (napped most of the day.) and NAUSEA (thought she was going to vomit, felt Nauseated) had resolved. On 19-Apr-2022, HEADACHE (significant headache) had resolved.            No concomitant medication was reported.    No treatment information was reported.  The patient received the Moderna 2nd Booster dose.  Patient reported that by Tuesday 19-Apr-2022 patient had no other issues.   This case was linked to MOD-2022-546346 (Patient Link).
Sore arm, extremely achy body all over, lasting 4 days, fever of 101.6, lasting 1 day, vomiting.
pain at the injection site; body pain; generalized weakness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date).   On 13th October 2020, the patient received the 2nd dose of Shingrix. On 13th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, general body pain and weakness generalized. On an unknown date, the outcome of the injection site pain, general body pain and weakness generalized were unknown.   It was unknown if the reporter considered the injection site pain, general body pain and weakness generalized to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-Jul-2022 Reporter's comment: The patient reported the case. The patient received a dose of Shingrix and experienced pain at the injection site, body pain and generalized weakness.  The reporter was given medical disclaimer. Referred to health care professional. Spoke per package insert (PI) and content. Provided medical information phone number for HCP reference. The reporter consented to follow up. Additional Supportive Information: The age at vaccination was auto populated in patient tab and product tab, which were different age.
Severe pain and swelling of R hip and L knee joints.  So severe the Meloxicam did not help. Took Tylenol but not effective. Could not walk up stairs due to hip and knee pain.  I reported these problems on vsafe.  Did have joint and muscle pain with previous 3 Moderna vaccine x2and 1booster but was less severe and shorter duration
Physician is calling in to report an AE on a patient that was administered MMR-II and VARIVAX while undergoing treatment for Lupus on immunosuppressive therapies BENLYSTA and prednisone; This spontaneous report was received from a physician and refers to a 40-year-old female patient. The patient's concurrent conditions included lupus. Concomitant therapies included belimumab (BENLYSTA) and prednisone. There was no information about the patient's drug reactions, allergies or medical history provided.   On 20-JUN-2022, the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) one injection intramuscularly for prophylaxis (indication also reported as "MMR-II PRE-EMPLOYEMENT AT MEDICAL CENTER") (exact dose, anatomical site, lot # and expiration date were not provided), and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) one injection intramuscularly for prophylaxis (exact dose, anatomical site, lot # and expiration date were not provided). The patient was administered the suspect products while undergoing treatment for lupus on immunosuppressive therapies of belimumab (BENLYSTA) and prednisone (Product use issue). It was unknown if the patient was treated for this event.
the patient received improperly stored vaccine.; Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medication were not provided.  On 30-SEP-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dose, lot number S004251, expiration date 22-SEP-2020, orally for prophylaxis (Product storage error). The storage temperature was 1.4 degrees Celsius for a time frame of 20 minutes. Previous temperature excursion was 10.5 degrees Celsius for 56 minutes. The call was because of a data logger.
Right leg (redness, warm to touch and itchy), treatment was ice on leg and Benadryl for itchy.
Approximately 30 minutes post vaccination, patient complained of not feeling well.  BP checked 130/92, P =82. Diabetic.  Had not taken meds this morning. Admits to having eaten irregularly throughout the day.  Hydrated with water, gave Gatorade and a snack.  Continued to monitor.  BP rechecked which was recorded at 145/97 and P= 80.  Resident on site.  Neuro checks done by resident.  Left sided weakness with sensory changes on left side were noted.   Ambulance called.  Patient transported to Hospital for observation.
PT reported feeling dizzy, noted visual disconnect. (pt looked sweaty) provided water/snack and also rest.
NAUSEA AND DIZZINESS, ONSET LESS THAN TWO HOURS FOLLOWING INJECTION.  PATIENT STATES NURSE GAVE TWO INJECTIONS, DUE TO NEEDLE FAILURE, VACCINE LEAKING DOWN ARM AFTER FIRST INJECTION.  UNABLE TO RETURN TO WORK AT HOSPITAL DUE TO SYMPTOMS.  HOME ON BED REST. 24 HOURS LATER, S/S HAVE NOT RESOLVED.