chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date, the patient was inadvertently vaccinated with VARIVAX (Merck) instead of ZOSTAVAX. Concomitant medications were not reported. No adverse effect reported. The outcome was unknown and causality was assessed as not related. Product quality complaint was not involved. No other information provided. Additional information is not expected.
Completed 2 Doses and Titers Does Not Show Protective Immunity; Initial Report Received on 15-Jan-2022  A medical assistant reported that a patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the did not show protective immunity.  No relevant medical history was reported.  No concomitant medications were reported.  On 06-Jul-2021, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported).  On 09-Aug-2021, the patient received the second dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported).    In Jan-2022, titers taken did not show protective immunity.  No additional information was reported.   Company Comment: The company assessed the event as non-serious. The event is not immunologically confirmed as the results of the titers is not available.; Sender's Comments: The company assessed the event as non-serious. The event is not immunologically confirmed as the results of the titers is not available.
Child ran a low grade fever for 2 days after immunizations. On 8/1/08. She broke out in a rash. Pink raised bumps all over her body, face, arms, legs and back. At the time of the call, she was not itching, had no fever and was acting fine.
On the next day, 06/02/2021 and lasting 4 days, I experienced the following:  painful left shoulder/arm, headache, extremely tired, uncontrollable diarrhea.  Note:  Daughter living in another city also had trouble over 4 days with the second shot.    My Mother had Guillen-Barre Syndrome over 40 years ago and was incapacitated for a year.
This spontaneous report as received from a healthcare student (degree: doctor of pharmacy) refers to unspecified female patient of unknown age. In March 2008 the patient was vaccinated with the first dose of GARDASIL (lot#, strength, dose, route and indication unknown). In May 2008 the patient was vaccinated with the second dose of GARDASIL (lot#, strength, dose, route and indication unknown). On approximately 16-MAY-2014 (reported as within the last one to two weeks) the patient was vaccinated with the third dose of GARDASIL (lot#, strength, dose, route and indication unknown). No adverse event was reported. Action taken with GARDASIL was unknown. The outcome of the event was not provided. Additional information has been requested.
Pt recvd a series of Hep B vax 13DEC90, 15DEC90 & 30DEC90 & reporter indicated that pt tested neg p/series; pt was retested approx 12-15 wks & is still negative;
On October 30, 2015 I received the vaccine before 3 PM I believe. On November 10, 2015 at between 6 AM and 8 AM my son was kicking and fine. Plenty of movement. At 10 AM I lost my appetite. At 11 AM I became sleepy and felt exhausted. At 2:15 I woke up to my alarm to get ready for work. At 230 it was obvious I was sick and the symptoms came on very quickly. First diarrhea, then body pain, then vomiting, malaise, fatigue. I felt horrible. It felt like the flu 100%. My baby died that day. Went to ER around 930 PM and couldn't keep water down. I felt horrible. The staff didn't address my dehydration immediately. Nor did they care about my pain, etc. They just wanted to check on baby. His heart was no longer beating on November 10, 2015. We had our last sono the next day November 11. He was lifeless. No cord around his neck. No obvious issues. No heartbeat. Nothing. He was stillborn at 3 lbs. 15 oz. On November 15, 2015. I tried to deliver him VBAC. We were going to test amniotic fluid however one of the residents came in and ruptured membranes November 14, 2015 night to November 15, 2015 early AM. My abdomen lost all fluid and she denied rupturing. She said she was washing me off. However, I watched her take a crochet hook like tool in between my legs and there was a pop and release of fluid. I felt the amniotic fluid leave my body and my abdomen deflated and kind of hugged the shape of my son. My abdomen was no longer perfectly round. The fluid was flushed. I spiked a fever that morning before surgery. Lost 1500 ml of blood during C-section. Lateral incision horrible infection. Low H and H. Baby had bright red face and bright red lips.
Patient was one of 8 patients sent from a local nursing facility secondary to COVID-19 outbreak. No reported complaints initially, but was found to be hypoxic on arrival. Improved to 95% on 3L nasal cannula. Febrile on admission at 100.1 degrees F. CT scan of chest showed no evidence for pulmonary embolus, but there was bilateral ground glass opacities, small pericardial effusion, and lytic lesions throughout the bones consistent with metastatic disease. Patient declined, satting at 80%, which led to intubation and PICC line placement. Patient was stabilized and eventually extubated. Discharged in stable condition.
Vomiting and chills began around 0300 on 07/14/20.  As of 07/15/20 at 1000, patient reports that she continues to have chills and body aches.  The injection site is red, hard, and warm to the touch per patient report.  She states that she vomited again this AM.  She denies fever; she has been checking her temperature at home.
Redness, swelling where the shot was given, soreness, aches. Hoarseness, wheezing, hives ( mild ) Shot was given on 11/15/05 I still have
pneumonia with pleural effusion; pneumonia with pleural effusion; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 18-NOV-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Less than one (1) month (approximately in 2016) after receiveing zoster vaccine live (ZOSTAVAX), the patient was hospitalized and diagnosed with pneumonia with pleural effusion. As a direct and proximate result, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX), the patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. 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.   Upon internal review, pneumonia was considered to be medically significant.    Both events were considered to be disabling due to the severe, permanent and incurable injuries.
At 2 PM on 6/6/2021 I received the second shot of the Moderna Covid-19 vaccine.  At approximately 1 AM early morning of 6/7/2021 patient experienced Chest pain and shortness of breath.  At approximately 4 AM I woke up and was itchy in several places on my body and saw rashes which were red and raised located on back of neck, both hands, both arms, her right hip behind both ears, left knee, right thigh and left shoulder,  right upper mid-chest area to right side. After that took an immediate shower and then left to go to the Emergency Room and arrived approximately at 5:30 AM. ER Doctors gave Prednisone and Benadryl at 6:10 AM.  After a few hours rashes appeared to start to leave.
Information has been received from a registered nurse concerning a 45 month old female who on 06/26/2002 was vaccinated with a dose of varicella virus vaccine live.  On 02/17/2005 a titer was taken that did not show seroconversion.  It was reported that the patient had no symptoms.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested.
Extreme pain in right sholder.  Can't lift arm above sholder or reach across body.
anemia; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (anemia) in a 29-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAEMIA (anemia). At the time of the report, ANAEMIA (anemia) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was reported.  It was reported that the patient now can't get kids anymore.  No treatment medication was reported.    Most recent FOLLOW-UP information incorporated above includes: On 06-Jan-2022: Live Follow-up: No new information was reported.
Black spots, and skin started peeling all over my body. On Dec 18th I went and seen doctor. He gave me prescription Triamcinolone 0.1% cream. Also using GOLD BOND lotion.
Rash all over my body. Still there .  Took Benadryl at advice of Doctor.
PARTIAL DOSE GIVEN; This spontaneous report received from a pharmacist concerned a male patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 25-MAY-2021) dose was not reported, administered to left deltoid on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, partial dose administered to the patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose given was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and partial dose given as not related. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  20210333938-COVID-19 VACCINE AD26.COV2.S - Partial dose - 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.
Got vaccine on a Wednesday, that Saturday I had no energy to move around, legs and arms felt very heavy.  That Sunday morning, I had a very bad migraine headache.  The extreme tiredness lasted for over a week, along with muscle weakness.  Second week, met with with my Dr., who did extensive bloodwork, but could not find anything, so he suggested I get some rest.  The tiredness, muscle fatigue and weakness continued, along with headaches.  By the third week, I had developed tinnitus in my left ear.  My ENT said said my ears and hearing are good, and that maybe the tinnitus would go away, I still have tinnitus in my left ear. It seemed that now I was also allergic to some foods and drinks I always consumed.
This case was reported by a other health professional via call center representative and described the occurrence of nonspecific mesenteric lymphadenitis in a 52-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of gastric ulcer (1st dose received on 2nd March 2018 (see case US2018132467)). On 29th June 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced nonspecific mesenteric lymphadenitis, injection site rash, fever, enlargement of lymph nodes, lumbar pain, local swelling and belching. On an unknown date, the outcome of the nonspecific mesenteric lymphadenitis, enlargement of lymph nodes, lumbar pain and local swelling were unknown and the outcome of the injection site rash, fever and belching were recovered/resolved. It was unknown if the reporter considered the nonspecific mesenteric lymphadenitis, injection site rash, fever, enlargement of lymph nodes, lumbar pain, local swelling and belching to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a medical technologist who was also the patient. At the time of reporting, the patient was 52 years old. The age at vaccination was not reported, but the patient could be 51 or 52 years old. After receiving the dose of SHINGRIX, the patient had a rash at the injection site, fever for 2 days, right groin lymph nodes were swollen and enlarged. His lumbar region was swollen and painful. The patient said it felt like he had a kidney stone infection and stated that he was belching for days. The patient was diagnosed with mesenteric lymphadenitis and had to go to an urgent care facility after the dose of SHINGRIX. The patient underwent a magnetic resonance imaging (MRI). The patient's call was escalated to a vaccine specialist. The patient had agreed for any additional information and had supported documentation if necessary. This case was linked with US2018132467, reported for the same patient for 1st dose of SHINGRIX.
Pt called and complained of tingling sensation in her arm after she got the flu shot on 9/24/19. Per pt, the pain didn't go away and still persists until now. Per pt, no redness, but cannot raise arm past her shoulder. She feels that range of motion is limited.
pt vax w/ 1st & 2nd hepta B. on 28Jun90 & 26Jul90.  01Oct90 pt devel itching and urticaria of shoulders bilaterally at inject site.  itch and rash spread down arms and body, pruritus, pt uncomfortable.  See worm...
12MAY93 fever 103.5 from 1PM-8PM, rash on rt cheek 6-8 dots; 13MAY93 fever 103, but not c/o; 14MAY93 no fever; 15MAY93 clingy, sleeping alot, 5 hr nap + 2-1 hr naps; touching mouth; 16MAY93 swelling & pain rt side of face; Bell's palsy;
Since the shot, I have had soreness in my left upper arm muscle.  It has now moved to my left armpit which is very tender and my lymph nodes are swollen.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site edema in a 63-year-old female patient who received SHINGRIX (batch number 4492P, expiry date April 2019) for prophylaxis. Concurrent medical conditions included reaction to drug preservatives. Concomitant products included amlodipine + benazepril and tretinoin. On 1st June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 1st June 2018, less than a day after receiving SHINGRIX, the patient experienced muscle pain, local swelling and localized erythema. In June 2018, the patient experienced injection site edema, injection site rash and injection site hives. On an unknown date, the outcome of the injection site edema, injection site rash and injection site hives were not recovered/not resolved and the outcome of the muscle pain, local swelling and localized erythema were not reported. The reporter considered the injection site edema, injection site rash, injection site hives, muscle pain, local swelling and localized erythema to be related to SHINGRIX. Additional details were provided as follows: Pharmacist did not speak to the patient directly. She read a note left by another pharmacist. The patient called and said that she had the SHINGRIX shot on arm and experienced redness, muscle aches and swelling since the day of vaccination. She still had rash and hives around the injection area without itching. The patient had has no fever nor breathing issues. The edema hat was 2 by 4 rectangular on her arm around the injection site. Pharmacist recommended taking BENADRYL to treat the symptoms. The call was transferred to Medical Information for questions.
Fever for 24 hours, chills, intense injection site pain for 48 hours. Fatigue and loss of appetite.
Booster administered less than 6 months apart from the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster administered less than 6 months apart from the second dose) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster administered less than 6 months apart from the second dose). On 09-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster administered less than 6 months apart from the second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.
Pt got her second dose of Moderna on 01/22/2021 01/23/2021 @ 9AM pt states feeling pain in her left arm.  She noticed a red bump around site of injection (deltoid)  She contacted her provider yesterday and was instructed to take Benadryl.  Today she still has the rash, warm at touch.  She will see her provider for FU on Thursday.
migraines; pressure in her eye; stabbing pain in her eye; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraines), OCULAR DISCOMFORT (pressure in her eye) and EYE PAIN (stabbing pain in her eye) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (migraines), OCULAR DISCOMFORT (pressure in her eye) and EYE PAIN (stabbing pain in her eye). At the time of the report, MIGRAINE (migraines), OCULAR DISCOMFORT (pressure in her eye) and EYE PAIN (stabbing pain in her eye) outcome was unknown.            No concomitant medication information was provided.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Updated contact information - Reporter details with consent to follow up.
Besides a sore arm, About 7 hrs after injection, I started feeling tired and achy all over. In next 3 hrs I tried my temp and had 100.4. I ran fever and had chills and body aches for the next 7 hours. At that time, my fever broke, but I stayed with body aches and fatigue for the next 12 hours.
1/30/21  Severe chest pain when breathing in. The lobe of my right lunng partially collapsed.  1/31/21 Went to ER.  On 2/22/22 went to ER again due coughing and being tired with 1 day of low grade fever and tested positive for COVID and Influenza A.  I did get the flu shot a work.
Reaction to L arm redness, raised, cellulitis lump 11cm x 8cm. Advised to put ice to area and follow up. Needs to follow up.
Information has been received from an office manager concerning multiple patients of unknown age and gender. Information about concurrent condition, medical history, drug reactions/allergies and concomitant therapies were unknown. On multiple unspecified dates, the patients were each vaccinated with a dose of improperly stored VAQTA (dose and route were unknown, lot # M036459 with expiration date 18-JAN-2018) for prophylaxis. No adverse effect was reported. The vaccines had been exposed under temperature 29.6 Fahrenheit and were out of range for 55 minutes. Temperatures were not recorded with a data logger and there was no previous excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003274: US-009507513-1612USA003275: US-009507513-1612USA000738.
Good sized knots; This case was reported by a other health professional via sales rep and described the occurrence of injection site lump in an unspecified number of adult patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent at an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was unknown.   It was unknown if the reporter considered the injection site lump to be related to FluLaval Quadrivalent.  Additional case details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the patients were employees and they had good sized knots after receiving the flu vaccination. The reporter consented to follow up. This case has been linked to US2019AMR176824, reported by the same reporter.
Pt given vaccine that expired on 7/20/18. Inventory completed and delivered this am and expiration date checked AFTER administration of medication.
Shots given 11-07-06, leg reddened overnight to dime size area, warm to touch 11/08/06 temp in pm 103.  Diarrhea and vomiting ER that night, admitted to hospital with IV's antibotics, released on 11/10/06. 11/30/06 Received medical records from hospital which reveal patient admitted 11/8/06 with fever, N/V & decreased urine output with fussiness.  Temp on admit was 101.1.  Improved with IV hydration & was d/c to home on 11/10. Final DX: fever, oliguria, nausea & vomiting & gastroenteritis.
arm itching, swelling all over arm-red, & hot to touch w/pain w/increasing intensity;rx APAP & ASA & ice packs;inner arm bright red now yellow still tender to touch;
Patient states her legs became very weak about 4 days after receiving vaccination. This required her to go to the ER where they asked her to call the pharmacy about the H1N1 vaccination. She had underlying neurologic issues, but the MD is confused about this particular condition.
3 days after receiving my 2nd dose shot, I developed a swelling in my injected arm, around 1pm in the afternoon. The swelling was not on the site of injection but more so towards the right-most upper side of my left arm and moved towards the adjacent underside. This entire area was very red/inflamed and itchy, albeit not an intense itchiness. It was moderately swollen. I checked the CDC website for "covid arm" and followed suggestion for taking an antihistamine. I took 1 benadryl 25mg tablet (otc) around 6pm. I became a bit drowsy about an hour or 2 later. Eventually went to sleep with no further problems. Woke up next morning and the situation seemed to have resolved. No swelling. No redness. No itchiness. No other issues.
The next morning I developed a fever that ultimately went up slowly all day. I alternated ibuprofen and acetominiphen and could not bring it down. Last night, around 8:00pm it was over 103. My husband wanted to take me to the ER, but with Covid I did not want to go to the hospital. It was after midnight that it began to creep down into the 102's and at some point I fell asleep.  This morning (Wednesday) my arm/injection site is very red and much larger than the injection itself and my fever is still 101.6.  I would also like to note that in 1996 I did have Shingles.