chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 35 year old female who on 30-OCT-2007 was vaccinated intramuscularly with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine, (lot # "0099U") and concomitantly was vaccinated with influenza virus vaccine (unspecified). It was reported that the patient experienced soreness and pain up her arm but not at the injection site, with a rash or redness of the blood vessels of her hands and wrists. She was treated with ibuprofen and ice. It was not known if the patient had received a pneumococcal 23 v polysaccharide vaccine in the past. The patient sought unspecified medical attention by phone. At the time of the report, it was unknown if the patient recovered. The nurse reported on two other patients that experienced adverse events after receiving pneumococcal 23v polysaccharide vaccine (0711USA02461 and 0711USA00610). The patient worked with 45 persons that were vaccinated during a vaccine clinic at their company. A total of 45 persons received the influenza virus vaccine (unspecified) and 12 persons received pneumococcal 23v polysaccharide vaccine. There have been no other adverse symptoms reported. Additional information has been requested.
I have not had my period for 4 months since I received an IUD. About 24 hours after receiving my vaccine I experienced cramping and heavy bleeding. The bleeding lasted for three days and then stopped. Also had a fever (100.0) both friday night and saturday morning.
This spontaneous report was received from a health care worker refers to a patient of unknown age and gender. No pertinent medical history of the patient was reported. On 21-MAY-2014 the patient was vaccinated with M-M-R II, 0.5 ml, subcutaneous (Lot # H010137; expiration date 17-MAY-2014). No concomitant medications were reported. It was reported that the patient received an expired lot of M-M-R II on 21-MAY-2014. No adverse effect reported. The outcome was unknown. The reporter reported that one more patient had received vaccination with expired M-M-R II on 20-MAY-2014. This case is linked to MARRS # 1405USA011648 via the same reporter link. Additional information has been requested.
she   got  couple episodes of vomiting  next day of vaccine and  by the  day after morning  she  became unresponsive and   took to ER and found   benign meningioma ( not known before ) and uncle  herniation,  thalamic infarct and  followed by went for the   decompressive surgery at the and   brought home after 2 week and at the 3 rd week put on  hospice and diet on  03/18/2021. She would be alive today if she hasn't received vaccine.
I took mine and still had a slight case of them/suspected vaccination failure; had a slight case of them.; 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.  It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient took the Shingles vaccine and still had a slight case of shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Within 3 hours of getting the shots, patient developed a high fever, shaking chills, fatigue, loss of appetite, and dizziness.  Her L arm was swollen and red. The pain was so severe she could not move the arm. She lost sensation in both hands and only felt tingling.  Patient states her temperature was around 102. Symptoms lasted 48 hours. Patient did not seek evaluation or treatment. She did report occurrence to clinic but did not respond to return telephone calls.
Enlarged lymph node on neck; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (Enlarged lymph node on neck) in a 61-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Enlarged lymph node on neck). At the time of the report, LYMPHADENOPATHY (Enlarged lymph node on neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: reporter details updated
10/2-10/4: febrile (101-102, tmax 104) 10/5-10/9: afebrile, went to school 10/10: headache 10/11: fever returned  10/12: started vomiting and having abdominal pain 10/13: still with abdominal pain, but no longer vomiting,decreased appetitie, still having headaches, fever persisting  Seen in clinic 10/14/21, labs drawn which showed leukopenia, thrombocytopenia, elevated LFTs, Ferritin > 3000, fibrinogen 159, fibrinogen 159,  and elevated bili 3.7 and splenomegaly on USi. Child admitted with probable diagnosis of HLH. Father concerned it is related to Flu shot.
hives/welts from her feet to her scalp; wheezing; shortness of breath; Where she received the injection looked like bubble wrap; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives/welts from her feet to her scalp), WHEEZING (wheezing), DYSPNOEA (shortness of breath) and INJECTION SITE REACTION (Where she received the injection looked like bubble wrap) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine. Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    In October 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives/welts from her feet to her scalp), WHEEZING (wheezing), DYSPNOEA (shortness of breath) and INJECTION SITE REACTION (Where she received the injection looked like bubble wrap). At the time of the report, URTICARIA (hives/welts from her feet to her scalp), WHEEZING (wheezing) and DYSPNOEA (shortness of breath) had not resolved and INJECTION SITE REACTION (Where she received the injection looked like bubble wrap) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient took steroid and when the steroids stopped her welts came back. They were not as severe as when they first started, but she continued to have them on her legs, back, shoulders, face, and chin.   Reporter did not allow further contact
Patient symptoms began 8/30/21.  Pt presented with low grade temp, nasal congestion, mild SOB and treated as outpatient on 8/30/21 with Augmentin and increased dose Prednisone by our team.  Tested positive for COVID 8/30/21.  Received monoclonal antibodies on 8/31/21.  She needed 2L O2 but at baseline on RA.  Outpatient labs showed AKI with Cr 2.64 so we asked her to come to hospital.  During hospitalization, pt did require O2 via NC (2.5L) and treated with Decadron and Remedesivir x 5 doses. Will complete 10 days course of Decadron as outpatient. Has received COVID vaccine x 3 doses. Patient received her last COVID vaccine booster within one week of symptom onset.
pt. recvd 2 doses of hepatitis B vaccine & 1 month after 2nd dose recvd 3rd inject w/no adverse effects.
Migraine; vomiting; flu like symptoms; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number : EN6198, via an unspecified route of administration in the left arm on 25Feb2021 at 12:00 (at the age of 55-years old) as a single dose for COVID-19 immunisation. Medical history included connective joint arthritis, HTN, fibromyalgia. Concomitant medications include prednisone (MANUFACTURER UNKNOWN), hydrocodone (MANUFACTURER UNKNOWN), fentanyl patch (MANUFACTURER UNKNOWN), duloxetine (CYMBATLA), all for unknown indication from unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 26Feb2021 at 00:00, the patient experienced migraine, vomiting and flu like symptoms. The clinical  outcome of the migraine, vomiting and flu like symptom was recovered on unknown date in 2021.   No follow-up attempts are possible needed.  No further information is expected.
Pt c/o headache, achy joints, swelling and redness@ SQ injection site 1 day post-vaccination. Pt was seen at another facility and given antibiotics.
Pruritic papulo vesicular eruption concentrated on distal extremities, few on palms/soles, thighs no oral lesions. Started on day 14. Tx with Cyclocert ointment due to severe pruritis. Improved in 3 days-resolved in 7.
headache, injection site sorenesss, nausea (moderate),  fatigue (moderate), body aches/chills (moderate), temp 99.4 deg,  notified employee health, had a Covid test (came out Negative),  sent home for the day.
having to walk with a cane; are really cold; feeling really sick; are really dizzy; This spontaneous case was reported by a non-health professional and describes the occurrence of ILLNESS (feeling really sick), DIZZINESS (are really dizzy), GAIT DISTURBANCE (having to walk with a cane) and NASOPHARYNGITIS (are really cold) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Feb-2021, the patient received second 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 10-Mar-2021, the patient experienced ILLNESS (feeling really sick), DIZZINESS (are really dizzy) and NASOPHARYNGITIS (are really cold). On an unknown date, the patient experienced GAIT DISTURBANCE (having to walk with a cane). At the time of the report, ILLNESS (feeling really sick), DIZZINESS (are really dizzy), GAIT DISTURBANCE (having to walk with a cane) and NASOPHARYNGITIS (are really cold) had not resolved.
Patient diagnosed with COVID on 6/6/21.  Patient was fully vaccinated.  Patient admitted to our hospital with respiratory failure and COVID-19 pneumonia on 6/9/21.   Patient was treated with oxygen, remdesivir, dexamethasone, and antibiotics.  His pneumonia progressed, oxygen requirements increased, and chest xray showed worsening airspace opacities and decreased aeration.  Patient's code status was updated to DNR/DNI per family request.  Patient's condition continued to deteriorate and patient expired on 6/13/21.
Covid vaccine monitoring documentation. PT admission 3/10/2022 ? 3/21/22 PFIZER 2/25/2021 LOT# EN6198 PFIZER 3/18/2021   LOT# EN6207 PFIZER 12/7/2021   LOT# FJ1620
patient was administered with Flublok Quadrivalent 2 times, 30 days apart with no AE; Initial information regarding this unsolicited valid non-serious case was received from other healthcare professional via agency (Reference number- 00321520) and transmitted to Sanofi on 19-Oct-2020.  This case involves a 66 years old male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] 2 times, 30 days apart (extra dose administered).  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  On an unknown date in Sep-2020, the patient received a first dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number unknown and expiration date unknown] via unknown route at unknown administration site for prophylactic vaccination and on 16-Oct-2020 (one month later from first dose), the patient received a 0.5 ml second dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number UJ455AA and expiration date 17-Mar-2021] via intramuscular route at unknown administration site for prophylactic vaccination (extra dose administered).  It was a case of actual medication error due to extra dose administered (latency: same day of extra dose administered).  At the time of reporting, patient had not experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
HPI from 2/22/19 office visit (ER follow up): Patient had onset of right upper arm pain beginning about 2 hours following administration of PPSV 23 here in our office on 2/18. The pain escalated to the point where it was extremely severe. She was unable to move the arm using the deltoid muscle and really could not even flex the elbow. The pain did not extend below the elbow. It was a deep ache, not a burning pain. She took a hot bath at home to try to relieve the pain and had an episode of syncope while in the tub. Fortunately, her husband was at home and was able to lower her down to a safe area. No head injury or submersion. She then had an episode of vomiting and diarrhea and 911 was called. She was transported to the ER and evaluated. She received 1 L of fluid, a shot of TORADOL and 10 mg of hydrocodone. Pain started to subside, vital signs were stable and she was discharged to home. There was no evidence of respiratory involvement or infection. On 2/19 she was about 50% improved though still had significant pain in her arm with any engagement of the deltoid muscle. She is taking hydrocodone at night and ibuprofen during the day. Today she found to stay she still had pain with muscle movement and it was not really improved from yesterday. HPI from 3/28/19 office visit: Patient was last seen by Dr. on 2/20/19 for pain in upper right arm after receiving PPSV 23 injection on 2/18/19. Last office visit was noted "Likely inflammatory reaction to the PPSV 23 injection. She is improving slowly.  Encouraged her to continue with heat application as it helps relieve pain. Gentle range of motion exercises as tolerated, Ibuprofen. She will watch closely for redness, increasing warmth, fever, worsening pain. Will come in or call for any of these symptoms." Patient called in on 3/6/19 requesting referral to physical therapy. This was generated and one progress report scanned in on 3/11/19 from Physical Therapy. Today patient states she has been getting PT twice a week for the last couple of weeks. States that it feels good but has on going pain and feels she has pain with some movements. Lateral raises will cause an achiness with a pain scale fo 3-4. Does not stop her from moving and is able to raise her arm laterally. At night will "bug her" and at times will have a dull ache to the deltoid muscle. She just wants to make sure that there is no abscess or fluid pocket that should be lanced, and that this is not related to the joint.
Pt states site is somewhat painful. Area is hot, swollen approx 5 in in irregular diameter.
H/o bluish purpura on both sites 1-2 hr after the immz. H/o transient inability to walk next AM lasting 1 hr or so.
A week ago l began experiencing my arm where the shot was given itched. Then my upper back and occasionally my upper chest. I felt l should report this just Incase it worsens. I am using anti itch meds.   I have had asthma and severe allergies my whole life. But felt that Jansen was the safest vaccine to get.  I felt l needed to get the vaccine due to my lungs not being ok. Asthma has taken its toll on them.
tiredness; muscle pain; headaches; chills off and on; joint pain; nausea a little bit; weakness; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 91-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 13Mar2021 at the age of 91-years-old as DOSE 2, SINGLE for covid-19 immunization.The patient medical history was not reported.The patient's concomitant medications were not reported.On an unspecified date the patient experienced tiredness, muscle pain, headaches, chills off and on, joint pain , nausea a little bit, weakness. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
On 10/21/09 you were given the H1N1 vaccine. On January 13th 2010, pt went OBGYN check up for 20 week check up and the baby had no heartbeat. On January 14th, pt delivered a stillborn baby. The baby was normal, the only thing pt. did differently this time is receive the H1N1 vax.
Patient was administered the Covid-19 vaccine, manufacturer Janssen at the off-site clinic on 04/09/2021. At the time vaccine was administered, patient just turned 17, under recommended age range for Janssen manufacturer. Patient's mom was reached at 3:40pm 05/12/2021. She confirmed that she was aware of the vaccine her son received was Covid-19 Janssen, and her son has been doing well since the date of administration. No adverse reaction was reported. The incident  was reported to liability intake.
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache after just just getting the second shot) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache after just just getting the second shot). At the time of the report, HEADACHE (Headache after just just getting the second shot) outcome was unknown.            No concomitant medication information was provided by the reporter.   No treatment information was provided by the reporter.   Reporter did not allow further contact
gave a Tdap instead of a Dtap  Advised mom to go to ER if adverse reactions. will follow up with mom for the next 2 days
Right arm. The pain in my under arm was painful. I also could not sleep. It felt like it was swollen. I could not put arm all the way down by my side or it would hurt. Right arm upper. This also happen with a flu shot back in 2010. When I took it. I don't know why this is happening. Left arm upper. It seems to be settling in the lymph nodes.
doses of improperly stored MMR II were administered to 9 patients on  unspecified dates; No additional adverse symptoms reported; This spontaneous report has been received from an officer manager, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and, previous drugs reactions or allergies were not provided by the reporter.  On an unknown date, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (therapy type: rha), lot number S006051, and expiration date 27-FEB-2021 for prophylaxis. Details about strength, dose, dose number, route of administration, and anatomical location were not provided. It was unknown if the sterile diluent (DILUENT MRK) (lot number and expiration date were unknown by the reporter) used for reconstitution of the vaccine, was stored at proper temperature.  The highest temperature was above 47 degree Fahrenheit (°F) (53 Fahrenheit), for a timeframe of 17 hours, with no previous temperature excursion. The call was due to the Digital Data Logger.  No additional adverse symptoms were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA005521: US-009507513-2001USA005522: US-009507513-2001USA005516: US-009507513-2001USA005524: US-009507513-2001USA005525: US-009507513-2001USA005519: US-009507513-2001USA005518: US-009507513-2001USA005520:
FEVER WITHIN 24 HOURS OF RECEIVING THE VACCINE; CHILLS WITHIN 24 HOURS OF RECEIVING THE VACCINE; FATIGUE THAT WORSENED WITHIN 48 HOURS AND THEN GOT BETTER IN 72 HOURS; BODY ACHES FOR TWO DAYS; This spontaneous report received from a consumer concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072 expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced fever within 24 hours of receiving the vaccine. On MAR-2021, the subject experienced chills within 24 hours of receiving the vaccine. On MAR-2021, the subject experienced fatigue that worsened within 48 hours and then got better in 72 hours. On MAR-2021, the subject experienced body aches for two days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever within 24 hours of receiving the vaccine, chills within 24 hours of receiving the vaccine, fatigue that worsened within 48 hours and then got better in 72 hours, and body aches for two days on MAR-2021. This report was non-serious. This case, involving the same patient is linked to 20200840971.