chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; administered to patient post excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.   This case involves Adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunization).   It is unknown if the patient experienced any additional symptoms/events It is unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
1. Family practice clinic. 2. Hepatitis A vaccine, 0.5 ml given in (R) thigh IM 3. I was notified by my lead supervisor that an 18 month old patient was given her 2nd dose of the Hepatitis A vaccine a week too early. This was found out through the XX State Child Profile website. I failed to check the last date when this patient's 1st Hepatitis A vaccine was given. I have notified the patient's mother and advised her to bring the patient back in to the office 6 months on/after this last dose was given. I advised her this 2nd Hepatitis A vaccine given in error will not help to boost the patient's immunity against the Hepatitis A virus. She verbalized understanding. The patient is doing fine. 4. I plan on checking the XX State Child Profile website for each vaccine date patients have received their vaccines to ensure accurate dosing and scheduled immunizations.
I experienced pain and swelling in my right arm-pit, as well as pain in my right arm when I move it around beginning on 3/10
Administered expired COVID-19 vaccine (5-11 year Pfizer formulation): 8/31/2022 expiration date assigned. The items were not properly quarantined in the pharmacy refrigerator storage unit, but dispensed to nursing staff. Doses administered to two patients, one an 11 year-old female receiving their first booster vaccine after completing the 2-dose primary series. The second patient a 9 year-old male, also receiving his booster after completing the 2-dose primary series. After the vaccines were administered, the nurse attempted to document the vaccines in the system. The expiration was noted, however the vaccine lot number was not available since the vaccine was expired. Pharmacy was notified as well as the doctor. Pfizer was contacted regarding available in-house viability data beyond the 12-month viability post-manufacture date. Per Pfizer, no viability data is available beyond current expiration date recommendation. Also, no further information is available regarding revaccination of the two patients. Another Pfizer help desk representative took the patient's information for further follow-up. Pfizer stated the information will be forwarded to their safety team to see if there is any physical stability testing on further viability beyond 12 months after manufacture. If viability information exists, then the CDC can be contacted for further clinical guidance. Response from the safety team may take 2-3 days. Since no further recommendation on revaccination the doctor recommends not revaccinating the patients at this time.
the next day, after being vaccinated, my left shoulder muscle (deltoid), right where the vaccine was administered, I felt a bit of a discomfort. and this lasted for about 3 days. after about 3 to 4 days after being vaccinated, "all" my muscles started to ache a bit, and I felt a bit weak. that passed after maybe 3 to 4 days. about 4 to 5 days later, or about 10 days after being vaccinated, the outside of my left arm (where the vaccine was administered) felt strangely over sensitive; to a touch and temperature. for the most part that has subsided now. However, about 4 days ago (a little over 2 weeks after being vaccinated) my left arm feels a bit weird. the feeling is similar to a mildly pinched nerve. for instance, if you sit for sometime with an arm at a weird position, (maybe twisted), you can get a weird feeling, of a bit of a discomfort. not the one where your arm goes numb, but a bit "uncomfortable". but that typically goes away after a couple of minutes after you get up and start moving your arm. Well, this is the feeling now, except that it's been like that for the past 4 days or so. However, no outside reactions, no skin discoloration, etc.  I spoke with a nurse, and she advised me to report this side effect, and to make appointment with my PCP if the symptom does not subside in the next few days.
Several hours after receiving the Moderna booster (02/25/2022), patient developed acute chest discomfort. She didn't know what to do, therefore waited and then sought treatment 03/01/2022 with PCP. Echocardiogram, CRP and EKG obtained. Trialed off Wellbutrin to see if this was the cause without improvement. Since seeking  medical evaluation and treatment she has not had significant alleviation of her symptoms. Seen by cardiology 04/21/2022 with continued chest discomfort that has not significantly alleviated since it started. Diagnosed with Acute pericarditis and currently undergoing treatment with ibuprofen and colchicine.
CHILLS; FEVER OF 100.7; This spontaneous report received from a patient concerned a 39 year old White (Not Hispanic/Latino) male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, high cholesterol, acid reflux, sleep apnea, sulfa allergy, alcohol use, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and  expiry: not reported) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced fever of 100.7. Laboratory data included: Body temperature (NR: not provided) 100.7 (not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and fever of 100.7. This report was non-serious.
Information has been received from a nurse practitioner concerning an 18 year old female patient who on approximately 21-MAR-2007 ("two days ago") was vaccinated with a dose , 0.5ml, of Gardasil vaccine (yeast). Concomitant vaccine administered included tuberculin purified protein derivative. On approximately 21-MAR-2007 the patient "had a reaction after receiving Gardasil (yeast), "described as "a tiny rash on both of her arms." Treatment included diphenhydramine HCl (BENADRYL). The nurse practitioner indicated that the patient was recovering from the rash. At the time of this report, the outcome was uinknown. The NP indicated feeling unsure if the rash was related to GARDASIL. Additional information has been requested.  No further information is expected.
8 hours post inj. temp 102.6 x 3 days. Rapid pulse, fatigue, day 4 temp down 99.8 c/o extreme fatigue x 4 days. 10/21/02 saw pediatrician-no diagnosis other than "let it run its course" child back in school still c/o fatigue and rapid pulse. To f/u with provider within 48 hours.
COVID-19 10 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19 10 days ago) in a male patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced COVID-19 (COVID-19 10 days ago). At the time of the report, COVID-19 (COVID-19 10 days ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information was provided.  Company Comment: This spontaneous case concerns a male patient, of unknown age, with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred on an unspecified date in Mar2022 after administration of the third dose (first booster dose) of the Moderna mRNA-1273 vaccine on an unspecified date. There was no information regarding the initial two doses. Treatment information was also not provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient, of unknown age, with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred on an unspecified date in Mar2022 after administration of the third dose (first booster dose) of the Moderna mRNA-1273 vaccine on an unspecified date. There was no information regarding the initial two doses. Treatment information was also not provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Day after vax, soreness, fatigue, that night felt. Pins and needles throughout body with cold and hot sensations.
I got the 2 dose shindig vaccine but this year got shingles/ suspected vaccination failure; got shingles; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles on face 4 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, got the 2 dose Shingrix vaccine but this year got shingles in same place. The reporter asked should get the Shingrix vaccine again. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
Uncontrollable shivering, vomiting, body pain, lethargy, no appetite
On Nov 16th, my mouth started feeling numb so my son took me to the doctor. They gave me a CT scan but told me I didn't have a stroke.  I went back the next day and was still told I didn't have a stroke.  They sent me home w/ prednisone.  A few days later, I checked myself into hospital and stayed over night and had another MRI which revealed I had a small stroke.  They put me on aspirin and Lipitor.
Leg pain and bruising; Leg pain and bruising/bruising above both kneecaps and down his legs; Muscle aches; Feet are a little colder than normal; he still aches; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration at the right arm on 13Jan2021 09:00 at single dose for COVID-19 immunization. Medical history included taking blood pressure medicine, medicine for uric acid, stated he takes three medications but did not provide product names. The patient had the first COVID shot on 23Dec2020 at 20:30 at the right arm at the age of 63-year-old and clarified he had no problems after first vaccination. The patient experienced leg pain and bruising which started immediately day after second COVID shot on 14Jan2021. Noticed bruising above both kneecaps and down his legs, which felt like pretty severe flu pain. After a period of time, it didn't' feel right. He didn't see anything like that listed as side effects. Has gotten a little better but was still there. Takes Ibuprofen and it helps a little with the leg pain and bruising. Feet are a little colder than normal and he still aches, also had muscle aches on 14Jan2021 which he never had before. The outcome of the event leg pain and bruising was recovering and unknown for the rest of the events.  Information on lot number/batch number has been requested.
Patient experienced a severe episode of coughing a few minutes after receiving the vaccine.  Patient was nervous prior to receiving the vaccine.  Patient's blood pressure was 100/70 at 4:1. Patient said that she could not breathe and was hot and sweating. Observer noted wheezing and administer the EpiPen into the left thigh.  911 called. At 4:15, patient's blood pressure was 130/70, and at 4:22, it was 130/90. The patient settled down and composed herself. At 4:26 paramedics arrived and took her to a local hospital.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 13-JAN-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report was received from an anonymous reporter referring to a 71 year old male patient as part of a market research. The patient's concurrent conditions included chronic obstructive pulmonary disease and his medical history was unknown. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX, intravenous route (Lot number, dosage and dose number were unknown). Concomitant therapies were not provided. On an unknown date the patient experienced injection site discomfort and pain in extremity. The outcome of injection site discomfort and arm soreness was reported as recovered within 24 hours. The reporter considered injection site discomfort and pain in extremity to be related to ZOSTAVAX. Additional information has been requested.
101.0 measured fever at 5:15 am on 3/12 after 2nd dose at 2:25 pm on 3/11. Subjective fever, chills, lightheadedness, and dry mouth started on 3/12 at 1:45 am at lasted until approx. 1 pm. I suspect fever was between 102 and 103 between 1:45 am and 4 am, however, as I did not feel well enough to find thermometer to take temperature until later on once fever had broken. Had 3 cycles of sweating and shivering between 1:45 am and 4 am. Lingering headache and body aches until 3 pm, fatigue and sore neck on side of vaccination (left) lasting rest of 3/12. All symptoms resolved morning of 3/13.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with ZOSTAVAX at an internal medicine office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2013, the patient was treated at the same internal medicine office for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
2nd dose of MMR given on 11/30/2017. On 12/4/2017 complained of Headache and dizziness  (note received 1st dose of MMR on 11/1/2017 at a different facility).
Within 3-4 minutes of receiving I felt as though my eyes "popped" .  I mentioned to my husband with me something happened to my eyes.  Vision was clear but eyes felt strange.  I looked at eyes when I got home but did not see anything other redness.  Next morning my eyes were very red and had seepage as if conjunctivitis.  I have had allergic conjunctivitis for years in spring or fall.  Two days later I could see my eyelids were swollen, inside eyes very red, scratchy feeling.  Today the sixth day and eyes no longer feel swollen but very irritated.  I am using refresh tears and Claritin 10mg.
Vaccine given w/12 (L) arm swelling. 11/10/11 - Pt c/o swelling in area of injection site/fever, myalgias.
This is a volunteer who was brought in with her mother to receive a Covid vaccine . The mother and child both received the vaccines on the same day and again 2 weeks later on 1/20/2021. Patient was underage and this was not identified by the administering RN. No side affects or adverse reactions were reported. The issue has been addressed and an action plan has been placed to prevent anyone underage from receiving the Covid Pfizer vaccine going forward.
Swelling within 2 hours, painful large red bump, extreme itching, unable to move arm up and down. 8 days later, swelling and itching had re-emerged
Red bumps on face, fever 102, lethargic. All happened 7 days after vaccine was given.
maculopapular rash, diffuse, itchy w/malaise, inc paralgia, fever, sore throat no tx;
6JUN96 started not eating well;10JUN96 some purple/red spots appear on body;12JUN96 red spots on face & body;15JUN96 high fever started & cont through 19JUN96;tx w/Ibuprofen;18JUN96 hosp dx w/ITP (low blood platelets);
no adverse effects; On 6/18/2019 a patient was administered an expired VAQTA; This spontaneous report was received from a nurse  refers to a 11 year old patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.   On 18-JUN-2019  date the patient was vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) lot # R009799 has been verified to be a valid lot number forhepatitis a vaccine, inactivated, expiration date reported as 02-JUN-2019, but upon internal validation established as 02-JUN-2019, for prophylaxis.         No adverse effects were reported.
sore arm; This is a spontaneous report from a Pfizer sponsored program. A contactable 65-years-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9264; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization.  Medical history included pain from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced sore arm on 31Jan2021. Patient did not require admission to hospital due to the event (Did not include emergency room visit without further admission). Therapeutic measures were taken as a result of sore arm as patient took ibuprofen. The outcome of event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
A 3-4 inch long and wide rash developed on the arm  in the area below the shot.
Mild body aches began a few hours after the vaccine on and off for three days. On day 4, I woke up with severe pain in my non-vaccinated arm (shoulder).  I suffered an injury in this shoulder 6 years ago, but hasn?t caused me any real pain since. I feel like the immune response from vaccine has caused this old injury to flare. It hurts just like it did when I injured it 6 years ago.  Definitely think something is going on here and should be reported.
Patient called and said 4 days after her injection she developed a lump about both elbows with the one on her left elbow being the larger one. She also mentioned that her left arm was itchy. She asked if she could take motrin for the pain. I said yes she could take the motrin and urged her to follow up with her primary care physician.
on day  4 inches of itchy redness on arm, swollen Applied cortisone cream and it helped  Much better now
13 y/o female received booster dose. No adverse events immediately following administration. Remained for standard 15 minute post administration monitoring period. Original Series of Pfizer\BioNTech Given: #1) 5/20/2021 #2) 06/10/2021
A non-serious spontaneous report of "brought home H1N1 mist and gave to 19-month-old" was received from a registered nurse, concerning her 19-month-old son, subsequent to H1N1, Intranasal. The patient's medical history included constipation. The concomitant medication was lactulose 5 cc per oral, once a day, for the treatment of constipation. Since beginning this medication, no further bouts of constipation had occurred for this patient. The reporter brought home the H1N1 from the physician's office where she works and administered the vaccine to her 19-month-old son on 13-Oct-2009. No sniffle, fever, wheezing or other symptoms were noted. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 09-Nov-2009 and incorporated into the narrative: event term was changed from "H1N1 mist brought home and given to her six-month-old" to "brought home H1N1 mist and gave to 19-month-old" and statement regarding medical history and concomitant medication was included.
Patient fell and her head hit the chair in the waiting room, about 3 to 5 minutes after vaccination, suffer scalp laceration.
1st dose in 2018, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-Aug-2022 Reporter's comment: The patient self-reported this case. The patient had not yet received the second dose of Shingrix. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.