chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via sales rep and described the occurrence of pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the physician for himself. The age at vaccination was not reported, the patient was in his 60's. The physician stated that after he received his first injection of SHINGRIX he had pain within the first 24 hours, which went away. This case has been linked with US2018GSK154784, reported by the same reporter for different patients.
This spontaneous case was initially received on 02-OCT-2015. The case report was received from a(n) Health Professional and concerns a(n) female, pregnant patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 02-OCT-2015 - unknown stop date, Batch no: 11349221A, Route of administration: Intramuscular, Dose: 1 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 02-OCT-2015, after starting / treatment with AFLURIA the patient received 1.0 ml IM dose of AFLURIA/Overdose (non serious, outcome: Unknown). No adverse reactions have been reported. Action taken: Details manually to be entered. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: not provided.
sleepy/feeling sleepy; flu like thing/flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 immunization, reaction(s): "flu like thing/flu like symptoms", "sleepy/feeling sleepy"; Bnt162b2 (Dose 2, single), for Covid-19 immunization, reaction(s): "flu like thing/flu like symptoms", "sleepy/feeling sleepy". The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "sleepy/feeling sleepy"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like thing/flu like symptoms". Additional information: Patient was kind of sleepy and with a flu like thing for a little while which is pretty typical, he had that before with some of earlier Pfizer vaccines.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Unbearable itching constantly from head to toe non-stop.  No over the counter or prescription medicine has worked.  Red marks appear everywhere before the itching starts.  This is an everyday all day nerve wrecking itch ever since the second injection
Prior to 1st Covid vaccination the patient reported a history of mast cell syndrome resulting in numerous anaphylactic events.  The patient had been consulted by her immunologist to proceed with vaccination and due to her history she was observed for a period of 30 minutes.  Upon returning for her 2nd vaccination she reported that she experienced some skin manifestations (hives) but no anaphylactic reaction resulting in difficulty breathing.  She stated that she had discussed this again with her immunologist and she wished to proceed with the 2nd dose and she was prepared to receive EpiPen if necessary if reaction develops.  Within 10 minutes of the vaccination she felt flushing sensation and then itching all over and her "throat closing up".  She was quickly administered 0.3 mg IM epinephrine and IM diphenyhydramine with some improvement in her symptoms.  While being transported to the ED an additional 0.3 mg dose of epinephrine was administered.  The emergency department also administered the following treatments: famotidine 40 IV x 1 dose, methylprednisolone 125 mg IV x 1 dose, racepinephrine nebulized x 1 dose.  The patient was ultimately discharged approximately 2 hours later with return to her baseline condition.
Rash 5 days after shot around site received PO Benadryl then rash to L thigh site injection of VARIVAX went down.
6:00 PM on 3/11/21 began experiencing chills and joint pain which lasted for approximately 18 hours.
Had Pneumovax on 11/1/06. By afternoon arm was aching and by evening was swollen to elbow. Also red and hot to touch. States temp of 100.6. Daughter works for a local physician and called him to report reaction. He prescribed Cephalexin 500mg BIDx10 days on 11/2/06. States she is feeling better this AM although she still has aches.
Client age 18 received Menactra vaccine #2 and HPV4 vaccine #1 today. At approximately 9:25 am, client was given injections. Immediately prior to injections, client stated that he has "passed out" with shots before when he was younger. Following the injections, RN assessed client's status, client was alert and responsive indicating that he felt fine and "it only feels weird right here" pointing to the area of injection and stated that he had not eaten yet today. RN obtained juice for client and before he could begin drinking it client became pale, slumped against the wall and lost consciousness for approximately 15 seconds accompanied by seizure-like movements that lasted approximately 10 seconds. Client was not responsive, his eyes were open but not focused, his body became rigid and his arms tightened up with slow uncontrolled movements. Client was seated throughout the episode. Following the episode the client became responsive stating "yes" when asked if he was ok, however appeared to be confused. Approximately 5 seconds later client stated "ok, now I remember where I am" and normal skin color returned. Throughout the episode, RN provided supportive care ensuring client safety. EMS was not called as client was fully recovered from the episode within 1 minute. Client drank 2 juice boxes and remained seated with RN monitoring for approximately 15 minutes and then moved to the waiting room, where he remained for an additional 15 minutes or RN monitoring. Client did not experience any additional side effects. Client states, he plans to continue the vaccine series, and was instructed to return in 2 months, and to be sure to have a full breakfast with natural sugars and juice prior to vaccinations. Based on my assessment and client statement, he was fully recovered, and left the clinic after approximately 30 minutes.
Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant medication was not reported. Subsequently within a week, the patient complained of weakness in the body. The reporting physician felt that complained of weakness in the body was not related to therapy with HPV rL1 6 11 16 18 VLP vaccine (yeast). The outcome of the event was not reported. Additional information has been requested.
Telephone call received from mother complaining of left arm swelling and redness, left arm and hand tenderness "painful to touch". Symptoms developed on 8/18/01. Child was taken to PMD. Mother states that the "doctor was unsure if symptoms were related to injections". Antibiotics were given.
Sine the shot was given, pt. has had severe headaches and acute nosebleeds. She has received two does, and will not receive a third. I was never made aware by the clinic by either written form or verbal as to the complications and deaths of this vaccine. I was simply told the arm may get sore, which both my girls had also. I think doctor should be required to tell the parents of the dangers in written form, including blood clots, death, as well as the potential for cervical cancer and/or warts.  I now have to worry about my 17 year old and my 11 year old for years to come, and have my 11 year old subject to pap smears for the next 3-5 years, this child hasnt even began a period yet.
2 months after my 2nd vaccine I experienced changes in my menstrual cycle.  I had pms symptoms for about 2 weeks then skipped my cycle for 2 months then started bleeding on May 18th.  Bleeding was very heavy.  After 1 week I saw my doctor and had a ultrasound which showed a fibroid which was very small and didn't explain the heavy bleeding.  I was started on methylprogesterone to stop the bleeding and that did nothing.  I went on to have a biopsy done, again results not conclusive to a reason for the heavy bleeding.  The doctor prescribed another few weeks of hormones and the bleeding still didn't stop.  On 7/26/2021 I had to have a total hysterectomy to resolve the issue.  I don't know if this event is correlated to the vaccine, but I do know that prior to getting it, I had very regular and normal cycles.
Pt reports bright blue color at injection site for 5 days.  Area was super tender to touch for 1.5 weeks.  For up to 4 weeks post vaccination area was still painful if struck or hit.
Patient presented to the hospital 1/24/2022 with progressive increasing dyspnea, COVID pneumonia and possible sepsis.  Patient tested positive on 1/24/22.  Onset of symptoms was 1/23/22.  Patient was started on remdesivir and dexamethasone.  Discharged 1/29/22.  Previously vaccinated Pfizer 3/1/21, 3/23/21, 11/19/21
Patient returned in 30 minutes complaining of scratchy throat, feeling hot/sweaty, and generally unwell.  Was not having difficulty swallowing or breathing.  Offered patient diphenhydramine for mild allergic-type reaction.  Patient reported feeling better 45 minutes later.
shingles; Information has been received from a lawyer regarding a case in litigation and referred to a male patient (pt) of unknown age. The pt's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not provided. On or about 13-OCT-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided), as prescribed and/or administered by a health care provider for the long-term prevention of shingles and zoster-related conditions. Subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, he was treated at a primary care at for shingles (Herpes zoster). As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, he had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the time of the report, the pt had not recovered from herpes zoster. The causal relationship between zoster vaccine live (ZOSTAVAX) and herpes zoster was reported as related.
Nauseas; Migraine; Throwing up non-stop; He felt his head was going to explode; Chills; Fever; Body aches; Headache/Acute non-intractable headache, unspecified type; This is a spontaneous report from a contactable consumer (Parent). A 16-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in left arm on 07Apr2021 12:30 (at the age of 16 years old) as dose 2, single for covid-19 immunization. Medical history included seasonal allergies, asthma, allergic to tree pollen and grass, all from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication. The patient previously took the dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER2613), on 17Mar2021 11:30 AM, administered in left arm, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Apr201, it was reported that the patient developed chills, fever, body aches and headache at around 11:00 PM, but did not report to parents. At 2:00 AM on 08Apr2021, his symptoms got worse. By 4:00 AM on 08Apr2021, he had nauseas and developed a severe migraine. He began throwing up non-stop, in addition to the chills, body aches and fever. He felt his head was going to explode. He had to be taken to the emergency room. Emergency doctor ordered an Angiogram CT scan to rule out a brain aneurism. He was given IV fluids and was treated for headache and vomiting. His CT came back normal, no sign of bleeding in the brain. He was discharged at 9:00 AM and was continued to treat symptoms at home with fluids, Tylenol and Ibuprofen. He was diagnosed with acute non-intractable headache, unspecified type. Treatment received for the events included 0.9% sodium chloride bolus, Benadryl, and Reglan. The outcome of the events was recovering.
A non-serious spontaneous report of "gave expired FLUMIST" was received from a nurse concerning an eight-year-old male. No medical history was reported. The FLUMIST was given  on 19-Feb-2009 and had expired on 24-Dec-2008. Based on the results of the investigation, the root cause for the medications errors were caused by 1) customers not discarding product form the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information received on 31-Mar-2009 included Product Complaint Investigative results. Follow-up information received on 28-Apr-2009 from reporter that confirmed no adverse events have occurred.
running fever of 102 degree F; horrible nausea; vomiting; rash on her left arm; This is a spontaneous report from a Pfizer-sponsored program by contactable consumer reported herself. A female patient of an unknown age and gender received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unknown), via an unknown route of administration on 11Mar2021 (Thursday) as dose 1, single for COVID-19 immunization. She was scheduled to return for her second shot on 01Apr2021. The patient's medical history and concomitant mediation were not reported. On an unknown date in Mar2021, after she took the first shot, the patient had a running fever of 102 degree F, had horrible nausea and vomiting. She also developed a rash on her left arm and was on bed rest for days. She mentioned she tested positive for COVID-19 last Jun2020. Any unaddressed medical questions were not referred or forwarded to Medical Information. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient became fussy a few minutes after receiving vaccines on 1-24-14.  Patient's mom undressed him around noontime later that day, and she noticed that patient had redness and swelling on both legs, starting at the injection sites on both legs and travelling distally to his toes, the right leg being worse than the left. Area of redness seemed tender to touch.  Patient was brought by his mother to ED, where patient was given an oral dose of Benadryl.  Pt's mom reports that 20-25 minutes after the administration of Benadryl to patient, patient's symptoms resolved.  Symptoms have not come back.  Patient also had a heart rate of 170-200 bpm while at the ED, heart rate was normal when patient seen at pediatrician on 1-27-14 for recheck appointment.
4/24/06-Client contacted Public Health, states that she became very sick on 4/13/06- with body aches, 101 temp, stiffness of the joints.  Went to doctor. She received antibiotics, Avelox 400 mg x 5 days. 4/25/06- T/C to client who states she is feeling better_now.
Redness, warmth, tenderness 9x11Cm in left deltoid, about 24 hrs.  Treated with Tylenol, Benadryl, ice packs at home/school. T 97.6F.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 13-JAN-2016, the patient was vaccinated with an improperly stored (temperature: 58 degrees Fahrenheit (F), time frame: 1 hour and 30 minutes; no previous temperature excursion was reported) dose of MMR II lot # L007217, expiration date 03-MAR-2017 (albumin status, dose and route of administration were not specified). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
PATAIENT RECEIVED THE VACCINE FOR A 5 YEAR OLD AND THE PATIENT IS 6.
Syncope, hypotension, Pt. Vitals returned to normal after the 30 minute observation. Pt. stated this was normal for her when she gets injections.
Only problem was sore arm.  First injection given at 21 weeks, 2nd injection given at 26 weeks.  No other adverse events occurred.  Still pregnant right now.  No current issues with health of the pregnancy.  No vaginal bleeding.  Will monitor for any abnormalities after birth.
back pain (from the neck down to the buttocks area on the right side and from the lower back down to the buttocks area on the left side); painful when he squeezed his eyes tightly; hypersensitive skin; wrist pains; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain (from the neck down to the buttocks area on the right side and from the lower back down to the buttocks area on the left side)), EYE PAIN (painful when he squeezed his eyes tightly), SENSITIVE SKIN (hypersensitive skin) and ARTHRALGIA (wrist pains) in a 68-year-old male patient who received mRNA-1273 (batch nos. 040A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced BACK PAIN (back pain (from the neck down to the buttocks area on the right side and from the lower back down to the buttocks area on the left side)), EYE PAIN (painful when he squeezed his eyes tightly), SENSITIVE SKIN (hypersensitive skin) and ARTHRALGIA (wrist pains). On 12-Mar-2021, BACK PAIN (back pain (from the neck down to the buttocks area on the right side and from the lower back down to the buttocks area on the left side)), EYE PAIN (painful when he squeezed his eyes tightly), SENSITIVE SKIN (hypersensitive skin) and ARTHRALGIA (wrist pains) had resolved.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
giving 1st dose to a 17 and 1/2 year old patient; A spontaneous report was received from a health care professional, concerning an unidentified patient of 17 and 1/2 years old, who received Moderna's COVID-19 vaccine and experienced no symptoms.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unspecified date, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 via unknown route for COVID-19 infection prophylaxis.  The patient experienced no symptoms.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event giving 1st dose to a 17 and 1/2 year old patient/Product administered to patient of inappropriate age was considered as resolved on an unknown date..; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 1/2 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.
VACCINE WAS  REFROZEN; VACCINE WAS REFROZEN AND ADMINSTERED TO PATIENT; This spontaneous report received from a health care professional concerned a 49 year old female. 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 (suspension for injection, route of admin not reported, batch number: 1821296 expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. Age at time of vaccination 49 years old. No concomitant medications were reported. On 24-MAY-2021, the patient experienced vaccine was refrozen and adminstered to patient. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was refrozen and vaccine was refrozen and adminstered to patient was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537356, 20220537683, 20220538238, 20220537444, 20220537548, 20220539045, 20220538425, 20220538428, 20220538297, 20220538573, 20220538480, 20220538149, 20220538379, 20220538437, 20220540435, 20220537688, 20220540474, 20220538890, 20220540853, 20220540611, 20220541180, 20220540524, 20220540570, 20220538316, 20220540688, 20220540420, 20220540765, 20220540814, 20220540816, 20220541085 and 20220538210.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A female patient  [Age: 85, Unit: Unknown] received on an unknown date a single dose of PREVNAR 13 for immunization. Medical history and concomitant medications were not reported. The patient after vaccination experienced on an unknown date severe bruising. Outcome was unknown.
Information has been received from a physician assistant concerning a 44 year old male who on 05-SEP-2008 was vaccinated with a first dose of VARIVAX (Merck) (lot # 658587/1520U). On 07-SEP-2008, the patient developed a rash. The patient's rash persisted. Additional information has been requested.
The patient reports immediate soreness in the left arm at the injection site following the vaccination. She says there was soreness at the site radiating up the left arm towards the shoulders. This eventually led to pain in the head. This lasted until mid-November and then stopped until the end of December, returning severely per the patient report on 12/30/21. The patient reports the pain is ongoing as of today (1/3/2022). The pain is controlled with over-the-counter ibuprofen taken regularly.
Patient wanted J&J and we think that he was given Pfizer.  When we went to count inventory, it was off after him, leaving an extra J&J and one less Pfizer;
After receiving the vaccine, the patient was walking out of the room and collapsed hitting his face on the floor.  He was breathing and had a pulse.  Ems was called, he regained consciousness shortly after.  Ems took him to the local hospital for evaluation.