chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received on 21 October 2011 from a company representative who is also the patient's daughter. A female patient (date of birth not reported) with no reported past medical history had received on 19 October 2011 one shot in each arm of INFLUENZA VACCINE (manufacturer, lot number, route and exact site of administration not reported) and a Pneumo vaccine (manufacturer, lot number, route and exact site of administration not reported) and within 24 hours after vaccination experienced swelling, redness, pain and elevated heat of the arm vaccinated with the influenza vaccine. The patient was evaluated by a school nurse and was told to "wait and that it may be a mild reaction to the shot". The patient returned to the nurse and reported that her arm was not getting any better, the symptoms had increased and she now had swelling into her back and front beyond her shoulder area. The patient contacted her physician's office. She spoke with a nurse who suspected cellulitis based on the symptoms reported. Treatments included cephalexin. According to the reporter, the reaction was actually in the arm that the patient had received the Pneumo vaccine. It was also reported that the physician does not think that the reaction was from either vaccination. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
VACCINE ADMINISTRATION ERROR: patient presented to a vaccinator who vaccinated him w/o checking to see when his first dose was administered. The patient was sent an email as his appointment was too early but he did not see it. He was vaccinated 5 days too early. CDC guidance changed this week and the grace period is 4 days. We informed the Chief Medical Officer who felt he would be fine and that it would count as his second dose. She recommended we call Pfizer for official guidance. I called Pfizer and it was  explained that the dose  given today, 5 days early was outside of the EUA prescribing information and the the CMO may use clinical judgement. I was told that he does not need to be revaccinated and this would count as his second dose. The patient  verbalized understanding.
Fluzone HD was inadvertently administered to a patient from the delayed shipment, no AE; Fluzone HD was inadvertently administered to a patient from the delayed shipment, no AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 90 years old female patient who received 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ274AA, Exp. Date 26-May-2020) via intramuscular route in the left deltoid on 18-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to incorrect product storage. It was also a case of product shipment delay.  It was reported that shipment of Fluzone HD was delivered on 16-Oct-2019, however was not received until 18-Oct-2019. Caller reports one dose of Fluzone HD was inadvertently administered to a 90 yo patient from the delayed shipment.  No adverse reaction reported.  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 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.
No additional AEs; TE for vaccines and confirms that PROQUAD was administered on 2/10/2023; This spontaneous report was received from Nurse and refers to a 6-year-old female patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 10-FEB-2023, the patient was vaccinated with an improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5ml/once, lot #W028568, expiration date: 06-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided). No additional adverse event was reported.
Information has been received from a registered nurse concerning a 7 year old male patient with asthma who on 19-AUG-2002 was vaccinated with one dose of VARIVAX. ON 24-JAN-2009 the patient developed chicken pox. The child has about 100 lesions and fever. At the time of reporting the patient had not recovered. Additional information has been requested.
Pain, swelling, warmth, redness, itching at injection site. RN recommended "ice, Benadryl cream-call back if no improvement or worse hives, neck and facial swelling occur or temp greater than 101 degrees F.
At 3am on 1/26/2021 I woke up feeling sick I had a fever of 102F, chills, muscle aches, nausea. I understand that these were expected with the second dose. However at 9:40am I began vomiting. By 11am my throat started to close so I went to the ER. I had a minor asthma attack while I was there (coughing fit and slight wheezing). I was evaluated and they gave me IV fluids as well as other medications through the IV. I received solu-medrol, Benadryl, antacid, and anti-nausea. They took blood tests, urinalysis, and chest x-ray, all of which were normal. I did not have a rash around the injection site this time. I was discharged at about 3:10pm
Patient c/o "chest heaviness" and lightheadedness approximately 5 minutes after vaccine administration.  Pt was observed by staff to be calm, alert and oriented.  BP and heart rate WNL.  Staff attempted to reach Medical Director, Pt stated he felt better after about 10 minutes and wanted to go home.
Dizziness LIGHTHEADED Narrative:  0940: C/O DIZZINESS AND LIGHTHEADED 111/57 65 100%  1000: NO CHANGE IN SYMPTOMS 124/80 64 R 18 1002: WATER GIVEN 1005: D/C STABLE PT DENIES ANY SYMPTOMS
Headache and Body Aches following shots, nonproductive cough starting the next day, diarrhea, temperature of 99 with sweating chills.
Approximately one minute after receiving flu vaccine, pt asked if he could sit down again, became light-headed, and collapsed to the ground in stages. Within moments of lying flat the pt rose and sat down for several minutes. Glass of filtered water given.
The patient has a history of emphysema. She presented to the ED via EMS from her assisted living facility after an unwitnessed fall on 10/20/23. EMS reports they were called to the facility after the patient was found lying on the ground, unknown how long she was down for. She additionally was found to be hypoxic en route, O2 sats in the 80's on room air. The patient additionally reported she tested positive for COVID the day prior (10/19) however denied any symptoms. Ultimately, the patient was admitted 10/20/23 - 10/30/23 with discharge diagnoses including acute hypoxic respiratory failure and COVID pneumonia, among other diagnoses. During admission, a COVID PCR test was done (10/24) which was also was positive. She required supplemental oxygen during admission, however by discharge she had been on room air for more than 24 hours.   Of note, the patient has received the Moderan Monovalent COVID vaccine (given 1/30/21; 3/25/21; 11/17/21; 7/28/22). The Vaccine Route and Vaccine site for the most recent vaccine administered on 7/28/22 is unknown.
about one week after receiving the Covid vaccination, employee developed a ed circle at the injection site which was approximately the size of a quarter and was itchy.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 09-JUL-2013 the patient was vaccinated with the first dose of oral ROTATEQ, 2 ml, orally. On 30-OCT-2013, the patient was vaccinated with a dose of expired oral ROTATEQ, 2 ml, orally. The oral ROTATEQ with lot number 0577AE had expired on 26-OCT-2013. No adverse effects were reported. This is one of two reports received from the same source (other case ID: 1311USA000165). Additional information has been requested.
Pt received vaccines (DTAP, PedvaxHIB, MMR and Varivax) on 3/16/06 in MD office. Pt was seen on 3/18/06 for seizure with fever, vomiting and diarrhea X 12. Seen again 3/19/06 at ER for dehydration/vomiting. 3/27/06, Pt had another seizure with fever 102.6. Dx'd with ROM. 5/25/06 Pt had another seizure with fever 103. Pt being evaluated for seizures.
Lower abdominal discomfort, onset 4 days after injection with nausea.  Symptoms lasted X 5 days.
Initial and follow-up information has been received from a physician concerning a 2 year old female (also reported as a preemie and 6 year old) who on 15-OCT-2007 was vaccinated with PNEUMOVAX 23 (lot# unknown) injection. On an unspecified date the patient developed cellulitis after the vaccine. The physician reported that the patient experienced symptoms 48 hours after the injection was given. It was also reported that the patient was on antibiotics (therapy unspecified) for a swollen lymph node at the injection site. Medical attention was sought. No further information was provided. At the time of reporting it was unknown if the patient had recovered. Additional information has been requested. This is one of two reports from the same source.
Day after administration, patient had a half-dollar size welt. We reported to her physician on 10-8-15.
10/22/2021 Presented with symptoms of a UTI. Tested negative for infection. 10/26/2021 Dr. visit with preliminary diagnosis of thinning uterus tissue, prescribed 1% estrogen cream.  First adverse condition was extreme nausea. Stopped the estrogen in mid November and nausea disappeared.  Continued experiencing indigestion, prescribed prescription Prilosec.  Indigestion is now mild and controlled without medication.  December I began noticing neve tremors in my left knee and foot.  Also had tremors in the 5th finger on both hands.  These tremors continue as of today's date.  I've had many, many diagnostic tests all resulting in normal outcomes.  Physical therapy has done little to decrease the tremors.  I see Neurology on July 28.
1 hour after, injection I experienced tachycardia - rate 120's ( HR usually 60-68) and upper chest and throat pressure, not pain, but a definite felling of air hunger and pressure-felt as  though I could not get  enough air- the  following day had extreme neuralgia (back, shoulder, and legs) plus the L upper deltoid was a 10/10 with movement  - still experiencing discomfort today ( 5 days later). I had absolutely no reactions to the other 2 vaccines
patient started complaining about arm soreness, dizziness, frequent headaches daily, and feeling sluggish starting 1 day after administration and continuing til today. patient has had some chest pain  with palpitations and syncope episodes. Felt very fatigued with feeling of nausea and has had some diarrhea.
my nerves flared up; "I" was unable to stand or walk for 12 hours; "I" was unable to stand or walk for 12 hours; My nerves flared up and went numb/ My left foot, left ankle, left knee, spine and neck stayed feeling of numbness; My left foot, left ankle, left knee, spine and neck stayed feeling of numbness and pain; My left foot, left ankle, left knee, spine and neck stayed feeling of numbness and pain; My left foot, left ankle, left knee, spine and neck stayed feeling of numbness and pain; My left foot, left ankle, left knee, spine and neck stayed feeling of numbness and pain; This is a spontaneous report from a contactable other healthcare professional, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3590) via an unspecified route of administration in the left arm on 15Oct2021 at 16:30 (at the age of 32-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the left arm on 24Sep2021 at 17:30 (at the age of 32-year-old), as a single dose for COVID-19 immunisation. On 16Oct2021 at 02:30, 10 hours post second dose of vaccine, the patient's nerves flared up and went numb. The patient was unable to stand or walk for 12 hours. The patient's left foot, left ankle, left knee, spine and neck had feeling of numbness and pain for the next 12 days which started to slowly decrease at day 5 until majority was gone at day 12. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events unable to stand or walk for 12 hours was resolved on 16Oct2021 at 14:30 and of nerves flared up and went numb, left foot, left ankle, left knee, spine and neck stayed feeling of numbness and pain was resolving at the time of this report.
LARGE RED SWOLLEN SHOULDER THAT FEELS WARM AND HARD TO TOUCH, DOESNT RESPOND TO IBUPROFEN
Prolonged and chronic nausea. Hormonal changes. Cramping, lack of period
Pt was given only the diluent portion/12 years old patient received half dose of Menveo; Pt was given only the diluent portion/12 years old patient received half dose of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amva391a, expiry date 30th September 2021) for prophylaxis.   On 2nd September 2021, the patient received Menveo. On 2nd September 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter was medical assistant. The patient was administrated by error only the diluent portion of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. In this way, the patient received only half dose of vaccine. No further events were reported. The reporter dropped before the call center representative could get any further information. There was no further information available since the call dropped. The reporter agreed to be contacted for follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021213528:Same reporter.
Patient complained of upset stomach 10 minutes after receiving the Pfizer vaccine. Stomachache subsided after 15 minutes according to patient.  Vital sign established and found to be hypertensive. 911 called, patient refused 911 care. Advised to call family to take her home. Patient refused and walked off despite medical advise after one hour of observation. Vital signs record:  2:00pm: BP 150/98, HR 74 bpm, SpO2 100%, RR 14, Temp 97.1 degree F. 2:08pm BP 147/97 HR 71bpm, SpO2 100% Temp 97.2 degree F, RR 14. 2:17pm: BP 159/101, HR 76 bpm, SpO2 100%, RR 14, Temperature 97.1 degree F
crying, irritable, not nursing or eating.  inconsolable despite being held by mom x2days
hive-like whelps/hives like rash; This case was reported by a other health professional via call center representative and described the occurrence of urticarial rash in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In May 2019, less than a month after receiving Shingrix, the patient experienced urticarial rash. On an unknown date, the outcome of the urticarial rash was recovered/resolved.   It was unknown if the reporter considered the urticarial rash to be related to Shingrix.  Additional case details were provided as follows: The patient received Shingrix in left deltoid. The patient had hive-like whelps (welts) around her trunk, on her shoulders and on the backs of both arms.   On 22nd May 2019, the patient called the reporter and stated, the whelps remained for at least a week.   The patient reported that, one and half months prior to getting the vaccine, she had returned from traveling and did not know if the hive-like rash was related to the Shingrix or something from traveling.  The reporter was unable to obtain additional information.
Patient reported experiencing lightheadedness within 5 minutes. Within 10 minutes, the patient became extremely lethargic and had difficulty responding to questions. He was also shaking slightly at this time. I took his blood pressure, and it had dropped to 103/60 with a pulse of 57. EMS arrived shortly after and took the patient for further evaluation.
LINGERING HIP PROBLEM; LINGERING HIP PAIN; This spontaneous report received from a patient via a company representative concerned a 51 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced lingering hip problem, and lingering hip pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lingering hip pain, and lingering hip problem. This report was non-serious.
On 12/17/05, I developed severe constant dizziness, nausea, fever of 102 and diarrhea.  I went home from work half way through my 1st shift and took 25mg of Meclizine thinking it was vertigo, which I have on rare occasions.  After 4 days in bed the all symptoms were resolved but I noticed that I was hard of hearing in my left ear.  This has not improved and has worsened.  I am being treated by a family doctor since 01/15/06 for possible fluid behind the inner ear and I am taking 250mg of Azithromycin tablets and Profen Forte DM Tab.
Received tetanus shot on Monday. Began to notice redness, heat, and abnormal swelling at injection site on Friday. Arm is tender to the touch and extremely red.
This spontaneous report as received from a physician refers to unspecified patients of unknown age and sex. Physician reported that MMR II exposed to 73F for upwards of 4 months and the improperly stored vaccines had been being administered to unspecified patients on unspecified dates (therapy type, strength, formulation, lot#, dose/frequency, route and duration were unspecified). It was unknown whether the patient had sought medical attention or not. The outcome was unknown. This was one of several reports that received from the same source. Additional information has been requested.
Second dose 125 days after first; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 125 days after first) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, 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 experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 125 days after first). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 125 days after first) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Arthritic type reaction with confluent red on anterior 3rd left finger, down into distal above the knee. Child still with active play; no systemic signs and symptoms. Given steroid and Zrytec-resolved on 24-36 hrs. Seen recheck 05 05/11/001.
There was immediate pain and tenderness at the Vaccination site.   I then developed a severe headache and muscle aches. I proceeded to develop chills that I couldn't get to go away no matter how much I warmed up.
A large painful lump developed on my shoulder, the injection area. This lasted for 7 days. Most significantly, I have experienced nerve pain in various areas of my left leg, above and below the knee, thigh and ankle areas for almost the past three months. This pain occurs in differing places on the left leg at different days and times. The pain feels similar to nerve pain that I experienced when I suffered shingles when I was 24 years old.  An MRI scan of my lower back on 11/30/2018 showed that that there is NO problem with my back that would cause this nerve pain in my leg.
Developed red left arm on 6/9/05. Evaluated at doctor's office. Erythema 11x12cm.
CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced chills and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills and fever. This report was non-serious.
I experienced ringing in my ears, pulsating ringing in my ears.  I saw a doctor yesterday and I have an appointment with an ENT in two weeks.
Patient developed lightheadedness, felt weak, had sweats/chills but no fevers.  Received vaccines on Monday morning 1/9/12, developed symptoms on Tuesday morning (1/10/12).  Symptoms continued through Wednesday, had resolved by Thurs 1/12/12.  Had Hepatitis B/Hepatitis A (Twinrix) and Pneumonia vaccines on Monday morning.   Both given in the same arm.  One of the vaccines had local reaction of erythema and swelling - not sure which vaccine it was that caused the localized reaction.