chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Spoke to patient on 10/16/2003.  Patient states having stepped on staple on 10/11/2003 for which she was seen in ED on 10/12/2003 and received Td injection. Patient then saw MD on 10/14/2003, and on that day received pneumococcal and flu vaccines.  Patient states that 2 hours after the injection she developed aching, chills, temperature to 101, joints hurt, shoulder also.  patient had difficulty sleeping and awoke with diaphoresis and nausea/diarrhea.  States she was sitting on commode and "passed out".  Could not estimate timeframe of LOC.  States woke up leaning against wall still on commode.  Patient then noted that she was "very, very, weak" and slowly improved over the course of the day.  Noted in the shower that she had some "sore" nodes under her left armpit (same arm as she got injection).  Patient pushed fluids and ate solids; voiding QS and was continuing to feel better when I spoke with her on the 16th.  Patient denies shortness of breath, chest pain, palpatations.  Patient informed that she had quite the reaction to the vaccines but was unlikely she was allergic to hem and should be able to receive them in the future although she shouldn't require pneumococcal v.  Patient to take it easy and follow up should she not continue to improve.  Will send VAERS to CDC.  Patient stated verbal understanding and had no further questions at this time.   Patient had bad reaction to flu shot.  Patient is fine now, but would like to know if she is allergic and would like to know if she should not get it again.  This was her first flu shot, and also received shots for pneumonia.
sick; Initial information received on 03-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves patient of unknown demographics who was sick while receiving vaccine Influenza vaccine..  The patient's past  medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect Influenza vaccine produced by unknown manufacturer (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient was sick (illness) (unknown latency) following the administration of Influenza vaccine.  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local Marketing authorization  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (sick).  At time of reporting, the outcome was Unknown for the event sick.
FOUND UNRESPONSIVE ON 8/2/2021, TAKEN TO ED IN CARDIC ARREST, FOUND COVID POSITIVE,  NEVER RESPONDED TO TREATMENT, DIED ON 8/2/2021
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional reported that there was one patient who experienced flu like symptoms after SHINGRIX which she previously reported to GlaxoSmithKline. Unable to obtain patient identifiers for previously reported adverse event, thus no duplicate case was identified. This case was linked to case US2018056944 and US2018GSK062805, reported by the same reporter.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 01-DEC-2016, the patient received an improperly stored dose of M-M-R II (therapy type: recombinant human albumin, RHA) injection (lot # M015931 with expiration date at 30-MAR-2018; dose, route of administration and anatomical location were not reported). The administered dose of vaccine was exposed to a temperature of -14.4 degrees Celsius (C) for 54 minutes. Digital data logger was used to track the temperature. There was no previous temperature excursion reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113.
On 2Oct12 pm patient noticed multiple "splotches" w/ lumps around vaccine site (+) itch (+) pain. On 3Oct12 pt noticed spreading.
chills & high temp same evening vaxed; seen in ER Friday & Sat noc t104 took APAP; weak & fatigued unable to resume ADL; fever & chills cont for 2 wks; having nervous spells;
a red bump at the site of injection; a red bump at the site of injection; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 70-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 05Mar2022 as dose 1, single (Lot number: FJ2601, Expiration Date: Jun2023) at the age of 70 years, in right deltoid for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE MASS (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 14Mar2022, outcome "unknown" and all described as "a red bump at the site of injection".  No follow-up attempts are possible. No further information is expected.
cold; This is a spontaneous report received from non-contactable consumer from a Pfizer sponsored program. This consumer reported similar events for four patients. This is one of the four reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced cold on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) :  same reporter, drug, event, different patient
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19; (2022) Negative, notes: Rebound COVID 3 days after and a few negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient taken treatment (Product: Paxlovid) from 04Dec2022 to 09Dec2022 for treatment of COVID-19.Patient did not received Other medication in 2weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
sinus infection; pediatric patient receiving 1st dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (pediatric patient receiving 1st dose of the vaccine) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (sinus infection) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (pediatric patient receiving 1st dose of the vaccine). At the time of the report, SINUSITIS (sinus infection) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (pediatric patient receiving 1st dose of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment included an unknown over the counter medication for the sinus infection.
Around 2:00-2:15 that afternoon I began feeling flu like symptoms which became progressively worse over the next several hours. When I left work around 5:00 PM I experienced severe muscle aches, had trouble walking, difficulty walking down stairs, severe difficulty moving in general. When I arrived home, lacking energy and needed to lay down as I felt very heavy and had trouble moving, walking, felt uncoordinated. I am 5-10, 212 lbs. By 7:30 PM it was much worse, I took 2 ADVIL Liquid capsules and went to bed and slept until 6 AM the next day. By the end of the day on Wednesday the flu like symptoms were better and mobility was much improved.
Red, swollen area on rt. deltoid region. Warm to touch. Measures 14cm x 14cm. Treated with antibiotics as possible cellulitis.
Patient reported that the vaccine site was achy "as usual" (she receives flu shots yearly), then started to feel itchy and appeared red and mildly swollen from shoulder to elbow about 2 days after the shot. The redness/ swelling/ itch persisted until the day this issue was reported to pharmacy (9/18/16) "unchanged", according to patient.
Patient presented to emergency room on 2/19 with a swollen, red right arm that was throbbing, tight, and painful.  She had a temperature of 100.5 F.  Patient had last received Td vaccine 11 years ago with no problems.
Patient cried for 3 hrs straight & was inconsolable. Mom called nurse line but nurses were not able to reach her to return call. Then became lethargic but could not go into deep sleep - woke easily & cried all night.
This spontaneous report was received from a pharmacist regarding a female patient who was in her mid fifties. Patient's pertinent medial history was not reported. The patient had no drug reactions or allergies. On 08-DEC-2015 the patient was vaccinated with ZOSTAVA lot # L032397, expiry date: 26-NOV-2016, 0.65 ml, subcutaneously. Concomitant medications were not provided. On an unknown date in December 2015, approximately, the patient experienced redness and warmth at injection site. The patient sought medical attention by visiting the pharmacy. No treatment was provided for the events. No laboratory diagnostics tests were performed. The outcome of redness and warmth at injection site was unknown. Causality assessment was not provided. Product quality complaint was not filled. This is one of the two reports from the same source. Additional information has been requested.
About 12 hours after receiving the shot, I woke up in the night feeling unusual. I went to the bathroom, where I felt pressure in my head, increased ringing in my ears, and increased loss of vision. A few moments later when I realized this was an emergency, I could no longer see or walk. I crawled blindly through the home feeling for the walls and familiar facets calling out for help. My family woke up and called emergency. By then, I was nearly gone/unconscious.  I was laid down on cold tile until the paramedics arrived. Heart, blood sugar, and blood pressure were all tested. Considering I'm a completely healthy individual, they attributed it to the vaccine.
NDC 0006-4827-00 Pt says these symptoms have improved today but redness is still present. Redness around injection site measuring 3.75inx2.75in, previously itchy and hot to the touch.
mild local rxn w/in 30min w/residual tenderness;next evening devel soaking night sweats 4/19/99 w/recurrence 4/22-24/99 & 4/28/99; labs nl;likely immune rxn;
Patient given ZOSTAVAX 12/17/08 at clinic. C/O right lip swelling and itching spreading to right jaw approximately 18 hours later. Took BENADRYL which helped. No SOB, CD. Says " It's still swollen. I will take another BENADRYL." If s/s continue f/u PCP. If s/s worsen, E.R. or Urgent care.
Information has been received from a pharmacist via agency regarding a 19 year old male international student started the M-M-R II of an unknown dose, "given on the left" for his first shot on 26-JUL-2013 "to meet the requirements of the school". The patient's relevant medical history includes no drug allergies. The patient's relevant concomitant medications and relevant past drug history are unknown. 2 to 3 days after receiving the M-M-R II vaccination (appropriately 28-JUL-2013, the patient developed itching and a rash on an unknown locations on hs body "here and there", further explained as the rash fades away and then comes back to different places all over the body. On 11-SEP-2013, this patient came to this pharmacy to get his second shot and the pharmacist reported that this patient was an international student who showed her a "pretty unusual rash" on his left palm described as bigger than a quarter, about 2 quarters in size and not raised but darker than the skin color. She explained that the first vaccination was given at a different pharmacy. It was unknown if there was any relevant laboratory data. As of 11-SEP-2013, it was unknown if the consumer would continue to receive the M-M-R II vaccination, he currently had a rash on his left palm and it was unknown if he continued to have the itching and a rash that fades away and then comes back to different places all over the body. Additional information is not expected.
site had redness & itchy;pt c/o 2-3 days fever p/inj
One sided facial swelling, drooping, double vision, and then diagnosed with Adie's Tonic Pupil
Bruising at site of shot on left leg, and a hard spot where the vaccine was given.
My migraines used to be just ocular with a slight pressure in my eyes. Light sensitivity and would go away after about 4 hours and nsaids.  The day I got the vaccine I got a huge pressure in the base of my skull in the back of my neck that wrapped to both sides of my jaw and ears and down my neck. It stays there for days. And then eventually turns into such a bad migraine with speech impairment thought process impairment and balance uncoordination. These episodes last for days. I got my first episode migraine the day I got my first shot and again on my second. I get 2 or 3 a month now. These are debilitating. Luckily they have all happened on my days off and only 2 days have been called in for.
Upper arm & shoulder pain that has never gone away in three months. Also loss in range of motion in arm as well.
The day after the vaccination on 10/14/2021 my arm was swelled up and sore. On the 6th, the arm appeared to be more swollen and tighter, so I called my PCP. He phoned in Prednisone and instructed me if the swelling did not calm down to go the ER to check for a possible blood clot. The swelling and the tightness resolved with the Prednisone within 2 days.
pt recv vax; was later seen in er experiencing a sz that lasted several mins p/ T of 105;
No additional adverse event reported; Administration of GARDASIL 9 to a 2 month old patient; This spontaneous report was received from a nurse, referring a 2-month-old patient of unknown gender.  The patient's medical history, concurrent conditions an concomitant therapies were not reported.  On 02-FEB-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #T036812, expiration date: 28-APR-2023 (strength, dose and, route of administration were not provided) (product administered to patient of inappropriate age). No additional adverse event was reported.
2:40- 3:39 Hives/maculopapular rash on head- neck- back- trunk- arms- back of legs, red face, tight swollen throat, unable to swallow, fast heartbeat, rapid respirations, hypotension, fainting, visual disturbance, LOC, numbness in extremities,  Tx: Bolus 1 L NaCl 0.9%, Methylprednisolone, Famotidine, Hydroxyzine
3x5cm hematoma @ site 1wk later-poss overlying cellulitis/abscess;tx warm soaks & ATB;
I immediately broke out in a herpes outbreak. Itchy around my neck. Doctor advised that I do not get my second vaccine. Blood pressure has been all over the place.  A lot of thick mucous in my throat.  BP Feb 3rd 105/51  Feb 13th 147/56 the lowest my diastolic has been 44.
Pt was immunized with MENACTRA vaccine at approximately 4:45pm. Rph evaluated all the DUR for immunization, and found no reason not to proceed with the vaccine. Rph had patient wait in the area for 15-20 minute to observe. Pt had no signs or symptoms of allergic reaction at that time. Pt reported back to pharmacy at approximately 5:45pm with redness in upper chest area and complained of moderate itchiness. Pt reported no problems breathing, etc. Pt stated no prior history of no allergic reaction to a drug or vaccine. Pt advised to take an antihistamine and counseled on sign/symptoms of anaphylaxis reaction. Pt advised to get medical attention if symptoms worsen or are of a concern to her.
Fever, chills, severe joint pain, numbness and tingle in knees and wrists and foot.  Slight Bell's Palsy on right side of face again.  Felt like my Lyme Disease was flaring up big time....  Is there a connection?
cough; Overall sick feeling; sore arm; fever; This spontaneous report was received from a consumer concerning herself, a 67-year-old female patient with allergy to shellfish and hypertension which had been treated with non-specified hypertension medicine.      On 22-MAR-2019, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) 19400 PFU (dose, routed, anatomical site, lot# and expiration date were unknown) for prevention of shingles.  On the same date, within minutes of receiving the vaccine, the patient's arm was sore down to the elbow (pain in extremity); the patient also reported that, in the evening of the same day,  she developed fever (pyrexia), cough and an overall sick feeling (malaise). The patient reported that pyrexia, cough and malaise became progressively worse causing her to make a physician visit and an unspecified treatment was given. Moreover, the patient underwent the following laboratory test: Complete blood count (CBC), "chem-panel," "mono-spot," "sed-rate," cortisol test, urinalysis, serum-protein electrophoresis, "GZP," Lactate dehydrogenase (LDH), thyroid testing and chest x-ray, with no results available at the reporting time.  The patient stated that she had had pyrexia, cough and malaise for more than three weeks and, at the reporting time, she still had not recovered; Furthermore, she reported that pain in extremity was also not recovered.  The causality between pain in extremity, pyrexia, cough and malaise and zoster vaccine live (ZOSTAVAX) was unknown.  The reporter considered that the reported events were no life-threatening.
Grandma reports tonic-clonic sz evening p/immun (denies fever); Had fever 104, morning p/immun;
arthritis in my joints; pain in my arms; It feels muscular, pain in the muscles of the upper arm pain the in muscles of the lower arm; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (arthritis in my joints), PAIN IN EXTREMITY (pain in my arms) and MYALGIA (It feels muscular, pain in the muscles of the upper arm pain the in muscles of the lower arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced ARTHRITIS (arthritis in my joints), PAIN IN EXTREMITY (pain in my arms) and MYALGIA (It feels muscular, pain in the muscles of the upper arm pain the in muscles of the lower arm). At the time of the report, ARTHRITIS (arthritis in my joints), PAIN IN EXTREMITY (pain in my arms) and MYALGIA (It feels muscular, pain in the muscles of the upper arm pain the in muscles of the lower arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was stated The patient has always exercised regularly. Prior to receiving the vaccine, patient was doing 100 pushups several times a week. She was using an 8 lb weight to bend over and up strengthening her arms. patient did a walk/run about three miles several times a week.  No Concomitant medication was provided. No Treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Follow-up information include patient demographics details, new events, event start date and outcome updated.
Patient caught Covid-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Patient caught Covid-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M1A, 939904, 001B21A and 031LZ0A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2022, the patient experienced COVID-19 (Patient caught Covid-19). At the time of the report, COVID-19 (Patient caught Covid-19) outcome was unknown.    Concomitant medication was not provided. After first 3 doses patient did not experienced adverse events.  Treatment information was not provided.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 72 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 28-MAY-2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
A few hours after immunization, swelling, redness, fever (05/03/04).  When in office 05/05/04 extreme swelling 10cm erythema.
Child received ROTATEQ Aug. 9, 2010. On 15th - pain - lethargy - vomiting, bloody stool - intussusception - needed open reduction.
Patient returned two days after Inj to pharmacy w/ red area at inj. site (size of a silver dollar). Redness & warm-to-touch in that area. Small knot below skin, complaints of severe itching at inj site area.
As the patient and her family were exiting the building after receiving vaccinations (Tdap, meningococcal, hepatitis A), she reported feeling nauseous and faint.