chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 13 March 2009 from a health care professional. A 20-month-old male patient had received on 04 March 2009 a fourth intramuscular left thigh injection of DAPTACEL (lot number C3083BA); a second intramuscular right thigh injection of VAQTA (manufacturer Merck, lot number 1379V); and a first intramuscular right thigh injection of MMR II (manufacturer Merck, lot number 13654). The patient has no family history of epilepsy, but the last week of February 2009 had experienced a fall where he hit his head on wooden furniture (no loss of consciousness) requiring emergency room visit and seven stitches in the head. On 05 March 2009, i.e., the following day after receiving the vaccinations, the patient was visiting the grandparents and in the afternoon he woke up from a nap lethargic, staring and moving his head around slowly with no facial "responses." This continued for a few hours. Later while trying to follow behind the grandmother the patient fell backwards on his head. At that time, the grandmother described the patient as looking like he had "hiccups over his whole body" and she summoned a neighbor for help who happened to be a physician. The physician "timed the activity for four minutes" and the patient was taken to the emergency room which was around 19:30 pm. The patient was afebrile and underwent diagnostic tests of a "spinal catheterization" and blood cultures that were negative. The following morning around 01:30 am, the patient had a temperature of 101.5 degrees Fahrenheit that lasted approximately one hour. A urine test revealed "few white blood cells" and the patient received a seven day course of BACTRIM. The patient was discharged from the emergency room 12 hours after arriving. On 13 March 2009, the patient was evaluated by his physician and at that time had no symptoms. Per the physician, the patient was active and "normal." An EEG was completed that was negative. The patient was then referred to a neurologist. The recovery status of the patient was reported as "unknown." Documents held by sender: None.
I'm suffering; I'm in a lot of pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 76 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 immunization. The following information was reported: EMOTIONAL DISTRESS (non-serious), outcome "unknown", described as "I'm suffering"; PAIN (non-serious), outcome "unknown", described as "I'm in a lot of pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of Zostavax. Subsequently, the patient developed a mild case of shingles. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
muscle stiffness; This is a spontaneous report from a contactable consumer.  A 59-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Formulation: solution for injection), dose 1 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization.The patient's medical history and concomitant medications were not reported. Caller states she received the first dose of the Pfizer COVID vaccine this morning between 09:30 and 10:00 am EST. Caller states she has some muscle stiffness and she already took some Tylenol. The outcome of the event was unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Client received the 1st dose of the Astrazeneca vaccine (lot# 77622)  on 07/23/2021. Per CDC protocol, client is authorized to re-start the COVID-19 vaccine series at least 28 days later if only 1 dose of Astrazeneca was administered to client. Client received the 1st dose COVID vaccine (Pfizer, lot#FF2587, expiration 12/2021) at 1155 in the L arm. No adverse reaction observed while client was in observation.
When I went to get my 3rd shot for Moderna the pharmacy was supposed to give me a 3rd full shot instead they gave me a booster shot.  I contacted the CDC and they advised me to fill this reporting form out; so that the facility needs to be retrained in regards to the 3rd shot distribution  because the pharmacist never asked if the 3rd shot was a booster (1/2 medicine dose) or a full medicine dose shot.  Based on my health history and medical conditions I should had received a full medicine shot.
Information has been received from a physician concerning a 15 year old female who in September 2007, was vaccinated with the first dose of GARDASIL (lot# reported as 02444). Concomitant therapy included MENACTRA and ADACEL. During follow-up on 22-JAN-2008, the patient has been complaining of reduced energy, not being able to participate in sports, tired type of reaction and reduced ability to use joints and arms. The intensity has increased since onset a few days after the administration of the first dose of GARDASIL. The patient has continued with the series and had doses two and three. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K003520, expiration date: 20-NOV-2016, 0.5 ml, once, intramuscularly (dose number was not reported). There was no adverse effect reported. Additional information has been requested.
Patient seen in consultation for myocarditis in temporal association to SPV. Pt received his primary SPV on 6/4/10 in his right upper arm (pt is left handed). He was in his normal state of good health at the time. On 6/9/10 the pt experienced 20-30 minutes of substernal chest pain (5/10) which he described as a squeezing pain which worsened with deep inspiration and improved with leaning forward. The chest pain was accompanied by dizziness, SOB and diaphoresis. The pt denied radiation of the pain, N or V. On 6/11/10 the pt experienced substernal and left sided chest pain (4/10; squeezing/pressure). The pt took 400mg on MOTRIN immediately and the pain resolved in about 45 minutes. The pt denied SOB, dizziness, diaphoresis, N or V. On 6/12/10 the pt noted about 5 inches of redness around the vaccination site, right axilla pain and swollen lymph nodes in the right axilla. On 6/13/10 the pt felt fatigued and he had an episode of chest pressure (3/10) across his upper chest (bilateral) with SOB; he took MOTRIN with improvement of his symptoms (1/10). Later in the evening he had a "burning" sensation in his chest. The pt took 400mg of MOTRIN without relief. The pain was not improved with positional change. After about 2 hours the "burning" increased and at that time the pt experienced SOB, diaphoresis, dizziness (no N or V). The pt decided to go to the ER. His EKG showed ST elevations in leads I, II and a VL; cardiac enzymes were elevated (Myoglobin 116 [0-98], CKMB 7.0 [0-4.0], Troponin I 2.01 [0.0-2]). He was subsequently admitted to Medical Center: cardiac cath: cardiomyopathy, mild/moderate LV dysfunction, normal coronaries; TTE: wall motion abnormalities, mild global hypokinesis, LVEF 45-50%; normal spiral chest CT; normal ESR (10); normal D-Dimer (178); and elevated Troponin I (6/14/10 6.77; 6/15/10 8.23). The pt was discharged on 6/15 on Ramipril 5mg qhs, ASA 81mg qd and CLINORIL 200mg bid. At that time he had constant (2/3) chest pressure and frequent SOB-- both of which increased with activity but quickly returned to baseline with rest. The pt had his initial cardiology appt at hospital on 6/21/10--he was diagnosed with myocarditis and placed on light duty, non-deployable for 6 months and scheduled for repeat TTE, EKG and stress test in 6 weeks. The pt returned to AFB on 6/23 with complaints of chest pressure (3/4) and SOB-(CK 31, CKMB < 0.5, Troponin I 0.05; CXR wnl; EKG SB)-he was released with instructions to keep scheduled appt in cardiology. The pt's last episode of chest pain was on 7/21/10. The pt was reevaluated by cardiology on 7/23/10. EKG: NSR-normal axis & intervals, no hypertrophy; Echo: EF 66%, normal; Stress test: (Bruce) for 14:21 minutes, PMHR 98% (193), METS 17.20, impression wnl. Found fit for full duty; given instructions for gradual increased activity and to d/c meds; non-deployable through mid Dec; f/u Dec.
Patient transported to ED for evaluation by EMS. Patient was at the PCP's office where she received dose # 2 of H1N1 Influenza. Approximately 15 minutes after the immunization was administered (IM in the left thigh), the patient was seated in the back seat of the car. Mother noted that the patient's face was stiffened and "contorted", her eyes were opened - but fixed straight ahead. She was not responding to verbal or physical stimulation. She was breathing well on her own. Either removed her from the car, noting her body was not rigid or stiff, but she was not responsive. EMS arrived, IV access was established, and the patient was given 25 mg of IV BENADRYL for concern for dystonic reaction. EMS noted that the patient's jaw was firmly clenched and they were unable to open the patient's mouth. There was no tonic clonic activity. Within a minute of BENADRYL administration, the facial contortion resolved. The patient was then crying, confused, and did not seem to react to her parents appropriately. There was no LOC or deterioration in cardio-respiratory status per EMS. No rash. Patient was otherwise well. No fever, runny nose, no history of allergic reactions or anaphylaxis. Patient has had H1N1 Influenza # 1 6 weeks ago without issues and there has been no previous reaction to vaccinations. Re-evaluation after nap (2 hours): Marked improvement in mental status with return with baseline mental. Patient subjectively feels much better. No further deterioration in neurologic or cardio-respiratory status in ED. Consultation with Neurology. Unclear if this was dystonic reaction vs. seizure. Likely a reaction to vaccination. Patient to follow-up as an outpatient for consultation and EEG. Would defer future Influenza vaccination. Consultation with PCP. PCP's office will file adverse reaction with VAERS (as they have vaccine maker and lot number information).
Ringing or continuous and ongoing sound in both ears that appears to be tinnitus. I have just requested a medical appointment for this.
Headache, Fever, NauseaVomiting, SORE THROAT Narrative:
Intense pain at the injection site, worse than 1st dose; Rash on lower back; Blisters on lower back; Is very itchy, asks if this could be Shingles; 1st dose few years ago, 2nd dose a year ago; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose few years ago (date unknown), for tolerance of 1st dose refer case US2022AMR046812).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain, rash, blister, pruritus and drug dose administration interval too long. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the rash, blister and pruritus were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain, rash, blister and pruritus to be related to Shingrix.     Additional details reported were as follows: A year ago, the patient went back to the pharmacy and received a second dose of Shingrix, as the pharmacist stated it was late for second dose but she should take it as soon as possible.  The patient received 2nd dose of Shingrix, late than recommended time frame, which led to lengthening of interval between vaccine doses. On the date of her vaccination the patient felt intense pain at the injection site which did resolve in a few days. Less than a year after receiving Shingrix, for the last few months the patient noticed a rash or blisters on her lower back near the coccyx which was very itchy and had not resolved.  The patient asked if this could be the Shingles.  The patient provided medical advice disclaimer and referred to healthcare professional.  The consent to follow up was given. The Permission to contact healthcare and pharmacy was provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR046812:Same reporter
Hives on all body parts (legs, trunk, arms, face). Diphenhydramine 25 mg relieves hives. They started 09/10/2021 and are still present.
From 10am -10pm on 1/29/2021 experienced nausea/vomiting/ fever from 102-104/chills/ body aches/fatigue/soar arm. Took tylenol for fever. 1/30/21 - nausea/vomiting/fever/chills all subsided 1/30/21-2/7/21- experienced fatigue and muscle soarness
Itching on left arm below injection site. Followed by a Red slightly raised area. Itches unpleasant and the combination of the itching & red raised area makes sleeping uncomfortable
Tiny red dots appeared on my stomach after the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 29Apr2021 at 09:30 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Previously the patient was not on any drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Apr2021 at 12:15, after the vaccination, the patient experienced tiny red dots on stomach. The clinical outcome of the event tiny red dots on stomach was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
had an adult covid shot it was so awful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "had an adult covid shot it was so awful". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported no product. Was not present.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
headache 10/10; Initial information received on 19-Nov-2021 regarding an unsolicited valid non-serious case from a other health professional via the Agency (under the reference 00865885).  This case was linked to case 2021SA392402(CLUSTER).  This case involves a 16-year-old female patient who experienced headache 10/10 (headache) after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) for Immunisation.  On 18-Nov-2021, the patient received a 0.5 mL total dose of suspect MENACTRA (0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin (TB) skin test-0.5 mL, frequency: once, lot U7208AA and expiration date: 10-FEB-2023) via intramuscular route in the left deltoid for prophylactic vaccination.   On 18-Nov-2021, the patient developed a non-serious headache 10/10 (headache) same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was reported "A nurse is calling to report adverse reactions with two patients after they received the MENACTRA vaccine. Caller is wanting to know if the vaccine is safe to continue to use. Both patients were seen in the emergency room. The status of the first patient has only been reported so far from the emergency room. The first patient had a headache 10/10, body shakes, nausea and vomiting and tachycardia as well as hypotension. Patient was given IV fluids and released. The second patient report a headache 10/10 and no other information as been reported other than the patient went to the emergency room."  No laboratory data reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event headache.
Body hurts everywhere, major diarrhea and going many times a day that stool looks mainly clear no signs of blood. Lots 4 lbs in three days
REDNESS AND ITCHING OF UPPER ARM AROUND INJECTION SITE AND DOWN TO THE ELBOW. NOTICED THE NEXT DAY AND WAS CLEARING BY THE SECOND DAY.
developed pain on her left arm just above the elbow going to the mid part of her chest; developed pain on her left arm just above the elbow going to the mid part of her chest; developed pain on her left arm just above the elbow going to the mid part of her chest; This is a spontaneous report from a contactable consumer. A 50-years-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 16Jul2021 (age at vaccination 50 years) as dose 2, single for covid-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot number was not reported), via an unspecified route of administration, on 22Jun2021 (age at vaccination 50 years) as dose 1, single for COVID-19 immunization. On an unknown date in Jul2021, patient developed pain on her left arm where she had the shot  just above the elbow going to the mid part of her chest. It was reported that she had her second Covid vaccine on 16Jul2021 and since then has had pain from her left arm where she had the shot to the middle of her chest. Stated that she thought that it would ease up and it has not. Stated that it was concerning her. Wanted to know if someone reported this before and if this was something that she should go to the hospital about. The patient had not yet recovered from the events.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Information has been received from a physician concerning a female patient over 60 years of age who in October 2008 was vaccinated with PNEUMOVAX vaccine (Lot#662599/1076X, therapy date, route, site unknown). "In the last 10 days", approximately 19-OCT-2008, this patient developed severe local reactions in the injection arm. The patient experienced welts and swelling on the arm. A lot check is requested for PNEUMOVAX Lot#662599/1076X. Unspecified medical attention was sought. The patient's outcome was unknown. This is one of several reports received from the same source. Follow-up information has been received from a physician and medical records concerning this patient. She was an 81 year old female with chronic abdominal pain, knee pain, irritable bowel syndrome, constipation, energy decreased, hypercholesterolemia, hypothyroidism, dementia, colonic polyp, uterine fibroids, cardiomegaly, drug hypersensitivity and a history of rib fracture, "valium in past for sleep" and kidney stone. The patient was allergic to "AUGMENTIN, VICODIN, PERCOCET, Codeine, IV Dye, Sulfa, Hyoscyamine, ASA, Tetanus, MOTRIN, NEOSPORIN, ERYC, Ibuprofen, Anti-inflammatories, ATIVAN, LEVSIN, DONNATAL, Pcn: Can Take Amox, Amitriptyline, Bella Alkaloids, Cephalexin, Hydroxyzine, Alprazolam, ZANTAC, Simethicone, Lovastatin: Myalgias, LIPITOR: Myalgias." Concomitant therapy included LIBRAX capsules, vitamin D (unspecified), ascorbic acid, omega-3 marine triglycerides, levothyroxine Na, folic acid, "therebec plus" garlic, COLACE, "SENOKOT", NIASPAN and zoster vaccine (Merck) (therapy date, route, dose unknown). On 27-OCT-2008 the patient was vaccinated with the first dose of PNEUMOVAX vaccine on left deltoid (therapy route unknown). On 30-OCT-2008 the patient experienced injection site welts on the arm and injection site swelling on the arm. She went to emergency room and was diagnosed as "Cellulitis NOS" and "Allergic reaction NOS". The patient outcome was unknown. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center and was released. No further information is available.
Is diarrhea a side effect of shingles shot; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced diarrhea after receiving shingle vaccine. No other information was reported.
Left thigh where Varivax immunization was placed developed a 1 1/2 x 1" indurated area with vesicles on skin.  ~4 vesicles which crusted.
pt complained of pain in left arm at injection site, pt checked into an urgent care and has been instructed to take caution and monitor for signs of infection and cellulitis
lymph nodes began swelling on left side of neck. Other lymph nodes in neck swelled later. Began having trouble swallowing. Lymph nodes eventually went down but still have trouble swallowing
pt woke w/fever 103 evening of 18MAY95; also vomited & was irritable; pt was taken to local ER & was given suppository which relieved sx;
Persistent and progressive muscular pain at right deltoid injection site for past 2 weeks. Unremarkable physical exam findings. Taking Tramadol for pain. Administered 40 mg. KENALOG injection at site of maximum pain/tenderness to palpation over right lateral deltoid 10 cm. distal to the AC joint. Seen by Dr of Ortho Clinic 03/15/2019. Given subacromial bursal pain/steroid injection. Still no relief. Using shoulder immobilizer which helps some. Still requiring tramadol for pain relief.