chrisvoncsefalvay/vaers-outcomes huggingface dataset:
- Severe Headache - Tingling in Both Arms on and Off - Occasional Blurry Vision - Euphoric Sensation, Very Incoherent like symptoms and Severe Weakness - Severe Swollen Injection Site and Upper Arm -2nd Day Severe Allergy like symptoms, sinuses, dry eyes, severely swollen sinus membranes -Fever of 102.8 day 2 & 3  -Day 4 still fever of 100 -Day 4 Severe Headache Returned
4PM 8/5/06 c/o right arm hurting, right arm edema and erythema, upper arm to elbow, 1 tsp children's Tylenol, 8pm 8/5/06, No Sx 8/6 or 8/7 only Tx mom used alcohol on arm.
Pt. stated that she was told by nurse aid her face was red.  Pt. stated she was feeling better.  Pt. evaluated by paramedics.   vss Pt. discharged home and advised to call 911 is symptoms worsened.
Initial report received on 08 July 2009 from a reporter.  A 70 year old female patient with a history of hypertension and hyperlipidemia and an allergy to Cephalexin received a first time dose of ADACEL (lot number C3246BA) intramuscularly in the right deltoid on 23 June 2009.  Concomitant therapy included SYNTHROID, Pravastatin and Co enzyme 10.  On 24 June 2009 the patient complained of abdominal cramps, fever, and chills.  By 30 June 2009 the patient's symptoms resolved.  Follow-up information was received 31 August 2009 from the patient's physician who reported that they had no additional information to provide.  List of Documents held by Sender: none.
Pt recvd vax 31AUG92 & 9SEP92 devel measles by nasal congestion, rash, t97.1, barking cough, runny eyes & an erythematous rash, lab eval showed WBC count 4400, hemoglobin 9.4, hematocrit 29.7, MCHC 31.6 & a platelet count 212;
p/vax pt exp varicella w/less than 50 lesions;MD noted few erythematous macules on arms, chest & trunk;
Couldn't raise right arm without having pain.  Red and swelling.  Chills, sweats, tired/sleepy, temperature, swelling across chest, collar bone.
given a 2nd booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (given a 2nd booster dose) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 051C21A and 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 11-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 11-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (given a 2nd booster dose). On 11-Jan-2022, EXTRA DOSE ADMINISTERED (given a 2nd booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient may have some dementia. .No concomitant drug details were reported. No treatment details were reported.
Right arm swelling, pain, blistering and chest tightness for 2 days.
Prolonged (lasting at least four weeks) significant autoimmune related flare-ups including extreme fatigue,  neuropathic pain, chills, and raynaud's phenomenon.  I first time occurrence of vitiligo on wrist/hand
Patient described itchiness in her throat about 10 minutes after vaccine was administered. Also became dizzy and then subsequently reported difficulty breathing and difficulty swallowing.   Administered 50 mg Benadryl IV, Solumedrol 125mg IV, and O2. Transported to Hospital via ambulance.
Rash on Chest, back and Arms.  Red speckled rash in groin area.
PAIN IN RIGHT ARM UNABLE TO MOVE WIITHOUT PAIN. LOSS OF APPETITE, NAUSEA, ELEVATED TEMPERATURE.
He is nervous about taking the second shot; He got dizzy when he went to go bed; every time he moved his head throughout the night he would wake up feeling dizzy.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NERVOUSNESS (non-serious), outcome "unknown", described as "He is nervous about taking the second shot"; DIZZINESS (non-serious), outcome "unknown", described as "He got dizzy when he went to go bed; every time he moved his head throughout the night he would wake up feeling dizzy.".  Additional information: Reporter stated, "He got dizzy when he went to go bed, as soon as he laid his head on pillow and then throughout the night, every time he moved his head throughout the night he would wake up feeling dizzy. We are wondering when it's going to get better because he is nervous about taking the second shot."  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 nurse concerning a 17 year old female patient with a history of depression, anxiety and behavioral disorder. Concomitant medication included LEXAPRO and ACZONE. On 31MAR2014 the patient was vaccinated with GARDASIL (lot # J013324, expiration date 12FEB2016), intramuscular, in the left arm for "Going to College". The patient also received a dose of MENACTRA in the left arm that same day. On 03APR2014, 4 days after onset of therapy, the patient experienced leg pain and complained of injection site pain and redness where she received MENACTRA. The outcome of leg pain and injection site pain and redness was unknown. Additional information has been requested.
At bedtime he began feeling chills, achiness, hot then cold, and fatigue.  He also reported having bizarre "fever" dreams. Symptoms continued throughout the night and he was up all night feeling lousy.  This morning he is still feeling sick.
I've had daily muscle aches ever since getting my first Shingles vaccine in November 2020 at Pharmacy. The muscle aches have continued since then. They were temporarily worse after my second Shingles vaccine, and after the Covid Moderna vaccines on 2/26/21 and 3/26/21. If I recall correctly, they weren't as bad after my Covid Moderna booster on 11/3/21, except for a day or so. I called my doctor toward the end of November about the muscle aches, because of how long they've been persisting. I was going to go into the office for an appointment, but because of the Covid risk of being in the public, I decided not to. I changed my mind and went in to see him in January 2022 about the daily muscle aches and new joint pain. He explained that muscle aches aren't a common side effect of vaccines, so perhaps there are other variables. My rheumatology lab work inflammation lab tests were all normal.
Pt c/o fever, L shoulder pain and swelling, body aches, back pain, red rash to shoulder, N/V, swelling in armpit about 3 hours after administration and worsening through 8/25/2015 AM.  Tx'd with ice packs and APA and to return to clinic if sxs persist/exacerbate.
I gave birth 5/8/2022 birth wight 8lbs 15oz, baby had low oxygen saturation and high temperature was place in prenatal ICU for three days. Right lung was collapsed reflated 2 days after delivery.
pain in his feet and pain in his hand; This is a spontaneous report from a contactable consumer (patient's wife) from a Pfizer-sponsored program.   A male patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: ER8736, Expiration date: unknown), dose 2 via an unspecified route of administration on 04Jun2021 as 2nd dose, single dose COVID-19 immunization. patient previously took first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection Lot Number: EW0167, Expiration date: unknown) via an unspecified route of administration on an unspecified date as first dose single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 04Jun2021 after second vaccine, the patient experienced pain in his feet and pain in his hand. Patient is still experiencing a pain in his feet and pain in his hand. The outcome of event was unknown.
persistant screaming started 10 min p/vax given & lasted about 7-8 hrs; full, nl, not unusual, cry; inject site became swollen & tender; no other sx or signs; epiosde ended when pt fell asleep for the noc; low grade temp;
About eight hours after the injection, I noticed some hearing impairment in my left ear.  Sounds are muffled, almost as if I have water trapped in the ear canal.  I noticed this right before I went to bed, and the hearing loss is still present and similar in magnitude this morning.  There is no pain, and the hearing in my right ear seems to be normal, although I can't rule out some slight loss on that side.  Aside from a slightly sore arm at the injection site, I've had no other side effects (e.g., no fever) from the vaccination.
Outbreak of chicken pox; 0 pox to body. No fever and no other symptoms.
Flu symptoms - fever, achiness, loss of appetite , arm redness, swelling and heat - diagnosed with cellulitis made three trips to er before being admitted for observation and treatment with steroids and Iv antibiotics.
None. Vaccine given prior to designated interval date (HPV #1 7/22/11, #2 9/26/11).
My fever was through the roof. My body ached so bad I couldn?t walk. I was on fire all over. Then came the adverse event- uncontrollable shaking. This was not a side effect written on the moderna sheet of risks. I was shaking so bad I thought I may have a seizure. I finally settled down and fell asleep. About an hour later, I woke up shaking out of control. I was going to call 911 but my partner was able to grab some NyQuil for me and knocked me out. It was the most terrifying experience of my life and I will not be getting the second shot because of it.
Two days following FLUMIST pt c/o HA every morning. On 11/11/14 patient woke with HA, neck pain et nausea. Presented to physician's office et sent to E.R. Admitted with possible viral meningitis, CD-1 form sent to HD. Recent vaccination noted on admit.
Information has been received from a physician concerning a 11 year old female patient who on 03-JUL-2000 was vaccinated with the first dose of MMR II. On 23-OCT-2002, the patient was vaccinated with the second dose of MMR II. On 14-JAN-2010, the patient experienced mumps (diagnosed 15-JAN-2010). The patient had left parotitis and temperature 102F. On 15-JAN-2010, laboratories performed showed: serum immunoglobulin M test (IgM) less than 1:10 (normal range less than 1:10), serum immunogobulin G test (IgG) 3.84 (normal range greater than 1.10) and serum amylase test 286. At the time of reporting, the patient's outcome was unknown. No further information is available.
Vaccine given too early (2 weeks instead of 3 week interval). No known adverse reactions.
PATIENT RECEIVED 2ND DOSE PFIZER 6 DAYS EARLY.
2 Days after the 2nd dose of Pfizer vaccine, Welts appeared on his back and chest.  Using some over the counter creams to address itching.  Over time the welts decreased in size and spots broke out all over his body ...much smaller but causing tremendous itching.  These spots covered whole body including extremities...everywhere except face.  When nothing seemed to address getting rid of the rash and not associating the rash at this time, he secured an appointment with his primary care doctor, who then referred him to the Dermatology dept.   This process took a month.  The first visit with Doctor, Dermatologist prescribed Clobetasol Propionate cream which was used for 3 weeks to no avail.  Doctor then prescribed Tacrolimus Ointment which again was used for 3 weeks to no avail.  On Aug. 19th Doctor performed a biopsy and the results were drug related Dermatitis.  At this time steroid medication is being prescribed which hasn't started yet.  Because of Type 1 diabetes, there was a hesitancy of using steriods.
Got the shot and bam broke out with shingles / it didn't work for me/Suspected Vaccination failure; broke out with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient was one of the unfortunate ones that had repeated cases of shingles. The patient got the Shingles shot and bam broke out with shingles. As per the patient, do not beat yourself up for not had taken the shot, vaccine did not work for the patient. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Pt developed varicella illness following vaccination with varicella virus vaccine live. Two of the pts siblings were reported to have had similar episodes. Additional information has been requested.
second vaccine 3 weeks after first; This case was reported by a physician via sales rep and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comments: The reporter was a GSK vaccine representative reporting an adverse event with limited information for Shingrix. The representative stated that a physician at one of their accounts gave a patient their second Shingrix vaccine 3 weeks after the first vaccine.  The representative had no further information regarding the patient or vaccine. The reporter did not consent to follow up. Additional supportive information: The patient received the Shingrix dose earlier than the recommended interval, which led to shortening of vaccination schedule.
Child and guardian did not speak the language, uncle was assisting family.  When uncle was asked to identify child, he gave the wrong name.  Patient was given Pediarix instead of Tdap, IPV, HBV. Later identified during sister's turn for vaccines.  MCIR was corrected.  No identifiable reaction by patient.
Pt had DTaP & Varicella vaccine 8/14/12 in (R) thigh 2 days later area was red, itchy & swollen (size of apricot per mom) Rx with hydrocortisone topical & ice) since then area has enlarged, still "itchy" & warming.
This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD with lot # M009745 and expiration date on 23-AUG-2017 (anatomical route of vaccination was not provided) for prophylaxis. It was reported that, PROQUAD was exposed to a temperature of > 5 °F but < 14 °F for a 5 minutes time frame. The vaccine was not involved in a previous temperature excursion and data logger was not stated. Furthermore, it was reported that, no adverse events were suffered and that no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA007257:
accidentally given an additional Pentacel with Prevnar at 3 years of age with no reported adverse event; Initial information received on 22-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 3 years old and unknown gender patient who was accidentally given an additional diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine [Pentacel (Vero)] with prevnar with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   Concomitant medications included pneumococcal vaccine conj 7V (CRM197) (Prevnar) for Prophylactic vaccination (immunization).  On 22-May-2023, the patient accidentally received an extra dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (batch number and expiry date unknown) via intramuscular route in unknown administration site for Prophylactic vaccination (immunization) along with prevnar with no reported adverse event (extra dose administered) (same day latency).  It is unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event accidentally given an additional pentacel with prevnar at 3 years of age with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
severe dyspnea; This is a spontaneous report from a contactable Physician (patient). This  30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 12Jan2021 (Lot Number: EK9231) at the age of 30 years, as single dose for COVID-19 immunization. Medical history included COVID-19 in Mar2020. The patient had no known allergies. There were no concomitant medications. Historical vaccine included BNT162B2, dose 1 in right arm, on 20Dec2020, lot # EK5730. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Jan2021 the patient experienced severe dyspnea, seriousness criteria reported as disability.  The clinical course was reported as follows:  Patient with history of COVID-19 infection in Mar2020 developed severe dyspnea approximately 2 weeks after vaccination. Refractory to treatment with bronchodilators. Only responsive to high-dose steroids. Of note, patients symptoms from COVID-19 had completely resolved months prior to vaccination and patient had no other medical history. Therapeutic measures were taken as a result of severe dyspnea and included Breztri, albuterol, prednisone. The clinical outcome of the severe dyspnea event was not recovered. . It was also reported that since the vaccination, the patient had tested for COVID-19: Sars-cov-2 test: negative on 04Feb2021 with nasal swab.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Dyspnea cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
12/20: Dr note History of rash and hand swelling - patient with dramatic rash acutely occurring 1 week after COVID booster vaccine (Moderna) - rash has remarkably improved and is nearly gone now - his hand swelling is gone but now has bilateral feet swelling - continue to observe
Patient arrived to the hospital 10/16/2021 after having SOB for 10 days. His oxygen saturations were in the 70's. He was found to have multifocal pneumonia along with a positive COVID test. Patient was placed on bipap. Vancomycin and Cefepime wee started along with Dexamethasone and Baricitinib. Patient remains on Bipap at night at 80% FIO2 and is on heated high flow via nasal cannula at 100%. He remains in the ICU FIO2.
Patient claimed at the 2nd dose that she has developed Shingle around her mouth ~ 2 months after the 1st shingle shot and was treated by her primary dr with valcyclovir.
No Adverse event; 12 year old received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster; 12 year old received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster), WRONG PRODUCT ADMINISTERED (12 year old received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster) and NO ADVERSE EVENT (No Adverse event) in a 12-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Sep-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster) and WRONG PRODUCT ADMINISTERED (12 year old received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster), WRONG PRODUCT ADMINISTERED (12 year old received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster) and WRONG PRODUCT ADMINISTERED (12 year old received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster).    No concomitant medication were reported.             No treatment information was provided by the reporter.