chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from an office manager and refers to a 4-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 14-DEC-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
inconsolable crying on 23JAN98 & 4-5hr low grade fever;
patient developed allergic reaction after vaccination. Lips were swollen white and very nauseous.  Epinephrine was injected in upper thigh and paramedics were called.  After few minutes of epinephrine injection, patient gradually was feeling better.  Paramedics came and left with patient .
Rubella vaccine ordered on post partum patient. Mumps vaccine was loaded into PYXIS on nursing station by pharmacy. Nurse administered mumps vaccine. Four healthcare professionals (2 pharmacy technicians, 1 pharmacist, 1 nurse) all misread the labeling. Products look very similar. We would like the manufacturer to better differentiate the products.
Hospitalization: 2/26/2023 - 3/3/2023 (5 days) Presentation to the ED: worsening shortness of breath and cough  COVID + date: 2/26/2023 Treatment: remdesivir, dexamethasone, ceftriaxone & azithromycin  Discharge to: home.  023M20A 2/25/2021 003B21A 3/25/2021 047C21A 10/26/2021
Became sore, achey, flueish and tired that night. Sore arm.   Next 10 days was extremely tired although other initial symptoms cleared up in 36 hours after shot.
Patient had sore arm after every mRNA shots; Patient had headaches after every mRNA shots; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Patient had sore arm after every mRNA shots) and HEADACHE (Patient had headaches after every mRNA shots) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Patient had sore arm after every mRNA shots) and HEADACHE (Patient had headaches after every mRNA shots). At the time of the report, PAIN IN EXTREMITY (Patient had sore arm after every mRNA shots) and HEADACHE (Patient had headaches after every mRNA shots) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-665512, US-MODERNATX, INC.-MOD-2022-665518 (Linked Report). This case was linked to MOD-2022-665505 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-665512:Husband cases- (MOD-2022-665512-1st dose and MOD-2022-665518-Bivalent dose) US-MODERNATX, INC.-MOD-2022-665518:Husband cases- (MOD-2022-665512-1st dose and MOD-2022-665518-Bivalent dose)
Fever and arm pain for 20 hours  Redness, swelling in cheeks in the location Juviderm dermal fillers injected Jan 8, 2021
pt recv vax & was breast-feeding @ time of vax;approx 3 wk p/vax pt exp elevated liver enzymes (SGOT, SGPT, LDH);
Complaints of mild arm soreness and fatigue.  1 Week later 6/24/14 complained of moderate to severe joint pain shoulder/hip, and fatigue.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received SHINGRIX. Concurrent medical conditions included ear infection (the patient was taking an antibiotic to treat the ear infection). Concomitant products included LUNESTA, Nature Thyroid and Progestin. On 7th May 2018, the patient received the 1st dose of SHINGRIX. On 7th May 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain and influenza-like symptoms. On 8th May 2018, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, influenza-like symptoms and injection site erythema were unknown and the outcome of the injection site swelling was not recovered/not resolved. The reporter considered the injection site pain, injection site swelling, influenza-like symptoms and injection site erythema to be probably related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX on the left arm. The patient experienced injection site pain immediately. Less than a day after receiving vaccination, the patient had flu-like symptoms. One day after receiving vaccination, the patient had a big round red circle of swelling and pain at the injection site.
Dizzy; This case was reported by a consumer via interactive digital media and described the occurrence of dizziness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Flu vaccine. On an unknown date, unknown after receiving Shingles vaccine and Flu vaccine, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was recovered/resolved.   It was unknown if the reporter considered the dizziness to be related to Shingles vaccine and Flu vaccine.     Additional Information: GSK receipt date: 28-OCT-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. After getting his/her flu shot and shingle shot he/she was dizzy for 3 days. The patient asked as what should he/she did. Additional supportive information: Follow up would not possible, as no contact details were available.
flu; Initial information was received on 04-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional under reference number - US-SA-SAC20211208000921  This case involves Adult female patient who experienced flu (influenza), after receiving vaccine INFLUENZA VACCINE.  The patient's past vaccination(s) included Flu Vaccine on 15-FEB-1976.  The patient's past medical history, medical treatment(s) and family history were not provided.   No other concomitant vaccines were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
13Mar19 1045am "shaking"(per mom rept) "eyes were rolling around head"-pt upright leaning against couch.These sx had subsided by 1130 when reached Peds ofc.T @ ofc 101 F,pt recved Tylenol @ home.Highest T 103F 13Mar91.Dx:ear infect @ MD ofc
1st polio dose and 2nd dtap dose; Kinrix after 7 years old; This case was reported by a physician via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 7-year-old female patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th January 2023, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 18th January 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate schedule of vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-JAN-2023 Reporter's Comment: The reporter was a physician. The reporter reported that the patient received Kinrix vaccine 13 days after her 7th birthday. The reporter stated that the patient received Kinrix vaccine as 1st dose of polio and 2nd dose DTaP. Additional supportive information: The patient received Kinirix who was older than the indicated age which led to inappropriate age at vaccine administration. The patient received Kinrix vaccine as 1st dose of polio and 2nd dose DTaP schedule, which led to Inappropriate schedule of vaccine administered
Initially there was no reaction but days later I developed what I have had previously (bronchitis).  I had severe coughing, to the point that I could not sleep.
I95.9 HYPOTENSION 2/16/2021 GI HEMORRHAGE I95.9 HYPOTENSION 2/16/2021 AORTIC VALVE STENOSIS I95.9 HYPOTENSION 2/16/2021 BRIGHT RED BLOOD PER RECTUM I95.9 HYPOTENSION 2/16/2021 PALLIATIVE CARE
9:45 AM client feels "throat closing, " shivering and cold. NP, safety, and EMT were called and arrived at scene. NP, assessed pt. no throat or tongue swelling present, client states he feels anxious, otherwise feeling "OK".  9:54 BP 134/77, HR 104, O2 92%, BS 142.  client was laid on the floor with a sheet with his legs elevated, blanket was placed on his upper body.  10:00 NP, reassessed pt and stated he is not having a reaction to the vaccine. Client states "I feel better." 10:08 Patient is sitting in the chair BP 127/80, HR 94, O2 99% 10:10 NP assessed client and stated that he is well enough to go home. Advised client that if he has chest pain, or shortness of breath  to report to the ER or call 911. Client verbalized that he feels much better.  10:15 patient is alert and oriented to person place time and situation, he safely ambulates to the car and his mother provides transportation.
Pain in spinal column and feet and hands.  Today is the 6th day after the shot.
brusing at injection site and red rash below injetion site that is warm to the touch.  told patient to use cold compress and otc antihistamine and to let us know if it worsens or doesn't resolve in a few more days
swelling in the PM; parotid gland swollen & tender; large posterior cervical nodes; skin over lt parodid gland has heavy crusted lesions; t99.1; cellulitus of lt cheek; seen by MD 24MAY93 w/above sx;
nasal mucus, ill feeling for about 1 wk, 3 wks p/flu vax;
Pt given wrong meningococcal vaccination. Should have received MENVEO Booster. No true adverse reaction to vaccination, solely administration error.
825AM onset of SOB, feeling of pressure in chest, some coughing, dryness of mouth, 910AM inc SOB, color pale, numbness of upper extremities; some rash & itching;
Initial report received from a health care professional on 07 September 2012. A 32-year-old female patient, whose concomitant medications and medical history was not reported, had received an intramuscular first dose of ADACEL on 07 September 2012 (lot number: U4384AA, expiry date: 11-30-14, anatomical site of vaccination was not reported). The patient was pregnant at the time of vaccination. The patient's last menstrual period date (LMP) was 05 April 2012 and expected date of delivery (EDD) is: 24 September 2012. As of 07 September 2012, the patient did not experience any adverse events. Follow-up information received from a health care professional on 03 September 2013. The patient experienced pre-eclampsia during the pregnancy, date not reported. The mother had a history of two pregnancies, details not provided. The pregnancy outcome was normal. The end of pregnancy date was reported as 15 September 2012 and the birth outcome was normal. The patient also received AFLURIA during pregnancy, manufacturer unknown, dose, date of vaccination and route not reported. It was reported that the patient did not experienced an adverse event following vaccination. Documents held by sender: none.
PARANOID THAT PATIENT HAD SARS SYNDROME; MUSCLE SPASMS IN FINGERS, TOES, AND BUTTOCKS; DISTURBING DREAMS AS IF PATIENT WAS IN A BARBER CHAIR AND SOMEONE WAS SPINNING PATIENT; SPINNING SENSATION DURING DREAMS AND WHEN AWAKE; FELT OFF/FELT LIKE HIT BY A TRUCK; FELT ILL; FEELING SUPER DUPER TIRED AND FATIGUE; FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies, no known previous medical conditions, and no current medication usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the patient experienced felt off/felt like hit by a truck. On 30-JUL-2021, the patient experienced felt ill. On 30-JUL-2021, the patient experienced feeling super duper tired and fatigue. On 30-JUL-2021, the patient experienced fever. On 30-JUL-2021, the patient experienced nausea. On 30-JUL-2021, the patient experienced headache. On 01-AUG-2021, the patient experienced disturbing dreams as if patient was in a barber chair and someone was spinning patient. On 01-AUG-2021, the patient experienced spinning sensation during dreams and when awake. On 08-AUG-2021, the patient experienced muscle spasms in fingers, toes, and buttocks. On an unspecified date, the patient experienced paranoid that patient had sars syndrome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt off/felt like hit by a truck, felt ill, feeling super duper tired and fatigue, fever, nausea, and headache, and disturbing dreams as if patient was in a barber chair and someone was spinning patient, spinning sensation during dreams and when awake, and muscle spasms in fingers, toes, and buttocks on AUG-2021, and the outcome of paranoid that patient had sars syndrome was not reported. This report was non-serious.
puritis in arms and legs. given 50 mg of benedryl and improvement started prior to discharge from vaccination site
Developed intussusception at 8mo of age, 1-13-08. Unrelated to Rotateq? Transferred to hospital where this was corrected. 2/14/08-records received for DOS 1/8-1/12/08-DC DX: Intussusception. Intermittent fussiness began Wed, seen in ED treated with suppository with positive stool and vomiting resolved. Thursday fussy, black stool and low grade temp.
pernicious anemia; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection), (Lot number and expiry date was not reported) dose 1 via an unspecified route of administration on 28Jan2021 as a single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced pernicious anaemia. The patient's 2nd dose will be on 18Feb, she should be on B12 injections, but she missed it this month due to the vaccine, she had pernicious anaemia. She would like to know if she can take it with the covid vaccine. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
received the doses Fluzone High-Dose Quadrivalent one month apart due to an oversite issue, no AE; Initial information received on 19-Jan-2021 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves patient (unknown demographics) who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number and expiration date not reported) one month apart due to an oversite issue via unknown route in unknown administration site for prophylactic vaccination on an unknown dates (extra dose administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   This was an actual medication error due to extra dose administered [latency was same day].  At the time of reporting, no adverse event was reported to the patient.  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.  There will be no information on the batch number for this case.
Started with body aches, chills, and nausea. Nausea and vomiting, more severe body aches and abdominal pain continued throughout night of receiving vaccine. Also had a mild fever and severe fatigue. Fatigue and aches persisted on day 2, but other effects began to subside. By day 3, I was able to function normally again.
Feeling numbness and tingling in my right hand ring and pinky finger. Ulnar area.; Feeling numbness and tingling in my right hand ring and pinky finger. Ulnar area.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 35-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL3248; Expiration Date: unknown) via an unspecified route of administration, administered in Arm Right on 13Jan2021 16:00 (at the age of 35-year-old) as 1st dose single for COVID-19 immunization. COVID-19 vaccine was administered at other. Medical history included diabetic (diabetes mellitus) from an unknown date. Patient had no allergies to medications, food, or other products. Concomitant medications patient received within 2 weeks of vaccination included empagliflozin, metformin hydrochloride (SYNJARDY), venlafaxine (VENLAFAXINE), atorvastatin (ATORVASTATIN), aripiprazole (ARIPIPRAZOLE) taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 25Jan2021 16:30, the patient experienced feeling numbness and tingling in my right-hand ring and pinky finger, ulnar area. Never had this issue before until after having the vaccine. The case was assessed as non-serious as per reporter with no seriousness criteria of Results in death/Life threatening/Caused/prolonged hospitalization/ Disabling/ Incapacitating/ Congenital anomaly/birth defect. No treatment was received for the adverse events. The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Presented with hypoxia, cough, SOB; dx with Covid 1 week PTA; Admit to tele with Covid PNA; tx with steroids, remdesivir, singulair, zinc, actemra, For the COVID-19 patient received remdesivir and also Actemra. Over the next several days patient shortness of breath has improved and he will be sent home on home oxygen.
Pt had 2-3 days of inlarged ant. cervical lymph nodes & body aches. Subsided without sequelae, Pt not seen in HS until 12Apr90. No enlarged nodes at this time.
A 56-year-old female patient with no current illness or preexisting conditions experienced erythema and swelling after receiving an intramuscular left arm injection of Adacel (lot number C2731AA). The vaccine was administered on 21 May 2007, and on 24 May 2007 the patient experienced erythema and swelling in a 6 cm by 12 cm area. The event subsequently resolved.
Ardor of joints and pelvis. Nausea, weakness.  At day #10 after the shot, I woke up with a rash.  Went to emergency room on day #11 and was diagnosed with an urticaria.  Prescription for 6 days: Methylprednisolone and Hydroxyzine.  As of today, still with the problem.
PATIENT REPORTS HAVING FEVER AND INJECTION SITE REACTION THE NIGHT AFTER THE IMMUNIZATION ON 6/27. ON 6/30/18 PATIENT CALLED SAYING FEVER HAS RESOLVED BUT ARE STILL SWOLLEN AND RED.
1/11/21Insomnia - Went to bed by 9pm (woke up 11:30 pm and did not sleep through the night) 1/12/2021 Muscle spams (neck) - body ached,  lethargy - Took Tylenol  1/12/2021 Headache (sinus pressure) started fading at around  8 pm 1/13/2021 Lightheaded  1/14/2021 Lightheaded 1/14/2021 back to normal
Dizziness, Headache, Myalgia,  Chills, Right arm soreness
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 21-AUG-2014, an expired PNEUMOVAX23 was inadvertently administered to a patient. No adverse effect reported. The outcome of expired PNEUMOVAX23 was inadvertently administered to a patient was unknown. Additional information has been requested.
LMP, 05/30/2021 Miscarriage, 08/2021