chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough case admission after 4 vaccines Pfizer 3/28/21 Lot# EN6207;  Pfizer 4/23/21 Lot# EW0158 ;Pfizer 12/13/21 Lot# 33030BD;  Pfizer 8/1/22 Lot# FP7135
0749 - tingling in body, scratchy throat for 10 minutes, flushing
Severe arm pain at injection site.; No swelling but can barely move arm; Chills; fatigue; moderate headache; This is a spontaneous report from a non-contactable nurse (patient). A 27-year-old non-pregnant female patient receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration at left arm on 22Dec2020 at 10:00 AM at single dose for COVID-19 immunization at pharmacy or drug store. Medical history was none and there was no known allergies.  Concomitant medication included oxybutynin hydrochloride (OXYBUTYNIN) and birth control received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe arm pain at injection site, there was no swelling but can barely move arm, chills and fatigue and moderate headache, all on 22Dec2020 at 09:00 PM. There was no treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination,  the patient had not been tested for COVID-19. The outcome of the events was not resolved.   No follow-up attempts are possible. No further information is expected.
Arm became red hot, swolllen and achy.  it was seen a week later by doctor and was still found to be hot to touch. It gradually faded away but to this day I have achiness and residual weakness in the left upper arm, with bouts of mild fever mid upper arm level. Pain upon mush use  which fades but never quite completely leaves.
a little headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jan2021 19:00 (Lot number: EK9231) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing), notes: Known allergies: yes; "Asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "a little headache".  Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was yes. First dose of the Pfizer Covid-19 vaccine is 06Jan2021 and the lot number is EK9231. Reporter stated that after administration of the first dose she only experienced a little headache which lasted a few days. Reporter stated that she did not have the start and stop dates of event a little headache.  No follow-up attempts are possible. No further information is expected.
Extreme pain in left arm, neck and left upper back for 8 days.  Severe headache, nausea and bloating still continuting after 16 days. I was in bed unable to move arm for over a week.  I continue to be sick with headaches and nausea.  It has left me so weak I can barely walk.  I was an active, healthy 69 year old before this injection. Dr. prescribed a steriod pack, hydrocodone and promethazine for nausea.  Nothing has helped the headaches and nausea.
No additional AE details; Adult patient was administered a dose of PROQUAD inadvertently; This spontaneous report was received from a nurse and refers to a 27-year-old patient of unspecified gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 20-JUN-2022, the patient was administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type rHA) subcutaneous injection (lot # U002530 has been verified to be a valid lot number, expiration date: 24-JUL-2022; dose and route of administration not reported) inadvertently, administered for prophylaxis (Product administered to patient of inappropriate age). Additional product reported included sterile diluent (MERCK STERILE DILUENT) (reported as "DILUENT MRK"). There were no additional adverse event (AE) details provided (No adverse event). There was no product quality complaint (PQC).
Received Moderna COVID-19 vaccines on 3/2/21 and 3/29/21.  Developed symptoms of productive cough, nasal drainage, fever to 102, shortness of breath and generalized weakness/fatigue on 9/11/21.  Was seen in the Emergency Dept on 9/16/21 after having a fall at home; tested + for SARS-CoV-2 and was admitted to the hospital.  Initially on room air, but oxygen levels progressively worsened.  Treated with Rocephin, Decadron, Remdesivir, and subsequently baricitinib.  Was transferred to larger hospital for escalation of care on 9/20/21.  Status continued to worsen.  Ended up requiring intubation, hemodialysis, pressors.  Transitioned to comfort care due to lack of improvement.  Extubated and died shortly thereafter on 10/26/21.  Cause of death was noted to be ARDS and acute hypoxic respiratory failure due to COVID-19 pneumonia with secondary MSSA pneumonia.
Dizziness and lightheaded for 7 days following the initial vaccine.   Upper respiratory infection beginning in the middle of May. Started as allergies with sinus congestion and cough.  Have been given 3 different antibiotics to date to clear up a lingering cough. Amoxicillin, Z-Pak, Rocephin.
Swollen left thigh, non-tender, full range of motion, very itchy. Treatment: Benadryl PRN, cool compresses.
Coughing started back up late February of 2022, persisting since then I have had chronic dry and wet coughs that cause a lot of anxiety due to the amount of coughing that comes. After speaking with my doctor, they stated that I should start using Flonase and Claritin, and I haven't seen any relief with these. I began using a vaporizer in the room and it does help momentarily. Loratadine was prescribed and did not help much. I was then given antibiotics after wards and it still has not helped with any symptoms. I am now going to be seeing a pulmonologist soon to get a diagnosis. I recently went to the ER on the 24th where they took blood and checked my heart ruling out congestive heart failure. Chest X-ray also showed no structural damage or issues with my lungs. I am unsure if this is related to the vaccine and would like to note that.
Patient received ADACEL in right deltoid and ZOSTAVAX SQ in right arm. Earlier that day he received a pneumonia shot from his doctor in his right arm as well. The next afternoon, he had redness, pain, and swelling that was severe and extended to his chest. On 10/8/17, he went to the ER. The Dr. said it was reaction to the vaccines and said it was cellulitis. He was prescribed Ibuprofen and KEFLEX. The swelling is gone but he still has pain.
Sligh soreness  at the injection site tiredness persistent headache bloating and gassiness stomach upset slight nausea
Patient presented to ED with fever and alerted mental status 10/12/21.  Initially concerned for stroke with negative imaging and then infectious etiology and possible encephalitis, but workup also negative with benign LP x2.  Prolonged EEG without perceptible seizures. Given empiric IVIG. L sided unilateral hemispheric gyral thickening/leptomeningeal enhancement found on repeat brain MRI, not present previously, and brain biopsy completed 10/25/21.  Results from biopsy as well as auto immune encephalitis and MOG antibodies pending.  Patient clinically slightly improved but MRI worse.  Remains hospitalized and workup is ongoing.
patient was administered an improperly stored of MMR II; This spontaneous report was received from a health professional (medical assistant) referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions/ allergies were not reported. Concomitant therapies included sterile diluent. On 17-DEC-2019, the patient was vaccinated with an improperly stored dose (1 dosage form) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S006647 and expiry date 05-MAR-2021, for prophylaxis (strength, route and anatomical location were not reported) (product storage error). The administered dose of the vaccine experienced a temperature excursion of 9.4 degree Celsius for 25 minutes, as recorded by a data logger. No previous temperature excursion was reported.
The vaccine arm hurt more when it was administered and felt worse. My chest was hurting on the left was hurting and kept touching it and felt a lump. I saw to urgent care on June 27, 2021. said I needed for monogram, A few days later, I went to my primary care doctor and its moveable and probably not cancer. My period was 11 days late. Waited a month and it came back every time my period came back. The lump was under the nipple on the left side, for the month or two, its gone and cycle is back to normal.
After 9 days left shoulder a lot of pain. Hurts to move shoulder. Hard to put pull over shirts on. No fever. No redness reported can only move left arm up 10 inches from waist then very painful.
Initial information received on 27-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2019SA000612, same reporter. This case involves a 16 years old female patient who received vaccine FLUBLOK QIV. The patients past medical history and family history were not provided. The patient did not receive any concomitant medication. On 20-Dec-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1818, expiry date 30-Jun-2019 via unknown route in the left deltoid. It was an actual medication error due to inappropriate age at vaccine administration. It was reported that 16y, female, received FLUBLOK QUADRIVALENT. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender- none.
JANSSEN COVID-19 EUA.  ADMINISTERED VACCINE TO PATIENT AT APPROXIMATELY 10:30 AM.  PATIENT WALKED OUT TO THE WAITING AREA AND WAS SITTING WHEN REPORTED THAT SHE WAS FEELING DIZZY AT ABOUT 10:45 AM.  OFFERED PATIENT AN ICE PACK AND WATER - SHE DECLINED;  SHE DRANK SOME TEA SHE HAD.  BY 11:00 AM HER SYMPTOMS WERE RESOLVED AND PATIENT LEFT OF HER OWN ACCORD.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 09:00 as dose 5 (booster), single (Lot number: GJ3277) at the age of 76 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 29Jan2021 at 14:00 as dose 1, single (Lot number: EH8932), in right arm, on 20Feb2021 at 14:00 as dose 2, single (Lot number: EN6200), in right arm, on 16Aug2021 at 13:00 as dose 3 (booster), single (Lot number: R3181), in right arm and on 01Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FJ9943), in right arm for covid-19 immunisation. The patient's relevant medical history included: "kidney cancer" (unspecified if ongoing); "known allergies penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
fever to 100.3, adenopathy (anterior cervical), sore throat;all sx started 24hr post vax;
UrticariaPruritus sweating Narrative:  Per supervisor report: "employee took first dose of Moderna today. States the employee c/o sweating and hives later and went home."
Flu shot 3pm, 40 minutes later developed numbness in arms and legs, severe lightheadedness, near syncope, palpitations, given EPIPEN by nurse in hospital. Patient was observed for recurrence of reaction and discharged with diphenhydramine.
Approximately 16 hours after vaccine administration developed 101 degree fever, severe body aches, chills, severe headache, swelling in right arm and in right auxiliary lymph notes, mailaise, loss of appetite
Taken to the ER with swollen right gland and doctor had to press on the gland to remove pus, 103 fever, body pains, could hardly speak or eat, was given morphe for 2 days as the pain was excruciating. Was in the hospital for 3 days and given IV clindamycin and steroids.
Typical effects immediately post vaccination x 2 days.  Resolved, then developed area of induration and warmth approx 2 cm in diameter overlying the injection site with mild pain.  No erythema/streaking/fluctuance.
After the injection, the pt fainted, loss of color, eyes rolled in back, chest red spots. Had him lay down for 10-15 mins. Child walked out and went home.
Started as redness around the injection site. Has spread to underarm, is now warm to touch and very sensitive/sore to touch.
MY LEFT ARM HAS A PAIN WHERE THE INJECTION WAS ADMINISTERED.  THE PAIN RUNS UP MY NECK WHEN I TURN MY HEAD LEFT OR RIGHT (HARD TO LOOK BEHIND ME).  IT IS SOMETIMES HARD TO LIFT MY ARM ABOVE MY HEAD.  WHEN I SLEEP I CAN NOT LAY ON THE LEFT ARM.  IT IS A DULL ACHING PAIN.  I TAKE 800 MG OF IBUPROFREN WHEN THE PAIN GETS TO BE TOO MUCH.
Spiked a fever 104.8 lasting 10 hours.  Chills and horrible muscle aches and lymph node enlargement.  Almost debilitating making it hard to walk .  Took Advil and Tylenol it did not bring down the fever .  Finally took benedryl and it helped . I am still continuing to take benedryl and Advil .  Muscle aches improved .  Lymph node under right arm is very enlarged.  Right shoulder joint itself very swollen I am unable to lift my arm above my head with that arm. Current temp 99.4.   -100.2 .  Feeling much better today.
swelling under left eye and minor swelling under right eye (dermal fillers under both eyes): swelling started 48 hours post injection and lasted for 3 days, i took Zyrtec and ibuprofen to help  my period started which is out of my standard monthly cycle: i started having cramping and breast tenderness 24 hours post injection, 48 hours post injection my period started, i have an IUD, I took ibuprofen to help with the cramps   back and body aches: took ibuprofen to help
Information has been received from a medical assistant concerning a 19 year old female with no pertinent medical history who on 06-OCT-2009 was vaccinated with the first dose of GARDASIL (lot # 663552/1350Y). There was no concomitant medication. Subsequently, the patient experienced arm numbness as soon as the vaccination. The patient recovered on 06-OCT-2009. Additional information has been requested.
Ppt collapsed at home on 3/27/2021 late morning. Presented to ED on 3/27/21 from home around 11am with altered mental status. Was found to have a hyper acute stroke per CT head (intracranial hemorrhage). Ppt was pronounced on 3/28/2021 at 1:45pm. UNSURE IF DEATH RELATED TO VACCINE.
Tongue started  swelling while driving home so I drank water. Pulled over and took liquid children?s Benadryl.  It didn?t really reduce it but I was having no trouble breathing.. Woke up the next morning with swelling almost gone.
Information has been received from a nurse practitioner and a 62 year old white female registered nurse consumer (220 pounds, 64 inches) with hypothyroidism and high blood pressure and no history of drug reactions/allergies. On 22-OCT-2007, the patient received a first dose of zoster vaccine live (Oka/Merck) (lot # 658081/0743U) in the right arm in the afternoon. On 26-OCT-2007 at the time of being vaccinated, the patient hand no illness. On 26-OCT-2007, the patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 655499/0988F) subcutaneously in the left arm in the evening. Concomitant therapy also given on 26-OCT-2007 included a 10 plus dose of FLUVIRIN (lot # 86435) given in the right arm about 1:30 PM. Other concomitant therapy included SYNTHROID, ezetimibe (+) simvastatin (MSD), metoprolol, sitagliptin phosphate (MSD), OMACOR, MOBIC, vitamins (unspecified) and niacin. On 27-OCT-2007, in the evening, the patient experienced arthralgia all over her body, nausea and a fever. At the injection site she developed a golf-sized lump that was warm, red and swollen. She was at the nurse's office on 29-OCT-2007 and the morning office manager told her that she had a small bruise at the injection site after getting pneumococcal 23v polysaccharide vaccine. The nurse practitioner also reported that the patient experienced an unspecified local reaction. Subsequently, the patient recovered from the events. Additional information was received from the registered nurse consumer. The patient had also experienced malaise. No diagnostic tests were performed. Subsequently, the patient recovered from the events. No additional information is expected.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 16-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX injection, lot # M028552, expiry date 07-JUN-2018 (dose, route of administration and anatomical location were not specified) for prophylaxis. The administered dose underwent a temperature excursion between 14 Fahrenheit degrees and 46 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, 2 weeks after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced shingles. The patient was treated with antibiotics nos. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient reported that patient had shingles few days ago and still taking antibiotics, just two weeks after he/she took the flu shot.
I GAVE THE PFIZER AND ABOUT 10 MINS LATER THE PT REPORTED NUMBNESS IN LIPS AND DIFFICULTY SITTING. I GAVE 5ML DOSE OF BENADRYL AND TOOK THE PT BP.  I ALSO GAVE WATER AND THEN SHE SAID THAT SHE WAS FINE
I became very sick for about 4 days following my shot - same thing happened with my 1st and second dose.  Second dose caused me to have 3 periods in a 5 week timeframe, the one following the second dose was exceptionally heavy and painful.  Since my third - booster - I have had ongoing covid symptoms - most concerning are shortness of breath and body tremors.  My doctor has done a series of medication trying to resolve these with minor improvements.
The next morning, his arm hurt and he did go to school but was sent home. He was tired, weak and cold. This lasted 24 hours. This happened periodically since after this vaccine. About 5 or 6 times. He saw the doctor once got blood test .On 25FEB2022. He reported to school nurse because he was tired, cold and weak, fever with 101 temp. He had telehealth visit with urgent care with pediatrician. He felt better on the 27Feb2022.
Tingling in hands; Tingling lips,; Lips felt swollen but it was not noticeable.; Forehead felt numb; Disorientation; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 05Mar2021 at 20:30 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history included recurring Epstein Barr virus, burning mouth syndrome, anxiety, osteoarthritis and COVID-19. The patient was allergic to mercury, pollen and penicillin. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN), cetirizine (ZYRTEC), folic Acid (MANUFACTURER UNKNOWN), and alpha lipoic acid (MANUFACTURER UNKNOWN); all for unknown indications from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 05Mar2021 at 20:45, the patient experienced tingling in hands, tingling lips, lips felt swollen but it was not noticeable, forehead felt numb and disorientation. The patient was advised to take BENADRYL for treatment of the adverse events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of tingling in hands, tingling lips, lips felt swollen but it was not noticeable, forehead felt numb and disorientation were recovered on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Pt recvd vax in JUNE92 & devel a burning sensation upon inject as well as soreness & or an aching sensation in the arm; heaviness in the arm also;
A 5 week old patient received Daptacel, no AE; Initial information was received on 24-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 5 week old male patient who received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number not reported, form: single dose vial) via unknown route in unknown administration site for prophylactic vaccination on an unknown date (product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day)  The reporter asked whether the vaccination is counted as a valid.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on lot number.
received dose on 2-19 Friday.  Saturday had body aches and 101.7 fever.  Felt better Sunday.  Rash at injection site started Monday March 22 and is still there today Friday March 26. It is red and itchy.  Its size is comparable to a dollar bill.