chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Upper lip swollen; tongue swollen; Very fatigue; sore throat; This is a spontaneous report from a contactable consumer, the patient. A 28-years-old female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the left arm on 15Mar2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient previously received a first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264) via an unspecified route of administration in the left arm on 24Feb2021 at 15:30 hours (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient had allergy to shellfish. Concomitant medication included Tylenol for an unknown indication. The patient did not receive any other vaccine within 4 weeks prior to the covid-19 vaccination. The patient had not diagnosed with covid-19 prior to vaccination. Since the vaccination, patient had not been tested for covid-19. On 16Mar2021, the patient experienced swelling of upper lip and tongue, sore throat and felt very fatigue. Therapeutic measured included as benadryl and tylenol for the reported events. Clinical outcome of the events upper lip and tongue swollen, very fatigue and sore throat were resolving at the time of report.   No follow-up attempts are needed and no further information is expected.
On day 2 post my second dose, I noticed a change in my heart rate, feeling like my heart was skipping beats. This was noted in the evening hours often at bedtime.  Last date I recorded noted the missed beats was February 24, 2021.
Case number PHEH2012US013317 is an initial spontaneous report received from a nurse on 27 Jun 2012. This case refers to multiple patients (four to five). These patients were vaccinated with MENVEO (batch number: unknown) intramuscularly on an unspecified date. After vaccination, they experienced seizure like activity. The outcome and causality of the events was not reported.
This spontaneous report was received from a certified medical assistant regarding a 6 months old patient of unknown gender. The patient's pertinent medical conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ, lot # N004817, expiration date: 06-OCT-2018 (dose and route of administration were not reported) for prophylaxis. The vaccines were stored in a temperature of 2 degrees Celsius to 8 degrees Celsius for 4 hours and in 9 degrees Celsius to 25 degrees Celsius for 76 hours (multiple excursions were reported). No previous temperature excursion. Call was due to digital data logger. No adverse effect reported. This is one of the several reports received from same reporter.
Approximately 14 hours after the injection I developed numbness and tingling radiating down the inside of my left arm, into my hands, and my pinky and ring fingers had no feeling.  The numbness persisted for approximately 18 hours and I slowly began to regain feeling in my hands and forearm.
This spontaneous report as received from a consumer refers to a patient of unknown age and gender. The consumer reported that she heard of a patient who got shingles after receiving ZOSTAVAX. Vaccination date, dose, route and lot number of ZOSTAVAX were not reported. Treatment and outcome of shingles were unknown. Additional information is not expected.
Bruising; redness and swelling from deltoid to elbow. Patient was seen by PCP due to side effects, and was instructed to ice and take BENADRYL. No pain. Significant redness and swelling.
After a week of shot my knees feel incredibly stiff and achy. Hurt to walk up steps and had to do it one step at a time. Could not squat and rise from squatted position due to inability to push off with left leg/knee. Intensity varied day to day but was always an issue right up to a few days before 2nd shot dose when things appeared to be dissipating.
Experienced severe headache, leg pain, shortness of breath.  Was admitted to Hospital on 4/11/2021. Discharged 4/12/2021. Follow up w Primary doctor
received DAPTACEL past the expiration date with no reported adverse event; Initial information received on 12-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 2023SA213495, 2023SA213484, 2023SA214713 and 2023SA213445.  This case involves a 5 years old patient of unknown gender diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] past the expiration with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications polio vaccine inact 3V (VERO) (Ipol Polio Vaccine); measles vaccine, mumps vaccine, rubella vaccine (MMR) and varicella zoster vaccine live (oka/merck) (varivax [varicella zoster vaccine live (oka/merck)]) all for Immunisation.  On 21-Mar-2023, the patient received a dose of 0.5 ml (dose 5) once of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: C5829AA; expiry date: 01-Mar-2023; strength: standard) via intramuscular route in unknown administration site for Immunization.   On 21-Mar-2023 the patient received daptacel past the expiration with no reported adverse event (expired product administered) (latency: same day).  It was reported, "Physician is reporting that 6 pediatric patients have received DAPTACEL past the expiration date and caller is looking for re-vaccination information. Physician reports that due to a "unscrupulous employee, who has since been fired", 6 children received DAPTACEL vaccines after expiration date. He states that 8 days ago, a box of DAPTACEL was opened and noted to be expired. That caused staff to look back at doses of DAPTACEL given after 01-Mar-2023 (DAPTACEL expiration date). That is when the administration of expired doses was discovered."  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 guidelines. 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.
Pt recvd measles vax 3MAR92 & on 9MAR92 pt devel maculopapular rash located primarily on face & trunk; Pt devel a fever of 103 & diarrhea; On 14MAR92 pt was hospitalized for severe lower back pain; pt recvd APAP;
Generalized micro papular rash, sparing the hands and feet 12-14 hours after vaccine administration prulitic lower extremities, resolved after 6 days.
I had a stroke at home working and my wife called 911 and took me to the hospital and Dr did a medical procedure because there was a blockage in my brain I don't have much memory of the event. I'm soon to schedule   another surgery.
Information has been received from a physician concerning a male who on 08-AUG-2007 was vaccinated with a dose of Pneumovax 23. Subsequently the patient now has an altered mental status and possible meningoencephalitis. Unspecified medical attention was sought. The reporting physician felt that possible meningoencephalitis and altered mental status were not related to therapy with Pneumovax 23. Upon internal review, possible meningoencephalitis was considered to be an other important medical event. Additional information has been requested.
Severe tinnitus.  Ringing in left ear, pressure in left ear, loss of high frequency hearing in left ear
Diagnosed with Right sided Bell?s  Palsy Adverse effect of COVID-19 vaccine
Five days after the first vaccine started experiencing severe psoriatic arthritis symptoms in hands, fingers, feet, toes, arms, legs, back and neck; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCIN) at the age of 65-years, via an unspecified route of administration on 02Apr2021 (Batch/Lot Number: ER8737) as a single dose for covid-19 immunisation. The patient's medical history included known allergies to tetanus shots, contrast solution, antibiotic; and arthritis (for three years prior to the vaccine). There were no concomitant medications. The patient previously took tetanus vaccine and experienced drug allergy. The patient experienced five days after the first vaccine started experiencing severe psoriatic arthritis symptoms in hands, fingers, feet, toes, arms, legs, back and neck on 08Apr2021. The patient was not treated for the event. The outcome of the event was not recovered. The patient did not have Covid-19 prior to vaccination and has not had a Covid test post vaccination.
wide spread rash on arms and trunk; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number MX2LT, expiry date 29th May 2021) for prophylaxis.   On 28th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a month after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient experienced a wide spread rash on her arms and trunk.  The rash had totally subsided, at the time of reporting. No further details were provided.
1 1/2 weeks after Twinrix Hep A/B pt has suffering with total body lethargy and fatigue with tingling of legs and arms.
Radiating pain to underneath left arm and down left side of trunk, chills and fever. Pain is worse than just injection site pain
Janssen COVID-19 Vaccine EUA Next morning, tired; groggy started about 10:00 a.m.; did errands from 1:00 - 3:00; extremely tired; went back to bed, awoke about 4:15 and from 4:30  - 5:15 p.m. received stabbing pain simultaneously in left & right areas behind ribcage.  Pain was odd in that it was at multiple small spots within both areas.  It subsided then, started up again, and was about to call 911 and then it went away completely around 5:15 p.m.  The next day (yesterday) i felt fine.
Dizziness and giddiness (began shortly after 1st dose 10/21/21 and I continue to experience it daily; symptoms enhanced when picking things up off floor or when sitting down); Abnormal EKG (12/16/21) - seeing cardiologist on 2/1/2022 for further testing; Dysnea on exertion; Headaches; Nausea (intermittent Moderate occurrences since 2nd dose); Neck pain on right side; Paresthesia of upper limb (right arm & hand; began 11/21/21; intermittent feelings of shocking/tingling/numbness have intensified since 12/23/21; negatively effects fine motor skills at times); Unusual tiredness and weakness; Significant increase in TMJ pain on right side only (now impacts my ability to eat, talk and sleep; dentist said likely due to inflammation); Changes in Menstrual Cycle (began after first dose; now pass blood clots size of marble to size of quarter)
I believe I have a swollen lymph node in my armpit. Its a little tender/uncomfortable.
pt recv vax; had a lot of paleness; tired, fussy, lack of alertness; swelling at inject site; infection at inject site;
Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment drugs were reported   This case was linked to US-MODERNATX, INC.-MOD-2021-066757 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-066757:Crossed linked
Patient hasn't received 2nd dose yet / More than 36 days after the first dose without receiving the second dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet / More than 36 days after the first dose without receiving the second dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet / More than 36 days after the first dose without receiving the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet / More than 36 days after the first dose without receiving the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Reporter details, Patient demographics was added , Start date of drug was updated , patient route of administration was updated ,Batch no added. Corresponding fields and narrative was updated.
This spontaneous report was received from a healthcare worker refers to an unspecified  patients of unknown age. On an unknown date, the patiens were vaccinated with an improperly stored RECOMBIVAX HB (lot # K026666, expiry date 22-OCT-2016). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
I received the Pfizer vaccine on 7/31/2021. About a week later, I developed tinnitus. I am reluctant to get a second or third dose for fear that they may aggravate my tinnitus. I went to my PCP, Dr.  on 8/24/2021. He checked my ears and saw no inflammation or abnormalities, and he referred me to an otolaryngologist, Dr. I am scheduled to see Dr. on 10/13/2021.
Eyes puffed, throat closing, dizziness, weak, rash over whole body - coming and going for months. White pus in mouth, bad sores in mouth, gum white for two weeks, joint pain, back aches, spleen enlarged, chest pain, body rash, yellow skin, very tired, headache, 104 fever, high blood pressure go to low blood pressure. The GARDASIL vaccine was such a horrible experience for my daughter, almost causing her to lose her life. Even today she still endures allergic reactions to medicines and headaches (this is something she encountered only after the vaccine). She lost 3 months of her life to being severely sick from this vaccine. Her health has never been the same. The past 7 1/2 years make me very sorry for having her vaccinated. Many of her friends have had rashes, headaches and tiredness, but it seems her reaction was severe. I sincerely thank you for allowing me to share this experience with you.
w/in minutes p/receiving vax in rt gluteal muscle, pt was assisted to sitting; reported burning in nose, difficulty breathing; MD adm Adrenalin & DPH; pt dyspnea resolved;
Seven days following the first vaccination, the patient developed a golf ball size rash, it was raised, red and inflamed but did not itch. The patient notified the pharmacy when she noticed it, and will keep us notified if the side effects worsen
Expired TENIVAC was administered to a patient after the expiration date, with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 67-year-old female patient to whom expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was administered to a patient after the expiration date, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine polysacch (Pneumococcal Polysaccharide Vaccine) PCV 23 for Immunisation.  On 11-Oct-2022, the patient received 2nd dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT Strength: standard, at 0.5ml (formulation, route: unknown) (lot number: U6852AA and expiry date: 07-Oct-2022) in unknown administration site for Immunization and an expired tenivac was administered to a patient after the expiration date, with no reported adverse event (expired product administered) (latency: same day).  This situation is reported as a medication error.  Action taken with DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) was not applicable.  At time of reporting, the outcome was Unknown.  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 guidelines. 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.
The patient received the Zostavax vaccine on 4/10/2009. After administration of the vaccine, she reported a dollar size red wheel around the injection site. It was not raised or bumpy. She did not experience any pain or itching.
After sitting prone for 10 minutes after administration of Tdap, MCV and HPV-9, the male patient left the exam room without difficulty and stopped at the nurse desk to pick a prize from a box that was chest level to him. Mother was standing beside him and asked him" are you ok" as he began to slump. I was near him and grasped him under both shoulders and gently lowered him to the floor. The physician came out immediately and after 5-8 seconds, the patient was again awake. He stated that "everything went black" and he remembers awakening on the floor. Patient remained on the floor for 5 minutes until dizziness subsided. He was then assisted to a sitting position for another 5 minutes and then to an upright position being supported by myself and the physician. No further dizziness was reported but we assisted the patient back to an exam room, had him seated in a chair and gave water and a rice crispy bar, observing for 10 more minutes. After this time, patient felt fine and he and mom were dismissed and advised to call back for any additional concerns or to see emergency care for s/s of anaphylaxis or trouble breathing. Mother VU to all and agreed with POC.
Developed Herpes Zoster on R chest about one week after second injection.  Minor pain, taking ibuprofen only, no antivirals.  Shared picture with Doctor and he agreed.
6-25-15-rash around site on arm, burning around injection site. 6-26-15 began with redness and swelling at inj. site. Area is itchy-the character is described as pruritic. Ineffective treatments include observation only-2 cm area of erythema. Advised ice and BENADRYL PO.
covid; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (covid) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced EXPOSURE TO SARS-COV-2 (covid). At the time of the report, EXPOSURE TO SARS-COV-2 (covid) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Baby admitted to hosp. 11/26/08 3 hrs after 2 mo vaccines. Mom states slept on way home from clinic awoke crying, continued for 10 min. Mom noted child limp and purple in face when she went to change diaper. Brought to hospital with decreased tone pneumogram done-neg.with low ph started on ZANTAC. 12/22/08-records received for DOS 11/27-11/28/08-DC DX: Episode of limpness with decrease in tone, resolved. Mostly likely Diagnosis-Breath Holding Spell.Acute life threatening event.
My left arm is tingling and sometimes feels numb. I can sometimes feel it in my left foot.
No adverse reactions took place. Patient had successful 15 minute observation period before leaving the clinic.  Patient was scheduled for a Pfizer booster shot. His vaccinating nurse saw that he already had 3 doses on the CIR (though the POV he provided only had 2 doses) and escalated to Program Manager. The CIR is the citywide immunization registry. Patient showed POV and attested that he had only received two doses of Pfizer on 4/11/21 and 5/2/21. He attested that he never received the additional dose on 3/21/21 that was on his CIR profile.  The patient was positioned next to the vaccination area by PM who then instructed the runner to hold the patient outside vaccination and that he would skip the as soon as DOV gave clearance to the CIR correction. This conversation was witnessed by EMR Lead. The PM then brought the patient's record to the onsite DOH representative whose contacts are able to investigate and correct CIR issues before giving clearance to vaccinate. Ten minutes later, program manager was informed by DOH that the patient appears to have been vaccinated before clearance was given. The PM confirmed that the runner had immediately brought the patient back into vaccination tent. She did not receive clearance from DOH or onsite management before doing so. When the patient was brought back to her tent, nurdr had believed at that point that clearance had been given despite seeing the CIR still had the extra dose on file.  At this time, onsite DOH ceased all investigation and intent to correct the earlier vaccine dose on the CIR. The patient attests that the dose he received was his third vaccine, which was a booster shot given on schedule. Without the DOH investigation, it is unclear if the patient received his third or fourth dose today.
5 hours after vaccine administration patient has experienced a very sore and painful arm. She felt as though she could barely lift it for 7 days after straight. Tylenol didn't help the pain at all and she is not able to take ibuprofen because of her xarelto. Pharmacist recommended lidocaine topical cream to help numb it.
Patient felt unwell and tired at 5 PM and then awoke with sweating and also tactile temp in middle of the night and had redness on arm next day.
Severe soft tissue reaction to pneumococcal vaccine 5 yrs after primary dose in a hypertensive 71 yr old male.
Vaccine was given 10/16/18 intramuscularly. Starting 10/17, patient expierenced a diffuse erythematous rash around injection site that had traveled down the arm a few inches. Pharmacist recommended ibuprofen for the pain as the rash and to monitor the rash to see if it gets any worse and to report back. Patient did not report any worsening of symptoms and called on 10/22/18 stating her rash has cleared and is no longer symptomatic.