chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Deltoid area of left arm had large red, itchy rash. Patient reported temperature of 99.3F during the night after her immunization.
Patient states she noticed her lip and eye swelling and lip numbness, Hives around neck and whole body about 11:00PM, no SOB. Symptoms is getting better after took BENADRYL one hour later.
Lower back muscle tightness and pain, targeting L5-S1 weak spot from three prior surgeries there, with another slight disc bulge previously found Jan 2020. Within the week, pain and stiffness progressed. Video appt doc prescribed muscle relaxer and steroid taper. As soon as that course finished, received second dose, and pain kicked back in immediately. Within a week, pain progressed to include shooting pains down right leg. MRI confirmed herniated disc worsened since last seen Jan 2020. Unbearable pain, leg weakness, and numbness down through calf. Awaiting further treatment.
Pt recv vax on 3/30/99; on 3/31/99 pt exp diffuse local erythema of upper LA w/ swelling & warm
No additional adverse effect reported.; patient received expired ROTATEQ; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 06-NOV-2020, the patient was vaccinated with an expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally administered as prophylaxis (lot number 1660943 which has been verified to be valid, expiration date reported as 05-NOV-2020, but upon internal validation established as 05-NOV-2021) (conflicting information) (dosage, frequency, and vaccination scheme were not reported). No additional adverse effects were reported in the patient.
Fever of 104F; hands/feet turned blue and apical pulse over 200. DGX of: tachycardia, tachypnea and hyperventilation.
Inflammatory pulmonary condition; This case was reported by a physician via call center representative and described the occurrence of lung inflammation in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced lung inflammation (serious criteria hospitalization). On an unknown date, the outcome of the lung inflammation was recovered/resolved.   It was unknown if the reporter considered the lung inflammation to be related to Shingrix.  Additional information was reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient developed an inflammatory pulmonary condition and the patient was necessitating hospitalization. The patient was admitted to the hospital and was discharged with apparent resolution of their condition. This case has been linked with case US2019AMR207416, reported by the same reporter.
p/ pt recv vax approx 1yr later pt exp 3 lesions which lasted approx 1 1/2wks
crushing headache,  extreme joint pain, extreme fatigue,  Fever starting evening of shot (2/8) lasting until evening of 2/11.  TMAX 102.4 F chills loss of appetite
Site of injection w/erythema, warmth, swelling, pain. The patient developed fevers and malaise x 48hrs. at site of PNEUMOVAX.
pt recv vax 20MAY97 & returned to office 23MAY97  w/ 3" red, swollen & warm area over deltoid, tender to touch;
Information has been received from a nurse practitioner concerning a patient who was vaccinated with a single dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (MSD). No adverse side effects were reported. The nurse reported that episode as a mistake. A product quality complaint was not involved. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. Since 06-JAN-2016, an unknown number of unspecified patients have been administered doses of GARDASIL lot # K011562,exp. 08-APR-2017 (dose, route and site of administration were not reported) that have been improperly stored. The temperature of the storage was 33 Fahrenheit degree for 3.5 hours. No adverse symptoms were reported. The outcome of the patient's event was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Redness, warmth, swelling, induration and tenderness lasting 36-48 hours.
Initial unsolicited report received from a pharmacist on 19 October 2015. This case involves a 26-year-old female patient who was vaccinated intramuscularly with a dose of FLUZONE QIV (batch number UI443AA, Expiry date 30 June 2016, dose and dose in series was not reported) in right deltoid on 18 October 2015. Illness at time of vaccination was unknown and Pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. On 18 October 2015, same day following the vaccination, the patient experienced pain in arm and injection site was red, warm and sore. Lab data and corrective treatments were not reported. The patient was not recovered from events. List of documents held by sender: none. Follow-up information received from a pharmacist on 27 January 2016. It was reported that the patient did not receive any vaccination within 4 weeks prior to 18 October 2015. Adverse events following prior vaccination was reported none. On an unspecified date within few days the patient recovered. No additional information was received. Follow-up information was received from a pharmacist on 12-Feb-2019. Patient age was reported as 52 years. Patient was vaccinated with one time dose (also reported as 0.5 mg) of FLUZONE QIV (batch number: UJ040AA and expiry date 12 June 2019) via intravenous route. It was a case of actual medication error due to inappropriate route of vaccination because the vaccine was administered via intravenous route. It was unknown if any adverse event occurred or not following the vaccination. 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. Follow-up information received from a pharmacist on 13-Feb-2019. No new information was received. Documents held by the sender: none.
I didnt have a menstrual period since November of 2020.  I received my vaccination and woke up in the middle of the night to my period.  I keep hearing that the vaccine doesn't have any affect on menstruation but I find it hard to believe this is a coincidence.
8APR99 joint pain w/o systemic sx, no rash, acute lyme titer drawn-result negative;19APR99 some improvement;26APR99 nl ESR (sedimentation rate);referred for rheumatology consult;3MAy99 resolving;return to flying status;
vaccine was used beyond its use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was used beyond its use date) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was used beyond its use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine was used beyond its use date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Patient received one of the Moderna COVID-19 vaccine vials was used on 7/5/2022 while it has a beyond use date of 7/2/2022 as it was placed at refrigeration temperature (36F-46F) on 6/2/2022. Treatment information was not provided.
16 y/o pt incorrectly received pedi dose of pfizer instead of regular dose for booster dose.
1:10 pm Pt. received influenza vaccine to right deltoid. 1:13 om on her way back to her desk while in elevator pt. felt "dizziness" "nausea" and like her right pinky was "falling asleep". Pt. walked back to clinic and immediately assisted to exam room and to lay down. BP 90/60, HR 63 req. exam unremarkable. Pt monitored closely, given water. Blood glucose 128. S/s resolved except for the sensation of her right pinky "falling asleep." No weakness or skin discoloration. Ne edema or erythema at injection site. Sensation in fact to B/L hands. Pt will monitor s/s and I will f/u tomorrow. BP improved to 100/60, HR 74 bpm reg. D/C at 220 om.
Patient received product 8 days past the beyond use date.  Manufacturer contacted and reviewing product stability.
her fingers hurt; she developed a rash that lasted 4 days,; migraines got worse; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Allergan (manufacturer control number: 2116268US), for bnt162b2.  A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included covid-19 from 16Mar2020 to Jul2020 patient was put on a ventilator for 34 days , paralysis from an unknown date and unknown if ongoing patient learns how to walk again and use her arms, cardiac pacemaker insertion from an unknown date and unknown if ongoing , ongoing pain in extremity. The patient's concomitant medications included: botulinum toxin type a (BOTOX), via an unspecified route of administration on 2021 (Batch/Lot number was not reported), at unspecified dose for migraine.   The patient clarified that she had Botox 3 months ago for migraines. She had about 10 shots total in her head and forehead. She does not have the lot number, exact date, or exact dose. She stated that the migraines got worse. Patient discontinued Botox. She will not take any future injections since migraines got worse.  Patient stated that she received the Pfizer vaccine 6 weeks ago and 2 weeks ago. The first injection she didn't have any side effects but the second injection she developed a rash that lasted 4 days, migraine that lasted 6 days, and her fingers hurt. She stated nobody could touch her fingers for 3 days and it has improved but not fully recovered from that.  The patient experienced migraines got worse (non-serious) on 2021 with outcome of unknown, her fingers hurt (pain in extremity) (non-serious) on Apr2021 with outcome of recovering, she developed a rash that lasted 4 days, (non-serious) on Apr2021 with outcome of recovered.   The action taken in response to the event for botulinum toxin type a was permanently withdrawn on an unspecified date.
Fever, headache, body aches including joints, nausea/no meds taken/let symptoms run their course/ symptoms began 4/10/21 and ran through 4/12/21
On 6/19 patient had had mild fever, sore arm (as expected at injection site), and general fatigue (as expected).  On 6/20 both of his feet were swollen and it felt as if he was walking on marbles. 6/21 feet had gone down and were normal but later in the day lymph nodes in neck were swollen and he developed a lump on the back of his neck.  On 6/22 the neck swelling went away but he then developed left hand and lower left arm swelling.  On 6/23 the left hand/arm had gone down but the right hand/arm was swollen.  On 6/24 patient experienced swelling around the eyes.
Vax given 12/30/2020 at 2030. Sxs developed later with nausea, vomiting, dizzyness, myalgias, headache.   Presented to ED. IVF, Zofran/diphenhydramine inj, tylenol. Neg COVID-19 test.
This spontaneous report was received from a medical assistant refers to unspecified patients of unknown age and gender. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unspecified dates between 11-SEP-2016 and 14-SEP-2016, the patient s were vaccinated with unspecified doses of improperly stored GARDASIL (lot # M014929, expiry date: 27-MAY-2017). No adverse reactions were reported. This is one of the five reports received from the same reporter. Additional information has been requested.
This patient had pain in the area where her shots were administered. Saw own MD - x-rays (2 times). Orthopedic, Cortisone shot - physical therapy.
"A little weak"; Fever of 100 degrees Fahrenheit/fever (ongoing); Very sore throat/sore throat (ongoing); Headaches; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Very sore throat/sore throat (ongoing)), ASTHENIA ("A little weak"), ARTHRALGIA (Joint pain), PYREXIA (Fever of 100 degrees Fahrenheit/fever (ongoing)) and HEADACHE (Headaches) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 012M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced ARTHRALGIA (Joint pain) and HEADACHE (Headaches). On 01-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (Very sore throat/sore throat (ongoing)) and PYREXIA (Fever of 100 degrees Fahrenheit/fever (ongoing)). On an unknown date, the patient experienced ASTHENIA ("A little weak"). At the time of the report, OROPHARYNGEAL PAIN (Very sore throat/sore throat (ongoing)) and PYREXIA (Fever of 100 degrees Fahrenheit/fever (ongoing)) had not resolved and ASTHENIA ("A little weak"), ARTHRALGIA (Joint pain) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) 100 degrees Fahrenheit.         Concomitant medication reported as unknown cholesterol medication. No treatment medication were provided.
Since I got the vaccine I felt cold and I had flu till now and my buddy so tired but the main problem is MY BLOOD PRESSURE IS TOO HIGH SINCE I TOOK IT UNTIL NOW it's over one month. My blood pressure never get down 160.
Patient was administered Jansen vaccine lot #1808980 on 04-08-2021 at another clinic.  Vaccine was not documented in IMMTRAC nor EMR of facility. When vaccine questionnaire was completed patient responded yes and no to having received another covid vaccine. Patient was then administered the Moderna vaccine lot # 016B21A on 04-19-21.  Patient has been in contact with Chief  Medical Officer via phone consultation,  who reports no adverse reactions to date. Will continue to assess for any reactions or complications.
Patient had varicella in his left arm on 3/29 and MMR in his right arm on 3/29. Yesterday he developed a fever of 101, today it went down to 99 but now his left arm is red, swollen, and painful to touch. Mom said the red ring area is about the size of the palm of her hand. Advised mom to use cold compresses, hydrocortisone/BENADRYL for itching, TYLENOL/MOTRIN PRN pain/fever. Mom declined appt, will monitor at home. Advised mom to call back with new/worsening Sx developed.
The night after patient received the Shingrix vaccine, at 2:00a.m. started to experienced increased body temperature( 38.5C), headache and weakness. Patient was taking ibuprofen for headache and fever with no good effect.Not able to sleep. During the day time, patient was feeling very weak and exhausted. Not having appetite at all . Wasn't able to come to work that day.
Vaccine administration error - booster dose given before 6 month minimum. 1st dose 3/31/21, 2nd dose 4/21/21, and booster 10/13/2021. Pt did not have card with her at time of immunization and no record found on state database or store record service. Pt confirmed and signed waiver stating was greater than 6 months, so pharmacist administered based on patient verbal histroy. But upon return to have us fill out COVID card it had not been a full 6 months.
vomiting, diarrhea, paleness, hoarseness, wheezing and coughing, muffled/quiet cry. symptoms started about 1 hour and 15 mins after vaccination and still present side effects
Started having severe itching in face/nose/eyes shortly after waiting period after vaccine given. Nose and face continued to increase in intensity of itching. Eyes became very red/watery and continued to itch. Benadryl taken to try to alleviate symptoms. Continued to worsen, slight shortness of breath/chest tightness (albuterol would have helped but did not have on hand). Took another Benadryl and Pepcid along with a Zyrtec. Symptoms began to improve around 1900, took albuterol inhaler once got home around 1920, breathing improved. 12/19/20, sore throat/cough remains, itching improved.
Information has been received from a 29 year old male pharmacist concerning his development of herpes zoster on 5/25/01 following his son's 1st SC dose vaccination on 5/3/01 with 0.5cc of varicella virus vaccine live (lot 638568/1888K). The reporting consumer had a history of varicella at 4-5 years of age and no known allergies. Also, the reporting consumer was on therapy with levothyroxine sodium (Synthroid). It was indicated that the reporting pharmacist had sought medical attention. At the time of the initial report, it was unknown whether the child had developed a rash, post vax, and created an exposure related herpes zoster experience via secondary transmission for the reporting pharmacist. Complete medical histories were not available at the time of the initial reporting. In follow-up on 5/30/01 and on 5/31/01, it was reported that the pharmacist as a child had chicken pox. The pharmacist had a history of Graves disease with radioactive iodine therapy in 6/00. Three weeks following his child's Varivax vaccination, he developed 10-12 lesions in a linear pattern on his right shoulder blade. In addition, the consumer had experienced a burning, stinging sensation prior to the "break-out".  Also, it was reported that the child that was vaccinated did not have a post vax rash. The father had recovered from his herpes zoster after treatment with acyclovir (Zovirax). No further information was available.
Flu-like illness with fever, malaise, rhinorrhea that didn't resolve for 5 days.
Immediately after the shot my arm was sore for a couple days then went away. Then a week later, it was tender, swollen, itchy, and hot to the touch.  It lasted until day 14 and it it went away. I didn?t take any meds at all
Patient reported developing new onset atrial fibrillation after receiving comarnity; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "Patient reported developing new onset atrial fibrillation after receiving comarnity".  Additional information: Patient reported developing new onset atrial fibrillation after receiving comarnity. Patient's cardiologist commented that he has seen a lot of new onset afib in patients and believes it to be related to the Pfizer Covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A contributory role of BNT162B2 to event atrial fibrillation cannot be excluded based on temporal association and available information. 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 to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Redness and swelling the size of a tennis ball, and it was itchy.  Resolved with cool and warm compresses.
Fever, night sweats, full body convulsions/shaking, headache and UTERINE CRAMPING. I was 15 weeks and 5 days pregnant at the time, this was NOT NORMAL.. I had to see my OB the next day for US/Doppler to ensure baby was okay.
Generalized myalgia symptoms occurring three months ago. Per patient started after third anthrax vaccination. Describes upper back, neck, bilat shoulder, knee, and foot pain. No noted history of trauma. No other known history for myalgia conditions.
Nausea, headache that increased to monstrous proportions throughout day and lasted 3 days;  severe joint and muscle pain., incoherent thinking process, fatigue, some dizziness. Presently have shortness of breath. Surprisingly, injection site only hurt the first day.
This case was reported by a healthcare professional and described the occurrence of wrong vaccine administered in a 11-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). On 20 August 2010, the subject received unspecified dose of INFANRIX (.5 ml, unknown route and injection site) instead of a dose of Tdap. No adverse event occurred. No further information was available. The case was closed.
Patient call pharmacy at approx 8:15PM on 10/5/10 to describe what she said was an allergic reaction swelling whelps and redness/itching. No throat closure, chest tightness. She was instructed to get BENADRYL and take 50mg and report to ER if other signs develop. I followed up the next morning and she is doing fine. Redness and swelling are almost gone. Will continue BENADRYL for several days and follow up with MD if necessary.
A report has been received from a Health Professional concerning a 5 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 20-Jan-2015. Reporter stated that the three patients received expired FLUMIST quadrivalent which started on 20-Jan-2015. The outcome of the event of three patients received expired FLUMIST quadrivalent is unknown. The report was considered to be non-serious. Corrected report 20-Oct-2015: Key ingredient corrected.
low grade fever & rash on abd & back;13OCT95 f/u rash resolved w/in a few hr w/o tx;
Received flu vaccine IM 6:00 PM, 15 minutes later mother noted cough, wheeze, itchy neck, hive-like rash x 2mo. Mom gave albuterol puffs, less rash.
-Onset of postpartum bleeding (lochia alba on 03/02/2022) after it had already ceased, accompanied with my typical PMS symptoms (headache, general malaise/fatigue).  Small streaks of blood appeared when wiping in otherwise clear discharge prior to onset of lochia alba. Reminder that lochia alba stage had already been completed and spontaneously restarted after vaccination with significant amounts of lochia alba. Also currently experiencing chest pains 2 days later.  It is important to mention that just 7 hours after my 1st vaccination on 01/31/2022, I experienced Premature Rupture of Membranes and significant bleeding/passing of clots at only 19 weeks pregnant (I have submitted a separated VAERS report for this incident). I went into preterm labor at 20 weeks and my baby passed away due to not being viable. No pregnancy concerns nor complications prior to vaccination; What happened to me and my baby still remains unexplained. I TRULY hope all will consider that this vaccine may be causing hormonal/reproductive disturbances, especially in women of color.