chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site of Menactra administration became raised with mild pruritis.  Sx only lasted for 5 min, then resolved completely.  Since then, every week give or take a few days, the site becomes raised again with similar pruritus, and again resolves after a few minutes.  No treatment up to this point.  Pt returned for his final Gardasil dose and has had the same reaction occur at this new administration site.  Have now suggested to the pt to apply Hydrocortisone and Benadryl cream bid for 2 wks to see if this resolves sx completely.
Pt was administered vaccine 11/03/2012 (ZOSTAVAX). Pt came back Monday 11/05/12 with area red, swollen and warm. Pt was recommended BENADRYL & ibuprofen.
No Adverse event.  The vaccine expired on 03/08/2022.  We administered the vaccine on 03/21/2022.  Called and spoke to mom and she said Patient is doing fine and had no adverse reaction.  MOM, refused to come back for a revaccination.  Spoke to Pfizer and they said the did not have any data on viability on vaccine that is expired by 13 days.
Pt given penumovax 11/8/99.  Pt then developed redness and swelling 19 cm .  Dx = cellulitis.
This spontaneous report as received from a medical assistant refer to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patients were vaccinated with doses of PNEUMOVAX 23 (dose, frequency, route of administration, injection anatomical location, lot# and expiry date were not reported), which were improperly stored. There were no concomitant or co-suspect therapies reported. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
The patient received the Moderna vaccine on Monday 4/12/21 and called today 4/14/21 stating they were experiencing side effects they believed to be related to the moderna vaccine. Side effects include per the patient problems with holding urine, felt really sick, and troubles walking (need to use their walker more often).
pt recvd vax;2 days p/dose 3,exp paresthesia feet/hands & arthralgia fingers/wrist/ankles;resolved w/ x/ 3 fingers of rt hand being stiff & inflamed;3 nodules formed on knuckles;same sxs reappeared in march+exp swelling & stiffness;resolved
Arm pain radiated up shoulder and neck and down arm on L side was still present several weeks out.  Also had bumps near LD injection site.  Saw PCP, who wrote Rx for topical cortisone, which the patient did not fill.
Swelling, redness, and hot to the touch on right arm from below inject site to wrist. Patient complained extremely painful and cannot lift her arm. Patient's doctor was contacted and followed up with patient. Counseled patient to seek medical help at urgent care as ibuprofen did not help.
09:20 PATIENT PRESENTED 20 MIN AFTER IMMUNIZATION COMPLAINING OF DIZZINESS, CHILLS, AND SHAKING. 09:20 VS  80HR, 16 RR, 178/180, O2 SAO2 96%.  PATIENT HAD MINIMAL BREAKFAST.  SHE WAS ALERT AND ORIENTED X3, SKIN APPEARED PINK, WARM, AND DRY.  RR UNLABORED.  PATIENT PLACED IN SUPINE POSTITION WITH LEGS ELEVATED. 09:20 80 HR, 16 RR, 160/98 BP, SAO2 95%. 09:45 80HR, 16RR, 174/100 BP, SA02 98% 10:00 100 HR, 16RR, 172/100 BP, SAO2 100% 10:15 79 HR, 16 RR, 170/101 BP, SA02 96% 10:00AM PATIENT STATES SHE IS STILL CHILLED, AND BP CONTIUES TO BE ELEVATED.  OTHER VS WNL.  DENIES CP OR SOB.   PATIENT UNABLE TO DRIVE.  EMT CALLED FOR EVA;UATION.  TRANSPORTED TO HOSPITAL.
Fever (100.5), cold chills, aches, headache, joint pain, fatigue, confusion, sore arm started 24 hours after shot and progressively got worse for two days.  Symptoms have got better, but still lingering.  A few red scabs appeared on upper arm of arm shot administered to, but not sure if related or not.
Pt has off-site PCP, received 1st dose of Jassen vaccine at our center on 03/17/2021. Pt's roomate called in on 03/18/2021 to report pt had fever max to 104 F and fatigue since 03/17/2021 post vaccination.  Denies respiratory symptoms, rash, muscle aches or GI symptoms.   Did not take any medication due to concern that may affect vaccine efficacy.  Pt's PCP office was closed on 03/18/2021.  Pt's temp was 101F at the moment of talking to provier.  Instructed pt to start antipyretics, tylenol 650mg every 4-6 hours.  monitor s/s.  contact PCP if condition persists or worsen. Pt verbalized understanding.
Patient presented to covid vaccine clinic for Pfizer booster. Patient was a 30 mins observation due to history of anaphylaxis to walnuts, peanuts, and tree nuts. 7 minutes after receiving the Pfizer booster, patient reported feeling hot/a flush of warmth and dizziness. Patient taken to nurse clinic where vitals were taken. At 1613, BP: 147/54 (73), HR: 87, RR: 18, and O2 sats 98%. At 1615, BP: 127/49 (65), HR: 81, and O2 sats 97%. Patient denied feeling short of breath, having any difficultity breathing, nausea/vomiting, body hives, swelling, or abdominal cramping. Patient given water and reported feeling better and declined to be seen by MD. Patient assisted back to covid vaccine clinic and waited there to be further observed. Patient no longer felt the hot flashes, but reported to having a tingling sensation in her head and difficulty concentrating/focusing as well as a heaviness on her shoulders. Patient assisted back to nurse clinic where her care was taken over by the nursing staff. Patient seen by provider.
pain at injection site about 5 minutes later, injection site had a 1 inch red raised rash that resolved within an hour after taking ibuprofen 400 mg (taken 5 minutes after vaccine). Lip tingling and swelling occured within 15 minutes; lower area of face/ lips were slightly puffy for one week after treating with ranitidine, antihistamines, and ibuprofen  Treated with ranitidine 400 mg to 600 mg daily, Zyrtec 10 mg tablet at night, Allegra 180 mg tablet in the morning, ibuprofen 400 mg every 4 hours during the day, Aleve 220 mg 2 tablets at bedtime, chlorpheniramine every 4 hours at night for 1 week. Continued ranitidine 150 mg twice daily during the second week along with Zyrtec 10 mg tablet in the evening and Allegra 180 mg tablet in the morning that was usually taken.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider, recommended and or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 05-OCT-2016, a physician's assistant (at the office) administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On or about 05-NOV-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (not further specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Rash down her right arm; Shingles was diagnosed; Nerve pain in mid right upper shoulder and back/shoulder and back pain; Still has a lot of pain on her right side upper quadrant; Still has a lot of pain going down her arm; Pain into into her right breast; This case was reported by a nurse via call center representative and described the occurrence of neuralgia in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included acyclovir tablet for rash and shingles and prednisone for neuralgia.   On 8th October 2021, the patient received the 1st dose of Shingrix. In October 2021, the patient started acyclovir 800 mg at an unknown frequency and prednisone 60 mg at an unknown frequency. On 12th October 2021, 4 days after receiving Shingrix and not applicable after starting acyclovir, the patient experienced neuralgia. In October 2021, the patient experienced upper abdominal pain, pain in arm and breast pain. On 17th October 2021, the patient experienced rash and shingles. The action taken with acyclovir was unknown. The dose of prednisone was decreased. On an unknown date, the outcome of the neuralgia, rash and shingles were unknown and the outcome of the upper abdominal pain, pain in arm and breast pain were not recovered/not resolved.   It was unknown if the reporter considered the neuralgia, rash, shingles, upper abdominal pain, pain in arm and breast pain to be related to Shingrix. It was unknown if the reporter considered the upper abdominal pain, pain in arm and breast pain to be related to acyclovir.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received the vaccine on her right arm. Four days after the vaccination, she developed nerve pain in her mid right upper shoulder and back.  On 15th October 2021, the patient needed to be started on Prednisone (60mg for 3 days) and then was titrated down daily.  Nine days after vaccination, she developed a rash down her right arm and shingles was diagnosed. The patient was started on Acyclovir (800mg 5 times a day for 7 days).  The patient still had a lot of pain on her right side upper quadrant, going down her arm and into her right breast. The reporter consented to follow -up. The reporter was upset during the call so details like date of birth or lot and expiration date of Shingrix were not asked during the call.  The reporter did agree to follow-up via phone or email.
PATIENT DEVELOPED HIVES AFTER GETTING IPV, DTaP, AND MMR.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Additional Details: pt may have experienced an adverse side effect after 2nd covid vaccine received 02/04/2022. Had swelling of the lips, consulted to go to urgent care, no reports of difficulty breathing. Spoke to pt on 02/08/22 state swelling going down not difficulty breathing
Swollen, red, very hot to touch, the size of a tennis ball.  I used cold compress and ibuprofen 800mg.
SOB, ear drainage, and sinus sx on admission. Found COVID positive. Treatment includes oxygen, hydration, and sepsis protocol.
Patient indicated diarrhea, fever, general body discomfort. Recommended acetaminophen, fluids, and phone primary care Dr. if symptoms not improved in 24-48 hrs.
had the blood clot after the vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of THROMBOSIS (had the blood clot after the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (had the blood clot after the vaccine) (seriousness criteria hospitalization and medically significant). The patient was treated with APIXABAN (ELIQUIS) ongoing since an unknown date for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (had the blood clot after the vaccine) outcome was unknown.            No concomitant medications was reported.  patient had blood clot in his leg and had the first two initial shots and then the first booster and mentioned that cant say that has anything to do with Moderna.  Company Comment: This spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the unexpected, serious (medically significant and hospitalization), and adverse event of special interest, Thrombosis which occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the unexpected, serious (medically significant and hospitalization), and adverse event of special interest, Thrombosis which occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Shortly after sitting down in post vaccination area, client began to feel chest tightness, heart started racing, headache, lightheaded and weak.  7:33 pm: Pulse 68.  Oxygen saturation 99%.  Monitor placed on patient.  12 lead EKG within normal limits.  7:42 pm chest tightness and headache gone.  BP: 122/78.  7:48 pm heart begins to race slightly again. BP: 126/80.  7:56 all symptoms gone.  Refused further treatment.  Released to home accompanied by significant other.
Pressure under eyes; Watery eyes; Swelling of her left eye; This spontaneous case was reported by an other health care professional and describes the occurrence of OCULAR DISCOMFORT (Pressure under eyes), LACRIMATION INCREASED (Watery eyes) and EYE SWELLING (Swelling of her left eye) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Restylane-L (was injected approximately 3.5 months prior to receiving vaccine.). Past adverse reactions to the above products included No adverse reaction with Restylane-L.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OCULAR DISCOMFORT (Pressure under eyes), LACRIMATION INCREASED (Watery eyes) and EYE SWELLING (Swelling of her left eye). At the time of the report, OCULAR DISCOMFORT (Pressure under eyes), LACRIMATION INCREASED (Watery eyes) and EYE SWELLING (Swelling of her left eye) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medication use information was not provided by reporter.  It was reported after lips started swelling patient went to ER (previous injection of Volbella approximately 1.5 years ago) where she was treated with IV steroids and was sent home with an oral steroid script took for the following 5 days.  Currently treatment medication use information was not provided by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Paralysis in legs, face, prolonged numbness in hands - still current weakness, soreness in back and hips, legs. Plasma replacement - physical therapy.
REDNESS, ITCHING, SWELLING, WARMTH, PAIN, MUSCLE PAIN AT INJECTION SITE.
Hours 12 to 36 after injection were the most miserable 24 hours of my life that I can recall. I had body aches all over. It hurt so bad to move. The first 14 of the 24 hours I slept straight. I woke up with a massive headache, to the point where I could barely lift my head. I drank a little water and urinated. I went back to sleep for 4 more hours. I ended up sleeping on my back on the floor because that felt the most "comfortable." The last 6 hours I just sat up in bed essentially useless. I wasn't hungry; everything still hurt and I didn't feel like doing anything. I watched TV and drank water. Then right around 36 hours after injection, I felt completely fine again. Appetite back, no more aches, energy back. Just an awful 24 hours in between.
Immediate swelling in arm and mild bruising. Had the patient sit for 20 minutes or so to ensure she was okay.  Followed up with patient the following day and  the patient explained she had some nausea, headache, and vomiting after eating dinner that night. The headache persisted for 2 days as well. Other than bruising, all other side effects were gone when I followed up on 9/23/19. Her arm was feeling fine just bruising at injection site remained.
Mild shingles outbreak; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2022, the patient received the 1st dose of Shingrix. In June 2022, 1 week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's Comment: One week later of vaccination, the patient developed a mild shingles outbreak. She had nothing else to report.
2 hrs p/shots total body covered w/red spots progressing to blotchy red rash by noc; next day pt w/swollen feet, puffy eyes, t100, rash still blotchy; seen by MD 1OCT92; also devel hives & wheezing; r/o allergy to pertussis;
Headache fatigue, headache Narrative:  Took OTC tylenol for above sx  Other Relevant History:
Information has been received on 2/28/02 from a registered nurse who was inadvertently vaccinated with a dose of pneumococcal vaccine 23 polyvalent, intradermally, instead of given a tuberculin test. The consumer reported having a lot of reaction at the site. On 2/28/02 the consumer reported that "about a year ago, although not intradermally," she was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. On 2/28/02 it was reported that the pt had not spoken to her physician yet. The pt did not seek medical attention. No further info is available.
Information has been received from a physician concerning a 7 year old American Indian female with no known drug allergies, who on 09/22/1997 was vaccinated with the first dose of Varicella virus vaccine live. Subcutaneously. on 03/09/2001, the  pt presented  with about 15 vesicular lesions and no other symptoms". In follow-up, the physician reported the patient had "mild chickenpox". The pt's Varicella Igm was negative < 1:10. Subsequently, the pt recovered from the Varicella. the physician also reported on the pt's sibling who had an experience following vaccination with Varicella virus vaccine live. Additional information is not expected.
FATIGUE; This spontaneous report received from a patient concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the subject experienced fatigue. The action taken with covid-19 vaccine  was not applicable; and action taken with adalimumab was not reported. The patient recovered from fatigue. This report was non-serious.
No additonal adverse events reported; dose of PROQUAD that was admnistered improperly stored during a temperature excusion; This spontaneous report was received from a medical assistance and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  On 07-SEP-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml, lot number T034614 with expiration date 10-APR-2022 (route of administration and anatomical location were not reported) for prophylaxis, which was improperly stored during a temperature excursion at 6°F to 14°F (8.5F) for 0 hours 18 minutes and 0 seconds, and 6°F to 14°F (11.9F) for 1 hours 0 minutes and 0 seconds (product storage error). No additional adverse events reported (No adverse events). There were no previous temperature excursions.
Day 2 after receiving the 3rd dose of the Pfizer COVID vaccine I experienced significant swelling in my lymph nodes under the arm that I received the vaccine as well as on my neck/chest. That arm was extremely swollen and sore to the touch and resulted in limited range of motion. These symptoms listed above lasted for an additional 3 days until complete resolution.
3MAR99 healthy;recv vax around 1:30-3:30PM;wednesday evening vomiting/diarrhea started;4MAR99 AM fever 101 ax started;giving Ibuprophen q 6hr;fever cont to go up 1-2hr p/fever reducer;5MAR99 fever cont, vomiting dec & eating a little;
Initial information received on 20-Jun-2018 regarding an unsolicited valid non-serious case received from an office person medical assistant. This case involves a patient (age and gender not reported) who was vaccinated with a ACT-HIB (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. It was case of an actual medication error due to wrong solution used in drug reconstitution. It was reported that ACTHIB was mixed with sterile water and given to one patient. 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 and Module VI of the 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. Documents held by sender: none.
headache, body aches, low fever, neck and back pain, swelling in the eye,  severe hives. miserable! Tylenol helps some.  I will start on steroids in the morning.
Patient had fever and chills the night of the vaccine which persisted for 3 days and disrupted patient's quality of life - was not able to do daily functions.