chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blind spot in eye; spider webbing; This non-serious case was reported by a consumer and described the occurrence of scotoma in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced scotoma (Verbatim: Blind spot in eye) and floaters (Verbatim: spider webbing).  The outcome of the scotoma and floaters were not reported.   It was unknown if the reporter considered the scotoma and floaters to be related to Shingles vaccine.     It was unknown if the company considered the scotoma and floaters to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by the patient via interactive digital media. The patient reported that was a good alternative cause the vaccine gave him or her a blind spot in eye and spider webbing. Follow-up would not possible as no contact details were available.
developed disseminated HZV infection 15 days post his first dose of the Pfizer COVID 19 vaccine; This is a spontaneous report from a non-contactable physician. A 63-year-old male patient received the first dose of bnt162b2 (BNT162B2, Lot number Unknown), via an unspecified route of administration on an unspecified date as a single for COVID-19 immunization. Medical history included hairy cell leukaemia from 2006 to an unknown date Hairy Cell leukemia in 2006  remission since 2016. The patient's concomitant medications were not reported. The patient developed disseminated varicella zoster virus infection 15 days post his first dose of the Pfizer COVID-19 vaccine on an unspecified date with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained; Sender's Comments: While patient risk factors may likely predispose patient to reported event, a possible contributory effect of suspect BNT162B2 cannot be excluded.  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.
Patient reports anaphylaxis 15 min post injection, requiring intubation and admission into ICU for 7 days.
Caller states that she received her 1st vaccine on /3/1.  Has notice a rash at injection site with itching and redness.  Instructed to apply cold compresses for comfort and notify PCP if symptoms worsens.   RN
This spontaneous report was received from a certified medical assistant (healthcare worker) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-JAN-2016, the patient was vaccinated with an improperly stored GARDASIL 9 lot # L016428, 30-JUL-2017. This is one of the several reports received from the same reporter. Additional information has been requested.
03/06/2014 Pt has erythema to Lt arm at injection site measuring 6X5.5 in area with darker erythema at injection site measuring 1X1.5 in area. Hot to touch. Mother states that he has been sick with fever from vaccination. Dr. Dx as adverse vaccine reaction.
Starting having issues with sense of taste and smell. Everything tastes and smells like dirt or feces. Started one week after being vaccinated with the second dose and had continued since.
A nurse reported that a pt received an injection of Flu Shield '00-'01 on 11/15/00 and subsequently developed an injection site reaction. No further information was available at the date of this report. The reporter indicated that 5 pts  experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Sore injection site arm after first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm after first vaccination) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore injection site arm after first vaccination). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm after first vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.  No treatment medications were reported.   This case was linked to MOD-2021-350471 (Patient Link).
Injection site was sore all day. Around 3PM onset of entire body aches. Chills started along with a headache and fever 101.3. The fever started to come down after several hours and noticed red splotches on the same arm. Slept for 10 hours. Fever was normal next morning but still had some body aches and the red splotches got a bigger and the entire top part of the arm is sore.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021 at 3:50 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 3:50 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 38.37.  Concomitant medication of the patient was not reported.  Batch number 019B21A underwent temperature excursion on 30-Mar-2021 with temperature of 33 degrees Fahrenheit at 09:00 AM. These vials were moved to fridge on 23-Mar-2021 and beyond use date for the vials was reported as 22-Apr-2021. The vaccines moved to clinic on 30-Mar-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and fisher brand traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
pt recvd vax;tightness in throat,t 99-100;some sneezing;to MD who dx viral infection & prescribed amantadine;cough non productive;some body aches,weakness;transient mild laryngitis;MD felt illness not related to vax;8dec well but hoarseness
I noticed a few bumps on both of my underarms. The next day I saw them on my thighs. The following day after that I had them on my buttocks and my breasts. As the bumps move to different parts of my body it kind of goes away and then comes back. The rashes are red and raised. They are swollen and they itch. I was applying a topical steroid triamcinolone which I already had. It did help for a short period. On 05/18/2022 I did have an appointment with my doctor. He thinks it is an allergic reaction from taking both the COVID-19 vaccine and Shingrix vaccine at the same time. He prescribed methylprednisolone also known as Medrol Dose Pack. Because the rash is looking really red this morning, I will watch it and if it isn't any better the following day I will contact my doctor again.
Pt started to feel "funny" within 3 minutes of 2nd vaccination, had tingling in mouth.  Pt took Benadryl 25 mg at 11:04. At 11:15  gave 0.5 ml of epi due to developing cough and flushing.  Pt started on 02@10L via nonrebreather by EMS.  SP02 stayed between 98%-100% during duration of treatment at clinic, lungs clear.   Sent to ER via ambulance.
Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a patient who was vaccinated with IMOVAX RABIES that accidentally injected into the gluteal region (batch number, expiration date, dose, route and site of administration was not reported) on 30-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate site of administration. No AE was noted at the time of the injection. 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. List of documents held by sender: none.
My right arm was itching near the injection site and when, I looked at it, there was a large area from just below the shoulder down to the elbow and the width of the arm that was red and swollen with the hives.  Hydrocortisone was applied to the area and Benadryl taken to relieve the itching.
9-28-09  Right deltoid seasonal vaccine 5 days later muscle spasim right side. 10-30-09 H1N1 vaccine Left deltoid 48 hrs later began having trouble breathing, muscle and joint pain and stiffing . Rash headache 5 days after shot muscle spasims left side also dizziness above standing.
At the end of January started having symptoms (extreme lower back pain, worsening upon laying down, and cough). Was treated with azithromycin for 5-7 days. After no improvement, was sent to ER. and a pulmonary embolism was confirmed.
A report was received from a health care professional on 16Oct02, concerning a 6 month old male vaccinee who was inadvertently administered 0.25ml IM into the vastus lateralis on the 16Oct02. On 16Oct02, the infant suffered a medication error by receiving 0.25ml Fluvirin into the vastus lateralis. The infant had not experienced any adverse events at the time of the report but was being closely monitored. There was insufficient information to determine the reporter's causality assessment. PJP200200609, PJP200200671, PJP200200670, PJP200200669, PJP200200668, PJP200200666, PJP200200665, PJP200200664, PJP200200662, PJP200200663.
83-year-old male patient presented after experiencing cough for 1 day and tested positive for COVID today.  He does have history of ESRD, which he has hemodialysis on Mondays, Wednesdays, and Fridays.  The facility did not allow for COVID positive.  Dx Pneumonia due to COVID-19.  D-Dimer 1257-12-59.  NSTEMI with Positive troponins.  Treatment:  remdesivir, antibiotics, Eliquis, albuterol, hemodialysis. Discharged home.
The muscle at the injection site was sore. It progressively got worse over about 12 hours and the next morning I could barely lift it equal to my shoulder.  The soreness was manageable and it was gone by the next morning.
3 x 3" indurated area on anterior (R) thigh, warm to touch, non tender, no drainage.
Tingling starting in feet three days after vaccination, now w/ muscle spasm in back, feet and leg tingling and feeling of weakness in legs.
COVID-19 mRNA LNP-S, bivalent PF 12yrs-adult booster (Pfizer), 30mcg/0.3mL - was given instead of 2nd dose of Primary Series
pain in her breasts became worse; tenderness in her breasts became worse; depression in skin like a hole on the side of her breast; pain at the injection site; couldn't function due to being tired,couldn't function due to being run down; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (pain in her breasts became worse), BREAST TENDERNESS (tenderness in her breasts became worse), BREAST DISCOMFORT (depression in skin like a hole on the side of her breast), VACCINATION SITE PAIN (pain at the injection site) and FATIGUE (couldn't function due to being tired,couldn't function due to being run down) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025c21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CALCIUM and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 21-May-2021, the patient experienced BREAST PAIN (pain in her breasts became worse), BREAST TENDERNESS (tenderness in her breasts became worse), BREAST DISCOMFORT (depression in skin like a hole on the side of her breast), VACCINATION SITE PAIN (pain at the injection site) and FATIGUE (couldn't function due to being tired,couldn't function due to being run down). On 23-May-2021, VACCINATION SITE PAIN (pain at the injection site) and FATIGUE (couldn't function due to being tired,couldn't function due to being run down) had resolved. At the time of the report, BREAST PAIN (pain in her breasts became worse), BREAST TENDERNESS (tenderness in her breasts became worse) and BREAST DISCOMFORT (depression in skin like a hole on the side of her breast) outcome was unknown.
The vaccine vial was diluted with 0.8ml of sodium chloride instead of 1.8ml , The 0.3ml dose was then administered . The patient was checked on the evening of 8/30/21 and around 11:30am on 8/31/21 and no adverse events occurred.
both upper & otter arms w/red areas, warm to touch, upper arms edematous from above elbow to middle humerus 29OCT96;itching 30OCT96;
Client called Monday 05/23/2005 to report reaction.  Instructed to come to health department to complete adverse vaccine forms- right deltoid with redness, hot to touch.  Recommended Benadryl and Ibuprofen, states had taken Benadryl and had heating pad on arm.  Recommended cold pack to area and see doctor if worsens.
I had diarrhea about 20-40 minutes after receiving my first dose. I then got my period a few hours later. It was on time, however, it was extremely heavy. On the 3rd day, I began to have very large blood clots. I spoke to my gynecologist and she started me on birth control that sane day in order to stop the bleeding.
Blood clot in lung; fever; Difficult breathing; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Blood clot in lung) and DYSPNOEA (Difficult breathing) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concurrent medical conditions included Hypertension.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced DYSPNOEA (Difficult breathing) (seriousness criterion medically significant). On 27-Feb-2021, the patient experienced PULMONARY EMBOLISM (Blood clot in lung) (seriousness criteria hospitalization and medically significant) and PYREXIA (fever). At the time of the report, PULMONARY EMBOLISM (Blood clot in lung), DYSPNOEA (Difficult breathing) and PYREXIA (fever) outcome was unknown.            Treatment details included Heparin, Xarelto.  Based on the current available information a temporal association between the use of the product and the onset date of the events, and with reoccurrence of blood clot with second vaccine use, causal relationship with the events cannot be excluded. Fever is consistent with the known safety profile of the vaccine.; Sender's Comments: Based on the current available information a temporal association between the use of the product and the onset date of the events, and with reoccurrence of blood clot with second vaccine use, causal relationship with the events cannot be excluded. Fever is consistent with the known safety profile of the vaccine
redness around injection site; hot injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced injection site erythema and injection site warmth but went away after the first 1 to 2 days. This case has been linked with case US2019AMR113921, reported by the same reporter.
Employee was given flu vaccine. Reports facial swelling, difficulty breathing, hives, was evaluated in ED and treated. Rx prednisone and released to home.
Lower joint pains in legs and feet. Swelling on ankles and top of feet that comes and goes. Leg pains and bottom of feet have continued to hurt since 7/25/2021. Takes ibuprofen to help with pain/discomfort.
Case number PHEH2044UYS019582, is an initial spontaneous report received from a health care professional on 26 SEP 2014. This report refers to a 52 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 012031A) intramuscularly at a dose of 0.5 ml on 26 SEP 2014 and it was reported that the vaccine which she received  reached 61 F for more than 11 hours. No adverse events were reported following the maladministration.
Wednesday PM exp pain, swelling @ inj site;swelling inc, began using hot wet packs Sunday AM, Monday AM noted redness w/induration;also noted local rxn to the bandaid;this afternoon, redness nearly gone;taking APAP for pain;aching to wrist
Severe chest pressure, mainly on left side, shortness of breath, pain on inspiration. Was treated with morphine, Norco, and indomethacin (2 weeks) and colchicine (3 months).
She got her vaccine, and when she woke up on Friday 10/13/23 she had cold sores running from the bottom of her nose, down through both lips and even some cold sores on her chin.  They hurt like crazy like somebody had just punched her.  They were on the stages of forming she believes.  The one that is still there does not hurt anymore.  They were burning when they were first blooming.  She called the pharmacist and asked her and she said that it sounded like an AE and that she should report it and call the doctor and ask for something.  She went and bought Abreva and went through a tube and then ended up with a 4th tubes.  She called the doctor to see if she could get a prescription, and could not get anywhere with them as he was out of town and her doctor could not give her anything as she does not have an APT until 11/3/23.  She just kept putting the Abreva on and her neighbor is a retired RN, and she has continued to use the medicine.  She is better today, one on her lip and one tiny one on her nose and feels that they are on their way of healing up.  The pharmacy recommended Zovorax but she did not get it as she could not get anybody to be able to see her.   She also feels that her face was sore as she has some swelling in her face as well.
Not even 24 hours after my second vaccine I had a mild headache, then all my joints were in extreme pain like some one was wringing out my joints, chills and could not warm up even with warming blankets and hand packs, nausea with no vomiting, no diarrhea, possible fevers but never took temp, extreme lethargy. Missed 4 days of work and was contemplating going to the ED on several occasions as I was only getting worse. Opted not to go but was unaware these symptoms could last up to 4 days. The pain was horrible and I was able to stay awake, other wise I was sleeping most the day away. Loss of appetite, nothing sounded good except for peanut butter and jelly.  My husband commented he has never seen me so sick and out of it. I guess I was confused and my speech was not very clear. Cough and my chest would hurt with the coughing. No SOB noted. Left neck lymph node swelling. Left deltoid pain even my cloths hurt and I was unable to lay on that side for at least 3 days.
Confirmed Breakthrough  -  COVID-19 (Pfizer) 1 01/15/2021 Pfizer EL3248   COVID-19 (Pfizer) 2 02/05/2021 Pfizer EM9809   COVID-19 (Pfizer) 3 10/06/2021 Pfizer EW0183
States noted shortness of breath 5-10 min after admin. - used inhaler with relief. Sympt returned in about 4 hours. PCP not available referred to ER given Prednisone, BENADRYL etc... States MD said it was some additive in flu shot. Pt has gotten flu shots routinely for years. She has numerous allergies & freq. URI's. 10/21/10 600 PM - Noted fever return of SOB back to ER. States chest x-ray showed congestion - antibiotics prescribed & cont nebulizer tx.
Information has been received from a medical assistant concerning a female with allergy to penicillin, eggs, sulfa and yeast who was vaccinated with RECOMBIVAX HB (manufacturer unspecified). Subsequently the patient experienced severe reaction involving swelling after she received the vaccine. This occurred "years ago" and was not administered by the office where the medical assistant worked. The patient sought medical attention by unspecified contact. Subsequently, the patient recovered. Additional information has  been requested.
-Swollen axillary lymph nodes starting 2 days after the second dose of the vaccine that did not resolve until 2 weeks later. -Swollen neck/inside elbow/inside knee lymph nodes leading to mild upper respiratory tract symptoms starting 2 weeks after the second dose of the vaccine, this still has not fully resolved.
First dose: -moderate arm soreness/injection site pain for 3 days ~8:00 PM 4/7/2021 (day of dose 2): -mild dizziness (30 min) ~4:00 PM 4/8/2021 -?brain fog? spaced out and very tired, trouble focusing (~30 min) -tiredness continued throughout the rest of the day ~5:00 AM 4/9/2021 -vivid bad dream -slight head ache  -mild injection site pain/arm soreness since 4/8/2021