chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On October 5th I woke up and worked ( I work from home ) and started to experience chest pain. My chest felt achy and sometimes a sharp pain (on sides of each brest) and sometimes the pain would move to top part left breast above it by chest and then it would be all over. I then felt like my heart was "lurching" and center of chest pain.    I continued working and tried to just relax at home.  On October 6th I woke up and it felt alot worse and was also going up my neck and back. I was just sitting working. That is when I decided to go to the ER as I was afraid I was having a heart attack or a blood clot may have been forming.  When I went to the ER I had blood tests done and an EKG. They came back normal. I also had a chest xray which was clear. But, the Doctor acknowledged the chest pain and said it was chest wall inflammation Costochondritis is the term and she said it was very possible it could be from the vaccine.   I was sent home after about 7 1/2 hours of being in the ER since all tests were fine but chest still hurt. Today is 10/7 and I am still having the chest pain, it is not as intense but still there it volleys from feeling dull and a bit more increased pain back down to dull again.
Dizziness, Nausea, vomiting, chills, fever (reached up to 103 degrees)
Initial report received from a consumer on 17 August 2010. A 26-year-old pregnant female, with an allergy to tape, received on 07 April 2010 an intramuscular (IM) injection (dose 1) of ADACEL (lot number unknown) and an IM injection (dose 1) of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number unknown). The patient denies any medical conditions and was taking prenatal vitamins. Her date of last menstrual period was 20 January 2010 with an estimated date of delivery on 11 October 2010. The patient stated that her arm was bruised and very sore for approximately 4 weeks following receipt of the vaccine. The outcome was reported as recovered. Documents held by sender: None.
pt recvd vax 17NOV92 & exp a recurrence of earache, shoulder pain & general malaise; 24JUN93 lab eval was neg for anti-HBs; No further details were provided;
Small white bumps on lower leg, became red, raised, some appear to have lighter color in center, approx 8 to 10 spots on ea. leg (red nodules), 1 or 2 on back as well, moderately itching, says will be following up with doctor on 7-6 following holiday weekend.
Headaches ,body aches , chills , back hurts , soreness all over my body  Fatigue, allergies acting up .3:00pm
No adverse Effects as of Now. Peds Pfizer Given and Was Not Diluted. Notified Mother of Pt. to look out for any adverse effects and to report if there are any.
labored breathing; dizziness; lost all his core strength and had trouble getting out of bed; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (labored breathing), DIZZINESS (dizziness), ASTHENIA (lost all his core strength and had trouble getting out of bed) and HEADACHE (severe headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021 at 1:00 AM, the patient experienced DYSPNOEA (labored breathing), DIZZINESS (dizziness), ASTHENIA (lost all his core strength and had trouble getting out of bed) and HEADACHE (severe headache). At the time of the report, DYSPNOEA (labored breathing), DIZZINESS (dizziness), ASTHENIA (lost all his core strength and had trouble getting out of bed) and HEADACHE (severe headache) was resolving.            Concomitant medication was not provided. The patient had a pretty severe reaction to the second dose at 1 AM in the morning on 27Mar2021 includes labored breathing, dizziness, severe headache and he lost all his core strength and had trouble getting out of bed. He went to the hospital, got rehydrated, and started getting back to normal. He was in the hospital from about 2 PM to 5 PM on 27Mar2021.   This case was linked to MOD-2021-390847 (Patient Link).
Information has been received from a Nurse concerning a 4 year old female who on 30-AUG-2004 at the age of 1 year was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 648080/0079P). In the interim between ages of 1 and 4 years, the patient experienced shingles. Medical attention was sought. The 4 year old was a new patient at this doctors office. The patient was recovered. No product quality complaint was involved. Additional information has been requested.
Initial and follow up information has been received from a physician and a nurse concerning a 24 year old  female patient, who on 26-JAN-2007 (reported by the nurse as 25-JAN-2007) was vaccinated with the first dose, 0.5ml, of Gardasil, and on approximately 26-MAR-2007 ("two months later") with the second dose of Gardasil. There was no concomitant medication. On 27-JAN-2007 the patient developed diarrhea, nausea and vomiting. The patient recovered from the events (date unspecified); following the second vaccination, the physician reported that there were "no ill effects." The patient sought unspecified medical attention. No further information is expected.
Patient broke out with severe shingles over her right face and eye 1 day after receiving the Zostavax injection.
Face begin to itch, then neck.  About 20 minutes later started to notice large hives on face and neck.  Very red and itchy. Went to pharmacy to get Benedryl and pharmacist suggested to go to ER immediately.  Went to ER and was evaluated and kept for observation.  No swelling of tongue or difficulty breathing.  Stayed for observation and given prednisone (deltasone) .  Given an epi pen and instructed to take benedryl.  Hives subsided.  No reactions since that night.  Arm a bit sore but nothing severe.  Seeing an allergist next week as followup.
My son had a fever and was crying alot the day after his second set of immunizations. We were called by the daycare staff to come get him for medical attention, that he was feverish and crying all day. He also had an inflamed area at the injection site.  He continued to spend more time crying over the next few weeks and we were unable to get him to smile or laugh. He had an episode of spasmodic activity that seemed quite unusual however we were told that it may just be colic. Over the next week or so my wife said she noticed him tightening up when she was holding him several times but thought he had a stomach ache.  She did not mention this to me untill after he got worse.  He continued to spend alot of time crying and would not smile or laugh. Some day around 3/31/04 or 4/2/04 Daycare called and reported that he was exhibiting some strange spastic activity. I thought the spastic activity that I witnessed a few weeks earlier was an isolated incident however it apparently had been occuring all along and was becoming more frequent and exaggerated enough for his daycare staff to become alarmed.  We videotaped him having the spasms for his pediatrician who told us to get him to the hospital for an upper GI study and EEG. We took him to our local hospital who performed the upper GI study which was mostly negative. They couldn't get him in for anEEG until Monday, 4/5/04 so we drove 2 1/2 Hours to have the EEG. This was positive for Hypsarrhythmia and he was diagnosed with Infantile Spasms. He has been put on a strong, hazardous medication, ACTH and has been on it for a week. He continues to be barely responsive, crys and moans most of the day when he is not sleeping or eating. He seems to be. Weak and lethargic. He does not grab for things put in fron of him or play with his toys. I am told by his neurologists that he should start to perk up as his dosage of ACTH is reduced but I cannot help but think that he is showing signs of brain damage.
After receiving the Influenza vaccine in the right deltoid, she had pain,  swelling and redness of the area. PCP saw her and put her on Prednisone, with improvement of symptoms.
Headache, Chills, Sore Joints   all day after the second dose and Dizziness in the evening also the day after the second dose, it also seemed more difficult to swallow  in the evening the day after the second dose. Still have joint pain, especially my neck, 2 days after my second dose.
03/07/2023 I developed a blood clot in my right leg. I contacted my Physician and was given an Ultrasound of my leg. I was prescribed on ELIQUIS indefinitely to prevent further clotting.
This spontaneous report as received from a registered nurse refers to a female of unknown age. On an unknown date the patient was vaccinated with GARDASIL. On an unknown date a week after the administration of GARDASIL the patient experienced red erythema a little bigger than a size of quarter that was  hard and warm to touch at the site of the injection. The outcome of red erythema a little bigger than a size of quarter that was hard and warm to touch at the site of the injection and red erythema a little bigger than a size of quarter that was hard and warm to touch at the site of injection was unknown. Additional information has been requested.
On day 4 (3/4/03) and 5 (3/5/03)post vaccination(Monday 3/and Tuesday following vaccination) she had severe back pain radiating from under her left breast into her back.  She says it felt like a "heart attack pain".  Her vaccine was in the left arm and the majority of swelling was on day 4 and 5 also.  She took some tylenol and the pain was gone by Tuesday evening.
c/o of dizziness and sweating after receiving vaccine. Vital signs taken BP 190/109 HR  114. Sent to ED for evaluation.
I experienced hypersensitivity, arm pain dizziness, chills, and joint pain after my second dose vaccine after 24hours.  I went to the ER twice because I almost passed out.  On 03-15-21, went to the ER, was told I was dehydrated. At the ER labs were elevated also MRI and CT scans were performed.  I was placed on steroids for ten days. For two weeks I could not do my normal activities. I saw my endocrinologist. I felt so sick and had to ask for time off at work.  I was told to follow up with my endocrinologist.
A day after receiving the vaccine I broke out in hives that covered my entire body and kept spreading. The next day my fingers were swelling as well as my eyes and my hives were still there as well.
FLU LIKE SYMPTOMS FOR A DAY, THEN DEVELOPED CHEST PAIN, DIZZINESS, LEFT ARM AND HEAD NUMBNESS
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for hyperlipidemia, advanced age, prostate cancer, CAD, HTN. Patient presented to Emergency facility, outside entity, on 5/3/2021 with a CC of SOB. Deceased on 5/5 with no notation of death or cause of death. Limited information available. Only one dose of Moderna Covid Vaccine is documented.
Information has been received from a medical assistant concerning a 5 month old patient who on an unspecified date was vaccinated PO with a 21 ml dose of ROTATEQ (lot number not reported).  It was unknown if medical attention was sought.  The outcomes of the patients were not reported.  Additional information has been requested.
Body rash developed on front and back of torso and both arms and has persisted in spite of 2 courses of steroids and treatment with antihistamines.  See 3x's for this - first time - Urgent Care on 4/24/21, PCP- 4/29/21, PCP - 5/6/21
pt recv vax in AM about 3-4hrs later started w/t102-103,persistent high pitched cry,lasting for about 2hrs;started vomiting;mom phoned MD told to cont w/APAP & make appt w/MD;saw MD next day still had fever;MD felt it was a vax rxn
Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jun-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not applicable.
pityriasis lichenoides et varioliformis acuta in Trunk, extremities; Dose 2, Progressed(Multiple papules); This is a literature report.  A male patient in his 10's received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for covid-19 immunisation. The following information was reported: PITYRIASIS LICHENOIDES ET VARIOLIFORMIS ACUTA (medically significant), 23 days after the suspect product(s) administration, outcome "recovering", described as "pityriasis lichenoides et varioliformis acuta in Trunk, extremities"; CONDITION AGGRAVATED (medically significant), outcome "recovering", described as "Dose 2, Progressed(Multiple papules)". The patient underwent the following laboratory tests and procedures: CD30 expression: negative; CD4/CD8 ratio: 1:3; Histology: T-cell-predominant lymphoid infiltrates, notes: consistent with pityriasis lichenoides et varioliformis acuta; SARS-CoV-2 test: unknown; T-cell receptor gene rearrangement test: positive. Therapeutic measures were taken as a result of pityriasis lichenoides et varioliformis acuta, condition aggravated. Clinical information: Patient was in his late teens. Patient had no clinical history. All patients received the Pfizer/ BioNTechCOVID-19 mRNA vaccine. Median time between the first vaccine dose and lesion development was 22 days (range, 4-42 days). Cutaneous eruptions were characterized by single (n = 2) or generalized (n = 4) papulonodules on the trunk and/or extremities. Histologic examination revealed T-cell- predominant lymphoid infiltrates consistent with pityriasis lichenoides et varioliformis acuta. Events were near complete remission. Patient received treatment with oral doxycycline, narrowband UVB light and topical corticosteroids.; Sender's Comments: Based on the currently available information the possibility of causal association between the events and the suspect drug BNT162B2  cannot be ruled out. The case will be reassessed once new information is available. 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,Linked Report(s) : US-PFIZER INC-PV202200028643 Same article/ drug and different patient/event.;US-PFIZER INC-PV202200028643 Same article/ drug and different patient/event.;
on the 5th day post Moderna vaccine I developed muscle twitching on my right arm (injection site) for a whole day. The following day, I developed hives around the injection site and my back for 3 days.
Nausea, dizziness, rapid heart rate, fever, chills, weak muscles, sore joints, swollen tongue, dry mouth.  7:30am -8pm.
38 year old female who has completed a 60-minute observation period with the following signs and symptoms of an adverse reaction: sensation of throat swelling or throat closure and other - Hypertension, Tachycardia, Palpitations. Moderna COVID-19 vaccine#2 in series administered.  o Action(s) taken: Epinephrine administered and Another drug administered - Benadryl o Allergy to COVID-19 vaccine documented in Allergies activity: Yes o Patient advised to discuss second dose considerations with a clinician    1357- BP 169/92, HR 104, SpO2 97% 1358- Epi Administered 1400-  MD in room evaluating patient. 1406- 50mg Benadryl PO given. BP 154/85, HR 103, SpO2 98%. 1420- 141/77, HR 88, SpO2 98% 1430- Per  MD, Pt is safe for discharge. Strict ED instructions given to patient.      1406- Verbal order of Benadryl of 5o mg PO given by  MD, 5 right of administration were checked. Medication read back to MD for verification.
Moderna vaccine pulled from freezer on 16-Dec-2021 and on 26-Jan-2022, it was noted that the vaccine was still in the fridge; Expired 5 doses had been given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 5 doses had been given) and PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 16-Dec-2021 and on 26-Jan-2022, it was noted that the vaccine was still in the fridge) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2022 at 3:20 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Jan-2022 at 3:20 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 5 doses had been given). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 16-Dec-2021 and on 26-Jan-2022, it was noted that the vaccine was still in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired 5 doses had been given) and PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 16-Dec-2021 and on 26-Jan-2022, it was noted that the vaccine was still in the fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Moderna vaccine was pulled from the freezer on 16-Dec-2021. The beyond use date was 15-Jan-2022 printed in red and taped to the top of the boxes. On 26-Jan-2022, it was noted that the vaccine was still in the fridge and expired 5 doses had been given at that point. On 31-Jan-2022, Moderna responded that revaccination not required.  Later, the patient was notified of error and repeat vaccine was not required. Patient denies any adverse event.  No treatment medications were reported.
4/2/21 - Large red, hot itchy rash approximately 4" in diameter around left arm vaccination site, lasting approximately 6 days.  Inflamation treated with Zyrtec, per pharmacy advice. Subsequent hypersensitivity/allergic reactions to insect bites on multiple occasions following vaccines, including on 5/2/2021 and 8/28/2021 not previously experienced and lasting over one week.  Unknown insect and mosquito bites red, hot, itchy, burning, raised and inflamed up to 3" in diameter with additional swelling over large area surrounding the bite.  Treated with Benadryl, per pharmacy advice.
A non-serious spontaneous report of administration of H1N1, Intranasal to 15-month-old male child was received from a non-health professional. The patient had been healthy with no medical history and had not been prescribed daily medications. On 19-Nov-2009, the patient received H1N1 LAIV. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 04-Dec-2009 and incorporated into the narrative: Medical history and concomitant medications.
expired on 23Mar2022, Continuously stored in stable FREEZER environment/Only stored in fridge on date of administration for thaw period, date of administration on 15Apr2022; 1 Expired Doses Administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 Expired Doses Administered) and PRODUCT STORAGE ERROR (expired on 23Mar2022, Continuously stored in stable FREEZER environment/Only stored in fridge on date of administration for thaw period, date of administration on 15Apr2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 Expired Doses Administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired on 23Mar2022, Continuously stored in stable FREEZER environment/Only stored in fridge on date of administration for thaw period, date of administration on 15Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 Expired Doses Administered) and PRODUCT STORAGE ERROR (expired on 23Mar2022, Continuously stored in stable FREEZER environment/Only stored in fridge on date of administration for thaw period, date of administration on 15Apr2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The vaccine was administered past expiry date. The vaccine was continuously stored in stable freezer environment and only stored in fridge on the date of administration for thaw period.  No treatment information was provided.
Felt sick but was manageable; Body aches; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Oct-2021 and was forwarded to Moderna on 09-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt sick but was manageable), MYALGIA (Body aches) and PYREXIA (Fever) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced ILLNESS (Felt sick but was manageable), MYALGIA (Body aches) and PYREXIA (Fever). The patient was treated with IBUPROFEN in September 2021 for Adverse event, at an unspecified dose and frequency. On 10-Sep-2021, ILLNESS (Felt sick but was manageable), MYALGIA (Body aches) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported.  The reporter was calling on behalf of the patient who after five hours post getting their first dose of the Moderna COVID-19 vaccine experienced body aches, a fever and felt sick which was manageable.  Reportedly, the patient took ibuprofen and the symptoms went away on the 10-Sep-2021.   This case was linked to MOD-2021-347141 (Patient Link).