chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diagnosed with shingles; Experienced sensation below the breast; A spontaneous report was received on 22-FEB-2021 from a concerning female patient of 76 years old, who was administered with Moderna's COVID-19 vaccine for prophylaxis of COVID-19 infection. On12-FEB-2021, patient received the first dose of mRNA-1273 vaccine in the left arm. The patient's medical history was not provided.  Concomitant medications were not provided by the patient.  Patient experienced the adverse events such as sensation below the breast and diagnosed with shingles.  The treatment for the adverse events was Antiviral medications as provided by the patient.  Action taken with the dose of mRNA-1273 vaccine was not reported. Consent to follow up from safety was provided by the patient.
CRYING FOR 6 HOURS WITHIN THE FIRST 48 HOURS AFTER RECEIVING VACCINES.
Fingers feeling numb, nausea during times of stress, general malaise, trouble concentrating, weakness (ussually very active) after third shot in January 2003 while deployed. Member experienced same symptoms after fifth shot in May 2004. Member was hospitalized in theater during first adverse episode. First episode lasted approximately over the course of 8 months. The second episode lasted approximately 2 weeks. Follow up: sxs described as tunnel vision, unable to speak, thick tongue, difficulty speaking. Worked up in hospital. abroad Test negative except cholesterol of 238. Prescribed blood thinner, but doesn't recall the name. Pt returned to US and continued to experience sxs on occassion. usually these were milder and abated after pt took 2-3 aspirin. In August 2003, sxs recurred and did not abate. Pt hospitalized and worked up extensively again. Tests were apparently negative. Previous blood thinner replaced by Plavix. Pt states sxs occur less often sincet that time, but were more pronounced after Anthrax dose 4 onn 5/1/04. He adds sxs of slurred speach to those previously noted. Per review of medical records: facial pain, rhinitis, sinusitis, and rash possibly due to Amoxicillin in 7/04.  Nurse follow up on 09/17/04 states: "Per review of hospital d/c summary for admission of 8/12/2003, final diagnosis was TIA, aphasia resolved."
4 hrs later I got sever tachycardia & its been going on for over a month & I'm having to see a cardiologist. They put me on heart medication but its still accelerated.
4 hours after injection - pain at site -nausea-vomiting 9 hrs- Temp -101.4 - 12 hrs. See attached for detailed acct
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On an unspecified dates, the patients received an improperly stored doses of GARDASIL (dose and route of administration were not provided) (lot numbers: J012438, expiration date: 5-OCT-2015; J009098, expiration date: 04-DEC-2015; J012435, expiration date: 05-OCT-2015; L001442, expiration date: 04-NOV-2016; K023435, expiration date: 05-NOV-2015; K011492, expiration date: 22-JUN-2016; K001500, expiration date: 06-NOV-2016; reported as "K004601", expiration date: 04-NOV-2016; J003727, expiration date: 07-NOV-2016; K008213, expiration date: 17-DEC-2016; reported as " K020246", expiration date: unknown, L004601 expiration date: unknown). No adverse effects were reported. No product quality complaint (PQC) was involved. Lot numbers: K004601 and K020246 are invalid lot numbers for GARDASIL. This is one of several reports received from the same reporter. Additional information has been requested.
Ringing in the ear started 10 days after my 2nd dose of Moderna. I went to my general physician and he sent me to an Ear Nose and Throat Specialist. From there, I started doing research and saw other posting online regarding these effects from the vaccine.
Patient became hot and dizzy. Symptoms lasted about 7 minutes. Patient sat down and drank water.
A report has been received from a Health Professional concerning a 10 year old, Female subject, who had been received Nasal FLUMIST QUADRIVALENT (INTRANASAL) started on 04-Dec-2013. The nurse reported that patient was given expired FLUMIST which started on 04-Dec-2013. The outcome of the event of PATIENT WAS GIVEN EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Elevated HR, Fever of 103.7, chills, extreme muscle pain and weakness, dizziness, lethargy
Patient reports that about 3 hours after getting the Pneumovax 23 shot in her left arm, the arm above the elbow swelled up and started to hurt. No heat, trouble breathing, or fever was reported. Patient tried to use Benadryl and ibuprofen without which did not help much.
Fevers to 103 rash on chest and and neck. Peeling skin on the lips and roof of mouth.
My arms began to itch the evening of my second dose of the Covid vaccine. Then a few days later my legs started to itch. It felt like the itching you get with Shingles, but covering both arms and both legs (only below the knees). This continued for approximately three weeks non-stop. No over the counter anti-itch or allergy cream or pill seemed to help. I still get this itching a couple of days a week, but it's no longer constant.
Severe pain at left arm (injection site was left arm  near shoulder). Sore lump on inside of forearm near wrist. Lump has reduced in size but still there on 4/13/21 but no soreness. Pain raising arm or even just when arm was doing nothing. Severe pain lasted about 18 hours and lingered for another 12 hours afterward.
Patient initially felt sore and tired day after the shot but 3 days after the shot she noticed her face was swollen.  She had swelling below both eyes, and below ears that was also tender to the touch.  After seeing a doctor, she was advised to take Benaryl for a few days.  Her swelling has gone down and only slight puffiness on face 4 days after shot.
The patient presented to the hospital with chief complaint of shortness of breath. He was found to have acute COVID-19 infection and acute CHF exacerbation. Admitted for IV diuretic therapy, echocardiogram pending. Patient left AMA prior to completion of medical therapy and diagnostic imaging.
Positive Covid after vaccine; Positive Covid after vaccine; This is a spontaneous report from a contactable other hcp. A patient of unspecified age and gender received BNT162b2 (COMIRNATY, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unknown date in Jan2021 as unknown, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced positive covid after vaccine. In an ongoing clinical trial the Pfizer BioNTech covid-19 vaccine has been shown to prevent covid-19 following two doses given to 3 weeks apart the duration of protection against covid-19 is currently unknown. When asked about risk of Pfizer biotech covid-19 vaccine, stated side effects that have been reported with pfizer biontech covid-19 vaccine includes: injection site pain, tiredness, headache, muscle pain , chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell, swollen lymph nodes (lymphadenopathy). There is a remote chance that the pfizer biontech covid-19 vaccine could cause a severe allergic reaction. a severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of pfizer biontech covid-19 vaccine. Signs of a serious allergic reactions can include difficulty breathing, swelling of the face and throat, fast heartbeat, a bad rash all over the body, dizziness and weakness, this may not be all the possible side effects of pfizer biontech covid-19 vaccine serious and unexpected side-effects may occur. Pfizer biontech covid-19 vaccine is still being studied in clinical trials. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event COVID -19 and the suspect drug  BNT162b2  cannot be excluded. The case will be reassessed once new information is available
Vaccine given in left arm.  Tingling in left breast started yesterday and continues on and off today.
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # J013394 with expiration date of 25-AUG-2016, dose strength and route unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Nausea  Diarrhea  Wheezing  Rash and welts  Bruising  Swelling  Headache
Pt had only mild arm soreness until she started Doxycycline for a sinus infection 5 days after immunization. In the evening after starting Doxycycline she started to develop rash, pain, and hot to the touch. Pt came to pharmacy on 2/28/20 to ask what was wrong with her arm; now having a large red area that was hot to the touch from the injection site down to a few inches above her elbow. I advised her to go see a doctor. She returned later in the day with a Rx for Cephalexin and told me that the dr said it was cellulitis likely caused by the doxycycline interacting with the prevnar 13. Talked with pt on 3/2/20 and she is feeling much better, the pain and redness has greatly reduced and is better every day.
hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not received any treatment. Patient allergies and medical history was not provided. Patient concomitant medications was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Non-Significant follow up appended to AER
Pinkish rash @ injection site - spread toward elbow 5 days after injection Not itchy or painful Slightly warm & indurated tx: ice site PRN; antihistamines
Seizure activity at 3-4 minutes duration with eyes rolled back, not responsive to parents. Temperature 104.2 F rectal at urgent care center. No preceding history of illness. Patient became interactive, appropriate after TYLENOL and MOTRIN administered. No residual deficits. No labs or imaging done.
Rhabdomyolysis 6/1/2021. Hospitalization 6/8/2021. Persistent swelling of both arms following release from Rhabdomyolysis.  Ultrasound noted signs of prior blood clots in arms 10/25/2021. Compartment surgery on right forearm 5/16/2022.
That evening about 11:00 pm I became extremely cold, teeth chattering , complete body ache , nauseated and had a slight headache. The next morning about 6:30am I had a major headache I can only describe as a migraine times 10. All day and all night. Did not go away at all . The next day it was very very slight and by the evening the headache was gone.
Covid monitoring documentation. PT admitted 12/21/22 documented to have positive covid. PT received Pfizer 1/20/21 Lot EJ1685 for dose 1. Dose 2 was Pfizer given on 2/10/21 Lot EL9269.
I developed vision abberations such that when i focus or concentrate (e.g. reading a book or computer screen) my vision would 'jump' or 'blink' or flicker causing me to not follow words I had been reading.  Very clearly concentration of attention driven. This condition came on slowly. It took weeks after injections for the symptoms to develop. They remain. And seem to be getting more severe.  My opthamologist has refered me to a neuroopthamologist.  I can not think of any other causative factor in the last years, month, and weeks that could account for what I am experiencing. I have had NO illnesses. I have not had Covid-19 to the best of my knowledge.  (Note: date & time given for #5 above is approximate)
patient described pain in the deltoid/shoulder in which she received her vaccination beginning 3 days post vaccination. The pain has remained.
This spontaneous report was received from a nurse via a company representative and refers to a 11-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced rash at the injection area. The patient's mother sought medical attention via calling the office. The outcome of the event was reported as recovered on an unknown date. The causality assessment was not reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1903USA003143:
Raised blisters; Skin eruptions on both arms/ Red patches under skin; Skin eruptions on both arms/ Itch/ red patches under skin; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Raised blisters), RASH ERYTHEMATOUS (Skin eruptions on both arms/ Red patches under skin) and RASH PRURITIC (Skin eruptions on both arms/ Itch/ red patches under skin) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included XANTOFYL, ZEAXANTHIN (LUTEIN ZEAXANTHIN) for Macula abnormality, FINASTERIDE for Prostate tenderness, METFORMIN, INSULIN LISPRO, IRBESARTAN, AMLODIPINE BESYLATE, ATORVASTATIN, CHROMIUM PICOLINATE and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, 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 experienced BLISTER (Raised blisters), RASH ERYTHEMATOUS (Skin eruptions on both arms/ Red patches under skin) and RASH PRURITIC (Skin eruptions on both arms/ Itch/ red patches under skin). At the time of the report, BLISTER (Raised blisters), RASH ERYTHEMATOUS (Skin eruptions on both arms/ Red patches under skin) and RASH PRURITIC (Skin eruptions on both arms/ Itch/ red patches under skin) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   other concomitant medications include Insulin Lantus 30 units and vitamin D 5000 IU. treatment included antibiotic cream and eucerin cream.
about 6PM started screaming uncontrollably;630PM mom gave APAP then fever 730PM & 8AM; t100 ax; screaming cont about 11PM; temp & they called 911 & then was taken to ER; t101 ax; screamed for 2 hrs; site of DTP vax was swollen;
Information has been received from a physician concerning an 89 year old female with high cholesterol, high blood pressure and osteopenia who on 09-OCT-2006 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX. Concomitant vaccination included a dose of influenza virus vaccine (unspecified) on 05-OCT-2006. In the morning of 10-OCT-2006 the patient experienced excruciating body pain, burning and throbbing of ears, pressure in head, stomach pain, severe headache and was lightheaded. She had achiness and tightness with sore muscles of the neck, shoulders and arms. Her entire body was weak, she was unable to turn her head. She also had burning in mouth and tongue. Unspecified medical attention was sought. The patient had improvement, but was not fully recovered. There was no product quality complaint involved. Additional information has been requested.
received shingles vaccine on April 1, 2010.  On 4/3/10 in evening, noticed itchiness on L hip & red patch.  By 4/5/10, slightly bigger, bumpier, & slightly swollen - 2 inches in diameter.
Brief (less than 2 minutes) itching in throat. Sore left arm for 2 days.  On day 2, inability to lift arm for about 1 hour, improved after ibuprofen. Significant fatigue for 2 days.  By day 3, all symptoms resolved.
Your vaccine almost killed me/sent me to the hospital; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Your vaccine almost killed me/sent me to the hospital) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Your vaccine almost killed me/sent me to the hospital). At the time of the report, VACCINATION COMPLICATION (Your vaccine almost killed me/sent me to the hospital) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  No treatment information was provided.
The patient had very swollen glands and neck pain a few days after the immunization.  Cyclobenzaprine and Methylprednisolone  were prescribed to help on 1/25/2021.  He was then prescribed some lidocaine patches on 02/17/2021.  Finally he was prescribed celecoxib for pain and inflammation on 02/25/2021.  His symptoms have lasted for about 3 months and with the help of the celecoxib his pain is not there anymore.
pt recv vax; swelling started 6 hr p/ vax;over next 3 days swelling 10x10cm w/ erythema;vesicles formed at site of inject
Vaccination date: 1/30/21. Nausea, vomiting & abdominal pain started 1/31/21, day after vaccination.   Presented to emergency room 2/1/21. found to be hypoxic 85% (pt. had not been on supplemental 02). chest x-ray showed some patchy opacities likely COVID-19 induced fibrosis (per MD progress notes)
Severe leg (confined to the thigh/quad area) muscle pain; This is a spontaneous report received from a non-contactable consumer (patient). This 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EP7534) via unspecified route of administration in left arm on 30Mar2021 at single dose for COVID-19 immunization. Medical history included strong seasonal allergies, eosinophilic esophagitis. No known allergies to medications, food, or other products. Concomitant medications were not provided. On 04Apr2021, the patient experienced severe leg (confined to the thigh/quad area) muscle pain following a routine run 3 days after the injection. The intense pain worsened over the subsequent days peaking at about 6 days from onset when the right leg suddenly got better leaving the left still in extreme pain. At 8 days from onset the pain slowly started to subside. Patient was still in moderate pain at day 10 from onset. Over the counter pain meds were not effective, so patient tried 50mgs tramadol, also not effective, 200mgs celecoxib 2x/day brought some relief. This report was assessed as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Received MMR # 2, IPV # 4, DTAP # 5 at approximately 14:45.  RTO at approximately 15:20 with facial swelling and conjenital edema.  Benadryl 20 mg and salumedrol 40 mg, IM given.
I first tasted a metallic taste, and then about a week later, had swelling not directly under my eyes, but right where the cheekbones are located. At first i tried allergy medicine, thinking it was allergies, but that did not work. After thinking about it, I realized it must have been a reaction to the shot. It is like someone cut open the area and poured 2 tablespoons of water in the area and stitched it back up. Also, the day the swelling started, i got a severe headache and it lasted for four days. The headache is gone, the metallic taste is gone, but the swelling is still there and i am extremely thirsty all of the time.
pt recv vax 23FEB96 & 9MAR96 pt devel swollen lymph nodes on throat, under arms, & back of neck;neck pain, conjunctivitis, raised pruritic rash on elbows, palms & dorsal side of fingers;h/a;
hard to breathe, trouble breathing; distended stomach; looks like he is 9 months pregnant like he is going to pop; Sweating; feels like he has pins and needles; Cramps; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (hard to breathe, trouble breathing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (had reoccurring covid for the weeks following with symptoms coming and going. ) on 09-Mar-2021.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 23-Apr-2021, the patient experienced DYSPNOEA (hard to breathe, trouble breathing) (seriousness criterion medically significant), GASTRIC DILATATION (distended stomach), GASTROINTESTINAL INFLAMMATION (looks like he is 9 months pregnant like he is going to pop), HYPERHIDROSIS (Sweating), PAIN (feels like he has pins and needles), MUSCLE SPASMS (Cramps), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, DYSPNOEA (hard to breathe, trouble breathing), GASTRIC DILATATION (distended stomach), GASTROINTESTINAL INFLAMMATION (looks like he is 9 months pregnant like he is going to pop), HYPERHIDROSIS (Sweating), PAIN (feels like he has pins and needles), MUSCLE SPASMS (Cramps), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included continuous positive airway pressure (CPAP) to help patient breathe.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Chills and headache are consistent with the product safety profile
expired dose of YF-VAX was administered with no adverse event reported; Initial information received on 25-Oct-2021 regarding an unsolicited valid non-serious case from other health professional via Global Media information (under the reference: 00826494)  This case involved a 29-year-old female patient receiving expired dose of YELLOW FEVER VACCINE - US [YF-VAX] (expired product administered).  On an unknown date, the patient received a 0.5mL dosage form total dose of suspect YELLOW FEVER VACCINE - US [Frequency: once, Strength: standard lot U6428AA, expiry date: 30-Sep-2021] via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine use. (latency: same day)  It was reported  "expired YF-VAX administered to 5 patients."  At the time of report, no adverse event reported.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. The classification as a medical error was 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 had contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2021SA356701: US-SA-2021SA354618: US-SA-2021SA355405: US-SA-2021SA357534: US-SA-2021SA356051: