chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rapid pulse  high blood pressure dizziness.  ER  Pulmonary embolisms. 1 in each lung  Xarelto
Patient during his 2nd shingrix vaccination mentioned his shoulder still has pain from the 1st vaccination.  Pain is worse when patient raises arm toward ceiling.  Location of pain is around shoulder area/ high side of deltoid.  Potential shoulder injury due to vaccination but it's hard to ascertain for certain.  Patient said this pain started after vaccination.
A grandmother reported that her grandson received an injection of Prevnar. Subsequently, the child developed a fever, screaming, and was "not eating." The reporter considered screaming to be an "extreme" reaction. The symptoms resolved "in a couple of days." No further info was available at the date of this report.
Hives all over body, swelling in arms, hands, legs and feet. Itchiness on arms and legs. BENADRYL resolved symptoms. Doctor prescribed a 72 hour medicine to help calm symptoms until vaccine works through her body.
Developed a rash behind my left ear, which turned into my entire ear being red and hot.  Bumps developed as time went on along with nerve pain.  Finally diagnosed with Shingles in my ear by ENT after misdiagnosis by urgent care.
Patient reported feeling of "wind burn" to face, anterior chest, and both arms, no other locations on body. Patient stated no visible signs of rash or skin discoloration. Sensation of windburn reportedly lasted 24 hours. Left arm soreness began after vaccination (11/17) and persists today (11/21).
administered an expired (3/26/21) Pediarix / received dose on 3/31/21.; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 53HA4, expiry date 26th March 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st March 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 31st March 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received an expired Pediarix dose, which led to expired vaccine used. The reporter consented to follow up.
itching; redness; soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (soreness) and VACCINATION SITE ERYTHEMA (redness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness). On 19-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (redness). On 13-Feb-2021, VACCINATION SITE PAIN (soreness) had resolved, VACCINATION SITE ERYTHEMA (redness) outcome was unknown. At the time of the report, VACCINATION SITE PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment details were provided.    Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: NNI
Chills; Dry mouth; weird sensation on tongue (like sandpaper); Tightening sensation of soft palate; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: GP6599) via an unspecified route of administration in the right arm on 20Mar2021 at 15:00 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea and cervical radiculopathy. Concomitant medication were not reported. The patient was allergic to tomatoes and wool. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 15:30, the patient experienced chills, dry mouth, weird sensation on tongue (like sandpaper) and tightening sensation of soft palate. On 17Mar2021, the patient was tested for COVID-19 virus test (nasal swab) which resulted in negative and on 22Mar2021, the patient was tested for COVID-19 virus test (blood test) which resulted in negative. It was unknown if treatment was received for the events. The clinical outcome of the events chills, dry mouth, weird sensation on tongue and tightening sensation of soft palate were unknown.   No follow-up attempts are needed. No further information is expected.
Admitted to hospital on 11/13/08 with complaint of weakness. Onset over last 10-14 days, becoming gradually worse, probable Guillain-Barre syndrome.   12/18/2008 MR received for DOS 11/3-9/2008 with D/C DX:  Guillain-Barre Syndrome.  Acute Renal Failure 2' to dehydration.  Dehydration 2' to diarrhea.  Constipation 2' GBS.  Hypertension.  Osteoarthritis. Pt presented to ER with progressive weakness x 10-14 days.  Admitted for concern for GBS. Symptoms were preceded by 4 days of diarrhea. Pt reports pins and needles sensations beginning in her feet and progressing up the legs to waist. PE (+) for diminished strength and sensation of lower extremities 3/5. Upper 4/5. Pt started having falls 2' to unsteady gait.  Tx with IVIG. Able to use walker and d/c for outpt f/u.
Patient received 3 Shingrix shots; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date, (4-6 months apart for each shot) ).   In October 2022, the patient received the 3rd dose of Shingrix. In October 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 04-NOV-2022 Reporter's Comments: The reporter stated that she was contacted by outpatient nurse regarding a patient who received 3 doses of Shingrix vaccine, few months apart each (4-6 months apart for each shot) with the last dose being administered sometimes in the last week.  THe reporter stated that she was no additional information related to this incident.  The reporter who declined consent for safety follow-up as she did not have additional information related to the incident.  The reporter could not provide the name of the outpatient nurse when asked.  Pharmacist could not provide product information including formulation, route/site of administration, lot numberor expiration date when asked. Pharmacist could not provide patient's initials, gender or DOB when asked The reporter did not consent to follow-up. Additional supportive information:  The patient received 3rd dose of Shingrix, which led to extra dose administered.
Soreness; Product administration  issue; Inappropriate dose of vaccine administered; This case was reported by a non-health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number H7JY4, expiry date unknown) for prophylaxis.   On 28th March 2019, the patient received the 2nd dose of Shingrix. On 28th March 2019, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: This case was reported by the office manager. The patient was erroneously given adjuvant only (no antigen), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Office was not aware of guidance to wait 4 weeks before giving correct dose and gave a correct dose same day (28th March 2019).  No adverse events were reported, thus far from patient, to reporter knowledge. The reporter agreed to be followed up.   Follow up information received from the non-health professional on 24th April 2019: The patient demographic details were updated. On 29th March 2019, 1 day after receiving Shingrix, the patient experienced soreness. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to Shingrix. This case was a medication error with harm.
The patient experienced a fever of 101.9F, joint pains, chills, dizziness, chest tightness, a headache, and body pain. The patient was treated with Motrin and Rocephin.
Dizziness x 45 minutes.  Normal  neuro and cardiac exam. Hemodynamically stable. After hydration and maintaining supine position, then sitting upright after 2 minutes, patient was then able to walk normally.
mom called clinic on 29DEc to stated that pt became very sleepy, nauseated, pale, irritable & had 2 episodes of vomiting on 28DEC92 @ approx 3PM; immed called MD who states probable mild reaction to HIB vax;
ARM GIVEN IN BECAME RED, SOMEWHAT SWOLLEN, AND PAINFUL TO THE TOUCH. PATIENT DID NOT CALL THE PHARMACY UNTIL 10-20-16. PATIENT STATED SHE DID NOT SEEK TREATMENT BECAUSE SHE THOUGHT IT WOULD GO AWAY. AND ONLY REPORTED IT TO THE PHARMACY BECAUSE SHE FORGOT SHE HAD 5 LYMPH NODES REMOVED FROM THAT SIDE OF HER BODY AND THINKS THAT'S WHAT LED TO THIS REACTION. I TOLD HER TO USE BENADRYL, ICE TO THE AFFECTED AREA AND TYLENOL FOR ANY PAIN ASSOCIATED WITH IT.
Patient received Janssen COVID vaccine at a clinic today at approximately 2:10pm.  When seated in a chair in the waiting area, patient stated she started to feel light headed and sweaty and has fainted before (not from a vaccine), so she sat back in the chair and then awoke on the floor.  She bumped her forehead on the floor and has an egg-sized raised bump on her forehead.  We applied ice instantly and monitored her blood pressure until she felt well enough to sit up.  She did not feel she needed an ambulance and refused going to urgent care. She is feeling fine other than the bump.  A worker took a report and I discussed with her what to watch for to monitor for concussion.  Her roommate is driving her home.  Event will also be reported today.
Quick sharp pain in left chest and legs at store. Later that night severe shakes, vomiting, sweats, severe pain in all parts of body especially back and head.
Raised, warm, red rash in a 4" x 4" square on the left arm around the vaccination site.  Mild pain and swelling.  Symptoms started 7 days after injection.  Starting to fade 3 days later but still swollen, warm and mildly painful.  Treating with ibuprofen.
I woke up with heavy fever symptoms, sweating, chills, weakness in legs. The unexpected event included elevated resting pulse of 120, O2 level of 92 and a heavy pounding in my chest. I could feel my pulse throughout my extremities, and was short of breath.  Symptoms subsided about an hour later. The next day I experienced anticipated fever symptoms and slept all day.
Cerebral Venous Thrombosis; This literature-non-study case was reported in a literature article and describes the occurrence of CEREBRAL VENOUS THROMBOSIS (Cerebral Venous Thrombosis) in a 29-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBRAL VENOUS THROMBOSIS (Cerebral Venous Thrombosis) (seriousness criterion medically significant). At the time of the report, CEREBRAL VENOUS THROMBOSIS (Cerebral Venous Thrombosis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company comment:  This is a Literature-Non-Study case concerning a 29-year-old, female patient with no relevant reported medical history, who experienced the unexpected serious (medically significant) event of Cerebral venous thrombosis which occurred after the administration of a dose of mRNA-1273 vaccine. Latency could not be assessed due to lack of information. No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Client self reported swelling of throat and difficulty breathing, felt diaphoretic, pulse seemed excessively fast.  Client went to personal MD after leaving clinic and was prescribed Prednisone and cautioned against taking any further MMR vaccine.
Patient was given 0.6 mls of the Pfizer vaccine after receiving J&J for his first dose
Atrial fibrillation began 6 days after first immunization. Patient needed cardioconversion.  Atrial fibrillation began 5.5 days after second immunization. Patient currently awaiting cardioversion.   Patient has underlying hypertrophic cardiomyopathy and  2 prior episodes of atrial fibrillation (December 2019, and February 2020) apparently triggered by surgery/anesthesia. However, the atrial fibrillation was completely controlled for more than one year by the addition of a beta-blocker (atenolol) to long-standing (30+ yrs) of a calcium channel blocker (verapamil).
Information has been received from a certified medical assistant concerning a 63 year old white male with gastroesophageal reflux disease, chronic obstructive pulmonary disease and chronic bronchitis who on 01-AUG-2005 at 16:38 was vaccinated intramuscularly into the left arm with a second dose of pneumococcal 23v vaccine (lot 649694/0386P).  On 02-AUG-2005, the patient's left arm was sore,"felt hard" and was not warm to the touch.  The patient stated that he just doesn't fell well.  The patient experienced a local site reaction of redness, tenderness and edema.  He stated that he felt better when he took ibuprofen (ADVIL).  On 03-AUG-2005, the patient stated that his arm was better and he felt better.  He also stated that he really felt had he took ibuprofen (ADVIL) all day, but he did not need a follow up appointment.  Unspecified medical attention was sought.  The patient's outcome was unknown.  The medical assistant requested a lot check.  No product quality complaint was involved.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.  Additional information has been requested.
Information has been received from a RN concerning a 4 year old male with a food allergy to mango and no illness at the time of vaccination who on 07/07/04 was vaccinated SQ in the RA with a 2nd dose of MMR live. . On 07/07/04 immediately post vaccination the pt developed hives above the injection site. Unspecified medical attnetion was sought. The pt was treated with oral Benadryl. The pt was observed fro 60 minuted and then dismissed. Subsequently, the pt recovered. It was reported that no immunization was given within 4 weeks prior to vaccination with MMR vaccine. A pediatric allergy consult was performed and the pt will need skin testing prior to immunizations. No additonal information is expected.
Right off that bat, I noticed heart palpitations and also flushing on the chest. I was getting a rash on chest. The EMT there told me to go home and take Benadryl. I took two of them. It didn't help with the symptoms. I called the doctor - he told me to take three Benadryl every six hours. I didn't really sleep that night - I was tired due to Benadryl. I put ice on my chest in the middle of the night because it was on fire. I remembered that I tried to go to work the next day but I couldn't. I went to the doctor. He told me to take 2 Benadryl one hour before the next shot. It took awhile for the symptoms to go away - I took Benadryl during the next week. I still had the rash on my chest. I went to the OB/GYN after that for my annual exam and after that I was bleeding and I thought it had been from my pap smear. I was  bleeding very heavily - altogether it was three months of heavy bleeding. Medication to stop bleeding: Filled on Provera - 10 mg - on 2/8/2021 - they told me to take it for 10 days. Tranexamic acid -650 mg 2 tablets 3 times a day for up to 5 days..  They did bloodwork. I did a Sonogram.  I had to leave during my work duties a couple of time (I'm a surgical assistant in surgeries)  because I was bleeding and my co-workers told me I didn't look good. Had second dose of vaccine (lot number 004M20A) on 2/5/2021 - the bleeding got heavier (and in fact, immediately after I had the shot, I had to go to the bathroom I started bleeding so heavily - heavier than I had ever bled before) after the 2nd vaccine and the rash that I had after the first vaccine was still there but would come and go with Benadryl. I did testing on April 20th - for pre-surgery.  I had a DNC on April 27th  and after the DNC I felt so much better. The rash is gone; I'm not as  tired. And I feel better.
Received Pfizer Booster Oct 2021 after J and J initial vaccination March 2021.  In addition to general malaise, I had phantom smells that woke me up (acrid, burning smell).  My husband did not smell anything.  The phantom smells continued throughout day and most of night.  By morning of 10/27/2021 general vaccine side effects and phantom smell was gone.
pt recv vax 1996 & on 6/4/98 pt exp chickenpox w/6 lesions
Muscle soreness at injection site was fairly intense for a couple of days, but deep muscle soreness is still present.  On 8/12 I developed a nodule at the injection site that is about 4 mm in diameter and 1 mm high.
Received MENACTRA & Tdap on 6/3/09. Had a seizure on 6/12/09. Eyes rolled back, she stiffened and turned blue around the lips. Vomited & unresp. for 10 min. 2nd seizure on 8/3/09.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: 01Nov2019, stop date: 20Apr2022; PRALUENT, start date: 01Jul2020, stop date: 27Apr2022; TRUVADA, start date: 01Jan2016, stop date: 18Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of suspected covid-19.The patient took other medications/products within 2 weeks of starting COVID-19 treatment with brand name Paxlovid and dates include treatment start date19Apr2022, treatment stop date 24Apr2022, Indication is Treatment of COVID-19. The patient previously received a COVID-19 Vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. On an unknown date an unspecified patients received improperly stored M-M-R II (route, dose, frequency and lot # not reported). No adverse effects were reported. No further information was provided. This is one of several reports from the same source. Additional information has been requested.
Pt recvd 5 doses of Engerix-B & did not convert;
has pneumonia in her right lung; This is a spontaneous report from a Pfizer sponsored program.  A contactable consumer reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 27Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient (reporter's sister) has pneumonia in her right lung on an unspecified date. The patient was hospitalized for pneumonia in her right lung from 19Mar2021. The patient underwent lab tests and procedures which included covid test: unknown results on an unspecified date, She did a covid test but has not gotten the results yet. She is wondering what she should do about the second dose. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Beginning approx 72 hours after vaccination, right arm  just above elbow (well below site of shot) developed a warm, red, itchy area about 3 inches in diameter. Ice packs helped relieve some of the discomfort temporarily.  Symptoms gradually subsided over following 3 days. Now, 4 days after onset,  issue is fully resolved.
15 mins after administration of vaccine patient began complaining of diaphoresis, nausea, heart palpitations, tingling in throat
Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Nausea-Medium, Additional Details: patient's temp is elevated at 102 degrees and feels lethargic. advised to call PCP
On 8/17 I experienced a Transient Ischaemic Attack (TIA), I spent 3 days in the hospital to try and determine the cause and have also had a loop recorder put in my chest.  Results- I am perfectly healthy.  No cardiac or neurological causes found.  Since the TIA I have had a hard time concentrating on work, though no damage was found in my tests.  The TIA happened while I was working and I suddenly couldn't read, write or speak correctly for about an hour.
had sz-like activity 24hrs p/vax;also has family hx of epilepsy
Patient came to the pharmacy to ask for 1st dose of Moderna. Patient denied of having any previous COVID-19 vaccine previously. After counseled patient on Moderna vaccine, and the vaccine was administered, pharmacist found out that patient had Johnson & Johnson vaccine via vaccine records in March 20, 2021. Even though patient was counseled by the pharmacist that J&J and Moderna haven't been approved for any booster, patient didn't disclose to the pharmacist that patient had J&J already. Patient and her spouse admitted that they did some research on J&J that wasn't effective to protect them from the variant, so both of them decided to get Moderna . No symptoms and adverse effects were reported at this point.