chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe nose bleed. Strange that both boosters this happened at same hour after shot. I have informed my doctor and will discuss this at next appointment.
Patient began with redness/pain/warmth in left deltoid; then had redness, swelling, tingling, pain and numbness that began in bilateral fingers and toes that night and spread progressively proximal over next 48 hours (to metatarsal and metacarpal region). Redness/pain/warmth and PNEUMOVAX site began in right deltoid on day 2...after initial RXN had begun. She also began having some tingling around mouth on day 2...when she came in for treatment. Treated with prednisone taper...75% improved after 3 days. Still awaiting complete recovery.
Pt states "<48 hours after the vaccine I was so sick I should have gone to the ER but didn't have anyone to watch my kids." Pt states <48 hours s/p vaccination she woke up @ 3 am with "extreme nausea, vomiting, a 103 degree fever, and difficulty breathing. Pt stated that "It felt like I had a straw for lungs." Pt took her SO's inhaler and this helped w/breathing. Pt also states that he was "sweating profusely." Pt also states that she had an "extremely sore and painful arm even at the injection site. "Pt state that "it still hurts me to touch it to this day, one month later." Pt declined an appointment with her provider. Pt also wanted to make known that she is declining all further HPV vaccine
Body aches - 2nd dose; Fever for less than 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches - 2nd dose) and PYREXIA (Fever for less than 24 hours) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Lymphoedema.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches - 2nd dose) and PYREXIA (Fever for less than 24 hours). At the time of the report, MYALGIA (Body aches - 2nd dose) and PYREXIA (Fever for less than 24 hours) had resolved.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-350318, MOD-2021-350366 (Patient Link).
I didn't make the connection of the vaccination to difficulties I had right around the same time following the vaccination.  I don't know if it is related but I suddenly began to  have difficulty breathing with brisk walking, running, excessive talking (ie facilitating a meeting).  It was more like a dry cough with a tightness in the back of my throat or upper chest.  I could take a deep breath in but would cough upon exhale.  In some instances, the coughing was so bad that I had to stop what I was doing to try to catch my breath.  It sometimes occurred at night when I layed down to sleep. I contacted my doctor who did an initial series of xrays of my lungs, heart. Did a blood draw. Did an EKG.  Everything was considered normal except for high blood pressure. I continued off and on for the about three months with different intensities. During that time, we did a stress test and pulmonary function test which were within normal range.  Doctor prescribed Alvesco and have been taking two doses for the past month reducing to one dose.  Symptoms have definitely lessened in intensity and happening with very mild and less frequent intensity.  Still occurs occasionally but very mildly.
Numbness Random paralysis Tremors Vertigo Fever Difficulty walking Loss of motor skills Loss of strength Brain fog Numbness over whole body
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: ER8737), in left arm, on 29Apr2021 as dose 2, single (Lot number: EW0171), in left arm and on 16Nov2021 as dose 3 (booster), single (Lot number: FH8027), in right arm for covid-19 immunisation. The patient's relevant medical history included: "sulpha allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Patient received treatment for COVID-19: PF-07321332, ritonavir (PAXLOVID), from 31May2022 (Lot number: GA1513) to 05Jun2022.
After the first shot, I developed tinnitus in my right ear a few days later. At first, it was intermittent but became permanent as time went on. It was permanent by the time I received the second shot. After the second shot, it remained and the tinnitus that was in my left ear is also now much louder.
4-5 minutes after administration of vaccines, syncopal episode falling to floor & hitting occipat of head. Immediately revived. Ice to occipat with 3cm swelling/tenderness present. Observed x 45 min then sent home with parents.
Fainting; Fever of 103; Vomiting Green Fluid; Nausea; Body Aches; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration, administered in left arm on 03Apr2021 15:00 as single dose for COVID-19 immunisation. Medical history included psoriasis. The patient was not pregnant and had no known allergies. There were no concomitant medications. The patient received first dose of bnt162b2 on 13Mar2021, 14:30 for COVID-19 immunisation. On 04Apr2021 03:45, the patient experienced fainting, fever of 103, vomiting green fluid, nausea, body aches and shortness of breath that lasted 7 days after the second dose. There was no therapy for the events. There was no other vaccine in four weeks and no other medications in two weeks. The patient did not have Covid prior vaccination and was not covid tested post vaccination. Outcome of the events was recovered on an unspecified date.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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.
Cough; Rash; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (coughing), RASH (rash on chest) and HEADACHE (headache) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included Claritin for Seasonal allergy.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced COUGH (coughing), RASH (rash on chest) and HEADACHE (headache). At the time of the report, COUGH (coughing), RASH (rash on chest) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient has used Benadryl and Sudafed as treatment medication
Body aches, joint pain, rash; numbness, tingling of hands & feet; swelling and redness in (L) arm from elbow to shoulder. 11/10/10 - Neurology consult & hospitalization til 11/12 2/08.
I stay in severe pain; Two days after vaccine severe reflux; This non-serious case was reported by a consumer and described the occurrence of gastroesophageal reflux in a 63-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14-JUN-2023, the patient received Shingles vaccine. On 16-JUN-2023, 2 days after receiving Shingles vaccine, the patient experienced gastroesophageal reflux (Verbatim: Two days after vaccine severe reflux). On an unknown date, the patient experienced pain (Verbatim: I stay in severe pain). The outcome of the gastroesophageal reflux was not resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the gastroesophageal reflux and pain to be related to Shingles vaccine.     It was unknown if the company considered the gastroesophageal reflux and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date:08-JUL-2023 This report was submitted via the online direct entry reporting system by site: Public Reporting.  Two days after vaccine the patient had severe reflux that gastroenterologist could not find reason. The gastroenterologist doctor did an upper endoscopy and could not find reason for the severity of the issue.  She went to emergency room once thinking she was having a heart attack and later to a cardiologist. It was not her heart, she stayed in severe pain and even water could set it off. The reporter consented to follow up.
Information has been received from certified physician assistant (PAC) concerning a 3 day old, 7 pounds, 5 ounce, 19.75 inch, female with a history of jaundice who on 09-APR-2008 was vaccinated with RECOMBIVAX HB (manufacturer unknown).  There was no concomitant medication.  On approximately 12-APR-2008 the patient was seen by the (PAC) for jaundice.  There was no reported history of mom/baby incomparability per the parents.  It was reported that the infant was a healthy appearing, alert, normally nourished, well hydrated child in no acute distress.  The infant had skin symptoms of jaundice to the hips.  Bilirubin levels were drawn and were as follows: neonatal bilirubin was high at 12.3; and indirect bilirubin was high at 12.0.  The infant was seen in follow-up the following day 13-APR-2008.  Neonatal bilirub was high at 13.3; and indirect bilirubin was high at 12.9.  On 14-APR-2008 the mom reported that the child "looks less yellow today."  The physician assistant reported the jaundice to be improved.  On 23-APR-2008 at a follow-up visit, the baby was reported to be "doing well presently without any significant abnormalities identified on exam."  On 12-MAY-2008 at a well exam, it was reported that the patient experienced gas and explosive stools with similac.  The infants weight was noted to be 8 pounds and 12 ounces, and height was 22 inches.  The patient was to continue with routine immunizations.  Additional information has been requested.
This spontaneous report was received from a doctor of pharmacy concerning an approximately 61 year old female patient with no pertinent medical history. Current conditions of the patient included Nitrofurantoin allergy and lodine allergy. On 11-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as J000447 and 11-APR-2014 respectively), subcutaneously. Concomitant medication included an antidepressant (unspecified). On 16-JUL-2013, the patient experienced tingling and itching sensation after receiving ZOSTAVAX. The patient sought medical attention (called the pharmacist). She took 4 tablets of valacyclovir to prevent the cold sores. The patient did not have cold sores at the time of report (reported as currently). No lab tests were performed. The patient was not recovered from tingling and itching sensation. The relatedness for tingling and itching sensation was unknown for ZOSTAVAX. Additional information has been requested.
PATIENT WAS GIVEN FIRST DOSE OF PFIZER COVID 19 VACCINE ON 8/30/21 AT 2:59. AT 3:08 SHE REPORTS THAT HER BOTTOM LIP IS STARTING TO FEEL TINGLING. SHE STATES SHE DID GET A METALIC TASTE AT TIME OF INJECTION BUT THE TINGLING HAS JUST BEGAN. DENIES ANY OTHER SYMPTOMS AT THIS TIME. BLOOD PRESSURE CHECKED AT 3:11 160/90 AND PULSE IS 72. AT 3:16 PATIENT DENIES ANY OTHER SYMPTOMS, AND BLOOD PRESSURE IS 152/82 AND PULSE IS 70. AT 3:22 PATIENT STATES SHE DOES FEEL TINGLING SENSATION BUT IT SEEMS TO BE GETTING BETTER, BLOOD PRESSURE RE-CHECKED AT 150/78 AND PULSE IS 70. AT 3:36 PATIENT STATES SHE FEELS BETTER. LEFT FACILITY BY PERSONAL VEHICLE AND APPEARS TO BE IN STABLE CONDITION.
PATIENT WAS ADMINISTERED A FLUSHOT AND HAD AN ADVERSE REACTION, POSSIBLY ANAPHYLAXIS. PATIENT CLAIMED TO HAVE SHORTNESS OF BREATH AND TIGHTNESS OF CHEST WALL.
fever 104 degrees, rash on trunk - macules and erythematous palpules on erythematous background, Novesicles. About 8 lesions
The night following the second shot I experienced all over body aches for the next 24 hours. I also had nauseau for the first night only. My left arm was very hard and felt hot to the touch for 4 days.
13JUL94 woke up this morning vomiting denies fever or diarrhea;
Periorbital edema more on the right than the left; Herpes labials; This is a spontaneous report from a contactable Physician (patient). A 59-years-old male patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EH9899) via an unspecified route of administration on 17Dec2020 18:45 at single dose in left arm for COVID-19 immunisation. Medical history included Hypertension, Hyperlipidemia, nocturnal seizures and known allergies: Quinolones. Concomitant medications included Atorvastatin, Gabapentin, magnesium chloride (MAG), Telmisartan and riboflavin (VIT B2). The patient experienced Periorbital edema more on the right than the left at 25Dec2020 08:00, herpes labials on 21Dec2020. The patient did not receive any treatment. Outcome of events was not recovered.
pt recv flu & pneumococcal vax combined & given in one inject & exp redness, swelling, site arm, fever;
sore arm; Headache; fever; chills; upset stomach; fatigue; vomited once; soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th February 2022 18:30, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th February 2022, 1 days after receiving Shingrix, the patient experienced pain in arm, headache, fever, chills, upset stomach, fatigue, vomiting and injection site pain. On an unknown date, the outcome of the pain in arm, vomiting and injection site pain were recovered/resolved and the outcome of the headache, fever, chills, upset stomach and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, headache, fever, chills, upset stomach, fatigue, vomiting and injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient received a dose of Shingrix and next day experienced sore arm, headache, fever, chills, upset stomach, fatigue and he vomited once. The soreness in his arm had resolved, but he was still experiencing all the other symptoms listed till the time of reporting. Consent to follow up was granted.
pt stated developed a lump under skin and redness over entire right upper arm, 10 days later lump remains but redness is subsiding
Upon revieweing the expiration date for Phizer-Biontech covid 19 vaccine, bivalent (NDC 59267-0304-02), find out that pharmacist was accidentally gave expired vaccine to patient. Lot #GJ6739 extended expiration date 1/31/24. Date took out from Cooler (@-90 to -60C) was 11/21/22. Beyond use date (@2 to 8C) was 1/31/23 (10 weeks or 70th day). Date given to patient was 1/31/23 (71st day). Reached out Pfizer Manufacturer for guidance for information about vaccine stability. According to Pfizer medical information, recommended/labeled storage time in the prescribing information and excursion time. Vaccine was stable for total time of 72 hours = (10 weeks or 70 days labeled time plus 2 days excursion time) at temperature of 2 - 8 C. Unable to reach out patient at this time but left voicemail.
Severe chills, moderate muscle aches, mild nausea and headache, mild subjective fever sensation starting approximately 12 hours post injection. Moderate injection site pain starting approximately 8 hours post injection. Treated with APAP 1000mg q6h and ibuprofen 800mg q6h alternating every 3 hours. All symptoms resolved completely by 24 hours post injection.
Patient received vaccinations and then was sitting in chair watching younger brother get his vaccinations, patient passed out and fell on floor, lips were cyanotic, clammy.  Patient was assessed by MD and RN at bedside, patient did not hit head. Blood pressure slightly low upon initial check of 78/50. Patient's legs were raised above heart , patient  started to get color in  face. Patient given Sprite to drink and Blood pressure improved to 90/52 and 90/60 when rechecked. Patient had pulse of 60 and 66 with O2 sats 98-99% after incident. Patient had no complaints of pain or any concerns. Patient was observed for 30 min after incident and had returned to baseline vital signs, Mom was confident that she was back to baseline and patient left the clinic in the care of mom.
This spontaneous report as received from a nurse refers to a multiple unspecified patient of unknown age and gender. The patients concomitant therapies, medical history and concurrent conditions were not reported. On 22-SEP-2015, the patient were vaccinated with improperly stored doses of VARIVAX (Merck) injection, lot # K021934, expiration date 10-NOV-2016 (dose and route of administration were not reported). No adverse effects were reported. This one of the two reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a medical assistant reported that an unknown number of patients were administered M-M-R II (lot number, dose, route and indication unspecified) since June 2013 that had been improperly stored. The medical assistant was unable to provide the exact number of identities of the patients involved at the time of the report. No adverse effects reported. It was unspecified if the patients had sought medical attention. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). Co-suspect products included Influenza vaccine Quadrivalent. Concomitant products included BOOSTRIX. On 14th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On 14th March 2018, less than a day after receiving SHINGRIX and not applicable after receiving Influenza vaccine Quadrivalent, the patient experienced pain in arm and activities of daily living impaired. On an unknown date, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the activities of daily living impaired and vaccine administered at inappropriate site were unknown. The reporter considered the pain in arm to be related to SHINGRIX. It was unknown if the reporter considered the activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the SHINGRIX vaccine in her left upper arm muscle yesterday morning on 14th March 2018. The patient was not able to report to work this afternoon due to the pain. The patient had pain from her elbow up to her neck on her left arm. The patient was in tears this morning because she could not roll over in her bed. The patient noted she also received the BOOSTRIX vaccine, and asked the nurse practitioner that was giving the medications to give her the one that would hurt the most in her right arm, but she stated her pain is all in the left. The patient drives a school bus, had to lift kids and press airbrakes and she was not able to do any of that. The patient also noted she would like to get the second shot of the SHINGRIX in her buttock and asked it that could be done, she was referred to her physician. The patient noted she had received a flu vaccine in her buttock three years ago and had no problems. The patient did not know the manufacturer of the flu vaccine.
My shoulder began to become stiff and sore. The pain increased over the next sever days and had persisted for two weeks.
Nausea about 30 minutes after first does and still nauseas after 5 days. Mild headache for one day
inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and CLOPIDOGREL BISULFATE (PLAVIX) for Acute myocardial infarction, ASPIRIN [ACETYLSALICYLIC ACID] for Myocardial infarction acute.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021 at 12:05 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 15-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-163703 (Patient Link).
Felt sluggish; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Felt sluggish) and PAIN IN EXTREMITY (Arm was sore) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 032L20A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL, LISINOPRIL, TAMSULOSIN and APIXABAN (ELIQUIS) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-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 SLUGGISHNESS (Felt sluggish) and PAIN IN EXTREMITY (Arm was sore). At the time of the report, SLUGGISHNESS (Felt sluggish) and PAIN IN EXTREMITY (Arm was sore) outcome was unknown. Not Provided
Onset of the following symptoms 2 hours:  Chest pain:  Administration of Nitrostat and ASA once in the ER Nausea:   Dizziness HA Change in LOC, fuzzy memory recall Contact made with PCP's office, I was encouraged to proceed to the ER. Chest pain improved over time as did the nausea and dizziness.