chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient contacted us 3 full weeks after injection and informed us she had been to the doctor for arm pain. Doctor suspects the injection hit a nerve and is treating with medication, still painful.
Approx. 5 days after receiving ZOSTAVAX vaccine, I developed the abrupt onset of progressive pain and weakness involving my entire arms and legs bilaterally that ultimately became significantly incapacitating. I saw a rheumatologist approx. 7 wks. after the onset. He dxed. polymyalgia rheumatica, and started me on a long-term course of prednisone, which I am still taking, and will be for at least 6 mos.-1 yr. My sxs. completely abated within 48 hrs. of starting prednisone. Dr. did not believe my condition was caused by or related to the vaccine.
This spontaneous report was received from a physician refers to unspecified patients of unknown demographics. On an unknown date the patients were vaccinated with improperly stored doses of ZOSTAVAX (dosing regimen unspecified). It was reported that an email was sent by the reporting physician after being informed by a colleague that a shipment of ZOSTAVAX came to the hospital unfrozen, at 4 degrees. The reporting physician knew that Merck made some lyophilized Varicella Zoster Virus (VZV) vaccines that were not stored frozen, but did not think they were available in the country. Her concern was that patients vaccinated with unfrozen zoster vaccine could develop insufficient VZV immunity. She indicated that she would try to learn more and contacted. Per the regulatory, only frozen formulation of ZOSTAVAX was marketed. Upon follow-up with the reporting physician she provided her contact of another physician and learned that the doses were received in the pharmacy and that the was quite sure that patients had been vaccinated with the shipment. Physician was not aware as to the number of doses administered. Was also not able to learn the time frame of the shipment or the dates of vaccination. Physician was not aware of any reports of adverse events but was concerned for the potential lack of efficacy for doses received at an improper temperature. Additional information has been requested.
2 inch square of site is red and itchy  occurred 1 week after vaccination. Has not gone away
Very concerned about negative side effects from the Moderna second dose vaccination; Sick; Covid symptoms; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Very concerned about negative side effects from the Moderna second dose vaccination), ILLNESS (Sick), SUSPECTED COVID-19 (Covid symptoms), NAUSEA (Nausea) and VOMITING (Vomiting) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Very concerned about negative side effects from the Moderna second dose vaccination), ILLNESS (Sick), SUSPECTED COVID-19 (Covid symptoms), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, VACCINATION COMPLICATION (Very concerned about negative side effects from the Moderna second dose vaccination), ILLNESS (Sick), SUSPECTED COVID-19 (Covid symptoms), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved.            Consumer stated his fiance was sick for  4 days after 2nd vaccine. Her adverse event which consisted of nausea, vomiting, and other Covid symptoms. Reporter stated from his knowledge she had recovered.  No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-319901, MOD-2021-319901 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow-up received on 15 Sep 2021contains information included reporter contact details, New events and outcome of event vaccination complication updated to recovered.
After about 2 weeks from 2nd dose taken on Jan 13, 2021, starting having tinnitus (ringing in the ear ) in right ear  started having a headache on back part of head where connects neck, First I Felt , I must have slept on the wrong side but this pain persisted over a month, now I get similar pain every 1-2 weeks for a day or so . When I chew, I am feeling noise on my left ear  my eye sight has deteriorated and have to see ophthalmologist to get new prescription for eye glasses, I am also getting thorbing headache on my right side of head , comes and goes away ,happens once in a while
SOB, Lightheaded Ipratropium Bromide 0.5mg/2.5ml nebs treatment given on site by EMS Patient transported to ER  after treatment due to c/o SOB
Right calf pain similar to previous DVT pain she had experienced in the past. Symptoms starting 4/11/21 day 2 after receiving COVID 19 vaccine.
Left eye not fully open, left side face was droopy, left arm decreased use, left hand had less motion.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 24-JAN-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # L049314, expiration date 03-DEC-2017. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Patient inadvertently given Moderna 0.25 ml booster instead of the approved Pfizer adult booster based upon age restrictions. No other adverse event noted.
Moderna vaccine given on 6/28/21, 1 day after Beyond Use Date expiration 6/27/21.
Doing 12 month shots I gave varicella and grabbed a PROQUAD instead of MMR.
Pain. It began as lower back pain at 1800 on 1/8/2021. By 0230 1/9/2021 pain progressed. Anterior sharp bilateral pain noted in kidney region (below ribs). Lower back pain continued to worsen. Pain began to subside by 1000 1/9/2021. No pain by 1400 1/9/2021. Tylenol taken. Did not weaken the symptom. Additional signs and symptoms: Headache. Fever (range 99.2-101.6). Lasting 1/8/2021 (0230) through 1/9/2021 (2000). Tylenol taken for all signs and symptoms. every 8 hours. One pill.
Client received the COVID vaccine (Moderna dose 1, lot # 024C21A, expiration date 6/26) at 2010. Client reported feeling "lightheaded" at 2016. EMTs and RN responded at that time. The client appeared pale and diaphoretic, and complained of the "room spinning". The client denied any shortness of breath, chest pain, difficulty breathing, changes in vision, or nausea. The client was alert and oriented x4 at this time. The client's vital signs were as follows: heart rate 56, O2 99%. The client was tranferred to the zero gravity chair by staff with no difficulty. At 2020, the client's vital signs were as follows: BP 150/88, pulse 66, respiratory rate 12, O2 99%. The client had been given snacks, water, and juice by POD staff previous to her vaccination, but had last eaten a meal at 1445. The client stated she does have a fear of needles. The client stated she doesn't have any medical conditions and doesn't take any medications. The client has allergies to bees, cats, and penicillin. At 2030, the client stated her lightheadedness and "room spinning" had resolved. The client no longer appeared diaphoretic and her skin color had returned to normal. The client's vital signs were as follows: blood pressure 138/96, respiratory rate 12, O@ 99, heart rate 74. At 2040, the client's vital signs were as follows: blood pressure 138/86, heart rate 56, O2 99%. Education provided regarding AMR activation and emergency management, primary care follow up, symptom management, and v-safe. At 2048, the client's vital signs were as follows: blood pressure 130/84, heart rate 62, O2 99%, respiratory rate 14. The client left at that time, ambulating with a steady gait, with her partner who stated he would be driving her home.
I was sitting outside on my deck knitting about 2:30 PM when my vision became distorted.  My vision was blurry waves.  I tried to read a text on my phone and I could only see every few words.  My heart began to pound as if coming through my chest.  I took my blood pressure which was 187/107 with pulse rate of 127.  I take my blood pressure every morning and that morning it was 123/68.
Patient noticed swelling around vaccine site. Swelling continued for a couple of days.  He then experienced edema in feet with redness and extreme pain on 12/20/14.  Advised patient to go to ER, where he was seen.  ER physician indicated to patient that it was most likely a reaction to the tetanus portion of the vaccine.  Followed up with patient on 12/22/14, he was feeling much better and edema had gone down with use of furosemide.
At time of vaccine administration, "very painful" R deltoid IM pain with decreased R arm range of motion x 3-7 days. Since then, pain has improved but is still present - most notably while washing hair (arm in extended, adducted, externally rotated position)
nose bleeds after 2nd dose of the shots for about a week; This is a spontaneous report from a Pfizer-sponsored programs, COVAX US Support. This is a report from a contactable consumer (registered dietician reporting on herself). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 21Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), was received on 31Dec2020, lot number EL0140 for COVID-19 immunization.  Medical history included immunodeficiency from an unknown date and unknown if ongoing (she was informed she may not be able to build antibodies) and splenectomy (her spleen was removed 30-35 years ago). The patient's concomitant medications were not reported.  The patient experienced nose bleeds after 2nd dose of the shots for about a week in Jan2021 with outcome of recovered in 2021.  States the nosebleeds started a couple of days after the vaccine and she had the nose bleeds for a week.  No treatment was received.  No follow-up attempts are needed. No further information is expected.
Pressure at vaccination site with pain, dizziness, sweating, felt like can't breathe.  Everything went blank
From patient to after hours provider with c/o head and leg pain after Johnson & Johnson CVD19 vaccine. She states symptoms started 24 hours after vaccine and has not resolved. Patient advised to proceed to the nearest ER for evaluation for potential side effect due to J&J vaccine. Patient states understanding.
Malaise and nausea, Chest pain, fever of 100.2; Tylenol 1000 mg every four to six hours; on-going for nausea, chest pain lasted for 24 hrs, fever lasting  for approximately 72 hrs; symptoms resolved except nausea
31.8°F excursion and Vx administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 2-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 2A3H9, expiry date 30-JUN-2023) for prophylaxis.   On 16-MAR-2023, the patient received FluLaval Quadrivalent 2022-2023 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced incorrect storage of drug (Verbatim: 31.8°F excursion and Vx administered). The outcome of the incorrect storage of drug 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 Information: GSK Receipt Date: 16-MAR-2023 The reporter reported that the patient received dose of FluLaval (Quadrivalent) which had been in excursion where it reached the temperature of 31.8 degree Fahrenheit which was below freezing. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The FluLaval Quadrivalent vaccine temperature was exposed to 31.8 degree Fahrenheit, which led to incorrect storage of drug. This case was 1 of 3 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2023041462:Same reporter US-GSK-US2023041463:Same reporter
9 days later, pt had a 102F fever and stopped eating for 2 days. He acted very dazed and fuzzy which lasted 2 days with symptoms but fussy a few days prior.
erythema, swelling & inc warmth @ lt thigh noted this AM;DPT given in lt thigh yesterday;thigh looked red last noc;
Patient starts getting tingly lips after 5-10 minutes of administration and then facial swelling starts within a few minutes after the tingling lips. The pharmacy call 911 to get an ambulance for the patient, patient self administer 1 dose of Epipen 0.3mg injection. The ambulance came within 5-10 minutes and brought the patient to the hospital.
Breathing is off; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathing is off) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pulmonary disorder.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced DYSPNOEA (Breathing is off). At the time of the report, DYSPNOEA (Breathing is off) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.  The patient stated in the follow up that she did not have a reaction first time.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow up was received and no ne w information was provided.
Initial misuse report received from a healthcare professional on 19 September 2013. The cases were received on 21 March 2014 at GPV. 2-year-10 month old patient received 0.5 ml dose of FLUZONE. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Runny eyes and nose, cough, wheezing, shortness of breath, swollen tongue and mouth.
Mom states 7 days after shot pt developed fever of 101, lasted 2 days. On 8/20 rash started, described as "blotches covering face, neck, legs, stomach, arms." Mom said rash gone on 8/24/2011.
Pt presented for initial vaccine @ 1500.  At 1520 reported feeling lightheaded.  Quickly resolved but patient noted her lower jaw became painful.  Resolved in 5 minutes.  Then patient reported L arm pain and chest tightness.  Resolved in 6 minutes.  Patient reported  body aches which quickly resolved.  Patient had all symptoms resolve by 1700 at which time she reported feeling only fatigue
flu symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: 3306BD) as dose number unknown, (booster) single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 Immunization. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "flu symptoms". Additional information: Concern about adverse reaction. After I received Pfizer booster 3306BD I came down with flu symptoms. I was not sick previously.   No follow-up attempts are possible. No further information is expected.
Information was received on 25-JUL-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age.  Medical history, concurrent conditions, or concomitant medication was not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 24-SEP-2014 at a hospital as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 27-DEC-2014 the patient was treated at a clinic for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. On or about 30-DEC-2014, the patient was treated in the emergency department of the hospital for ongoing and worsening symptoms of shingles accompanied by excruciating pain. The patient was diagnosed with post-herpatic neuralgia. On or about 13-JUL-2015 he was treated by a physician at a clinic for new or worsening outbreak symptoms and nerve pain, and the diagnoses of shingles and post-herpatic neuralgia was affirmed and all ongoing prescription regiments were doubled in strength. The patient was prescribed valacyclovir, gabapentin, and capsaicin cream for treatment of his painful symptoms.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Received DAPT vaccine on 4-20-04 developed bright red, tender rash 6 cm x 10 cm.
It was reported that a female patient received a TD Adult and a Pneumococcal (Unspecified) vaccination on 7 Jun 2000. Reportedly sometime after the vaccinations the patient developed a hard nodule at the injection site. Further information requested. From follow-up received 10/15/01 it was reported, "No additional information at this time." This case is closed.
patient received an expired ADACEL with no adverse event; Initial information regarding an unsolicited valid non-serious case from a pharmacist via Medical Information (Reference number- 00638033) and transmitted to Sanofi on 11-Jun-2021.  This case involves a 49-year old male patient who received an expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] On 11-Jun-2021 [lot number: U6214AA and expiration date: 14-Mar-2021] via intramuscular route in the left arm for prophylactic vaccination.  It was unknown if the patient had any medical history, concomitant disease or risk factor, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of report, no adverse event was reported.  It was unknown if there were lab data/results available.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
rapid heart rate chest; nose bleeds; chills; night sweats; headache; chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 05Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "ASTHMA" (unspecified if ongoing) notes: controlled with an inhaler. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 IMMUNIZATION. The following information was reported: HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "rapid heart rate chest"; EPISTAXIS (non-serious) with onset 2021, outcome "unknown", described as "nose bleeds"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; NIGHT SWEATS (non-serious) with onset 2021, outcome "unknown", described as "night sweats"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; CHEST PAIN (non-serious) with onset 2021, outcome "unknown", described as "chest pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had some questions regarding covid-19 antibodies. she had two vaccines Pfizer, had very adverse side effects reported, now upon recent testing with covid-19 exposures (she worked in Dental where colleagues and patients were covid-19 positive symptomatic), now have no covid-19 antibodies. She would like to provide my provider and blood test information for further study. Her medical provider is suggesting the third booster as I have asthma and no present antibodies. Caller added she had been exposed to co-workers, patients, and family members that were Covid positive but every PCR test she takes was negative, even thought she was symptomatic at one time, and her antibody tests had all been negative. She and her doctor think it is an anomaly. She received her second dose of Pfizer Covid 19 vaccine on 05Feb2021. Her doctor says she needs to get the booster even though she had a rapid heart rate, chest pain, nose bleeds, chills x48 hours, night sweats x2 months, and headache after a previous dose of the vaccine. She is also asthmatic controlled with an inhaler. She wants to be sure that is the correct protocol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information was expected.
1845: Pt. received vaccine in rt. arm. and was instructed to wait in Covid vaccine clinic waiting room for 15 min. for monitoring of adverse reaction.  1850: While waiting in waiting room of clinic, pt. reports starting to feel itchy and anxious, causing her to feel SOA. Pulse oximeter shows saturation of 98%, HR 86, BP 150/100. Pt. reports the high BP is normal for her and that it is time for her to take her BP medication, which is at home. Discussed need for continued monitoring for adverse reaction and evaluation in ED. Pt. refuses treatment or eval. in ED at this time. Pts. husband is with her in clinic. Pt. agrees to take Benadryl PO.  1858: Benadryl 25 mg tab admin. PO at this time, explained to pt. that she needs to stay for continued monitoring, she agrees. 1910: Pt. reports decreased anxiety, denies SOA, still feels "a little" itchy on face. O2sat 99%, HR 78, BP 146/92. Pt. requesting to go home with Husband. Reviewed S&S to call for and ED treatment. Pt. verb. understanding and denies current questions.  1921: Pt. ambulatory out of clinic, accompanied by her husband. Pt. stable at time of departure, mild c/o itchiness.
Dizziness/nausea at onset of Influenza vaccination in left arm administration 9/14/2016 at 0700. Initial symptoms of lower back pain/heaviness in legs from hips down, muscle aches and fatigue occurred at 9:15am-10:30am.