chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It felt like a spike was driven into my head, top right side then eventually felt like a long pointed ice cycle was driven into that spot, then 6 months later when I had a full body skin check which I get every 6 months because I have genetic mutation for melanoma, I found out I had malignant melanoma on my right leg.  It wasn't there at my last check but was there this time 6 months after this vaccine in August 2021 .  I'm sure that there wasn't anyone in the test group with this and I should not have been told it was safe for me.  Through epigenitics I have been able to keep melanoma away for 32 years and the only thing different introduced to my clean healthy body was this vaccine which encouraged the gene to wake up.
pt recv vax & exp gen rash;nurse reports 6 patients w/same exp;
I was diagnosed with achalasia. Although there is no direct link, we know some AI issues linked to it in men.   I was diagnosed with the condition. My lower esophagus stopped working almost completely. I started showing symptoms three mo the after the injection.
pt recv vax;2 wk later,devel a full body rash which was varicella like;
Weakness, fatigue, inability to sleep, fever of 99.9 degrees,, muscle and joint soreness beyond injection point.
accidentally gave an expired IPOL vaccine to a patient with no reported adverse event; Initial information received on 16-Mar-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves 6 years old female patient who accidentally gave an expired poliomyelitis vaccine (inactivated) IPV (VERO) [IPOL] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Mar-2023, the patient received a standard dose 3 of suspect poliomyelitis vaccine (inactivated) IPV (VERO) Suspension for injection (lot U1A45, expiry date- 20-Feb-2023) at a dose of 0.5 ml total via intramuscular route in the left deltoid for Immunization.  On 16-Mar-2023, the patient developed a non-serious event of accidentally gave an expired poliomyelitis vaccine (inactivated) IPV (VERO) vaccine with no reported adverse event (expired product administered) (latency- same day).  It was reported, HCP who reported expired IPOL was administered to patient. She asks for appropriate follow-up. She asks is there a period of time before repeating. She asks where adverse events are listed.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the 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.
pt began w/ c/o itching @ inj site;mom noticed egg sized red area @ site of inj w/pea sized nodule in center;also had whelps inside red area w/ exception of nodule @ site;identical area were found on 4-5 other place on lt side of upper body
Constant ringing in ears which has become progressively louder over time.  Significantly impacting sleep and ability to concentrate on tasks.  Didn't have any ringing in ears prior to receiving the vaccine.
Shortness of breath reported with first dose of vaccine when pt presented for second dose on 6/3.  Pt was refused for second dose due to reaction.
sore neck; fatigue; Sore arm muscle at injection site; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient (who was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, in arm left, on 18Feb2021 15:00, as single dose for COVID-19 immunization, at workplace clinic. Patient's medical history included Asthma, Herpes, Bipolar 2 Disorder. Patient had no Allergies to medications, food, or other products. Concomitant medications included valacyclovir, montelukast and lamotrigine (within two weeks of vaccination). Historical vaccine included first dose of BNT162B2 (lot number; unknown), via an unspecified route of administration, in Left arm, on 28Jan2021 3:00 PM, as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. On 18Feb2021 15:00, the patient experienced sore arm muscle at injection site after injection and continuing into second day (19Feb2021); sore neck and fatigue starting the next morning. Patient was not received treatment for adverse events. Seriousness of the events was reported as non-serious. Outcome of the events was recovering.  Information on the lot/batch number has been requested.
I started feeling bad after the vaccine and I kept get weaker and weaker. I decided to see a doctor 3/25/21 ( after hours clinic ) the doctor at that clinic was not sure what was going but he did not do any bloodwork or anything. I kept getting sicker and weaker and my fever kept going up. I called the triage nurse at the clinic and they told me that I needed to go the hospital. I went to the hospital where I was admitted on 3/27/21. I was placed on antibiotics and I started feeling better in about 24 hours. I had fever 103, weakness, and fatigue. I had a lung biopsy, MRIS, CT Scans, Bloodwork( everyday), CPK test, and urine test. I was diagnosed with mycoplasma pneumonia and erythema forme. I was  released on 4/4/21.
I woke up at 2am (about 12 hrs after vaccine) with fever and sweats. Took acetaminophen and went back to bed. Up at 6am feeling very fatigued and exhausted. Fever again.  Got a shower but couldn't stand up that long too exhausted, dizzy and naseau.   Went back to bed and called in sick to work. Took IBU 800mg.  Back to sleep.  Up at 9m more Tylenol.  This continued all day trying to keep fever down.  48hrs later still taking acetaminophen to manage symptoms (back to work) still feeling tried and low grade fever.
This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 years old male patient was vaccinated IM in the right arm with second dose of GARDASIL (lot # 671994/1537AA). Other suspect vaccine included ADAEL (lot # U3486AA, Dose 1) IM left deltoid muscle on 22-MAY-2012 and MENVEO (lot # M10032, Dose 1) IM left deltoid muscle on 22-MAY-2012. On 23-MAY-2012 the child developed reaction. Symptoms included pain, swelling, erythema of left deltoid muscle. Lab tests showed cellulitis left upper arm. The patient did not seek medical attention. The original reporting source was not provided.
WITHIN 1/2 HOUR NAUSEA SHAKING CHILLS WITHIN 2 HOURS. 102.8 AT EVENING. SUNDAY TEMPMAX AT 102.7 , EXTREME FATIGUE, MONDAY SHE HAD 101.4 COUGHINGAND TUESDAY TEMP < 100 COUGHING.
no adverse event; underwent a temperature excursion and was administered; This spontaneous report was received from a medical assistant referring to a 4 year old, unknown gender patient. No information was provided regarding the patient's medical history, historical drugs, allergies and concurrent conditions. No concomitant therapies were reported.    Since 19-NOV- 2020, the vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (albumin status: rHA (recombinant human albumin) (PROQUAD) lot # T013537, expiration date 17-Oct-2021, underwent a temperature excursion (31.6 F). On 30-Nov-2020, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (albumin status: rHA (recombinant human albumin) (PROQUAD), 0.5 milliliter, for prophylaxis (route of administration was not provided). Time frame was 22 days until 11-DEC-2020. The call was not due to data logger. There were not previous temperature excursion. No additional averse events were reported.
Patient began to experience what she described as "fogginess, very hot, sweaty, nausea", then her hands began to shake. We gave her an icepack. After about 45minutes he symptoms resolved, with the exception of the hand shaking, which had improved. She also stated that she was really tired. She walked back to get her things. Upon returning to the pharmacy, patient said she felt good to go, and that she would put her husband on speaker phone while driving. After she made it home, she called the pharmacy to inform us that she had made it home
Temp of 105F onset 2 hrs post inject; 3rd DTP, no local erythema or sx; Temp down to 101-102 p/few hrs;
3/10/23- edema, swelling, redness, warmth, itching of entire upper arm.  Benadryl and hydrocortisone cream for symptoms.
SOB; Hypoglycemia; Hypotension; Dry skin; Diaphoresis; Lightheadedness; Generalized rash; This is a spontaneous report from a non-contactable other HCP. A 38-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6205 and expiration date was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. As per the description, it was reported that patient had eaten a turkey sandwich and had water prior to coming for vaccination. During 15 mins waiting period after the injection, the patient experienced lightheadedness, SOB and diaphoresis. Differential diagnosis was reported as systemic reaction (hypoglycaemia, hypotension and generalized rash). She had a hypotensive response to the vaccine and had dry skin. She denied rash, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. Treatment included water, snacks, body position and ice packs. Follow up response to treatment was excellent. She was discharged as she was stable and was advised to follow up with PCP. The patient underwent lab tests and procedures which included VS as stable, normotensive, normal heartrate and rhythm and a &O x 4. She was suggested to lay down for her next vaccine out of precaution. She was pleased with her care and walked out to the front with RN. The outcome of the event was recovered well after almost an hour of observation/intervention.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Patient allergies and Pfizer ingredient/component list discussed with patient prior to administration. She denied any known allergy to any vaccine components. Advised to stay in the waiting area for 15-30 min for monitoring. Vaccine was given at 1504, then at 1518 the patient started complaining of feeling itchy all over her body, having a hard time getting a full breath, and chest pain. She was assisted from the seated position to standing and then laid supine on the exam table. VSS, SpO2 98%, HR 84, BP 96/60. 50mg IM Benadryl given at 1525 to right deltoid. About 5 minutes later the patient reported relief of her full body itching but still complained of chest pain, having a hard time breathing, and also was dizzy and slight difficulty swallowing. No tongue swelling noted, patient was speaking in completed sentences and handling her own secretions. She has a history of POTS and stated that chest pain and dizziness was not uncommon for her. 911 called at 1530pm. VSS at 1537pm, BP 96/70, HR 106 regular, 98% Spo2 on RA,
after recv vax pt devel fever 103-105 for 3-4 days starting approx 6-8 hr p/vax
Patient seen in the ED on 2/9/23 for cough, weakness, shortness of breath, and 'right ear crackling' that started the day prior. She had a known COVID exposure three days prior. She tested positive for COVID-19 by PCR, and was discharged with a prescription of Paxlovid. She returned to the ED on 2/11/23 for confusion and shortness of breath. She was admitted 2/11 - 2/16 with discharge diagnoses including acute respiratory failure with hypoxia due to severe COVID-19 viral pneumonia. During admission, she was on supplemental oxygen, but ultimately was able to be weaned off prior to discharge. She was also started on Decadron during her admission. Of note, the patient has completed the primary COVID vaccine series and a booster but had not received the bivalent vaccine at time of admission.
The day following vaccination the patient's mother took temperature and it was 102F. The patient's temperature was off and on during the day. The patient also complained of no appetite, nausea, and vomiting. The patient was treated with Benadryl. The mother noted there was redness and hardness at the injection site.
Pt c/o tingling in throat progressing to difficulty swallowing and mid sternal CP.  Pt given 180 mg allegra and with in 5 minutes was feeling  better. VS stable. Released to home with instructions. BP: 125/71, P=100z, Pox=97% 1215 BP=129/73, P=103, Pox=97% 1225 BP=121/66, P=82, Pox= 99%
Vaccine was given 09/29/2021 around 10:15am  while waiting throat began to get scratchy. I asked the nurse for water to insure air ay was clear. Scratchiness progressed and tongue  started to swell.  Code was called and take n to Nurses clinic given an IV  given given in IV ;BP take 180/? in and out of consciousness doctor put cardiac monitor on and epi administered. Then transported to ED
I became extremely ill with fever, muscle aches, lethargy, extreme nausea, and headache.
This is a spontaneous report from a contactable healthcare professional received via a sales representative. A 19-year-old male patient of an unspecified race received TRUMENBA)(Lot # M37316; Exp. date Apr2017) at 0.5 ml single and human papilloma vaccine (Lot # M003659, Exp. date 20Sep2017), both intramuscular on 12Jul2016 for immunisation.  The patient medical history and concomitant medications were not reported. The patient almost passed out on an unspecified date after vaccinations. He elevated his legs and felt better. The event was resolving at time of report. On 12Jul2016, the patient experienced vasovagal near syncope with outcome of recovered. Treatment was not required. Follow-up attempts completed. No further information expected. Follow-up (03Nov2016): New information obtained from a contactable other HCP includes: Patient's date of birth, vaccines details, additional event (Vasovagal near syncope), onset and outcome, no treatment. Follow-up attempts completed. No further information expected. Sender's Comments: 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, as appropriate. The case will be reassessed if additional information becomes available.
Persistent and severe: fatigue, need much extra sleep, low energy. Later developing: "brain fog", worsened hyperacusis, earache, slightly worse hearing.  No consistent improvement since vaccination, though some day to day fluctuation. First few weeks, also experienced: Diminished and distorted smell and taste, recurrent mild nausea, abdominal "buzz", dizziness, frequent day naps, episodic but intense smell of tobacco smoke hallucination, episiodic synesthesia. These have improved after first few weeks. First vaccine in series was a known bad batch, for immediate reactions. Very long wait for 2nd vaccine: tired, drained, distressed ... immune suppressed.
Developed fever up to 102 degrees along with bulging of anterior fontanelle. Was seen in ER next day where labs done and L.P. done. Was admitted on antibiotics pending cultures. Did well at the hospital, culture negative.
Patient was given the wrong dose for the COVID vaccine patient was given 0.3 mL instead of getting 0.2mL.
Case number PHEH2014US019675 is an initial spontaneous report received from a Medical Assistant on 29 SEP 2014. This report refers to a 58 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 141001, 141301) intramuscularly at a dose of 0.5 ml on or between 19 SEP 2014 to 23 SEP 2014. It was reported that before vaccination the FLUVIRIN multi dose vial was kept at -1.7 to 11.8 degree C for a total of 191 hours. No adverse event was reported following this medication error (incorrect storage of drug).
Started with itching on left neck; swelling below left eye; hands were swelling; This is a spontaneous report from a contactable consumer (patient) reported that a 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 27Jan2021 14:30 at a single dose for covid-19 immunization. The vaccine was administered at the pharmacy. Patient was not pregnant at the time of vaccination. Medical history included sarcoidosis and hypertension both from an unknown date, and one unknown anaphylaxis a year ago (2020). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included amlodipine besylate. On 27Jan2021 16:30, it was started with itching on left neck, then swelling below left eye and hands were swelling. The patient was concerned enough she took a Benadryl. The events result in doctor or other healthcare professional office/clinic visit. Treatment received for the events was Benadryl. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown).  The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient was prescribed ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 08-SEP-2014, the patient was administered the ZOSTAVAX vaccine by a pharmacist. The patient was treated by a physician for the flowing injury resulting from the patient's use of ZOSTAVAX: shingles.  Additional information has been requested.
Unexplained, sudden Loss of Consciousness while driving.  Syncope. Abnormal EKG, Cardiac Monitoring indicates 2nd degree AV 2:1 block. Cardiac MRI scheduled.  Treatment TBD.
This is a spontaneous report received from a noncontactable reporter consumer or other non-HCP (patient). A 74-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EY4825), in left arm left, on May 5, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had injection site pain (pain at the injection site: left arm), with outcome of unknown. No follow-up attempts possible. No further information expected.
vaccine liquid dripped on his arm; needle wasn't connected very well to the plastic part of the syringe; A spontaneous report was received from a 74 year old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and the needle wasn't connect well, so the liquid dripped on his arm.   There were no medical history or concomitant medications reported.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 025L20A) on 07 Jan 2021. On 03 Feb 2021 the patient received their second of two planned doses of mRNA-1273 (Batch number: 010M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  After receiving the vaccine, the patient reported that the needle wasn't connect very well to the plastic part of the syringe so the liquid dripped on his arm. According to the nurse, nothing was administered so she went ahead and administered a newfull dose. No treatment information was provided.  Action taken with study drug was not applicable as the subject had already received both scheduled doses.  The outcomes of the events vaccine liquid dripped on his arm and needle wasn't connected very well to the plastic part of the syringe were considered resolved on 03 Feb 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting Device connection issue and Exposure via skin contact without any associated adverse events.
if she touches she can know where she received the vaccine; uncomfortable; some positions are difficult to keep because has pain in the arm; fever; very very painful at the injection site; red at the injection site; swollen at the injection site; tenderness at the injection site; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (if she touches she can know where she received the vaccine), DISCOMFORT (uncomfortable), PAIN IN EXTREMITY (some positions are difficult to keep because has pain in the arm), PYREXIA (fever) and VACCINATION SITE PAIN (very very painful at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 0L0ML0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced FEELING ABNORMAL (if she touches she can know where she received the vaccine), DISCOMFORT (uncomfortable), PAIN IN EXTREMITY (some positions are difficult to keep because has pain in the arm), PYREXIA (fever), VACCINATION SITE PAIN (very very painful at the injection site), VACCINATION SITE ERYTHEMA (red at the injection site), VACCINATION SITE SWELLING (swollen at the injection site), VACCINATION SITE PAIN (tenderness at the injection site) and VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, FEELING ABNORMAL (if she touches she can know where she received the vaccine), DISCOMFORT (uncomfortable), PAIN IN EXTREMITY (some positions are difficult to keep because has pain in the arm), VACCINATION SITE PAIN (tenderness at the injection site) and VACCINATION SITE PAIN (soreness at the injection site) had not resolved and PYREXIA (fever), VACCINATION SITE PAIN (very very painful at the injection site), VACCINATION SITE ERYTHEMA (red at the injection site) and VACCINATION SITE SWELLING (swollen at the injection site) had resolved.            Treatment of events was reported with acetaminophen (Tylenol, only first days).
It cause my menstrual cycle to come back on after only 10 days of ending my last cycle.   I notified my doctor immediately thinking that it was just going to be spotting and it ended up being a whole entire heavy menstrual cycle that lasted around 7 to 8 days. I am very regular and never miss a beat with my menstrual cycle so I know that this was a result of receiving the booster shot 2 days prior. My concern was that I was losing a lot of blood again in such a short amount of time and it did somewhat effect my daily energy and mental acuity.