chrisvoncsefalvay/vaers-outcomes huggingface dataset:
low grade fever, headache for approx 24 hrs., body aches 24-48 hours, 5 days after injection heavy bleeding from cut on my tongue.   A small cut developed when eating and then bleed profusely for 2 1/2 to 3 hours.  My blood wasn't clotting.  That has never been a problem.  Very heavy bleeding from a very small cut finally stopped after putting ice on it.
The 2nd day after my 2nd vaccine my chest began to feel tighter with occasional chest pains that feel like lungs cramping. My muscle strength is weak now and feels I have half the physical strength I had prior to the 2nd vaccine and it's been 2 weeks since my 2nd vaccine. It feels challenging now to even bend down to pick something up. I also now have yellow mucus I cough up in the morning and more mucus than normal and my throat is feeling irritated. I also feel brain fog and fatigue still.
It first started in my knees, severe pain in my right knee and shortly after in my left knee. It was an aching pain and I also noticed my knees were clicking, my left knee also bruised and swelled up all around it. The pain started three days after my vaccine and lasted for about two weeks.. The bruising was all around my knees and it went up to my hips. I still have problems, severe aches in my knees that come and go. I had it last night 7/19/2021 and it was severe. Even just sitting still sometimes it will ache. I had contacted my DR on 4/29/2021 and he prescribed me a five day course of Prednisone for anti-inflammatory. I'm not sure if that helped or if it was time, but most of the bruising went away and the severe pain went away but since that I had also had aches come ago go from those areas anyway.
Large red welt  at injection site; hard and hot to touch, painful to touch; chills, muscle ache, headache and horrible neck pain
I began to experience very painful nerve pain in my body, most noticeable in my feet area making it painful to walk.  I had been exercising and after the Pfizer covid vaccine shot, it hurt too much to exercise.
diaphoresis, pallor, nausea, vomiting over 20 minute period
Patient diagnosed with shingles following ZOSTAVAX administration. Primary doctor gave diagnosis on 11/5/12.
Patient started experiencing shallow breathing and had a hard time breathing two days after vaccination. She said her ankles were swollen and hurting and she could not sleep for three days after these symptoms started.  She did not seek medical attention and the symptoms resolved on their own without treatment.
p/vax pt exp reddened area approx size of 1/2 dollar c/welt & raised area; applied cold compress/ice to site; benadryl; no known allergy to eggs
Breakthrough case admission after 2 vaccines ; Pfizer 4/6/21 lot# Ew0151;  Pfizer 4/27/21 Lot# ER8735
there is like a red rash, it is about the size of a quarter and it is going all the way around the side and on her back and it is red, raw looking and it hurts; there is like a red rash, starts like a 'blister'; it hurts; This is a spontaneous report from a contactable Consumer (Patient's daughter). An 87-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunisation. Medical history reported as none. The patient had been on different medications for all these years, and she had never had a rash. On 16Jan2021 there was like a red rash and it was unknown if it had been anything to do with that or not but it started like a 'blister' and it was about the size of a quarter and it was going all the way around the side and on her back and it was red, raw looking and it hurt. The patient did not receive treatment. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
I began to develop pain in my RIGHT upper arm the morning after my vaccination. (I was vaccinated in my LEFT arm, both doses). Over the course of May 7-9, a red/purple rash began to develop on my upper RIGHT arm. It remains warm and painful to the touch. I have mild pain but no rash on my left arm where I was injected. In short, I developed Covid Arm --  but in the wrong arm.
headache; stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE and ABDOMINAL PAIN UPPER in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-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 HEADACHE and ABDOMINAL PAIN UPPER. The patient was treated with TYLENOL for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE and ABDOMINAL PAIN UPPER outcome was unknown.            Concomitant medication was not provided. The patient experienced headache and stomach pain which has continued. The patient had Tylenol.
21AUG93 noticed rash on forearms that progressed to trunk, abdo, back, buttocks & legs; none on face; c/o burning & itching @ involved sites; DPH w/some relief; then Atarax; no fever or fatigue exp;
I had to go to the Emergency room for difficulty breathing, tachycardia at rest, and stomach pain.  I received the 2nd dose on 5/8/21, and had normal side effects.  Then on the evening of 5/10, I started having a lot of stomach pain around 6 or 7 pm.  I could not sleep, and every time I did drift off, I would get an electric shock that woke me.  Around 12 am, I started having much difficulty taking a breath.  I would cough when I got about half a breath.  My heart was racing as well, and pain in torso.    At the ER, my x ray was normal, white blood cells (neutrophils) high, inverted t-waves, but no signs of heart attack or thrombocytopenia.  They monitored me for a few hours, until I received a normal EKG. I felt pretty bad the rest of that day 5/11/21, then still bad on 5/12/21, then totally fine by 5/14/21.
Information has been received from a physician referring to a current 60 years old male patient. There was no pertinent medical history. Information about drug reactions and concomitant medication was not reported. On unknown dates the patient was vaccinated with a dose of ZOSTAVAX (strength, dosage, frequency and route unspecified), PNEUMOVAX 23 (strength, dosage, frequency and route unspecified) and influenza virus vaccine (strength, dosage, frequency and route unspecified) in the left deltoid area within days of each other. On an unspecified date (reported as "now"), the patient was experiencing a tremor in his left wrist and hand when his hand was at rest. The patient denies pain or motor/sensory loss and the patient was fully alert and oriented. The patient sought medical attention. The physician was suspicious of the ZOSTAVAX, traveling up the patient's nerve tract to the patient's central nervous system. The physician reported that this tremor was non-existent before the patient received these vaccines and had ordered an Magnetic Resonance Imaging (MRI) to evaluate the source of the tremor (date and result unspecified). The physician stated that he suspected either a focal seizure or parkinsonian symptoms. Action taken of the suspected therapies also reported as continued. The outcome of the events was reported as not recovered. The causality was not reported. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA - Sore and sensitive right arm
This spontaneous report was received from a registered nurse and refers to a patient of unknown gender and age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date in October 2017, the patient was vaccinated with the first dose of GARDASIL 9 (strength, exact dose, route of administration, indication, lot number and expiration date were not reported). On 19-JUN-2018, the patient was vaccinated with the second dose of GARDASIL 9 lot number N017832, expiration date 19-JUN-2018 (also reported as 16-NOV-2019) (strength, exact dose, route of administration and indication were not reported). No adverse effects were reported. No additional information.
Adverse event: Patient had negative rapid COVID-19 antigen test at the clinic. The COVID-19 Pediatric Pfizer Vaccine was administered after the negative rapid test. On 12/8/21, the PCR COVID-19 test came back positive.   Outcome: The patient's mother was notified of the positive result on 12/8/21 and to have the patient isolate for 10 days. Since receiving the vaccine, the patient has had no side effects. The provider will continue to monitor the patients health status and the mother was directed to contact the facility if the patient developed any new symptoms.
Rapid heart rate that started 3 days after vaccination On April  20 rapid heart rate around 5pm and was 103 the it fluctuates between that and 110/114.  Stayed elevated constant and called the clinic to report and appointment.  Was seen by a dr and immediately transferred to ER.  Test done for heart attack and blood clot. Negative. It slowly came down and was released with instructions if persist to contact provider and heart monitor might be option.  O4/22 and still hovering around 95.
In the middle of the night I my skin became very itchy. Everywhere I would scratch, a welt would pop up. I tried some topical treatment(oatmeal bath), it didn't help. It moved into my scalp,legs, torso and some on my face. Much like shingles from what I understand. I contacted my doctor in the morning and she prescribed a series of  prednisone and banophen. Dose 2 my doctor prescribed the same medications as before, to be taken before the inoculation. I had no skin reactions but did have a mild flue like feeling for a brief period. Dose 3, I took the same medications, prednisone and banophen. I didn;t have any adverse reactions.
Pt's fiance called about 2 hrs later stating her had red welts all over body. Had pt back in office for re-evaluation. Called into pharmacy Prednisone 40 mg 1 daily x 3 days.
10 minutes after injection, pt complained of right arm numbness, It began to spread to her throat. She reported throat tightness. , nausea and dizziness. 2 MDs were in the Observation area. They assessed her, gave her 25 mg Benadryl IM and 3 puffs of Albuterol inhaler. Heart rate 110, Resp Rate 12, O2 sat 98% on room air. Pt continued to fell warm and "weird." MDs wanted her to go to hospital but pt refused. Her employer offered to drive her to the ER but she refused. The MDs remained with her, monitoring for another hour. Pt was feeling better and chose to have her husband pick her up.
This morning this pt and her husband came into our immunization clinic asking to get a meningitis vaccine and this nurse explained that they did not meet the criteria to receive one without specific risk factors. This nurse then asked to look at their vaccine records, which the husband provided. This nurse asked if they had received their vaccines at the same time because most were given at the pharmacies. They both said yes. As this nurse looked through his, it was noted that it had been more than 5 years since he had a Prevnar 13 or Pneumo 23, which would render him eligible for one more dose of Prevnar 20. Our receptionist was given copies of their immunization records to enter into the immunization registry and the couple was sent back to see the immunization nurse. The immunization nurse was told the vaccine history was being entered into system and that they needed a Prevnar 20, which she administered. As the receptionist was entering this pt's  immunizations she noticed that she had received a Prevnar 20 less than a year ago, which was different from her husband's. This was of course an oversight on this nurse's part, by taking for granted that they had the same vaccine history based on their verbal report and failed to verify this to be the case before making the vaccine recommendations for both individuals. In the future, this nurse will review more carefully review all vaccine records before making any recommendations and not rely on a patient's verbal report of vaccine history if there is paper documentation available. Reported occurrence to FNP. He provided authorization to cover the cost of the vaccine as insurance will not reimburse for an unnecessary vaccine. Report completed for medication error and submitted.  Reported to VAERS and Vaccine Errors Program and all scanned to pt documents.   Called pt and reported incident of receiving an extra dose of Prevnar 20 (PCV20). Explained how this occurred and offered opportunity to ask any questions. Pt asked about possible side effects and explained that this event could be associated with inflammatory like symptoms including muscle aches, joint pain, headache, fatigue, fever and general flu symptoms. Asked pt if she had been told by her doctor not to take Tylenol and she reports she takes it occasionally for aches and pains. Advised pt to take a dose before bed and if she were to experience any of the above inflammatory symptoms to take it every 6 hrs if they persist. If she is not feeling better at 48 hrs. advised to call her doctor. Explained that this nurse would call back in 48 hrs to see how she is feeling. Understanding verbalized and pt was very gracious and appreciative of information.
This case was reported by a healthcare professional (also the subject) and described the occurrence of injection site redness in a 67-year-old female subject who was vaccinated with HEPATITIS A vaccine, (manufacturer unspecified), PNEUMOVAX.  Concurrent medical conditions included high blood pressure.  Concurrent medications included blood pressure medications.  On May 2008 at 11:00 the subject received 1st dose of HEPATITIS A vaccine in the right arm.  On the same date, the subject also received a one time dose of PNEUMOVAX.  Twenty four hours after vaccination with HEPATITIS A vaccine and an unspecified time after vaccination with PNEUMOVAX, the subject experienced injection site redness, heat at the injection site and swelling at the injection site.  She described this as a terrible reaction.  At the time of reporting the events were resolved.  The subject does not plan to continue the hepatitis A series. Follow-up 2/11/09 Still having Seizures & seeing a neurologist.
in the bed; tiredness; chills; sore arm that is painful when you move it; knocked her out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (in the bed), FEELING ABNORMAL (knocked her out), FATIGUE (tiredness), CHILLS (chills) and VACCINATION SITE PAIN (sore arm that is painful when you move it) in an 8-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M21A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (in the bed) and FATIGUE (tiredness). In 2021, the patient experienced FEELING ABNORMAL (knocked her out), CHILLS (chills) and VACCINATION SITE PAIN (sore arm that is painful when you move it). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (in the bed), FEELING ABNORMAL (knocked her out), FATIGUE (tiredness), CHILLS (chills) and VACCINATION SITE PAIN (sore arm that is painful when you move it) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided. The patient was not on any medication aside from vitamins but was supposed to be on a baby aspirin.   This case was linked to MOD-2021-419412, MOD-2021-419795 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2021: Non significant follow up no new information was added
40-year old received Fluzone High-Dose Quadrivalent in error/no AE; 40-year old received Fluzone High-Dose Quadrivalent in error/no AE; 40-year old received Fluzone High-Dose Quadrivalent in error/no AE; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 40-years-old female patient who received quadrivalent influenza vaccine (Fluzone high-dose quadrivalent) in error (product administered to patient of inappropriate age, medication error and overdose).   The patient's past medical history and family history were not provided.  Concomitant medication of the patient included sodium (NA).   On 12-Oct-2020, the patient received quadrivalent influenza vaccine (Fluzone high-dose quadrivalent) at a dose of 0.7 mL (frequency: once) at untranslated region (UTR) for prophylactic vaccination.   On 12-Oct-2020, same day after initiation of quadrivalent influenza vaccine, the nurse administered quadrivalent influenza vaccine to a 40-year-old patient in error with no AE (adverse event) was reported (product administered to patient of inappropriate age, medication error and overdose).   Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and module VI of the Good Pharmacovigilance Practices. 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.  It was a case of overdose and also a case of actual medication error due to inappropriate age at vaccine administration (latency was on same day).  No other relevant information was reported.
woke up feeling very fatigue/felt very tired and exhausted; swelling on injection site; feverish (low grade fever); bit dizzy; chills; muscle pain on injection site; This is a spontaneous report from a non-contactable consumer (patient). A 35-years-old non-pregnant female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL3247, patient was 35-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 12Feb2021 at 01:30 PM as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL3247, patient was 35-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm right on 22Jan2021 at 11:30 AM as DOSE 1, SINGLE for covid-19 immunisation. Reported that within 24 hours of 2nd dose patient experienced events with injection site pain. Next morning at 8 AM, woke up feeling very fatigue. I also noticed swelling on injection site and but started to go down as the day passed by. Throughout the day, I felt very tired, exhausted, feverish (low grade fever), chills and bit dizzy. Next morning, I felt much better and recovered by Sunday afternoon to normal. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient was not tested for COVID-19. No allergies to medications, food, or other products reported. On an unspecified date in Feb2021, the patient experienced muscle pain on injection site, on 13Feb2021 at 08:00 AM the patient experienced woke up feeling very fatigue/felt very tired and exhausted, swelling on injection site, feverish (low grade fever), bit dizzy, chills. Patient received treatment for events with took short nap in afternoon, but it didn't help. The symptoms started to go down in the evening only after 2 hours of taking a Tylenol (500mg). No seriousness criteria reported. The outcomes of events were recovered on 14Feb2021.  No follow-up attempts are possible. No further information is expected.
Case number PHEH2013US009254 is an initial spontaneous report received from a pharmacist on 23 Apr 2013. This case refers to a 73-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: not available) intramuscularly in his left arm on 29 Aug 2012. Immediately after vaccination, he developed knot, scab and rash. The knot and scab are at the left arm injection site. The rash started at the left wrist area. It was like dry patch of skin type rash with little bumps, and the patient stated that it was very itchy and painful. Rash was predominantly on the left side of the body and an area at the spine. He had a physician visit due to these events. The patient's physician stated to patient that the rash was an atopic rash and it was allergy related; the physician also ruled out shingles. He received a cream (not specified) with steroid in it and he had been using it all over his body. The patient stated to the pharmacist that he still has knot and rash (all over his body) at the time of this report. The patient also stated to the pharmacist the rash, knot, and scab come and go. The seriousness and causality were not reported.
Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness in arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced INJECTION SITE PAIN (Soreness in arm). At the time of the report, INJECTION SITE PAIN (Soreness in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment details was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
pt recvd vax & was crying a c/o H/A; pt taken to MD & was lethargic & still c/o H/A & stomach discomfort;
Small tiny red rash from head to toe, fever of 101.3, general feeling unwell, no appetite, lasted for 5 days.
myocarditis - chest pain, elevated troponin to 0.09. Normal EKG.
Allergic reaction to vaccine including 103.2 fever and was given Tylenol & ibuprofen.
has blood clots throughout his body; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer stated that after three of her family members received the Pfizer Covid-19 vaccine that they all developed blood clots. The patient has blood clots throughout his body and didn't have long to live and was sent home with morphine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101076809 same reporter/product, similar event, different patient.;US-PFIZER INC-202101076810 same reporter/product, similar event, different patient.