chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (Lot#K012457, exp. date 04-JUN-2017; Lot#K019560, exp. date 02-JUN-2017; Lot#L007559, exp. date 01-JUN-2017; Lot#L018499, exp. date 25-FEB-2017) (Strength, dose, route and frequency were not provided). Concomitant medication was not reported. No adverse effects reported. This is one of several reports from same source. Additional information has been requested.
The morning after I received the flu shot, I awoke with a sore arm and shoulder and the pain became worse every day after that. I was unable to lift my arm and shoulder. I couldn't work at my cleaning job. This has continued to date.  I called the pharmacist and he suggested giving it time. It is still painful and I haven't been able to return to work...but I have had no relief to date.
Thrombosis With Thrombocytopenia syndrome  after COVID-19 vaccination; This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (medically significant), outcome "unknown", described as "Thrombosis With Thrombocytopenia syndrome after COVID-19 vaccination".  Author's Conclusion: Thrombosis with thrombocytopenia syndrome is a rare but serious adverse event associated with Ad26.COV2.S vaccination; different demographic characteristics of the 3 cases reported after mRNA-based vaccines and the much lower reporting rate suggest that these cases represent a background rate.  No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : PFIZER_INC-202200162797 Same article/ drug/event and different patient;US-PFIZER_INC-202200162798 Same article/ drug/event and different patient
The area that received the vaccine has swollen and is running a fever. It started happening shortly after the shot was given but did not escalate much until the next day. The swollen area has now doubled in size and continues to have a fever and grow. The affected area also feels hard to the touch.
A report has been received from a Health Professional concerning a 10 year old female patient. The relevant history and concomitant drugs of patient were not reported. The patient had been receiving nasal FLUMIST started on 19-Feb-2013. The  reporter stated that the patient received both FLUZONE and FLUMIST in the same season. FLUZONE was administered on 08-Jan-2013 and FLUMIST was administered on 19-Feb-2013. The mom denied that the patient received both FLUMIST and FLUZONE, bu they have record of the patient receiving both vaccines at the office. The outcome od the event of receives both FLUZONE and FLUMIST in the same seasonal was unknown. The reporter considered event of receives both FLUZONE and FLUMIST in the same season to be non-serious. Corrected report 30-Apr-2014: Dose of FLUMIST was added. Relation to patient was corrected. The case has been updated with full data due to KUR term additions for FLUMIST/Q/Laiv.
patient passed out in the waiting room after vaccination and vomited after standing up. pharmacist gave patient water, granola bar, and had patient elevate legs.
I woke up in the middle of the night and my left arm was itching near injection site. I scratched a bit and fell back to sleep. The next morning I found an irregular shaped, red rash, which was approximately 5 inches long near the injection site and it itched. I started to apply Cortisone 10 , which I purchased from the drugstore to help alleviate the itchiness
Caller also had double pneumonia.; both contracted covid, caller tested positive; This is a spontaneous report received from a contactable consumer. A 59-year-old male patient received, first dose  of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number unknown and expiry date was not provided), via an unspecified route of administration on 18Mar2021, as single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not provided. The patient reported that he contracted with covid on 25Mar2021 and had double pneumonia. On 25Mar2021, the patient underwent lab test and found positive with Covid-19. The patient wanted to know if he can take the second dose.  Information on the lot/batch number has been requested.
Information was received on 26-MAY-2017 regarding a case in litigation concerning a male (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On or about 24-AUG-2013 the patient received a dose of ZOSTAVAX (lot # and dose not specified) as recommended for routine adult health maintenance 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 22-APR-2016 the patient was seen by a physician and was treated for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed famciclovir (FAMIR) and hydrocodone for management 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.
Swollen lymph nodes in axilla; same side as injection with pain, induration with distinct margin at injection site. No erythema.
As soon as shot was given, it hurt at the injection site + pain con't. to radiate down arm to tip of fingers.  Pain at level 3-4 with 10 being severe.  Feels tingly + numb.
I started feeling very tired. Quickly, my body got very achey, as in my ankles hurt when I moved my foot from one pedal to another while driving. Within an hour of the fatigue setting in, I had a fever, chills, and was extremely nauseous. I slept for 14 hours and took Tylenol and felt much better by 4:00pm the next day.
SEVERE SIDE EFFECTS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced severe side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20210417646.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure, suspected covid-19 infection. The reporter stated that "I caught it from my vaccinated wife who caught it at a party where everyone was vaccinated. 8 of them caught it. My son and I both caught it and had mild symptoms. No loss of taste or smell or even a cough. No vaccines, and I have multiple issues that probably should have made me very ill at least. My vaccinated wife got very sick and lost taste and smell for 4 months. I see vaccinated people every day coming down with covid. Most tell me they were at least very ill. They're not telling you the whole truth. I was definitely less sick than most people tell me about their personal experience with vaccine side effects." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint: 90000217213. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the RA evaluation/investigation performed. This case, from the same reporter is linked to 20220230277 and 20220230299.  Additional information received from Regulatory authority 24-FEB-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result added. Upon review following information was amended: case is considered as valid since it was received from website (identifiable reporter).; Sender's Comments: V1: This version followup updates the information regarding Product quality complaint investigation result and information was amended: case is considered as valid since it was received from website (identifiable reporter). This updated information does not change the causality of the previously reported events. 20220230393-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Fever for 24 hrs, as high as 102 for several hours. Muscle aches and sever joint pain for 24 hrs. Headache Very hot skin.
constant headache, dizziness, lightheaded, swelling and pain in neck, shoulders, head and left arm. Swollen lymph nodes in head, neck and softball size lymph node under left armpit. Hypertension (blood pressure 131/81).
Information has been received from a consumer concerning her 83 yr old mother, who on 1 day post vaccination, experienced a very large, swollen, bright red area extending from the site of injection down her arm past the elbow. It was noted that fluid is also building up in the under arm area. The pt was taken to the physician's office and told it would eventually get better. It was reported that it had spread with the amount of fluid increasing. Additional information has been requested.
Vasovagal Syncope  Sudden drop in blood pressure.  occurred day after vaccination 9:00pm Called my cardiologist. Encouraged to monitor and keep them informed   reduce blood pressure meds until stable. Discontinue chlorthalidone until BP is stable   Blood pressure seems to be stable today (3-9-10). Still slight headache and mild dizzy spells
Migraine headache, dizziness, weakness, face pain and the whole right side of my head, face and neck pains.
Flu-ish symptoms; Achy joints; This spontaneous report was received from a physician reporting on herself, a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date in 2013, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported).   On an unknown date in 2013, the patient had a strong response to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), and she felt achy joints (arthralgia) and "flu-ish" symptoms (influenza like illness). She considered this response to be normal, predictable and consistent with the label. She did not report any serious or lasting problems. In 2013, she recovered from influenza like illness and arthralgia.  The reporter considered arthralgia and influenza like illness to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
She then contracted COVID 19 virus; She then contracted COVID 19 virus; feeling tired; arm pain; nausea; stomach ache; not being able to sleep at night anymore; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration, administered in arm on 28Jul2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter's daughter was concerned about getting the vaccine because she had heard that it could cause problems with fertility. Caller stated that she was scheduled to have injections in her knees that would be a series and the medication started with a VO. She would like to know if she could still have these injections done after having the second dose of the vaccine. Relayed to caller that there was no information on drug interaction with the vaccine at this time. Referred to let HCP know of recent health events and vaccination prior to the shots being given to discuss possible interactions. She had side effects with the first dose of the Pfizer COVID 19 vaccine of felt tired, arm pain, nausea, stomach ache, and she reported not being able to sleep at night anymore but she was unsure if that was due to the vaccine or the COVID virus. She would like to know if the second dose of the vaccine would cause her to have worse side effects or not. Caller stated that she was being transferred when she was disconnected. She relayed that she had spoke with multiple departments and she was unsure of what departments she spoke to. After 1 dose of vaccine, she contracted COVID 19 virus and received an antibody infusion to decrease her illness. After the vaccine, she was tested positive Covid 19 virus. She would like to know if this was true and if you had to wait to get the vaccine second dose for this case. Relayed to caller that there was no information at this time on the amount of time she should wait to receive the second dose after receiving the said infusion to decrease Covid 19 symptoms. She relayed that she was told that she needed to wait 90 days before getting her second dose of the vaccine. Referred to speak with site where she received the infusion and an HCP to discuss further. Someone told her to get the vaccine second dose (information withheld). She stated that her doctor pasted away and so she did not have a doctor at that time. The patient underwent lab tests and procedures which included sars-cov-1 test: positive on an unspecified date in 2021. The outcome of all events was unknown.  The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
04/04/2022 Vaccination; 05/06/2022 I had lots of fatigue, weakness and very bad HA. COVID; +; I went to urgent care that day, started Paxlovid. By end of that course, I was symptom free. Antigen testing was getting lighter. By 05/14/2022 it was negative. 05/17/2022 I was feeling lousy again; cough and running nose, fatigue. Retested; COVID+; Presently still have some residual symptoms; COVID x2.
FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193;   This case involves (an adult) male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  It was a case of actual medication error due to incorrect product storage.  At the time of report no adverse event was reported.  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.  Documents held by sender: none.
difficulty breathing, paresthesia, dizziness.  1.5 hours after vaccine worsening dyspnea, tingling in fingers and toes, felt like a ball was in her throat, previous anaphylactic reaction.  Pepcid, benadryl, solumedrol  with continued worsening epinephrine IM give.  O2 sat 81% room air, O2 provided with increase sat to 100%, second dose of epinephrine 0.3 IM.  Weaned of O2 and discharged with prednisone.
Fever; Chills; Body ache; Vaccine exposure during pregnancy; A spontaneous report was received from a consumer concerning a 38-year-old, female patient who Vaccine exposure during pregnancy, Fever/pyrexia and Body ache/Myalgia.    The patient's medical history was not provided.   Concomitant product includes prenatal vitamins.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 025L20A) on 07 Jan 2021.  On 04 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.   First dose of vaccine was administrated on 07 Jan 2021 and second dose on 04 feb 2021. Patient is received vaccine during the pregnancy. And experienced chills, fever and body ache.  Treatment for the event included Tylenol 500 mg.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events was not reported.
Received #2 MMR in clinic for low titre and no documented hx of MMR on Wed 2/15; called into clinic today 2/24 to report that he started with flu like sx's on 2/17 (2 days after receiving vaccine); denied issues at injection site, instead noted fatigue, scratchy throat and then developed canker sores; evaluated at Urgent Care  on 2/20, reports he was neg for flu/covid; re-eval at PCP on 2/23, still suffering from the sores, otherwise feels better as of today.  Did not lose work time/continued working
Inj was administered in Left deltoid, then two days post inj. Left arm from shoulder to elbow was red, hot & swollen.
Pt's left arm was swollen with a large bump at the injection site and hurts to touch.  Pt had full range of motion of left arm. Luke warm compresses and Motrin as needed for pain.
The injection long term effect has been ringing in my ears nonstop. I've had ringing before but not like this. Regarding my Covid case - I lost taste and smell 2 days after testing positive. I had all the symptoms but a cough. I had runny nose, sweat, chills, achiness, all my joints felt so sore that I can't even explain it (elbows, fingers, knees, ankles). That lasted about a week after testing negative. It slowly started getting better. Loss of smell and taste lasted 5 days. My right leg swelled up and was stiff and could barely bend it. It felt like a blood clot the doctor also thought it could be so I started taking aspirin and the swelling went down within 24 hours. I went back to the doctor and they said to add ADVIL and switch them off to help and I did that for about a month and then stopped.
Patient presented to pharmacy with initial red spot on arm at injection site, then came in this morning with red spots forming under her right eye, under her right ear and on the left side of her mouth. Patient stated the spots are red, raised and slightly itchy. She has not been working in the yard or garden and does not believe it is poison ivy.
Information has been received from a a licensed practical nurse concerning a 12 month old patient who was vaccinated on an unspecified date with a first dose of MMR. The nurse reported that the patient had an injection site reaction within one to two hours after vaccination. The reaction was described as swollen and red. No information on the duration of the rash was available. The nurse did not have first hand knowledge of the reaction since the vaccination was given at another office. Unspecified medical attention was sought. Follow-up has been received from the nurse, who reported that she spoke with the child's mother, and there is no additional information. No further information is expected.
client reports of about 7:00 am Friday morning, waking up, he had pain in all this joints, head feeling  "foggy, had a mild headache in the back of his head, feeling fatigue and not his usual self. This lasted about 24 hours.