chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer reporting for herself. A 73-year-old female patient received PREVNAR 13, intramuscular in the left arm, on 20Aug2016 at 02:40 PM, at 0.5 ml single, for immunisation. Relevant medical history included osteoporosis from 2010 (she has shrunk 2 1/2 inches from osteoporosis), osteopenia from 2005, fractures (history of three fractures), allergy multiple (to Penicillin, Clarithromycin, egg whites, cats, horses, dust mites), high cholesterol, hypoactive thyroid, sickness from 1995, pneumonia from 1995, flu from 1995, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities, diabetes, obesity. Past drug history included tetanus diphtheria (unspecified trade name) in 2011 for immunisation and the patient experienced vaccination site reaction, swelling, redness and soreness; Levaquin (unspecified trade name) and experienced tendon disorder. Concomitant medications included simvastatin (unspecified trade name) from 2004 and ongoing, for high cholesterol and SYNTHROID from an unspecified date and ongoing, for hypoactive thyroid. The patient previously took tetanus diphtheria for immunisation and experienced skin reaction, swelling, erythema and pain. The patient experienced hoarseness of voice on 27Aug2016 with outcome of recovered, wheezing on 29Aug2016 with outcome of recovering, coughing on 29Aug2016 with outcome of recovering, tightness in chest on 29Aug2016 with outcome of recovering, difficulty breathing added to PREVNAR 13 on 29Aug2016 with outcome of recovered, got sick with the PREVNAR 13 on an unspecified date with outcome of unknown. Events wheezing, cough and tightness in chest were evaluated at physician office. The patient underwent lab tests and procedures which included: chest x-ray, no pneumonia scarring from previous pneumonias on Aug2016; computerised tomogram, negative on 22Sep2016; echocardiogram, everything was ok on 07Oct2016. Therapeutic measures were taken as a result of wheezing, coughing, tightness in chest and difficulty breathing added to PREVNAR 13.
Pt. had swelling, redness and tenderness at injection site and appeared to have flu like symptoms. She was transported to hospital.
body aches/chills             sore arm for 3 days fatigue malaise diarrhea
Patient stated that her face was warm and flush and that she reacted the same way when she got steroid injection. Took vitals at 11:54 am heart rate 73 o2 97, BP 108/79, again at 11:59 heart rate 79, o2 97, resp. 20 , BP 111/78, again at 12:04 am heart rate 81, o2 97, resp. 20 and BP 113/79. Patient was feeling better and was released with other.
lt arm swollen @ site of inject red & warm to touch w/in 48 hrs; told to apply ice; 10 cm area of induration;
vaccines given post excursion (with no reported adverse event); vaccines being given post temperature excursion (with no reported adverse event); Initial information received on 06-May-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 11 years old male patient who experienced vaccines given post excursion (with no reported adverse event) while receiving meningococcal A-C-Y-W135 (D conj) vaccine [Menactra].     The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (Adacel) for Prophylactic vaccination; and hpv vaccine (HPV vaccine) for prophylactic vaccination.  On 02-May-2022, the patient received a dose of 0.5 ml 1 day total Strength: standard suspect meningococcal a-c-y-w135 (d conj) vaccine lot U7208AA, expiry date:10-Feb-2023 via intramuscular route in the left deltoid for prophylactic vaccination.  On 02-May-2022 (Latency: same day) vaccines given post excursion (with no reported adverse event) (poor quality product administered) and (product temperature excursion issue). This situation was reported as a medication error due to vaccines being given post temperature excursion.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for all the events.   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 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.; Sender's Comments:  PENTACEL case 01092869: PENTACEL case 01092879: QUADRACEL case 01092814: QUADRACEL case 01092832: QUADRACEL case 01092891: ADACEL case: 01092687: DAPTACEL case:  01092746: FLUZONE QIV case 01092709: FLUZONE QIV case 01092741: FLUZONE QIV case 01092787: FLUZONE QIV case 01092803: FLUZONE QIV case 01092850:
I experienced a breakthrough case of COVID-19 with a sore throat, dry cough, runny nose, glands were sore, fatigue, fever and tiredness.
generalized papular rash, not pruritic, not erythematous; no systemic react; mom says happened w/2 prev doses; MD thinks related to preservative;
24 HOURS WITH A TOUGH FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced 24 hours with a tough fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 24 hours with a tough fever. This report was non-serious.
Initial report received from Health Authority on 30 Sep 2010. This patient was vaccinated with H1N1 (batch number unknown) on an unknown date. During the time of vaccination, the patient was pregnant (12 weeks). This patient took prenatal vitamins concomitantly. The patient had miscarriage on an unknown date. As per the physician, the baby died around 13 weeks. The outcome of the events was not reported.
Reimmunization-dose 4 was given 6 days after manufacturer advised expiration.
Bells Palsy diagnosed on 09/19/18 (3 weeks after vaccination). Ear discomfort for approximately 10 days prior to 09/19/18. Severe headache for approximately 4 days prior to 09/19/18.
Pt was negative 1 2/3 yrs p/vax series was completed; Given 5 doses 5OCT88, 2NOV88, 21APR89, 14DEC90, 22MAR91 fr lot#s 1893P, 0302S, 1238S not recorded for dose 1 & 2;
pain from the heel to the groin; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a Other Health Professional.  This case involves male patient who experienced pain from the heel to the groin (PT: Pain in extremity), while he received vaccine influenza usp trival a-b high dose subvirion vaccine (fluzone high dose).  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient was treated with gemcitabine (gemcitabine) and carboplatin (carboplatin).  On an unknown date, the patient received a dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine lot number UJ242AA and expiry 15-May-2020 via intramuscular route in the upper arm.  On an unknown date, the patient developed a non-serious pain from the heel to the groin (PT: Pain in extremity), following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine.  Other relevant tests included no lab data.  Action taken was not applicable with respect to event.  Corrective treatment was provided.  At the time of reporting, event outcome was unknown.  No further relevant information was reported.
This is my first known positive test for COVID-19. That Tuesday evening the 12/27, I was feeling tired and was having a little bit of a sore throat. It felt like I had been talking all day and night, so I didn't think much of it. Wednesday morning, I had a little bit of congestion and the sore throat was there and it was a little bit worse. I took an at home COVID-19 test and it was negative. Throughout the day, my symptoms started to increase with the amount of congestion and fatigue. I started to have a headache and started to feel sore. Thursday, all of those symptoms were more intense and I stayed in my room in bed the whole day. I started to have a low grade fever so I decided to take another test on Friday. That test Friday morning was positive. I was isolated at that point and had already been. I had continued joint pain, body aches, muscle pains, nausea and diarrhea. I had a headache, fever, sore throat, extreme congestion and sinus pressure. My ears were clogged and felt a lot of pressure internally. I was very tired. That was the peak by Friday. Saturday was similar. I had also noticed that my sense of taste and smell were altered. I did not lose these senses, however some things were tasting like bleach. Saturday evening, I started to feel a bit better. I didn't have any fever anymore and I started to have a little bit of a cough. The congestion was still really bad along with my sinuses. By Sunday, a lot of those symptoms started to feel a lot better. They continued to feel better by that Monday on 01/02/2023. I stayed remote for work that week and I was still masking at this point. Tuesday 01/03/2023, I started to feel worse again. My throat felt worse and started coughing a lot more. It felt like it was moving down to my chest and I started to feel more tired. However, my taste and smell did begin to improve at this point. I had more muscle aches again, and that's when I contacted the doctor. They agreed after the exam and listening to my symptom progression, to give me a z-pack antibiotic. I took that for 5 days and I had improvement for all my symptoms during that time. I still had some sinus congestion and a cough but it was improving. I finished the z-pack, and a few days after, the cough came back and the sinus pressure came back worse again. I was getting more fatigued again. Since I improved on the z-pack, the doctor decided to start another round of antibiotics. They gave me Doxycycline and I took that for 7 days and was on Prednisone for 5 days. I improved significantly on those medications. My last day of antibiotics was 01/17/2023. I was greatly improved after that and the last day of the prednisone was 01/15/2023. Since then, I did have one flare up since I've been off the prednisone after 24-48 hours. It felt like my body and all my lymph nodes swelled up. That cleared after 24 hours and I'm not sure what that was in relation to. I've been doing better. The cough and congestion did take a while to improve, but I'd say they're basically cleared. I did take Mucinex DM, Ibuprofen, and Sudafed to manage symptoms up until I was put on antibiotics to manage my symptoms.
This spontaneous report as received from an office manager refers to a 49 year old male patient. On 10-JUN-2014 the patient was inadvertently, intramuscularly vaccinated in the deltoid with 0.5 ml dose of PROQUAD (lot/batch number as K005196, expiration date 10-OCT-2015) post excursion. It was reported that PROQUAD was stored in refrigerator for 5 days (120 hours), excursion not supported. The patient did not seek medical attention. No adverse effects reported by patient. Additional information has been requested.
Severe body aches, chills, headache, and nausea that lasted for approximately twenty (20) hours after receiving the vaccine.
Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a 6 month old female pt who experienced "strep throat". The pt received the second dose on 16Mar04. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 16Mar04. Dose regimen was 1 dose (IM). Concomitant medications were not reported. The pt experienced "strep throat" (pharyngitis streptococcal) in Jun2004. The pt recovered. No additional information was available at the time of this report.
sinus infection; severe pain in the left shoulder; joint pain in both shoulders; joint pain in hips; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (severe pain in the left shoulder), ARTHRALGIA (joint pain in both shoulders), ARTHRALGIA (joint pain in hips), FATIGUE (fatigue) and SINUSITIS (sinus infection) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 023M20A) for COVID-19 vaccination.     The patient's past medical history included Diabetic since an unknown date, Hypertension since an unknown date, Acid reflux (esophageal) (esophagus reflux) and Cancer in 2017. Concomitant products included CIPROFLOXACIN and DOXYCYCLINE for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2. On 28-Jan-2021, the patient experienced ARTHRALGIA (severe pain in the left shoulder), ARTHRALGIA (joint pain in both shoulders), ARTHRALGIA (joint pain in hips) and FATIGUE (fatigue). On an unknown date, the patient experienced SINUSITIS (sinus infection). At the time of the report, ARTHRALGIA (severe pain in the left shoulder), ARTHRALGIA (joint pain in both shoulders), ARTHRALGIA (joint pain in hips), FATIGUE (fatigue) and SINUSITIS (sinus infection) had resolved.            The consumer stated that she has a cleft pallet and frequently gets sinus and ear infections. On 25Feb2021 she stated that she received the second dose in the series from the Moderna vaccine. The IM injection was given into the left arm. Lot # 023M20A reported. After the injection she reported experiencing muscle spams under the right eye that lasted for 2.5 days and resolved. On 05Mar2021, she reported muscle spasms in the upper right cheek and her left eye is hurting inside the eye and is swollen. She stated she is going to make an appointment with her HCP.
Shingles (Herpes Zoster).  Rash back of neck, left shoulder, left back above belt line.
Swelling of upper left arm with redness and induration of 4 to 5 cm. Prescribed Duricef for 10 days.
ADMINISTRATION ERROR (WAS GIVEN MONOVALENT PFIZER COVID VACCINE as BOOSTER)
Child was given a fluzone Quad vaccine 12/22/21 and also 9/22/21 child is over 1 year old so he did not need to get this flu vaccine from 12/22/20.  Previous on 3/15/21 he was given flulaval quad and 12/16/20  he was given fluzone quad this would have been his 2 dose series of under 1 year old
severe headache, nausea, fever:101.5, chills/tremors.  Body is so hot, can cook on it.  Muscle and skeletal weakness,  can barely walk
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 75 year old female. 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 not reported, batch number: 1805018, and expiry: 23-AUG-2021) dose was not reported, administered on 07-MAR-2021 on left arm around 13:00 for prophylactic vaccination. No concomitant medications were reported. On 17-AUG-21 patient had an antibody test with her healthcare professional. On 19-AUG-2021 her doctor called her and told she had no antibodies, the test came back negative (confirmed immunological vaccine failure). On 20-AUG-21 patient had another antibody test was performed. The results from the second test came back on the day of report as negative and with no antibodies. Both tests were SARS COV2 Spike Protein and IGG antibody tests. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210843278-covid-19 vaccine ad26.cov2.s -Confirmed Immunological Vaccine failure. This event(s) is considered not related. 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
On 3/17/2021 I started feeling I felt like I was going to faint. My heart rate started to go up to 135, I felt dizzy, I had cold sweat & it felt a little hard to breath. This symptoms lasted for about 2 days. I had to see the doctor the same date on the 3/17/2021. He sent me to do lab work.
I had fever, stomach pain, and diarrhea. I felt nauseas, cough, and sniffles. Very flu like symptoms. I took Nyquil.
Fever, chills, malaise, weakness and myalgias.  Self treated with Tylenol and rest
The day after getting vaccinated, my mother felt tired and had mild chills.; The day after getting vaccinated, my mother felt tired and had mild chills.; Sore Arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 74-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 05Mar2021 15:45 (Batch/Lot number: unknown) at the age of 74 years as DOSE 2, SINGLE for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Mar2021, outcome "unknown", described as "Sore Arm"; FATIGUE (non-serious), CHILLS (non-serious) all with onset 07Mar2021, outcome "recovered" (2021) and all described as "The day after getting vaccinated, my mother felt tired and had mild chills.". Therapeutic measures were not taken as a result of pain in extremity, fatigue, chills.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if patient received any other medications within 2 weeks of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19 and since the vaccination was not tested for COVID-19. No treatment was received for adverse events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a nurse and described the occurrence of pain in arm in a child patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details were provided as follows: This case was reported from a nurse practitioner. The age at vaccination was not reported. The reporter was the parent of the patient and stated that the patient had arm pain after receiving BEXSERO.
every joint on her body has been hurting/joint issues and her fingers also hurt; hurt pretty bad; hurt pretty bad/injection site that hurt pretty bad; fibromyalgia; retaining water; she also had a bruise on that same arm; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 06Aug2021 (Batch/Lot Number: FA7484) as DOSE 1, SINGLE for covid-19 immunisation (age at vaccination 50-years-old). The patient Medical history, family history and concomitant medications were none. It was reported that, patient still needs to get the 2nd shot of the Comirnaty vaccine but she was concerned if she should get it because the 1st shot hurt pretty bad and every joint on her body has been hurting for the last week and a half and was reported as worsened. As per caller, she clarified that it was the arm where she got the injection site that hurt pretty bad later afternoon. She added that she felt the injection go in and then she screamed because it hurt. She felt that for 2 and a half to 3 days and she also had a bruise on that same arm which was her left arm. Those symptoms went away and now she has body joint issues and her fingers also hurt. Caller received her 1st dose on 06Aug2021 and was set to receive the 2nd one this Friday. She was told that the 1st shot would not bother her and would only feel the side effects after the 2nd shot. She called to know if these are normal side effects of the vaccine because she was nervous to get the 2nd shot. She mentioned that she would be calling her doctor after the call as well. She stated that she felt comfortable knowing that these are normal side effects. She was nervous on day 6 it hurt pretty bad, she had pain when it happen and two and a half to three days later it hurt and bruising. For about a week and a half now every joint in her body hurts. Her husband said it did not hurt him. She hated needles, and she talked to her daughter and she said she also had pain in her joints. Hurt pretty bad: The pain stopped where she got the injection. It went away. The patient experienced hurt pretty bad/injection site that hurt pretty bad on 06Aug2021, every joint on her body has been hurting/joint issues and her fingers also hurt on 09Aug2021, she also had a bruise on that same arm, fibromyalgia and retaining water on an unspecified date in Aug2021. Her mother has fibromyalgia and she was thinking that was what she has. She was double checking with us and the doctor before the second shot. The patient did not receive any treatment. The patient not required to visit emergency room and physician office. There were no prior vaccinations (within 4 weeks). There were no relevant tests performed. Outcome of the events hurt pretty bad/injection site that hurt pretty bad was recovered on 09Aug2021, every joint on her body has been hurting/joint issues and her fingers also hurt was not recovered and unknown for other events.
The individual threw up 60 seconds or less after receiving the RotaTeq vaccine. Contents were white - breast milk colored. Situation and contents assessed by individual's PCP directly after individual threw up. The individual did NOT have a systemic reaction after receiving the RotaTeq vaccine. Individual remained in office with his guardian for a period of time to monitor for any adverse reaction(s).
Fifteen minutes after receiving the vaccine shot, I experienced a strong, distorted smell similar to burning wood.   When I was diagnosed with Covid -19 in April of 2020, I completely lost my sense of smell.   My smell did return over the next months, but it was distorted and smelled like burning wood or maple.  It finally went away in January only to return when the vaccine was administered.     It has now dissipated.
pt recvd vax;fever 100-105 & sudden change in behavior w/ irritability & hitting head on the table, falling over twice; eyes rolling w/ jerking;no LVL; next day pharyngitis;
Cough, congestion, severe headache, lethargic, dizziness, chills, fever
Patient reports experiencing symptoms of Myasthenia gravis after receiving Moderna Booster. Pyridostigmine prescribed after receiving booster dose.