chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am having major fall outs; I get hot; drip sweat; It feels like someone is pouring hot water over my head and I can't do anything about it until I collapse.; starting to get sick.; went from 160 to 180 pounds and feel puffy, big, and different; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program, Pfizer Oncology Together. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation; and Palbociclib (IBRANCE, Formulation: Capsule), via an unspecified route of administration from 05Feb2021 to an unspecified date, at 125 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. Patient stated, she was having major fall outs, she got hot, and drip sweat. She got a limo and got hot inside, like she was melting with sweat. At the hospital she got a shot of something she could not pronounce (maybe extevia) and the Pfizer vaccine for Covid. It felt like someone is pouring hot water over my head and she could not do anything about it until she collapse. She may have had these problems because of the side effects from the shots. She was blowing up like a blimp, went from 160 to 180 pounds and feel puffy, big, and different. She had not been okay the last couple of weeks. This medicine was putting her in bed, and she was starting to get sick. The patient underwent lab tests and procedures which included weight increased: from 160 to 180 pounds. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Redness in her arm; Swelling in her arm; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness in her arm), SWELLING (Swelling in her arm), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced SWELLING (Swelling in her arm), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). On 16-Feb-2021, the patient experienced ERYTHEMA (Redness in her arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, ERYTHEMA (Redness in her arm), SWELLING (Swelling in her arm), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Temp up to 102 on day following vaccine admin. Exam negative. Strep quick test negative. No prescription given with Tylenol for fever.
CHILLS; FEVER (101 F TEMPERATURE); BODY PAIN; HEADACHE; This spontaneous report received from a patient concerned a male 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, intramuscular, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fever (101 f temperature). On 09-MAR-2021, the subject experienced body pain. On 09-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, body pain, and headache on MAR-2021, and the outcome of fever (101 f temperature) was not reported. This report was non-serious.
Pfizer Covid-19 vaccine EUA  Patient hospitalized for term birth of baby. No complications
Nausea, vomiting, 102 fever, bodyaches, headaches  -- tylenol some relief,. Fever lasted for 7 day continuously,  alt tylenol and ibuprofen. Urgent Care 1/7/21 re-tested for COVID 19 -negative and flu- negative
A three year old received a monovalent spikevax pediatric dose 25 microgram that has been 35 days out of freezer.; A three year old received a monovalent spikevax pediatric dose 25 microgram that has been 35 days out of freezer.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (A three year old received a monovalent spikevax pediatric dose 25 microgram that has been 35 days out of freezer.), POOR QUALITY PRODUCT ADMINISTERED (A three year old received a monovalent spikevax pediatric dose 25 microgram that has been 35 days out of freezer.) and NO ADVERSE EVENT (No adverse event) in a 3-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 25 microgram. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (A three year old received a monovalent spikevax pediatric dose 25 microgram that has been 35 days out of freezer.), POOR QUALITY PRODUCT ADMINISTERED (A three year old received a monovalent spikevax pediatric dose 25 microgram that has been 35 days out of freezer.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (A three year old received a monovalent spikevax pediatric dose 25 microgram that has been 35 days out of freezer.), POOR QUALITY PRODUCT ADMINISTERED (A three year old received a monovalent spikevax pediatric dose 25 microgram that has been 35 days out of freezer.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (A three year old received a monovalent spikevax pediatric dose 25 microgram that has been 35 days out of freezer.) and POOR QUALITY PRODUCT ADMINISTERED (A three year old received a monovalent spikevax pediatric dose 25 microgram that has been 35 days out of freezer.).    No concomitant medications details were reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medications details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jan-2023: Follow-up received wherein updated from location to alternate location. .
Day of vaccination, Monday, patient states he have blurred vision, nausea within 30 mins of receiving vaccine. Later that evening, the injection site was very sore, red, and painful to touch and movement of arm. Next day, Tuesday, the redness was spreading and increase pain to area of injection. Also, area very hot feeling, especially to touch. Third day, Wednesday, symptoms not being relieved, getting worse. Area of injection site now enlarged to 6" x 6" area. Came to pharmacy for advice. Advice given by pharmacist on duty, confirmed a true allergic reaction and recommended patient go to PCP or emergency room. Patient went to ER and treated for cellulitis. Given DEMEROL injection for pain and an injection for inflammation and infection. Also given Rxs for oral KEFLEX, Loratadine, and Ibuprofen. If condition not better or worsens in 7 days, return to hospital.
Morning after began severe stuttering with facial tics, twitching eyes, shaking and was completely gone on the 4th day, as suddenly as it began. Dx'd over phone and given steps for stopping stuttering.
On January 8, 2021 upon waking that morning, had a large red  swollen area where I received injection.  As time when on it became larger in sizeand redder in color and  went completely around my arm.  Saw my family doctor today and he gave me an antibiotic and cream to put on it.  Now itching.
Pt had a syncope event 5 minutes after administration. Called 911. Pt laid down on the ground and no injury was found during the incident. Pharmacist and his girlfriend assisted patient. Pt was conscious and blood pressure, pulse, and breathing was normal.  EMS arrived and his vitals were normal. He sat down approximately 10 more minutes and was able to stand up.  He declined to hospital and walked with assistance of EMS and his girlfriend.
Developed lightheadedness after vaccine that lasted 20 min. No facial paralysis or motor symptoms . Symptoms resolved after 30 min. Patient ambulated on his own without difficulty. No symptoms at discharge .
Fatigue the next day, then extreme joint pain, extreme headache, difficulty in breathing, foggy feeling in brain, allergy symptoms, weakness
increased intraocular pressure; corneas were inflamed; bilateral eye pain; achiness; headaches; Sore throat; coughing; Initial information was received on 16-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or other non-professional (patient).  This case involves a 65 year old female patient who experienced increased intraocular pressure (with symptoms of eye pain and headache), corneal inflammation (Keratitis), achiness (pain), sore throat (oropharyngeal pain) and coughing (cough), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient had received the INFLUENZA VACCINE [flu shot] for many years and the first time she received the regular dose she reacted to it, just felt achy (pain) and had a sore throat (oropharyngeal pain). It was reported that patient had received FLUZONE HIGH DOSE [lot number: UJ243AD, expiry date not reported] in 2019. Medical history, medical treatment, concomitant medication and family history were not provided. It was reported that, the patient was allergic to formaldehyde [Drug hypersensitivity].  On an unknown date, the patient received a 0.5 (unit unspecified) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number and expiry date not reported] via an unknown route at the left arm for prophylactic vaccination.  On 13-Sep-2020, the patient developed a non-serious sore throat (oropharyngeal pain), achiness (pain) and coughing (cough) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.   The patient took some ALEVE [NAPROXEN SODIUM] and felt decreased these events.  On 13-Sep-2020, the patient felt severe bilateral eye pain (eye pain), headaches, corneal inflammation (Keratitis) and had increased intraocular pressure, (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.  The patient was treated with Prednisolone eye drops.  It was reported that, the patient was recovering from reported events.   There will be no information available on the batch number for this case.
This spontaneous report as received from a 76 year old female patient with high blood pressure regarding herself. The patient had no drug reactions or allergies. On 11-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, and dose were not reported) in the left arm subcutaneously. Approximately on an unspecified date in March 2013, the patient developed a red dot at the vaccine site, left arm, that was about 2 inches x 3 inches. The patient sought no medical attention. No laboratory test was performed and no treatment was given. The reporter stated that it had subsided to about a 50 cent piece. The outcome of the event was reported as recovering/resolving. The reporter wanted to know how long it would last. Additional information is not expected.
Breakthrough case admission after 3 vaccine Moderna 2/8/21 lot# 013M20A;  Moderna 3/8/21 lot# 030A21A;  Pfizer 11/15/21 lot# FH802
No adverse event; Maternal exposure during breast feeding; This spontaneous case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and NO ADVERSE EVENT (No adverse event) in a 41-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.  On 18-Nov-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Nov-2022, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 18-Nov-2022, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. At the time of the report, NO ADVERSE EVENT (No adverse event) outcome was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding).    No concomitant and treatment medications were reported.   Reporter did not allow further contact
Noted large reddened area of Lt deltoid after receiving TDAP and FLUZONE in the same arm.
She was having difficulty breathing after receiving the first shot, could not breathe; Very tired afterwards; Carotid artery sore and hurting her; This is a spontaneous report from a contactable consumer. An 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date (reported as 3 weeks ago) as single dose for COVID-19 immunisation. Medical history included she was a cardiac patient and has chronic obstructive pulmonary disease (COPD), immune system disorder (taking Synthroid). The patient's concomitant medications were not reported. It was reported that the patient was having difficulty breathing after receiving the first shot on an unspecified date. She was hard of seeing she couldn't find her albuterol pump, so the daughter gave her oxygen. The daughter spoke to the cardiologist and pneumologist. They advised her that it's not an allergic reaction and the patient can take the second dose of the vaccine. It was further reported that night, the patient woke up out of sleep and was very tired afterwards. The patient never had experienced this before, but her left carotid artery was very sore and hurting her and could not breathe on an unspecified date. It woke her out of a sound sleep. When the patient woke up that night, she was looking for her inhaler. She has an oxygen concentrator. Between that and the albuterol, that helped calm her down. The patient was concerned with any respiratory issues she might have. The patient was terrified if she already was compromised after the first one to get the second shot. She would like some guidance.  She was worried about second shot and the potential for her to have this happen again. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Lightheaded, metal fog, fatigue, irritable,  felt drugged, continued for over 72 hours.  Heartburn after that (may or may not be related) but not going away with usual methods.
Pt was seen today 5/13/19 complaining of rash, warmth around injection site on (R) arm, and general pruritis. Has been taking Benadryl. Site on (R) arm is 10x15cm - warm, red, and tender. Started on prednisone, doxycycline and triamcinolone.
Patient describes feeling "very dizzy" a few hours after receiving their first Pfizer COVID-19 vaccine. No other symptoms noted by the patient at this time.
Injection site pain; tiredness; chills; fever; joint pain; feeling unwell; swollen lymph nodes; This is a spontaneous report from a contactable consumer (Patient). A 56-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0173, patient was not pregnant at the time of vaccination), via an unspecified route of administration on an unspecified date (at the age of 56-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No covid prior vaccination, no Covid tested post vaccination. On 27May2021, the patient experienced injection site pain, tiredness, chills, fever, joint pain, feeling unwell, swollen lymph nodes. The outcomes of events were recovering.  No follow-up attempts are possible. No further information is expected.  Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.
Received expired vaccine beyond 12 hours after puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after puncture) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after puncture). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.
Red, swollen injection site Welt two-three inches below site; not connected directly to site Fever of 101 Aches Chills Difficulty breathing- needed rescue inhaler Fatigue
5 hrs after injection pt felt like sx of nausea, chills, fatigue and body aches.
On 1/17/2021 had sudden onset SOB and tachypnea. Was in ER 1/18 and 1/19. Required 10l low flow/high flow nasal cannula to slow respiratory rate. Was discharged home requiring oral steroids antibiotics and inhalers. Cause I know but could not rule out delayed response  to vaccine had covid test x 5 all negative
Of note, patient had received J&J vaccine 3/17/2021 (approx 8 months prior), this was the Moderna to boost him. He had vaccine in the morning; that same night, his symptoms started: subjective fevers, chills, body aches. Later, facial swelling. He came to the hospital, where he was noted to have gross lab abnormalities (below). He remains hospitalized, quite sick. Overall, no other explanation for his sudden symptoms and apparent multiorgan dysfunction (including oliguric renal failure), other than the vaccine.
Case number PHHY2013US041470, is an initial literature report received on 23 Apr 2013. This report refers to multiple patients of unspecified age and gender. Patients with heart failure were recruited in a consecutive fashion from a heart disease clinic. Patients enrolled had a diagnosis of heart failure and were stable on guideline-based heart failure therapies for at least 1 month and had previous immunization with the influenza vaccine. This study enrolled patients during the 2009/2010 influenza season. The patient's were randomized in a permuted block fashion and were stratified by age (greater than or less than 70 years old), to receive a Standard Dose (SD) of 15 mg/strain of the 2009/2010 influenza vaccine or a Double dose (DD) containing 30 mg/strain administered by intramuscular injection. Antibody responses were determined by haemagglutination inhibition assay, which measured serum influenza antibody concentrations. More participants in the SD group took beta-blockers (100% vs. 67%, P 1/4 0.013). A few other numerical differences included higher use of the combination of hydralazine and isosorbide (8% and 31%, P 1/4 0.06), use of diuretics (50% and 81%, P 1/4 0.08), and use of digoxin in the standard dose group (8% and 63%, P 1/4 0.07). Seroprotection rates at 2-4 weeks did not differ between DD and SD groups (A/H3N2 100% vs. 93%, P 1/4 0.38; A/H1N1 91% vs. 80%, P 1/4 0.45; B-type 73% vs. 67%, P 1/4 0.74). The rates of seroconversion were higher in the DD group compared with the SD group for the A/H3N2 strain (92% vs. 56% for A/H3N2, P 1/4 0.04), and numerically but not significantly higher for the A/H1N1 (75% vs. 50%, P 1/4 0.17) and the B-type strain (58% vs. 25%, P 1/4 0.35). There were no significant differences in antibody responses between participants older (n 1/4 6) or younger (n 1/4 22) than 70 years of age. Seroprotective antibody titres remained for 77% and 87.5% of participants in the SD and DD groups, respectively. The most common adverse event was injection site soreness, which occurred in three individuals per group. Two participants in the DD group experienced severe soreness. One participant in the SD group experienced muscle aches. The author concluded that patients with heart failure randomized to a DD of influenza vaccine exhibited higher initial antibody titres to A/H3N2, A/H1N1, and B-type antigens. At 4-6 months post-vaccination, absolute antibody titres were similar between DD and SD groups but well above seroprotective levels. These findings suggested that higher doses of influenza vaccine might be more protective in heart failure patients and should be further evaluated in larger randomized outcomes trials.
Severe pain at site, arm, fingers, and shoulders for the first couple of days; and then itchiness of legs.  April 27- manifestation of rash behind both knees and upper calves.  April 30 swelling and edema in both calves.   May 1- Swelling to left foot. Symmetrical pain in pressure points.  May 2- Severe swelling to both feet, and both calves (left side, which was injection side, was worst on lower extremities). Right eye was almost swollen shut. Left eye was beginning to swell. Severe swelling to face, neck, jaw, and throat, as well as tightness of throat. Anaphylactic reaction. Emergency room visit on the May 2,   May 3 was a bad day, filled with pain in joints and pressure points, as well as swelling in feet and calves.  Followed up visit to pcp on May 4. Still have rash, itchiness, and swelling of lower extremities.  Today, May 8, still experiencing swelling, pressure point pain, and manifestation of rash, as well as it's itchiness.