chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Headache; Tiredness; Body ache; This is a spontaneous report from a contactable consumer, the patient. A 67-years old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: en6206) via an unspecified route of administration in the left arm on 06Mar2021 at 09:00 (at the age of 67-years-old), as a second single dose for COVID-19 immunisation. The patient's medical history included T2diabeties, high blood pressure and asthma. The patient had allergy to erythromycin. Concomitant medications included insulin (MANUFACTURER UNKNOWN), dulaglutide(TRULICITY), Lisinopril (MANUFACTURER UNKNOWN), Amlopine (MANUFACTURER UNKNOWN) and paracetamol(TYLENOL) were taken for unknown indications received on unknown dates. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lo t number: el9266), via an unspecified route of administration in the left arm on 13Feb201 at 09:00, for COVID-19 immunisation. On 07Mar2021 at 11:00, the patient experienced chills, headache, tiredness, body ache, continue to experience extreme tiredness where the patient had to lie down various time throughout the day. The was patient had doctor or other healthcare professional office/clinic visit due to the adverse events and patient did not received any treatment for the adverse events. The clinical outcome of chills, headache, tiredness and body ache were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt recv vax on 3/23/98; on 3/24/98 pt exp pallor, 7x6 cm warm swelling at site of injection,  and 14x14 cm erythema.  As of 4/23/98 pt recovery is unknown.
extreme facial swelling; extreme facial hives; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING FACE (extreme facial swelling) and URTICARIA (extreme facial hives) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concurrent medical conditions included Ulcer and Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, AMOXICILLIN for Tooth abscess, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced SWELLING FACE (extreme facial swelling) and URTICARIA (extreme facial hives). At the time of the report, SWELLING FACE (extreme facial swelling) and URTICARIA (extreme facial hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included Benadryl
fever; chills; severe headache; severe muscle and joint pain; chest tightness; mild nausea; lungs felt inflamed, making it difficult to take deep breaths; unable to sleep; severe muscle and joint pain; This is a spontaneous report from a contactable health care professional (patient).  A 29-year-old female patient recived the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EK4176) via an unspecified route of administration on 12Jan2021 at 08:45 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies.  Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL], manufacturer unknown), vitamin B12 (manufacturer unknown), vitamin c  (manufacturer unknown), melatonin (manufacturer unknown), biotin (manufacturer unknown) and elderberry [sambucus nigra] (manufacturer unknown). The patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EJ1685) on 22Dec2020 at 9:00 PM on the left arm. The patient did not receive other vaccines in four weeks. The patient reported that after her second dose, she began experiencing severe side effects around 5:00 pm the same day (about 7 hours after the dose was administered). These side effects were fever, chills, severe headache, severe muscle and joint pain, chest tightness, and mild nausea. She also added a difficult symptom to describe, but her lungs felt inflamed, making it difficult to take deep breaths. These symptoms lasted for 36 hours unabated, and she was unable to sleep, go to work, eat, or go about daily activities during this time. After 36 hours, the fever, chills, headache, and nausea subsided, but the muscle and joint pain and chest tightness persisted. It has been 50 hours since her second dose and the muscle and joint pain and chest tightness still persists, although its severity is reduced and it is not preventing her from work or daily activities.  The patient did not receive any treatment for all the events. The outcome of the events severe muscle and joint pain and chest tightness was not recovered while the outcome of the other events was recovering.The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination.
Started with cough and runny nose, then tightness in chest (used inhaler) then shivered for 3 hrs. Followed by fever and heart rate that went from 80 to 110 in two hrs at which point I went to the er
Pt is 30 yo female s/p full Moderna COVID vaccination: dose 1 on 1/22/2021 and dose 2 on 2/19/2021. Pt is an employee of this institution reporting new onset headache, sore throat, and congestion/runny nose. She confirms possible exposure to COVID-19. Pt has agreed to receive casirivimab/imdevimab infusion.
Initial report received from a healthcare professional on 26 September 2012. A 21-year-old pregnant female patient, whose concomitant medications and medical history was not reported, had received first dose of intramuscular (IM) ADACEL (Lot number U4421AA, Expiry date of vaccine 18 January 2015, anatomical site of vaccination was not reported) on 26 September 2012. The patient had her last menstrual period on 18 February 2012 and the expected date of delivery was reported as 24 November 2012. As per reporter the patient did not experience any adverse event. The previous pregnancy history and other medical history were not reported. List of documents held by the sender: None. Follow-up information was received from a healthcare professional on 02 August 2013. Based on the new information, this case has been upgraded to serious. The patient also received AFLURIA during pregnancy (lot number, route, site and date of administration not reported). The patient experienced severe pre-eclampsia during pregnancy. End of pregnancy was 16 October 2012 with a normal birth outcome/infant. Outcome was not reported.
It was reported that on 10/3/01 a 4 month old patient received an IPOL vaccination lot #92030 administered in right thigh. Patient also received DT, lot # 470641 and Hib lot # 0343L vaccination. Some time after administration the patient developed redness, swelling and a lump at the injection site of the right thigh. This was noted on physician visit 10/9/01. The physician prescribed acetaminophen and ice packs. Second follow up scheduled week of 10/22/01. Physician reported no acute or chronic illness or medication at time of immunizations. Indicated a possible reaction to the pertussis component of the DTaP shot at 2 months of age. From follow up information received on 9/24/02, it was stated from the physician that the patient is no longer seen by him. His office has since closed and the physician no longer has access to the patient's records. The adverse event coding was updated to include injection site reaction and injection site mass. It was not reported whether the patient recovered. The case is closed.
p/vax pt devel a blister @ the inj site; MD does not know if it is varicella because pt was not seen in office;
Developmental speech apraxia with sensory integration/ fine motor control issues. Occupational therapy until 02/26/2002. Speech therapy ongoing, Mild Autism
03/26/2001 - enlarged lymph nodes in groin; 04/03/2001 - enlarged lymph node in right arm; 04/05/2001 - continued above symptoms and stiff joints in knees, ankles, hips and painful left and right hands/wrists; 04/10/2001 - seen by PMD for labs/evaluation; 04/14/2001 - ER visit due to pain in hands; treated with Neurontin; 04/15/2001 same as above and treated with Percocet and Nortriptyline
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/23/2021, 2/11/2021, and 9/28/2021. Per patient recent diagnosis of COVID on 12/29/2021 and then again on 1/18/2022. On 1/26/2022, presented to the ED for shortness of breath, admitted for acute hypoxic respiratory failure due to Covid PNA. Received vitmin C, budesonide, cholecalciferol, steroids, and zinc. Patient's respiratory status continued to decline status changed to DNR/COT on 2/1/2022. Transitioned to comfort care on 2/2/2022 and expired at 1911.
Patient called pharmacy day after vaccine and complained of sore arm. Subsequently Injection site became swollen and red. Now, Patient has rash to down below elbow. Pharmacy made aware of rash on 2/17/17.
Rash on back, pain, fatigue. Very similar to shingles. Dr. is unsure if it is shingles or an adverse reaction since rash is not blistering.
Left leg - red, swollen, warm to touch, thigh area, 4 cm in size, raised
I immediately felt dizzy, like I was drunk. At around 4pm, I started feeling wheezy. It felt like there was a mastiff sitting on my chest. I took some benadryl, which helped. The next day, the feeling persisted and I had a mild cough, especially while lying down. More benadryl. Same on the third day. I did not seek medical attention because I didn't think it was an extraordinary reaction and I have had much worse reactions to other things in the past that have been managed with benadryl. I thought what I was experiencing was an expected side effect based on the information I had been given. The feeling started to ease by the 4th day, but then the insomnia, mood swings, exhaustion and body aches set in. The cough was sporadic, but still present. Today, I still get the heavy chest feeling intermittently, activity doesn't seem to have any effect or cause. My arm still itches at the injection site and hurts when touched.  I went back to get my second dose on 4/9. When the nurse asked me if I had had any adverse reactions to the first one, I told her about the chest heaviness and coughing and the other symptoms. She stopped what she was doing and called her medical director. They both decided that the first response was enough of an anaphylactic reaction to be a caution for the second. They refused to give me the second dose because they thought the second would elicit a much worse reaction - possibly to the point of intubation. They told me that I would have to be evaluated by a physician and that I would need a "doctor's note" in order to get the second vaccine.
Emesis, fever of 102.3; fatigue. Emesis started about 10 minutes following final injection. Fever controlled with acetimenophen and ibuprofen. Additional fluids given, appetite severly decreased.
mom called HD 8/11/06 stating child's arm (left) red and swollen. Appointment made to see Dr. ASAP. Seen per Dr. 8/11/06. Left arm moderate ecchymosis 8cmx8cm left lateral deltoid. No hematoma, slightly warmer than surrounding skin.
body aches; terrible headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (body aches) and HEADACHE (terrible headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (body aches) and HEADACHE (terrible headache). At the time of the report, MYALGIA (body aches) and HEADACHE (terrible headache) 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 did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported
I contracted COVID-19 on 06/24/2022 with symptoms of irritated throat, and mild headache. I was prescribed Paxlovid on 06/25/2022. My symptoms initially resolved on 06/25/20022. On Day 7 of my illness a slight headache returned and I developed a runny nose. I am still experiencing a slightly runny nose, and slight headache but they are not as prominent.
This spontaneous report as received from a nurse refers to a 14 year old female patient, with no pertinent medical history and no drug reactions or allergies, who was not pregnant. On 08-JUL-2014, the patient was vaccinated with a dose (dose number not reported) of GARDASIL lot number J009243, expiration date 23-APR-2016, 0.5 ml, intramuscularly as a routine vaccination. There were no concomitant medications. On 08-JUL-2014, the patient experienced bilateral leg pain after receiving GARDASIL. No treatment was given for the adverse event. There were no lab diagnostics studies performed. The patient did not seek medical attention. The outcome of bilateral leg pain was reported as recovered after about a week (on approximately 15-JUL-2014). The relatedness between the bilateral leg pain and GARDASIL was not reported. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment information provided
For her previous vaccinations she had prolonged reactions to the vaccines.She had the worst reaction to the bivalent vaccine.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (For her previous vaccinations she had prolonged reactions to the vaccines.She had the worst reaction to the bivalent vaccine.) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown whether the patient had relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (For her previous vaccinations she had prolonged reactions to the vaccines.She had the worst reaction to the bivalent vaccine.). At the time of the report, IMMUNISATION REACTION (For her previous vaccinations she had prolonged reactions to the vaccines.She had the worst reaction to the bivalent vaccine.) outcome was unknown.            It was unknown whether that patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine or not. No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2023-748669, MOD-2023-748676 (Patient Link).   Reporter did not allow further contact
she had developed an headache; fever; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) on 28-Dec-2020.  This case involves a 39-year-old female patient who developed a headache and fever (pyrexia), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included paracetamol (Tylenol).  On 27-Dec-2020, at 11: 30 the patient received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at a dose of 0.5 ml via intramuscular route [lot number: unknown and expiration date: unknown] for prophylactic vaccination.  On 27-Dec-2020, By 19:00, 7 hours after initiation of the suspect, patient had developed an headache and fever (pyrexia).   The patient was treated with Acetaminophen.  She stated that the headache had resolved but the fever had not. She reported her temperature as 101.4F.  There will be no information available regarding batch number in this case.
Fever, chills? ultimately now have myocarditis. Chest pain. Rapid heart beat.
I am a menopausal woman with last date of period August 2019.  On 4/7/21 I developed abdominal bloating and cramping related to menstruation.  On 4/8/21 I developed mild mucous vaginal discharge with blood streaks.  Thereafter, I developed tan discharge for a few days.   I've continued to have upper GI pain for the next 2 weeks.  I went to the ER on 4/18/21 for lab work up and they performed a right upper quadrant Ultrasound. I have a GI appointment today for further work up.
Pt received DTAP Rt upper IM and Flu vaccine Rt lower IM on 9-30-09 about 4:30pm. Mom called the office about 4:00 pm on 10-1-09 and stated area was 1/4"-1/2" raised and hard. about 1 1/2 inches in diameter and red. Warm to touch. She will call office on 10-02-09 if pt has a change and gets worse.
Varicella vaccine given on 4/1/13 left upper deltoid SC. Pt reported localized redness and swelling at injection site on 4/2/13 at 5:02pm. Pt did not want to come in for eval. S/S of infection and anaphylaxis reviewed. Tx ice compress, elevation, and ibuprofen.
Information has been received from a registered nurse concerning an elementary school aged child who on 21-MAR-2000 was vaccinated with a dose of varicella virus vaccine live. On 04-MAR-2006, the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
About 3hrs after 6 month vaccines administered pt had some difficulty breathing. Color changes and tremors. Transported via EMS and given O2.  04/17/2007 VAERS report received with records attached for a 2 night hospital admission 03/29-31/2007 for c/o a reported episode of decreased responsiveness and dusky color witnessed by the infant's grandmother 2 hours after receiving vaccinations.  Grandmother also reported shaking.  Child was transfered to the hospital via EMS.  O2 and Albuterol nebs were admisnitered in the field with improvement in symptoms. PE: Temp 103.1F Rectally. 2/6 systolic ejection murmur.  Lung sounds (+) for upper airway noises otherwise WNL. No further spells during hospitalization.  To be followed as an outpatient. Discharge DX:  1) Spell.  2) Fever with Upper Respiratory Sx.  3) Possible Seizure.
Confusion,  anxiety,  elevated heart rate and blood pressure,  swollen throat, fatigue
Rash all over under left arm, skin very tender, hurt, reaction occurred the Monday after the shot (shot was given 7/30/18). Pt thought it was mosquito bites, then saw lots of papules on her skin left arm and some on back. Made appointment to see Dr on 8/15/18. Dr diagnosed it was shingles.
not received second dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 03 February 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received second dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-SEP-2023 The reporter stated that she got her first dose of Shingrix and had not yet received her second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
vaccine exposed at below 30-32 F for one hour due to opening and closing of refrigerator door/no AE; Initial information was received on 19-Jun-2020 regarding an unsolicited valid non-serious case from a physician.  This case is linked with cases 2020SA161184, 2020SA161064, 2020SA161181, 2020SA161182 and 2020SA161203 (same reporter).  This case involves a 2 month old female patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was exposed at below 30-32 Fahrenheit for one hour due to opening and closing of refrigerator door (product storage error).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 10-Jun-2020, the patient received first 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ015AAA and expiry date 26-OCT-2020) via unknown route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to product storage error temperature too low.  At the time of reporting, 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 holder's 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.
Pt recvd 2nd dose of Hep B vax 25JAN91 & 2 1/2 hrs post vax pt devel generalized pruritic rash; @ time of report, the rash appeared to be subsiding;
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Additional Details: Patient has a mark on arm; is worried that it will scar.  She began noticing itching 2 days after dose.  Has been intching and painful since then
pt states he had the normal side affects on the first day after taking the vax but today 4/8/2021 when he woke up he had chills and his entire body feels numb. Including his face, both arms, torso, both legs and both feet.