chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extremely swollen lymph nodes; Body aches; Lethargy; Over sleeping; Trouble staying awake; Headaches; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 15Apr2021 at 15:45 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included paroxetine hydrochloride (PAROXETINE HCL) and calcium carbonate (MANUFACTURER UNKNOWN), both taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 25Mar2021 at 16:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 04:00, the patient experienced extremely swollen lymph nodes, body aches, lethargy, over sleeping, trouble staying awake, headaches and dizziness. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely swollen lymph nodes, body aches, lethargy, over sleeping, trouble staying awake, headaches and dizziness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Left posterior thigh swollen and tender to touch for 2 days, even after ice applied. Documentation shows that immunization was given in left deltoid. Mother states one was given in left deltoid and one in left thigh.
This spontaneous report as received from a physician refers to an 11 years old female patient. On an unknown date, the patient was vaccinated with GARDASIL (lot# not reported). No other co-suspects were reported.  Concomitant medications included tetanus toxoid (manufacturer unknown) and meningococcal vaccine (manufacturer unknown). Then the patient experienced a brief period of shaking, lost consciousness and could not hear. The patient also became very pale in color but all the reactions subsided shortly after without any treatment. The patient received the GARDASIL injection as well as the tetanus toxoid (manufacturer unknown) and meningococcal vaccine (manufacturer unknown) on the same day.  The patient did not sought medical attention. The outcome was reported as recovered/resolved. Upon internal review, lost consciousness and could not hear were determined to be the medically significant events. Additional information has been requested.
nausea is not huge; soreness is not huge; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reported for herself. A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Feb2021 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced soreness was not huge and nausea was not huge in Feb2021, she just wanted to know if she can take pain relievers. The outcome of events was unknown.   Information on the lot/batch number has been requested.
Received a dose of Pediarix on may 3rd, 2020 instead of Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 1-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 2KD4D, expiry date 8th May 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Hib (Hiberix).   On 3rd May 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 3rd May 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device and an unknown time after receiving Hiberix, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The health care professional reported that the patient received a dose of Pediarix instead of Infanrix, which led to wrong vaccine administered and also received a dose of Hiberix on the same day of vaccination. The vaccines were given at her 15 month wellness visit. The reporter consented to follow up.
Headache started about 12 hours following and remained constant increasing in severity over the following days becoming a migraine that lasted for 18 days. With that, visual regression, light sensitivity, burning eyes, sensitive to smells and nausea. Extreme fatigue started on day three, disassociation, overly emotional, small rash began on the right arm (hive response) that spread across the chest, torso, left arm and groin area and legs. Foggy headed, chest pain, strong heart palpitations, difficulty breathing. Sore throat, cough, chest pressure, clogged ears, eye pain, full body aches, mental fog, shakes, diarrhea, lack of coordination, full body/joint pain, cold with the inability to get warm. Low BP. Symptoms progressively got worse as each day passed.
Seven year old patient was received Quadracel/No AE; Initial information was received on 29-Jun-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 7 year old male patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided. It was reported that patient was not vaccinated since he was one year old.  Patient received concomitant medications included HEPATITIS A VACCINE (HEPATITIS A), and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE, VARICELLA ZOSTER VACCINE (MMRV).  On 19-Jun-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot C5656AA, expiry date: 13-Aug-2021] via an intramuscular route at the right thigh for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration.   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 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.
Noticed right side of tongue was numb and then noticed right side of face was distorted, unable to blink right eye and move checks and lips as usual.
Very bad uncontrollable shaking for more than an hour.  hands & teeth feet.  Dizzy.   Much, much worse than symptoms after second shot March 23/2021
This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received ENGERIX B (batch number 3B93H, expiry date 26th September 2015), (batch number AHBVC148BB, expiry date 8th September 2014) and (batch number FB3A3, expiry date 28th January 2016). Co-suspect products included HAVRIX (batch number N434L, expiry date 19th February 2016), (batch number 793JR, expiry date 15th February 2016) and (batch number PC527, expiry date 8th June 2015) and INFANRIX (batch number AC14B153AA, expiry date 18th September 2014). On an unknown date, the patient received ENGERIX B. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received HAVRIX. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received INFANRIX. On an unknown date, an unknown time after receiving ENGERIX B, HAVRIX and INFANRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Public Health Nurse called on behalf of office to find out the stability of INFANRIX, ENGERIX-B and HAVRIX after being exposed to temperatures above recommended storage range (up to10.2C) intermittently for 232 hours. Vaccine doses have been given to patients. HCP did not have information about these patients available.
Patient received the Moderna shots before Pfizer COVID-19 vaccine bivalent shot; 3rd time patient had Covid was in Dec2022,; 3rd time patient had Covid was in Dec2022,; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation.  Patient received the 2 Moderna shots, caller unknown the specific name of product, just knows it was the Moderna original 2 shot series. Then patient had either 1 or 2 boosters that caller thinks were also Moderna. Then the patient received Pfizer COVID-19 vaccine bivalent shot in either late Sep2022 or early Oct2022. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: 1st time patient had Covid was prior to patient receiving the Modera shots or the Pfizer COVID-19 vaccine bivalent shot.; "COVID" (unspecified if ongoing), notes: 2nd time patient had Covid was after patient received the 2 Moderna shots, was 8 or 9 months later.; "anemia", start date: Mar2022 (unspecified if ongoing), notes: diagnosed early last year. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "3rd time patient had Covid was in Dec2022,"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Patient received the Moderna shots before Pfizer COVID-19 vaccine bivalent shot". The patient underwent the following laboratory tests and procedures: Antibody test: no autoimmune disease, notes: test recently and found patient has no autoimmune disease.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Pfizer adult Bivalent given to a 5 yo.  It was her first dose of covid vaccine.
Patient received Pfizer COVID 19 vaccine on 3/31/21 and was inadvertently given Moderna COVID 19 vaccine on 4/1/21.
pt recvd vax; fever 1 wk later; throat itching; broke out w/ rash on stomach;
Breakthrough COVID infection. Patient fully vaccinated 03/12/2021. Patient tested positive for COVID on 09/08/2021.
Patient received a COVID-19 vaccine at the COVID vaccination clinic. The vaccines were shipped to destination from starting point, addressed to 2 people who were hosting the vaccination clinic. The vaccination were alarming in transport and both Pfizer and other company both told the people that the vaccines were no longer viable and should not be given to the patients. Due to a lack of and miscommunication, 5 patients received the vaccines.
Shot at 16:15 - swelling started around 1800 - 1950. Had swelling on her face and her lips - no resp. distress. Took BENADRYL x 2 and next AM swelling in face gone but legs still swollen.
Swollen neck on the left side, maybe a lymph node; Third dose/ Booster dose; Off-label use; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Oct2021 at 14:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications included pentosan polysulfate sodium (ELMIRON) and an unspecified vitamin; both for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Feb2021 (at the age of 44-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27Feb2021 (at the age of 44-years-old); both as a single dose for COVID-19 immunisation. On 15Oct2021 at 13:00, the patient experienced swollen neck on the left side, might be a lymph node. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen neck on the left side, maybe a lymph node was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Multiple outbreaks of herpes zoster; Information has been received from a lawyer regarding a case in litigation referring to a currently 83-year-old patient (pt). The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. On or about May 2010, pt was vaccinated with zoster vaccine live (ZOSSTAVAX) at a local pharmacy (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, pt was treated by local providers for multiple outbreaks of herpes zoster (Herpes zoster) which resulted from zoster vaccine live (ZOSTAVAX)'s use. Pt claimed damages as a result of injury to themselves and economic losses. At reporting time, the outcome of herpes zoster was unknown.
It started with extreme stomach cramping and gas pains that lasted for about a week. I them had enlarged lymphnodes and developed pain and swelling under my left armpit. I now how intense joint pain and am having trouble using my hands & fingers. I t also hurts to walk.. even my toe joints are sore.
ANKLE ALMOST GAVE OUT; LEFT EYE HAD REDNESS LIKE A BROKEN BLOOD VESSELS OF THE 3MM SQUARE SIZE AREA AND RED SPOT IN EYE; HIP PAIN ON RIGHT SIDE; PAIN IN BOTH KNEES WHEN WALKING OR GOING UPSTAIRS; SORE ARM IN LEFT; This spontaneous report received from a patient concerned a 57 year old male. 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: 202A21A and expiry: 21-SEP-2021) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-SEP-2021, the patient experienced sore arm in left. On 20-SEP-2021, the patient experienced pain in both knees when walking or going upstairs. On 01-OCT-2021, the patient experienced ankle almost gave out. On 01-OCT-2021, the patient experienced left eye had redness like a broken blood vessels of the 3mm square size area and red spot in eye. On 01-OCT-2021, the patient experienced hip pain on right side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm in left, and the outcome of pain in both knees when walking or going upstairs, ankle almost gave out, hip pain on right side and left eye had redness like a broken blood vessels of the 3mm square size area and red spot in eye was not reported. This report was non-serious.
Guillian Barre syndrome; High inflammatory markers; This is a spontaneous report from a non-contactable consumer or other non-HCP. A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose number unknown single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Events took place after use of product. On an unspecified date in 2021, the patient experienced high inflammatory markers, suspected Guillian Barre syndrome. The symptoms began around 40 days after vaccine, he had reported to Pfizer and another regulatory authority. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
1/12 vaccination About 4-5 hours later, I started feeling like I was going to black out; tightness in my chest. Could see little black dots. I pulled over as I was driving. I got off the interstate and was on the phone with my daughter. She told me to call 911, I put my head down and laid down. The ambulance got there, my daughter was there, and they could feel the skipping of beats. My BP was up, my HR was irregular. I still had the tightness in my chest. The medic said I am going to give you some nitro to see if would help with the tightness. I felt like I was going to black out. Arrhythmia was noticed on the monitor; EMT gave me a jolt of  and it immediately stopped the dysrhythmia. Transported to ER, inpatient overnight. Medical team decided I could go home, set up with follow up appt. Put me on a echo, stress test, HR monitor for a month (caught one episode and it lasted 1 hour in the middle of the night).  *i feel better but once in a while I get the lightheadedness and can feel the skipping.
A bumpy, itchy rash that has been all over his torso front & back & a little bit on the arms; Itchy rash; The rash started on his right side, then went to the front of his; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (A bumpy, itchy rash that has been all over his torso front & back & a little bit on the arms), RASH PRURITIC (Itchy rash) and RASH (The rash started on his right side, then went to the front of his) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 007M20A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced RASH PAPULAR (A bumpy, itchy rash that has been all over his torso front & back & a little bit on the arms), RASH PRURITIC (Itchy rash) and RASH (The rash started on his right side, then went to the front of his). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PAPULAR (A bumpy, itchy rash that has been all over his torso front & back & a little bit on the arms), RASH PRURITIC (Itchy rash) and RASH (The rash started on his right side, then went to the front of his) was resolving.            No concomitant medication were reported.   The date of his 1st dose was not written on his vaccination card, but he thinks it was in January of 2021.  About a week after getting the booster dose he began getting a bumpy, itchy rash that has been all over his torso front & back & a little bit on the arms.  It seems like it's was clearing up now.  He has used calamine lotion & a lotion prescribed by a dermatologist.  He does not have the contact information for the dermatologist with him at this time but could provide that for her & the vaccination facility if he receives a form.  The rash started on his right side, then went to the front of his torso, then left side, then into armpit area, then collar bone, which is itchy but no longer bumpy, then upper back.  The bumps are sort of like poison ivy but not patchy like poison ivy.  He says that the areas on his arms have been in the same place on each arm at the same time.
Cellulitis left arm.  Keflex 500mg, TID for 10 days.
Patient received J & J vaccine on Saturday April 3rd.  On Sunday he developed a fever of 102 fever and chills.  On 4/6 he developed vertigo.
Warmth at injection site; Induration at injection site; Redness at injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site warmth in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number K72SN, expiry date 30th June 2020) for prophylaxis.   On 8th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular) .5 ml. On 9th October 2019, 1 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site warmth, injection site induration and injection site erythema. On an unknown date, the outcome of the injection site warmth, injection site induration and injection site erythema were recovering/resolving.   It was unknown if the reporter considered the injection site warmth, injection site induration and injection site erythema to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient developed induration, redness and warmth at the injection site. The red indurated area was 6cm x 5cm. The patient returned to the clinic on the day of reporting to have the healthcare professional take a look at her arm.
Patient had bowel movement after waking up and going to bathroom. He fainted, calling for help to his parents on his way down to the floor. Parents found him on floor cognitively responsives but not moving body (He does not remember anything after coming to kneel on floor). Parents found him clammy. Mother called 911 and was instructed to keep him lying on floor. He complained of being cold but was sweaty. Blanket placed over him on floor and kept there until EMS arrived. Patient c/o nausea.  They got him into rolling chair and was going to leave when he had another episode of dizziness, clammy and nausea. EMS transported him to hospital. Blood work was done with no abnomalities noted. Upon discharge he complained of headache. Nausea dissipated upon eating and some ginger ale.  Patient had previous had "covid arm" with first injection but no other complaints.