chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was pretty weak/Felt very weak; bad headache; fever; Nausea; couldn't eat anything; dry heaves; pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), FEEDING DISORDER (couldn't eat anything), RETCHING (dry heaves), ASTHENIA (I was pretty weak/Felt very weak) and HEADACHE ( bad headache) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 012M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol, Acid reflux (oesophageal) and Blood pressure. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), TELMISARTAN for Blood pressure, EVOLOCUMAB (REPATHA) for Cholesterol.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (pain in arm). On 28-Aug-2021, the patient experienced FEEDING DISORDER (couldn't eat anything), RETCHING (dry heaves), HEADACHE ( bad headache), PYREXIA (fever) and NAUSEA (Nausea). On 29-Aug-2021, the patient experienced ASTHENIA (I was pretty weak/Felt very weak). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in arm) was resolving and FEEDING DISORDER (couldn't eat anything), RETCHING (dry heaves), ASTHENIA (I was pretty weak/Felt very weak), HEADACHE ( bad headache), PYREXIA (fever) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated that reaction from this previous dose was worse and more intense.   This case was linked to MOD-2021-302268 (Patient Link).
Lethargy, low-grade fever the day of vaccines. The next day, had 3 hours of (less than 24 hours) inconsolable crying and low-grade fever then infant was ok.
Pt recvd vax 25FEB92 @ 330PM; @ 530PM began crying felt sick all over cried for 2 hrs went to bed @ 7PM got up @ 10PM fever, chills, pale face w/blue tinge around eyes; no sz, glazed look;
Presented with sylucel - CTA chest showed massive suddle pulmonary embolis, with massive bilateral clot burden. Underwent major surgery requiring sternotomy for embolectomy Hospitalized 7 days, now recovered
Information has been received from a registered nurse concerning her 11 year old daughter with no pertinent medical history who on 28-MAR-2008 was vaccinated with a first dose GARDASIL (Lot # 658556/1060U). There were no concomitant medications. On 28-MAr-2008, several hours after vaccination she developed  a rash. The rash covered her body except her face and neck. The patient required an office visit and was treated with BEABDRYL. The rash resolved in 3 to 4 days. Additional information has been requested.
Patient presents with two days increased tenderness in the arm, swelling, supraclavicular lymphadenopathy. No fevers or chills. No erythema or fluctuance noted. Normal ROM of left shoulder.
10/08/2008 Patient received FLUVIRIN and PNEUMOVAX administered to left deltoid.  Approximately 15 minutes later developed chest pain, back pain, loss of vision, and weakness lasting 20-25 minutes.  Patient states hospital told him he had a reaction to one of the vaccines probably, other treatment unknown.
Information has been received for the pregnancy registry for GARDASIL from a pharmacist concerning her 23 year old daughter with no pertinent medical history and no drug reactions/allergies who on 24-NOV-2008 was vaccinated the first "standard dose" of GARDASIL. The second dose of GARDASIL was vaccinated on 24-JAN-2009 and the third dose of GARDASIL was vaccinated on 23-APR-2009. Concomitant therapy included birth control pill. The patient received GARDASIL and became pregnant. The last menstrual period was on 29-APR-2009. The patient delivered a female baby on 03-FEB-2010. The apgar score of the baby was 9. On an unspecified date, the baby experienced elevated bilirubin and was resolved within 1 week. The mother's experience has been captured in WAES# 0907USA00774. Additional information has been requested.
He felt like he was going to pass out, like he was disoriented; He felt like he was going to pass out, like he was disoriented; He experienced disorientation; Itchiness on the abdomen area, knees, and toes; Feeling weird; feeling overwhelmed; Like itchy or pins and needles all over his body; Lightheaded; This is a spontaneous report from a contactable consumer (patient himself). A 39-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6207), via an unspecified route of administration in right arm on 25Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's prior vaccinations included tetanus shot on 09Feb2021. On 28Mar2021, 2 days after taking the first dose, the patient experienced reactions from the vaccine which included Itchiness on the abdomen area, knees, and toes and disorientation and went to emergency room for treatment. The patient wanted to know whether these are normal side effects of the vaccine. Upon follow-up on 28Mar2021, the patient reported that he felt weird after receiving the vaccine and lightheadedness. He told the nurse that he didn't eat before getting the vaccine. And wasn't sure if getting the vaccine was like having blood drawn so he hadn't eaten anything. The nurse told him he might be feeling lightheaded because he didn't eat and she gave him some lollipops and the patient felt much better. The patient also stated that on 28Mar2021, he was feeling overwhelmed and cannot describe the feeling. It was like itchy or pins and needles all over his body. The patient felt like he was going to pass out, as he as disoriented. The patient stated that he went to the Emergency Department. They kept him overnight, checked his heart, did some blood work, checked his blood sugar, gave him a Covid 19 test. The patient stated that everything came back normal. The Emergency Department concluded that the events could be due to the Covid 19 vaccine and described that his system was fighting the Covid 19 vaccine or something. The patient was asking if this is normal. He was also asking for a copy of this safety report for work purposes. The patient went to the Emergency Department on 28Mar2021 (around 7pm) and was in observation overnight. He was discharged from the Emergency Department this morning, 29Mar2021 at around 11:00AM. The patient confirmed that he was not hospitalized. The patient stated that he may be overthinking about the events and really paying attention to his body. He thinks he needs to rest as he was in the Emergency Department for a long time. The patient lab test included Blood sugar test. The outcome of the events was resolved for dizziness, unknown for feeling abnormal and overwhelmed and not resolved for other events.  Information on lot/batch number obtained. Additional information has been requested.
Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment information was provided.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-AUG-2018, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # R000301, Expiry date : 29-AUG-2020) 1 DF for prophylaxis (product storage error). Temperature was reported as 20 F and time frame was 5 days. There was no previous temperature excursion. The call was due to data logger. There was no adverse effects were reported. No product quality complaint was involved. This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-1808USA007503:
Nausousness, Chills and Sweats, Dry Mouth, and Severe Lactic Acid build up in the Shoulder Blades
Employee received the 2nd COVID-19 vaccine shot in the morning with no immediate reaction.  Employee did wait the 30 minutes for observation purposes and went home.  Employee went home and started to feel short of breath and called 911.  Paramedics administered Epi via an Epipen.  Employee recovered and was not transported to the hospital.
Fever to 103 F within 12 hours of vaccination. Fever lasted 72 hours.  96 hours after vaccination exanthem all over body.
red spot expanding to the size of a grapefruit; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was recovered/resolved.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient had red spot expanding to the size of a grapefruit also occurred following 1st dose Shingrix at an unspecified date, but not flu-like symptoms. The reporter consented to follow up. The reporter did not collect the date or vaccine details of 1st Shingrix dose. For tolerances of 2nd dose, refer case US2019179897 and linked with US2019179912, reported by same reporter.
STAYED IN BED ALL DAY; NAUSEOUS; BAD HEADACHE; This spontaneous report received from a parent concerned a 43 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: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021, the patient experienced stayed in bed all day. On 07-APR-2021, the patient experienced nauseous. On 07-APR-2021, the patient experienced bad headache. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) High Immunity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stayed in bed all day, nauseous, and bad headache on 07-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210852035.
5 days after shot - Extreme exhaustion 7 days after shot - swelling, heat, redness, itchiness (Covid Arm)
Patient got vaccine and within a few days had all the classic side effects such as pain, redness, swelling at injection site. However, she also developed small blisters around the injection site that were painful to the touch, red and inflamed.
Pt developed submandibular gland swelling and fever with 1st shot in the series. Her MD recommended she receive the 2nd (or continue the series) on 4/2/01. At 14:00, she received the 2nd vaccine and again developed glandular edema unilateral within 24 hours. No fever.
felt very sleepy, muscle fatigue, slept most of next 24hr, fever 104 for about 24 hr; client came to clinic to receive dose #3 on 20JUl95 & it was not given due to these reported rxn in FEB95
Information has been received from a physician who reported that her mother was talking with her friend, a at least 75 year old patient who was vaccinated with a dose of ZOSTAVAX (Merck). Subsequently the patient experienced a rash. At the time of the report, the patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested
clotting; welts; This spontaneous case was reported by a consumer and describes the occurrence of COAGULOPATHY (clotting) and URTICARIA (welts) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine and Pfizer vaccine. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COAGULOPATHY (clotting) and URTICARIA (welts). At the time of the report, COAGULOPATHY (clotting) and URTICARIA (welts) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Dosage text was reported as Unknown. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-735551, US-MODERNATX, INC.-MOD-2023-735554, US-MODERNATX, INC.-MOD-2023-735567 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735551:Same reporter US-MODERNATX, INC.-MOD-2023-735554:Same reporter US-MODERNATX, INC.-MOD-2023-735567:Same reporter
When I took this vaccine the next day my body was aching especially my arm. Then on the 5th I have been experiencing nosebleed n stuffy nose. I am still experiencing this now. Today is the 15 of February. Mine you I took this vaccine on the 3rd of February.
Hives covering body that last multiple days (have not left) ease with Benadryl but return. shortness of breath (wheezing).
about 10 minutes after injection, whole tongue and roof of mouth went numb.  This self-resolved.
Pt vomited.  BP 142/73, HR 54, RR 17 -- > 136/68, 50, 16.  Pt in stable condition after one emesis episode.  Pt stayed for 25mins observation and ambulated out with family at her side. Vitals WNL. Pt A&O x3.  Pt stable and released from the vaccination site.
Herpes zoster post vaccine. Patient hit head on bath tub per mom and it's the only place the herpes zoster appeared.
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from an other non health professional (reported as office staff). This case involves a 5 years old patient of unknown age who had egg allergy received a dose of vaccine FLUBLOK QUADRIVALENT (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's past medical history included Food allergy. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to inappropriate age at vaccine administration. It was not reported that if any adverse event was occurred or not. It was also reported that Officer Manager refused to provide any AE information. Stated that they have their own internal way of managing these 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 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. List of documents held by sender: none.
This spontaneous report was received from a doctor of pharmacy refers to a 60 years old female patient with no pertinent medical history and no drug reaction or allergies, who on 26-JUL-2012, was vaccinated subcutaneously with a dose of ZOSTAVAX (dose and lot number not reported). No other co-suspects were reported. Concomitant medications included CYMBALTA and acyclovir. The pharmacist reported that on 28-JUL-2012, the patient stated on two-inch by two-inch red patch developed around the injection site. By 29-JUL-2012, that same two-inch patch was blistering and the redness had wrapped around her entire arm in a two-inch band. No labs diagnostics studies were performed. The patient took BENADRYL which helped. At the time of the report, the patient had not recovered. The patient sought medical attention by calling the pharmacist. The relatedness for a two-inch by two-inch red patch developed around the injection site was now blistering, and redness and wrapped around her entire arm in a two-inch band was unknown for ZOSTAVAX. Additional information has been requested.
I started getting headache, nausea, face swelling, and dizziness episodes. I went to the doctor, they did blood work and found positive A and A in my blood. This is still ongoing.
Local area of erythema about 3-4cm on left deltoid area around shot site; non-tender. Moving arm normally.
Fatigue, muscle and joint pain, chills, rash, fever, extreme burning sensation located on and around the injection area.
This is 86-year-old female patient Came into the ER with a complaint of edema of legs going on for last few days Worsened over in 24 hours Patient has a history of DVT when she was diagnosed with breast cancer 11 years ago
The vaccinating nurse accidentally administered to the patient 0.3 ml of undiluted Pfizer COVID-19 vaccine instead of  0.3 ml of the diluted vaccine with 1.8ml of normal saline. Patient was informed and the patient said he is currently fine and has no adverse reaction yet with the vaccine even though he got a higher dose.
Employee here with COVID vaccination site reaction. Left arm below deltoid and to the posterior is red, swollen, warm to the touch, and itching. The area measures 6 X 5 cm. States noticed redness2 days after vaccination and worsened 12/29/30. No medications have been taken so far. Advised to try conservative measures first cool compress, OTC IBU and Benadryl. The site was outlined in pen. Advised if reaction worsens to be seen by PCP or urgent care.
Mom states redness & "some puffiness" noted last night at bath time. States she gave patient BENADRYL at that time. Mom brought patient to clinic 9-20-12 0810 2" x 2" red bound reaction noted on (R) deltoid area.
Mild headache, muscle stiffness, lack of energy, Uncontrollable shaking chills overnight followed by low grade fever.
At a routine office visit on Sept 30 the patient complained of some shortness of breath on exertion.  He states he first started noticing it about May 2021.   During the work-up a CT of chest was done and the following was found:  There is a nearly occlusive thrombus of the distal right main pulmonary artery extending into right lower lobar, segmental and subsegmental pulmonary arteries.  Occlusive thrombus in the right upper segmental and subsegmental pulmonary arteries.  Nearly occlusive embolus in the left lower lobar, segmental and subsegmental pulmonary arteries.
got the shot on my left bicep muscle.  By night, extremely sore and had a large red square where I got the shot.  The area was also hot.  I applied ice and gave some comfort.  Now, 10 days, later, it's very itchy, still warm and has raised bumps.  A little splotchy red, also.
Woke up with 1 swollen finger on left side in the morning. It looks red and felt somewhat painful, but patient doesn't think it's due to a bug bite or cut, she thinks it's due to the vaccine.  She does not report any itching, facial swelling, difficulty breathing, or any other symptoms.  Just a red swollen finger. I advised her to take a Benadryl to see if that helps, but also call her doctor to see if they want her to come in and have it looked at.
Patient presented to pharmacy for appointment of first Shingrix vaccine. I reviewed medication/vaccination history in dispensing system and vaccination history in vaccine registry to be sure patient had not received additional doses. I asked patient to confirm if she had ever received a vaccine for shingles before. She told me that she had received the old vaccine years ago, which matched what I saw in system that she had received a dose of Zostavax. We briefly discussed the vaccine, when to come back for the second dose, and what to expect later for side effects. She interrupted me a number of times and told me not to discuss what I was doing because she didn't want to know when I was going to administer the shot. She sat with her back to me. After the vaccination, she came back over to the pharmacist terminal and asked me if she could have a print out of all of her vaccines. I could not see anything in her history before 2 years ago, so I gave her the information that I had for her.  She told me she thought her doctor had incomplete records and asked if I could go back beyond 2 years. I was unsure at the time how to print the report and she said it wasn't urgent to have and that she could come back another day, so I reached out to my supervisor. I called her after I printed the report later that day, and discovered that this was her third dose of the series.  I told her again about side effects and told her that the extra dose was not going to give her extra protection. The patient later presented to the emergency room that night, and was discharged around 4am per a different conversation with staff at the store the following day.
Severe soreness at injection site, redness, warmth at injection site. C/O pain that was all the way down her arm rated 9/10 and bringing her to tears.
Initial report received on 27 February 2009 from a physician. A 4-year-old female patient, whose past medical history was not provided, had received a dose of DAPTACEL on an unspecified date. The lot number, route and site of administration were not provided. At an unspecified amount of time later, the patient experienced what "sounded like an anaphylactic type reaction." At the time of this report, the physician was not at his office and did not known the specifics of the reaction. It was not reported whether the patient required hospitalization. The patient did recover (date not provided). Documents held by sender: None.
Aunt called health department stating that Friday 6/3/05 the child's neck had 2 bumps then he had rash on bottom and than 2 days later blisters appear red on hands - aunt not aware of any fever - stated child acts like he feels fine.
Urothelial carcinoma of kidney. Procedure and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.