chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Restless and crying on the night of the shots. Fever was up to 102F with diarrhea. Next morning, still had fever of 102F and diarrhea. Returned to office on 4/26/01 with temperature up to 103F. DTAP reaction versus viral illness, per doctor's notes.
Within an hour of vaccination, swelling of arm, warmth, and pain that radiated from injection site; took 2 Acetaminophen, iced injection site. Within two hours of vacc., onset of chills, fatigue, and nausea; went to bed. Slept hard for four hours, woke with 100 deg fever, neck- and headache, weakness, pain increase in arm, which had swollen and hardened. Took 400 mg Ibuprofen, hot tea, returned to bed. Slept hard. Following morning, continued all symptoms, added severe joint pain. Fever to 102.2 on Sunday. Continued cycling acetaminophen/ ibuprofen / icing injection site. Monday A.M. could not get out of bed without help. Phoned doctor to report symptoms. Advised to continue as I was going with rest/ med / ice, and avoid pertussis vaccine in future. Tuesday much the same as Sun & Mon, but no further nausea. Wed, was strong enough to get out of bed, headache and joint pain mostly gone, swelling in arm subsided from size of grapefruit to about regular orange, but with hoarseness in throat, slight wheezing; Wed eve took 2 Benadryl for swollen throat, wheezing. Thurs fever back to 101, severely swollen throat, wheezing, beginning of cough. Determined to visit doctor Friday if no improvement. Arm less swollen Thurs eve (about size of Clementine only, could tolerate touch). Friday AM, woke with still swollen throat, cough, mild wheezing, 100 deg fever, arm only golfball swelling. Will see doctor for assessment/ further recommendation.
Sore throat, headache, nausea/vomiting, muscle aches and pains, drowsiness, confusion
All started 2 days after injection Severe Headache, Diarrhea , Chills, congestion nose
Six hours after receiving the fist shot of the Moderna vaccine there was pressure in my head that made my ears stuffy. My arm also started to hurt at this time.  23 hours after the shot I felt extreme fatigue, dizziness, stiffness and pain at the injection site, and nausea. The nausea was intensified after looking at a computer screen.  48 hours after the vaccine the fatigue reduced but the dizziness and nausea were still there. I vomited from looking at a computer screen for a work meeting 59 hours after the vaccine was administered. The nausea was caused by pressure in my head and also caused the stuffy ears and dizzy feeling.
PATIENT REPORTS CHILLS, MUSCLE ACHES, AND SEVERE NAUSEA, VOMITING, AND DIARRHEA STARTING 8 HOURS AFTER VACCINATION.
Information has been received from a healthcare worker concerning a 61 year old white female with a codeine allergy who at 3:45 on Mar 17 2005 was vaccinated in the left deltoid with a second doses of pneumococcal 23v polysaccharide vaccine (first dose administered in approximately 1995) (lot 648139/0009P). It was reported that the patient has an ear infection at the time of vaccination. At 4:30 on Mar 17 2005, the patient developed redness, swelling, soreness, and hotness to touch at injection site traveling to the elbow. The patient had a limited range of motion and area was tender to the touch. Unspecified medical attention was sought. the symptoms subsided in 4 days. The patient recovered on Mar 23 2005. No additional information is expected.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a adolescent female patient who received BEXSERO. Co-suspect products included Meningococcal ACWY Vaccine (potential MENVEO)). On an unknown date, the patient received BEXSERO and Meningococcal ACWY Vaccine (potential MENVEO). On an unknown date, less than a month after receiving BEXSERO and Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced injection site pain, injection site mass and injection site redness. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the injection site mass and injection site redness were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site mass and injection site redness to be related to BEXSERO and Meningococcal ACWY Vaccine (potential MENVEO). Additional details were reported as follows: The age at the reporting was 16 years old. The age at vaccination was not reported. the reporter emailed a GlaxoSmithKline Sales representative who then emailed a GlaxoSmithKline Medical Science Liaison on the same day who contacted the GSK response center. It was reported that, she had given one of her daughters BEXSERO along with the meningococcal vaccine (MCV4) to a 12th grade student. The GSK Medical Science Liaison said that she spoke with the reporter the reported commented that her daughter's arm became sore at the injection site after receiving the BEXSERO vaccine and the reporter told her that her daughter also had somewhat pink, not bright red, know on her arm at the injections site which lasted 4 to 5 days and then resolved. The reporter commented that she does not plan in the future to give her daughter a 2nd dose of BEXSERO vaccine. The GSK Medical Liaison had no further related details to provide. The GSK Medical Science Liaison said that the reporter gave permission for GCSP to contact her further related details.
rapid heart rate and tingling/numb face; low grade fever; extreme fatigue; arm that received injection increasingly tender upon touch  began ~15 minutes after injection; all but tingling has continued through today (3/19) at one week; fever and arm pain improving but rapid heart rate upon any exertion and painful arm continuing
Immunization given 6/20/01, MMR and Td same day symptoms. Lungs burning, throat burning with mucus gathering in back of throat. Pt states 6/21/01 was hoarse and couldn't went to ER. X-ray taken of lungs, x-ray neg per pt. Was given? 4mg. Pt stated 6/22/01 was better.
Hives started on Monday. Hives weren't improving with over the counter medication. Having screen rays when something touching her skin.
Injection site swelling about 1 and 1/4 inch diameter with rash surround area and upper arm.
This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported that a female patient of an unspecified age received PREVNAR 13, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient stated, "I need to talk to someone about the pain I'm feeling after the shot", on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible; information on the batch number cannot be requested. No further information is expected.
Information has been received from a physician concerning a 12 year old female who, approximately 3 months ago, on approximately 22-JUL-2007, was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (DTaP). On approximately 22-JUL-2007, after the administration of HPV rL1 6 11 16 18 VLP vaccine (yeast) the patient's heart rate speeded up, she got shaky and woozy but did not faint. The patient was laid down in the office, lights turned down and was monitored. Subsequently, the patient fully recovered from heart rate speeded up, got shaky and woozy. Additional information has been requested.
Per Patients Wife  - Same day - Flu like symptoms, Nausea, Headache.  Restless that night.  Next day - Weak, shortness of breath.  Wife called squad to get him out of his wheelchair but patient refused hospital as it gets him agitated.  Patient passed away around 11 AM the day after vaccination.
From initial info received on 7/16/04 from an RN regarding an adverse event occurring in the USA, it was reported that a 69 year old female pt received a dose of TD ADS ADULT, lot U1185AA, expiration date 3/15/06, administered in the right deltoid on 7/8/04. Route of administration was not reported. Eight days later, the pt developed a 3" circle on her right deltoid at the site of injection, which was red, swollen and hot. The pt requested that the nurse report this event. Pt's recovery status was not reported.
COVID-19 symptoms; headache; coughing; fever; chills; lost sense of smell, nausea; muscle aches; fatigue. Also my oxygen levels was 80 I was admitted for Hypoxia and was given infusions of remdesivir and erythromycin.
pt recvd vax; exp numbness in both feet;29jul,pain in lower back;had discomfort;h/a;following week,became weaker,episodes of stumbling & feeling very heavy limps;22aug,weakness & malaise;lab showed elevated triglcerides & liver enzymes;
Pediarix was administered on 2/10/04 in the left lateral thigh to a 3 month old child.  When the mother returned 2 months later she reported an indentation at the injection site, which she reports as enlarging.  The area of indentation was approximately 5 mm. The mother does not remember exactly when the indentation first occured.   Mother denies any redness, swelling, knots or other problems with any of the vaccinations given.  The patient's physician feels that it is fatty necrosis, which should resolve.
Heart Palpitations; This is a spontaneous report received from a contactable consumer, the patient. A 69-year-old female patient 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 18Mar2021 at 10:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included SYNTHROID for unspecified indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in Mar2021, the patient experienced heart palpitations. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether the patient receive any treatment for the event.  The clinical outcome of the heart palpitations was not resolved at the time of reporting.  Information about lot/batch number cannot be obtained. No further information expected.
light rash (discrete raised red bumps) began on chest & thigh 24SEP93; no fever spots ince in number & in size & on 26SEP93 became darker, blotchy. pt had difficulty sleeping was seen in ER; fuzziness;
Received 12 month vaccines on 5/2 (including varicella vaccine in right thigh) and initially had bruising and a small bump on his thigh, which he has had after other vaccines as well. 1 week after vaccines, however, he developed a red area on his right thigh which became itchy and then developed some an area that looked yellowish, some firmness, and a couple of small papules next to the red area. No apparent pain of this area, and the redness became lighter by the time of presentation to clinic 9 days after vaccination. Had "low grade fever" a couple of days before presentation but was also teething. No fever the past day or so. No other symptoms of illness. On exam on 5/11 there was an erythematous area on right lateral thigh with 2 papules close by, one that looks possibly to be a vesicle; and flat, larger, yellowish papule within area of erythema. Firm, indurated, elongated area 1- 1.5 cm long within area of erythema. Erythema not well-defined. Differential diagnosis included post-vaccine swelling along with mild rash from varicella vaccine, insect bites (possibly spider - looks like 3 bites close together), and cellulitis. Treated for potential cellulitis with cephalexin.
Fever for 3 days from day of immunization then rash developed (maculopapular, red, blanching).
patient called pharmacy with complaints of feeling itchy since the date of the vaccine. instructed patient to start benadryl and contact primary care physician for follow up. patient said she had no other symptoms. she stated she would follow up with pcp and advice us of any changes or new symptoms
Pt. received his second moderna vaccine on 03/05/2021 and his son reported that the pt. passed away after receiving his vaccine.
started crying 5-6 hr p/vax;cried for 2hr family took pt to ER was told rxn was from immun;
left arm stiffness and pain Sunday evening followed by headache that was relieved by 2 tablets acetaminophen.  Monday injection site tenderness and upper arm stiffness increased with small areas of erythema.  Monday stiffness resolved by areas of erythema increased and itchy.  Tuesday areas of erythema pretty much stable in size - located on the upper arm but 4-6 cm from the injection site that now sports a raised area with a small blister. No treatment
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: VOMITING ONCE-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild
On November  16, 2022 the patient came in to receive a Flu  and Pneumovax 23 immunization...the patient's daughter came by the store on 11/19/22 to tell us both of her mom's arms are swollen and irritated.  The patient received Flu in the right arm  and said  it is itching, red, and swollen.  The patient received Pneumovax 23 in the left arm and it is swollen, red, itching, hot to touch, and has small red spots.  The daughter was instructed to give patient Claritin, Pepcid, Tylenol and use a cold compression.
Confirmed Breakthrough   COVID-19 (Moderna) 1 04/29/2021 Hospital Moderna 007B21A   COVID-19 (Moderna) 2 05/26/2021 Hospital Moderna 043B21A
Contracted COVID-19 while hospitalized with ulcerative colitis for two weeks. I was tested on admittance on 05/30 negative, I tested negative again on 6/03 and tested positive 6/06. I experienced no symptoms during my infection and was placed on antivirals.
Information has been received from a nurse concerning a 21 year old female with allergies to amoxicillin and cefaclor and no illness at the time of vaccination who on 16-MAR-2007 was vaccinated intramuscularly with a 0.5 mL first dose of Gardasil (lot 657006/0188U).  During the evening of 16-MAR-2007 the patient developed a fever of 102-103 F, a severe headache, and hallucinations.  The patient was treated with alternating doses of acetaminophen and ibuprofen.  By the morning of 17-MAR-2007, "all issues resolved" and the patient recovered.  Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. No additional information is expected.
PATIENT RECEIVED ONE VACCINE IN EACH ARM- NOT LONG AFTER THE SECOND DOSE THE PATIENT GOT LIGHTHEADED AND SLUMPED OVER IN HER CHAIR. SHE WAS PALE AND SWEATING AND RESPONDED TO AMMONIA INHALANT. SHE WAS NAUSEATED AND GAGGED A FEW TIMES.
At the time of the injection I had some tingling in my arm. I had arm neck and shoulder soreness as well which continued for a few days. A couple of hours after the injection I began itching all over. I deduced that it could be an allergic reaction so I took an antihistamine and relaxed.I did not check for hives as I don't know much about allergic reactions. the Itching went away. On day 8 I had the itching again accompanied by hives.  Once again I took an antihistamine and improved. On day 11 I had itching again and took an antihistamine. The antihistamine did not work as well this time. It is day 12 as I write this.
Nausea, vomiting, flushing, sweating, redness of face, hands chest, lower legs, high blood pressure 180/102 pulse oximeter 97-99. Given 25 mg of benadryl as a liquid. Approximately 4:30 my oxygen level still good and blood pressure was down to 146/75 and pulse 74. Redness was fading. No other problems after this.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information was received from a Medical assistant on 02-JUL-2015 concerning a patient of unknown age and gender who on 14-APR-2015, the patient was vaccinated with a dose of ROTATEQ lot # K011663 (expiration date, dose, route and site of administration were not reported) that was exposed to temperatures outside of the recommended range. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
The patient presents with allergic reaction, skin rash, hives, face swelling and not throat swelling. The onset was just prior to arrival. The course/duration of symptoms is constant. Location: diffuse. The character of symptoms is rash, redness and swelling. The degree at onset was severe. The degree at present is severe. Potential allergen(s) MMR vaccine. Risk factors consist of none. Prior episodes: none. Therapy today: prescription medications including 1 mg/kg BENADRYL. Associated symptoms: none. Additional history: none. 4 YO female with PMH MR presenting to the ED with anaphylaxis. Apparently, just PTA, she was getting a MMRV vaccine when she broke out into diffuse hives and had lip swelling. She was given 1 mg/kg BENADRYL via her PEG tube and immediately wheeled to the ED from her PCP which is in-house. VSS on arrival. Mild lip swelling with diffuse erythema of her skin. 4 YO female presenting with anaphylaxis. Received EPI, BENADRYL, PEPCID, steroids and resolved. Watched for four hours with complete resolution of symptoms. VSS. Well appearing. Steroids, EPI pend and BENADRYL Rxed. Follow up given for allergist. Impression and Plan. Diagnosis: Allergic reaction: Discharge, Medical Plan Condition: Stable. Patient was given the following educational materials: Anaphylactic Reaction, Adult, Epinephrine Injection. Follow up with: Follow up with Specialist Within 3-5 days Please call to set up an appt with an allergist; Within 3-5 days.
Covid positive after the Moderna Covid vaccine was applied; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid positive after the Moderna Covid vaccine was applied) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid positive after the Moderna Covid vaccine was applied). At the time of the report, COVID-19 (Covid positive after the Moderna Covid vaccine was applied) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        The question is if I should apply the second dose on the scheduled date or if I should change it for being positive for COVID after the first dose.
Men B instead of MCV4; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 10-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th May 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 13th May 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, 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 Information: GSK receipt date: 10-May-2022 Reporter's comment: An anonymous provider gave Meningococcal B vaccine instead of MCV4 to a 10-year-old patient. No adverse event details were available. Additional Supportive Information: The patient received Meningococcal B vaccine instead of MCV4, which led to wrong vaccine administered. Follow-up could not be possible as no contact details were available. Note: As event onset was reported and for medication error vaccination date and event onset date will same so in worst approach vaccination date was captured same as onset date. Suspect was coded as Bexsero, clarification was raised for the same.
redness; swelling; pain to the touch; This case was reported by a consumer and described the occurrence of erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2019, the patient received Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced erythema, swelling and tenderness. On an unknown date, the outcome of the erythema, swelling and tenderness were unknown.   It was unknown if the reporter considered the erythema, swelling and tenderness to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  On Tuesday, the patient received Shingrix and experienced redness, swelling and pain to the touch. The patient did not miss the work. The reporter stated follow up was not required. This is 1 of the 3 linked cases, reported by the same reporter.
Headache, Fever, CoughWheeze, Diarrhea, NauseaVomiting, Injection Site Pain an Hot to Tough day 1-3, Vomiting, Headache, Fever, Chills day 2-3, Stomach pain, Diarrhea day 3-6. Cough, SOB day 6-7 Narrative:
On day 8 after receiving Moderna vaccine #1, I developed a very large, red rash near the vaccination site of injection on my upper left arm.  I first noticed it Sunday morning (4/4), and because it was a little itchy, I put some anti-itch cream on it.  That evening,  when getting ready for bed, I noticed it was red and larger.  Mild itching, but I applied more anti-itch cream. Today, the rash is lighter pink in color. I put anti-itch cream on it this morning and it's not bothering me.  As of the time I'm writing this, 1435hrs on 4/5/2021, it's not bothering me and remains a large, light pink rash.