chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 18 year old female with penicillin allergy and no pertinent medical history who on 26-APR-2007, 25-JUN-2007 and 16-NOV-2007 was vaccinated IM at left deltoid with the first (655503/0012U), second (657622/0388U) and third (658560/1062U) 0.5 ml doses of GARDASIL. Concomitant therapy included NUVARING. The nurse reported that the patient experience tenderness of lymph nodes in axilla and neck after the first dose of GARDASIL. After the second dose of GARDASIL, administered on 25-JUN-2007, the same lymph nodes were painful and swollen. The patient was examined by oncologist and family physician (names not provided). One lymph node was removed by oncologist. The third dose of GARDASIL was administered on 16-NOV-2007. She experienced problems with lymph nodes over a 1.5 year period. The oncologist diagnosed her with benign reactive lymph nodes due to GARDASIL. A lymph node biopsy was performed on 24-JUL-2007, and the result was benign. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
02/02/2022 late afternoon COVID symptoms started. I started having an itchy throat and headache in the afternoon, and then late evening into early morning the next day I started to lose my voice and it was difficult to swallow. I called in on the 3rd and was tested. The sore throat lasted a week and the headache lasted a couple of days. That first day I was very nauseous and had some vomiting and diarrhea. I still have a slight cough and I had an issue with my tongue and was told that I had thrush so I was given medicine for that. I just had a check up today because I'm still having issues with my tongue and they don't think it's related even though I didn't have it before. They said it's burning mouth syndrome and gave me other antibiotics to try. The biggest thing is the cough and tongue issue. I was very tired as well.
About 10 min following administration of H1N1 inactivated vaccine, pt. vomited and had syncopal episode. Assessed by paramedic. No LOC. Supine with legs elevated, slowly advanced to sitting, standing. Left with mother. Advised to seek medical care if symp. recur.
I got the shot and got shingles anyway./every now and then/ suspect vaccination failure; got shingles anyway. In my ear and my head of all places; got shingles anyway. In my ear and my head of all places; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster otitis externa (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the herpes zoster otitis externa and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and got shingles anyway in his/her ear and head of all places. The patient stated still a ya up every now and then. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: TINGLING AND PAIN ON MOVEMENT IN SHOULDER JOINT.  PT REPORTS 2-3 DAYS AFTER VACCINE, STARTED HAVING PAIN IN SHOULDER ON MOVEMENT. PT SAID THAT IT FELT LIKE THE RPH HAD HIT BONE WHEN VACCINE WAS ADMINISTERED.  PT REPORTS IT FELT DIFFERENT FROM HIS OTHER VACCINES LIKE COVID.  PAIN AND DIFFICULTY AND LESS RANGE OF MOTION IN LEFT SHOULDER JOINT.  PAIN LEVEL 5-6 WITH MOVEMENT FEELS LIKE ELECTRIC SHOCK.  PAIN ONLY WITH MOVEMENT.  NO PAIN WHEN NOT USING ARM OR SHOULD.
Initial and follow-up information has been received from a physician concerning a 68 year old male with hypercholesterolaemia, depression, oesophageal acid reflux, and no drug allergies, who on 17-OCT-2007 was vaccinated intramuscularly in the right arm with a 0.5mL dose of PNEUMOVAX (Lot# 657526/0555U).  Concomitant therapy included ZOLOFT, NEXIUM and niacin.  On 18-OCT-2007 the patient developed erythema, warmth, and swelling at the injection site of the right arm.  On 18-OCT-2007 the physician examined the patient and noted that the erythema and swelling extended into the right axillary area.  The patient was treated with a warm compress and TYLENOL.  No laboratory diagnostics were performed.  At the time of the report, the patient's outcome was unknown.  No product quality complaint was involved.  This report is one of two reports from the same source.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the agency and was released.  Additional information has been requested.
I had really bad back pain. I was very fatigue. I stayed in bed in for 3 days. I had chills. I went to a clinic to get a COVID-19 test, positive results.
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 03-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot # K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. 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.
Friday morning started Diarrhea, felt like vomiting, night sweats., slight headache. Friday woke occasionally  for sips of water. didn?t feel like water or food.  Continued the diarrhea  until the afternoon.  On Saturday  was able to get out of bed but was very tired,  and no energy.  Just stayed on the couch.  Woke Sunday and felt fine.  The systoms  were the same as when i had Covid in October. I felt as bad.
Information has been received from a nurse concerning a 13 year old female with asthma and no known allergies who in approximately September 2007, was vaccinated SC with a 0.5 ml second dose of varicella virus vaccine live (Oka/Merck) (Lot# 658291/1100U). There was no concomitant medication. It was noted that the patient received the first dose on 02-SEP-1999. On 11-SEP-2007 the patient experienced an injection site reaction which was described as an area of redness approximately four inches in diameter with a cluster of blisters in the center of the circle. The patient was seen at the office. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Initial report received from a healthcare professional on 23 April 2013. A 31-year-old female patient, had received an intramuscular 2nd dose of IMOVAX (lot number H1180-1) in left deltoid on 22 April 2013. The patient's illness at the time of vaccination, allergies, and medical condition were reported as unknown and concomitant medication was not reported. On 23 April 2013 i.e. one day post vaccination, the patient's had complained of neck stiffness, burning and pain in shoulder on the left side. Corrective treatments and complimentary investigations were not reported. The patient's outcome was not recovered. List of documents held by sender: none
6/28/01 - spots on face & back also gums today - white spots on gums. Will not eat solid since yesterday, will take juice. Had fever 101.2F since Monday, tonsil look red, raw meat. Referred to Dr. 6/29/01 reaction to chickenpox per Dr.
Within a few hours of immunization, the patient developed 105.8 fever with Children's Tylenol already administered.  Additional doses were given to get fever down which only lasted for 2-3 hours for 6 days straight.  Child was taken to Urgent care on 04-25-08 and parents were instructed to continue fever reducing treatment.  Fever broke after 6 days.  Baby was in pain and had no appetite along with very high fever.
flu-like symptoms; Headache; swollen glands; pain in breast; pain near kidneys; nausea; vomiting; tiredness; This is a spontaneous report received from a contactable reporter (Pharmacist).  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 68 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: VITAMIN D3. Vaccination history included: Bnt162b2 (swelling and redness for 9 days), when the patient was 68 years old, for Covid-19 immunisation, reactions: "redness", "swelling".  The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 04Mar2021 20:30, outcome "unknown", described as "flu-like symptoms"; HEADACHE (non-serious) with onset 04Mar2021 20:30, outcome "unknown", described as "Headache"; LYMPHADENOPATHY (non-serious) with onset 04Mar2021 20:30, outcome "unknown", described as "swollen glands"; BREAST PAIN (non-serious) with onset 04Mar2021 20:30, outcome "unknown", described as "pain in breast"; RENAL PAIN (non-serious) with onset 04Mar2021 20:30, outcome "unknown", described as "pain near kidneys"; NAUSEA (non-serious) with onset 04Mar2021 20:30, outcome "unknown", described as "nausea"; VOMITING (non-serious) with onset 04Mar2021 20:30, outcome "unknown", described as "vomiting"; FATIGUE (non-serious) with onset 04Mar2021 20:30, outcome "unknown", described as "tiredness". Therapeutic measures were not taken as a result of influenza like illness, headache, lymphadenopathy, breast pain, renal pain, nausea, vomiting, fatigue.  Additional Information: The patient did not receive other vaccine within four weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021244753 Same reporter, patient, and product; Different dose and events
approx 1 hrs p/receiving meningococcal vax & flu vax c/o chest heaviness exam revealed scattered wheezes in upper lung fields; treated w/Epi;
Mom stated pt. broke out in a rash on trunk 3 hrs post injection. Mom stated injection site was free from redness or rash but did report warmth at site.
It was reported that a male patient received a TD Adult vaccination on 25 Jul 2000. Reportedly about 18 hours after the vaccination the patient developed nausea, vomiting, hypotension and syncope. Further information requested.
This spontaneous case reported by a consumer, describes the occurrence of peripheral swelling (legs really swollen after 2nd dose) and fatigue (tired after both doses) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included no adverse event. On Feb 3, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced peripheral swelling (legs really swollen after 2nd dose) and fatigue (tired after both doses). At the time of the report, peripheral swelling (legs really swollen after 2nd dose) and  fatigue (tired after both doses) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Itchiness, redness, and swelling at the site of injection Dizziness, stomach pain, and nauseous after administration
Covid-19 test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 ( Covid-19 test) in a 79-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 ( Covid-19 test). At the time of the report, COVID-19 ( Covid-19 test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication were provided.    Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up information received on 07-Jul-2021 reporter information updated.NNI
26JUN95 redness on both knees & top of feet spread to hands & between fingers; no fever;; no apparent itching; 10JUL95 rxn lasted about 3 days & cleared;
c/o fever aches and chills evening of shot. Was also diagnosed with sinus infection and bronchitis in addition to cellulitis.
LARGE BLACK + BLUE MARK AREA 6" LONG + 5" WIDE TURNED FIRE RED AND HEAT POURED OUT OF IT, SATURDAY + SUNDAY I SAT WITH ICE PACK ON IT MONDAY MORNING I CALLED MY PULMONARY DOCTOR + HE IMMEDIATELY CALLED IN PREDNISONE 20 MG TABLETS AND BANOPHEN (DiPHENHYDRAMINE) 25 MG AFTER 6 DAYS IT WAS MUCH BETTER
delayed rash, sent to EC and treated with antihistamine, H2 vlocker Pepcid, and prednisone, discharged home
The morning after the vaccine I had Orthostatic intolerance-inability to be upright. I was very confused, very nauseous and weak. I was unable to stand or sit upright more than a minute with with severe hypotension, it lasted for about a month or 2. I also had Migraines and headaches constantly the first 2 weeks. I was unable to look at a screen. Migraines are still frequent and headaches are constant. Peeling skin and peeling lips all over. I also have dry mouth and dry throat at night. Dizziness and muscle fatigue and joint pain. After all of this began I saw my doctor 3 weeks after it began.
5 days after the  first shot-severe gastric pain (which went away after 1 hour) and then chills for 5 days & fever & weakness-- ater 5 days, I was 100% ok---  Exactly 5 days after teh 2nd dose, the same gastric pain arose in same spot--lower intestines--followed by onset of  intestinal colitis & severe rectal wall inflammation-- I have no previous history of either--
Mother examined baby's temperature was 104 with hives on face, several hours after receiving vaccines.  Mother took baby to ER.  Received vaccines on 10/23 AM to ER 10/23 PM.
arm tingled; a little pain around the injection site; This is a spontaneous report from a contactable consumer. This female consumer (patient) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 20Dec2020 at 4:00 pm at single dose for COVID-19 immunisation in her left arm. The medical history and concomitant medications were not reported. At 4:00 pm a nurse placed the vaccine in her left arm. When she placed the medication the patient felt a zing and a burning sensation with a tingle down her arm. She didn't say anything, she thought maybe the medication was just a thicker consistency like Betamethasone, which can sometimes burn when injected in the muscle. The patient's arm tingled for about 3 to 5 minutes and then it stopped. The patient felt the medication go in and felt burning and tingling. It's 6pm and the patient feel fine, just a little pain around the injection site. The skin surrounding the injection site was normal in color and cool to the touch. No visible swelling. She personally think she placed the vaccine a little too high and hit a nerve. The outcome of the events was recovered on 20Dec2020 6pm.  Information about Lot/Batch number has been requested.
Information has been received from a licensed practical nurse concerning a 12 month old male with no allergies or medical history who on 07-Nov-2005 was vaccinated in the left thigh with a dose of PROQUAD (lot # 651812/0769R). Concomitant vaccinations on the same day included a dose in the right thigh of PEDVAXHIB (OMPC) (lot # 651665/0482R) and a dose in the arm of influenza virus vaccine (unspecified). The patient's mother called the physician's office on 09-Nov-2005 to report that the child had a fever of 100.4 on 08-Nov-2005. She gave him MOTRIN. The fever went to 102.8 on 09-Nov-2005. The child was seen by the physician on 09-Nov-2005 and his fever was 103. The child was kept in the office and TYLENOL and MOTRIN were alternated to get his temperature down. The last temperature was 101.3. Laboratory tests were performed. A stat CBC was "basically within normal limits," a urinalysis looked normal, and cultures were pending. The child was seen on 10-Nov-2005 by the physician and had some chest congestion and was fussy. Albuterol syrup was ordered and the mother was told to call if there was any change. It was noted that therapy with PROQUAD  was discontinued. At the time of the report, the patient was recovering. A product quality complaint was not involved. Fever, chest congestion, and fussy were determined to be other important medical events  by the reporter. Additional information has been requested.
WENT TO ER ON 09/02/06 FOR A WEEK ADMISSION. PT WAS HAVING SEIZURES DUE TO THE VACCINE. HOSPITAL DX PT WITH MENINGITIS. records received for DOS 09/04-09/07/2006 DC DX: Aseptic Meningitis Admitting DX: meningitis.  Prior to admission had 5 episodes lasting approximately 5 seconds each in which she flexed both her arms and legs and appeared stiff. In between episodes she was somewhat groggy. Temp 95 degrees rectal. No HX of fever, rash vomiting diarrhea. In ER received Decadron 3 mg and Rocephin 250mg. During pregnancy mom positive for GBS and HX of human papilloma virus.  PE: WNL skin: medial side right ankle small approximately 5mm erythematous somewhat of a papule.  RX in hospital with IV Vancomycin, Ceftriaxone and Acyclovir. Developed diarrhea secondary to antibiotics.
Initial report received on 30/Jan/2006 from a health care professional. A 50 year old patient with a history of allergy to Codeine, had received her first intramuscular injection of DECAVAC, lot number U1676AA, in the left arm, her first intramuscular injection of Menactra, lot number U1877AA, in the right arm and her first subcutaneous injection of YF-VAX, lot number U8664AB, in the left arm on 25/Jan/2006 at 16:35. One day later on 26/Jan/2006 at 23:00 she experienced a possible allergic reaction to the vaccines. She was seen in the emergency room with a possible rash to her arms and stomach that was accompanied by a fever and headache. She was prescribed Prednisone and Tagamet, but at the time of this report, the prescriptions had not been filled. The patient had recovered from these events at the time of this report.
Blood seepage and clot from nose. After expelled blood clot, no blood seepage from nose until after 2nd Moderna vaccine (May 5 to May, 14 2021 #048B21A). Expelled blood clot from nose again. No blood seepage from nose after expelling blood clot.
Extreme left arm pain.  Site is redden and warm to touch.  Low grade fever.  Head ache. Loss of appetite   I had a hard time sleeping. I just took Tylenol.
4MAR92 devel fever 105 10 days p/MMR was given & fine rash to abdomen was noted & pt taken to ER because of a sz;
flu like symptoms, headache, fever, sore arm, body ache; dizzy, nauseous, memory issues
full body rash; Benadryl not effective.  Prednisone seemed to help with reaction for first vaccine dose, - treating with that again.
Fingertips are cold; Muscle pain in hip area; Feel super cold; This non-serious case was reported by a consumer via call center representative and described the occurrence of cold hands in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18-SEP-2023, the patient received the 1st dose of Shingrix. On 21-SEP-2023, 3 days after receiving Shingrix, the patient experienced cold hands (Verbatim: Fingertips are cold), muscle pain (Verbatim: Muscle pain in hip area) and feeling cold (Verbatim: Feel super cold).  The outcome of the cold hands, muscle pain and feeling cold were unknown.   It was unknown if the reporter considered the cold hands, muscle pain and feeling cold to be related to Shingrix.     It was unknown if the company considered the cold hands, muscle pain and feeling cold to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-SEP-2023 The reporter reported that the patient received Shingrix vaccine on Monday, and on last night 21st September 2023 experienced to feel super cold, her fingertips are really cold and had muscle pain in the hip area. The reporter did not consent to follow up.
Pt devel n,v,d following vax w/Hep B vax; No further details were provided;
Fussy, intermittently, inconsolable baby, not sleeping, decreased feeding even after day 5 since vaccines given.
At site of Hib vaccine, 3-4cm area of swelling, erythema, very tender, developed within one hour of administration. Infant broke back to my office, so I saw it. Resolved after 3-4 hours without treatment. Follow up on 12/10/03: "This reaction was only related to the HIB site."
felt like her chest had fluid and pressure; This is a spontaneous report from a contactable consumer (patient) via Pfizer.   A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration on 25Feb2021 as dose 1, single for covid-19 immunization. The patient's medical history concomitant medications were not reported. Patient reported she had her first dose of the covid-19 vaccine on 25Feb2021, afterwards felt like her chest had fluid and pressure on an unspecified date inquiring if she should receive the second dose. The outcome of event was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Chills for close to a couple hours, light-headed, heart beating fast and past out. Same day of vaccine: sore shoulder, bump and tender around injection area and difficulty lifting arm above head. Vaccine was in left shoulder.
recieved shingrix vaccination on 3/11/23.  minimal local reaction next day.  however 6 days latter adeveloped a burning sore in righr groin crease. I am a physician but could not see it owing to position.  My wife a retired rn looked and saw what looked like a "skin tear"  in the groin crease.  it was treated with aquaphor and seemed to heal.  However  4 to 5 days latter when  was able to hike developed a painful what felt like chaffing in groin crease.  On inspection  by wife there ws no apparent redness or irritation and original sore was healed.  I treated it with vasoline or Aquaphor and these helped but continued to be irritated. on returning home saw dermatology and it all appeared normal. Despite normal appearance it continued to be sore??  I am a physician my self and at that point i began to look for another explanation.  It occured to me perhaps i had had a mild shingles attack and was left with a form post herpetic neuralgia with chief feature being pain from mild rubbing skin in groin crease. Gp treated with neurontin and worked well!!