chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning a female patient over 60 years old who on 17-APR-2007 was vaccinated SC with a dose of Zostavax (Merck). On 19-APR-2007 the patient developed a hematoma that started to spread down her arm down to the injection site. The patient had called the pharmacy on same date to report the event and was told to go to the local hospital. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
From moments after injection, dizziness and nausea, lack of focus, tingling sensation throughout body, injection site pain and body aches, vivid dreams, elevated heart rate during sleep (150bpm), difficulty pronouncing some words, unaware of date and time, fatigue. Nausea, lack of focus, dizziness and tingling sensation improving, but still happening at the time of this report.
Information has been received from an office manager concerning a 7-year-old female patient with no relevant medical history nor drug allergies, who on 05-NOV-2008 was vaccinated IM with a dose of 0.5 ml PNEUMOVAX (lot number unknown) in the right deltoid. There was no concomitant therapy. Subsequently (date not specified) she experienced swelling and tenderness at the injection site. The patient was seen in the office on 08-NOV-208 and was prescribed (AUGMENTIN). No laboratory test were performed. The patient has recovered on an unspecified date. This is one of several reports received from the same source. Additional information has been requested.
High fever up to 104. Rash: localized to trunk only, chest stomach, some in groin, nothing on extremities.
Information has been received from a nurse concerning a 24 year old female who on an unspecified date was vaccinated with the first dose of GARDASIL and at the end of February 2008 was vaccinated IM in the arm with the second 0.5 ml dose of GARDASIL.  The patient passed out after receiving the first dose of GARDASIL.  The patient had what was described as a "high anxiety" response after receiving the second dose of GARDASIL.  The patient reported both hands and legs went numb.  The patient "stiffened up" and began breathing rapidly and crying hysterically.  No treatment besides observation and supportive methods for either episode.  Unknown medical attention was sought in the physician's office.  Patient outcome was recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
Patient had flu vaccine (Flulaval Quad Lot# 4TM23)  on 9/8 at Cardiology office. Came to PCP office following day for routine follow-up with no concerns. Wanted updated vaccines for asplenia. Patient had vomiting in the evening of 9/9 and then was lethargic and weak with hypotension requiring ICU level care with pressor support due to sepsis, AMS, secondary adrenal insufficiency, and acute CVA.
Received first dose of Moderna 2/26/2021.    She returned to clinic on 3/17/2021 thinking her second dose was due in 3 weeks.  She provided her vaccine card to the staff and received her 2nd Moderna vaccination 19 days following the first dose.   She experienced muscle aches, nausea and a headache following 2nd dose.  Denies other side effects.
Ongoing Stomach cramps; Nausea; bloating; lethargy; foul smelling gas; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is 2nd of three reports.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced ongoing stomach cramps, nausea, bloating, lethargy, foul smelling gas on an unspecified date. The outcome of all events stomach cramps, nausea, bloating, lethargy, foul smelling gas was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
PATIENT EXPERIENCED SOME COVID-19 SYMPTOMS BUT THE CALLER WAS NOT SURE WHAT THE SYMPTOMS WERE SPECIFICALLY; A HUGE BUBBLE FORMED AND WENT DOWN ON THE AREA ADMINISTERED ON THE LEFT LOWER FOREARM DESCRIBED AS ON THE TOPSIDE WITH THE PALM FACING UP DUE TO BEING ADMINISTERED INTRADERMALLY; ACCIDENTAL ADMINISTRATION OF THE JANSSEN COVID-19 VACCINE INTRADERMALLY; IMMEDIATE PAIN SORENESS AT THE INJECTION SITE AND COMPLAINED THAT THE NEEDLE HURT WHEN IT WAS INSERTED INTRADERMALLY; This spontaneous report received from a parent concerned an 18 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intradermal, batch number: Unknown) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-JUL-2019, Laboratory data included: COVID-19 antigen test (NR: not provided) positive. On 09-JUL-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) negative.  On 24-AUG-2021, the patient experienced a huge bubble formed and went down on the area administered on the left lower forearm described as on the topside with the palm facing up due to being administered intradermally. On 24-AUG-2021, the patient experienced accidental administration of the janssen covid-19 vaccine intradermally. On 24-AUG-2021, the patient experienced immediate pain soreness at the injection site and complained that the needle hurt when it was inserted intradermally. On 25-AUG-2021, the patient experienced patient experienced some covid-19 symptoms but the caller was not sure what the symptoms were specifically. Laboratory data included: COVID-19 antigen test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a huge bubble formed and went down on the area administered on the left lower forearm described as on the topside with the palm facing up due to being administered intradermally on 24-AUG-2021, had not recovered from immediate pain soreness at the injection site and complained that the needle hurt when it was inserted intradermally, and the outcome of accidental administration of the janssen covid-19 vaccine intradermally and patient experienced some covid-19 symptoms but the caller was not sure what the symptoms were specifically was not reported. This report was non-serious.
Patient reeived third dose; had an episode where he could not breathe  / could not get air in for about 45 seconds; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (had an episode where he could not breathe  / could not get air in for about 45 seconds) and EXTRA DOSE ADMINISTERED (Patient reeived third dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A, 047C21A and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV infection. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for HIV infection, AMLODIPINE, IRBESARTAN, BIOTIN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (had an episode where he could not breathe  / could not get air in for about 45 seconds). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Patient reeived third dose). In April 2021, DYSPNOEA (had an episode where he could not breathe  / could not get air in for about 45 seconds) had resolved. At the time of the report, EXTRA DOSE ADMINISTERED (Patient reeived third dose) had resolved.            In concomitant medications, Daily vitamin was also reported. No treatment details were reported.  It has been reported that, caller says it is not true - that he had no issues whatsoever with the vaccine. Agent reviewed with the caller the previous case but he stated that he didn't report anything.   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow-up received, updated patient comment into inarrative
Patient developed left leg limping several days after vaccine administration.  No ambulation for 1 - 2 days.  Remained afebrile.  She was somewhat fussy and appeared in pain whenever she was put down to walk.  On follow-up examination, she ambulated well, but with a mild limped gait favoring the left leg.  Vital signs were stable.  Naproxen 100 mg every 8 hours was prescribed for 1 week duration.  A follow up appointment was recommended when her Naproxen medication course was complete, or sooner if fever develops and/or no symptomatic improvement results.
After only an hour outside in low 60s weather, I had felt symptoms similar to heat exhaustion. My vision got extremely spotty, and couldn?t see much. There was a loud ringing in my ears and everything else sounded muffled. I felt dizzy and my skin felt like tissue paper.  It faded after I went inside and got water. However, I still have a headache, 6 hours later.
Under my right arm(armpit) is very sore, it?s sore to touch with a little swelling, I had the injection on Saturday and I woke up this way on Sunday morning
I have not had a normal period in about two months. I was very regular before this and I made sure I wasn?t pregnant but I am also using the Paraguard IUD.
Pt RTC the next day with bruises & pain on her R thigh & buttock area.  Then on 1/19/10 pt RTC to be seen @ the clinic, which at that time the provider find out that the patient developes shingles.
Vaccine was retrieved from pharmacy on the morning of 12/9/2021.  It was mistakenly grabbed from the area of the refrigerator that had been partitioned off for recently expired vaccine that is separate from the active vaccine refrigerator area.  Vaccine was brought to clinic in a temperature-controlled cooler that stored the vaccine at refrigerated temperatures (36F to 46F).  Vaccine was reconstituted and drawn up to administer.  Pharmacist gave vaccine and documented data.  It was discovered that vaccine was expired at this time.  Any additional vaccine from expired vials planned to give was postponed and remaining vaccine wasted.  No adverse effects noted post administration.  Called pharmacy who ensured expired vaccine was removed completely to prevent any further errors.  Notified facility administration to notify staff member affected for follow-up.  Followed guidance to contact manufacturer regarding error and gain additional information.  Will follow-up with facility and patient tomorrow to make sure there have been no adverse effects/events post administration.
Covid-19 treatment; Covid-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 5 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Menieres Disease" (unspecified if ongoing), notes: Other medical history: Menieres Disease , high blood pressure; "high blood pressure" (unspecified if ongoing), notes: Other medical history: Menieres Disease , high blood pressure. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Started symptoms 7 days after full dose of paxlovid and tested positive again the next day. Horrible congestion and sinus/head pressure. Didn't have these symptoms with the original week of covid , which were extreme body aches and fatigue. No known allergy.  No follow-up attempts are possible. No further information is expected
aching & pain in back & hips bilat;also lt shoulder pain, some rt shoulder pain;hx back & shoulder pain, hx of stress;one episode of lower abd pain & diarrhea;
Initial misuse report received from health care professional on 16 Oct 2013 and on 21 March 2013. A 1.5 year old patient had received a 0.5 ml dose of FLUZONE on an unspecified date. No adverse event was reported. List of documents held by sender: none.
After about 20 minutes following the administration of the vaccine, pt felt warm, flushed, and wheezy. Vital signs obtained and lung sounds asculatated. 911 was called, pt declined transport to ED for eval as pt verbalized improved symptoms.
Difficulty breathing, ambulance ride to hospital, 2 day stay in hospital for bilateral pneumonia
after both vaccine they notices that they were very tired and low blood pressure; very tired after first dose; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE DECREASED (after both vaccine they notices that they were very tired and low blood pressure) and FATIGUE (very tired after first dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029l20a) for COVID-19 vaccination.     Concurrent medical conditions included Coronary disease, Hypertension and Overweight. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), AMINOPHYLLINE, LOSARTAN, METOPROLOL, MULTIVITAMIN [VITAMINS NOS] and AMLODIPINE for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced BLOOD PRESSURE DECREASED (after both vaccine they notices that they were very tired and low blood pressure) and FATIGUE (very tired after first dose). At the time of the report, BLOOD PRESSURE DECREASED (after both vaccine they notices that they were very tired and low blood pressure) and FATIGUE (very tired after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided.   This case was linked to MOD-2021-330514, MOD-2021-330881.   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Follow-up contains Concomitant medication and their frequency and new event
Patient called 11/2/18 to report to us that he experienced flu like symptoms that lasted for one week.
PATIENT PRESENTED AS A HEALTHY ADULT FEMALE. SPOKE WITH HER AND INFORMED HER OF THE SHOT AND WHAT SIDE EFFECTS TO EXPECT.  GAVE SHOT IN LEFT DELTOID, AND CONTINUED CONVERSATION ANSWERING ANY QUESTIONS. VIS SHEET GIVEN AND I WENT TO PLACE SHARPS CONTAINER IN PHARMACY. APPROXIMATELY 4 MINUTES HAD PASSED. AS I TURNED AND TOOK 2 STEPS, SHE PASSED OUT. SHE DID SLIDE/FALL OUT OF THE CHAIR. PATIENT IMMEDIATELY REGAINED CONCIOUSNESS AND ON QUESTIONING, SHE HAD NOT EATEN SINCE EARLY THAT MORNING, AND INFORMED ME THEN THAT SHE DID THE SAME THING WITH HER BIRTH CONTROL SHOT. PATIENT STAYED APPROXIMATLY 35 ADDITIONAL MINUTES AND WAS FINE WHEN SHE LEFT. BLOOD PRESSURE AND PULSE WERE NORMAL. SHE DID HAVE A FRIEND WITH HER WHO WAS TAKING HER TO GET SOMETHING ELSE TO EAT. SHE WAS GIVEN A COCA COLA AND COOKIES BY THE PHARMACY TO SUSTAIN HER UNTIL THEN.
4/36/08 - Patient received in left arm Tdap Boostrix AC52B021AA 5/09 and MCV4 U539AA 3/13/09 - There is redness and swelling in left arm from bicep to tricep staring 2" below the deltoid - when looking for injection sites clearly below the deltoid muscle - vaccines were given in site to same. Patient also feels nauseated with headaches since Saturday 4/26/08
approx 3yrs p/vax pt exp a mild chickenpox-like rash
Blood that was starting to appear in the white of her eye; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) and OCULAR HYPERAEMIA (Blood that was starting to appear in the white of her eye) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Macular degeneration ((age related) The patient was taking prescribed eye drops.).    On 07-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). On 08-Jan-2021, the patient experienced OCULAR HYPERAEMIA (Blood that was starting to appear in the white of her eye). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 UNK. On 14-Jan-2021, OCULAR HYPERAEMIA (Blood that was starting to appear in the white of her eye) had resolved. In January 2021, PAIN IN EXTREMITY (Arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  On 04 Feb 2021, patient received the second dose of vaccination in the left arm and no adverse event was reported. Treatment information included eye drops.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow up received on 25 Jun 2021 included reporter information, rechallenge was updated, events stop date and outcome was updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Left arm was sore for 2-3 days, then fine until I had carpal tunnel surgery on left hand 9 days after shot. Then on the same evening as surgery my covid vaccine injection site began to get red and hard and grew to approximately 3? in diameter. It was hot and red. This persisted for about 2-4 days then back to normal again?
Pt reports left deltoid injection site became swollen, tender and reddened down arm and into bicep area; today this is a 10cm area of redness with slight tenderness distal to the injection site over bicep.
Pt complains of flu like symptoms. Pt complains of muffled hearing. Pt complains of cold sweats
Patient was taken to ER on 29May2021 where tests confirmed appendicitis; patient developed flu like symptoms; abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 13-year-old male patient received bnt162b2 (BNT162B2, Lot Number: Ew0177), dose 1 via an unspecified route of administration, administered in left arm on 26May2021 15:30 (at the age of 13-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took azithromycin (Zithromax) and amoxicillin;clavulanic acid (AUGMENTIN), and experienced hives to both drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient developed flu like symptoms and abdominal pain on 28May2021 at 10:30 AM, requiring pick up from school. Patient was taken to ER on 29May2021 where tests confirmed appendicitis. The patient received surgery on 30May2021. The adverse events resulted in Emergency room/department or urgent care. The patient was hospitalized in May2021 for 1 day due to the reported events. Therapeutic measures were taken as a result of the events. The patient recovered from the events on unspecified date in 2021.
Shivering, chills, occasional muscle spasm, very thirsty, low urine output.  Lasted 4 hours.
10:33 am Client felt dizzy with cold clammy skin and pale immediately after last vaccine was administered.  VS BP 100/70, R 24 P 76 sitting with head between legs 10:41 Feeling better, color better, cool compress applied to neck and face 10:50am Feeling better,  color returned, BP 110/80, P 64 R 32 rechecked R 29  10:56 Left walking out of clinic accompanied by father
His arm is swollen; his arm is swollen and sore; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PERIPHERAL SWELLING (His arm is swollen) and PAIN IN EXTREMITY (his arm is swollen and sore) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 14-Oct-2023, the patient experienced PERIPHERAL SWELLING (His arm is swollen) and PAIN IN EXTREMITY (his arm is swollen and sore). At the time of the report, PERIPHERAL SWELLING (His arm is swollen) and PAIN IN EXTREMITY (his arm is swollen and sore) had not resolved.            Concomitant medication not reported.   Treatment medication not reported.
Left arm got a little sore; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL8982), via an unspecified route of administration on left arm on 19Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing high blood pressure, had had all her life. There were no concomitant medications. The patient experienced left arm got a little sore on 20Jan2021. She went for her second dose by 10Feb2021. The patient did not receive any treatment from event. The outcome of event was recovered on 20Jan2021.
Patient said the injection was painful and she felt burning while the vaccine was injected into her right arm. She came to the pharmacy 5 days later with large swelling running down her right arm. She has wine-colored bruises towards the injection site. She said the injection site started swelling, felt hot and was red to the touch a few hours after the vaccine was administered. The bruising developed the day after the vaccine was administered.
Three majorly swollen lymph nodes in armpit of arm that received the vaccination. I noticed this reaction a couple of days after and contacted my PCP. She encouraged me to come in. She ordered an ultrasound of the nodes. Nodes showed no malignancy. Order to follow up in 3-6 months. Nodes are still currently present, but seem to be reducing in size. Second vaccination dose given 1/21/21 on left arm. No nodes in left armpit to date.
Covid Arm. I have a very large, swollen, painful rash underneath, not on, the injection site.
Slight ear pain lasting only a few seconds and happening about 5 times, brief itching on the neck, shakiness, dry mouth, severe cramps (felt like something between period cramps and bowel movements, but more intense) that lasted about 40 minutes (subsided about 20-30 minutes after I took 2 ibuprofen pills), followed by a rash on the head, neck, ears, back, stomach, arms, and wrists and a slight fever.