chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm was sore; super fatigued; mild frontal lobe headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), FATIGUE (super fatigued) and HEADACHE (mild frontal lobe headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 006B21A) for COVID-19 vaccination.     The patient's past medical history included Gastric bypass.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), FATIGUE (super fatigued) and HEADACHE (mild frontal lobe headache). At the time of the report, PAIN IN EXTREMITY (arm was sore), FATIGUE (super fatigued) and HEADACHE (mild frontal lobe headache) outcome was unknown.            No concomitant medications were reported. Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-066678 (Patient Link).
Pt. developed redness, tenderness and pain at injection site w/swelling in region. Symptoms improved since injection placement. Started on Bactrim DS for abx coverage of cellulitis.
Reportedly on 8/15/00, the pt developed redness and swelling of the injection site of the left deltoid. Further information has been requested. Follow up data received 09/29/2000 states no further information is anticipated for this report. Case is closed.
pain at the injection site, ~4" in diameter red spot, unusually heavy fatigue, nausea, feel "chilled"
red rash began 22APR94 w/fever, cough, clear rhinorrhea, & irritability; ER eval by MD nl chest, blood cult; hematuria on 23APR93;
Hives and pruritus that began about 1 hour after vaccines, on her torso and extremities mainly. No airway compromise. Resolved with BENADRYL.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 03-DEC-2015, the patient was vaccinated with a dose of an improperly stored Gardasil 9 (strength: 0.5 ml) lot# L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 800 hours, with the recorded temperature of -1.66 to 8.8888 degrees Celsius. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Fatigue - chills-sweating - joint pain Severe for 3 days. Back to normal  day 7
Systemic: Headache-Medium, Systemic: DIZZINESS & HOT FLASHES-Medium
Janssen COVID-19 Vaccine EUA Around 8 hours after receiving vaccine, began experiencing body aches and chills which became progressively worse over the next 3-4 hours.  Also experienced light headedness, nausea, sweats, and numbness in face.  Took Zofran for nausea and ibuprofen.  Began to feel better after 14 hours except still experiencing fatigue and body aches.
Localized swelling of L arm. No redness/warmth. Pain and swelling better 10/1/18 when patient reported event to writer.
fever, headache, and very sore arm (feels like lymph nodes in underside of arm are swollen)
On or around 6/4/2021, I started feeling mild/moderate abdominal pain.  It would come and go. The abdominal pain increased in duration & intensity over the next few days.  It became severe by 6/9/2021.  I saw my primary care physician the morning of 6/9/2021. He sent me home with pain meds and made an appointment for an ultrasound the next day.  The pain became so severe later that day that I went to the local ER, around 3:30 pm on 6/9/2021.  Around 10:30 pm on 6/9/2021, I was diagnosed with appendicitis.   I had an emergency appendectomy on the morning of 6/10/2021.
I had the vaccine at 3:45pm Thursday, Oct 8th, 2020.  While sleeping at about 11pm I awoke with nausea and starting to vomit. I had an bad stomach ache with bloating. I also had a very bad head ache. I do not normally get head aches. I could not fall back asleep. I tried to get up at 6am but was dizzy and unsteady. My husband helped me to the bathroom 4 feet away. Through out Friday I was dizzy, had a very bad head ache and continued to be bloated. I could not eat. Saturday I woke up feeling not as bloated but still with a mild stomach. Later in the day around 4pm I had heart palpitations while sitting out in the back yard. They only lasted about 2 minutes. On Sunday I broke out in a full body rash. Red raised splotches all over my body. I do get this reaction to a cold so I was not concerned. The rash finally started to go away on Tuesday.
Information has been received from a nurse prescriber referring to an unspecified number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L033548, expiration date 14-MAY-2017; oral: dose and dose number were not reported). No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sensation of fullness in back of throat, progressing to tingling sensation of mouth/face and upper body, and then tachycardia.   Became very nervous with the strange sensation and took pulse which was initially in normal range.  This however progressed to a rapid heart rate.  Overall symptoms lasted 3-4 minutes.  Pulled over and exited a busy highway.  Called 911 (2:22 pm) during symptoms and they said they could only call an ambulance.   Had some confusion when speaking to operator, as I couldn't tell them which exit I was at although I know the exit.  Ultimately, drove myself to the hospital parking lot (about 4-5 min away) as heart rate had started to return to normal.   Heart rate was in normal range when I rechecked in hospital parking lot.  Sat in car for about 5 minutes before deciding to drive back to vaccine clinic to report my symptoms.  Clinic about 3-4 minutes away.   Pulse ox was normal x 2.  BP was actually elevated x 2.   Waited 30 minutes before being released home.
Had a high temperature, rash (bumps and redness) on trunk and arms and moving to face.  Clt mom reports that she is drinking and not eating and is lethargic.  Mom reports child now has a head ache.  Swelling around her eyes and eyes are hurting.  mom reports child is constipated, and reports giving her prune juice and did give  milk but ER told her not to give that anymore.
Information has been received from a physician concerning a patient who was vaccinated with a first dose of Rotateq. Subsequently the patient vomited. It was noted that the patient refused the second and third dose of the vaccine. Additional information has been requested.
chill; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Feb2021 10:30 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient age at vaccination was 24-year-old. The patient medical history was not reported. The patient's concomitant medication included ongoing cetirizine hydrochloride (ZYRTEC [CETIRIZINEHYDROCHLORIDE]). The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247) on 19Jan2021 and age was 24-year-old for COVID-19 immunisation and experienced Fatigue, Dizziness, and Increased Hunger. On 09Feb2021, the patient experienced Chill.  The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash) and VACCINATION SITE INFLAMMATION (Injection site slightly inflamed) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced RASH PRURITIC (Itchy rash) and VACCINATION SITE INFLAMMATION (Injection site slightly inflamed). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Itchy rash) and VACCINATION SITE INFLAMMATION (Injection site slightly inflamed) outcome was unknown. No concomitant medications was reported. This case was linked to MOD21-048583 (E2B Linked Report). This case was linked to MOD-2021-039088. Most recent FOLLOW-UP information incorporated above includes: On 07-Aug-2021: Follow-up information received on 09 Aug 2021 contains no new information. added dose 1 information which was missed to capture in initial version.; Sender's Comments: MOD21-048583:
pt c/o bad h/a 2 hrs p/recvd vax; pain was constant, on top of head;
5-Year old patient was administered the Pfizer 5-11yr Bivalent Booster dose today 11/10/202 at the vaccination clinic, although patient has not yet completed the primary series.  Patient previously received Dose 1 and Dose 2 of the 3-dose Pfizer 6mth-4yr Monovalent Primary Series when she was 4 Years old.  Patient was scheduled for Pfizer 5-11yr Booster appointment today instead of the Pfizer 6mth-4yr Dose 3 appointment, which the patient's parent thought that they were coming in for. This was not caught and the Pfizer 5-11yr Bivalent booster was administered to the 5-Year old patient.   We have contacted the vaccine manufacturer (Pfizer Medical Information) on 11/10/2022, whose recommendation in this situation was "do not repeat dose" if a Pfizer Bivalent booster vaccine was administered in place of the primary series. They also directed us to see the vaccination error guidelines from CDC.  We also called patient's parents and informed them of the vaccine administration error that occurred on 11/10/2022, and of the recommendations we received from the vaccine manufacturer (Pfizer) and CDC guidelines. We also informed them that we will loop in patient's PCP, and the vaccine clinic's management will be following up with patient/parent
Burning sensation started on back of neck - intense sunburn feeling.   Later on arms, hands, feet and back.  Also pins and needle feeling.  Started taking Advil and Benadryl.    Helped a little.  Moved to Advil and Zyrtec during the day.   The intensity varies during the week.  To a little sunburn feeling to more intense on other days.  Been doing on for two months now.
Large red area, hard, hot to touch, sore  This started the next evening after the injection.  My Dr. advised I could ice it and take Ibuprofrin/Benedryl if needed.  It got better after about 4 days, but became larger on the following Thursday.  I went to the doctor on 2/26 for her to see it.  I was advised to ice it every 2 hours and take ibuprofrin.  It was better by Sunday, 2/28.  This past Thursday evening is swelled up again and there was a small bump (hive?) at the injection site.  It lasted all evening and was better by morning.  It still has an area where it's mildly hard.  By nighttime it's usually more noticable.
Pt. seen 6/6/17 at PCP office for 2 mo. WCE REC'D 2 mo immunizations. Developed increased fussiness next PM. Seen again at PCP office 6/7/17 PM. During OV PT had a 'bloody stool' and was referred to ED to R/O intussusception R/T oral vaccine. ED DX with anal fissure - D/C'd home. FU PCP OV on 6/9/17.
At Pharmacy, within the first few minutes of receiving the shot, I became dizzy and nauseous. After 5 minutes the tip of my tongue began to itch then stopped after sitting there for 15-20 minutes. At 5pm, August 28th, I developed abdominal cramps and began having diarrhea,  multiple times a day, randomly for the next 4 days. I went to urgent care August 31st where they determined I was having a reaction to the shot. I was prescribed bentyl, lomotil, Zofran and prednisone to take po for the next 5 days.
Continuous muscle pain in shoudler area which became worse after second dose.  Pain area has now spread to elbow and armpit.
Extreme chills starting at 11:30pm. Needed to wear layers of clothing and turn up heat to get warm.  Wife was hot while I was freezing and shivering uncontrollably, so I know something was wrong with me.  The shivering and chills lasted for a couple of hours until about 2:30-3:00am.  Then I got really hot.  Took my temperature, was at 99.1 degrees.  But room was really warm so I turned down the temperature and took off my layers of clothing.  Woke up this morning, around 7am, to a headache and aching legs.  I took 2 Excederin, but the headache is still there.  Legs are feeling better after a couple of hours.
This spontaneous report has been received from a healthcare worker referring to unspecified number of patients. Concurrent condition and medical history were not reported. On unknown dates the patients were vaccinated with GARDASIL 9 (dose, frequency and route not reported, lot # L016428, expired date: 30-JUL-2017). No adverse event were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received from a 68 year old female consumer with penicillin, and sulfonamide allergies, and an allergic reaction to antibiotics and anti-depressants who on 10-MAR-2008 was vaccinated SQ with 0.65 once with zoster vaccine live (Oka/Merck). Concomitant therapy included venlafaxine HCL (EFFEXOR), amlodipine besylate (NORVASC), acetaminophen/hydrocodone bitartrate (LORTAB) and zolpidem tartrate (AMBIEN). Subsequently, "a day or 2 after  the shot" on
approx 3 wks p/vax pt devel a rough red rash behind knees, inside elbows, forehead & below eyes; rash lasted for 4 wks & then disappeared;
Injection site redness; Injection site itching; Difficulty taking a deep breath; Arm swollen; Arm warm to the touch; not doing well; Dizziness; This case was reported by a physician and described the occurrence of dizziness in a 28-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 72RS4, expiry date June 2020) for prophylaxis.   On 24th October 2019 13:00, the patient received FluLaval Tetra 2019-2020 season. On 24th October 2019, less than an hour after receiving FluLaval Tetra 2019-2020 season, the patient experienced dizziness, difficulty breathing, swelling arm, skin warm and unwell. On 24th October 2019 13:50, the patient experienced erythema of extremities and injection site itching. The patient was treated with benadryl (nos) (Benadryl) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the dizziness, erythema of extremities, injection site itching, difficulty breathing, swelling arm, skin warm and unwell were unknown.   It was unknown if the reporter considered the dizziness, erythema of extremities, injection site itching, difficulty breathing, swelling arm, skin warm and unwell to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient received Flu vaccine in the right arm. The patient received 50mg Benadryl intramuscularly in her right arm. The patient experienced redness and itching at the site of injection. No other complaints were noted. The patient had no difficulty in breathing or swelling anywhere. The patient was given ice and was told to monitor because all other systems were intact. The patient was told to follow up if the events get wore. At 14:00, the staff person from the front office called and told that the patient was not doing well. The physician went to the office with all the emergency supplies. The patient was sitting down and reported that she experienced difficulty taking a deep breath and felt dizzy. The patient's right arm looked more red, slightly swollen and warm to touch. At 14:21, EMS was called and it came at 14:25. The vital signs were the blood pressure was 124/91 mm hg and the heart rate was 94. At the time of reporting, the patient was fully cognitive and was aware of the situation. The patient's husband was notified about the events. The patient was then transferred to the hospital for follow-up with the ambulance at 14:35. The patient remained calm during the process. The case has been linked with case US2019AMR196157 reported by the same reporter.
he examined her and noted "swelling above the elbow, with redness". The Pharmacist reported that the patient stated it "feels like the swelling is travelling to the back of my arm".; swelling in the arm and trouble lifting the arm; he examined her and noted "swelling above the elbow, with redness". The Pharmacist reported that the patient stated it "feels like the swelling is travelling to the back of my arm".; he examined her and noted "swelling above the elbow, with redness". The Pharmacist reported that the patient stated it "feels like the swelling is travelling to the back of my arm".; swelling in the arm and trouble lifting the arm; This spontaneous report was received from a pharmacist (R.Ph.) and refers to a non-pregnant female patient of unknown age.  No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.    On 17-SEP-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R016640 with expiration date of 28-JAN-2020, intramuscularly, for prophylaxis. It was reported that the patient called later in the day (17-SEP-2019) reporting swelling in the arm (peripheral swelling) and trouble lifting the arm (limb discomfort). The pharmacist reported that the patient returned to the Pharmacy, where he examined her and noted swelling above the elbow (joint swelling), with redness (erythema). The Pharmacist reported that the patient stated it "feels like the swelling was travelling to the back of her arm", pharmacist reported the swelling as "transient limb swelling, not directly associated with the injection site" (oedema). It was referred the patient did seek medical attention but not treatment was provided.   The outcome of oedema, peripheral swelling, erythema, joint swelling and limb discomfort was not provided.  The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Client left vaccine room stating she felt fine and then heard her down the hall stating, "I am going to have a seizure and heard a thud" Found on back, oreintated x3 and alert, states hit back of head on concrete floor, no concussion symptoms. Did not want treatment but then when correctional officiers were walking her back to cell she become woozy and came to nurse office where she laid on exam table and ice to back of head. Was very pale, appeared to be syncope.
This spontaneous report has been received from a licensed practical nurse referring to a 16 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccines of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided), RECOMBIVAX HB, M-M-R II (strength, dose, route, anatomical location and lot/batch# were not provided) for prophylaxis. The vaccines were exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
4/19/05 He rec'd the Varicella Vaccination at about 1:30 in the afternoon.  At about 5:30 he had a temp of 103.1 ax.  We contacted the Emergency room and were instructed to alternate infants motrin and tylenol, and give a tepid bath.  We were able to get his temp down to 102 ax.  The following day, 4/20/05, he still had an elevated temp.  ranging from 102-103 ax/ear therm.  We contacted his physician and gave the symptoms and were given instructions to continue doing what we were doing.  The following morning 4/21/05 the inside of his mouth was swollen and irritated looking, he complained when drinking or trying to eat (crying, fussy etc).  His physcians office closed at noon that day. We noticed that he had white patches in his mouth, on his gums and they would bleed when he would attempt to eat. We again contacted the local ER and were instructed to keep forcing fluids, keep giving tylenol and motrin alternating, and contact his physcian the following morning, the ER physcian felt that they could not do anything other than what we were doing at home.  We contacted the doctor the next morning 4/22/05, he was seen an hour later.  At the time he was seen he had approx 10 chicken pox on his chin/lips, however his mouth, throat and gums had a lot of chicken pox lesions that were bleeding if touched or if he tried to eat or drink. Doctor instructed us to watch for certain things since it appeared to be in mucous membranes.  He advised us to continue with forcing fluids, managing his fever and gave us the name of an over the counter medication to swab his mouth with "Magic Mouth" GlyOxide Liquid Antiseptic Oral Cleanser 4 x per day, and infants 12.5mg Benadryl every 4 hours as needed. The next morning (saturday, April 23, 2005) he had a few more chicken pox lesions on his cheek and chin, and the roof of his mouth was covered, he had several more on his gums, his gums were bleeding and very swollen. (we were not surprised by this, doctor has informed us that this would happen, and if we thought he was having digesive issues or if his breathing changed to contact him asap).  He continued to get small amounts of new chicken pox for 3 more days.  Finally they started clearing up in his mouth,(around April 27, 2005)he was able to drink freely, and eat small amounts of soft foods.  Today is Wednesday, May 4, 2005 he a few chicken pox scabbed over around his mouth, he is eating much better.  His gums are still inflamed and very red and irritated looking.  We have put in a call to our dentist to have him look at his teeth and gums.