chrisvoncsefalvay/vaers-outcomes huggingface dataset:
it's breaking out into blisters/lower part of my arm has tiny little blisters; hurts/ exacerbates the pain; wrapping her arm to ease the discomfort; burns; where I got the shot, there's a little knot in there; my arm is red where she got the shot; itching at the injection site/itching became worse; swelling at the injection site; this rash has not gone away; my arm was swollen; it constantly itches; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (it's breaking out into blisters/lower part of my arm has tiny little blisters), PRURITUS (it constantly itches), PAIN (hurts/ exacerbates the pain), LIMB DISCOMFORT (wrapping her arm to ease the discomfort) and PERIPHERAL SWELLING (my arm was swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included IMATINIB MESILATE (GLEEVEC) for Leukemia, CHLORPROMAZINE (THORAZINE [CHLORPROMAZINE]) for Muscle relaxant, HYDROCODONE, GABAPENTIN, DULOXETINE HYDROCHLORIDE (CYMBALTA) and ORLISTAT (XENICAL) for an unknown indication.   On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jul-2021, the patient experienced PRURITUS (it constantly itches). 04-Jul-2021, the patient experienced PERIPHERAL SWELLING (my arm was swollen). On 10-Jul-2021, the patient experienced BLISTER (it's breaking out into blisters/lower part of my arm has tiny little blisters), PAIN (hurts/ exacerbates the pain), LIMB DISCOMFORT (wrapping her arm to ease the discomfort), BURNING SENSATION (burns), VACCINATION SITE MASS (where I got the shot, there's a little knot in there), VACCINATION SITE ERYTHEMA (my arm is red where she got the shot), VACCINATION SITE PRURITUS (itching at the injection site/itching became worse), VACCINATION SITE SWELLING (swelling at the injection site) and RASH (this rash has not gone away). At the time of the report, BLISTER (it's breaking out into blisters/lower part of my arm has tiny little blisters), PRURITUS (it constantly itches), PAIN (hurts/ exacerbates the pain), LIMB DISCOMFORT (wrapping her arm to ease the discomfort), PERIPHERAL SWELLING (my arm was swollen), BURNING SENSATION (burns), VACCINATION SITE MASS (where I got the shot, there's a little knot in there), VACCINATION SITE ERYTHEMA (my arm is red where she got the shot), VACCINATION SITE PRURITUS (itching at the injection site/itching became worse), VACCINATION SITE SWELLING (swelling at the injection site) and RASH (this rash has not gone away) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The treatment information was not provided.   This case was linked to MOD-2021-261816 (Patient Link).
Initial unsolicited misuse report received from the nurse on 21 April 2017. This case involves a 6 months old female patient who was inadvertently vaccinated with a dose of PENTACEL (batch number- C5241AA, expiry date-03 December 2017) via intramuscular route in left thigh; a dose of ACTHIB (batch number- UI727AAA, expiry date-21 November 2017) via intramuscular route in right thigh 06 April 2017.On same day the patient received dose of PREVNAR (batch number- R37130) via unknown route in right thigh and a dose of ROTAVIRUS VACCINE (ROTAVIRUS) (batch number-M031807) via oral route of administration. The patient had allergic to lactose. Illness at the time of vaccination and other medical history was none. Concomitant medications were not reported. On 06 April 2017, same day following the vaccination, the patient experienced fever (reported as stated mother of patient called on call doctor on evening reporting her daughter had a fever). On 07 April 2017, one day following the vaccination (at 04:00 pm) patient's mother reported that patient had started vomiting dark red blood. It was a case of extra dose administered. The patient was seen in the ER (emergency room). Lab data was not reported. Had been advised to administer Tylenol for fever. On an unspecified date the patient was recovered from all events and was discharged from ER room. Upon internal review, the case was considered as serious due to important medical event: vomiting dark red blood. On an unspecified date the patient was discharge. List of documents held by sender: none. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: This case concerns a 6 months old female patient with a history of lactose allergy received PENTACEL), ACT-HIB, PREVNAR and ROTAVIRUS VACCINE and was vomiting blood on the next day of vaccination. Time to onset is compatible with the role of vaccine. Lactose allergy could be a possible cause for the event. Moreover, as multiple vaccines were administered concomitantly, the role of each component cannot be assessed separately.
patient felt warm to touch and requested a cooling pad and coke which was provided. Patient was then lowered to floor by husband and administering rph
Started with fatigue,  chills, some confusion, and fever (101.4).  I left work and went home to bed.
No further information provided. No additional AE reported.; Caller stated the adult patient over 40 years old received the first dose of GARDASIL 9 in 2019. There was a gap between the first and second dose. Second and third doses were both administered sometime in 2021.; This spontaneous report has been received from an unspecified reporter (conflicting information as it was reported as physician and other) and refers to an adult patient of unknown gender reported as over 40-years-old. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On an unspecified date in 2019, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (ml) for prophylaxis (vaccination scheme frequency and route and anatomical site of administration were not provided; lot number and expiration date were unknown by the reporter).   On an unknown date in 2021 (also reported as "sometime in 2021"), the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (ml) (vaccination scheme frequency and route and anatomical site of administration were not provided; lot number and expiration date were unknown by the reporter). It was reported that there was a gap between the first and the second dose (inappropriate schedule of product administration).  On an unspecified date in 2021 (also reported as "sometime in 2021"), the patient also received the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (ml) (vaccination scheme frequency and route and anatomical site of administration were not provided; lot number and expiration date were unknown by the reporter). No additional adverse event (AE) was reported.
This spontaneous report was received from a patient's mother and refers to a 5-year-old male patient. There was no information about the patient's concurrent conditions and concomitant therapies. Historical vaccines included M-M-R II and medical history included seizure on 08-JUN-2016. On the same day, the patient was vaccinated with PROQUAD (dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On the same day, in the evening, the patient experienced fever of 99.5 degrees. The outcome of fever was unknown. There was no causality assessment between PROQUAD and fever provided. Sender's Comments: US-009507513-1902USA001268.
Patient is a 68-year-old female with a past medical history of HTN, HLD, hypothyroidism, diabetes, neuropathy, CAD presented to the ED with complaints of altered mental status.  Her last known normal was yesterday morning around 10 am. It was reported that patient was watching TV yesterday evening, trying to speak with her relative, had some trouble getting her words out. She states that she did not feel well, had dizziness, called her husband, did not remember anything after that what happened. As per EMS, her blood sugar was 152, gave D10 en route to ED, improved mental status slightly. Currently she is alert and oriented x 3. Denies any complaints. She had headache earlier, resolved currently. CT of head, MRI brain diffusion weighted shows no acute abnormalities.
Swollen left arm. Warm to touch and swelling. Depo Medrol 12 mg given to patient and prescription for Keflex.
21MAY91 temp of 103 APAP Q 4 hrs; started vomiting, congested, temp, ear infect, no balance, couldn't walk; Hospitalized started IV Pred & ampicillin, WBC up to 11,000, restless, pale, did not sleep last night, not eating;
Chills, fever, malaise, L arm pain. L arm at deltoid area with some swelling and tenderness, also some redness and warmth, ROM of L UE restricted sec to pain.
pt devel shingles to lt ulnar side of arm & hand from elbow to 3rd finger including lesions to palm & back of hand lesions began 13DEC96 in evening;when lesions broke open still progressing w/new lesions 19DEC96;cx taken;
arm has been red from shoulder to elbow and hard and hot to the touch for past 2 days. I advised her to see a doctor
Chills, fever, heavy breathing, body aches (began around 7PM 3/25/21 lasted until 3/26/21 night when they improved drastically, but did not feel all the way better until 3/26/21 from these symptoms) hallucinations (woke up in the middle of the night when this happened- 1x occurrence) dizziness (ongoing from 3/25/21 night and still continuing)
Started feeling aching evening of 1/22, woke up with sever aches and fever at 4:30 am 1/23. Fever continued to rise and fall all day (highest temp 100.9), accompanied by muscle aches and pain, swelling and redness at injection site. Pain from muscle aches diminished on 1/24, fever continued off & on most of the day but still painful, red and very swollen at injection site.
Acute pulmonary embolus with mild right heart strain.  Woke at 3am on 4-3-21 with severe pain and difficulty breathing, went to emergency room and was given a CT scan,  diagnosed and treated with Heparin IV.  drip and admitted to the hospital.  Later an ultrasound test showed another clot in my left leg so I was started  on Apixaban (Eliquis) 5 milligram .  Released and sent home on 4-5-21
pain in all the areas where I had shingles; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles two and one half years ago). Concomitant products included Herpes zoster (Shingrix).   In April 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm and pain. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the pain in arm and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got the first Shingrix vaccine in mid January 2019 and the second one in mid April 2019. After the second dose the patient had a sore arm for one day.  Now, the patient experienced pain in all the areas where the patient had shingles previously. The patient was not happy and was not told about reactions and saw very few listed on GSK site. There were lot of comments on side effects. The patient was not happy and wish that never had either of the Shringrix shots. The patient had a lot of shingle pain for over two years and now going through it again.
8 days after I received the first dose of Moderna, I woke up and my arm at the injection site was swollen, painful to touch or lift my arm, tight, itchy and red.  The patch is about the size of my cupped hand over the mass.
Information has been received through the pregnancy registry for GARDASIL from a physician concerning a 18 year old female with a history of smoking (quit when she had a positive pregnancy test) and no known drug allergies, who on 27-JUL-2007, was vaccinated in the right arm with the first dose of GARDASIL (lot#65822/0927U). On 15-Nov-2007, the patient received the second dose in the left arm (lot# 659437/1266U). On 05-Apr-2008, the patient received IM in the right arm a 0.5 ml third dose (lot#659964/1978U). Other medications included prenatal vitamins from 03-APR-2008 to present, once daily. The physician reports that the patient is 15 weeks pregnant. The patient's LMP was 24-DEC-2007, the estimated delivery date is 29-SEP-2008. The patient sought unknown medical attention with her OB/GYN. Follow up information was received which reported that on 08-APR-2008 and 12-MAY-2008, ultrasound indicated low lying placenta. From 16-JUN-2008 to 21-JUN-2008, the patient was treated with ampicillin, 500mg, q8h, for urinary tract infection. From 13-AUG-2008 to 20- AUG-2008, the patient was treated with amoxicillin, 500 mg, q8h, for urinary tract infection. On 03-SEP-2008, the patient delivered a female infant at 36+ weeks from The infant's weight is 6 lb 11 oz with apgar scores of 7/9. The infant was normal, without congenital anomalies and other complications or abnormalities. There was no medical condition after the delivery. Additional information is not expected.
48 hrs after vaccines administered (Varicella, MCV & P) chills, fever, redness, swelling of arm near injection sites.
Pain/swelling/discomfort of left arm (injection location).; Pain/swelling/discomfort of left arm (injection location).; Pain/swelling/discomfort of left arm (injection location).; Six days later still have pain/swelling/discomfort, lumps, rash, swelling from left shoulder, chest, to sternum.; Six days later still have pain/swelling/discomfort, lumps, rash, swelling from left shoulder, chest, to sternum.; Six days later still have pain/swelling/discomfort, lumps, rash, swelling from left shoulder, chest, to sternum.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 17Apr2021 at 15:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 27Mar2021 at 15:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 at 17:00, the patient experienced pain, swelling, discomfort of left arm (injection location). Six days later, the patient still had pain, swelling, discomfort, lumps, rash, swelling from left shoulder, chest, to sternum. All side effects were reported on left side from shoulder to left leg. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with prescribed steroid and blood test. On an unknown date in 2021, the patient underwent lab test which included blood test and the result was unknown. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain, swelling, discomfort of left arm (injection location), six days later, the patient still had pain, swelling, discomfort, lumps, rash, swelling from left shoulder, chest, to sternum were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Injection site reaction.  Became red and swollen and painful.  Let red mark with lump underneath skin.  Patient says it has been improving day by day.  He did not seek medical treatment.
Soreness, lump under skin, increased in size X 3 days, redness at site, no itch, no fever.
Left leg reaction to DTap or Prevnar/ hot warm to the tuoch is red but not raised.
AR- Thyroid T3 Insufficiency  SX- - [ ] Swollen/Ulcerated Tongue Glossitis  - [ ] severe Fatigue, Weakness, Shaky - [ ] Cognitive Pbs: Confusion, brain fog, word recall, short-term memory lapse, Slurred speech, difficulty enunciating - [ ] Respiratory: Cough chronic, Winded easily shortness of breath - [ ] Balance, coordination gate unstable - [ ] Constipation - [ ] Temperature regulation pb ?Sweating, chills, cold intolerance, cold extremities - [ ] Pale dry skin, Itchy, Tingling feet & legs, back and neck - [ ] Anxiety and depression worsening (rebreathing CO2) - [ ] Tennetus worsening - [ ] Disrupted sleep trouble falling and staying asleep Nightmares (sleep used to be excessive 10+hrs) - [ ] Orthostatic hypotension dizziness/syncope  - [ ] Weight Gain - onset 1998 (noticed accelerated gain w/o change in activity or cal intake), prior weight 130's - 2020 reached 180, stabilized at current weight of 155 with <1500 cal diet and routine exercise (45+ min 5+ x per week brisk walk in hilly terrain or rowing, and light weights) - [ ] Numbness in hands - [ ] Lower HR: 40's, sitting 50's, walking 60-70's, exertion 80-100, rarely over 110  - [ ] Lower blood pressure <110/60  - [ ] No labido - [ ] Urination and thirst/water intake increase - [ ] Blurred vision - [ ] Nausea and loss of appetite - [ ] Headache (frequent) migraine (occasional) - [ ] Light sensitivity  - [ ] Deeper corse raspy voice - [ ] Increasingly thirst (72+ oz per day) and frequent urination (>2x per hour, often 4+x per hour) - onset 2000; - [ ] minor loss of bladder control - leaking just before urination or on coughing - [ ] Heightened Startle Response  TX- T3 Rx Liothyronine 5mcg  Onset SXS 11/25/22,   Rx 11/28/22,  Onset SXS  Relief 12/6/22
hives - most significant on right arm. responsive to cetirizine. did spread to other arm, stomach, thighs. by 48 hrs after vaccination, still had hives appear, but smaller and fewer.
Muscle soreness at injection site; Muscle soreness at injection site; left bicep muscle twitching for about 1-2 minutes at around midnight; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN5318, on 26Jan2021 07:00 at single dose in left arm for Covid-19 immunization. Medical history included high blood pressure, allergies to penicillin and amoxicillin. Concomitant medications included amlodipine besilate (NORVASC), atorvastatin (LIPITOR), pseudoephedrine hydrochloride (SUDAFED), VITAMIN D NOS, and cetirizine hydrochloride (WAL ZYR). The patient was not Pregnant at the time of vaccination. The patient had no any other vaccines within 4 weeks prior to the COVID vaccine. The patient had Muscle soreness at injection site that was still occurring but lessened 24h later and left bicep muscle twitching for about 1-2 minutes at around midnight. No treatment was received for all events. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. The outcome of all events was resolving.
This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, unspecified number of unspecified patients were administered an unspecified number of improperly stored doses of ROTATEQ (strength, dose and lot# were not reported) oral. No adverse effect reported. No Product Quality Complaint (PQC) was involved. This is one of the two reports from the same source. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 76-year-old female patient who received SHINGRIX (batch number ZP3P9, expiry date 11th September 2021) and (batch number 3K73L, expiry date 11th September 2021) for prophylaxis. On 3rd April 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 4th April 2019, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site tenderness, injection site warmth, injection site swelling, injection site lump and injection site induration. On an unknown date, the outcome of the injection site erythema, injection site tenderness, injection site warmth, injection site swelling, injection site lump and injection site induration were not reported. It was unknown if the reporter considered the injection site erythema, injection site tenderness, injection site warmth, injection site swelling, injection site lump and injection site induration to be related to SHINGRIX. Additional details were provided as follows: On 3rd April 2019, around noon eastern time, the patient received the 1st dose of SHINGRIX. The batch number was captured as 3K73L, instead of 3K7L, as per sales data sheet. On 4th April 2019, at the day of reporting, the patient reported that, the injection site was red, warm, swollen, sore, had a hard knot that was not raised but did have a quarter size spot around it. The patient also reported that the injection site was more tender at the hard spot.