chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reginal lymphadenopathy; injection site pain; reports dark urine (workup in progress)
Pt vaccinated with MMR pt lungs were clear before the MMR was given. Within 2 1/2 hrs had moderately severe wheezing. This resolved with Epinephrine. pt has no hx of asthma.
Presented to ER on 11/25/21. This 81-year-old female patient who recently started seeing Dr.  , called the paramedics to come in since she has been very weak, unable  to take care of herself at home, and wants to go to a nursing home for  convalescence.  Unfortunately, patient has been having trouble eating for last  3 weeks.  Every time she eats, she feels like she os going to upchuck, and  then it goes down, but she gags, and she does not want to throw up, so has not  been eating much.  Yesterday, she ate pudding and coffee, and that is about  it.Was started on ceftriaxone.  Blood cultures were done and were positive for MSSA.  She was continued on ceftriaxone to completion.  Was started with physical therapy and occupational therapy.  Remained quite weak and appeared would require nursing home placement she was amenable to that.  She was to be discharged to senior housing facility.  Was found to have pressure ulcers on her buttocks and coccyx and local care initiated.  Had had difficulties as well with fecal incontinence.  Was started on daily fiber and there was significant improvement.  Fall precautions were maintained throughout patient's hospital stay.  Unfortunately as part of routine testing for admission to the nursing home she was found to be COVID-19 positive.  She required isolation for 10 days.  She was monitored in regards to O2 saturation.  She remained asymptomatic throughout her whole hospital stay.  She did not require any medical therapies for the COVID-19.  Continued with physical therapy as well as wound care to the buttocks and coccygeal area.  On 12/13/2021 she had completed her quarantine.  Was discharged in stable condition to Nursing Home as originally planned.
No additional AEs; Caller reported VARIVAX administered after temperature excursion.; This spontaneous report was received from an administrator and refers to patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. There was no information regarding the patient's allergies or drug reactions.   On 20-MAY-2022, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 0,5 ml, administered subcutaneously, lot #U022321, expiration date: 15-JUL-2023, (strength and anatomical location were not provided) for prophylaxis (product storage error). No additional adverse events was provided (no adverse event).  For varicella virus vaccine live (oka/merck) (VARIVAX), temperature excursion was reported as 6 Fahrenheit (F) degrees for 30 minutes. There was no previous temperature excursion reported.
Pt received Pneumovax left arm on 9/28/04. Given IM. Pt called office 9/30/04 with c/o stinging, burning, and erythema of moderate amount to left upper arm. Area of concern-18x14cm of erythema. Area described as splotchy with some clear areas moving down inferiorly and slightly above the area of injection. It was warm, no streaking. No vesicles. No breathing diff. noted. Followed up 10/04/04 1555 see note
Information has been received from a nurse concerning an approximately 14 to 15 year old female who was vaccinated with what the nurse thought was the second dose of GARDASIL on an unspecified date. The nurse reported that the patient slid off the table on the floor and apparently "hit her face up pretty bad after the vaccination". The patient had been seated when she was vaccinated and the patient went from a seated position right to the floor. Additional information has been requested.
Called at 8:16 AM on 11/02/2016 C/O arm pain in L arm. Advised movement, cold pack, monitor. Seen at 3:36 PM for "extreme pain, red, numb L arm", nausea, headache, T 100.1 F.
Significant pain in left arm. Excruciating headaches. Fever/Chills. Rapid heart rate in 120s at rest. Muscle pain Left outter thigh and low back. Fatigue.
Sudden itching at injection site - similar to insect bite - 8 days after injection (Wed., April 14). By the next morning (Thurs., April 15) the area around the injection site was red, hard, and warm. Redness gone by second evening (April 15).  Still warm through next morning (Friday, April 16).  Itching didn't last long.  - Wouldn't have bothered reporting it, but I've heard this is a reaction, and wanted to give you more statistics on how often it happens.
shingles; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer (patient) reported a female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on unknown date. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on unknown date. The patient developed shingles after the second dose and was on antivirals. Outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Information has been received from a healthcare worker (certified medical Assistant (C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 08-MAY-2015, the patient was administered with a dose of improperly stored ZOSTAVAX, lot # L002422, expiration date 23-APR-2016 (dose not provided), subcutaneous. No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Myaglia left arm is painful Narrative:  Employee reports onset of body aches on 12/29. She denies fever. Her left arm is also very painful. 12/31 - symptoms resolved.
injection site was very itchy and red; injection site was very itchy and red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site was very itchy and red) and VACCINATION SITE PRURITUS (injection site was very itchy and red) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site was very itchy and red) and VACCINATION SITE PRURITUS (injection site was very itchy and red). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (injection site was very itchy and red) and VACCINATION SITE PRURITUS (injection site was very itchy and red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt recvd vax on 22JUN92 & 2 days later pt devel itchy rash over entire body;
Generalized hives within 10 mins following immunizations. Pt was given Benedryl 25mg IM. Hives were resolving after 15 min.
pt recv vax 24OCT96 510PM & 815PM pt woke w/high pitched crying;mom noticed pt very pale & blotchy;pt attempted to breast feed but stopped p/10sec;became pasty grey color w/dec muscle gone & lethargic;not responsive to stimuli;taken to ER;
Client is an 11 yr old girl whom received her first dose of pediatric pfizer. Client was waiting in recovery area and started to feel unwell. EMS was assessing client and talking with mom when Nurse arrived. Client states that she started to lose her vision. 15:55 V/S B/P 80/40 O2 98% HR: 86 R:30. A/O x3. clamy and cool to touch, pale in skin color. Clients mother states that she has NKA. Nurse gave client a sprite to drink and some Teddy grahm crackers. 15:59 B/P 90/62. Client states that she feels better. Warm to touch, not clamy anymore. did teaching with Clients mother to monitor and DCHD will f/u on Monday.16:05 B/P 98/64. Skin pink in color. Client states that she feels better and ok to go home.
Fever 100-101.0 degrees lasting about 40 hours, pain at injection site, marked lethargy, and severe pain at the site of ganglion cyst of a toe.  Swelling of this site resolved when the fever resolved.
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown gender who would be 4 years old. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M023384 and expiration date on 20-JUL-2018 of lot # M033906 with expiration date on 06-JUN-2019 (dose and route of administration were not reported) for prophylaxis. The reporter could not provide details of which lot number the patient received. The doses of VARIVAX were exposed to a temperature excursion of 14.9 degrees Fahrenheit (°F) during a time frame of 11 hours, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the several reports received from the same source.; Sender's Comments: US-009507513-1710USA008686: US-009507513-1710USA008693: US-009507513-1710USA008688: US-009507513-1710USA008689: US-009507513-1710USA008690: US-009507513-1710USA008691: US-009507513-1710USA008692: US-009507513-1710USA001141: US-009507513-1710USA008684: US-009507513-1710USA008687:
Began feeling like I had a gas bubble/burb in my upper abdomen that wouldn?t come up.  Then I developed a very mild headache. In the late evening around 9pm on 7-Jan, I was standing up at my desk and began to feel faint. That resolved by 8-Jan, but the pressure in my upper abdomen, mild headache, and light headedness didn?t resolve until  10-Jan. Since then I?ve felt fine. If the symptoms hadn?t started to lessen on 9-Jan, I would have called my doctor.
On 3/31 the patient received Jenssen Covid vaccine at 9:30 am.  At 9:39 patient complained of N/V and lightheadedness.   9:40  BP 110/90  Pulse 104.  Blood pressure faint.  Patient pale and diaphoretic.  His mother is with him. 9:43  BP 150/82 9:55  BP 142/74  Ate a granola bar and juice pack.  Sitting at the edge of the cot.  Skin cool and dry.  Alert and oriented 10:10  BP 142/98  Remains sitting.  Reports "feeling OK".  Patient was DC'd with parent to home. Numerous attempts to contact via phone for follow up.  Have not received a call back.
This is a prospective pregnancy case. This 36-year-old female subject was enrolled in a study. The subject received the 1st dose of BOOSTRIX (unknown) on 23rd December 2014. The subject's last menstrual period was on 28th May 2014 and estimated date of delivery was 4th March 2015. The subject received BOOSTRIX at week 29 of the pregnancy and during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional information received on 31 December 2014: The type of conception was normal (no in-vitro fertilization). There was no evidence of a defect from prenatal testing. The number of gestational weeks was not reported but was calculated with the last menstrual period.
MMR-11 was administered to 3 patients on 10/26/2020 after a temperature excursion and prior to having vaccines evaluated.; This spontaneous report was received from a health care professional, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 26-OCT-2020, the patient was vaccinated with improperly stored measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) injection (lot number S031482 which has been verified to be valid, expiration date reported and validated as 07-OCT-2021) (dose and frequency were unknown by the reporter; vaccination scheme, route of administration, and anatomical site of injection were not reported) as prophylaxis. The administered vaccine was stored at a temperature of below 36 degrees Fahrenheit (F)/2 degrees Celsius (C) (0.9 C to 1.9 C), during a time frame of 10 hours; above 47 F/9 C (9.1 C), during a time frame of 30 minutes. There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA010939: US-009507513-2010USA011380:
COVID 19 Moderna Booster Develope severe Bullous pemphigoid patient had 3rd COVID 19 vaccine 3rd shot Booster developed within days Bullous lesions on hands Abdomen Arms with residual scars & needed a Biopsy steroids & Antibodies
fever; chills; extreme body aches; This is a spontaneous report from a contactable nurse. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 18Mar2021 at 14:30 as a single dose for COVID-19 immunisation. Medical history included diabetes, hypothyroidism, mild asthma, extreme sensitivity to medications which was being monitored by an immunologist, COVID-19 and the patient had penicillin allergy from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (UNITHROID), insulin degludec (TRESIBA), metformin (MANUFACTURER UNKNOWN) and deflazacort (PRANDIN), all taken for unspecified indications from unknown dates. The patient previously took vancomycin, augmentin, bactrim, keflex and macrodantin and experienced drug allergy with all of these. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021, the day after the shot, the patient experienced fever, chills and extreme body aches for 24 to 48 hours. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. On 12Apr2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. The clinical outcome of the events fever, chills and extreme body aches were resolved on 21Mar2021.   No follow-up attempts are needed. No further information is expected.
INJECTION SITE REACTION - SWELLING, REDNESS SPREADING DOWN ARM BELOW ELBOW, HEAT AMD PAIN, (ALL X 3 WEEKS) PAIN, HEADACHE AND SICK FEELING FOR 3 DAYS POST VACCINATION.
pt recv vax 7MAR98 & 9MAR exp n/v, h/a, T100;
Reports itching began on feet on 3-3-10. Then whelps began to appear on body. Treated self with OTC BENADRYL. By 3-5-10 whelps were on face. Went to ER the night of 3-5-10. Was given IV DECADRON, BENADRYL and ZANTAC. Rash has resolved and on no further treatment.
FEVER 100.5 AXILLARY 7/26 PM, FUSSY AFTER FEEDINGS, VOMIT X1 EPISODE, INCREASED NIGHT WAKING,VERY LOOSE STOOL,VAGINAL DISCHARGE.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium
Suspected vaccination failure; Shingles; having the horrible neuralgia; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included immunodeficiency.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and post herpetic neuralgia (Verbatim: having the horrible neuralgia).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-SEP-2023 This case was reported the patient via interactive digital media. The patient had 2 bouts of Shingles and as the patient was immune compromised. The patient told it could possibly got it again even though had vaccinations after the 1st breakout. 2nd time the patient only had 2 pots but the arm still having the horrible neuralgia that followed it, going on 5 months and it was still making the life a living hell. The patient going to pain management for treatment but wondering what else was out there to help him/ her. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.  Follow-up not possible as no contact details provided.
Patient received vaccination in the left arm 5 to 10 seconds after the administration patient started to pass out. While trying to keep him in the chair patient began to seize and fell forward out of chair. Once out of the chair patient began shaking (convulsing) while on ground for 10 seconds. Patient regained consciousness in 10 to 15 seconds after and asked where he was and began feeling nauseas. Patient was asked to stay to be monitored for 30 minutes and asked if he needed further medical attention. Patient stated he was fine and it had happened to him before when getting blood drawn.  Patient waited for 30 minutes after incident seated, was asked again if needed medical attention and stated he was ok to leave. Patient was walked to exit of building on own accord with no issues.
Elevated temperature (100.2), body aches, chills, sore arm, extremely swollen auxiliary lymph nodes on left side.  All symptoms began about 24hrs post vaccine. Swollen lymph nodes and near breast , below armpit stayed very sore and swollen for 5 days. All other symptoms were gone after about 24 hrs (48hrs post vaccine). Treated with ice, cool compress, probiotic, ibuprofen.
Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-Aug-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient just got his/her first Shingles shot, and despite reading about the awful side effects, he/she had a sore arm for 2 days, nothing more.  The patient was ready for Shingles shot 2nd in 3 months.  The patient did not want this horrible thing. Additional Supportive Information: The follow-up would not possible as no contact details were available. This case was linked with case US2022AMR124752, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR124752:Same reporter
Moderna COVID-19 Vaccine EUA.    Injection date Friday 1/29.  Exactly one week later, Friday 2/5, I experienced pain and itching and swelling at the injection site.   Red rash developed and spread  significantly over a couple of days, covering most of my upper arm.  Started to show improvement on Sunday, 2/7 but then a significant flare up the night of Sunday 2/7.  Today, Monday 2/8, there is so far significant improvement with only a couple of hot spots.
A physician reported the occurence of an injection site reaction in a 15-month-old female who received diptheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  The vaccinee's medical history, concurrent conditions, and concurrent medications were not provided.  The vaccinee had no adverse experiences following receipt of prior immunizations.  On 04/26/2002, the vaccinee received her fourth injection of INfanrix.  On that date, she also received an injection of inactivated poliomyelitis virus vaccine (IPOL).  On 04/27/2002, the vaccinee experienced an injection site reaction at the site of Infranrix administration characterized by swelling, redness and warmth.  The reaction was described as "hive-like" and measuring three inches by two inches.  The vaccinee was seen by the physician.  The injection site reaction resolved on 04/30/2002.  The reporter considered the events to be probably related to Infanrix administration.
petechiae on the skin; conjunctival hemorrhage; This is a spontaneous report from a contactable Consumer reporting for her mother in law. A 72-years-old female patient received the second dose of  bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 12Feb2021 at single dose for covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient received the first dose of BNT162B2 vaccine on an unknown date. The patient experienced conjunctival hemorrhage on 13Feb2021 with outcome of unknown , petechiae on the skin  on 14Feb2021 described  as round, red spots on the arm, leg, and belly with no more than 6 spots, with outcome of unknown.   Conjunctival hemorrhage was considered an Important Medical Event.  Information about Lot number has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in his arm like with the previous shots or with any shots that you get in the arm), PAIN (This pain became progressively worse) and HYPOKINESIA (I can barely move my arm 1/4 the way I normally can) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A, EN6198 and EL9266) for COVID-19 vaccination. No Medical History information was reported.On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced PAIN IN EXTREMITY (Pain in his arm like with the previous shots or with any shots that you get in the arm) and PAIN (This pain became progressively worse). In November 2021, the patient experienced HYPOKINESIA (I can barely move my arm 1/4 the way I normally can). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency and IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in his arm like with the previous shots or with any shots that you get in the arm), PAIN (This pain became progressively worse) and HYPOKINESIA (I can barely move my arm 1/4 the way I normally can) had not resolved. No Concomitant medication were reported.