chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Violent diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Violent diarrhea) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided bye the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced DIARRHOEA (Violent diarrhea). On 17-Feb-2021, DIARRHOEA (Violent diarrhea) had resolved.            Concomitant medications reported included medicine for her blood pressure and cholesterol. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Contact information updated
Patient had a 6th nerve palsy noted 24 hours after vaccines given.  Admitted to the hospital and by 2nd day symptoms resolved.
Fever, chills, nausea, flushed face, headache, dizziness, fever
Vaccine administered into top of arm at shoulder location. Extreme pain radiating into and down the arm. Doctor said it possibly hit the bone and/or nerve. Improperly given.
Severe pain at injection site (right deltoid) started 2 days post injection, radiated down arm to dorsa medial metacarpal area and into back of neck.  Pain has persisted up to this time (patient told me about this, first time today). She says she had a similar but milder reaction to a flu shot given by her primary care provider 1 year earlier, pain lasting 6 months (unknown by me until today).
On March 5th I experienced shortness of breath around 1:30 that lasted for 10 minutes.  I had no other symptoms and it subsided. On 3/9 around 2:30 am I had another episode of shortness of breath that lasted about 5 minutes. I was able to return to sleep. I went to work that morning and had shortness of breath, sweating, and dizziness. I drove myself to the ER where I was diagnosed with an acute saddle pulmonary embolism.   I was admitted and started on IV heparin.  On 3/10, I was also found to have a DVT in my right leg.
This  72  year old  female received the Covid shot on 03/15/2021 and went to the ED on 4/3/2021  and was admitted  on    4/3/2021    with    abdominal pain, nausea, chest pain, NSTEMI     and died on  04/24/2021 .  Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
Patient describes receiving vaccines during the day and by the evening, had broken out in a dry,  raised, red rash on her forehead that seemed to her like "acne." A similar rash developed on her eyelids and jaw. She also described arm soreness, which has improved as of the patient interview. Patient denies fever and denies rash on other parts of her body. As of today, she also describes swelling under her eyes and persistent rash. Patient has taken "TYLENOL" for discomfort associated with vaccines. Denies use of any new facial products.
Pt called & said 1 wk ago got Tdap, 3 days later got mall bruise at site, said it has gradually gotten large like bleeding under skin. Now below elbow on inside of forearm. Told to go to her MD. Pt said she wanted to come here & let us look at it first. To come at 7 pm 1-7-13 did not come called MD appt tomorrow came in - has MD appt.
Systemic: Chills-Medium, Systemic: Headache-Mild, Systemic: Joint Pain-Severe, Systemic: Unable to Sleep-Severe, Systemic: Nausea-Medium; symptoms lasted 0 days
on 5/27/21 I gave patient and pneumonia vaccine that was expired on 5/18/2021. I did have it checked, and it is  document it in her chart. I did not realize it until I started to put in the vaccine information that it was expired.  I called patient on that day and let her a message explaining what had happened. She called me back today and said she wanted to discuss at her next appointment if she should get another dose  in a month. She was very understand and was not upset.
mouth is sore; swollen toes; swollen arm; weak; taste the medicine in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), ASTHENIA (weak), DYSGEUSIA (taste the medicine in her mouth), ORAL PAIN (mouth is sore) and PERIPHERAL SWELLING (swollen toes) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN, ATORVASTATIN, PANTOPRAZOLE and VITAMINS NOS for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), ASTHENIA (weak), DYSGEUSIA (taste the medicine in her mouth) and PERIPHERAL SWELLING (swollen toes). On 18-Mar-2021, the patient experienced ORAL PAIN (mouth is sore). The patient was treated with ALCOHOL for Swelling, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swollen arm), ASTHENIA (weak), DYSGEUSIA (taste the medicine in her mouth), ORAL PAIN (mouth is sore) and PERIPHERAL SWELLING (swollen toes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Applied alcohol on arm for swelling.
symptoms were the same after both vaccines and started the day after and lasted approximately a week.  Basically flu like symptoms.  Fever, bad chills, achy all over, headache, weakness.
Starting about two hours after receiving the the shot I started to feel light headed and vertigo. It progressed into headache, sensitivity to light, loss of appetite, fatigue and body aches. Later I developed fevers/chills and extreme discomfort. These effect lasted about ten days, and I was essentially bed-ridden for that time.  About eight days into the symptoms I developed night sweats. These night sweats and fatigue lasted for at about another month.
Swollen cheeks; Red cheeks/ Red ears; Rash/ rash on her trunk that goes down both legs; Soreness/soreness at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of cheek swelling in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number CA374, expiry date 28th June 2021) for prophylaxis.   On 2nd May 2019, the patient received the 1st dose of Shingrix .5 ml. On 3rd May 2019, 1 days after receiving Shingrix, the patient experienced cheek swelling, red face, rash and injection site pain. On an unknown date, the outcome of the cheek swelling, red face, rash and injection site pain were unknown.   It was unknown if the reporter considered the cheek swelling, red face, rash and injection site pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that a patient had a major reaction after receiving her 1st dose of Shingrix. The patient received the shot yesterday and this morning had red and swollen cheeks, ears are red, and a rash on her trunk that goes down both legs. The patient also had soreness at the injection site. The patient did not notice the reactions until this morning and she had not done anything differently or eaten anything different. The patient had not seen a doctor.
Per patient: "I received the PNEUMOVAX 23 vaccination at the office. I subsequently had a very adverse reaction to it causing cellulitis to that arm as well as a very high temp (103.7) causing admission to ER. Also rather large bump on arm at injection site."
This patient has a history of epilepsy. He received the vaccine approximately 1pm. This is a minor who was here with his father. At approximately 1:10pm  we were alerted that he started to seize. 911 was called. The father had him on the floor. He came out of the seizure prior to  EMS arriving. Once they arrived, the parent declined ambulance transportation to the hospital and said he would call his physician.
Small, red, itchy bump. No pus or discharge. Advised pt to try hydrocortisone cream for itching x 3 days, if worsens or no relief see medical doctor.
Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Tinnitus-Mild, Additional Details: ems called - taken for monitoring
INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; OFF LABEL USE; PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2.s (dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination.  No adverse event reported after primary vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 13-APR-2021 for prophylactic vaccination which was an off label use as inappropriate schedule of vaccine administered (dose number in series 2).  The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in APR-2021, the patient experienced pain (dose number in series 2). On 14-APR-2021 at 09:00, the patient took Tylenol (paracetamol).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain, and the outcome of off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Extreme muscle pain and weakness all over. It began about 6 hours after the shot and continued for about 24-36 hours.
MUSCLE/JOINTS PAIN AND SORE; FEEL CHILLED; FEVER 100.0; TOOK ADVIL 200 MG IN THE MORNING AND NIGHT.
Woke up to severe chills, fever, muscle pain, headache. Took Advil.
Pt vaccinated with DTP/OPV developed initability, language delay, still has developmental delay; seizures resolved.
Patient's husband called the pharmacy on 03/25/21 and reported that his wife was experiencing fatigue, nausea (with not vomiting) and pain that was in the midsection and spread to her back. He stated that the pain began the previous day. I inquired about other possible injuries and illnesses and he denied she had any. He also stated that the pain was not relieved with otc pain relievers. I instructed him to alternate ibuprofen and acetaminophen and if the pain was not improved to report to the ER. The pharmacy staff was notified on 03/29/21 that the patient did report to the ER on 03/25/21 and was possibly intubated.
Pt called 10/29/10 said she has a welt around site. Said she could not take BENADRYL. Pt advised to put hydrocortisone cream on it. Pt called 11/1/10 & said that welt resolved. On Wednesday day following the day shot received, 10/27/10, her finger started twitching. The index finger in her right hand. It has not quit twitching. I told her that I would file a report and she should contact her doctor. She said she couldn't afford to see him, should she go to the ER? I said I couldn't advise her on that. She rang off.
Anaphylactic shock; Hives; Rashes; Face and lip swollen; Face and lip swollen; This is a spontaneous report from contactable nurse via a Pfizer Sales Representative.  A 16-year-old female patient received the first dose of meningococcal group b rlp2086 (TRUMENBA) via an unspecified route of administration on 27Dec2018 at single dose for immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced anaphylactic shock, hives and rashes all over the body, face and lip swollen. Lip covered bottom half of mouth. The patient went to ER (hospitalization was also considered as seriousness criteria). The patient recovered from the events on an unspecified date. It took about a month for full recovery.  The information on the batch number has been requested.
inability to walk without back spasms and needing a cane while standing; needing a cane while standing; dry plaque on right hip; dry plaque on right hip; itchy plaque; intense red, blister-like, slightly raised; describes it as intense red; pain in back / back aches, pains; muscle aches/ Muscle pains; back spams / severe muscle cramps in calves/ spams; This case was reported by a consumer via call center representative and described the occurrence of back pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, less than a week after receiving Shingrix, the patient experienced spasms. On 24th October 2020, the patient experienced back pain and muscle pain. On 5th November 2020, the patient experienced dry skin, skin plaque, localized itching, blister and localized erythema. On an unknown date, the patient experienced walking difficulty and difficulty in standing. On 3rd November 2020, the outcome of the back pain, spasms and muscle pain were recovered/resolved. On an unknown date, the outcome of the walking difficulty and difficulty in standing were unknown and the outcome of the dry skin, skin plaque, localized itching, blister and localized erythema were not recovered/not resolved.   It was unknown if the reporter considered the back pain, spasms, muscle pain, walking difficulty, difficulty in standing, dry skin, skin plaque, localized itching, blister and localized erythema to be related to Shingrix.  Additional details were provided as follows: The patient received first dose Shingrix in left arm and within a day or two developed severe muscle cramps in calves. Four days after Shingrix dose, the patient developed muscle aches and pain in back. Last week to the time of reporting, the patient's back was out the entire week. The affected area was lower right-hand side of back. The patient reported inability to walk without back spasms and needing a cane while standing. The back aches, pains and spams resolved on 3rd November 2020. The night before reporting and 16 days after vaccination, the patient felt a dry and itchy plaque on right hip towards buttocks. The patient observed area on the morning of reporting day and described it as intense red, blister-like, slightly raised. The area was approximately the size of a quarter and the plaque-like area appeared to be bigger. The reporter consented to follow up.
The father states, the patient received 3 shots in the AM. Father reports a change of behavior laying on couch all day after vaccines afterwards the patient was staring into space and unresponsive. Mother denies shaking during seizure. Pt was transported via EMS to hospital.
Started feeling "unwell" sometime around midnight morning of Saturday, April 24, 2021. Was found deceased 10:00am CST Saturday, April 24, 2021.
Received Adacel immunization on 10/10/2006.  On 10/12/06 c/o sorenes at immunization site; Site became red, swollen, & warm to touch.  Left ear red & warm to touch.
Rash presented early evening  Saturday, 10/16/21 belly, chest, armpits, inner thighs
Child at school-based clinic scheduled to receive 1st COVID-19 vaccine and Flu Mist.  When vaccinator administered COVID-19 vaccine, the child pulled arm away.  Only about  0.1mL of the 0.25 dose was administered.  Contacted mother to inform of error, and advised that this dose is not valid and child will need to get full dose of COVID-19 vaccine.  Mother expressed understanding and reported that she would take her child to clinic to get vaccinated.  Informed Public Health Deputy Public Health Office, Dr.
red blister like bumps developed on right index finger wed night post vaccine, then right middle and right pinky finger on thurs. Thurs night developed right tonsillar ulcer. Red spots on fingers were itchy and hands felt burning. OB  asked me to follow up with PCP.  PCP appointment friday, more spots appeared on hands. Continued to burn and itch. Negative strep test and HSV 1 culture ordered (result still pending). PCP stumped as I was not presenting typically for HSV infection, Hand Foot Mouth, or other but mentioned erthema multiforme as possibility. Had me follow up with dermatologist for monday appt. Saturday additional spots appeared on soles of feet, buttocks, and pubic area but not on mucous membranes. Sore throat and extreme fatigue all weekend. Treated with tylenol, benadryl, and topical cortizone cream for relief. Derm appt monday am. More spots developed by then, on shoulder, toes, hands. Derm suspected a viral eruption related to influenza vaccine. Took a 3mm core biopsy from spot on left wrist and prescribed clobetasol cream 0.05%. Today is wed... cream is making spots shrink, less red, no itching. Blisters now peeling. Still feeling fatigue, headache, and soreness. No new spots.  At time of vaccine 10/12/21, was 29 weeks pregnant. As of 10/17, 30 weeks pregnant. Due Dec 26 2021. No prior history of adverse reactions to vaccines.
I had torn meniscus surgery on my left knee.  The vaccine caused an extreme flare and extreme pain in the joints; I had torn meniscus surgery on my left knee.  The vaccine caused an extreme flare and extreme pain in the joints; The second dose caused a flare and my knee is now very weak; I am limping and will seek a Dr.The joint pain and flares were not there prior to this vaccine.; This is a spontaneous report from a contactable consumer who reported for herself. An adult female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0165), dose 1 via an unspecified route of administration on 10Apr2021 as 1st dose, single dose, dose 2 via an unspecified route of administration on 01May2021 (Batch/Lot Number: EW0162) as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. She stated that she had torn meniscus surgery on her left knee. The vaccine caused an extreme flare and extreme pain in the joints. The second dose caused a flare and her knee was now very weak and she was limping and will seek a Doctor. The joint pain and flares were not there prior to this vaccine. The outcome of the events was reported as not recovered.  Follow-up attempts are needed. further information is expected.
Large red rash on shoulder, itchy spreading to entire triceps, hot to touch x 2 days after vaccine, self-resolving
Bruising throughout entire body. Body blue. No physical injuries occurred to cause this. Appeared on body without trauma or cause.
Breakthrough case admission after 3 vaccines Moderna 3/3/21 lot# 010A21A; Moderna 3/31/21 lot# 017B21A ; Moderna 12/10/21 lot# 058H21A
Information has been received from a medical assistant concerning a female with penicillin allergy and a history of Papanicolaou smear test abnormal who on 26-AUG-2009 was vaccinated with a 0.5 mL dose of GARDASIL (lot # 659054/0311Y), intramuscularly. There was no concomitant medication. The patient was having pain at the injection site, the area felt hard, and there was a lump. The patient called the office because her arm had been feeling sore. No laboratories studies performed. At the time of this report the patient had not recovered. Follow up information received on 24-SEP-2009 from a medical assistant indicated that the patient was a 23 year old female with no illness at the time of vaccination, who on 26-AUG-2009 (also reported as 16-SEP-2009) at 11:15 was vaccinated with a first dose of GARDASIL (lot # 659054/0311Y), intramuscularly into the right deltoid. On 01-SEP-2009 at 16:10 the patient developed pain at the injection site, the area felt hard, and there was a lump. The patient called the office because her arm had been feeling sore. The patient recovered on 18-SEP-2009. No further information is available.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL3248), in right arm, on 24Feb2021 as dose 2, single (Lot number: EN6200), in left arm and on 12Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: ADVAIR (also reported as ADVAIR 250/50) resp inhalation, start date: Jan2020; KETOTIFEN oral, start date: Aug2021; ESTRADIOL oral, start date: Jan2018; MONTELUKAST oral, start date: Jan2018; METFORMIN oral. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of vaccination failure, covid-19. COVID 19 treatment included PAXLOVID treatment (Lot number: GA1188) start date on 02Jun2022 via oral. Group provided investigational results on 06Jun2022 and 07Jun2022 for bnt162b2: The complaint for lack of effect of the Pfizer biotech COVID-19 vaccine INJECTABLE lot FL3197, lot EN6200 and lot EL3248 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FL3197, fill lot FJ8803, and the formulated drug product lot FL3180; lot EN6200, fill lot EN5332, and the formulated drug product lot EN5321; lot EL3248, fill lot EL3231, and the formulated drug product lot EL3224. A complaint sample was not returned and photographs were not received. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause  were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.