chrisvoncsefalvay/vaers-outcomes huggingface dataset:
p/vax pt arm was swollen & red, hot & hard;pt then started on medrol pack & DPH;
Had mild arm rash at injection site 2-4 days after, then gone.  Rash returned about 10 days after injection, larger area, deeper pink and a slightly darker ring around the rash.  No bumps or raised area.  Itch, slightly warm.  Using cold compress and an "itch calming" body lotion.  Rash has continued 4-5 days, less itching as days pass and slightly less pink.  Does not seem to be growing larger.  Will try Benadryl and/or acetimenphen.
April 12/Day 1 -  1:35pm : 5 minutes after the shot my throat hurt Afternoon: Felt light-headed, woozy and hard to focus on work.  No fever yet.  8:30pm: Chills so bad I was convulsing and could barely hold anything in my hands.  Got in bed and stayed there.  9:30pm: 102.6 fever  Evening and in the middle of the night: Drank lots of water and coconut water.  Took 2 Tylenol before bed.   April 13/Day 2 -  Morning - took 2 more Tylenol Had fever all day, around 101.8 and going down to 101.3.  Slept all morning.  12:30pm - Got out of bed to try to eat chicken soup and crackers - took 3 bites and felt nauseated, like I would throw up so I got back in bed and went back to sleep.  5pm - Woke up and ate a little dinner.    April 14/Day 3 - Temperature dropped to normal.   April 15 - present:  Didn't have fever but continued to feel sick and have symptoms:  Day 3-5:  Hard to focus at work.  Someone would call me to talk about something.  Then we started talking about other things and I couldn't remember why they called in the first place - what was the topic we were talking about.  Felt very tired and had to rest periodically throughout the day, in between work meetings.    Day 6-12: Continued to feel tired and weak.  Have to take at least 1 nap to get through the day.  Brain fog - memory not as good.  Felt sick, like I had a cold (eyes hot and itchy, throat periodically hurt. I don't normally have allergies.)  Took lots of echinacea, elderberry syrup and Vitamin C.   Day 12 - Present:  Still feel tired all day long except for the first 4 hours after I have coffee in the morning.  Need to take a nap most days.  I don't feel as healthy as I did prior to taking the shot on April 12.
31OCT92 pt swelled up gained 20# in 2 wks had a rash; no fever; pt taken to MD mom told pt OK then returned dx URI; dx nephrotic synd;
Initial report received on 19 October 2007 from a nurse. A seven-year-old male patient, with no concurrent illnesses, or pre-existing medical history had received a left arm intramuscular dose of FLUZONE No Preservative 2007-2008 (lot number UZ461BA) on 04 October 2007. The following day, the patient began having swelling, redness, itchiness at the injection site that progressed to include the area between the shoulder and elbow with no joint involvement. At an unspecified amount of time after receiving the vaccine, the patient developed blistering below the injection site. The patient was evaluated by a physician and treated with BACTROBAN, BENADRYL, and ADVIL. No diagnostic tests or laboratory data were performed. At the time of this report, the patient was recovered and was to have testing for allergies.
Demarcated redness to vaccine site, pain for 3-4 days post vaccine to injection site, headache 3-4 days post vaccine, severe fatigue 5 days post vaccine.
Pain at injection site to neck region. S/S increased with movement and touch.  C/O nausea and vomiting several times during the night.  Ice pack applied and OTC given. Pt seen by provider and anti-inflammatory medication and ice treatment ordered.
Red spots last night, itchy, spread this AM. Oatmeal bath, Benadryl as needed.
An additional patient, who was 17 years old, received two doses of PROQUAD; No additional AE reported; This spontaneous report was received from a physician and refers a patient of a 17-years-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient received two doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dosage form, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). No additional adverse events were reported.  This is one of two reports from the same reporter.
This is a spontaneous report received from a contactable healthcare professional, the patient. A 23-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) on the left arm on 24Mar2021 at 16:00 as single dose (at the age of 23-year-old) for COVID-19 immunization. The patient's medical history was not reported. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 at 03:00, the patient experienced sore throat. No treatment was taken for the adverse event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore throat was recovering at the time of this report. No follow-up attempts are possible; information about lot number cannot be obtained.
FLASHING LIGHT ON RIGHT EYE; DUST PARTICLE/ FLOATERS; PAIN IN RIGHT ARM; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included degenerative arthritis at right hip, high triglycerides, and pinched nerve on left of the neck above the shoulders, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 25/MAY/2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021, the subject experienced pain in right arm. On 10-APR-2021, the subject experienced dust particle/ floaters. On 12-APR-2021, the subject experienced flashing light on right eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in right arm on 02-APR-2021, and the outcome of dust particle/ floaters and flashing light on right eye was not reported. This report was non-serious.
12/20/09- Bruising on the Left deltoid area.  Saw Md on 12/22/09, sent to ER, bloodwork done Platelets fell to 2,000. Pt. received Platelets, and globulin. Admitted for 2days. Received prednisone and more globulin. 1/19/10 still being monitored at home.
This spontaneous report was received from a pharmacist referring to a 10-year-old female patient. The information about the patient's medical history, concomitant medication, concurrent conditions and drug reactions/allergies was unknown by the reporter. On 08-FEB-2019, the patient received a dose of M-M-R II subcutaneously (lot number N032427 and expiration date 16-NOV-2019) for prevention of measles/mumps/rubella (prophylaxis). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date unknown by the reporter). On 19-FEB-2019, following the administration of M-M-R II, the patient developed a fever between 99 Fahrenheit degrees and 101 Fahrenheit degrees and a rash described as "little bumps" on her cheeks and back (pyrexia and rash). It was reported that the patient called the pharmacist due to the events. No treatment was given for the adverse events and it was unknown by the reporter if lab diagnostics/studies were performed. At the time of reporting, the patient had not recovered for the events and there was no causality assessment provided between the events and M-M-R II and sterile diluent (MERCK STERILE DILUENT).
Patient came in with Caregiver. Caregiver stated that he had never received a Covid Vaccine before. After the vaccination, registry of immunization was entered and noticed that he was given the Pfizer vaccine at a facility. Patient was given Moderna today.
Abdominal pain began 15 October; back pain began 16 October; rash began on back 17 October and continued to spread; burning pain, fever. Dr at Urgent Care diagnosed shingles on 21 October and prescribed acyclovir. Painful rash is continuing to spread.
Pt. was administered this vaccine on 2/1/21 and the vaccine had an expiration date of 1/28/21. Pt. didn't report any adverse effects of the vaccine.
Pain at site of Covid vaccine; site was sore the day of. By 2 pm the next day the site looked like a welt (I confirmed this with my roommate); by Sunday, the swelling decreased but there was a deep bruise at the site. There is still a faint shadow of a bruise at the site.
Received 5 Pfizer vaccines, still tested positive with Covid; Received 5 Pfizer vaccines, still tested positive with Covid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and in 2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: PNEUMOCOCCAL 13 VALENT VACCINE taken for immunisation as dose number unknown, single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Received 5 Pfizer vaccines, still tested positive with Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No energy; Flu like symptoms; Dry throat which makes patient cough a lot; Runny nose; Dry throat which makes patient cough a lot; Fatigue; Head aches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No energy), INFLUENZA LIKE ILLNESS (Flu like symptoms), DRY THROAT (Dry throat which makes patient cough a lot), RHINORRHOEA (Runny nose) and COUGH (Dry throat which makes patient cough a lot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (No energy), INFLUENZA LIKE ILLNESS (Flu like symptoms), DRY THROAT (Dry throat which makes patient cough a lot), RHINORRHOEA (Runny nose), COUGH (Dry throat which makes patient cough a lot), FATIGUE (Fatigue) and HEADACHE (Head aches). At the time of the report, ASTHENIA (No energy), INFLUENZA LIKE ILLNESS (Flu like symptoms), DRY THROAT (Dry throat which makes patient cough a lot), RHINORRHOEA (Runny nose), COUGH (Dry throat which makes patient cough a lot), FATIGUE (Fatigue) and HEADACHE (Head aches) outcome was unknown.            Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable.
Hospitalized 11/28/2021; COVID-19 positive 11/28/2021; fully vaccinated  BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider:  MD Admission Date: 11/28/2021 Discharge Date:  12/01/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Congestive heart failure, unspecified HF chronicity, unspecified heart failure type  COVID-19 virus infection  COVID-19  Acute on chronic diastolic (congestive) heart failure HOSPITAL COURSE: Admitted to the hospital with dyspnea however no oxygen desaturation encountered, no need for supplemental oxygen.  COVID positive therefore he qualified for monoclonal antibodies, infused on hospital day 1. Subsequently the patient made full admission due to coexisting CHF exacerbation that was diagnosed on admission as well add adequate diuresis could not be accomplished on hospital admit 2. Therefore additional hospitalization was required for that.  Diuresis was accomplished via Bumex however the patient does have chronic kidney disease stage 4 limiting the effectiveness of the diuretic.
06/18/2005 high fever 104 continuing until 6/20/05 saw Dr put on Azithromycin 250mg completed 6/25/06, Methylprednisone 4mg 21 tabs, 2 remaining tablets.
Chills; Fever (102 Fahrenheit); Headache; Body aches; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP6955), via an unspecified route of administration in the left arm on 30Mar2021 at 09:00 (at the age of 23-year-old), dose 2, single for COVID-19 immunisation. Medical history included migraines. Concomitant medication included propranolol. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247) administered via an unspecified route of administration in the left arm on 09Mar2021 at 09:00 (at the age of 23-year-old), dose 1, single for COVID-19 immunisation. On 30Mar20221, the patient experienced chills, fever (102 Fahrenheit), headache, body aches. No treatment was received for the event. The outcome of the event chills was recovered on an unspecified date and outcome of other events was recovered on 01Apr2021.  No follow-up attempts are possible; No further information is expected.
This case was reported by a consumer and described the occurrence of infection in a adult female patient who received SHINGRIX. On 14th May 2018, the patient received the 1st dose of SHINGRIX. On 14th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and arm discomfort. In May 2018, the patient experienced infection. On 15th May 2018, the patient experienced tiredness, shivering, fever and erythema of extremities. The patient was treated with Antibiotics (Brand Names Not Known). SHINGRIX was discontinued. On an unknown date, the outcome of the infection and erythema of extremities were unknown and the outcome of the pain in arm, arm discomfort, tiredness, shivering and fever were recovered/resolved. It was unknown if the reporter considered the infection, pain in arm, arm discomfort, tiredness, shivering, fever and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. By the time the patient had walked outside to car and her arm was hurting and feeling heavy. Approximately 24 hours later, tiredness, shivering and chills came on suddenly and had a fever with body temperature 101.8 degree F, which lasted several hours. The next day of vaccination, arm turned pink or reddish, and ended up with an infection and had to his see primary care physician. The patient still on antibiotics for the infection. The physician suggested not get the 2nd dose of the vaccine. The physician however could not be certain that the infection was not caused by the needle prick opening. The patient did not contact the pharmacy.
After vaccine administration, patient stated that she felt light headed, had difficulty breathing, and her legs felt like they were burning.
01/11/2023 I was coughing, I took a COVID-19 home test and it was positive. 01/12/2023 I contacted urgent care and was prescribed a course of PAXLOVID. I felt better after the third day.
dribbles; heart rate when down to 38 beats per minute; loose bowels; breathing situation has gotten worse; feels terrible; increased amount of phlegm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRADYCARDIA (heart rate when down to 38 beats per minute) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031a21a and 032L20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Coronary artery disease, COPD, Enlarged prostate, Atrial fibrillation and Bronchitis. Concomitant products included WARFARIN for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced DIARRHOEA (loose bowels), DYSPNOEA (breathing situation has gotten worse), FEELING ABNORMAL (feels terrible) and PRODUCTIVE COUGH (increased amount of phlegm). On 21-Mar-2021, the patient experienced BRADYCARDIA (heart rate when down to 38 beats per minute) (seriousness criterion medically significant). On an unknown date, the patient experienced URINARY INCONTINENCE (dribbles). At the time of the report, BRADYCARDIA (heart rate when down to 38 beats per minute), DIARRHOEA (loose bowels), URINARY INCONTINENCE (dribbles), DYSPNOEA (breathing situation has gotten worse), FEELING ABNORMAL (feels terrible) and PRODUCTIVE COUGH (increased amount of phlegm) outcome was unknown. Not Provided          Treatment of these events included steroids.  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
4 yo female was given 4 yr shots and flu vaccine on 28 Dec 2012 the following AM patient had rash and redness over the right thigh area at the injection sites. Rash was small bumps and itchy about a quarter size. Rash spread to inner thigh area but resolved in the prior areas as it did. Mother describe local reaction as red, bruised, and welted up and started as a size of a quarter then increase in size as big as her palm of her hand.  No difficulty breathing, no wheezing. Patient still complaints of itchiness on her legs. Patient has continued to have cough and congestion for several weeks now. Pt had fever of 101 on 01/03/2013 but no fevers prior to this. Patient with small non red bumps on back now felt. But not similar to rash around the injection site.
Pains at the left side of the head/ pain location changes each time; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Pains at the left side of the head/ pain location changes each time) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A. and 002B21A) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced HEADACHE (Pains at the left side of the head/ pain location changes each time). The patient was treated with PARACETAMOL (TYLENOL) for Head pain, at an unspecified dose and frequency. At the time of the report, HEADACHE (Pains at the left side of the head/ pain location changes each time) outcome was unknown. Not Provided          The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.
States driving home 4:30 PM, began to feel tickle in throat.  Further he drove, became worse and began having difficult breathing (he did stop to vote).  Had chills , shaky, temp 103 degrees.  Called PMD--advised to take Tylenol/ibuprofen q 2 hours.  When fever broke, increased sweats.  Went to door to get fresh air and passed out (BP 85/60--wife is RN)  No appetite.  Stayed home next day and felt fine.  Returned to work 11/6/2008 with no problems.
fell backwards after getting the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FALL (non-serious), outcome "unknown", described as "fell backwards after getting the vaccine".  Additional information: Caller also reports that her girlfriend also experienced something from the vaccine and that her girlfriend fell backwards after getting the vaccine. Caller also wanted to know if anyone else had it (experienced the same AE's she had).   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Swelling under arm; Swollen lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the right arm on 22Mar2021 at 10:00 for COVID-19 immunisation. Medical history included diabetes and COVID-19. The patient had a history of allergy to Reglan. Concomitant medications included vitamin d, rosuvastatin and cabergoline (MANUFACTURER UNKNOWN); all for unknown indication received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 23Mar2021 at 7:00 following day after injection, the patient began to feel swelling under arm, lymph node was swollen and was currently as big as a lemon. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swelling under arm and swollen lymph nodes was not resolved at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Head cold with very runny nose.   Temperature 97.1 Ate chicken noodle soup
sore throat; croaky voice; This spontaneous case was reported by a patient family member or friend and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and DYSPHONIA (croaky voice) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and DYSPHONIA (croaky voice). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and DYSPHONIA (croaky voice) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The reporter wanted to know if there are any side effects to the current booster if the vaccine was not thawed properly before administered. Reporter's boyfriend woke up the next day with a sore throat and a very croaky voice.  No treatment information was provided.