chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Anaphylaxis, tongue swelling, difficulty breathing, & hives, Ambulance transported pt to the nearest ER, required Epinephrine injections 1mg  IM X3, IV Methylprednisolone 50mg  and IV Benadryl 50mg, pt had to be transferred to higher level of care due to ongoing symptoms and was kept until 1/24/21. Pt  said staff at the ER told her they knew they should report the reaction to someone but didn't know how to report it.
Intense diarhea and rectal bleeding. Started about 2 days after the first shot and continued for about 5 days. Second shot was just intense diarhea
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-NOV-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # L008057 and expiration date 01-DEC-2016, 2 ml administered orally. No adverse effects were reported. The vaccine had one temperature excursion of 48 hours with a lowest recorded temperature of 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a physician refers to a 65 year old female patient without pertinent medical history. The patient had drug reactions/ allergies to prednisone, sulfasalazine, methotrexate, hydroxyquine and meloxicam. There was no concomitant medication. On 02-DEC-2011 the patient was vacccinated with ZOSTAVAX (lot number 670816/0693AA, expiry date 11-AUG-2012) subcutaneously. The patient experienced oral herpetic lesions in January 2013 as well as a rash and cellulitis two weeks ago, approximately on 25-MAR-2013. The outcome of oral herpetic lesions, rash and cellutlits was reported as not recovered. Oral KENALOG base, CLEOCIN T anmd CIPRO were given for adverse event. No lab diagnostics studies were performed. The patient was being treated by the reporting physician. Additional information has been requested.
Contracted COVID; Contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. She was by no means overweight and her diet was primarily gluten free products and balanced diet with supplements.The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "Contracted COVID". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1/6/2021 3:30 PM RECEIVED VACCINE 4:00 PM ONSET OF RASH/CHEST HEAVINESS 4:30 PM TOOK BENADRYL 25 MG PO AND PEPCID 20 MG PO 6:00 PM TOOK 2ND DOSE OF BENADRYL 25 MG PO 6:30 PM IMPROVEMENT OF RASH/CHEST HEAVINESS 1/7/2021 9:00 AM ONSET OF FATIGUE/MALAISE/INJECTION SITE PAIN/CHEST HEAVINESS 1/8/2021 9:00 AM MALAISE/INJECTION SITE PAIN
Enlarged Heart; sleeping too much; headache; Haven't been able to get her energy back; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6202) via an unspecified route of administration, administered in arm left on 27Feb2021 (at the age of 71-years-old) as dose 2, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included arthritis, osteoarthritis, lump in her lung, and underwent hip replacement. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9264), via an unspecified route of administration, administered in arm Left on 06Feb2021 (at the age of 71-years-old) as dose 1, single for covid-19 immunisation. The patient had a horrible experience with the second shot, she mean it, it wasn't just of a couple of days of sleeping too much and a headache. She meant that she slept 15 hours straight, have excruciating headache amongst other things and for 9 days and she just haven't felt the same, she haven't been able to get her energy back to normal, she still get an 10 to 12 thousand steps a day but she knew there was something going on with her heart. She was a VA patient and she had to go in for as they have been checking a lump that she had on her lung to make sure that it hasn't grown, and yet it had been (before vaccination), but what they found was that she had an enlarged heart. And she saw today they were showing that there was a co-relation between Moderna and Pfizer and the information of the heart and she was getting ready to go and see a Cardiologist, but what she was wondering, what do, does it was ever go back to normal. She just don't understand, if she had it to do it over again there was no way she would take any of this medication, any of this shot, she mean it was that horrible. The patient had a CT test and that's how she found out she have an enlarge heart and she have never had anything to do with her heart. There was no treatment, the patient just laid on bed for 9 days. The outcome of enlarged heart was not recovered; and the rest of the events was unknown. The reported event 'enlarged heart' was considered as serious, disabling.   Information on the lot/batch number has been requested.
c/o chest pressure, tightness, dizziness 5 mins after vaccine. denies SOB , double vision, confusion. No redness or swelling no rash noted to vaccination site.  151/79, 90  O2 sat 99%. Refused transport.
3 x 4 mm warm erythematous patch on right deltoid. Temp 99. Affected area grew big in size over days, then symptoms improved. Pt completely recovered now as of 1SEP04.
general tiredness on first day of vaccine.  Second-third day, large rash at injection site:  1"  red center with 3: concentric pink circle--raised, hard, and warm to the touch.
Swollen, itchy circle rash at injection site, "covid arm." Rash is about 2" diameter. Resembles cellulitis.
ACHES; CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. 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, the patient experienced fever, chills, and aches. The action taken with covid-19 vaccine  was not applicable. The patient recovered from fever, chills, and aches. This report was non-serious.
Headache, Fever, NauseaVomiting, headache, fever, nausea, chills Narrative: took Tylenol
Redness, itching, swelling at right deltoid area. Mother reports symptoms began approximately 20 minutes after vaccine was administered.
Cough started ~8 hours after shot and continued since then.. Doctor today advised me to increase water intake and use an Albuterol inhaler
Pt recvd vax on 30JUN92 & approx 24 hrs p/vax devel sudden onset of chills, vertigo & vomiting but no fever; seen in ER;
hair loss; This is a spontaneous report from a contactable other health care professional (patient). A 88-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 88-years), administered in arm left on 25Feb2021 as dose 1, single for COVID-19 immunization. Medical history included hypothyroidism (Caller was diagnosed when she was 18 years old), high blood pressure (Caller was diagnosed in her 50s) and covid-19 from Nov2020 to an unknown date. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism as 0.150mg once daily by mouth, lisinopril (LISINOPRIL) taken for hypertension as 10mg once daily by mouth, start and stop date were not reported. The patient was taking the other products. On an unspecified date, the patient experienced hair loss. It was further stated that she was calling regarding the Pfizer BioNTech COVID Vaccine. She was having a side effect she would like to report. She stated that she did have COVID in the middle of Nov2020, but she got her first shot of the vaccine two weeks ago, and she is having hair loss. She was wondering if this is a side effect of the product. She stated that she noticed there might have been some hair loss in with the COVID Virus, when she had that back in Nov2020, but there was more with this. She had the COVID vaccine two weeks ago, and she started noticing she was having to take hair out of her brush more, and today, she went to the hairdresser and the hairdresser noticed it as well. She stated that it was just a concern of hers, that it will get worse with the second shot. The patient was taking Pfizer BioN-Tech COVID Vaccine because her doctor told her to. She stated that the lot number on her card was covered with a sticker saying Pfizer BioNTech. She wanted to know if hair loss is a reported AE associated with the Pfizer COVID-19 vaccine. If it is, how often is it reported. She had a prior COVID-19 infection and is experiencing hair loss after the first dose of the Pfizer COVID-19 vaccine. She mentioned that she had heard other people who are having this adverse event. Her friend saw on TV that a per-son was having clumps of her hair were coming out after having the COVID-19 vaccine but she was not sure which vaccine the news is pertaining to. She wanted to know if she should get the second dose of the vaccine considering her AE. Considering she had prior COIVD-19 infection and got the first dose of the Pfizer COVID-19 vaccine, how much is the protection. The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19. The clinical outcome of the events was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Slight cough; Nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Slight cough) and NASAL CONGESTION (Nasal congestion) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Slight cough) and NASAL CONGESTION (Nasal congestion). At the time of the report, COUGH (Slight cough) and NASAL CONGESTION (Nasal congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2021 and was forwarded to Moderna on 04-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Slight cough) and NASAL CONGESTION (Nasal congestion) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Slight cough) and NASAL CONGESTION (Nasal congestion). At the time of the report, COUGH (Slight cough) and NASAL CONGESTION (Nasal congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    No treatment information was provided.
Baby developed 1 hive approximately 2" from injection site (above left knee), within 5 minutes of injection. Mom had given Tylenol prior to clinic. Ice pack to leg to 10 minutes. Baby "Talking" playful. Mom to call MD to discuss advisability of Benadryl.
Dizziness restlessness, insomnia, lightheadedness, sore arm, body aches
The night following my first dose, I experienced the worst mentrual cramping I have ever had in my life, so much so that it felt like I was having contractions.  As I have an IUD, I have not had a period for over two years now, though I do experience cramps during the time in my cycle where I should bleed. The cramps experienced were nothing like my normal menstrual cramps, I was doubled over in pain. And on the third day after the shot, I bled for the first time in 2 years (since getting an IUD). My breasts also doubled in size and extremely painful.
After second dose, tired, very fatigued, whole body was sore, chest rash, injection site pain, this was the day after the shot and last for about 4 days.  Felt bad for weeks after 2nd dose.  On 3/23/21, Syncope and collapse, 3 days in hospital.  Dr's could not find the cause of syncope and collapse, they ran many tests.  On 3/23/21, woke up with severe chest pains and collapsed, large gash on my head, taken to hospital by ambulance.  Dr's did not think it was from 2nd dose, but they could not find another reason for Syncope and collapse.
Rash; Skin warm; Pain; This regulatory authority case was reported by a consumer and describes the occurrence of RASH (Rash), SKIN WARM (Skin warm) and PAIN (Pain) in a 21-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient experienced RASH, SKIN WARM, (seriousness criteria hospitalization and medically significant) and PAIN (Pain) (seriousness criteria hospitalization and medically significant). At the time of the report, RASH (Rash), SKIN WARM (Skin warm) and PAIN (Pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test.     The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Patient had severe pains in left arm and hand, Left side Chest pain, pain in top of left shoulder, red rashes all over the upper body and both Forearms, Discomfort around muscle and Forearms areas. Patient was taking antihistamine.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient received vaccine 11/30/12 at pharmacy. Patient returned to pharmacy on 12/2/12 with large, red, round wheal at injection site.
Pt requested Pfizer COVID vaccine but was administered 0.3 ml of Janssen instead. No side effects were reported after letting the patient know about the error.
p/ pt recv vax approx 2yrs later pt devel 36 chickenpox lesions
Mon 7/2/12 gave pt ZOSTAVAX. Thurs 7/5/12. Pt called pharmacy described small rash on leg. Counseled pt to cover rash with gauze & go to dr to have diagnosed.
Got the Pfizer shot August 24th following day woke up at 6 a.m. 25th of August with severe allergic reaction to Pfizer lymph nodes extremely swollen hives all over my body and swells all over my body extremely itchy. Call my doctor to see what I could take through my insurance they advised me to go to the emergency room then I was prescribed  Prednisone 20 mg tablet,Loratadine 10mg Claritin,Famotidine 20 mg Pepcid. Then send home and to schedule an appointment with my doctor that itching continue with swells for 8 days was seen by Dr. doctor sent me to get blood results at a lab and was prescribed omeprazole 40mg.
01/26/2010 -8:40am Nasal given - 9:00 am Teaching staff had called Mom due to the child feeling ill - 10:30am received a call from staff member outside concerning a child. Found the child sitting in a chair complaining of dizziness and nausea. 10:35am VS taken by paramedic. BP 130/80, pulse 107 irregular, chest clear, resp. 16, Ox. Sat. 98 - The child reported had a cold recently and had taken ROBITUSSIN and Ibuprofen. 10:35am Pulse 83 - The child's mother was called. 10:45am The child walked off the campus with the mother. No distress noted. Advised mother to take the child to her physician for evaluation
10x10-inch area of erythema warm to the touch on right arm extending from deltoid to bicep muscle.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 3:36 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 3:36 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 21.44 for dose administered on 11-Jan-2021.  No concomitant medications were reported.  Batch number 041L20A underwent temperature excursion on 11-Jan-2021 with temperature 34 degrees Fahrenheit at 09:00 AM and 35 degrees at 02:00 PM. This vial was moved to fridge on 08-Jan-2021 and beyond use date for the vial was reported as 07-Feb-2021. Product moved to clinic on 11-Jan-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Note that I do not know the precise flu shot I received; I simply picked the first flu shot in the dropdown list.  Timeline of events: Oct 2, 2023: received flu shot in left should (don't know which kind of flu shot) Oct 5ish: I began feeling pain in my chest and back. It was decidedly not muscular pain ? it felt like it was in my bones. Oct 8: rash/pimples characteristic of shingles appear on the right side of my chest Oct 9: go to doctor; receive confirmation that I have shingles Oct 18: am writing this with shingles  At 29 years of age, to suddenly get shingles is certainly odd? the only thing that happened in the preceding days is me getting the flu shot, which almost perfectly coincides with the onset of pain three days later that preceded the outwardly visible shingles.
Headache, Myalgia, Arthralgia, Fever,  NauseaVomiting,  chills  Narrative:
headache, fever, chills, aches (18 hours) painful swollen lymph nodes under right arm (7 hours at time of report and continuing)
Lymph node under left arm sore, headache, nausea, temp of 100.2, body aches and chills for approximately 20 to 24 hours. Left Lymph node still very tennder
Patient came in for second dose in series.  He stated that he has been experiencing severe headaches since he received the first dose.  This happens off and on and mainly at night.  It is relieved enough that he can sleep and get thru the next day after he takes Advil.
About a minute after I had the injection, my arm started hurting and it felt like hot water was coursing through my veins. I got an immediate headache that progressed into light headedness, my vision got blurry and I saw colors and then I started to lose my hearing, it felt like there was cotton in my ears. The nurses said I went pale and they called it a panic attack, but it was unlike any panic attack I have ever had in my life. I?ve had my TDAP updated a few years ago and got a flu shot and did not feel anything like this. I was rolled out of the room on a wheel chair because I was too dizzy to walk and then threw up several times into a bag and peed myself. It took about 20 minutes before I felt normal again.   The following day my arm felt numb and incredibly sore, I couldn?t raise it that far up without excruciating pain. I felt weak, fatigued and dizzy and was unable to use the bathroom. I had fever sweats and chills on and off. I was not able to sleep well, but I think that?s because of the pain in my arm.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. In October 2012 the patient was vaccinated with ZOSTAVAX dose 1. Lot number, expiration date, route and anatomical location were not reported. In March 2013 the patient was vaccinated with ZOSTAVAX dose 2, 0.65 ml, subcutaneous. Lot number and expiration date were not reported. The second dosage was reported as an accidental administration. On MAR-2013. Treatment information was not reported. Additional information is not expected.