chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 days later: Sore throat, runny nose, cough, congestion, sinus pain. 3 days later: Worsening of symptoms. 4 and 5 days later: In bed with flu-like symptoms continuing, with addition of sinus pain, migraine, painful jaw and head, slight fever.
Headache; Major fatigue; Felt like going through Covid all over again; Body sensitivity and aches; Body sensitivity and aches; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: ER8730) via an unspecified route of administration in the left arm on 26Mar2021 at 03.30 pm as a single dose for COVID-19 immunization. Medical history includes allergies and prior prostate CA. Prior to the vaccination, the patient was diagnosed with COVID-19. There was no COVID-19 test post vaccination. Patient was not had other vaccine in four weeks. Patient had no known allergies (medications, food, or other products). Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)) and fluticasone furoate (ARNUITY ELLIPTA) 100mcg. On 27Mar2021 patient experienced headache, major fatigue, body sensitivity and aches. Felt like going through COVID-19 all over again. The patient did not receive any treatment for the events. The clinical outcomes of the events are unknown.   No follow-up attempts are needed.  No further information is expected.
This spontaneous report as received from a registered nurse via a company representative concerning to a female patient, who was not in pregnant, had none pertinent medical history and none drug reactions/allergies on her "early 20's", who on an unknown date received her second dose of GARDASIL (dose and Lot not reported), intramuscular. None concomitant medications were reported. On an unknown date reported as eight days later she broke out in hives up and down her arm. The patient informed her healthcare professional that she also had an injection site reaction after the first dose of GARDASIL (dose, route and lot# not reported) and she did not report before having the second injection administered. At the time of the report the patient was recovering from broke out in to hives up and down her arm. The patient sought medical attention via telephone call to physician's office. No treatment information, lab diagnostics, drug reaction or allergies were reported. The causality between broke out in hives up and down her arm and GARDASIL was not reported. Additional information has been requested.
Urticaria after Adacel and Menactra (36 hrs. post/vax). I treated with Prednisone and Zyrtec and urticaria resolved.
pt recvd vax; exp excessive crying; redness/pain/swelling at inject site; SOB; T 100
Herpes hv2  groin  outbreak approximately 3 days after first Moderna shot. Resolved within 5 days  of onset.. "Covid-toe" swelling and red and blue on left foot, middle and  adjacent toe approximated 2 weeks after first Moderna shot. Treatment with fungicide and antibiotic creams did not resolve.  Appeared to worsen after second Moderna shot on Feb 17, 2021. Treating now with  cortisone ointment.
Vaccines were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines were administered beyond use date after thaw process) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 72 years and 6 months. No concomitant medications were reported. On 10-Jun-2022, the vaccination facility was notified of an audit that was done and it was informed that vaccines were administered beyond use date after the thaw process.  There was no patient that had any adverse reactions and no reports of any reactions after the administration of these vaccines. The patient got Moderna with vaccine Ndc code 80777027399.  It was unknown whether the patient was ever diagnosed/tested positive for COVID-19.  It was unknown whether the patient had any acute illness at the time of vaccination and up to one month before it. It was unknown whether the patient had any chronic or long-standing health conditions. Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and/or at the time of adverse event was unknown. No treatment medications were reported.
Altered taste/ eat a cookie everyday to test it, and it tasted terrible/ now its just bad; This is a spontaneous case received from a contactable consumer (patient herself). A female patient (age:83, Units: unknown) received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 19Feb2021 at approximately 08:00 as SINGLE for COVID-19 immunization. The patient medical history included immunocompromised. The patient concomitant medications was not reported. The patient historical vaccine included first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 22Jan2021 at approximately 08:00 for COVID-19 immunization and experienced altered taste/ metallic taste, also very hungry and tired. The following morning after second vaccination on 20Feb2021, the patient experienced altered taste.  Also stated, I eat a cookie everyday to test it, and it tasted terrible. After second dose she ate a lot and slept. It was stated it was more metallic first time (after 1st dose), now its just bad (after 2nd dose). Caller stated she did rinse mouth with Listerine in the morning, and asking if that could affect the taste.  Asking if this was a side effect from the vaccine. Made caller aware there is currently no information to provide on altered taste post vaccination. The outcome of the event was unknown.  Follow-up attempts are completed. No further information was expected.
Client had ZOSTAVAX injection 5/28/09. Awakened this morning (5-1-09) with a raised, red rash over "upper chest." States the rash "itches and burns" with "moderate" intensity. Denies fever or any other symptoms. Used cortisone cream on area with some relief of sx. Has called her doctor.
muscle aches; fever; headache; "I was throwing up"; "I had Diarrhea"; "We just laid around for two days doing nothing"; "My reaction was worse than my husbands"; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA ("I had Diarrhea"), BEDRIDDEN ("We just laid around for two days doing nothing"), ADVERSE REACTION ("My reaction was worse than my husbands"), MYALGIA (muscle aches) and PYREXIA (fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced DIARRHOEA ("I had Diarrhea"), BEDRIDDEN ("We just laid around for two days doing nothing"), ADVERSE REACTION ("My reaction was worse than my husbands") and VOMITING ("I was throwing up"). On an unknown date, the patient experienced MYALGIA (muscle aches), PYREXIA (fever) and HEADACHE (headache). On 17-May-2021, DIARRHOEA ("I had Diarrhea"), BEDRIDDEN ("We just laid around for two days doing nothing"), ADVERSE REACTION ("My reaction was worse than my husbands") and VOMITING ("I was throwing up") had resolved. At the time of the report, MYALGIA (muscle aches), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided. Treatment medication not provided.Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Non-significant follow-up appended; Sender's Comments:
Bilateral neck pain,  scalp pain and severe debilitating headache. Duration of several months prior to diagnosis.  Treatment was physical therapy for 9 weeks.
7 days after receiving vaccine (1/22) patchy, well demarcated, slightly raised, red rash over vaccine site ~ 8 x 5.5 cm without pruritus or pain 1/22-1/23 increased in size of the rash to 10.5 x 6.5 cm, area does blanch.  1/24 similar size, but slightly less red. Ongoing at time of submission of this reaction.
I felt dizzy and like I was going to pass out. I also had slight blurred vision. EMT needed to be called. Then 4 days later I was in the ER for another dizziness event. Still dealing with the dizziness.
This spontaneous report was received from a currently 66 years old female patient via Pharmaceuticals (manufacturer control# 2017TAR00369), reporting on herself. The patient's concurrent conditions included diabetes, high blood pressure, kidney stones, gastrooesophageal reflux disease (GERD), cancer. The patient had a port placed in the right shoulder and developed a clot post port insertion. The patient's historical drug included lovenox taken until approximately July 2016. On an unknown date, the patient was vaccinated with hepatitis b vaccine (manufacturer unknown) injection (lot#, expiration date, dose and route of administration were not reported). Concomitant therapies included warfarin, irbesartan, glimepiride, sodium bicarbonate and omeprazole. On an unknown date, the patient experienced muscle spasms. The outcome of muscle spasms and the causality between the event and hepatitis b vaccine (manufacturer unknown) were unknown. Additional information has been requested.
cant move arm. My right arm in sling. I went to ER 2 times because of my arm and your vaccine. My shoulder also not able to move
For 2 days: High  fevers up to 103.6, muscle and joint aches, chills, extremely cold hands and feet, night sweating, dehydration,  weakness , headache, earaches, congestion,
Neck pain stiffness followed by should pain and stiffness.  Cannot lift right arm over my head.
leg pain; balance problems; dizziness; hasn't been able to work in the past week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 41 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Sep2021 (Lot number: FE3592, Expiration Date: 10Oct2021) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, LOT: FC3184 and EXP: Oct2021, Anatomical location: left arm), administration date: 20Aug2021, when the patient was 41 years old, for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "not recovered", described as "leg pain"; BALANCE DISORDER (non-serious) with onset Sep2021, outcome "not recovered", described as "balance problems"; DIZZINESS (non-serious) with onset Sep2021, outcome "not recovered", described as "dizziness"; IMPAIRED WORK ABILITY (non-serious) with onset 2021, outcome "not recovered", described as "hasn't been able to work in the past week". The events "leg pain", "balance problems", "dizziness" and "hasn't been able to work in the past week" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, balance disorder, dizziness.  Additional information: Since vaccination, she had leg pain, balance problems and dizziness. They went to ER, and they gave her medication, caller wasn't sure what it was and they wrote prescription to go by store pharmacy to pick up. The reporter said it was unknown what meds were given to her at the ER, which she went there on 15Oct2021. She has not gotten any better, patient hasn't been to work. She had already seen their HCP who said her symptoms were caused by the vaccine.  Caller wanted to know if these have been reported before, and how long to expect them to last.  No follow-up attempts are possible. No further information is expected.
patient was given bivalent booster for ages 12+ instead of monovalent for ages 5-11 on 10/3/2022 Parent was notified 10/5/2022, patient had no side effects or adverse reactions.
Shot received at approx. 10:45 am on 4/17/2021. Started feeling very tired in afternoon, by 6pm on same date, completely exhausted, achy and headache, sore arm, started having chills on and off 4/18/20 - woke up at approx. 4am crying in excruciating pain. I literally hurt from my hair to my toe nails and everything in between. More than regular muscle aches, could barely function. At some point during the day, I developed a fever. Several times checked thru the day, maintained around 100. Complete exhaustion 4/19/20 - woke up approx. 6am. The excruciating pain had moved to extremely sore muscle, still exhausted, no longer have fever. Notice swollen lymph nodes on left side. I have a welt about the size of a baseball located next to my armpit towards my left breast. VERY swollen and painful. Injection site is still sore and very hot.  Fatigue is still keeping me from working. I had to call out sick to work today.
soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included FARXIGA                                                      and PIOGLITAZONE HYDROCHLORIDE (PIOGLITAZON) for Diabetes mellitus, ATORVASTATIN for Hypercholesteraemia, LOSARTAN for Hypertension, ACETYLSALICYLIC ACID (BABY ASPIRIN) and CYANOCOBALAMIN (B-12) for an unknown indication.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN (soreness). At the time of the report, PAIN (soreness) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-078059 (E2B Linked Report).; Sender's Comments:  MOD-2021-078059:First dose case
Febrile seizure at 12 hours after received, he had runny nose but no fever at visit (sibling had been ill with suspected RSV the previous week). Seizure resolved, no repeat but then progressed to continued fevers, cough. On 1/2/19 normal exam except slight nasal drainage. On 1/3 mom took him to ED for seizure (occurred just before midnight - no eval done in ED other than exam and TYLENOL). 1/4/19 came into clinic for eval with continued fevers, exam markedly different from 1/2 with copious nasal congestion, cough, fever on exam. (B) otitis media and concern for possible viral pneumonia (increased hilar markings with air bronchograms throughout - bronchiolitis vs. pneumonia). Mom described episode the evening of 1/2 - eyes rolled back, body stiffening for 20 no more than 30 seconds, breathing erratic. No color change and then stopped crying as soon as episode stopped - mom took him directly to ED - did not need to call 911.
I have a small patch of shingles / Got a vaccine 4 weeks ago; This case was reported by another health professional via interactive digital media and described the occurrence of vesicular rash in an adult patient who received Herpes zoster (Shingrix).   In October 2020, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.  It was unknown if the reporter considered the vesicular rash to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group of patients was not reported but was captured as an adult as per vaccine indication. The patient was vaccinated with Shingrix 4 weeks ago from reporting day. The patient thought that, had a small patch of shingles. No further details were reported.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date, the patient had to reschedule a visit to receive a dose of VARIVAX due to the cloudy appearance of the vaccine (Product appearance cloudy, product quality issue). PQC (product quality complaint) was filed. No adverse effects were reported.
Injection site on right thigh became erythematous and swollen. Seen in clinic on 15 Nov. Continued monitoring and no treatment was necessary. Resolving on its own.
Dizziness near syncopal episode.  Room spinning per patient and head ache.  VSS.  Family at patient's side.  No acute distress however patient with anxiety about situation and complains of neuro symptoms ongoing.
Within minutes of receiving vaccines pt began sneezing repeatedly, had throat secretions and sl cough. Over next 15 min hives developed, bloodshot eyes with periorbital swelling. EPIPEN administered and pt taken to ER.
Some chest pain started about 24.5 h after injection.  Has occurred a few more times today.    Mild
Information has been received from consumer, for VARIVAX (Merck), a Pregnancy Registry product concerning herself, a 35 year old female with a history of fibroid surgery in 2006 who on 10-MAR-2009 was vaccinated with the first dose of VARIVAX (Merck). Lot # not available. On 06-APR-2009, patient was tested positive for pregnancy at physician's office through a urine pregnancy test (LMP: 01-MAR-2009, EDD: 06-DEC-2009). On the same date, the patient reported that she had been experiencing nausea and stomach ache. At the time of reporting the patient's nausea and stomach ache persisted. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 69 year old female patient with high blood pressure and none drug reactions/allergies. On 01-AUG-2014 the patient was vaccinated with ZOSTAVAX, (dose, lot# and expiration date not reported), subcutaneous. Concomitant medication included unspecified medication. The patient stated that on the night of 01-AUG-2014, after receipt of the injection, she experienced pain the left arm (in which she received the injection) which traveled down the side of her body to her left breast. She also stated that she did also experience swelling at the injection site. The patient said that this pain almost completely resolved itself by "Saturday morning" (on 02-AUG-2014). Patient did state that she did take an unspecified medication for the pain. None lab diagnostics studies were performed. The outcome of events was reported recovering. The patient had sought medical attention by calling the pharmacist on 04-AUG-2014. Additional information has been requested.
24 hrs p/vax pt site of inject was painful more sore; following day site was observed pink & later was red & spread under the arm; neck & armpit were sore as well, fever 101 on Thursday 102, still aching;
I would like to report an adverse event with Flucelvax. I received Flucelvax at my local pharmacy on 10/2/20 in the afternoon. I went to get the shot after lifting weights. It was administered IM into my upper left arm (deltoid) by a pharmacy student/technician, who was overseen by the pharmacist. By the evening, my arm was in significant pain where I could not use it. I rested, and by the next morning most of the pain had resolved, but it was still sore. I'm reporting an adverse event because my arm has been sore every day since 10/2/20, and it is still sore now. It is the most sore when I lift up or am changing shirts. I am a 30 yo female with no significant medical history. I have seasonal allergies (ragweed, pollen, etc). My only concurrent medication is birth control (Kariva), which I have been taking for 10 years. I have gotten my annual flu shot for many years, but this was my first time receiving Flucelvax. The vaccine's lot #: 276580, Expiration date: 6/30/21.
C/o itching, throat itching and hives. Pt was in ER at time of symptoms onset.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent conditions and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot# N008825, expiry date: 12-SEP-2018 and lot# M035690, expiry date: 06-FEB-2018) for prophylaxis. Nurse reported that the vaccine underwent a temperature exposure at -14 to -10 degrees Celsius, for 3 hours and 9 minutes. There were not previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of the two reports received from the same reporter (MARRS# 1707USA009610). Additional information has been requested.; Sender's Comments: US-009507513-1707USA009610:
Patient was given a premature anthrax booster, given 2 weeks early. He developed headache and muscle aches for 2 days, otherwise no symptoms.
Entire leg swelling. discomfort.  no  redness. no fever or rash
red band 4 inches wide around upper arm under injection site with extreme itchy for at least 7-10 days.  I took allergy medication to relieve and over the counter cortiosteriod cream.  Pharmacist recommends I take claritin two days before second dose and two weeks after.  I am not prepared to do that.
swelling in her right armpit; tiredness; achiness; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cancer (history of cancer). Previously administered products included Shingrix (received first dose of Shingrix an unknown date).   On 26th February 2021, the patient received the 2nd dose of Shingrix. In February 2021, 24 hrs after receiving Shingrix, the patient experienced local swelling, tiredness and pain. The action taken with Shingrix was unknown. On an unknown date, the outcome of the local swelling was not recovered/not resolved and the outcome of the tiredness and pain were recovered/resolved.   It was unknown if the reporter considered the local swelling, tiredness and pain to be related to Shingrix.  Additional details were provided as follows: The reporter does not know lot or expiration date of vaccine.  The reporter reported that she received dose of Shingrix on her right arm at pharmacy. On 27th February 2021, the patient noticed swelling in her right armpit, tiredness, and achiness. The reporter stated she was concerned as she had a history of cancer. The reporter consented to follow up. The reporter had called her health care professional and had given GlaxoSmithKline permission to follow up with her HCP.
Immediately after, low energy, lethargic and loss of appetite. Slightly elevated temperature. About a week after - nasal congestion and wheezing. Diagnosed bronchitis and given nebulizer for treatment.
Vaccine refrigerator went out and there  was a temperature excursion which affected  the IPOL dose. No adverse effects on  patient.