chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortness of breath; This spontaneous case was reported by a physician and describes the occurrence of DYSPNOEA (Shortness of breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lung cancer in 2007 and Lung cancer recurrent (Relapse in 2010 treated with radiation. In remission since.). Concurrent medical conditions included Type 2 diabetes mellitus, Hypertension, Restless leg syndrome, Tobacco user, Neuropathy and Hyperlipidemia. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), GABAPENTIN, IRBESARTAN, ROPINIROLE, INSULIN GLARGINE (LANTUS), METOPROLOL and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2021, Computerised tomogram: other (abnormal) CT scan of chest showed vague ground-glass opacities left lung base possibly representing pneumonitis or atelectasis. Confluent right hilar lymphadenopathy and a large effusion was seen.. On 16-May-2021, Cytology: other (Inconclusive) Cytology was significant for reactive mesothelial cells and negative for any malignancy.. On 16-May-2021, Full blood count: other (normal) Result: normal. On 16-May-2021, SARS-CoV-2 test: other (Negative) Result: negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details were reported.   This case was linked to MOD-2021-162971 (Patient Link).
Abdominal pain (severe(, nausea, diarrhea, vomiting, headache, fever and chills. "Itchy" skin without rash. Still has some residual effects.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 06-NOV-2012 at 14:33, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from an approximately 45 year old licensed practical nurse who in 1991 was vaccinated with the first, second and third doses of hepatitis B virus vaccine rHBsAg (yeast)(manufacturer unknown)("probably Recombivax HB).  The pt received the fourth, fifth and sixth doses of hepatitis B virus vaccine rHBsAg (yeast)(manufactuer unknown) in 2000.  The pt has "now developed" elevated LFT's and steatosis (per CT scan).  The pt is negative for hepatitis.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Pt received Anthrax vaccine on 17 Aug 2011. Pt is on antibiotic LEVOQUIN. Pt states he started to feel joint pain in his hips & shoulders on 20 Aug 2011. Pt states pain intensifies when he moves or sits for long periods of time.
Received flu vaccine 10/12/2005. On 10/13/2005 Developed diffuse rash, itching and joint swelling, Evaluated by allergist on 10/17/2005 and prescribed prednisone and Atarax. Seen in Occupational health on 10/19/05 symptoms still present.
Patient developed herpes zoster on 12.26.08.  Patient presented with grouped blisters on the right posterior neck, right upper chest and right upper back.  Patient stated a "burning sensation" and mild itching / pain.  Because of mild condition, suggested OTC hydrocortisone cream.
Patient received J&J vaccine in the left deltoid muscle at 11:45am on 05/21/2022. Immediately after administration he stated that he was feeling light headed and very dizzy. RPh on duty provided him with cold water bottle and guided him to sit in an upright position against a wall on the floor for better stability. Patient remained coherent to questions and speech was not effected. He began sweating profusely, and reported spotty vision, cloudy thoughts and loss of hearing in the right ear. These symptoms remained for several minutes before he reported that he was feeling better. Patient returned to normal after about 10 minutes. Was able to leave pharmacy under his own power.
Received vaccine on 4/8/21 and states reacting to vaccine.  States severe dizziness within 3 hours of receiving vaccine  and lasted for a couple of minutes, severe headache, and nausea.  Sx resolved within a few minutes.  Denies home tx. Denies fever.  Denies any other episodes
Saturday morning 3:00 AM I woke up with severe chills.  I?m assuming I had a high fever.  I then developed horrible body pains/aches everywhere.  I alternated 500 mg Tylenol and 600 mg Ibuprofen all day long with no relief until about 9 PM that night.   Throughout the day my temperature ranged from 100 -101 degrees.    I was nauseated all day as well, but did not vomit.  I made sure to drink lots of fluids, especially water.  Sunday morning I still had a low-grade fever and achy.  I also developed a huge red hive at the injection site.  Then starting about 11 AM I started getting light-headed.  By mid-afternoon I developed what I believe to be a case of Vertigo.  It progressively has gotten worse throughout the day, but not unbearable at this point.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 07-AUG-2017 the patient was vaccinated with M-M-R II lot # L027431 (rHA) for prophylaxis. On 07-AUG-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event.
came to urgent care on 2/27/2021  complaining of burning and itching -- entire body after vaccination. Also bodyaches and  "small red bumps " to scalp Solumedrol IM  given
couldn't raise arm above a certain height; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date at a single dose in arm for immunization. The patient's medical history and concomitant medications were not reported. The patient had a reaction to pneumonia vaccine in the past and couldn't raise arm above a certain height. She took diphenhydramine hydrochloride (BENADRYL) after the pneumonia shot and the symptoms then resolved.  Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein)in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. No further information is expected.
Several hours after vaccines given pt complained of HA and dizziness, insomnia. Next am s/s worse fainted. taken by paramedics to Hospital ER on 12/6/06.
Patient ordered to receive Bivalent vaccine during hospitalization. When preparing batch of bivalent vaccines, pharmacy erroneously used a monovalent vial and subsequently labeled as bivalent. As a result, patient received the monovalent vaccine when they were intended to receive bivalent.
Information has been received from a physician concerning a patient who was vaccinated with 2 doses varicella virus vaccine live (Oka/Merck) and failed to seroconvert. The patient was tested for seropositivity after exposure to the varicella-zoster virus and had a negative titer. No additional information is expected.
Diagnosed with Peracarditis on May 5, 2021 with no prior history of heart illness.
ADM Tdap, GARDASIL and MENACTRA at 1620 on 1-25-11. At this time pt c/o dizziness closed eyes became limp aroused in 1/2-1 min. started crying left clinic with mom after fully aroused. After leaving clinic c/o throat tightness. Seen in local ER.
Reddness and swelling noted to lt deltoid the day after receiving vaccines.Cold compresses applied and tylenol given.
pt recv vax 26AUG98 & same day pt devel feverish sx, chills, fatigue, heat sensations, dizziness & a feeling of passing out;
Vacianted at 12;45pm, 4pm arm began to hurt, 12midnight skin started to feel like it was burning, took cold shower. 12/31/2020 - 6am-woke up large knot on arm at injection site, arm hurt, arm felt heavy, rash from elbow to fingers on both arms. Fever -102/7, took 50mg Benadryl, 20 mg Pepcid AC, Tylenol for fever, Albuterol breathing treatment. Went back to sleep. Awoke around 2pm- felt better, arm continues to be sore. No rash, no burning of skin, no itching.  Discussed s/s to look for and advised if symptoms reoccur and get worse, call 911. He stated he is a nurse and knows what to do. I asked him did he sign up for V-Safe , encouraged him to sign up and record his information. He stated he would - RN
High fever, sore throat, coughing, aches and pains all over, weakness, trouble breathing.
Within 48 hours of dose 2 I experienced fever and headache.  My fever did subside but the headache continued almost daily and I am still dealing with the daily headache. I have consulted my doctor regarding this she is scheduling blood work and a MRI of brain. My doctor did prescribe medications to help with headaches. I currently have 5 medications prescribed to me that I did not have before this vaccine. I have a debilitating migraine every 3-4 days to the point is difficult to work and take care of my children.  It is causing me anxiety and stress and has changed my life. I do at this time regret having the vaccine because of these changes.
42 days post first shot and No Second Shot yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (42 days post first shot and No Second Shot yet) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dose UNK. On 01-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (42 days post first shot and No Second Shot yet). On 01-Jun-2021, PRODUCT DOSE OMISSION ISSUE (42 days post first shot and No Second Shot yet) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.         No treatment medication were provided. No concomitant medication information was provided.   This case was linked to MOD-2021-194257 (Patient Link).
paient received two doses of Menactra one year apart/no AE; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a patient (unknown demographics) who was vaccinated with two doses of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] in one year apart (batch number, route, site of administration and expiry date not reported) on an unknown date for prophylactic vaccination (extra dose administered).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to extra dose administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Pain and swelling in the eyes and momentary blindness. I still have a lot of pain in my eyes.
Rashes on back of both legs being the knees and rashes between the thighs. Itchy and burning rashes
Received vaccine Friday afternoon. Woke up Sunday with radiating back pain. Progressively worsened throughout the night. Woke up Monday morning with severe radiating back pain. Went to urgent care. Diagnosed with muscular issue (muscular spasms, I think). Never had this issue before. Prescribed lidocaine patches and cyclobenzaprime 5mg tablets. Back has improved over time, mostly better today. Doctor hypothesized that it may have resulted from dehydration after night sweats post-vaccine, but could have also been a number of other factors.
Administered on 1-5-16 at 3:22 PM. Per patient noticed lump on injection site at night. On 1-7-16 noticed swelling and redness. Patient seen by Dr today 1-8-16 for recommendations.
Pt. states that the next day his  left shoulder begin to hurt and is still hurting when he moves it like putting on a shirt or something. States the discomfort gets to about a 6 at times. {Plans to see md. But elected to take the second dose, Can't remember doing anything to his shoulder
Patient received second Moderna vaccine at a pharmacy on 10/20/21. On 10/21/21, room started spinning fast, felt "hot and sweaty", when stood up, fell into couch. Patient made it to the kitchen and vomited multiple times. Patient went to local Hospital ED for evaluation and treatment. Patient was admitted and treated for BBPV.
Arm pain; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     The patient's past medical history included Chest pain.    On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-334946 (Patient Link).
On 3/31/2022, I received my second Pfizer booster for COVID-19. On 6/21/2022, I woke up with a very dry throat, body aches, and head congestion. My oxygen level was 97% or higher. I didn't have a fever or cough, though. That afternoon, I took an at-home COVID-19 test; the result was negative. On 6/22/2022, I still had the same symptoms and felt unwell. I took a second at-home test; this time, the result was positive. I called a clinic at a local pharmacy and got an appointment for 5 PM that day. I took a rapid test at the clinic, and I again got a positive result. The nurse advised me to go to the ER, because my blood pressure was high and so that I could get antiviral medication. The ER doctor prescribed me a 5-day course of molnupiravir. My blood pressure had decreased by 6/23/2022; my hypertension is a pre-existing condition that is unrelated to COVID-19. After I started taking molnupiravir on the evening of 6/22/2022, my congestion got slightly worse, but the dry throat went away. I developed a fever of 100.1 for only a couple of hours, and the only cough I had was a productive one that was related to the head congestion. I was told by both the clinic nurse and the ER doctor that my lungs were clear. Since I have had COVID-19, I have never had any oxygen levels below 96%. At the time of this writing, I feel for the first time like my congestion is almost gone. I have ceased to have any other symptoms.
Patient describe shoulder discomfort starting 15 minutes after injection. As of today 10/30/2020, is still reporting  shoulder soreness/tenderness. I am reporting to ensure if bursitis or shoulder discomfort continues long term.
Sudden Retinal detachment without any prior symptoms occurring approximately 20 days after having received vaccination.  Had to have emergent retinal eye surgery.
Mom called after hours on 7/3/10, 2 days after vaccine given and reported site (L) arm very red and swollen.
My son received his 1st covid shot on Wednesday March 16th, 2022 at 8:40 am. After a few minutes (we waited for 15 minutes) he said he had metallic taste in his mouth. That lasted several hours. Within the hour after the vaccine, he fell asleep on the ride to school, and he consequently did not go to school that day (wed), and the rest of the week (Thu-Fri), because he felt very tired, he was in bed fatigued and drained. Over the weekend he started to feel better.  He woke up on Monday, March 21st, 2022 claiming he had blue vision on both eyes. Blue spots and blue band across the eyes, everything was blue. Immediately, we went to see a pediatric ophthalmologist, and did a workup that did not determine a cause. The symptoms continued until Thursday when he claimed that it had improved slightly and by Saturday, the symptoms were completely gone. We went ahead and did a whole workup to discover why this occurred to my son and if it was connected to the vaccine. We did MRI, CT scan of head, EEG, we went to see a neuroophtamologist as well as several visits to the optometrist and ophthalmologist. All these tests came back negative and couldn?t pinpoint the cause of this occurrence of seeing blue. The inconclusiveness of the side effect and the cause if it prompted us to report this.
This is a spontaneous report from Pfizer-sponsored program, from a contactable consumer reporting for his son. This 16 year-old male patient of an unspecified ethnicity received the first single dose of TRUMENBA via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. The patient had a sore arm on an unspecified date with outcome of unknown.
On 2/4/08 pt took 1st oral typhoid tab at 8pm.  On 2/5/08 B/T 10-11pm experienced severe diarrhea, vomiting that lasted all night.  C/O sinus plugged up & coughing up mucus and very tired; took Immodium.  On 2/8/08 reported event to health department.  States took no other of typhoid tabs, stomach settled but diarrhea persists.
Jan 28 4:30am - woke up to excruciating muscle pain in left leg.  As the day progressed, I had the following symptoms: injection site pain, fatigue, headache, muscle pain, chills, fever (ranging from 100.3 to 101.7) nausea, swollen lymph nodes  Jan 29 achy, chills, headache, injection site pain, swollen lymph nodes, trouble falling asleep  Jan 30 - headache, throat hurt, achy, slight sniffles, got a cold sore, ear pain, trouble falling asleep  Jan 31 - ear pain, headache, slight aches, trouble falling asleep  Feb 1 - feeling better, some ear pain, trouble falling asleep
No additional adverse events; the patient was inadvertently administered a dose of PROQUAD, that was expired.; This spontaneous report as received from registered nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On 20-NOV-2019, the patient was inadvertently administered an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R013575 (therapy type: recombinant Human albumin (rHA)), expiration date 10-NOV-2019; strength, vaccine dosage detail, route of administration were not reported) for prophylaxis (expired product administered). No additional adverse events.
7/24/07 Yesterday AM had Tdap - L. deltoid. Wed, 7/25/07 - felt tired and bump/soreness of L. arm at inj. site. Feverish, chills, sweats. Pt took Advil last night. Ice - ibuprofen pain/fever
Bone Pain when lying in bed; Joint Pain; Chills; Fever 101 F; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone Pain when lying in bed), ARTHRALGIA (Joint Pain), CHILLS (Chills), PYREXIA (Fever 101 F) and NAUSEA (Nausea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation.   On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced BONE PAIN (Bone Pain when lying in bed), ARTHRALGIA (Joint Pain), CHILLS (Chills), PYREXIA (Fever 101 F) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, BONE PAIN (Bone Pain when lying in bed), ARTHRALGIA (Joint Pain), CHILLS (Chills), PYREXIA (Fever 101 F) and NAUSEA (Nausea) outcome was unknown.            Concomitant medication was not provided   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: declined follow up
Per spouse, redness, swelling, irritation and "veins surfacing" in the last few days
Patient received Pfizer dose (dose #1) from pharmacy on 8/6/2021 and received Moderna (dose #2) from different pharmacy on 12/30/2021 when it should have been a second dose of Pfizer, not Moderna for the primary series. Patient did not have any ill effects, symptoms, or side effects. Patient came in on 1/23/2023 to get Moderna Bivalent Booster dose, and that is when the error with the primary series was identified.