chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   The reporter considered the injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient wanted to know how long the pain at the injection site from Shingrix vaccine continue. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Pt received 2nd dose of Covid vaccine and afterwards c/o of fever/Headache/chills/night sweats/fatigue.Denies sore throat/congestion.Took 650mg of Tylenol at 0730 with some pain relief.
5th day after receiving covid vaccine my lymph nodes in my right axilla were swollen and painful. It has been 2 days and remains swollen and painful.
Severe Headache; Soreness in left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 09:00 (Lot number: EP6955) at the age of 45 years as 2nd dose, single and administered in arm left, administration date 17Mar2021 09:30 (Lot number: EP6955) as 1st dose, single for covid-19 immunisation. Relevant medical history included: "Hashimotos" (unspecified if ongoing), notes: Verbatim : hashimotos. Concomitant medication(s) included: SYNTHROID. The following information was reported: HEADACHE (non-serious) with onset 09Apr2021, outcome "recovering", described as "Severe Headache"; PAIN IN EXTREMITY (non-serious) with onset 09Apr2021, outcome "recovering", described as "Soreness in left arm". Therapeutic measures were not taken as a result of headache, pain in extremity.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with an expired dose of lot # (665266/1378Y, expiration date reported as 12-JUN-2012) GARDASIL on 25-JUL-2012. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
test for COVID-19/Positive; test for COVID-19/Positive; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received the first dose of BNT162b2 (Lot number: EL1284), via an unspecified route of administration in left arm on 22Dec2020 17:00 at single dose for covid-19 immunization. Medical history included High Cholesterol. The patient's concomitant medications were not reported. The patient previously took codeine and experienced allergies. The patient received the Rapid throat swab test for COVID-19 on 30Dec2020, the result was positive. The outcome of the events was unknown.
FEVER; SEVERE HEADACHE; VERY ACHY; CHILLS; PAIN IN ARM; This spontaneous report received from a patient concerned a 34 year old female. The patient's weight was 117 pounds, and height was 62 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-APR-2021 12:30 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced pain in arm. On 06-APR-2021 19:00, the subject experienced very achy. On 06-APR-2021 19:00, the subject experienced chills. On 06-APR-2021 23:45, the subject experienced fever. On 06-APR-2021 23:45, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, and pain in arm, and the outcome of fever, chills and very achy was not reported. This report was non-serious.
One day after vaccination - reports feet feel like "shivering - walking on sand, tingling".  Also complained of sniffles, cough 2 days after vaccination.  Referred to primary doctor for evaluation.
PATIENT PRESENTED WITH RASH 7 DAYS AFTER VACCINATION; VACCINE ACQUIRED MEASLES
Her vision started half black then progressed to full black and then she passed out in the shower, falling. When she came back to consciousness, her vision stayed black for several seconds.
Patient is a 15 year old female who comes in today because of syncope, weakness, headache, and diffuse body pains. She was seen yesterday for routine physical. She complained then of having lots of fatigue. She received a MENACTRA vaccine and was sent to the lab for a blood draw. She had a brief syncopal episode after the blood draw. Today she felt weak and somewhat achey when she got up this morning. She tried to go to work but felt even more weak "as if she couldn't lift her arms or bear weight on her legs" and then had another episode of feeling faint and had to sit down to abort it. Since then she says her head, back and limbs are all hurting (to the point of tears). She has not had a fever. She has had blood work done in the past and never had a syncopal episode. She does not think that these symptoms are due to a panic attack.
Red rash all over, dizziness, pain in joints, fever. Felt like I couldn't move. Lasted all of first day, slightly better second day. Rash subsiding gradually but still very itchy. Dr not in to see me.
This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (fatigue), MYALGIA (muscle aches), DIZZINESS (dizziness), FATIGUE (bad fatigue) and ARTHRALGIA (joint pain) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 032L20A) for an unknown indication. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced MYALGIA (muscle aches), DIZZINESS (dizziness), FATIGUE (bad fatigue) and ARTHRALGIA (joint pain). On an unknown date, the patient experienced FATIGUE (fatigue), CHILLS (chills) and PYREXIA (mild fever). At the time of the report, FATIGUE (fatigue), CHILLS (chills) and PYREXIA (mild fever) outcome was unknown and MYALGIA (muscle aches), DIZZINESS (dizziness), FATIGUE (bad fatigue) and ARTHRALGIA (joint pain) had not resolved.    The patient stated that symptoms are ongoing, but getting better. No concomitant medication provided. Treatment inulded  ibuprofen
APPROXIMATELY 30 SECONDS AFTER THE VACCINE WAS ADMINISTERED, PT'S HEAD STARTED TO WOBBLE, AND PT PUT HIS ARM ON THE COUNTER AND HIS HEAD ON HIS ARM.  PT LOST CONSCIOUSNESS FOR ABOUT 5 SECONDS, BUT WAS BREATHING.  NO SEIZURES WERE OBSERVED.  PT REGAINED CONSCIOUSNESS QUICKLY AFTER THE 5 SECONDS.  PT DID NOT REALIZE HE HAD PASSED OUT.  PT HAS NO HISTORY OF SYNCOPE AFTER VACCINES, NO HX OF SEIZURES, NO HX OF MEDICAL CONDITIONS, NO HX OF ANY RX OR OTC MEDICATIONS.  PT ASKED FOR WATER, AND WE PROVIDED BOTTLED WATER.  PT WAS FULLY CONSCIOUS AND EVERYTHING WAS WITHIN NORMAL LIMITS QUICKLY AFTER PT GAINED CONSCIOUSNESS.  PT WAS ABLE TO STAND UP AND WALK TO A CHAIR IN THE WAITING AREA IN FRONT OF THE PHARMACY.  PT NEVER FELL OUT OF THE CHAIR DURING THE SYNCOPE EPISODE.  AND PT WAS COMFORTABLE WITH SITTING DOWN AFTER REGAINING CONSCIOUSNESS.  WE OBSERVED PT FOR 30 MINUTES AND PT WAS OK.  WE HAD PT CALL A FRIEND TO COME PICK HIM UP TO TAKE HIM HOME.
Mom had called us stating that two doses of the Pfizer were administered too close to each other within 2 weeks time frame. 1st dose was administered 05/19/2021, 2nd dose 06/02/2021
1402: Pt received the injection and waited to sit for a couple of minutes before being monitored. 1408: Complained of feeling faint, color was pale.  Vitals BP:102/60, HR:5< RR:18, OxSat. 99%  Given fluids and allowed time to lay down.  1417: States "feeling much better."  Vitals: 104/58, HR:71, OxSat: 98%.  Transferred to  monitor station for remained monitored period.  No further issues.  Discharged at 2:35PM.
This spontaneous report has been received from a medical assistant regarding a 49 year old male patient (also reported as turned 50 years of age). Information regarding the patient's medical history, drug reactions or allergies, and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On an unknown date in 2014, the patient was vaccinated with PROQUAD (strength, dose, route, anatomical location, lot# and expiration date were not provided) for prophylaxis. On an unknown date a titer was performed in which the patient came up low. Therefore, the second time the vaccination was administered to the patient on 30-JAN-2018 (lot# N010114 with expiration date: 24-SEP-2018) in left arm. No adverse effects were reported. This is one of the report received from the same reporter.
Patient had mild symptoms immediately after injection- his skin felt dry, uncomfortable. Symptoms progressed. ny 5pm (4 hours post vaccination), his voice changed, throat was swelling, lips tingling, congestion in throat, nose. Sought treatment at ED: received Solumedrol, Benadryl and Pepcid. No Epinephrine. Told Anaphylactoid reaction. monitored 4 hours in ED, then discharged to home. FU with PO benadryl. Some congestion persisted 24 hours after event.
Patient was given the first dose of Shingrix vaccine. Approximately 15 minutes later patient complains of very dry throat and potential tongue swelling. 5 minutes after that patient begins to hyperventilate saying that she could not breathe. At this time I administered the epipen (which patient had on her) and called emergency services. Patient was given 2 puffs of her albuterol since she was still hyperventilating. Immediately following the albuterol she was breathing normally. Patient was laid down on the ground and approximately 5 minutes later she started having seizures. The fire department arrived first and administered oxygen to patient. EMS arrives shortly after and takes patient away.
Information has been received from a physician concerning a female patient who in approximately 2009 ("approximately 1 year ago"), was vaccinated with GARDASIL series (date vaccines were given was unspecified). The patient developed HPV positive now. The patient was showing as "high risk HPV". At the time of reporting, the patient's HPV positive persisted. The patient sought office visit. Additional information has been requested.
I received three vaccines on 09/08/2022 the COVID-19, DTap and Influenza.  I had a fever and extreme tiredness within hours of receiving the vaccines.  I just rested and let my system do its thing. I felt better within a day. Six months later, I began having shortness of breath on exertion.  My doctor believes it is due to being shut in since the pandemic. The shortness of breath is getting better as I am trying to get out more.
Five hours after vaccination, patient said he had a severe dizzy spell that lasted about 20 minutes. He said this was very unusual for him to be dizzy. He reported this to the pharmacy where he received the immunizations.
Patient received a Tdap vaccine along with other inactivated vaccines and PPD with Tubersol to the LFA. He  returned with a local reaction to the vaccine measuring about 6cm x 7cm.  The area was indurated slightly, definitely erythematous.
The first day the patient received the GARDASIL 9 shot, the patient experienced soreness in arm; The first day the patient received the GARDASIL 9 shot, the patient experienced inflammation at the location of the shot; The first day the patient received the GARDASIL 9 shot, the patient experienced headaches; The first day the patient received the GARDASIL 9 shot, the patient experienced fatigue; The patient was diagnosed with ADHD , wsa hypostatic when he standed up, and had distractions.; when be eats a heavy meal like pi7..7..a or lots of carbs, be throws up"; This spontaneous report was received from the patient's mother referring to her currently 20 year old male patient. The patient had no medical history, concurrent conditions, concomitant medications, and historical drugs reported.  On an unknown date, the patient was vaccinated with one shot of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL)(strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. The patient's mother did not reported an adverse event after her son received the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) shot.  Subsequently, approximately in 2017 (reported as"3 years ago"), the patient was vaccinated with three shots of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) via intramuscular route (strength, dose, frequency, anatomical location, lot # and expiration date were unknown) recommended by the family physician. The patient's mother reported that starting on the first day the patient received the  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) shot (unspecifed dose number), the patient experienced soreness in his arm (pain in extremity), inflammation at the location of the shot (injection site inflammation), fatigue and headaches. Additionally, it was also reported that on unspecified dates the son was diagnosed with Attention-deficit/hyperactivity disorder (ADHD),  and was hypostatic when he standed up, and had distractions, and when he eat a heavy meal like pizza or lots of carbs, be throwup. The patient seek for medial attention but did not received any treatment for the events.  At the time of the report, the outcome of pain in extremity, vomiting, attention deficit hyperactivity disorder, fatigue, headache and injection site inflammation was reported as not resolved. The report did not mention the causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination.
This was not an adverse event. 2nd Booster dose given 1 month early. Patient has 2nd booster on 1/20/2022 and received an additional booster on 4/14/2022.
This report was received from a health care professional on 03 November 2008. Seriousness Criteria: Other-Medically Significant. A 76-year-old female patient, with no reported medical history and no illness at time of vaccination, received an intramuscular left deltoid injection of FLUZONE SV (lot number not reported) on 28 October 2008. Concomitant medication included Actonel. On 31 October 2008 she awoke with diplopia and paresthesia of the left hand. An exam revealed limited tracking in the left eye, with no other symptoms. She was scheduled to see an opthamologist on 04 November 2008. Outcome was not reported. Documents held by sender: None.
Daughter complaining of whole body itching since event onset date.  Irritability has escalated to all day whining and feelings of discomfort.   She has been complaining constantly of feeling cold and has noticeable chills without a fever for 4 days.  Onset of fever began on 8/29/13.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a male patient who received SHINGRIX. On 14th March 2018, the patient received SHINGRIX. On 14th March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site induration, injection site warmth and fever. On an unknown date, the outcome of the injection site erythema, injection site induration, injection site warmth and fever were unknown. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site warmth and fever to be related SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced possible fever, warmth, redness, and a hardened area at the injection site. On 18th March 2018, the injection site was pink, warm, and hard. This adverse events were reported to medical information by a sales rep who received a voicemail with the reported events. Product and patient identifiers were not provided.
Information has been received from a female with no relevant medical history reported who was vaccinated "a couple of years ago" with a dose of MMRII (Lot # unknown).  She had been vaccinated twice as a child with MMRII (dates of vaccination not reported, lot # unknown). There was no concomitant therapy.  The pt reported that she did not have antibodies for rubella. She was not checked for antibodies for measles or mumps. Unspecified medical attention was sought. The pt was 29 years old at the time of this report. Additional information has been requested.
Approx 2-3 hours after vaccination mother noticed progressive redness on right leg were two of vaccines were given, no fever, baby became very fussy, crying, and less appetite.
Patient received Pfizer COVID vaccine on 5/29/21 and 6/19/21. On 8/18/21, patient admitted to our facility with acute hypoxemic respiratory failure due to recurrent malignant pleural effusion on the right and COVID pneumonia. As of 8/21/21, patient is still admitted in the med/surg unit.
That day, I was feeling kind of weak. I think I had  mild headache - or just pressure in my head really.  I could not walk normal. I was walking very slow. I felt very hot just before it started. I apparently fainted for a few minutes. They called an ambulance. I was first taken to the ER at a local hospital and then I was transferred to an Urgent Care. I have talked to my PCD since then and a pulmonologist; cardiologist and a neurologist since then. I will get a stress test in October. Still no conclusion as to what is causing the headaches and fainting. The pressure in my head is what has been ongoing since December 2020. In Dec 2020, I had a very, very bad headache and the Urgent care put me on medication that put me in hospital.  On July, 2020 -  I felt faint one day and didn't faint but ended up in the Urgent Care for that.  I think I had an MRI of my head that time. I had a CT scan of my head and I think they did a did a chest x-ray, too, but not sure. The symptoms seem to be escalating and but still no diagnosis of what it is.
Patient supposed to receive Moderna 6month-4years old dose, bur received Pfizer 5years old- 11years old dose
I have only gotten the first shot so far. I got the shot last Sunday and then on the following Tuesday I went to donate plasma. I frequently donate plasma. I had no side effects from the shot up until that point. Immediately after donating, I got in my car and looked down to see that my needle injection site from donating was pouring out an excessive amount of blood. I lost all vision and the employees helped to rebandage the site and put pressure. That had never happened before after donating. It seemed that my blood failed to clot.
Severe headaches/migraines which cause sleeplessness, stomache aches, painful menstrual periods, nausea, always tired and feels like sleeping all the time, dizziness, heartburn.  Unable to eat certain foods like fast food burgers.  Had appendix taken out October 31, 2008 after one week of fevers above 103 for one week and emergency room visits.  Finally after one week surgeon looked at records and determined appendix should have been removed one week earlier.  9/29/09 PCP records received DOS 1/5/07 to 8/7/09. Assessment: Transferred migraine, rebound analgesic headache, anxiety.  Patient c/o recent headaches. Repeated strep pharyngitis. Plan B emergency contraception. Oral contraception initiated. Flat affect. Anxiety. Pelvic inflammatory disease. Headaches with photophobia and phonophobia. Pharyngitis/laryngitis with productive cough and wheezing. Bronchitis. Dry eczematous rash  skin arms and legs. Abdominal pain, diarrhea, constipation. Gastroenteritis. Depo-Provera initiated. Muscle tension headaches. Insomnia. Painful intercourse.     9/29/09 Hospital records received DOS ER 10/25/08 Inpatient 10/31/08. Assessment: Appendicitis. Patient presented with right lower quandrant abdominal pain. Hematuria. Nauseous, vomited. Discharged from ER. Presents several days later with same complaints. Laparoscopic appendectomy. Pelvic inflammation.  ICD-9 Codes: 540.9 Acute Appendicitis NOS, 784.0 Headache, 305.1 Tobacco use disorder/depend.
Unknown onset of symptoms.  Pt sought attention after 3 weeks of pain in left arm following injection.
Patient presented with "pressure on the throat, difficulty swallowing". Airway patent and lungs clear on initial observation  in lower lobes with developed slight wheeze in upper airway on arrival to hospital 30 mins later. Patient received Albuterol 2.5mg/3cc saline nebulizer treatment during transport.
Developed 5cm x 7cm area erythema at injection site w/in 24 hours of vaccine. (+) pruritis.
Both legs red, hot, swollen and painful.  Started several hours after they got home and mom gave her a warm bath on 12/5/05.  Not wanting to move legs-12/6/05.  Mom called Dr. and he started her on Benadryl, Tylenol and Motrin and cool compresses.
One week after vaccination, developed inflamed, painful back, underarm, chest - all on right side.  10 days after vaccination rash appeared in same area as inflammation - spreading from upper right back  around underarm to right chest.  General fatigue, eyes sensitive to light.  Diagnosed with shingles 8/22/2020.
My daughter was visiting and the day after she got home, she called to let me know she had tested positive for COVID-19. I felt good for a couple days but by day four I tested using a home test and it came back immediately showing. I called my PCP to see what I should do. I had a telehealth visit and was prescribed dexamethasone, PAXLOVID, and TUSSIONEX. I still have not recovered as of yet but the coughing has calmed down some.
A non-serious spontaneous report of H1N1 LAIV inadvertently administered to 50-year old was received from a health professional concerning a patient of unknown gender. The patient's medical history was not provided. On an unknown date in 2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Significant blood that came out from the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Significant blood that came out from the injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Significant blood that came out from the injection site). On 21-Apr-2021, VACCINATION SITE HAEMORRHAGE (Significant blood that came out from the injection site) had resolved. Not Provided          Concurrent medication details not provided.  Treatment details were not provided. Patient stated that vaccination provider cleaned the site and put band aid on it.
Breakthrough case admission after 3 vaccines  Pfizer 3/10/21 Lot# EN6199;  Pfizer 3/31/21 lot# ER8733;  Pfizer 11/30/21 lot# 330308D