chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient inadvertenty recieved 0.3 mL of Pfizer for 12+ patient population although patient 8 years old.  Patient and parent made aware prior to leaving the office, encouraged to follow up as needed for any concerning side effects.  Nothing noted.
Patient states that she has been having pain in her left arm since she received the vaccine. She states that her left arm is sore and she can't lift it without hurting. She has not gone to the doctor yet to get it checked.
niece / got the shot / had shingles / never really recovered from them / had them in her skull; more than painful; This case was reported by a consumer and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles and pain.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's family member. The age at vaccination was not reported. The patient received Shingles vaccine and within a week patient experienced shingles again. The patient had shingles in her skull. The reporter stated that she was the person that reporter heard that getting the shingles after the shot was more than painful than the first time.
Patient is fully vaccinated. He did test positive for COVID this morning.The patient developed body aches fever and general illness yesterday.No headache but has rhinorrhea sore throat and a mild cough.  No vomiting or diarrhea. + fatigue, + fever.  HR 128. CXR: No acute lung process. Treatment: fluids, Toradol. O2 sat 95%. Discharged home.  Recommend rest.  Zinc and vitamin D.  Self-isolation for 10 days.  Watch for shortness of breath.
Lymph nodes on one side hurt a lot; Arm got sore; Got tired about an hour; Slept a long while; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Lymph nodes on one side, painful), PAIN IN EXTREMITY (Arm sore), FATIGUE, and HYPERSOMNIA in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lymphoma.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPH NODE PAIN (Lymph nodes on one side), PAIN IN EXTREMITY (Arm sore), FATIGUE, and HYPERSOMNIA. At the time of the report, LYMPH NODE PAIN, PAIN IN EXTREMITY (Arm got sore), FATIGUE, and HYPERSOMNIA had resolved.            No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter. Action taken with mRNA-1273 in response to the drug was not applicable.   This case was linked to MOD-2021-026446.
next day:  chills (24hr);  low grade fever (2 days); pain , slight swelling and redness at injection site (5 days); pain under armpit (1 week)
Covid 19 hit me hard this past January of 2022. 5 days in Intensive Care and 3 days out. Neuropathy pain has tripled and even today I feel worn out. Hospital diagnosis Covid post
EE received 2nd vaccination for her Hepatitis B series- at approximately: 9:15AM on: 8/19/2017- without instance. Around 1:25PM, EE began to feel nausea- which led to vomiting. Medical Staff evaluated- EE does not take any medications (prescribed nor OTC/PRN), has not had any illnesses in past 1 month- no recent pregnancies and no HX of any allergies. EE c/o nausea- did vomit x2- c/o of headache post emesis. No other S/S noted nor disclosed per EE.
Patient presented to ER on 8/29/05 with a 5 day hx. of neck pain, malaise, photophobia and nausea and vomiting. Had been seen 5 days prior with what the patient thought was a possible reaction to the smallpox vaccination he received on 8/19/05. He was ordered Z-pak at that time and was confined to quarters. He thought that he was feeling better so he returned to field duty. He represented again the morning of 8/29/05 and he was then referred to the ER, at which time he was evaluated and consultation with another campus was sought. He was transferred to the Hospital where he was admitted for questionable meningitis. He was given IV therapy and was given Zofran for his nausea and Toradal for pain. Diagnoses at time of discharge: viral syndrome with meningismus. He was discharged from the hospital on 8/30/05 with orders for strict bed rest and follow up in am of 8/31/05. On 8/31/05 he returned with an increase in his sx. Uncontrollable emesis and photophobia. He was then transferred back to the hospital where he was then readmitted. He is currently hospitalized. 01/09/2006 Review of discharge summaries. Admission of 8/29/05-8/30/05 was for viral syndrome with meningismus. Symptoms included 5-day history of HA, neck pain, photophobia, persistent vomiting, myalgias, and ever. Head CT was normal. He was treated with Zofran and Toradol. LP was WNL. Admission of 8/31/05-9/05/2005 was for HA with meningismus and photophobia s/p recent smallpox vaccine. Additional symptoms include persistent nausea and vomiting. Treated for HA with Toradol IV.  Follow-up: An initial VAERS was filed on this patient in August 2005. A VAERS update was then filed in November 2005. The patient's headaches have significantly decreased in frequency-now only having one severe headache every 3 months.
Immunization screening/counseling. No contraindications noted and NKA Client fainted while on table, assisted to lying position with assistance of mother. LOC approximately 5 seconds, verbal, but groggy x 10 seconds. Applied cold pack to base of neck. B/P 104/60 which is around "my usual" states client. Increase HOB to Semi reclined position x10 minutes w/o any dizziness. Mom expressed concern with fainting on previous occasions, usually assoc. with a medical procedure. Recommended asking her Dr as a precaution.
During administration of vaccine, pt. turned head away from vaccinator and did not answer any questions would not respond to his name.  A rapid response was called and pt. transported via ambulance to ER.  Pt. had a history of seizures.  "Not controlled with medications" per pt. Pt. discharged stable.
His symptoms were fever and the fever was 101-103. He had a cough, runny nose trouble sleeping, easily irritated. We took him to a doctor and they inspected him. He had mild pneumonia in his bottom left lung. They prescribed azithromycin 100mg/5ml.
10/28/2009 felt very achey, general muscle ache, tired, headache. Lasted until 10/31/2009. Has completely resolved. Never had a fever.
9/7/21 PMH of ESRD status post complicated life donor renal transplant, hypertension, hyperlipidemia, CHF, CAD, DVT on request, secondary hyperparathyroidism, type 2 diabetes mellitus; presented for SOB
Had Varivax 6/8/1995. Had chicken pox 5/25/2000
product was administered to patient after it was received late due to delay in shipment/no AE; shipment is more than 2 days not to use and to obtain a replacement of the products/no AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA308920, 2019SA309165 and 2019SA308846 (same reporter).  This case involves a 69 years old male patient who received a 0.5 mL dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ290AB, Exp. Date 09-Jun-2020) via intramuscular route in the left deltoid on 04-Nov-2019 that had a shipment delay.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient was not on any concomitant therapy.   It was an actual medication error case due to incorrect product storage and Product shipment delay.  It was reported that the vaccines were shipped 30-Oct-2019 and were delivered this morning 04-Nov-2019. She has taken care of the replacements. Before they received the email, one dose of Fluzone High Dose had been administered to this patient.  It was reported that no adverse event was experienced.  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.
This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM-9809) via an unspecified route of administration in the left arm on 26Feb2021 at 12:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), polycarbophil calcium (FIBER), multivitamins (MANUFACTURER UNKNOWN); all medications from an unknown date and unknown if ongoing for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL-9261) via an unspecified route of administration in the right arm on 05Feb2021 at 12:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 28Feb2021 at 14:30, the patient experienced swollen lymph nodes in armpit. On 28Feb2021 at 19:00, the patient experienced severe vomiting and diarrhea. The patient was surprised that these symptoms did not start until 48 plus hours after injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph nodes in armpit, severe vomiting and diarrhea were resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
On my first dose, received 10/30/21 at a hospital clinic site, I felt just fine after leaving and after one full day/approximately 32 hrs later I developed severe muscle cramping in my feet and hands, slight tinnitis. The muscle cramps were so bad that it was difficult to walk.  I took no medication for the symptoms except magnesium and on the third day of symptoms added in potassium. Two days after the muscle cramps started I developed muscle spasms in my thigh area and sporadic muscle spasm in my waist area, just above my hip bone. Activity or non-activity did not seem to make a difference. The muscle spasms increased in calves, thighs and hips, feeling like a pin-ball machine when you lay down to go to sleep. I would have a spasm about every 30 seconds. From everything I read online, I expected symptoms to subside so I waited it out. The first week of December is when the activity had significantly decreased but did not go away. Mainly the spasms in the outer thigh area still continue.  -  On February 4, I received my second dose of Pfizer at a work-sponsored vaccine clinic, administered by a pharmacy. The people giving the vaccines were very knowledgeable and I don't believe that symptoms have anything to do with the delivery. Although well-hydrated and rested, the muscle cramping and spasms continued in much the same fashion as the first dose. Currently, February 15, I still have muscle twitches in my legs and sides of hip, several times in one minute. The ringing in the ears is slightly worse on this dose.
Patient reported feeling pain in the base of the head, difficulty swallowing,  jaw pain, and dizziness Patient seen by medical team and ambulance was called Patient stated symptoms improved a little  Patient refused medical transport because ?it?s too expensive? and signed AMA form Patient stated she will be driven by husband to ER
This spontaneous report was received from a medical assistant referring to a multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ orally (strength, dose number, lot number and expiration date were not provided) for prophylaxis. No adverse events reported. No product quality complaint was involved. The vaccines were improperly stored with a temperature of excursion of: 32-36°F (Fahrenheit degrees) for 8 hours and 12 hours respectively. There were no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA005002: US-009507513-1702USA002890: US-009507513-1702USA005001:
Headache; muscle cramps; rash; This is a spontaneous report from a contactable other hcp (patient).  This 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot # unknown), via an unspecified route of administration at single dose in the left arm on 13Jan2021 for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), venlafaxine hydrochloride (EFFEXOR). The patient previously took Keflex [cefalexin] and experienced drug allergy. On 13Jan2021, the patient experienced headache, muscle cramps, rash, all with outcome of recovering. No treatment required. The vaccine was administered at Hospital Facility. The patient had not been tested for COVID-19 post the vaccination. The patient was not pregnant at the time of vaccination.  Information on the lot/batch number has been requested.
Information has been received from a 42 year old female with hypersensitivity to SOMA and a history of two pregnancies, and two unspecified abortions who on 9/5/06 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast (0.5ml). Concomitant therapy included Lasix and Wellbutrin. The pt reported that on 9/5/06 she developed an injection site reaction. The pt reported that the reaction was like straph infection and described the reaction as looking like and itching like a big mosquito bite. The pt had not yet contacted her physician. At the time of this report, the pt had not yet recovered from the injection site reaction. No further information is expected.
Low immune system; This is a spontaneous report from a contactable consumer. A 76-year-old female consumer (patient) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose and dose 2 via an unspecified route of administration on an unspecified date as single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced low immune system on an unspecified date. Patient due for a refill: Patient stated, "she had a low immune system and had taken both the shots for COVID-19. She was concerned if I had to get the booster dose." Patient was prescribed Xeljanz XR 11mg. Therapeutic measures were taken as a result of low immune system (immune system disorder). Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a pharmacist concerning a patient who on 23-FEB-2009 was vaccinated intradermally with a dose of ZOSTAVAX (Oka/Merck). The reporter stated that after she gave the ZOSTAVAX (Oka/Merck) there was a "bubble" under the skin which then "diffused to the size of a nickel". The pharmacist stated that the patient went to see her physician after she was given the ZOSTAVAX (Oka/Merck). At the time of reporting, the patient had not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Follow up information has been received from a health professional on 17-MAR-2009.  It was reported that on 23-FEB-2009, the 78 year old female patient was vaccinated subcutaneously in the left arm (previously reported as intradermally) with one dose of ZOSTAVAX (Merck) (Lot # 663881/1787X) at 11:00 a.m.   At 11:15 a.m., the patient had visible "bubble" under skin and some redness.  No discomfort was involved.  The patient went to PCP and was told to use cold compressess.  The patient stated that redness and bubble went away the following day.  Additional information is not expected.
exhaustion lasted almost 3 days.  felt like I had a severe cold for 3 days. called doctor and was told to just rest and call back if problem persisted longer than 5 days.
OBSTRUCTIVE SLEEP APNEA 11/16/2022 CKD (CHRONIC KIDNEY DISEASE)
Patient reported to hospital ER department the day following second vaccination.  Patients issues at ER was: breathing difficulty, Respiratory arrest, Cardiac arrest, aspiration vomit.  The patient died while in ER.  It should be noted patient had been on hospice prior to vaccination.
This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a physician concerning an 18 year old female with unspecified allergies and acne and a history of chickenpox and eczema, who on 15-MAY-2007 at 17:25 was vaccinated IM into the left deltoid with a second 0.5 ml dose of GARDASIL (lot# 657736/0389U). Concomitant therapy included hormonal contraceptives (unspecified). On 17-MAY-2007, the patient developed a small fine rash. It was reported that on 15-MAR-2007, the patient received a first dose of Gardasil and did not experience any adverse event. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Contracted Covid-19 on September 2, 2022.  Runny nose, some sneezing, headache on first day, chills on first day, 100.4 degree fever on first day.  Treated with Paxlovid
Mild sore arm x 2days , fatigue x2days and lymphadenopathy of bilateral axillae and swelling of right breast x5 days
LINGERING  MEDICINAL/ IRON TASTE IN MOUTH; MILD HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient was previously treated with influenza vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-MAY-2021, the subject experienced lingering medicinal/ iron taste in mouth. On MAY-2021, the subject experienced mild headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from lingering medicinal/ iron taste in mouth, and the outcome of mild headache was not reported. This report was non-serious.
One day post vax, the pt had edema, hives and fever. The fever went to 100 and started at 9:00pm on 4/16/01 and the hives and edema by next day. Hives were from the waist down. Right hip is swollen and red.
Patient states severe headache, felt out of it and was in bed for 3 days. Patient contacted her MD was told to take ADVIL.
2/6 (vaccine given): No side effects. 2/7: mild fever and chills (expected), weakness, low appetite 2/8: Severe weakness and fatigue,  subjective fever/chills, low appetite, nausea, in evening diarrhea started. 2/9:  Symptoms not improved in the morning. Went to ED. Hospital stay: Dehydration, give IV fluids. Continued symptoms, plus vomit and diarrhea with blood.  Placed on clear liquid diet. GI consult. Diagnosed with duodenitis and gastritis. Started on oral PPI,  no improvement in symptoms, switched to IV PPI. Vomiting resolved after a few days. Stool cultures all negative. Onset sore throat (possible reflux/esophagitis). Confirmed gastritis, gastric erosions. Fevers recurred. Consult with ID, possible TB, placed on isolation. Blood cultures and stool cultures all negative. AFB negative x2 (results of 3rd AFB pending as of today). Rheumatology consult for continued fevers, weakness, fatigue. Started on prednisone ~2/15, fevers resolved soon after. Severe weakness (bed bound), fatigue, low appetite, and diarrhea throughout hospital stay. Started on Megace and Immodium with slight improvement in appetite and diarrhea, respectively. 2/19: ALT and ALT increased, prednisone was dc'd (received 4 of 5 day treatment of prednisone). Crestor held. Anticipate dc for PT/rehab once LFTs are back to baseline.
Immediate numbness on left side from hands to feet. Facial numbness. Itchy raspy throat, itchy neck. Tachycardia post injection for 6 days. Severe migraine post injection for 6 days. Nausea. Chills. Joint stiffness.
1 of 5 pts (out of 40 pts) vaxed from the same lot who devel a local rxn consisting of rash surrounding site;rash appeared w/in 3 days of vax (varying in size in all 5 pts; largest from shoulder to elbow);area sore & tender;no fever;
7/8/03 received 5 vaccine shots. On 7/21/03 rash. Called doctor 7/22/03. Said viral infection. Doctor got bloodwork done on 7/22/03. On 7/24/03 doctor said neutrophils very low. Sent me to a hematology specialist, redid blood work, neutrophils went from 350 to 900. Dr. said probably from vaccines. We got back in 1 month.
"Covid" or "Moderna" arm.  Rash that started small on first day, spread into a rectangular shape on upper arm where injection site had been.  Itchy, warm to touch, minor, if any swelling.  Seems to be almost completely gone 2 days later.
"HIVES" ON TRUNK AND FACE DEVELOPING APPOXIMATELY 12 TO 24 HOURS AFTER VACCINE.  SAW MD 2 DAYS AFTER VACCINATION.  MD PRESCRIBED MDEROL DOSE PACK.  HIVES LASTED A WEEK
Ten hours after I had a Severe allergic reaction. My eyes were itching and watering. I was incredibly nervous and anxious. I couldn't relax or sleep. NO SHOULDER OR ARM PAIN.  Swelling and puffiness in my face ( eyes, nose, and sides of my head).  I was fine the next day.
3rd dose 2/4/08  Extreme reaction 5/29/08 confusion, extreme fatigue, difficulty breathing, feeling of throat closing, non-epileptic seizures, inability to focus, light sensitivity, bradychardia and tachycardia, temporary loss of memory
I was having severe neck and shoulder pain in both arms and also the pelvic area and thigh area.
a patient received improperly stored vaccine; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 15-APR-2019, the patient was administrated with improperly stored one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (strength, frequency and route were not reported) (lot # R028189, Expiration Date: 06-JUN-2020) for prophylaxis and with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (strength, dose, frequency and route were not reported) (lot # R021078, Expiration Date: 12-JUN-2021) for prophylaxis. The stored temperature was 52.5 Fahrenheit (F) for 4 hours 40 minutes and the data logger was involved. There was no previous temperature excursion.; Sender's Comments:  US-009507513-1908USA013062: