chrisvoncsefalvay/vaers-outcomes huggingface dataset:
@1106 on 1/16/21 experienced arm tenderness at injection site.     @1400 on 1/16/21 experienced headache and took ibuprofen and headache resolved about 1 hour later @2130 on  1/16/21 began to experience chills and general malaise and another headache, took ibuprofen. @0130 on 1/17/21 woke up sweating, with a headache, continued malaise, and chills, took ibuprofen @0730 on 1/17/21 woke up with headache, took ibuprofen @1300 on 1/17/21 fatigue, chills and malaise returned.  Still present at time of this submission.  Rest and ibuprofen have provided minimal relief.
pt states within a minute of getting the vax she had a burning feeling in the top of her right hand.  The next morning she woke up with a red spot on her arm.  It is a dark red achy 3x1 spot on her right forearm that starts in the middle of her arm and goes lateral.  This spot looks more like a bruise than a rash but does not hurt to touch.    She contacted her PCP and showed her a picture of her arm.  The doctor said since it wasnt related to the vaccination since it wasnt at the injection site but the pt says it all started after taking the vax.  Pt said it has not improved any and not changing colors.
Patient was given Influenza vaccine at his appt on 1/9/2023 and he is 3 months old and it was not on schedule. He is not due to receive the vaccine until he is 6 months old.
Pain in right big toe.  Pain got worse throughout the night, pain on touch and in joint of toe.  Unable to put pressure on it, unable to sleep.  Pain subsided~12 hours after start.  After 24 hrs no pain at all.  No other adverse effects.
expired Pentacel vaccine was given to a patient/no ae; Initial information received on 10-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 month old female patient who was vaccinated with an expired 0.5 mL dose of vaccine  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot C5552AA, Expiration date: 10-Oct-2019 via unknown route at an unknown administration site).  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  It was a case of actual medication error due to Expired vaccine used.  It was unknown whether adverse event was experienced or not.  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.
Swollen, red area approx. 4 inches by 3 inches, hot and hard developed within 1-2 days after vaccination.  No rash, fever or other sx. Lasted for approx. 4 days, better with oral Benadryl.
This patient was identified through conducting the investigation in March 2022. This individual was not a patient of our health department and the health department has not had any contact with the individual. All information has been obtained from medical records at the medical facility where individual received medical and prenatal care. Medical records have since been destroyed per agency policy. All information provided in this narrative was obtained directly from case notes that were submitted to the National Center.   Patient was pregnant with twins at time of vaccination. The patient had a routine prenatal appointment with her OBGYN on 09/03/2021 at 15w6d gestation. As documented in notes provided by OBGYN provider's medical office, "Discussed COVID vaccination". Patient received her first dose of COVID-19 vaccine (Pfizer) on 09/08/2021 per providers notes; verified on system as well.   The patient presented to Emergency Department on 9/9/21 at 17w with concerns for exposure to COVID and tested negative. On 10/1/21, patient presented to Emergency Department at 20w0d with complaints of palpitations and hypertension associated with shortness of breath and "heart beating out of chest" while walking at a store; checked BP and reported 160/100 - contacted OBGYN and instructed to go to ED. Patient reported she received 2nd Pfizer COVID vaccine on 9/29/21 and denied symptoms other than arm hurting after shot.   ED notes include that this is new onset of hypertension and patient reported she has a history of blood clotting disorders that was diagnosed recently with her new IVF. Dimer was positive- patient has anaphylaxis to CT contrast. OBGYN recommended patient get a V/Q scan and admitted for observation. Ultrasound showed fetal heartrate 130-135 bmp for both fetuses. Was discharged on 10/2/21. Attended prenatal appointment on 10/8/21 - no complaints and fetal heartrates within normal limits.  On 10/11/21, patient reported she had an episode of bleeding at around 7:00pm and presented to the emergency department on 10/11/21 at local rural hospital. Presented there at 21w5d with painless cervical dilation and bulging bag of membrane. Before being transferred to level 3 birthing hospital, patient was given 1 dose of Indocin 50mg. Upon arrival, rule of rupture membrane was performed and negative and 2nd dose Indocin was given.  On day 4 of hospital admission (10/11/21), patient reported worsening contractions with leakage of fluid - rupture of membrane was positive and further cervical dilation was observed. Latency antibiotics were started and patient later reached complete cervical dilation with regular contractions and delivered via spontaneous vaginal delivery.  Infant A and B were delivered spontaneously secondary to previable ROM and advanced cervical dilation progressing to active labor. No Neonatal heartbeats noted at 2205.
Approx at 1630, Patient c/o dizziness and burning sensation to left upper arm. Pt was assist to supine postion with legs elevated. Alert/oriented. Able to follow commands. Vital signs were taken at the time of event and remain stable. Gatorade was given for hydration.  Approx 1700 EMS was notified and en route; Pt c/o dizziness. Pt assist inside mobile unit to lie down. Remain stable.
tested positive a couple of days after 1st dose/SARS-CoV-2 antibody test: positive; tested positive a couple of days after 1st dose/SARS-CoV-2 antibody test: positive; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on Mar2021 as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient tested positive a couple of days after 1st dose of the vaccine on Mar2021. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test: positive on Mar2021. Outcome of events was unknown.   Information on the lot/batch number is requested.
This spontaneous report as received from a Registered Nurse regarding a 4 year old Child patient of unknown gender. There was no information about concurrent condition, historical medication and concomitant medication. On 02-AUG-2018, the patient was vaccinated with improperly stored PROQUAD for prophylaxis (product storage error). Vaccine was stored out of range at -6 degrees for an approximate time of 15 minutes. This is one of several reports received from the same reporter.
Within a couple weeks of second dose (I'm unable to identify specific time because the onset was not sudden) I began experiencing extreme sensitivity to sound and ringing in my ears (tinnitus). This began to become very intense by the first weekend of June. It's continued since then. Along with a strange discomfort in one and sometimes  both ears. I have gone to an ENT and multiple doctors. No infections ,etc. My hearing "normal." Condition continues and brings me great distress.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns an 80 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 19-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 19-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Presented to Health clinic complaining of cough and shortness of breath which started on 6/29/22. She is found to have COVID-19 and had room air oxygen saturations as low as 87% in the ER. She had been doing well on 2L NC and does not use supplemental oxygen at home.
BAD HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 18020772, and batch number: 18020772 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 11:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021 19:00, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad headache. This report was non-serious.
? 9:37AM ? 2nd dose of Moderna vaccine administered IM into right arm ? Patient waited 15 minutes for observation  ? 9:52 AM - Patient checked out with technician at 9:52AM and reported nausea and trembling ? 9:53 AM ? BP was measured 176/90mmHg ? 10:01 AM ? BP reassessed 151/94mmHg; Patient reported that symptoms did not improve so 10mL of diphenhydramine 12.5mg/5mL (total 25mg) administered to patient and emergency number was called. Continued to observe patient.  ? 10:06AM ? Patient reported difficulty breathing and no improvement in symptoms. Observed rapid shallowing breathing, so 1 dose (0.3mg) of epinephrine auto-injector was administered IM into left outer thigh  ? ~10:08-10:15AM ? Ambulance arrived, reported incident to paramedics, and patient was taken to hospital
On Thursday afternoon, after the vaccine, I started having intense chest pain, it got worse and worse, so I stayed home from work on Friday. I went to the doctor ( PCP ) and she said I was not having a heart attack. On Monday, I stayed home from work again, I was having intense chest pain I could not even stand up. On Tuesday, I was out of doctors note so I had to go back to work. I could not even walk I had such shortness of breath. I contacted my doctor and she said to stay home from work, so I took the rest of the week off. All through the month of November and December, I had such horrible shortness of breath and chest pain. I could not stand more than 3-5 mins. I could not even walk 100 yards across campus to use the rest room. By early December, I wasn't getting any better, I had a telehealth visit with my doctor. She put me on prednisone and that did help me a lot. I was able to stand up and walk longer. My doctor referred me to a cardiologist, and he said that I was not having a heart attack, he said he thinks I have myocarditis. He said he could not give me a diagnosis but said I have all the symptoms. He said since no one tested me since early November he can't for sure give me and exact diagnosis. He put me on prednisone again. Dr. ordered a bunch of tests and I'm not in heart failure. I was running 5KS and half marathons before this happened so not being able to walk or run was not normal for me.
Uveitis in left eye approximately 25 hrs. Urgent care visited within 48hrs as sight/sensitivity to light/pain was increasing rapidly/unbearable.
The day after the vaccination, I had one of the heaviest and painful menstrual cycles of my life. I am on birth control that gives me a period every 3 months. I had just had a period in August.  I was not due yet, but had a full week of a heavy period (each of the 7 days). Then in December when I was due again. I had one of the lightest cycles only lasting 3 days with no cramps. Now for the last 4 days, I have had severely painful cramps. I started my period again when I wasn't due until end of March.
LOCALIZED BRUISING AND PAIN STARTING THE EVENING OF VACCINATION 6/7/22 ON THE RIGHT DELTOID.  PT SAID SITE OF INJECTION GETTING HARD.  PICTURES (SHE DOCUMENTED OVER THE LAST TWO WEEKS) SHOWS SITE OF INJECTION GETTING LESS BRUISING AND PURPLE RING AROUND INJECTION SITE GETTING SMALLER.  TODAY 6/25/22, SHOWS BRUISING AND SITE OF INJECTION FIRM.
Severe headache lasting over 2 full days, severe body aches, fever of over 99.8 degrees, chills, minor temporary nausea, SEVERE, HOT, RED, PAINFUL LARGE HARDENED RASH measuring approx. 2.5" long by 3" wide at injection site.  Rash and related injection site symptoms continue presently over 4 days after vaccine. Headache and other symptoms were so severe that absolute bedrest was necessary for 2.5 days.  No appetite and no thirst.  Also, tech at Pharmacy did not provide me with the specific information form showing lot number or other required information.  She also dropped the vaccine on the floor. When asked if she was going to get a new one she did not comment and injected my arm with the vaccine.  On 11/19/23 I contacted the pharmacist at this facility and spoke to person and advised her of my adverse reaction as well as experience with tech and not receiving required paperwork.
The patient came in for booster COVID-19 vaccination at our office and was inadvertently injected with an outdated vial of vaccine which was expired with Shelf Life Extension since September 2021. Appropriate administrative tasks and report was made through our channel and patient was reassured of no harm would come from having this vaccine. It is worth noted that the expired vaccine was kept in -80 degree celsius freezer at all time and as we consulted with our infectious disease specialist who consider that it is possible that this dose is still valid, we explained the situation to the patient and offer option to get another booster dose in the next 10 to 12 weeks.
arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm hurt). On 28-Feb-2021, PAIN IN EXTREMITY (arm hurt) had resolved. Not Provided          No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
This spontaneous report as received from a physician refers to a 6 month old patient who on 30-JAN-2014 was vaccinated with a dose of M-M-R II lot # J003623, HSA, exp date 22-MAR-2015 (dose and route not provided) and with a dose of VARIVAX (Merck), Lot # J006732, exp date 30-MAY-2015 (dose and route not provided). No adverse effects were reported. Additional information has been requested.
eye pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Jan2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Dec2020, for Covid-19 immunization. The following information was reported: EYE PAIN (non-serious) with onset Sep2021, outcome "unknown". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. No patient's concurrent conditions, medical history or concomitant medications were reported. On an unknown date, while the patient (who was a pharmacist) was drawing up ZOSTAVAX (strength, dose, LOT#, expiration date were not reported), the vial broke on an unspecified was and the vaccine got on the patient's skin (unspecified location). On an unknown date, an unspecified time after being topically exposed to ZOSTAVAX, patient developed shingles. The outcome of herpes zoster was reported as unknown. The causality between shingles and ZOSTAVAX was not specified. Additional information has been requested.
It felt more like a cold, I had a sore throat, cough, no fever. I used my home COVID-19 test, that came back positive. I called my doctor to discuss my symptoms and let him know I was positive for COVID19. I was prescribed the PAXLOVID that I started taking that evening. I started feeling better within a few days of taking the PAXLOVID antiviral. I was fatigued a few days after feeling better but it did not last long.
I looked at our Pfizer inventory today to check for possible incorrect expiration dates (because of the 10 week fridge time after receiving shipment). I found two incorrect expiration dates. I ran a "dosage report" in database to see if any patients were vaccinated with these two expired vaccines. COVID PFR MONO 6m-4y FT9142 - expired 11/16/2022  (report ran from 11/18/2022 - 03/02/2022 given the two additional days per Pfizer, see attached)
Now in with syncopal episodes. Has had a loop recorder in place Jan 2021. dx with POTS
30 yo woman w/ no known PMH who was transferred for w/u of headache, AMS, found to have CSF lymphocytic pleocytosis along with elevated opening pressure and parietal and occipital infarcts in the setting of multiple recent presentations to the ED over the past several weeks for ongoing headache now status post EVD placement 4/7 intubated and sedated. She developed progressive, unrelenting headache right after the Moderna vaccine according to her mother. We are not sure if the Moderna vaccine is related at all to her current illness but the timing was suspicious and mother very worried about the timing of the vaccine and the start of her headaches. All workup has remained negative so far, but some studies are still pending. Diagnosis clinically most consistent with ADEM but unclear trigger.
Varicella s/p Varivax, 1-2mm papular on chest, abdomen, neck, exts
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 19-DEC-2015, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-JAN-2016, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. The patient has been prescribed ibuprofen, oxycodone and valacyclovir for management of her painful condition. As a direct and proximate result of these malfunctions, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Pentacel has an expiration date of Sept. 16, 2023.  Patient did not have reaction or symptoms.  Expiration date was noticed/documented after administration.
sore arm after the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after the booster dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 010M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced PAIN IN EXTREMITY (sore arm after the booster dose). At the time of the report, PAIN IN EXTREMITY (sore arm after the booster dose) outcome was unknown.            No concomitant medications were reported It was reported that the patient did not remember which arm patient received the booster dose in. No treatment drugs were reported   This case was linked to MOD-2022-521319, MOD-2022-521217 (Patient Link).
I received my 5th dose of Pfizer Bivalent Booster on 10/11/2022. My symptoms started on 12/20/2022 at 01:00AM. I had a sharp pain in my larynx, cough, low grade fever, and sore throat. I went to my doctor's office on 12/22/2022 they did COVID-19, RSV, and Flu tests. I was positive for RSV and Influenza B. Since it wasn't concerning they said if it gets worse all us back. I took over the counter cough syrup medication and I slept in bed for 3 days. I felt better afterwards. It took 2 weeks for me to recover completely.
Woke up and unable to move. My body felt as if I was 'hit by a bus'-pain from head to toe. I felt ice cold but when someone touched me, they said I felt to be on fire. Head congestion so bad it felt as if someone was squeezing my head and when I coughed, it hurt worse and I coughed up phlegm. I was not able to perform any activities as I was in terrible pain and slept on/off for about 30 hours.
Patient received 2nd dose of Pfizer 14 days after 1st dose instead of the recommended 21 days.  Patient has not had any adverse events as of yet from 2nd dose other than receiving it early.
About 2 weeks ago I started having dizziness when I moved. I went to see my PCP on 11/4/2021 and they told me I had ongoing vertigo. They said it would resolve on its own and to come back if it has not resolved by then. They did not prescribe any medications and did not do any medical tests.
Woke up with mild headache and mild tiredness. Went on walk and felt fine. Was eating lunch (sitting down) and suddenly felt faint. Fainted and was unconscious for about 10 seconds. Back to feeling how I was prior to the event now.
Pt was given the Covid bivalent Boster on 4/5/23 and it had expired on 4/3/23
Its been 11 days my arm is still red and swollen where i got the vaccine . if I put my arm on the effected area it feels warm.