chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow up information has been receiving from a healthcare worker concerning a 27 year old female patient with a hypothyroid and a history of ovarian cyst and gastroenteritis, who on 01-NOV-2008 at 12:45 was vaccinated with a dose of PNEUMOVAX (lot # 660685/0619X). Concomitant vaccination included influenza virus vaccine (unspecified) (manufacturer unknown). On 04-NOV-2008 the patient developed cellulitis of the arm, at the injection site, after receiving the vaccine, and was placed on CEFTRIAXONE SODIUM (manufacturer unknown), 1gr, intramuscularly. On 05-NOV-2008 the patient sought medical attention, through an office visit and complained of arm pain, at that time therapy with BACTRIM was continued. Telephone memo information received on 11-NOV-2008 contained the following information: on 03-NOV-2008, the patient was seen by the physician. The patient complained that she thought that she had a possible allergic reaction to PNEUMOVAX vaccine. On 03-NOV-2008 the patient was diagnosed with a urinary tract infection (UTI) and was placed on BACTRIM, twice a day. The health care worker stated the patient's urine was positive for blood and leukocytes. On 04-NOV-2008, the patient returned to the physician's office and complained that her arm pain was worse. The patient was diagnosed with cellulitis. The patient was treated with ROCEPHIN, 1gm, IM and therapy with BACTRIM continued. On 05-NOV-2008 the health care worker stated the patient was seen again at the physician's office and still complained of arm pain and BACTRIM continued. The patient had not been in the physician's office since 05-Nov-2008. On follow up information received on 12-DEC-2008 was stated that the patient was vaccinated in the right deltoid and developed erythema (18cm X 18cm). The patient recovered after about 2 weeks. The cellulitis of the arm, at the injection site was considered to be disabling. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the center and was released. This is one of two reports from the same source. No further information is available.
Fever, headache, chills, stomachache, nausea, soreness at vaccine site.
I've been running a fever for almost 4 weeks now.  I have to continually take Advil.    My liver enzymes are high.  Tiredness and fatigue.  At times I have an upset stomach.  I have been checked for Covid 3 times and each time is negative.  I went to the emergency room on March 15.  I was given fluids and an antibiotic through the IV.  I have been to the Dr. multiple times.  They have checked me from head to toe and are puzzled.   This all started the day after I got the first shot.
Blue hands bilaterally when outside walking - Raynaud's phenomenon.  Placed hands in pockets to help warm up and when home put in warm water about 15 min later.  Hands pinked up
7/5/2023 - 7/12/2023 (7 days) admitted with Covid pneumonia as well as sepsis and the patient was treated with Remdesivir as well as decadron during the hospitalization 030M20A 2/15/2021 001A21A 3/15/2021 058H21A 12/7/2021
Within seconds of getting the vaccine i became very dizzy and d disoriented . This lasted around 30 minutes. After I had trouble walking, was light headed, dizzy on and off for weeks
Sore left arm upon injection, but felt fine throughout the day. Once I got into bed around 10:00pm I developed severe chills and recorded a temperature of 101degrees one hour after taking two extra strength Tylenol in the middle of the night. Did not sleep due to severity of symptoms. The next day when I felt strong enough to shower, I discovered a red rash on my chest primarily between my breasts. The following day, Wednesday 9/21, I noticed my injection site was red, raised and very hot. The spot resembled the size of an apple.  Yesterday, 9/22, I still felt weak but the other symptoms improved or went away. However, since yesterday I?m itchy everywhere on my body. Today, 9/23, I have energy to bike and be active, injection site is almost better but I?m still itching.
Chills and fevers (102), muscle weakness (needed assistance to stand and walk); Tylenol and Motrin. after a day the symptoms were gone.
had apnea, limpness & cyanosis about 4hr p/vax; lasted for 20-30min total;
Post vax, the patient developed a 3cm x 5cm welty redness with minimal tenderness.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Dec2022 at 13:00 as dose 4 (booster), single (Lot number: GJ3275), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EL9266), on 24Mar2021 as dose 2, single (Lot number: EN3518) and on 26May2022 at 13:00 as dose 3 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300154212 Same reporter/patient,different drug/AE;
my arm was sore with all the shots; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (my arm was sore with all the shots) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Patient states had a huge list of allergies. There was no history of myocarditis or pericarditis reported.  Concurrent medical conditions included Arthritis (started 50 years ago, recent change in status was worsened), Asthma (started 20 years ago, recent change in status was worsened but was not on any medications for it), Neck pain (started 5 years ago, recent change in status was worsened), Heartbeats irregular (History of irregular heart beat started 20 years ago, recent change in status was stable.), Drug allergy (anti-inflammatory drugs allergy), Food allergy (green pepper allergy), Food allergy (garlic allergy), Milk allergy (milk products allergy), Food allergy (raw onions allergy) and Food allergy (spicy food allergy). Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, DULOXETINE, FAMOTIDINE (PEPCID [FAMOTIDINE]), ATORVASTATIN, TRAZODONE and LOSARTAN for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced VACCINATION SITE PAIN (my arm was sore with all the shots). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (my arm was sore with all the shots) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient had experienced similar reaction to the flu shot many years ago.  Patient never had COVID positive test or diagnosis.   This case was linked to MOD-2022-564313, MOD-2022-565146 (Patient Link).
Child had temp of 104 to 105 for 2 days p/2nd immun given. Mom took child to ER & general Practitioner fever subsided by Sunday night 20JAN91.
Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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, the patient experienced CHILLS (Chills) and HEADACHE (Headache). At the time of the report, CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  Company comment: Although temporality cannot be established due to the known safety profile of the vaccine, a causal relationship with the event cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Follow up information was received on 31 Mar 2021: added reporter E mail ID
Shortly after vaccine was administered - patient states within minutes - she states she felt tickling in her throat and noticed heart rate was elevated "upwards of 110" per Apple Watch and not a normal resting heart rate per patient; also reports she became light headed. States nasal congestion, rhinorrhea, and post-nasal drainage worsened almost immediately as well. After that, patient took Benadryl that evening. 1/24- light headed the next day as well as dizzy; started to develop fatigue, headache, arm soreness. Reports she also had a "weird vibrating" in the back of her throat and had to lay down entire day. Developed "drenched sweats" that evening.  On 1/24 developed GI symptoms, tactile fever, sweats, chills and increased fatigue that has worsened today (1/25). No fever has developed.
Menstrual Cycle started after getting 2nd dose, even though it had just completed the day before. Cycle is on a routine schedule because of IUD, making this odd.
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 08-MAY-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004890: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889:
Mild weakness & diarrhea. Redness, tenderness, pain, swelling, warmth noted at cranial nerve V1/V2 distribution.
Breakthrough case admission after three vaccines Moderna 1/3/21 Lot# 011L20A;  Moderna 10/28/21 Lot# 088D21A;  Moderna 4/21/22 Lot#  002M21A
Pt developed a 50 cent sized induration with redness at injection site. 2 days prior to observation pt states redness radiated to left axillary.
The pt. was treated for shingles and other zoster-related conditions; The pt. was treated for shingles and other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation and refers to a patient (pt.) of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 01-JAN-2015, the pt. was inoculated by a health care provider (HCP) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration was not specified) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, (reported as subsequently after vaccination with zoster vaccine live (ZOSTAVAX)), the pt. was treated by a physician for shingles (herpes zoster) and zoster-related conditions (ill-defined disorder). As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt. had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
After booster dose of Flumist, child experienced fever, coughing, chills, and vomiting.  Mom reported he was 'raspy', which is unusual.
Syncopal episode. HR 76; RR 20; BP 122/78; O2 saturation 98%. No medications given.
Within 5 minutes of receiving vaccine, child vomited. Observable S/S included profuse perspiration, skin clammy/cold to tough. Semi-conscious state with hyperventilation initially. Benadryl 2.5 teaspoon given orally and vitals monitored. Child released in stable condition at 11:00 AM.
I had an allergic response that included itchiness, watery eyes, congestion... then settled into bronchitis.  I still have the bronchitis.
This spontaneous report as received from a pharmacist refers to a 63 years old female patient. The patient was vaccinated with 0.5 ml PNEUMOVAX23 on 14-SEP-2012. Route was unspecified. Lot# was reported as H015581, exp 30-MAR-2012. The reporter stated the patient received PNEUMOVAX23 on 14-SEP-2012 and developed redness, a rash and soreness in her left deltoid where she received the vaccine. Patient also received FLUZONE (manufacturer unknown) on 13-SEP-2012 and developed a similar reaction in her right arm where she received FLUZONE (manufacturer unknown). No treatment was given for the event. No lab diagnostic study was performed. The patient was not recovered. The physician contacted pharmacist to seek medical attention. Additional information has been requested.
Pt got HEP A & flu vaccine - about 10 min later LOC, fell & hit head on file shelf.  LOC X 3 min, pulse 46-48 O2 100 1/1, BP 100/58 increased pulse to 78 by 5 min.  To ER via ambulance to rule out bleed of brain.  Neuro ok when awake.
I was given flu shot on 10/04/14 and have had severe pain in my arm since then. On 10/7/14 I went to hospital to seek assistance. I have been unable to complete my job duties, due to the pain.
I went into the doctor for a routine skin check and asked where in the facility I could get a flu shot. I had a six week baby at the time and a toddler and needed to get a flu shot during my visit to the facility. The dermatologist's office said that they could give me the shot. After my skin test, the nurse prepared to give me the shot in my upper right arm. She stuck the needle in, administered some of the vaccine, and then removed the needle. She then reinserted the needle and put the rest of the vaccine in my arm. She covered it with a Band-Aid. Immediately after the shot, I had discomfort, soreness and limited range of motion in my arm but - having had a flu shot in the past - thought that this was normal and ignored it. The pain persisted and got progressively worse over the course of two weeks. Finally, the pain got so bad on day 10 and 11 that I contacted the doctor's office and let them know and asked to be seen. I cannot lift my right arm higher than shoulder height and if my arm is bent, I can't lift it at all. This means that I cannot pick up my infant daughter (now 8 weeks old) or my toddler, or do normal things with my arm. This is my dominant arm and it has made day to day activities very difficult and painful. The pain is greatest when I am trying to move my arm - but there is also dull pain when it is at rest. The pain kept me up several nights ago. The pain is localized in the location of where the shot was administered. It feels like muscle damage. There is no external signs of infection.
Patient reports when she comes to the clinic for her second Covid Vaccine, that 5 days after the first vaccine, she developed sudden and complete loss of the use of both legs and one arm.  She and husband report that it lasted about 1-2 hours and then resolved.  Patient states that this is the same type of reaction she sometimes have as a result of her neurologic condition.  She states that she did not call her doctor or report this to anyone as she has experienced similar issues in the past but mentions it today because it did happen after her first covid shot.  States she has felt fine since. Contacted patient's physician office on day of presentation for second shot (2/23/21) and physician asked her to come to office next day for evaluation. Patient went to physicians office the next day and was instructed not to take the second dose.
Patient did not have any adverse effect but  was  given 2nd dose of flu shot , 1 month apart each, due  to miscommunication. The first shot was given at the doctor's office and the second shot was given at the pharmacy.  The patient had no adverse effect what so ever even though he got 2 doses of the flu shot a moth apart from each other.
PATIENT IS 17 YEARS OLD. HE WAS INADVERTENTLY GIVEN THE JANSSEN COVID-19 VACCINE BY THE CERTIFIED MEDICAL ASSISTANT. ERROR WAS NOTED IMMEDIATELY AFTER ADMINISTRATION. PATIENT AND MOTHER WERE BOTH NOTIFIED. PATIENT WAS OBSERVED AND DID NOT HAVE ANY ADVERSE EFFECTS. WAS INFORMED OF WHEN TO SEEK MEDICAL ASSISTANCE IF NEEDED.
PT HAD RASH FROM PAST POSITIVE COVID TESTING.  RASH INCREASED DRASTICALLY AFTER FIRST DOSE. RASH IS NOTED FROM NECK TO FINGERTIPS AND DOWN LEGS.
I was positive for COVID-19 on 29DEC2022, I had a bad sore throat, no fever no other particular symptoms except a little bit of fatigue. I saw my doctor and gave me PAXLOVID, I started feeling better about 24 hours after. I feel so much better now.
felt my left arm sour, heavy to lift; felt my left arm sour, heavy to lift; muscle ache on both shoulders; headache; fatigue; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3247), via an unspecified route of administration on 17Feb2021 13:15 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of BNT162B2 on 27Jan2021 03:00 PM at left arm with lot number EL3247 for covid-19 immunization, also at age of 54 years old. Patient is not pregnant at the time of vaccination. The patient medical history was none, concomitant medications were not reported. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. Two hours after the 2nd dose, patient felt headache and fatigue. She took 500mg of Tylenol at 6 pm on 17Feb2021. The headache went away during the night. The next morning, she felt left arm sour, heavy to lift. Some level of muscle ache on both shoulders. Patient took another 500 mg of Tylenol. The arm sourness was much less in the afternoon on 18Feb2021, and totally disappeared on 19Feb2021. The outcome of event headache was recovered on 17Feb2021, events fatigue and "heavy to lift" were recovered in Feb2021, the other events were recovered on 19Feb2021. The events were reported as non-serious.
pt recvd vax & 49 days p/vax exp alopecia areata totalis, affecting scalp, eyelashes, & eyelids;
Nausea; Diarrhea; This spontaneous case was received on 22-Sep-2022 from other healthcare professional (nurse (reference number: SEQW22-03395) and concerned a 67-years-old, female patient.  The patient's concurrent condition included diabetes. The patient's concomitant medications were not reported.   On 21-Sep-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for active immunization against influenza disease caused by influenza virus subtypes A and types B. The batch number reported was 346341 and the expiry date 28-Apr-2023. The reporter stated that the vaccination went normal as always.   On the same day, during the night, 18 to 24 hours after receiving Fluad Quadrivalent, the patient developed nausea and diarrhea. The patient was given 7up and acid as a corrective treatment. Also, a couple of patients did receive anti-diarrhea pills.  On the same date, the patient recovered from both events. The patient no longer had these symptoms.   The reporter did not provide causality assessment.   The case was assessed as non-serious.  This case is linked to the cases 202204733, 202204735, 202204736, 202204737, 202204738, 202204739 and 202204740 (the same reporter).  Company comment: The events of nausea and diarrhea are assessed as possibly related to Fluad Quadrivalent due to a plausible temporal relationship.; Sender's Comments: The events of nausea and diarrhea are assessed as possibly related to Fluad Quadrivalent due to a plausible temporal relationship.
initially,  it was a splitting headache, piercing pain that came in waves and immobilized me.  It lasted two days and was worse when standing or moving.  It was less intense on the second day, but hives appeared on my left arm and my arm was more sore on the second day, and stayed sore for 5 days. The body aches started around 10:00 pm on the first day.  Then fatigue and joint pain.  Really awful.
Peripheral swelling behind both knees that cause pain when I?m working my PCP did multiple tests and imaging and they said if it does not go away I?m going to need surgery
Fever 101.3, chills, aches all over, arms, legs, back and neck.  Motrin taken .
Chills, shaking, cold extremities, then mild fever, aches, headache unable to sleep all night until 6 am. Following day unable to get out of bed, still aching, fatigue and headache. Third day still tired feeling a bit feverish but getting better. A more severe reaction than from first shot on 2/8/2021 with similar side effects that lasted about 3 days. Fatigue did not go away.
Patient is experiencing extreme pain in her body. She does not have arthritis and her hand cramped up and she had to loosen it up her self and now she is having constant pain one of her fingers.
4/30/04: woke with fever up to 103.2 which lasted until 5/2/04 along with vomiting up to "30 times" from 4/30-5/1: pt didn't call office or seek treatment.
Individual received vaccine at 0915 and was in the monitoring area for approximately 13 minutes when she raised hand stated "I am going to pass out".  She was placed into a wheelchair where became diaphoretic and she had a very brief loss of consciousness. She was placed lying on stretcher and vitals were obtained. Initial BP 72/32 and heart rate 46. Patient recovered to baseline within a short period of time. She was sat up and drank orange juice.  She left clinic at 1015 stating she felt "back to normal self".