chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received his Anthrax Shot on 19May, and states within an hour, he began to have symptoms. Patient had symptoms of Fever (subjective, x48 hours), anorexia, and headache, congestion, and cough 3-4 days following vaccination. Patient states symptoms have improved, though some lingering sinus issues. Pt did not report event for 8 days.  He states he has gotten HA/anorexia each time he's had the anthrax vaccine (total 4 times).
Information has been received from a medical assistant concerning a 22 year old female patient with asthma, which is currently under control, who on 11/13/2002 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M) in the left deltoid.  Concomitant vaccine therapy included a dose of influenza virus vaccine.  There was no illness at the time of vaccination.  Concomitant medication included montelukast sodium (MSD), fluticasone propionate (+) salmetrol xinafoate (ADVAIR), loratadine (CLARITIN), and albuterol.  On 11/14/2002 the patient presented to the physician;s office with a hot, swollen, painful rash at the injection site with a red and tender area that measured 1 3/4cm in diameter.  On 11/14/2002 a CBC revealed an elevated WBC count of 12.9 and the patient was diagnosed with cellulitis of the left deltoid.  On 11/15/2002, a raised red lesion measuring 2.5cm x 2.5cm was noted and the WBC was 16.5.  See laboratory section for additional test results.  It was noted that the patient received a second opinion about the reaction.  Additinoal information has been requested.
p/vax pt exp h/a, inj site redness, a fever that goes between nl & 101;
Since Dose 2 in September 14,2021 I had pneumonia out of nowhere I was hospitalized for 6 days at a health care facility. My hands started back peeling on last week.
5x6 cm area of warm erythematous induration at site of vaccine noted ~7days post injection
Pt has a PMH of  COPD with chronic hypoxic respiratory failure and is on 2.5 L nasal cannula. She presents to the ED with 3 days of worsening shortness of breath. Her O2 sats were in the mid 80s and she is not requiring 4L. She has a nonproductive cough and was found to be COVID positive. She was admitted due to COVID positivity and COVID exacerbation.
This spontaneous report as received from a pharmacist refers to a 60 year old female patient. The patient had no pertinent medical history and no drug reactions or allergies. On 06-OCT-2014, the patient was vaccinated with ZOSTAVAX 19400 PFU, lot # K009769, expiration date: 09-OCT-2015, subcutaneous for to prevent shingles. Concomitant therapies included Lisinopril (Manufacturer unspecified), hydrochlorothiazide (reported as HCTZ) Metformin, LIPITOR, Omeprazole (Manufacturer unspecified) and potassium chloride (Manufacturer unspecified). On 08-OCT-2014,the patient experienced redness, swelling and warmth at the injection site following the administration of ZOSTAVAX. There was no treatment given for adverse events and no lab diagnostics studies performed. The outcome of redness, swelling and warmth at the injection site was reported as recovering/resolving. The relatedness between the events and the vaccination with ZOSTAVAX was unknown. The patient sought medical attention. Additional information has been requested.
Swelling, pain, and redness around inj site (left arm) 7 cm x 6 cm (diameter).
Woke up in the middle of the night with stabbing chest pains and a racing heart (no clock didn't know exact time, but put down 2 am on this form as it required a time and that is my best estimate.)  I tried to get up and I could feel all the blood drain out of my head and upper reaches of my body and the best I could do was sort of crumple up and collapse downward in stages successfully managing to prevent any major drops that might result in a head injury, and then I passed out.  I came too later (not sure exactly how long, again no clock in the room.)  I managed to get back in bed, but it was hard and most of my body was painfully asleep and as I fumbled around I could feel lots of cold apparently mostly-stagnant blood run from various extremities back into the warmer more actively circulating part of my body.  Exhaustion sent me back to sleep quickly.  In the morning I went to the emergency room to check my heart and minus a brief six second sampling EKG and a quick thrombin test they refused to do anything that might actually properly look for things like pericarditis, myocarditis, or other adverse heart inflammation events.  As such we will never be able to get the tests to actually know what we need to know.
Itchy rash appeared on legs within 1/2 hour of administration. Administered 25 mg of Benadryl and patient went home. Tried to call patient several times to follow up. No hives on face/trunk, no signs of anaphylaxis.
Spiked temp of 101.4, gave TYLENOL. 7am next morning vomiting everything she ate, screaming and crying non-stop, arching back, bringing legs up to chest.
Constant tinnitus in both ears.  I noticed it after my second shot but don't know the exact date (the date above is not necessarily correct).  The sound is loud but bearable, given the consequences of no vaccine.  I have had tinnitus as long as I can remember, and it still comes and goes as before except at a different pitch than the vaccine tinnitus.  It can occur several times a week and for short lengths of time - one to several minutes.  It is not as loud as the tinnitus caused by the vaccine and it's occurrence has not changed.  My concern is having the tinnitus get louder if I get a booster.  I'm not sure if I can handle a louder, constant noise.
Patient came to crew claiming to feel dizzy and racing heart. Patient claims to handle needles shots, and blood draws fine. Crew took vitals and they were ? at room air. Second set of vitals where taken and hypertension was discovered. 152/94 BP 107 HR 99%. Patient signed an AMA advised if she feels worse to go to hospital.
Patient almost passed out (similar to mini seizures) right after the shot (3-4 mins later). Called ED and Asst immediately. He then recovered quickly. Paramedics checked his vitals and seems all ok. They told him to call them if he has any other symptoms.
Felt slightly dizzy and woozy following the injection. Then had a mild anaphylactic reaction that started about an hour and 45 minutes following the injection. Throat swelled, and had difficulty breathing. I took two courses of Benadryl, and the throat swelling went down, and breathing got better. Lasted about seven hours or so.
pt reported horrible abdo cramping 12 hrs p/vax; no diarrhea, vomiting, cramping cont until 2 days p/last dose of vax; did not call for advice;
Sluggish feeling on 1/16/2021; extreme thirst chills, gassy, loose bowel movement - caramel color . Injection site soreness; today 1/18/21 slight headache - Tylenol dose, headache now subsiding; all other symptoms have resolved.
10/28/04 8: mom states pt with right leg swollen and right leg red. Blop 3cm. O: Right Oriten thigh red, hard, no strive, no exudate, painful to touch 4cm, Left red, not hard, mild tenderness
red marks right below the entry point/2.5 inch red mark on her arm; it is swollen right below the entry point and sore.; it is swollen right below the entry point and sore.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 13:30 (Lot number: ER8727) at the age of 30 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 21Mar2021, outcome "not recovered", described as "red marks right below the entry point/2.5 inch red mark on her arm"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 21Mar2021, outcome "not recovered" and all described as "it is swollen right below the entry point and sore.". The events were assessed as non-serious.  No follow-up attempts are possible. No further information is expected.
SkinRash, Rash, injection site pain/itching Narrative:  Employee reports a rash on shoulder blade, side of shoulder, and down to forearm, from first shot on 12/23/2020, which is still present on 01/22/2021. Employee received second dose on 01/19/2021. Reports has been putting "clearasil" on rash. Reports injection site pain and itching on date of report (01/22/2021), though unclear if from first injection or second.
At clinic, colleague given Booster dose #2 of Bivalent COVID vaccine (Pfizer). After ~ 5-7 minutes after vaccine given, pt stated she was "not feeling great." Stated her tongue was "feeling funny." Taken to room to lie down, vitals taken at that time and brief assessment taken by NP and LVN. Pt was clearing throat and said tongue was tingling. Pt given 1st dose of Benadryl at that time (12.5 mg) followed by a second dose approximately 10 minutes later (25 mg total). Pt also examined by MD who was covering in the Urgent Care clinic. Pt continued to describe that she felt tingling in her tongue and throat. LVN directed to call 911 at that time. Epi pen was at bedside, however no signs of respiratory distress and no s/s anaphylaxis, so Epi was not used. Pt was awake, alert, oriented x 4 and continued to converse with our team throughout the entire event. Paramedics arrived at clinic and transported to Hospital. I accompanied pt to ED via ambulance. Pt triaged at ED, seen by department, and discharged later that evening.     Report #2    Dr received the Pfizer-BioNTech COVID 19 Bivalent vaccine in the primary care clinic around 2040. At around 2050 she stated "I feel weird," she complained of numbness on the lips. Her baseline vitals 135/89 RR 20 HR 77 98%O2 on Room air, five minutes later she became hypertensive 147/91 80 20 98% O2, breathing was regular and unlabored. She did complained of any difficulty breathing. She had a sip of water and started clearing her throat several times stating she felt something blocking the area. She also stated her throat felt tight. NP was at bedside an ordered to give 12.5mg of Benadryl. BP 157/95 80 20 98%02. Dr arrived and asked 911 to get her transfer to ED for further evaluation. Paramedics arrived and took her to Hospital.
Pt presented to ER 5 days post vax c/o pain & swelling @ inject site; A 12 cm meter by 12 cm area of erythema & tenderness noted in rt lateral upper arm; No signs & sx of infect were noted;
feeling really sick; everything she smells, smelling like the sickening sweet dried cat food smell; wasn't really that unpleasant to begin with but with everything tasting and smelling like that; feeling really bad and aching all over; feeling really bad and aching all over; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 16Mar2021 (Lot number: EN6205) at the age of 69 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "sleeping difficulty" (unspecified if ongoing). Concomitant medication(s) included: SEROQUEL taken for insomnia, start date: 04Mar2021. Vaccination history included: BNT162B2 (dose 1, lot no.: EN6203), for COVID-19 immunisation. The following information was reported: MALAISE (non-serious) with onset 16Mar2021, outcome "unknown", described as "feeling really sick"; PAROSMIA (non-serious) with onset 16Mar2021, outcome "not recovered", described as "everything she smells, smelling like the sickening sweet dried cat food smell"; DYSGEUSIA (non-serious) with onset 16Mar2021, outcome "not recovered", described as "wasn't really that unpleasant to begin with but with everything tasting and smelling like that"; FEELING ABNORMAL (non-serious), PAIN (non-serious) all with onset 16Mar2021, outcome "recovering" and all described as "feeling really bad and aching all over"; NAUSEA (non-serious) with onset 16Mar2021, outcome "recovering", described as "nausea".  Additional information: Clinical course: She went for the second one Tuesday morning and she was fine for about 5-6 hours then she started feeling really sick/feeling really bad and aching all over, she had a little bit of nausea and she called a united healthcare nurse and asked she said she thought that was pretty normal for the second shot so she was not too worried about that. But one of symptoms was strange, it smells like, everything she smells, smelling like the sickening sweet dried cat food smell and the thing she is really kind of worried about with this thing was she would be testing positive and if she could give this to her father who is in his 90s. It was not really that unpleasant to begin with but with everything tasting and smelling like that, and she still had that. Other than that, she was feeling about 75 percent better. With the taste and smell that was still ongoing, it had stayed about the same but with everything else she feels about 75 percent better.   No follow-up attempts are possible. No further information is expected.
Patient got a shot in right arm.  She said the immunizer was standing over her while she was sitting. Her arm hurt after shot. She thought after two weeks of pain that the pain should have gone away by now. She emailed her MD. Dr told her to put on warm compresses on the site and take motrin.  Any heat/signs of infection/fever/swelling/redness to get evaluated. She came in today still in pain. She is going to make an appointment with her MD.
On the day of the booster, I noticed tingling and pin pricking started in my face, chin, upper lip and tongue.  I also had this feeling in my hands, feet, and genital area.  This last for two or three days.  On the Saturday after the booster, I was feeling better.  On Sunday night the symptoms came back, and it was an acute neuropathy in these areas but primarily in my hands and feet.  There was burning in my feet after riding the stationary bike.  I saw my doctor on October 20, 2022.  I was prescribed Gabapentin and a shot of Toradol.  I will see a neurologist appointment soon.  I am monitoring the symptoms for now.  As of today, I still have the symptoms but am able to manage okay.
had multiple seizures over a few day; This is a spontaneous report from a contactable (patient) via COVID-19 Vaccine Adverse Event Reporting System (COVAES). A non-pregnant 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 23Apr2021 at 10:45 AM (Lot Number: Ewo172), at the age of 48 years, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 The patient had prior history of epilepsy, petit mal seizures. None for the last 20 years. The patient did not receive any other medication within 2 weeks of vaccination  Past drug events included penicillin [benzylpenicillin], ampicillin, amoxicillin, clindamycin, vancomycin. The patient reported that on 27Apr2021 at 08:30, four days after vaccine she  had multiple seizures over a few days. No treatment was given for the event. The clinical outcome of the event was recovered. She reported "I am now seizure free again". It was also reported that since the vaccination, the patient had not been tested for COVID-19.
After a first few days, my heart started fluttering bad. My heart was racing. Itch behind my heart; something back there itching - something coughed up, the doctor said. The doctor gave me an Atralovit inhaler. (He ordered the inhaler for me 1/26/2021.) Once I started doing an inhaler four times  a day - two inhalants each time.  a it started going away - both the fluttering in my heart and the racing. Immediately after the vaccine:  I had pain in my left arm and it traveled  from the muscle in my arm around to my back to right arm for a day. My bones hurt. But I didn't have a fever.
Onset of fever (101.3), tachycardia (131), rigors, and myalgias that lasted about 12 hours followed by 24 hours of fatigue and increased need for sleep.  Similar reactions were shared with 6 co-workers who received the vaccination at about the same time. My concern is that if this second dose of Moderna COVID-19 vaccination is making people ill, then it is imperative that CDC and FDA advise the public what to expect and maybe how to ameliorate.  Otherwise people who become ill will tell their friends and family.  This disclosure will make members of the public disinclined to get the shot which would be a public health nightmare.  I have used this adverse report as the forum to ensure that the FDA and CDC are aware of these reactions and will consider their consequences.  Thank you.
HIB vaccine expired on  5/6/2022 and administered on 5/16/2022 ; will need to be repeated.
Several drops of vaccine squirted out of the arm; Several drops of vaccine squirted out of the arm; A spontaneous report was received from a consumer concerning a 28-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and when given the vaccine, several drops of the vaccine squirted out of the arm.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their second of two planned doses of mRNA-1273 (Batch number: 030L20A) on 10-FEB-2021.  On 10-FEB-2021, the patient received the second dose of Moderna vaccine. Consumer reported that when given the vaccine, several drops of vaccine squirted out of the arm.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The event outcome was considered resolved on 10-FEB-2021.; Reporter's Comments: This report refers to a case of Vaccine Underdose and exposure via skin contact for mRNA-1273, lot #030L20A with no associated Adverse event.
This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 53-year-old male patient who received SHINGRIX (batch number 27K24, expiry date 2nd February 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than 4 months after receiving SHINGRIX, the patient experienced nausea, general body pain and joint pain. On an unknown date, the outcome of the nausea, general body pain and joint pain were unknown. It was unknown if the reporter considered the nausea, general body pain and joint pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported his patient had experienced above events following vaccination with SHINGRIX.
medication error due to the extra dose of acthib given since it was concomitantly administered with pentacel with no reported adverse event; Initial information received on 15-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old male patient who experienced medication error due to the extra dose of acthib given since it was concomitantly administered with pentacel with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  On 15-Sep-2022, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE once ( lot UJ583AB; expiry date: 15-Oct-2022) via unknown route in unknown administration site for immunization.  On 15-SEP-2022 the patient reported a non-serious event medication error due to the extra dose of acthib given since it was concomitantly administered with pentacel with no reported adverse event (extra dose administered) following the administration of HIB (PRP/T) VACCINE.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event extra dose administered.   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 the guidelines. 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.
Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042l20a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and METOPROLOL for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in the arm). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in the arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-335494 (Patient Link).
Lg area of erythema, increased warmth & pain surrounding injection site, 9x13cm, indurated occurring 36 hrs later. Sx of lightheadedness,ha,nausea,myalgias,malaise,anorexia,fever100.6
awful problem with arthritis in hands; sleepy; hands were hurting a lot; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 1 via an unspecified route administration on 02May2021 (at the age of 66years) as single dose for covid-19 immunization. The patient medical history included Diabetes mellitus from ongoing to unknown, Arthritis from unknown to unknown, and A1C from unknown to unknown. The patient's concomitant medications were not reported. She has had an awful problem with arthritis in her hands since. Her husband is a veterinarian. She did not have a prescribing doctor. She has had arthritis, but it has never been this bad. Her arthritis is usually only bad in cold rainy weather. She has never had an issue before. The pain got worse the next day or maybe two days after the vaccine. she took a nap, and she never takes a nap. She took a nap the first and second day after, and then after the second day her hands were hurting a lot. She does have Diabetes, but she has never had to take anything for it. She has kept her A1C down to 6.3 through diet and exercise. She was diagnosed 11 years ago. On an unspecified date, the patient experienced awful problem with arthritis in hands, hands were hurting a lot, and sleepy. The outcome of the event awful problem with arthritis in hands was not recovered. The outcome of other events was unknown.  Information on Lot/Batch number is available; Further information has been requested.