chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lost all my taste and smell; Lost all my taste and smell; now everything taste like metal or rotten; was tired for 4 days; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 20Apr2021 at 13:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant past medical history. The patient did not have any known allergies to food medications or other products. The patient did take any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Apr2021, the patient lost all his taste and smell. He had a super great sense of smell and taste, now everything tasted like metal or rotten, hard to describe. He was tired for 4 days, the lack of smell and taste was strange to him as he felt he had a strong sense of smell. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lost all taste and smell, everything taste like metal or rotten and tired for 4 days were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
I received the 2nd dose of the Pfizer COVID-19 vaccine around 9:15 am on 2/23/21. Initially, my only symptoms were injection site soreness and minor swelling. Gradually throughout the day, my entire left arm become more and more sore. By 5:00pm, I felt exhausted and dizzy and was having chills. My temperature was 99.8 degrees Fahrenheit. I took a dose of Extra Strength Tylenol, but felt no change. My joints and muscles began to ache around 6:00pm on 2/23/21 and did not stop aching until around 9:00pm on 2/24/21. During the evening of 2/23/21, my dizziness increased and I felt as if I would pass out any time I sat up or stood. My temperature had returned to 98.2 degrees Fahrenheit by 10:00pm on 2/23/21. I then took a dose of Motrin to help with my soreness. On 2/24/21 from morning until 8:30pm, I had no fever or chills, but still felt exhausted and had minor muscle/joint achiness. I took 3 doses of Motrin on 2/24/21 to help with the soreness. Throughout the day, I had some difficulty breathing (felt like a mild asthma attack) and used my emergency inhaler once. At 8:30pm on 2/24/21, my temperature was 100.5 degrees Fahrenheit. I took another dose of Motrin and went to sleep. Around 3:00am on 2/25/21, I woke up drenched in sweat, but feeling better. My temperature was normal then. When I woke up at 7:00am on 2/25/21, I no longer felt achy, dizzy, or tired. I still feel (now at 1:30pm on 2/25/21)as though my asthma is aggravated, but am not having difficulty breathing.
temp excursion due to moving products to other refrigerators, with no AE [Incorrect product storage]; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.   This case involved no identifiable patient (conflict information, due to the patient was a female) and it was reported that temp excursion due to moving products to other refrigerators (product storage error), with insulin glargine (TOUJEO), insulin lispro (ADMELOG), dulaglutide (TRULICITY), semaglutide (OZEMPIC), galcanezumab-gnlm (EMGALITY), etonogestrel (+) ethinyl estradiol (NUVARING), calcium undecylenate (+) undecylenic acid (+) zinc undecylenate (CRUEX), gabapentin, acyclovir (reported as aciclovir (ZOSTER)), insulin aspart (NOVOLOG), insulin human (HUMULIN R), quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, route, lot# and expiration date were not reported), insulin glargine (BASAGLAR) and insulin lispro (HUMALOG) batch number and expiry unknown for all.  On an unknown date (latency unknown), the pharmacist reported a temperature excursion due to moving products to other refrigerators (product storage error). Excursion limits: 50.3 degree F for 3 hours. No lab data provided. It was not reported if the corrective treatment received.  Action taken and outcome of the event, both were not applicable.  Disclaimer: this suspected adverse reaction report was 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 was 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 had contributed to or was to be held liable for the occurrence of this medication error.  There would be no information about batch number was reported for this case.  No further relevant information was reported.
Patient reported fear of needles before being vaccinated. Reported feeling light headed and having a sore arm. Skin became pale. Patient laid down and noted to have vitals: Bp 108/50, P 72, and R 18 with no distress noted. Water given to patient. Patient reported feeling better as soon as she was laid down. Monitored for additional 30 minutes noting color to return and patient's vitals remaining stable: Bp 110/60, P 68, and R 18.
This spontaneous report was received from a registered nurse, and refers to a 5 year old patient of unknown gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 31-JUL-2018, the patient was vaccinated with PROQUAD and sterile diluent (MERCK STERILE DILUENT) subcutaneosly, lot # R006216 with expiration date on 28-AUG-2018 for prophylaxis but pulled away during vaccination and did not receive full 0.5ml dose (final total dose was not reported). No adverse effect were reported.
This spontaneous report as received from a pharmacist refers to a 73 year old female patient. No information on patient's medical history or concurrent conditions was provided. On 19-JUN-2015 and 20-JUL-2015, the patient was respectively vaccinated with dose 1 and 2 of RECOMBIVAX HB injection, 10 microgram/ml, adult formulation, lot # L000717, intramuscularly (dose and expiration date were not reported). On 20-OCT-2015 (reported as "approximately six weeks ago"), the patient had an unspecified surgery for unspecified reason and afterwards developed a hip infection (in 2015, dates and details unspecified). The patient was on intravenous ANCEF (manufacturer unknown) therapy from her treating physician and would start BACTRIM (also reported as manufacturer unknown) in about two weeks from the time of the report. The outcome of the adverse events was reported as not recovered. The causality between the adverse events and RECOMBIVAX HB was not provided. Upon internal review, unspecified surgery was determined to be medically significant. Additional information has been requested.
Nothing major.  A weeping painful welt to the right of injection site started overnight on the day of injection.  Did not report   Subsided several days later
I noticed pruritic erythematous papules on my right little finger as I woke up the next morning (6:00 am) after the vaccine. The affected area has increased in size (about 2.5 x 1 cm now), and the finger is slightly swollen, with pain in the proximal interphalangeal joint when pressure is applied. Two days ago (1/15/2021; 8 days after vaccination), a small pruritic purple papule (2-3 mm) appeared on my ring finger over the distal interphalangeal joint, same hand, and the area is slightly painful when pressure is applied; today, the papule measures 3 x 5 mm. Skin lesions in both fingers are on the dorsal surface. I will seek medical attention.
anemia; elevated liver enzymes; low protien; Elevated Blood Sugars; Fatigue; Headache; Chills; Fever; Feels awful/ I feel really bad; Feel terrible; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205 and expiration date not reported) via an unspecified route of administration, administered in right arm on 08Mar2021 05:00 as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pravastatin; tamsulosin and insulin aspart (NOVOLOG). The patient reported that he regulates his blood sugar by insulin pump giving him insulin when he needed it. The patient stated that he felt awful. He felt terrible. He could not function. Without drugs, he feels really bad. He got the vaccine on 08Mar2021 and for a couple of days, he felt okay but after that, he just feels really terrible. He does not know what to do. He stated that the events probably started on 10Mar2021. He does not remember but it has been a couple of days since he got the vaccine, quite "hard feeling for him". He stated that he drove up to the stadium in his car, answered a bunch of questions, sat down at his reservation number, got his shot on his arm and drove away. As treatment for these events, he stated, Tylenol, he had taken about 1000 units at least once a day or sometimes twice a day but it varies. If he does not take it, he feels really bad. He does not like to take drugs so, he was trying not to take it. He asked what he was supposed to do. It was also reported that on 11Mar2021 16:00, the patient experienced Fatigue, Headache, Chills, Fever. He had elevated blood sugars on 19Mar2021. On an unspecified date, he had a CBC done which showed anemia, elevated liver enzymes and low protein. He had not been able to function at a normal level. No treatment was given in response to these events. The outcome of the events was not recovered. The patient underwent COVID test post vaccination via nasal swab (PCR) on 02Mar2021 and was negative and on 19Mar2021 and was negative. The reporter assessed the events Feels awful and Feel terrible was related.
Local redness and edema at site of injection. A follow up report received 10/25/2001 adds: Reporter states Pt was treated with Augmentin and problem cleared within a few days.
Mom called on 03-27-2018 and mentioned that his left thigh looked like he had gotten a mosquito bite and was a little soar. We saw patient on 03-28-2018 where he presented with left thigh erythema, 7 x 4 cm rash, and warm to the touch. No fever, or itchiness.
Patient develop rash after receiving 4 vaccines noted above.  He was treated in the ED and released.  EHR updated with adverse effect.
Breakthrough case admission after 4 vaccines moderna 2/18/21 lot# 006M20A;  Moderna 3/18/21 lot# 045A21A;  Moderna 11/26/21 lot# 045J21A;  Moderna 4/16/22 lot# 002M21A
Fever, diarrhea, cough, runny nose, congestion, dry patches of skin on legs, irritabile, sweating, chills/shakes, red cheeks.
A few days after administration patient experienced redness/swelling/and itchiness to the injection site only.
Office's practice was to draw up all doses from a vial and discarded vial. They used a sticky not with bivalent NDC, lot and expiration to enter data into database. At some point they realized that some days they had pulled monovalent and had administered instead of the bivalent booster as intended. It is impossible to know if patient received monovalent of bivalent.
Information has been received from a pharmacist concerning a 70 year old female patient who on 07-FEB-2011 was vaccinated with a first 0.65ml dose of ZOSTAVAX (Merck) (Lot#669192/1457Z, Exp Date 29-JAN-2012). Concomitant mediation included "sleeping pills". The pharmacist stated that on approximately 07-FEB-2011 after receiving ZOSTAVAX (Merck) the patient experienced redness in the arm where the injection was administered. At the time of the report the patient outcome was unknown. The patient sought unspecified medical attention. Follow-up information has been received from a registered pharmacist who reported that the 70 year old female patient with no illness at the time of vaccination received a first dose of ZOSTAVAX (Merck) (Lot#669192/1457Z), unknown time in afternoon on 07-FEB-2011. The registered pharmacist stated that on 17-FEB-2011 (previously reported as 07-FEB-2011) in afternoon the patient complained of redness around area, 10 days past injection the patient called on 02-MAR-2011, and stated that the redness went away a couple of days after vaccination. On approximately 19-FEB-2011 and 20-FEB-2011 the patient had recovered. The patient did not seek medical attention. There was no laboratory diagnostic studies performed. No further information is available.
3 days after, patient had a first time seizure at night time requiring transport to the ER
I received the Pfizer Bivalent COVID-19 booster and a flu shot on 9/23/2022. On 11/24/2022, I woke up with a sore throat, headache, and fever, which was probably about 101.5. I stayed at home and stayed in bed. I took acetaminophen, which helped moderate the fever and the accompanying chills, sweats, and body aches. I took a home antigen test on 11/24/2022, and the result was positive. On 11/25/2022, I had a telehealth visit with my doctor, who prescribed me PAXLOVID. I managed to take two doses of the PAXLOVID on 11/25/2022. On 11/26/2022 and 11/27/2022, I continued to have fever, night sweats, chills, body aches, and a headache. The acetaminophen helped moderate the symptoms, and they abated in the evening of 11/27/2022. I also developed an extremely sore throat on either the night of 11/27/2022 or the morning of 11/28/2022. I took a lot of throat lozenges, which helped provide some relief. Despite the sore throat, though, I felt like I was getting better, because I no longer had the headache or brain fog that had plagued me between 11/24/2022 and 11/27/2022. Since I didn't have brain fog or a headache, I was able to focus and be fully present. On 11/30/2022, I took another home antigen test, and the result was still positive. I tested again on 12/1/2022, and the result was still positive, but the line was much fainter. When I tested again during the late morning of 12/2/2022, the result was negative. I did not have any more symptoms afterwards. Even though I was symptom-free, though, I took the advice of my doctor and took it easy for about a week afterwards. I minimized my activity levels and didn't do anything strenuous.
Patient was given a third bivalent vaccine, despite only two being approved for immunocompetent seniors. Patient had already received a second bivalent vaccine in error in early January. Staff checked to ensure the requirement for a 4 month interval since the last dose was met but did not realize she had previously received a bivalent vaccine in October. No immediate adverse reaction and patient was immediately informed of error once noticed.
Pt. states that after receiving the 3rd Booster of Phizer 10/23/2021, started experiencing symptoms that evening of loss of vision (both), chest pain, pain in the hips and feet, fever (101.0), headache, and chills. Self-treating with (Advil, Aleve, Tylenol) no relief, still continuing to experience symptoms. No noted Primary visit/communications.
Case number PHEH2012US012272 is an initial spontaneous report received from a nurse via sales representative on 19 Jun 2012 with a follow-up received on 10 Jul 2012: This report refers to a male child. His medical history included unspecified allergies. He was vaccinated with a dose of MENVEO (batch number: M11071 and A11071, expiry date: Dec 2013) intramuscularly on 15 Jun 2012. On an unspecified date, the patient experienced red firm swelling and itching on injection site. The patient was treated with AUGMENTIN. The outcome of the event was not reported and the causality was not assessed. Follow-up received from the nurse on 10 Jul 2012: Updated patient demographics, medical history and route and date of vaccination with MENVEO.
Felt flu like the next morning after second shot ~8 AM (3/7) intense headache, lower back ache, over all achy, nausea, vomiting, abdominal pain/pressure, chills/sweats off and on, until around 8 PM. Very weak for few days, no appetite. On Thursday 3/11 relapsed with blurry vision around 10 AM, dizziness, intense headache, nausea, vomiting, freezing cold with noticeable body shaking. This was as bad as Sunday and lasted most of the day into early evening. Felt worse than any flu I've ever had. Today (3/14) is best I've felt since Sunday (3/7).
Pt vaccinated Meruvax II developed polyarthralgia w/o swelling especially in the rt hand & wrist.
Child developed fever 9 days after Proquad-105 degree fever possible seizure, child brought to ER by ambulance and lab tests Ne, fever under control. D/C on supportive (stable) care possible vaccine reaction/viral syndrome
Almost 2 weeks after injection I noticed a red spot the size of a quarter at my injection site - it was itchy.  The next morning my left arm ached and the red spot spread a little.  I was concerned due to length of time since shot.  Went to - doctor said it appeared to be a reaction to the injection and to use cortazone cream - no other symptoms at that time.  The red spot continued to spread over the next couple days to about the size of the palm of my hand, no more aching and then started to fade. This is day 6 I can still see the spot and slightly itchy but no other symptoms.  Odd that it would take so long to react.  I am allergic to some types of medical tape but at the time of injection they just used a band-aid.  Due for next injection March 13.
Pt received a 3rd dose of Pfizer vaccine since HIV/AIDS, 73 years old and multiple co-morbidities, at high risk for adverse outcomes due to COVID19.  Vaccination dates 1/12/21, 2/2/21 and 9/15/21.  Pt left a voicemail on 9/15, sounded inadvertent, where can hear family say "mom, if you don't eat, I'm going to take you to the hospital".  Attempted to call pt back but unable to reach.  After additional calls pt finally spoke with RN, approx 17:00 on 9/15/21.  reported was in a hurry to pick up grandchildren at school and didn't wait the 15 min observation time.  She became short of breath and felt she couldn't breath while driving.  At the school, the staff called 911 and she was transferred to hospital by EMS.  She was given oxygen and this improved all symptoms.  After feeling  better, pt left AMA because of concerns for out of pocket expenses.  At time of phone call, pt was feeling better and at home.  Additional follow-up the next day, spoke with patient's daughter.  She said her mom was doing ok, "almost back to normal", some soreness in her ribs and tired.  The  patient came to phone, asked if she had been on anxiety medication previously, felt she had a panic attack after the vaccine.  Pt still has unpaid hospital bills from prior situations so was concerned about money.   Pt was scheduled with Dr., internal medicine and psychiatry, to determine if needs intervention for possible anxiety/panic attack on 9/21/21, pt did not keep this appointment.
Muscle pain in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain in shoulder) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced MYALGIA (Muscle pain in shoulder). At the time of the report, MYALGIA (Muscle pain in shoulder) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant information  provided. No Treatment information  provided.
Patient received 2nd dose of Moderna 10/12/21, it was found on 10/13/21 that the vial expired 10/10/21. Patient has no symptoms of illness or adverse reaction.
Initial misuse report received from a healthcare professional on 25 November 2013 and at agency on 21 March 2014. A patient over 65 years old of unknown gender had received FLUZONE ID. The patient received FLUZONE ID at an incorrect age. No adverse event was reported. The list of documents held by sender: None.
Pt is a 64 YO female s/p Pfizer vaccination: first dose 3/11/2021 and second dose 4/1/2021. Pt called this institution with complaint of new onset dry cough, congestion, fatigue, headache, low-grade fever on 5/26. Nasopharyngeal swab obtained and resulted positive later that day. Pt met criteria for administration of Casirivimab/Imdevimab per the criteria of the Emergency Use Authorization (EUA) and received this on 5/27.
Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with PROQUAD (Merck) (lot# L033698, expiration date 28-FEB-2017; lot# L024124, expiration date 30-DEC-2016; lot# L030587, expiration date 10-FEB-2017) which were exposed to temperatures outside of the recommended range (incorrect product storage). No adverse effects have been reported. This is one of several reports received from the same source. Additional information has been requested.
MISSED AND PROMPTLY TOOK THE THIRD DOSE WHEN REMEMBERED; This spontaneous case report (PVX2019-2971) was received from a healthcare professional on 03-Dec-2019. It described a consumer who "missed and promptly took the third dose when remembered" (PT: Inappropriate schedule of product administration) while being on Vivotif for typhoid fever.  Case report: The consumer took the first two doses of Vivotif according to schedule but the consumer missed the third dose and promptly took it when remembered.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A consumer missed third dose of Vivotif and promptly took it when remembered ( Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer missed third dose of Vivotif and promptly took it when remembered ( Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). On 19th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, 1 day after receiving SHINGRIX, the patient experienced pain in arm and injected limb mobility decreased. In March 2018, the outcome of the pain in arm and injected limb mobility decreased were recovered/resolved. The reporter considered the pain in arm to be related to SHINGRIX. It was unknown if the reporter considered the injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. After receiving SHINGRIX, the patient reported that her left arm was so painful that she could not raise her left arm and this pain was lasted for approximately 3-4 days.
Pt recvd 2nd dose of vax & 1 wk p/inject devel severe diuresis, rash, high fever, transient aches & pains as well as aches & pains @ inject site; No further details were provided;
Reddened, swollen area, lump 2.5cm x 4cm on L arm 48 hours post immunization. Treated with Prelone syrup x 5 days and Zyrtec syrup qd x 5 days. No further c/o.