chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (01Aug2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (25Jul2022) Positive, notes: Symptoms reoccurred on day 10 along with a positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course- Patient received other vaccine. Patient did not received other medication in 2weeks. From 15Jul2022 patient received Paxlovid to 19Sep2022 for COVID 19 Treatment. Patient Symptoms reoccurred on day 10 along with a positive test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Immediately after vaccine pt stated she felt light headed and slid off the chair on her right knee.  Pt held by brother.  Resolved and discharged after 20 mins.
Patient Reported Half dollar size bruise on arm approx 12 hrs after injection with moderate s0reness, Protocol Physicians nurse said to use warm compress and Tylenol pm,  Adult.
Red, non tender, non itchy rash (7 cm x 4.5 cm) distal to injection site.
Soreness in area of injection Right upper arm which persisted for months and worsened. I sought treatment in December and was treated with steroid injections, Medrol dose packs, Toradol-and one session of physical therapy which exacerbated symtoms so I did not seek further therapy until 2014. I saw pain specialist Dr. who tried one steroid injection and then referred me to another physical therapy department which I have continued to receive treatments 3 times per week to regain functionality of right arm.
Administered to patient younger than 18 years old. Patient was 17 years and 9 months old. No adverse side effects during nor after 15 minutes from administering vaccine.
The pt states that he has been getting bumps at least 1 to 2 times a week on his left tricep area. He has been getting these bumps since Dec/Jan time frame. He is concerned that it may be a reaction to the anthrax vaccine. He is scheduled to get it checked out on 05/25/2002.
Pain, swelling, stiffness to bilateral wrists and knees. Worse in AM, improves throughout the day.
felt like maybe she had a mild case of the flu for half a day or two; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (felt like maybe she had a mild case of the flu for half a day or two) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA (felt like maybe she had a mild case of the flu for half a day or two). At the time of the report, INFLUENZA (felt like maybe she had a mild case of the flu for half a day or two) had resolved.            No Concomitant medication was reported.     No treatment medications were reported   This case was linked to MOD-2021-392965, MOD-2021-393118 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up contains Significant information: Updated contact information.
Shingles recurred sev days after vaccine admin. Hx varicella infection Sev-yrs ago Vaccine 6/24/2020. visit with vesicular rash 6/29/2020
Metal taste in mouth Swollen face bright red. Later tinnitus rash on legs and arms a few racing heart beats. Itchy face. Headache Today (3/17) face swells and itches then better headache tinnitus but much better than last night.
The patient was scheduled to come in for her 2nd series of the Trunemba. She had already completed the 2 doses of Menactra on June 20, 2013 (1st dose) and  May 18, 2020 (2nd dose). She was given her 2nd series dose of Trunemba and what was thought to be the 2nd dose of Menactra during the office visit on 6/23/2021. She was not supposed to have a 3rd series dose of the Menactra. Patient did not have any signs or symptoms of a reaction, but was concerned due to the extra series dose of Menactra. Dr. spoke with the patient's mother regarding their concerns.
Not eating and drinking very little.; chills; Tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (Not eating and drinking very little.), CHILLS (chills), FATIGUE (Tired) and PYREXIA (Fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A.) for COVID-19 vaccination.     The patient's past medical history included Surgery (for cancer condition). Concurrent medical conditions included Cancer. Concomitant products included SIMVASTATIN for an unknown indication.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced FEEDING DISORDER (Not eating and drinking very little.), CHILLS (chills) and FATIGUE (Tired). 03-May-2021, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEEDING DISORDER (Not eating and drinking very little.), CHILLS (chills), FATIGUE (Tired) and PYREXIA (Fever) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-238955 (Patient Link).
Exposed to chickenpox multiple times before getting vaccine. Broke out in rash, 1 week, post injections. Mother stated he was covered.
Red, Swelling 6cm x 6cm, fever, soreness right arm at site.
Gotten injected in her triceps vs her deltoid muscle; A spontaneous report was received from a consumer concerning a 45-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) in her triceps vs her deltoid muscle/incorrect route of product administration.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 08 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On 08 Mar 2021, the patient got injected in her triceps vs her deltoid muscle. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of the event got injected in her triceps vs her deltoid muscle was resolved on 08 Mar 2021.; Reporter's Comments: This report refers to a case of error for mRNA-1273 with no associated AEs.
NOTHING AT THE TIME. BREAKTHROUGH COVID IN JAN 2023. FLU LIKE SYMPTOMS FOR A DAY OR TWO. TIREDNESS.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # L017757, expiration date: 08-APR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 52.8 degrees Fahrenheit for 1 hour and 15 minutes. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
ERYTHEMA AT INJECTION SITE. MODERATE TO SEVERE LOCAL REACTION WITH 1 WEEK SORENESS.
Headache, Myalgia, NauseaVomiting, restless; sweating
feeling crappy / general malaise; headache; This case was reported by a consumer via call center representative and described the occurrence of malaise in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHingrix with an associated reaction of malaise (1st dose received on an unknown date, experienced general malise and headache, refer case US2020AMR040869).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced malaise and headache. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the malaise and headache were unknown.   It was unknown if the reporter considered the malaise and headache to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported.
Patient was sitting down after his vaccine. ~5 minutes later he complained of blurred vision, loss of hearing, numbness, feeling cold, and headache. Patient was sweating and appeared very pale. Patient was told to remain seated, maintain breathing. he was given water, pepsi, peanut butter crackes, kit kat, and peanut m&ms. Blood pressure of wrist was 111/49. 911 was called.
Covid arm and sore swollen lymph node in left armpit. Started last night into this morning. Taking tylenol for pain from lymph node, benadryl for the covid arm. No insurance, so haven't seen a doctor.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 18-JUL-2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster. On or about 07-JUL-2016, the patient was treated for a burning vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Pt developed oral thrush 3 days after vaccine. Emergency room Dr said it could be vaccine & prescribed Nystatin suspension & it resolved.
Developed hives on 6/28/07 in area of shot. then temp. developed also lesions and swelling at sight.
Within 30 minutes of administering vaccines, pt broke out in hives. Eyes became very itchy-face, legs, arms. Contacted allergist for advice. Hives starting to subside with Benadryl.
27Mar88 pain/swell inj site lt thigh;5Apr88 rashx3 days;thigh pain cont,13Apr88 bilat knee/foot pain/swelling,quit walking;T101;RF&ANA-neg;1yr cont T knee/ankle pain/swell;Apr89 PE delayed devel&nl joints;polyarthralgia;dx:JRA;12jan93ANA-40
This spontaneous report as received from a Licensed Practical Nurse refers to a multiple unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date and before their first birthday, the multiple patients were vaccinated with doses of VARIVAX (Merck) (dose, route, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. Additional information has been requested.
This spontaneous report was received from a registered nurse concerning an approximately 27-year-old female patient. The patient was vaccinated with dose 1 RECOMBIVAX HB (lot#, expiration date and route not reported) on 24-FEB-2012. On 05-NOV-2012 the patient was vaccinated with dose 2 RECOMBIVAX HB (lot#, expiration date and route not reported). No concomitant medications were reported. No adverse effect was observed or reported. Additional information has been requested.
Pt. w/vesicular discrete pruritic rash consistent w/varicella 2 wks. post-imm.
Left arm had swelling approx size of a baseball, redness and now a bruise per the client. Client stated she is also experiencing vertigo symptoms such as light headed, dizziness, nausea, poor taste in mouth and fever. Fatigue for 2 days.
Injected 3 rd booster Pfizer shot undiluted. I contacted  several times with patient starting 10/25/2021 to 10/28/2021 Patient said every thing ok. He doesn't have any side effect or adverse effects
Pt. developed a dimpling/indent of the skin where the intradermal flu vaccine was administered. There was some discomfort noted. The indent worsened over the next few months, but has since stopped. Indent remains to left upper arm.
Information has been received from a physician concerning a currently 10 year old male patient with bee sting allergy and no other pertinent medical history who on 07-AUG-2006, was vaccinated with a dose of MMR II (Lot # 653317/0211F) (dose and route not reported). There was no concomitant medication. The physician reported that on an unspecified date, after receiving the vaccination, the patient experienced anaphylactic reaction, sore throat, rash on face and vomiting. On an unspecified date, the patient went to an emergency room. Laboratory tests included allergy testing by an allergist (date and results not provided). The patient was given BENADRYL for the treatment of the events. On an unspecified date, the patient recovered. The anaphylactic reaction, sore throat, rash on face and vomiting were determined to be immediately life threatening by the physician. The patient subsequently experienced anaphylactic reaction, rash on trunk, sore throat, swollen lip and coughing after vaccination with VARIVAX (Merck), and hepatitis A vaccine (WAES#1110USA01829). A lot check has been initiated for MMR II (Lot # 653317/0211F). Additional information has been requested.
Immediately following injection patient had syncopal episode for 15 seconds. She had Flailing of arms/ Legs when she was unconscious, as nurse was exposing pt to smelling salt pt upper.
Information has been received from a physician concerning a 35 month old female who on an unspecified date was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On an unspecified date in 2007, the patient developed chickenpox after being exposed to another child who had shingles. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
I had acute appendicitis resulting in surgery; I had abdominal bloating; A weight gain of 6 lbs; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 34-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 11Dec2021 13:30 (Lot number: FJ8757) at the age of 34 years as dose 2, single for COVID-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRIPLE MAGNESIUM COMPLEX. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot No: EG3527, Left arm, at 10:45 AM), administration date: 20Nov2021, when the patient was 34 years old, for COVID-19 Immunization; Flu, administration date: 26Oct2021, for vaccination. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The following information was reported: APPENDICITIS (hospitalization, medically significant, life threatening) with onset 19Dec2021 09:00, outcome "recovering", described as "I had acute appendicitis resulting in surgery"; ABDOMINAL DISTENSION (hospitalization, life threatening) with onset 13Dec2021, outcome "recovering", described as "I had abdominal bloating"; WEIGHT INCREASED (hospitalization, life threatening) with onset 13Dec2021, outcome "recovering", described as "A weight gain of 6 lbs". The patient was hospitalized for appendicitis, abdominal distension, weight increased (hospitalization duration: 1 day(s)). The events "I had acute appendicitis resulting in surgery", "I had abdominal bloating" and "a weight gain of 6 lbs" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: antibody test: (Sep2021) positive; sars-cov-2 test: (20Dec2021) negative, notes: Nasal Swab; weight increased: (Dec2021) gain of 6 lbs. Therapeutic measures were taken as a result of appendicitis, abdominal distension, weight increased. Additional information: The day after the second dose, the patient had abdominal bloating and a weight gain of 6 lbs by 13Dec2021, which subsided. Then on 19Dec2021 (day 8 after 2nd dose), the patient had an acute appendicitis resulting in surgery by day 9. The patient was positive for antibodies in Sep2021 prior to vaccine. Treatment for the event appendicitis included laparoscopic appendectomy.
This spontaneous report was received from a physician refers to a female patient of unknown age. on 08-JUL-2013, the patient was vaccinated with first dose of GARDASIL (dose, route and frequency were not reported). On 13-SEP-2013, the patient was vaccinated with the second dose of GARDASIL (dose, route and frequency were not reported). The patient reported that she not yet received the third dose of GARDASIL. The patient also stated that it has been months between the second dose of GARDASIL and now. No adverse events were reported. Additional information has been requested.
After dose one, I began experiencing heart palpitations in days after which subsided a week or two after. Then a few weeks out ongoing constant muscle twitching in arm of injection which is abnormal - mostly in hands. Also pain in this arm in the joints of the hand/wrist. Twitching is spreading now to other areas of the body as well as a noticeable numbness in my vaccination arm's hand last week.
Patient had second Moderna covid vaccine on 5/10/2021 at 10:30 am, the following day he was fatigued with chills when he then became dizzy and had a syncopal episode 5/11/2021 at 8:30 am.
Moderna COVID-19 Vaccine EUA Early Sunday afternoon about 19 hours after the shot, I was reading the paper, and every time I read an article, it was as though it was totally different, but I couldn?t quite remember how. I truly read one article five times, and each time it was as though I was reading something completely new. It unnerved me a bit, so I unloaded the dishwasher without any problems, spoke aloud to myself and was coherent, and looked in the mirror to be sure my face wasn?t lopsided. You can see what I was thinking. My wife was downstairs, so I thought I?d probably better let her in on this. She immediately suggested taking my blood pressure (a very good idea), and it was perfectly normal. I took a nap that was about three times longer than any others (I rarely take one at all), but not before I worked a simple crossword puzzle to reassure myself. Woke up, read the same article twice with a five minute interval between, and sure enough?it looked like the same article. It was not simply being fatigued, at least not like any fatigue I have ever felt before. It was temporary, I was fine later Sunday and have been fine today (Monday).
3 in x 3 in raised, swollen and hot area. Patient unable to sleep. Ordered BENADRYL 25mg q6h x 24h ZANTAC 75mg q12h x 2.
Called to waiting area for client with c/o lightheadedness, nausea, HA, and disorientation 5 minutes after receiving vaccine. Monitored VSS and WNL. Lungs CTA. Heart RRR. Monitored for 15 minutes and took additional VS prior to client leaving. Felt better upon discharge from site.
Information has been received from Pfizer (manufacturer control# 2017058517) on 06-MAR-2017. This spontaneous report as received from a pharmacist referred to two female patients who were 65 years of age or older. Information about medical history, concurrent condition and concomitant medication was unspecified. On unknown dates the patients were vaccinated with PNEUMOVAX 23 (lot#, dosage, frequency and route unspecified) for prophylaxis. On unknown dates the patients experienced the swollen arm and pain at the injection site due to vaccination. The outcome of the events was unknown. The reporter considered the events to be related to PNEUMOVAX 23. This case is one of three reports received from the same reporter. Additional information is expected. Sender's Comments: US-009507513-1703USA002520.
Headache, Myalgia, Arthralgia, Fever, chills, injection site pain/swelling Narrative:
Lethargy, muscle pain, joint pains, headache, chills, nausea.  After 24 hours, symptoms gone except for redness & swelling at injection site.
This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 04-MAY-2016, the patient was vaccinated with an expired dose of VAQTA lot #: L018498, expiration date on 28-APR-2016 (strength, dose number, route and anatomical location were not provided). There was no concomitant medication described. No adverse effects were reported. Additional information has been requested.
Flu symptoms 12 hours after the vaccination that lasted for another 12 hours. Fatigue the rest of the week.  Intermittent fatigue for the next few weeks. On 5-11-2021 another bout of flu like symptoms that lasted 2 days. Started having severe back spasms randomly for the next 2 1/2 weeks. On 5-30-2021 the back spasms became so severe and painful I was rushed to the ER. The first diagnosis I received was a Plural Effusion caused by a bacterial infection that later turned into Pneumonia, requiring a chest tube  in my right lung, and a 10 day hospital stay. Before I was hospitalized I had no fever, no cough, no shortness of breath.
Some swelling at the site of injection, and since then it's been growing increasing erythematous. It itches a little. Area, red, raised and hot and hard. No treatment (L) thigh.
devel paresthesias of hands & legs w/numbness then progressive weakness arms & legs then resp depression requiring intubation secondary to GBS:
Patient noticed a few hours after getting the shot that her arm was very sore and a little warm to the touch. By the next day, it had become swollen and was purplish in color. She went to see her doctor who thought she should recover within a few days and gave her a prescription for Keflex 500mg, 1 four times a day for 7 days, in case there was a secondary infection. Patient's arm continued to become swollen and fluid built up in the arm, color was purplish/yellowish. The bruise and swelling then moved downwards to the lower part of her upper arm on on the side of her body. It took approximately 7 to 10 days before the problems subsided and she was back to normal.