chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe hip left pain; Light headed feeling like I was going to pass out; Fast heart beat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Aug2021 16:30 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Chronic cough" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ARTHRALGIA (non-serious) with onset 14Aug2021, outcome "recovered" (2021), described as "severe hip left pain"; DIZZINESS (non-serious) with onset 14Aug2021, outcome "recovered" (2021), described as "Lightheaded feeling like I was going to pass out"; HEART RATE INCREASED (non-serious) with onset 14Aug2021, outcome "recovered" (2021), described as "Fast heartbeat".  Additional information: Patient was not received any other vaccine four weeks prior vaccination and patient did not receive any medication two weeks prior vaccination. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19. The patient had no known allergies.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
No additional adverse event reported; The patient received an expired MMR II vaccine; This spontaneous report as received from nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drug and concomitant therapies were not reported.  On 11-FEB-2022, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S029456, expiration date # 19-SEP-2021 (dose, lot number, frequency and dose description were not reported), for prophylaxis (expired product administered). No additional adverse event reported.
RN giving injection of Moderna vaccine to client noted vaccine leaking out at the hub, RN determined the leur lock connection between the needle and syringe was loose. Unknown amount of vaccine injected into the client, rest of vaccine in syringe discarded. New dose of vaccine with new needle/syringe injected into the client at that time. RN drawing up vaccine, and RN administering the vaccine need to double check the leurlock connection is tight prior to injecting the vaccine. Syringe/needle, Hypodermic NEEDLE-PRO EDGE, Safety Device with Syringe was used, most likely from lot #432510, 3 ml/LL 25G x 1in, that was provided in the ancillary kit that came with the vaccine.
Sore throat; Developed a cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Developed a cold) and OROPHARYNGEAL PAIN (Sore throat) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-2021, the patient experienced NASOPHARYNGITIS (Developed a cold). On 03-Jul-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On 05-Jul-2021, OROPHARYNGEAL PAIN (Sore throat) had resolved. At the time of the report, NASOPHARYNGITIS (Developed a cold) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was reported.
This is a spontaneous report from a contactable physician through Pfizer sales representative. A 18-year-old female patient of unspecified ethnicity received first dose of TRUMENBA; (Batch/Lot # M37314; expiration date 30Apr2017) intramuscular on deltoid muscle at 0.5 ml single on 04May2016 at around 12:30 pm. The patient medical history was not reported. Concomitant medications included fluoxetine for anxiety at 10- mg daily since two and half years and ORTHO EVRA transdermal patch, for birth control once a week, since 6 months. On 04May 2016 at around 5:00 pm the patient developed body aches, chills and nausea. She was seen in the emergency room (ER) but was not hospitalized. Lab tests done on an unknown date included urinalysis, full blood count (CBC), comprehensive metabolic panel (CMP), rapid flu test and urine human chorionic gonadotropin (HGC);she was diagnosed to have urinary tract infection (UTI) based on urinalysis findings. She was prescribed MACROBID oral and ZOFRAN and her symptoms resolved within the next 2 days. She recovered from the events on 06May2016. Follow up (12Jun2016): New information received from a contactable physician includes:vaccine details, concomitants, event onset/outcome, lab tests. Follow-up attempts completed. No further information expected.
Moderna COVID 19 Vaccine was administered to 2 patients after the beyond use date.  Director of Clinical Services and Vaccine Coordinator are working with local DOH to reconcile the errors and provide appropriate follow upto affected patients.
Pink to slight erythematous flaky patches over torso, more scattered papules over torso, few macules and excuriations over torso and face. No hives/urticaria . Suspect dermatitis - concurrent exacerbation due to recent immunizations. Clinically improving.
At 2 am on Saturday early morning, I awoke with chills. By 4 am, I had a fever accompanying the chills. I had body aches, fever and chills for most of the day Saturday until the fever broke that night at about 7 pm. Chills persisted for another hour or two. Body aches and severe headache lasted all day Saturday and all day Sunday into today which is Monday. I have a headache and back aches and it is currently 10 am.
Left arm injection site red and warm to touch. Redness and warmth extends 6 inches below the site and is 4 inches wide. No tenderness or swelling.
Information has been received from a registered nurse concerning a 4 year old female patient with no pertinent medical history and no drug reactions/allergies who on 05-JUN-2012 was vaccinated SC with a 0.5ml dose of VARIVAX (Merck) (Lot #: 669193/0096AE, expired date: 11-NOV-2012). On the same day, she was also vaccinated with a dose of KINRIX at the same arm. There was no concomitant medication. The patient developed a small vesicular, skin colored (with possibly a slight yellow tinge) rash that appeared to be closer to the KINRIX injection site, rather than the VARIVAX (Merck) injection site. The patient had sought unspecified medical attention. At the time of report, the patient was recovering. Follow-up information has been received from a registered nurse concerning a 4 year old female patient (35 lbs, 42") with no known allergies who on 05-JUN-2012 was vaccinated subcutaneously in left arm with the second 0.5ml dose of VARIVAX (Merck) (Lot #: 669193/0096AE, expired date: 11-NOV-2012) as well as a dose of KINRIX also in the left arm. On the same date, the patient was vaccinated subcutaneously in the right arm with a dose of M-M-R II (manufacturer not specified). The left arm had gotten red and swollen. On 07-JUN-2012, the patient was seen by the physician. The patient's mother reported that she had used a cool pack to the patient's arm twice the previous day for about ten minutes each. The previous night, her mother noticed a dime sized area of water blisters that had spread. No itching was noted, although the arm was sore and swollen. No induration noted. The child was using both arms, although she was sensitive to touch at shot sites. Her mother had given her some ibuprofen. Physical exam showed 3 1/2 x 5 cm pinpoint, vesiculations. Location was on the arm (upper), on left. The problem was spreading. Assessment included vaccination reaction. The Physician would expect that the rash was related to the vaccine, but not a typical reaction. The patient was to increase the dose of ibuprofen for pain, apply cool compresses to vesicles and consult with dermatology. At the time of report, the patient had recovered. Other medications included PROAIR HFA as needed. Additional information has been requested.
Headache; muscle pain; extreme nausea; brain fog; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8735) via an unspecified route of administration on 30Mar2021 at 14:45 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 08:00, the patient experienced headache, muscle pain, extreme nausea, and brain fog. The patient did not receive treatment for the reported events. The clinical outcomes of the events headache, muscle pain, extreme nausea, and brain fog were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
hives initially on face-noticed by parent approx 730AM on 18SEP;840AM hives on ears, neck, face, back, abd, legs (whole body);pt acting nl x/scratching @ ears;seen by MD prescribed DPH;rash almost gone w/in 1.5 hr;recovered w/in 2 days;
Acute/chronic uticaria (hives), starting 11/30/2021. Still occurring daily at time of reporting, 1/26/22. Treated 2x with prednisone to no effect.  Current treatment is OTC allergy medication (zyrtec and pepcid AC) to treat symptoms until hopefully reaction wanes.
injection site was swollen; injection site was firm; knot at the injection site; red line across the injection site; itches; pain in arm; A spontaneous report was received from a consumer concerning a 58-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in arm, injection site was swollen, injection site was firm, knot at the injection site, red line across the injection site and had itches.  The patient's medical history included that she was allergic to antibiotics, lactose, gluten and oats. she had a previous medical history of Hypogammaglobinemia. Concomitant medications reported were Mucinex for drug use for unknown indication.  On 9 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013MZ0A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced pain in arm (pain in extremities), injection site was swollen(injection site swelling), injection site was firm (injection site mass), knot at the injection site (injection site nodules) and red line across the injection site (injection site redness) and  itches (injection site pruritus).  Treatment details was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown..
Arm all the way up to neck was very sore for the first 2 days. This evening I noticed 3 welts about 4? away from the injection site that are painful to touch and have no other explainable cause..
Fussy pt w/t103 A x 4 days while on APAP, nasal congestion, poor appetite & pulling on ears, teething; Seen in ER dx fever post vax, teething; no fever on 13DEC92, however, on APAP @ time of ER visit;
No adverse event; inadvertently gave a patient a dose of PROQUAD and a dose of VARlVAX on the same day; This spontaneous report was received from a medical assistant referring to a 19-year-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 04-MAY-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 millilitre, lot number T021639, expiration date 21-DEC-2021 (route of administration was not provided) and a dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number T020650, expiration date 16-JUN-2022 (route of administration was not provided), both for prophylaxis (accidental overdose). No adverse event was reported.
Arm severely swollen, skin was hot and hard to the touch from shoulder almost to wrist. Heat had no effect, cold press had no effect, had to take max daily dose of BENADRYL to reduce swelling.
Chills. Injection site hot red swollen hard. Weakness. Diarrhea. No appetite. Muscle aches. Headache. Racing mind, Rapid heartbeat. Sharp pain in upper right abdomen. Sleeplessness. Thirsty. Still weak and achy this morning 11/05/2015 but feeling better.
chills, sweats, body aches, abdominal pain, fever, nasal congestion, chest pain, and shortness of breath, fatigue
Rash, itching, arms, face and back. Red spots all over. Face Swollen. Medication administered at School -Nurse - Benadryl.
After 2nd COVID shot on Tuesday, April 27th at 11:30 am about 6-8 hrs later I became very weak and that evening started with expected fatigue, 100.8 fever, bone and muscle aches in extremities, severe headache in nape of neck, little ability to sleep, no appetite, hot and cold chills until Thursday morning at 6:30am I awoke with severe headache in forehead and loud ringing in both ears. This ringing has continued for 4 days and gotten worse with pain and pressure deep in my ears, forehead headache, and altered hearing when I bend forward or chew food. This has greatly affected my daily activities. I?m very worried about my hearing. I?m scared about the ringing as it is distressing and I have not experienced this before. The fever broke Thurs. am (I was very sweaty) and chills, fatigue, weakness subsided but Ear pain, ringing has gotten worse.  I contacted Dr. by app text communication within 2 hours of the ear ringing on Thursday morning at 8 am and she said symptoms can last a week and that I could take Tylenol and ibuprofen.  I did not take Tylenol or ibuprofen until Thursday and have taken 2 times daily since but this has not helped my headache, ear pain, or ringing. I did not take any Medication Tuesday or Wednesday for fever and vaccine side effects because I saw on news and read that you should let immune system and vaccine work.  I had only a sore arm for 24 hrs with first shot.  I am normal BMI, normal weight, hypothyroidism, no alcohol, no smoking, no drugs, moderate activity.
Fever 101 F; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on the right arm, on 26Mar2021 at 15:00 (at the age of 32-years) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, asthma, A-fib heart condition. The patient had allergy towards penicillin and meat. The patient had no any concomitant medications received within two weeks of vaccine. Previously patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on the right arm, on 06Mar2021 at 18:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks of vaccination or any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 00:00, the patient experienced fever of 101 F. On 27Mar2021 at 00:00, the patient had body temperature measurement of 101 F. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for event fever. The clinical outcome of event fever was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a female who on approximately 13-AUG-2007, "about a week ago," was vaccinated with the first dose of Gardasil. On 20-AUG-2007, the patient developed a hard knot on her arm at injection site. The patient sought unspecified medical attention. At the time of this report, the patient was not recovered. Additional information has been requested.
I am post COVID (July 22,2020) I had uncontrollable shivering/fever of 102/ Elevated BP/ Elevated Heart rate of 150/ o2 states was 89/the worse headache I've had (since I had covid in July)Extreme fatigue (these symptoms lasted about 12 hours.  The following 24 hours I am still having slight headache/extreme fatigue.
lump on arm; itches at injection site; hardness at injection site; redness the size of a fifty cent piece at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (lump on arm), VACCINATION SITE PRURITUS (itches at injection site), INJECTION SITE INDURATION (hardness at injection site) and INJECTION SITE ERYTHEMA (redness the size of a fifty cent piece at injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No relevant concomitant medications reported. No relevant medical history was reported.     On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (lump on arm), VACCINATION SITE PRURITUS (itches at injection site), INJECTION SITE INDURATION (hardness at injection site) and INJECTION SITE ERYTHEMA (redness the size of a fifty cent piece at injection site). At the time of the report, VACCINATION SITE MASS (lump on arm), VACCINATION SITE PRURITUS (itches at injection site), INJECTION SITE INDURATION (hardness at injection site) and INJECTION SITE ERYTHEMA (redness the size of a fifty cent piece at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Medications were not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Additional information included address and email.
Both Meningococcal and H1N1 vaccines given IM in L deltoid. Area is painful especially when pt lifts L arm. No erythema however below inj site there is egg sized swollen area. There is no reaction directly in inj sites.
This is a spontaneous report from a 67 year old male who in late May, 1999 and late June, 1999, received his 1st and 2nd Lymerix, respectively. At the end of July, 1999, the pt developed a full body rash, which was treated with Atarax, Eurax lotion and Lidex cream. He was dx'd with bullous pemphigoid, which physician described as a "blistering disease." The most recent information, received on 9/1/99, reports that the pt has not yet recovered.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 31-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided. Reporter stated that no adverse reactions were reported by any patients.   This case was linked to MOD-2022-501575 (Patient Link).
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient after the fact told me he faints after blood work all the time. Also stated he didn't eat anything yet today. We got him OJ, and a gronala bar and he sat and then felt much better.
This spontaneous report as received from a nurse, refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/ allergies were reported. On 24-AUG-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ orally (which had a lot # of N029670 and an expiration date of 03-SEP-2019; however, dosage number was not reported), for prophylaxis. The diluent used to reconstitute the vaccine was properly stored. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursions: 47 F degrees to 77 F degrees for 20 minutes. Reportedly, there had been no previous temperature excursions and the aforementioned one was identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA011662: US-009507513-1808USA011770.
Developed pain, swelling and decrease ROM in both wrists one week after receiving Typhoid injection. She was told at a Sports Medicine facility that she was just tight and it was tendonitis and would respond to stretching. One week later, family "texted" me as they were leaving for the airport to go to foreign country. Pt now had swelling of her feet and toes as well as pain in her left shoulder. Mother was concerned that the stretching wasn't helping. She asked if I could recommend anything that might help with the discomfort for the duration of their trip. The only things I could suggest without seeing her were ibuprofen and OTC strength NAPROXEN. She tried both while travelling, with no relief. She was seen in my office within 24 hours of arriving back in town.
Chills and fever of 101.6; took Ibuprofen.  Fever was gone after several hours.