chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"On 12th Mar 2021, he was hospitalised for bad neck pain and couldn't sleep for 3 nights."; "He also mentioned that when reaching under the bed, he is thinking that he cracked one of his ribs"; woke up sweating; Inappropriate schedule; Extremely hurt; Last couple of nights could not sleep; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN ("On 12th Mar 2021, he was hospitalised for bad neck pain and couldn't sleep for 3 nights.") in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bone fracture (not spontaneous) (The patient broke his collar bone and pacemaker was placed on the left side.) in August 2020, Neck pain (The patient  was hospitalized for bad neck pain and couldn't sleep for 3 nights.) on 12-Mar-2021, Cerebral haematoma (On the day of hospitalization, It was thought that he had dried blood in his brain.) on 12-Mar-2021 and Pacemaker insertion (cardiac) in August 2020. Concomitant products included ATORVASTATIN, CARVEDILOL, CHOLECALCIFEROL, ENALAPRIL, ESCITALOPRAM, FISH OIL, GLIMEPIRIDE, METFORMIN HYDROCHLORIDE (METFORMIN SANDOZ), OXYBUTYNIN, TAMSULOSIN, PANTOPRAZOLE, ACETAMINOPHEN, MULTIVITAMINS [VITAMINS NOS], TADALAFIL, ATORVASTATIN, CARVEDILOL, CHOLECALCIFEROL, ENALAPRIL and ESCITALOPRAM for an unknown indication.   On 07-Mar-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced NECK PAIN ("On 12th Mar 2021, he was hospitalised for bad neck pain and couldn't sleep for 3 nights.") (seriousness criterion hospitalization). On an unknown date, the patient experienced RIB FRACTURE ("He also mentioned that when reaching under the bed, he is thinking that he cracked one of his ribs"), HYPERHIDROSIS (woke up sweating), INSOMNIA (Last couple of nights could not sleep), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule) and VACCINATION SITE PAIN (Extremely hurt). At the time of the report, NECK PAIN ("On 12th Mar 2021, he was hospitalised for bad neck pain and couldn't sleep for 3 nights."), RIB FRACTURE ("He also mentioned that when reaching under the bed, he is thinking that he cracked one of his ribs"), HYPERHIDROSIS (woke up sweating), INSOMNIA (Last couple of nights could not sleep) and VACCINATION SITE PAIN (Extremely hurt) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule) had resolved.            Based on the case description and the patient's prior medical history, the events are assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the case description and the patient's prior medical history, the events are assessed as unlikely related to mRNA-1273.
I have contracted COVID-19 3 weeks after getting 1st COVID Vacc; Covid-19 positive; mild allergy; lot of weird going on/ feeling odd; This is a spontaneous report from a contactable consumer (patient) via support team. Follow-up (08Apr2021) received from a contactable consumer was processed together with initial information.   A 64-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown), dose 2 via an unspecified route of administration on 06Apr2021 as SINGLE DOSE for COVID-19 immunization. Patient received 1 Pfizer dose on an unspecified date three weeks prior to second dose as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 07Apr2021 after receiving second dose the patient contracted COVID-19. Further details are as follows: Patient was notified a few hours later that a niece he spent time with on 02Apr2021 just tested positive for COVID. Patient had been feeling odd and attributed it to allergies but after hearing news of his niece he scheduled a COVID test the next morning on 07Apr2021. He got the results that same night that he was also positive. On 06Apr2021, the patient has been feeling alright but have had feeling of allergies kind. The next day he was still feeling odd but not really, anything terrible just like mild allergy and lot of weird going on so he just assumes what it was. After testing positive the patient spoke to contact centre and he was informed that she had never heard of anybody doing that. Patient was having anecdotes individual here just one case, but it is kind of unusual. He doesn't mind testing for the variant he was having. Patient stated he is having symptoms to the onus. The symptoms of the onus he experienced, Monday 5Apr2021. Outcome of events was unknown.   Information about lot/batch number has been requested.
The patient has not reported any side effects; After the vaccine was administered on 10May2019, the pharmacist realized the patient was administered vaccine that expired 19Apr2019; This spontaneous report was received from a pharmacist, referring to a 20 year old female patient. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided.   On 09-APR-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (strength, lot number and expiration date were not reported), for prophylaxis.  After the vaccination, the product was placed back in the refrigerator.   On 10-MAY-2019, the patient was administered the second dose (strength, administration route and lot number were not reported). However, the pharmacist did not confirm the product expiration date and, after the patient was vaccinated, realized that the vaccine expired on 19-APR-2019. The patient had not reported any side effects related to receiving the expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Laboratory data was unknown.   As of 12-MAY-2019, it was unknown if the patient would be re-vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Polymyalgia Rhuematica, Inflammatry arthritis Ongoing symptoms, prednisone, methotrexate
This spontaneous report was received from a registered nurse and referred to an unspecified number of patients of unknown age and sex. On an unknown date, the unspecified number of patients may have received improperly stored PNEUMOVAX 23 (lot #, expiration date, strength, dose and frequency were not reported). No adverse effects were reported. This is one of four reports received from the same source. Additional information has been requested.
SORE NECK; STIFF NECK; LETHARGIC; DROWSY; SLEEP MOST OF THE DAY/ DIFFICULT TO STAY AWAKE; INTENSE HEADACHE; FEVER; This spontaneous report received from a vaccine facility via a company representative concerned a 37 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced sore neck. On 06-APR-2021, the subject experienced stiff neck. On 06-APR-2021, the subject experienced lethargic. On 06-APR-2021, the subject experienced drowsy. On 06-APR-2021, the subject experienced sleep most of the day/ difficult to stay awake. On 06-APR-2021, the subject experienced intense headache. On 06-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103.3 F, 104.4 F, ABOVE 101 F. On 07-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.9-102.5 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, intense headache, sore neck, lethargic, drowsy, stiff neck, and sleep most of the day/ difficult to stay awake. This report was non-serious.
Numbness on side of body receiving vaccine (left arm, left side of neck, left side of face) Heart palpitations Chest pain Flu-like symptoms (fever, headache, coldness, lethargy)
Information has been received from a female consumer with a history of shingles who on 23-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On 24-JUL-2007 (within 24 hours) the patient developed a severe headache, swelling of the arm, and a large red itchy area that was hard and hot to the touch.  The patient was uncomfortable and unable to sleep.  The patient treated the condition with BENADRYL for five days, and eight hour TYLENOL.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
2 days of sore throat with moderate productive cough, nasal discharge, upper body aches; progressing into 2 more days of severe productive cough, worsening sore throat, severe body aches and generalized weakness, copious nasal discharge, anorexia.
Patient received orginal Moderna instead of Bivalent. Patient gave me a wrong DOB and was adamant that was his DOB.  I was on site at his home and looked up his DOB and a variety of combinations of what he stated was his legal name.  Upon my supervisor reporting she double checked using his address and found his actual DOB (day of the month) is different from what the patient originally gave.
Vaccine administered after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021 at 1:25 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 1:25 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 41.98  Concomitant medication was not provided.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.   Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
raw throat; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (raw throat), PYREXIA (fever) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (raw throat), PYREXIA (fever) and CHILLS (chills). At the time of the report, THROAT IRRITATION (raw throat), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported. Treatment medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Follow up received on 01-MAY-2021: Contain No new information. patient to follow up through regular mail. On 09-Jul-2021: Follow Up was received on 09-JUL-2021 Contain no new information.
Tested positive for Covid between my first and second shot; Tested positive for Covid between my first and second shot; This is a spontaneous report from a contactable consumer, the patient. A 35-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: and expiration date was not reported) via an unspecified route of administration on 24Mar2021 (at the age of 35 years) as single dose, for COVID-19 immunization. The patient medical history and concomitant medication was not reported. On an unspecified date 2021 she experienced tested positive for COVID between her first and second shot.  Patient had COVID test and result was positive. Caller wants to know if she needs to wait to take the 2nd dose or if the 2nd dose is necessary. The outcome of both events were unknown.  Medical Information YES: Customer and/or medical inquiry forwarded or referred to MI  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
loose stools; stomach troubles; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (loose stools) and ABDOMINAL DISCOMFORT (stomach troubles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (loose stools) and ABDOMINAL DISCOMFORT (stomach troubles). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 1 dosage form. At the time of the report, DIARRHOEA (loose stools) and ABDOMINAL DISCOMFORT (stomach troubles) outcome was unknown.            No concomitant medications were reported
I have an infection at the injection site. I believe this could happen with any vaccine but wanted to report just in case. I am experiencing a large circle (a little smaller than a baseball) of swollen red skin that is painful around the injection site. Last night, the lymph nodes in my armpit, neck and collar bone on the right side swelled up and were painful. I feel fatigued.
6:00 pm 2-10-21- Left arm extremely sore, redness and inflammation. 11:00 pm 2-10-21 Difficulty sleeping, yet exhausted. 5:00 am 2-11,21 -. Fever 101.7. Intense throbbing headache. Nauseated. Body aches more intense than my fibromyalgia pain.  2:30 am 2-12-21 Fever broke.  7:00 am 2-12-21 Headache has reduced but still throbbing. Fever gone. Lightheaded. Tired and achy.
Progressively enlarging area of erythematous inflammation on the L upper arm with accompanying fever, occurring within two days after administration of the pneumococcal vaccine to the LUE (8/5/2022). Physical exam findings (erythema with poorly demarcated borders, overlying area of small blisters (which developed 8/8), warmth to touch, mildly edematous) most consistent with cellulitis with vaccination as suspected nidus for infection. Patient prescribed a 10-day course of antibiotics, with plan for close follow up in clinic in 2 weeks. Patient provided with strict return precautions.
After 1st dose,  stated that blood pressure increased significantly 24 hours after receiving the dose and that after the 2nd dose, she stated that 24 hours after receiving she was driving and had a near black out experience, with high blood pressure that took 12 hours to resolve.
At the shot location where it was given, my arm swelled up as big as a soft ball and turned bright red. The following morning after receiving the vaccine the front part of my shoulder was very sore. A couple of hours later I noticed I had a lump on my collar bone. I went to urgent care at Rochester Regional Help on either 10/23/2021 or 10/24/2021. They told me it was a swollen lymph node. They said if it didn't go down in a few days then I would need to see my PCP. It did go down about the 4th day.
lump on her arm/a small lump; lump on her arm that was red and swollen; lump on her arm that was red and swollen; This is a spontaneous report from a Pfizer sponsored program, from a contactable nurse and consumer. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  Patient stated got the second covid vaccine and got a lump on her arm that was red and swollen its been about a week and there was a small lump there. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The patient experienced chills the evening of the vaccine which resolved by morning time.  She also experienced injection site reactions which included redness, warm to the touch at site of injection, and a tingling at injection site.  The tingling at the injection site continues to today,  4 days later, all other symptoms resolved.
Information has been received from a Licensed Practical Nurse referring to an unspecified number of unspecified patients. On unknown dates in 2015 and 2016 (over the past 3 months) the patient as vaccinated with an unspecified number of doses of GARDASIL (lot# K023432, expiration date 18-JUN-2016), which were improperly stored at 1 Centigrade for 48 hours (incorrect product storage). No adverse effect reported. There was no previous temperature excursion. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
I got home from work at 4:30 PM, and I started feeling bad. I had a terrible headache, a temperature of 102.5, and a dry, unproductive cough. I took Tylenol PM, but it didn't help. The following morning, I showed up for work, and I was sent to the workplace clinic at 7:30 AM. I underwent a PCR test and got a positive result for COVID-19. I was also tested for RSV, influenza A, and influenza B, and the results on those were negative. I was then sent home to isolate for ten days. I was given Tessalon Perles, Tylenol, Motrin, and Paxlovid. It took four days for the fever to break. During my fever, I sweated profusely. I often had to change my bedclothes and the clothes I was wearing. After the fourth and fifth day, I started having issues with my right ear. Whenever I went to bed, it was clogged, but it was clear whenever I woke up the following morning. My problem with my right ear persists to this day, and it has affected my hearing to the point that I can't really gauge the volume of my own voice, so I often sound like I'm yelling. I went to an audiologist on 2/27/2023. My hearing in the left ear was fine, but when the audiologist administered the audiograph to the right ear, it flatlined. I couldn't hear anything out of that ear. She then checked my right ear with the otoscope and noted that there was a lot of fluid buildup. I get my healthcare through the agency, and I have been waiting ever since to see an ENT specialist. I was told that it would probably take three months.
pt called stated had sore throat, sl on Tuesday a/receiving vax; 830PM severe sore throat & inc glands in neck & very painful; felt warm; c/o sore throat w/dizziness & h/a;
This case was reported by a physician via sales rep and described the occurrence of erythema in a 63-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema, local reaction, induration and swelling. On an unknown date, the outcome of the erythema, local reaction, induration and swelling were unknown. It was unknown if the reporter considered the erythema, local reaction, induration and swelling to be related to SHINGRIX. Additional details were provided as follows: Patient reported that, the reaction occurred 3 months before and she just notified to physician. In 2018, the patient experienced huge local reaction, redness, hardness and swelling of about 10 cm. It was lasted for almost 2 weeks.