chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lump in armpit; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of AXILLARY MASS (Lump in armpit) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AXILLARY MASS (Lump in armpit). At the time of the report, AXILLARY MASS (Lump in armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication was reported.
body aches; joint pain on left toe after 2nd dose; Joint pain on left toe; diarrhea; flu like symptoms; pain on injection site; fatigue; Difficult to walk; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Difficult to walk), DIARRHOEA (diarrhea), INFLUENZA LIKE ILLNESS (flu like symptoms), ARTHRALGIA (joint pain on left toe after 2nd dose) and ARTHRALGIA (Joint pain on left toe) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Squamous cell carcinoma of the tongue on 01-Jun-2004. Concurrent medical conditions included Iodine allergy (Iodine), Hypertension since 01-Feb-2007 and Gout. Concomitant products included TELMISARTAN for an unknown indication.   On 01-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE PAIN (pain on injection site) and FATIGUE (fatigue). On 03-Mar-2021, the patient experienced DIARRHOEA (diarrhea). On 13-Mar-2021, the patient experienced ARTHRALGIA (Joint pain on left toe). On 12-Apr-2021, the patient experienced ARTHRALGIA (joint pain on left toe after 2nd dose). On an unknown date, the patient experienced GAIT DISTURBANCE (Difficult to walk) and MYALGIA (body aches). The patient was treated with BIFIDOBACTERIUM INFANTIS (ALIGN) for Diarrhea, at an unspecified dose and frequency. On 06-Mar-2021, DIARRHOEA (diarrhea) had resolved. On 23-Mar-2021, ARTHRALGIA (Joint pain on left toe) had resolved. On 30-Apr-2021, ARTHRALGIA (joint pain on left toe after 2nd dose) had resolved. At the time of the report, GAIT DISTURBANCE (Difficult to walk) had resolved and INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE PAIN (pain on injection site), FATIGUE (fatigue) and MYALGIA (body aches) outcome was unknown.            This case was linked to MOD-2021-243762 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Significant Follow up received on 30-JUN-2021. Patient details were added., Other relevant history were added. Concomitant medications and vaccine facility information were added. New events were reported.
pain in shoulder; This is a spontaneous report from a contactable consumer (patient) from a Pfizer.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced pain in shoulder. The patient also wanted to know if she can take ibuprofen after receiving the first dose. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
muscle joint aches lt arm pain at site nwollen glands neck and above clavicle nausea tired slight fever headache
GlaxoSmithKline was the mfg. I began having right side headaches every day which moved around on the right side of head, pain rating 2-4.  I also was having blurry vision in the left eye which did not get better or worse.  I self medicated with Tylenol or Aleve but the symptoms did not go away. Ultimately I contacted my optometrist and had an evaluation on March 18, 2019. He prescribed Valacyclovir HCL 500 mg tab for seven days and I also had a drastic change in left lens. MIR was negative and I still have blurry vision
Fast heart beat; Fluttering; Redness near the injection site; Itching near the injection site; Swelling near the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (Fast heart beat), PALPITATIONS (Fluttering), VACCINATION SITE ERYTHEMA (Redness near the injection site), VACCINATION SITE PRURITUS (Itching near the injection site) and VACCINATION SITE SWELLING (Swelling near the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced TACHYCARDIA (Fast heart beat), PALPITATIONS (Fluttering), VACCINATION SITE ERYTHEMA (Redness near the injection site), VACCINATION SITE PRURITUS (Itching near the injection site) and VACCINATION SITE SWELLING (Swelling near the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (Fast heart beat), PALPITATIONS (Fluttering), VACCINATION SITE ERYTHEMA (Redness near the injection site), VACCINATION SITE PRURITUS (Itching near the injection site) and VACCINATION SITE SWELLING (Swelling near the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
The evening after the vaccine and the day after, the injection site was painful, a little swollen and red. The pain subsided after 1 or 2 days, but remained red and swollen. The injection site is still swollen (approximately 3 inches across), red, a bit itchy, and the swollen portion is hard compared to the rest of my arm.
This spontaneous report as received from a physician refers to an 18 years old male patient. The patient was vaccinated with an adult dose of VAQTA (Lot # not reported) on an unspecified date. The physician reported that the patient weighted greater than 180 lbs. Additional information has been requested.
PT became dizzy, short of breath, and nervous . IV started at site. PT transported to facility and given IV diphenhydramine and solumedrol.
Diarrhea started 5AM 4/24/15-ran day and night. Took KAOPECTATE and IMODIUM no results to stop. Saw Dr's 5/5 and 5/11/15 no relief. So bad was hospitalized 4 days, many tests done also a colonoscopy and upper GI endoscopy. All tests negative. I still have pain where the shot was given. 6/9/15 Emergency room hospital.
This is a spontaneous report from a contactable nurse (pediatrics). A 4-month-old female patient receive the 1st doses of PREVNAR 13 (Lot # R66271, Expiry Date May2018) intramuscular at 0.5ml IM left vastus lateralis, PEDIARIX (GlaxoSmithKline; Lot: 9b4cd/Expiry date: 10Mar2019) via an unspecified route of administration at 1 DF, single at left vastus lateralis, rotavirus vaccine (Merck; Lot: M040267/Expiry date: 14May2018) oral at 1 DF, single, PEDVAXHIB (Merck; Lot: M046140/ Expiry date: 27Sep2019) via an unspecified route of administration at 1 DF, single at right vastus lateralis, all on 13Jun2017 in afternoon at about 3 or 4 for immunization, at physician office. The patient medical history and family medical history were none. The concomitant medications were not reported. The patient previously received PREVNAR 13 (Lot: R37129; Expiry date: Mar2018) at right vastus lateralis, PEDIARIX, ROTAVIRUS VACCINE and PEDVAXHIB, all on 11Apr2017 at 2 month of age for immunisation and experienced pyrexia. No prior Vaccinations within 4 weeks. On 13Jun2017 the patient received the product after temperature excursion: they had a temperature alarm for 30 minutes, 1.1 degrees Celsius. The nurse requested viability information. On unspecified date in 2017 she experienced mild fever with outcome of unknown. No relevant tests performed. The patient did not require a visit to Emergency room nor physician office.
Menstrual Cycle started 2 weeks early.; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8027) via an unspecified route of administration on an unknown date (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date in 2021, the patient's menstrual cycle started 2 weeks early. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 15Oct2021, the patient underwent BinaxNOW COVID-19 test via nasal swab and the result was negative. The clinical outcome of the event menstrual cycle started 2 weeks early was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Soreness L arm with numbness/paresthesias L arm, mild swelling L arm. Tx: observation, Motrin prn.
Moderate, to severe reaction to pneu. red - area - where shot was given. 4 x 5 cm on 3-1-2012. 5 x 6 cm on 3-2-12.
The pt experienced redness, swelling, pain along the injection site, pain left hip, fussiness.
herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.  On or about 19-MAR-2012, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (strength, lot number, expiration date and anatomical location were not reported) for the long-term prevention of shingles and zoster-related conditions.  Subsequently, on an unspecified date, the patient was treated by a provider for the following injuries resulting from patient´s zoster vaccine live (ZOSTAVAX) use: herpes zoster. The outcome of the herpes zoster was unknown and the casuality assessment between this event and the vaccination with zoster vaccine live (ZOSTAVAX) was reported as related.
4 days after immunizations, patient developed fever, chills, swelling of the arm, & muscle aches. Was seen in the hospital and was treated for cellulitis.
Initial report was received 07 October 2010 from a health care professional.  A 90-year-old female patient had received an intramuscular injection of FLUZONE HIGH-DOSE No Preservative 2010-2011, lot number U3604BA on 04 October 2010 and two days later, the patient reported she had swollen lips and the inside of her mouth was swollen.  She had no concurrent illness at the time of vaccination.  Outcome was reported as unknown.  No additional information was provided at the time of the report.  Documents held by sender: None
woke up Sunday morning with blurry vision (distance).  Employee to let us know if did not improve in next 24hrs.
Body Aches, Fever, Chills, Headache, numbness/tingling in the legs and arms, Warm tingling and tightness of the chest, legs were tingling and had a lump in left leg, High blood pressure.
Vaccine administered, pt advised to stay in store for 10 to 15 minutes. She returned to pharmacy after appx. 10 min c/o chest tightness/throat felt like it was swelling. Took her to clinic bp check 132/64 pulse 54. No respiratory distress noted. Had her wait in pharmacy for about 10 min to see if improvement. After when there was no improvement. Administered EPIPEN and advised ER.
For a few days I felt like I was coming down with a cold. I had a sore throat, runny nose, and a little fever 99.7 degrees. In the evening it went up to 100.6 degrees. I had congestion with thick mucous. I still get thick mucous in my throat. I was doing a lot one day and I was aching all over. I don't know if I was exposed to something over Christmas but I took a COVID-19 and it was negative.
I had noticeable but trivial side effects to the first vaccine of the series on March 2, 2018 (sore arm at injection site, mild headache, tiredness for a day or two, very mild stomach upset). I was just a little 'off' for 2-3 days. Essentially nothing of note other than to make sure to avoid getting the second vaccination if I had something important on my calendar. I expected similar or no reaction to the second shot. However the second shot produced a severe reaction. For the first 11 hours post-injection I felt absolutely great, other than a sore arm at the injection site. At 11 p.m. I began to fell shivery and feverish, as if I was coming down with the flu. By midnight, I was headachy, shivery, felt like I had a fever (though I didn't seem to) but even worse various muscles in my upper body kept intermittently twitching (this has NEVER happened before). I was frightened enough to consider going to an Urgent Care center, but I honestly felt too exhausted and sick to go. The symptoms continued for the next 3 hours (I was unable to sleep), peaked at 2 a.m., and then slowly abated over the next 6-8 hours. I had bouts of nausea and gi distress, though never vomited. I spent all of Saturday exhausted and dozing in bed (again, as if I had the flu). The headache was there, but mild.  (I rarely get any headaches). By late afternoon, I could get up, though had no energy or appetite. By Sunday morning, I was still extremely tired and 'off' (mild headache, exhaustion, little appetite). By dinner on Sunday, I was able to eat a normal meal and by 8 p.m. I felt fantastic again. All symptoms just ended. So it was a very frightening experience, even though I assumed it was a reaction to the vaccine. All of my symptoms were listed as potential side effects, other than the twitching muscles in my arms and back which was very scary. It was completely unexpected, given my mild reaction to the previous vaccine in the series a little over 2 months earlier. My underlying health at the time was great (other than seasonal allergies), and I returned to feeling that way after 2-3 days.
itching and swelling, redness at the site of vaccine(left arm); swelling,  at the site of vaccine(left arm); itching and swelling, redness at the site of vaccine(left arm); pain on injection site; fatigue; A spontaneous report was received from a non-health professional who was a female consumer, of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced fatigue, itching, swelling, pain and redness at the site of vaccination.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Dec 2020, prior to the onset of the events, the patient received their first of two scheduled doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 25 Dec 2020, the day after receiving her vaccination, the patient began to feel fatigued. On 01 Jan-2021, she developed itching, swelling, pain and redness at the site of vaccination. Treatment for the event included topical hydrocortisone applied to the injection site.   Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events, fatigue, itching, swelling, pain and redness at the site of vaccination, were considered unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced NS events of expected vaccination site urticaria, vaccination site pain, vaccination site erythema, vaccination site swelling, fatigue. Fatigue onset on Day 2 after the first dose of mRNA-1273, followed by other events on Day 9. Treated with topical hydrocortisone. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Severe vomiting accompanied by severe diarrhea starting  around 10pm and lasting over 2 hrs.  Finally stopped and allowed me to return to bed sleeping until 7am next morning.  Felt good in morning.
On 01/16/21 after first dose of pfizer vaccine, pain and weakness went down both arms twice that day.  First was around noon and second was around 4PM.  No other symptoms that day.  Pain started in left shoulder blade and back of arm and was so severe it kept me awake at night.  Took pain medication and started physical therapy.  Therapy didn't help at all.  If anything it made it worse.  Stopped physical therapy and on 02/05/21, I got the second dose.  Pain was still previlant.  Five days after the second dose, I woke up and was completely pain free.  Fast forward to 08/27/21 when I noticed a little numbness in my lips.  By the next afternoon, I could tell that I was having some facial paralysis.  That was on a Saturday.  By Monday, the paralysis was full blown on the right side of my face.  I had developed shingles in and around my right ear (Herpes Zoster Oticus).  I have been vaccinated against shingles (Zostavax in 2011 and Shingrix in Dec 2018 and Mar 2019).  Herpes Zoster Oticus also known as Ramsay Hunt Syndrome is a rare disorder.  After 5 1/2 months, I'm still working to get my facial function fully restored.
w/in 2hr of vax complete shoulder & neck area have became extremely sore;the soreness is deep & not localized @ the shot area;the first two sx were over a week long;
chest pain when breathing in and nausea, vomiting. Pt went to PCP and was diagnosed with stomach virus and prescribed medication for nausea.
Patient awoke in the morning, took a shower and became very dizzy to the point she felt she was going to faint. She laid down and was given some juice. She continued to feel dizzy throughout the day, symptoms did ease slightly.
Approximately 5 minutes after receiving vaccine, patient got lightheaded and started to pass out. He did lose consciousness.  He was helped to the floor and we elevated his feet.  We also gave him a cool compress for his forehead.  After about 3 minutes, he moved to a chair.
This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 11-DEC-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. K007263; expiration date 09-JUN-2016) (Route of administration and anatomical location were not reported). There was no concomitant therapy reported. On an unspecified dates, the RECOMBIVAX HB had two temperature excursions: one of 16 hours and 288 hours. The lowest recorded temperature was 33 F (0.555555556 Celsius) and the highest recorded temperature was 34 F (1.111111111 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Excruciating headache. Took Sudafed, Excedrin, Imitrex. Vomited at 7:40 AM. Slept for a few hours and awoke with headache. Headache did not ease until awakening on 6/9/10.
Vomiting occurred after having vaccines.  Vomiting lasted about 10 hours.
Patient was to receive dose 3 of prophylaxis series on either day 21 or day 28. Dose 3 was given inadvertently on day 15. No adverse reaction was reported. When speaking to pt she stated she felt fine. We discussed having titers drawn in 6 months.
Ringing "tinnitus"  in one ear. Started off intermittently on the 3rd day after the fist dose of vaccine.  A week after vaccine first dose it is continuous ringing in one ear.
The evening after receiving the Influenza Vaccine patient was having SOB, fever, pale, dizzy and went to ER to be evaluated.
and after the second dosage its even worse; condition aggravated; This case was reported by a other health professional and described the occurrence of herpes virus infection in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of herpes virus infection (received 1st dose on unknown date,refer case US2020AMR079265.). Concurrent medical conditions included herpes virus infection (herpes had been dormant for over 30 years.).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced herpes virus infection and condition aggravated. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the herpes virus infection was not recovered/not resolved and the outcome of the condition aggravated was unknown.   The reporter considered the herpes virus infection and condition aggravated to be unrelated to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and herpes got worse after 2nd dose. The reporter consulted with Doctor who told there was no connection and had only had one sex partner it the last 30 years.  The patient had not a major change to my lifestyle or diet, the biggest change has been the shingles vaccine.  This did not appear to be a coincidence.
This spontaneous report was received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. From 14-APR-2016 until 02-DEC-2016, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L042257, expiration date: 17-AUG-2018 (strength, dose and route were not reported) for prophylaxis (incorrect product storage). No adverse effects were reported. The vaccine doses were exposed a temperature of 1 °C for 68 cycles for a time frame of 12 hours each time; data logger was involved. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA006775: US-009507513-1701USA007899.
Patient received her Janssen vaccine around 5:05pm. She reports itching of her throat shortly after receiving her vaccine while sitting in the observation area.  She brought Benadryl from home and had it on her. She took 15mg while during her observation time. She later notified one of the staff Her vital signs were all within normal range. She denied any other symptoms and her injection site was without swelling, erythema or itching. She continued to be observed by EMS and she reported resolution of her itching throat.