chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 9:37 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 30.91.  Concomitant products were not provided.  On 27-Apr-2021, Excursion time was 09 AM, temperature was 35, total doses given for the day was 42, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 27-Apr-2021. 8 vials were sent to clinic. Vaccine BUD date was 19-May-2021.  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.
Information has been received from a healthcare professional concerning a 73 year old female who on 8/31/05 was vaccinated subcutaneously with a 0.5ml dose Pneumococcal 23v polysaccharide vaccine lot 649914/0578P. On approximately 8/31/05 the pt experienced erythema and soreness at the inject site. Unspecified medical attention was sought. The pt recovered without treatment within 48 hours. The reporter would like to know if there have been any other problems with this lot number. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards an was released. Additional information has been requested.
shot   administrator, injected  vaccine to high up on the arm/ shoulder , pain and  loss of range a motion in right arm/shoulder  3 days after vaccine
Left arm below sites of injection 3" red circle, warm, not at poke site. Advised cool and warm compresses-alternating ibuprofen-call if increased swelling, increased heat, increased redness.
Pt was administered 3 doses of Shingrix. Pt had appropirate interval in between dose 1 and dose 2 and 3rd dose was not indicated. Contacted pt and pt states he did not incur any adverse reaction that he was aware of.
numbness; This spontaneous case was reported by a health care professional and describes the occurrence of HYPOAESTHESIA (numbness) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced HYPOAESTHESIA (numbness). On 08-Jan-2021, HYPOAESTHESIA (numbness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Based on the 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.
I received the booster on March 14th and immediately and gradually started experiencing symptoms such as diarrhea, dizziness, tiredness, a fever, chills, night sweats, shortness of breath, injection site pain and swelling, vomiting 2 weeks after, nausea, arm pain, and lymphadenopathy. Since I've received the booster I have been experiencing issues with swollen ankles daily, vomiting 2x, tiredness, and difficulties breathing as well as a decline in my mental health.  It's been 20 days since I've received the booster.
abdominal pain and cramping; This is a spontaneous report from a contactable pharmacist received from a Pfizer- sponsored program. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), 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. The patient experienced abdominal pain and cramping on an unspecified date and they are wondering if this is a side effect. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Sinus infection. Concurrent medical conditions included Pollen allergy.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (Sinus infection). The patient was treated with PREDNISONE ongoing since an unknown date for Sinus infection, at an unspecified dose and frequency. At the time of the report, SINUSITIS (Sinus infection) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product used was not provided by the reporter.  Patient was advised to hold off on the steroid until his second shot of vaccine.  Treatment included local prednisone.   This case was linked to MOD-2021-233333 (Patient Link).
After the first shot, two days later all the skin on my hands started to peel off,  After the second shot all of the skin on my feet started to peel off.
This spontaneous report was received from a certified medical assistant and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies were reported. On unknown dates, the patients might have been vaccinated with improperly stored doses of GARDASIL 9 injection (dose, route of administration, anatomical location, lot # and expiry date were not provided) for prophylaxis. The administered doses of GARDASIL 9 underwent a temperature excursion at 30 degrees Fahrenheit for 14 days. There were no previous temperature excursions reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. Follow-up information has been received on 27-JAN-2017. A call was placed to the certified medical assistant. The call went directly to voicemail. A message was left requesting a return call. Additionally, a request was made for the patients' identifiers, lot number, expiration dates, and dates of vaccination. This is one of several reports received from the same reporter. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1611USA010344: US-009507513-1611USA003050: MERCK 1611USA010343:Mfr number.
Case was vaccinated and boosted against Covid by 11/2/21, then was hospitalized for Covid 1/31/2022. Hospitalized. COVID-19 virus infection Assessment & Plan Positive test 1/19 and received monoclonal Ab in the ED. Really no symptoms, though diarrhea may have been related. Chest x-ray clear. One episode of hypoxia documented at 88%, but otherwise saturated normally on room air. She did not receive steroids.
A week or so after the vaccine legs started to swell up, extreme pain in legs and lower back, then discoloration of skin, followed by hardening of skin that continue to this date.  Prior to the vaccine I did not have any of the symptoms described above.   It is just too much coincidence that the adverse symptoms started soon after the vaccine.
My daughter watched nurse give the shots (she always prefers to watch). She acted normal...stood up gave nurse a hug and picked out a sucker. We walked down the hallway to the waiting area where she started playing with her sister and the toys. I went over to the check-out window to make sure they had everything they needed and get the "what to look for sheets" for the MMR and Polio. I turned and told the girls it was time to go. Patient had a funny look on her face and sat down on the end table and started to sob quietly. I went over and put both hands on her shoulders and asked what was wrong. She quit sobbing and pushed back hard enough to make me off balance. I tried to pull her forwards, but she was stiff for a few seconds. I yelled, "We have a problem here!" The gals helped lay her on the floor. She was only out maybe 30 seconds. When she came to they gave her some lemonade. She was quite weak and it took about 15 minutes for her to regain color and energy. Patient said the first thing she noticed was her vision changing colors and that is why she sat down. Then she became very weak and her vision went black. This is her 4th polio immunization. We have not had anything else happen up to this time.
At 11:45 am on 10/27/2021 I was sitting on the couch and I went to go put my head down on the pillow and I felt a wave of something come over me, and my partner walked over at me and saw that my body was shaking and I was not responsive he said it looked like I was having a seizure and it lasted approximately 10 to 15 seconds. I stood up almost immediately disoriented and I walked from the living room to the bedroom and then back to the living room again when he told me I needed to go sit down and call 911. I asked him what happened and he told me but I have no memory of it.
This spontaneous reprot as received from a nurse practitioner refers to a 5 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 14-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported), which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a healthcare worker referring to an unspecified number of patients with unknown age and gender. On unknown dates the patients were vaccinated with doses of improper stored GARDASIL 9 (lot # K011325, expiration date 08-APR-2017) (dose and route were not reported). No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
About 2 hrs. after injection I became clammy and sweating with a pulse rate of 180 with palpitations. 15 min. later I got a severe headache. Lasted 45 min. until I could take a LOPRESSOR. HR dropped to 100. Headache lasted until next day. I don't ever get headaches. Doing fine since 4-11-14.
Had nausea; diarrhea; aches, pains, chills, constant low grade fever; headache and a slight cough - for over a week. Stand up /got dizzy. Over and over. Taking anti-nausea meds to stay okay. I did a telehealth with Dr and she told me to stay hydrated and get rest. I only worked 12 hours for that week.  Sometimes I still wake up coughing at night.
BLOOD CLOTS IN LUNGS; This spontaneous report received from a consumer via a company representative by social media (J and J Corporate) concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no history of blood clot in family. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, form of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis.  It was unknown whether the patient had adverse events following vaccination with covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, form of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date (apart a year) for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died twice from blood clots in lungs (Dose number in series 2). The patient received CPR (Cardiopulmonary resuscitation) by the medics. The patient was airlifted and now on blood thinners the rest of life.  Laboratory data (dates unspecified) included: Blood test result not reported. The reporter stated that " My sister got 2 J and J Covid shots, about a year apart, died twice from blood clots in her lungs, airlifted and now on Blood Thinners the rest of her life thanks to the COVID J and J vaccine. Thank GOD the medics were close and able to do CPR. No history of blood clots in our family. Oh and the Doc made a comment about her blood test "I've never seen anything like this before". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots in lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221210582- blood clots in lungs. The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
flu; Initial information was received on 11-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via media.  This case involves patient (gender and age not specified) who had flu (influenza), after patient received INFLUENZA VACCINE.  Past medical treatment(s), vaccination(s) , concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date in October, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in last week they performed laboratory test: covid test with an unknown result and flu test with result indicating that patient has flu.   On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Burning itching skin from injection site to neck and face. Began  around 11am 9/18/21 and subsided slightly after taking Benadryl.  Swollen lips, bottom and top lip swollen when I woke up the morning of 9/19
27MAR97 fever 30MAR97;5APR t102-103ax;APAP/Ibuprofen given q 6hr x 6 days;seen by md ? sore throat;started on ATB;5APR AM fever broke;415PM rash starting on face/back/stomach to arms & legs (tiny raised red spots) inside mouth;eating better
Following vaccination the pt stood up and started walking away but was asked to walk back to sign some papers. Once the pt sat down she became unresponsive and presented with pursed lip breathing. The pt laid flat with her feet elevated. The pt became responsive with smelling salts, and was taken to student health for evaluation. The pt reportedly recovered form this experience. It was also reported that the pt also experienced incontinent of urine with this episode.
The day after the shot the injection site and left arm were extremely sore, and it was very difficult to lift my arm. I have been having headaches and body aches. I have had trouble sleeping and wake up with soreness  and aching in my joints where I typically do not have soreness. Today, I am experiencing some soreness and muscle strength loss in the arm where I received the injection.
mild aches, fever, lethargy.  Woke in the night with pain in my legs.  Took tylenol and later ibuprofen.  Felt ok by afternoon of the next day.
This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age. On multiple unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot # J014281 and expiry date: 16-SEP-2016. No adverse effects were reported. The vaccine was stored as 63F for 156 hours. There was no previous excursion reported and no data logger. No product quality complaint was reported for PEDVAXHIB. This is one of the two reports from the same reporter. Additional information has been requested.
Patient report trouble swallowing about 20 minutes after vaccine.  Patient was given 50mg of oral Benadryl and observed for further complications.
Headache, Myalgia, NauseaVomiting, left arm myalgia after vaccine on 12/23/2020; on 12/25/2020 lost taste with waxing waning headache and nausea through 12/26/2020; no symptoms on 12/27/2020; today 12/28/2020 has waxing waning headache and nausea.
Patient given FLULAVAL which is not indicated for patients < 18 yrs. Patient without any side effects.
This spontaneous report was received from a certified medical assistant regarding a patient of unknown age and gender. Information on the concurrent conditions and medical history of the patient was not reported. On 29-MAR-2016, the patient was vaccinated with unspecified doses of improperly stored GARDASIL lot #, expiry date dose, units, frequency, route and anatomical location were not specified). Concomitant medication were not reported. There were no adverse effects reported. There was no Product Quality Complaint (PQC) involved. Temperature and time frame at which the product was exposed was 33 degree Fahrenheit for 72 hours. Temperature and time frame at which the product was exposed previously: 34 degree Fahrenheit for 72 hours and 47 degree Fahrenheit for 12 hours. This is one of several reports received from same reporter. Additional information has been requested.
I received my 5th dose of Moderna Bivalent on 10/05/2022. My flu like symptoms started on 11/30/2022 in the morning around 8:00AM. I had a postnasal drip  and sore throat. My head was clogged up. On the same day I had a Diabetes check so my doctor did a COVID-19 which was negative. I went to the urgent care on 12/30/2022. The symptoms moved up in my chest. I had a severe cough. I was diagnosed with a Sinusitis. Before visiting the urgent care I took over the counter cold medications such as DAYQUIL, NYQUIL, and albuterol inhaler. In the urgent care they prescribe me with amoxicillin and prednisone. I am still taking the antibiotics. Before the vaccines came out I came down with COVID-19 infection on October 2020. I still have some congestions in my head and some pressure in my ears. The urgent doctor told me that I had fluids in my ear which was why my ears were ringing.
LOSS OF APPETITE, FATIGUE, CONTINUOUS COUGH, WHEEZING, FELT LIKE THROAT WAS CLOSING UP, HOARSENESS, SORENESS, RED ITCHY EYES, EYES WERE DISCHARGING (ALMOST LOOKED LIKE EGG WHITE DISCHARGE-VERY THICK) HARD TIME BREATHING.
Case number PHEH2015US004597, is an initial spontaneous report from the consumer (patient) received on 06 Mar 2015. This report refers 70-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly in Sep 2014 and went out of the country in Feb 2014. On 02 Feb 2015, she experienced sore throat, fever, runny nose and sneezing. The outcome of the event sore throat was condition unchanged. The outcome of the other events was complete recovery. The seriousness and causality assessment of the events was not reported.
extreme pain, swelling & hives on legs & arms started where shot was administered,swollen leg,pain, hives 4d later, lasted 2d.
I developed gestational diabetes.  The Vaccine Safe form asked if I had new health problems, so I said yes.  I doubt it's related to the vaccine.  I am currently 27+4 weeks pregnant, due 10/7/21.
Mom stated pt came home form Daycare on Thursday 5-28-09 and c/o pain in (L) arm, Mom also stated it was itchy.  Area was reddened, itchy and slightly warm to touch.  Mom stated he had been itching affected area.  Advised Benadryl and Ibuprofen.  In to be seen if sx worsened- Spoke to mom on 6-1-09- area better- no further redness or pain.
I had general soreness at the injection site for a couple of days after the injection.  My first round of sinusitis started on 10/24/2022 with a headache, mucus and drainage.  My husband had tested positive for COVID-19, but I never tested positive. Second round of sinusitis started 12/07/2022 with a cough and lot more mucus. I developed pain in both eyes on 12/27/2022. I took ibuprofen which helped each time. I also had light sensitivity. I developed visual issues in my right eye and went to an eye doctor. I was prescribed a steroid which helped my symptoms. It is believed that my visual problem developed due to my sinus issues. I never tested positive for COVID-19. As of today, I continue to have drainage from the sinus, and I can see normally.
Fever, febrile seizure 1 wk p/MMR/HIB no sequelae
Entire thing lasted 13 hours. Started with chills at 12:30 am that provoked high tremors thru my body. Not unusual if I get cold. But later in the morning, I had trouble walking, this was new. I "furniture" walked to the couch, later I could not get off the couch. I crawled to the bathroom. Later I tried boosting myself into be by pulling on the blankets at the end of my bed. My legs would not engage, (I was kneeling). I tries to position my legs in a bent  position so I could rise up. My arms had problems moving my legs..so heavy. I did get myself back into bed after 15 minutes of attempting. I slept till 1pm. When I woke up I felt better. My walking was better. Still off but I felt safer. I took a walker I had in a closet out and used sparing the rest of the day. Built up the height of the couch cushion to make it easy for me to get up and down. The next day I was fine. Crazy!! Funny, I received a full dose for my 3rd shot, again Moderna. I was prepared this time. I had the walker out, couch built up, and lots of warm clothes. Happy to report nothing happened. I often wonder, I went swimming after getting the 2nd vaccine. If I had depleted all my energy and that's why I had so much trouble. I didn't go swimming before or after the 3rd vaccine.