chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; they had given two vaccines that was expired/2 patients were vaccinated with vaccines after manufacturing expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they had given two vaccines that was expired/2 patients were vaccinated with vaccines after manufacturing expiry date) and NO ADVERSE EVENT (no adverse event) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 053B22A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Unknown.     On 30-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (they had given two vaccines that was expired/2 patients were vaccinated with vaccines after manufacturing expiry date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they had given two vaccines that was expired/2 patients were vaccinated with vaccines after manufacturing expiry date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (they had given two vaccines that was expired/2 patients were vaccinated with vaccines after manufacturing expiry date).    No concomitant medications were reported.   No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-708315 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2023: Follow-up information included patient's date of birth, gender and vaccination date updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-708315:same reporter
Patient presented with chest pain, left arm pain, troponin elevation within 20 hours of vaccination.
This spontaneous report was received from a practice administrator referring to a 4 months old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 28-FEB-2019, the patient was inadvertently administered VARIVAX (Lot: R023737; expiry date: 20-AUG-2020) 0.5 ml once subcutaneously instead of PREVNAR 13 (wrong product administered). Concomitant medication included sterile diluent (manufacturer unknown) (lot: N028745; expiry date: 15-MAR-2020). Practice administrator reported that the patient received PREVNAR 13 at the same visit after the error was discovered. No adverse effects reported.
1/7/21: Multiple falls x3, generalized weakness, fatigue, increased blood glucose, diarrhea, confusion, fever
17OCT95 w/in 1 hrs of vax arm & shoulder became very painful;took Ibuprofen; ice or heat better;danger signs discussed w/ ER plans; 18OCT arm better
Swelling and redness day one, with increased swelling and redness until day 14. The redness encompassed 3/4 of my upper arm from the injection site to the elbow (day 14). On day 9 after injection the site was bumpy and the skin felt rough. The infection site was also bruised and there was still a bump at the site. It was itchy and warm to the touch from day one until day 17.  From days 14-17 there was 2 inflamed bumps on the outside of my arm, on the back side, not at the injection site, which were very itchy and red.  There were also itchy areas on the upper arm but no inflamed bumps.  I went to care my primary care physician and she recommended Clariton daily for the allergic type reaction with cold compressing if needed and was prescribed an antibiotic with instructions to call her office the day before my second scheduled shot, on March 8th.
I had no pain or discomfort immediately after the shot, during the 15 minute observation period, or an hour after. About 2 hours later (at 2:00 pm), I developed some hives around my neck, and the part of my arm near the injection site started to become more and more sore. I applied Benadryl to the hives and they went away. However, my left arm hurt to touch or move, much worse than any vaccine I've had before (flu, HPV). That night, I had trouble sleeping because the discomfort because of the sore left arm. I also could not sleep because of chest tightness and pressure, which worsened when lying down, but that pressure did not progress to the point of wheezing (I have asthma).  Sleeping on my back was the only option because sleeping on either side was painful, which worsened the chest pressure. When I woke up, my fingers felt stiff and I had joint pain in both hands, more so in my left hand. Throughout this, I did not see any redness on my arm. This day it was agonizing to move my left arm. I could pick things up, but raising it above my the height of my waist or twisting it behind my back to get on my backpack was near impossible and was avoided. The chest pressure went away. The second night, I still had trouble sleeping, but the pain was much better, although I still could not sleep on my side. When I woke up, I had no more joint pain. That day, although the left arm was still sore, I could move it pretty well. If I made too strong of a movement, it felt like the injection site would tense up, the pain would slowly ramp up, and then diminish. That afternoon, at 4:30, I was able to play tennis with minimal soreness, and that night, I was able to sleep on my side. The following day, I had a cough, but that might have been because I didn't dress for the weather, and experiences close to zero soreness.
Sudden onset of chest pain that persisted over more than 24 hours. Evaluated in doctor office, transported to ER and then hospitalized and underwent coronary angiography.  These along with marked troponin elevation and ECG findings confirmed a non ST elevation myocardial infarction with thrombus
103.0 fever the night of injection, headache, nausea, slight redness at injection site.
heart rate 188 bpm on 5/6/2021 and over 120 bpm multiple times and days thereafter PCP (Dr.) visit 5/13/2021 Cardiologist (Dr.) visit 5/25/2021 Cardiologist re-visit scheduled for 7/2/2021
This spontaneous report as received from a physician assistant refers to a 8 year old patient. On 13-AUG-2013 the patient was vaccinated with the first dose of GARDASIL, 0.5ml, intramuscular (lot#, expiry date, frequency and indication not reported), when the patient was 8 years 6 months of age. On 14-OCT-2013, the patient was vaccinated with the second dose of GARDASIL, 0.5ml, intramuscular (lot#, expiry date, frequency and indication not reported), when the patient was 8 years 8 months of age. No adverse effects reported. It was reported if the patient had sought medical attention. Additional information has been requested.
Information has been received from a nurse practitioner concerning a 15 year old female who on 09-APR-2007 was vaccinated with Gardasil. On 09-APR-2007 the patient experienced a tickly feeling in her throat for about 24 hours after receiving the vaccine. She needed to clear her throat constantly. It was reported that the subject unspecified medical attention. Subsequently, the patient recovered from tickly feeling in her throat. This is one of two reports that was received from the same source for a sibling. No further details were provided. Additional information is not available.
Pt came to vaccine clinic on 5/20/2021, filled out encounter as this being the 1st dose of COVID vaccine, on encounter the answer no is checked where asking, "Have you ever received a dose of COVID 19 vaccine?"  When the encounter was entered into , it was discovered the pt had received a dose of Pfizer vaccine on 4/2/2021. After multiple attempts to contact pt, this nurse spoke with her on the  phone 5/25/21, pt confirmed receiving Pfizer vaccine on 4/2/21. She was advised by a pharmacist and Dr. to restart the vaccine series using Moderna.  This nurse advised pt she did not need to restart the vaccine, that she had received to doses and this should complete the ser
Limited mobility in arm, can't lift above shoulder level at side, or across body. And pain in arm in shoulder. Feels it was given in shoulder. Taken ibuprofen, currently in physical therapy.
Pt received her 1st dose of the Moderna vaccine then about 8 minutes later she complained of losing her hearing for about 5 minutes. No other signs or symptoms. EMS and paramedics on site. They assessed pt. Vital signs were stable. Pt reported her hearing returned and she feels well. Pt was discharged home.
Elevated liver enzymes, speech disturbance, muscle weakness lower extremities, brain fog, fatigue.
Well adolescent, received first GARDASIL vaccine. Within 2 minutes she complained of headache while sitting on exam table, then slumped over having fainted. Heart rate 40, returned to normal in 2 minutes. Fully alert after 2 minutes.
I got my covid vaccine back in October, the maderna & since then I have been having late/irregular periods. I have never been irregular & the only time I have ever had a later period was when I got pregnant.
Around after the 2nd week of having the vaccine, I started to develop joint pain. Bones cracked more often and it hurt to walk a bit. This  joint pain then resulted in tingling in my hands, which made my arm feel weird. Almost numb. Sometimes my face feels a bit numb too. My heart rate was elevated.
Information has been received from a health professional concerning female over 60 years of age who on 02-AUG-2006 was vaccinated with a dose of varicella-zoster virus vaccine live.  Subsequently on 02-AUG-2006, the patient developed a red line at the injection site.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested.
A-fib; sore arm; a little tired; This is a spontaneous report from a contactable consumer or other non hcp (patient sister). A female patient (age 77 unspecified units) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 07Apr2021 as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on May2021 as dose 2, single both for covid-19 immunisation. Medical history included pacemaker (patient has a pacemaker). The patient's concomitant medications were not reported. Patient experienced some symptoms after the vaccine. On an unspecified date in 2021, patient experienced a little bit of a-fib because the pacemaker does monitor for that, sore arm, a little tired. Patient has a pace-maker. Patient got Pfizer, both of them and did not seem to have anything. Just had a sore arm, and was doing great, was just a little tired. Patient had a little bit of A-FIB because the pacemaker does monitor for that. It normally wasn't anything like that. She got her vaccine and she does not know if her A-Fib was related but it was in the back of her mind. She went for her check-up in Jun2021 and everything was ok. She had the first dose 07Apr2021 and the second dose 4 weeks after the first dose. Infrequent episodes showed up early Jun2021 or Jul2021 and they noted A-Fib, her doctor had noted it. When they were doing her regular 3 months check-up for the pacemaker recording information, the doctor noticed infrequent episodes, less than 12 seconds. Patient had an emergency room visit for the event atrial fibrillation. The report was not related to study or program. The outcome of the events was unknown.  Information on Lot/Batch information has been requested.
Information has been received from a registered nurse, concerning her daughter who got a rash after receiving treatment with GARDASIL. The daughter's friend also experienced a rash. No lot number provided. All telephone attempts to obtain follow-up information have been unsuccessful. No further information is available.
Nurse hit a vein, arm now sore, hard and hot lump, very painful. Fever and chills, achiness.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 23-APR-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot # H015537, expiry date JUL-2015), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
On 09/19/18 around 12:30 PM patient called to report adverse events related to her high dose flu shot received on 09/15/18. Patient reported having to visit the emergency room around 8:00PM due to swollen arm, temperature of 102.0, nausea, pain, generalized pain from the top of her head to the bottom of her feet and toes with tenderness specially on her neck. She stated that the ER provider told her that the shot was too much for her body and ended up receiving IV fluids, Morphine drip and stayed at the ER overnight. As of 9/19/18 patient stated she was still nauseated and with generalized pain, needing to stay in bed.
Approx 90 minutes after receiving the vaccine, the patient was eating sandwich and noticed his eyes felt swollen bilaterally. He also noted his right sclera was reddened. He denied pain or itching. He had no other rash, no N/V/D, no abdominal pain, no swelling or redness at site of vaccine, no tongue or mouth swelling, no shortness of breath or difficulty swallowing. He was seen immediately for a visit and given Benadryl 50mg PO & Prednisone 60mg PO. His vitals were stable and his exam was normal other than the eye swelling and redness. He was observed for about 45 minutes, during which there was no improvement or worsening of his symptoms. Rx for Zyrtec, Pepcid, & Prednisone was sent to his preferred pharmacy. He was sent home with his mother and instructed to seek emergent care if any new s/sx developed or if his s/sx worsened.
pt recvd vax;exp flu-like sxs & achy joints for approx 2 mo p/ inject;previously recvd 1st dose in jul92 & exp similar sxs but not to the severity as exp p/ 2nd dose;
sudden onset of headache, nausea and vomiting, treated with injected compazine followed by oral compazine
Dull pain lasting more than 1 week. Hurts to lay on. No redness or swelling.
experience  swollen lymph nodes in the left axillary area; This is a spontaneous report from a contactable consumer (patient). A male patient (Age 43; units: Unspecified) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration on 14Feb2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported, a reaction to Pfizer covid vaccine to get on the 14Feb2021. On an unspecified date, the patient had experienced swollen lymph nodes in the left axillary area and wanted to know if that is normal. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Dizziness - 1 hr afterwards Sever Inflammation and pain in head, neck, jaw, - 5/15/2021 onward and still have it Pulsatile Tinnitus - 5/15/2021 and still have it.  Neurological throbbing in jaw - 5/15/2021 onward, and still have it
No additional AE reported; MMR II involved in temperature excursion on 01/01/2021; This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions and allergies were not provided.     On 16-JAN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose and route were not provided; lot# was S037500 and expiration date was 20-NOV-2021) involved in temperature excursion (on 01-JAN-2021) for prophylaxis (product storage error). No additional adverse event reported.   The administered dose experienced a temperature excursion at 47.01 Fahrenheit for 1 minute 30 seconds. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of the 16 cases received from the same reporter.; Sender's Comments:  US-009507513-2102USA005232: US-009507513-2102USA005231: US-009507513-2102USA005230: US-009507513-2102USA005229: US-009507513-2102USA005228: US-009507513-2102USA005227: US-009507513-2102USA007564: US-009507513-2102USA007563: US-009507513-2102USA007562: US-009507513-2102USA007561: US-009507513-2102USA007568: US-009507513-2102USA007559: US-009507513-2102USA007558: US-009507513-2102USA007557: US-009507513-2102USA003923:
Starting approximately 15 minutes after injection started with tingling in lips and lips feeling swollen, developed minor tightness in throat and feeling tongue swollen along with tremors and lightheadedness. BP 140/102, HR low 100s. Took  Benadryl 50mg with bottle of water.  Symptoms resolved over next 30 minutes. Developed numbness in left 4th and 5th digit which resolved at approximately 1 hour. About 1 1/2 hours after injection some abdominal cramping and 1 episode of diarrhea. BP and HR back to normal at about 1 hour after event.
tiredness; headache; nausea; feeling of her lungs swelling and expanding in her thorax; terrible back pain; dry and bloody mucus in her nose; dry and bloody mucus in her nose; bloody mucus from her mouth; chills; fever; This is a spontaneous report from a contactable consumer (patient) reported that a 48-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: ER8729), via an unspecified route of administration, administered in the left arm on 22Apr2021 as a single dose for COVID-19 immunization. Medical history included menstrual irregularity and tear meniscus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received he first dose of BNT162B2 (lot number: ER8737) on 31Mar2021 on 24:00 on the left arm for COVID-19 immunization and after 8 days, the patient had scleritis. It was reported that on 22Apr2021 at 23:45 the same day that the patient received the second dose, she had chills and fever. The next day, 23Apr2021, the patient had tiredness, headache, nausea, feeling of her lungs swelling and expanding in her thorax and terrible back pain. The patient could not use a bra for two days, there was bloody mucus from her mouth, dry and bloody mucus in her nose. The patient stated that all side effects stayed for two days except for the fever which was only for one and a half. The patient was tested for any cause of sickness in the blood test on an unknown date and everything was negative. The events resulted in a visit to the doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization on an unspecified date. The patient received prednisolone eye drops and Atrophine sulfate eye D as treatment for the events. The outcome of the events was recovering. The events were reported as non-serious.
60 seconds after receiving first dose, patient reported symptoms of not being able to move both arms, nauseous, dizziness, black spots/blurry vision, hyperventilating patient was given EpiPen injection & 911 was called  EMT and paramedics arrived & said it was most likely anxiety related & patient looked much better after being calmed down thru breathing techniques  patient was feeling and looking better after 15-20 minutes and opted NOT to go to hospital.
Pain in shoulder joint 4 mos. Fainted 3 days later 1st ever! Developed tremors, loss of balance, hard to walk, blood pressure jumped for 3 mos; injection felt like it went in bone, couldn't lay on left side for 4 mos.
Erythematous raised area of induration approximately 8-10cm in diameter at site of injection.
Symptoms. Fever, 101.8, Increased respirations, joint pain, chills, nausea, dizziness.
Severe headache  Severe Joint pain Feet feeling like there was glass inside  Extreme fatigue, unable to stay awake  Whole body felt heavy
Swollen lymph nodes in neck and armpit and this morning started having severe pain in my left thumb/wrist
chills; body aches; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 27Apr2021 at 13:30 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of  BNT162b2  (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 06Apr2021 at 13:15 (at the age of 38-year-old) as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 01:00, within 12 hours of vaccination, the patient experienced chills and  body aches. The clinical outcome of the events chills and body aches was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Had the pneumonia vaccination on Friday.  Saturday a.m. nauseated, lungs hurt to take a breathe, headache with a red bump at the injection site.  Sunday the bump turned in a 8x3 raised bump and was very hot to the touch with a very stiff neck.  Went to Urgent Care on Sunday with a differential of either shingles or adverse reaction to the pneumonia vaccination or the flu vaccination (I've had the flu shot every year w/o any problems).  Today, Tuesday, the rash has grown and is still very hot to the touch.
patient tested positive for COVID-19; patient tested positive for COVID-19; she is also pregnant; This is a spontaneous report from a contactable pharmacist via Pfizer sponsored program. This pharmacist reported information for both mother and fetus/baby. This is mother case. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date: was not reported), via an unspecified route of administration on 18Mar2021 as Dose 1,single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient was tested positive for COVID-19 and she is also pregnant. The mother reported she became pregnant while taking BNT162B2(Pfizer covid 19 vaccine). The patient underwent lab tests and procedures which included sars-cov-2 test positive on unknown date. The patient reports the caller about the vaccine as product complaint issue. The patient was in quarantine before the 2nd Dose was due. The outcome of event was unknown.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event Covid 19 and Drug ineffective and the use of suspect product BNT162B2 cannot be fully assessed as full immunity is known to acquire only after full dosage of Covid19 vaccination. The case will be reassessed if additional information becomes available.