chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PAINS/ACHES; SWEATY; WEIRD ANXIETY; FEELING COMATOSE; LACK OF CONCENTRATION; WEIRD TWITCHING IN ARMS/ WHOLE BODY; DIZZY; HEADACHE; This spontaneous report received from a patient concerned a 47 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: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the subject experienced pains/aches. On 02-APR-2021, the subject experienced sweaty. On 02-APR-2021, the subject experienced weird anxiety. On 02-APR-2021, the subject experienced lack of concentration. On 02-APR-2021, the subject experienced weird twitching in arms/ whole body. On 02-APR-2021, the subject experienced feeling comatose. On 02-APR-2021, the subject experienced dizzy. On 02-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pains/aches, sweaty, weird anxiety, and feeling comatose on APR-2021, had not recovered from headache, lack of concentration, and weird twitching in arms/ whole body, and the outcome of dizzy was not reported. This report was non-serious.
Patient received the booster dose of Pfizer COVID vaccine (lot FJ6369) at approximately 1100. At 1109, RN approached patient and asked how he felt. Patient reported not feeling well. PHN approached. RN and PHN assisted patient in transferring to zero-gravity chair and placed supine. Patient given water and cookies. Patient reported symptoms to include blurry vision, sweating, and nausea. PHN noted pallor. At 1112, vital signs: respirations 18, blood pressure 110/62, O2 100%, pulse 80. Patient reported not eating or drinking anything that day. Patient reported no allergies, medical condition includes asthma, medication includes albuterol rescue inhaler. Patient reported no prior history of similar reaction. PHN educated on remaining onsite for 30min from time of reporting symptoms, to follow up with provider, and ER precautions. PHN offered Benadryl but patient declined. At 1125, vital signs: blood pressure 116/70, respirations 16, O2 97%, pulse 86. Patient reported symptoms had resolved, PHN assisted patient to seated position, patient continued to report no symptoms. At 1139, vital signs: blood pressure 118/74, respirations 16, pulse 80, O2 99%. At 1130, Patient stood up, monitored by PHN, continued to report no symptoms. Patient reported his wife was in the car and would drive him home. Patient left walking with steady gait at 1142.
cellulitis, infection under the skin; A spontaneous report was received from a consumer who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the serious event of cellulitis.   The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced cellulitis, infection under the skin. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the event, cellulitis was unknown.; Reporter's Comments: This case concerns a female patient with who experienced a serious unexpected event of Cellulitis.  The event occurred at an unspecified time after first dose of mRNA-1273.  Very limited information regarding this event has been provided at this time and a causal relationship cannot be excluded.
Improperly stored vaccine administered; Caller states they received a shipment of GARDASIL 9 late. Caller states FedEx tried to deliver it on 2/26/2021, but they were unable to and it was actually delivered on 3/1/2021.; This spontaneous report was received from a medical assistant and refers to a 11-year-old patient of unknown gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. The case concerns 1 patient and 1 combination product.  On 01-MAR-2021, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prefilled syringe injection, 0.5 milliliter, lot # T008151, expiration date 21-JUN-2021 (injection site and route of administration were not reported) for prophylaxis.  The reporter stated they received a shipment of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) late. They tried to deliver it on 26-FEB-2021, but they were unable to and it was actually delivered on 01-MAR-2021 and administered to a patient. The temperature excursion details were unknown. The digital data logger was not involved in recording the temperature excursion details. It was unknown if the previous temperature excursion had occurred.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T008151; expirationdate: 21-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA001107:
Headache aspirin still have.  Hives: steroids, prescription anti itch creams; will fade in one place and pop up in another can not make them go away completely.
2/2/05 9AM, phone call from mother of pt: pt had DTaP to left deltoid on 01/31/05 about 5:30PM. Pt has red, swollen, warm to touch L upper arm. No fever. No other sx's. At 11:30AM. Pt came to clinic with mom. Red area 4 in x 5 1/2 in, warm, swollen to slightly beyond red area.
diarrhea, vomiting, headache, body ache, insomnia, dehydration for which went to ER for
Pt called to make me aware that almost 72 hours after immunization, she was having a red ring around area and it was itchy and sore. Pt was told that this is a normal reaction but we would report it. She was told she could take TYLENOL for pain or use an ice pack. It was recommended to try a moisturizer to see if this would help with the itching.
Pain, erythema with streaking, lymphangitis. Tx: Augmentin/Motrin prn 7 po bid x 3 days.
c/o burning sensation 10min after injection on the injection site, rated sensation as 3/10 on a scale of 0-10.  Denies chest pain, SOB, lightheaded, rash.  Cleared, no acute distress. Advised to go to ER if symptom worsen
Pt recvd 3 doses of Engerix-B on 11SEP90, 10OCT90, & 5MAR91 & was found to be a non-responder;
not feeling well; fever; her arm hurt; injection site reactions described as redness and itching. Both injections were in different places.; injection site reactions described as redness and itching. Both injections were in different places.; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number PR-AMGEN-PRISL2021038613). This case was split from master case 2021287765. A 31-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 03Jun2021 (at the age of 31-year-old), as a single dose, for COVID-19 immunization. The patient's medical history included ongoing rheumatoid arthritis and ongoing ankylosing spondylitis. Concomitant medication included etanercept (ENBREL, solution for injection in pre-filled pen, 50 mg), 50 mg weekly taken for rheumatoid arthritis and ankylosing spondylitis, start and stop date were not reported. The patient would resume Enbrel use on 10Jun2021. The patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were not provided), via an unspecified route of administration, on an unknown date, as a single dose, for COVID-19 immunization. On 04Jun2021, the patient not feeling well, fever and her arm hurt. On an unknown date in Jun2021, the patient developed injection site reactions described as redness and itching. The outcome of the events was recovered on an unknown date in Jun2021.  No follow-up attempts are possible. No further information is expected.
On 28 Aug 06, patient came to clinic with chest pain, noted to have stress test elevations in leads II, III, AVF.  Transferred to local emergency room, then transferred to a hospital in other state for ICU admission.  Underwent cardiac catheterization , no evidence of coronary artery disease.  Echocardiogram-normal limits.  Diagnosed with pericarditis.  Doing well. 10/26/06-DX: probably acute myopericarditis associated with the administration of the smallpox vaccine.  Assessment: pericarditis currently on minimum of a 4 week profile of light duty. He may return to full duty on 9/25/06 as long as he continues to be pain free.
blood in my feces; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included asthma, hay fever, and allergies. The patient's concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. The patient stated that he had his second shot on Tuesday, 22Apr. The patient was okay on Wednesday, Thursday and Friday. On 25Apr2021, the patient had a bowel movement and had a quite a bit of blood in his feces. The patient stated that he has not had blood coming out of his rectum ever. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
03/11/2022 I began to feel like I had a bad cold, I woke up achy and fatigued, a few days later I couldn't smell my soap or anything in the kitchen, I took the home COVID-test and was positive, I then went to urgent care for a PCR test and that came back positive as well. I kept feeling worse over the next couple days, I was then able to get the monoclonal antibodies and after two days I started to feel immensely better. I still feel a bit tired and congested but I am feeling much better.
Received vaccine about noon on 2/1/18. Onset of chills, shaking/rigors (could barely walk to BR), spiked temp at about 36 hours (12:30a, 2/3/18), diuresed 5.5# (2.5 kg) overnight, prostrate, headache, stiff neck and shoulders. Local reaction 3.5" x 2", indurated, red, very sore, "ropey." Temps: 100F @ 1a, 100.5F @ 1:45a, 101F @ 3a, 99.9F @ 3:30p, 98.2F @ 8p. Tried to stay hydrated, drank lots of water through the night. This was not the flu -- no respiratory symptoms, no sore throat, congestion or cough. Symptoms  subsided by evening, appetite returned, though "sticky" from fever and diuresis. Did not require treatment beyond rest, acetaminophen and hydration. History of previous PNEUMOVAX 23 received 11/24/1986.
received 1st Shingrix dose almost 4 years ago; This case was reported by a pharmacist via interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received almost 4 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting the patient did not received 2nd dose, which led to incomplete course of vaccination. The pharmacist asked as a pharmacist, if he/she should go ahead and administer the 2nd dose or he should start the series over.
Pt recv vax on 11/5/98; immediately post vax pt exp pain/swelling/weak in LA at vax site, spasms
Fever blister on upper lip: (9/20/2019 at 6:30am) started Abreva on  9/20/2019 at 4:30pm: Currently healing  Swollen Round, hot red inflamation about 1 inch below site of vaccination: Started on 9/19/2019 at approximately 9:30pm.  Taking OTC Naproxin Sodium to treat on 9/19/2019 at 10:00 pm. Continued to grow to the size of a baseball.  Remained that size through Sunday, 9/22/2019. Now, on 9/23/2019 it is the size of a plum, still hot, red, and raised, with small white dots on it. Still hot to the touch, painful and swollen. Unresponsive to Naproxen Sodium.  Joint and muscle aches and pains: Started on 9/20/2019. Treated with OTC Naproxin Sodium 250 mg. BID. Unresponsive to treatment. Worsened through 9/21/2019. Patient went to bed with severe muscle and joint aches and pains on 2/21/2019 at approximately 4:30pm. Muscle and joint aches and pains have lessened, but continue as of 9/23/2019 at 11:30 am.  Low grade fever, 99.7 F: Started on 9/21/2019 at approximate 6:30 pm. Treated with OTC Naproxin Sodium 250 mg. BID. Fever broke in the middle of the night sometime between 9/21/19 at 6:30pm to 9/22/19 at 7:00am.
Redness and puffiness around injection site measuring 4x5 inches in diameter; itchiness and burning sensation.
Four weeks after my first shot of the Moderna vaccine (first shot on March 16, 2021) I got my period -- a very heavy one (started April 12, 2021). This was after 13 months after being in menopause (my previously last period was in March of 2020, and I had been sporadic through 2019). The period lasted for 6-7 days with 4 days of fairly heavy flow. I was quite tired, but I also got my second Moderna shot the morning of Day 2 of my period. Hard to tell what was causing the mild fatigue at that point.
Received vaccination today 02/12/2021 at11 am. Around 10 pm I had epistaxis only in the left nostril. Stopped after three min. No trauma to the nose.
Sensation of ?fried nerves? over entire body intermittent. Sometimes have sharper prickling pain on bottom of feet and face.  Pulsing tinnitus; ringing in ears constant and loud; dizziness: sensation of spinning at times; brain fog; increased blood pressure ( normally on lower end); pressure in mask of face as if I am about to get a nose bleed; sharp pain intermittently around temples like a clamp on head.  The symptoms have increased significantly over the last  5-6 months.
fever/the fever started to skyrocket to 104 or 105.; Dry throat; feeling a bit nauseous; lower body feels weak; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 14-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 03Aug2021 16:00 (Batch/Lot Number: SC3180) as dose 1, single for COVID-19 immunization at a pharmacy. The patient has no medical history and concomitant medications. No history of previous immunization with the Pfizer vaccine. No additional vaccines administered on same date. No vaccinations 4 weeks prior. No relevant tests. On 04Aug2021 03:00, the patient experienced fever/the fever started to skyrocket to 104 or 105, dry throat, feeling a bit nauseous, and lower body feels weak. The patient got the fever of 104 in the morning after the vaccine, now it has lowered to 102 but stayed consistently at 102. He has been taking ibuprofen 600mg for the fever. He took them every eight hour, one each eight hours. It has been breaking up his fever since it lowered it from 104 to 102. The patient underwent lab tests and procedures which included body temperature: 104 or 105 (fever) on 04Aug2021 at 03:00, body temperature: 104 (fever) on 04Aug2021 morning after vaccination, and body temperature: 102 on 06Aug2021. The outcome of the event fever and dry throat was not recovered, for the event nauseous was recovered on an unspecified date, for lower body feels weak was recovered on 04Aug2021.   Follow-up attempts are completed. No further information is expected.
Sore throat, fever, chills, couch, SOB, body aches, loss taste - two negative COVID tests - Admitted to Hospital in  around 9/25/20 and diagnosed with Myocarditis and Rhinovirus.  Fluids given and bedrest 3-4 days then discharged.  Admitted again on  11/9/20 for increased HR and SOB discharged on 11/11/20 and she received her flu shot on 11/11/20 at discharge and had to be readmitted that same evenings/early morning on 11/12/20 with high fever and heart rate and MD stated due to flu shot and wanted to monitor because of the myocarditis.  She was discharged on 11/12/20 and will begin PT and Cardiac Rehab
Moderna Covid-19 EUA delayed cutaneous reaction; approximately 5 days after receiving vaccine a rash occurred at the injection site; injection given in right arm; arm developed a hard, hot lump with itchy rash; rash traveled all around the arm from the shoulder down to the elbow; after 3 days hard lump faded but hot spot continued; itch continued for 10 days total
Moderna COVID-19 Vaccine EUA Hot red firm to touch welt developedat injection site6 days after vaccination.  Peaked in size 24 hours after onset at approximately  3 inches across. Persisted at peak size for an additional 24 hours and then began to shrink and return to Normal color and temperature. Discoloration and temperature and firmness gone after approximately 52 hours
NAUSEA, VOMITING, RESPIRATORY SYMPTOMS- SHORTNESS OF BREATH, WHEEZING, HIVES, ITCHING, REDNESS, TENDERNESS AT SITE.
6 hours after receiving the vaccine I became achy, with chill s and uncontrollable shaking and freezing cold.
Severe pounding headache. Excruciating pain. Lasted several hours. Tylenol did not relieve the pain.
Pure Hypercholesterolaemia; This spontaneous case was reported by an other health care professional and describes the occurrence of TYPE IIA HYPERLIPIDAEMIA (Pure Hypercholesterolaemia) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019b21a and 030A21A) for COVID-19 prophylaxis.     Patient had no known allergies to medications, food and other products.    On 19-Apr-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-May-2021 at 10:58 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 07-Sep-2021, the patient experienced TYPE IIA HYPERLIPIDAEMIA (Pure Hypercholesterolaemia). The patient was treated with ROSUVASTATIN ongoing from 07-Sep-2021 at a dose of 5 milligram. At the time of the report, TYPE IIA HYPERLIPIDAEMIA (Pure Hypercholesterolaemia) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient height and weight was reported as 5'3 and 150.2.  No concomitant medication information was provided.   This case was linked to MOD-2022-503512 (Patient Link).
Pfizer use for COVID-19 under Emergency use Authorization (EUA): Was giving patient 1st COVID19 vaccine, and while pushing down on plunger to administer vaccine noted to have visual backflow through syringe tip and needle junction where both pieces join and unknown amount of vaccine ran down patient's left arm. Used HS since use syringe Luer Slip 1mL lot #20201110. Used BD eclipse Needle 25gx1 lot #1204217. Informed I would be in contact with patient once I spoke with manufacturer; hours of operation are M-F 0900-1900EST. Telephone number verified with patient for future contact once I gather more information from Pfizer. Patient verbalized understanding and had no further questions.
Caused erratic uterine bleeding for extremely long periods and even after the bleeding stopped, it caused spotting. This went on for four weeks.
High blood pressure; insomnia, anxiety, depression, stress disorder; chest pain; vision problems and rash.
Sister observed patient's eyes roll back and slid and hit the floor , did not hit the floor Color returned after a few minutes, seen by paramedic, went home with father and sisters
Knot at the area of injection; Wrong Route of Administration; This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 2F977, expiry date 1st December 2019) for prophylaxis.   On 29th April 2019, the patient received Pediarix (subcutaneous). On 29th April 2019, unknown after receiving Pediarix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site lump to be related to Pediarix.  Additional details were provided as follows: The patient received Pediarix subcutaneously instead of intramuscularly, which led to inappropriate route vaccine administration. The patient experienced a knot at the area of the injection.
small heart pains; felt like his heart was fluttering; felt like his heart was fluttering; like it was beating really fast; and had small heart pains; dizziness/light headed/felt like he was going to fall or faint; vertigo; Vomiting; Felt like he was kind of sick; nausea; This is a spontaneous report from a contactable consumer (patient). A 20-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, via an unspecified route of administration, administered in arm left on 26Aug2021 13:17 (Lot Number: FC3184) at the age of 20 years old, at single dose for covid-19 immunisation. Medical history included ongoing asthma (Diagnosed when he was born). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced dizziness/light headed/felt like he was going to fall or faint on 27Aug2021, vertigo on 27Aug2021, vomiting on 27Aug2021, felt like his heart was fluttering; like it was beating really fast; and had small heart pains on 29Aug2021 02:00, felt like he was kind of sick in Aug2021, nausea in Aug2021. Clinical course: The dizziness was really bad the first day on 27Aug2021; he couldn't get up. The next day was better; he could get up. Stated that the dizziness disappeared around the 29th or 30th, but he still felt like he was kind of sick. Then the dizziness came back today (31Aug2021) a little bit. He also had vertigo; felt like he was going to fall, or faint; vomiting; and was light headed, all these side effects began when he woke up around noon 27Aug2021, and they disappeared on the 28Aug2021; except the dizziness which he previously stated came back today (31Aug2021). He also felt like his heart was fluttering; like it was beating really fast. Stated that happened on Sunday (29Aug2021) around 2am. He also had small heart pains every now and then when his heart was fluttering, but he doesn't know if this was a side effect of the vaccine, or if it could be his history. Clarified that this has happened to him even before he got the vaccine. Treatment: He took something for the nausea, but didn't remember what he took. The outcome of the events dizziness/light headed/felt like he was going to fall or faint was recovered in Aug2021, of the events vertigo, vomiting was recovered on 28Aug2021, of the other events was unknown.  Follow-up attempts are completed. No further information is expected.