chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got cold; tired; fever of 101.2; threw up; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (got cold), FATIGUE (tired), PYREXIA (fever of 101.2) and VOMITING (threw up) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017321A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced VOMITING (threw up). On an unknown date, the patient experienced NASOPHARYNGITIS (got cold), FATIGUE (tired) and PYREXIA (fever of 101.2). On 12-Apr-2021, PYREXIA (fever of 101.2) had resolved. At the time of the report, NASOPHARYNGITIS (got cold), FATIGUE (tired) and VOMITING (threw up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Blood pressure measurement: 160/100 (abnormal) 160/100. On an unknown date, Body temperature: 101.2 (High) 101.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received when patient was 60 years of age). On 4th December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.  It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient had experienced some pain with 1st dose of injection of SHINGRIX vaccine. The event was resolved.
Patient reports immediately after the shot he did have some numbness in (L) arm and chest. Then he started having bilateral leg pain and leg weakness. His legs feel like they are locking up. And pain is worse when he stands or walks. It does improve with running but did not go away.
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 21-MAY-2013, patient received improperly stored VARIVAX dose 1, from batch/lot # 0610AE (expiry date, dose units, route and anatomical location were not specified). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Unable to lift arm above head, headache, fever, body aches, tinnitus, maculopapular rash on trunk
This is a spontaneous report from a Contactable consumer (patient). An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318), dose 1 via an unspecified route of administration on 05Feb2021 as a single dose for COVID-19 immunization. There was none medical history. Concomitant medication included atenolol taken for an unspecified indication, start and stop date were not reported. Her leg was swollen and there was edema and there was a lump on the side and it was pink or getting red and she was on medicine (Clarification Unknown) for 7 days, twice a day and the leg is still (incomplete sentence), the edema has gone down some. The leg was still pink and it is tender to touch and if she stand on her leg for too long or walking around too much it hurts. She got pain. She was also sleeping whereby she was watching television and all of sudden she was sound sleep and she wake up over an hour or two after that and then she awake for a while but she have no trouble sleeping at night again. She had chest pain and it's not angina because that she did have (Further clarification was unknown if consumer had angina in past hence not captured on tab) but it's a sharp pain and it does not want her taking Nitroglycerin because it went away and it last for maybe (incomplete sentence) it just like a stabbed wound. She was dizzy. That's still, it's not like what it was but it is getting less but she was still dizzy. She cannot walk a straight line. She lived in an apartment house and she had to walk down the hall to go down the stair but she sometime had to stop because she was dizzy. she kind of lean against the wall for few seconds and then she continued on. Concern was not the word for it. It made her very nervous and the circulation was very poor in both feet now and one leg, the right leg that has the pink and still the tenderness in that leg. The foot turns very dark pink and the big toe that she had turned dark purple. She wrote everything down and she will say this at the time after the injection she did not have any problem until about four days later but she did have problem with doing my cross- word puzzles and doing her puzzles. She could not do any of her puzzles, nothing was computing in her brain (Clarification unknown) but that's coming back slowly, so is that to be expected. Start date of event: Consumer stated "It was 4 days after the 5th, about 09Feb2021. She went there and saw a doctor an MD of course and she went there on 12th so it was a week later. She went because the pain was terrible. The outcome of events Leg is still pink and it is tender to touch; If I stand on my leg for too long or walking around too much it hurts, I got pain; Dizzy; is not recovered, all of sudden she was sound sleep; Cannot walk a straight line; Nervous; Circulation is very poor in both feet now; Foot turns very dark pink and the big toe that I have turned dark purple; Nothing was computing in my brain; pain was terrible was unknown, outcome of the other events was recovering. No follow-up attempts are possible. No further information is expected.
Injections given 10-13-12 in left arm. PNEUMOVAX 23 and FLUZONE HD. Arm warm, swollen, red - saw doctor at walk in clinic. Adverse reaction vs infection.
rt arm gland irritated, could not lift rt arm, swelling & painful could not lift; severe h/a & very weak; dx'd pneumonia;
A 11 year old boy was inadvertently given Pediarix vaccine (combination of DTaP, IPV, and Hep B) instead of Tdap.
sever nausea, h/a, chills, fever, hives on stomach-back;tx took calritin-ASA;
Patient reported that approximately 2 hours after vaccine was given her arm was very sore. It became worse as the night progressed. She tried cold compress but that seemed to make it hurt worse so she put heating pad on it. Kept her up most of the night. Was seen in ER on 9/17. Complained of pain up to neck, area was hot to touch and swollen. Had numbness in hand and fingers.
Information has been received from a physician through the pregnancy registry for VARICELLA ZOSTER VIRUS CONTAINING VACCINES, concerning a female with morning sickness who in October 2008, was vaccinated with VARIVAX (Merck).  The patient was vaccinated while pregnancy.  LMP: 13-SEP-2008 and EDD: 20-JUN-2009.  On 23-JAN-2009 an ultrasound was performed to check fetal health and was normal.  All telephone attempts to obtain follow-up information has been unsuccessful. Follow up information has been received from a nurse who reported that the primipara female patient had a normal, spontaneous, vaginal delivery on 24-JUN-2009.  The nurse reported that the baby was "perfectly fine", there were no congenital anomalies.  The baby birth weight was 9 lbs 1.4 ounces.  It was reported that the mother had a 3rd degree spontaneous laceration at delivery which had healed.  It was noted that at the time of the report, the patient was returning to the office for her annual examination. No further information is available.
W/in hrs of DTP & HIB vaxs T102-103; lt leg red & swollen to half-dollar size & warm to touch;
fever; pain at  the injection site; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), VACCINATION SITE PAIN (pain at  the injection site), FATIGUE (fatigue) and HEADACHE (headache) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A, 022M20A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included VALSARTAN, ATORVASTATIN, HYDROCHLOROTHIAZIDE, SILODOSIN, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM & VITAMIN D3), VITAMIN C [ASCORBIC ACID], ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) and OMEPRAZOLE for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced PYREXIA (fever), VACCINATION SITE PAIN (pain at  the injection site), FATIGUE (fatigue) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL 8 HR ARTHRITIS PAIN) for Adverse event, at a dose of 650 mg. On 18-Aug-2021, PYREXIA (fever), VACCINATION SITE PAIN (pain at  the injection site), FATIGUE (fatigue) and HEADACHE (headache) had resolved.            This case was linked to MOD-2021-308164, MOD-2021-308129 (Patient Link).
Hives/whelps, hot to the touch, on arms, legs, stomach, back, face, and lips.
Patient had headache and congestion initially after receiving the vaccine. Then starting 9-10 days later, patient started running a low grade fever between 100.1 and 101, chills, body aches, and joint pain.
April 7th cold chills lasted 20 min. April 14th a rash on both forearms and both thighs. Also had swelling of feet and hands with ankle and wrist joint soreness. April 16th started taking 4 Benadryl a day. 3 days later rash gone. Swelling and joint pain also gone.
Developed fever and diarrhea that evening. Mom not sure what actual temperature was. Gave TYLENOL and stated it did not work to reduce fever. Denies vomiting. By Sunday became lethargic. Took to ER where temp was 103. Child was admitted to the hospital. CXR taken - states they told her "something was in the lungs" but was not given any definite diagnosis with that. No cough. Had IV's for fluids and antibiotics. Did not know what antibiotics he was given. Fever broke on Monday evening. Was discharged from hospital on Tuesday late afternoon/evening. Took 1 week for his BM's to return to "normal". Feels may be due in part to the Flu vaccine and does not want to subject her child to further doses. Follow up with Pediatrician 2 days after discharge from hospital.
Delayed reaction 1 week after shot. Swollen & hot at the injection site also tender & very sore. Fatigue, body aches and low grade fewer that lasted 48 hours & then subsided.
Call from mother reports noting significant swelling to upper right arm approx 1 1/2 hrs ago. Swollen area is red and warm to the touch. No swelling noted last eve as son took a bath or this am. No fever noted pt this time. Instructed to apply cool pack to upper arm and ibuprofen q 6 hrs per package inst. Watch for fever and any problem with arm. To call if further concerns.
high fever, excessive crying, area of shot sore w/redness & tenderness; rt leg w/ 1.5cm indurated @ site of DTP inj;
This spontaneous report was received from a medical assistant referring to an 11 month old patient of unknown gender. Patient's pertinent medical history and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with the first dose of VAQTA (25/0.5), for prophylaxis (lot number and expiry date were not reported). The reporter described that the first dose occurred one week before the patient's first birthday (Drug administered to patient of inappropriate age). The second dose of VAQTA was administered six months after the first dose. No concomitant medications were reported. No adverse effects were reported.
A few hours after the first dose (1/15), a welt grew around the injection site about the size of a silver dollar.  This went away after three days. Arm was sore for the first two days.  One week later (1/22), injection site became itchy, red and was very warm to the touch.  A welt formed as well. It started out the size of a silver dollar, and over the course of  48 hours the welt, itchiness, and redness grew to  the size of a large russet potato (Friday 1/22- Saturday1/23).  It was the most red around the injection site, with the most red being about the size of a silver dollar.  After 48 hours, it remained itchy, red, and had a welt  for the next 24 hours  (Sunday 1/24). The next morning (Monday 1/25) redness and swelling were gone but site was still a little itchy.  Site was only slightly tender throughout these three days but not painful. No other side effects were noticed i.e. fever, chills, chest pain.  Slight dizziness was felt if I hadn't eaten anything.
Pt admitted on 8/8/2021 with worsening fatigue/weakness. COVID positive on 7/30/2021. He was given monoclonal antibody treatment in ED.  Pt is still an inpatient at this time.
first dose on 21Dec2020/ second dose on 04Jan2021; first dose on 21Dec2020/ second dose on 04Jan2021; her fever went up to 101.4/ her fever is down to 99.6; still does not feel good/ felt sick/ felt terrible; wanted throw up; shaking chills; extreme weakness; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via unspecified route of administration on 21Dec2020 at single dose, and second dose (lot number: EL3246), via unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient stated that she got it in the evening and had a fever and felt sick like she wanted throw up. She stated that her fever went up to 101.4, that she felt terrible, had shaking chills and extreme weakness. She tried to drink a lot of liquids thinking that would help. Stated that it was a really bad experience. She clarified that all of these side effects were with the second dose. She had no side effects with the first dose. She reported all of this previously. She stated that she called in fever down 99.6 and did not feel good. She stated that the Tylenol brought fever down a little bit. She was still not able to go to work. The outcome of the event "her fever went up to 101.4/ her fever is down to 99.6" was recovering, the event "still does not feel good/ felt sick/ felt terrible" was not recovered, while other events were unknown.
Itching, rash, swelling and skin hot around injection site appearing a week after injection.
01/29/2021 Fatigue, soreness at injection site. Pt took OTC Tylenol/Advil. 02/18/2021 Epigastric pain, dyspnea, nausea, vomiting. Pt took OTC Tylenol/Advil and went to Dr.  office because pt thought she had gallbladder pain/concern. 02/20/2021 Pt went to ED: tested negative for Covid-19 virus but found to have elevated liver enzymes. Pt remained at hospital inpatient status until 02/24/2021. Pt states she was never given any diagnoses/causes for symptoms. 03/05/2021  Pt went to her PCP, and blood labs obtained; pt continues to have elevated liver enzymes per pt's report.
Patient received 2nd dose (booster) of Pfizer with no incident. After being in observation for 10 minutes, she became acutely short of breath, red, and complained of her throat tingling. Within 2 minutes patient was impending airway compromise and tachypneic. Patient was given EPI auto-injector (0.3mg) IM. Patient symptoms did not improve. Patient was given a second 0.3mg Epi Auto Injector in opposing thigh. Patient was also administered 50mg Benadryl IV. Ambulance from Fire/Rescue transported patient to St. Joseph hospital. Patient condition improved greatly following second dose of Epi.
Information has been received from a physician concerning a male patient with unknown drug reactions and asthma who was vaccinated with a second dose of MMR II vaccine (lot # not reported). It was reported that the patient developed hives after the vaccination. No additional AE information was provided. It was reported that this patient also had an adverse experience following vaccination with VARIVAX (Merck) (WAES # 0903USA03185). Additional information has been requested.
mild soreness at the injection site; This is a spontaneous report from a contactable consumer (patient's parent).  A 14-years-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number and expiry date was not reported) as single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number and expiry date was not reported) as single dose for covid-19 immunisation and expereinced mild soreness at the injection site. It was reported that the patient received the Pfizer vaccine yesterday afternoon (his second shot) and developed mild soreness at the injection site. Outcome of the event mild soreness at the injection site was reported as unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
patient , age 15 received a vaccine for patients 19+.No adverse events or side effects noted.
An allergic reaction after having had 3 doses of the same vaccine /local and systemic reactions to each vaccine; An allergic reaction after having had 3 doses of the same vaccine /local and systemic reactions to each vaccine; This spontaneous case was reported by a physician and describes the occurrence of LOCAL REACTION (An allergic reaction after having had 3 doses of the same vaccine /local and systemic reactions to each vaccine) and HYPERSENSITIVITY (An allergic reaction after having had 3 doses of the same vaccine /local and systemic reactions to each vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 012M20A and 033F21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Medication allergy to sulfa (rash), Sulfa products but no vaccines and PEG), Hypertension (Recent change in status such as improvement or worsening: No) since 2019 and Depression (Recent change in status such as improvement or worsening: No) since 1997. Concomitant products included MODAFINIL and LAMOTRIGINE for Depression, CHLORTHALIDONE for Hypertension.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced LOCAL REACTION (An allergic reaction after having had 3 doses of the same vaccine /local and systemic reactions to each vaccine) and HYPERSENSITIVITY (An allergic reaction after having had 3 doses of the same vaccine /local and systemic reactions to each vaccine). At the time of the report, LOCAL REACTION (An allergic reaction after having had 3 doses of the same vaccine /local and systemic reactions to each vaccine) and HYPERSENSITIVITY (An allergic reaction after having had 3 doses of the same vaccine /local and systemic reactions to each vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered LOCAL REACTION (An allergic reaction after having had 3 doses of the same vaccine /local and systemic reactions to each vaccine) and HYPERSENSITIVITY (An allergic reaction after having had 3 doses of the same vaccine /local and systemic reactions to each vaccine) to be related.    The patient reported a potential lot-related safety issue. The patient had a primary series (Jan-Feb 2021) with the Moderna vaccine followed by one booster in Nov 2022. Although patient had local and systemic reactions to each vaccine, patient had no hypersensitivity symptoms. Also reported it was unusual to had an allergic reaction after 3 doses of the same vaccine without any similar symptoms.   The patient never had COVID positive test or diagnosed.  No treatment information was provided.   This case was linked to MOD-2022-650999 (Patient Link).
9/9/11 1700 patient fainted, laid patient down on exam table. Responded in 30 sec, then had 2nd episode of syncope which lasted about 45 sec, pt required O2 BP 80/60 P 51, BP 80/60 P 51 gave patient glucose tablet, and water 1723 BP 82/50 P 51 at 1745 BP 97/66 color returned, feeling better 1800 O2 D/C. Left clinic with boyfriend he drove her home.
ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE DVT OF LEFT POPLITEAL VEIN ACUTE PULMONARY EMBOLISM
Patient was given vaccine to Right deltoid at 4:22pm (3rd dose) with no previous reaction to vaccine. At approx. 4:23pm patients mom started yelling for staff and patient was observed with head down to chin seemingly "passed out" patient was laid back and upon touching his chest to check respirations the patient then lounged forward with his eyes open. Patient said "I blacked out". Nursing staff checked his Pulse and it was 58 and oxygen level was 98%. Patient was given juice incase a blood sugar issue but blood glucose checked and it was 85. Patient has no known previous medical history. Patient was alert and orientated to person and place but was unable to say it was August but did say the month before September so was orientated to time. There is a language barrier as patient is Spanish speaking as well an English speaking.
This spontaneous report as received from a health care worker refers to a patient of unknown age. On 10-SEP-2013, the patient was vaccinated with a first dose of PENUMOVAX23 (lot # J005011, expiry date was 04-DEC-2014). Approximately on 10-SEP-2013, within a few hours, the patient experienced redness, swelling, warmth and pain at the injection site. Later approximately on an unknown date in September 2013, these symptoms got worsened and spread to the entire upper arm. Patient sought medical attention for the same (office visit) and was prescribed Keflex for what the physician thought looked like cellulitis. The reporter mentioned that the injection site reaction was not local anymore but had encompassed the entire arm. The outcome of all the reported events was not recovered/not resolved. This is one of the 3 reports received from the Same Reporter Link (MARRS#1309USA005556 and 1309USA014075). Additional information has been requested.