chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bottom lip became numb ten minutes after vaccine receipt.  no other symptoms like shortness of breath or itching.  vital signs obtained and recipient hypertensive at 184/113.  patient waited for an additional 15 minutes and no change in symptoms.  bp 161/101.  advised recipient to follow up with pcp about her hypertension and current symptom as soon as possible.
Chest tightness.  No radiation to Arm.  VS 84, 116/80, 99%
Patient reported that after vaccine, she developed soarness in her left arm that has persisted to this date. The patient does not report any redness or swelling.
mom stated the pt cried inconsolably for >3hr;mom tried walking, rocking etc;pt cont to cry;
Information has been received from a licensed practical nurse concerning a 6 year old male with no known drug allergies who on 08/07/2001 was vaccinated with a second dose of varicella vaccine. There was no concomitant medication. Within an hour of being vaccinated, the pt developed a fever that rose to 103 deg F and resolved within 24 hrs. It was noted that the first dose was given about two years ago, approximately 1999. The pt sought unspecified medical attention. Additional info has been requested.
devel severe chest & head congestion w/fever; p/4 days of no response treated w/supra 10 days;
On 11/01/2002 pt was given the flu vaccine. She returned on 11/04/2002 stating she developed a rashy red area at injection site. She denied pain and itchy. This disappeared within 2 days.
Fever and febrile seizure on 2/11/08 (day 6).
received the 2 shingles shots BUT I got shingles anyway/Suspected Vaccination failure; got shingles anyway; severe stress can bring them on; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and stress. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the vaccination failure, shingles and stress were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and stress to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received the 2 shingles shots but got shingles anyway.  Doctor said severe stress could bring them on. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
pt rcvd vax; pt devel inc t 100 & episode vomiting somewhat lightless after & inc irritability lasting x2dys; pt taken to hosp; MD's evaluation shows no abnormal exam; tx w/ APAP since incident;
Heavy rash worsening daily around injection site and spreading. Runny nose and cough 2 days after shot without any symptoms prior to shot.
No adverse event; bivalent booster inadvertently administered instead of 1st dose of primary; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (bivalent booster inadvertently administered instead of 1st dose of primary) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027E22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 05-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (bivalent booster inadvertently administered instead of 1st dose of primary). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (bivalent booster inadvertently administered instead of 1st dose of primary) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (bivalent booster inadvertently administered instead of 1st dose of primary).    No concomitant medication was reported. No treatment information was provided.
Developed: headache, nausea, stomachache and "fever" several hours after vaccination. (Temp not checked). Seen in ER on 11/17/14 to eval bumps on lower legs. COPA visit on 11/18/14: Painful lower leg bumps w/o itch. No cough, slight runny nose, no vomit/diarrhea, afebrile. No sore throat. Dx with erythema Nodosum (possibly due to Tdap). Rx: Ibuprofen every 6 hours.
cannot raise her arm up.; left arm is now sore; was told to come back to get her second injection in two weeks; first Shingrix vaccine on September 4, 2020 / today / received her second injection; injection was given near her left arm shoulder joint; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 2nd October 2020, the patient received the 2nd dose of Shingrix. On 2nd October 2020, less than a day after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced injected limb mobility decreased, pain in arm, drug prescribing error, drug dose administration interval too short and vaccine administered at inappropriate site. On an unknown date, the outcome of the injected limb mobility decreased, pain in arm, drug prescribing error, drug dose administration interval too short and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself. On 4th September 2020, the patient received 1st dose of Shingrix. The patient was told to come back to get her 2nd dose in two weeks, which led to drug prescribing error. The patient received 2nd dose near her left arm shoulder joint, which led to drug dose administration interval too short and vaccine administered at inappropriate site. The patient's left arm was sore and could not raise her arm up. The patient was referred to her physician and provided MI number for her physician. The reporter did not consent to follow-up.
Confirmed pulmonary embolism in 3 locations.  Prescribed Xaralto.  Symptoms include Chest pain, rapid heart rate, increased blood pressure, dizzy, light headed feeling
Developed rash next day - 2 PCP visits and 1 ER visit - steroid shot did not improve rash 2nd steroid shot helped - previously client has taken Tetanus Diphtheria only - no respiratory distress.
Nauseous; Utimately threw up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5 year-old male patient received bnt162b2 (BNT162B2), administration date 10Dec2021 (Lot number: FK5618) at the age of 5 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 13Dec2021, outcome "recovered" (13Dec2021), described as "Nauseous"; VOMITING (non-serious) with onset 13Dec2021, outcome "recovered" (13Dec2021), described as "Utimately threw up".  Additional information: Patient received the Pfizer vaccine for 5-11 year old's on Friday, 10Dec2021. He was fine all weekend but woke up this morning nauseous and ultimately threw up. No other symptoms were exhibited and he is feeling fine now. Temperature is fine also.   No follow-up attempts are possible. No further information is expected.
Left arm 16 x 20 cm induration with edge of erythema central pallor, warmth administered 9:30 swelling by 5 pm follow day current description. Right arm 4 x 4.5 cm total erythema, swelling, warmth at sit of Menactra 24 hours later.
Reaction started at 10 p.m.on 12/23 with body aches at site of injection & new ankle/calf pain. Woke up in middle of the night nauseous. Nauseousness lasted into next day along with chills, fatigue, fever, headache, joint pain.   Lasted about 24 hours and cleared up, felt fine by Friday afternoon.
devel chickenpox on 4/30/99 exposed to older sibling 4/16/99;pt seen in office by MD 200 lesions over body;
Information has been received from a medical assistant concerning three patients who between June 2008 and August 2008 were vaccinated with the second dose of VARIVAX (Oka/Merck). The patients developed chickenpox after receiving the second dose of vaccine. No other symptoms and no treatment reported. No other information available. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. "This is one of several reports provided by the same source". Since the reporter mentioned the other 3 school-aged kids (WAES #0809USA04612). Additional information has been requested.
Sore arm the first morning About 26 hours after injection I became cold. 2:00pm at 28 hours my teeth began to chatter uncontrollably.  4:00pm until 8;45pm - I had 4 tylenol during this time frame Became very achy and uncomfortable around 8:45 pm   At 1:00 am I felt inflamation on my whole left side.  My arm hurt to the shoulder to touch or move, left breast sore, left knee (artifical replacement) was sore under knee cap.  I took two extra strength tylenol for inflamation and slept for 2 hours.  Woke up in a pool fo sweat, but felt fine! Should I take the second dose?
8/25: 101.8 fever and chills, Moderate dull headache, redness/warmth/swelling/extreme tenderness of injection site,  sudden severe stabbing joint pains, body aches, skin sensitivity, fatigue. 8/25: Moderate dull headache, redness/warmth of injection site, moderate swelling /knot to injection site approximately the size of a golf ball, fatigue, quick stabbing joint pain. Symptoms still ongoing.
Redness & itching in about a 3" circle around injection site. Headaches off & on and body aches. Increased fatigue & napping 3 hrs during day - then can't sleep at night.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX (batch number 273BZ, expiry date 15th May 2021) for prophylaxis. On 15th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 15th January 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site erythema and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. Initially, the patient experienced injection site pain along with redness and swelling after the injection that lasted for one week and resolved. However approximately 8 weeks after receiving the 2nd dose of SHINGRIX, the patient reported recurrence of the injection site pain in her left arm.
Customer says that he has had blurred vision that has not gone away. started 1 day after being vaccinated. encouraged him to check with doctor
At 10:45 the patient was escorted into the health unit by a coworker. Patient was oriented x 3. She was assesed and nursing intervention was provided. Patient stated she felt her throat was closing up while upstairs at her desk so she self administered 25mg of Benedryl sublinqually. Patient stated her throat still fells like it is closing although she took 25 mg of Benedryl. Patient stated she carries sublinqual Benedryl and an epi-pen because she has allergies to certain medication and foods. Upon the patients arrival into the health unit at 10:45 A.M., RN called 911. RN immediately administered 25mg of Benedryl p.o to the patient while (10:50 A.M.) RN administered  0.3cc of epinephrine sub-cu into the patients right arm. Vital signs were as follows: 10:45 A.M. B/P 140/84 P 76  10:55 A.M B/P 144/100 P 88. Paramedics arrived at the health unit at 11:00 A.M. They assessed and evaluated the patient and asked her if she wanted to be transported to the hospital. The patient stated her throat was feeling better. The patient initally declined and then agreed to go to the hospital via ambulance. The patient declined to lie on the stretcher so walked out of the health unit into the ambulance.  The patient left the health unit in stable condition.
Patient presented to the emergency department on 4/10 with a complaint of left leg pain.  Patient reports onset of symptoms on Wednesday (4/7).  He states that initially it just felt like a cramp in his calf.  He states that over the past couple days, the pain has gotten significantly worse.  He states the pain is now sharp and severe in nature.  He states that he is having due to the severity of the pain.  He states the pain is now moving up into his medial thigh.  Patient states that around noon on 4/10, he began having chest pain and shortness of breath.  Patient describes a tightness across his chest and states that he cannot breathe associated with this.  Patient does have a history of asthma and states that he has had a couple of episodes like this in the past.  Patient also reports a history of diabetes, hypertension.  Patient does report a family history of coronary artery disease as well as a family history of blood clots.  He received his Pfizer Covid vaccine 2nd dose on 4/9/2021 (Lot # ER8729)  and 1st dose (Lot # EN6204) given on 3/12/2021 at an outside facility  He does report arm soreness but is otherwise doing well. No recent travel.  No recent immobilization.  Upon evaluation in the ED, he was noted to have positive US for DVT in the LLE. Follow up CTA Chest was positive for bilateral lobar and segmental PE with right heart strain. CVM was consulted for possible PE intervention evaluation.  Patient started on therapeutic Lovenox, but discharged home on 4/11 with Eliquis. . The next day 4/12/21 he returned to ED for SOB/Wheezing and LLE pain. On 4/15/21 he underwent EKOS, IVCF and iliac stent placement per Vascular surgery and subsequently sent home on Eliquis 4/16/21. Pt returned to the ER again 4/21/21 for recurrent SOB. CTA chest with no significant change in clot burden, no associated hypoxia.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Bladder cancer surveillance" (unspecified if ongoing), notes: Bladder cancer surveillance; "Allergic rhinitis" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Eczema" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Migraines" (unspecified if ongoing). The patient's concomitant medications were not reported.The following information was reported: COVID-19 (medically significant) with onset 29Jun2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jun2022) Positive; (08Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She tested positive for covid-19 on 29Jun2022 and started treatment that day with paxlovid. she had rebound covid symptoms on 7Jul2022 and tested positive again 08Jul2022 with a covid antigen test (turned positive before control line).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On "Monday" (30-SEP-2013) the patient was vaccinated with ZOSTAVAX (lot number, dose, route and indication were not reported). On an unknown date in 2013, after the patient received ZOSTAVAX the injection site was warm to the touch with a "slight" knot that was extremely painful at the time of report. The pharmacist stated the patient was having trouble moving their arm and could not sleep because of the pain. The outcome and action taken were not provided. It was unspecified if the patient sought any medical attention. Additional information has been requested.
face burning & itching, welts on face a/taking DPH;to ER 27JUN96 tx w/meds;ER MD advised f/u w/pvt MD poss desensitization a/dose #3;
Dizziness, Headache, Arthralgia, UrticariaPruritus, Constipation, Diarrhea, NauseaVomiting, also altered taste, and unsteady on feet Narrative:
Had neuromuscular issues; Sciatica; Cant put a lot of pressure on his left foot; Low grade fever of 100; A spontaneous report was received from a consumer, concerning a 69- year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, neuromuscular issues (Neuromyopathy), Sciatica (Sciatica), Can't put a lot of pressure on his left foot (Limb discomfort) and Low grade fever of 100 (Pyrexia)  The patient's medical history was stiff lower back provided by the reporter. It was reported that, patient tested positive for the antibodies in August. Patient said he never tested positive for the virus and he said that he tested negative but had symptoms. Concomitant medications was not included by the reporter.   On 14 FEB 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 006M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 15 Feb 2021, the patient experienced neuromuscular issues (Neuromyopathy), Sciatica (Sciatica), Can't put a lot of pressure on his left foot (Limb discomfort) and Low grade fever of 100 (Pyrexia). The event, neuromuscular issues (Neuromyopathy) was medically significant. Treatment details were not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, neuromuscular issues (Neuromyopathy), Sciatica (Sciatica), Can't put a lot of pressure on his left foot (Limb discomfort) and Low grade fever of 100 (Pyrexia) were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Received MMR and Varivax 10/02/2001. OM diagnosed 10/5, put on Amox, red spots on 10/12/2001, increased spots over next several days. ER 10/14 to give Benadryl PO. 10/15 rash worse. Extensive moribilliform rash on face, trunk and extremities. Slightly raised erythmacules 3- 6 mm in size. Zero target lesions.
Patient reported swelling, pain, tenderness, & warm to the touch 2 days after receiving FLUVIRIN & PNEUMOVAX injections in his right deltoid. His left arm could not be used, he had just had surgery on the shoulder. He was instructed to apply ice & use BENADRYL & hydrocortisone cream.
Administered expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) in a 63-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses.  The vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to MOD-2022-581986 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up received included non significant information of secondary reporter was added.
sick; hurts your arm; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid vaccine with an associated reaction of pain in extremity (dose received on an unknown date).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced sickness and pain in arm. On an unknown date, the outcome of the sickness and pain in arm were unknown.   It was unknown if the reporter considered the sickness and pain in arm to be related to Shingles vaccine.  Additional details were provided as the patient self reported the case. The patient received Shingles shot and his/her arm hurts more than Covid shot and patient was sick the next day. The patient stated that debated the second, but it's still a month away patient will get it. The follow up would not be possible as no contact details were available. This case has been linked with case US2021AMR178217, reported by the same reporter. Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178217, comment response case.
Shortness of breath, fever, headache, pain in neck and arm, extreme fatigue, disorganization, irritability, itching at the site of injection