chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain (level 4 of 10) starting in right rear of neck, becoming more intense on 01/19/21. By evening head movement was very difficult, I could not sleep in bed that night. I slept on the couch sitting up trying to immobilize head. During the night pain spread into the base of my skull. I applied heat to help relieve the pain and tightness. On 01/20/21 the pain (6 of 10) spread into the left side of neck and skull, it became difficult to eat, swallow and to get up from couch. I tried to sit motionless most of the day. On 01/21/21 the pain (6 of !0) moved down into my left rear shoulder, I continued to apply heat and immobilize sitting on couch, eating and swallowing still difficult. On 01/22/21 pain in neck and base of Additional information for Item 18:  skull subside to level 5, movement of head still difficult, able to to get up and move slowly. Could not lift head to drink, still needed to use straw. Slept on couch again this night. On 01/23/21 pain still subsiding to level 4, head movement still difficult, still needed straw to drink, slept on couch again. On 01/24/21 pain continuing to subside to level 3, head movement still difficult, still needed straw to drink, slept on couch again. On 01/25/21 conditions unchanged. On 1/26/21 pain subsided to level 2, head movement stiff but not difficult, swallowing less difficult but still need straw to drink. Slept in bed for first time since 01/19/21. On 01/27/21 pain continued to subside to level 1, head movement improved but still limited, still need straw to drink, able to move around more freely but still not normal. Improvement is slow but I hope to be back to normal in a few days. I am concerned that my second vaccination may cause a more severe reaction, please have someone call or contact me so I can discuss this issue.
Eight hours after receiving vaccine, a fever of 100-102 lasted for 40 hours.  Body aches, fatigue, headache, arm redness, under arm soreness were additional symptoms.
Received FLUZONE High Dose, which I was not aware that the pharmacist was giving me. Just wanted regular flu shot. Beside all the regular problems from the shot. 6 day later, broke out with a rash.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 30-OCT-2014 the patient was vaccinated subcutaneously with an expired dose of ZOSTAVAX (0.65ml, lot # J004269, expiration date 12-JUL-2014). No adverse effect was reported. No PQC (product quality complaint) was involved. Additional information has been requested.
pt recvd vax & began crying & devel fever 1 1/2 hr later; pt took apap; pt cried all night & am; pt had puffiness at inject site; no redness; pt moves legs freely; 21oct at 11:30 grandma reported pt was asleep now & had not sleep since inj;
Needle disconnected from syringe; Majority of dose did not go in arm; Technician experienced backflash; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (Needle disconnected from syringe), UNDERDOSE (Majority of dose did not go in arm) and UNEVALUABLE EVENT (Technician experienced backflash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced DEVICE CONNECTION ISSUE (Needle disconnected from syringe), UNDERDOSE (Majority of dose did not go in arm) and UNEVALUABLE EVENT (Technician experienced backflash). At the time of the report, DEVICE CONNECTION ISSUE (Needle disconnected from syringe), UNDERDOSE (Majority of dose did not go in arm) and UNEVALUABLE EVENT (Technician experienced backflash) had resolved.
Seen 11/16 with swollen left arm from axilla -> mid forearm, tender SI: warmth to touch.
Had trouble sleeping; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Had trouble sleeping) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, PROPRANOLOL, ENALAPRIL MALEATE (LOTRIL [ENALAPRIL MALEATE]), TIZANIDINE and TEMAZEPAM for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Had trouble sleeping). At the time of the report, INSOMNIA (Had trouble sleeping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
The past weekend I had a gout/Gout attack; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable 76-year-old male physician (patient) reported that he received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on 22Jan2021 (Batch/Lot number was not reported) as dose 1, single and dose 2 via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications were not reported. The patient was retired orthodontist stated, "I've had both doses of the Pfizer vaccine, my last dose was Wednesday 10Feb2021 (22Jan2021 was my first dose). He had his second dose of the covid vaccine on Wed 10Feb2021. His first dose was on 22Jan2021. The past weekend I had a gout attack. On Monday 08Feb2021 gout attack, I took 3 tablets of indomethacin 50mg during the days three times a day an anti-inflammatory and states it depresses t cells. He took no medicine on Tues, Wed, or Thurs. He was asking if there is a diminished response or efficacy to the vaccine if taking indomethacin. He was asking if he can he take more indomethacin. He was an orthodontist. On Tuesday, Wednesday, Thursday the patient took no medicine. Indomethacin was an anti-inflammatory and suppresses T-Cells, what was the interactions and the vaccine? The patient was able to take the indomethacin at this time, gout was attacking up a little bit. I want the ability to take it if it's gets worse? How long would it take generally for 2nd dose antibody titer to show up? What testing was available if it would be appropriate?" The patient stated on 08Feb2021 he took Indomethacin 3 - 50mg tabs, on 10Feb2021 received his second dose of the covid-19 vaccine, wondering if he can take the medication today, caller states he has not taken that medication in about 4 years. Therapeutic measures were taken as a result of the event. The outcome of the event was unknown.   Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
03/07/2006 Fever lasted for 3 days. 03/10/2006 Rash large vascular macular blanchable trunk on extremities and palms.
Information has been received from a registered pharmacist concerning a patient, who an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not reported). The pharmacist reported that the patient developed erythema multiforme. At the time of the report, the patient's outcome was unknown. This is one of two reports received from the same source. Additional information has been requested.
pt recvd flu vax & pt was 1 of 5 who devel influenza & died;
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe
Had normal light S.E  headache, 100 fever, jt & body aches  over within 30 hrs, approx 10 hrs  after  these SE disappeared  got angioedema side effects of the face & lips, decreased gradually hrly
At 3:49 pm, the patient was vaccinated with her third dose of Pfizer vaccine (1st booster). At 3:55 pm she reported feeling nausea and reported slight upper lip swelling. The reports that she experienced both of those with some medications and that she gets especially nauseated with her blood pressure medications that she takes at 11 am. The experienced lip swelling with the last 2 does of the vaccine. Her BP was elevated, 204/110 even above baseline and she reported feeling very stressed and having worked very hard today. Nausea was relieved at 4:15 pm. Vital signs were taken every 5 minutes for 30 minutes. She reported a decrease in lip swelling . She declined offer for EMT and was released to family.
Rash to injection site. Flat, red, marked borders. Mom to monitor call if: raised site, give BENADRYL and call office. Go to ED with SOB, swelling.
"It was just my period came a week early and was heavy"; "It was just my period came a week early and was heavy"; This spontaneous case was reported by an other health care professional and describes the occurrence of MENSTRUATION IRREGULAR ("It was just my period came a week early and was heavy") and HEAVY MENSTRUAL BLEEDING ("It was just my period came a week early and was heavy") in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUATION IRREGULAR ("It was just my period came a week early and was heavy") and HEAVY MENSTRUAL BLEEDING ("It was just my period came a week early and was heavy"). At the time of the report, MENSTRUATION IRREGULAR ("It was just my period came a week early and was heavy") and HEAVY MENSTRUAL BLEEDING ("It was just my period came a week early and was heavy") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Pt. became tachacardic post 2nd vaccine injection. BP 155/99 HR 130-140 Lightheaded. No shortness of Breath. Discharged at 1515 - okay.
Intense pain in lower back and right hip and pain down my legs (all weak and vulnerable areas where I have issues now and then). It is bothersome to the point that I cannot find a comfortable position to relieve the pain.  It feels like my lower body is being seized up, so to speak.  The only way I can sleep is to take 2 Aleeve PM tablets. I take regular Aleeve throughout the day to take the edge off the pain.   The reason I suspect it is a side effect is that a year ago I took the new Shingles 2-dose vaccination.  I had this same reaction after taking the first dose - and it occurred about 2 weeks after that shot.
I got my third dose of Pfizer's vaccine and developed lymphadenopathy on the side that I had my shot (left arm). Swollen lymph nodes in my arm pit all the way up to my neck just to underneath the jaw. The swelling made my neck very sensible to touch (even when showering) and felt them when stretching my neck. This also happened after my second dose. Since all doses have not been received at a doctor's office, I didn't know they could be related to the vaccine. It was not until a few days later of the second dose, that while visiting my allergist that the connection of the swollen lymph nodes was made. He asked about my vaccine status and how did I do. While talking I mentioned the sensitivity I had to the touch in my armpit and neck on the left side. He assessed the area and said that I had a strong immune response and thus the swelling of the lymph nodes on the side of the injection. Also, the malaise on this third shot was awful, but was able to still get up from bed and be somehow functional to take care of my elder mom.
4/20/21: Vaccination @ 1:40pm.  Vaccination site sore only when pressed.  4/21/21: Upper left arm sore when moved.  Upper throat swollen.  Began to feel feverish & lethargic c. 9am.  Feverish feeling passed c. 11am.  Slept 2-6pm.  Slept 11:30pm 4/21/21-4/22/21.   4/22/21: Woke up at 1:20pm.  Unresponsive to regular alarms.  Vaccination site sore only when pressed.  Upper throat still swollen, but less-so.
she felt real bad; feverish; hot and sweaty; body ache; really tired; leg cramps; nausea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8730; Expiration Date: 31Jul2021), via an unspecified route of administration on 25Mar2021 08:45 as dose 1, single for COVID-19 immunisation. Medical history included ongoing COPD, Diabetes, Fibromyalgia, and High Blood Pressure. The patient's concomitant medications were not reported. On 25Mar2021 at 8:45, patient received her first vaccine and about an hour and a half later she experienced leg cramps in the back of her legs. Her friend rubbed her legs and they were fine after that. On the same day, at night, 8:00PM she felt real bad and started feeling feverish, being hot and sweaty. On 26Mar2021 she got up and everything seemed ok, so she went out to have breakfast with friends and then a half hour after she got to work, she was having body aches, feverish, felt really tired, and had the hot, sweaty feeling again with mild leg cramps. The leg cramps were better than previous day. She mentioned that it was not really a fever where her forehead was not hot, but was difficult to describe. She felt like the sun was beating on her, the skin was on fire, and felt hot and sweaty like she just worked out. She also mentioned that she would have a really weird feeling of nausea that would last about 1 minute every, now and then. She has started taking Emergency, which is a regimen of 1000mg Vitamin C with Zinc. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Patient was given Pfizer Bivalent vaccine on 09/21/2023. As of September 12, 2023 all formulation of Pfizer COVID vaccines for all ages had been deauthorized.
Stated she had a sore, red arm on 1/4-1/6. Stated it went away but last night on 1/11 she noticed the injection site was swollen again, but now is red, warm and "bigger than the palm of my hand" stated is it not tender. Advised to reach out to PCP.
This case was reported by a other health professional via call center representative and described the occurrence of burning sensation in a female patient who received ENGERIX B (batch number 94S22, expiry date 4th September 2020). This case was associated with a product complaint. On an unknown date, the patient received ENGERIX B. On an unknown date, 14 days after receiving ENGERIX B, the patient experienced burning sensation and pain. On an unknown date, the outcome of the burning sensation and pain were unknown. It was unknown if the reporter considered the burning sensation and pain to be related to ENGERIX B. Additional information was received as follows: The reporter stated that the patient in the same day received an ENGERIX B injection, it was unspecified if it was for adult or pediatric. The patient experienced burning and soreness two weeks after the injection. The reporter noted this had never happened before. The patient had denied permission to contact their physician. The caller was the nurse practitioner but did not wish any contact. The reporter tried explaining the importance of full information. This was all the information she would give. The nurse practitioner reported that she the batch of ENGERIX-B may had caused the adverse event. The reporter did not wish to provide other specifics, nor wished to be contacted about this report. There was no product to return. This case was linked with case US2018079546, reported by the same reporter.
Case is hospitalized at Hospital. Per EMR, case was admitted for weakness and altered mental status; also complaining of abdominal pain. "CT of the abd was done in the ED which shows distended bladder with emphysematous cystitis." It was later documented in EMR that case had "asymptomatic COVID".
Reactions to second dose only: Fever, fatigue, aches, headache, cough for about a week, then hospitalized for pneumonia & extremely high BP for several days.  Sent home on hospice.  Nursed back to health over several weeks.  Changed to home Healthcare, in order to rehabilitate with physical & occupational therapy.  Is ambulatory currently.  Has oxygen in home, but not currently needed.  Blood pressure is under control.
Fatigue, achiness, vomiting, severe chills and cold feeling, fever 101.5, stomach pain, injection site pain. All symptoms persisted for 48 hours. At 72 hours fatigue and nausea remained. Unable to complete daily life activities.
Patient received vaccination then went to sit in chairs for 15 minutes. Several minutes later his mother stated he was feeling hot, clammy, and faint. The patient was seated but was asking to lay down. We kept him in a supported, seated position in case he vomited. His skin was cold and clammy and he was acting as if he might faint. We monitored for a few minutes and he seemed to fade in and out of consciousness. No signs of anaphylaxis were noted. I asked the mother if she wanted me to alert EMS. Store management and 911 were called. The patient was transported to the hospital.
Petichiae, bruising, fatigue...Idiopathic thrombocytopenic purpura (ITP).
Hives/urticaria- upper legs, back of arms, chest, neck and back. swollen eyes, welts under eyes, itchy/irritated skin, injection site swollen and firm/hard. Symptoms lasted 12-24 hrs
Pt received his first vaccine booster earlier than recommended. He completed primary series of Pfizer on 2/19/22. Asymptomatic at time of dose administration. Vaccine should have been administered anytime on or after 6/19/22
6 inch wide, raised, hot area with some pain, around the injection area x 7 days. (pharmacist stuck her twice).
lost consciousness w/in few seconds p/vax;spastic movement noted in extremities lasting for few seconds;diaphoretic states lightheaded, nauseous lasting 25min when MD notified;transferred to LMD per WIC;given orange juice, graham crackers
Rash on left arm; Swelling; Pain at injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain at injection), INJECTION SITE RASH (Rash on left arm) and INJECTION SITE SWELLING (Swelling) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 11-Feb-2021, the patient experienced INJECTION SITE PAIN (Pain at injection) and INJECTION SITE SWELLING (Swelling).   On 13-Feb-2021, the patient experienced INJECTION SITE RASH (Rash on left arm). The patient was treated with HYDROCORTISONE at a dose of UNK UNK, tid.   On 12-Feb-2021, INJECTION SITE PAIN (Pain at injection) and INJECTION SITE SWELLING (Swelling) had resolved. At the time of the report, INJECTION SITE RASH (Rash on left arm) had resolved.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
Presented to ED with SOB and decreased appetite with oxygen saturation in 70's on RA.  Patient was DNR/DNI, per daughter who confirmed this status, wanted to proceed with comfort focused care.   In the ED was noted to have black tarry stool.  Admitted to hospitalist team COVID unit.  Therapy was not initiated, and was discharged to Hospice 1 day after admission.
Itching, Redness, Swelling, Soreness which converted to cellulitis Narrative:
Arm got shouting pain and muscle spams the night after vaccination. On the next morning (12/30/2021), she said that she could not move arm well. She is still experiencing pain and decreased mobility with worsening pain in evening and at night. When she rolls her neck around, she gets tingling down her arm.
This case was reported by a physician via call center representative and described the occurrence of neuropathic pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced neuropathic pain, fever, erythema, chills and feeling hot. The patient was treated with TYLENOL. On an unknown date, the outcome of the neuropathic pain, fever, erythema, chills and feeling hot were recovering/resolving. It was unknown if the reporter considered the neuropathic pain, fever, erythema, chills and feeling hot to be related to SHINGRIX. Additional details were provided as follows: The reporter reported this case for his wife. The age at vaccination was not reported. The patient developed fever, neuropathic pain, redness, hot to touch chills within 10 hours of receiving the SHINGRIX. The symptoms subsided in 2 to 3 days. The patient stated that she took TYLENOL for the pain. The patient gave permission the contact pharmacy in Hospital. The patient did not have all the information and was reluctant to provide some due to a billing issue. No additional details were provided.
PT DEVELOPED VERTIGO DAY AFTER IMMUNIZATION WHICH HAS PERSISTED FOR 4 DAYS
another pregnancy test was done and it was positive with no reported adverse event; Initial information received on 15-May-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 16 years old female patient who was had to vaccine influenza quadrival a-b vaccine [fluzone qiv] in context of another pregnancy test was done and it was positive with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported another pregnancy test was done and it was positive with no reported adverse event occurred at unknown gestation period. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  Concomitant medications included meningococcal vaccine a/c/y/w conj (tet tox) (menquadfi) for prophylactic vaccination; and meningococcal vaccine b (meningococcal vaccine b) for Immunisation.  On 19-Dec-2022, the patient received 0.5 ml once of suspect influenza quadrival a-b vaccine Suspension for injection lot UT7695LA via unknown route, strength, expiration date in unknown administration site for immunisation.  On 19-Dec-2022 the patient developed a non-serious another pregnancy test was done and it was positive with no reported adverse event (exposure during pregnancy)(latency: same day).  Relevant prenatal testing after exposure included was unknown.  Relevant laboratory test results included: Pregnancy test - On 19-Dec-2022: Negative; on an unknown date: Positive  Action taken was not applicable.  Outcome: Unknown for the event another pregnancy test was done and it was positive with no reported adverse event. Additionally, at time of reporting, the outcome of the pregnancy is unknown.; Sender's Comments:  US-SA-2023SA151221: