chrisvoncsefalvay/vaers-outcomes huggingface dataset:
right leg in sever pain; fell a couple of times getting out of bed; Weakness from lower spine down his foot; Wakness down right leg; Right leg unusable / right leg gives out when walking; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right leg in sever pain), FALL (fell a couple of times getting out of bed), ASTHENIA (Weakness from lower spine down his foot), MUSCULAR WEAKNESS (Wakness down right leg) and GAIT DISTURBANCE (Right leg unusable / right leg gives out when walking) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and 015M204) for COVID-19 vaccination.     Concomitant products included LEUPRORELIN ACETATE (LUPRON) and ENZALUTAMIDE (XTANDI) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (right leg in sever pain), FALL (fell a couple of times getting out of bed), ASTHENIA (Weakness from lower spine down his foot), MUSCULAR WEAKNESS (Wakness down right leg) and GAIT DISTURBANCE (Right leg unusable / right leg gives out when walking). At the time of the report, PAIN IN EXTREMITY (right leg in sever pain), FALL (fell a couple of times getting out of bed), ASTHENIA (Weakness from lower spine down his foot), MUSCULAR WEAKNESS (Wakness down right leg) and GAIT DISTURBANCE (Right leg unusable / right leg gives out when walking) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information  received on 13 May 2021 and updated patient's date of birth. On 14-May-2021: Follow-up information  received on 14 May 2021 and  additional events provided and date of initial dose of vaccine was updated.; Sender's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Anaphylaxis, Angioedema, NauseaVomiting, ABDOMINAL PAIN Narrative:   Other Relevant History:
After first dose, I had moderate to severe low back pain, starting on January 7th, 2021.  I never had back pain before.  I did a round of US with an athletic trainer, acupuncture, and massage.  This lasted over a week and a half.  That month, I also had a menstrual period that was excessively heavy and lasted off and on over two weeks.  After the second dose, I had the same symptoms, with the same course and very heavy flow.  I am perimenopausal, so variations are normal;  however, this was very unusual.  The symptoms were self limiting.
Redness and warmth, cellulitis on right thigh. Pt rx'd Keflex 250 mg TID x 10 days.
Hives on neck and chest. It is 6:10 pm, and the hives have not gone away.
Lump on left shoulder - Arm not red or swollen. Enlarging lump on (L) upper arm.
Patient received a dose that was one day past the 31-day use-by timeframe as indicated on Pfizer packaging.   The following day I contacted Pfizer and learned that according to their own research the vaccine is equally viable 32 days after thaw.  No adverse signs or symptoms reported by the patient.
Fever and chills (lasted roughly 5 or 6 hours); Pain at injection site and the surrounding area (lasted roughly 14 hours); Fatigue and headache (lasted roughly 28 to 30 hours).
Case number PHEH2011US05580 is a combined initial and a follow up spontaneous report received from a health care professional on 29 Sep 2011 and 30 Sep 2011 respectively. The pharmacist stated that after attempting to withdraw reconstituted MENVEO vaccine with needles ranging in gauge from 18 to 27, and using different types of needles, they ended up taking the entire foil and the plastic thing off prior to withdrawing two doses of NENVEO that were subsequently administered to two patients. This case pertains to a patient of unknown age and gender who was vaccinated with one of this dose of MENVEO vaccine (batch number: M100047) three weeks before the time of this report. It was also reported that they causality reconstituted the Men A lyophilized conjugate vaccine component of MENVEO with a sterile diluent, which was the reason there was difficulty withdrawing the dose after reconstitution. The patient did not receive the MenCYW-135 liquid conjugate vaccine component of MENVEO. Potential medication error was reported due to potential that sterility of doses could have been compromised due to removal of the stopper prior to withdrawing up two separate doses of MENVEO. No additional patient administration errors were reported. No adverse event was reported at the time of the report. The other patient was vaccinated on 22 Sep 2011 (see linked case: PHEH2011US05576). Following an internal review on 10 Nov 2011 from the information received on 29 Sep 2011, following correction was done. The verbatim 'pt received dose after removal of stopper' changed to 'sterility of the vaccine doses could have been compromised due to removal of the stopper prior to withdrawing two separate doses', and coded to product sterility lacking. An event during administration error is added.
Extreme weakness in lower limbs especially, leg cramping and spasticity, concern of Guillan-Barre Syndrome, dehydration all within a few hours of the vaccination.
During a vaccine clinic, a 16 year old patient was inadvertently given the Janssen Covid-19 vaccine which is approved for 18 years and older.  The patient was observed for the required 15 minutes post vaccination; no adverse events observed.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 13th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th February 2019, several hours after receiving SHINGRIX, the patient experienced pain in arm and welts. On 14th February 2019, the patient experienced chills, nausea, dizziness, palpitation and blood pressure decreased. In February 2019, the patient experienced localized itching and fatigue. On an unknown date, the outcome of the pain in arm, welts, chills, nausea, dizziness, fatigue, palpitation and blood pressure decreased were recovered/resolved and the outcome of the localized itching was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, welts, localized itching, chills, nausea, dizziness, fatigue, palpitation and blood pressure decreased to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. The patient experienced soreness in her left arm and a welt the size of her palm on her left arm. In the next morning, 1 day after vaccination, the patient experienced chills, nausea, dizziness, heart palpitations and a decrease in blood pressure. These symptoms lasted for approximately 12 hours. Less than a week after vaccination, the patient experienced fatigue that lasted approximately 4 days. The patient stated that the soreness and the welt was gone, but now, less than a month after vaccination, the area on her arm was itchy. The reporter consented to follow up.
Feel like he had flu after injection; Warm feeling at the site; This spontaneous case was received on 03-Dec-2020 via Communications (reference number: SEQW20-05553), reported by other non-health professional (consumer) via and concerned a male patient of an unreported age.  The patient's relevant medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; route of administration, anatomical location and dose: not reported) for influenza prophylaxis. The batch number was not reported.  On an unspecified date, after receiving influenza virus vaccine polyvalent, the patient experienced a warm feeling at the site and felt like he had the flu after injection.  The outcome of the events was not reported.  The reporter assessed the event to be related to influenza virus vaccine polyvalent. The reporter has had a reaction in the past with flu vaccines and he was trying to figure out which ingredient could have caused the reaction.  Company comment: A patient of an unreported age was administered influenza virus vaccine polyvalent. On an unspecified date, after receiving influenza virus vaccine polyvalent, the patient experienced vaccination site warmth and influenza like illness. Although chronology needs more clarification, causality is assessed as possibly related for both events.; Reporter's Comments: The reporter has had a reaction in the past with flu vaccines and he was trying to figure out which ingredient could have caused the reaction.; Sender's Comments: A patient of an unreported age was administered influenza virus vaccine polyvalent. On an unspecified date, after receiving influenza virus vaccine polyvalent, the patient experienced vaccination site warmth and influenza like illness. Although chronology needs more clarification, causality is assessed as possibly related for both events.
A 40 year old male pt who was bitten by a bat experienced dizziness after his third dose of RabAvert for post exposure treatment. The pt completed all five doses of RabAvert (dates unspecified). Medical history and concomitant medications were not reported. Following the third dose of RabAvert the pt complained of dizziness without other associated symptoms. At the time of the fifth dose the pt reported that the dizziness had persisted with the same intensity as when it first started but had not increased. Follow up received 19Nov04: The pt an approx 40 year old male, was initially treated at an alternate facility and received the first dose of RabAvert on 19Sep04. The subsequent four doses in the RabAvert series were on 22Sep04, 27Sep04, 04Oct04 and 18Oct04. He had not past medical history including no prior history of vertigo. The pt began the RabAvert series and developed several episodes of vertigo, described as the room spinning when he was lying down. The events resolved two days after his last injection of RabAvert.
Vaccine given at approximately 1143am.  Individual told to sit in waiting area so they could be observed for 15 min.  Within approximately 5 mins individual reported having a rapid heart rate, tingling in hands, & felt they were having issues catching their breath.  Individual walked into medical area for evaluation & additional medical staff including LIP called to scene. 1150 am HR 150 & O2 86% before nonrebreather applied.  Nurse applied O2 at 15L with nonrebreather while LIP assessed, 1154am 50mg IM benadryl given per verbal order from LIP.  911 called.  vitals at 1154 were O2 99% on 15L HR 115 BS 99.  Ice packs & cold compresses placed on individual while additional questions asked by LIP.  Individual admitted to having a little chest tightness 3 days prior, which was not told to the RN giving the covid 19 vaccine prior to vaccination. Individuals breathing began to slow down after 5 mins and they stated they were able to catch their breath more easily.  At 1215 O2 was removed O2 sat 98% RA and HR 107.  Individual began to feel more tired after benadryl injection and was more lethargic in response.  Ambulance arrived at approx 1215 & individual transported to ER for further evaluation.
Severe muscle aches 48 hrs post vaccination. Intermittent burning/tingling sensation in right arm, started Saturday afternoon.  Saturday and Sunday night unable to write notes at work, unable to sleep on that side.  Took Acetaminophen 2/15/21, slight improvement, Took Ibuprofen 2/16/21 with more improvement.
Chest pain, daily migraines, brain fog, neck tension, joint pain in hands, wrists, elbows and shoulders. Went chiropractor and seeking neurologist.
Information has been received from a registered nurse concerning a 79 year old female with a penicillin allergy who on 15-NOV-2006 was vaccinated with a 0.5 mL dose of Pneumovax 23 (Lot# 655289/0958F). Concomitant therapy included Atenolol, clonazepam ("klonazpam"), losartan potassium (manufacturer unknown), LODINE, MEVACOR, PREVACID, "PREVACOL", lactulose and REGLAN. On the evening of 15-NOV-2006 the patient experienced a temperature of 101F degrees and the injection site was warm to the touch. There was no redness. She was seen in the emergency room and sent home. The patient was reported as recovering. Additional information has been requested.
NOT AN ADVERSE EVENT--ADMINISTRATION ERROR--vaccine dose given outside the manufacturer's recommended temperature. Vaccine was punctured and sat at room temperature an hour longer than recommended time frame.  Patient notified, recommended that he come back for another dose since he would have received a subpotent dose. Pt verbalized understanding .
Patient received her COVID-19 Moderna vaccine this afternoon.  She then started "feeling strange" a few minutes later, requesting fresh air. She was monitored outside for 30 minutes. Her O2sat remained >96%ile the entire time. Her HR remained in 60s-70s. Her initial blood pressure was elevated at 210s/140s and improved to 140s/110s with calming relaxation techniques.  She did have brief jerking episodes of her lower extremities intermittently. They were suppressible. She remained conscious the entire time and maintained good eye contact.  At minute ~20 post-vaccination, she endorsed not remembering why she was there, requesting to stand up. She stood up with support and then sat back down. Repeat BP was elevated to SBP 200s.  Decision was made to continue observation in Urgent Care as her blood pressure was still elevated and she still appeared anxious. She was speaking in full sentences and was drinking water without assistance.  She was placed into wheelchair and brought to Urgent Care. However, during UC triage, she  reportedly informed nursing that she didn't want to be in the enclosed observation room in UC, that she wanted to go home. Her partner wheeled her outside to the patio. When nursing went to go find her, the patient had eloped.
patient received fluzone high dose quadrivalent shots in a time frame of 2 weeks with no reported adverse event; Initial information received on 18-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 93 years old female patient who had received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] shots in a time frame of 2 weeks with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 17-Oct-2022, the patient received a 2 (0.7ml) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation was unknown, lot UJ937AA and expiry date: 30-Jun-2023) via intramuscular route in unknown administration site for Immunization.  On 17-Oct-2022 the patient developed a non-serious event of patient received fluzone high dose quadrivalent shots in a time frame of 2 weeks with no reported adverse event (extra dose administered) (Latency: same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
severe involuntary movement in my hands, sometimes up my arms to include my shoulder and neck muscles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing), notes: before my first two immunizations. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: DYSKINESIA (non-serious), outcome "unknown", described as "severe involuntary movement in my hands, sometimes up my arms to include my shoulder and neck muscles".  Additional information: the patient took the third (as) booster in Oct2021 and the patient's life hadn't been the same since. The patient had severe involuntary movement in the patient's hands, sometimes up to the patient's arms to include the patient's shoulder and neck muscles. The patient tried to report the vaccination injury, but it fell on deaf ears. The patient's quality of life had significantly decreased.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300144572 same reporter/patient/suspect product; different dose/events;
Nose bleeds; Right arm sore at injection site; This is a spontaneous report from a contactable consumer. This consumer reported for a 57-year-old female patient (wife). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6208, Expiry date: unknown), via an unspecified route of administration, administered in Arm Right on 12Mar2021 08:25 (at the age of 57-year-old) as dose number unknown, single for COVID-19 immunisation. Medical history included Diabetic/diabetes mellitus (diagnosed 5 years ago), blood pressure abnormal and blood cholesterol abnormal (She was taking blood pressure medication, diabetes medication and cholesterol medication). There were no concomitant medications reported. Vaccination facility type was Hospital and not a military facility. No history of previous immunization with the Pfizer vaccine. No additional vaccines administered on same date of the Pfizer suspect. NO ER or physician's office required. No Prior Vaccinations (within 4 weeks). No AE following prior vaccinations. No family medical history. The patient experienced right arm sore at injection site about 10 hours after receiving vaccine on 12Mar2021 17:00-18:00 and had a nosebleed for 2 days. It was very light, like a drip and started noticing the nosebleed on 13Mar2021 19:00-20:00. It had improved since then. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
autoimmune disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune disease".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
R09.02 HYPOXIA 12/14/2022 INFLUENZA PNEUMONIA R09.02 HYPOXIA 12/14/2022 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE)
severe headache, muscle aches, dizziness, stomach ache, pain at the injection site for 48 hours. Treatment Tylenol, bed rest.
Patient states "Rash with draining spots on back and both legs. Rash is very itchy." Advised patient to go see MD. Voiced understanding. Client works in nursing home she says so is going to MD today.
swelling near site of injection. on day 2 increased swelling and fever exceeding 100 degrees
Pneumonia, ARDS, Pulmonary edema, not necessarily related. Pt transferred to hospital so unknown at this time what evaluation has shown. Discharge summary states dyspnea, fever, cough, apnea, ARDS, cardiac diastolic disfunction. msv Follow-up: Vaccinated as part of State wide effort after out-weaks.
Routine TD given in clinic. Returned, 2 days, later with erythemic area 5" X 3", just proximal to elbow. Tenderness, inflammation. No lesions, no drainage.
pt recvd vax; redness, swelling, itching at site after dose 1 & 2; pain at site p/ dose 2;
Pt was inadvertently adm MMR in lateral thigh IM instead of SC on 05AUG90; @ time of report, there was no adverse response;
Immunized on 10/20/08. Next day: stabbing pain in left shoulder, arm and side, especially when taken a breath. Went to see MD - he suspected it was caused from shot. Told her to take IBUPROFEN and to contact us. She contacted us on 10/23/08. Still symptomatic.
MUSCLE SPASMS IN FEET, THIGHS, HANDS AND ARMS.  HEADACHE.
15 hours post vaccination, I am experiencing headache, nausea, fever, and body aches
Patient developed a rash on left hand a few minutes after receiving vaccine. Rash got better before he left but it was still there. I advised him to wait at least another 20 minutes to make sure he doesn't have any other severe reactions. He said he felt okay and left after about a total of 35 mins. I advised him to take benadryl when he got home and to contact his doctor if he felt worse. I left a message with his doctor about the incident. I also advised him to use v-safe to report the symptoms.
Moderna COVID-19 Vaccine EUA - may have been first or second dose (I was first vaccined by Dr. on 3/17. All of her administered vaccines were subsequently invalidated). Adverse symptoms included body aches (muscluar, joint and bones), severe chills and significant skin sensitivity. Unusual tiredness as well. No fever recorded. Two 500 mg single-doses of generic Tylenol given four hours apart approximately 11 hours after symptom onset relieved most symptoms.
This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown age and gender. The patients' medical history, drug reactions or allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (dose and route of administration were not provided), Lot # L016427, expiry 13-APR-2017; L018500, expiry date 13-APR-2017; L025738, expiry date 14-AUG-2017; L029631, expiry date 14-AUG-2017; and L027733, expiry date 13-SEP-2017. No adverse effects were reported. No additional information was provided. This is one of six reports received from the same reporter. Additional information has been requested.
Client stated after 1st dose Pfizer COVID vaccine received in Right arm 04/07/21 (LOT ER8729) at vaccination site he gradually developed Left hip pain rated a 9.5/10 and stated he had to use a cane to walk. The pain lasted 36 hrs and then resolved. Client took Motrin to help manage the pain. Client denied shortness of breath, chest pain, dizziness, headache or tingling in mouth, face or throat.  Denied pain anywhere else and denied trauma to the area. Client denied any allergies to medication/food/environment and denied any other medical history or medication use. He stated he did not consult with a PCP because he is newly moved to the area and has not yet established care.