chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe muscle weakness in her legs the next day/the patient was not able to walk without assistance; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age, who was the pharmacist's sister. There was no information concerning the patient's pertinent medial history, concomitant medications, concurrent conditions, drug reactions or allergies provided. On an unknown date in approximately 2015 (reported as 3-4 years ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9),intramuscularly (dose, lot# and expiration date were not provided) for prophylaxis.  On an unknown date in approximately 2015, reported as on the next day, the patient developed severe muscle weakness in her legs.The patient sought medical attention and on the same day, she went to an unspecified hospital however it was unknown at the time of call if she was admitted. Reporter stated that the symptoms lasted for four weeks and the patient was not able to walk without assistance however it gradually got better and went away on an unspecified date. The causality assessment was not provided.
Sore arm after first dose; This is a spontaneous report from a contactable other hcp (patient, retired registered nurse).    A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EL9264, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 04Feb2021 13:00 as 1st dose, single dose for covid-19 immunisation. The patient medical history included diabetes mellitus, hypertension. Concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer suspect. It was reported that, on 4Feb2021 patient had her first vaccine and had no symptoms of a reaction. She had a sore arm after first dose for a couple days from 4Feb2021 to 6 Feb 2021. Patient took Pfizer Covid-19 vaccine to prevent the disease. Relatedness for event sore arm after first dose was related. The patient underwent lab tests and procedures which included ultrasound scan: numerous blood clots below the knee on 04Apr2021.  Seriousness for sore arm after first dose was reported as not serious. The outcome of the event was recovered.  Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021499940 same patient/drug, diff dose/event
Started with low grade fever 99.8, throbbing headache, muscle aches, chills, this happened 1/28 6 pm , then took some ibuprofen. Hardy time sleeping. Next day 1/29 fever 100.4, chills, increased muscle aches, headache still and now heart palpitations. Took ibuprofen again, but not much relief.
pt recv vax 5JAN98 & 30MAR98 pt exp stomach pains & felt ill;
I experienced dizziness, nausea, and headache.  This began around 12:15 PM and worsened throughout the day.  By evening I had body aches and chills.
Day 1:  Fatigue 3 hours following injection Day 2:  Increasing pain in left arm Day 3:  headache and fatigue Day 4-6: I felt fine Day 7-8: 101 fever, severe body aches, chills, severe headache, cough Day 9: 100 fever, chills, body aches, cough
Left sided CVA... Dose #2 of moderna given 2/25/21...patient then had second, right sided CVA on 3/13/21
18 month old patient presented on 3/30 for well-visit and was prescribed to HiB PRP-OMP conjugate vaccine 3 dose IM (PedvaxHIB) and MMR and Varicella combined vaccine SQ (PROQUAD), age 12mo12yo by MD. CMA prepared vaccines and administered Hib (PRP-OMP, PedvaxHIB) IM in patient's left thigh (LOT # U024489) and MMRV subcutaneously in patient's left thigh (LOT # U029322). On 4/5, parent sent message noting patient had "knot at injection site". RN responded on 4/6 asking following up questions. RN also noted that following MMRV vaccine is common to see a rash develop and low grade fever (up to 7-10days post injection). System lists the following as adverse reactions for PedvaxHIB include irritability, pain, swelling Additional information for Item 18:18 month old patient presented on 3/30 for well-visit and was prescribed to HiB PRP-OMP conjugate vaccine 3 dose IM (PedvaxHIB) and MMR and Varicella combined vaccine SQ (PROQUAD), age 12mo12yo by MD. CMA prepared vaccines and administered Hib (PRP-OMP, PedvaxHIB) IM in patient's left thigh (LOT # U024489) and MMRV subcutaneously in patient's left thigh (LOT # U029322). On 4/5, parent sent message noting patient had "knot at injection site". RN responded on 4/6 asking following up questions. RN also noted that following MMRV vaccine is common to see a rash develop and low grade fever (up to 7-10days post injection). System lists the following as adverse reactions for PedvaxHIB include irritability, pain, swelling, tenderness at injection sites, and fever. Patient's symptoms are likely and not unusual reaction for vaccine administration. Currently no follow up from parent to clarify follow up questions. As both PedvaxHIB and MMRV were given in same thigh, unclear as to which vaccine may have caused injection site reaction without further clarification from parent.
hurt arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in extremity in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in extremity. On an unknown date, the outcome of the pain in extremity was recovered/resolved.   It was unknown if the reporter considered the pain in extremity to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient had both shots and his/her arm hurts with second shot. The reporter mentioned that, had to get both shots or not effective, 90 percent chance it works, but to be expected, putting foreign vaccine in body which attacks it, 12 hours of symptoms but it was in there and worth the price of not insured. The follow-up would not possible, as no contact details were available. This case had been linked with US2021AMR020541, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR020541:same reporter
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Report about covid treatment yes, Reporter type patient, If vaccine received yes, No other medication in 2 weeks, Product COVID 19 Treatment start date 25Jan2023, stop date 30Jan2023. vaccine lot unknown reason unable to locate or read the details  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient reports feeling dizzy shortly after receiving vaccines. Report walking out of health dept when dizziness began, severe headache hours after vaccine. Reports weakness, nausea and stomach problems on Friday night. Vomited once on Saturday. Reports problems lifting objects. Reports continues to feel weak with nausea and soreness with redness to injection site.
18-24 hrs p/receiving vax-pt mod amt pain around inject site to finger tip, fever, shaking, weakness, diarrhea, numbness in fingertips & difficulty lifting arms; Area not inflammed movable nodule; Awake most of noc w/pain & discomfort;
Peripheral neuropathy, tingling in arms and feet; Burning sensation in legs; Could not sleep well; Swellng in lymph node on right side; Sore Arm; Fatigue; Chills; Body Aches; Debilitating; A spontaneous report received from Healthcare Professional concerning, 40-year-old female patient who received dose of Moderna COVID-19 vaccine experienced sore arm, fatigue, chills, and body aches. /MedDRA PT: [Sore Arm]   The patient's medical history was not included. Patient's concomitant was not included.    On 05-JAN-2021 date, the patient received their first dose of the two planned doses of mRNA-1273 in right arm (Batch #: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.   Patient who is a Pharmacist received the 1st Moderna vaccine on 05Jan2021 in her right upper arm. Patient stated initially she had a sore arm, fatigue, chills, and body aches. Patient stated 5 days later she had redness and swelling in her lymph node on her right side. Patient stated 10 days later she had peripheral neuropathy and tingling in arms and feet. Patient stated she then developed a burning sensation in her legs. Patient stated that the MD did a full workup on her. Patient stated that all tests came back negative. Patient stated that the MD gave her gabapentin. Patient stated she could not sleep well due to tingling sensation and pain. Patient would like to know if this has been reported. Patient stated today she feels fine. Patient stated this was a scary episode for her and 1st dose of the Moderna COVID-19 vaccine was very debilitating. Patient stated that she has not received the 2nd dose and does not want to receive the 2nd dose of the Moderna COVID 19 vaccine.   Patient was treated with Gabapentin by an MD.  Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported event, a causal relationship cannot be excluded. Chills fatigue and lymphadenopathy are consistent with the known safety profile of the vaccine.
Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program Pfizer First Connect. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the 13th of 20 reports.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
lethargy for 7hrs (?hypotonic) started 1/2 hrs p/vax lasted 7hrs;went to ER & was fine by the time pt got to ER
2/01/2023 I had pain in my left foot while walking. I had an MRI and was diagnosed with bursitis in my left foot, mild intermetatarsal bursitis at the second-third and third ? fourth metatarsal heads. This is ongoing. I was given NSAIDs, a cortisone shot, and a metatarsal pad.   Starting 2/25/2023 I have had two colds , each of which left clogged ears and hearing impairment.   I did not see a doctor, just emailed.  He had me just take time with the first cold, and am treating the second cold with Flonase, it is still going on.
Dose administered after 30-day Use By Date; 108 doses given instead of 120; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and ACCIDENTAL OVERDOSE (108 doses given instead of 120) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and ACCIDENTAL OVERDOSE (108 doses given instead of 120). In 2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and ACCIDENTAL OVERDOSE (108 doses given instead of 120) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Number of doses/vials: 108 doses Date the vial was initially stored in the refrigerator: 16Sep2021 Date(s) of administration of vaccine: 18Oct2021-2Nov2021  No concomitant and treatment medication was reported
NauseaVomiting lymph node swollen, sore arm, fatigue, back ache Narrative:
10 days after the vaccine, I received a positive PCR Coronavirus test result; This is a spontaneous report from a contactable consumer or other non hcp.  A 70-years-old female patient first dose of received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient had positive PCR Coronavirus test. It was reported that two days after first Pfizer Coronavirus vaccine patient was exposed to someone who had the virus and 10 days after the vaccine, the patient had positive PCR Coronavirus test result. The following day patient's physician set her up to receive the monoclonal antibody infusion and told that she cannot get the second dose of the Pfizer vaccine for 90 days from the date she received the infusion, but her physician says she may have to start the vaccine over again.  The outcome of event was unknown.
Pt felt itchy and developed hives around 7 pm and took one ZYRTEC PO when he felt that his mouth felt weird.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 10-MAR-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M025871, expiration date: 24-MAY-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required data has been obtained. Sender's Comments: US-009507513-1611USA004113.
Constant tinnitus, ears ringing since the 1st Pfizer dose on 28May2021.
No adverse effects; inadvertently administered one dose of the adult VAQTA; This spontaneous report was received from a registered nurse refers to a 2 year old patient. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 30-MAY-2019, the patient was vaccinated with adult hepatitis a vaccine, inactivated (VAQTA) (50/1 unit/milliliter) (lot # R012739 and expiry date 09-AUG-2019, frequency and anatomical location and route of administration were unknown) dose 2, 1 dosage form for prophylaxis (also reported as booster) (product administered to patient of inappropriate age). On 24-FEB-2018, the patient was vaccinated with the first dose. No adverse effects reported.No product quality complaint (PQC) reported.
Normal side effects: headache, chills, body aches/stiffness, joint pain, sore injection arm, fatigue  Side effects had slow onset after shot was given. However, I took Tylenol (650mg) preemptively because of my experience with the first dose. This may have affected onset time and severity. Side effects had set in by 9 PM that evening, with the worst being the headache. Ringing in my ears (tinnitus) came with the onset of other side effects, and the severity coincided with the severity of the headache. I took Tylenol, which helped reduce (but not eliminate) side effects, but ringing in ears persisted, if only less intensely.  I have continued to take Tylenol (and occasionally Ibuprofen--I tend to avoid because of stomach sensitivity), with all symptoms lessening over the week (5/3-5/10), except for ringing in ears and slight headache. The ringing does not seem to go away with OTC meds (Tylenol, Ibuprofen). It is worse in the left ear, which is the side I got the shot in.
Approximately 5 minutes post vaccines child became very pale especially in her mucous membranes, weak, and appeared as she was tired with yawning and not answering questions. Child was put in supine position, did not lose consciousness and vital signs were monitored which were within normal  limits. Child remained pale and weak for approximately 10 minutes. Child was slowly advanced to sitting and walking over a 30-4- minute period before leaving clinic.
lips tingling; fingertips/fingers tingling; This is a spontaneous report from a contactable consumer (patient's wife). A 58-years-old male patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot Number: EP7534, Expiration date and NDC number was unknown) via an unspecified route of administration, administered in upper left arm on 20Mar2021 at 10:00 hours as dose 1, single (at the age of 58-years) for COVID-19 immunisation. The patient had no relevant medical history or family history, and concomitant medications. Patient had no prior vaccinations (within 4 weeks). Patient had no history of previous immunization with the Pfizer vaccine considered as suspect and did not received any additional vaccine. On 21Mar2021 around 08:00 hours, the day after he got the shot, patient had lips tingling, fingertips/fingers tingling, and events lasted for about 30 minutes. Reporter asked were these an allergic reaction to the shot, side effects of the vaccine. Patient did not treat any symptoms or received any treatment for the events. Patient had no physician office or emergency room visits. No relevant tests were performed. Patient was scheduled for tomorrow (10Apr2021) for the second dose. The outcome of all the events was recovered on 21Mar2021 at 08:30 hours.    No follow-up attempts are needed. No further information is expected.
Head ache, Soreness in Neck and Back, Nasal Congestion, Chills, Low grade fever
From initial information received on 09/27/2004 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a female patient, age unknown, received her 5th dose of Daptacel vaccine, lot number C1996AA, on 09/23/04. That same day she also received a dose of IPV vaccine, a dose of Act Hib vaccine, a dose of Prevnar vaccine and a dose of MMR (manufacturer unknown). Information regarding the lot numbers, dose and route of administration were not provided for these products. Reportedly, within 24 hours the patient experienced a large red blotch and an area that was warm to the touch around the injection site which lasted 4-5 days. Reportedly the patient recovered from the event. From additional information received on 11/02/04 from a health care professional, the patient's date of birth was  provided. The patient was 4 months old at the time of the event. Reportedly, the patient received her 2nd dose of Daptacel, lot number C1996AA, administered intramuscularly in the right thigh, her first dose of Act Hib, lot number UE250AC (Aventis Pasteur SA lot number X0703), administered intramuscularly in he left thigh, her 2nd dose of IPOL, lot number X1038, administered SQ in the left thigh, a 2nd dose of Prevnar, lot number A57559A, manufacturer Lederle, administered intra muscularly in the right thigh and a does of MMR/ Measles, Mumps, and Rubella Vaccine, manufacturer unknown (lot number, route and site of administration not reported) on 09/24/2004. Reportedly at 2:30 PM that same day, 09/24/04, the patient developed the adverse event. No further information is anticipated. This case is considered closed. The reporter of this case is the same reporter of cases 200403223, 200403224, and 200403226.
(R) arm where injection was given became red, swollen and painful into the evening of 10/14/08. She took some Ibuprofen (pain reliever) preventatively after receiving shot. 10/15 Today, swelling down but is hot to touch and red. Notified doctor and she's being evaluated at doctors office. They will call her.
Slight to moderate headache starting at 1:00 p.m. (3 hours after vaccination) that lasted for approximately 3 hours.  Soreness at site of vaccination (left arm) ONLY when attempting to sleep on that (left) side for 1st night; otherwise, no pain.
Infant was given hep B vaccine at 0700, within 5 minutes a red rash with few whitish welts appeared all over the face, the infant had been fed part of his bottle and he began to vomit within 10 minutes of the immunization being given, at intermittent episodes his hands also turned purple 10 minutes after the immunziation was given. No other reactions were noted and the rash went away within 12 hrs of the initial episode.